Manual Usuario Phoenix Gambro (ENG)

Operator’s Manualservice code 6991376 revision C rev. sw 3.36 date 2010-02 Manufactured by: GAMBRO DASCO S.p.A., Via Modenese 66, 41036 MEDOLLA (MO) Italy. Questions or comments about this publication can be directed to your Local Representative. © 2009-2010 GAMBRO LUNDIA AB. All rights reserved. PHOENIX is a trademark of GAMBRO HOSPAL (Schweiz) AG registered in: Australia, Austria, Benelux, Denmark, Estonia, France, Georgia, Germany, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Republic of Moldova, Romania, Russian Federation, Slovakia, Slovenia, Sweden, Turkey, United Kingdom, United States and in the European Community. PHOENIX is a trademark of GAMBRO LUNDIA AB registered in Canada. The logo is a trademark of GAMBRO HOSPAL Schweiz AG registered in the United States. GAMBRO® is a registered trademark of GAMBRO LUNDIA AB. HOSPAL® is a trademark of GAMBRO HOSPAL Schweiz AG and is registered in Algeria, Austria, Belarus, Benelux, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Japan, Liechtenstein, Macedonia, Monaco, Morocco, Norway, North Korea, Poland, Portugal, Romania, Russian Federation, San Marino, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United States, Vietnam, Yugoslavia. Phoenix ® machine is protected by one or more of the following patents: US4889635; US5276611; US5111683; US5590237; US5228889; US5567320; US5895578; US4784495; US5024756; US4798090; US5041215; US5928177; US5609770; US5394732; US5641144; US6811707; US6881344; US6794194; US5647984; US5733457; US5650071; US5776091; US5624572; US5618441; US5629871; US5685835; US5948251; US6003556; US5620608; US6468427; US6949214; US4740755; EP0243284; EP0403401; EP0428676; EP0418171; EP0465381; EP0467805; EP0501894; EP0658352; EP0813880; EP0900093; EP0330892; EP054702; EP0643301; EP0830155; EP0830156; EP0831945; EP0836486; EP0830153; EP0835493; CA1327022; CA2032156; CA2208931; CA1286284; CA1282012; CA1308569; CA1265403; CA2016863;CA1253919; JP2059115; JP3129326; JP3001235; JP2753242; JP3095223; JP3200594; JP1777042; JP2542728; JP2823513; IT1241624; IT01267416; IT01256865; IT01320264; IT01320247; AU595423; BR- PI8800439-2; KR094404; SE467142; SE465404; TW032116; DE-P3620743.8-35; DE4031613; FR9014523; GB2239820; MX5077; Phoenix ® machine is protected by one or more of the following design registrations: US-D446861; US-D446860; US-D464060; US-D462698; US-D462362; US-D462696; DM/051905; DM/055087; IT80564. Certifications Indicates that the equipment conforms to Council Directive 93/42/EEC, of 14 June, 1993 relating to Medical Devices. Also indicates that the notified body which has approved the manufacture’s quality system is the British Standards Institution (BSI). Indicates that the equipment conforms to the rules related to the Safety of Medical Electrical Equipment for U.S. and Canada. The “C” and “US” indicator adjacent to the CSA mark signifies that the product has been evaluated to the applicable ANSI/UL and CSA Standards, for use in the U.S. and Canada. Only for 115V machine configuration. REVISION TABLE Revision C SECTION PAGES IN REV. C INTRODUCTION --- SECTION 1 --- SECTION 2 --- SECTION 3 --- SECTION 4 --- SECTION 5 --- SECTION 5A --- SECTION 5B --- SECTION 5C --- SECTION 5D --- SECTION 5E --- SECTION 5F --- SECTION 6 --- SECTION 7 --- SECTION 8 --- SECTION 9 32, 33 WARRANTY --- APPENDIX A --- APPENDIX B --- APPENDIX C Note The revision corresponds to page. When the modification is related to a table all the pages of the table goes on revision. INTRODUCTION I INTRODUCTION IEC Symbols WARNING: CONSULT ACCOMPANYING DOCUMENTS TYPE B APPLIED PART This apparatus provides an adequate degree of protection against electric shock, particularly regarding allowable LEAKAGE CURRENTS and reliability of the protective EARTH connection. OFF (Main power disconnected) ON (Main power connected) ALTERNATING CURRENT PROTECTIVE EARTH (GROUND) This symbol indicates that: - the equipment may not be disposed of together with other municipal waste; - the equipment was placed on the market after 13 August 2005. Rev. B II PHOENIX OPERATOR MANUAL Keep dry Year of Manufacturing Name and address of the Manufacturer Serial Number Catalogue Number Handle with care This way up (from IEC 601.1) Rev. B INTRODUCTION III Operator Manual Symbols WARNING Very important information related to patient or operator ....... safety, or given to avoid machine malfunction. Read carefully before operating the machine. NOTE Important information related to the correct functioning ...... of the machine. Read carefully before operating the machine. Rev. B IV PHOENIX OPERATOR MANUAL INTENDED USE The PHOENIX® Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The PHOENIX system is to be used with either high or low permeability dialysers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit. WARNING Fluid balance deviations, even if within the specified Phoenix accuracy, can exceed a level that can be tolerated by low-weight patients. WARNING The use of procedures not recommended by the manufacturer may result in patient injury or death. The Manufacturer does not assume responsibility for patient safety if the procedures described in this manual are not followed carefully and if staff who perform the procedures have not been appropriately trained and are not qualified. WARNING It is responsibility of the physician to ensure that the appropriate dialyser and Cartridge Blood Set is selected for the weight of the patient being treated. WARNING This manual contains a number of references to accessories and disposables for use with the Phoenix machine. The Phoenix machine has been tested and validated for use with the accessories and disposables listed in this manual. The Manufacturer has not validated the use of accessories or disposables other than those specified in this manual. The Manufacturer does not assume responsibility or liability for use of accessories or disposable other than those specified in this manual. It is the responsibility of the user to validate that other accessories or disposables provide safe and effective performance. Rev. B INTRODUCTION V SPARE PARTS Note The Manufacturer will maintain spare parts availability for ten years after the end of production of the PHOENIX. At the end of that time the involved product is considered obsolete and therefore it must be disposed of according to local applicable regulations. The final user will be informed about spare parts that are no longer available through the technical service or the commercial representative. For questions, ask for information from the Local Representative. WARNINGS Introduction WARNING Fluid balance deviations, even if within the specified Phoenix accuracy, can exceed a level that can be tolerated by low-weight patients. WARNING The use of procedures not recommended by the manufacturer may result in patient injury or death. The Manufacturer does not assume responsibility for patient safety if the procedures described in this manual are not followed carefully and if staff who perform the procedures have not been appropriately trained and are not qualified. WARNING It is responsibility of the physician to ensure that the appropriate dialyser and Cartridge Blood Set is selected for the weight of the patient being treated. WARNING This manual contains a number of references to accessories and disposables for use with the Phoenix machine. The Phoenix machine has been tested and validated for use with the accessories and disposables listed in this manual. The Manufacturer has not validated the use of accessories or disposables other than those specified in this manual. The Manufacturer does not assume responsibility or liability for use of accessories or disposable other than those specified in this manual. It is the responsibility of the user to validate that other accessories or disposables provide safe and effective performance. Rev. B VI PHOENIX OPERATOR MANUAL Section 1 WARNING To operate the machine correctly, pay careful attention to the messages displayed in the Operator Message Area of the Touch Screen. WARNING Check that the alarm lights and audible indicators come on for a short time immediately after the machine is powered ON (see Section 5.B - Test Procedures, in this manual). If either signal is not present, one or both signals have malfunctioned. Call for service. Do not operate the machine if the alarm safety system is not functioning. The operator takes full responsibility when a dialysis treatment is carried out in the absence of the audible and visual alarms. WARNING If the two values, stored by the Protection Module, for the same Safety Relevant parameter are not identical at the time of use, a class Pd alarm is triggered (see Section 08 Alarms and Signals, in this manual). Modification of a Safety Relevant parameter may cause a class Pd alarm, since the machine recognizes a change in the parameter. This alarm is controlled by the machine in the normal way for class Pd alarms, but the audible alarm is automatically disabled for 2 minutes. WARNING Monitoring of the Venous Pressure could not always detect the disconnection of a venous needle from its access site, which may result in extracorporeal blood loss to the environment. When a venous needle disconnects from its access, pressure at the venous monitoring side may only decrease by the pressure maintained within the patient's access site. This pressure drop may be less than the width of the machine's venous pressure alarm window: in this particular case the disconnection of a venous needle from its access site is not detectable by the machine, even if pressure alarms and alarm windows are properly set. To reduce the risk of needles disconnection: • ensure that venous needle and line are firmly secured to the access site area according to your clinic's protocol; • ensure that the patient's access is visible at all times during the dialysis treatment; • inspect frequently the patient's access; • adjust properly the venous pressure alarm window: the venous pressure alarm lower limit should be set as closely as practical to the actual patient’s venous pressure value without generating excessive nuisance alarms. Rev. B INTRODUCTION VII Section 2 WARNING Setting of the Configuration environment must be performed exclusively under the authority of a physician. The physician is solely responsible for clinical adequacy of the parameters setting. WARNING Before confirming a value for a Safety Relevant parameter (refer to “2.1.2 Parameters List”: the Safety Relevant parameters are marked in the Parameters List) make sure that the value to be confirmed is the same as the value displayed, for that parameter, in the yellow SAFETY BOX. Confirming a value different from that displayed in the yellow SAFETY BOX can cause machine alarms related to that parameter. If you erroneously confirm a value which is different from the value displayed, for that parameter, in the yellow SAFETY BOX, switch OFF the machine, wait 5 seconds, then switch ON the machine again. WARNING Verify that at least one chemical disinfection process is configured. WARNING If the INITIAL BOLUS is set from 0-10 ml, at the Heparin Pump start, the heparin quantity set is injected automatically as a bolus after which the linear heparinization starts. WARNING This feature must exclusively be used under the authority of a physician, who is solely responsible for the use of the information processed by the software. Rev. B VIII PHOENIX OPERATOR MANUAL Section 3 WARNING The user is responsible for checking compliance of Central Concentrate Systems with the IEC 601.1.1 standard. WARNING The user is responsible for the proper connection of the PHOENIX machine to the Central Concentrate Supply System and to verify proper functioning of this connection. WARNING The three internal lines from the Central Supply Ports on the Rear Panel of the PHOENIX to the three Front Concentrate Connectors marked 1, 2, 3 are subject to the same Disinfection requirements as the Central Supply System. The manufacturer is not responsible for the Disinfection of these lines. It is the responsibility of the user to carry out Disinfection and Rinse procedures of these lines, and to: • Check the efficiency of Disinfection. • Perform a mandatory Rinse after Disinfection with chemical agents. • Perform a residual test after Rinse. WARNING It is the responsibility of the user to verify that the proper concentrates are used for the patient. This includes the choice of Acid Concentrate as well as Bicarbonate Concentrate. The machine, while maintaining all the checks (Conductivity, Temperature and pH) of Final Dialysate, disables the check on concentrate dilution that is normally performed when concentrates are provided in containers. The check on concentrate dilution is disabled when Central Concentrate Supply is used in order to prevent the occurrence of ”! Concentrate Cans” #40 alarm. For further information on the concentrate solutions see Section 9 – Specifications, in this manual. WARNING In case of a switch from Central Concentrate Supply to the use of External Containers, it is the operator’s responsibility to verify that proper Concentrates are being used. WARNING In case of a switch from Central Concentrate Supply to the use of External Containers, if the machine has not been correctly calibrated for the liquid Concentrates in the External Containers, the “! Concentrate Cans” #40 Alarm can occur. After carefully verifying that the correct concentrates are being used, and that the dialysate Conductivity is correct, the operator may clear the alarm by performing the PA and/or PB Autocalibration Procedure (see Section 5.B - Special Procedures for complete instructions.) Rev. B INTRODUCTION IX WARNING Before instilling Cleaning/Disinfecting chemicals into the 3 Central Concentrate Lines, it is advisable to perform a Rinse procedure to avoid chemical reaction or precipitation due to possible incompatibility of the chemical used with any residual Acid or Bicarbonate Concentrate that is left in these lines. WARNING The efficiency of the Central Bicarbonate Line disinfection process has been tested and can be guaranteed only if the following conditions are satisfied: • The Central Bicarbonate Line connecting the Rear Connector (3) of the PHOENIX (See Figure 3.1) to the Central Concentrate Supply system is a PVC line, maximum 3 metres (118.11 in) in length and with an internal diameter of 3 mm (0.118 in), • Sodium hypochlorite solution (active chlorine from 50,000 to 60,000 ppm)/Bleach is used. WARNING Before starting a Central Bicarbonate Line disinfection process, it is the operator’s responsibility to verify that all the Acid and Bicarbonate connectors are correctly placed to ensure the disinfection process is properly performed. WARNING Before starting a Central Concentrate Rinse process, it is the operator’s responsibility to verify that all the Acid and Bicarbonate connectors are correctly placed to ensure all the lines involved in the Central Concentrate Rinse process are properly rinsed. Section 4 WARNING Do not stand on Chemical container shelf. WARNING Check the continuity and the reliability of the ground connection. WARNING Verify the quality of the protective earth ground at the time of installation. WARNING This operation must be performed by authorized personnel. If Service is performed by unauthorized personnel, the manufacturer cannot accept any responsibility for any damage which may occur, and such damage is not covered by the warranty. Rev. B X PHOENIX OPERATOR MANUAL WARNING Do not use this machine near flammable gas or flammable anaesthetic mixtures with air, with oxygen or with nitrous oxide. Section 5 WARNING The use of the Gambro/Hospal Cartridge Blood Set designed for Phoenix machine has been tested and validated to provide safe and proper functioning of the system. The Manufacturer has not validated the use of blood lines other than those specified in this manual. The Manufacturer does not assume responsibility or liability for use of blood line other than the Gambro/Hospal Cartridge Blood Set. It is the responsibility of the user to validate that other blood lines provide safe and effective performance. WARNING It is the responsibility of the physician to ensure that the appropriate Gambro/Hospal Cartridge Blood Set is selected for the weight of the patient being treated. Before installing a Gambro/Hospal Cartridge Blood Set, carefully read the Cartridge Blood Set Instructions for Use. WARNING Reverse Ultrafiltration of fluid from the dialysate compartment into the blood compartment may occur when High Flux dialysers are used. Because of their high ultrafiltration coefficients, high flux dialysers will quickly transfer fluid across the membrane in response to pressure differences between the dialysate compartment and the blood compartment. WARNING Never insert fingers in the Venous Line Clamp and in the Arterial Line Clamp (if Single Needle is available on the machine). WARNING When the cover of the blood pump is open, verify that the pump is off. WARNING Improper connections of the extracorporeal circuit may cause potential patient safety hazards, that might not be detected by the machine: for instance, hemolysis caused by kinks, twists, loops, sharp bends, clamps or other restrictions on the blood line, blood loss to the environment/air into the blood circuit due to leakage in the extracorporeal circuit. Rev. B sensor slot . Do not refill the BiCart cartridge. If required to replace the BiCart when a dialysis treatment is in progress. disconnect the patient from the machine. which may be deposited in the hydraulic pathway. depending on the conditions listed above.Remove venous line from patient sensor . B . Do not turn off the machine with bicarbonate dialysate in the flow pathway. Or: . 2. press CONFIRM. substituting the chemical disinfectant for an acetic acid solution 30% v/v (add 120 ml of glacial acetic acid to 280 ml of water to obtain 400 ml of solution). It is recommended to perform an acetic acid rinse at least twice a week to remove the calcium and any precipitate residues. in this manual). Refer to “6.Special Procedures. WARNING If bicarbonate dialysis is performed: 1. follow the instructions for the Disinfection process (see Section 6 - Clean/Disinfect.Put venous line back in the patient Sensor . Rev. follow the “BiCart Change” procedure in the Section 5.1 External surface cleaning” paragraph. WARNING Ineffective cleaning with acetic acid may cause the machine to malfunction (the lines or the solenoid valves may block and the sensor readings may be affected). Fluid and gel substances applied on the Air Bubble Detector may reduced the Air Bubble Detector sensitivity causing patient injury or death. WARNING Check the Expiry date on the BiCart label. It is responsibility of the user to check the efficiency of the acetic acid rinsing procedures and to alter the frequency that they are performed. in the Section 06 – Clean/Disinfect.Clean and dry venous line and pt. in this manual. Press the CONFIRM button to allow the machine to continue.8. this “BLOOD detection” can be caused by incorrect placement of the venous line. WARNING If the machine has detected blood at the Patient Sensor during SETUP. To do this. for the description of how to clean the Air Bubble Detector.Press CONFIRM If the patient is already connected to the machine.A . the following message is displayed: If the line has blood in it. If there is no patient connected to the machine. INTRODUCTION XI WARNING Before inserting the venous line in the Air Bubble Detector clean and dry it. priming of the blood side may be performed before priming the dialysate side.A . (Refer to Section 5. special rinsing techniques must be employed to assure the concentration of disinfectant is reduced and maintained at an appropriate level. WARNING Use an aseptic technique when connecting/disconnecting the white priming connector of the arterial line to/from the WHO in order to avoid any potential contamination of the line. These rinsing procedures are the responsibility of the medical director. Rev. it is recommended to set the DIALYSATE FL. DO NOT USE the WHO. parameter to a value lower than or equal to 500 ml/min. WARNING When selecting SETUP . The procedures must include a test of residual disinfectant and techniques to avoid rebound of disinfectant. Dialysate side priming may be started before blood side priming is complete. in this manual). WARNING If performing MANUAL PRIM or PRIME W/O UF .XII PHOENIX OPERATOR MANUAL WARNING DO NOT transfer a primed Cartridge Blood Set to another PHOENIX for continuation of treatment before dialysate preparation completion. WARNING The Waste Handling Option (WHO) must be cleaned each time blood enters the WHO drain port before continuing with another patient treatments or once per day if the WHO has been in use. WARNING Verify that fluid is not present in the Waste Handling Option drain port by visual inspection before inserting the Cartridge Blood Set’s priming connector into the port. signalled by the appearance of the following Operator Message: End Of Dialysate Prep. If the dialysers are filled with a chemical disinfectant. To mitigate the risk of excessive weight removal. If fluid is present in the port for more than six seconds after opening the cover. the limits of the Venous Pressure alarm window are automatically set at -50 to +250 mmHg and the Arterial Pressure alarm window limits are set at -400 to +150 mmHg. special attention should be given to the dialysate flow rate setting. You Can Proceed You Can Now Connect The Dialyser WARNING When performing dialysis treatment for patients with a body weight of less than 40 kg. B . WARNING Hemolysis may occur if blood comes in contact with disinfectant remaining in the blood pathway of dialysers that have not been completely rinsed.Special Procedures. These values are maintained for the duration of the PRIME mode. the heparin pump is stopped. proceed according to your facility’s protocol. Diaphragm Neutral Position Procedure). discard the rinse saline bag and attach a new bag of saline. in this case strictly follow these procedures.. WARNING Once the patient has been connected. the limits of the Venous Pressure alarm window are automatically set to -50 and +250 mmHg and the limits of the Arterial Pressure window are set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg and +150 mmHg. if the operator stops the Blood Pump pressing the ON/OFF button on Blood Pump Control Panel: • The venous pressure alarm window lower limit is automatically set to +10 mmHg and the upper limit is set to the VEN PRES LIMIT parameter value decreased of 50 mmHg (see Section 2 .e. If the residual level is unacceptable. • When the residual level is acceptable. proceed as follows: • Verify that the level of residual chemical disinfectant in the extracorporeal circuit is acceptable according to your facility’s protocol or to the instructions for use of the disinfectant’s manufacturer. in this manual). WARNING When WASHBACK is selected. after the Blood Pump restart. do not open the Blood Pump Cover unless it is required by special procedures described in this manual (i. INTRODUCTION XIII WARNING If using a dialyser that has been filled with a chemical disinfectant. WARNING The PATIENT CONNECT and WASHBACK MODES have associated safety hazards due to the reduced efficacy of the Protective System. These values are maintained for the duration of the WASHBACK mode. • The arterial pressure alarm window lower limit is automatically set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg and the upper limit is set to +150 mmHg. These values are maintained for all the time the Blood Pump is OFF and for 30 sec. WARNING When WASHBACK is selected.Configuration Description. Rev. B . these must be carried out under the control of the user and are the responsibility of the user. • Before initiating dialysis flush the administration set and the entire extracorporeal circuit with fresh saline according to your facility’s protocol. Opening of the Blood Pump Cover without following procedures described in this manual may infuse air to the patient through the arterial line causing patient injury or death. WARNING From the moment that blood is detected in the venous line at the Patient Sensor to the WASHBACK phase. and other disposables per local regulations.XIV PHOENIX OPERATOR MANUAL WARNING The FILTER CHANGE Action key must be used only when the dialyser needs to be replaced (Refer to “Dialyser replacement” in the Section 5.Special Procedures) when the operator accesses the MACHINE view by pressing the MACHINE Navigation key.Special Procedures in this manual). WARNING In the case of bicarbonate dialysis.A . Its duration may be set with the DESCALING TIME parameter. The blood pump stops and the Protection System is no longer active. WARNING Follow facility procedures for proper disposal of used Cartridge Blood Set. WARNING At the end of WASHBACK. Press CONFIRM to proceed with emptying. During this phase the value of the DESCALING TIME parameter is displayed. the blue dialysate connector can be reattached to its bypass port on the machine so that the dialysate side is emptied through the hydraulic circuit (standard EMPTYING). This can be done using the VINEGAR DESCAL Action key. dialysers. if the user does not activate the AutoEmptying procedure. Press the CONFIRM button on the Main Control Panel to continue. WARNING Only in the event of the “! Concentrate Cans: A Pump or B Pump or A&B Pumps” (#40) alarm is it possible to perform Autocalibration of PA or PB pump during DIALYSIS (see “Autocalibration procedure for the peristaltic pumps during dialysis” in the Section 5. Rev. B . it is strongly recommended to perform a descaling of the hydraulic circuit with vinegar following every treatment. the Acid/Acetate concentrate connector must be left on the machine so that the DESCALING procedure can be performed. WARNING In order to verify that the patient has been disconnected properly. WARNING In bicarbonate dialysis. Press CANCEL otherwise.A . the following message is displayed when the operator presses the EMPTYING Action key the first time: WARNING! Ensure that the patient has been disconnected. WARNING During a power failure. it is strongly recommended to follow the “Precipitate Control (ADR)” recommendations provided in Section 06 – CLEAN/DISINFECT. in this manual. Refer to local representative to verify if your machine is already equipped with the BATTERY BACKUP Kit. WARNING This emergency procedure for Power Failure is applicable only if your Phoenix machine is equipped with the Battery Backup Kit.A WARNING Failure to remove the venous line from the Venous Line Clamp can result in rupture of blood lines or dialyser when hand cranking the Blood Pump. the patient must be manually disconnected (see Patient Disconnection section in the Manual). WARNING If a power failure lasts for more than 2 minutes. WARNING If. B . INTRODUCTION XV WARNING Before starting a new dialysis treatment. all safety systems of the machine are disabled or are not operational. above the Blood Pump. WARNING The use of a Fast Recovery of the Dialysis process procedure must be limited to exceptional cases where the normal recovery procedure can not be performed in accordance with the standard use of the machine. are closed in this situation. Section 5. It is particularly important to check that all four clamps in the 4 Position Line Clamp. ensure that the used Cartridge Blood Set and dialysers have been removed and a new Cartridge Blood Set and dialysers have been installed. the DESCALING process is partially or completely skipped by pressing the STOP RINSE Action key. after a bicarbonate dialysis. Rev. but where the current dialysis treatment must be continued. i. following a Fast Recovery of dialysis. after PATIENT CONNECT) and has been interrupted before the EMPTYING mode. B .e. Therefore. the Fast Recovery of the Dialysis process procedure cannot be performed and the patient must be disconnected. set for the current treatment instead of the DIALYSIS TYPE stored in CONFIG/Rx Config.e. all safety systems of the machine are disabled or are not operational.XVI PHOENIX OPERATOR MANUAL WARNING After pressing the SETUP Action key. WARNING If the operator erroneously selects a procedure other than “SETUP”. Do not remove the venous line from the Air Bubble Detector/Patient Sensor. Rev.buttons selection. WARNING The Fast Recovery of an interrupted dialysis treatment can only be performed if TREATMENT has already started (i. the only treatment parameters that are retained are: − for RX dialysis → the default data values stored in Rx Config − for Standard dialysis → the default data values stored in CONFIG The only exception are: − for RX dialysis → the machine retains the PAT CONN B FLOW parameter value stored in CONFIG instead of the value stored in Rx Config − for Standard dialysis and RX dialysis → the machine retains the DIALYSIS TYPE: ACETATE/BIC CONC/BICART. This procedure can be performed if the Patient Sensor has detected blood in the venous blood line and no service processes (ADR or calibration) have been performed before restarting the dialysis treatment. DO NOT select a dialysate type (ACETATE/BICARB CONC/BICART) if the patient is still connected to the machine and the Red and Blue Dialysate Connectors are connected to the dialyser. they are lost when a Fast Recovery of the Dialysis process procedure is performed. WARNING Note that any treatment parameters that were set for the dialysis treatment are transient. WARNING Do not remove the Blood Pump Segment from the Blood Pump. WARNING During the time between the machine switching OFF and the next restart of the interrupted treatment by the +/. NOTE: in case of Computer Prescription of the Treatment (see Section 7 - Communication System) the restored treatment parameters are: Dialysis Mode: the last one selected Dialysis Type: the last one performed by the machine. This can be done by taking dialysate samples at different conductivity values (e. Call for Service.15 mS/cm) and sending them to a laboratory for analysis. in this section.11 Procedure for Autocalibration of the Peristaltic Pumps during DIALYSIS”.4% bicarbonate concentrate is being used. the operator may clear the alarm by performing the PB Autocalibration Procedure (see “5.4% Bicarbonate concentrate. INTRODUCTION XVII WARNING If during the course of the restarted DIALYSIS. 13. the cause is not a temporary malfunction. verified by clinical laboratory results. WARNING If switching from the use of BiCart to the use of Liquid 8. and the dialysate solute content.14. the “! Concentrate Cans” #40 Alarm can occur.g.11 Procedure for Autocalibration of the Peristaltic Pumps during DIALYSIS”.) Rev. if the machine has not been correctly calibrated for the liquid Concentrate used. the operator may clear the alarm by performing the PA Autocalibration Procedure (see “5.A. it is the operator’s responsibility to verify that proper 8.) WARNING Both with Acid/Acetate concentrate container change and with switch from the use of acid in external containers to the use of acid concentratet delivered from the Central Concentrate Supply system.A. WARNING If a switch from the use of BiCart to the use of Liquid 8. WARNING Both with an Acid/Acetate concentrate formula change and with a switch from Central Concentrate Supply system to the use of acid in external containers. the same problem reoccurs. After carefully verifying that the correct concentrates are being used. if the machine has not been correctly calibrated for the acid/acetate Concentrate used.4% Bicarbonate concentrate in external containers. and that the dialysate Conductivity is correct. it is the operator’s responsibility to verify that proper acid/acetate concentrate is being used. for complete instructions. The machine must be turned OFF and the patient manually disconnected. and that the dialysate Conductivity is correct. After carefully verifying that the correct concentrates are being used. for each dialysate concentrate used for dialysis treatment. WARNING It is the responsibility of the user to determine the correspondence between the dialysate conductivity. both in external containers and delivered from the Central Concentrate Supply system. the “! Concentrate Cans” #40 Alarm can occur. displayed by the machine. in this section. B . for complete instructions. that may not be detectable by the Protection System. WARNING If the Autocalibration Process and the following Test fail. call for Service. The Autocalibration Process will proceed only after this confirmation. B . the user must always verify that the correct concentrates are connected to the machine’s concentrate connectors. WARNING If the Autocalibration Process and the following Test fail. but the following Test passes. Rev. • Following a change in the type of concentrate being used.XVIII PHOENIX OPERATOR MANUAL WARNING The CONFIRM button. WARNING If the “! CONCENTRATE CANS: A PUMP or B Pump or A&B PUMPS” #40 alarm occurs frequently. It is recommended that the Autocalibration Procedure be repeated or the pump insert replaced. If the Autocalibration Process fails. the machine guarantees a degree of accuracy for the value subject to autocalibration. WARNING In the case of the Acid/Acetate or Bicarbonate Pump Autocalibration. • Following a change from Central Concentrate Supply System to the use of External Concentrate Containers. Autocalibration must be repeated or the pump insert changed and then the autocalibration must be repeated. Autocalibration must be repeated or the pump insert changed and then the autocalibration must be repeated. When the correct concentrates have been verified the CONFIRM button must be pressed on the Main Control Panel. WARNING The three Autocalibration Action keys are available only before Dialysate Preparation is complete. the machine is unable to acquire the relevant value with sufficient accuracy. the machine is unable to acquire the relevant value with sufficient accuracy. must be pressed only after having completed the WASHBACK mode. The use of incorrect concentrates may result in an a incorrect dialysate conductivity. for Dialyser Change. WARNING The PA/PB Autocalibration Procedure is mandatory in each of the following cases: • Following a change of the pump insert. WARNING DO NOT transfer a primed Cartridge Blood Set to another PHOENIX for continuation of treatment before dialysate preparation completion. INTRODUCTION XIX WARNING The alarm system is inactive or impaired when power to the machine or Touch Screen is off. signalled by the appearance of the following Operator Message: End Of Dialysate Preparation You Can Now Connect The Dialyser WARNING During OVERRIDE. If air is seen. While manually returning blood. WARNING The Waste Handling Option (WHO) must be cleaned each time blood enters the WHO Drain Port before continuing with another patient treatment or once per day if the WHO has been in use. which are being overriden. immediately stop returning blood. watch the venous line for air. Failure to do this may result in patient blood loss. WARNING Before performing this procedure. WARNING Following the WHO bleach procedure. the operator is responsible for monitoring parameters. WARNING DO NOT LEAVE undiluted bleach in the flow pathway of the machine. B . ensure that the Cartridge drip chambers are no more than half full of fluid. WARNING The patient must not be connected to the machine during this procedure. WARNING DO NOT USE this priming connector for patient related uses or any sterile connections. Rev. before performing a Chemical Disinfection using a chemical other than Bleach. allow the WHO to rinse at least 3 minutes in the ADR Rinse cycle. or any time irregular performance is suspected or observed. The BPM should be tested and calibrated at least once every 4000 hours. WARNING Notify Service as to which test has failed. WARNING The BPM must be used only for patients with a body weight greater than 15 Kg and using a BPM cuff of the appropriate size. Section 5. Check (e. Call for Service.C WARNING If the BPM is not factory installed.g. It is the operator’s responsibility to carefully check the parameters involved in the failed test if the decision is made to continue treatment despite the test failure. It is NOT recommended to carry out a dialysis treatment in the absence of the audible and/or visual alarms. In the event of accidental wetting of the cuff or the hydraulic connections.XX PHOENIX OPERATOR MANUAL WARNING It is the operator’s responsibility to check that the quantity of heparin delivered to the patient is enough to prevent blood clots from forming in the extracorporeal circuit during the transfer of a primed Cartridge Blood Set to another machine. Avoid compression or restriction of pressure tubes. B . carefully follow the instructions supplied with the BPM kit.B WARNING It is not advisable to continue treatment. the presence of a short audible and visual signal must be checked (red and yellow lamps illuminated). If one of the signals is not present. Section 5. Its composition (insulating material) protects the BPM "Applied Part" (Type BF) against the effect of a defibrillator discharge. Rev. but to notify Service as to which test failed. WARNING During the BUZZER AND LAMP test. the respective signalling device (buzzer or lamp) is malfunctioning. by observing the limb concerned) that operation of the equipment does not result in prolonged impairment of the blood circulation of the patient. wipe immediately to prevent moisture from entering the machine. WARNING For this software version. Section 5. Or • A Fast Recovery of the Dialysis process is performed In such cases DIASCAN™ is inactivated (OFF) for the remainder of the treatment. Rev.D WARNING It is the responsibility of the operator to check that the numerical values that represent the Profile (on the bottom of the graph) correspond to the values in the graph. the manufacturer advises the user that the information originating from the BPM cannot be used alone as a unique source of information to induce any therapeutic or pharmacological actions. WARNING The physician is responsible for ensuring that the chosen profiles are appropriate for the patient being treated. WARNING DIASCAN™ measurements are not performed if the blood flow is ≤ 80 ml/min.E WARNING DIASCAN™ is automatically disabled if: • Dialysate Flow Rate is set to a value lower than or equal to 450 ml/min by the operator Or • Dialysate Flow Rate is set to a value greater than 750 ml/min by the operator Or • The patient connection is performed before the completion of the initial auto- calibration. Section 5. INTRODUCTION XXI WARNING In order to be in full conformity with the indications of the European Medical Device Directive 93/42. the accuracy of the DIASCAN™ Monitoring System is not guaranteed in the SINGLE NEEDLE mode. B . . Therefore. any changes in the dialysis prescription made on the basis of Diascan analysis should be made in consideration of at least two consecutive readings. They are also compatible with the PHOENIX Haemodialysis System. it is mandatory to perform an ADR: RINSING to prime the DIACLEAR. change in blood flow rate. WARNING For the disinfection of the Ultrafilter it is mandatory to use only the chemical agents recommended in the DIACLEAR Instructions for Use. WARNING The physician is responsible for the clinical adequancy of the parameters set for the correct dialysis dose.. Do not use a single Diascan measurement as the only source of clinical information to initiate therapeutic or pharmacologic actions (e. It is the operator’s responsibility to assess the clinical validity of these parameters. dialysate flow rate. as unstable operating conditions during a single DIASCAN measurement may result in an artefact in the values computed from the individual reading. etc. based upon the Diascan measurements. which must be entered and confirmed by the operator. dialyser. WARNING The DIACLEAR Ultrafilter MUST be installed when the PHOENIX machine is in the IDLE view. B . Some solvents and other chemical products used for cleaning can damage the DIACLEAR Ultrafilter: refer to the DIACLEAR Instructions for Use for the list of prohibited products. Rev.F WARNING When the Ultrafilter has been installed.XXII PHOENIX OPERATOR MANUAL WARNING The KT/V computation is based on two parameters: DRY WEIGHT and DISTRIB VOLUME. Section 5.g.). The maximum concentration allowed for the disinfectant used is: 6% Sodium Hypochlorite 4% Peracetic acid 40% Formaldehyde 100% Instrunet 100% Steridial Refer to the DIACLEAR Instructions for Use. Following DIACLEAR installation. an ADR: RINSING must be performed. treatment time. WARNING The DIACLEAR Ultrafilter can only be changed when the PHOENIX machine is in the IDLE view. in order to replace the used DIACLEAR Ultrafilter following the maximum dialysis session directions provided in the DIACLEAR Instructions for Use. WARNING The Ultrafilter Bypass connector MUST be installed when the PHOENIX machine is in the IDLE view. WARNING The connection of the DIACLEAR Ultrafilter to the PHOENIX machine must be performed aseptically. it is mandatory to perform a disinfection cycle. so that the fluid pathway is not contaminated. by resetting the DIACLEAR Ultrafilter installation parameters each time a new DIACLEAR Ultrafilter is installed/replaced. Following DIACLEAR installation. WARNING It is imperative that an ADR: RINSING is performed after each DIACLEAR Ultrafilter installation. before entering a DIALYSIS phase. WARNING Avoid tapping the DIACLEAR Ultrafilter too vigorously to remove air as this may cause damage. WARNING The following operations must be performed when the machine is in the IDLE view. WARNING The user is responsible for monitoring the DIACLEAR Ultrafilter working time. Rev. it is mandatory to perform an ADR: RINSING cycle to prime the DIACLEAR Ultrafilter before entering a DISINFECTION cycle or a DIALYSIS phase. When an Ultrafilter Bypass connector has been installed. Perform a DISINFECTION procedure before patient connection. B . INTRODUCTION XXIII WARNING The DIACLEAR Ultrafilter MUST be installed when the PHOENIX machine is in the IDLE view. Failure to use the CWP Adapter kit may result in damage to components in the PHOENIX machine. WARNING To be compatible with this feature the PHOENIX machine must be retrofitted with the CWP Adapter kit. WARNING Do not use Sodium hypochlorite to clean the Blood Pump Crank to avoid damaging the metallic parts of this component. before connecting a dialyser. WARNING For the Touchscreen cleaning use the following disinfectants: • Isopropyl alcohol (70%). WARNING The temperature of the inlet water to the machine must be lower than 95°C (203°F). • Sodium hypochlorite solution (active chlorine from 50. it is important that only citric acid is used and no other disinfectant. toluene. WARNING Do not use chemicals which might damage the plastic parts of the machine. WARNING Verify the absence of residual disinfectant. WARNING A disinfection process must be followed by a complete RINSE process. acetone or similar solvents.XXIV PHOENIX OPERATOR MANUAL Section 6 WARNING A disinfection process must be followed by a complete RINSING process. xylene.000 ppm)/Bleach diluted with water at a ratio of 1:50. on subsequent SETUP the machine will not allow the selection of the DIALYSIS process. Rev. Avoid chemicals containing benzene. If not. B . WARNING In the Heat Citric phase.000 to 60. If machine is stored for more than 7 days. B . WARNING Stagnant water may contaminate the machine.to a steam sterilisation procedure (121°C for at least 30 minutes). It is the responsibility of the physician to verify all data. WARNING To prevent damage to the components listed above. WARNING After a prolonged period of storage.SPECIFICATIONS. The intended use of this information is to support the physicians. Peresal™. One week for: Sodium Hypochlorite at Bacteriostatic strength (1:750 dilution). Only store at temperatures below 0 °C when the hydraulic circuit has been completely emptied. follow the same time limits: 4 hrs for: Amuchina™. (For further information see Section 9 . from blood leakage from the bloodline or from the dialyser (including blood leak into the hydraulic circuit) the components listed above must be cleaned by immersing them into a disinfectant solution or by exposing them – except the Concentrate Wands . the proper immersion time is related to the disinfectant dilution used. Service must be called to return the machine to proper working order. Section 7 WARNING PHOENIX makes available the dialysis related data through connection to various external devices for storage and display. When the dilution is the same as that used in the machine during DISINFECTION. Instrunet HD™ and Sodium Hypochlorite at Disinfectant strength (1:25 dilution). in this Operator’s Manual). Careful attention must be paid to dismounting and re-mounting Dialysate Connectors. Actril® and Renalin®. for example. Acetoper™. do not leave them immersed in the disinfectant solution for a prolonged period. INTRODUCTION XXV WARNING Any liquid spilt on the machine must immediately be removed to prevent it from seeping into the machine. Concentrate Connectors and Chemical Connectors in order to avoid damages to those components and leakages from those components. the water line should be disinfected and rinsed. but it cannot be considered as the sole data to prescribe any therapeutic or pharmacological action for the patient. 24 hrs for: Dialox™. 48 hrs for: formaldehyde solution and Steridial™. Rev. WARNING To prevent cross-contamination problems resulting. In the Alarm Area of the screen only two alarm messages can be displayed. on the Touch Screen. relative to existing alarms. in alternative ways. WARNING The PHOENIX machine can be programmed by receiving data through connections to various external devices. Alarms that are generated as a result of the original malfunction are not displayed in the alarm window. Some important parameters relating to the safety of the patient are shown twice. B . the control system automatically prioritizes them.6 mS/cm will be recorded in CentryNet as a Sodium Level of 136 mEq/Liter. Only those alarms which describe the presumed cause of malfunction are displayed in the alarm window. Section 8 WARNING If more than one alarm occurs at the same time. the CentryNet entries for Sodium will be approximate values obtained by multiplying the Final conductivity (mS/cm) by 10. Rev. As soon as PHOENIX reads the data. It is necessary to pay close attention to these values and check their congruency. WARNING The selection of the OVERRIDE button has effect on all the alarms that are active and can be set to the OVERRIDE state (refer to the “Alarms List” in this section for the list of alarms that can be set to the OVERRIDE state). WARNING The present SOFTWARE must be used exclusively with the authority of a physician. Refer to Section 9 – Specifications of this manual for the exact relation between concentration and conductivity. the additional alarms may be viewed on the Machine view by pressing the Machine Navigation key. The user shall therefore take all necessary measures to ensure the confidentiality of the information which is monitored by means of the software.XXVI PHOENIX OPERATOR MANUAL WARNING The present software allows information to be gathered about individuals and the user must be aware that the use of the information processed or generated by the software is restricted in most countries by legal dispositions such as the Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995. it is displayed on the Touch Screen. As the PHOENIX provides only conductivity information (in mS/cm). A Final conductivity of 13. who is solely responsible for the use of the information processed by the SOFTWARE. if there are more than two alarms active. WARNING The CentryNet system displays on its treatment screens the concentrations for two conductivity related values (Sodium Level and Bicarbonate Level) in mEq/Liter. It is the responsibility of the user to verify all the data before confirming it is correct. Never press the RESTART key more than 2 or 3 times if the problem has not been identified that will remove the cause of “RESTART”. • The Blood Pump is stopped. The machine is stopped and the patient isolated. WARNING If the first time the RESTART key is selected. Rev. • The Ultrafiltration Pump is stopped. Otherwise. the Protection Module generates a > GENERAL SAFE STATE < alarm and the following steps are taken: • The Dialysate Flow through the dialyser is stopped. The operator is warned by: • An alarm window with the message: → > GENERAL SAFE STATE < ← • An Operator Message in the help window: You Must Switch Off The Machine • A Visual alarm. • The Venous Clamp is closed. WARNING In some Protection alarms. i.e. WARNING In each alarm condition critical to the safety of the patient (Class P alarms). INTRODUCTION XXVII WARNING During OVERRIDE. the machine returns to the RESTART condition. WARNING It is the Operator’s responsibility to determine and to correct the cause of the Arterial or Venous Pressure Alarm (#155 and #305) PRIOR to pressing the OVERRIDE Button. If this test passes. as described on the Touch Screen. the user is responsible for monitoring the parameters that are being overridden. if the safe state is not correctly configured. with a flashing red light of a 6-2 modulation (two flashes lasting 3/8 of a second with an intervening pause of 1/8 of a second) • A high volume Audible alarm of 6-2 modulation. the audible alarm is active only after DIALYSIS is initiated. the Protection Module checks that the actions relating to the specific safe state are performed correctly by the machine. B . wait at least ten seconds before pressing the RESTART key again. WARNING Press the RESTART key only after having removed the cause requiring the “RESTART”. the machine remains in the safe state until the cause of the alarm is removed (as indicated in the Suggested Action). the following message is displayed: ! T1 TEST FAILED If a General Safe State is due to incorrect voltage. • Blood has been detected and all the relevant safety systems are activated. These values are maintained for all the time the Blood Pump is OFF and for 30 sec. for each alarm in this section. Therefore. the machine must be switched OFF. This is a latching alarm and in order to reset it. Rev. If a General Safe State occurs as a result of a T1 test failure. after the Blood Pump restart. This condition of the Patient Sensor is indicated by an Icon in the Icon Area on the Touch Screen. the relevant safety systems are locked until the presence of blood is detected to allow a smooth start to the process. • The arterial pressure alarm window lower limit is automatically set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg and the upper limit is set to +150 mmHg. the following message is displayed: ! TEMPERATURE EXCESSIVE VALUE WARNING When the Blood Pump stops due to an alarm condition: • The venous pressure alarm window lower limit is automatically set to +10 mmHg and the upper limit is set to the VEN PRES LIMIT parameter value decreased of 50 mmHg (see Section 2 . since the patient’s blood has not yet reached the venous line in the Patient Sensor. the following message is displayed: ! Voltages Incorrect If a General Safe State is due to a Temperature elevated value alarm. the possibility of an automatic OVERRIDE by the Patient Sensor and the related effects are indicated. The Patient Sensor Icons are: • No blood has been detected • Blood has been detected but the operational test has failed. The GENERAL SAFE STATE is a shutdown alarm and the treatment is stopped.XXVIII PHOENIX OPERATOR MANUAL • A numerical code relative to the specific safe state that was not correctly configured (see below). by highlighting the symbol in correspondence to the safe requests which are active only after either the Patient Sensor has detected blood in the venous line. or after the DIALYSIS Action key has been pressed. B .Configuration Description. For each Class P alarm. Not all the relevant safety systems are activated. WARNING The machine is supplied with a special device called the Patient Sensor which has the task of setting some class P alarms in an automatic OVERRIDE state when DIALYSIS has not yet started. in this manual). re-check carefully all the possible causes of the alarm then press again the RESTART key. to clear the ! VENOUS PRESSURE HIGH LIMIT #154 alarm. WARNING When AC power is interrupted. a continuous audible alarm is turned on. WARNING Never press the OVERRIDE button. B . It is the operator’s responsibility to carefully monitor the parameters involved in the failed test if the decision is made to continue treatment despite the test failure. WARNING 2 RESUME has no effect if the venous line is not inserted in the Venous Line Clamp (in this case the alarm #205 appears). to clear the ! Ven Pressure Alarm #155 alarm. if the first selection of the RESTART key doesn’t clear the alarm. WARNING When the patient is connected. which causes a GENERAL SAFE STATE and consequently stops the machine. INTRODUCTION XXIX WARNING 1 Do not open the clamp in between the dialyser and the venous chamber (in DOUBLE NEEDLE mode) or in between the dialyser and the post-dialyser expansion chamber (in SINGLE NEEDLE mode) because the positive pressure at the blood side of the dialyser could push air bubbles to the patient. if the problem that is causing the alarm condition has not been identified and removed. WARNING Never press the OVERRIDE button. if the problem that is causing the alarm condition has not been identified and removed. a Class P signal (see Class P alarms section). but to notify Service as to which test failed. WARNING It is not advisable to continue treatment. Presence of blood in dialysate might result in a possible contamination of the hydraulic circuit with bacteria or viruses. Rev. blood into the hydraulic circuit may cause cross-contamination problems resulting in patient injury or death. WARNING After patient connection this signal becomes #160. If the ADR disinfection is not correctly performed before starting a new dialysis treatment. WARNING If the ”!Blood Leakage” # 28 alarm occurs and the identified cause is “Dialyser is leaking blood into the hydraulic circuit”. Never press the RESTART key more than 2 or 3 times if the problem that is causing the “RESTART” condition has not been identified. perform an ADR disinfection before starting a new dialysis treatment. Refer to. if the problem that is causing the alarm condition has not been identified and removed. to keep a minimum distance of 10 m (33 ft) from the equipment. (For additional information about special precaution regarding EMC. If an external scale is not being used. WARNING OVERRIDE has no effect if the venous line is not inserted into the Venous Line Clamp (in which case the alarm number 205: “W! Venous Line Not Fitted “ appears).XXX PHOENIX OPERATOR MANUAL WARNING If the T1 TESTS DISABLED#203 alarm appears. to prevent any problems. local standards and guidelines. at least. B . If an external scale is being used. WARNING After the ! UF Mass Balance (#144) recurs 10 times. WARNING Never press the OVERRIDE button. WARNING The PHOENIX system conforms to IEC 60601-1-2 standard on Electromagnetic Compatibility. the machine must not be used for a patient treatment. to clear the ! Art Pressure Alarm #305 alarm. discontinue DIALYSIS. to clear the ! Art Pressure Limit #306 alarm. it is not recommended to use cellular phones (hand-held) in the dialysis room or. and be compliant with. thus it has an adequate degree of protection against electromagnetic disturbances. However. if the problem that is causing the alarm condition has not been identified and removed. refer to Appendix A in this manual). Rev. A Service Technician must re-enable the T1 Tests before using the machine for a patient treatment. WARNING Never press the OVERRIDE button. Section 9 WARNING Storage under 0°C (32°F) is not recommended unless the hydraulic circuit has been emptied (see Maintenance section of the Service Manual). the TOT. FLUID REMOVED displayed on video is no more reliable. refer to the weight measured by the scale to check the value of the TOT. FLUID REMOVED. displayed by the machine. However. WARNING It is recommended to use concentrates which conform to the requirements of the local standards or of the AAMI RD61 "Concentrates for hemodialysis" standard or of the European Pharmaceutical standards. The control of alarm thresholds and dialysate conductivity precision is of major medical importance in ensuring a safe dialysis treatment. B . for each dialysate concentrate used for dialysis treatment. WARNING The correct installation of a MEDICAL ELECTRICAL SYSTEM requires that each SYSTEM component be individually connected to the main power. WARNING Before moving the machine. WARNING It is the responsibility of the user to determine the correspondence between the dialysate conductivity. which may cause the permitted leakage current to be exceeded. WARNING Do not stand on Chemical Container Shelf.g. This can be done by taking dialysate samples at different conductivity values (e. WARNING The PHOENIX machine is provided with ports for connecting it with an external personal computer or a communication network. INTRODUCTION XXXI WARNING Possible hazards may arise from equipment (other than the accessories listed below) being connected to machine. 13. they must comply with the IEC 60601-1-1 Standard and must NOT BE PLACED ON THE FLOOR. and the dialysate solute content.15 mS/cm) and sending them to a laboratory for analysis. if using multiple portable socket-outlets. verified by clinical laboratory results. check that the brake is released and remove infusion bags or any other weights or hanging objects from the IV pole or from the concentrate container shelf. WARNING Wait at least 5 seconds after switching OFF the machine before turning it ON again. It is strongly recommended: NOT TO USE MULTIPLE PORTABLE SOCKET-OUTLETS. Rev. All external equipments connected to the PHOENIX machine must be compliant with IEC 60950.14. Always follow the chemical manufacturer's instructions when handling these products or cleaning spills. WARNING Contact with cleaning and/or disinfection chemicals may pose a risk of burns. WARNING Bicarbonate value in Final Dialysate depends on both the Final conductivity and the Bicarbonate conductivity settings. WARNING When the pressure of the dialysate exceeds the alarm threshold. Acetoper™. the audible and visual alarms are triggered. One week for: Sodium Hypochlorite at Bacteriostatic strength (1:750 dilution). BiCart® may only be used by staff. the audible and visual alarms are triggered. Instrunet HD™ and Sodium Hypochlorite at Disinfectant strength (1:25 dilution). WARNING To prevent damaging the machine. Peresal™. 48 hrs for: formaldehyde solution and Steridial™. using the PHOENIX Operator’s Manual (see Section 5 – Dialysis Operation in this manual). do not leave disinfectant solution in the machine for periods over the following limits: 4 hrs for: Amuchina™. WARNING Carefully read the BiCart® Instructions for Use before using the device. B . WARNING When the conductivity of the dialysate exceeds the alarm threshold. It is the responsibility of the user to set conductivity in accordance with the type of concentrate used to obtain the desired value of bicarbonate in the final dialysate. 24 hrs for: Dialox™. the audible and visual alarms are triggered. skin irritation or other adverse reactions. Rev. WARNING When the temperature of the dialysate exceeds the alarm threshold.XXXII PHOENIX OPERATOR MANUAL WARNING Attention must be given to the safety hazards related to incorrect choice of dialysate concentrates. the audible and visual alarms are triggered. WARNING When the pH of the dialysate exceeds the alarm threshold. Actril® and Renalin®. who are specially trained for haemodialysis treatments. it is important that only citric acid is used and no other disinfectants. to prevent such an effect. • inspect frequently the patient's access. Its lower value is set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg.Configuration Description in this manual). which may result in extracorporeal blood loss to the environment.2 kg/h. When a venous needle disconnects from its access. WARNING In the "UF only" process or with the hydraulic circuit in BYPASS. WARNING Modification of Blood Flow Rate causes a fluctuation in the Arterial Pressure and therefore an alarm may be triggered. INTRODUCTION XXXIII WARNING In the Heat Citric Disinfection phase. while the upper limit is set to the VEN PRES LIMIT parameter value decreased of 50 mmHg (see Section 2 . B . When this alarm is activated the Ultrafiltration Pump is stopped. To reduce the risk of needles disconnection: • ensure that venous needle and line are firmly secured to the access site area according to your clinic's protocol. while the upper value is set to +150 mmHg. • adjust properly the venous pressure alarm window: the venous pressure alarm lower limit should be set as closely as practical to the actual patient’s venous pressure value without generating excessive nuisance alarms. due to the operating conditions and dialyser characteristics. WARNING When the Centralized Heat Disinfection System is used. the Blood Leak alarm may be delayed. • ensure that the patient's access is visible at all times during the dialysis treatment. an audible and visual alarm is triggered. Following a change in the Blood Flow Rate. to prevent such an effect. WARNING Modification of the Blood Flow Rate causes a fluctuation in the Venous Pressure and therefore an alarm may be triggered. pressure at the venous monitoring side may only decrease by the pressure maintained within the patient’s access site. the Alarm Window is automatically set wider for 30 seconds. WARNING Monitoring of the Venous Pressure could not always detect the disconnection of a venous needle from its access site. the temperature of the inlet water of the machine must be less than 95°C. Rev. even if pressure alarms and alarm windows are properly set. the Alarm Window is automatically set wider for 30 seconds. Following a change in the Blood Flow Rate. Its lower value is set to +10 mmHg. This pressure drop may be less than the width of the machine’s venous pressure alarm window: in this particular case the disconnection of a venous needle from its access site is not detectable by the machine. WARNING If the difference between the actual flow of the Ultrafiltration Pump and the set UFR is greater than ±20% with a UF Rate greater than 0. However. The user should periodically check the correlation between the stated and the actual diameters.Dialysis Operation in this manual) the limits of the Venous Pressure alarm window are automatically set to -50 and +250 mmHg and the limits of the Arterial Pressure window are set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg and +150 mmHg. WARNING These diameters have been taken from samples from many countries and are correct at the time of printing. The Manufacturer does not assume responsibility or liability for use of blood line other than the Gambro/Hospal Cartridge Blood Set. WARNING The user must take precautions against the hazard of cross-contamination between patients by using only extracorporeal circuits with hydrophobic filters on the pressure ports and by disinfecting the accessible surfaces of the equipment. WARNING The use of the Gambro/Hospal Cartridge Blood Set designed for Phoenix machine has been tested and validated to provide safe and proper functioning of the system. Rev. the manufacturer cannot be held responsible for changes in syringe dimensions that may occur. Before installing a Gambro/Hospal Cartridge Blood Set. B .XXXIV PHOENIX OPERATOR MANUAL WARNING A dedicated warning (W! Low Art Flow For Too Long #204) exists in order to avoid blood loss due to coagulation resulting from interruption of blood flow. WARNING In WASHBACK (see Section 5 . WARNING It is the responsibility of the physician to ensure that the appropriate Gambro/Hospal Cartridge Blood Set is selected for the weight of the patient being treated. The Manufacturer has not validated the use of blood lines other than those specified in this manual. carefully read the Cartridge Blood Set Instructions for Use. WARNING Verify the absence of disinfectant residuals before connecting the dialyser. WARNING The manufacturer recommends the use of a dialyser with dialysate and blood connections that comply with ISO 8637. It is the responsibility of the user to validate that other blood lines provide safe and effective performance. If machine is stored for more than 7 days. the water line should be disinfected and rinsed. If necessary. B . ask qualified staff to open the panels. WARNING Before replacing or checking any component in the Hydraulic Circuit. Do not touch the blocking system. WARNING Turn the Blood pump OFF before touching the Blood Pump Rotor. with oxygen or with nitrous oxide. WARNING The manufacturer does not accept any responsibility for damage caused by any operation carried out on the machine by unauthorized staff. Disconnect the machine from the main power supply before every cleaning. a DESCALING Procedure must performed. INTRODUCTION XXXV WARNING Do not remove the panels. WARNING Do not assemble. checking or maintenance operation. The machine could be damaged if handled in an improper way. WARNING Do not use this machine near flammable gas or flammable anaesthetic mixtures with air. Rev. install or use the machine before having read the manual carefully. WARNING Stagnant water may contaminate the machine. WARNING Carefully move the machine by using the handle on the rear panel. It is the responsibility of the user to validate that other accessories or disposables provide safe and effective performance. THIS WARRANTY IS IN LIEU OF ANY OTHER EXPRESSED OR IMPLIED WARRANTIES.A..P. THE WARRANTY ON THIS MACHINE WILL BE VOIDED BY ANY SUCH ATTEMPTED REPAIR AND NO PARTS OR LABOR COSTS INCURRED BY THE OWNER WILL BE REIMBURSED BY THE MANUFACTURER. INCLUDING ANY IMPLIED WARRANTY OF SALEABILITY OR SUITABILITY OF USE AND OF ANY OTHER OBLIGATION ON THE PART OF THE MANUFACTURER.P. The Phoenix machine has been tested and validated for use with the accessories and disposables listed in this manual. OR THE EFFECT OF SUCH WORK ON MACHINE OPERATION AND PERFORMANCE. HAS NO CONTROL OVER THE MANNER IN WHICH SERVICE OR MAINTENANCE WORK IS CONDUCTED BY PERSONS OTHER THAN TRAINED PERSONNEL BELONGING TO THE SERVICE REPRESENTATIVE IN YOUR COUNTRY. DOES NOT ASSUME RESPONSIBILITY OR LIABILITY FOR ANY DAMAGES RESULTING FROM THE OPERATION OR PERFORMANCE OF ANY DEVICE. The Manufacturer does not assume responsibility or liability for use of accessories or disposable other than those specified in this manual. The Manufacturer has not validated the use of accessories or disposables other than those specified in this manual. GAMBRO DASCO S.XXXVI PHOENIX OPERATOR MANUAL Warranty IMPORTANT NOTE SINCE GAMBRO DASCO S. THE MANUFACTURER. B .A. ITS LIABILITY HEREBY BEING LIMITED SOLELY TO REPAIR OR REPLACEMENT. UNDER NO CIRCUMSTANCES WILL THE MANUFACTURER BE LIABLE FOR INDIRECT OR CONSEQUENTIAL DAMAGES OF ANY KIND. WARNING This manual contains a number of references to accessories and disposables for use with the Phoenix machine.A. GAMBRO DASCO S. OR ANY INJURY CAUSED BY SUCH DEVICE AFTER REPAIRS HAVE BEEN ATTEMPTED BY ANYONE OTHER THAN QUALIFIED PERSONS BELONGING TO THE SERVICE REPRESENTATIVE IN YOUR COUNTRY.P. Rev. DOES NOT RECOGNISE THE OWNER OF A PRODUCT AS AN AUTHORISED SERVICE REPRESENTATIVE. ...................................... 1-26 1.................................................................................... 1-30 Rev.....2 Description of the machine................................. v Section 1....................................... 1-18 1........................................................................................................3.............................................................................................................1............................... vi Section 2..........................4 Parameter Modification ...............................B .................................................................................... xxiv Section 7.......... xlv 1............................ 1-1 1........................................................C..........................3 Operator interface....1 Background shape........................... INTRODUCTION XXXVII Tables of contents INTRODUCTION ...................................................... 1-9 1.................................................................................. iv SPARE PARTS ...................................................................................................................................3.....................................................................................................................................................3....... xv Section 5.....................................................................................................................2 Structure of the machine............ 1-21 1................................................. 1-21 1.......................................... viii Section 4................................................................................................ 1-1 1... v Introduction ..........2 List of Pictograms ...................................1 Therapies Description .................................................. xxxvi Tables of contens............ vii Section 3.............................................................................. xxx Warranty.........................................1 Front view ................. i Operator Manual Symbols ....................3.... B ........................................................ 1-2 1....................................................................................... xxvi Section 9.........................3............................................................. xx Section 5......................................................................................................................................................................................................D ........................................................................................................E....................................................................................................................................... xx Section 5......................... iii INTENDED USE .......... xxxvii ADDRESSES ...........................5 Monitoring of Venous Pressure and Venous Needle Dislodgement ................................................................................................................ xxii Section 6...............................................................................................................................1 Icons representing processes ..................................1 Structure of the machine ..............................................................................................................................................................................................2 HOME icons..................F.................................................................................................................................... 1-6 1................. xxi Section 5............................................3 Pictograms ..............................................................2......................A..................3............................................................2 Rear view ................................................................................ 1-1 1......... ix Section 5...................... 1-3 1................................................................................................................ iv WARNINGS........................................................... GENERAL DESCRIPTION................................................................... 1-21 1............................................................................. 1-20 1.................................................................... i IEC Symbols.......2...........1........................ xxv Section 8............................................................................. 1-3 1.................................................3....... x Section 5.................................................. xxi Section 5.............................................................................................................. .............2 WLR ....2 FUNCTION .....................................4.......3 DATE/TIME.........3-1 3...................................................2.............................3-1 3..............3 RINSE .4 AutoStart.........3...........2-28 2............XXXVIII PHOENIX OPERATOR MANUAL 2.........................2-1 2..3 BPM ...............................1........................1 Entering Data on the Configuration Environment ........................................4 ALARMS.................................1 Rx Config General View .............6 KT/V Configuration............................................................2.......................................4...................5.......1 Switching from Central Concentrate Supply to the use of External Concentrate Containers .......................2-23 2....................3................4..................1 MACHINE Data Configuration ......................2-25 2........3.............5 CLEAN DIAL .4 Central Concentrate Supply Lines Maintenance....2-54 2...2-29 2......1 General ........2...................................3 LIMITS.........4...................................................................................................2-42 2...............1 STD HD...............3 Rx Config Views..........1...............2-24 2.........................1...............................................2 Parameters List..........................2 HEPARIN.........................2......3.................2..........2-57 2.................................2...............................................3-2 3.....................................2-50 2.................................2...........1 Configuration Environment General Description........2.....................2-20 2.................................................................2 HEAT..........3-8 3............................................................................................4 WAIT TIME .....1 Disinfection Procedure.......................................................1..2-47 2........................2-18 2......................3-9 3.................................................2-46 2................................................2............................2-26 2.....4.........................2-49 2..........................2............................2...................................................................................................................2-42 2......................................3 Cond ......................................................... CENTRAL CONCENTRATE SUPPLY ................2-4 2..................................................................................... B ...............................4.........................................................................................2...............................................................3 ADR Data Configuration .................................................................................................2-39 2...........2....4 Treatment Data Configuration .....4.........................3..........2-52 2..........2-22 2..3 Operating Instructions.........2......................2-27 2....................1 PROFILE General view ....1 PROFILE General view ....................3...........2 COMMUNICATION.................................................2-40 2....................1 OPTIONS...........................2 CENTER Data Configuration.....................3.....................................................2...............1 Specifications.............................2..............................................................3-4 3......................2.............................................................................4..........................................................................................................................2-55 2.............2-29 2......2..2 Connection to the Central Concentrate Supply System .........................2-48 2.2........3 Cond .............................................................................................................2....................2...............................2-56 2....................2 UF ........2-18 2.........4..........................................2-35 2.....2-52 2...............3.1.3...3.....3...........................................1 AUTO ....................................................2-25 2.....2......2 Central Bicarbonate Line Disinfection & Rinse: automatic processes ................1 CHEMICAL .....1..5 Kt/V Configuration......2-1 2.......................4 Profiling Configuration ...........2.........................................................................2 CONFIG Views ...........2......3-9 Rev.......................................1.........3-7 3.................................................2-48 2...............2-55 2...........2...............................2....5.....3..2-6 2............2................................................................................5 Profiling Configuration ...............................................2 Rx Data Configuration .........................................2-58 3.................2-51 2....................3-8 3...5..............2-18 2.......2.................................................................2.3 Rx Add Configuration........2-53 2..............2.............3............... CONFIGURATION DESCRIPTION ......................... ..3 Acid and Bicarbonate Lines Rinse: automatic process...................................5 Draining of Central Concentrate Lines..................................................................................... 5-2 5....... 5-35 5.4.....................1....5...................4 First service ........4................3.........2 Extracorporeal Circuit preparation .............. 5-11 5..........1 Priming with Dialysate Connectors on the Dialyser ...........4................................................1 Install dialyser.................. 5-27 5.........1 Rinse Procedure............3 SETUP selection ....... 5-13 5......................................1..............................................4....4............................................. 5-31 5.2 ADR: RINSE following the Central Bicarbonate Line disinfection................................................2......................................................................................... 5-1 5................... 5-29 5..................................1 Starting .............................2 When Liquid Bicarbonate Dialysate is programmed in the Configuration menu ............... 3-22 3...............2 RX Dialysis Mode ..............3 Fill and install heparin syringe ......................................................3........1 Adaptor Setup .................................... Rinse and Drain): manual procedure .2 Load the Cartridge Blood Set.1 Residual Disinfectant Concentration Test .................. B .....4....................2 Priming Mode Selection View ..................................................... 5-10 5.............1......4...........................................................3........ 5-36 Rev..... DIALYSIS OPERATION.................................4 Rinse Verification...2 Shipping Carton Contents ................. 5-23 5. 4-2 4....................................................... 3-22 3....................................2.......................3 Installation ..1...................................................................................1 Possible operations during the dialysate preparation phase ............1 To prime the blood side of the dialyser and the heparin line ..................1..............4.............1 When Acetate Dialysate is programmed in the Configuration menu.....1.......... 5-2 5........3..................2 Priming with Dialysate Connectors on the Rinse Ports.........3 Rinse Procedure.......4........................ 3-23 3........................................4 Acid and Bicarbonate Lines Maintenance (Disinfection...................4 Preparing for a patient treatment ... 3-14 3........ INSTALLATION................................................................................ 5-2 5.............4... 5-17 5........... 3-17 3................................ 3-23 3..............................................5..............5..........................2.....................................................................................4...............................................................2 Disinfection Procedure................... 4-1 4..........2....................................... 5-1 5........4............... 5-10 5....................... 5-23 5........................................................................................ 3-24 4...................1...2 To fill the dialysate side of the dialyser.............................................4.1 To prime the blood side of the dialyser and the heparin line ...............4........................................1 Unpacking instructions.....................................2................2 Sampling of dialysate ...............................2 Checking dialysis parameters configuration ...................4 Connect saline ........................................ 5-7 5......................1.................... 4-4 5..2 To fill the dialysate side of the dialyser.................5........... 5-33 5........................ 3-16 3................ 5-32 5..........5.................................................................................1 Dialysate preparation ....................................................4.................................... 5-26 5.......3.............1............................................5 Priming of the dialyser......4.................. 5-27 5............................... 5-25 5...... 3-23 3..........6 Recirculation...4.............................................................................2............................................................................................................. 4-1 4................. 5-8 5...............................1 Standard Dialysis Mode (when SETUP has been selected)............................. 4-1 4...3.............5......................................................... 5-6 5................... 5-1 5....................... 5-25 5......3 When BiCart Dialysate is programmed in the Configuration Menu .......... 5-1 5........... INTRODUCTION XXXIX 3................................................4.....2................................................. .....................................13 Procedure for Automatic Autocalibration of the UF Pump during the Dialysate Preparation Process ....A.....A-32 Rev............1 Performing Dialysis ...2 Emergency procedures for Power Failure with the BATTERY BACKUP feature .2 Heparinization ............. B ............5..........................................A........................A-18 5.........................................A-3 5....................................................................A-16 5.......A...............................................5 Quick Access to the Next Dialysis Treatment..........A-28 5...................................A-29 5..................9 Dialysis ...............................5 Sampling of Dialysate ..................15 Diaphragm Neutral Position Procedure .......................................................A.......................1 Fill the extracorporeal circuit with fresh saline prior to treatment .......................................3 Fast Recovery of the Dialysis process .......10......5-39 5..............................5-36 5.............................5....................... SPECIAL PROCEDURES ......A-1 5........10 End of Dialysis..........5-47 5..........................5-54 5.................................................5-44 5........5-36 5.................1 Prepare to perform recirculation ...........................................10.............................................1.......5..6..................................A......................5..2 Select Recirculation .......................5-37 5............1 Ready for patient connection.................................................A.......A-25 5.........................5.........................5-36 5....5.3 Initiating patient connect............................1 Manual Emptying...........5-52 5......8.........5...........5-59 5.................A..........................................................................................................................A.........A.2 Emptying the dialyser..........................A-9 5....8...................4 Sampling of water from the machine.......................................8....................................11 Procedure for Autocalibration of the Peristaltic Pumps during DIALYSIS.....................................5............A..........................A..................5........A.....A-20 5..............7 Level adjustment of the Cartridge chambers ....................A-30 5....................5.....................................10.........................A...................3 Removing the BiCart .........................................5-48 5.................5.................................................10.....................................................................1 Emergency procedures for Power Failure...............2 AutoEmptying.......16 Manual Cleaning procedure for the Waste Handling Option (WHO) ......A.................5..................................................................................5................12 Procedure for Standard Autocalibration of the PA........5........3..........5-57 5....................................9.................................................................................................................................. or PUF Pumps during the Dialysate Preparation Process ...........................................................2.............................................8........................................................................................................................................................................................................................4 End of Treatment ....4 Dialysis change mode: Single Needle and Double Needle mode ..5-43 5......A..2.....10..............................10.......8 Switching from BiCart Dialysate to the use of Liquid 8.............14 Manual Disconnection of the Patient....6.....9 Acid/Acetate Concentrate Supply Change . PB............10 Dialyser Replacement........................5-52 5....................................................................A-14 5........6 Temporary Disconnection of the Patient : PAUSE THERAPY Procedure ...................5-60 5....8 Patient Connection..................................8..5-41 5........................................5-48 5...............2 Connect patient ..4% Bicarbonate Dialysate........3.............10..........A....................A-9 5.......................................................A-12 5.........................5-62 5.5...................A...5....................XL PHOENIX OPERATOR MANUAL 5.5-39 5...........1 Patient disconnection and Emptying dialyser................................................5-43 5.....................................6........................................................................A-23 5............A-6 5.................7 BiCart Change .8....5...............................................A-1 5..............................................................................5-54 5......1 Unclamp lines ...... .........................2 DIALYSIS TIME Setting ..................................................D......1 Introduction....D..............................3..E.........E-1 5.........1 General................. 5..................2 Parameters....................................2 Entering the PROFILE View ....D-18 5.......D-30 5......5 Modify Profile Parameters ..........D-7 5.........3..........C...........................4.........................E-10 Rev............ 5..2..........................................................................1 Test procedures.............D-25 5.......C................................................................D-10 5........... BLOOD PRESSURE MONITORING SYSTEM..............C-5 5..... 5............. 5.......B-1 5..E...1 Ultrafiltration Rate Step Curve Profiles . 5............... 5.......................3............................... 5............3........E-7 5....................................17 Transferring a primed Cartridge Blood Set to another PHOENIX machine for continuation of treatment ........................................................D-9 5....D.................... 5................ 5.....................................D........A-36 5.... 5.....3 Cuff application.......D-4 5............................................................................................ 5................................1 General ................ 5.....3.D-1 5........................ 5........3...........2 Conductivity Step Curve Profiles..................................................................................................................D.........................................C-1 5....D....... B ...........D-11 5..2 Dialysis Mode with Profiling not enabled ..............3....1...........................3..........................................................D-11 5..............................E...D.D-13 5...........................................2 Cuff selection..................1...........4.1.................................3................................1 Conductivity Progressive Curve Profiles: parameters explanation. 5.................7...3 Programming the Progressive Curve .....1..............1....D-9 5.........D-2 5...........3.. 5...............D........... 5.........C........... 5.......3...........C-1 5.....................D-12 5....................3....B................................3............................. 5. 5......D......................A.................................................. 5...................7............D...D-16 5..........B..3........................................ 5..... 5....................................... 5....................3.......D................................................................E-8 5............................3........1 DIASCAN™ Monitoring System...................6 Activation of Profile...3....................................3........3 Initial Auto-Calibration .........B-1 5.................... 5......D......................D-4 5.....1.......................D.....................C...........E.........D-15 5..E-1 5.......................................D..3 Profile during WASHBACK .....7...E...... 5...2 Ultrafiltration Rate Progressive Curve Profiles: parameters explanation.........................E............C-4 5.D......................... 5..4 Step Curve Profiles ..............A.............C............3 Profiled Dialysis Mode .................. PROFILE ...........................D..............E.................2 Modification of a Curve during DIALYSIS........D... 5.........D...D-21 5.D... 5................... MONITORING..............................3................ 5......8 Deactivation of Profiling ..........................D...............1 CURVE TYPE Setting .. TEST PROCEDURES........D-29 5.................D-23 5...............3.................. 5.........4 MEASUREMENTS ................D...............7 Profile during Dialysis ....D..............D-29 5............18 Installation of the Single Needle Holder..........3 Progressive Curve Profiles ..... 5........... INTRODUCTION XLI 5...................4 BPM User interface........1 Display Profile during DIALYSIS ................................... 5...4........................................................1 General .................... 5.................D-15 5....E-4 5.................................................................. 5.....................A-33 5................................. 5...........D-1 5.....2.............. 5...........5 Operator Interface........3 Programming the Step Curve .............................D...........D................D-17 5................................C-6 5............................. 5.. 5..................... 5.E-1 5............................................. 5......................1 Display UFR and Conductivity graph in Dialysis Mode with Profiling not enabled ...... ....F-13 5.................................................................2............................6-12 6...........................1..............F......................F.........F-18 5....5 Clean Dialysate.1 HOW TO PROCEED ......6-25 6...............................................F....4......................6-7 6.........7 Water Inlet Line Disinfection .......2...................F-16 5...5 Chemical Disinfection and Descaling.6...............................................3...............2...............................6-5 6...............5......F...1 List of Parameters and their meanings ..............6-12 6......................................5 ADR Action Keys availability.....................................................4 Rinsing ....................F-11 5.....6-18 6...............................5......... 6-8 6......F......................................................6-25 6...........3........................2.......F..........1.....5.......................................................1 General...........7................................3 Heat/Heat Citric Process in Progress (not available on 12 A version)................................F......... CLEAN DIALYSATE System .......1 Removal of the DIACLEAR Ultrafilter..2 CENTRALIZED HEAT DISINFECTION SYSTEM...............5......................5................6 Verification of the Absence of Residual Disinfectant.........4.....5.........1............F....F-17 5.....................1 Removal of the Ultrafilter Bypass connector (old version) .....................F-2 5.............3 Disinfection with heat (not available on 12 A version)......................................F.............F....... 6-13 6.....................................6-12 6..................................1 DIACLEAR Instruction for Use .......6-19 6.6-11 6...........................................................6-24 6..... B .......6-15 6.....1 Installation of the new DIACLEAR Ultrafilter.............6 Heat/Heat Citric Disinfection.1 Rinsing in progress ................5...............5.........4 Installation of the Ultrafilter Bypass connector on a machine equipped with the DIACLEAR Ultrafilter......5...............1 HOW TO PROCEED .........................................................F.....2 Installation of the Ultrafilter Bypass connector (old version) ....1 Disinfection .......................................................................5......................1 Configuration ...............F.........F-16 5....... Priming/Rinsing of the dialyser and performing the dialysis treatment ...........2 Heat Citric disinfection .F-5 5...................................2 Installation of the DIACLEAR Ultrafilter ........5...............................5.....F...................5..............................1....................................2...................2 Ultrafilter information......................2 Dialysate Preparation.F........................3.3........................................5............6-7 6.....F-17 5..........................F..........................2...................XLII PHOENIX OPERATOR MANUAL 5...................................F.F-3 5........................................F-20 6....2.1 Disinfection.....................................5...............1 List of Parameters and their meanings ........3...........F-19 5...........................F................2 Icons...........F-17 5....................1............................................... CLEAN/DISINFECT ............1...........................1 HOW TO PROCEED .5...................6-1 6.......5............5.......F.....F-4 5.......2 Chemical Disinfection Process in progress .................... 6-17 6...4.............5.......................................2 Chemical Disinfection...1 List of Parameters and their meanings .......3..3........................F...1 Heat disinfection ..........................5........4 Resetting of the DIACLEAR Ultrafilter Installation parameters.......6 PHOENIX Operator Interface ..................................3........................1 General ..2 Disinfection Procedure ........6-9 6...F-16 5...................................F-18 5...................................................6-14 6..1 Priming/Rinsing of the DIACLEAR Ultrafilter ..............6-21 6..................................F..............................................................F-11 5......3 Changing the DIACLEAR Ultrafilter .......................F-1 5...........5........................................5.........................2 HOW TO START THE PROCESS .....................6-25 Rev........................................................6-7 6..........7............3.........................................F-19 5..5....5......................6-21 6.......F...3..............3.5.F-8 5.....1...................................................2.......................................................................5....5..........................................1.........................................6-15 6.5................3 Installation of the DIACLEAR Ultrafilter on a machine equipped with the Ultrafilter Bypass connector.........................................................6....................F-1 5........1..................................... ..1 What CentryNet Does..................................................................................................... 7-4 7.......... 7-19 7.. 7-18 7.............. 7-15 7.............................................................................. 7-18 7.....4 Dialysis Report...7............................... 7-37 8................ 8-6 8.......... 7-13 7................................................................ 7-9 7................................3 Operator Tasks and Guidelines for CentryNet ...................................................4. 7-1 7...1 General Description...................................... 7-1 7.......................1....................4 Storage .................................... 7-8 7...8 External Cleaning and Periodic Inspections ....3 CONFIGURATION of Communication Environment........7............. 7-17 7.. 7-23 7.................... B ...............................7..... 6-31 6..............................................................................................5 Dialysis Treatment Data .......................................................................7 CentryNet System Connection .................................................................................8.....6 Communication Icons relating to the state of the network link........................... 7-36 7......4..3 Visual inspection ..........................7............................. 6-28 6........5................................................7....................................................7....................................................8 Operator Keys relating to manual data collection ...................7..............1.....................................................................1...................... 7-35 7.......................................................2 External components Cleaning .......1...... 7-8 7.....................................................5 Cartridge Holder O-Rings Inspection and Greasing ................... 7-29 7................... 7-26 7...................................3 Error Messages related to Computer Prescription .................... 7-22 7.............................1 Classification and modes of intervention.......................... 6-31 6...1 OVERRIDING Arterial and Venous Pressure Alarms .......4...........................1 Operator Guidelines for responding to Alarms on the PHOENIX machine.............................4................................. 8-20 Rev................................................................ 6-32 7......2 Operator Actions required after pressing the OVERRIDE Button for Arterial and Venous Pressure Alarms.................1 External surface cleaning.... 8-8 8..........................2 Numerical List of Alarms and relevant description...................7..........1...............................1 General Description ..............................3 Event/Intervention Marking..............................................................5............... 7-32 7... 8-1 8.5.............8...................2 Exalis Functional Description ...... 6-28 6....................... 7-31 7.........................8.....5 CentryNet Option Screen Setup Keys ........ 7-21 7.... 7-24 7......10 CentryNet option activation/deactivation after a Fast Recovery of the Dialysis process .......... 8-8 8...........................9 Alarm signals relating to CentryNet..................... INTRODUCTION XLIII 6........ 7-18 7..........................4 Configuring the unit with the CentryNet option ...... 8-1 8..............................................................................6 Communication Libraries......................1 Patient Login ..............7 Operator Keys relating to the state of the treatment ..................2 Functional Specifications....7................................................................4 Options of the Communication System...............................1.........................8......... 6-29 6............4.........2 Alphabetic List of Alarms.2 PRE POST Dialysis data handling.....................5 Prescription Download with the Exalis System.... ............................................... 7-25 7.......8..................2 How CentryNet Communications Work....................................... 8-7 8................... COMMUNICATION SYSTEM............................................. 7-3 7......7....... ALARMS AND SIGNALS ...................................... ......................3...............................................6 Ultrafiltration system..................................................9-9 9.......................................I A...9-39 9.............4 Descaling....9-41 9.........9-37 9..............2 Dialysate...3.......B-1 C................9-22 9..2 Hydraulic section .........................9-28 9......................................9-1 9...........................................................................................9-1 9.....................................................................3 Extracorporeal Circulation ..........................Electromagnetic Emissions and Immunity...............9-26 9..........1 Disconnection of the three Ultrafilter Bypass connector lines .......................................................................2 Connection of the Ultrafilter Bypass connector ..........2........................C-1 C.................................2.........................................................................................................C-1 C........5 Main Surveillance Devices ........... SPECIFICATIONS ................................................................... APPENDIX A: Guidelines and Manufacturer’s Declaration ..............................................................9-31 9......1 General specifications ........................................................................................................2...........................2....XLIV PHOENIX OPERATOR MANUAL 9.............9-25 9.....3................................6 Technician Maintenance.....................................................................................9-35 9..................................................................................9-22 9..................................................... APPENDIX C: Ultrafilter Bypass Connector Installation ..............................3..... 9-8 9...........8 Operating Modes...................................................................5 Disinfection......................................... concentrates and water...................4 Automatic Functions...............C-9 Rev............................... APPENDIX B: Special Troubleshooting ........................................................ B ..2.1 Operating Modes.......................................................................................................................1 Water supply ..........................9-8 9............................3.........9-33 9............................A-1 B................................................................9-23 9........................9-40 9...........................9-38 9.......................9-43 WARRANTY ....................................2....................6 Safety system actuators .....3.....................................................2 Blood Pumps ...........................7 Detection of Extracorporeal Blood Loss ...................2............9-31 9.................3 Materials in contact with dialysate.....4 Protection System.......................................................................5 General Safety Controls ...................................................................................3 Heparin Pump.2............................................................................ 10810 West Collins Avenue Lakewood. INTRODUCTION XLV ADDRESSES Should you require technical assistance. Head Office 8th Floor. CO 80215-4498 Tel. 9157 Champ d'Eau St Leonard Quebec H1P 3M3 Tel 514 327 16 35 Fax 514 327 08 22 KOREA : Gambro Korea Ltd. 800 525 2623 303 232 6800 Fax 303 231 4032 CANADA : GAMBRO Inc.2 415 97 72 Fax 82 . B .2 424 31 25 Rev. USA GAMBRO Renal Products. Hanmi Tower 45 Bangee-dong Songpa-Ku KR-SEOUL 138-050 Tel 82 . contact your Local Service Representative as listed below. Inc. A.XLVI PHOENIX OPERATOR MANUAL MEXICO : Gambro de Mexico S. (Sydney) P. de CV Vasco de Quiroga 1900.O.2 9 680 27 11 Fax 61 . Box 6604 BHBC Baulkham Hills AU-NEW SOUTH WALES 2153 Tel 61 . B .2 9 634 13 75 Rev. 01210 Tel 52 . F.55 52 92 31 13 AUSTRALIA : Gambro Pty. Piso 3 MX-Santa Fe MEXICO D. Ltd.55 52 92 31 00 Fax 52 . The machine has many built-in features which are intended to enhance the ease of providing patient dialysis treatments. Depending upon the therapy in use. and back to the patient. a heparin-filled syringe. Hemofiltration In hemofiltration. As the blood passes through the filter. a dialyser. Rev. The replacement solution adds back some or all of the water removed. Ultrafiltration In ultrafiltration. 1. the body’s excess fluid is removed through the dialyser membrane by means of a pressure gradient between the blood and dialysate compartments in the dialyser. a BiCart® column (sodium bicarbonate powder). the desired treatment processes take place. the treatment processes can include fluid removal and/or solute clearance. In the dialyser. 1 GENERAL DESCRIPTION 1. accumulated metabolic products are removed from blood by the process of convective transport as a consequence of ultrafiltration of fluid across a dialyser semi-permeable membrane of high-flux type.1. and other appropriate dialysate concentrates.1 Structure of the machine PHOENIX is a self-contained. microprocessor-controlled device that provides haemodialysis. it does not monitor and control infusion of replacement solution. The entire ultrafiltration process is monitored and controlled by the dialysis machine. hemofiltration and ultrafiltration therapies. in a blood tubing set properly designed for the machine. B . The Phoenix machine can carry out the following therapies: • Ultrafiltration • Hemofiltration • Hemodialysis. The volume of filtered fluid that exceeds the desired weight loss is replaced by sterile pyrogen-free infusion solution infused into the blood flowpath.GENERAL DESCRIPTION 1. While the dialysis machine monitors and controls the entire ultrafiltration process. SECTION 1 .1 Therapies Description The Phoenix Hemodialysis Machine pumps blood from the patient. through the dialyser where purification takes place. The system consists of the Haemodialysis Machine in use with a blood tubing set designed for the machine. the blood and the dialysate fluid flow on opposite surfaces of a thin semi-permeable membrane. as well as the prescribed solutes. Rev. The PHOENIX is a single-pass system. The body’s excess fluid is removed through the membrane by means of a pressure gradient created by the dialysis machine.1. Hydraulic and Blood Modules is called the Control System. MASTER MODULE Supervises the functioning of all machine processes. The unit consisting of the Master. may be mixed with heparin to prevent coagulation. Arterial blood is withdrawn from the patient. The modules are described below. The entire hemodialysis process is managed by the dialysis machine which monitors and controls the total ionic composition of dialysate solution together with the ultrafiltration process. The machine reverts to a specific safe state when patient safety is in question.E – Monitoring. PROTECTION MODULE Manages all processes related to safe operation of the machine and alarm conditions that occur during dialysis due to unsafe conditions. dialysate passes through the circuit once.e. It is made up of five modules that carry out independent functions. passed through the dialyser and then is returned to the patient. through which it is possible to: • select various operations • set parameter values • receive operator and alarm messages HYDRAULIC MODULE Supervises the dialysate preparation and the measurement and control of ultrafiltration. i. Dialysate preparation is continuous and its conductivity is determined by the parameters selected by the operator.2 Structure of the machine PHOENIX has a modular structure. B . It allows the operator to communicate with the machine via a colour. causing these solutes to diffuse from a compartment of greater concentration (the patient’s blood) to a compartment of lesser concentration (the dialysate solution) across a natural or synthetic semi- permeable membrane. The machine is fail-safe in the event of a single point failure occurring during treatment. BIO MODULE Manages all processes related to Diascan (see Section 5.1-2 PHOENIX OPERATOR MANUAL Hemodialysis In hemodialysis. 1. In this case the concentration of solutes unwanted or to be cleared is lower or null in the dialysate with respect to the blood. BLOOD MODULE Manages all the machine processes on the blood side of the extracorporeal circuit. normalizing ionic content and adding buffer through the process of diffusive transport. the chemical composition of blood is corrected by removing accumulated metabolic products. touch screen graphical user interface. in this manual). 2 Description of the machine 1.2. B .GENERAL DESCRIPTION 1-3 1.1 Front view (For machines with Serial Number greater than PH25160 the Patient Card reader is not available. SECTION 1 .) Rev. The four clamps are colour coded for correct line placement as follows: Green-heparin line.1-4 PHOENIX OPERATOR MANUAL Machine Components – Front View (A) Patient Card Reads the Patient Card. resume blood pump speed and decrease/increase blood pump speed. HELP button (CURRENTLY NOT AVAILABLE) and EVENT/INTERVENTION (CURRENTLY NOT AVAILABLE) button. Option) (K) Acid/Acetate Connects to a container of acid concentrate (for bicarbonate Line (red haemodialysis) OR acetate concentrate (for acetate haemodialysis). (For machines with Serial Number greater Reader than PH25160 the Patient Card reader is not available. mute or reset/override alarms. B . The cover latch keeps the blood pump cover closed during operation and the Cartridge securely in place over the arterial and venous pressure sensors. connector) and The acid/acetate line is connected to its red rinse port during rinse Rinse Port and storage. Red (right)- arterial access line. Prevents blood flow to the patient.) (B) Display/ Allows the operator to communicate with the PHOENIX Haemodialysis Delivery System via colour Touch Screen and control Touch Screen buttons. can be programmed with any combination of the following: stop the blood pump. Blood Pump Pumps blood through the extracorporeal circuit. An additional button. Red (left)-cartridge saline line. (I) Venous Line Occlusive clamp that closes the venous line during certain red-light Clamp alarms. (C) Main Control A panel of buttons whose functions allow the operator to access and Panel modify parameters. or enter minimum UFR. (E) 4-Position Line Plastic assembly that holds the four access lines extending from the Clamp top of the Cartridge Blood Set. HEART button (initiates a blood pressure measurement). some self-tests. the SAFE button (CURRENTLY NOT AVAILABLE). If macro or micro air is detected. an “! AIR & FOAM DETECTOR” alarm (number 4) occurs (blood pump stops and Patient Sensor venous line clamp closes). (F) Blood Pump A plastic cover that protects the blood pump from foreign objects Cover and Cover and provides a track inside the cover to hold the pump segment of Latch the Cartridge Blood Set on the pump rollers. The blood pump will not run unless the door is securely latched. and when power is off. (G) Air Bubble Ultrasonic sensor that detects macro and micro air in fluid/blood Detector within the venous line. (D) Blood Pump A panel of buttons that allows the operator to control blood pump Control Panel functions: turn blood pump on/off. Rev. bypass the dialyser. The infra-red Patient Sensor detects the presence of blood in the venous line. (J) WHO™ (Waste Connects a WHO priming connector on the Cartridge Blood Set to a Handling drain port to dispose of waste fluids produced during priming. Blue-venous access line. (H) Arterial Line Clip Secures arterial line to the machine. When blood is detected the Protection Module is fully activated. GENERAL DESCRIPTION 1-5 (L) Bicarbonate Line Connects to a container of bicarbonate concentrate. (P) Heparin Syringe Holds the barrel of the heparin syringe. Heparin Pump Controls the rate of heparin delivery into the blood flow path. The Panel Latch latch can be opened with a hex key. (U) Main Power Turns machine power On/Off. if desired. (V) BiCart Holder Holds a BiCart (powdered bicarbonate cartridge) for bicarbonate dialysis. and during rinse and storage. During the main machine phases it must be connected to connector) and its rinse port. moves horizontally to push Plunger Clamp heparin into the blood flow path at the specified rate. (inside machine) Heparin can be delivered continuously or in bolus amounts. Rinse Port (N) Concentrate Located on bottom front. holds containers of liquid concentrates Container Shelf needed for haemodialysis therapy. If blood is detected. (M) Disinfectant Line Connects to a chemical container used during the machine chemical (yellow processes. when the and Rinse Port machine is used for acetate dialysis. The holder arms open to allow a BiCart to be inserted Note: Bicarbonate concentrate in a container can be used for bicarbonate dialysis instead of BiCart. (O) Locking Brake Prevents the machine from moving when in use. a Blood Leak alarm (#28) occurs (blood pump stops and venous line clamp closes). Blood Leak Infrared light detector that detects red blood cells in the dialysate Detector (inside leaving the dialyser. The switch is also a circuit breaker and shuts off Breaker power in the event of an internal electrical overload. B . Holder (T) Blood Module Secures the blood module panel (middle third of front panel). (R) Heparin Syringe Holds the plunger of the heparin syringe. Holder (Q) Heparin Control Panel of two buttons that move the plunger clamp to ( ) or away Panel ( ) from the syringe plunger. Only Service technicians should open the latch (to service the internal blood module components). Rev. then ON. SECTION 1 . Blood in the dialysate indicates a leak or tear in machine) the dialyser membrane. The breaker can be reset by turning the machine OFF. The label “I” means ON and the label Switch / Circuit “O” means OFF. (S) BPM Cuff Houses the BPM cuff when not in use. The bicarbonate (blue connector) line is connected to its rinse port when a BiCart is in use. 1-6 PHOENIX OPERATOR MANUAL 1. B .2.2 Rear view Rev. (C) IV Pole Adjusts up/down for convenient placement of IV solutions.GENERAL DESCRIPTION 1-7 Machine Components – Rear View (A) Solution Bag Hooks Holds containers of IV solutions for administration through the Cartridge Blood Set. the machine is operating in Bypass or Minimum UFR. Switch (F) Hour Meter Accumulates hours of full power operation. the operator should intervene immediately. A condition of possible patient or machine hazard exists. but the operator should investigate. (E) Ultrafilter Detection Detects the presence of the Diaclear Ultrafilter. Depending on the machine version. (I) BP Tubing Connects luer lock on tubing of the PHOENIX BP Monitor to the Connector internal electronic module. for example. allowing manual blood return to the patient. Immediate patient safety is not compromised. (D) Status Lights Illuminate to give a general indication of operating conditions. Hours spent in low power are not counted on the meter. (J) Air Vents Provide continuous ventilation of interior components.0 in the Section 09 – Specifications). if necessary. (H) Ultrafilter Bypass A connector linking the ultrafilter lines when the Diaclear Connector Ultrafilter is not being used. The flashing red light will be displayed in the event of a general safe state condition. for example the machine has detected air in the venous line or blood in the dialysate line. (N) Chemical Container Holds containers of liquid chemicals needed for ADR procedures. B . (P) Inlet Water Hose Connects to the facility’s water supply and carries water to the machine. SECTION 1 . (K) Blood Pump Crank Crank fits on the blood pump rotor. (G) Computer Interface Provides ports for PHOENIX options including connection to Panel external networks. Yellow A flashing yellow light indicates: • one or more alarms have been overridden. Rev. (B) IV Pole Adjustment Loosens/tightens to adjust and hold the IV pole at the desired Knob height. equipment) (M) Wand Holder Stores the concentrate wands and the conductivity sampler when they are not being used. (L) Cable Holder (for Holds the power cable when the machine is being moved or not storage of being used. Shelf (O) Power Cord The power cord is permanently attached. • a low priority alarm has occurred. the Hour Meter can be located either on the left side of the Ultrafilter Bypass Connector (as shown in the Figure) or in the Computer Interface Panel (see Figure 9. Red A flashing red light indicates a high priority alarm has occurred. this line must connector) and be connected to its bypass port. (R) Dialysate Line From Carries used dialysate from the dialyser. ADR procedures. Bypass Port (T) Cartridge Holder Accepts the Cartridge Blood Set and secures it in position with the Cartridge clip (on the left) and the blood pump rotor (on the right). During the hydraulics Dialyser (blue portion of T1 TEST. Consists of a movable arm and two grippers attached to the machine. the blue cone connects with the venous chamber. and storage. (V) Inlet Water Filter Inlet Water Filter Standard (250 μm). B . and storage. Has two pressure transducers with sealing cones for pressure monitoring. The red cone connects with the arterial chamber.1-8 PHOENIX OPERATOR MANUAL (Q) Drain Hose Connects to the facility’s drainage system and carries away used dialysate. Bypass Port (S) Dialysate Line To Carries fresh dialysate to the dialyser. Rev. ultrafiltrate. During the hydraulics Dialyser (red portion of T1 TEST. ADR procedures. (U) Dialyser Holder Holds the dialyser. and other waste fluids. this line must connector) and be connected to its bypass port. Rx/Patient Name Area: displays the therapy or name of the patient selected through personalised dialysis treatment procedures. Status Area: one message is displayed to describe the current status of the machine. which contains both the name and the number of the alarm. The alarm messages are the current active alarms that are occurring on the machine or the most significant. the Touch Screen has the following configuration: 1 2 3 4 TIME RX /PATIENT NAME AREA ALARM AREA STATUS AREA AREA 5 6 7 BPM AREA OPERATOR MESSAGE AREA PICTOGRAM AREA 10 9 12 ARTERIAL/VENOUS PARAMETER AREA ACTION 8 SELECTION PRESSURE BAR GRAPHS OPERATION IN PROCESS I KEYS AND VIEW DISPLAY C O N A R E 11 A BLOOD PUMP SPEED FLOW AREA 14. SECTION 1 . 3. If there are more than 2 alarms. the additional alarms may be viewed on the Machine view by pressing the Machine Navigation key. will appear in this area.GENERAL DESCRIPTION 1-9 1.3 Operator interface General description The PHOENIX operator interface consists of: • A colour Touch Screen display that shows: − parameters and commands which the operator can select − alarm messages − operator messages − status icons and pictograms − Navigation keys to access different views on the Touch Screen. 4. NAVIGATION KEYS HOME 1. Time Area: displays the current time of day. 2. an alarm message window. 13. During normal operation. if more than 2 are occurring. Rev. B . Alarm Area: in the event of any alarm. Pictogram Area: displays a visual indicator of machine state/operation. 10. pay careful attention to the messages displayed in the Operator Message Area of the Touch Screen. (see “Pictograms ” in this section) 8. 11. Moreover it displays the time of the last BPM measurement. In this manual they are described as “CURRENTLY NOT AVAILABLE”.Blood Pump Speed/Flow Area: displays current blood pump speed and compensated blood flow rate. 6. 13. Parameter Area: displays parameters appropriate to the operation in process and view displayed. 14. B . Icon Area: displays the icons that represent current feature/option enabled. Note Format of time representation is user settable in Configuration environment.Action/Selection Key Area: displays Action keys used to start each specific operation and Selection keys for selection menus. 12. 7.HOME Navigation Key Area: displays the HOME Navigation Key icon.Arterial/Venous Pressure Bar Graphs: displays current arterial and venous pressures. Note Some Action keys and parameters appearing on the Touch Screen are currently not available. Operator Message Area: displays the operations that need to be carried out or messages regarding the status of the machine. BPM Area: displays the last systolic and diastolic blood pressure and the heart rate as measured by the Blood Pressure Monitor. • a Main Control Panel below the Touch Screen: Or Rev. (see “Icons representing processes” in this section) 9.1-10 PHOENIX OPERATOR MANUAL 5.Navigation Keys Area: used to access each available Touch Screen view. Format of time representation in this manual is only for reference. (see “HOME icon” in this section) WARNING To operate the machine correctly. SECTION 1 . The buttons located on the Heparin Pump Control Panel are called HEPARIN PUMP Function buttons: Rev. (CURRENTLY NOT AVAILABLE) or HELP button (CURRENTLY NOT AVAILABLE) HEART button: Initiates a BPM measurement outside of the automatic interval. (CURRENTLY NOT AVAILABLE) See Section 7 .Communication System in this manual for a detailed description. Pressing the HEART button initiates a blood pressure measurement. B . PLUS and MINUS buttons increase/decrease the parameter values when the parameter has been selected in Set mode and it has a numeric value.GENERAL DESCRIPTION 1-11 • a Blood Pump Control Panel above the Blood Pump: • a Heparin Control Panel above the Heparin Pump: The buttons located on the Main Control Panel are called FUNCTION BUTTONS: MUTE button used in an alarm condition to silence the audible alarm (see Section Alarms and Signals). SET button is used to enter the Set Mode set CONFIRM button. Used to confirm and store the values selected or actions requested. EVENT/INTERVENTION button: Allows the user to mark a patient event/intervention and store it in the system memory. OVERRIDE/RESET button used in an alarm condition to override/reset an alarm (see Section Alarms and Signals). SAFE button allows the user to put the machine in the safety state customized by the facility in Configuration. Placement of this clamp against the syringe plunger is very important to ensure accurate delivery of heparin. The Led is Flashing: • When the Blood Pump speed is controlled by the machine and can not be changed by pressing the PLUS and MINUS buttons (i. • In SN dialysis. B . following the selection of a button. is stopped due to an operator intervention (for example Recirculation phase stopped due to the selection of the RECIRC Action key). The Led is OFF: • When the Blood Pump is stopped by using the ON / OFF button. the ON / OFF button is not active. • A superimposed window is present on the Touchscreen and the selection of that particular button is not requested by the superimposed window.e. Note: When the Blood Pump is stopped due to an alarm condition. • When the Blood Pump is stopped due to an alarm condition. • The PLUS and MINUS buttons are pressed but a manual increment/decrement of the blood pump speed is not possible in that machine phase. PLUS and MINUS buttons are used to change the blood pump speed The green Led on the ON / OFF button can be ON. • When a machine phase. during the Automatic Gradual Ramping). in this case wait at least 5 seconds before pressing again a button to let the machine recognize the selection made. has been correctly completed (for example the programmed RINSEBACK VOLUME value has been reached). in which the Blood Pump is running. RESUME button is used to restart the blood pump at the previous set value or to restart the blood pump after an ! Air & Foam Detector alarm (#4). in which the Blood Pump is running.1-12 PHOENIX OPERATOR MANUAL ARROW LEFT and ARROW RIGHT buttons are used to position the heparin syringe plunger clamp against or away from the syringe plunger. • When a machine phase. when: • The machine has not been temporarily able to detect correctly the button previously selected. The buttons located on the Blood Pump Control Panel are called BLOOD PUMP Function buttons: ON / OFF button is used to start the blood pump at the preset start value or to stop it when it is running. OFF or flashing depending on the machine operating conditions. The Led is ON: • When the Blood Pump is running. Rev. during both the arterial and the venous phases of the cycle. Note An audible signal (an high tone followed by a low tone) triggers. the Idle view is displayed on the Touch Screen indicating which procedures are available to run. Switch OFF the machine. in this manual). B . one or both signals have malfunctioned. If either signal is not present.Test Procedures. 12:30 IDLE PATIENT DATA SETUP ADR BPM REPORT CONFIG RX MACHINE CONFIG Each view is referred to by its Navigation key name.B . The operator takes full responsibility when a dialysis treatment is carried out in the absence of the audible and visual alarms. Note If the Touch Screen turns black or white during the software loading process. a temporary machine malfunction has occurred. Call for service. Rev. WARNING Check that the alarm lights and audible indicators come on for a short time immediately after the machine is powered ON (see Section 5. The operator can choose which procedures to run as described in the following sections of this Operator’s Manual.GENERAL DESCRIPTION 1-13 Operating modes When the machine’s ON/OFF switch is turned ON the software program is loaded. At the end of the software loading process. wait 5 seconds and then switch ON the machine again. SECTION 1 . The progress and the successful completion of the software loading process can be seen on the Touch Screen. Do not operate the machine if the alarm safety system is not functioning. the specific function of each ACTION key is explained as well as the operations to be carried out. It takes a few minutes for the machine to become fully operational. The pictogram displayed in the upper right hand corner of the touch screen indicates the current status of the machine. For each process/procedure. NOT Performed Correctly h:min – day/month/year (1) User Stop or Alarm message (if present) Phase XX (See Note 3) Heat Proc. B . NOT Performed Correctly h:min – day/month/year (1) User Stop or Alarm message (if present) Phase XX (See Note 3) Rev.1-14 PHOENIX OPERATOR MANUAL At Power ON. is displayed on the Touch Screen. some of the following Icons and relevant Help Messages may appear on the Touch Screen in the Parameter Area. Depending on the process. correctly completed or interrupted just prior to the machine Power OFF. Performed Correctly h:min – day/month/year (1) Chemical Proc. Performed Correctly h:min – day/month/year (1) Heat Proc. information related to the status of the last machine process. as listed below: Acetate Dialysis Completed h:min – day/month/year (1) NO ICON Bicarbonate Dialysis Completed h:min – day/month/year (1) NO ICON BiCart Dialysis Completed h:min – day/month/year (1) NO ICON Acetate Dialysis h:min – day/month/year User Stop Phase XX (See Note 1) Bicarbonate Dialysis h:min – day/month/year or (1) User Stop Phase XX (See Note 1) or BiCart Dialysis h:min – day/month/year User Stop Phase XX (See Note 1) Acetate Dialysis h:min – day/month/year Alarm message (if present) Phase XX or (See Note 2) Bicarbonate Dialysis h:min – day/month/year or or Alarm message (if present) Phase XX (1) (See Note 2) or BiCart Dialysis h:min – day/month/year Alarm message (if present) Phase XX (See Note 2) or or Rinsing Performed Correctly h:min – day/month/year (1) Rinsing not Performed Correctly h:min – day/month/year (1) User Stop or Alarm message (if present) Phase XX (See Note 3) Chemical Proc. A Disinf. NOT Perf. Correctly h:min – day/month/year (1) User Stop or Alarm message (if present) Phase XX (See Note 3) Process AutoStart Enabled (2) RINSING or HEAT or HEAT CWP or CHEMIC. Performed Correctly h:min – day/month/year (1) Heat CWP Proc. SECTION 1 . 1 or CHEMIC. B . 3 or CHEMIC. NOT Performed Correctly h:min – day/month/year (1) User Stop or Alarm message (if present) Phase XX (See Note 3) Heat Citric Proc. To allow SETUP remove connector from (4) NO ICON Central bicarb port and reinsert if needed (See Note 6) SETUP not Allowed. CITRIC Failure of the…[test failed]…Test h:min – day/month/year (3) New Session Feature not Allowed (See Note 4) Failure of the…[test failed]…Test h:min – day/month/year (3) (See Note 5) SETUP not Allowed. Correctly h:min – day/month/year (1) User Stop or Alarm message (if present) Phase XX (See Note 3) CCK Lines Rinse Performed Correctly h:min – day/month/year (1) CCK Lines Rinse NOT Performed Correctly h:min – day/month/year (1) User Stop or Alarm message (if present) Phase XX (See Note 3) Chem+Bicarb Line Proc. Performed Correctly h:min – day/month/year (1) Heat Citric Proc. NOT Performed Correctly h:min – day/month/year (1) User Stopor Alarm message (if present) Phase XX (See Note 3) Rinse+Bicarb Line Performed Correctly h:min – day/month/year (1) Rinse+Bicarb Line Not Perf. 2 or CHEMIC.GENERAL DESCRIPTION 1-15 Heat CWP Proc. 4 or H. Process (5) NO ICON Must be performed to allow SETUP (See Note 6) Rev. Venous Clamp. in this manual. the time and the machine operating phase in which the dialysis treatment has been interrupted. are also displayed the first alarm message that was displayed in the Alarm Area (if present) before machine Power OFF. the time and the machine operating phase in which the dialysis treatment has been interrupted. Electrovalves. Note 6 Refer to Section 3 – Central Concentrate Supply. are also displayed the reason that caused the ADR process to be interrupted (user intervention or the first alarm message that was displayed in the Alarm Area before machine Power OFF). Rev. Blood Pump. Voltages (24V).1-16 PHOENIX OPERATOR MANUAL Note Format of date representation in the Help Messages displayed at the machine power ON is user settable in Configuration environment. Note 5 This message is displayed in case of failure of one of the following T1Tests: Board CPU. the time and the machine operating phase in which the ADR process has been interrupted. EPROM CRC. Cond A. Note 1 This message is displayed in case of dialysis treatment interrupted during dialysate preparation or priming phase due to an operator intervention. Note 4 This message is displayed in case of failure of one of the following T1Tests: Temperature. Along with the Help message on the type of dialysis interrupted. Note 3 This message is displayed in case of ADR process interrupted due to an operator intervention or in case of machine Power OFF during an ADR process. Along with the Help message on the type of dialysis interrupted. for the detailed description of the CCK Bicarbonate Line Disinfection and of the CCK Acid and Bicarbonate Lines Rinse. Art/Ven Pressure. Battery. PI/PO Pressures and Ultrafiltration Pump. Note 2 This message is displayed in case of machine Power OFF following dialysate type selection. Along with the Help message on the type of ADR process interrupted. are also displayed the message informing that an user stop caused the dialysis treatment to be interrupted. B . Cond B and BLD. Format of date representation in the above table is only for reference. Comparator. for information about the CCK Bicarbonate Line Disinfection and about the CCK Acid and Bicarbonate Lines Rinse refer to Section 3 – Central Concentrate Supply in this manual. In the above table are indicated as (5) BPM REPORT CONFIG RX MACHINE CONFIG For information about the Dialysis process refer to Section 5 – Dialysis Operation. PATIENT DATA In the above table are indicated as (1) Message related to the Autostart feature. B . for information about the ADR Cycle refer to Section 6 – Clean/Disinfect. In the above table are indicated as (4) Message related to the completion of the Central Acid and Bicarbonate Lines ADR Rinse. SECTION 1 . In the above table are indicated as (2) Line Not Used Line Only for Service use SETUP Messages related to the T1Tests failure.GENERAL DESCRIPTION 1-17 The above Help Messages appears on the Touch Screen in the Parameter Area. Rev. in the following order: 12:30 IDLE Messages related to the completion of a process. In the above table are indicated as (3) Message related to the completion of the Central Bicarbonate Line Rinse. 1-18 PHOENIX OPERATOR MANUAL 1. Rev. positioned on the venous line in the Air Bubble Detector housing. positioned on the venous line in the Air Bubble Detector housing. Automatic bolus heparinization has been selected. has not detected the presence of blood. The UFR value suggested for recovery is shown in the SET Mode.3. The Patient Sensor. The machine is in bypass and dialysate flow is diverted from the dialyser. The UFR value suggested for recovery is shown in the SET Mode selecting the UFR parameter. Not all machine safety systems are activated. The Patient Sensor. The Heparin Pump is performing a linear heparinization. The Total Fluid Removed is at least 100 g more than the Total Fluid Removed forecasted for that time. The BPM device has been activated (automatic mode) A BPM measurement (manual or automatic) is in progress BY-PASS. has detected the presence of blood or there is a failure of the congruency test. The Heparin Pump is performing an automatic bolus heparinization Manual bolus heparinization has been selected. selecting the UFR parameter. The Total Fluid Removed is at least 100 g less than the Total Fluid Removed forecasted for that time. The Heparin Pump is performing a manual bolus heparinization. positioned on the venous line in the Air Bubble Detector housing.1 Icons representing processes The icons relating to particular machine processes or alarms are listed below: The Patient Sensor. has detected the presence of blood and all machine safety systems are activated. Linear heparinization has been selected. B . When there are records to be taken by the CentryNet network controller this icon flashes until the controller has successfully taken all records. Please refer to this Section for their description. Conductivity and UF Profiling have been activated CentryNet option has been deactivated. these icons will not be not shown. Waiting/reading data. SECTION 1 . B . Rev. CentryNet is active and effective communication is in progress. In the description of each process. Diascan is active and calibrated • Diascan autocalibration in progress • A Diascan measurement (manual or automatic mode) is in progress Diascan is present but not working The machine is configured for use of the Patient Card. CentryNet option is active but communication between the network controller and the machine does not occur. (This icon is not currently displayed) Conductivity Profiling has been activated. UF Profiling has been activated.GENERAL DESCRIPTION 1-19 A transmembrane pressure alarm is present and a negative TMP condition exists. 1-20 PHOENIX OPERATOR MANUAL 1.3.2 HOME icons The icons displayed in the HOME Navigation key Area are listed below: HOME Navigation key icon selected. B . HOME Navigation key icon not selected. HOME Navigation key icon selected in Set mode. Rev. GENERAL DESCRIPTION 1-21 1.2 List of Pictograms Idle: the machine is waiting for an operator action Rinsing: the machine is performing a RINSING process.3.1 Background shape Different shapes are used for each pictogram.3. The shapes and their meanings are listed below: Alert: this shape is used to draw the operator's attention to an alarm or warning situation.3 Pictograms 1. Transitory Status: this shape means the machine has been put in a temporary situation after an operator action.3. B . Treatment starts when the operator initiates the preparation and ends after the FINAL RINSE. The operator has to respond to exit this status.3. SECTION 1 . 1. Rev.3. Out of Treatment: this shape means "out of treatment process" In Treatment: this shape means "in treatment process". Heat Citric Disinfection/Heating: the machine is performing a Heat Citric disinfection. Heat Disinfection/Cooling: the machine is performing a heat disinfection. The cooling phase is in progress. Dialysate Preparation & Test: the machine is performing the dialysate preparation and the functional test is in progress. Chemical Disinfection: the machine is performing a Chemical disinfection. B . The heating phase or the temperature sustained phase is in progress. The Cooling phase is in progress. The heating phase or the temperature sustained phase is in progress. Rev.1-22 PHOENIX OPERATOR MANUAL Heat Disinfection/Heating: the machine is performing a heat disinfection. Dialysate Preparation & Test completed: the machine is performing the dialysate preparation and the functional test is completed. Dialysate Preparation & PA or PB or PUF Autocalibration: the machine is performing the dialysate preparation and the PA or PB or PUF Autocalibration. Heat Citric Disinfection/Cooling: the machine is performing a Heat Citric disinfection. Dialysate Priming of dialyser: the machine is rinsing the dialysate compartment first. (This pictogram is not currently displayed) Priming ended awaiting Recirculation: the machine has completed the priming phase and is waiting for an operator action to start Recirculation. Dialysis Priming without UF: the machine is performing dialyser priming without UF. awaiting Patient Connect: the machine has completed priming and is waiting for an operator action to start patient connection. (This pictogram is not currently displayed) Diascan Autocalibration: Diascan autocalibration is in progress. only the dialysate side is filled. Rev. only the blood side priming is started. B . the blood side and the dialysate side are filled. Dialysate Recirculation: the machine is performing RECIRCULATION. End Priming.GENERAL DESCRIPTION 1-23 Dialysate Preparation ended awaiting Priming: the machine has completed the dialysate preparation and is waiting for an operator action to start priming. or Manual Priming: the machine is performing the manual priming of the dialyser. Dialysis Priming with UF: the machine is performing dialyser priming with UF. SECTION 1 . Single Needle Dialysis: Single Needle dialysis is in progress. WASHBACK: WASHBACK is in progress. Descaling: The machine is performing the DESCALING process with acid or vinegar solution after EMPTYING. Rev. Dialysis: treatment is in progress. Pause Therapy: The PAUSE THERAPY Action key has been selected for a temporary disconnection of the patient during treatment.1-24 PHOENIX OPERATOR MANUAL Patient Connection: patient connection is in progress. Rinsing: FINAL RINSE is in progress. Dialyser Emptying/Autoemptying: The dialyser emptying process is in progress. B . SECTION 1 . Set: SET MODE. Rev. In the description of each process. these pictograms will be not shown. Select: selection menu. B .GENERAL DESCRIPTION 1-25 Warning: warning yellow lamp. Please refer to this Section for their description. Alarm: alarm red lamp. 1-26 PHOENIX OPERATOR MANUAL 1. the operator must first press the SET button on the Main Control Panel. • To increase or decrease the value by using the PLUS and MINUS buttons on the Main Control Panel. the SET MODE is activated and a view that has all parameters available for modification will appear as shown below: 12:30 IDLE Parameter Name Parameter Name Parameter Name Parameter Name Parameter Value Parameter Value Parameter Value Parameter Value Unit of Measure Unit of Measure Unit of Measure Unit of Measure Min Max Min Max Min Max Min Max Parameter Name Parameter Name Parameter Name Parameter Name Parameter Value Parameter Value Parameter Value Parameter Value Unit of Measure Unit of Measure Unit of Measure Unit of Measure Min Max Min Max Min Max Min Max Parameter Name Parameter Name Parameter Name Parameter Name Parameter Value Parameter Value Parameter Value Parameter Value Unit of Measure Unit of Measure Unit of Measure Unit of Measure Min Max Min Max Min Max Min Max Parameter Name Parameter Name Parameter Name Parameter Name Parameter Value Parameter Value Parameter Value Parameter Value Unit of Measure Unit of Measure Unit of Measure Unit of Measure Min Max Min Max Min Max Min Max Parameter Name Parameter Name Parameter Name Parameter Name Parameter Value Parameter Value Parameter Value Parameter Value Unit of Measure Unit of Measure Unit of Measure Unit of Measure Min Max Min Max Min Max Min Max HOME (NOTE 1) (NOTE 1) (NOTE 1) (NOTE 1) (NOTE 1) (NOTE 1) (NOTE 1) Note The Navigation keys change according to the Config category selected. B . Once the desired value for the parameter has been reached. In order to modify parameter values. Each parameter must be confirmed individually. At this point it is possible: • To select a specific parameter to be modified by touching the parameter box on the Touch Screen. press the CONFIRM button on the Main Control Panel to accept and store the value in memory.4 Parameter Modification All significant parameters for the current process appear in the view chosen on the Touch Screen. • To select a different parameter for modification by touching that parameter box on the Touch Screen. By pressing the SET button on the Main Control Panel. Rev. The value range is selectable from 10 to 90 seconds (for more details see Section 2 . in this manual). The length of this timeout may be programmed in the Configuration menu. The parameter value displayed during normal operating processes is the same as the current value. The duplicate image in the yellow SAFETY BOX disappears as soon as the value is confirmed. SECTION 1 . the parameter being modified is shown in two places: it appears on the Touch Screen in the usual position and it appears in the yellow SAFETY BOX in the lower right hand corner of the Touch Screen.GENERAL DESCRIPTION 1-27 A yellow SAFETY BOX appears in the lower right hand corner of the Touch Screen when a Safety Relevant parameter has been selected for modification (refer to Section 02 – Configuration Description. since the machine recognizes a change in the parameter. but the audible alarm is automatically disabled for 2 minutes. The machine will exit the SET Mode automatically if the elapsed time without a key or button being pressed exceeds the value set for the TO VIDEO parameter. Note 30 seconds is the default interval. This alarm is controlled by the machine in the normal way for class Pd alarms. WARNING If the two values. Carefully check the two values to make sure they are the same. in this manual). Press the SET button a second time when the parameter modification has been completed to exit the SET MODE and to return to the current process view. in this manual: the Safety Relevant parameters are marked in the Parameters List).Configuration Description. in this manual: the Safety Relevant parameters are marked in the Parameters List). Rev. B . Note If the operator selects a Safety Relevant parameter for modification (refer to Section 02 – Configuration Description. Pressing CONFIRM allows the Protection Module to accept the value displayed in the yellow SAFETY BOX and store it in two different memory locations. stored by the Protection Module. Modification of a Safety Relevant parameter may cause a class Pd alarm. a class Pd alarm is triggered (see Section 08 Alarms and Signals. for the same Safety Relevant parameter are not identical at the time of use. SN MAXIMUM and SN MINIMUM PRESSURE (Single Needle transition pressure) The SN P and SN P parameters control the cycling of the single needle transition from the arterial phase to the venous phase. rather than a specific value. These minimum/maximum pressure values are selected using the PLUS (increase maximum) and MINUS (decrease minimum) buttons. by pressing the PLUS (increase high/low limit) and MINUS (decrease high/low limit) buttons to move the alarm limit window to positive/negative pressure values and then by pressing the CONFIRM button on the Main Control Panel. is selected for each pressure and it is displayed on the colour coded (red = arterial. In Single Needle dialysis. blue = venous) bar graph. the machine automatically recognizes the new venous and arterial pressure value. The arterial and venous pressures appear on separate pressure bar graphs.1-28 PHOENIX OPERATOR MANUAL Setting Alarm Limits for ARTERIAL. B . VENOUS. the limits are +10 mmHg and the value set for the VEN PRES LIMIT parameter in Config/Centre Conf/Treat. Store values by pressing the CONFIRM button on the Main Control Panel. created by the change in the blood pump speed. The maximum (high arterial pressure) limit of the alarm window corresponds to a value 100 mmHg greater than the confirmed arterial pressure value. The minimum (low venous pressure) limit of the alarm window corresponds to a value 40 mmHg less than the confirmed venous pressure value. Note Following adjustment of the blood pump speed. The maximum (high venous pressure) limit of the alarm window corresponds to a value 70 mmHg greater than the confirmed venous pressure value. the value set for the VEN PRES LIMITparameter has to be the same as the value set for the SN Pparameter to avoid the “! Ven Pressure Limit” #154 Alarm occurrence. An alarm limit window. • can be adjusted by selecting the colour coded area on the graph in Set mode.Conf. Rev. The alarm limit window can be selected in the following ways: ARTERIAL / VENOUS PRESSURE The negative and positive pressure alarm limit window: • can be confirmed by selecting the colour coded area on the graph in Set mode and then pressing the CONFIRM button on the Main Control Panel. respectively. SN MAXIMUM and SN MINIMUM PRESSURE. Note In Single Needle dialysis. The minimum (low arterial pressure) limit of the alarm window corresponds to a value 100 mmHg less than the confirmed arterial pressure value. in this manual). • The arterial pressure alarm lower limit is automatically set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg and the upper limit is set to +150 mmHg. Note Adjustment of the blood pump speed may lead to venous and arterial pressure fluctuations and a venous pressure/arterial pressure alarm may be triggered. for 30 seconds following a change in the blood pump speed: • The venous pressure alarm lower limit is automatically set to +10 mmHg and the upper limit is set to the VEN PRES LIMIT parameter value decreased of 50 mmHg (see Section 2 . Note If the blood pump speed is set to zero by the operator. the machine will automatically set the UFR to its minimum value. Note Calculation of the BLOOD FLOW in SN mode may be done by using the blood pump activation time and the blood pump speed: Blood Pump Speed x TART BLOOD FLOW = TCYCLE TART = Active time of Blood pump TCYCLE = Cycle time (activation + deactivation) Rev. using the PLUS (increase) or MINUS (decrease) buttons on the Blood Pump Control Panel. To prevent this. The arterial pressure window has a range of -400 mmHg to +150 mmHg. When the blood pump speed is reset to a value greater than zero.Configuration Description. B .GENERAL DESCRIPTION 1-29 Note The venous pressure window limit is automatically set to between -50 and +250 mmHg: • In PRIME and WASHBACK • After the RESUME button selection in case of! Air & Foam Detector alarm (#4). the UFR returns to the value set by the operator. SECTION 1 . Setting BLOOD PUMP SPEED This value is set from the Blood Pump Control Panel. 5. which may result in extracorporeal blood loss to the environment. This pressure drop may be less than the width of the machine's venous pressure alarm window: in this particular case the disconnection of a venous needle from its access site is not detectable by the machine. carefully follow the guidelines below: 1. blankets. it is recommended that the lower venous alarm limit is set as close as possible to the actual value of the patient venous pressure. Recommend patient to inspect its access site frequently. To reduce the risk of needles disconnection: • ensure that venous needle and line are firmly secured to the access site area according to your clinic's protocol. Ensure that the venous needle and the venous line are adequately fixed to the patient according to your facility's protocol. 4. 3. Undetected venous line needle dislodgement during hemodialysis. 1 Sandroni S. This particular situation is described in the literature1 To reduce the risk related to a Venous Needle Dislodgement event. SN MAXIMUM and SN MINIMUM PRESSURE” paragraph in this Section for the description of how to set the alarm limits for venous pressure). • ensure that the patient's access is visible at all times during the dialysis treatment. User has to be aware that venous pressure monitoring system is not always able to detect the pressure drop caused by a venous needle dislodgement. In particular. • inspect frequently the patient's access. Make sure that the patient's access is visible at all times during the dialysis treatment. 2. Pay a special attention to patients who are moving a lot during the dialysis treatment. linens.5 Monitoring of Venous Pressure and Venous Needle Dislodgement The Phoenix hemodialysis machine is provided with a venous pressure monitoring system able to trigger an alarm condition in case that the patient venous pressure falls below the venous pressure alarm threshold set by the operator (Refer to the “Setting Alarm Limits for ARTERIAL. Medical Device Safety Reports. Rev. • adjust properly the venous pressure alarm window: the venous pressure alarm lower limit should be set as closely as practical to the actual patient’s venous pressure value without generating excessive nuisance alarms. Venous needle dislodgement during hemodialysis: An unresolved risk of catastrophic hemorrhage. 27: 404-406. WARNING Monitoring of the Venous Pressure could not always detect the disconnection of a venous needle from its access site. Do not cover the access with clothing. Visually inspect the patient's access frequently for needle security and site bleeding.1-30 PHOENIX OPERATOR MANUAL 1. B . even if pressure alarms and alarm windows are properly set. 9: 33-34. Health Devices 1998. Hemodialysis International (abstract) 2005. When a venous needle disconnects from its access. pressure at the venous monitoring side may only decrease by the pressure maintained within the patient's access site. Properly adjust the venous pressure alarm windows. VENOUS. B .1 Configuration Environment General Description Before carrying out a dialysis process. 2 CONFIGURATION DESCRIPTION 2. SECTION 2 . the operator can set the parameter values to be used during dialysis entering the Configuration environment. from the IDLE View.CONFIGURATION DESCRIPTION 2. the Config Navigation key or the Rx Config Navigation key (in case of individual prescription parameters configuration – Patient/Rx keys will individualize a particular prescription parameters configuration). This may be done by selecting. 12:30 IDLE BPM REPORT KT/V PROFILE CONFIG RX MACHINE CONFIG Rev. B . the following view is displayed: 12:30 IDLE CONFIG MACHINE CENTRE ADR TREATMENTS PROFILE KT/V CONF Rev.2-2 PHOENIX OPERATOR MANUAL • When the Config Navigation Key is pressed. allowing customization of machine performance. B .CONFIGURATION DESCRIPTION 2-3 • When the Rx Config Navigation Key is pressed. SECTION 2 . Note Both the Config and the Rx Config Navigation Key are only available when the machine is in the IDLE mode. the following view is displayed: 12:30 IDLE 1ST PATIENT 2ND PATIENT 3RD PATIENT 4TH PATIENT 5TH PATIENT 6TH PATIENT 7TH PATIENT RX CONFIG The user can navigate through the views grouping all the configuration parameters of the machine by using the Navigation keys: pressing each Navigation key allows the user to access the parameters related to the designated function. Rev. The physician is solely responsible for clinical adequacy of the parameters setting. a view with the following structure is displayed: 12:30 IDLE PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER NAME NOTE 1 NOTE 1 NOTE 1 NOTE 1 NOTE 1 NOTE 1 NOTE 1 Note 1 The Navigation keys vary depending on the selection made from the Configuration environment. B . The following procedure must be followed to modify machine parameters: After selecting the Navigation key for the parameters to be modified. Note The number of parameters displayed in the Parameter Area can be variable.1. A list of all the parameters related to the Navigation key pressed is displayed in this view. with corresponding parameters are described. Each parameter appears on the parameter area in a double column representation.2-4 PHOENIX OPERATOR MANUAL 2. Rev. In the next paragraphs all the views of the Configuration environment.1 Entering Data on the Configuration Environment WARNING Setting of the Configuration environment must be performed exclusively under the authority of a physician. • To change a parameter with a “numeric” value by using the PLUS and MINUS buttons on the Main Control Panel. as shown in the example below: 12:30 IDLE PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER PARAMETER PARAMETER PARAMETER VALUE VALUE VALUE VALUE UNIT OF MEASURE UNIT OF MEASURE UNIT OF MEASURE UNIT OF MEASURE MIN MAX MIN MAX MIN MAX MIN MAX PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER PARAMETER PARAMETER PARAMETER VALUE VALUE VALUE VALUE UNIT OF MEASURE UNIT OF MEASURE UNIT OF MEASURE UNIT OF MEASURE MIN MAX MIN MAX MIN MAX MIN MAX PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER PARAMETER PARAMETER PARAMETER VALUE VALUE VALUE VALUE UNIT OF MEASURE UNIT OF MEASURE UNIT OF MEASURE UNIT OF MEASURE MIN MAX MIN MAX MIN MAX MIN MAX PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER PARAMETER PARAMETER PARAMETER VALUE VALUE VALUE VALUE SAFETY UNIT OF MEASURE UNIT OF MEASURE UNIT OF MEASURE UNIT OF MEASURE MIN MAX MIN MAX MIN MAX MIN MAX PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER NAME PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER BOX UNIT OF MEASURE UNIT OF MEASURE UNIT OF MEASURE MIN MAX MIN MAX MIN MAX VALUE UNIT OF MEASURE MIN MAX At this point it is possible: • To select a parameter by touching the parameter box area. Once the desired value has been selected. • To change a parameter with a “string” value: after touching the parameter box area. pressing the CONFIRM button on the Main Control Panel accepts the value and stores it in memory. Rev. Once the desired value has been reached. pressing the CONFIRM button on the Main Control Panel accepts the value and stores it in memory. These buttons are used to modify the desired value for a parameter within a fixed range. The parameter box corresponding to the current value for the parameter selected is yellow highlighted. SECTION 2 . • To move from one parameter to another by pressing a different parameter box area. When the SET button is pressed. B . by touching these areas the operator selects the desired value. This view has the same form as the previous one: the possible values for the parameter are located in parameter boxes. the SET Mode is activated and the view will change.CONFIGURATION DESCRIPTION 2-5 The operator may modify any parameter value by pressing the SET button on the Main Control Panel. a new view appears with a list of all the values for that parameter. in the yellow SAFETY BOX. Note All the parameters may be seen on the Configuration views. Their values are automatically calculated by the machine. in the yellow SAFETY BOX. for that parameter. switch OFF the machine. Note After modifying a parameter value in the CONFIGURATION environment and before switching off the machine.1. Note The previous parameter selection view may be accessed again by pressing the SET button on the Main Control Panel. If you erroneously confirm a value which is different from the value displayed. appears when a Safety Relevant parameter has been selected (refer to “2. but their values can no longer be modified. a yellow second box. Press the SET button again when parameter modification has been completed: the previous view appears. wait 5 seconds.1. wait at least 5 seconds to avoid a failure in the data storage. which may be verified by the operator.2 Parameters List Below is an alphabetic list of all the parameters.2-6 PHOENIX OPERATOR MANUAL The SAFETY BOX. for that parameter. WARNING Before confirming a value for a Safety Relevant parameter (refer to “2. then switch ON the machine again. Confirming a value different from that displayed in the yellow SAFETY BOX can cause machine alarms related to that parameter. B . a list of all the available parameters in their proper view is presented. Note set The parameters marked may not be changed by the operator. 2. Rev. Note The parameters marked are Safety Relevant parameters. with their respective limits or possible values.2 Parameters List”: the Safety Relevant parameters are marked in the Parameters List) make sure that the value to be confirmed is the same as the value displayed.2 Parameters List” for a list of all the Safety Relevant parameters: the Safety Relevant parameters are marked in the Parameters List). Note In the following paragraphs.1. CITRIC ACETATE DIAL USE YES/NO Enables/disables the use of the Acetate Dialysis mode.7 to 3. 2/CHEMIC. ART P From the value set for the MIN mmHg Arterial pressure alarm threshold.4 % Type of bicarbonate concentrate formulation. 2/CHEMIC. BICART COND 2. 4/H. the Cleaning Autostart. NO turns off BPM. AUTOMATIC allows BPM readings to start automatically with the initiation of Dialysis.6% COND 4.6% formulation is used BIC 8. B . Speed of the data transmission 9600 BEEP ON TOUCH YES/NO Enables/disables the generation of a loud beep for all user actions. 4/H.CONFIGURATION DESCRIPTION 2-7 PARAMETER VALUE UNIT 1st PROC NONE/RINSING/HEAT/HEAT First process that can be programmed for the CWP/CHEMIC. YES turns on BPM . 3/CHEMIC. 1/CHEMIC.7 in steps of 0. 3/CHEMIC. 2/CHEMIC. Cleaning Autostart. SECTION 2 .1 mS/cm Bicarbonate conductivity value when the 8. BICART DIAL USE YES/NO Enables/disables the use of the BiCart Dialysis mode. AUTOCHART TIME 00:00 to 01:00 in steps of 00:15 h:min Sampling time used by the machine to automatically acquire records for CentryNet/Exalis AUTOEMPTYING YES/NO Enables/disables the use of the Autoemptying procedure at the end of a DIALYSIS. MEMORY CARD. 4/H. BIC 6.1 mS/cm BiCart conductivity value. 1/CHEMIC. ART PRESSURE parameter increased of 100 to +50 BPM USE YES/NO/AUTOMATIC Enables/disables use of BPM (accessory in Patient dialysis mode). Cleaning Autostart.4% formulation is used. AUTO OFF YES/NO Enables/disables automatic Power OFF following RINSE.6 to 6. 2400 . Rev. CITRIC 2nd PROC NONE/RINSING/HEAT/HEAT Second process that can be programmed for CWP/CHEMIC. 1/CHEMIC. 3/CHEMIC.7 in steps of 0. BAUD RATE 1200.0 in steps of 0.7 to 3.4% COND 2.1 mS/cm Bicarbonate conductivity value when the 6. BICARB CONC 6. CITRIC 3rd PROC NONE/RINSING/HEAT/HEAT Third process that can be programmed for the CWP/CHEMIC. AUTO OFF YES/NO Enables/Disables automatic Power OFF following ADR processes.6/8. Depurated Vol set 0 to 200 l Volume of body water purified during DIALYSIS. CCM IDENTIF 1 to 255 in step of 1 Machine identification number for communication with CCM.0 to 17.1 mS/cm Final conductivity value. CENTR BICARB LINE set YES Selection of the Central Bicarbonate Line Disinfection process. dd/mm/yy mm/dd/yyyy mm/dd/yy dd mmm yyyy dd mmm yy mmm dd yyyy mmm dd yy DAY 1 to 31 dd Current day (calendar context) DAY NAME Monday/Tuesday/Wednesday/Thu Name of the current day (calendar context) rsday/Friday/Saturday/Sunday DELTA WEIGHT 1 to 20 Kg Difference between patient weight pre and post dialysis. DATE DISPLAY MODE dd/mm/yyyy Format of Date representation. CLEARANCE ALA. BOLUS INTERVAL 00:05 to 02:00 in steps of 00:05 h:min Time interval between each Heparin Bolus. COND STEP 13. YES/NO Enables/disables clearance alarm.0 in steps of 0. CURVE COEFF 20 to 80 in step of 5 % Percentage of the rate of change in Cond or UF during Profiling. Rev. BLOOD FLOW set 10 to 580 in step of 10 ml/min Blood flow value.0 to 17.2-8 PHOENIX OPERATOR MANUAL PARAMETER VALUE UNIT BLD SENS LOW/HIGH Sensitivity level of the Blood Leak Detector to the presence of blood in dialysate. DESCALING TIME 03:00 to 10:00 in step of 01:00 min:s Length of time for rinsing with an acidic solution after EMPTYING (Bicarbonate dialysis). COOLING set YES/NO Execution of the cooling phase after the heat disinfection. CONDUCTIVITY 13. CON CURVE TYPE PROGRESSIVE/STEP/CONSTANT Selection of the Conductivity curve type in Profiling.0 in steps of 0. B . CLEARANCE LEVEL 50 to 300 in steps of 5 Threshold value for clearance alarm SW COMM SYSTEM Exalis/CentryNet /Rims / Other / Selection of the software system to which the None machine will be connected.1 mS/cm Conductivity value for the conductivity step. DIAL AUTO PRIME YES / NO Enables/disables the priming mode selectable during dialysate preparation. 5 Kg Patient’s dry weight for the Volume calculation in Diascan. 350 to 800 step of 50 ml/min Dialysate flow rate during DIALYSIS. END DIA ALARM YES/NO Enables/disables alarm at the end of DIALYSIS. INCIDENT Patient event occurring during dialysis EXT SYNCHRO 00:00 to 01:30 in steps of 00:05 min:s Timeout used at the switch on to detect the network presence.CONFIGURATION DESCRIPTION 2-9 PARAMETER VALUE UNIT DIALYSATE FL. 30:00 or 28:00 to 43:00 in steps of 00:10 if END PROCESS MODE is set Bact. END PROCESS MODE None/Bact. / Rins. DRY WEIGHT 8. heat disinfection (not available on 12A version):18:00 to 36:00 in steps of 18:00 min or 20:00 to 40:00 in steps of 20:00 if the DIACLEAR Ultrafilter is installed. DIASCAN USE YES/NO Use of Diascan as accessory.1 mm Heparin syringe diameter DIASCAN YES/NO Enables/disables use of the Diascan feature in DIALYSIS. EXTERNAL JUG USE YES/NO Enables/disables use of external jugs for chemical processes. Enables the ending mode of the Chemical or Heat citric process.0 in step of 0. heat citric disinfection: 24 min or 28 min if the DIACLEAR Ultrafilter is installed.0 to 25. DIFFUSION TIME set From the value set for the h:min Time remaining until the end of DIALYSIS. SECTION 2 . INIT DIAL B FLOW 50 to 580 in step of 10 ml/min Blood pump speed at the initiation of DIALYSIS. B . DISINF TIME chemical disinfection: 15:00 to min:s Duration of disinfection process.0 in steps of 0. Rev. END DIALYSIS TWL/TIME/ T BL/DIFF. END DIA DATA set REQUESTED End dialysis data transferring mode END PRE ALARM YES/NO Enables/disables alarm at the end of dialysate preparation. FINAL RINSE TIME set From 01:00 to 00:00 min:s Time remaining until the end ofFINAL RINSE. TIME End point of the DIALYSIS treatment.0 to 200. DIALYSIS TYPE ACETATE/BIC CONC/BIC BICART Type of dialysate concentrates configured for DIALYSIS. DIALYSIS TIME parameter to Time is stopped when the machine is in 00:00 BYPASS or when the blood pump stops. DIAMETER 13. 9 in step of 0. GATEWAY 4th 0 to 255 in steps of 1 Parameter for Internal use. BOLUS/NONE HOURS 0 to 23 Hours (calendar context) INITIAL BOLUS 0.1 ml Volume of bolus injected automatically.0 in step of 0.0 in steps of 0. GATEWAY 2nd 0 to 255 in steps of 1 Parameter for Internal use. HEPARIN RATE 0. GATEWAY 0 to 255 in steps of 1 Parameter for Internal use.01 Kg/h Initial value for UF Profiling curve INITIAL VALUE 13.1 mS/cm Conductivity at the end of treatment for the COND profiling curve.5 to 10.0 to 17.0 in step of 0.1 ml Initial heparin bolus (before the linear heparinization mode) INITIAL VALUE 0. INTAKES 0 to 1000 g Food or fluids given during DIALYSIS. HEPARIN TYPE LINEAR/AUTO BOLUS/MAN Heparin infusion mode in DIALYSIS. Rev.1 mS/cm Initial value for COND Profiling curve INSTALL TIME set 0 to number of days elapsed from days Days elapsed from installation of the DIACLEAR DIACLEAR Ultrafilter installation Ultrafilter counted from the selection of the CLEAN DIAL Action key. 0.0 in steps of 0. END HEP ALARM YES/NO Enables/disables alarm at the end of heparin administration PRE STOP TIME 00:00 to 04:00 in step of 00:05 h:min Time between the end of heparin administration and the end of DIALYSIS.2-10 PHOENIX OPERATOR MANUAL PARAMETER VALUE UNIT FINAL VALUE 13. HEART Rate set 40 to 180 pulse Measurement of heart rate. GATEWAY 3rd 0 to 255 in steps of 1 Parameter for Internal use. B .00 in step of 0.10 to 4. Ionic Mass Bal set -500 to 800 mmol Mass Balance of ionized substances.0. INTERMEASUREM 00:00 to 01:00 in steps of 00:15 h:min Interval between two clearance measurements. PRIMING HEP YES/NO Enables/disables automatic priming of heparin line duringSETUP. IONIC CLEARANCE set 0 to 300 ml/min The average effective Clearance of ionized substances.00 Dialysis Dose (on Monitoring Graphs).1 ml/h (in linear heparinization mode) HEPARIN ALARM YES/NO Enables/disables alarm if heparin has not been activated at the start of DIALYSIS.0 to 17. KT/V set 0 to 3. HEPARIN BOLUS 0.5 to 9.0 to 10. Rev. MASK ROUTE1 3rd 0 to 255 in steps of 1 Parameter for Internal use.5 to 10.0 in steps of 0. MASK ROUTE1 4th 0 to 255 in steps of 1 Parameter for Internal use. HD SAFE THRE. MAX 45 to 250 in steps of 5 pu/min Maximum pulse rate alarm. 0. SYST PRE MAX 55 to 270 in steps of 5 mmHg Maximum systolic pressure alarm. MASK ROUTE1 2nd 0 to 255 in steps of 1 Parameter for Internal use. MANUAL BOLUS 0. 350/450 mmHg Alarm threshold on dialyser transmembrane pressure. MEDICATION Medicine/s administered during DIALYSIS.5 to 360. HEART R. SAMPLE INTERV (BPM) 00:05 to 02:00 in step of 00:05 h:min Time between 2 blood pressure measurements. B . MED QUANTITY Medicine quantity/dosage administered during DIALYSIS. VEN PRES LIMIT 200 to 450 in step of 50 mmHg Max venous pressure limit.1 ml Heparin bolus amount for manual bolus administration. IP ADDRESS 3rd 0 to 255 in steps of 1 Third part of the TCP/IP Configuration Addresses of the unit in case of Ethernet connection.5 l Total blood treated during treatment.0.0 in steps of 0. DIAST PRE MAX 35 to 250 in steps of 5 mmHg Maximum diastolic pressure alarm. MIN ART PRESSURE -400 to -100 in step of 50 mmHg Minimum arterial pressure limit. IP ADDRESS 2nd 0 to 255 in steps of 1 Second part of the TCP/IP Configuration Addresses of the unit in case of Ethernet connection. SECTION 2 .CONFIGURATION DESCRIPTION 2-11 PARAMETER VALUE UNIT IP ADDRESS 1st 0 to 255 in steps of 1 First part of the TCP/IP Configuration Addresses of the unit in case of Ethernet connection. MAX BLOOD FLOW 250 to 580 in steps of 10 ml/min Maximum Blood Flow. LIQUID INLET FRONT/REAR 1/REAR 2 Identifies the inlet port location for the disinfectant used in the chemical disinfection process. MASK ROUTE1 0 to 255 in steps of 1 Parameter for Internal use. IP ADDRESS 4th 0 to 255 in steps of 1 Fourth part of the TCP/IP Configuration Addresses of the unit in case of Ethernet connection. TOTAL BLOOD 0. BIC LIQUID DIAL USE YES/NO Enables/disables the use of Liquid Bicarbonate Concentrate. SYST PRE MIN 40 to 255 in steps of 5 mmHg Minimum systolic pressure alarm. MIN 30 to 235 in steps of 5 pu/min Minimum pulse rate alarm. NEW SESSION USE YES/NO Enables/disables the use of the New Session procedure and a shortened T1 Test. pH Min 1. NETWORK TYPE Serial/Ethernet Selection of the hardware network topology.1 pH units High alarm threshold for chemical solution pH monitor used in chemical process.0 to 12. BLOOD ALARM YES/NO Enables/disables an alarm when the Patient Sensor detects blood for 5 minutes and the machine is not in DIALYSIS mode. pH MONITOR YES/NO Enables/disables pH monitoring during disinfection processes. Each patient must have aunique identifier within the system.2-12 PHOENIX OPERATOR MANUAL PARAMETER VALUE UNIT DIAST PRE MIN 20 to 235 in steps of 5 mmHg Minimum diastolic pressure alarm.00 to 12.100 Kg/h Minimum fluid removal rate. TMP THRESHOLD -100 to +10 in steps of 5 mmHg Alarm threshold on dialyser transmembrane pressure. Rev. pH Max 7.5 in steps of 0. NET ROUTE1 3rd 0 to 255 in steps of 1 Parameter for Internal use. pH VALUE set 1.00 pH units Measurement of the pH value of fluid in the hydraulic pathway.5 to 14.0 in steps of 0. PATIENT ID 0 to 9999 in steps of 1 Code that identifies the patient within the communication system. WLR MINIMUM 0 to 0.300 in steps of 0. B . HEART R. NET ROUTE1 4th 0 to 255 in steps of 1 Parameter for Internal use. NET ROUTE1 2nd 0 to 255 in steps of 1 Parameter for Internal use.1 pH units Low alarm threshold for chemical solution pH monitor used in chemical process. NET ROUTE1 0 to 255 in steps of 1 Parameter for Internal use. PAUSE THERAPY YES/NO Enables the use of Pause Therapy Mode. MONTH January/…/December month (calendar context). JUMP PRIMING YES/NO Enables/disables priming of a dialyser and Cartridge Blood Set on another machine and then treatment using this machine. OFFLINE TIMEOUT 0:01 to 04:15 in steps of 00:01 min:s Timeout initiated when CentryNet/Exalis indicates lack of communication with the machine. MINUTES 0 to 59 min (calendar context). PRE SITTING H.00 mS/cm Representation of the effective plasma osmolarity. POST WEIGHT 8.00 to 17. Post Stand Hrat 30 to 250 pu/min Post dialysis heart rate measurement in a standing position. POST SITTING SYST 40 to 270 mmHg Post dialysis systolic pressure measurement in a sitting position. Rev. SECTION 2 . Post Stand Syst 40 to 270 mmHg Post dialysis systolic pressure measurement in a standing position. Post Stand Dias 20 to 250 mmHg Post dialysis diastolic pressure measurement in a standing position. PRE SITTING SYST 40 to 270 mmHg Pre dialysis systolic pressure measurement in a sitting position. Post Lying Hrat 30 to 250 pu/min Post dialysis heart rate measurement in a lying position.CONFIGURATION DESCRIPTION 2-13 PARAMETER VALUE UNIT Plasma Conduct set 13.0 to 200. B . Pre Stand Hrate 30 to 250 pu/min Pre dialysis heart rate measurement in a standing position. Pre Lying Hrate 30 to 250 pu/min Pre dialysis heart rate measurement in a lying position. Pre Lying Syst 40 to 270 mmHg Pre dialysis systolic pressure measurement in a lying position.0 Kg Patient weight after dialysis. Post Lying Syst 40 to 270 mmHg Post dialysis systolic pressure measurement in a lying position. PRE SITTING DIAS 20 to 250 mmHg Pre dialysis diastolic pressure measurement in a sitting position. Pre Lying Dias 20 to 250 mmHg Pre dialysis diastolic pressure measurement in a lying position. POST SITTING H.RATE 30 to 250 pu/min Pre dialysis heart rate measurement in a sitting position. Pre Stand Syst 40 to 270 mmHg Pre dialysis systolic pressure measurement in a standing position. Post Lying Dias 20 to 250 mmHg Post dialysis diastolic pressure measurement in a lying position.RATE 30 to 250 pu/min Post dialysis heart rate measurement in a sitting position. Pre Stand Dias 20 to 250 mmHg Pre dialysis diastolic pressure measurement in a standing position. POST SITTING DIAS 20 to 250 mmHg Post dialysis diastolic pressure measurement in a sitting position. RINSEBACK VOLUME 0 to 1000 in steps of 20 ml Volume of saline to be given in WASHBACK prior to alarm.0 Kg Patient weight before dialysis. If the DIACLEAR Ultrafilter is installed: 19:00 to 50:00.2-14 PHOENIX OPERATOR MANUAL PARAMETER VALUE UNIT PRE WEIGHT 8. Pparameter decreased of 40. set If performing a Central Concentrate Lines Rinse: 3 (fixed value) RINSING TIME 15:00 to 50:00 min:s Duration of rinsing for chemical disinfect in steps of 01:00. BLOOD FLOW 250 to 580 in step of 10 ml/min Blood pump speed in DIALYSIS mode. Ramping is from 50 mL/min to the value set for INIT DIAL B FLOW over the time defined forRAMPING TIME. LOW CONSUMPTION 0:00 to 02:00 in steps of 00:15 h:min Interval between the IDLE view and the blanking of the Touch Screen (machine low power consumption) after an ADR process correctly completed. REAL TREAT TIME set 00:00 to 23:59 h:min Real time of diffusion during DIALYSIS.100 Kg/h UF rate value during the Recirculation phase. RECIRCULATION TIME 01:00 to 55:00 in step of 01:00 min:s Recirculation time duration. RAMPING TIME 0:00 to 10:00 in steps of 00:30 min:s Time period for Automatic Gradual Ramping of the blood pump speed at initiation of DIALYSIS. B . PRIME PUMP SPEED 50 to 150 in step of 10 ml/min Blood pump speed value during the priming phase. RECIRCULATION UF 0. PRIME VOLUME 100 to 4000 in steps of 100 ml Volume of fluid infused during Dialyser Prime.100 to 3. SINGLE NEEDLE USE YES/NO Enables/disables use of Single Needle accessory. in steps of 5 SN P 100 to the value SET for the SN mmHg Single Needle min commutation pressure. Pparameter increased of 40. PAT CONN B FLOW 50 to 200 in step of 10 ml/min Blood pump speed value during PAT CONNECT phase. process.0 to 200. in steps of 5 Rev. in steps of 01:00. If the Clean Dialysate system is installed: 19:00 to 50:00.000 in step of 0. RINSEBACK B FLOW 50 to 200 in step of 10 ml/min Blood pump speed initial value during the rinseback phase. SN P 400 to the value SET for the SN mmHg Single Needle max commutation pressure. RINSE TIME 15:00 to 50:00 min:s Duration of ADR:RINSE process. RECIRC B FLOW 50 to 580 in step of 10 ml/min Blood pump speed initial value during the Recirculation phase. TARGET Kt/V Reached YES/ NO Enable/disable alarm for the percentage of Kt- Kt/V TARGET reached.CONFIGURATION DESCRIPTION 2-15 PARAMETER VALUE UNIT STATION ID 1 to 255 in steps of 1 Communication code that identifies the placement of the PHOENIX within the room.00 in steps of 0.300 in step of 0.05 Kg Amount of fluid to be removed during DIALYSIS.100 and then in (Note 3) step of 0. Rev. B . 0. SUBNET MASK 4th 0 to 255 in steps of 1 Fourth part of the Subnet Mask for the machine. TIME 2nd P 00:00 to 23:59 in step of 00:10 h:min Time of the second Autostart process programmed. SUBNET MASK 2nd 0 to 255 in steps of 1 Second part of the Subnet Mask for the machine. SECTION 2 . TARGET KT/V 0 to 3. Each PHOENIX machine must have a unique identifier.00 in step of 0. TOT WEIGHT L 0. SYRINGE TYPE ANOTHER 3S BERTONI (30) BD PLASTIPAK (30) PIC LL (30) ICO GAMMA PLUS (30) PENTA (30) DISPOMED (30) TERUMO (30) ICO GAMMA PLUS (20) ICO MONOSTERIL (20) BD PLASTIPAK (20) TERUMO (20) PIC LL (20) PENTA (20) MONOJECT (20) MONOJECT (12) BD PLASTIPAK (10) TERUMO (10) SYRYNGE TYPES 10 and 20 ml / 20 and 30ml Selection of the heparin syringe volume. TEMPERATURE 34.100 to Kg/h UFR value related to the step selected. TARGET KT 0 to 200 in steps of 1 l Volume of body water to be purified during DIALYSIS.1 °C Temperature of the dialysate TIME 1st P 00:00 to 23:59 in step of 00:10 h:min Time of the first Autostart process programmed.5 in steps of 0. from 0.000.100 to 4. STEP UFR 0.05 Dialysis Dose to be achieved during DIALYSIS.050 SUBNET MASK 0 to 255 in steps of 1 First part of the Subnet Mask for the machine. TARGET Kt/V THRESH 0 to 100 in steps of 1 % Threshold for the target Kt\Kt/V alarms.10 to 30.0 to 39. SUBNET MASK 3rd 0 to 255 in steps of 1 Third part of the Subnet Mask for the machine. 00. PRES LIMIT parameter decreased of +70 VINEGAR DESCAL NO/YES/ALWAYS Enables/disables use of the Vinegar Descaling feature. if (Note 3) WLR MINIMUM=0 the minimum value for WEIGHT LOSS/H is 0. MINIMUM parameter to 4. TOTAL FLUID REMOVED set 0 to 32 Kg Total amount of fluid removed during treatment HEPARIN TOTAL set 5 to 30 ml Total heparin infused. TMP set -100 to 450 mmHg Transmembrane pressure TMP ALARM YES/NO Enables/disables Transmembrane pressure alarm (Note 2) TO VIDEO 00:10 to 01:30 in steps of 00:05 min:s Length of time the machine remains in SET MODE if a selection key is not pressed.100 to 3.2-16 PHOENIX OPERATOR MANUAL PARAMETER VALUE UNIT TIME 3rd P. CURVE TYPE PROGRESSIVE/STEP/CONSTANT Selection of the UF curve type in PROFILING. DISTRIB VOLUME 20 to 80 in steps of 1 % Total volume of body water for the patient YEAR 2000 to 2099 year Current year (calendar context) Rev. WEIGHT LOSS/H From the value set for the WLR Kg/h UF rate during DIALYSIS. B . TIME DISPLAY MODE 12 h/24 h/AM/PM Format of Time representation. UF PRIMING 0.000 in steps of 0. USE YES/NO Enables/disables use of the Clean Dialysate system. ULTRAF PRES 20 to 200 in steps of 10 mmHg Pressure at the outlet of the DIACLEAR Ultrafilter. VEN P +50 to the value SET for the VEN mmHg Venous pressure alarm threshold.100. ULTRAFIL. from the selection of has been used the CHANGE CLEAN DIAL Action key. TREATM NUMBER set 0 to number of treatments in Number of treatments in which the DIACLEAR which the DIACLEAR Ultrafilter Ultrafilter has been used. 00:00 to 23:59 in step of 00:10 h:min Time of the third Autostart process programmed.100 Kg/h Ultrafiltration rate during PRIMING. DIALYSIS TIME (Note 1) 00:30 to 08:00 in step of 00:05 h:min Dialysis treatment time duration. by pressing the MINUS button in SET mode. the TMP alarm is generated. by pressing the PLUS button in SET mode. SECTION 2 . The TMP icon always appears in the event of a TMP alarm and may not be reset. Rev. • once the maximum parameter value is reached. this button is no more available. appears on the Touch Screen.CONFIGURATION DESCRIPTION 2-17 Note 1 The remaining DIFFUSION TIME. If NO has been selected in the parameter TMP. this button is no more available. the OVERRIDE button will reset this alarm and an audible reminder will be triggered every 5 minutes. Note 3 Only for the WEIGHT LOSS/H and Step UFR parameters: • once the minimum parameter value is reached. B . Note 2 The first time the TMP is outside of the range set. calculated from the DIALYSIS TIME set. Times 2. S Note The Clean Dial. • Date/Times • Wait. B .2. Rev.1.1 OPTIONS When the MACHINE Navigation key from the Config view is pressed. where the parameters relative to specific functions available on the machine are displayed: 12:30 IDLE EXTERNAL JUG USE DIASCAN USE SINGLE NEEDLE USE ULTRAFIL. DATE/TIMES WAIT. When MACHINE is pressed the Accessories view is displayed and the following Navigation keys are available: • Communic.2-18 PHOENIX OPERATOR MANUAL 2. USE parameter is set to YES. the following view appears.TIMES CLEAN DIAL. Navigation key is available only if the ULTRAFIL.2 CONFIG Views 2. USE HOT CITRIC USE CONFIG MACHINE ACCESSORIE COMMUNIC.2.1 MACHINE Data Configuration The machine data configuration parameters may be changed by the operator by selecting the MACHINE Navigation key from the Config view. in the PHOENIX Service Manual for a detailed description of settings necessary to configure the machine for use of the Heat Disinfection processes). USE parameter is visible and can be set only if the DIACLEAR Ultrafilter is used. SECTION 2 . Note Parameters can only be modified when the machine is in the IDLE mode. B . Rev.CONFIGURATION DESCRIPTION 2-19 Note The SINGLE NEEDLE USE parameter is visible and can be set only if the arterial clamp is installed. Note The HOT CITRIC USE parameter is only available if the proper service configuration has been performed in the machine calibrations environment (Refer to Section 8. Note The ULTRAFIL. after modifying a communication parameter: -. a window appears advising the operator that the PHOENIX is synchronizing with the Exalis System. When the Communic.Wait 5 seconds and then switch OFF the machine. ES Some of the above parameters are available only setting a specific value for some other parameters: for further details see Section 7 . Navigation key is pressed. when the machine is powered on.1.2.TIMES CLEAN DIAL. Rev. Note If the parameter EXT SYNCHRO is set to a value different from 0. menu contains the communication parameters. DATE/TIMES WAIT.Communication System. in this manual.2-20 PHOENIX OPERATOR MANUAL 2. B . In order to allow a proper configuration of the communication environment. the following view appears: 12:30 IDLE CCM IDENTIF OFFLINE TIMEOUT BAUD RATE AUTOCHART TIME EXT SYNCHRO STATION ID SW COMM SYSTEM IP ADDRESS 1st NETWORK TYPE SUBNET MASK GATEWAY NET ROUTE1 MASK ROUTE1 CONFIG MACHINE ACCESSORI COMMUNIC. This window remains on the Touch Screen for the time set for the EXT SYNCHRO parameter.2 COMMUNICATION The Communic. Note Parameters can only be modified when the machine is in the IDLE Mode. -.Wait 5 seconds and then switch ON the machine. Rev. in the PHOENIX Service Manual. in this manual. for a detailed description of the CentryNet relevant parameters setting. for a detailed description of the parameters to be set). view but the parameter value is not modifiable in Set mode of this view. the values set for the IP ADDRESS 1ST and SUBNET MASK parameters must be entered also in the machine Calibration environment by a service technician (Refer to Section 8. See Section 7 .CONFIGURATION DESCRIPTION 2-21 Note In order to allow a proper configuration of the communication environment. the STATION ID parameter is displayed in the Config\Mach.Conf\Communic. SECTION 2 .Communication System. Note If the SW COMM SYSTEM parameter is set toCENTRYNET USE. B . 2-22 PHOENIX OPERATOR MANUAL 2.3 DATE/TIME The Date/Times menu contains the parameters relative to the calendar. DATE/TIMES WAIT. Rev. When the Date/Times Navigation key is pressed. the machine must be switched OFF and then ON to allow the proper updating of those values.1.TIMES CLEAN DIAL.2. B . ES Note Parameters can only be modified when the machine is in the IDLE Mode. the following view appears: 12:30 IDLE YEAR TIME DISPLAY MODE MONTH DATE DISPLAY MODE DAY NAME DAY HOURS MINUTES CONFIG MACHINE ACCESSORI COMMUNIC. Note After changing the value set for the HOURS and MINUTES parameter. TIMES CLEAN DIAL.4 WAIT TIME The Wait. Rev.CONFIGURATION DESCRIPTION 2-23 2. Note The blanking of the Touch Screen (low machine consumption) can be performed by both setting the LOW CONSUMPTION parameter (blanking at the time interval set) and pressing the SCREEN OFF Action key in Home/MACHINE view (the Touch Screen becomes immediately blanked).1. DATE/TIMES WAIT. SECTION 2 . ES Note Parameters can only be modified when the machine is in the IDLE Mode.Times menu contains the parameters relative to delays introduced to exit from certain conditions.Times Navigation key is pressed. When the Wait. the following view appears: 12:30 IDLE TO VIDEO LOW CONSUMPTION CONFIG MACHINE ACCESSORI COMMUNIC.2. B . Note The Clean Dial.2.2-24 PHOENIX OPERATOR MANUAL 2. the following view appears: 12:30 IDLE ULTRAF PRES CONFIG MACHINE ACCESSORI COMMUNIC.1. menu contains the parameters relative to the DIACLEAR Ultrafilter alarm thresholds. When the Clean Dial.5 CLEAN DIAL The Clean Dial. ES Note Parameters can only be modified when the machine is in the IDLE Mode. Navigation key is only available if the ULTRAFIL. B . Navigation key is pressed. Rev. DATE/TIMES WAIT.TIMES CLEAN DIAL. USE parameter is set to YES in Config/MACHINE/Accessories. Conf • Alarms 2. SECTION 2 .CONFIGURATION DESCRIPTION 2-25 2.2. When the JUMP PRIMING parameter is changed from YES to NO. Rev. When Centre Config is pressed. the following view appears: 12:30 IDLE PRIMING HEP DIAL AUTO PRIME CONFIG CENTRE AUTOMATION FUNCTIONS TREAT.2.2. Note The DIAL AUTO PRIME parameter is only settable if the JUMP PRIMING parameter is set to NO in Config/Centre Conf/Functions. B . the Automation view is displayed and the following Navigation keys are available: • Functions • Treat.2 CENTER Data Configuration The Centre data Configuration parameters may be changed by the user by selecting the Centre Conf Navigation key from the Config view. the DIAL AUTO PRIME parameter is automatically set to NO. Note Parameters can only be modified when the machine is in the IDLE Mode.1 AUTO When the Centre Conf Navigation key is pressed.CONF ALARMS CONF Note Pressing the Config Navigation key will return the machine to the Config selection view. the following view appears: 12:30 IDLE ACETATE DIAL USE NEW SESSION USE BIC LIQUID DIAL USE VINEGAR DESCAL BICART DIAL USE AUTOEMPTYING BEEP ON TOUCH JUMP PRIMING PAUSE THERAPY CONFIG CENTRE AUTOMATIO FUNCTIONS TREAT.2-26 PHOENIX OPERATOR MANUAL 2. Rev. B .2 FUNCTION The Functions menu contains the parameters relative to the activation of particular functions during DIALYSIS.2.CON ALARMS CONF N F Note Parameters can only be modified when the machine is in the IDLE Mode. When the Functions Navigation key is pressed.2. CON ALARMS CONF N F Note Parameters can only be modified when the machine is in the IDLE Mode. SECTION 2 .2. Note Attention should be given to setting the VEN PRES LIMIT and MIN ART PRESSURE parameters consistently with the patient prescription (needle size.Conf Navigation key is pressed. the following view appears: 12:30 IDLE WLR MINIMUM VEN PRES LIMIT HD SAFE THRE. B . When the Treat. TMP THRESHOLD MAX BLOOD FLOW RAMPING TIME MIN ART PRESSURE CONFIG CENTRE AUTOMATIO FUNCTIONS TREAT.2.Conf menu contains the parameters relative to specific threshold settings. blood flow rate) to avoid pressure alarms.3 LIMITS The Treat.CONFIGURATION DESCRIPTION 2-27 2. Rev. 2-28 PHOENIX OPERATOR MANUAL 2. B . Rev.2. When the Alarms Navigation key is pressed.4 ALARMS The Alarms menu contains the parameters relative to some alarm settings. the following view appears: 12:30 IDLE END PRE ALARM BLOOD ALARM HEPARIN ALARM END HEP ALARM TMP ALARM END DIA ALARM TARGET KT/V REACHED CONFIG CENTRE AUTOMATIO FUNCTIONS TREAT.CON ALARMS CONF N F Note Parameters can only be modified when the machine is in the IDLE Mode.2. 2.CONFIGURATION DESCRIPTION 2-29 2. CHEM PERS 2. Rev. B .3. where the parameters related to the chemical disinfection process may be set: 12:30 IDLE CHEM PERS 1 CHEM PERS 2 CHEM PERS 3 CHEM PERS 4 CHEM+CENTRAL BICARB LINE CONFIG ADR CHEMICAL HEATING Rinsing AUTOSTART Note The CHEM+CENTRAL BICARB LINE Action key is only available if the proper service configuration has been performed in the service environment. CHEM PERS 4 or CHEM+CENTRAL BICARB LINE Action keys. the following view appears.1 CHEMICAL When the ADR Navigation key is pressed. The chemical process name may be changed on this view. SECTION 2 . When ADR is pressed the Chemical view is displayed and the following Navigation keys are available: • Heating • Rinsing • AutoStart 2. Different types of Chemical processes can be performed by pressing the CHEM PERS 1.3 ADR Data Configuration The ADR data parameters may be changed by the user by selecting the ADR Navigation key from the Config view. (Refer to your technical service for information on your machine configuration).2. CHEM PERS 3. the following view appears: 12:30 IDLE CHEM PERS 2 RINSING TIME DISINF TIME CHEM PERS 2 END PROCESS MODE pH MONITOR pH Min pH Max AUTO OFF LIQUID INLET CONFIG ADR CHEMICAL HEATING Rinsing AUTOSTART CLOSE Note When the pH MONITOR parameter is set to YES. B . two further parameters are accessible: pH Min pH Max WARNING Verify that at least one chemical disinfection process is configured. Rev.2-30 PHOENIX OPERATOR MANUAL CHEMICAL 1/2/3/4 When a chemical process has been selected pressing one of the Action keys in Chemical view. B .CONFIGURATION DESCRIPTION 2-31 The chemical process name can be changed by pressing the Set button: a view similar to the following appears: 12:30 IDLE Chem Name Chemical 2 DISINF TIME END PROCESS pH MONITOR MODE AUTO OFF LIQUID INLET RINSING TIME Rev. SECTION 2 . Rev.2-32 PHOENIX OPERATOR MANUAL Pressing the Chem Name parameter box will cause a new view to appear: NEW NAME Area 1! 2" 3£ 4$ 5% 6& 7/ 8( 9) 0= Q W E R T Y U I O P Lock A S D F G H J K L Shift Z X C V B N M coma.: semicol on \| ? ì^ èé[ +*] òç@ ù§ <> -_ à°# BackSpace << Space >> AltGr Chem NameChemProc 2 BackSpace The operator can modify the chemical process name by touching the keypad. the new name is written in the NEW NAME Area and can be confirmed with the CONFIRM button. Pressing UNDO will allow an exit from this view without saving the changes made. B . . the following view appears: 12:30 IDLE Chem Name RINSING TIME DISINF TIME CENTR BICARB LINE END PROCESS MODE pH MONITOR pH Min pH Max AUTO OFF CHEM+CENTRAL BICARB LINE LIQUID INLET CONFIG ADR CHEMICAL HEATING Rinsing AUTOSTART CLOSE Note When the pH MONITOR parameter is set to YES. B . two further parameters are accessible: pH Min pH Max WARNING Verify that at least one chemical disinfection process is configured.CONFIGURATION DESCRIPTION 2-33 CHEM+CENTRAL BICARB LINE When the CHEM+CENTRAL BICARB LINE Action key has been selected in the CHEMICAL view. SECTION 2 . Rev. . • END PROCESS MODE: always set to Rins. Line”. • CENTR BICARB LINE: always set to YES. Rev. B .2-34 PHOENIX OPERATOR MANUAL The chemical process can be set by pressing the Set button: the following view appears: 12:30 IDLE DISINF TIME END PROCESS pH MONITOR MODE AUTO OFF LIQUID INLET RINSING TIME Note The following parameters are not accessible in Set Mode: • Chem Name: always set to “Chem + B. in the PHOENIX Service Manual.3. When the Heating Navigation key is pressed.2. for a detailed description of settings necessary to configure the machine for use of the Heat disinfection option).CONFIGURATION DESCRIPTION 2-35 2.2 HEAT The Heating menu contains the parameters relative to the heating processes. B . the following view appears: 12:30 IDLE HEAT HEAT WITH CWP HEAT CITRIC CONFIG ADR CHEMICAL HEATING Rinsing AUTOSTART Note The HEAT Navigation key is only available if the proper service configuration has been performed in the machine calibrations environment (Refer to Section 8. Rev. SECTION 2 . the following view appears: 12:30 IDLE DISINF TIME HEAT AUTO OFF COOLING CONFIG ADR CHEMICAL HEATING Rinsing AUTOSTART CLOSE Note When performing a standard heat disinfection. Rev. by selecting the HEAT Action key. the COOLING parameter value is YES.2-36 PHOENIX OPERATOR MANUAL HEAT When the HEAT Action key is pressed. B . SECTION 2 . B .CONFIGURATION DESCRIPTION 2-37 HEAT WITH CWP When the HEAT WITH CWP Action key is pressed. the following view appears: 12:30 IDLE DISINF TIME AUTO OFF HEAT WITH CWP COOLING CONFIG ADR CHEMICAL HEATING Rinsing AUTOSTART CLOSE Note When using the Centralized Heat Disinfection system. by selecting the HEAT WITH CWP Action key. the COOLING parameter value is NO. Rev. 2-38 PHOENIX OPERATOR MANUAL HEAT CITRIC When the HEAT CITRIC Action key is pressed. the following view appears: 12:30 IDLE pH MONITOR pH Min pH Max HEAT CITRIC AUTO OFF LIQUID INLET CONFIG ADR CHEMICAL HEATING Rinsing AUTOSTART CLOSE Rev. B . the following view appears: 12:30 IDLE RINSING TIME AUTO OFF CONFIG ADR CHEMICAL HEATING RINSING AUTOSTART Rev.3 RINSE The Rinsing menu contains the parameters relative to the rinsing process.3.CONFIGURATION DESCRIPTION 2-39 2.2. When the Rinsing Navigation key is pressed. B . SECTION 2 . NONE --/-. NONE --/-- Tuesday NONE --/-. NONE --/-- CONFIG ADR CHEMICAL HEATING RINSING AUTOSTART Rev. Sunday NONE --/-. NONE --/-- Wednesday NONE --/-. NONE --/-. NONE --/-. NONE --/-- Monday NONE --/-. NONE --/-. NONE --/-. NONE --/-. B .2. NONE --/-- Thursday NONE --/-.3. NONE --/-- Saturday NONE --/-. where the disinfection and rinsing processes may be configured to start automatically: 12:30 IDLE 1ST PROC TIME 1ST P 2ND PROC TIME 2ND P 3RD PROC TIME 3RD P.4 AutoStart The AutoStart menu contains the parameters relative to the autostart process. NONE --/-. the following view appears. NONE --/-- Friday NONE --/-. When the AutoStart Navigation key is pressed.2-40 PHOENIX OPERATOR MANUAL 2. CITRIC Note If FRONT is selected for the LIQUID INLET parameter in Config/ADR/Chemical or in Config/ADR/HEAT. 2. 4 H. CHEMIC. 3. To modify the value of the TIME PROCESS parameter press the SET button. 2 CHEMIC. CITRIC parameter are not displayed. select the TIME PROCESS parameter to be configured by touching the parameter box on the Touch Screen and change the value by using the PLUS and MINUS buttons on the Main Control Panel. the selection made is stored in the AutoStart table and the related TIME PROCESS parameter becomes available. 1. then selecting the process to be configured by touching the parameter box on the Touch Screen. 1 CHEMIC. the related TIME PROCESS parameter is not modifiable and is displayed as --/-. theCHEMIC. 3 CHEMIC. The following view will appear: 12:30 IDLE NONE RINSING HEAT HEAT CWP CHEMIC.CONFIGURATION DESCRIPTION 2-41 Each process can be programmed by pressing the SET button. CHEMIC.in the AutoStart view. Rev. Note If a process is programmed as NONE. SECTION 2 . Press the CONFIRM button to accept the new value for the parameter. 4 and H. CHEMIC. By pressing the CONFIRM button. B . 4 Treatment Data Configuration The Treatment data parameters may be changed by the user by selecting the Treatments Navigation key from the Config view.4.2. Rev.2.1 STD HD When the Treatments Navigation key is pressed. the following view appears: 12:30 IDLE PRIME PUMP SPEED DESCALING TIME ACETATE PAT CONN B FLOW SN P LIQUID BIC INIT DIAL B FLOW SN P BICART RINSEBACK B FLOW RECIRC B FLOW RECIRCULATION UF RECIRCULATION TIME RINSEBACK VOLUME CONFIG TREATMENT STD DIALYS HEPARIN BPM S The parameters relating to the different types of treatments can be programmed by pressing the ACETATE.2-42 PHOENIX OPERATOR MANUAL 2. B . LIQUID BIC or BICART Action keys. When Treatments is pressed the Std Dialysis view is displayed and the following Navigation keys are available: • Heparin • BPM 2. SECTION 2 . Rev.CONFIGURATION DESCRIPTION 2-43 ACETATE Note The ACETATE Action key is accessible only if the parameter ACETATE is configured YES on the Config/Centre Conf/Functions view. UF PRIMING PRIME VOLUME END DIALYSIS BLD SENS CONFIG TREATMENT STD DIALYS HEPARIN BPM CLOSE S Note When selecting TOTAL BLOOD for END DIALYSIS in this menu. the TOTAL BLOOD parameter also becomes available. B . When the ACETATE Action key has been pressed the following view is displayed: 12:30 IDLE DIALYSIS TIME TOTAL BLOOD ACETATE CONDUCTIVITY TEMPERATURE DIALYSATE FL. When selecting a value of 8. When the LIQUID BIC Action key has been pressed the following view is displayed: 12:30 IDLE DIALYSIS TIME PRIME VOLUME CONDUCTIVITY END DIALYSIS LIQUID BIC BICARB CONC BLD SENS BIC 8. the TOTAL BLOOD parameter also becomes available. Rev. the parameter relative to the conductivity value is BIC 8. the parameter relative to the bicarbonate conductivity is BIC 6.6% for the BICARB CONC parameter.4% for the BICARB CONC parameter.6% COND TEMPERATURE DIALYSATE FL. UF PRIMING CONFIG TREATMENT STD DIALYS HEPARIN BPM CLOSE S Note When selecting TOTAL BLOOD for END DIALYSIS in this menu.4% COND.4% COND TOTAL BLOOD BIC 6. B .6% COND. Note When selecting a value of 6.2-44 PHOENIX OPERATOR MANUAL LIQUID BIC Note The LIQUID BIC Action key is accessible only if the parameter LIQUID BIC is configured YES on the Config/Centre Conf/Functions view. UF PRIMING PRIME VOLUME END DIALYSIS CONFIG TREATMENT STD DIALYS HEPARIN BPM CLOSE S Note When selecting TOTAL BLOOD for END DIALYSIS in this menu. Rev. SECTION 2 .CONFIGURATION DESCRIPTION 2-45 BICART Note This Action key is accessible only if the parameter BiCart is configured YES on the Config/ Centre Conf/Functions view. the TOTAL BLOOD parameter also becomes available. B . When the BICART Action key has been pressed the following view is shown: 12:30 IDLE DIALYSIS TIME BLD SENS CONDUCTIVITY TOTAL BLOOD BICART COND BICART TEMPERATURE DIALYSATE FL. • Wait 5 seconds and then switch ON the machine. In order to allow a proper configuration of the heparinization mode.4. after modifying the DIAMETER parameter: • Wait 5 seconds and then switch OFF the machine. the following view appears: 12:30 IDLE PRE STOP TIME DIAMETER HEPARIN RATE INITIAL BOLUS HEPARIN BOLUS BOLUS INTERVAL MANUAL BOLUS Syringe Type SYRYNGE TYPES CONFIG TREATMENT STD DIALYS HEPARIN BPM S WARNING If the INITIAL BOLUS is set from 0-10 ml. at the Heparin Pump start. Note Parameters can only be modified when the machine is in the IDLE Mode.2. When the Heparin Navigation key is pressed. Rev. B .2-46 PHOENIX OPERATOR MANUAL 2. the heparin quantity set is injected automatically as a bolus after which the linear heparinization starts.2 HEPARIN The Heparin menu contains the parameters relative to all the heparinization modes. 4. MAX SAMPLE INTERV BPM USE CONFIG TREATMENT STD DIALYS HEPARIN BPM S Rev. When the BPM Navigation key is pressed.3 BPM The BPM menu contains the parameters relative to the BPM measures. SECTION 2 . the following view appears: 12:30 IDLE DIAST PRE MIN DIAST PRE MAX SYST PRE MIN SYST PRE MAX HEART R. MIN HEART R. B .CONFIGURATION DESCRIPTION 2-47 2.2. 2.5. may be set: 12:30 IDLE DIALYSIS TIME TOT WEIGHT L ULTRAFILTRATION CURVE AREA CURVE TYPE CONDUCTIVITY CURVE AREA CON CURVE TYPE CONFIG PROFILE WLR COND Note See Section 05.D . in this manual. the following view appears. Note In case of CONSTANT curve type. for a detailed description of the Profile relevant parameters setting. where the parameters for both the curves. UF and Conductivity.2. the curve displayed Config/PROFILE environment is drawn with default values set by the Manufacturer.Profile.1 PROFILE General view When the PROFILE Navigation key is pressed. When PROFILE is pressed the PROFILE General view is displayed and also the following Navigation key are available: • WLR • Cond 2.5 Profiling Configuration The Profiling parameters may be changed by the user by selecting the PROFILE Navigation key from the Config view. B .2-48 PHOENIX OPERATOR MANUAL 2. Rev. 5.2. the following view appears: 12:30 IDLE ULTRAFILTRATION CURVE AREA PARAMETER AREA ◄ Time CURSOR AREA UF R ► CONFIG PROFILE WLR COND CURVE TYPE: PARAMETER AREA: SET MODE: TOT WEIGHT L CURVE TYPE STEP CURVE TYPE TOT WEIGHT L STEP UFR STEP UFR TOT WEIGHT L CURVE TYPE PROGRESSIVE INITIAL VALUE TOT WEIGHT L CURVE COEFF INITIAL VALUE CURVE TYPE CURVE COEFF CONSTANT CURVE TYPE CURVE TYPE Rev. B .CONFIGURATION DESCRIPTION 2-49 2. SECTION 2 .2 WLR The WLR menu contains all the parameters related to the Ultrafiltration curve. When the WLR Navigation key is pressed. When the Cond Navigation key is pressed.3 Cond The Cond menu contains all the parameters related to the Conductivity curve. the following view appears: 12:30 IDLE CONDUCTIVITY CURVE AREA PARAMETER AREA ◄ Time CURSOR AREA Cond ► CONFIG PROFILE WLR COND CURVE TYPE: PARAMETER AREA: SET MODE: CON CURVE TYPE CON CURVE TYPE STEP COND STEP COND STEP INITIAL VALUE CON CURVE TYPE PROGRESSIVE FINAL VALUE INITIAL VALUE CURVE COEFF FINAL VALUE CON CURVE TYPE CURVE COEFF CONSTANT CON CURVE TYPE CON CURVE TYPE Rev.5. B .2-50 PHOENIX OPERATOR MANUAL 2.2. 12:30 IDLE DIASCAN TARGET KTt CLEARANCE ALA. TARGET KT/V THRESH CLEARANCE LEVEL TARGET KT/V DRY WEIGHT DISTRIB VOLUME INTERMEASUREM CONFIG KT/V Note When selecting YES. becomes available and when selecting YES the CLEARANCE LEVEL parameter becomes available. B .2.CONFIGURATION DESCRIPTION 2-51 2. When the kT/V Navigation key is pressed. Rev. the following view appears: Note The kT/V Navigation key is only available if the parameter DIASCAN USE is configured YES on the Config/MACHINE/Accessories view.6 KT/V Configuration The kT/V menu contains all the parameters related to the Diascan feature. the CLEARANCE ALA. SECTION 2 . 2. who is solely responsible for the use of the information processed by the software. 2. the individualized Treatment Data may be set and the individual dialysis session names can be modified using the same procedure described in the 2. Patient/Rx keys will individualize a particular set of prescription parameters. By pressing the Action keys. the following view is displayed: 12:30 IDLE 1st PATIENT 2nd PATIENT 3rd PATIENT 4th PATIENT 5th PATIENT 6th PATIENT 7th PATIENT RX CONFIG The machine allows 7 customized dialysis sessions to be configured that can be selected by the operator during SETUP for dialysis.3 Rx Config Views WARNING This feature must exclusively be used under the authority of a physician.3. The individualized prescription parameters (Patient/Rx) parameters may be changed by the user by pressing the Rx Config Navigation key from the IDLE View.3. When one of the Rx 1/2/3/4/5/6/7 Action keys has been pressed also the following Navigation key are available: • Rx Data • Rx Add • PROFILE • Kt/V Rev.1 Rx Config General View When the Rx Config Navigation key is pressed.2-52 PHOENIX OPERATOR MANUAL 2. B .1 paragraph for the personalization of the chemical process name. heparinization is not automatically activated during DIALYSIS. MAN BOLUS. is selected. If one of the three modes. the heparinization is automatically activated. the TOTAL BLOOD parameter also becomes available.3. LINEAR. SECTION 2 .6% COND RECIRCULATION UF BICART COND PAT CONN B FLOW TEMPERATURE RINSEBACK VOLUME DIALYSATE FL.4% COND RECIRC B FLOW BIC 6.2 Rx Data Configuration When one of the Patient 1/2/3/4/5/6/7 Action keys has been pressed the following view is shown (Rx Data view): 12:30 IDLE 2nd PATIENT INIT DIAL B FLOW DIALYSIS TIME RAMPING TIME DIALYSIS TYPE PRIME PUMP SPEED CONDUCTIVITY RECIRCULATION TIME BIC 8. Rev. Note If NONE is selected for the HEPARIN TYPE parameter. AUTO BOLUS. RINSEBACK B FLOW END DIALYSIS TOTAL BLOOD BLD SENS PRIME VOLUME UF PRIMING RX RX DATA RX ADD PROFILE Kt/V CONFIG Note When selecting TOTAL BLOOD for END DIALYSIS in this menu. B .CONFIGURATION DESCRIPTION 2-53 2. where additional treatment data parameters may be set: 12:30 IDLE HEPARIN TYPE PRE STOP TIME INITIAL BOLUS HEPARIN RATE HEPARIN BOLUS BOLUS INTERVAL MANUAL BOLUS BPM USE DIAST PRE MIN DIAST PRE MAX SYST PRE MIN SYST PRE MAX HEART R.2-54 PHOENIX OPERATOR MANUAL 2.3. MAX SAMPLE INTERV RX RX DATA RX ADD PROFILE Kt/V CONFIG Rev. the following view appears. B .3 Rx Add Configuration When the Rx Add Navigation key is pressed. MIN HEART R. in this manual. UF and Conductivity. the following view appears. Rev. where the parameters for both the Profile curves.4. may be set: 12:30 IDLE DIALYSIS TIME TOT WEIGHT L ULTRAFILTRATION CURVE AREA CURVE TYPE CONDUCTIVITY CURVE AREA CON CURVE TYPE RX PROFILE UF COND CONFIG Note See Section 05.3. for a detailed description of the Profile relevant parameters setting. the curve displayed Rx Config/PROFILE environment is drawn with default values set by the Manufacturer. Note In case of CONSTANT curve type.Profile. B .D .CONFIGURATION DESCRIPTION 2-55 2. SECTION 2 .3.4 Profiling Configuration The patient’s personalised (Rx) Profile parameters may be changed by the user by selecting the PROFILE Navigation key from the Rx Config view. When PROFILE Navigation key is pressed the PROFILE General view is displayed and also the following Navigation key are available: • UF • Cond 2.1 PROFILE General view When the PROFILE Navigation key is pressed. 3.2-56 PHOENIX OPERATOR MANUAL 2. B . the following view appears: 12:30 IDLE ULTRAFILTRATION CURVE AREA PARAMETER AREA ◄ Time ClkTime UF R ► RX CONFIG PROFILE UF COND CURVE TYPE: PARAMETER AREA: SET MODE: TOT WEIGHT L CURVE TYPE STEP CURVE TYPE TOT WEIGHT L STEP UFR STEP UFR TOT WEIGHT L CURVE TYPE PROGRESSIVE INITIAL VALUE TOT WEIGHT L CURVE COEFF INITIAL VALUE CURVE TYPE CURVE COEFF CONSTANT CURVE TYPE CURVE TYPE Rev.4. When the UF Navigation key is pressed.2 UF The UF menu contains all the parameters related to the Ultrafiltration curve. SECTION 2 .3 Cond The Cond menu contains all the parameters related to the Conductivity curve.3. When the Cond Navigation key is pressed. the following view appears: 12:30 IDLE CONDUCTIVITY CURVE AREA PARAMETER AREA ◄ Time ClkTime Cond ► RX CONFIG PROFILE UF COND CURVE TYPE: PARAMETER AREA: SET MODE: CON CURVE TYPE CON CURVE TYPE STEP COND STEP COND STEP INITIAL VALUE CON CURVE TYPE PROGRESSIVE FINAL VALUE INITIAL VALUE CURVE COEFF FINAL VALUE CON CURVE TYPE CURVE COEFF CONSTANT CON CURVE TYPE CON CURVE TYPE Rev.CONFIGURATION DESCRIPTION 2-57 2. B .4. the CLEARANCE LEVEL parameter becomes available. TARGET KT/V THRESH CLEARANCE LEVEL TARGET KT/V DRY WEIGHT DISTRIB VOLUME INTERMEASUREM RX KT/V RX ADD PROFILE KT/V CONFIG Note When setting DIASCAN USE to YES.5 Kt/V Configuration The patient’s personalised (Patient/Rx) Diascan parameters may be changed by the user by selecting the Kt/V Navigation key from the Rx Config view. Rev. When the Kt/V Navigation key is pressed. becomes available and when setting CLEARANCE ALA.3. the following view appears: 12:30 IDLE DIASCAN TARGET KT CLEARANCE ALA. the CLEARANCE ALA. to YES. B .2-58 PHOENIX OPERATOR MANUAL 2. not listed above.4% CONDor BIC 6. become available. MIN HEART R. further new parameters. DRY WEIGHT DISTRIB VOLUME INTERMEASUREM CLEARANCE ALA. SECTION 2 . MAX JUMP PRIMING NO DIAL AUTO PRIME Rev.6% COND BIC BICART BICART COND END DIALYSIS TOTAL BLOOD TOTAL BLOOD HEPARIN TYPE LINEAR PRE STOP TIME HEPARIN RATE INITIAL BOLUS AUTO BOLUS PRE STOP TIME HEPARIN BOLUS BOLUS INTERVAL MAN BOLUS MANUAL BOLUS DIASCAN USE YES CLEARANCE ALA. B . Below is a table with the various possibilities: PARAMETER SELECTED VALUE NEW PARAMETER(S) DIALYSIS TYPE BIC CONC BIC 8.CONFIGURATION DESCRIPTION 2-59 Note When a specific value is selected for some parameters. YES CLEARANCE LEVEL BPM USE YES or SAMPLE INTERV AUTOMATIC SYST PRE MIN SYST PRE MAX DIAST PRE MIN DIAST PRE MAX HEART R. B .2-60 PHOENIX OPERATOR MANUAL This page is left intentionally blank Rev. Note The connection to Central Acid Concentrate using BICART will be allowed only if 8.4% • Acid Concentrate : two different acid concentrate formulas may be used. A1 and A2. B .50 psi) • Bicarbonate Concentrate : 8.CENTRAL CONCENTRATE SUPPLY 3. WARNING The user is responsible for checking compliance of Central Concentrate Systems with the IEC 601. Rev.1. • Central Acid Concentrate Supply may be used with either the BiCart or Liquid Bicarbonate Concentrate.1 Specifications The Phoenix Haemodialysis System. equipped with the Central Concentrate Supply kit. SECTION 3 .14.30 °C (41-86°F) • Concentrate fluid Pressure : 0 . whose composition must comply with the specifications described in the Section 9 .3 CENTRAL CONCENTRATE SUPPLY 3.Specifications of the Operator’s Manual. is compatible with Central Concentrate Supply Systems for BICARBONATE DIALYSIS meeting the following requirements: • Concentrate fluid Temperature : 5 .1 bar (0.4% for Bicarbonate Concentrate has been selected in the Configuration menu.1 standard. 3. 3.BLUE BICARBONATE CONCENTRATE Fig. B .RED ACID A1 CONCENTRATE for BICARBONATE DIALYSIS 2 .2: Connector positions on the Front Panel Rev. 3.2 Connection to the Central Concentrate Supply System In the following figures (fig.2) the positions of the Connectors on the Rear and Front Panel are illustrated with the following numerical and colour-coding: 1 .1 and 3.RED ACID A2 CONCENTRATE for BICARBONATE DIALYSIS 3 .1: Connector positions on the Rear Panel Fig.3-2 PHOENIX OPERATOR MANUAL 3. 2. 2. WARNING The user is responsible for the proper connection of the PHOENIX machine to the Central Concentrate Supply System and to verify proper functioning of this connection.2. and to: • Check the efficiency of Disinfection.3 on the Front Panel. Rear Connectors marked 1. B . The manufacturer is not responsible for the Disinfection of these lines. It is the responsibility of the user to carry out Disinfection and Rinse procedures of these lines.3 match respectively with the female Concentrate Connectors marked 1.CENTRAL CONCENTRATE SUPPLY 3-3 The connection to the Central Concentrate Supply must be done by connecting one or more of the three Rear Panel Connectors to the facility’s Concentrate Supply System following the numerical and colour code. • Perform a mandatory Rinse after Disinfection with chemical agents. 3 are subject to the same Disinfection requirements as the Central Supply System. • Perform a residual test after Rinse. Rev. SECTION 3 . WARNING The three internal lines from the Central Supply Ports on the Rear Panel of the Phoenix to the three Front Concentrate Connectors marked 1. BICARBONATE DIALYSIS with A1 ACID In this case the male Connector A must be connected to the RED (1) female Connector.3-4 PHOENIX OPERATOR MANUAL 3. and the male Connector B must be connected to the BLUE (3) Connector (see figure 3. fig. while maintaining all the checks (Conductivity. Temperature and pH) of Final Dialysate. B . in this manual. The check on concentrate dilution is disabled when Central Concentrate Supply is used in order to prevent the occurrence of”! Concentrate Cans” #40 alarm.3 Operating Instructions WARNING It is the responsibility of the user to verify that the proper concentrates are used for the patient. For further information on the concentrate solutions see Section 9 – Specifications.3: Connector positions in BICARBONATE DIALYSIS with A1 ACID Rev. 3. The machine. disables the check on concentrate dilution that is normally performed when concentrates are provided in containers. This includes the choice of Acid Concentrate as well as Bicarbonate Concentrate.3). B .5). fig. and the male Connector B must be connected to the BLUE (3) Connector (see figure 3. 3.4). 3. and the male Connector B remains in its Rinse Port (see figure 3.5: Connector positions in BICART DIALYSIS with A1 ACID Rev. SECTION 3 .4: Connector positions in BICARBONATE DIALYSIS with A2 ACID BICART DIALYSIS with A1 ACID In this case the male Connector A must be connected to the RED (1) female Connector.CENTRAL CONCENTRATE SUPPLY 3-5 BICARBONATE DIALYSIS with A2 ACID In this case the male Connector A must be connected to the RED (2) female Connector. fig. 3. B . and the male Connector B remains in its Rinse Port (see figure 3.6: Connector positions in BICART DIALYSIS with A2 ACID Rev.3-6 PHOENIX OPERATOR MANUAL BICART DIALYSIS with A2 ACID In this case the male Connector A must be connected to the RED (2) female Connector.6). fig. and that the dialysate Conductivity is correct.B . in this manual for a detailed description of the Acid Concentrate supply change procedure. • Acid Container: Refer to Section 05.A – Special Procedures.1 Switching from Central Concentrate Supply to the use of External Concentrate Containers In case of a malfunction of the Central Concentrate Supply System. if the machine has not been correctly calibrated for the liquid Concentrates in the External Containers. WARNING In case of a switch from Central Concentrate Supply to the use of External Containers.3. SECTION 3 . it is possible to continue the dialysis treatment using External Containers. WARNING In case of a switch from Central Concentrate Supply to the use of External Containers. BICART DIALYSIS with A1 or A2 ACID • Acid Container: Refer to Section 05.CENTRAL CONCENTRATE SUPPLY 3-7 3.Special Procedures for complete instructions.) Rev. After carefully verifying that the correct concentrates are being used. BICARBONATE DIALYSIS with A1 or A2 ACID According to the External Containers that will be used.A – Special Procedures. the “! Concentrate Cans” #40 Alarm can occur. the operator may clear the alarm by performing the PA and/or PB Autocalibration Procedure (see Section 5. it is the operator’s responsibility to verify that proper Concentrates are being used. B . in this manual for a detailed description of the Acid Concentrate supply change procedure. perform the following procedures: • Bicarbonate Container: Disconnect the male Connector B from the BLUE Connector (3) and connect it to the Wand inserted into a container of the correct Bicarbonate Concentrate. WARNING Before instilling Cleaning/Disinfecting chemicals into the 3 Central Concentrate Lines. The frequency of cleaning these lines can be the same as the frequency of cleaning Clinic’s Supply System. it is recommended to have them disinfected at the same time that the overall system is cleaned/disinfected.4. since the fluids are identical. The Bicarbonate Line is where bacterial growth will occur rapidly thus frequent Cleaning/Disinfecting is recommended. Clinical practices for cleaning other portions of this delivery system can be used as a baseline for the Cleaning/Disinfection frequency. 3 are subject to the same Disinfection requirements as the Central Concentrate Supply System. 2. • Perform a mandatory Rinse after Disinfection with chemical agents. it is advisable to perform a Rinse procedure to avoid chemical reaction or precipitation due to possible incompatibility of the chemical used with any residual Acid or Bicarbonate Concentrate that is left in these lines. Rev. is also recommended. shipped. Note It is the responsibility of the user to determine the frequency of the Cleaning/Disinfection procedures of the Central Concentrate Lines. or left in Idle for a long period of time. It is the responsibility of the user to carry out Disinfection and Rinse procedures of these lines. B . Note The Acid Lines may not require the same frequency of Cleaning/Disinfecting as the Bicarbonate Line since the Acid formulations typically do not support bacterial growth. • Perform a residual test after Rinse.4 Central Concentrate Supply Lines Maintenance 3. from the Central Concentrate Supply Ports on the Rear Panel of the Phoenix to the three Front Panel Concentrate Connectors marked 1. The manufacturer is not responsible for Disinfection of these lines. If the machine needs to be stored.3-8 PHOENIX OPERATOR MANUAL 3.1 General WARNING The three internal lines. draining these Central Concentrate Lines. Since these lines are practically integral to the clinic’s piping system. and to: • Check the efficiency of Disinfection. after Disinfection and Rinsing. this frequency must be not lower than the frequency of the Cleaning/Disinfection procedures performed for the Clinic’s Supply System. 7).1) to the Central Concentrate Supply system has to be a PVC line. 2.1) to the Central Concentrate Supply system has to be adapted so that the end side of this line (connected to the Central Concentrate Supply port) is a Phoenix Bicarbonate Male Connector. • Only Sodium hypochlorite solution (active chlorine from 50.1 Disinfection Procedure 1. WARNING The efficiency of the Central Bicarbonate Line disinfection process has been tested and can be guaranteed only if the following conditions are satisfied: • The Central Bicarbonate Line connecting the Rear Connector (3) of the Phoenix (See Figure 3. Disconnect the Bicarbonate Connector from the Bicarbonate Port (B) on the Front Panel and connect it to the BLUE (3) port on the Front Panel.CENTRAL CONCENTRATE SUPPLY 3-9 3.000 to 60. To carry out the Central Bicarbonate Line disinfection and the following rinse the following conditions have to be satisfied: • The Central Bicarbonate Line connecting the Rear Connector (3) of the Phoenix (See Figure 3. • The proper service configuration has been performed in the service environment.118 in). (See Figure 3. SECTION 3 . Disconnect the Central Bicarbonate Line on the Rear of the machine from the Central Concentrate Supply system and connect it to the Bicarbonate Port (B) on the Front Panel of the machine.000 to 60. (Refer to your technical service for information on your machine configuration).118 in).11 in) in length and with an internal diameter of 3 mm (0.000 ppm)/Bleach has to be used. WARNING Before starting a Central Bicarbonate Line disinfection process. (See Figure 3.000 ppm)/Bleach is used. maximum 3 metres (118. 3. Rev. 3. Verify that the Acid Connector is connected to the Acid Port (A) on the Front Panel.1) to the Central Concentrate Supply system is a PVC line. • Sodium hypochlorite solution (active chlorine from 50. B .4. it is the operator’s responsibility to verify that all the Acid and Bicarbonate connectors are correctly placed to ensure the disinfection process is properly performed.7).2 Central Bicarbonate Line Disinfection & Rinse: automatic processes The Central Bicarbonate Line disinfection is a chemical process that allows to disinfect both the hydraulic flowpath of the machine and the central bicarbonate line from the rear panel of the machine to the male dialysate connector fitting to the Central Concentrate Supply System. maximum 3 metres (118.4.11 in) in length and with an internal diameter of 3 mm (0.2. • The Central Bicarbonate Line connecting the Rear Connector (3) of the Phoenix (See Figure 3. Place the disinfectant connectors in the correct position. Depending upon the selection of the parameters EXTERNAL JUG USE and LIQUID INLET: EXTERNAL JUG USE:NO LIQUID INLET:FRONT • Disconnect the Yellow Connector from its Rinse Port on the lower front panel of the machine and connect it to the Yellow Wand.7: Connector positions in Central Bicarbonate Line Disinfection 4. EXTERNAL JUG USE:YES LIQUID INLET:FRONT • Perform the previous procedure. Rev. Immerse the Yellow Wand into the disinfectant container.3-10 PHOENIX OPERATOR MANUAL fig. Also verify that there is enough liquid to perform a disinfection procedure. B . 3. EXTERNAL JUG USE:YES LIQUID INLET:REAR 1/REAR 2 • Ensure that the disinfectant connector (present on the rear of the machine) is correctly inserted in the disinfectant container located on the rear of the machine. Note If any problems occur while the disinfectant is being taken up into the internal tank. B . To clear this alarm and restart the disinfection procedure reinsert the Yellow Connector into its Rinse Port. Rev.7). An Operator Message will appear: Emptying Disinfectant Tank And Repeat Filling Disinfectant Tank Note If LIQUID INLET is set to FRONT at the completion of disinfectant uptake. the machine will automatically empty and refill the tank.7). The following view is displayed: 12:30 ADR PROGRESS DISINF TIME RINSING TIME min:s min:s END PROCESS AUTO OFF MODE pH VALUE LIQUID INLET BPM REPORT MACHINE CLOSE Note If the Bicarbonate Connector is not inserted in the BLUE (3) port on the Front Panel (see Figure 3. the following alarm message is displayed: Disinf Connector Position with an audible alarm (#47).CENTRAL CONCENTRATE SUPPLY 3-11 5. the alarm message “B Connector Position“(code #18) is displayed. The machine will start uptaking of disinfectant to fill an internal tank (approximately 180 ml). Bicarb Connector Position” (code #272) is displayed while in the Operator Messages Area the following message will appear: Central bicarb wall connector must be in blue port and blue connector in CCK blue port If the Central Bicarbonate Line is not inserted in the Bicarbonate Port (B) on the Front Panel of the machine (see Figure 3. • Press the CHEM + CENTR BICARB LINE Action key. the alarm message “Centr. Perform the Bicarbonate Line Disinfection process: • Select the ADR Selection key on the IDLE view and then press the CHEM PROCESS Selection key. SECTION 3 . • When the machine goes into an alarm condition during the process and the operator takes no action.2 ADR: RINSE . In this case the process selection is cancelled and all the keys that were available before starting the Disinfection process will remain available.4. • When the CLOSE Action key is selected 30 seconds after the disinfection process has been started and before the DISINF TIME has elapsed.2. • When the CLOSE Action key is selected within 30 seconds after the disinfection process has been started. in this section) Note The Central Bicarbonate Line disinfection can not be programmed by the AutoStart feature. The machine will automatically turn OFF after 30 minutes following completion of the DISINF TIME. B .3-12 PHOENIX OPERATOR MANUAL 6. At the next switch on Central Bicarbonate Line disinfection must be performed again to allow the selection of the DIALYSIS process. In this case the process is not considered complete and the Central Bicarbonate Line disinfection must be performed again to allow the selection of the DIALYSIS process. Rev. an ADR:RINSE process will automatically start. Central Bicarbonate Line disinfection stops: • When the time value set for the DISINF TIME parameter is elapsed. When the Central Bicarbonate Line disinfection has been correctly completed. (See 3. 7. RINSING TIME: this parameter can be set to a value between 15 min and 50 minutes. REAR 1 or REAR 2. LIQUID INLET: This parameter specifies the line through which the uptake of disinfectant is performed. During the process an alarm is triggered when the pH value is outside the range selected by the operator for the two parameters. CENTR BICARB LINE: this parameter is always set to YES and can not be modified. AUTO OFF: if NO is selected. and can not be modified. END PROCESS MODE: this parameter is always set to Rins. Once the Central Bicarbonate Line disinfection has been correctly completed. the EXTERNAL JUG USE parameter allows the machine to uptake disinfectant from the chemical connector (yellow) on the FRONT of the machine or from REAR 1 or REAR 2 at the back of the machine. the machine returns to the IDLE view after performing the RINSE process.BICARB LINE view is set to YES. It indicates that a disinfection process will be performed disinfecting both the hydraulic flowpath of the machine and the central bicarbonate line from the rear panel of the machine to the male dialysate connector fitting to the Central Concentrate Supply System. This parameter can be set to FRONT. the machine turns OFF automatically. SECTION 3 . the machine performs a RINSE process for the time set for the parameter RINSING TIME parameter. only if the EXTERNAL JUG USE parameter is set to YES in the Config/MACHINE view. a rinsing phase is automatically performed. pH Min and pH Max: these parameters appear only if the parameter pH MONITOR on the Config\ADR\CHEM+CENTRAL. When set to YES. The default value for this parameter is the lowest value necessary to ensure disinfection of the machine when an approved disinfectant is used. B .CENTRAL CONCENTRATE SUPPLY 3-13 List of Parameters and their meanings DISINF TIME: this parameter can be set to a value between 15 min and 30 minutes. if YES is selected. at the end of the chemical disinfection process. Rev. When set to NO the internal disinfectant tank is filled by drawing disinfectant from the Yellow Connector on the front of the machine. 2 ADR: RINSE following the Central Bicarbonate Line disinfection The RINSING process described below described allows to rinse both the hydraulic flowpath of the machine and the central bicarbonate line from the rear panel of the machine to the male dialysate connector fitting to the Central Concentrate Supply System. Rev.3-14 PHOENIX OPERATOR MANUAL 3. During the RINSING process. Bicarb Connector Position” (code #272) is displayed while in the Operator Messages Area the following message will appear: Central bicarb wall connector must be in blue port and blue connector in CCK blue port If the Central Bicarbonate Line is not inserted in the Bicarbonate Port (B) on the Front Panel of the machine (see Figure 3.7).7). the alarm message “B Connector Position“ (code #18) is displayed. 1. B . the alarm message “Centr. During the RINSING process the following view is displayed: 12:30 ADR PROGRESS RINSING TIME AUTO OFF min:s BPM REPORT MACHINE CLOSE Note If the Bicarbonate Connector is not inserted in the BLUE (3) port on the Front Panel (see Figure 3. The RINSING process starts automatically once the Central Bicarbonate Line disinfection is completed.4. connectors must remain in the same configuration of the Central Bicarbonate Line disinfection.2. 2. • Disconnect the Central Bicarbonate Line from the Bicarbonate Port (B) on the Front Panel of the machine and connect it to the Central Concentrate Supply system (See Figure 3. • When the CLOSE Action key is selected before the RINSING TIME has elapsed. To make available the SETUP Action key and delete the above Help message: • Disconnect the Bicarbonate Connector from the BLUE (3) port on the Front Panel. Rev. SECTION 3 . B . The machine will automatically turn OFF after 30 minutes following completion of the RINSING TIME. the machine performs the UF Vessel Level Detectors Test. Note The Central Bicarbonate Line Rinse process can not be programmed by the AutoStart feature. the following Help message will appear on the Touch Screen in the Parameter Area: To allow SETUP remove connector from Central bicarb port and reinsert if needed 6. At the next switch on. In this case the process is not considered complete and the Central Bicarbonate Line Rinse process (maintaining the same connectors configuration of the Central Bicarbonate Line disinfection) must be performed again to allow the selection of the DIALYSIS process.CENTRAL CONCENTRATE SUPPLY 3-15 3. and connect it to the Bicarbonate Port (B) on the Front Panel (See Figure 3. Central Bicarbonate Line Rinse process must be performed again to allow the selection of the DIALYSIS process. 5. the following operator message will appear: Emptying UF Vessel forced The process time will be increased.7). During RINSING.7). If the UF Vessel Level Detector Test fails. Central Bicarbonate Line Rinse process stops: • When the time value set for the RINSING TIME parameter is elapsed. When the Central Bicarbonate Line Rinse process has been correctly completed. • When the machine goes into an alarm condition during the process and the operator takes no action. 4. 1) to the Central Concentrate Supply system has to be maximum 3 metres (118. The Central Acid (A2) Line connecting the Rear Connector (2) of the Phoenix (See Figure 3.118 in).2). • If Central Acid (A2) Line Rinse has to be performed: The Central Acid (A2) Line connecting the Rear Connector (2) of the Phoenix (See Figure 3. in the Phoenix Service Manual).11 in) in length and with a diameter of 3 mm (0.2).11 in) in length and with a diameter of 3 mm (0.118 in). • If Central Bicarbonate Line Rinse has to be performed: The Central Bicarbonate Line connecting the Rear Connector (3) of the Phoenix (See Figure 3. To carry out the Central Concentrate Lines Rinse process the following conditions have to be satisfied: • The proper service configuration has to be performed in the machine calibrations environment (Refer to Section 8. The Central Acid (A1) Line connecting the Rear Connector (1) of the Phoenix (See Figure 3.1) to the Central Concentrate Supply system has to be adapted so that the end side of this line (connected to the Central Concentrate Supply port) mates to the Female Acid Connector (A) on the Front of the machine (See Figure 3.4.3-16 PHOENIX OPERATOR MANUAL 3.2). The Central Bicarbonate Line connecting the Rear Connector (3) of the Phoenix (See Figure 3.3 Acid and Bicarbonate Lines Rinse: automatic process An automatic process can be performed to rinse both the Central Bicarbonate Line and the Central Acid Lines (A1 and/or A2).1) to the Central Concentrate Supply system has to be adapted so that the end side of this line (connected to the Central Concentrate Supply port) mates to the Female Acid Connector (A) on the Front of the machine (See Figure 3.118 in).11 in) in length and with a diameter of 3 mm (0. • If Central Acid (A1) Line Rinse has to be performed: The Central Acid (A1) Line connecting the Rear Connector (1) of the Phoenix (See Figure 3.1) to the Central Concentrate Supply system has to be adapted so that the end side of this line (connected to the Central Concentrate Supply port) mates to the Female Bicarbonate Connector (B) on the Front of the machine (See Figure 3. B . Rev.1) to the Central Concentrate Supply system has to be maximum 3 metres (118.1) to the Central Concentrate Supply system has to be maximum 3 metres (118. Disconnect the Central Acid Line (A1) on the Rear of the machine from the Central Concentrate Supply system and connect it to the RED (2) port on the Front Panel. Note: If only the Central Acid Line (A1) is rinsed verify the Bicarbonate Connector is connected to the Bicarbonate Port (B) on the Front Panel. Note: If only the Central Acid Line (A1) and (A2) are rinsed verify the Bicarbonate Connector is connected to the Bicarbonate Port (B) on the Front Panel.8 (B)). • Central Acid Line (A1) and Central Acid Line (A2): Disconnect the Acid Connector from the Acid Port (A) on the Front Panel and connect it to the RED (1) port on the Front Panel.8 (E)).8 (D)). Note: If only the Central Acid Line (A2) is rinsed verify the Bicarbonate Connector is connected to the Bicarbonate Port (B) on the Front Panel. (See Figure 3. Disconnect the Central Acid Line (A1) on the Rear of the machine from the Central Concentrate Supply system and connect it to the Acid Port (A) on the Front Panel of the machine.3.8 (F)). (See Figure 3.8 (A)). • Central Acid Line (A1): Disconnect the Acid Connector from the Acid Port (A) on the Front Panel and connect it to the RED (1) port on the Front Panel. (See Figure 3. Disconnect the Central Acid Line (A2) on the Rear of the machine from the Central Concentrate Supply system and connect it to the Acid Port (A) on the Front Panel of the machine. (See Figure 3. Disconnect the Central Bicarbonate Line on the Rear of the machine from the Central Concentrate Supply system and connect it to the Bicarbonate Port (B) on the Front Panel of the machine. Rev. verify the Acid Connector is connected to the Acid Port (A) on the Front Panel. • Central Acid Line (A1) and Central Bicarbonate Line: place the connectors as described in the above steps “Central Bicarbonate Line” and in “Central Acid Line (A1)”.4. • Central Acid Line (A2) and Central Bicarbonate Line: place the connectors as described in the above steps “Central Bicarbonate Line” and in “Central Acid Line (A2)”. Depending on the Central Bicarbonate Lines to be rinsed: • Central Bicarbonate Line: Disconnect the Bicarbonate Connector from the Bicarbonate Port (B) on the Front Panel and connect it to the BLUE (3) port on the Front Panel. • Central Acid Line (A1). SECTION 3 .8 (G)). (See Figure 3. (See Figure 3. Disconnect the Central Acid Line (A2) on the Rear of the machine from the Central Concentrate Supply system and connect it to the Acid Port (A) on the Front Panel of the machine.8 (C)). Note: If only the Central Bicarbonate Line is rinsed.1 Rinse Procedure 1. Central Acid Line (A2) and Central Bicarbonate Line: place the connectors as described in the above steps “Central Bicarbonate Line” and in “Central Acid Line (A1) and Central Acid Line (A2)”. • Central Acid Line (A2): Disconnect the Acid Connector from the Acid Port (A) on the Front Panel and connect it to the RED (2) port on the Front Panel. (See Figure 3. B .CENTRAL CONCENTRATE SUPPLY 3-17 3. 3-18 PHOENIX OPERATOR MANUAL (A) Central Bicarbonate Line (B) Central Acid Line (A1) (C) Central Acid Line (A2) (D) Central Acid Line (A1) and Central Acid Line (A2) fig.8: Connector positions in Central Concentrate Lines Rinse Rev. 3. B . B .8: Connector positions in Central Concentrate Lines Rinse Rev. 3. SECTION 3 .CENTRAL CONCENTRATE SUPPLY 3-19 (E) Central Bicarbonate Line + Central Acid Line (A1) (F) Central Bicarbonate Line + Central Acid Line (A2) (G) Central Bicarbonate Line + Central Acid Line (A1) + Central Acid Line (A2) fig. the machine will start the Central Concentrate Rinse process. 3. Select the ADR Selection key on the IDLE view and then press the CCK LINES RINSE Action key. B . The machine will automatically turn OFF after 30 minutes following completion of the RINSING TIME. Note The RINSING TIME parameter is automatically set to 3 minutes. • When the machine goes into an alarm condition during the process and the operator takes no action. Central Concentrate Supply Rinse process stops: • When the RINSING TIME is elapsed.3-20 PHOENIX OPERATOR MANUAL WARNING Before starting a Central Concentrate Rinse process. At the next switch on. During all the time the process is in progress the following message will appear in the Operator Messages Area: To rinse one or more central concentrate lines. 4. all the ADR processes allowed before the CCK LINES RINSE Action key selection are still available except a standard RINSING process. The following superimposed window will appear: CONFIRMATION LAST ACTION MADE ENTER To Confirm By pressing the CONFIRM button. it is the operator’s responsibility to verify that all the Acid and Bicarbonate connectors are correctly placed to ensure all the lines involved in the Central Concentrate Rinse process are properly rinsed. In this case the process is not considered complete but all the ADR processes allowed before the CCK LINES RINSE Action key selection are still available except a standard RINSING process. • When the CLOSE Action key is selected before the RINSING TIME has elapsed. 2. ensure they are disconnected from the wall and inserted in rinse ports and the corresponding connectors are in central concentrate ports. Note The CCK LINES RINSE Action key is not available if the ADR processes (Chemical Disinfection or Heat Citric Disinfection) previously performed were not been correctly completed. Rev. this parameter value cannot be modified. A Disinf. Rev. B . To make available the SETUP Action key and delete the above Help message perform a Disinfection process. Restore the previous connectors configuration. Note The Central Concentrate Lines Rinse process can not be programmed by the AutoStart feature. 7. Process Must be performed to allow SETUP 6.CENTRAL CONCENTRATE SUPPLY 3-21 5. the following Help message will appear on the Touch Screen in the Parameter Area: SETUP not Allowed. When the Central Concentrate Supply Rinse process has been correctly completed. SECTION 3 . 4. The Lines may be disinfected simultaneously or independently. use a male Bicarbonate Male Connector as one end of the adaptor. can be applied to any of the 3 Central Concentrate Lines. contact your Local Representative. Rinse and Drain): manual procedure Note The Disinfection. This adaptor should be built such that when pressure is applied to the Central Concentrate System. • Acid Male Connector code 6954291. this frequency must be not lower than the frequency of the Cleaning/Disinfection procedures performed for the Clinic’s Supply System. Rev.4 Acid and Bicarbonate Lines Maintenance (Disinfection. Verification and Draining procedures. • Bicarbonate Male Connector code 6948996.4. It is the responsibility of the user to determine the frequency of the Cleaning/Disinfection procedures of these Central Concentrate Lines. 95 inch roll.3-22 PHOENIX OPERATOR MANUAL 3.1 Adaptor Setup Assemble an adaptor that mates to the female Central Concentrate fitting(s) on the Front of the machine: • If the Bicarbonate Line is to be disinfected. Note The Dialysate Sampling Connector (Universal) can also be used. one end of the adaptor would be an Acid Male Connector. The length of the tube would depend on whether one wanted to divert the Disinfectant/Rinse flow into a container. • If the Acid line(s) is to be disinfected. Rinse. The following components can be used to assemble the adaptor: • Dialysate Sampling Connector (Universal) code 6961031.4. or the components required to assemble it. described below. Two additional components may be required: • A Restrictor: may be needed to reduce flow (depending on the pressure and flow conditions within the facility’s Central Concentrate System) while Disinfection/Rinsing is taking place. flow should occur through this connector. 3. • A Check Valve: may be inserted into the line to prevent any back flow. • 1/8 inch silastic tubing. It is recommended to attach a silicone tube to the outlet side of this adaptor. Note For further information on the availability of this adaptor. B . 4. B .4. Rinsing efficacy for the Central Concentrate Lines within the machine can be verified at the outlet of the adaptor. 3. mentioned above. Chemical presence can be verified at the outlet of the adaptor.4. Disinfect the concentrate lines in the machine and the Central Concentrate Delivery System.CENTRAL CONCENTRATE SUPPLY 3-23 3. the adaptor may be removed after this Rinse verification step. 2. 2. Turn the machine OFF. However. 3.4 Rinse Verification 1. This will depend somewhat upon Drain or Container position. Verify the efficacy of Rinsing. described above.2 Disinfection Procedure 1. to the female Central Delivery Port on the Front Panel of the machine that is to be disinfected. Leave the adaptor in the Central Concentrate Port. Note The pressure used within the Central Concentrate System for the Cleaning and Disinfection of the 3 lines must be adequate to push water through this system. 3. A pressure range of 250-500 mmHg is recommended as an initial estimate for an acceptable pressure. 2. for cleaning and disinfection of the lines within the machine. Put the outlet tubing from the adaptor into a container.4.4. Verify the efficacy of the disinfection procedure. Rinse the Central Concentrate Supply System with water to remove chemicals introduced during the Cleaning/Disinfection process. 4. Route the Rinse water directly to a container. Rev. SECTION 3 . the pressure should be limited to prevent disconnection due to excessive pressure.3 Rinse Procedure 1. 3. Connect the adaptor. If draining is not to be done.4. This line(s) should be open. 1. Attach this adaptor the Central Concentrate Line where fluid is to be drained. Remove the adaptor. and exposed to atmosphere. Use the syringe to remove all fluid from the Central Concentrate Line. or long Idle period. Make certain that the Disinfection. Use the adaptor and attach a syringe to the outlet tubing (the side opposite of the male Concentrate Connector). Rev. 3. 4. 4. Remove the Central Concentrate Line(s) from the rear of the machine. 2.3-24 PHOENIX OPERATOR MANUAL 3. B .4. Let machine run until the lines are empty. shipping. Remove Central Concentrate Line(s) at the back of the machine from the Central Concentrate Supply. Enter SETUP. 3. Turn the machine ON. 2. and Rinse Verification steps have previously been performed on the Central Concentrate Line(s). Alternative Drain Procedure: 1. Rinse. Make certain that the Disinfection. Insert the male Concentrate Connector on the front of the machine into the Central Delivery Port that is to be drained. Rinse.4. 5.5 Draining of Central Concentrate Lines Note Draining of Central Concentrate Lines is recommended for machine storage. and Rinse Verification steps have previously been performed on the Central Concentrate Line(s). 3 lb) • pH probe assembly • Blood pump crank • BPM CUFF • Single Needle holder (only with machines that have been configured with an Arterial Line Clamp). B . Rev. WARNING Do not stand on Chemical container shelf. SECTION 4 . 4.2 lb) Note Adjustment of IV pole height must be done without bags on the hooks. Note The PHOENIX shipping carton. foam packing and other packaging materials should be disposed of according to local regulations.1 Unpacking instructions • Check that the shipping container is not damaged.2 Shipping Carton Contents The machine packaging contains the following components: • PHOENIX Haemodialysis System • PHOENIX Operator’s Manual • Installation Checklist • Water inlet and drain hose • Hose clamps • Sampling connector • Dialysate connectors and tubing • IV pole (maximum load: 6 Kg or 13. notify the transporter before opening. • If the shipping container is damaged. • Carefully take the machine out of its packaging.INSTALLATION 4. • Concentrate/disinfectant wands • Chemical container shelf (maximum load: 16 Kg or 35.4 INSTALLATION 4. located on the label on the rear panel.4. The Drain Port symbols. Attach the water inlet hose to the treated water for haemodialysis. • Maximum Dialysate flow: 1. of the PHOENIX Operator’s Manual. Connect the drain hose to a drainage system that satisfies the following requirements: • Maximum height above floor level: 1 m (39 inches).1 l/min. hospital-grade main power outlet (suitable for continuous operation) according to the voltage and current rating listed on the identification plate at the rear of the PHOENIX machine.3 Installation Power supply Connect the power cord to a grounded. show where the drain hose is to be connected. onto the drain port on the rear of the PHOENIX machine (see fig. using a stainless steel hose clamp. Water inlet connection Connect the 8x14 meshed PVC hose to the water inlet port on the rear of the PHOENIX (see fig.1).1).6 psig). located on the label on the rear panel. Requirements for water for haemodialysis can be found in Section 9 – Specifications. • Resistant to high temperature (~100°C) water. Note Check that the pressure is between 1 Kg/cm2 and 6 Kg/cm2(14. WARNING Verify the quality of the protective earth ground at the time of installation.4. Drain hose connection Connect the 8x14 PVC hose. contained in the shipping carton. of the PHOENIX Operator’s Manual. • Resistant to treated water and chemicals used for disinfection. The Water Inlet Port symbol. drained during the heat disinfection process. Electrical power requirements can be found in Section 9 – Specifications. B .6 to 87. shows where the inlet water hose is to be connected. Rev.4-2 PHOENIX OPERATOR MANUAL 4. WARNING Check the continuity and the reliability of the ground connection. SECTION 4 . in respect of separation of devices (drain line and drain itself). These ports are coloured blue and red appropriately. Drain Port Water inlet Port Figure 4. Insert the dialyser connectors onto the other end of the lines: • Blue connector: TO dialyser line • Red connector: FROM dialyser line Insert the dialysate connectors onto their colour coded bypass ports. B . Rev.INSTALLATION 4-3 Make connections as described in the international standards or in the local plumbing and electrical regulations.1 Dialyser connection Insert the “TO” and “FROM” dialysate lines onto their ports on the left side of the PHOENIX machine. back syphonage and the air clearance between the drain connector of the machine and the drain itself. Connect the probe’s BNC connector to the pH circuit board. supplied in the pH probe box. • Insert the tube connectors in the seats on the collar.4 First service WARNING This operation must be performed by authorized personnel. • Before mounting. General • Open the machine panels and visually inspect the hydraulics and electronics for any loose connections or damage from shipment. Mount a pump insert on each of the four peristaltic pumps as follows: • Open the mechanical lock on each peristaltic pump. Verify that the collar and tube are mounted correctly onto each pump. Note Carefully read the instruction sheet in the pH probe box. Mount the pH Probe as follows: • Remove the plastic cover that protects the pH probe holder • Remove the cap from the hydraulic circuit where the probe will be mounted. B . If Service is performed by unauthorized personnel. This initially stretches the tube. the manufacturer cannot accept any responsibility for any damage which may occur. • Remount the protective plastic cover on the pH probe holder. • Check that all tubing and connection are correct and secure. • Assemble the collar and tube onto each pump. • Remove the cover from the probe. Verify that the tubing connector is snug in its mount. twist the collar and tube backwards. • Attach the pH probe to the support using the plastic tie wrap contained in the pH probe box. and such damage is not covered by the warranty. • Route the wires from the pH probe so that they are secure in their path to the pH circuit board.4-4 PHOENIX OPERATOR MANUAL 4. • Mount the pH probe using the pH Holder Nut. Rev. as per AAMI and CDC guidelines. Rev. Follow your facility protocol for collecting and culturing the sample. B . • Perform the complete installation procedure found in the PHOENIX Service Manual. Prior to the first patient use. The purpose of these procedures is to calibrate the insert in the PS pump. SECTION 4 . The machine is calibrated by the manufacturer to guarantee the operating range described in the Specification Section for the specified concentrates. therefore the efficacy of these first disinfections is not guaranteed. the PHOENIX must be tested by a trained Service technician.INSTALLATION 4-5 Functional Check WARNING Do not use this machine near flammable gas or flammable anaesthetic mixtures with air. Notify the operator that a post-dialyser dialysate sample should be cultured for machine bioburden levels. Perform a heat citric disinfection procedure with the disinfectants that are in use in the dialysis facility. • Perform the autocalibration procedure for the concentrate pumps using the concentrate formulas used in the dialysis facility. Notify the operator that the machine must be disinfected again prior to use. Perform a chemical disinfection procedure with the disinfectants that are in use in the dialysis facility. with oxygen or with nitrous oxide. • Machine disinfection: Perform the Water Inlet Line Disinfection procedure. This is done so that the speed of the pumps for the facility’s concentrates will be stored in the concentrate exchange safety system. B .4-6 PHOENIX OPERATOR MANUAL This page is left intentionally blank Rev. SECTION 5 .1. Note It is not necessary to discard liquid before obtaining a sample for the Residual Disinfectant Concentration Test. 5.5 DIALYSIS OPERATION 5. prior to connecting the dialyser for priming. prior to pressing the SETUP Action Key. found in Section 5.1 Residual Disinfectant Concentration Test The Residual Disinfectant Concentration Test may be performed in SETUP. The Config view is only accessible from the IDLE view. Follow the Dialysate Sampling procedure.1 Starting 5.A – Special Procedures of this manual. B . with the machine in the SETUP Mode.1.2 Checking dialysis parameters configuration Parameters related to processes configured in the machine are displayed on the Config view. Rev. prior to using the machine for a patient treatment.DIALYSIS OPERATION 5. Press the Cartridge against the machine. • The blood pump cover can be closed when the blood pump rotor is in the default position. a.5-2 PHOENIX OPERATOR MANUAL 5. Close the holder arm. It is the responsibility of the user to validate that other blood lines provide safe and effective performance. Before installing a Gambro/Hospal Cartridge Blood Set. 5. The pressure pods should seat evenly on the pressure transducers.2. Place the pump segment of the Cartridge Blood Set around the blood pump rotor. b. Note • The blood pump rotor is in a horizontal position. Lift the holder arm and position the dialyser between the arm and the grippers attached to the machine. 5.2. Open the Blood Pump Cover by pressing the cover latch then open the Air Bubble Detector/Patient Sensor cover. Because of their high ultrafiltration coefficients. Close the Blood Pump Cover.) WARNING Reverse Ultrafiltration of fluid from the dialysate compartment into the blood compartment may occur when High Flux dialysers are used. c.1 Install dialyser Place the dialyser into the Dialyser Holder (left side of machine). The Manufacturer has not validated the use of blood lines other than those specified in this manual. (The dialyser is held in position between the holder arm and the grippers. WARNING It is the responsibility of the physician to ensure that the appropriate Gambro/Hospal Cartridge Blood Set is selected for the weight of the patient being treated.1): a.2 Load the Cartridge Blood Set To load the Cartridge Blood Set proceed as follows (see Fig 5. high flux dialysers will quickly transfer fluid across the membrane in response to pressure differences between the dialysate compartment and the blood compartment. Insert the tab of the Cartridge Blood Set into the cartridge clip (left side of cartridge holder). d. (Cover makes a clicking sound as it latches). Rev.2 Extracorporeal Circuit preparation WARNING The use of the Gambro/Hospal Cartridge Blood Set designed for Phoenix machine has been tested and validated to provide safe and proper functioning of the system. B . • This is the default position after switching ON the machine. carefully read the Cartridge Blood Set Instructions for Use. The Manufacturer does not assume responsibility or liability for use of blood line other than the Gambro/Hospal Cartridge Blood Set. b. f. then connect the arterial dialyser line to the arterial dialyser port. Adjust dialyser position to prevent sharp bends in tubing and to prevent tubes from interfering with Phoenix machine or its parts. rotate the arterial dialyser line counter-clockwise (about 1 full turn). Close the Air Bubble Detector cover (cover makes a clicking sound as it latches). 2. Route the lines from right to left as follows: Heparin line green clamp Arterial access line red clamp (right) Cartridge saline line (with priming connector) red clamp (left) Venous access line blue clamp The Arterial access line. 9. 10.dialyser pumping chamber) to the venous dialyser port (on the bottom of the dialyser). Route the Cartridge access lines into the 4 Position Line Clamp above the blood pump. Before attaching the arterial dialyser line (from the bottom of the pre.dialyser pumping chamber) to the arterial dialyser port (on the top of the dialyser). Route the venous line through the Air Bubble Detector/Patient Sensor and through the Venous Line Clamp. i. for the Installation of the Single Needle holder procedure).DIALYSIS OPERATION 5-3 e. then connect the venous dialyser line to the venous dialyser port. Mount the Single Needle holder (see Section 5. B . Be sure that the clamp above the pre-dialyser expansion chamber and the clamp above the post-dialyser expansion chamber are closed. h. Adjust dialyser position to prevent sharp bends in tubing and to prevent tubes from interfering with Phoenix machine or its parts.Special Procedures. Route the arterial line through the arterial line clamp. 8. 3. 4. 11. Route the venous line into the Air Bubble Detector and through the Venous Line Clamp. g. 6. Ensure that lines are untangled. Use a Cartridge Blood Set equipped with expansion chambers. Before attaching the venous and arterial dialyser lines of the Cartridge Blood set to the dialyser blood ports. To mount the post-dialyser expansion chamber press with the thumb the top side to the lower single needle holder arm while levering to the Single Needle holder with the rest of the hand. Ensure that lines are untangled. Before attaching the venous dialyser line (from the bottom of the post. SECTION 5 . The Single Needle holder is provided of two clip connections to secure the pre and post-dialyser expansion chambers. rotate the dialyser lines counter-clockwise (about 1 full turn). Route the lines from right to left as follows Heparin line green clamp Arterial access line red clamp (right) Rev. Both pre and post-expansion chambers must fit properly to the single needle holder arms. 5. If performing a Single Needle dialysis (option): 1. Route the Cartridge access lines into the 4 Position Line Clamp above the blood pump. in this manual.A . Insert the pre-dialyser and post-dialyser expansion chambers in their respective holders (with the level adjustment lines pointing upwards). Cartridge saline line and Venous access line make a clicking sound when they are firmly inserted in the 4 Position Line Clamp. Close the Air Bubble Detector/Patient Sensor cover (cover makes a clicking sound as it latches). 7. rotate the venous dialyser line counter-clockwise (about 1 full turn). then connect the dialyser lines to the dialyser blood ports. To mount the pre-dialyser expansion chamber press with the thumb the bottom side to the higher single needle holder arm while levering to the Single Needle holder with the rest of the hand. Refer to "6. WARNING Before inserting the venous line in the Air Bubble Detector clean and dry it. twists. blood loss to the environment/air into the blood circuit due to leakage in the extracorporeal circuit. in the Section 06 .5-4 PHOENIX OPERATOR MANUAL Cartridge saline line red clamp (left) Venous access line blue clamp The Arterial access line. WARNING Never insert fingers in the Venous Line Clamp and in the Arterial Line Clamp (if Single Needle is available on the machine).8. clamps or other restrictions on the blood line. Note Clamp all lines except the heparin line.Clean/Disinfect. verify that the pump is off. Leave the heparin line unclamped so it can be primed with heparin from the heparin syringe. B . Rev. WARNING When the cover of the blood pump is open.1 External surface cleaning" paragraph. Fluid and gel substances applied on the Air Bubble Detector may reduced the Air Bubble Detector sensitivity causing patient injury or death. that might not be detected by the machine: for instance. for the description of how to clean the Air Bubble Detector. WARNING Improper connections of the extracorporeal circuit may cause potential patient safety hazards. loops. hemolysis caused by kinks. Cartridge saline line and Venous access line make a clicking sound when they are firmly inserted in the 4 Position Line Clamp. sharp bends. 1 Cartridge Blood Set Loading Rev. SECTION 5 .DIALYSIS OPERATION 5-5 Fig. B . 5. b. c. d. Verify that the heparin line of the Cartridge Blood Set is installed in the green clamp of the 4 Position Line Clamp. Rev.3 Fill and install heparin syringe a. move the heparin syringe plunger clamp to fit the syringe. With the (ARROW LEFT) and (ARROW RIGHT) buttons on the Heparin Control Panel. B . e.2. Verify that the heparin line on the Cartridge Blood Set is unclamped. Fill a syringe with the desired amount of heparin solution and push the syringe plunger to expel any air. Position the wings of the syringe against the syringe holder so that they will fit between the plastic clips. Lock it in place with the clamp and close the syringe holder with the clip (to keep the syringe in place).5-6 PHOENIX OPERATOR MANUAL 5. Attach the heparin line to the heparin syringe. b.4 Connect saline a. B . SECTION 5 . Rev. Remove the cover from the saline administration line and insert the spike into a 1000 ml bag of saline.DIALYSIS OPERATION 5-7 5. Hang a saline sterile bag on the IV pole.2. Clamp the saline administration line that is connected to the venous line. 5-8 PHOENIX OPERATOR MANUAL 5. after the selection of the SETUP Action key. the Cartridge Blood Set has not been installed. the Operator Message will disappear and the ACETATE. CHOICE view appears which displays options for the type of dialysate to be used (ACETATE. It disappears at the end of the day. Rev. It doesn’t appear if the dialysis treatment has been interrupted and then restarted using the Fast Recovery of the Dialysis process procedure. BICARB CONC and BICART Action key will become available.3 SETUP selection Overview The dialysate preparation process is started by selecting the SETUP Action key from the IDLE view. Only after the Cartridge Blood Set installation. BICART). CHOICE ACETATE BICARB CONC BICART NEW SESSION BPM REPORT KT/V PROFILE HEPARIN MACHINE CLOSE Note The NEW SESSION Action key appears following the first dialysis treatment of the day. Note If. The DIAL. SELECT DIALYSATE VIEW: 12:30 DIAL. BICARB CONC. B . the following message will be displayed in the Operator Message Area: Warning: the cassette MUST be installed before starting the preparation. Select the dialysate type Action key to begin uptake of the concentrates into the machine.4% COND (Note 1) PATIENT DATA VEN ART BLOOD FLOW PRIME VOLUME CONDUCTIVITY BPM REPORT KT/V PROFILE HEPARIN MACHINE STOP SETUP Note 1 This parameter changes following the selection made in Config/Treatments for the parameters related to the Action keys ACETATE. Select the desired parameter by touching the parameter box on the Touch Screen and change the value by using the PLUS or MINUS buttons. SECTION 5 . Rev. The following view is then displayed: SETUP VIEW: 12:30 SETUP PRIME TIME pH VALUE PRIME DIALYSATE FL. B . Select the name of the desired Patient/Rx prescription by pressing one of the seven Selection keys. PATIENT DATA (PATIENT DATA/Patient/Rx SELECT): Access this view to select the personalised prescription parameters. The corresponding Patient/Rx parameters are then displayed. Note To modify the values of the Patient/Rx parameters press the Set button on the Main Control Panel. Each parameter must be confirmed individually.DIALYSIS OPERATION 5-9 Connect the appropriate acid and bicarbonate (if applicable) concentrates to the machine. BIC 8. Confirm the parameters so that the machine may use them from the beginning of the preparation process or modify the parameters by pressing the Set button. BICARB CONC or BICART. then press CONFIRM to accept the new value for the parameter. The machine will return to the IDLE view. To stop SETUP.1. CHOICE view. B .1 When Acetate Dialysate is programmed in the Configuration menu To start the preparation of Acetate dialysate: • Disconnect the white concentrate connector on the lower front panel of the machine and connect it to the white concentrate wand.3.1 Standard Dialysis Mode (when SETUP has been selected) 5. and then place the wand into in the acetate concentrate container.3. press the STOP SETUP Action key and confirm the operation by pressing the CONFIRM button on the Main Control Panel. • Press the SETUP Action key on the IDLE view. Rev. The following view is displayed: 12:30 SETUP PRIME TIME pH VALUE PRIME DIALYSATE FL TEMPERATURE PATIENT DATA VEN ART BLOOD FLOW PRIME VOLUME CONDUCTIVITY BPM REPORT KT/V PROFILE HEPARIN MACHINE STOP SETUP The dialysate preparation process starts. • Select the ACETATE Action key on the DIAL.5-10 PHOENIX OPERATOR MANUAL 5. If the other type of liquid bicarbonate concentrate is required.DIALYSIS OPERATION 5-11 5. If BIC 6. the BICARB CONC parameter in the configuration menu must be re-entered To start the preparation of Liquid Bicarbonate dialysate: • Disconnect the white concentrate connector on the lower front panel of the machine and connect it to the white concentrate wand and then place the wand into the acid concentrate container. BIC 6.1. CHOICE view. • Press the SETUP Action key on the IDLE view.3. SECTION 5 .6% is selected in the configuration menu. the following view is displayed: 12:30 SETUP PRIME TIME pH VALUE PRIME DIALYSATE FL. in this manual. • Select the BICARB CONC Action key on the DIAL.4% The type of liquid bicarbonate concentrate is entered in the Configuration menu. B .2 When Liquid Bicarbonate Dialysate is programmed in the Configuration menu Before pressing the SETUP Action key.3. Note The type of bicarbonate concentrates to be used on the PHOENIX is described in the Section 9 – Specification. ensure that the BiCart holder is in the rinsing position.6% COND (Note 2) PATIENT DATA VEN ART BLOOD FLOW PRIME VOLUME CONDUCTIVITY BPM REPORT KT/V PROFILE HEPARIN MACHINE STOP SETUP Rev.6% / 8. 1) Note BICARBONATE 6. • Disconnect the blue concentrate connector on the lower front panel of the machine and connect it to the blue concentrate wand and then place the wand into the bicarbonate concentrate container. with the arms closed (see Fig 5. • Quality of the bicarbonate. • Type of solutions used for chemical disinfection. in this manual). WARNING If bicarbonate dialysis is performed: 1. press the STOP SETUP Action key and confirm the operation by pressing the CONFIRM button on the Main Control Panel. To do this.5-12 PHOENIX OPERATOR MANUAL Note 2 This parameter changes following the selection made in Config/Treatments/BICARB CONC. 2. this frequency may be increased or decreased depending on the following conditions: • Number of bicarbonate dialysis sessions a day. substituting the chemical disinfectant for an acetic acid solution 30% v/v (add 120 ml of glacial acetic acid to 280 ml of water to obtain 400 ml of solution). WARNING Ineffective cleaning with acetic acid may cause the machine to malfunction (the lines or the solenoid valves may block and the sensor readings may be affected). depending on the conditions listed above. To stop setup and to return to the IDLE view. B . It is recommended to perform an acetic acid rinse at least twice a week to remove the calcium and any precipitate residues. It is responsibility of the user to check the efficiency of the acetic acid rinsing procedures and to alter the frequency that they are performed. which carry out two bicarbonate dialysis sessions a day. Rev. follow the instructions for the Disinfection process (see Section 6 - Clean/Disinfect. Do not turn off the machine with bicarbonate dialysate in the flow pathway. • Quality of water. Twice weekly rinsing with acetic acid is recommended for machines. which may be deposited in the hydraulic pathway. As required. on the responsibility of the operator. To fully open the upper arm (B). • Place the bottom of the BiCart cartridge (D) into the hole in the lower arm (C). pull the arm out slightly. press the BICART Action key to initiate priming of the BiCart.3. • Open both arms (B. The spike inside the hole of the upper arm pierces the top port of the BiCart (A). Pressing theBICART Action key initiates priming of the BiCart cartridge. Note The BiCart cartridge must be inserted into the BiCart holder before selecting the BICART Action key.2). and then place the wand into the acid concentrate container.4% COND (Note 1) PATIENT DATA VEN ART BLOOD FLOW PRIME VOLUME CONDUCTIVITY BPM REPORT KT/V PROFILE HEPARIN MACHINE STOP SETUP Rev. The following view appears: 12:30 SETUP PRIME TIME pH VALUE PRIME DIALYSATE FL.3 When BiCart Dialysate is programmed in the Configuration Menu To start the preparation of BiCart dialysate: • Disconnect the white concentrate connector on the lower front panel of the machine and connect it to the white concentrate wand. then tip it upward. Turn the BiCart by a quarter turn to place it in working order. Note It is recommended to invert the BiCart before placing it in the BiCart holder. At the same time. Hold the BiCart in an upright position and press down firmly on the upper arm (B) of the BiCart holder. CHOICE view is displayed. B . SECTION 5 . BIC 8. the BiCart moves downward and the spike in the lower arm pierces the bottom port. • When the DIAL.1. C) of the BiCart holder (see Fig 5.DIALYSIS OPERATION 5-13 5. A B D C Fig 5. check the position of the BiCart and verify that both BiCart holder arms are completely pressed into the BiCart ports. press the STOP SETUP Action key and confirm the operation by pressing the CONFIRM button on the Main Control Panel.2 BiCart holder Rev. B .5-14 PHOENIX OPERATOR MANUAL It takes about 1 minute to fill the BiCart with water. To stop SETUP and to return to the IDLE view. If this does not happen. • Store at a temperature lower than 40 °C (104 °F). SECTION 5 . check that it is undamaged. Note In the event of a “Bicart Connector Position” #22 alarm. Rev. B .A .DIALYSIS OPERATION 5-15 WARNING Check the expiry date on the BiCart label.Special Procedures. If required to replace the BiCart when a dialysis treatment is in progress. in this manual. Do not refill the BiCart cartridge. IMPORTANT: • Before using the BiCart cartridge. the BiCart priming process will not start. follow the “BiCart Change” procedure in the Section 5. 5-16 PHOENIX OPERATOR MANUAL 1 2 3 Fig 5. Rev. the machine prompts the operator to perform a DESCALING.3 BiCart connection Note In bicarbonate dialysis. DESCALING may be performed with the BiCart cartridge in the BiCart holder if a dialysis treatment will follow the DESCALING process or with the BiCart removed and the BiCart holder arms closed.e. at the end of EMPTYING. i. B . rinsing of the hydraulic circuit. using either acid concentrate or vinegar. it indicates that a Communication System. when present. B . When the PATIENT DATA Action Key is selected. The PAT NETWORK Action key allows to assign a Patient identifier to a treatment. SECTION 5 . • When the the SW COMM SYSTEM parameter is set to Exalis. Rev. including the Exalis System. can collect treatment data but cannot send prescriptions. Note If the communication between the Exalis System and the machine is interrupted for more than the time set for the OFFLINE TIMEOUT parameter.3. • When the SW COMM SYSTEM parameter is set to OTHER. the PAT NETWORK Action key disappears.2 RX Dialysis Mode Note This Section contains references to all the communication software systems to which the Phoenix machine can be connected. this assignment will be recognized by the Communication System. The PATIENT DATA Selection key in SETUP view. the PATIENT CHOICE view appears: 12:30 PATIENT CHOICE PATIENT MACH PAT NETWORK BPM REPORT KT/V PROFILE HEPARIN MACHINE CLOSE Note The PAT NETWORK Action key is available only if the SW COMM SYSTEM parameter is set to Exalis or to OTHER in Config/Communic. it indicates that the Exalis Dialysis Management System is active and can send prescriptions.DIALYSIS OPERATION 5-17 5. other than Exalis or CentryNet or RIMS.. allows the selection of one of the personalised Patient/Rx prescriptions or allows retrieval of the personalised Patient/Rx prescriptions stored in the Exalis database or allows to assign an identifier to the treatment data collected by the Communication System. the keypad allows to assign a Patient identifier to the treatment that will be collected by the Communication System. B . Press the Action key on the Touch Screen to select the desired prescription Patient (Rx). a superimposed window appears advising the operator about the error in the patient prescription: …accessory has not enabled in this machine . Press ENTER To Confirm And Proceed The operator must press the CONFIRM button to proceed with the treatment. Rev. deactivate Profiling.5-18 PHOENIX OPERATOR MANUAL By pressing PAT NETWORK a keypad appears allowing the entry of the Patient Name: • if the SW COMM SYSTEM parameter is set to Exalis. press the CONFIRM button on the Main Control Panel as requested by the message on the Touch Screen. • if the SW COMM SYSTEM parameter is set to OTHER. if it is has been already activated. To confirm the selection. for a detailed description of the prescription download with the Exalis System. By pressing PATIENT MACH the following PATIENT CHOICE view will appear: 12:30 1ST PATIENT 2ND PATIENT 3RD PATIENT 4TH PATIENT 5TH PATIENT 6TH PATIENT 7TH PATIENT BPM REPORT KT/V PROFILE HEPARIN MACHINE CLOSE Note Before selecting a new personalised Patient (Rx) prescription. refer to Section 07- Communication System. Note If the prescription selected is not consistent with the machine features. the portion of the patient prescription related to the accessory that has not been enabled will be ignored. the following superimposed window appears: Patient Not Recognized by Clinical Software Check the Patient Name and retry. the WRONG PRESC PAR: parameter displays the prescription parameter causing the failure.if the PAT CONNECT Action key does not become available in the WAIT FOR PT. Press ENTER To Proceed Press the CONFIRM button and repeat the procedure. a superimposed window appears advising the operator about the error in the patient prescription: Prescription Not Valid. after this confirmation: .all of the patient prescription will be discarded. Entering the Machine view. B . select the PATIENT DATA Action key and then press the CLOSE Action key to make the PAT CONNECT Action key available. . Note If the patient prescription selected is not available in the Exalis database. Please Access the Machine Page to Check the Wrong Parameter. The operator must press the CONFIRM button to proceed the treatment. Press ENTER To Confirm And Proceed. Rev. SECTION 5 .DIALYSIS OPERATION 5-19 Note If at least one of the parameters in the patient prescription can not be accepted by the machine. CONNECT view.. some of the relevant dialysis parameters are displayed. B .5-20 PHOENIX OPERATOR MANUAL When a Patient is selected. the DIALYSIS TIME and WEIGHT LOSS/H parameters are not displayed in the Patient/Rx Safety Parameters Area of the screen. • When COND PROFILE is active. Rev. as shown in the following example: 12:30 PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE SAFETY PARAMETERS PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE Note • When UF PROFILE is active. the DIALYSIS TIME and CONDUCTIVITY parameters are not displayed in the Patient/Rx Safety Parameters Area of the screen. B . with the selected displayed in the RX/Patient Name Area: 12:30 PATIENT 1 IDLE PATIENT DATA SETUP ADR BPM REPORT CONFIG MACHINE Rev. the following view will appear. If it was the IDLE view. SECTION 5 .DIALYSIS OPERATION 5-21 When the CONFIRM button on the Main Control Panel is pressed the system will automatically return to the previous view where the PATIENT DATA Selection key was pressed. this “BLOOD detection” can be caused by incorrect placement of the venous line.3 • Press the SETUP Action key.Remove venous line from patient sensor . Or: .1. press CONFIRM. depends on the specific selections made for the Patient WARNING If the machine has detected blood at the Patient Sensor during SETUP. Press the CONFIRM button to allow the machine to continue. If the type of dialysate is: • ACETATE: follow the instructions in 5. Rev. Note If the equipment has detected an incorrect pressure during T1Test. the following message is displayed: If the line has blood in it.1 • BIC CONC: follow the instructions in 5.1. the warning message “W! Wait for Pressure Test Execution” appears and the following message is displayed: Please Close the Saline Bag and Open the Cassette Chambers to the External Environment By doing this the pressure decreases and the user can reposition the Cartridge correctly. Note The parameters list displayed. the corresponding Patient name is displayed in the Patient Name Area in the upper left corner of the screen. If there is no patient connected to the machine.Clean and dry venous line and pt.1.3. to start the preparation of the dialysate: • Attach the concentrate connectors on the lower front panel of the machine to the appropriate concentrate containers. Note When a Patient personalised dialysis is selected.3. according to the type of dialysate selected for this Patient.3. sensor slot .2 • BIC BICART: follow the instructions in 5.Put venous line back in the patient sensor .Press CONFIRM If the patient is already connected to the machine. disconnect the patient from the machine. B . due to improper Cartridge positioning.5-22 PHOENIX OPERATOR MANUAL When programming a Patient treatment: Before pressing the SETUP Action key. CHOICE view. the following message appears: Wait Dialysate Preparation In Progress..B – Test Procedures. and a progress bar is displayed informing that the dialysate preparation phase is in progress. B . BIC 8. Note The parameters on the Touch Screen will differ depending on the type of dialysis therapy previously selected. Rev.. appropriate messages are displayed in the operator message window. 12:30 SETUP PRIME TIME pH VALUE PRIME DIALYSATE FL. dialysate preparation starts. the machine carries out the automatic T1 test (see Section 5. in this manual).1 Dialysate preparation After pressing one of the Dialysate Selection keys on the DIAL.DIALYSIS OPERATION 5-23 5. SECTION 5 . When no test is occurring.4% COND (Note 1) PATIENT DATA VEN ART BLOOD FLOW PRIME VOLUME CONDUCTIVITY BPM REPORT KT/V PROFILE HEPARIN MACHINE STOP SETUP Note During the T1 test.4 Preparing for a patient treatment 5.4. During dialysate preparation. signalled by the appearance of the following Operator Message: End Of Dialysate Prep.5-24 PHOENIX OPERATOR MANUAL WARNING DO NOT transfer a primed Cartridge Blood Set to another PHOENIX for continuation of treatment before dialysate preparation completion. B . the operator may modify some parameters using the SET button on the Main Control Panel. You Can Proceed You Can Now Connect The Dialyser Note During the dialysate preparation phase. Rev. 2 Sampling of dialysate A sample can be obtained after the “End Of Dialysate Prep. Press ENTER To Confirm And Proceed Press UNDO to Cancel the Selection By pressing the CONFIRM button the machine will perform the PA/PB pump Autocalibration procedure during the dialysate preparation process.1 Possible operations during the dialysate preparation phase Dialysate Preparation may be interrupted by pressing the STOP SETUP Action key to return to the IDLE view. the machine detects a condition that could produce a “! Concentrate Cans: A Pump/B Pump/A+B Pumps” #40 alarm in the dialysis treatment in progress. in this manual. The following message will appear: CONFIRMATION LAST ACTION MADE ENTER To Confirm UNDO Note If AutoCalibration of the PA and PB concentrate pumps or the UF pump is necessary during the dialysate preparation phase.A - Special Procedures. You Can Proceed” message appears – refer to “Dialysate Sampling” in the Section 5. SECTION 5 . refer to Section 5. refer to Section 5. Note If during the dialysate preparation phase.A .1. the following message will be displayed in the Operator Message Area: Arterial Cover is Open Please Close it Only after the Blood Pump Cover has been closed. By pressing UNDO. Note If during the dialysate preparation phase. the machine will proceed with the dialysate preparation process.4. in this manual.DIALYSIS OPERATION 5-25 5. the following superimposed window will appear: Check the dialysate concentrates to ensure the usage of the correct concentrate type. 5.Special Procedures. the machine detects that the Blood Pump Cover is not properly closed. B .1. Rev.Special Procedures.A .4. the Operator Message will disappear and the machine will proceed with the dialysate preparation process. 5-26 PHOENIX OPERATOR MANUAL 5. WARNING The Waste Handling Option (WHO) must be cleaned each time blood enters the WHO drain port before continuing with another patient treatments or once per day if the WHO has been in use. BIC 8.2 Priming Mode Selection View After selecting a dialysate type on the Dialysate Selection view.Special Procedures.A . WARNING Use an aseptic technique when connecting/disconnecting the white priming connector of the arterial line to/from the WHO in order to avoid any potential contamination of the line. (Refer to Section 5. Rev. B . in this manual). open the Waste Handling Option (WHO) door and insert the white priming connector attached to the arterial line into the Waste Handling Option drain port (use the pre-connected priming connector). DO NOT USE the WHO.4% COND (Note 1) PATIENT DATA VEN ART BLOOD FLOW PRIME VOLUME CONDUCTIVITY BPM REPORT KT/V PROFILE HEPARIN MACHINE STOP SETUP Note In Prime mode. WARNING Verify that fluid is not present in the Waste Handling Option drain port by visual inspection before inserting the Cartridge Blood Set’s priming connector into the port. If fluid is present in the port for more than six seconds after opening the cover. the blood pump runs in the reverse direction (clockwise). the following view is displayed where the priming parameters of the dialyser may be selected: 12:30 SETUP PRIME TIME pH VALUE PRIME DIALYSATE FL.4. Once the PRIME Selection key appears. SECTION 5 .5.1 Priming with Dialysate Connectors on the Dialyser During Dialysate preparation. WARNING Hemolysis may occur if blood comes in contact with disinfectant remaining in the blood pathway of dialysers that have not been completely rinsed.5. the priming procedure can start immediately after the appearance of the PRIME Action key (Refer to the below section 5. B .Priming with Dialysate Connectors on the Dialyser).5. • If the DIAL AUTO PRIME parameter is set to YES. the priming procedure can start only when the machine is within proper conductivity (Refer to the below section 5. These rinsing procedures are the responsibility of the medical director. 5. Once it disappears the dialysate lines can be still connected to the dialyser. if not yet done. Note The connection of the dialysate lines to the dialyser can be performed during all the dialysate preparation phase except when the following Operator Message is displayed: Do Not change Current position of dialysate connectors until Dialysate Prep. If the dialysers are filled with a chemical disinfectant.2 .Priming with Dialysate Connectors on the Rinse Ports). is Complete This message appears immediately before the end of the dialysate preparation phase. • Connect the Red dialysate connector to the outlet dialysate port (red end) of the dialyser.1 . once the PRIME Action key appears: • Connect the dialysate lines to the dialyser: • Connect the Blue dialysate connector to the inlet dialysate port (blue end) of the dialyser. • If the DIAL AUTO PRIME parameter is set to NO. The procedures must include a test of residual disinfectant and techniques to avoid rebound of disinfectant.5 Priming of the dialyser The priming procedure may vary depending on the value set for the DIAL AUTO PRIME parameter in Config\Centre Conf\Automation. special rinsing techniques must be employed to assure the concentration of disinfectant is reduced and maintained at an appropriate level.DIALYSIS OPERATION 5-27 5. Rev. the following view is displayed: 12:30 MANUAL PRIM PRIME W/ UF PRIME W/O UF BPM REPORT KT/V PROFILE HEPARIN MACHINE CLOSE • Select the priming mode.5-28 PHOENIX OPERATOR MANUAL • Press the PRIME Action key. • Select the CLOSE Action key to return to the SETUP PRIME view. Rev. B . the limits of the Venous Pressure alarm window are automatically set at -50 to +250 mmHg and the Arterial Pressure alarm window limits are set at -400 to +150 mmHg. if no priming mode has been selected. These values are maintained for the duration of the PRIME mode. WARNING When selecting SETUP. it will not start or stop automatically but is controlled by pressing the blood pump ON/OFF button on the Blood Pump Control Panel. • Depending on the priming mode selected proceed as follows: • if MANUAL PRIM is selected. use the buttons on the Blood Pump Control Panel. The UFR is set at the UF PRIMING value selected in Config and is also adjustable in the SET mode. and priming starts as soon as the operator press the ON/OFF button on the Blood Pump Control Panel. An operator message will direct the user to the required steps in order to complete priming. Rev. To manually control the blood pump speed. and the blood pump starts automatically. the following Operator Message is displayed: Manual Priming is in Progress: the Blood Pump has to be running and the BYPASS has to be deselected.1. Note The BYPASS Action key remains activated (yellow) during all the priming of the blood side of the dialyser.1 To prime the blood side of the dialyser and the heparin line Note Before selecting the PRIME Action key. The following Operator Message will appear: End Of Dialysate Preparation You Can Now Connect The Dialyser The BYPASS Action Key automatically changes in colour.DIALYSIS OPERATION 5-29 5. • if PRIME W/ UF is selected. During manual priming mode. make sure that the saline bag is hanging correctly on the IV Pole. priming will start automatically when the machine is within proper conductivity. To start priming of the dialysate side of the dialyser the BYPASS Action key has to be manually de-activated (grey). • Unclamp the saline administration line and the venous and arterial lines. Note If the RESUME button was pressed just before selecting the MANUAL PRIM Action key. from yellow to grey.5. The pump will start at its minimum preset speed. The operator can increase or decrease the blood pump speed using the PLUS or MINUS buttons on the Blood Pump Control Panel. The blood pump will stop when the programmed Dialyser Prime Volume has been infused. The blood pump must remain ON until at least 120 ml of saline has been infused and an operator message appears that indicates that MANUAL PRIM may be stopped. the blood pump will start automatically at the selection of the MANUAL PRIM Action key. SECTION 5 . the blood pump is controlled by the operator. B . The UFR is at the UF PRIMING value selected in Config and it is also adjustable in the SET mode. • Observe the dialyser and Cartridge Blood Set. From this view the HEPARIN PR Action key may be pressed to activate priming. B . refer to “Level adjustment of the Cartridge chambers”. Note A blood pump speed of 150 ml/min is recommended to obtain the best extracorporeal circuit deaereation. An icon indicating the activation of the heparin pump appears on the icon bar. • Priming of the heparin line starts automatically at the start of the blood side priming. the blood pump starts automatically immediately after the Action key selection and will stop when the programmed Dialyser Prime Volume has been infused. Note In the Prime mode. from yellow to grey. When the machine is within proper conductivity and the following Operator Message will appear End Of Dialysate Prep. the blood pump turns in the reverse (clockwise) direction. access the Heparin view by pressing the Heparin Navigation key. Note To prime the heparin line. NO UFR is performed. Note If set up for Single Needle and a Single Needle treatment is programmed. Rev. perform prime as in Double Needle mode and select Single Needle mode at the end of PAT CONNECT (refer to Dialysis change mode). The syringe containing heparin must be correctly installed prior to the time of the HEPARIN PR selection. You Can Proceed You Can Now Connect The Dialyser the BYPASS Action Key automatically changes in colour.5-30 PHOENIX OPERATOR MANUAL • if PRIME W/O UF is selected. • Check/adjust the fluid level in the venous and arterial chambers. if the parameter PRIMING HEP is set to YES in the Config screen. during dialysate side priming the following message appears: Wait. Dialysate side priming may be started before blood side priming is complete. the RECIRC Action key becomes available. Note The selection/activation of the PRIME Action Key allows the operator to re-start priming.1. If the PRIME Action key is deselected/deactivated before the end of the dialysate side priming. • When priming is complete. • The end of the dialysate side priming is signaled by the appearance of the RECIRC Action key. B . the RECIRC Action key will become available to initiate the recirculation phase prior to patient connection. WARNING If performing MANUAL PRIM or PRIME W/O UF.2 To fill the dialysate side of the dialyser • If MANUAL PRIM has been selected. SECTION 5 . deselect/deactivate the BYPASS Action key on the SETUP: PRIME/PREPARATION view to prime the dialysate side of the dialyser. priming of the blood side may be performed before priming the dialysate side.DIALYSIS OPERATION 5-31 5. Priming in progress … and a progress bar is displayed informing that the dialysate side priming phase is in progress. Rev. Note If PRIME W/ UF or PRIME W/O UF has been selected.5. BIC 8.2 Priming with Dialysate Connectors on the Rinse Ports When the machine is within proper conductivity. the following Operator Message will appear: End Of Dialysate Prep.5-32 PHOENIX OPERATOR MANUAL 5.4% COND (NOTE 1) PATIENT DATA VEN ART BYPASS BLOOD FLOW PRIME VOLUME CONDUCTIVITY PAT CONNECT BPM REPORT KT/V PROFILE HEPARIN MACHINE STOP SETUP WARNING When selecting SETUP.5. You Can Proceed You Can Now Connect The Dialyser and the following view is displayed: 12:30 SETUP PRIME PRIME TIME PH VALUE PRIME DIALYSATE FL. Rev. These values are maintained for the duration of the PRIME mode. B . Note The PAT CONNECT Action key is available only if the JUMP PRIMING parameter is set to YES in Config/Centre Conf/Functions. the limits of the Venous Pressure alarm window are automatically set at -50 to +250 mmHg and the Arterial Pressure alarm window limits are set at -400 to +150 mmHg. 5.5. • Connect the Red dialysate connector to the outlet dialysate port (red end) of the dialyser. • When the PRIME Selection key is pressed the following view is displayed: 12:30 MANUAL PRIM PRIME W/ UF PRIME W/O UF BPM REPORT KT/V PROFILE HEPARIN MACHINE CLOSE Rev. the PAT CONNECT Action key is available only after the START COLLECT Action key has been pressed. B . make sure that the saline bag is hanging correctly on the IV Pole.1 To prime the blood side of the dialyser and the heparin line Note Before selecting the PRIME Action key.DIALYSIS OPERATION 5-33 Note If the machine is connected to the CentryNet system. • Connect the Blue dialysate connector to the inlet dialysate port (blue end) of the dialyser. • Unclamp the saline administration line and the venous and arterial lines. Connect the dialysate lines to the dialyer. SECTION 5 .2. The operator can increase or decrease the blood pump speed using the PLUS or MINUS buttons on the Blood Pump Control Panel. • Select the CLOSE Action key to return to the SETUP PRIME view. The UFR is at the UF PRIMING value selected in Config and it is also adjustable in the SET mode. The pump will start at its minimum preset speed. NO UFR is performed. and the blood pump starts automatically. The blood pump will stop when the programmed Dialyser Prime Volume has been infused. • if PRIME W/O UF is selected. After the selection of the MANUAL PRIM Action key. the blood pump is controlled by the operator. • if PRIME W/ UF is selected. if no priming mode has been selected. Note A blood pump speed of 150 ml/min is recommended to obtain the best extracorporeal circuit deaereation. The blood pump will not start or stop automatically but is controlled by pressing the blood pump ON/OFF button on the Blood Pump Control Panel. the blood pump starts automatically and will stop when the programmed Dialyser Prime Volume has been infused.5-34 PHOENIX OPERATOR MANUAL • Select the priming mode: • if MANUAL PRIM is selected. the BYPASS Action Key automatically changes in colour. from yellow to grey. B . Note If set up for Single Needle and a Single Needle treatment is programmed. An operator message will direct the user to the required steps in order to complete priming. the following Operator Message is displayed: Manual Priming is in Progress: the Blood Pump has to be running and the BYPASS has to be deselected. The blood pump must remain ON until at least 120 ml of saline has been infused and an operator message appears that indicates that MANUAL PRIM may be stopped. the blood pump turns in the reverse (clockwise) direction. Note In the Prime mode. perform prime as in Double Needle mode and select Single Needle mode at the end of PAT CONNECT (refer to Dialysis change mode) Rev. The UFR is set at the UF PRIMING value selected in Config and is also adjustable in the SET mode. From this view the HEPARIN PR Action key may be pressed to activate priming. • Check/adjust the fluid level in the venous and arterial chambers. If the PRIME Action key is deselected/deactivated before the end of the dialysate side priming. • When priming is complete. access the Heparin view by pressing the HeparinNavigation key.DIALYSIS OPERATION 5-35 • Priming of the heparin line starts automatically at the start of the blood side priming. Note To prime the heparin line. during dialysate side priming the following message appears: Wait. • The end of the dialysate side priming is signaled by the appearance of the RECIRC Action key. An icon indicating the activation of the heparin pump appears on the icon bar. B . the RECIRC Action key will become available to initiate the recirculation phase prior to patient connection. The syringe containing heparin must be correctly installed prior to the time of the HEPARIN PR selection. refer to “Level adjustment of the Cartridge chambers”. Priming in progress … and a progress bar is displayed informing that the dialysate side priming phase is in progress. Dialysate side priming may be started before blood side priming is complete. deselect/deactivate the BYPASS Action key on the SETUP PRIME/PREPARATION view to prime the dialysate side of the dialyser. if the parameter PRIMING HEP is set to YES in the Config screen. 5. Rev. priming of the blood side may be performed before priming the dialysate side. Note The selection/activation of the PRIME Action Key allows to re-start priming. SECTION 5 .2 To fill the dialysate side of the dialyser • If MANUAL PRIM or PRIME W/O UF has been selected. the RECIRC Action key becomes available.2. WARNING If performing MANUAL PRIM or PRIME W/O UF.5. • Observe the dialyser and Cartridge Blood Set. Note If PRIME W/ UF or PRIME W/O UF has been selected. there is danger of contaminating the arterial line with fluid that has been in contact with the Waste Handling Option. the PRIME. d. c. Clamp the heparin line. Connect the venous and arterial lines together utilizing the white priming connector on the venous line. the Blood Pump will stop.5-36 PHOENIX OPERATOR MANUAL 5.1 Prepare to perform recirculation a. b.6 Recirculation 5.1. Recirculation continues for the time set in the RECIRCULATION TIME parameter.2 Select Recirculation a. Close the Waste Handling Option door. Remove the arterial line from its priming connector. e. The blood pump will run at the pump speed value previously set for the RECIRC B FLOW parameter. When the time has elapsed the blood pump continues to run in the forward direction (counter-clockwise) and the UFR stops until Patient Connection. Rev. The recirculation timer (RECIRCULATION TIME parameter) will be stopped while the Waste Handling Option door remains open. the saline administration line. 5. Remove the white priming connector from the Waste Handling Option drain port and discard it.1 Unclamp lines Unclamp the venous and arterial lines. Pressing the RECIRC Action key automatically starts the blood pump. the alarm message “WHF Door Positioning” (#326) will appear. To prevent contamination of the arterial line. venous and arterial lines and the saline administration line. for details about the RECIRC B FLOW parameter setting). BYPASS and PAT CONNECT Action keys are not available. Note If the arterial line is removed from the Waste Handling Option with the white priming connector attached. and the Cartridge saline line clamps. B . Note During the Recirculation phase. WARNING Use an aseptic technique when connecting/disconnecting the white priming connector of the arterial line to/from the WHO in order to avoid any potential contamination of the line. (Refer to Section 02 – Configuration. always disconnect the arterial line from the white priming connector in the WHO drain port. leaving the priming connector in the WHO drain port. 5. If the WHO door remains open at the activation of the RECIRC phase.6.6. Disconnect the saline administration line from the venous line and connect it to the Cartridge saline line utilizing the white priming connector on the Cartridge saline line.6. Ensure the saline administration line is still clamped. SECTION 5 - DIALYSIS OPERATION 5-37 b. Use the PLUS or MINUS buttons on the Blood Pump Control Panel to adjust the blood pump speed during RECIRC. c. Set a UF PRIMING to greater than 0.1 l/h to prevent saline from flowing backwards into the saline administration line. d. Recirculate according to your facility’s protocol. To stop RECIRC and stop the blood pump, press the RECIRC Action key. 5.7 Level adjustment of the Cartridge chambers Level Adjustment without using syringe in Double Needle Treatment Adjust the fluid level in the venous Cartridge chamber by aseptically opening both the white cap on the venous access line and the blue clamp on the 4 Position Line Clamp, with the blood pump ON in the forward (counter-clockwise) direction. When the target level is reached, close the blue clamp and replace the white cap on the venous access line. During the PRIME mode the fluid level in the arterial Cartridge chamber may be adjusted with the blood pump ON in the reverse (clockwise) direction, by aseptically opening both the white cap on the arterial Cartridge access line and the right red clamp on the 4 Position Line Clamp. When the target level is reached, close the right red clamp and replace the white cap on the arterial access line. To adjust the fluid level in the arterial Cartridge chamber, when not in the PRIME mode, turn the blood pump OFF and then aseptically open both the white cap on the arterial Cartridge access line cap and the right red clamp on the 4 Position Line Clamp. When the target level is reached, close the right red clamp and replace the white end cap. Note The fluid level in the chambers (arterial or venous) should be stabilized at approximately the bottom of the pressure pod. The target fluid level in the chambers is indicated by a frosted line on the chamber themselves. Level Adjustment using syringe in Double Needle Treatment To adjust the fluid level in the venous Cartridge chamber open the white cap on the venous access line, connect a sterile syringe to the venous access line and open the blue clamp on the 4 Position Line Clamp. Slowly and cautiously aspirate until the target level is reached, then close the blue clamp, remove the syringe and replace the white cap on the venous access line. To adjust the fluid level in the arterial Cartridge chamber, open the white cap on the arterial Cartridge access line, connect a sterile syringe to the arterial access line and open the right red clamp on the 4 Position Line Clamp. Slowly and cautiously aspirate until the target level is reached, then close the right red clamp, remove the syringe and replace the white cap on the arterial access line. Rev. B 5-38 PHOENIX OPERATOR MANUAL Note The fluid level in the chambers (arterial or venous) should be stabilized at approximately the bottom of the pressure pod. The target fluid level in the chambers is indicated by a frosted line on the chamber themselves. Level Adjustment in Single Needle Treatment Adjust the level in the pre and post dialyser expansion chambers and be sure that the clamp above the pre-dialyser expansion chamber and the clamp below the post- dialyser expansion chamber are closed. To perform the procedure, follow the instructions in the “Level Adjustment using syringe in Double Needle Treatment” paragraph by operating on the pre and post dialyser expansion chambers. Note The fluid level in the expansion chambers (pre and post dialyser) should be stabilized at approximately 1/3 of the height of the expansion chambers. Rev. B SECTION 5 - DIALYSIS OPERATION 5-39 5.8 Patient Connection 5.8.1 Ready for patient connection After prime is complete the following view is displayed: 12:30 SETUP WAIT PATIENT RECIRCULATION TIME RECIRCULATION UF PRIME RECIRC DIALYSATE FL. BIC 8.4% COND (NOTE 1) PATIENT DATA VEN ART BYPASS BLOOD FLOW PRIME VOLUME CONDUCTIVITY PAT CONNECT CHANGES BPM REPORT KT/V PROFILE HEPARIN MACHINE STOP SETUP Note During the initial DIASCAN Autocalibration, the BYPASS Action key is not available (see Section 5.E – Monitoring, in this manual). Note If the CURVE TYPE parameter or/and the CON CURVE TYPE parameter is(are) set to STEP or to PROGRESSIVE, the PAT CONNECT Action key becomes available only if the corresponding Profile curve(s) has/have been activated ACTIVATE (UF RATE CURVE or/and the ACTIVATE CONDUCT. CURVE Action key(s) selection). Refer to Section 5.D – Profile, in this manual. WARNING If using a dialyser that has been filled with a chemical disinfectant, proceed as follows: • Verify that the level of residual chemical disinfectant in the extracorporeal circuit is acceptable according to your facility’s protocol or to the instructions for use of the disinfectant’s manufacturer. • When the residual level is acceptable, discard the rinse saline bag and attach a new bag of saline. If the residual level is unacceptable, proceed according to your facility’s protocol. • Before initiating dialysis flush the administration set and the entire extracorporeal circuit with fresh saline according to your facility’s protocol. Rev. B 5-40 PHOENIX OPERATOR MANUAL Once all the preparations and settings have been completed and the patient is ready, the operator can select the PAT CONNECT Action key, confirm the selection pressing the CONFIRM button and then proceed to connect the patient. WARNING When performing dialysis treatment for patients with a body weight of less than 40 kg, special attention should be given to the dialysate flow rate setting. To mitigate the risk of excessive weight removal, it is recommended to set the DIALYSATE FL. parameter to a value lower than or equal to 500 ml/min. Note If the presence of blood has already been detected at the Patient Sensor the machine automatically goes to the PAT CONNECT view (see Initiating patient connect). Note When Profiling has not been activated, these parameter values must always be confirmed: − DIALYSIS TIME − TOT WEIGHT L − WEIGHT LOSS/H If these values are not confirmed, a confirmation request is displayed in the Operator Message Area and the PAT CONNECT Action key will not appear. When UFR Profiling has been activated, the TOT WEIGHT L parameter value must always be confirmed in the PROFILE/UF view to make the PAT CONNECT Action Key available. Refer to Section 5.D - Profile. Note In case of error in the retrieval of the RX prescription from an external communication software system (Refer to Section 7.5.3, Error Messages related to Computer Prescription, for details about the error message displayed in case of failure), the PAT CONNECT Action key might not be displayed. To make the PAT CONNECT Action key available, select the PATIENT DATA Action key and then press the CLOSE Action key. Note When Profiling is active, the END DIALYSIS parameter can not be modified. Before activating Profiling ensure the END DIALYSIS parameter is correctly set for the current dialysis prescription. The END DIALYSIS parameter becomes again available at Profiling deactivation (Refer to Section 05.D – Profile, for a detailed description of Profiling deactivation conditions). Note The DIALYSIS TIME, TOT WEIGHT L and WEIGHT LOSS/H parameters have to be confirmed following the listed sequence. To allow the operator to confirm them in the right order, they are automatically selected in sequence. Note If the machine is connected to the CentryNet system, the DIALYSIS Action key is available only after the START COLLECT Action key has been pressed. Rev. B SECTION 5 - DIALYSIS OPERATION 5-41 5.8.2 Heparinization By pressing the Heparin Navigation key the following view will appear: 12:30 SYRYNGE TYPES LINEAR AUTO BOLUS PARAMETER 1 (NOTE 3) PARAMETER 2 (NOTE 3) MAN BOLUS VEN ART BLOOD FLOW PARAMETER 3 (NOTE 3) PARAMETER 4 (NOTE 3) BOLUS ON HEPARIN PR BLOOD FLOW BPM REPORT KT/V PROFILE HEPARIN MACHINE Note 3 These parameters are displayed only if the heparin delivery type has been selected by pressing the LINEAR or AUTO BOLUS or MAN BOLUS Action key. In the case of: • LINEAR Parameter 1 = PRE STOP TIME Parameter 2 = HEPARIN RATE Parameter 3 = INITIAL BOLUS Parameter 4 = HEPARIN TOTAL • AUTO BOLUS Parameter 1 = PRE STOP TIME Parameter 2 = HEPARIN BOLUS Parameter 3 = BOLUS INTERVAL Parameter 4 = HEPARIN TOTAL • MAN BOLUS Parameter 1 = MANUAL BOLUS Parameter 2 = HEPARIN TOTAL If this view is accessed during the PRIME mode, the operator can initiate the priming of the heparin line by pressing the HEPARIN PR Action key. At this point the heparin pump injects a fixed quantity of heparin into the line. Or, priming of the heparin line starts automatically at the start of the blood side priming if the parameter PRIMING HEP is set to YES in Config/Centre Conf/Automation. Rev. B 5-42 PHOENIX OPERATOR MANUAL The HEPARIN PR Action key is available only during the dialyser prime and the dialyser change. The volume injected is equivalent to the volume of the heparin line on the Cartridge Blood Set. The heparin delivery type can be selected by pressing one of the following Action keys: LINEAR: heparinization is continual during the treatment at the HEPARIN RATE set. In this mode, a programmable quantity (initial bolus) of heparin can be injected before starting the continual heparinization. To do this, the user must set a value for the INITIAL BOLUS parameter before starting the treatment. Pressing the LINEAR Action key disables the AUTO BOLUS and MAN BOLUS Action keys. AUTO BOLUS: a heparin bolus is delivered by the machine at a fixed time interval. The quantity of the bolus corresponds to the value set for the HEPARIN BOLUS parameter, while the timing corresponds to the value set for the BOLUS INTERVAL parameter. Pressing the AUTO BOLUS Action key disables the LINEAR and MAN BOLUS Action keys. MAN BOLUS: a heparin bolus is delivered every time the BOLUS ON Action key is pressed. The quantity of the bolus corresponds to the value set for the MANUAL BOLUS parameter. Pressing the MAN BOLUS Action key disables the LINEAR and AUTO BOLUS Action keys. During treatment, the HEPARIN TOTAL parameter displays the volume of heparin infused to the patient. The HEPARIN TOTAL parameter value for a treatment remains available: -until the machine switch off at the end of treatment; -until the selection of the heparinization delivery type for the next treatment, if the machine is not switched off between two subsequent dialysis treatments. Once the heparinization delivery type is selected and the appropriate Action key pressed, the corresponding heparin icon appears on the left side of the Touch Screen, on the Icon bar, indicating that the mode is activated. The Heparin Pump will start in patient connection. To return to the previous view press the Home icon Navigation key. Rev. B SECTION 5 - DIALYSIS OPERATION 5-43 5.8.3 Initiating patient connect The machine is ready for patient connection. Press PAT CONNECT, the blood pump stops automatically to allow connection of the patient to the machine. Press the blood pump ON/OFF button to restart the blood pump if the patient is not yet available. The following view appears on selection of PAT CONNECT: 12:30 PATIENT CONNECT DIALYSIS TIME WEIGHT LOSS/H TOTAL FLUID REMOVED TOT WEIGHT L VEN ART BLOOD FLOW TOTAL BLOOD CONDUCTIVITY CHANGES BLOOD FLOW BPM REPORT KT/V PROFILE HEPARIN MACHINE To access the BPM view press the BPM Navigation key. Proceed with the patient connection to the machine according to the facility’s protocol. 5.8.3.1 Fill the extracorporeal circuit with fresh saline prior to treatment a. Clamp the venous and arterial lines and disconnect them from each other leaving the priming connector on the venous line. b. Place the arterial line over a collecting basin, being careful not to contaminate the line. c. With the blood pump OFF, open the clamps on the saline administration line, Cartridge saline line and the arterial line. d. Allow approximately 60 ml of saline to run out of the saline bag, through the arterial chamber and arterial line into the collecting basin. Clamp the arterial line. e. Being careful not to contaminate the line, connect the arterial line to the patient’s arterial access. Leave both lines clamped. Rev. B 5-44 PHOENIX OPERATOR MANUAL f. Insert the priming connector on the venous line into the Waste Handling Option drain port. Press the blood pump ON/OFF button to start the blood pump and immediately open the clamp on the venous line. Note The Heparin Pump will start after a minimum value (20 ml) of TOTAL BLOOD has been reached. g. Flush the remaining extracorporeal circuit with enough saline to replace the recirculated saline it contains. DO NOT let air enter the lines. h. When enough saline has been allowed to flush the extracorporeal circuit, press the blood pump ON/OFF button to stop the blood pump and clamp the venous line. WARNING Verify that fluid is not present in the Waste Handling Option drain port by visual inspection before inserting the Cartridge Blood Set priming connector into the port. If fluid is present in the port more than six seconds after opening the cover, DO NOT USE the Waste Handling Option. 5.8.3.2 Connect patient Note The steps below give instructions for connecting the patient and discarding the prime. The venous line is still connected to the Waste Handling Option drain port. a. Verify that there are no active alarms (check the alarm display area of Touch Screen); unclamp the heparin line. b. Clamp the saline administration line and Cartridge saline line. c. Unclamp the arterial line and the patient’s arterial access. Press the blood pump ON/OFF button to start the blood pump (blood begins filling the arterial line and chamber). d. Unclamp the venous line. When blood enters the venous chamber, simultaneously clamp the venous line and press the blood pump ON/OFF button to stop the blood pump. Once the Patient Sensor detects blood in the venous line, an alarm “W! Blood in the Venous Line” will be given and the blood pump will stop. OVERRIDE this alarm to continue. e. Disconnect the venous line from the white priming connector, leaving the white priming connector in the Waste Handling Option. f. Being careful not to contaminate the line, connect the venous line to the patient’s venous access. Unclamp the venous line and the patient’s venous access. g. Remove the white priming connector from the WHO and discard it. Close the Waste Handling Option door. Note The DIALYSIS Action Key will not appear until the Waste Handling Option door is closed. Rev. B SECTION 5 - DIALYSIS OPERATION 5-45 Note From the moment that blood is detected in the venous line at the Patient Sensor the Patient Sensor icon appears to indicate the presence of blood. WARNING From the moment that blood is detected in the venous line at the Patient Sensor to the WASHBACK phase, if the operator stops the Blood Pump pressing the ON/OFF button on Blood Pump Control Panel: • The venous pressure alarm window lower limit is automatically set to +10 mmHg and the upper limit is set to the VEN PRES LIMIT parameter value decreased of 50 mmHg (see Section 2 - Configuration Description, in this manual). • The arterial pressure alarm window lower limit is automatically set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg and the upper limit is set to +150 mmHg. These values are maintained for all the time the Blood Pump is OFF and for 30 sec. after the Blood Pump restart. WARNING Once the patient has been connected, do not open the Blood Pump Cover unless it is required by special procedures described in this manual (i.e., Diaphragm Neutral Position Procedure); in this case strictly follow these procedures. Opening of the Blood Pump Cover without following procedures described in this manual may infuse air to the patient through the arterial line causing patient injury or death. The DIALYSIS Action Key is displayed: 12:30 PATIENT CONNECT DIALYSIS TIME WEIGHT LOSS/H DIALYSIS TOTAL FLUID REMOVED TOT WEIGHT L VEN ART BLOOD FLOW TOTAL BLOOD CONDUCTIVITY CHANGES BLOOD FLOW BPM REPORT KT/V PROFILE HEPARIN MACHINE Rev. B 5-46 PHOENIX OPERATOR MANUAL Note If a Patient Dialysis is performed and the Communication System is Exalis, once the patient connection has been made, the machine sends to the Exalis database the name of the patient that has been connected. If the name of the patient sent to the Exalis Communication System is not present in the Exalis database, the following superimposed window appears: Patient Not Recognized by Clinical Software. To retrieve the current treatment data, , Link manually the patient in Exalis. Press ENTER To Proceed Press the CONFIRM button to proceed with the treatment. Refer to the Exalis Operator’s Manual for the procedure of how to link manually the patient in the Exalis database. Once the patient connection has been made, select the DIALYSIS Action key to start the dialysis treatment. The blood pump will start: • at the speed value set for the INIT DIAL B FLOW parameter, if the RAMPING TIME parameter is set to 0. • at 50 ml/min, if the RAMP TIME parameter is set to a value different from 0. In this case the blood pump will automatically reach the pump speed value set for the INIT DIAL B FLOW parameter in a interval time equal to the value set for the RAMPING TIME parameter. During this Automatic Gradual Ramping time period the PLUS and MINUS button on the Blood Control Panel are not active. WARNING The PATIENT CONNECT and WASHBACK MODES have associated safety hazards due to the reduced efficacy of the Protective System; these must be carried out under the control of the user and are the responsibility of the user. Rev. B SECTION 5 - DIALYSIS OPERATION 5-47 5.8.4 Dialysis change mode: Single Needle and Double Needle mode Pressing the CHANGES Selection key, from the PATIENT CONNECT view, where it is available, allows the user to change the operating mode of the blood module. 12:30 CHANGES CHANGE TO SN DIALYSIS TIME WEIGHT LOSS/H CHANGE TO DN FILTER CHANGE TOTAL FLUID REMOVED TOT WEIGHT L VEN ART PAUSE BICART BLOOD FLOW BICART PRIM. TOTAL BLOOD CONDUCTIVITY CHANGE TO LIQ BIC BLOOD FLOW CHANGE ACID BPM REPORT KT/V PROFILE HEPARIN MACHINE CLOSE Note The BICART PRIM. Action key does not appear until the PAUSE BICART Action key has been pressed. CHANGE TO SN and CHANGE TO DN Action keys are only displayed if Single Needle is set to YES in Config/MACHINE /Accessories. The possible transitions depend on the starting conditions, since in DN only the DN > SN key is enabled, while in SN only the SN > DN key is enabled. From Double Needle DN > SN From Single Needle SN > DN CLOSE allows the user to return to the previous view. Rev. B 5-48 PHOENIX OPERATOR MANUAL 5.9 Dialysis 5.9.1 Performing Dialysis When the DIALYSIS Action key is selected, the following view is displayed: 12:30 TREATMENT DIALYSIS TIME DIFFUSION TIME BYPASS UF ONLY TOTAL FLUID REMOVED TOT WEIGHT L WLR MINIMUM VEN ART BLOOD FLOW WEIGHT LOSS/H TOTAL BLOOD CHANGES BLOOD FLOW BPM REPORT KT/V PROFILE HEPARIN MACHINE WASHBACK This view remains until the end of dialysis. CHANGES allows the operator: • to change the operating mode of the blood module as described in the Dialysis Change Mode Section; • to temporarily disconnect the Patient (Refer to Section 05A – Special Procedures, in this manual, for the description of the PAUSE THERAPY procedure); • to change the BiCart if it becomes empty during the treatment (Refer to Section 05A – Special Procedures, in this manual, for the description of the BiCart Change procedure); • to replace the dialyser (Refer to Section 05A – Special Procedures, in this manual, for the description of the Dialyser Replacement procedure); • to switch from the use of BiCart to the use of Liquid 8.4% Bicarbonate concentrate (Refer to Section 05A – Special Procedures, in this manual, for the description of the CHANGE TO LIQUID BICARB procedure); • to change the Acid/Acetate Concentrate Supply (Refer to Section 05A – Special Procedures, in this manual, for the description of the CHANGE ACID procedure). Rev. B SECTION 5 - DIALYSIS OPERATION 5-49 Note When an Patient/Rx Personalised Treatment is performed, the name of the dialysis type in the view above is replaced with the Patient/Rx name. Note During DIALYSIS, the icons relative to the treatment appear in the Icon bar. Note In the event of a “! Concentrate Cans: A Pump or B Pump or A+B Pumps” alarm during a treatment, it is possible to carry out a recalibration: refer to Section 5.A - Special Procedures, in this manual. When a critical condition for the patient arises, the operator can use three emergency functions. • Minimum UF Rate: when selecting the WLR MINIMUM Action key, the hourly ultrafiltration rate is set to the minimum value selected in Config, i.e., a value between 0.0 and 0.3 kg/h. When selected, the Action key is highlighted. • Dialysate Flow in Bypass: when pressing the BYPASS Action key, the flow through the dialyser is interrupted. When selected, the Action key is highlighted: 12:30 TREATMENT DIALYSIS TIME DIFFUSION TIME BYPASS TOTAL FLUID REMOVED TOT WEIGHT L WLR MINIMUM VEN ART BLOOD FLOW WEIGHT LOSS/H TOTAL BLOOD CHANGES BLOOD FLOW BPM REPORT KT/V PROFILE HEPARIN MACHINE WASHBACK Rev. B 5-50 PHOENIX OPERATOR MANUAL Note If the operator has selected BYPASS for 7 minutes during the dialysis process, the alarm “! Bypass Wrongly Extended” (#302) appears. Pressing the BYPASS Action key again will restart the normal dialysis process: • The dialysate flow through the dialyser is restarted. • The BYPASS Action key is no longer highlighted • Ultrafiltration Only: The dialysate flow through the dialyser may be interrupted by pressing the UF ONLY Action key. The following confirmation request will appear: CONFIRMATION LAST ACTION MADE ENTER To Confirm UNDO By pressing the Confirm button the Action key becomes highlighted and the BYPASS Action key disappears indicating that the function is no longer selectable. 12:30 TREATMENT DIALYSIS TIME DIFFUSION TIME UF ONLY TOTAL FLUID REMOVED TOT WEIGHT L WLR MINIMUM VEN ART BLOOD FLOW WEIGHT LOSS/H TOTAL BLOOD CHANGES BLOOD FLOW BPM REPORT KT/V PROFILE HEPARIN MACHINE WASHBACK Rev. B To disconnect the patient. After pressing the Confirm button the normal dialysis process restarts: • The dialysate flow through the dialyser is restarted. select WASHBACK. SECTION 5 . B . • The BYPASS Action key reappears. the above confirmation request will appear. Rev.DIALYSIS OPERATION 5-51 By pressing the UF ONLY Action key again. • The UF ONLY Action key is no longer highlighted. • The patient may then be disconnected from the machine according to the facility’s protocol.10.10 End of Dialysis 5. In this mode: • The blood pump stops to allow disconnection of the patient and to enable the Washback of blood from the extracorporeal circuit to the patient. the heparin pump is stopped.1 Patient disconnection and Emptying dialyser Select the WASHBACK Action key. When selecting WASHBACK. the following view is displayed: 12:30 WASHBACK DIALYSIS TIME DIFFUSION TIME EMPTYING TOTAL FLUID REMOVED TOT WEIGHT L VEN ART BLOOD FLOW RINSEBACK VOLUME TOTAL BLOOD CHANGES BLOOD FLOW BPM REPORT KT/V PROFILE HEPARIN MACHINE TREATMENT Rev. These values are maintained for the duration of the WASHBACK mode. WARNING When WASHBACK is selected. B . WARNING When WASHBACK is selected.5-52 PHOENIX OPERATOR MANUAL 5. the limits of the Venous Pressure alarm window are automatically set to -50 and +250 mmHg and the limits of the Arterial Pressure window are set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg and +150 mmHg. If selecting one of the three Action keys (POST STANDING/POST SITTING/POST LYING) before the EMPTYING Action key selection. SECTION 5 . When the RINSEBACK VOLUME value set has been reached.g. The different Selection/Action keys available on this view allow access to particular procedures: • EMPTYING Action Key allows emptying of the dialyser following WASHBACK. CHANGE ACID and DIALYSIS MODE CHANGE are available Note The DIALYSIS MODE on the CHANGES view allows WASHBACK in a different dialysis mode to that that used during dialysis (e. Single Needle to Double Needle). POST SITTING and POST LYING Action keys becomes available. Rev. these must be carried out under the control of the user and are the responsibility of the user. WARNING Only in the event of the “! Concentrate Cans: A Pump or B Pump or A+B Pumps” (#40) alarm is it possible to perform Autocalibration of PA or PB pump during DIALYSIS (see “Autocalibration procedure for the peristaltic pumps during dialysis” in the Section 5.A . FILTER CHANGE. the TREATMENT Action key disappears and it is no longer possible to return to dialysis. the POST STANDING. WARNING The FILTER CHANGE Action key must be used only when the dialyser needs to be replaced (Refer to “Dialyser replacement” in the Section 5. WARNING The PATIENT CONNECT and WASHBACK MODES have associated safety hazards due to the reduced efficacy of the Protective System. the Dialyser Replacement procedure will be no more allowed for the current dialysis treatment.A . CHANGE TO LIQ BIC. B . • CHANGES Selection key gives access to another view where PAUSE BICART. the UFR parameter value is 0.DIALYSIS OPERATION 5-53 Note During WASHBACK.Special Procedures) when the operator accesses the Machine view by pressing the Machine Navigation key. Note When the RINSEBACK VOLUME value set has been reached and the DIALYSIS Action key disappears. • TREATMENT allows the operator to return to DIALYSIS.Special Procedures in this manual). 1 Manual Emptying At the end of the WASHBACK procedure. The selection of EMPTYING acts as a confirmation to the machine that the patient has been disconnected. WARNING In order to verify that the patient has been disconnected properly.10. the dialysate side of the dialyser is now emptied by the machine and the following view is displayed: 12:30 EMPTYING TOTAL FLUID REMOVED TOTAL BLOOD EMPTYING HEPARIN TOTAL DESCALING TIME STOP RINSE VEN ART AUTO EMPTYING BLOOD FLOW VINEGAR DESCAL BLOOD FLOW DESCALING BPM REPORT KT/V MACHINE FINAL RINSE Rev.10. Press CANCEL otherwise. Press CONFIRM to proceed with emptying. B .5-54 PHOENIX OPERATOR MANUAL 5. the EMPTYING and the AUTOEMPTY (if activated) Action key are available.2 Emptying the dialyser 5. the following message is displayed when the operator presses the EMPTYING Action key the first time: WARNING! Ensure that the patient has been disconnected.2. The blood pump stops and the Protection System is no longer active. After the selection of EMPTYING. Press the CONFIRM button on the Main Control Panel to continue. the STOP RINSE Action key becomes available. (This operation is prompted by an operator message). Refer to “5.10. In particular. During this phase the value of the DESCALING TIME parameter is displayed. Its duration may be set with the DESCALING TIME parameter. Deselecting EMPTYING allows the EMPTYING process to be interrupted.2. the VINEGAR DESCAL Action key is not available. This can be done using the VINEGAR DESCAL Action key. if the VINEGAR DESCAL parameter in Config is set to NO. WARNING In bicarbonate dialysis. in this section. • Disconnect the red dialysate connector from the dialysate port of the dialyser and reattach it to its bypass port on the machine. for a detailed description of the AutoEmptying feature. it is strongly recommended to perform a descaling of the hydraulic circuit with vinegar following every treatment. the descaling function (VINEGAR DESCAL and DESCALING Action key) becomes available. B . Note Only after the EMPTYING mode has been completed. the FINAL RINSE Action key becomes available. only the VINEGAR DESCAL Action key is available. • Disconnect the blue dialysate connector from the dialysate port of the dialyser and reattach it to its bypass port on the machine. SECTION 5 . (This operation is prompted by an operator message).DIALYSIS OPERATION 5-55 Note Only after the EMPTYING mode has been completed and if a bicarbonate dialysis has been performed. Note Only after the EMPTYING mode has been completed and if an Acetate dialysis has been performed.2 AutoEmptying”. To proceed with EMPTYING without using the AutoEmptying feature: • Rotate the dialyser so that the blue end of the dialyser is up. The AUTO EMPTYING Action key allows to proceed with emptying procedure using the AutoEmptying feature. If the VINEGAR DESCAL parameter in Config is set to ALWAYS. This Action key disappears when the dialyser has been emptied. Rev. if the VINEGAR DESCAL parameter in Config is set to YES both the VINEGAR DESCAL and the DESCALING Action key are available. remove the blue bicarbonate connector from the blue concentrate wand and reinsert it into its blue rinse port on the machine. the concentrate connectors (Acid and bicarbonate/BiCart) may be left in place on the machine during the DESCALING and FINAL RINSE processes. Rev. • Remove the Acid/Acetate connector from the white concentrate wand and reinsert it into its red rinse port on the machine.remove the BiCart cartridge from its holder and close the BiCart Holder arms. • BiCart . Note The FINAL RINSE is performed even if the acid connector has not yet been positioned in its rinse port. If another dialysis treatment will not be performed: • Liquid Bicarbonate .5-56 PHOENIX OPERATOR MANUAL If another dialysis treatment is going to be performed. B . press the OVERRIDE button to clear the alarm. from the dialyser. which is now at the bottom of the dialyser. • If the “End of WashBack Procedure” #332 alarm is present. Rev. the following Operator Message is displayed: You Can Replace The Blue Dialys. the machine will perform the DESCALING procedure with vinegar.2 AutoEmptying To proceed with AutoEmptying: • Leave the blue and red dialysate connectors on the dialyser. • The blood pump starts automatically at 100 ml/min (this is indicated by the flashing light on the Blood Pump Control Panel).). (Do not disconnect the red dialysate connector. When the Cartridge Blood Set and blood side of the dialyser are empty. Note In the case of bicarbonate dialysis. Note The AUTO EMPTYING Action key is only available if the AUTOEMPTYING parameter in Config is set to YES. B .DIALYSIS OPERATION 5-57 5. • Venous and arterial lines must be connected together in the same configuration as used for RECIRC and the lines unclamped. upon selecting the AUTO EMPTYING Action key. press the AUTO EMPTYING Action key to deactivate it. If the VINEGAR DESCAL parameter in Config is set to ALWAYS. Connector All Connectors Must Be Replaced Leave A Connector In Concentrate Disconnect the blue dialysate connector from the dialysate port of the dialyser and reattach it to its bypass port on the machine. to do this: • When the value set for the DESCALING TIME parameter is elapsed. The emptying procedure can continue in order to empty the dialysate side. • Wait until the following Operator Message is displayed: AutoEmptying Procedure has Been Interrupted and Open in Air the Venous Chamber then open the blue clamp (on the Venous access line) in the 4-Position Line Clamp to allow air to enter the extracorporeal circuit. SECTION 5 . a DESCALING procedure is automatically performed.10. • Select the AUTO EMPTYING within 20 seconds Action key to start the procedure. The blood pump speed can not be modified. Ensure the saline administration line is not clamped. The AUTO EMPTYING Action key will disappear.2. During AutoEmptying it is possible to stop the procedure by deselecting the AUTO EMPTYING Action key. • Open the left red clamp (on the Cartridge saline line) in the 4-Position Line Clamp. WARNING In the case of bicarbonate dialysis. the Acid/Acetate concentrate connector must be left on the machine so that the DESCALING procedure can be performed. The red dialysate connector can be disconnected from the dialyser and reattached to its bypass port on the machine. Rev. an operator message will appear on the Touch Screen and the EMPTYING Action key disappears. Deselecting EMPTYING allows the EMPTYING process to be interrupted. when the dialysate side of the dialyser is empty. • After a short time. B . • Press the FINAL RINSE Action key to initiate this process. if the user does not activate the AutoEmptying procedure.5-58 PHOENIX OPERATOR MANUAL • Rotate the dialyser so that the blue end of the dialyser is up. the blue dialysate connector can be reattached to its bypass port on the machine so that the dialysate side is emptied through the hydraulic circuit (standard EMPTYING). WARNING At the end of WASHBACK. 3 Removing the BiCart See Fig 5.DIALYSIS OPERATION 5-59 5.4. • Place the holder arms in their original position (see Fig 5. 3): a. • Cover the hole on the top of the BiCart (see Fig 5. 2).10. b.4.4. • Disconnect the BiCart and immediately cap the lower end. Close the upper arm by tipping it down. B . Close the lower arm by pulling the arm forward slightly and tipping it up. • Dispose of the empty BiCart per your facility’s practice.4 • Open the upper arm of the BiCart Holder by pulling the arm forward slightly and tipping it up. SECTION 5 . • Pull out the top of the BiCart while leaving the base in place (Fig 5. 1 2 3 Fig 5.4 Removal of the BiCart® Rev. 1). During the DESCALING process (selection of the VINEGAR DESCAL or the DESCALING Action keys). the following view is displayed: 12:30 EMPTYING TOTAL FLUID REMOVED TOTAL BLOOD HEPARIN TOTAL DESCALING TIME STOP RINSE VEN ART BLOOD FLOW FINAL RINSE TIME VINEGAR DESCAL BLOOD FLOW DESCALING BPM REPORT KT/V MACHINE FINAL RINSE Note The VINEGAR DESCAL and DESCALING Action keys appear only when a Bicarbonate dialysis was performed. Rev. If the VINEGAR DESCAL parameter is set to YES or to ALWAYS. the operator must check that the acid/acetate line is connected to the vinegar container. Note The FINAL RINSE Action key appears only when an Acetate dialysis was performed.10. In the case of VINEGAR DESCAL. the DESCALING TIME value will decrease. The following message also appears: Wait. and if a Bicarbonate dialysis treatment has been performed.5-60 PHOENIX OPERATOR MANUAL 5. indicating the time remaining in the DESCALING process. a FINAL RINSE is performed automatically following a DESCALING procedure. the VINEGAR DESCAL Action key is available. Descaling in progress… and a progress bar is displayed indicating that DESCALING is occurring.4 End of Treatment When the EMPTYING mode has been completed. B . The DESCALING Action Key appears if the VINEGAR DESCAL parameter in Config is set to NO or to YES. for a detailed description of this procedure. Before starting a new dialysis treatment remove the used Cartridge Blood Set and dialyser. and other disposables per local regulations. • The DESCALING TIME value is no longer displayed. indicating the time remaining in the Final Rinse process. FINAL RINSE will begin automatically following a DESCALING procedure. WARNING Follow facility procedures for proper disposal of used Cartridge Blood Set. SECTION 5 . The STOP RINSE Action key allows a quick access to the next dialysis treatment skipping partially or completely the DESCALING process and/or the FINAL RINSE process. dialysers.DIALYSIS OPERATION 5-61 After the DESCALING or VINEGAR DESCAL Action keys have been pressed they will not be available again until the end of the next dialysis treatment. in this section. Pressing the FINAL RINSE Action Key initiates the Final Rinse process. Before selecting a new process. Rev. During the FINAL RINSE process: • The FINAL RINSE TIME value decreases. If an ACETATE dialysis has been performed the FINAL RINSE Action Key appears immediately after EMPTYING has been completed. Refer to “5.10. wait at least 1 minute to complete the T1 Tests. Note When FINAL RINSE is completed. B .5 Quick Access to the Next Dialysis Treatment”. • the FINAL RINSE Action key disappears and will not be available until after the next dialysis treatment. the machine returns in Idle phase and performs the T1 Tests. B . WARNING If. WARNING Before starting a new dialysis treatment. ensure that the used Cartridge Blood Set and dialyser have been removed and a new Cartridge Blood Set and dialyser have been installed.5-62 PHOENIX OPERATOR MANUAL 5. Rev. it is strongly recommended to follow the “Precipitate Control (ADR)” recommendations provided in Section 06 – CLEAN/DISINFECT.5 Quick Access to the Next Dialysis Treatment When the EMPTYING mode has been completed. the machine will return in Idle phase and. After the STOP RINSE Action key is pressed. after a bicarbonate dialysis.10. the DESCALING process is partially or completely skipped by pressing the STOP RINSE Action key. By pressing the CONFIRM button. in this manual. it is ready for the next dialysis treatment. the following superimposed window will appear: CONFIRMATION LAST ACTION MADE ENTER To Confirm WARNING: Remove the Cartridge Blood Set and install a new one. after T1 tests completion. It allows the machine to skip partially or completely the DESCALING process and/or the FINAL RINSE process and to return in Idle phase for the next dialysis treatment. the STOP RINSE Action key becomes available and remains available for all the DESCALING process and FINAL RINSE process. SPECIAL PROCEDURES 5.A . B .SPECIAL PROCEDURES 5. Proceed as follows: • Clamp the venous line under the Venous Line Clamp.A SECTION 5. the Protection System starts the procedure to reset the proper conditions. SECTION 5.A-1 5. • Remove the Blood Pump Crank from its holder on the rear of the machine and place it in the operating position in the Blood Pump Rotor.A SPECIAL PROCEDURES 5. above the Blood Pump. the patient must be manually disconnected (see Patient Disconnection section in the Manual). are closed in this situation. − A visual alarm is given with a flashing yellow light. Rev. • Carefully remove the venous line from the Venous Line Clamp by depressing the button on the Venous Line Clamp and pulling the venous line to the left. WARNING Failure to remove the venous line from the Venous Line Clamp can result in rupture of blood lines or dialyser when hand cranking the Blood Pump.A. • Unclamp the venous line and with the crank manually turn the Blood Pump Rotor counter-clockwise at a flow rate high enough to prevent stagnation or clotting of the blood. It is particularly important to check that all four clamps in the 4 Position Line Clamp. WARNING During a power failure.. all safety systems of the machine are disabled or are not operational. − The duration of the power failure is monitored. The machine reverts to one of two specific Safe States depending on the duration of the power failure: − Short Power Failure : less than 20 seconds − Long Power Failure : more than 20 seconds and less than 4 minutes WARNING If a power failure lasts for more than 2 minutes.1 Emergency procedures for Power Failure In the event of a power failure: − An audible alarm is sounded for at least 2 minutes. • Remove the arterial line from the Arterial Clamp (if Single Needle is available on the machine).A . Once the power supply has been restored. Note If the machine is switched OFF and bicarbonate dialysate remains in the hydraulic pathway for more than 30 minutes. • Reinsert the venous line into the Venous Line Clamp. the specific Safe State is automatically cleared. Rev. B . • Return the Blood Pump Crank to its holder on the rear of the machine. if the operator does not press the OVERRIDE button within 30 seconds.5. Note In the case of a Short Power Failure. • Return the clamps on the 4 Position Line Clamp to the appropriate positions for dialysis.A-2 PHOENIX OPERATOR MANUAL Proceed as follows: • Remove the Blood Pump Crank from the Blood Pump Rotor. The Blood Pump will start at the pre-programmed speed. it is recommended that an acetic acid rinse should be performed when the machine is switched back ON. reinsert the arterial line into the Arterial Line Clamp. • Clear the specific Safe State by pressing the OVERRIDE button. • If in Single Needle mode. once the AC Power Supply returns: • The “NO POWER” #353 alarm disappears. the blood module and all the safety systems will remain enabled and operational for approximately 15 minutes. Note If the power failure lasts for less than 3 minutes.A-3 5.SPECIAL PROCEDURES 5. The interruption of the AC supply voltage is signaled by the “NO POWER” #353 alarm. • In Dialysis. Refer to local representative to verify if your machine is already equipped with the BATTERY BACKUP Kit. B . proceed as follows: • In Rinsing or Disinfection: Switch OFF the machine. in case of a power failure. Note During power failure the heater is turned off. A message is also displayed in the Operator Message area suggesting the proper action to be performed during each specific machine operating condition. • In Emptying or Descaling: Switch OFF the machine. Then Switch OFF the machine. A BATTERY BACKUP feature is available on Phoenix machine so that. Note If the interruption of the AC supply voltage occurs when the machine is in IDLE mode. during the Dialysate Preparation phase up until the Patient Connection: Switch OFF the machine.2 Emergency procedures for power failure with the BATTERY BACKUP feature WARNING This emergency procedure for Power Failure is applicable only if your Phoenix machine is equipped with the Battery Backup Kit. during the Treatment phase: perform a Rinseback to return the blood and disconnect the patient. • The interrupted process automatically restarts and no operator intervention is required. In case of a power failure. This alarm remains on the Touchscreen for the duration of the power failure. Rev.A. depending on the machine operating conditions. • In Dialysis. The machine will continue to operate. allowing the operator to rinseback the blood and disconnect the patient.A . SECTION 5. no alarm will be activated. the Battery loses a quantity of its power and it has to be recharged by leaving the machine switched ON. decreasing in tone. If the storage temperature is greater than 25°C. TOT WEIGHT L. Rev. the machine will be automatically Switched OFF. it is recommended that an acetic acid rinse should be performed when the machine is switched back ON. After a long storage (at ambient temperature). • Clamp the venous line under the Venous Line Clamp. A continous audible signal. Each time a power failure occurs. Proceed as follows: • Record DIALYSIS TIME. before using again the machine. and TOTAL BLOOD. the Battery gradually loses its charge. • Switch OFF the machine. above the Blood Pump. the time necessary to fully recharge the Battery is 10 hours. is able to maintain the machine operational during a power failure for approximately 15 minutes before it discharges. if possible. when fully charged. WEIGHT LOSS/H. are closed. WARNING Failure to remove the venous line from the Venous Line Clamp can result in rupture of blood lines or dialyser when hand cranking the Blood Pump. After a power failure lasting 15 minutes. and other treatment data.A-4 PHOENIX OPERATOR MANUAL Note In Rinsing or Disinfection. TOTAL FLUID REMOVED. • Ensure that all four clamps in the 4 Position Line Clamp. Note When the machine remains switched OFF. sounds for approximately 5 seconds once the machine is switched OFF. if the “NO POWER” #353 alarm is displayed for more than 3 minutes. the time necessary to recharge the Battery doubles. • Carefully remove the venous line from the Venous Line Clamp by depressing the button on the Venous Line Clamp and pulling the venous line to the left. Note If the machine is switched OFF and bicarbonate dialysate remains in the hydraulic pathway for more than 30 minutes. Note The Battery. it is recommended to keep it switched ON for a minimum time of 2 hours for each month it has been left switched OFF. If the BATTERY BACKUP is discharged or becomes discharged during a power failure. a >GENERAL SAFE STATE< alarm is generated and the BATTERY BACKUP feature is no longer active. B .5. SPECIAL PROCEDURES 5.A .A-5 • Remove the arterial line from the Arterial Clamp (if Single Needle is available on the machine). WARNING If a power failure lasts for more than 2 minutes. • Perform the Fast Recovery procedure (See “Fast Recovery of the Dialysis process”. SECTION 5. B . in this Section). Once the power supply has been restored: Proceed as follows: • Switch ON the machine. • Reinsert the venous line into the Venous Line Clamp. the patient must be manually disconnected (see Patient Disconnection section in the Manual). reinsert the arterial line into the Arterial Line Clamp. • Return the clamps on the 4 Position Line Clamp to the appropriate positions for dialysis. Rev. • Remove the Blood Pump Crank from its holder on the rear of the machine and place it in the operating position in the Blood Pump Rotor. • If in Single Needle mode. • Unclamp the venous line and with the crank manually turn the Blood Pump Rotor counter-clockwise at a flow rate high enough to prevent stagnation or clotting of the blood. A-6 PHOENIX OPERATOR MANUAL 5. − No service processes (rinsing or disinfection or calibration) were performed before restarting the dialysis treatment.3 Fast Recovery of the Dialysis process During the course of a dialysis treatment certain conditions may cause the machine to halt: • As a consequence of an alarm condition a General Safe State is generated (see Section 8 .Alarms and Signals). If the machine halt was caused by a temporary malfunction or by unexpected operations. • A problem with the Power Supply reduces the voltage to the machine’s electronics. B . therefore. In both cases it is impossible to continue the dialysis treatment and the machine must be turned OFF. Note The possibility to restart DIALYSIS using the Fast Recovery of the Dialysis process procedure is allowed if. WARNING The Fast Recovery of an interrupted dialysis treatment can only be performed if TREATMENT has already started (i. WARNING After pressing the SETUP Action key. This procedure returns the machine to the PATIENT CONNECT mode. the Patient Sensor has detected blood (the icon is highlighted on the icon bar). and only if: − The previous treatment was interrupted after the PATIENT CONNECT mode and before the EMPTYING mode. WARNING The use of a Fast Recovery of the Dialysis process procedure must be limited to exceptional cases where the normal recovery procedure can not be performed in accordance with the standard use of the machine. after PATIENT CONNECT) and has been interrupted before the EMPTYING mode. but where the current dialysis treatment must be continued.5. The Fast Recovery of the Dialysis process may. Rev.A. turning the machine OFF and then back ON may clear the incorrect condition. so that the Blood Pump is active within a few seconds after the machine is turn ON. DO NOT select a dialysate type (ACETATE/BICARB CONC/BICART) if the patient is still connected to the machine and the Red and Blue Dialysate Connectors are connected to the dialyser. − At subsequent Power ON. This procedure can be performed if the Patient Sensor has detected blood in the venous blood line and no service processes (ADR or calibration) have been performed before restarting the dialysis treatment. be attempted without manually disconnecting the patient.e. TOT WEIGHT L. Reset the TOT WEIGHT L. press .A-7 To perform the Fast Recovery of the Dialysis process procedure: WARNING Do not remove the Blood Pump Segment from the Blood Pump. Do not remove the venous line from the Air Bubble Detector/Patient Sensor.and hold.buttons selection. 8. Activate Heparin and BPM. The operation to be performed for a Fast Recovery of the Dialysis process is indicated in the Operator Message Window: Press + and hold. are closed. SECTION 5. for a detailed description of the CentryNet option re-activation or deactivation procedure after a Fast Recovery of the Dialysis process. 4. DIALYSIS TIME and the WEIGHT LOSS/H using the SET mode. refer to Section 07 – Communication System. Turn the machine OFF. To restart the interrupted treatment. it is possible to manually turn the Blood Pump Rotor counter-clockwise at a flow rate high enough to prevent stagnation or clotting of the blood. Clamp the venous line below the ABD and then turn the machine ON. Record DIALYSIS TIME. all safety systems of the machine are disabled or are not operational. Once the SETUP Action Key appears. The machine will immediately go to the PATIENT CONNECT mode. 3. 7. 1.A . 9. release + then release . the Fast Recovery of the Dialysis process procedure cannot be performed and the patient must be disconnected. − remove the clamp from the venous line below the ABD.SPECIAL PROCEDURES 5. TOTAL FLUID REMOVED. 2. B . if possible. WEIGHT LOSS/H. and TOTAL BLOOD. after the selection of the Blood Pump ON/OFF button to start the Blood Pump. return the clamps on the 4 Position Line Clamp to the appropriate positions for dialysis. above the Blood Pump. 6. Press the SETUP Action key. Rev. if prescribed. WARNING During the time between the machine switching OFF and the next restart of the interrupted treatment by the +/. Before manually turning the Blood Pump Rotor: − remove the venous line from the Venous Line Clamp by depressing the button on the Venous Line Clamp and pulling the venous line to the left. Note During the time between the machine switching OFF and the next Blood Pump activation. Unclamp the venous line. Press the Blood Pump ON/OFF button to start the Blood Pump. Wait for the software to load. and other treatment data. by using the Blood Pump Crank. 5.to restart interrupted treatment Select these buttons on the Main Control Panel. reinsert the venous line in the Venous Line Clamp. If the CentryNet option was activated before the machine halt. WARNING If the operator erroneously selects a procedure other than “SETUP”. − ensure that all four clamps in the 4 Position Line Clamp. If a “! Blood Leakage” #28 alarm occurs. following a Fast Recovery of dialysis. Call for Service. At subsequent power ON. The machine must be turned OFF and the patient manually disconnected. NOTE: in case of Computer Prescription of the Treatment (see Section 7 - Communication System) the restored treatment parameters are: Dialysis Mode: the last one selected Dialysis Type: the last one performed by the machine WARNING If during the course of the restarted DIALYSIS. the only treatment parameters that are retained are: − for RX dialysis → the default data values stored in Rx Config − for Standard dialysis → the default data values stored in Config The only exception are: − for RX dialysis → the machine retains the PAT CONN B FLOW parameter value stored in CONFIG instead of the value stored in Rx Config − for Standard dialysis and RX dialysis → the machine retains the DIALYSIS TYPE: ACETATE/BIC CONC/BIC BICART. do not select a Fast Recovery of the Dialysis process with the “+/ -” keys.e. An ADR process must be selected to remove the data related to the Fast Recovery of the Dialysis process from the machine’s memory. select the type of dialysis required (SETUP and proceed as usual with the preparation of the machine. During the current dialysis treatment it is no longer possible to re-activate UF and Conductivity Profiling. Therefore. the same problem reoccurs.5. Select the DIALYSIS Action key on the PATIENT CONNECT view. set for the current treatment instead of the DIALYSIS TYPE stored in CONFIG/Rx Config. Rev. WARNING Note that any treatment parameters that were set for the dialysis treatment are transient. they are lost when a Fast Recovery of the Dialysis process procedure is performed. press the OVERRIDE button. Note Once the patient has been manually disconnected and the following dialysis may be started normally. both the UF Profile curve type and the Conductivity Profile curve type are set automatically to CONSTANT. do not perform the Fast Recovery of the Dialysis process procedure: disconnect manually and the machine OFF. the cause is not a temporary malfunction. Then.A-8 PHOENIX OPERATOR MANUAL Note After a Fast Recovery of the Dialysis process. i. B . 10. reconnect the Blue Dialysate Connector to its Blue Bypass port on the machine. b. Note When a dialysate sample is obtained during DIALYSIS using the Sampling Device. This action could generate a flow error evidenced by an alarm and a RESTART condition on the Touch Screen. This can be done by taking dialysate samples at different conductivity values (e. after the appearance of the operator message “End Of Dialysate Prep.4 Sampling of water from the machine If local regulations or the facility’s procedures requires to test the chemical-physical characteristics of water flushing in the hydraulic circuit of the machine or in order to culture the water to be used for dialysis.15 mS/cm) and sending them to a laboratory for analysis. displayed by the machine. Press the RESTART button on the Touch Screen to restore the flow in the hydraulic circuit.A . per your facility’s protocol.5 Sampling of Dialysate A sample of dialysate may be taken to carry out laboratory tests. the alarm message A Connector Position#2 will appear on the Touch Screen. verified by clinical laboratory results. prepare the Dialysate Line Connector.g. • While the flow from the Blue Dialysate Connector has stopped because of the RESTART condition. Rev. a sample of water may be obtained from the machine during SETUP. for microbiological monitoring.A-9 5.14. but not less than 2 minutes) has been reached. During DIALYSIS. At this time a sample may be collected.A. • Press the RESTART button on the Touch Screen to restart dialysate flow from the Blue Dialysate Line. for each dialysate concentrate used for dialysis treatment. SECTION 5. and before starting to prime the dialysate side of the dialyser. To obtain a sample: • Press the SETUP Action key to start dialysate preparation. 13. WARNING It is the responsibility of the user to determine the correspondence between the dialysate conductivity. 5. Continue pressing the RESTART button on the Touch Screen to continue flow from the Blue Dialysate Connector until an appropriate time or flow (as defined by the facility’s protocol. and the dialysate solute content. You Can Proceed”. Prior to initiation of treatment. • After the sample has been collected. PERFORMING DIALYSATE SAMPLING Samples for conductivity testing may be obtained at the following times: a. B . prior to dialysate concentrate connection.SPECIAL PROCEDURES 5. • Remove the Blue Dialysate Connector from the machine and hold it over a collection receptacle.A. • Hold the Blue Dialysate Connector over a sample collection container. prior to obtaining a sample. In both the procedures. • Collect the dialysate sample then press the BYPASS Action key to stop the dialysate flow. it is recommended to: • Discard the fluid flowing from the Acid/Acetate Rinse Port during the first minute of sampling. Rev. • Discard the fluid flowing from the Bicarbonate Rinse Port in the first 2 minutes of sampling.5. B . • Press the BYPASS Action key to resume flow of dialysate through the dialyser.A-10 PHOENIX OPERATOR MANUAL HOW TO OBTAIN THE DIALYSATE SAMPLE Dialysate sample through the Blue Dialysate Connector Follow this procedure prior to initiation of treatment. leaving the Blue Dialysate Connector unattached. • Connect the Blue Dialysate Connector to the dialyser’s blue (inlet) dialysate port. connect the Red Dialysate Connector to the dialyser’s red (outlet) dialysate port. • Obtain the dialysate sample when the conductivity is stable. Note For reliable sampling. To obtain the dialysate sample proceed as folows: • Insert the Sampling Device in the Rinse Port corresponding to the Acid/Acetate Connector (or the Blue Bicarbonate connector for bicarbonate sampling). • Press the BYPASS Action key to start the flow of dialysate into the sample collection container. if Priming during Dialysate Preparation is performed (DIAL AUTO PRIME parameter set to YES) • or during TREATMENT. Dialysate sample through the Sampling Device Follow this procedure: • either prior to initiation of treatment. • Obtain the sample. it is important not to change the conductivity of the machine during sampling. only if Priming after Dialysate Preparation is complete is performed (DIAL AUTO PRIME parameter set to NO): • After appearance of the operator message indicating that Dialysate Preparation is Complete. A . B .. • Insert the sampling device in the Blue Rinse Port corresponding to the Bicarbonate Connector for bicarbonate sampling.1 (A) ) • Disconnect the Blue Bicarbonate (blue) Concentrate Connector (See Fig. 1 Rev. A B C Fig.1 (C) ) from its Rinse Port.A-11 OBTAINING A BICARBONATE SAMPLE WITH BICART DIALYSIS • Open the upper arm of the BiCart Holder. • Obtain the sample.SPECIAL PROCEDURES 5. (See Fig. SECTION 5. 3. appropriate operator’s messages will direct the user to the required steps in order to correctly perform the procedure. 4. 4. B . 9. select the CHANGES Action key. Disconnect the blood lines by removing the sterile priming connector or recirculation device.6 Temporary Disconnection of the Patient : PAUSE THERAPY Procedure Note This feature is available only if the PAUSE THERAPY parameter is set to YES in the CONFIG menu. This selection must be confirmed using the CONFIRM button on the Main Control Panel. Reconnect the arterial and venous lines to the patient’s’ access sites. Press the PAUSE THERAPY Action key to deselect PAUSE THERAPY.5. 2. Unclamp the Cartridge Saline Access Line and the Saline Administration Line. In order to temporarily disconnect the patient during TREATMENT: 1. the standard treatment view will be displayed. The Blood Pump stops automatically. Turn the Blood Pump OFF using the ON/OFF button on the Blood Pump Control Panel. 8. Unclamp the arterial and venous lines. 5. Note The PAUSE THERAPY Action key is highlighted while the procedure is activated. Rev.A.A-12 PHOENIX OPERATOR MANUAL 5. 6. 6. the PAUSE THERAPY Action key is present in the CHANGES view when accessed during the TREATMENT mode. 3. Clamp the arterial and venous lines. then the CHANGE TO DN Action key on the CHANGES view. Connect the arterial and the venous line together using a sterile priming connector or recirculation device. 8. Clamp the arterial and venous lines and the patient’s access sites. 7. Turn the Blood Pump ON using the ON/OFF button on the Blood Pump Control Panel to recirculate the blood in the extracorporeal circuit. When the patient returns : 1. Press the CLOSE Action key on the CHANGES view. 7. Turn the Blood Pump ON using the ON/OFF button on the Blood Pump Control Panel. 2. 5. per your facility’s protocol. Select the PAUSE THERAPY Action key on the CHANGES view. If configured. If performing a Single Needle dialysis. Clamp the Cartridge Saline Access Line and the Saline Administration Line. Unclamp the arterial and venous lines and the patient’s access sites. Note During the PAUSE THERAPY procedure. B . and the WEIGHT LOSS/H.A-13 Note During the PAUSE THERAPY procedure the alarm “W! STILL IN PAUSE THERAPY“ is displayed to advise the operator that the machine is in a temporary status. Note During the PAUSE THERAPY procedure. the updating of the parameters is automatically reactivated. It is not necessary to set the TOT WEIGHT L parameter again. Note The CLOSE and FILTER CHANGE Action keys in the CHANGES view disappear while the PAUSE THERAPY procedure is activated. Rev.A . Note During the PAUSE THERAPY procedure: • the updating of DIALYSIS TIME. TOTAL FLUID REMOVED and TOTAL BLOOD parameters are interrupted • the WEIGHT LOSS/H is stopped. This value is maintained throughout the PAUSE THERAPY procedure. • the Heparin program is stopped. • Profiling is stopped. Profiling and the Heparin program are resumed. SECTION 5. the limits of the Venous Pressure Alarm Window and Arterial Pressure Alarm Window are set to the wider range. When the treatment is restarted.SPECIAL PROCEDURES 5. TOTAL BLOOD CONDUCTIVITY CHANGE TO LIQ BIC BLOOD FLOW CHANGE ACID BPM REPORT KT/V PROFILE HEPARIN MACHINE CLOSE Note 1 Depending on the machine operating phase the FILTER CHANGE Action key or the PAUSE THERAPY Action key is displayed.A. • Press the PAUSE BICART Action key to momentarily stop flow through the BiCart. Action key is available only after the PAUSE BICART Action key has been pressed. the BiCart may be replaced.5. Rev. This helps avoid splashing liquid when the BiCart is removed. once dialyser PRIME is completed and all the preparations and settings have been completed. Note The BICART PRIM. B . • The following view appears: 12:30 CHANGES CHANGE TO SN DIALYSIS TIME WEIGHT LOSS/H CHANGE TO DN PAUSE THERAPY TOTAL FLUID REMOVED TOT WEIGHT L (See Note 1 below) VEN ART PAUSE BICART BLOOD FLOW BICART PRIM.7 BiCart Change When the PAUSE BICART Action key is selected.A-14 PHOENIX OPERATOR MANUAL 5. BICART CHANGE procedure • Press the CHANGES Action key. B . • Replace the BiCart and then press the BICART PRIM. Warning: Pressing BICART PRIME again will stop BICART priming procedure. Press BICART PRIME to start the procedure. Action key. Action key to start the priming procedure (advice on how to perform the operation will appear in the Operator Messages Area). Again the BICART Procedure will be Stopped.. Press BICART PRIME to complete procedure. the following message will appear: Remove the BICART and insert a new one. SECTION 5. Note If the operator stops the priming procedure by pressing the BICART PRIM. priming will be stopped: Wait : BICART Priming in Progress.A-15 • After the PAUSE BICART Action key has been pressed. Action key is pressed again.A . • The following message will appear in the Operator Messages Area with a warning saying that if the BICART PRIM. Warning : if You Push BICART PRIM.SPECIAL PROCEDURES 5. • Priming can be considered finished when the above operator message disappears. the following message is displayed: Bicart priming interrupted.. Rev. B . CHANGE TO LIQ BIC procedure • Press the CHANGES Action key. both in external containers and from the Central Concentrate Supply system.4% bicarbonate from external concentrate containers or delivered from the Central Concentrate Supply system. TOTAL BLOOD CONDUCTIVITY CHANGE TO LIQ BIC BLOOD FLOW CHANGE ACID BPM REPORT KT/V PROFILE HEPARIN MACHINE CLOSE Note 1 Depending on the machine operating phase. Rev. • The following view appears: 12:30 CHANGE TO SN DIALYSIS TIME WEIGHT LOSS/H CHANGE TO DN PAUSE THERAPY TOTAL FLUID REMOVED TOT WEIGHT L (See Note 1 below) VEN ART PAUSE BICART BLOOD FLOW BICART PRIM.4% Bicarbonate concentrate.8 Switching from BiCart Dialysate to the use of Liquid 8. the CHANGE TO LIQ BIC Action key allows continuing the dialysis treatment using liquid 8.4% Bicarbonate Dialysate If the operator wants to change from BiCart dialysate to liquid bicarbonate dialysate.A. it is not possible to return to using BiCart dialysate in the current dialysis treatment. Note After switching from the use of BiCart to the use of Liquid 8.5. either the DIALYSER PRIME Action key or the PAUSE THERAPY Action key is displayed.A-16 PHOENIX OPERATOR MANUAL 5. the operator may clear the alarm by performing the PB Autocalibration Procedure (see “5.) Rev. WARNING If a switch from the use of BiCart to the use of Liquid 8.4% Bicarbonate concentrate.4% COND value set. • Press the Set button to enter in Set mode. B . if the machine has not been correctly calibrated for the liquid Concentrate used. • The following superimposed window will appear: Confirm the Change from BiCart to Liquid Bic. • Press the CHANGE TO LIQ BIC Action key. it is the operator’s responsibility to verify that proper 8. • Remove the BiCart and close the BiCart arms.A.SPECIAL PROCEDURES 5. both in external containers and delivered from the Central Concentrate Supply system. in this section. for a detailed description of connector positioning in Bicarbonate dialysis.A-17 Note The CHANGE TO LIQ BIC Action key is available only if the BIC LIQUID DIAL USE parameter is set to YES in Config/Centre Conf/Functions view. • If switching to the use of Liquid Bicarbonate 8.A . • If switching to the Central Concentrate Supply system: disconnect the blue concentrate connector on the lower front panel of the machine and connect it to the blue connector dedicated to bicarbonate concentrate delivery from the Central Concentrate Supply system. WARNING If switching from the use of BiCart to the use of Liquid 8.4% bicarbonate concentrate is being used.4% in an external container: disconnect the blue concentrate connector on the lower front panel of the machine and connect it to the blue concentrate wand and then place the wand into the bicarbonate concentrate container. Press CONFIRM to Proceed Remove Bicart. in this manual. • Press the CLOSE Action key to exit from the CHANGES view. Conductivity set • Press the CONFIRM button to allow the machine to proceed in BICARB CONC dialysis mode. Refer to section 03 – Central Concentrate Supply. Connect blue connector to the correct position for the new bicarb source Warning: To avoid compromizing Pt Safety Ensure the proper Bic. Check and if necessary adjust the BIC 8. and that the dialysate Conductivity is correct. SECTION 5. the “! Concentrate Cans” #40 Alarm can occur.11 Procedure for Autocalibration of the Peristaltic Pumps during DIALYSIS”. After carefully verifying that the correct concentrates are being used. That will clear the “Bicart Connector Position” #22 Alarm. That will clear the “B Connector Position” #18 Alarm.4% Bicarbonate concentrate in external containers. That will clear the “B Connector Position” #18 Alarm. for complete instructions. or to change from containers to acid delivered from the Central Concentrate Supply system. the CHANGE ACID Action key is used. TOTAL BLOOD CONDUCTIVITY CHANGE TO LIQ BIC BLOOD FLOW CHANGE ACID BPM REPORT KT/V PROFILE HEPARIN MACHINE CLOSE Note 1 Depending on the machine operating phase.A-18 PHOENIX OPERATOR MANUAL 5.9 Acid/Acetate Concentrate Supply Change If the operator needs to change acid/acetate concentrate containers. • The following view appears: 12:30 CHANGE TO SN DIALYSIS TIME WEIGHT LOSS/H CHANGE TO DN PAUSE THERAPY TOTAL FLUID REMOVED TOT WEIGHT L (See Note 1 below) VEN ART PAUSE BICART BLOOD FLOW BICART PRIM. either the FILTER CHANGE Action key or the PAUSE THERAPY Action key is displayed. B . Rev.A.5. or to change from the Central Concentrate Supply system to an acid/acetate container. CHANGE ACID procedure • Press the CHANGES Action key. A . press OVERRIDE to clear the alarm and to start uptake of acid from the Central Concentrate Supply system. press OVERRIDE to clear the alarm and to start uptake of acid from the concentrate container. • Press the Set button to enter in Set mode. If the “Ace Can is Empty” #1 Alarm is present. If the “Ace Can is Empty” #1 Alarm is present. B . in this manual. • When switching from Central Concentrate Supply to the use of acid/acetate concentrate in external container: disconnect the white concentrate connector connected to the RED connector dedicated to acid concentrate delivery from the Central Concentrate Supply system and connect it to the white concentrate wand placed in the acid concentrate container. • Press the CLOSE Action key to exit from the CHANGES view. Refer to section 03 – Central Concentrate Supply. Rev. • When switching to the Central Concentrate Supply system: disconnect the white concentrate connector connected to the white concentrate wand and connect it to the RED connector dedicated to acid concentrate delivery from the Central Concentrate Supply system. • The following superimposed window will appear: Change the Acid supply and press CONFIRM to Proceed then press OVERRIDE to resume treatment Warning: To avoid compromizing Pt Safety Ensure the proper CONDUCTIVITY set • Press the CONFIRM button to proceed with the procedure. f the “Ace Can is Empty” #1 Alarm is present. for a detailed description of connectors positioning in Bicarbonate or BiCart dialysis.SPECIAL PROCEDURES 5. • When changing the acid/acetate concentrate external container: disconnect the white concentrate connector connected to the white concentrate wand and connect it to the white concentrate wand placed in the new acid/acetate concentrate container. SECTION 5. press OVERRIDE to clear the alarm and to start uptake of acid/acetate from the new container. press the OVERRIDE button to clear the alarm.A-19 • Press the CHANGE ACID Action key. • If the “Ace Can is Empty” #1 Alarm is present. Check and if necessary adjust the CONDUCTIVITY value. WARNING Both with an Acid/Acetate concentrate formula change and with a switch from Central Concentrate Supply system to the use of acid in external containers. B .A.A-20 PHOENIX OPERATOR MANUAL Note If the acid/acetate concentrate supply change procedure has been performed without the occurrence of “Ace Can is Empty” #1 Alarm. if the machine has not been correctly calibrated for the acid/acetate Concentrate used. it may appear after completion of the procedure. After carefully verifying that the correct concentrates are being used.11 Procedure for Autocalibration of the Peristaltic Pumps during DIALYSIS”. the “! Concentrate Cans” #40 Alarm can occur. WARNING Both with Acid/Acetate concentrate container change and with switch from the use of acid in external containers to the use of acid concentratet delivered from the Central Concentrate Supply system. and that the dialysate Conductivity is correct. in this section. the operator may clear the alarm by performing the PA Autocalibration Procedure (see “5. for complete instructions.5. it is the operator’s responsibility to verify that proper acid/acetate concentrate is being used.) Rev. Press the OVERRIDE button to clear the alarm and to start uptake of acid/acetate. To replace the dialyser proceed as follows: During the Patient Connection phase: • Stop the Blood Pump and follow facility’s procedures to restitute blood and disconnect the patient. During a dialysis treatment: • Press the WASHBACK Action key on the DIALYSIS view and CONFIRM to perform WASHBACK. When the patient has been disconnected: • Press the CHANGES Action key.SPECIAL PROCEDURES 5.A . select the desired priming procedure. SECTION 5.A. • Press the FILTER CHANGE Action key. • Press CONFIRM. the dialyser may be replaced. • The following message will appear: PROTECTION SYSTEM Do You Confirm Filter Changing ? Press ENTER To Confirm. the following message will appear: Do not remove the Cartridge now Place the dialysate hoses on their rinse ports.10 Dialyser Replacement Dialyser can be replaced both during the Patient Connection phase and during the dialysis treatment.A-21 5. must be pressed only after having completed the WASHBACK mode. B . • Wait until the following message is displayed in the Operator Messages Area: Replace the cartridge and dialyser. for Dialyser Change. • Disconnect the dialysate connectors from the dialysate ports of the dialyser and reattach them to their bypass ports on the machine. WARNING The CONFIRM button. After the venous clamp opens. Note Starting from the above Operator’s message appearance. Rev. • Perform WASHBACK. during the WASHBACK mode. according to the type of dialyser being used. • After confirming the DIALYSER CHANGE message. • After patient connection. Note If Conductivity Profiling and/or UF Profiling were selected. At the restart of DIALYSIS. the dialyser re-priming view will appear and the priming procedure must be repeated. Rev. TOTAL FLUID REMOVED and TOTAL BLOOD are suspended. the updating of these parameters is automatically reactivated without having to set the TOT WEIGHT L again. replace the Cartridge Blood set. press the TREATMENT Action key to restart the interrupted treatment. the updating of DIALYSIS TIME. During the priming procedure the message “Wait. B .A-22 PHOENIX OPERATOR MANUAL • Replace the dialyser (if not yet done).5. the PAT CONNECT Action key becomes available. Note During the PAUSE THERAPY and the FILTER CHANGE modes. • When the priming procedure is complete. Priming in progress …” will appear on the Operator Messages Area. • After the Venous Clamp opens. the profiling is stopped. TOTAL FLUID REMOVED and TOTAL BLOOD values retained. • Press the PAT CONNECT Action key and reconnect the patient to the extracorporeal circuit. • The treatment will automatically restart with the previous TOT WEIGHT L and DIALYSIS TIME. When the treatment is resumed the profiling will restart from the last executed values. The autocalibration procedure during DIALYSIS is slightly different from the calibration procedure performed by Service personnel. During Autocalibration.A. B . • Press the Machine Navigation key.6 Bic 8. the user must always verify that the correct concentrates are connected to the machine’s concentrate connectors. • Select the PA AUTOCALIB or PB AUTOCALIB Action key corresponding to the pump that requires autocalibration. Press the appropriate AUTOCAL Action key.SPECIAL PROCEDURES 5. an autocalibration of the Peristaltic Pump Inserts may be performed.. • Verify that the appropriate concentrate is attached.A . The Autocalibration Process will proceed only after this confirmation. the “W! . if a “! CONCENTRATE CANS: A PUMP or B Pump or A+B PUMPS” #40 alarm occurs. A request to CONFIRM this action will be displayed on a superimposed window on the Touch Screen. AUTOCALIBRATION FAILED” alarm message will appear. The selected Action keys will remain highlighted and the Autocalibration pictogram is displayed until the start of the Autocalibration process. WARNING In the case of the Acid/Acetate or Bicarbonate Pump Autocalibration. Rev. in order to have a stable conductivity. that may not be detectable by the Protection System. Note The only Action keys that will be displayed are those that are appropriate for the type of dialysate concentrate that is being used. the Action key will disappear but the pictogram will remain on the Pictogram area. The use of incorrect concentrates may result in an a incorrect dialysate conductivity. as indicated in this table: Acid/Acetate Bic 6.11 Procedure for Autocalibration of the Peristaltic Pumps during DIALYSIS During DIALYSIS.A-23 5. When the correct concentrates have been verified the CONFIRM button must be pressed on the Main Control Panel.4 Bicart % % PA YES YES YES YES PB NO YES YES NO If the Autocalibration Procedure fails. To prepare the machine for an Autocalibration procedure: • Deactivate Profiling and/or Diascan. SECTION 5. Rev. Note The Peristaltic Pump Autocalibration Procedure is an emergency operation intended only to enable completion of the current DIALYSIS treatment. PB.5. If the Autocalibration Procedure fails. WARNING If the “! CONCENTRATE CANS: A PUMP or B Pump or A+B PUMPS” #40 alarm occurs frequently. the pump speed calibration values are not saved.A-24 PHOENIX OPERATOR MANUAL Note The indication of the relevant pump (PA or PB) appears in the alarm message. B . It is recommended to perform the Standard Autocalibration Procedure (see “Procedure for Standard Autocalibration of the PA. or PUF Pumps during the Dialysate Preparation Process” in this section) during SETUP of the machine for the next dialysis treatment. the pump autocalibration is not completed and the “! CONCENTRATE CANS: A PUMP or B Pump or A+B PUMPS” #40 alarm may reoccur. call for Service. the user must always verify that the correct concentrates are connected to the machine’s concentrate connectors. • When these operations have been completed. SECTION 5.A . When the correct concentrates have been verified the CONFIRM button must be pressed on the Main Control Panel. • Select the PA AUTOCALIB. The use of incorrect concentrates may result in an a incorrect dialysate conductivity. Rev.SPECIAL PROCEDURES 5. or PUF Pumps during the Dialysate Preparation Process To prepare the machine for Standard Autocalibration: • Turn the machine ON.A. the dialysate preparation will begin and the Standard Pump Autocalibration may be performed. a superimposed window displays a request to CONFIRM the appropriate concentrates are attached.12 Procedure for Standard Autocalibration of the PA. • Press the appropriate Action key to activate the Autocalibration Procedure (it is necessary to CONFIRM this action) • The selected Action key remains highlighted and the Autocalibration pictogram is displayed until the start of the autocalibration process. or PB AUTOCALIB. the Action key will disappear but the pictogram will remain on the Pictogram area. • Press the SETUP Action key. PB. • During Autocalibration. WARNING The three Autocalibration Action keys are available only before Dialysate Preparation is complete. • At initiation of Autocalibration. that may not be detectable by the Protection System. or PUF AUTOCALIB Action key relating to the pump for which autocalibration is required.A-25 5. • Select the type of dialysate required. The Autocalibration Process will proceed only after this confirmation. WARNING In the case of the Acid/Acetate or Bicarbonate Pump Autocalibration. To initiate the autocalibration process: • Press the Machine Navigation key. B . ... B . AutoCalibration • If the process is incorrectly completed because the calculation or the controls provide negative results: W! … AutoCalibration Failed • If the process is incorrectly completed because an error has occurred during the saving of the pump speed calibration values: .AUTOCALIBRATION FAILED Note The indication of the relevant pump (PA. If the Autocalibration fails.A-26 PHOENIX OPERATOR MANUAL Note The only Action keys that will be displayed are those that are appropriate for the type of dialysate concentrate that is being used. When the Autocalibration process is being performed. If the Autocalibration Procedure fails.. as indicated in this table: Acid/Acetate Bic 6. No further message appears.6 Bic 8. one of the three following alarm messages appears: • If the process is incorrectly completed because the calculation has not been carried out within the maximum time available: Timeout on . The Autocalibration pictogram will disappear from the Pictogram area.. the new pump speed calibration values are not saved and the pump autocalibration is not correctly completed. The machine then immediately performs the test relating to the relevant values. using the previous pump speed calibration coefficients: • Acid/Acetate pump → Final Conductivity Test • Bicarbonate pump → Bicarbonate Conductivity Test • Ultrafiltration pump → Ultrafiltration Test Rev. the following message is displayed in the Operator Message Window: Wait Autocalibration In Progress. or PUF) appears in the alarm message. PB.5.4 Bicart % % PA YES YES YES YES PB NO YES YES NO PUF YES YES YES YES Autocalibration is performed during the Dialysate Preparation process.. If the process is correctly completed. the machine proceeds with normal operation. It is recommended that the Autocalibration Procedure be repeated or the pump insert replaced.A-27 If the Ultrafiltration Pump Test fails. • Following a change from Central Concentrate Supply System to the use of External Concentrate Containers. SECTION 5. the machine proceeds after confirmation. WARNING If the Autocalibration Process and the following Test fail. the machine guarantees a degree of accuracy for the value subject to autocalibration. • Following a change in the type of concentrate being used.A .SPECIAL PROCEDURES 5. If the Acid/Acetate or Bicarbonate Pump Test fails. Rev. B . the machine proceeds with normal operation. If the Autocalibration Process fails. Autocalibration must be repeated or the pump insert changed and then the autocalibration must be repeated. The machine must be turned OFF. the machine is unable to acquire the relevant value with sufficient accuracy. but the following Test passes. WARNING The PA/PB Autocalibration Procedure is mandatory in each of the following cases: • Following a change of the pump insert. If the Acid/Acetate or Bicarbonate Pump Test passes. a > GENERAL SAFE STATE < alarm occurs. the machine is unable to acquire the relevant value with sufficient accuracy. Rev.13 Procedure for Automatic Autocalibration of the UF Pump during the Dialysate Preparation Process The Autocalibration of the UF Pump is automatically performed by the machine if it detects that the pump insert characteristics require this operation. B .A. it is recommended to call for Service. Autocalibration must be repeated or the pump insert changed and then the autocalibration must be repeated. In this case.A-28 PHOENIX OPERATOR MANUAL 5... during the Preparation Process the autocalibration pictogram is dispayed while. in the Machine view. In case of failure of this Autocalibration Procedure. WARNING If the Autocalibration Process and the following Test fail. the PUF AUTOCALIB Action key becomes highlighted and the following message appears in the Operator Message Window: Wait Autocalibration In Progress.5. • Clamp the arterial line and the patient’s arterial access site. B . • Disconnect the arterial line from the patient’s arterial access site. WARNING The alarm system is inactive or impaired when power to the machine or Touch Screen is off. In these particular situations the manual disconnection of the patient may be performed. SECTION 5. display backlight failure. • When ready. keyboard is not functioning). turn the Blood Pump Crank counter clockwise to return blood to the patient.14 Manual Disconnection of the Patient During the course of a dialysis treatment certain conditions that make impossible to continue the dialysis treatment may occurs (e. WARNING Failure to remove the venous line from the Venous Line Clamp can result in rupture of blood lines or dialyser when hand cranking the Blood Pump..A . • Remove the venous line from the Venous Line Clamp by depressing the push button and pulling the venous line to the left. While manually returning blood.i. • Open the clamps on the arterial line and the saline administration line. • Verify that the Cartridge Saline Line and Saline Administration Line are clamped. immediately stop returning blood.SPECIAL PROCEDURES 5. • Insert the crank through the hole in the Blood Pump Cover and into the Blood Pump Rotor. If air is seen. To manually disconnect the patient: • Switch OFF the machine. watch the venous line for air.A. • Open the clamps on the venous line and the patient’s venous access site. • Remove the Blood Pump Crank from the rear panel of the machine. • Attach the Saline Administration Line to the arterial line using the priming connector from the Cartridge saline line. Return the blood in the patient’s access site to the patient according to the facility’s protocol. remove the arterial line from the Arterial Line Clamp. • Remove the Saline Administration Line and priming connector from the Cartridge saline access line. • If Single Needle mode was chosen. • Clamp the venous line under the Venous Line Clamp. Rev.A-29 5. Expose Diaphragms to Atmospheric Pressure/Clean Sealing Cones Supplies Needed: 0.5% bleach solution. Move the Cartridge slightly to unseat the diaphragms from the Red and Blue Sealing Cones. 9. Failure to do this may result in patient blood loss. 2. one or both diaphragms of the Cartridge Blood Set may move out of the neutral position. Part A. then Part B (a longer procedure) must be done. you may also perform it any time there is fluid/blood in the set and you suspect pressure monitoring to be inaccurate.5% bleach solution and lint-free cloth Note To make a 0. Part B. 3. Open the Blood Pump Cover.25% to 6% bleach with 9 parts water. (Neutral position is where the diaphragms fall naturally when not exposed to pressure).A-30 PHOENIX OPERATOR MANUAL 5. mix 1 part 5. 8. Expose Diaphragms to Atmospheric Pressure 1. B . WARNING Before performing this procedure. 4. (This exposes the air-only side of diaphragms to atmosphere) 7. Rev. or reconnect previously attached lines/syringes. Allow approximately 5 seconds for pressures to stabilize on both sides of the diaphragms. Unclamp the venous and arterial lines. Clamp the venous and arterial lines below the Cartridge. (This exposes the blood side of diaphragms to atmosphere) 6. clamp all Cartridge access lines in the 4-position Line Clamp. Align the diaphragms with the Sealing Cones. lines. but if the situation is not remedied. if present. Disconnect any caps. Close the Blood Pump Cover. being careful not to dislodge the pump segment.A. Open the clamps on the venous and arterial access lines and remove the end caps. restart the Blood Pump. 5. When ready. or syringes connected to the Cartridge venous and arterial access lines. This causes pressure monitoring to become inaccurate and can result in pressure alarms or T1 Test failures. Close the venous and arterial access line clamps. The Diaphragm Neutral Position procedure restores both diaphragms to their proper position. 11. 10.15 Diaphragm Neutral Position Procedure Note In certain conditions. Part A of this procedure can be tried first. This procedure may be required to remedy certain alarms. press lightly on the Cartridge to reseat the diaphragms on the cones.5. replace end caps. ensure that the Cartridge drip chambers are no more than half full of fluid. Make sure the Blood Pump is stopped and the Cartridge chambers are no more than half full of fluid/blood. Close the Blood Pump Cover. restart the Blood Pump. Unclamp the venous and arterial lines. Tilt the Cartridge away from machine so that the Red and Blue Sealing Cones are accessible. Reroute all Cartridge access lines into the 4-position Line Clamp. B .A-31 1. Note Debris on a Sealing Cone prevents an airtight seal between the machine and the diaphragm and causes a diaphragm to lose its neutral position. 3. Clamp any unused lines in the 4-position Line Clamp.5% bleach solution. 8. 5.SPECIAL PROCEDURES 5.A . align the diaphragms with the Sealing Cones. Replace the Cartridge in the slot. 6. When ready. press the Cartridge toward machine to seat the diaphragms on the cones. 7. Grasp the Cartridge and pull the tab out of the slot. 2. Clean the Sealing Cones with a lint-free cloth and the 0. 4. SECTION 5. Remove all Cartridge access lines from the 4-position Line Clamp. Rev. Replace the end caps of the venous and arterial access lines (or reconnect lines to previously connected lines/syringes). Perform Steps 1 through 5 of Part A of this procedure. Close the WHO door by placing the thumb on the middle of the door and pushing. before performing a Chemical Disinfection using a chemical other than Bleach. WARNING DO NOT USE this priming connector for patient related uses or any sterile connections. • Remove the syringe and priming connector. Rev.5. allow the WHO to rinse at least 3 minutes in the ADR Rinse cycle.A-32 PHOENIX OPERATOR MANUAL 5. Note Non-sterile components can be used to manually clean the WHO. WARNING Following the WHO bleach procedure.25%-6% sodium hypochlorite) into the WHO when the machine is in IDLE phase. • Open the WHO door by placing the thumb on the middle of the door and gently lifting the WHO door tab. B .16 Manual Cleaning procedure for the Waste Handling Option (WHO) WARNING The Waste Handling Option (WHO) must be cleaned each time blood enters the WHO Drain Port before continuing with another patient treatment or once per day if the WHO has been in use. inject 15 cc of undiluted bleach (5. • Immediately begin SETUP for the next treatment or perform an ADR: RINSE procedure to rinse the undiluted bleach from the WHO. WARNING The patient must not be connected to the machine during this procedure. • Using a syringe with a priming connector as an adapter.A. WARNING DO NOT LEAVE undiluted bleach in the flow pathway of the machine. if present. Step 1: Preparing the PHOENIX machine to which you will transfer the patient. signalled by the appearance of the following Operator Message: End Of Dialysate Preparation You Can Now Connect The Dialyser To transfer a primed Cartridge Blood Set to another PHOENIX for continuation of treatment. Verify the Blood Pump Rotor is in the horizontal position.A . return the patient’s blood per the WASHBACK procedure. reposition if necessary. Remove the venous line from the Venous Line Clamp and the arterial line from the Arterial Line Clamp (if Single Needle is used). then start the preparation process by selecting the SETUP Action key and then select the dialysate type to be used. Do not prime this Cartridge Blood Set. Step 2: Removing the Cartridge Blood Set from the PHOENIX machine for continuation of treatment on the PHOENIX machine previously prepared. Step 3: Placing the primed Cartridge Blood Set on the PHOENIX machine previously prepared for continuation of treatment: 1. then open the Air Bubble Detector/Patient Sensor cover. 5. B . by pressing the cover latch. 2. If possible. Select the Diascan DIASCAN parameter box and select NO. Press the kT/V Navigation key and press SET. 4. select Config/Centre Conf/Functions and change JUMP PRIMING to YES. SECTION 5. Rev. Open the clamps on the 4 Position Line Clamp. If unable to return blood. clamp the arterial and venous lines. 2. 2.17 Transferring a primed Cartridge Blood Set to another PHOENIX machine for continuation of treatment WARNING DO NOT transfer a primed Cartridge Blood Set to another PHOENIX for continuation of treatment before dialysate preparation completion. from the Syringe Holder. Place a new Cartridge Blood Set on the machine to allow the T1 test and dialysate preparation to proceed. Wait for the PAT CONNECT Action key to appear. 3. Open the Blood Pump Cover. the arterial and venous dialyser lines. From the IDLE view. removing the Cartridge access lines from the clamps. 4. 1. Remove the unprimed Cartridge Blood Set that had previously been placed on the PHOENIX machine to allow dialysate preparation. the priming process may be skipped by temporarily changing the JUMP PRIMING parameter to YES in the machine’s Config settings. the Saline administration line and the Heparin line (if a heparin syringe is present).A. Press CONFIRM.A-33 5. Return to the Home view. 6. Press CONFIRM. make sure the blood pump is stopped. 3. 1. 5. Open the Blood Pump Cover and remove the Cartridge Blood Set from the Blood Pump Rotor and the heparin syringe. Turn the machine ON. 3.SPECIAL PROCEDURES 5. Close the 4 access lines on the top of the Cartridge Blood Set using the proper end caps. This machine is now ready to receive the primed Cartridge Blood Set from the other machine. Override any alarms. 10. Route the arterial line into the Arterial Line Clamp (if Single Needle is used). 9. WARNING During OVERRIDE. Remove the clamps from the arterial and venous lines to the patient. Start the Blood Pump by pressing the ON/OFF button on the Blood Pump Control Panel. Activate Heparin. Close the Air Bubble Detector/Patient Sensor Cover (cover makes a clicking sound as it latches). 19. Rev. Press the Cartridge against the machine. 18. 6. Set the treatment parameters for the remainder of the treatment to be performed. Place the primed dialyser into the Dialyser Holder. Connect the Dialysate Lines to the dialyser and press BYPASS to reprime the dialysate side of the dialyser. 4. Insert the tab of the Cartridge Blood Set into the Cartridge Clip (left side of cartridge holder). 13. 12. 5. BPM.5. which are being overriden. 16. Insert the heparin syringe (if present) into the Heparin Syringe Holder and close the Syringe Holder with the clip to keep it in place. The pressure pods should seat evenly on the Red and Blue Sealing Cones. move the heparin syringe Plunger Clamp to fit the syringe. 20. Press the DIALYSIS Action key to reinitiate the treatment. the operator is responsible for monitoring parameters. Wait approximately 30 seconds and then press the PAT CONNECT Action key and CONFIRM the selection. Place the pump segment of the Cartridge Blood Set around the Blood Pump Rotor. arterial and venous dialyser lines. Replace the end caps. (Cover makes a clicking sound as it latches). With the ⇐ (ARROW LEFT) and ⇒ (ARROW RIGHT) buttons on the Heparin Control Panel. 14. Remove the end caps from the venous and arterial access lines of the Cartridge Blood Set: this exposes the blood side of diaphragms to atmosphere. 22. Route the venous line into the Air Bubble Detector/Patient Sensor and through the Venous Line Clamp. 11. Route the Cartridge access lines into the 4-Position Line Clamp above the Cartridge Blood Set. 8.A-34 PHOENIX OPERATOR MANUAL Note The Blood Pump cover can be closed only when the rotor is in the horizontal position. UF or Conductivity Profiling if desired. 7. 21. 17. Allow approximately 5 seconds for pressure to stabilize on both sides of the diaphragms. Close the Blood Pump Cover. saline administration line and the heparin line (if a syringe is present). Route the lines from right to left as follows: Heparin line Green clamp Arterial access line Red clamp (right) Cartridge saline line Red clamp (left) (with priming connector) Venous access line Blue clamp 15. B . if needed to perform the Priming Procedure with Dialysate Connectors on the Dialyser. select Config/Centre Conf/Automation and change DIAL AUTO PRIME to YES.SPECIAL PROCEDURES 5. before initiating another treatment on this machine. SECTION 5.A-35 WARNING It is the operator’s responsibility to check that the quantity of heparin delivered to the patient is enough to prevent blood clots from forming in the extracorporeal circuit during the transfer of a primed Cartridge Blood Set to another machine. Following completion of the treatment and return to the IDLE view. select Config/Centre Conf/Functions and change JUMP PRIMING to NO. Rev. From the IDLE view. • The DIAL AUTO PRIME parameter must be changed to YES. Press CONFIRM.A . B . set the following parameters: • The JUMP PRIMING parameter must be changed to NO From the IDLE view. Press CONFIRM. A. 2 Rev. The Single Needle holder is provided with a clip connection to latch it to the Dialyser Holder. The Holder must stay in the upright position (see Fig. Fig. B . 1 Fig.18 Installation of the Single Needle Holder The Single Needle Holder accessory allows SETUP of the Single Needle Cartridge Blood Set. pull out the Dialyser Holder and then press the Single Needle Holder firmly to the shaft as displayed in Fig.A-36 PHOENIX OPERATOR MANUAL 5.5. Note The Single Needle Holder can be left on the machine when a double needle treatment is performed. 1. 2). To mount it to the Dialyser Holder. When the machine is powered ON or after the end of the dialysis treatment. only the tests that do not involve the conductivity probes are performed. Only in the specific case of CPU test failure. The machine will then sequence through each remaining T1 tests automatically.B .B SECTION 5. After the successful completion of the test. From IDLE. the machine continues normal operation. In order to allow the T1 testing to continue. Rev.B. the machine continues normal operation. while the remaining can be performed in a different machine status. Normally following completion of a dialysis treatment when the machine returns to IDLE.B . dependent on user manipulations performed. Conductivity and UF tests. the user needs to connect the appropriate concentrates. the related test message disappears from the window. dialysate connectors are on their bypass ports and dialysate concentrates are not connected. Following successful completion of all the T1 TESTs. SECTION 5. a bar graph is displayed together with an operator ‘s message informing the operator that the T1 test execution is in progress and which specific T1 test the PHOENIX machine is performing.1 Test procedures The machine automatically carries out a series of tests to check the components and processes that make a dialysis treatment safe. If the T1 TEST fails. the machine goes into IDLE. will appear informing the operator of the failure. the machine gets stuck without displaying any alarm message. press the SETUP Action key and choose the dialysate type. one of the four possibilities listed below occurs depending on the seriousness of the condition. An operator ‘s message will inform the operator which specific T1 test failed. During this time. The user is advised with an Operator Message to confirm the use of the NEW SESSION to proceed. an alarm message.TEST PROCEDURES 5. During the T1 test execution. Temperature. If a T1 test passes. Normally when the machine is in IDLE after being powered ON.B TEST PROCEDURES 5. If a T1 test fails. Some tests are carried out in a precise functioning phase. the user has the opportunity to select the NEW SESSION Action key which will allow the T1 test to be performed without repeating the Dialysate Pressure (Pi & Po). the T1 Test begins automatically. the dialysate connectors are on their bypass ports and dialysate concentrates may still be connected.B-1 5.TEST PROCEDURES 5. T1 TEST FAILED. If the machine detects that it is in IDLE for more than a minute. B . but to notify Service as to which test failed. Rev.. in this manual) The machine proceeds with normal operation. WARNING It is not advisable to continue treatment. the following message appears: Press ENTER To Confirm And Proceed Press STOP to Interrupt the Process The CONFIRM button must be selected within 2 minutes (i. If the operator decides not to continue the treatment and to return to the IDLE view. 2. the STOP Action key must be pressed. the OVERRIDE button on the Main Control Panel must be pressed. WARNING The operator is advised of the test failure with an alarm message (number 183): W! T1 Test Failed (see Section 8 . B . Note After pressing the STOP SETUP Action key.e.B-2 PHOENIX OPERATOR MANUAL 1. When the OVERRIDE button is pressed. E.Alarms and Signals.5.:” The TEMPERATURE TEST Has Failed" If the operator decides to continue the dialysis treatment despite this test failure. If the CONFIRM button is not pressed. wait at least 20 seconds before restarting again dialysate preparation. Press OVERRIDE To Proceed Note On the first line of the message the failed test is indicated. The audible and visual alarm is disabled by pressing the OVERRIDE button.Alarms and Signals. in this manual) In the Operator Messages Area the following message will appear: . the machine remains in a wait state.g. It is the operator’s responsibility to carefully check the parameters involved in the failed test if the decision is made to continue treatment despite the test failure. TEST FAILED.. when the OVERRIDE LED is still lit) to confirm the intention to proceed with the dialysis treatment. WARNING PLUS USER CONFIRMATION REQUEST The alarm message (#188) is displayed: W! Wait to Continue (see Section 8 . then switch ON the machine again..B . switch OFF the machine. MACHINE STUCK Only in the specific case of CPU test failure.. SECTION 5.TEST PROCEDURES 5. 4. B . If this occurs.B-3 3. GENERAL SAFE STATE The machine is placed in a GENERAL SAFE STATE: • Ultrafiltration Pump stops • Blood Pump stops • Venous Clamp closes. wait 5 seconds. Rev. the machine gets stuck without displaying any alarm message. You Must Switch Off The Machine WARNING Notify Service as to which test has failed. • Machine goes into BYPASS It is impossible to continue with a treatment. Test in Progress... The following message appears in the alarm window: > GENERAL SAFE STATE < ! T1 Test Failed In the Operator Message Area the following message will appear: Failure of the . B . and the results of a test failure: Test Execution phase Failure 1 CPU Test • During loading of the program (when Machine Process control unit Power is switched ON) stuck • In IDLE phase 2 CRC EPR Test • During loading of the program (when General System memory check Power is switched ON) Safe • In IDLE phase State 3 Comparator Test • During loading of the program (when General Internal comparator Power is switched ON) Safe • In IDLE phase State 4 RAM IC’s Test • During loading of the program (when General Memory units Power is switched ON) Safe • In IDLE phase State 5 Battery Test • During loading of the program (when warning Power is switched ON) • In IDLE phase 6 Buzzer & Lamp Test • During loading of the program (when NA (see Audible and visual alarms Power is switched ON) warning • In IDLE phase below) 7 free 8 free 9 free 10 24 Volt Test • During loading of the program (when General Power supply Power is switched ON) Safe • At the end of WASHBACK State 11 Venous Clamp Test • During loading of the program (when General Venous line clamp Power is switched ON) Safe • At the end of WASHBACK State 12 free 13 Electrovalves Test • At the beginning of dialysate preparation General Valves command Safe State 14 Arterial & Venous • In IDLE phase General Pressure Test OR Safe Venous & Arterial State • At the beginning of dialysate preparation pressures 15 Blood Pump Test • At the beginning of dialysate preparation General Safe State Rev.B-4 PHOENIX OPERATOR MANUAL The table below lists the individual T1 tests. their execution phase (the 2 conductivity tests can occur outside the normal sequence since they are only executed during dialysate preparation).5. Call for Service. Note 1 The bicarbonate conductivity test is only carried out if Bicarbonate Dialysis/BiCart has been selected. State & loss of filter bypass circuit 17 Temperature Test (Note • During the dialysate preparation warning 2) + confirm. SECTION 5. Rev.& out-let filter pressure. 19 Bicarbonate Conductivity • During the dialysate preparation warning Test + (Note 1 & 2) confirm. 18 Acid/Acetate • During the dialysate preparation warning Conductivity Test + Acid/Acetate conductivity confirm. the presence of a short audible and visual signal must be checked (red and yellow lamps illuminated). If one of the signals is not present. 21 Ultrafiltration pump Test • During the dialysate preparation General (Note 2) Safe Ultrafiltration State WARNING During the BUZZER AND LAMP test.TEST PROCEDURES 5. B . Bicarbonate conductivity 20 BLD Test • During the dialysate preparation warning Blood Leak Detector + confirm.B . It is NOT recommended to carry out a dialysis treatment in the absence of the audible and/or visual alarms.B-5 Test Execution phase Failure 16 PI/PO Pressures Test • At the beginning of dialysate preparation General (Note 2) Safe In. the respective signalling device (buzzer or lamp) is malfunctioning. the following T1 Tests are not repeated: • Dialysate (Pi&Po) Pressure • Temperature • Conductivity • Ultrafiltration Pump The user is advised with the following operator message when the NEW SESSION key is pressed the first time: In NEW SESSION Mode The Pi&Po. Temperature. Conductivity and UF T1 Tests won't be Performed. B . Press ENTER To Confirm And Proceed. Rev.5.B-6 PHOENIX OPERATOR MANUAL Note 2 If the dialysis treatment starts with the NEW SESSION mode selected by the user. C BLOOD PRESSURE MONITORING SYSTEM 5. Blood pressure data is derived by the oscillometric method. whichever is greater.BLOOD PRESSURE MONITORING SYSTEM 5. Rev.4. Assembly accuracy Meets ANSI/AAMI standards.C-1 5.2 and EN 1060-3. The maximum amplitude of these oscillometric pulses occurs at mean blood pressure.C SECTION 5. carefully follow the instructions supplied with the BPM kit. The following overall system accuracy values are applied: a. Maximum mean error of measurement: ±5 mmHg b. It then interpolates the systolic and diastolic blood pressures from the plot. WARNING If the BPM is not factory installed.4. SP10. The arterial pressure pulses are coupled in the cuff and result in pulses (oscillations) modulating the cuff pressure.1).1 General General description The Blood Pressure Monitoring system (BPM) provides measurement of patient blood pressures using an inflatable pressure cuff.C . B .C. Pressure cuff measurement ranges Systolic +40 to +270 mmHg Diastolic +20 to +250 mmHg Heart rate 30 to 250 beats/min. Maximum experimental standard deviation: 8 mmHg Those accuracy values are obtained with a measurement device with an accuracy of: • ±2% or ±3 mmHg.C . Overall System Accuracy Meets ANSI/AAMI SP 10 clause 4. The BPM plots the amplitude of the oscillometric pulses against the cuff pressure. SECTION 5.BLOOD PRESSURE MONITORING SYSTEM 5. over a range of 0 to 260 mmHg (compliant to ANSI/AAMI SP 10 clause 4. Oscillometric Blood Pressure Measurement Method The BPM uses a blood pressure cuff to apply pressure to the artery. Maximum time is 145 seconds. Once the BPM acquires the pressure data. Cycle time Typical measurement cycle time is less than 60 seconds. it analyzes the data to obtain systolic and diastolic pressure values and the heart rate. the cuff automatically deflates. The external materials of the inflation bags that are in contact with the patient are made of Dupont Dacron® Polyester with the hook and loop closures made of Dupont Nylon®.5. These materials has been tested by NAMSA (North American Science Associates) and are in compliance with bio-compatibility standards for irritation and skin sensitivity.Part 3: Supplementary requirements for electro- mechanical blood pressure measuring systems. Composition The inflation bags and the tube in the BPM cuff are made of a latex-free material. The inflation rate is less than 80 mmHg/second. Part 2: Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment. Cuff cleaning Small soiled or stained areas may be cleaned by gentle scrubbing with a sponge or cloth soaked in mild soap or water solution. B . Conformity with international standards The BPM complies with the applicable clauses of the following international standards: IEC 60601-2-30 Medical electrical equipment. EN 1060-1 Non-invasive sphygmomanometers . In the event of a power failure. Rev.C-2 PHOENIX OPERATOR MANUAL Zero setting No manual action is necessary: the assembly automatically sets the pressure transducer channel to zero. Cuff pressure The maximum pressure is 290 mmHg.General requirements EN 1060-3 Non-invasive sphygmomanometers . Check (e.g. wipe immediately to prevent moisture from entering the machine. Its composition (insulating material) protects the BPM "Applied Part" (Type BF) against the effect of a defibrillator discharge. B . by observing the limb concerned) that operation of the equipment does not result in prolonged impairment of the blood circulation of the patient. In the event of accidental wetting of the cuff or the hydraulic connections.C-3 WARNING The BPM must be used only for patients with a body weight greater than 15 Kg and using a BPM cuff of the appropriate size.C . or any time irregular performance is suspected or observed. just as during the manual readings. The BPM should be tested and calibrated at least once every 4000 hours.BLOOD PRESSURE MONITORING SYSTEM 5. Avoid compression or restriction of pressure tubes. SECTION 5. Make sure that the patient is quiet and not moving during the measurements. Note Excessive patient movement or speech can interfere with blood pressure measurements. Rev. the manufacturer advises the user that the information originating from the BPM cannot be used alone as a unique source of information to induce any therapeutic or pharmacological actions. WARNING In order to be in full conformity with the indications of the European Medical Device Directive 93/42. 9 in) 2.5 in) THIGH 46 – 66 6975254 (18.C.5 in) SMALL ADULT 18 – 26 6975221 (7. Select the appropriate cuff size as indicated below: Cuff size Limb circumference (cm) Service code CHILD 10 – 19 6975213 (3. Ensure that the rubber cuff bladder wraps at least halfway around the limb.2 in) ADULT 25 – 35 6975239 (9. It is the responsibility of the user to validate that other cuffs provide safe and effective performance.1-25. Rev.8 in) LARGE ADULT 33 .1-10.9-7. The Phoenix machine has been tested and validated for use with the cuffs listed in this table. The Manufacturer does not assume responsibility or liability for use of cuffs other than those specified.47 6975247 (12.5.C-4 PHOENIX OPERATOR MANUAL 5. Note The table above contains a number of references to cuffs for use with the Phoenix Blood Pressure Monitoring System (BPM).2 Cuff selection Selection of correct cuff size 1.8-13. Common errors in cuff size selection Cuff size Effect on readings Too Small False HIGH Too Large False LOW For correction to blood pressure reading refer to “Correction of blood pressure readings” in this section. The Manufacturer has not validated the use of cuffs other than those specified in this manual. B .9-18. 12.16.9 in) -8 -6 -1 0 +4 +2 40 (15.1 Arm circumference (cm) SBP DBP SBP DBP SBP DBP 26 (10. placing upper edge of cuff as high on arm as possible.8 in) 0 0 +4 +3 +7 +4 32 (12. Cuff too loose. Squeeze air from cuff.2 in) +5 +3 +7 +5 +9 +5 28 (11.9 in) 18 (7.7 in) Arm circumference range (cm) 26 .0 in) +3 +2 +5 +4 +8 +5 30 (11.8 in) 37.4 in) -4 -3 +2 +1 +5 +3 36 (14. Cuff full of air when first applied. Select the correct cuff size (see Selection of correct cuff size above).33 33 .BLOOD PRESSURE MONITORING SYSTEM 5.7 in) 15 (5.1) > 16. 4. SECTION 5. Place white arrow on cuff approximately over brachial artery. 3.1 in) -16 -11 -6 -3 0 0 48 (18.5(14.C . arm circumferences should be measured and corrections made using the following table (where SBP and DBP respectively represent the Systolic and the Diastolic Adult Blood Pressure Cuffs) Bladder width (cm) 12 (4. B .5 in) -12 -9 -4 -2 +2 +1 44 (17.C. Wrap cuff snugly. 4.2 in) -6 -4 0 +1 +5 +3 38 (14. Wrong cuff size 2. with lower edge 25 to 50 mm above the antecubital crease. 5.6 in) -2 -1 +3 +2 +6 +4 34 (13. Correction of blood pressure readings When accurate blood pressure measurements are necessary.1 in) Ideal arm circumference (cm) 30 (11.9) (12. 2.9 .41 > 41 (inch) (10. Common errors in cuff application 1.9 in) -18 -13 -7 -4 -1 -1 50 (19. Cuff too low on arm (lower edge of cuff must not rest on antecubital crease).3 Cuff application Proper cuff application 1.2 .3 in) -14 -10 -5 -3 +1 0 46 (18. Cuff is applied correctly when white arrow on cuff is placed on the inner surface of the arm (not near antecubital crease).C-5 5. 3.7 in) -21 -14 -9 -5 -1 -1 Rev.8 in) 45 (17.7 in) -10 -7 -2 -1 +3 +1 42 (16. POST LYING The measure taken is linked to the parameter related to the specific type of measure performed. Only the pressure values.PRE LYING . 5. PRE SITTING. the following Action keys will be available: POST STANDING.PRE SITTING . and is stored in the Dialysis Report table (see Section 7 - Communication System) in the lines reserved for the PRE/POST DIALYSIS DATA. Only during the time between the DIALYSIS Action key disappearance (after the RINSEBACK VOLUME value set has been reached) and the Patient Login event for the next dialysis treatment. are stored in the REPORT screen (see Section 7 .PRE STANDING . (The table data is taken from the American Heart Association). the following Action keys will be available: PRE STANDING. The BPM measurement can be performed in the DISINFECT or RINSING modes.POST LYING. Rev.C-6 PHOENIX OPERATOR MANUAL For correction of blood pressure readings in individual patients. and the TREATMENT process selection. POST SITTING.5. pressing one of the following Action keys: . (See Section 7 .POST SITTING .4 BPM User interface When selecting BPM from the Home view.C. the blood pressure monitoring environment is accessed. B .PRE LYING. or from the IDLE view.POST STANDING . measured starting from the Patient Login even throught EMPTYING. or • Depending on the operating phase of the machine. Note Only during the time between the Patient Login event.Communication System). positive numbers should be added to and negative numbers subtracted from the readings obtained.Communication System) on the lines between the Start and the Stop of Acquisition of events. as well as during TREATMENT. After having correctly positioned the cuff on the arm of the patient. a new blood pressure measurement can be taken by: • Selecting the HEART button on the Main Control Panel. • A graph on the BPM view displays heart rate measurements. SECTION 5./ --. Under the base line of the graph the time “00:00” is displayed. B ./ -- --.BLOOD PRESSURE MONITORING SYSTEM 5. Rev.CONF • A graph is displayed on the BPM view showing the patient’s blood pressure measurements: The last measurement of the systolic pressure (Ps): red line The last measurement of the diastolic pressure (Pd): yellow line. Three pointers on the graphs mark respectively: • The LOG event: starting when the machine enters the IDLE phase.C-7 Note When the BPM device is not connected a specific alarm is triggered. The last measurement of the pulse rate (h/r): red line. The BPM view has the following form: 12:30 TREATMENT -.C . pu/min STOP BPM ON PRE STANDING VEN ART PRE SITTING BLOOD FLOW PRE LYING BLOOD FLOW << TIME Clk Time Syst Dias H RATE >> BPM REPORT KT/V PROFILE HEPARIN MACH.mmHg --. • The INIT event: selection of the DIALYSIS Action key. Under the base line of the graph the time in which the LOG event occurred is displayed. Note The Auto-Repeat feature is active on the Function Bar Arrows: pressing and holding the arrows for more than 2 seconds allows the green cursor to move more quickly on the graph. Select the Home Navigation key to return to the Home view. Both the BPM graphs and the BPM data collected during a treatment and displayed in the Function Bar remains available in the BPM view until the Patient Login event for the next dialysis treatment is triggered. Data displayed in this area are not deleted by the Patient Login event. Note The BPM area is shown in each view. it displays the last BPM measurement data. or by selecting the EMPTYING Action key.C-8 PHOENIX OPERATOR MANUAL • The END event: end of the dialysis treatment is indicated either by selecting POST STANDING/POST SITTING/POST LYING. B . Note The base of the graph corresponds to zero and the top to the maximum permitted value. measured by the INIT event. Under the base line of the graph the time at which the END event occurred is displayed. Pressing the Function Bar Arrows (positioned on the lower part of the window) moves the position of the green cursor on the patient’s blood pressures and heart rate graphs. Rev. do not press simultaneously the two Function Bar Arrows. In the time interval between the INIT event and the END event. in the time interval before INIT event and after END event.5. Entering the BPM view a green cursor is positioned on the last BPM measurement. INIT event). the “Time” value displayed in the Function Bar. The Function Bar displays the following values at the point in time at which the green cursor is positioned on the graph: • The time into treatment ( Time) • The clock time (Clk Time) • The systolic pressure value (Syst) • The diastolic pressure value (Dias) • And the heart rate measurement (H Rat) for the point in time at which the green cursor is positioned on the graph (Time).e. in correspondence to the BPM measurements. is calculated starting from the DIALYSIS Action key selection (i. Note To prevent problems in the BPM graph visualization. if pressed before the EMPTYING Action key selection. Press the STOP Action key to stop the measurement. the “Time” value corresponds with the “Clk Time” value. if using Patient/Rx dialysis. may be programmed in the Configuration menu as follow: NO only manual measurements are possible YES measurements performed by the machine at each “SAMPLE INTERV” time AUTOMATIC the first measurement is performed by the machine immediately after the selection of the TREATMENT Action key.C-9 During the dialysis treatment. The BPM ON Action key will no longer be highlighted. press the BPM ON Action key to enable automatic pressure measurements at time intervals corresponding to the value set for the SAMPLE INTERV parameter on the Config/Treatments/BPM screen or on the Rx Config/Rx Add. Manual BPM measurements may be performed at any time by pressing the button. settable both during STD DIALYSIS and during Patient DIALYSIS. At the start of any process (TREATMENT/DISINFECT/RINSING and on the IDLE view) the machine uses the BPM parameters set in the Config/Treatments/BPM menu. When automatic pressure measurements are enabled. Rev. or from the IDLE view as well as during TREATMENT. B .BLOOD PRESSURE MONITORING SYSTEM 5. SECTION 5. the BPM ON Action key is highlighted and the heart icon appears in the Icon bar. To turn off the automatic pressure measurements. additional measurements are performed at each “SAMPLE INTERV” time. Note The BPM USE parameter. select the BPM ON Action key again. Note The HEART icon flashes for a minute before an automatic measurement.C . BPM measurements can be performed in the DISINFECT or RINSING modes. C-10 PHOENIX OPERATOR MANUAL By using the SET mode. • DIAST PRE MAX– Maximum threshold of the range of values within which the diastolic pressure must fall. a corresponding alarm is activated which can be reset with the OVERRIDE button. • SYST PRE MIN– Minimum threshold of the range of values within which the systolic pressure must fall. MAX SAMPLE INTERV HOME BPM REPORT KT/V PROFILE HEPARIN • DIAST PRE MIN– Minimum threshold of the range of values within which the diastolic pressure must fall.Time interval between two successive automatic BPM measurements. MIN.Minimum threshold of the range of values within which the pulse rate must fall. MAX. Note When a diastolic pressure.Maximum threshold of the range of values within which the pulse rate must fall. the value of the parameters relating to the measurements may be modified: 12:30 TREATMENT DIAST PRE MIN DIAST PRE MAX SYST PRE MIN SYST PRE MAX HEART R. • HEART R.5. • HEART R. • SYST PRE MAX– Maximum threshold of the range of values within which the systolic pressure must fall. • SAMPLE INTERV. MIN HEART R. in the BPM view. systolic pressure or heart rate measurement is outside the minimum or maximum thresholds. Rev. B . in this manual. ultrafiltration rate and final conductivity value can be set so that they follow a predetermined curve during the dialysis treatment in progress.PROFILE 5. Each configured Profile curve can be stored in the machine’s memory as a global Profile curve or it can be stored in the Patient/Rx Action keys as an individualized Profile curve. (Rx Config/PROFILE/UF and Rx Config/PROFILE/COND).D SECTION 5. (Refer to Section 05 – Dialysis Operation. By selecting a Patient/Rx Action key the pre-programmed Profile that was stored in that Patient/Rx Action key will be activated. By setting the curve type to STEP or to PROGRESSIVE the parameters for conductivity and ultrafiltration may be varied during the treatment following a predetermined profile. SECTION 5.D .D-1 5. Each of the Patient Action keys can be programmed in the CONFIGURATION view to different profiles or to different combinations of profiles.e.D . depending on the values set for the CURVE TYPE parameter. (Config/PROFILE/UF and Config/PROFILE/Cond. the Standard Dialysis Mode may be programmed with or without profiling. Rev.1 Introduction In order to make the dialysis treatment more effective. for a detailed description of the Patient/Rx Dialysis). Depending on the values set for the CURVE TYPE parameter in the CONFIGURATION view. in this section. for the description of how to set the CURVE TYPE parameter). (See “5.1 CURVE TYPE Setting”.PROFILE 5. Three curve types can be set for each parameter: • CONSTANT • STEP • PROGRESSIVE The CONSTANT curve type corresponds to a Dialysis Mode with Profiling not enabled: i. That can be done by entering the PROFILE environment.D.D.D PROFILE 5. B .1. ultrafiltration rate and/or conductivity and all the relevant parameters are constant during the patient treatment. 5. The background colour of the entry field will change from gray to yellow and a new view will appear where the three possible selections for the parameter are available: CONSTANT. Select the desired value and then press the CONFIRM button to accept the modified value. press the SET button to allow access to the view where it is possible to modify the parameter value. IN CONFIGURATION (in Idle phase) Press Config/PROFILE/UF and Config/PROFILE/Cond to gain access to the global profile parameters both for ultrafiltration rate and for final conductivity. In each view. Press Rx Config/PROFILE/UF and Rx Config/PROFILE/COND to gain access to the individualized (Patient/Rx) profile parameters. Press the SET button to exit this view.4 Kg/h 20% CONFIG PROFILE UF COND Press the CURVE TYPE Parameter Box. the profile will change to represent the new value entered.00 ULTRAFILTRATION 3. Rev.1 CURVE TYPE Setting The CURVE TYPE parameter can be set both in Configuration (Idle phase) and during Dialysis.D-2 PHOENIX OPERATOR MANUAL 5. below is an example of Config\PROFILE\UF view: 12:30 Kg/h Kg/h 4.00 2. both for ultrafiltration rate and for final conductivity.00 0:00 1:00 2:00 3:00 4:00 h:min h:min CURVE TYPE TOT WEIGHT L INITIAL VALUE CURVE COEFF PROGRESSIVE 4Kg 1.D.1. STEP. B .00 0.00 1. Changes to the CURVE TYPE parameter made in the CONFIGURATION view are retained in the machine‘s memory. PROGRESSIVE. If the CURVE TYPE parameter and/or the CON CURVE TYPE parameter are set to STEP or PROGRESSIVE the PAT CONNECT Action key will not appear until the profiles have been activated. An operator’s message is displayed at the end of the priming phase stating that Profiling must be activated to make the PAT CONNECT Action key available: The Profiling Mode has been selected Please activate Profiling to get PAT CONNECT Rev. i. they only remain until the end of the current dialysis treatment. Changes to the CURVE TYPE parameter made in those pages are only temporary. Select ACTIVATE UF RATE CURVE and/or ACTIVATE CONDUCT. B . CURVE in the PROFILE view to activate profiles.D-3 STARTING FROM PREPARATION Press PROFILE/UF and PROFILE/Cond Navigation key to gain access to the global profile parameters both for ultrafiltration rate and for final conductivity. The CURVE TYPE parameter value. both for ultrafiltration rate and for final conductivity.e. SECTION 5. Follow the same procedure described above for the CONFIGURATION view.D . can be changed until the PAT CONNECT Action key selection.PROFILE 5. 2 Dialysis Mode with Profiling not enabled If the CURVE TYPE or/and the CON CURVE TYPE parameter is/are set to CONSTANT. the ACTIVATE UF RATE CURVE Action key is not available in the PROFILE view. 5.800 Kg/h 2. Rev. 12:30 -.6 mS/cm 14.00 1. When the CON CURVE TYPE parameter is set to CONSTANT.2.D.00 TOTAL FLUID REMOVED 0.0 PUMP SPEED 0:00 1:00 2:00 3:00 4:00 Time h:min PROFILE UF COND Note When the CURVE TYPE parameter is set to CONSTANT.0 13.0 CONSTANT 15. B ./ ---mmHg --./ ----.0 CONDUCTIVITY 14.00 CURVE TYPE CONSTANT 3. changes to the UFR or/and CONDUCTIVITY value(s) can be done only by an operator intervention.00 UFR 1.000 Kg Kg/h ULTRAFILTRATION 4. pu/min DIALYSIS TIME 04:00 h:min TOT WEIGHT L 4.1 Display UFR and Conductivity graph in Dialysis Mode with Profiling not enabled When selecting PROFILE Navigation key the following view appears.D-4 PHOENIX OPERATOR MANUAL 5.5.0 CON CURVE BLOOD FLOW TYPE 16.00 1.D. CURVE Action key is not available in the PROFILE view. the ACTIVATE CONDUCT.800 Kg/h 0:00 1:00 2:00 3:00 4:00 VEN ART Time h:min mS/cm CONDUCTIVITY 17. Press any Navigation key to exit from this view.4 1.00 1.00 0:00 1:00 2:00 3:00 4:00 BLOOD FLOW Time h:min CURVE TYPE CONSTANT e f PUMP SPEED Time Clock Time UF R Curr 01:90 12:30 1. do not press simultaneously the two Function Bar Arrows. pu/min ULTRAFILTRATION Kg/h 4. Rev. Note The Auto-Repeat feature is active on the Function Bar Arrows: pressing and holding the arrows for more than 2 seconds allows the green cursor to move more quickly on the graph. SECTION 5.4 PROFILE UF COND Note When the CURVE TYPE parameter is set to CONSTANT./ -. Entering the PROFILE\UF view a green cursor is positioned on the current UFR value.00 3.D .D-5 • UF view When selecting PROFILE\UF the following view appears. B . Pressing the Function Bar Arrows (positioned on the lower part of the window) moves the position of the green cursor on the UF Profile graph. The red curve on the graph represents the last value set for the UFR parameter./ --mmHg --.00 VEN ART 0. Note To prevent problems in the Profile graph visualization. Both the UFR value set and the achieved UFR values are displayed in the Parameter Area. The Function Bar displays the following values at the point in time at which the green cursor is positioned on the graph: • The time into treatment (Time) • The clock time (Clock Time) • The last value set for the UFR parameter (UFR) • The UFR current value (Curr) for the point in time at which the green cursor is positioned on the graph (Time). --.00 2. while the yellow curve represents the achieved UFR values.PROFILE 5. 12:30 -. changes to the UFR and TOT WEIGHT L parameter values can be made only from the Home view in Set mode. Both the configured Conductivity Profile and the achieved Conductivity values are displayed in the Parameter Area.5 mS/cm Ionic Mass Bal nmol e f PUMP SPEED Time Clock Time Cond Curr 02:00 12:30 14.0 16. Rev. the following view appears. while the yellow curve represents the achieved CONDUCTIVITY values.D-6 PHOENIX OPERATOR MANUAL • COND Profile When selecting PROFILE\Cond. 13. Pressing the Function Bar Arrows (positioned on the lower part of the window) moves the position of the green cursor on the Conductivity Profile graph. changes to the CONDUCTIVITY parameter value can be made only from the Home view in Set mode./ ---mmHg --. pu/min mS/cm CONDUCTIVITY 17. do not press simultaneously the two Function Bar Arrows. The Function Bar displays the following values at the point in time at which the green cursor is positioned on the graph: • The time into treatment (Time) • The clock time (Clock Time) • The last value set for the CONDUCTIVITY parameter (CON) • The CONDUCTIVITY current value (Curr) for the point in time at which the green cursor is positioned on the graph (Time). 12:30 -./ -- --. Entering the PROFILE\Cond view a green cursor is positioned on the current Conductivity value.5 14. Note The Auto-Repeat feature is active on the Function Bar Arrows: pressing and holding the arrows for more than 2 seconds allows the green cursor to move more quickly on the graph. Note To prevent problems in the Profile graph visualization. B .0 VEN ART 0:00 1:00 2:00 3:00 4:00 Time h:min BLOOD FLOW CON CURVE TYPE CONSTANT Plasma Conduct.0 15.5 PROFILE UF CON Note When the CON CURVE TYPE parameter is set to CONSTANT.0 13. The red curve on the graph represents the last value set for the CONDUCTIVITY parameter.5.0 14. Press any Navigation key to exit from this view. B . • by pressing the SET button in the Config\PROFILE view or in the Rx Config\PROFILE view for Patient/Rx Dialysis. The value set for the DIALYSIS TIME parameter in the HOME view is automatically displayed in the PROFILE view and vice versa. 5.D. (See Section 5.2 DIALYSIS TIME Setting When both the CURVE TYPE and CON CURVE TYPE parameters are set to CONSTANT. Rev. Note Change of the DIALYSIS TIME parameter during DIALYSIS affects only the current treatment.E – Monitoring. SECTION 5.D-7 The PLASMA CONDUCTIVITY and IONIC MASS BALANCE values are displayed only if the DiascanTMMonitoring System is active and a Clearance measurement has been taken. for a detailed description of these parameters). • by pressing the SET button in the PROFILE view. Changes to the DIALYSIS TIME parameter during Idle phase are stored in the machine’s memory.2.D . Note Change of the DIALYSIS TIME parameter affects both the UFR and Conductivity graphs in the PROFILEview. When one of the two parameters CURVE TYPE and CON CURVE TYPE is not set to CONSTANT.PROFILE 5. STARTING FROM PREPARATION: • by pressing the SET button in the Home view. in this manual. the DIALYSIS TIME parameter can be changed: IN CONFIGURATION (in Idle phase): • by pressing the SET button in the Config\Treatments\Std Dialys view or in the Rx Config\Rx Data view for Patient/Rx Dialysis. the DIALYSIS TIME parameter can be changed: IN CONFIGURATION (in Idle phase): • by pressing the SET button in the Config\Treatments\Std Dialys view or in the Rx Config\Rx Data view for Patient/Rx Dialysis. 5. Note Changes of the DIALYSIS TIME parameter during Idle phase are stored in the machine’s memory. In PATIENT/RX DIALYSIS: In Patient/Rx Dialysis. The treatment time and the profile time automatically become the same. After deactivating both UF and CON Profiling curve: • by pressing the SET button in the Home view.D-8 PHOENIX OPERATOR MANUAL In STANDARD DIALYSIS: When the Dialysate Selection key is pressed in the SELECT DIALYSATE view. the DIALYSIS TIME parameter in the Config/PROFILE view is automatically changed to the time set in the Config/Treatments/Std Dialys view. The value set for the DIALYSIS TIME parameter in the HOME view and the DIALYSIS TIME in the PROFILE view automatically are changed to the same time. The treatment time and the profile time automatically become the same. STARTING FROM PREPARATION: DIALYSIS TIME may be changed before activating UF and/or CON Profiling curve: • by pressing the SET button in the Home view. After deactivating either the UF or the CON Profiling curve and one curve remains active: • by pressing the SET button in the PROFILE view. B . the value set for the DIALYSIS TIME parameter in the Rx Config\PROFILE view is automatically displayed in the Rx Config\Rx Data view and vice versa. After activating UF and/or CON Profiling curve: • by pressing the SET button in the PROFILE view. • by pressing the SET button in the PROFILE view. Rev. Note Change of the DIALYSIS TIME parameter affects both the UFR and Conductivity graphs in the PROFILE view. WARNING It is the responsibility of the operator to check that the numerical values that represent the Profile (on the bottom of the graph) correspond to the values in the graph. B .e. definition of the profile curve. Rev. i.3 Profiled Dialysis Mode 5. The Configuration phase is accessible from the CONFIG menu when the machine is in IDLE Mode. SECTION 5.1 General A Profiled Dialysis can be divided into two different phases: • Configuration phase. Note There are only two Profiles configured in the CONFIG menu for both conductivity and ultrafiltration (default Profiles configured by the Manufacturer): a Global Profile and a Patient/Rx Profile. • Activation phase. accessible from the PROFILE view.D.D .D. the Profile attributes can be changed (except during the last 15 minutes of DIALYSIS) and the profile curves can be activated and deactivated.PROFILE 5.D-9 5.3. In the Activation phase. i.00 1.00 UFR 0. Refer to Section 02 – Configuration Description.0 PUMP SPEED 13.00 TOTAL FLUID REMOVED 0.2 Entering the PROFILE View IN CONFIGURATION (in Idle phase) Press Config/PROFILE/UF or Config/PROFILE/Cond to gain access to the global profile parameters.0 CONDUCTIVITY 15. DURING DIALYSIS Select the PROFILE Navigation key to gain access to the profile parameters configured in the machine’s memory./ --. in this manual.0 0. for a detailed description of the configuration environment. pu/min DIALYSIS TIME 04:00 h:min TOT WEIGHT L 4. Thus any changes made cannot be saved in memory.D-10 PHOENIX OPERATOR MANUAL 5.000 Kg ACTIVATION Kg/h ULTRAFILTRATION CURVE TYPE UF RATE CURVE 4. Changes to the profiles parameters made in those pages are retained in the machine‘s memory.5. CURVE BLOOD FLOW 17.D.00 0.mmHg --. Rev. B ./ -- --.3.000 Kg/h VEN ART 0:00 1:00 2:00 3:00 4:00 ACTIVATION Time h:min mS/cm CONDUCTIVITY CONDUCT.e. Press Rx Config/PROFILE/UF or Rx Config/PROFILE/COND to gain access to the Patient/Rx profile parameters. below is an example of PROFILE view with Progressive curves: 12:30 -.0 0:00 1:00 2:00 3:00 4:00 Time h:min PROFILE UF COND Changes to the profiles parameters made from the Profile views are only temporary.00 PROGRESSIVE 3.000 Kg/h 2. they only remain until the end of the current dialysis treatment.0 CON CURVE TYPE PROGRESSIVE 16.0 mS/cm 14. D . This parameter can range from 20 % to 80 % DIALYSIS TIME: Length of the dialysis treatment. B . Set on the PROFILE view or in the Config\PROFILE view or in the Rx Config\PROFILE view.3 Progressive Curve Profiles This type of Profile allows programming the Ultrafiltration Rate and the Conductivity value so that. they follow a predetermined. during the dialysis treatment. 5.D-11 5.3. SECTION 5.1 Conductivity Progressive Curve Profiles: parameters explanation A conductivity profile may be established in the machine’s memory on the Config\PROFILE\Cond view or in the Rx Config\PROFILE\COND view. A conductivity profile may be configured for the current treatment in the PROFILE\Cond view: INITIAL VALUE: Initial value of Conductivity FINAL VALUE: Final value of Conductivity CURVE COEFF: coefficient of the curvature of the progressive curve. If a Conductivity Progressive curve is set with: INITIAL VALUE= 17 FINAL VALUE= 14 DIALYSIS TIME= 4 h:min CURVE COEFF= 50 % The following graph is shown: 17 mS/cm CURVE COEFFICIENT= 50 % INITIAL VALUE = 17 FINAL VALUE = 14 13 mS/cm 4 h:min Rev.PROFILE 5.3. continuous progressive graph.D.3.D. 2 Ultrafiltration Rate Progressive Curve Profiles: parameters explanation An Ultrafiltration Rate Profile may be established in the machine’s memory in the Config\PROFILE\UF view or in the Rx Config\PROFILE\COND view. INITIAL VALUE: Initial value of the Ultrafiltration Rate.5. creates the curve as follows: 17 mS/cm CURVE COEFFICIENT = 65% INITIAL VALUE = 17 FINAL VALUE = 14 13 mS/cm 4 h:min The greater the value for the CURVE COEFF (max 80%). the profile curve will have a concave shape. This parameter can range from 20% to 80% DIALYSIS TIME: Length of dialysis treatment. as shown below: CURVE COEFFICIENT= 17 mS/cm 35% INITIAL VALUE = 17 FINAL VALUE = 14 13 mS/cm 4 h:min 5. A conductivity profile may be configured for the current treatment in the PROFILE\UF view: TOT WEIGHT L: Target Weight Loss (instead of FINAL VALUE). CURVE COEFF: coefficient of the curvature of the progressive curve. the more convex the profile curve will become.D-12 PHOENIX OPERATOR MANUAL Increasing the CURVE COEFF.3. Rev. Set on the PROFILE view or in the Config\PROFILE view or in the Rx Config\PROFILE view.3. B .D. If the CURVE COEFF has a value less than 50%. The methods of inserting the UFR parameters are the same as those illustrated for the Conductivity parameters. An UFR profile may be configured for the current treatment in the PROFILE\UF view. An Ultrafiltration Rate Progressive Profile may be established in the machine’s memory in the Config\PROFILE\UF view or in the Rx Config\PROFILE \UF view. below is an example of Config\PROFILE\UF view: 12:30 Kg/h Kg/h 4. B .00 1.00 ULTRAFILTRATION 3.D-13 5.3 Programming the Progressive Curve WARNING The physician is responsible for ensuring that the chosen profiles are appropriate for the patient being treated.3.D.3.PROFILE 5. Press the SET button to allow access to a view where it is possible to modify the profile attributes.00 0:00 1:00 2:00 3:00 4:00 h:min h:min CURVE TYPE TOT WEIGHT L INITIAL VALUE CURVE COEFF PROGRESSIVE 4Kg 1.4 Kg/h 20% CONFIG PROFILE UF COND Rev.00 0.D . SECTION 5.00 2. 00 1.5 mS/cm 20% CONFIG PROFILE UF COND Both for UFR and Conductivity profiles: • Press the Parameter Box to be changed on the Touch Screen. • To change a parameter with a numeric value.00 0.00 CONDUCTIVITY 3. The modified profile is displayed in the “Parameter area”. • To change a parameter with a string value. the profile will change to represent the new value entered.0 mS/cm 13. • Press the SET button to return to the view where the profile is displayed.D-14 PHOENIX OPERATOR MANUAL A Conductivity Progressive Profile may be established in the machine’s memory in the Config\PROFILE\Cond view or in the Rx Config\PROFILE\COND view. If another parameter is selected and changed before pressing the CONFIRM button. Press the SET button to allow access to a view where it is possible to modify the profile attributes. another view will appear with the possible selections for that parameter. after touching the parameter box area. only the last change is retained in memory.00 2. Select the desired value.00 0:00 1:00 2:00 3:00 4:00 h:min h:min CON CURVE TYPE INITIAL VALUE FINAL VALUE CURVE COEFF PROGRESSIVE 15. A Conductivity profile may be configured for the current treatment in the PROFILE\Cond view. The background colour of the entry field will change from gray to yellow. press the PLUS or MINUS buttons on the Main Control Panel.5. B . • Press the CONFIRM button to accept the modified value. Rev. below is an example of Config\PROFILE\Cond view: 12:30 Kg/h Kg/h 4. 00 0:00 1:00 2:00 Time 3:00 h:min 4:00 3 4 TIME UF R 0:00 1.7 Kg/h CONFIG PROFILE UF COND TOT WEIGHT L: Target Weight Loss.D.PROFILE 5. An Ultrafiltration Rate Step Profile may be configured for the current treatment in the PROFILE\UF view. B . Below is an example of Config\PROFILE\UF view in Set mode: 12:30 Kg/h STEP UF RATE 4. SECTION 5.00 0.4 Step Curve Profiles This type of Profile allows the Ultrafiltration Rate and the Final Conductivity value to be programmed in 15 minute intervals of treatment time.3.00 1.D. The Ultrafiltration Rate Step Curve is programmed by selecting and setting each step (15 minute segment) of the treatment.00 2. Rev. STEP UFR: UFR value for the selected step (a 15 minute segment of the treatment).D . The selected step is red highlighted. WARNING The physician is responsible for ensuring that the chosen profiles are appropriate for the patient being treated.00 3.1 Ultrafiltration Rate Step Curve Profiles An Ultrafiltration Rate Step Profile may be established in the machine’s memory in the Config\PROFILE\UF view or in the Rx Config\PROFILE\UF view.4. all the other steps are yellow highlighted.3.7 CURVE TYPE TOT WEIGHT L STEP UFR STEP 4 Kg 1.D-15 5. DIALYSIS TIME: Length of dialysis treatment. 5. Set on the PROFILE view or in the Config\PROFILE view or in the Rx Config\PROFILE view. B . The Conductivity Step Curve is programmed by selecting and setting each step (15 minute segment) of the treatment. all the other steps are yellow highlighted.0 0:00 1:00 2:00 Time 3:00 4:00 h:min 3 4 TIME COND 0:00 14. Set on the PROFILE view or in the Config\PROFILE view or in the Rx Config\PROFILE view. Rev. A Conductivity Step Profile may be configured for the current treatment in the PROFILE\Cond view.0 13. DIALYSIS TIME: Length of dialysis treatment.0 14.3. Below is an example of Config\PROFILE\Cond view in Set mode: 12:30 mS/cm STEP COND 17.4.D.0 15.2 Conductivity Step Curve Profiles A Conductivity Step Profile may be established in the machine’s memory in the Config\PROFILE\Cond view or in the Rx Config\PROFILE\COND view.7 CON CURVE TYPE COND STEP STEP 14.7 mS/cm CONFIG PROFILE UF COND COND STEP: Conductivity value for the step (a 15 minute segment of the treatment). The selected step is red highlighted.0 16.5.D-16 PHOENIX OPERATOR MANUAL 5. it is possible to change the UFR value for the selected 15 minute Step. Note In Config\PROFILE. for the selected step. SECTION 5. also results in a change to the TOT WEIGHT L. Changing the UFR value. to move the red highlighted area to the right or to the left. press the Function Bar Arrows (located just below the graph). B . as desired. it is possible to change the Conductivity value for the selected 15 minute Step. Similarly. The Starting Time and the UFR value/Conductivity value for the red highlighted bar is displayed. after a Step has been programmed. while the TOT WEIGHT L remains constant.PROFILE 5. The bar that is red highlighted is the current selection.D-17 5. By pressing the CONFIRM button.4.3.D . Changing the DIALYSIS TIME value results in a change to the UF Rate.D. By selecting the STEP UFR Parameter Box on the PROFILE\UF or Config\PROFILE\UF view or in the Rx Config\PROFILE\UF view. by pressing the COND STEP Parameter Box on the PROFILE\Cond or Config\PROFILE\Cond view. which is automatically updated. which is automatically updated.3 Programming the Step Curve To select each bar (a 15 minute segment of the treatment) on the Step curve. Rev. the following Step is automatically selected. that Step is programmed to the previously confirmed UF R/Cond value. • by pressing the SET button in the PROFILE view. DIALYSIS TIME The DIALYSIS TIME parameter can be changed: IN CONFIGURATION (in Idle phase): • by pressing the SET button in the Config\Treatments\Std Dialys view or in the Rx Config\Rx Data view for Patient/Rx Dialysis. The treatment time and the profile time automatically become the same. After selecting ACTIVATION UF RATE CURVE Action key or/and ACTIVATION CONDUCT. B . CURVE Action key: • by pressing the SET button in the PROFILE view. In STANDARD DIALYSIS: When the Dialysate Selection key is pressed in the SELECT DIALYSATE view the DIALYSIS TIME parameter in the Config/PROFILE view is automatically changed to the time set in the Config/Treatments/Std Dialys view. The value set for the DIALYSIS TIME parameter in the HOME view and the DIALYSIS TIME parameter in the PROFILE view automatically are changed to the same time. CURVE Action key: • by pressing the SET button in the Home view. After deselecting both the ACTIVATION UF RATE CURVE Action key and the ACTIVATION CONDUCT. Note Changes of the DIALYSIS TIME parameter during Idle phase are stored in the machine’s memory. CURVE Action key deselection: • by pressing the SET button in the Home view.5 Modify Profile Parameters Note None of the profile parameters can be changed in the last 15 minutes of DIALYSIS.D.3. In PATIENT/RX DIALYSIS: In Patient/Rx Dialysis. • by pressing the SET button in the Config\PROFILE view or in the Rx Config\PROFILE view for Patient/Rx Dialysis. Rev. STARTING FROM PREPARATION: DIALYSIS TIME may be changed before selecting ACTIVATION UF RATE CURVE Action key or/and ACTIVATE CONDUCT.5. The dialysis time and profile time automatically become the same. the value set for the DIALYSIS TIME parameter in the Rx Config\PROFILE view is automatically displayed in the Rx Config\Rx Data view and vice versa.D-18 PHOENIX OPERATOR MANUAL 5. Change of the TOT WEIGHT L parameter during DIALYSIS effects only the current treatment. the updated TOT WEIGHT L parameter value is not displayed in the Home view until the selection of the DIALYSIS Action key. Note Change of the DIALYSIS TIME parameter affects both the UFR and Conductivity profiles. SECTION 5. After ACTIVATION UF RATE CURVE Action key deselection: • by pressing the SET button in the Home view.D . After ACTIVATION UF RATE CURVE Action key selection: • by pressing the SET button in the PROFILE\UF view. the UFR measurements will not be recorded by the machine and the UFR Profile graph will not display correct UFR values. STARTING FROM PREPARATION: Before ACTIVATION UF RATE CURVE Action key selection: • by pressing the SET button in the PROFILE\UF view. Note Change of the DIALYSIS TIME parameter during DIALYSIS affects only the current treatment. Note The minimum DIALYSIS TIME that may be set in the PROFILE view is 30 minutes. Connect phase. B . the PAT CONNECT Action Key will not appear until the TOT WEIGHT L parameter value is confirmed in the PROFILE/UF view.D-19 After deselecting either the ACTIVATION UF RATE CURVE or the ACTIVATION CONDUCT. the TOT WEIGHT L parameter can be changed: IN CONFIGURATION (in Idle phase): • by pressing the SET button in the Config\PROFILE view or in the Rx Config\PROFILE view for Patient (Rx) Dialysis. Note If the DIALYSIS TIME parameter value is decreased below the treatment time already elapsed. Note After UFR profile activation. Note After UFR profile activation. Rev. if the TOT WEIGHT L parameter is changed during the Pt.PROFILE 5. Note Changes of the TOT WEIGHT L parameter during Idle phase are stored in the machine’s memory. CURVE and one of the curves remains active: • by pressing the SET button in the PROFILE view. TOT WEIGHT L When the CURVE TYPE is set to STEP or to PROGRESSIVE. B . STARTING FROM PREPARATION: Before and after profiles activation and during the time profiles remain activated: • by pressing the SET button in the PROFILE\UF or in the PROFILE\Cond view. Note After the DIALYSIS Action key selection. Those parameters become available in the Home view.3.3 Progressive Curve Profiles” and “5. (See “5. depending on the parameter. FINAL VALUE (COND). none of the relevant parameters are available in the PROFILE view for the deactivated profile. depending on the parameter.3. INITIAL VALUE (UFR). CURVE COEFF (COND).D-20 PHOENIX OPERATOR MANUAL INITIAL VALUE (COND). (UFR). Rev.5. when a profile is deactivated. CURVE COEFF (COND). COND STEP and STEP UFR parameters can be changed: IN CONFIGURATION (in Idle phase): • by pressing the SET button in the Config\PROFILE\UF view or in the Config\PROFILE\Cond view. INITIAL VALUE (UFR). CURVE COEFF.D. COND STEP and STEP UFR The INITIAL VALUE (COND). for Patient /Rx Dialysis. • in the Rx Config\PROFILE\UF view or in the Rx Config\PROFILE\COND view. depending on the parameter. Note Change of those parameters during DIALYSIS effects only the current treatment. FINAL VALUE (COND). Note Changes of those parameters during Idle phase are stored in the machine’s memory.D. CURVE COEFF (UFR).4 Step Curve Profiles” for a detailed description of the profile parameters). 0 PUMP SPEED 0:00 1:00 2:00 3:00 4:00 Time h:min PROFILE UF COND Note The ACTIVATION UF RATE CURVE Action key is available only if the CURVE TYPE parameter is set to STEP or to PROGRESSIVE.00 CURVE TYPE UF RATE CURVE PROGRESSIVE 3./ -- --.6 Activation of Profile Activation of UFR or CONDUCTIVITY Profile Press the PROFILE Navigation key to access the PROFILE view: 12:30 -.000 Kg ACTIVATION Kg/h ULTRAFILTRATION 4.0 13. Note The ACTIVATION UF RATE CURVE Action key and the ACTIVATION CONDUCT. SECTION 5.000 Kg/h 0:00 1:00 2:00 3:00 4:00 VEN ART ACTIVATION Time h:min mS/cm CONDUCTIVITY CON CURVE TYPE CONDUCT. PROFILE must be activated (selection of the ACTIVATION UF RATE CURVE Action key or/and of the ACTIVATION CONDUCT. pu/min DIALYSIS TIME 04:00 h:min TOT WEIGHT L 4.00 0. press the ACTIVATION UF RATE CURVE and/or the ACTIVATION CONDUCT.D . The Action keys are highlighted when profile is activated and the PROFILE icon appears in the Icon Bar on the left side of the Touch Screen.PROFILE 5.3.0 CONDUCTIVITY 15. CURVE 17. CURVE Action key is available only if the CON CURVE TYPE parameter is set to STEP or to PROGRESSIVE.00 REMOVED 0.D-21 5.000 Kg/h 2.D.00 UFR 0.0 BLOOD FLOW PROGRESSIVE 16.0 0. CURVE Action key) before patient connection phase in order to make the PAT CONNECT Action key available.00 TOTAL FLUID 1. CURVE Action key are not available in the treatment phase between the PAT CONNECT Action key selection and the following DIALYSIS Action key selection. Rev.0 mS/cm 14. To activate PROFILE./ ---mmHg --. The ACTIVATION CONDUCT. B . CURVE Action keys. in this section. B . the END DIALYSIS parameter can not be modified. Connect phase. The END DIALYSIS parameter becomes available again at Profiling deactivation (See “5. Note When Profiling is active. the CONDUCTIVITY parameter value is not modifiable from the HOME view in Set mode. If the new CURVE TYPE parameter value is STEP or PROGRESSIVE. When CONDUCTIVITY Profile is activated. Before activating Profiling ensure the END DIALYSIS parameter is correctly set for the current dialysis prescription.8 Deactivation of Profiling”. a change of the CURVE TYPE parameter value will automatically deactivate PROFILE. If the new CURVE TYPE parameter value is CONSTANT. for the description of a detailed description of Profiling deactivation conditions). the action key must be activated again for that PROFILE.3.D. CURVE Action key is/are no longer available.D-22 PHOENIX OPERATOR MANUAL Once PROFILE has been activated. the ACTIVATION UF RATE CURVE Action key or/and the ACTIVATION CONDUCT. the updated TOT WEIGHT L parameter value is not displayed in the Home view until the selection of the DIALYSIS Action key. if the TOT WEIGHT L parameter is changed during the Pt. the UFR parameter value is not modifiable from the HOME view in Set mode. Note After UFR profile activation. Note When UFR Profile is activated. Rev.5. CURVE are available to deactivate Profile for a parameter.000 Kg/h 0:00 1:00 2:00 3:00 4:00 ART VEN Time h:min ACTIVATION mS/cm CONDUCTIVITY 17. the following superimposed window will appear: Compensation has been request.00 1. SECTION 5. can be changed. Upon pressing the CONFIRM button. The COMPENSATION Action key is displayed only if there is a “Error On Total Weight Loss” #60 alarm (difference between theoretical and actual Fluid Removed > 100 grams).00 TOTAL FLUID REMOVED 0. Rev.000 Kg ACTIVATION Kg/h ULTRAFILTRATION 4. CURVE TYPE BLOOD FLOW 16.00 0.0 mS/cm 14.0 CON CURVE CONDUCT.PROFILE 5.00 CURVE TYPE UF RATE CURVE PROGRESSIVE 3. both PROGRESSIVE and STEP.00 UFR COMPENSATION 0.0 CONDUCTIVITY 15. the following view is displayed. It may be displayed at any time during the dialysis treatment except in the last 30 minutes.0 13. When selecting the PROFILE Navigation key. Press ENTER To Confirm.. In addition to the COMPENSATION Action key.0 0.000 Kg/h 2.D . only the remaining part of the curve. B .3. When pressing the COMPENSATION Action key. 12:30 TREATMENT DIALYSIS TIME 04:00 h:min TOT WEIGHT L 4.7 Profile during Dialysis Once the DIALYSIS Action key has been selected.D-23 5.D. an icon is also displayed which represents whether the FLUID REMOVAL ERROR is in the positive or in the negative direction.0 0:00 1:00 2:00 3:00 4:00 PUMP SPEED Time h:min PROFILE UF COND The ACTIVATION UF RATE CURVE and ACTIVATION CONDUCT. a new curve is confirmed and used for the remainder of the DIALYSIS treatment. deactivate PROFILING. the following operator’s message is displayed: The Profiling Mode Cannot Continue Deactivate it and Continue in STD Mode To proceed with the dialysis treatment. Rev. B .D-24 PHOENIX OPERATOR MANUAL If the “Error On Total Weight Loss” #60 alarm appears in the last 30 minutes of dialysis treatment or if the alarm has not been cleared before the COMPENSATION Action key disappears (last 30 minutes of dialysis treatment).5. D . Note To prevent problems in the Profile graph visualization./ --. An example of Progressive UF profile is displayed: 12:30 -.00 1. --. Rev.00 0:00 1:00 2:00 3:00 4:00 BLOOD FLOW Time h:min CURVE TYPE PROGRESSIVE INITIAL VALUE 1.3.00 2./ -.00 VEN ART 0. Note The Auto-Repeat feature is active on the Function Bar Arrows: pressing and holding the arrows for more than 2 seconds allows the green cursor to move more quickly on the graph.00 3.5 0. SECTION 5. Pressing the Function Bar Arrows (positioned on the lower part of the window) moves the position of the green cursor on the UF Profile graph. pu/min ULTRAFILTRATION Kg/h 4.D-25 5.7.000 Kg/h CURVE COEFF 20% e f PUMP SPEED Time ClkTime UF R Curr 02:00 12:30 1.mmHg --. do not press simultaneously the two Function Bar Arrows.D. Entering the PROFILE\UF view a green cursor is positioned on the current UFR value.9 PROFILE UF COND WARNING It is the responsibility of the operator to check that the numerical values that represent the Profile (on the bottom of the graph) correspond to the values in the graph.500 Kg/h TOT WEIGHT L 4. B .PROFILE 5.1 Display Profile during DIALYSIS • UF Profile When selecting PROFILE\UF the following view appears. Both the configured UFR Profile and the achieved UFR values are displayed in the Parameter Area. The red curve on the graph represents the configured UFR Profile while the yellow curve represents the achieved UFR values. a view is displayed where the profile attributes can be modified. B . Press any Navigation key to exit from this view.D-26 PHOENIX OPERATOR MANUAL The Function Bar displays the following values at the point in time at which the green cursor is positioned on the graph: • The time into treatment (Time) • The clock time (ClkTime) • The UF rate programmed value (UF R) • The UF rate current value (Curr) for the point in time at which the green cursor is positioned on the graph (Time). Rev. By pressing the SET button.5. SECTION 5.7 mS/cm Plasma Conduct.0 14. Rev.PROFILE 5.0 VEN ART 0:00 1:00 2:00 3:00 4:00 Time h:min BLOOD FLOW CON CURVE TYPE PROGRESSIVE INITIAL VALUE 16. The red curve on the graph represents the configured Conductivity Profile while the yellow curve represents the achieved Conductivity values. Note To prevent problems in the Profile graph visualization. Pressing the Function Bar Arrows (positioned on the lower part of the window) moves the position of the green cursor on the Conductivity Profile graph. B ./ -- --.0 16. the following view appears. Note The Auto-Repeat feature is active on the Function Bar Arrows: pressing and holding the arrows for more than 2 seconds allows the green cursor to move more quickly on the graph.0 15.0 13./ ---mmHg --.5 mS/cm FINAL VALUE 14.5 PROFILE UF COND WARNING It is the responsibility of the operator to check that the numerical values that represent the Profile (on the bottom of the graph) correspond to the values in the graph.D . 13. An example of a Progressive Conductivity Profile is displayed: 12:30 -. Entering the PROFILE\Cond view a green cursor is positioned on the current Conductivity value. Both the configured Conductivity Profile and the achieved Conductivity values are displayed in the Parameter Area.0 14.4 mS/cm Ionic Mass Bal nmol CURVE COEFF 25% e f PUMP SPEED Time ClkTime Cond Curr 02:00 12:30 14.D-27 • COND Profile When selecting PROFILE\Cond. pu/min mS/cm CONDUCTIVITY 17. do not press simultaneously the two Function Bar Arrows. a view where the profile attributes can be modified is accessed. The Plasma Conduct and Ionic Mass Bal values are displayed only if the DiascanTMMonitoring System is active and a Clearance measurement has been taken. in this manual.5. Press any Navigation key to exit from this view.E – Monitoring. Rev. B . By pressing the SET button.D-28 PHOENIX OPERATOR MANUAL The Function Bar displays the following values at the point in time at which the green cursor is positioned on the graph: • The time into treatment (Time) • The clock time (ClkTime) • The Conductivity programmed value (Cond) • The Conductivity current value (Curr) for the point in time at which the green cursor is positioned on the graph (Time). (See Section 5. for a detailed description of these parameters). PROFILE 5. the first changeable Step on the Profile is the Step after the current Step. B .D-29 5.3 Profile during WASHBACK WASHBACK may be carried out without discontinuing Profiling. No modifications in a Progressive Curve are allowed in the last 15 min. of DIALYSIS. SECTION 5.D. 5.e. Thus the modification will only affect the remaining portion of the Profile. the INITIAL VALUE represents the first changeable point on the Profile after the current actual value. Thus the modification will only affect the remaining portion of the Profile.3. No modifications in a Step Curve are allowed in the last Step of DIALYSIS.7. Step curve When a change in a Step Curve is required during DIALYSIS. Rev. i.3. the next 15 minute Step.e.7. i.2 Modification of a Curve during DIALYSIS Progressive Curve shapes When a change in a Progressive Curve is required during DIALYSIS. at the next the 5 minute point.D.D . the Protection System continuously checks the accuracy of the activated profiles. Use -/+ button to modify UF R Press CONFIRM to discontinue UF Profiling. Profile deactivated cannot be re-activated for the current dialysis treatment. Rev. Use -/+ button to modify Conductivity.D-30 PHOENIX OPERATOR MANUAL 5. Then press the ACTIVATION UF RATE CURVE and/or the ACTIVATION CONDUCT.8 Deactivation of Profiling Deactivation by Operator request To deactivate PROFILE for a parameter. B . it is not possible to re-activate it for the current dialysis treatment. Deactivation requested by the Protection System During DIALYSIS. Press CONFIRM to discontinue Conductivity Profiling.D. the PROFILE view must be accessed.3. relative to the current value and the timing. the “! Conductivity Profile” #210 alarm or/and the “! ULTRAFILTRATION RATE PROFILE” #212 alarm is/are displayed and the machine automatically deactivates the erroneous profile or profiles. Deactivation at the end of DIALYSIS When the machine reaches the end of the treatment. The UF R/Cond value that was confirmed in the superimposed window will remain at that value for the reminder of the treatment. The UF R/Cond value must be confirmed. If PROFILE is deactivated after the DIALYSIS Action key selection. Or Confirm last action made. a superimposed window will appear: Confirm last action made. PROFILE is automatically deactivated and cannot be re-activated. If any problems are detected.5. CURVE Action key to deactivate the profile. E. It correlates to the sodium mass balance. The computation is based on repeated Clearance measures and on the assessment of the effective dialysis time. the inlet conductivity is automatically adjusted by 1.0 mS/cm for 2 minutes. This is a relevant parameter of the clearance actually obtained from the patient.MONITORING 5. since it includes effects of fistula recirculation and ultrafiltration rate on solute removal during dialysis.1 General The DIASCAN™ Monitoring System allows real time. As a result of this increment in conductivity. The basic principle of this monitoring system is to periodically measure. non-invasive and automatic monitoring of patients and dialyser parameters that can be computed from conductivity measurements on the dialysate side. This is a factor that governs the intra/extra cellular fluid shifts. with reference to small molecular weight solutes. This parameter allows the clinician to determine if the prescribed dialysis dose (which is influenced by different factors such as dialysate flow and blood flow.1 DIASCAN™ Monitoring System 5. 2) The KT/V: This value is computed by dividing the Depurated Vol by the Volume of Distribution (DISTRIB VOLUME).E-1 5. − The Plasma Conduct: An expression of the effective plasma ionic concentration. this value is strongly correlated to Urea Clearance. Three other parameters are derived from the IONIC CLEARANCE: 1) The Depurated Vol: The volume of body water completely cleared of solute during the treatment. The clinical purpose of this monitoring is to provide a measure of dialysis efficacy for quality control purposes. This parameter allows the clinician to understand if the dialysis dose that has been achieved is adequate for the patient. for each patient. During the measurement.E MONITORING 5. (The Ionic Mass Bal value is displayed in the PROFILE\Cond view if the DIASCAN USE parameter is set to YES). 3) The Ionic Mass Bal: This estimation is based on the continuous dialysate outlet conductivity measurement.E SECTION 5. type of dialyser and time) has been achieved.MONITORING 5.E .E . Rev. (The Plasma Conduct value is displayed in the PROFILE\Cond view if the DIASCAN USE parameter is set to YES). the dialysate conductivity at the hemodialyser outlet. following an adjustment of the inlet dialysate conductivity.E. during the dialysis treatment. which is to be established by the clinician. a mathematical model computes several parameters relevant to the dialysis process: − The IONIC CLEARANCE: Average Clearance of ionized substances. according to the patient’s dry weight and the ratio of the Total Body Water to Patient Weight. SECTION 5.1. B . Or • A Fast Recovery of the Dialysis process is performed In such cases DIASCAN™ is inactivated (OFF) for the remainder of the treatment. dialysate flow rate.. which must be entered and confirmed by the operator. WARNING The physician is responsible for the clinical adequancy of the parameters set for the correct dialysis dose. change in blood flow rate. Rev.E-2 PHOENIX OPERATOR MANUAL WARNING DIASCAN™ is automatically disabled if: • Dialysate Flow Rate is set to a value lower than or equal to 450 ml/min by the operator Or • Dialysate Flow Rate is set to a value greater than 750 ml/min by the operator Or • The patient connection is performed before the completion of the initial auto- calibration. WARNING For this software version. WARNING DIASCAN™ measurements are not performed if the blood flow is ≤ 80 ml/min. Therefore. Do not use a single Diascan measurement as the only source of clinical information to initiate therapeutic or pharmacologic actions (e.. treatment time. etc. as unstable operating conditions during a single DIASCAN measurement may result in an artefact in the values computed from the individual reading. dialyser. B .g.). any changes in the dialysis prescription made on the basis of Diascan analysis should be made in consideration of at least two consecutive readings.5. It is the operator’s responsibility to assess the clinical validity of these parameters. WARNING The KT/V computation is based on two parameters: DRY WEIGHT and DISTRIB VOLUME. the accuracy of the DIASCAN™ Monitoring System is not guaranteed in the SINGLE NEEDLE mode. based upon the Diascan measurements. MONITORING 5. SECTION 5.2 mS/cm .800 0 .) Resolution 1 ml/min 0.200 0-3 Measure ml/min mmol(o) liters Accuracy ±7 ml/min ± 0.01 1mmol 0. Err.17 mS/cm -500 .1 liters 0. Rev. B .300 13 . 2 liters (oo) - (Std. (oo) Accuracy Standard Error for a 4 hour dialysis.E .E-3 DIASCAN™ Characteristics IONIC PLASMA IONIC MASS DEPURATED KT/V CLEARANCE CONDUCT BAL VOL Range of 50 .01 mS/cm (o) Positive values correspond to solutes removed from the patient. YES NO NO CLEARANCE ALA. . DIASCAN Select the DIASCAN parameter to turn the DIASCAN function OFF or ON. Then select either the YES or NO Parameter Box and press the CONFIRM button.5. . is NO. in Patient dialysis. . YES NO NO DIASCAN USE Set the DIASCAN USE parameter to YES to enable the DIASCAN™ device.E-4 PHOENIX OPERATOR MANUAL 5.2 Parameters Selectable Parameters Unit Incr. YES NO NO CLEARANCE LEVEL ml/min 5 300 50 150 DRY WEIGHT Kg 0. the following parameters can be set: CLEARANCE ALA. The default setting for the CLEARANCE ALA. It can be set by pressing: • The Config\KT/V Navigation keys. 0. Min. Max. . Enter the SET Mode and select the DIASCAN USE Parameter Box on the Touch Screen. This alarm may be programmed ON or OFF.05 3. • Or the Rx Config Navigation keys. B .30 TARGET Kt/V THRESH % 5 100 0 0 TARGET Kt/V Reached .E. and entering in the Rx Config\kT/V view. The DIASCAN function may be turned OFF also after the start of the treatment in SET Mode. then selecting one of the seven personalised dialysis sessions (Patient/RX Action keys). Rev. If the CLEARANCE ALA parameter is turned ON. in Standard Dialysis.00 0 1. When the DIASCAN parameter is set to YES. Default DIASCAN USE . an alarm is triggered if the IONIC CLEARANCE falls below the value set for the CLEARANCE LEVEL parameter.5 200 8 60 DISTRIB VOLUME % 1 80 20 55 INTERMEASUREM h:min 0:15 1:00 0:00 0:30 TARGET KT l 1 200 0 40 TARGET KT/V .1. In the IDLE mode. press the Config\Machine\Accessories Navigation keys. This parameter must be set to YES to utilize DIASCAN. . YES NO NO DIASCAN . If the computed Clearance falls below this value. SECTION 5. DRY WEIGHT The DRY WEIGHT value is used in the calculation of KT/V. The default value for DRY WEIGHT is 60 kg. The default value is 0:30 TARGET KT The TARGET KT value defines the volume of body water to be purified during DIALYSIS. The TARGET Kt/V THRESH may be set to enable the occurrence of the “Forecast Dial. Possible SET values are: • 0:00 No automatic measurements are triggered (manual mode) • 0:15 A measurement is performed every 15 minutes (if Profiling mode is set to NO) • 0:30 A measurement is performed every 30 minutes • 0:45 A measurement is performed every 45 minutes (if Profiling mode is set to NO) • 1:00 A measurement is performed once an hour. The default value for TARGET KT is 40 l. dose not match Prescrip. The TARGET KT/V THRESH may be set to enable the occurrence of the “Kt-Kt/V Target Achieved”#355 alarm by entering the minimum accettable percentage of TARGET KT in the TARGET Kt/V THRESH parameter box. dose not match Prescrip. INTERMEASUREM The INTERMEASUREM value defines the time interval between two DIASCAN measurements. This value is entered by the clinician within a range of 8 kg to 200 kg. the “Forecast Dial. parameter is SET to YES. The value is entered by the clinician as a percentage of the patient’s DRY WEIGHT. B . Rev. The default value for CLEARANCE LEVEL is 150 ml/min.”#354 alarm will occur informing the operator that the FORECAST kT will not meet the prescribed Kt. is lower than a percentage of the TARGET KT value. The default value is 55.E-5 CLEARANCE LEVEL The CLEARANCE LEVEL parameter may be SET to a value between 50 ml/min to 300 ml/min. a CLEARANCE ALA. It may be SET to a value between 0 l to 200 l When the FORECAST kT. Once the Depurated Volume is greater than or equal to a percentage of the TARGET KT value and the TARGET Kt/V Reached parameter is set to YES. estimated by the machine.”#354 alarm by entering the expected percentage of TARGET KT in the TARGET Kt/V THRESH parameter box. The input range for DISTRIB VOLUME is from 20% to 80%.E . will occur. DISTRIB VOLUME (Volume of Distribution) The DISTRIB VOLUME value is used in the calculation of KT/V. The TARGET KT value has to be confirmed/entered to allow the “Kt-Kt/V Target Achieved”#355 alarm occurrence. The TARGET KT parameter is available only if the DIASCAN parameter is set to YES. and if the CLEARANCE ALA. the “Kt-Kt/V Target Achieved”#355 alarm will occur.MONITORING 5. dose not match Prescrip. dose not match Prescrip. 0:30. It may be SET to a value between 0 to 3. the “Kt-Kt/V Target Achieved”#355 alarm will occur. It may be set to a value between 0 to 100%. The TARGET KT/V value has to be confirmed/entered to allow the “Kt-Kt/V Target Achieved”#355 alarm occurrence. If the DIASCAN Parameter is set to NO.5.”#354 alarm by entering the expected percentage of TARGET KT in the TARGET Kt/V THRESH parameter box. the #355 alarm is triggered once the alarm conditions for this alarm occurrence are reached. When the FORECAST kT/V. This value is set to activate the “Forecast Dial. the “Forecast Dial.”#354 alarm will occur informing the operator that the FORECAST kT/V will not match the prescribed Kt/V. TARGET Kt/V THRESH The TARGET Kt/V THRESH parameter is available only if the DIASCAN parameter is set to YES. no additional manual measurements are allowed. The TARGET KT/V THRESH may be set to enable the occurrence of the “Forecast Dial. The default value for TARGET Kt/V THRESH is 0%. When the TARGET Kt/V Reached parameter is set to YES. Note DIASCAN™ can be de-activated at any time.”#354 alarm. The TARGET KT/V parameter is available only if the DIASCAN parameter is set to YES. Note The KT/V value will be displayed only if a valid number for DISTRIB VOLUME is present and the DRY WEIGHT of the patient has been confirmed. 0:45 or 1:00.. dose not match Prescrip. The TARGET KT/V parameter box will appear after the DRY WEIGHT and DISTRIB VOLUME have been entered and confirmed for the treatment.E-6 PHOENIX OPERATOR MANUAL TARGET Kt/V The TARGET KT/V value defines the Dialysis Dose to be achieved during DIALYSIS. The default value for TARGET KT/V is 1. by pressing the kT/V Navigation key. it is not possible to activate DIASCAN again after Dialysate Preparation is complete. The TARGET Kt/V THRESH may be set to enable the occurrence of the “Kt-Kt/V Target Achieved”#355 alarm by entering the minimum accettable percentage of TARGET KT in the TARGET Kt/V THRESH parameter box. Enter the SET Mode and select the DIASCAN Parameter Box on the Touch Screen. B . The default value for TARGET Kt/V Reached parameter is NO.00. then select NO and press the Confirm button.30. Note If the INTERMEASUREM parameter is set to 0:15. for the current dialysis treatment. estimated by the machine. TARGET Kt/V Reached The “Kt-Kt/V Target Achieved”#355 alarm may be programmed ON or OFF. is less than a percentage of the TARGET KT/V value. Once the KT/V is greater than or equal to the set percentage of the TARGET KT/V value and the TARGET Kt/V Reached parameter is set to YES. Rev. an initial Auto-Calibration Procedure is not repeated. the DIASCAN icon becomes dotted and the message "Diascan Initial Calibration Failed" will be displayed.. Enter the SET Mode. Note Following selection of a NEW SESSION Action key. Note If you disable Diascan during the Auto Calibration procedure. During Auto-Calibration. disable the DIASCAN™ Monitoring System by pressing kT/V Navigation key.MONITORING 5. the conductivity is increased. In this case. DIASCAN™ Monitoring System starts an Auto-Calibration Process. Then select NO and press the CONFIRM button. Note If the Patient Sensor detects BLOOD prior to the end of the Auto-Calibration Procedure.3 Initial Auto-Calibration At the beginning of each treatment.E-7 5. call for Service. Failure of the procedure does not affect the dialysis treatment. The goal of this Auto-Calibration is to verify the proper functioning of the conductivity measuring system. Note The initial Auto-Calibration Procedure is only required to verify the correct functioning of the DIASCAN™ Monitoring System. the DIASCAN icon stops flashing and the DIASCAN™ Monitoring System is ready for use. An Auto-Calibration Procedure will only be performed after the NEW SESSION Action Key is selected if the Auto-Calibration failed during the previous dialysis session. first. This message can be canceled by pressing the OVERRIDE button. Rev.E . In case of a failure of the Auto-Calibration.E. − If the alignment cannot be properly completed. B . Select the DIASCAN Parameter Box on the Touch Screen. the “Diascan Initial Calibration Failed ” #244 alarm may occur. Note If the “Diascan Initial Calibration Failed” #244 alarm occurs frequently during the initial Auto-Calibration Procedure.. switch OFF the machine. SECTION 5. two results are possible: − If the alignment is completed successfully. the DIASCAN Monitoring System is automatically disabled and its icon becomes dotted. then switch ON the machine again. The initial Auto-Calibration consists of measuring the outlet conductivity at two different conductivity set points: 14 mS/cm and 16 mS/cm.1. which is indicated by a flashing DIASCAN™ icon. to 14 mS/cm for 90 seconds (on average) and then is increased to 16 mS/cm again for 90 seconds to complete Diascan autocalibration.” displayed on the screen together with a progress bar informing that the DIASCAN autocalibration is in progress. At the end the Auto-Calibration. at the end of the conductivity T1 TEST phase. wait 5 seconds. The Auto-Calibration Process is signaled by the DIASCAN icon flashing and by the message “DIASCAN Autocalibration in Progress. both in Manual and PROFILE mode. Note A DIASCAN™ measurement will also be interrupted by any manual or automatic bypass condition. increases in conductivity of greater than 2 mS/cm should be avoided.1.4 MEASUREMENTS The measurement of Plasma Conduct and IONIC CLEARANCE is automatically triggered at the frequency selected in the INTERMEASUREM parameter. and measurements will not be executed. Note In order to ensure that DIASCAN™ functions correctly.5. such as the BYPASS or UF ONLY key. Note The user can stop a measurement in progress or switch OFF the DIASCAN™ Monitoring System at any time without any consequence to the dialysis treatment. the final conductivity is controlled by the DIASCAN™ Monitoring System and the user is not allowed to change the conductivity.E-8 PHOENIX OPERATOR MANUAL 5. Note If DIASCAN™ is switched OFF in the Config view or in the Rx Config view.E. If DIASCAN™ is switched OFF in the DIASCAN view (selected by pressing kT/V and then the Set button) this will cause the DIASCAN icon to disappear. Rev. Note The DIASCAN™ measurement will fail if there are any modifications to either of the following parameters during the measuring period: − blood flow rate − dialysate flow rate To ensure an accurate measurement it is recommended that modifications in these parameters are not performed within 2 minutes of the next DIASCAN measurement. or the occurrence of an alarm that causes the machine to go into BYPASS. This measurement phase is indicated by a flashing DIASCAN icon. During the entire time of the measurement (about 7 min). B . the DIASCAN view in the kT/V menu (selected by pressing kT/V Navigation key) will disappear. No values have been inserted/confirmed for the parameters DRY WEIGHT and DISTRIB VOLUME. DIASCAN parameters are not displayed in If noticed before starting treatment. enabled (DIASCAN parameter set to YES switch OFF the machine. Verify that the set-values for blood and dialysate flow rates are within the operating range for the DIASCAN and wait for the correct hydraulic condition. SECTION 5. B . The icon is dotted. Clean the DIASCAN™ probe by performing a Descaling procedure. Perform at least one manual measurement or wait for the first automatic measurement. Rev. All the DIASCAN parameters in the kT/V No measurements have been performed. when SET view even if the Diascan function is these parameters may have to be modified. wait 5 seconds and in CONFIG). Set the dialysate flow rate to a correct value. exist. view are “---”.MONITORING 5.E . DIASCAN™ failed the initial auto-calibration. The dialysate flow rate is set to a value outside of the proper operating range. Insert/confirm a value for DRY WEIGHT and DISTRIB VOLUME. switch ON the machine.E-9 Problem Possible cause/solution A manual measurement was requested Proper conditions for a measurement do not but the icon did not start to flash. 5.14 FORECAST KT 26 L FORECAST KT/V 1. an icon will appear on the Touch Screen. the main view of the Kt/V environment is entered. B .2 TARGET KT 150 l TARGET KT/V 2. By pressing the Kt/V Navigation keys it is possible to see the Clearance graph.E. when the Kt/V Navigation key is selected. KT/V MENU In TREATMENT.5 Operator Interface DIASCAN Icons If the DIASCAN parameter is set to YES.00 e f BLOOD FLOW Time ClkTime Thres Kurea B Flow KT/V Rev. 12:30 -. pu/min DIASCAN MEAS STOP MEASURE VEN ART BLOOD FLOW DEPURATED VOL6.E-10 PHOENIX OPERATOR MANUAL 5./ ---mmHg --. both during the Standard dialysis and during the Patient/RX dialysis./ -- --.1 L KT/V 0.1. The possible icons relating to the DIASCAN™ Monitoring System are listed below: • DIASCAN active (IDLE) • DIASCAN calibrated (TREATMENT) • DIASCAN present but Auto-Calibration failed Note The DIASCAN active icon flashes during both the initial Auto-Calibration and every measurement. From the kT/V view is possible to see: • The graph of the CLEARANCE measurements (YELLOW line). Entering the kT/V view a green cursor is positioned on the last DIASCAN measurement. B . the TARGET KT parameter disappears and the TARGET KT/V. Note The Auto-Repeat feature is active on the Function Bar Arrows: pressing and holding the arrows for more than 2 seconds allows the green cursor to move more quickly on the graph. The CLEARANCE ALA.E . KT/V and FORECAST kT/V parameters becomes available in the kT/V view. a “DIASCAN: LIMIT LOW CLEARANCE” #249 alarm occurs when the Clearance value falls below this threshold. • The graph of the B Flow (blood flow value) (BLUE line). do not press simultaneously the two Function Bar Arrows. If the CLEARANCE ALA. parameter can be activated (set to YES) or deactivated (set to NO) for the dialysis treatment. During every measurement. SECTION 5. If the INTERMEASUREM parameter is set to 0:00. parameter is set to YES. Rev. in correspondence to the DIASCAN measurements. Note If the INTERMEASUREM parameter is set to 0:15. 0:45 or 1:00 the DIASCAN MEAS Action key is not available. The Function Bar displays the following values at the point in time at which the green cursor is positioned on the graph: • The time into treatment (Time) • The clock time (ClkTime) • The CLEARANCE LEVEL alarm threshold (Thres) • The Clearance value (Kurea) • The blood flow value (B Flow) The “Time” value is calculated starting from the DIALYSIS Action key selection.MONITORING 5.E-11 Note After confirming the DISTRIB VOLUME and DRY WEIGHT parameter values. the STOP MEASURE Action key is present to allow an interruption of the DIASCAN measurement. Note To prevent problems in the Clearance graph visualization. the DIASCAN MEAS Action key is present and allows the manual initiation of a DIASCAN measurement. so the alarm threshold is active. Pressing the Function Bar Arrows (positioned on the lower part of the window) moves the position of the green cursor on the Clearance graph. • The graph of the CLEARANCE LEVEL alarm threshold (RED line). 0:30. the graph of the CLEARANCE LEVEL alarm threshold is shown as a RED line on the “Time” line (CLEARANCE LEVEL low limit line). when it is deactivated. Rev. After pressing the Set button the following view is displayed. B . are also displayed: • Depurated Vol. Note The KT/V. CLEARANCE DRY WEIGHT LEVEL DISTRIB VOLUME INTERMEASUREM TARGET KT TARGET Kt/V TARGET KT/V THRESH KT/V Note If confirming the DISTRIB VOLUME and DRY WEIGHT parameter values. • KT/V. TARGET KT/V and the FORECAST kT/V values are not displayed if the DISTRIB VOLUME and DRY WEIGHT parameters are not confirmed in Set Mode. • TARGET KT: The volume of body water to be purified during the treatment. the TARGET KT parameter disappears and the TARGET KT/V parameter becomes available. where all the DIASCAN relevant parameters may be set: 12:30 DIASCAN CLEARANCE ALA. • FORECAST kT/V: calculated with the following formula: FORECAST Kt FORECAST Kt/V = DISTRIB VOLUME × DRY WEIGHT • TARGET KT/V: Dialysis Dose to be achieved during the treatment. • FORECAST: The volume of body water completely cleared of solute during the treatment. estimated on the current Clearance value and the DIALYSIS TIME set.5.E-12 PHOENIX OPERATOR MANUAL In the kT/V view the following values related to the last DIASCAN measurement. CLEAN DIALYSATE System 5.F.F SECTION 5.5°C lower than the displayed temperature. The Clean Dialysate System has been expressly designed to be used with the DIACLEAR Ultrafilter. SECTION 5.F CLEAN DIALYSATE 5.0.3 . an alarm occurs.CLEAN DIALYSATE SYSTEM 5. If any defects in the Ultrafilter are detected.F . an ADR: RINSING must be performed. Rev. the temperature in the dialyser may be 0. Note When the DIACLEAR Ultrafilter is used. replace the DIACLEAR Ultrafilter before using the Clean Dialysate feature again. WARNING When the Ultrafilter has been installed.F-1 5.F .1 General The purpose of the Clean Dialysate System is to purify the dialysate before its use in the dialyser. B . The patient’s risk of exposure to bacteria and endotoxin can thereby be minimized. Note It is recommended that the Ultrafilter is replaced following the maximum dialysis session directions provided in the DIACLEAR Instructions for Use. Note If the machine is stored for more than a week. physical characteristics. Operational warnings and cautions appear in the appropriate sections of the text to help ensure a safe and effective treatment. B . The risk of exposure to bacteria and endotoxin may therefore be minimized.F-2 PHOENIX OPERATOR MANUAL 5. performance and limits of use. ADVERSE REACTIONS Refer to the DIACLEAR Instructions for Use. Some solvents and other chemical products used for cleaning can damage the DIACLEAR Ultrafilter: refer to the DIACLEAR Instructions for Use for the list of prohibited products. Rev.2 Ultrafilter information CAUTION This information must be read before the use of the DIACLEAR Ultrafilter. They are also compatible with the PHOENIX Haemodialysis System. materials. RECOMMENDATIONS WARNING For the disinfection of the Ultrafilter it is mandatory to use only the chemical agents recommended in the DIACLEAR Instructions for Use. INDICATIONS Bacterial contamination of dialysate has frequently been observed and may induce fever and inflammatory reactions in dialysis patients. The maximum concentration allowed for the disinfectant used is: 6% Sodium Hypochlorite 4% Peracetic acid 40% Formaldehyde 100% Instrunet 100% Steridial Refer to the DIACLEAR Instructions for Use. Ultrafiltration with the DIACLEAR Ultrafilter is indicated for purification of dialysate to obtain microbiologically high quality dialysate.5. refer to the DIACLEAR Instructions for Use. SPECIFICATIONS For the Ultrafilter specifications.F. CLEAN DIALYSATE SYSTEM 5. equipped with the Clean Dialysate feature. PROCEDURES This section describes the use of the DIACLEAR Ultrafilter when installed on a PHOENIX machine. SECTION 5. Aseptic technique must be employed when installing the DIACLEAR Ultrafilter to avoid contamination of the fluid pathway. Prime the DIACLEAR Ultrafilter following the Instructions for Use described below. B . Should the physician in charge decide to use the DIACLEAR for multiple uses. Conditions of disinfection and rinsing after the first use are the responsibility of the prescribing physician. it is imperative to use a chemical disinfectant that is recommended in the DIACLEAR Instructions for Use and that is also compatible with the PHOENIX machine.2.F. The instructions supplied by the manufacturer for the chemical disinfectant must be strictly followed.F . Introduction of air into the DIACLEAR during its use may cause an increased pressure drop and subsequent alarms on the PHOENIX machine.F-3 5. The microbiological quality of the system must be validated by the dialysis facility in order to demonstrate that the disinfection process is effective. Rev. to ensure that the system is completely purged of air.1 DIACLEAR Instruction for Use CAUTION Make certain that the procedures outlined in this Operator Manual are carefully reviewed before the DIACLEAR Ultrafilter is used on a PHOENIX Haemodialysis System that is equipped with the Clean Dialysate feature. 1 Disconnection of the three Ultrafilter Bypass connector lines” section then proceed with the installation of the DIACLEAR Ultrafilter as described in the “5.F. USE parameter is set to YES in Config/MACHINE/OPTION view.F.2 Installation of the DIACLEAR Ultrafilter” paragraph.3. Setup Instructions • Before installing the DIACLEAR Ultrafilter. Old version New version • If the machine is provided with the old version of the Ultrafilter Bypass connector: refer to the “5. it is mandatory to perform an ADR: RINSING to prime the DIACLEAR. ensure that the ULTRAFIL. Following DIACLEAR installation. then proceed with the installation of the DIACLEAR Ultrafilter as described in the “5. Note Before installing the DIACLEAR Ultrafilter. • If the machine is provided with the new version of the Ultrafilter Bypass connector: refer to the “Appendix C.F.F.5. B . Rev.” “C. Refer to the figure below to identify the Old or the New version.1 Removal of the Ultrafilter Bypass connector (old version)” paragraph. verify that a Rinsing has been performed as latest process in order to avoid the presence of chemical residues in the lines.2 Installation of the DIACLEAR Ultrafilter” paragraph. • Switch Off the machine.3.3. • Identify the Ultrafilter Bypass connector version present on the machine.F-4 PHOENIX OPERATOR MANUAL 5.3 Installation of the DIACLEAR Ultrafilter on a machine equipped with the Ultrafilter Bypass connector WARNING The DIACLEAR Ultrafilter MUST be installed when the PHOENIX machine is in the IDLE view. F .1 Removal of the Ultrafilter Bypass connector (old version) • Before disconnecting the three Ultrafilter Bypass connector lines. Fig.F-5 5.F. 1). 1 Rev.CLEAN DIALYSATE SYSTEM 5. SECTION 5. B .3. clamp them in order to prevent any possible spillage of water (see Fig. 2 Disconnection of the Filtrate Outlet Line (line connected to the middle Ultrafilter Bypass connector port) • Press the Filtrate Outlet Line’s pinch safety clip springs (see Fig. 2) from the upper Ultrafilter Bypass connector port by unscrewing the Luer lock from the threaded locking nut (turn the Luer lock counter clockwise while holding the threaded locking nut in place). B . 3) then unhook the Filtrate Outlet Line pinch safety clip from the middle Ultrafilter Bypass connector port.5. keeping firmly the Ultrafilter Bypass connector.F-6 PHOENIX OPERATOR MANUAL Disconnection of the Deaeration Line (line connected to the upper Ultrafilter Bypass connector port) • Disconnect the Deaeration Line (see Fig. Deaeration Line Luer lock Threaded locking nut Fig. Pinch safety clip springs Fig. 3 Rev. Threaded locking nut Luer lock Dialysate Inlet Line Fig. Rev. 5) from the lower Ultrafilter Bypass connector port by unscrewing the Luer lock from the threaded locking nut (turn the Luer lock counter clockwise while holding the threaded locking nut in place). 4 Disconnection of the Dialysate Inlet Line (line connected to the lower Ultrafilter Bypass connector port) • Disconnect the Dialysate Inlet Line (see Fig. 4).F-7 • Disconnect the Filtrate Outlet Line from the middle Bypass connector port (see Fig. SECTION 5. B .CLEAN DIALYSATE SYSTEM 5.F . 5 Removal of the Ultrafilter Bypass connector • Remove the Ultrafilter Bypass connector from its holder and store it for a further use. Filtrate Outlet Line Fig. Rev.F-8 PHOENIX OPERATOR MANUAL 5. Installation of the DIACLEAR Ultrafilter • Remove the DIACLEAR Ultrafilter from the package.2 Installation of the DIACLEAR Ultrafilter WARNING The DIACLEAR Ultrafilter MUST be installed when the PHOENIX machine is in the IDLE view. 1). because they will be used during the removal of the DIACLEAR Ultrafilter.3. 1 Note Do not throw the three DIACLEAR Ultrafilter caps away.F. to the Filtrate Outlet Port and to the Dialysate Inlet Port (see Fig.5. • Place the DIACLEAR Ultrafilter in the two fixing clips present on the machine upper rear panel (the blue cap must be upwards). as described in the 5. Following DIACLEAR installation.F. • Remove the three caps (without throwing them away) from the DIACLEAR Ultrafilter ports corresponding to the Deaeration Outlet Port. Deaeration Filtrate Outlet Outlet Port Port Dialysate Inlet Port Fig.1 “Removal of the DIACLEAR Ultrafilter” paragraph. it is mandatory to perform an ADR: RINSING cycle to prime the DIACLEAR Ultrafilter before entering a DISINFECTION cycle or a DIALYSIS phase. B .4. SECTION 5. • Screw all the way the Deaeration Line’s Luer lock to the Deaeration Outlet Port of the DIACLEAR Ultrafilter. 3). Luer lock Deaeration Line Fig.F . 2 Connection of the Filtrate Outlet Line • Spray the Filtrate Outlet Port of the DIACLEAR Ultrafilter with Ethyl Alcohol. • Hook the Filtrate Outlet Line pinch safety clip to the Filtrate Outlet Port (see Fig. 2). • Ensure that the Deaeration Line is not twisted or kinked (see Fig.F-9 Connection of the Deaeration Line • Insert the Deaeration Line’s Luer lock into the Deaeration Outlet Port. • Fully insert the Filtrate Outlet Line into the Filtrate Outlet Port. Pinch safety clip Filtrate Outlet Line Fig.CLEAN DIALYSATE SYSTEM 5. 3 Rev. B . if they have been clamped (see Fig. 5 • Perform a Rinsing procedure to prime the DIACLEAR Ultrafilter. • Screw all the way the Dialysate Inlet Line’s Luer lock to the Dialysate Inlet Port of the DIACLEAR Ultrafilter. 4 • Ultrafilter After Ultrafilter lines connection. Dialysate Inlet Line Luer lock Fig. 4).F-10 PHOENIX OPERATOR MANUAL Connection of the Dialysate Inlet Line • Insert the Dialysate Inlet Line’s Luer lock into the Dialysate Inlet Port. • Ensure that the Dialysate Inlet Line is not twisted or kinked (see Fig. Rev. B .5. remove the clamps from the three DIACLEAR Ultrafilter lines. Fig. 5). 5.F-11 5. WARNING The following operations must be performed when the machine is in the IDLE view. • Close the DIACLEAR Ultrafilter Filtrate Outlet Port by capping it. ensure that the ULTRAFIL. Disconnection of the Dialysate Inlet Line • Disconnect the Dialysate Inlet Line from the DIACLEAR Ultrafilter Dialysate inlet port. Note It is recommended to replace the DIACLEAR Ultrafilter following the dialysis session directions provided in the DIACLEAR Ultrafilter Instructions for Use. When an Ultrafilter Bypass connector has been installed. by unscrewing the Dialysate Inlet Line’s Luer lock from the DIACLEAR Ultrafilter Dialysate Inlet Port.4 Installation of the Ultrafilter Bypass connector on a machine equipped with the DIACLEAR Ultrafilter. USE parameter is set to NO in Config/MACHINE/OPTION view.F.CLEAN DIALYSATE SYSTEM 5. it is mandatory to perform a disinfection cycle. • Close the DIACLEAR Ultrafilter Dialysate Inlet Port by capping it. • Disconnect the Filtrate Outlet Line from the DIACLEAR Ultrafilter Filtrate Outlet Port. SECTION 5. the Filtrate Outlet Line and the Dialysate Inlet Line connected to the DIACLEAR Ultrafilter. Rev. B .1 Removal of the DIACLEAR Ultrafilter Before installing the Ultrafilter Bypass Connector. in order to prevent any spillage of water.4. Disconnection of the Filtrate Oulet Line • Press the Filtrate Outlet Line pinch safety clip springs then unhook the pinch safety clip from the DIACLEAR Ultrafilter Filtrate Outlet Port. • Close the DIACLEAR Ultrafilter Deaeration Outlet Port by capping it. by unscrewing the Deaeration Line’s Luer lock from the DIACLEAR Ultrafilter Deaeration Outlet Port. WARNING The Ultrafilter Bypass connector MUST be installed when the PHOENIX machine is in the IDLE view.F . before entering a DIALYSIS phase. Before disconnecting the Ultrafilter lines. clamp the Deaeration Line. Follow the instructions below to disconnect the three Ultrafilter lines: Disconnection of the Deaeration Line • Disconnect the Deaeration Line from the DIACLEAR Ultrafilter Deaeration Outlet Port.F. • Identify the Ultrafilter Bypass connector version to be installed on the machine.5. • If the new version of the Ultrafilter Bypass connector has to be installed: refer to the “Appendix C”.4. B .F. Rev.F-12 PHOENIX OPERATOR MANUAL Removal of the DIACLEAR Ultrafilter and Ultrafilter Bypass connector installation • Remove the DIACLEAR Ultrafilter from its holder and throw it away. “C. Refer to the figure below to identify the Old or the New version. Old version New version • If the old version of the Ultrafilter Bypass connector has to be installed: refer to the “5.2 Installation of the Ultrafilter Bypass connector (old version)” paragraph for the installation of the old version of the Ultrafilter Bypass connector. 2 Connection of the Ultrafilter Bypass connector” section for the installation of the new version of the Ultrafilter Bypass connector. F. 1).4.CLEAN DIALYSATE SYSTEM 5.2 Installation of the Ultrafilter Bypass connector (old version) Follow the instructions below to connect the three Ultrafilter lines to the Ultrafilter Bypass connector. therefore the upper and lower ports are equivalent). • Fix the Deaeration Line’s Luer lock by rotating clockwise the threaded locking nut onto it (see Fig.1 Rev.F-13 5. B . SECTION 5. Connection of the Deaeration Line • Insert the Deaeration Line’s Luer lock into the upper Ultrafilter Bypass connector port (the Ultrafilter Bypass connector is symmetric.F . Deaeration Line Threaded locking nut Fig. Rev. 2 Connection of the Filtrate Outlet Line • Spray the middle Ultrafilter Bypass connector port with Ethyl Alcohol. Threaded locking nut Dialysate Inlet Line Fig. • Fix the Dialysate Inlet Line’s Luer lock by rotating clockwise the threaded locking nut onto it (see Fig. 3 • After having connected the Ultrafilter lines.5. 2).F-14 PHOENIX OPERATOR MANUAL Connection of the Dialysate Inlet Line • Insert the Dialysate Inlet Line’s Luer lock into the lower Ultrafilter Bypass connector port. • Hook the Filtrate Outlet Line’s pinch safety clip to the middle Ultrafilter Bypass connector port (see Fig. 3). Filtrate Outlet Line Pinch safety clip Fig. • Fully insert the Filtrate Outlet Line onto the middle Ultrafilter Bypass connector port. insert the Ultrafilter Bypass connector into the lower fixing clip present on the panel. B . Fig. 4). SECTION 5.F . B .F-15 • Remove the clamps from the three lines connected to the Ultrafilter Bypass connector ports (see Fig.CLEAN DIALYSATE SYSTEM 5. Rev. 4 • Perform a disinfection cycle before starting a dialysis treatment. Rev. Note Rinsing of the DIACLEAR Ultrafilter can only be carried out during an ADR: RINSING cycle of the PHOENIX machine. Priming/Rinsing of the dialyser and performing the dialysis treatment • Before selecting DIALYSIS make sure that the DIACLEAR Ultrafilter has been rinsed. Monitoring of the DIACLEAR Ultrafilter related pressures occurs while the PHOENIX machine is operating so that problems may be detected. the DIACLEAR Ultrafilter must be primed by performing an ADR: RINSING cycle. at least.F-16 PHOENIX OPERATOR MANUAL 5.5 Clean Dialysate 5. • Check that the DIACLEAR Ultrafilter is correctly installed and make sure that the ULTRAFIL. Perform a DISINFECTION procedure before patient connection. USE parameter is set to YES. To correct these conditions. • If a line is clamped. Note The DIACLEAR Ultrafilter can be excluded from the circuit at any time by pushing the BYPASS Action key or the UF ONLY Action key.5. WARNING Avoid tapping the DIACLEAR Ultrafilter too vigorously to remove air as this may cause damage. • Refer to the Section 5 . The alarms. 30 min.F. check that the lines are not clamped.Dialysis Operation for instructions on dialysate preparation.5. • In case of alarms during the RINSE cycle. WARNING The connection of the DIACLEAR Ultrafilter to the PHOENIX machine must be performed aseptically. unclamp it and perform again the prime (ADR: RINSING) procedure of the DIACLEAR Ultrafilter. “Ultrafilter Is Packed” (#138) or “Ultrafilter Max Pressure” (#146) occur when there is a high resistance on the dialysate side inside the DIACLEAR Ultrafilter. This operation allows the dialysis treatment to be completed (it is necessary to replace the DIACLEAR Ultrafilter at the end of dialysis) when either alarm occurs. • Select ADR: RINSING.5.F. Only after a Rinsing cycle the DIALYSIS treatment can be selected.F. Set the RINSING TIME parameter to.2 Dialysate Preparation. reduce the dialysate flow to 350 ml/min to reduce the pressure. B . 5. so that the fluid pathway is not contaminated.1 Priming/Rinsing of the DIACLEAR Ultrafilter After its installation. 5.3.2 Installation of the DIACLEAR Ultrafilter” in this section. see paragraph “5. A new DIACLEAR Ultrafilter must be installed if a “Ultrafilter Max Pressure” alarm or a “Ultrafilter Is Packed” alarm occurs. SECTION 5. WARNING It is imperative that an ADR: RINSING is performed after each DIACLEAR Ultrafilter installation.CLEAN DIALYSATE SYSTEM 5. B . 5.5.F.F-17 5.5.F.5. WARNING The DIACLEAR Ultrafilter can only be changed when the Phoenix machine is in the IDLE view. while the machine is in Idle mode: CHANGE CLEAN DIAL POWER DOWN COUNT ABD DIAGNOSTIC ULTRAF PRE INSTALL TIME TREATM NUMBER MACHINE SERVICE STATUS RECORDE CALIBRAT R ION Rev.F .3 Changing the DIACLEAR Ultrafilter Note The changing of the DIACLEAR Ultrafilter must be performed following the directions provided in the DIACLEAR Instructions for Use.1 Installation of a new DIACLEAR Ultrafilter For the installation of a new DIACLEAR Ultrafilter.F.4 Resetting of the DIACLEAR Ultrafilter Installation parameters Both when installing a new DIACLEAR Ultrafilter and when replacing an used DIACLEAR Ultrafilter. the DIACLEAR Ultrafilter installation parameters must be reset by pressing the CHANGE CLEAN DIAL Action key in the MACHINE view.F.3. Rev. USE parameter is set to YES in the Config view. 5. WARNING: The user is responsible for monitoring the DIACLEAR Ultrafilter working time. the value displayed for this parameter (related to the old DIACLEAR Ultrafilter) is cleared and the machine restarts totalling the days elapsed from the installation of the new DIACLEAR Ultrafilter.5. in Section 6 .F. for Disinfection and the Descaling procedures. INSTALL TIME: This parameter totals the days elapsed from the installation of the DIACLEAR Ultrafilter by the operator.F-18 PHOENIX OPERATOR MANUAL Note The CHANGE CLEAN DIAL Action key is available only in Idle mode and if the ULTRAFIL. each disinfection process that can be executed by the PHOENIX can be executed through the ultrafilter. After the selection of the CHANGE CLEAN DIAL Action key. the value displayed for this parameter (related to the old DIACLEAR Ultrafilter) is cleared and the machine restarts totalling the number of treatments in which the new DIACLEAR Ultrafilter has been used.F. B .5. • TREATM NUMBER: This parameter totals the number of treatments in which the DIACLEAR Ultrafilter has been used.5 Chemical Disinfection and Descaling • Refer to the PHOENIX Operator’s Manual.6 Heat/Heat Citric Disinfection The compatibility of the DIACLEAR Ultrafilter membrane with PHOENIX processes has been validated for both the Heat Disinfect Process and the Heat Citric Disinfect Process. After the selection of the CHANGE CLEAN DIAL Action key.5. • Refer to the paragraph “RECOMMENDATIONS” in this section and refer to the DIACLEAR Instructions for Use for the list of approved disinfection agents. by resetting the DIACLEAR Ultrafilter installation parameters each time a new DIACLEAR Ultrafilter is installed/replaced.Clean/Disinfect. Therefore. 5. in order to replace the used DIACLEAR Ultrafilter following the maximum dialysis session directions provided in the DIACLEAR Instructions for Use. YES NO NO ULTRAF PRES mmHg 10 200 20 100 ULTRAFIL. in non-operating conditions where fluid passes through the membrane. Min. When the value set for the parameter is exceeded a warning message appears. but only if the ULTRAFIL.6 PHOENIX Operator Interface 5. .F-19 5. ULTRAF PRES This parameter measures the difference between the filter inlet and outlet pressures in the ultrafilter membrane during operating conditions. B . USE . This parameter is set in the Config\Machine\Clean Dial. The ULTRAFIL. view. SECTION 5.F. Max. Note The ULTRAF PRES parameter is displayed on the Machine view.CLEAN DIALYSATE SYSTEM 5.6. Note The value set for the ULTRAF PRES parameter must be in agreement with the value suggested in the DIACLEAR Instructions for Use.1 Configuration Parameters Unit Incr.F. Therefore. USE This parameter is used to enable the Clean Dialysate System. Rev. If there is an inconsistency between this parameter and the state of the DIACLEAR Ultrafilter.F . USE parameter must be set to YES in the Config/Machine view in order to allow the other parameters to be displayed. USE in the Config view is set to YES. this parameter will be zero since the pressure difference is not significant. Default ULTRAFIL. an alarm will occur. B . (Not currently available) Ultrafilter absent or a Switches Error Alarm occurred when ULTRAFIL.F-20 PHOENIX OPERATOR MANUAL 5.5. The possible icons relating to the Clean Dialysate process are listed below: Ultrafilter preset and in use.F. USE is set to YES (Not currently available) Rev. USE parameter in the Config view is set to YES.2 Icons If the ULTRAFIL.6. a related icon will appear on the icon bar of the Touch Screen. Requirements 1. • Procedure for cleaning the exterior of the PHOENIX machine and for inspection and storage of the machine. Internal Cleaning and Disinfection Protocol The PHOENIX provides several methods of achieving disinfection of the hydraulic pathway of the system. Follow the manufacturer’s instructions when performing ADR procedures.6 CLEAN/DISINFECT 6. B . SECTION 6 . A post-dialyser dialysate sample should be cultured monthly for machine bioburden levels. Rev.CLEAN/DISINFECT Overview This section contains information about cleaning (internal and external) and disinfection measures that should be performed on the PHOENIX Haemodialysis Delivery System. However. applicable regulatory requirements and facility practices. Note At the machine installation a post-dialyser dialysate sample should be cultured for machine bioburden levels. As a minimum. The choice of which of these methods to use is the responsibility of the facility. The Manufacturer validates the methods suggested based on in-vitro laboratory testing for adequate concentration or temperature distribution to obtain microbial efficacy and hydraulic circuit material compatibility. trending of microbiological monitoring results. Testing for residual chemicals must be done prior to patient treatment (see “6. This information includes: • Description of the ADR (Automatic Disinfection.6 Verification of the Absence of Residual Disinfectant” in this section). a daily disinfection (chemical. The PHOENIX can accommodate bleach disinfection as frequently as between each treatment or daily. 2. the frequency of disinfection should be based upon allowable bacterial and/or endotoxin limits in water and dialysate. Follow your facility protocol for collecting and culturing the sample. Follow your facility protocol for collecting and culturing the sample. • Step-by-step instructions for performing each of the machine’s ADR procedures. as per AAMI and CDC guidelines. heat or heat citric) is recommended. Frequency of disinfection or the method used may need to be changed if results do not meet either the facility or regulatory body requirements (if applicable). Rinsing) capabilities of the PHOENIX Haemodialysis Delivery System. as per AAMI and CDC guidelines. The PHOENIX offers a unique method for protecting the hydraulic pathway from microbial contamination with the preparation of a bacteriostatic level of disinfectant. Note It is recommended to alternate the disinfection methods and/or the disinfectants. This is to ensure that any accumulated organic material is periodically removed from the hydraulic pathway. Rev. Descaling with vinegar. Note The test procedure used for verification of the effectiveness of disinfection or sterilisation is available on request. in order to optimize cleaning. descaling and disinfection of the machine. citric acid or acetic acid is also an important process to periodically perform to remove mineral deposits which can also reduce the effectiveness of the disinfection process. B . and in addition a deproteinization procedure (for example: bleach) should be done at least two times per week if heat/heat citric disinfection is the primary (between each patient treatment or daily minimum) disinfection method. This procedure is performed by setting the END PROCESS MODE parameter to BACTERIOSTATIC in the Config/ADR/Chemical view and then leaving the machine filled with a dilute (1:750) bleach or sodium hypochlorite solution for a maximum dwell time of one week.6-2 PHOENIX OPERATOR MANUAL Heat disinfection is also an option. Such material can potentially reduce the effectiveness of a disinfection process. and in an acute setting where the time between uses is variable. This can be useful for overnight or weekend storage. or Daily 24 min or 28 Specifications Disinfect chemical min if the connector DIACLEAR (yellow) Ultrafilter is installed. (Configuration) Note Cycle Time may be increased for heavy precipitate. or Daily Chemical Vinegar or 5% Disinfect chemical Disinfect = 15 Acetic Acid connector min (yellow) (Configuration) Acetic Acid 30% Chemical Rear 1. B . or Twice a week Chemical Disinfect chemical Disinfect = 15 connector min (yellow) (Configuration) Citric Acid See Section .2.CLEAN/DISINFECT 6-3 Descaling Tables Precipitate Control (Descaling): Following every treatment Chemical Uptake ADR Uptake Site Frequency Cycle Time Concentration Cycle Acid ≥ 3 meq/L Acid Descaling Acid Following 3-5 minutes Concentrate Content Concentrate every treatment (Configuration) connector (Bicarbonate (white) dialysis) White Distilled 5% Acetic Acid Descaling Acid Following 3-5 min Vinegar or 5% Content Concentrate every treatment (Configuration) Acetic Acid connector (Bicarbonate (white) dialysis) Precipitate Control (ADR): Periodic procedures Chemical Uptake ADR Uptake Site Frequency Cycle Time Concentration Cycle White Distilled 5% Acid Content Chemical Rear 1. SECTION 6 .2. Rev.2. Heat Citric Rear 1. connector treatment END PROCESS Specifications (yellow) MODE is set for the Bact. Heat . Rev.2.6-4 PHOENIX OPERATOR MANUAL Disinfection Table Flow Path Disinfection (ADR) Method Uptake ADR Uptake Minimum Maximum Cycle Time Conc. 20 min or 40 min if the DIACLEAR Ultrafilter is installed. or Daily Following 15:00 to 30:00 or Specifications Disinfect chemical each 28:00 to 43:00 if (See Section .2. or Daily Following 24 min or 28 Specifications Disinfect chemical (Note 1) each min if the section. (Configuration) Citric Acid See the Heat Citric Rear 1. disinfectants (Configuration) list) Heat .e. Cycle Site Frequency Frequency Chemical See the Chemical Rear 1. section. B . Daily Following 18 min or 36 Disinfect (Note 1) each min if the treatment DIACLEAR Ultrafilter is not installed. connector treatment DIACLEAR (yellow) Ultrafilter is installed. Bleach) should be performed at least 2 times per week. (Configuration) Note 1 A deproteinization procedure (i. CLEAN/DISINFECT 6-5 6. Rev. This disinfection cycle includes the entire hydraulic circuit. At completion of the disinfectant tank filling. A new set of Action/Selection keys appear and the ADR schedule is displayed: 12:30 IDLE: SELECT ADR CHEM PROCESS HEAT RINSING CCK LINES RINSE BPM REPORT CONFIG MACHINE CLOSE Select CLOSE to return to the IDLE view. the Yellow Connector is replaced in its Rinse Port on the front panel of the machine.front of machine: The uptake of disinfectant is via the Yellow Connector on the front panel. Disinfection . A brief list is as follows: CHEMICAL DISINFECTION A. This disinfection cycle includes the entire hydraulic circuit. The PHOENIX machine is able to perform a variety of ADR procedures. Disinfection . B . B.1 Disinfection • Select the ADR Selection key on the IDLE view.rear of machine: Uptake of disinfectant is from the chemical container stored on the rear of the machine. SECTION 6 . D. Rev. RINSING Fresh RO water flushes the hydraulic circuit. B . E. Heat citric disinfection – rear of machine: Performed by using citric acid drawn into the machine from the disinfectant container stored on the rear of the machine in combination with circulation of heated water through the hydraulic circuit. in combination with circulaton of heated water through the hydraulic circuit. Heat disinfection: Performed by circulating heated water through the hydraulic circuit.6-6 PHOENIX OPERATOR MANUAL DISINFECTION WITH HEAT (Not available on 12 A version) C. Heat citric disinfection – front of machine: Performed by using citric acid drawn into the machine via the Yellow Connector attached to the disinfectant container on the front panel. This section describes only the chemical disinfection process when selecting CHEM PERS 1 TO 4. Note Selection of the CHEM+CENTRAL BICARB LINE Action key initates the Central Concentrate Lines Disinfection process.2 Chemical Disinfection 6. for the complete description of this process.1 Disinfection 6. Refer to Section 03 .2.1. SECTION 6 .1 HOW TO PROCEED To perform chemical disinfection: • Press the CHEM PROCESS Selection key.CENTRAL CONCENTRATE SUPPLY. The control of the process continues by displaying the next view: 12:30 SELECT CHEMICAL CHEM PERS 1 CHEM PERS 2 CHEM PERS 3 CHEM PERS 4 CHEM+CENTRAL BICARB LINE BPM REPORT MACHINE CLOSE Note CHEM PERS 1 TO 4 represent the four customized chemical disinfection selections available. Selections made in the Config\ Chemical view allow a different set of parameters for each chemical disinfection selection.CLEAN/DISINFECT 6-7 6. B .2. Rev. if YES is selected. the machine turns OFF automatically. the machine is left filled with a dilute bleach or sodium hypochlorite solution. The number of parameters that appears on this view depends on the selections made in the Config\ CHEM PROCESS \Chemical selection view.6-8 PHOENIX OPERATOR MANUAL 6. only if the EXTERNAL JUG USE parameter is set to YES in the Config/Mach. B . unless the disinfection procedure is stopped.. RINSING TIME: when this parameter is set to a value between 15 min and 50 minutes. In this case a Bacteriostatic Disinfection is performed. AUTO OFF: if NO is selected. When this parameter is set to Bact. END PROCESS MODE: this parameter may be set on the Config\ADR\Chemical \Chemical selection view. the EXTERNAL JUG USE parameter allows the machine to uptake disinfectant from the chemical connector (yellow) on the FRONT of the machine or from REAR 1 or REAR 2 at the back of the machine. This parameter can be set to FRONT. or None. When this parameter is set to None. LIQUID INLET: This parameter specifies the line through which the uptake of disinfectant is performed. Note Each customized chemical disinfection type could have a specific set of parameters different from the others. During the process an alarm is triggered when the pH value is outside the range selected by the operator for the two parameters. pH Min and pH Max: these parameters appear only if the parameter pH MONITOR on the Config\ADR\CHEM PROCESS view is set to YES. the rinsing process is not performed automatically.Conf view. REAR 1 or REAR 2.1. When the END PROCESS MODE parameter is set to Bact. When set to NO the internal disinfectant tank is filled by drawing disinfectant from the Yellow Connector on the front of the machine. A brief list of the possible parameters follows: DISINF TIME: The default value for this parameter is the lowest value necessary to ensure disinfection of the machine when an approved disinfectant is used (see Section 9 – Specifications.1 List of Parameters and their meanings When the customized chemical disinfection type is selected a new view with the corresponding parameters appears. When set to YES. Rev. a rinsing phase is automatically performed. When this parameter is set to Rins. To change the parameter selection press the SET button.1.2.. The operator may therefore accept this time or increase it. at the end of the chemical disinfection process. at the end of the chemical disinfection. the machine returns to the IDLE view at the end of the process. the machine returns to the IDLE phase. at the end of the chemical disinfection process. the machine performs a RINSING process for the time set for the parameter RINSING TIME. in this manual). with the BiCart Holder Arms closed.2 HOW TO START THE PROCESS This procedure depends upon the selection of the parameters EXTERNAL JUG USE and LIQUID INLET: EXTERNAL JUG USE: NO LIQUID INLET: FRONT • Disconnect the Yellow Connector from its Rinse Port on the lower front panel of the machine and connect it to the Yellow Wand. Select the appropriate Chemical Action key. EXTERNAL JUG USE: YES LIQUID INLET: FRONT • Perform the previous procedure.1. The following view is displayed: 12:30 ADR PROGRESS DISINF TIME RINSING TIME min:s min:s END PROCESS AUTO OFF MODE PH VALUE LIQUID INLET BPM REPORT MACHINE CLOSE Rev. with the BiCart Holder Arms closed. Immerse the Yellow Wand into the disinfectant container. • Check that the all connectors (white. blue and yellow) are inserted in their Rinse Ports on the lower front panel of the machine. The BiCart Holder must be in the rinse position. • Check that the Concentrate Connectors (white and blue) are in their correct position in their Rinse Ports on the lower front panel of the machine.2. B . The BiCart Holder must be in the rinse position. Also verify that there is enough liquid to perform a disinfection procedure.CLEAN/DISINFECT 6-9 6. SECTION 6 . EXTERNAL JUG USE: YES LIQUID INLET: REAR 1/ REAR 2 • Ensure that the disinfectant connector (present on the rear of the machine) is correctly inserted in the disinfectant container located on the rear of the machine. The alarm will automatically clear and the disinfection procedure will restart. An Operator Message will appear: Emptying Disinfectant Tank And Repeat Filling Disinfectant Tank If LIQUID INLET is set to FRONT at the completion of disinfectant uptake. • Reinsert the Yellow Connector into its Rinse Port. the machine will automatically empty and refill the tank. Note If any problems occur while the disinfectant is being taken up into the internal tank. the following alarm message is displayed: Disinf Connector Position with an audible alarm (#47). the corresponding name appears highlighted in the status area. B . The machine uptakes approximately 180 ml of disinfectant to fill an internal tank.6-10 PHOENIX OPERATOR MANUAL Note After selection of the type of chemical disinfection. Rev. The current disinfection process begins disinfection of the hydraulic circuit of the machine. Note If the END PROCESS MODE parameter is set to None on the Config\ADR\Chemical view. the machine will automatically turn OFF after 30 minutes following completion of the DISINF TIME or RINSING TIME. • To prevent damaging the machine. do not leave the machine filled with disinfectant solution for a prolonged period: follow the same time limits. Note A disinfection process in progress has priority over a process programmed in the Config/ADR/AutoStart view. B . − When the machine goes into an alarm condition during an ADR process and the operator takes no action. Note When the machine goes into an RESTART alarm condition during an ADR process programmed by the AutoStart feature. No other automatic process will be performed until the operator will successfully complete a disinfection process that has been started manually. on subsequent SETUP the machine will not allow the selection of the DIALYSIS process. at the end of the chemical disinfection process.CLEAN/DISINFECT 6-11 6.2 Chemical Disinfection Process in progress The value of the DISINF TIME parameter automatically decreases as the process proceeds. Note At the end of a process programmed by the AutoStart feature. WARNING A disinfection process must be followed by a complete RINSING process.2. if the AUTO OFF parameter is set to YES. If the CLOSE Action key is pressed before the default time has elapsed. − When the CLOSE Action key is selected. for each disinfectant solution. An Operator Message will appear informing the operator than an alarm occurred. SECTION 6 . the machine will ignore this selection and will return to the IDLE view. the process is not considered complete. listed in the Section 9 – Specifications. If not. Rev. the machine will automatically return to the IDLE view 10 minutes after the alarm appearance. • Perform a complete RINSING process before the subsequent SETUP. the machine returns to the IDLE phase without performing a RINSING process. of this manual. Disinfection stops: − When the time value set for the DISINF TIME parameter is elapsed. 1 Heat disinfection 6. The following view is displayed: 12:30 HEAT SELECTION HEAT HEAT WITH CWP HEAT CITRIC BPM REPORT MACHINE CLOSE Rev. The BiCart Holder must be in the rinse position with the Arms closed.3.1. blue and yellow) are inserted in their Rinse Ports on the lower front panel of the machine.1 HOW TO PROCEED To perform a Heat Disinfection: • Check that all the connectors (white.6-12 PHOENIX OPERATOR MANUAL 6.3. B .3 Disinfection with heat (not available on 12 A version) 6. • Press the HEAT Selection key on the ADR view. 6°F). the machine returns to the IDLE view at the end of the process. The operator can therefore accept this time or increase it.1 List of Parameters and their meanings The default value of the DISINF TIME parameter is the lowest value necessary to ensure disinfection of the machine. or 1 minute after reaching the threshold temperature of 37°C (98. SECTION 6 . COOLING: When performing a standard Heat Disinfection. the machine will perform the cooling phase at the end of the Heat Disinfection process. Note The COOLING parameter can not be changed by the operator. B . Its value is automatically set by the machine with the selection of the Heat Disinfection process. the machine turns OFF automatically. the machine will perform only a brief rinsing/cooling phase (30 sec.1. press the SET button. The following view is displayed: 12:30 HEAT PROC.CLEAN/DISINFECT 6-13 • Select the HEAT Action key. When performing a Heat Disinfection using a Centralized Heat Disinfection System. AUTO OFF: If this parameter is set to NO. If set to YES. Rev.3.) at the end of the Heat Disinfection Process. if the parameter value is YES. the parameter value should be set to NO.1. 15 minutes after the beginning of the cooling phase. IN PROGRESS DISINF TIME AUTO OFF min:s COOLING YES BPM REPORT MACHINE CLOSE 6. To change the parameter selection. at the end of the brief rinsing/cooling phase (approx.2 CENTRALIZED HEAT DISINFECTION SYSTEM A Centralized Heat Disinfection System may be used. WARNING To be compatible with this feature the PHOENIX machine must be retrofitted with the CWP Adapter kit. 30 sec.). blue and yellow) are inserted in their Rinse Ports on the lower front panel of the machine. The following view is displayed: 12:30 HEAT PROC. • Press the HEAT Selection key on the ADR view and then press the HEAT WITH CWP Action key. IN PROGRESS DISINF TIME AUTO OFF min:s COOLING NO BPM REPORT MACHINE CLOSE When a Centralized Heat Disinfection System is used. B .3. Failure to use the CWP Adapter kit may result in damage to components in the PHOENIX machine. WARNING The temperature of the inlet water to the machine must be lower than 95°C (203°F). Rev.6-14 PHOENIX OPERATOR MANUAL 6. To perform a Heat Disinfection using a Centralized Heat Disinfection System: • Check that all the Connectors (white. even if the liquid is not cold. The BiCart Holder must be in the rinse position with the Arms closed.1. the selection of the AUTO OFF parameter to YES causes the machine to turn OFF. 2 Heat Citric disinfection 6. EXTERNAL JUG USE: YES LIQUID INLET: FRONT • Perform the previous procedure.3. with the Arms closed.3. • Disconnect the Yellow Connector from its Rinse Port on the lower front panel of the machine and connect it to the Yellow Wand. SECTION 6 . • Check that the Concentrate Connectors (white and blue) are in the Rinse Ports on the lower front panel of the machine. with the Arms closed. EXTERNAL JUG USE: YES LIQUID INLET: REAR 1/ REAR 2 • Press the HEAT Selection key from the ADR view and then select HEAT CITRIC. Immerse the wand into the citric acid container.2. The BiCart Holder must be in the rinse position.CLEAN/DISINFECT 6-15 6.1 HOW TO PROCEED This procedure depends upon the selection of the parameters EXTERNAL JUG USE and LIQUID INLET: EXTERNAL JUG USE: NO LIQUID INLET: FRONT • Press the HEAT Selection key on the ADR view and then select HEAT CITRIC. Rev. blue and yellow) are inserted in their Rinse Ports on the lower front panel of the machine. The BiCart Holder must be in the rinse position. • Ensure that the Disinfectant Connector (present on the rear of the machine) is correctly inserted into the citric acid container located on the rear of the machine and that there is enough liquid to perform a disinfection procedure. B . • Check that the all Connectors (white. 6-16 PHOENIX OPERATOR MANUAL Select the HEAT CITRIC Action key. B . The alarm will automatically clear and the disinfection procedure will restart. it is important that only citric acid is used and no other disinfectant. Rev. A message is displayed: Emptying Disinfectant Tank And Repeat Filling Disinfectant Tank At the end of this process. The following view is displayed: 12:30 DISINF TIME AUTO OFF min:s LIQUID INLET PH VALUE BPM REPORT MACHINE CLOSE Note If any problems occur while citric acid is being taken up into the internal tank. • Reinsert the Yellow Connector into its Rinse Port. the machine will automatically empty and refill the tank. the following message is displayed: DISINF CONNECTOR POSITION with an audible alarm (#47). WARNING In the Heat Citric phase. 2. if YES is selected. This parameter can be set to FRONT.3. SECTION 6 . To change the parameter selection. LIQUID INLET: Identifies the line through which the uptake of citric acid is performed. Rev. B . the machine returns to the IDLE view at the end of the process. REAR 1 or REAR 2. press the SET button.CLEAN/DISINFECT 6-17 6. AUTO OFF: If NO is selected.1. the machine turns OFF automatically.1 List of Parameters and their meanings pH Min and pH Max: These parameters appear only if the parameter pH MONITOR on the Config/ADR/HEAT/HEAT CITRIC view is set to YES. An Operator Message will appear informing the operator that an alarm occurred. B . the machine will ignore this selection and will return to the IDLE view. Rev. During whole process heat water flows in the Hydraulic circuit. − When the machine goes into an alarm condition during Disinfection and Rinsing and the operator takes no action. In order to alert the operator the following message appears: “Don’ t remove any connectors: hot water” Disinfection stops: − When the time value set for the DISINF TIME parameter is elapsed. − When the CLOSE Action key is selected. No other automatic process will be performed until the operator successfully completes a disinfection process that has been started manually.3 Heat/Heat Citric Process in Progress (not available on 12 A version) The value of the DISINF TIME parameter automatically decreases as the process proceeds.6-18 PHOENIX OPERATOR MANUAL 6. Note A disinfection process in progress has priority over a process programmed in Config/ADR/AutoStart. if the AUTO OFF parameter is set to YES.3. the machine will automatically return to the Idle view 10 minutes after the alarm appearance. the machine will automatically turn OFF 30 minutes after completion of the DISINF TIME or RINSING TIME. Note At the end of a process programmed by the AutoStart feature. Note When the machine goes into an alarm condition during an ADR process programmed by the AutoStart feature. the machine will turn OFF automatically. if it is set to YES. To change the parameter selection. with Arms closed. SECTION 6 . the machine will return to the IDLE view at the end of the process. The default value is the lowest one which will ensure rinsing of the machine. for the complete description of this process.4 Rinsing To perform this process: • Select the RINSING Action key on the ADR view: 12:30 IDLE: SELECT ADR CHEM PROCESS HEAT RINSING CCK LINES RINSE BPM REPORT CONFIG MACHINE CLOSE Note Selection of the CCK LINES RINSE Action key initates the Central Concentrate Lines Rinse process. • Set the appropriate value for RINSING TIME using the SET button. blue and yellow) are inserted in their Rinse Ports on the lower front panel of the machine.CENTRAL CONCENTRATE SUPPLY. The BiCart Holder must be in the rinse position.CLEAN/DISINFECT 6-19 6. B . This section describes only the Rinsing process when selecting the RINSING Action key. Rev. Refer to Section 03 . press the SET button. • Check that all connectors (white. AUTO OFF: If this value is set to NO. Therefore this time can be accepted or increased. 6-20 PHOENIX OPERATOR MANUAL The process now begins and the following view is displayed: 12:30 ADR PROGRESS RINSING TIME AUTO OFF min:s BPM REPORT MACHINE CLOSE During Rinsing. B . the following operator message will appear: Emptying UF Vessel forced The process time will be increased. Note When the UF Vessel Level Detector Test fails. the machine performs the UF Vessel Level Detectors Test. Rev. CLEAN/DISINFECT 6-21 6.5 ADR Action Keys availability Depending on the correct or incorrect completion of the last ADR process performed. the machine will automatically turn OFF 30 minutes after completion of the DISINF TIME or RINSING TIME. before connecting a dialyser. the machine returns to the IDLE view. When the time value set for the RINSING TIME parameter is elapsed. Note At the end of a process programmed by the AutoStart feature. the machine will ignore this selection and will return to the IDLE view. if the AUTO OFF parameter is set to YES. SECTION 6 . the process is not considered complete. the following ADR Action keys are available: Rev. When this process has been completed. The process stops: − When the time value set for the RINSING TIME parameter is elapsed. − If the CLOSE Action key is pressed. − When the machine goes into an alarm condition during Disinfection and Rinsing and the operator takes no action. B . Note A rinsing process in progress has priority over a process programmed in Config/ADR/AutoStart. If the CLOSE Action key is selected before the default time has elapsed. 6. Note When the machine goes into an RESTART alarm condition during an ADR process programmed by the AutoStart feature.1 Rinsing in progress The value of the RINSING TIME parameter automatically decreases as the process proceeds. An Operator Message will appear informing the operator than an alarm occurred. No other automatic process will be performed until the operator successfully completes a disinfection process that has been started manually. the machine will automatically return to the IDLE view 10 minutes after the alarm appearance.4. WARNING Verify the absence of residual disinfectant. the machine will perform a tank emptying phase. NOT Perf. Performed Correctly X Chemical Proc. Performed Correctly X X X X X X X Heat Proc. NOT Performed Correctly X X X X X X X Heat CWP Proc. NOT Performed Correctly (See Note 2) X X Rinse+Bicarb Line Performed Correctly X X X X X X X Rinse+Bicarb Line Not Perf. NOT Performed Correctly X X X X X X X Heat Citric Proc. Performed Correctly X X X X X X X Heat CWP Proc. Correctly X CCK Lines Rinse Performed Correctly X X X X X X CCK Lines Rinse NOT Performed Correctly X X X X X X Chem+Bicarb Line Proc. Correctly X Chem+Bicarb Line Proc. Performed Correctly X X X X X X X Heat Citric Proc. NOT Performed Correctly (See Note 2) X Heat Proc. Perf.6-22 PHOENIX OPERATOR MANUAL HEAT HEAT HEAT WITH CHEM CHEM+CENTRAL RINSING CCK LINES CITRIC CWP PROCESS BICARB LINE RINSE Rinsing Performed Correctly X X X X X X X Rinsing not Performed Correctly (See Note 1) X X X X X X X Chemical Proc. Correctly X (See Note 3) Rev. B . SECTION 6 . the process selection is cancelled and all the keys that were available before starting the Disinfection process will remain available. Note 3 When a Central Bicarbonate Line disinfection has not been correctly completed.CLEAN/DISINFECT 6-23 Note 1 When a RINSING process has not been correctly completed and the ADR process previously performed was a Chemical Disinfection or a Heat Citric Disinfection not correctly completed. only the RINSING Action key remains available. Rev. only the Central Bicarbonate Line disinfection can be performed. Note 2 When the CLOSE Action key is selected within approximately 30 seconds after the Disinfection process selection (Chemical or Heat Citric). B . • Acid/Acetate Connector. B . Rev. the Residual Disinfectant test performed at the drain hose of the machine does not reflect the quality of the rinsing of the PHOENIX machine and can give a positive result even if the PHOENIX has been rinsed correctly. • Obtain a sample for testing. at the end of RINSING or in SETUP prior to using the machine for a patient treatment.6-24 PHOENIX OPERATOR MANUAL 6.6 Verification of the Absence of Residual Disinfectant Samples for residual disinfectant concentration testing may be obtained. • Allow liquid to flow from the sampling connector for a few seconds to adequately rinse the sampling connector. from the following sites: • Dialysate line: remove the inlet dialysate line (blue connector) from its bypass port on the left side of the machine and collect a fluid sample. To take a sample from the Acid/Acetate Connector: • Insert the Sampling Connector into the red Acid/Acetate Rinse Port. Note Due to the fact that the internal volume of the PHOENIX machine is less than 750 ml and the drain hose may have a volume of between 300 ml and 600 ml. CLEAN/DISINFECT 6-25 6. • Alternately. as shown in Figure 6. Rev.7 Water Inlet Line Disinfection 6. • Turn OFF the machine and leave the water inlet hose filled with the disinfectant solution for a period of time sufficient to achieve microbiocidal efficacy. it is recommended that the following special cleaning/disinfection procedure is performed.7.25% sodium hypochlorite solution in 500 ml of room-temperature treated water) in a chemical- resistant container. • Prepare a dilute sodium hypochlorite (bleach) solution (15 ml of 5. Press the CHEM PROCESS Selection key and then select a customized disinfection key that corresponds to the uptake of disinfectant from the Yellow Connector on the lower front panel of the machine.7. in this manual. • Disconnect the machine’s water hose from the treated water supply and connect it to the connector on the pump device (on the left side of the device.1 General The segment of the water inlet line between the treated water supply and the end of the hose connected to the inlet port of the heater exchanger is not automatically cleaned/disinfected by the machine. Contact your Local Representative for information about where to obtain this device. • Turn ON the PHOENIX machine and enter the ADR/DISINFECTION mode.1. use the syringe on the pump device to pump the disinfectant solution into the inlet water line. Note Point the syringe downward during the emptying phase to prevent air from entering the water inlet line. or the components to assemble it. • Turn OFF the treated water supply to the PHOENIX machine. • Carefully disconnect the end of the inlet water hose from the pump device. • Repeat this operation until the disinfectant solution container is almost empty. B . • When the machine alarms because of the absence of water.2 Disinfection Procedure • Assemble a pump device with the components described in Figure 6. 6. or is in IDLE for a long period.1. If the machine is stored.) • Insert the free end (disinfectant suction line) of the pump device into the disinfectant solution container. completely fill the syringe with the disinfectant solution and then completely empty it into the water inlet line line by firmly pushing in the syringe plunger. switched OFF. but not for a period longer than the maximum time recommended in Section 9 – Specifications. SECTION 6 . • Remove Yellow Connector from its Rinse Port and allow it to hang unconnected. B .6-26 PHOENIX OPERATOR MANUAL • Switch the PHOENIX machine ON. Note To perform a test for residual disinfectant concentration. • Insert the Yellow Connector in the Rinse Port on the lower front panel of the machine. • Turn on the treated water to the PHOENIX machine. • The RINSING process will restart. • Reconnect the machine’s water inlet hose to the treated water supply system. Wait until the machine has completed the. Note It is recommended to avoid the selection of HEAT DISINFECTION process when disinfectant solution is present in the initial section of the machine’s hydraulic circuit. Rev. enter the ADR/DISINFECTION mode. RINSING process WARNING A disinfection process must be followed by a complete RINSING process. and select RINSING until the machine goes into an alarm condition due to the absence of water. Note The purpose of this operation is to empty the end of the water inlet hose to avoid disinfectant from contacting the treated water supply flowpath. • Proceed with the standard procedure to SETUP the machine for DIALYSIS. follow the “Verification of the Absence of Residual Disinfectant” Procedure described in this section. B .5 * 5. L = 200 mm PVC tube φ 4.8 mm.6 * 6. SECTION 6 .CLEAN/DISINFECT 6-27 NO return valves adaptor for the Disinfectant suction connection to the inlet water line Silicon “T” connector PVC tube φ 3.5 mm. L= 1000 mm 50 ml Syringe Figure 6.1 Rev. 8. Note If residual detergent/disinfectant remains on the surface of the machine after external cleaning. − Sodium hypochlorite solution (active chlorine from 50. The PHOENIX has been designed to function with a minimum of maintenance. All other deposits can be removed with a soft cloth dipped in a detergent/disinfectant solution.8 External Cleaning and Periodic Inspections The PHOENIX must be cleaned as often as required by operating conditions and the facility’s protocol. as well as frequency and duration of use determine the required cleaning frequency. B . − Ethyl Alcohol (90%). − Isopropyl alcohol (70%). 6.000 ppm)/Bleach diluted with water at a ratio of 1:50. Rev.1 External surface cleaning The external surfaces of the machine to be cleaned are: • Blood Pump and the Line Clamp • Air Bubble Detector • Clamp Housings • Heparin Pump Syringe Holder • Arterial and Venous Pressure Sensors • BiCart Holder • Dialyser Holder • Single Needle Holder • the WHO Drain Port and WHO door • the Touchscreen Particles and dust on the external surface of the machine can be removed with a soft cloth or brush. The ambient conditions. Detergents/Disinfectants have to be removed from the external surface of the machine only after the minimum dwell time for cleaning is elapsed (refer to the detergent/disinfectant instructions for use for the minimum dwell time recommended to guarantee an effective cleaning).000 to 60. it has to be removed with a soft cloth dipped in water to avoid damaging or discoloring the plastic parts of the machine. The following detergents/disinfectants are suggested: − Liquid soap.6-28 PHOENIX OPERATOR MANUAL 6. Avoid chemicals containing benzene.000 ppm)/Bleach diluted with water at a ratio of 1:50. The CLEANING SCR Action Key disables all the Touchscreen functions for 10 seconds. The length of the immersion depends on the disinfectant concentration used. WARNING For the Touchscreen cleaning use the following disinfectants: • Isopropyl alcohol (70%). 6. the machine components must be thoroughly rinsed with treated water to remove all disinfectant residuals. toluene. xylene.CLEAN/DISINFECT 6-29 Note The PHOENIX Touchscreen may also be cleaned when the machine is switched on. allowing the Touchscreen to be wiped with a soft cloth without activating any Action keys. WARNING Any liquid spilt on the machine must immediately be removed to prevent it from seeping into the machine. acetone or similar solvents. WARNING Do not use Sodium hypochlorite to clean the Blood Pump Crank to avoid damaging the metallic parts of this component.2 External components Cleaning It is advisable to clean periodically certain external components of the machine. Rev. • Sodium hypochlorite solution (active chlorine from 50.000 to 60. B . WARNING Do not use chemicals which might damage the plastic parts of the machine.8. such as: • Dialysate Connectors • Concentrate Connectors • Chemical Connectors • Concentrate Wands by immersing them in a disinfectant solution. The frequency of this cleaning procedure depends on the use of the machine. Press the Machine Navigation Key. SECTION 6 . then the CLEANING SCR Action Key. on the operating conditions and the ambient conditions. prior to using them during dialysis. After the immersion in the disinfectant solution. the proper immersion time is related to the disinfectant dilution used. from blood leakage from the bloodline or from the dialyser (including blood leak into the hydraulic circuit) the components listed above must be cleaned by immersing them into a disinfectant solution or by exposing them – except the Concentrate Wands .SPECIFICATIONS. Peresal™. 48 hrs for: formaldehyde solution and Steridial™.to a steam sterilisation procedure (121°C for at least 30 minutes). When the dilution is the same as that used in the machine during DISINFECTION. One week for: Sodium Hypochlorite at Bacteriostatic strength (1:750 dilution). for example. do not leave them immersed in the disinfectant solution for a prolonged period. follow the same time limits: 4 hrs for: Amuchina™. Instrunet HD™ and Sodium Hypochlorite at Disinfectant strength (1:25 dilution). Concentrate Connectors and Chemical Connectors in order to avoid damages to those components and leakages from those components. (For further information see Section 9 . B . 24 hrs for: Dialox™. Acetoper™. Actril® and Renalin®.6-30 PHOENIX OPERATOR MANUAL WARNING To prevent cross-contamination problems resulting. in this Operator’s Manual). WARNING To prevent damage to the components listed above. Careful attention must be paid to dismounting and re-mounting Dialysate Connectors. Rev. 3 Visual inspection The machine must be periodically inspected (at least once a week) to check for: • Broken or damaged switches • Broken or twisted power supply cables • Cracks in the structure • Corroded metal parts • Unattached loose or missing hardware • Blood Pump Rotor damage and that the Rotor surface remains smooth • Damage to the Arterial and Venous Pressure Port seals and that their surface is smooth If any of the damage listed above is noted. WARNING After a prolonged period of storage. until the damage has been repaired and the machine is in proper working order. the water line should be disinfected and rinsed.8.8. B . the machine must be kept in a safe place such as a closet free from dust. Avoid storing in conditions of high humidity. in this manual. If machine is stored for more than 7 days.4 Storage When not in use. it is suggested to carry out a chemical bacteriostatic disinfection at least once per week. To perform chemical disinfection refer to “6. WARNING Stagnant water may contaminate the machine. in ambient conditions.2 Chemical Disinfection” in this section. Rev. 6. Service must be called to return the machine to proper working order. If the machine will be stored for an extended period. as recommended in the Section 9 – Specifications. avoid using the machine. Only store at temperatures below 0 °C when the hydraulic circuit has been completely emptied.CLEAN/DISINFECT 6-31 6. SECTION 6 . Avoid storing in busy areas where the machine may be moved or knocked over. • Pay careful attention to ensure that no grease enters inside the metal stems: grease in the stems may result in false pressure readings. B . (See Figure 6.2). To inspect and grease the O-rings proceed as follows: 1. Refer to the two procedures described below.8. The silicon grease can be applied either manually or using a grease Dispenser. Remove possible grease in excess using an alcool based solution (refer to the list of chemicals for external cleaning suggested on this section). • Grease the 4 O-Rings to improve the seal to the Cartridge and reduces wear of O-rings. Replace the O-Rings if necessary. Check. damage or wear.5 Cartridge Holder O-Rings Inspection and Greasing Every 2 weeks it is necessary to: • Check the four O-rings on the Cartridge holder pressure monitoring sensors for nicks.6-32 PHOENIX OPERATOR MANUAL 6. Apply a very thin coating of silicon grease (PHOENIX spare part code 6975395) all around the four O-Rings. damage. 3. that the O-Ring surface and the metal stems are free from any extraneous particles and check for nicks. Figure 6.2 Rev. 2. Manual Greasing procedure • Place a small quantity of silicon grease on your finger and apply it uniformly all around the O-Rings. or wear and replace them if necessary. B .4 4. • Screw the Grease Dispenser to the silicon grease tube and then insert the pin of the Grease Dispenser in the pressure coupling hole (See Figure 6. (See Figure 6. SECTION 6 . Figure 6. Rev. • Verify that a thin quantity of grease has been applied all around the O-Ring. • Press the silicon grease tube to allow a thin quantity of grease exits and rotate the tube twice.3 • Press firmly to fit the Grease Dispenser against the pressure coupling.3). Figure 6. • Remove the Grease Dispenser.CLEAN/DISINFECT 6-33 Procedure with Grease Dispenser: • Ensure that no grease is present on the Grease Dispenser (spare part code 6977854) around the Grease Dispenser pin. that the front of the couplings and the holes in the metal steams are free from any extraneous particles and exceeding grease.4). Check. B .6-34 PHOENIX OPERATOR MANUAL This page is left intentionally blank Rev. COMMUNICATION SYSTEM 7. Depending on the configuration of the unit. This chapter refers to programs running on a Personal Computer connected to PHOENIX. Rev.7 COMMUNICATION SYSTEM 7. the output may be as follows: 1. SECTION 7 . press the Report Navigation key. The programs able to manage the PHOENIX Communication System and described in this section are: CentryNet system Data Collection software Exalis Dialysis Management Tool Refer to each software’s manual for a detailed description of the program. the user can mark different patient related events that occur during the treatment (incidents. In addition. The communication system is able to transfer to different media the results of data acquired during a dialysis treatment. and the type of acquisition system the PHOENIX will be connected to. An internal backup memory. The system is designed to be compatible with different data acquisition systems running on external networks. The PHOENIX is also able to display a run-time dialysis report on the Touch Screen. 2. medication and medication dose) in order to highlight them on the dialysis report. intake. refer to the proper software’s manual for a detailed description of the program features. If the PHOENIX machine is connected to the RIMS system or if programs other than CentryNet system Data Collection software and Exalis Dialysis Management Tool are used. Note The communication system features are linked to an external system able to acquire data from PHOENIX. containing the data acquired since the start of the treatment. B . A personal computer or network directly connected to the PHOENIX dialysis machine (for example CentryNet or Exalis system). including the Exalis System. To view this report. This function would be processed by a dedicated PC program (Exalis).1 General Description Note This Section contains references to all the communication software systems to which the Phoenix machine can be connected. B . but it cannot be considered as the sole data to prescribe any therapeutic or pharmacological action for the patient. WARNING The present software allows information to be gathered about individuals and the user must be aware that the use of the information processed or generated by the software is restricted in most countries by legal dispositions such as the Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995. As the PHOENIX provides only conductivity information (in mS/cm). It is the responsibility of the physician to verify all data. Rev. WARNING The CentryNet system displays on its treatment screens the concentrations for two conductivity related values (Sodium Level and Bicarbonate Level) in mEq/Liter.7-2 PHOENIX OPERATOR MANUAL WARNING PHOENIX makes available the dialysis related data through connection to various external devices for storage and display. The intended use of this information is to support the physicians. Refer to Section 9 – Specifications of this manual for the exact relation between concentration and conductivity.6 mS/cm will be recorded in CentryNet as a Sodium Level of 136 mEq/Liter. A Final conductivity of 13. the CentryNet entries for Sodium will be approximate values obtained by multiplying the Final conductivity (mS/cm) by 10. The user shall therefore take all necessary measures to ensure the confidentiality of the information which is monitored by means of the software. The PHOENIX can store up to 3 or 4 treatments. Data storage The PHOENIX Config environment allows the user to select the data storage mode for the records acquired by the acquisition task. which can be personalised via a personal computer. Instantaneous acquisition The system is able to transfer the real time machine status. The PHOENIX has a default pre-setting for this type of acquisition. typically 5 minutes.2 Exalis Functional Description The information in this section is valid when the PHOENIX unit is configured for Exalis. The records are saved in the backup memory. The operation of the PHOENIX machine when used with the CentryNet Data Collection System is described in the CentryNet System Connection section.e. Rev. depending upon the acquisition sample time(s). B . Alarm acquisition The system is able to immediately acquire information regarding alarms active on the equipment. Exalis includes: Synchronous acquisition The system is able to define a sampling time. The systems use different data acquisition methods. SECTION 7 . Asynchronous acquisition The system can be configured to define threshold limits for those machine parameters which can be acquired. The system acquires the whole machine status at the moment a parameter exceeds its threshold limit. Operating phase acquisition The system is able to record the input and the output from the different operating phases of the machine. alarms and events. and a storage buffer dimension for each machine parameter that can be acquired. Event recording includes alarm activation and their reset.COMMUNICATION SYSTEM 7-3 7. The system also acquires this status when the parameter returns within its threshold limits. i. which is the “data acquisition” state. Note This chapter mentions a defined machine operating condition. Thus it refers to start and stop conditions of this state. the following table will apply: Rev. B . Depending on this selection.3 CONFIGURATION of Communication Environment The configuration of the Communication environment is described below. 7. Stop of acquisition: confirmation of the EMPTYING Action key. These events are: Start of acquisition: DIALYSIS phase running after PAT CONNECT. The first choice to be made is the type of acquisition system that will be connected to the PHOENIX: • CentryNet system • Exalis system • RIMS system • OTHERS • NONE Note Any modification in the type of acquisition system must be done when no PC is connected to the PHOENIX and the communication between the acquisition system and the PHOENIX has not been activated.7-4 PHOENIX OPERATOR MANUAL Storage on backup memory This mode records all the data in the backup memory of the equipment so that it can be retrieved later by the appropriate PC program (Exalis). 0.21. SECTION 7 . (fixed to RS485 Default Ethernet • Seriall Serial communication) BAUD RATE • 9600(default). If NetworkType == 2400.255.255.0) CCM IDENTIF Selectable from 1 to 255 (default 50) STATION ID Selectable from 1 to 255 (default 50) AUTOCHART TIME Selectable from 0 to 1 hour (steps of 15 minute (default 30) increments) OFFLINE TIMEOUT Selectable from 00:10 to 04:15 Coordinate with the (1:30 min:sec or 5 (Note 1) min:sec. The parameter applies and is enabled (displayed in Config \Communic. Recommended minimum value = 1:30 min:sec EXT SYNCHRO From 00:00 to 01:30 min:sec in step of 5 sec.250) Ethernet Ethernet SUBNET MASK/ From 0 to 255 for each field If NetworkType == If NetworkType == SUBNET MASK (default 255. (default: 1:30 min:sec) setting in Exalis install which ever is larger) setup.31) NET ROUTE1/NET From 0 to 255 for each field ROUTE1 2nd/3rd/4th (default 0.A.4. If NetworkType == N.0) Ethernet Ethernet 2nd/3rd/4th GATEWAY/GATEWAY From 0 to 255 for each field 2nd/3rd/4th (default 10. “Poll Delta Time” seconds/station.COMMUNICATION SYSTEM 7-5 Parameter Values Exalis CentryNet RIMS OTHERS NONE SW COMM SYSTEM • CentryNet If NetworkType == • Exalis Ethernet • RIMS • OTHER • NONE (default NONE) NETWORK TYPE • Ethernet Default Ethernet N.21.0.4.0) MASK ROUTE1/MASK From 0 to 255 for each field ROUTE1 2nd/3rd/4th (default 0. 1200 Serial (fixed to 9600 baud Serial for CentryNet) IP ADDRESS From 0 to 255 for each field If NetworkType == If NetworkType == 1st/2nd/3rd/4th (default 10. 4800. view) Rev.0.0. B .A. menu (GATEWAY. for the SW COMM SYSTEM parameter. is dedicated to the PHOENIX machines connected to software systems other than CentryNet. for a detailed description of the parameters to be set).used if the network connection is Ethernet. NETWORK TYPE: Selection of the hardware network topology. CCM IDENTIF: Communication code (CCM) that uniquely identifies the PHOENIX within the network system. NET ROUTE1/NET ROUTE1 2nd/3rd/4th: parameter for internal use. B . for a detailed description of the parameter meaning with the CentryNet communication system. Note The choice “OTHER”. SUBNET MASK/SUBNET MASK 2nd/3rd/4th: Subnet Mask for the machine. the values set for the IP ADDRESS 1ST and SUBNET MASK parameters must be entered also in the machine Calibration environment by a service technician (Refer to Section 8. is dedicated to the PHOENIX machines not connected to communication systems. in this section. NET ROUTE1 and MASK ROUTE1) are required only for some data communication software. MASK ROUTE1/NET ROUTE1 2nd/3rd/4th: parameter for internal use. If the acquisition system connected to the PHOENIX machine is the Exalis system. Each PHOENIX must have a unique identifier. STATION ID: Code that identifies the placement of the PHOENIX within the clinical network setting. Note Certain parameters on the Communic. The choice “NONE”. refer to “7.7. Rev. Note In order to allow a proper configuration of the communication environment. GATEWAY/GATEWAY 2nd/3rd/4th: parameter for internal use.5 CentryNet Option Screen Setup Keys”. in the PHOENIX Service Manual. Contact a Gambro authorized technician to determine if the parameters are relevant to your software. Exalis and RIMS system. the STATION ID parameter configuration allows to display of each PHOENIX location in the Exalis room overview window. Each PHOENIX must have a unique identifier. Each PHOENIX must have a unique identifier. BAUD RATE: Selectable by the user depending on the communication speed required by the external software system program (default 9600 BAUD) IP ADDRESS 1st/2nd/3rd/4th: TCP/IP Configuration Address of the unit .7-6 PHOENIX OPERATOR MANUAL SW COMM SYSTEM: Selection of the software system to which PHOENIX will be connected. for the SW COMM SYSTEM parameter. If the acquisition system connected to the PHOENIX machine is the CentryNet system. SECTION 7 . must be calculated using the following formula: Time = 3 x Poll Delta Time x Number of machines Where “Poll Delta Time” is an Exalis configuration parameter and “Number of machines” is the number of machine stations in the network. for Exalis. • Exalis: Timeout function used to signal a lack of communication with the Exalis software system. for CentryNet. Rev. The recommended minimum value is 1:30 min:sec. must be calculated using the following formula: Time = 5 x Number of machine stations EXT SYNCHRO: Timeout used at the switch ON of the machine to detect the network presence. B . Note 1 The OFFLINE TIMEOUT value. OFFLINE TIMEOUT: • CentryNet: Alarm timeout used to signal a lack of communication with the CentryNet software system. The OFFLINE TIMEOUT value.COMMUNICATION SYSTEM 7-7 AUTOCHART TIME: Sampling time used by the PHOENIX to automatically acquire records for CentryNet. 1 Patient Login For the Communication System the Patient Login is a unique event for each dialysis session. it cannot be re-triggered until the dialysis session is concluded or cancelled.4. Note If a Standard Dialysis has been selected and the LOGIN Action Key has not been pressed. after selecting the SETUP Action key. Automatic Patient Login In case of Patient/Rx Dialysis. press the Report Navigation key and then press the LOGIN Action Key.4 Options of the Communication System 7. the Patient Login event is automatically triggered.7-8 PHOENIX OPERATOR MANUAL 7. The Patient Login can be manual or automatic: Manual Patient Login In case of Standard Dialysis. When the Patient Login is activated. the LOGIN Action Key is enabled only after the SETUP Action key has been pressed. Rev. B . the Patient Login event is triggered automatically after pressing the PAT CONNECT Action Key. Note If a Standard Dialysis has been selected. after selecting a patient. the LOGIN Action key disappears until the subsequent dialysis session. Rev. This option allows the user to record data (manually or automatically) related to the patient’s weight and blood pressure before and after the dialysis treatment. SECTION 7 . B .COMMUNICATION SYSTEM 7-9 7. the system allows the user to input data. Depending on the operating phase of the equipment. The values that the acquisition system stores are: • PRE and POST WEIGHT • DELTA WEIGHT • PRE and POST LYING SYST • PRE and POST LYING DIAS • PRE and POST LYING PULSE • PRE and POST SIT SYST • PRE and POST SIT DIAS • PRE and POST SIT PULSE • PRE and POST STAND SYST • PRE and POST STAND DIAS • PRE and POST STAND PULSE Note This information has no effect on the treatment.4.2 PRE POST Dialysis data handling. Rev. -mmHg POST SITTING SYST .RATE mmHg POST STAND SYST .Kg TOTAL BLOOD .l TOTAL FLUID REMOVED -l HEPARIN TOTAL .mmHg DELTA WEIGHT . If the measurement has been taken by an external device. mmHg POST SITTING DIAS .mmHg POST WEIGHT .mmHg POST STAND DIAS . B .7-10 PHOENIX OPERATOR MANUAL PRE DIALYSIS DATA The time between the Patient Login event and the DIALYSIS Action key disappearance (after the RINSEBACK VOLUME value set has been reached) is dedicated to the pre-dialysis data input (automatic or manual entry). it is displayed in the view above and in the REPORT table (See the Dialysis Report section). if the value was inserted in SET mode.mmHg PRE SITTING SYST. all three Action keys become available again. if the Action key is pressed again.mmHg PRE SITTING PRE STAND DIAS mmHg POST STAND HRAT .mmHg PRE LYING HRATE .Kg PRE STAND HRATE .RATE . or the time the measurement was stored.mmHg PRE STANDING PRE SITTING H. the value can be manually entered using the SET button.ml REAL TREAT TIME -h:min REPORT SUMMARY The selection of the Action key related to the value to be stored starts the BPM measurement. then the Summary Navigation key.mmHg PRE LYING SYST mmHg POST LYING DIAS .mmHg PRE STAND SYST . The following view will be displayed: 12:30 POST LYING SYST . To enter the pre-dialysis data press the Report Navigation key. The pressure measurement is stored by the acquisition system.mmHg PRE SITTING DIAS mmHg POST SITTING H. Note When the operator selects one of the three Action keys.Kg PRE LYING PRE WEIGHT .mmHg PRE LYING DIAS mmHg POST LYING HRAT . The pre-dialysis data can be changed any time by using the SET button before the EMPTYING phase. The REPORT table records the time that the measurement was taken. it becomes highlighted and the others disappear. in case of BPM measurement. h:min POST SITTING REPORT SUMMARY POST LYING The selection of the Action key related to the value to be stored starts the BPM measurement. SECTION 7 . then the Summary Navigation key. it becomes highlighted and the others disappear.mmHg POST SITTING H.mmHg PRE SITTING SYST .COMMUNICATION SYSTEM 7-11 POST DIALYSIS DATA The time between the DIALYSIS Action key disappearance (after the RINSEBACK VOLUME value set has been reached) and the Patient Login for the following dialysis treatment is dedicated to the post dialysis data input.Kg POST STANDING TOTAL BLOOD -l TOTAL FLUID REMOVED -l HEPARIN TOTAL .RATE . the Dialyser Replacement procedure will no longer be allowed for the current dialysis treatment.mmHg PRE STAND HRATE .mmHg POST LYING SYST .mmHg POST STAND DIAS .mmHg PRE LYING DIAS . B .mmHg POST SITTING DIAS . Rev.mmHg PRE SITTING H. all three Action keys become available again.ml REAL TREAT TIME .mmHg POST LYING DIAS . Note When selecting one of the three Action keys (POST STANDING/POST SITTING/POST LYING) before the EMPTYING Action key selection.RATE .mmHg PRE SITTING DIAS .mmHg PRE STAND DIAS . The following view will be displayed: 12:30 PRE LYING SYST . Note When the operator selects one of the three Action keys. The pressure measurement is stored by the acquisition system and is displayed in the view above and in the REPORT table (See the Dialysis Report section).Kg DELTA WEIGHT .mmHg POST LYING HRAT .mmHg PRE STAND SYST . To enter the post-dialysis data press the Report Navigation key. If the Action key is pressed again.mmHg POST STAND SYST .mmHg PRE WEIGHT -Kg POST WEIGHT .mmHg POST STAND HRAT .mmHg PRE LYING HRATE .mmHg POST SITTING SYST -. if the value was inserted in SET mode.7-12 PHOENIX OPERATOR MANUAL If the measurement has been taken by an external device. the following parameters are displayed as in the view above: • TOTAL BLOOD • HEPARIN TOTAL • TOTAL FLUID REMOVED • REAL TREAT TIME Note After the insertion of the PRE and POST WEIGHT the DELTA WEIGHT is automatically calculated and displayed in the POST DIALYSIS DATA view. Rev. or the time that the measurement was stored. The data can be changed any time before the Patient Login Login event (Patient/Rx key select. in case of BPM measurement. LOGIN) for the following dialysis treatment. When the post dialysis data has been specified. the value can be manually inserted using the SET button. B . The REPORT table records the time that the measurement was taken. The events recorded are stored by the acquisition system (for example Exalis).4.3 Event/Intervention Marking The PHOENIX communication system allows the user to record specific patient- related events. This feature is active only when the acquisition is running: starting from the selection of the DIALYSIS Action key (Start of data acquisition) until the confirmation of the EMPTYING Action key (Stop of data acquisition). which have occurred during the dialysis treatment. The following view is displayed: 12:30 INTAKES MEDICATION INCIDENT MED QUANTITY REPORT SUMMARY DATA EVENTS Rev.COMMUNICATION SYSTEM 7-13 7. The data recorded are displayed also in the Report view (see the Dialysis Report section). The user can enter the EVENTS environment by pressing the Report Navigation key. SECTION 7 . then the Events Navigation Key. B . MEDICATION) as follows: 12:30 INTAKES INCIDENT MEDICATION MED QUANTITY 150 CRAMPS NaCl 10 g mEq REPORT SUMMARY DATA EVENTS Note The MEDICATION and the MED QUANTITY parameter are strictly linked and must be inserted in sequence. The medication data and the related medication dose are stored by the communication system only if both the parameters. have been confirmed. B . including its typology.7-14 PHOENIX OPERATOR MANUAL By pressing the SET button the operator can store particular events that are related to the patient. Three main event groups are identified (INTAKES. timing and value. MEDICATION then MED QUANTITY. INCIDENT. Rev. Dialysis Mode Change (SN and DN). LOGIN is pressed. BYPASS. BiCart Change.WLR MINIMUM. Whenever a new Patient Dialysis is selected and confirmed. after the last change) • Stop of Data Acquisition event • Post Dialysis data The data collection for a patient starts: • after the Patient confirmation in Patient Dialysis • after PAT CONNECT in Standard Dialysis • when the LOGIN Action key is pressed The data collected during a treatment remains available in the REPORT environment until one of the three events listed above occurs. the report shows: • Pre Dialysis data • Start of Data Acquisition event • BPM measurements • DIASCAN measurements • Selection/deselection of the UF ONLY Action key • Patient events recorded within the PHOENIX interface: SUMMARY and Events view • Start of particular procedures such as: Dialyser Replacement. Rev. Acid Concentrate Supply Change.4. B . • Selection/deselection of the Action keys: PAUSE THERAPY. or PAT CONNECT is selected (in Standard Dialysis). • Occurrence of particular alarms such as: “No Power”. the REPORT table is emptied and is filled in with the data of the current dialysis session. In particular. “No Water” • Selection of the SNAPSHOT Action key in the Report view • Pump speed changes (the values is stored 30 sec.COMMUNICATION SYSTEM 7-15 7.4 Dialysis Report The Dialysis Report contains a “snapshot” of some parameters related to specific machine and patient events. SECTION 7 . WASHBACK completion. Change to the use of Liquid Bicarbonate dialysate. PSpeed (Blood Pump speed). PRE LYING MEAS -. -. Kt. -. it is a “reminder” for the operator. Art P (Arterial Pressure). is displayed in two different ways: • the “Time” column displays the time of the event recorded as time elapsed from the Start of Acquisition event. Qd (Dialysate Flow). The SNAPSHOT Action key allows recording a generic event. TMP (only displayed in DN). Rev. Cond (Conductivity). PRE STANDING MEAS -. The following view is displayed: Clk Ven P Art P BFlow Time Syst Dias Hrate Event Descrr Qty Unit LOGIN Time -. -. Some of the data recorded for each event can be seen only by pressing and keys: Ven P (Venous Pressure). T Hep (Total Heparin infused). Using the PAGE UP . Dep V. the data pointer is placed onto the last event recorded. LP (Liters Processed). Stroke (Stroke Volume in SN). -. Pl Con (Plasma Conductivity). B . DOWN keys the user can scroll through the Events list. -. Kurea (Clearance). • the “Clk Time” column displays the clock time of the event. -. UF R (UF Rate). UP . TWL (Target Loss). PAGE DOWN . BFlow (Real Blood Flow). The time in which each event has occurres. Note Modifications in the Blood Pump Speed are stored in the Report view only 30 seconds after the last change in the Pump Speed value.7-16 PHOENIX OPERATOR MANUAL The user can enter the REPORT environment by pressing the ReportNavigation key. PRE SITTING MEAS SNAPSHOT REPORT SUMMARY DATA EVENTS When the user enters this view. then the Data Navigation Key. ml/min TOT WEIGHT L Kg TMP mmHg WEIGHT LOSS/H Kg/h END DIALYSIS TWL TOTAL BLOOD l BLD SENS HIGH CONDUCTIVITY mS/cm STROKE VOLUME ml BICART COND mS/cm REPORT SUMMARY DATA EVENTS Note The STROKE VOLUME parameter is displayed only if performing a Single Needle dialysis. B .4. SECTION 7 . The following view is displayed: 12:30 DIALYSIS TIME h:min TEMPERATURE °C DIFFUSION TIME h:min pH VALUE TOTAL FLUID REMOVED Kg DIALYSATE FL. Rev. The user can enter the Data environment by pressing the Report Navigation key.COMMUNICATION SYSTEM 7-17 7.5 Dialysis Treatment Data This view displays a list of some relevant dialysis parameters. 5.1 General Description The PHOENIX machine allows the user to start a dialysis treatment with a treatment prescription received from a Personal Computer (Exalis software).5. which is configured for transfer of the patient prescription. .2 Functional Specifications If the PHOENIX is connected to the Exalis System.5 Prescription Download with the Exalis System WARNING The present SOFTWARE must be used exclusively with the authority of a physician. 7.7-18 PHOENIX OPERATOR MANUAL 7. the PAT NETWORK Action key selection (in the PATIENT CHOICE view) starts the procedure described below: 1) A keypad appears allowing the entry of the Patient Name: NEW NAME Area Q W E R T Y U I O P Lock A S D F G H J K L Shift Z X C V B N M .: \| ‘? ì^ èé[ +*] òç@ ù§ <> -_ à°# BackSpace << Space >> AltGr PATIENT NAME UNDO Rev.. 7. B . who is solely responsible for the use of the information processed by the SOFTWARE. In the Machine view. Press ENTER To Proceed Press the CONFIRM button and repeat the Patient Name entry procedure.3 Error Messages related to Computer Prescription In the event of an error during the transfer of the prescription. 7. the PHOENIX warns the user with a specific superimposed window. • If at least one of the parameters in the patient prescription can not be accepted by the machine: Prescription Not Valid. • If an error occurred when trasferring prescription data from a personal computer: Timeout on Data Receiving. B . 3) The external Computer System retrieves the prescription assigned to that Patient Name from its database and sends it back to the PHOENIX. Press ENTER To Confirm And Proceed. Press CONFIRM to Proceed Rev. SECTION 7 .5.COMMUNICATION SYSTEM 7-19 2) The PHOENIX displays a message to signal that it is waiting for an external prescription. 4) PHOENIX displays the prescription received to the user for confirmation (it may be modified on the PHOENIX before starting the treatment) Note The Parameters not managed by the computer prescription are set with a default value. • If the Patient Name entered is not available in the Exalis database: Patient Not Recognized by Clinical Software Check the Patient Name and retry. the WRONG PRESC PAR: parameter displays the prescription parameter causing the failure. Press ENTER To Confirm And Proceed • If the connection between the PHOENIX machine and the personal computer is interrupted while transferring prescription data: Connection lost with Clinical SW. Please Access the Machine Page to Check the Wrong Parameter. Rev. It is necessary to pay close attention to these values and check their congruency. WARNING The PHOENIX machine can be programmed by receiving data through connections to various external devices. B . on the Touch Screen. it is displayed on the Touch Screen. It is the responsibility of the user to verify all the data before confirming it is correct. in alternative ways. all of the patient prescription will be discarded.7-20 PHOENIX OPERATOR MANUAL The operator must press the CONFIRM button to proceed the treatment. As soon as PHOENIX reads the data. Some important parameters relating to the safety of the patient are shown twice. 6 Communication Libraries Some information libraries (e. The modifications to the library apply when the PHOENIX machine is subsequently powered ON. SECTION 7 . B . The file transmission can be performed only when the PHOENIX is in the IDLE state.COMMUNICATION SYSTEM 7-21 7. Patient Events) are stored in a dedicated memory section of the PHOENIX system. Rev. During this transmission. the PHOENIX control panel is disabled and the user is informed accordingly on the Touch Screen.g. This data can be either downloaded or uploaded to/from the PHOENIX with dedicated application software. how it performs. Understanding the CentryNet system involves understanding what the CentryNet controller does. and how the collection of treatment data is managed when using the CentryNet software. how it communicates. The RS485 interface cards contain the necessary circuitry to receive incoming information from and transmit dialysis treatment data back to the network controller.7 CentryNet System Connection The CentryNet network consists of a series of CentryNet capable dialysis machines (PHOENIX. PHOENIX CentryNet Wall Outlet Host Computer (Optional) Network 1 CentryNet (Max 32 Machines) Wall Outlet Network 2 (optional) Network Controller Centrysystem 3 CentryNet Wall Outlet Termination Printer (Optional) Assembly Typical CentryNet Network Configuration Rev. B .7-22 PHOENIX OPERATOR MANUAL 7. Centrysystem 3) with RS485 Network Interface Cards. e. • The CHARTS Action key is pressed. The CentryNet-collected data for such a treatment will be incomplete. and whenever the machine enters DIALYSIS. the treatment data collection may be prematurely concluded. • All REPORTS and BPM data.. data-generating tasks between treatments. • Machine status changes..COMMUNICATION SYSTEM 7-23 7.7. or when the CentryNet controller is started up or shut down. or both. B . • The blood pressure monitor fails to record a requested reading. The end data collection event takes place either when the operator presses the STOP COLLECT Action key or automatically at the Patient Login event for the following treatment.g. • Automatic readings taken at selected timed intervals. • The machine is taken into or out of the DIALYSIS mode. • Changes that may occur in the machine SETUP. • The Heart ♥ button on the Main Control Panel is pressed. i. SECTION 7 . When the PHOENIX machine is between treatments. the treatment will be “broken”. at START COLLECT. the operator should remember not to perform any therapy-related. sorts and stores data generated by the PHOENIX machine during the dialysis treatment.e. the CentryNet controller automatically collects data without operator assistance or intervention. If for any reason the operator does not press the START COLLECT and STOP COLLECT Action keys on the PHOENIX machine in the required sequence. Several functions initiate a reading of PHOENIX machine data: • Blood pressure readings taken at selected timed intervals. PHOENIX machines are cabled together for communication with a network controller. e. During DIALYSIS.g. treatment data is collected (as taken) for the following information: • Machine SETUP parameters.1 What CentryNet Does With the CentryNet option. At the end data collection event the CentryNet controller stops collecting data for that treatment and the treatment is summarized and “closed out” on the network controller. a specially configured computer that collects. or if data collection is interrupted for any mechanical reason. Rev. when a PHOENIX machine goes ONLINE or OFFLINE.. This data is organized into a Treatment Record run sheet format and can be sent to a printer. Therefore. a host computer system. the CentryNet controller collects no treatment data. After the operator presses the START COLLECT Action key. Rev. CCM IDENTIF. or “poll”.7-24 PHOENIX OPERATOR MANUAL 7. The CentryNet controller collects data based upon the following: • The ID SET: Unique data identifiers (per machine) that include theSTATION ID. CCM IDENTIF. If the CentryNet controller does not poll the PHOENIX machine at least once during the time established by the OFFLINE TIMEOUT setting. All treatment data generated for this treatment will contain these four data identifiers. PATIENT ID. PATIENT ID. the PHOENIX collects and stores treatment data and ultimately transfers the data to the network controller along the cabling that links the network controller and the dialysis machines. The physical location (the STATION ID) of a PHOENIX machine within a clinic determines the order for communication between the CentryNet controller and the PHOENIX units.2 How CentryNet Communications Work When using the CentryNet option with PHOENIX system. all four data identifiers (STATION ID. If any of these identifiers are changed during a treatment. When the operator presses the START COLLECT Action key on the PHOENIX machine. B . • The START COLLECT and STOP COLLECT Action keys initiate and close out the sequence number.” or prematurely ended. A series cable connects all the PHOENIX machines on a network. treatment data already collected in the network controller will be retained.invisible to the operator . the PHOENIX machine will display an alarm indication.corresponds to the chronological sequence of treatment data and will change only when a new treatment is started. which identifies specific treatment information with a particular machine (ID Set). and the sequence number) are sent to the network controller and logged in.7. and after the PATIENT ID value is confirmed. however. Note The sequence number .CentryNet Station Offline. the network controller considers the treatment “broken. Note The installation technician sets the CCM IDENTIF and the OFFLINE TIMEOUT limit within the PHOENIX machine at installation. The operator may not start or end data collection when this message is displayed. one machine at a time. and a sequence number to identify data with a specific treatment. In this type of network the network controller can only “communicate” with. SECTION 7 .. i.COMMUNICATION SYSTEM 7-25 7. ∗ Login the next patient.7. 3. Doing so will cause the treatment in CentryNet to be broken. the CentryNet network controller begins collecting data again for that machine only when the operator presses the PATIENT ID Action key. press LOGIN. Note Switching the CentryNet option Off ends data collection . Note Do NOT return to the IDLE view from SETUP after entering the PATIENT ID without first pressing STOP COLLECT. B . and confirm. 2.3 Operator Tasks and Guidelines for CentryNet The basic tasks the operator performs directly at the PHOENIX machine are: • Verify the physical location of the PHOENIX machine (theSTATION ID) • Perform the Patient Login (LOGIN Action key selection). Always conclude the treatment in the normal fashion (see above). Note Post Treatment measurements can be taken until the next Patient Login event. Note When data collection for a treatment terminates. A few simple rules aid the clinician when using the CentryNet option: 1.e. Rev. Always press the LOGIN Action key and enter a new PATIENT ID for each patient to start the collection of data for a treatment. • Conclude the treatment ∗ Press the STOP COLLECT Action key to manually end data collection for a treatment. • Press the START COLLECT Action key on the PHOENIX machine to start data collection for a treatment. Perform only those tasks between treatments for which data is neither required nor expected. or select PAT CONNECT (in Standard Dialysis). Note The PATIENT ID value cannot be inserted prior to the Patient Login event. select and confirm a new Patient/RX Dialysis.breaking the treatment. • Enter a unique PATIENT ID using the alpha-numeric keypad. Any data acquired will be transferred to Broken Treatments and unavailable in the Treatmens database in CentryNet. from the Home view (in IDLE view) press the Config Navigation key. B .7-26 PHOENIX OPERATOR MANUAL 7. The following view will be displayed: 12:30 IDLE CONFIG MACHINE CENTRE ADR TREATME PROFILE KT/V CONF NTS Rev.7.4 Configuring the unit with the CentryNet option To configure the PHOENIX machine for operation with CentryNet. the Communic.without it. the important items to verify are: • CCM IDENTIF Machine Identifier • SW COMM SYSTEM System type • OFFLINE TIMEOUT Polling Timer • AUTOCHART TIME Automatic interval CCM IDENTIF CCM IDENTIF is used to set the Machine Identifier for CentryNet. Pressing this parameter box activates the PLUS and MINUS buttons on the Main Control panel. SECTION 7 . The PHOENIX CCM IDENTIF must be set at installation . Rev. then press the SET button on the Main Control Panel to access the SET Mode. and allows the user to increase or decrease the CCM IDENTIF. The following view will be displayed: 12:30 IDLE CCM IDENTIF 50 SW COMM SYSTEM AUTOCHART TIME OFFLINE TIMEOUT CentryNet 00:30 01:30 min:s min:s IP ADDRESS 1st t IP ADDRESS 2nd IP ADDRESS 3rd IP ADDRESS 4th 50 20 10 50 SUBNET MASK SUBNET MASK 2nd SUBNET MASK 3rd SUBNET MASK 4th 50 10 10 20 For CentryNet.COMMUNICATION SYSTEM 7-27 Press the MACHINE Navigation key. This ID does not normally change throughout the use of the machine. B . the CentryNet system will not communicate with the machine. The CCM IDENTIF for each PHOENIX machine in a clinic must be a unique three-digit number. between 1 and 250. A record of CCM IDENTIF’s for each clinic should be kept so that new CCM IDENTIF’s do not duplicate any existing ones. Navigation key. Pressing this parameter box activates the Plus and Minus buttons on the Main Control panel. B . Pressing this parameter box activates PLUS and MINUS buttons on the Main Control Panel. Rev. The polling time must be set in the machine at installation to avoid unnecessary alarms. in this manual. set the polling timer to a higher value allowing more time before the Station Off-line alarm occurs. it may cause the PHOENIX to go into alarm as it goes off-line and online. The timeout setting calculates to be (15 x 5). or 75. Example 2: There are 30 machine stations in the network. however. use 90 in each. for the procedure to configure the SAMPLE INTERV.C . AUTOCHART TIME The AUTOCHART TIME parameter box allows the user to select when readings will be taken automatically for CentryNet. Insert this value (30) into the formula. 75 is the value that would normally be used for all machines on the network. If you set it at too short of a time span. therefore. Use the following formula: Time = 90 or (Number of stations x 5). whichever is greater Example 1: There are 15 machine stations in the network. The timeout setting calculates to be (30 x 5). Note The system also takes a REPORT reading according to the Blood Pressure Module sample interval. It must be set to CentryNet for the CentryNet system to communicate with this machine. REPORT readings are a snapshot of the machine’s operation at that moment. However. Note Do not set the polling timer to a value lower than the recommended default setting of 90.7-28 PHOENIX OPERATOR MANUAL SW COMM SYSTEM This parameter box activates a sub-view with several selections on it. or 150. OFFLINE TIMEOUT The Polling Timer: A defined period of time during which the CentryNet network controller must communicate with each machine. Insert this value (15) into the formula. 150 is the value to be used in all machines on this network. allowing the user to select an appropriate time interval setting. These items allow the user to select a destination for the data.Blood Pressure Monitoring. allowing the user to select an appropriate timeout setting. See the Section 5. a minimum of 90 is recommended. You may. the time between REPORT readings. SECTION 7 . is accessed by first pressing the Report Navigation key. 12:30 PATIENT ID STATION ID 0 0 CENTRYNET USE CCM IDENTIF YES 50 REPORT CENTRYNET Press the SET button on the Main Control Panel to enter the SET Mode.5 CentryNet Option Screen Setup Keys The CentryNet option. when active. 12:30 IDLE CENTRYNET USE STATION ID YES 0 Rev.7.COMMUNICATION SYSTEM 7-29 7. and then pressing the CentryNet Navigation key. B . The STATION ID key will now be present. Navigation key. no operator action is required. The CentryNet option can be switched OFF at any time during the treatment. To activate the parameter box. the CentryNet data collection function is active and begins immediately when the START COLLECT Action key is pressed. between 1 and 250. a new STATION ID must be entered to allow the system to correctly proceed with the station assignment. The CCM IDENTIF for each PHOENIX machine in a clinic must be a unique three-digit number. Finally. When the option is set to YES (ON).the STATION ID must be present as one of the active stations in the network controller. The CentryNet option can be switched ON at any time except when the machine is in the Dialysis mode. i. When the CENTRYNET USE option is set to NO (OFF). activating the CentryNet option during Dialysis is disallowed. STATION ID The STATION ID parameter box allows adjustment of the STATION ID for the machine. The PATIENT ID may not be changed after start of data collection. and then the Communic. Switching from ON (YES) to OFF (NO) abruptly interrupts data collection relating to the treatment in progress. CENTRYNET USE=NO.7-30 PHOENIX OPERATOR MANUAL CENTRYNET USE The CENTRYNET USE parameter box allows the operator to activate or deactivate the CentryNet option. The STATION ID is typically the number assigned to the physical location (the station) within the facility. press the SET button on the Main Control Panel to enter the SET Mode. The PATIENT ID entry keypad may be accessed through the REPORT screen. switch the CENTRYNET USE parameter box from YES to NO. when CentryNet polls that station the PHOENIX machine will respond automatically. The PHOENIX CCM IDENTIF is accessed (from the IDLE view) by pressing the Config Navigation key. Station assignment for the PHOENIX machine is automatic with CentryNet . These buttons allow the user to increase or decrease the STATION ID. It may be changed only after the treatment has been terminated. the PHOENIX machine always assumes the value previously assigned for the STATION ID. The value entered into the PHOENIX must correspond to this location. Pressing this box activates the PLUS and MINUS buttons on the Main Control panel. Values from 1 to 255 may be selected. If the PHOENIX machine has a valid STATION ID present in memory. data collection does not take place and all CentryNet alarm signals are deactivated. PATIENT ID The PATIENT ID can be a number from 0001 to 9999. CCM IDENTIF CCM IDENTIF is used to set the Machine Identifier for CentryNet. then the MACHINE Navigation key. Rev.e. Each patient should have his or her own unique ID. B . The STATION ID parameter box may not be present when first entering the SET Mode. Upon power up.. If the unit is moved within the facility. Once the desired PATIENT ID is entered it is possible to start data collection. The STATION ID may only be changed when the CentryNet option is Off. This must be accomplished before data collection can begin.6 Communication Icons relating to the state of the network link Several icons are associated with CENTRYNET USE. The following icons indicate the state of the CentryNet option: Use = NO Use = YES Use = YES CentryNet is Off CentryNet = On CentryNet = On Station = Offline Station = Online (When data is available. this icon is yellow and flashes until the controller has successfully taken all records. This icon warns the operator that there is no communication and data is not being collected by the network controller. and. or when the PHOENIX machine has not received a communication within the established time limit for the Offline Timeout (polling timer). CENTRYNET ON / STATION OFFLINE The STATION OFFLINE icon appears when CentryNet is active but communication between the network controller and PHOENIX does not occur. B . The icon indicates that the machine’s STATION ID and CCM IDENTIF are accepted by CentryNet. While this message is displayed. When there are records to be taken by the CentryNet network controller. no communication with CentryNet takes place. Rev. all CentryNet alarms are deactivated. Data from an incorrectly assigned station is not collected.7. CENTRYNET ON / STATION ONLINE The STATION ONLINE icon appears when the CentryNet option is active and effective communication is in progress. icon is yellow and flashes) CENTRYNET OFF The CENTRYNET OFF icon appears when the CentryNet option has been deactivated. SECTION 7 . The PATIENT ID Action key is disabled until the station is successfully assigned. Note A machine assignment must take place when a specific machine ID does not match the list in CentryNet. When the option is activated the CENTRYNET OFF icon is replaced by one of the following.COMMUNICATION SYSTEM 7-31 7. The assignment function takes place automatically when the PHOENIX machine and the CentryNet network controller begin communicating after (the machine has just been turned on and) a STATION ID has been entered. -. • It initiates the Patient Login event and clears previous data in the Report screen.7. PRE LYING MEAS -. PRE STANDING MEAS PATIENT ID -. Rev. PRE SITTING MEAS STOP COLLECT CHARTS REPORT SUMMARY DATA EVENTS LOGIN This action key (event) performs several functions for the communication system.7-32 PHOENIX OPERATOR MANUAL 7. • It enables the PRE-/POST. B . -. -.7 Operator Keys relating to the state of the treatment There are several Action keys that control when data is being collected. • If not already concluded.data-handling feature of the BPM system. • It allows the user to initiate a new treatment in CentryNet by activating the START COLLECT Action key and the PATIENT ID entry keypad. Clk VEN P ART P BFlow Time Syst Dias HRAT EVENT DESCR QTY UNIT LOGIN Time E -. • LOGIN • START COLLECT/PATIENT ID entry keypad • STOP COLLECT The Report screen provides access to these Action keys. -. it closes out (ends) the current treatment registered in CentryNet (as if the STOP COLLECT Action key had been pressed). -. -. It may. TREATMENT and ADR PROGRESS. The PATIENT ID may also be changed after the treatment has been terminated. Once the PATIENT ID is entered data collection begins. data collection has been ended. The PATIENT ID can be any number from 0001 to 9999. and assigns the data to the PATIENT ID for that treatment. be changed before dialysis has been initiated.. 123 << Clear >> 7 8 9 4 5 6 1 2 3 BackSpace 0 Enter the ID number through the keypad and press the CONFIRM button on the Main Control panel to confirm. It is normally available in all modes exceptIDLE. the START COLLECT Action key is not available for the following: • The Patient Login event has not been triggered. If an Rx selection key has been pressed the LOGIN Action key is not displayed – the START COLLECT Action key will be displayed. START COLLECT Pressing the START COLLECT Action key activates the PATIENT ID entry keypad. the PATIENT ID Action key. and then enter the new ID through the keypad and press confirm. Note The PATIENT ID may not be changed after the start of dialysis. B . a keypad appears allowing the entry of the PATIENT ID. PATIENT ID Keypad After pressing the START COLLECT Action key. SECTION 7 .COMMUNICATION SYSTEM 7-33 Note The Patient Login event is triggered automatically by pressing an PATIENT DATA Selection key in Patient/Rx dialysis. • The STOP COLLECT Action key has not been pressed. Rev. However. or by pressing the LOGIN Action Key in a Standard dialysis. . the LOGIN Action key. If a new PATIENT ID is required press the STOP COLLECT Action key. begins the collection of treatment data to the network controller.e. for this patient . i.follow the standard procedure for setting up a new patient. Pressing CONFIRM clears the treatment database in PHOENIX machine. however. • If any CentryNet alarms exist on the PHOENIX system. by pressing an Patient/Rx Management patient selection key. Doing so will cause the treatment in CentryNet to be broken. the STOP COLLECT Action key might become available only after the completion of the CentryNet polling loop and the downloading of all charts and related records from the PHOENIX machine. It appears after the PATIENT ID has been entered and data collection has begun. The CentryNet controller does not collect treatment data from a machine when it is in this mode Note The STOP COLLECT Action key is made available if certain conditions in the treatment are met. It is not available if any CentryNet alarms exist on the system... Any data acquired prior to the power-off will be transferred to Broken Treatments and unavailable in the Completed Treatments database in CentryNet. or pressing the PAT CONNECT Action key. Whenever the CentryNet option is turned OFF.e.7-34 PHOENIX OPERATOR MANUAL STOP COLLECT The STOP COLLECT Action key stops data collection and ends the treatment in CentryNet. Rev. This key may be pressed to manually conclude collecting data for a particular treatment (PATIENT ID). the machine is also “between” treatments. Doing so will cause the treatment in CentryNet to be broken. One condition includes a successful polling (status response) communication between the PHOENIX machine and the CentryNet software. Note Do NOT return to the IDLE view from SETUP after entering the PATIENT ID without first pressing STOP COLLECT. Note After STOP COLLECT and before PATIENT ID the PHOENIX is considered “between” dialysis treatments. As a consequence. i. pressing the LOGIN Action key. Another requires that all records from the treatment in progress have been collected by CentryNet. B . the availability of the STOP COLLECT Action key may be delayed under some conditions. Note Do NOT turn OFF the machine without first pressing STOP COLLECT. for example. or the operator may conclude the treatment automatically by setting up for the next patient. Any data acquired prior to returning to IDLE will be transferred to Broken Treatments and unavailable in the Completed Treatments database in CentryNet. Note The system also takes a CHART reading according to the Blood Pressure Module sample interval.COMMUNICATION SYSTEM 7-35 7. Rev. SECTION 7 . B .7. This chart record is identical to those automatically generated by the machine.8 Operator Keys relating to manual data collection There is one additional Action key that controls when data is collected. as defined by the time established in the AUTOCHART TIME interval. See the Blood Pressure Monitoring section of this manual for configuring the SAMPLE INTERV. • CHARTS CHARTS Pressing the CHARTS Action key triggers a chart record to be generated and sent to CentryNet. i.consists of full interaction. Data Collection . the station assignment is accepted and the PHOENIX machine automatically comes Online. • The CentryNet: Incomplete Data Collection (#323) alarm may occur if the CentryNet network controller has not received all records from the PHOENIX machine and an attempt to end the treatment has been made. For additional information see the CentryNet Operator’s Guide. parameters. B . However. Background Information for Investigating CentryNet Alarms Communication in the CentryNet network occurs as following: 1. Note See Section 8 .9 Alarm signals relating to CentryNet Several alarms may be generated regarding the CentryNet option.7-36 PHOENIX OPERATOR MANUAL 7. Possible Causes/Suggested Action. When the PHOENIX machine successfully detects communication the CENTRYNET STATION OFFLINE message is masked. data is not lost if the alarm-causing situation is corrected without breaking the treatment. Whenever the PHOENIX machine displays any CentryNet-related alarms during a treatment. Machine Actions..consists of the PHOENIX machine being able to send out an assignment request and correctly interpret the network controller's response.e. data collection is suspended. Machine Assignment . with the network controller requesting specific data from the PHOENIX machine and acknowledging the transmissions. Rev. PHOENIX machine cannot detect communications. • The CentryNet Station Offline (#322) alarm indicates a communication problem in the network. At that point the STATION ONLINE icon will display and the STATION ID ERROR message is masked. 3. It provides detailed information about status. • The CentryNet: Duplicate Station (#321) alarm will occur whenever one of the STATION IDs is duplicated on more than one machine in the network. 2.consists solely of the PHOENIX machine being able to detect communication on the network.Alarms and Signals in this manual for a detailed description of these alarms: Reason for Alarm. • The CentryNet: Station ID Error (#325) alarm indicates that a problem exists with the STATION ID assignment for a particular machine. and current charts data. Initial Reception .7. If received successfully. Press the Confirm button. press the PATIENT ID Action key and enter thePATIENT ID.and hold. • Press the Blood Pump ON/OFF button to start the Blood Pump. release + then release . release + then release . DIALYSIS TIME and the WEIGHT LOSS/H using the SET mode. • Reset the TOT WEIGHT L.COMMUNICATION SYSTEM 7-37 7. Starting a new data collection session Perform the following procedure to start a new treatment data collection session for the same patient and to restart the interrupted treatment: • Press the SETUP Action key • Follow the directions in the Operator Message Window: Press + and hold. • From the Report\CentryNet view. Note After a Fast Recovery of the Dialysis process.and hold.to restart interrupted treatment The machine will immediately go to the PATIENT CONNECT mode.to restart interrupted treatment The machine will immediately go to the PATIENT CONNECT mode. B . the DIALYSIS Action key becomes available only after properly entering the PATIENT ID. • Press the Blood Pump ON/OFF button to start the Blood Pump. • Select the DIALYSIS Action key on the PATIENT CONNECT view. • Reset theTOT WEIGHT L. Rev. press . • Select the DIALYSIS Action key on the PATIENT CONNECT view. • From the Report\CentryNet view.7.10 CentryNet option activation/deactivation after a Fast Recovery of the Dialysis process In case of dialysis treatment interrupted and then restarted with a Fast Recovery of the Dialysis process procedure. press . enter in Set mode and set the CENTRYNET USE parameter value to NO. if the CENTRYNET USE parameter value is set to YES. DIALYSIS TIMEand the UFR using the SET mode. Deactivating the CentryNet option Perform the following procedure to deactivate the CentryNet option and to restart the interrupted treatment without recording treatment data: • Press the SETUP Action key • Follow the directions in the Operator Message Window: Press + and hold. Press the Confirm button. SECTION 7 . the operator can • either start a new treatment data collection session for the same patient • or deactivate the CentryNet option and continue the dialysis treatment without recording treatment data. 7-38 PHOENIX OPERATOR MANUAL Note After a Fast Recovery of the Dialysis process, the DIALYSIS Action key becomes available only after setting the CENTRYNET USE parameter to NO. Re-activating the CentryNet option during the same dialysis treatment If the CentryNet option has been deactivated, it can be reactivated, during the same dialysis treatment by performing the following procedure: • Press the WASHBACK Action key on the TREATMENT view and then press the Confirm button. • Enter in the Report\CentryNet view and press the SET button on the Main Control Panel to enter the SET Mode. • Select the CENTRYNET USE parameter box and set the parameter to YES, then press the Confirm button. • From the WASHBACK view, press the TREATMENT Action key to continue the dialysis treatment with a new treatment data collection session for the same patient. Note When the RINSEBACK VOLUME value set has been reached, the DIALYSIS Action key disappears from the WASHBACK view and it is no longer possible to return to dialysis. Rev. B 8 ALARMS AND SIGNALS 8. SECTION 8 - ALARMS AND SIGNALS 8.1 Classification and modes of intervention The machine has been designed to recognize and control various types of malfunctions and faults. There are three ways in which the operator is advised of an alarm condition: • Modulated audible alarm, high or low tone. • Visual alarm with a flashing light at the top of the machine. • Message in the alarm window on the Touch Screen with a description of the alarm. The alarms are classified according to the part of the machine affected and the type of intervention required from the operator. All the alarms are indicated in the alarm window on the Touch Screen, while the type of visual and audible alarm depends on the class of alarm. Note Depending on the version of the buzzer installed on the machine, the tone of the audible alarms may be: • High or Low: for machines in which the Standard buzzer is installed; • Only High: for machines in which the Magnetic buzzer is installed. To install and configure the machine for the use of the Magnetic buzzer a service intervention is required. Refer to “CLASSES OF ALARMS” in this section, for the detailed description of the audible alarm type depending both on the class of the alarm and on the version of the buzzer. WARNING If more than one alarm occurs at the same time, the control system automatically prioritizes them, relative to existing alarms. Only those alarms which describe the presumed cause of malfunction are displayed in the alarm window. Alarms that are generated as a result of the original malfunction are not displayed in the alarm window. The classes of Alarms will be described in decreasing order of importance, i.e the first is the most serious type of alarm. CLASSES OF ALARMS P Alarms related to the safety of the patient, which may be controlled by the machine or by the intervention of the operator as described below. They may be identified by: • A Visual alarm with a flashing Red light of 4-4 modulation (one flash of 4/8 second, followed by a 4/8 second pause). • An Audible alarm with a 4-4 modulation that has a high pitch, modulated tone. • A Message on top of the Touch Screen preceded by an exclamation (!) mark. Rev. B 8-2 PHOENIX OPERATOR MANUAL Note Some class P alarms have a descriptive "attribute", which specifies the type of fault. Pd Alarms not related to the safety of the patient, which are due to an error in the reading of process data contained in the memory of the Protection Module. These require operator intervention as described below. They may be identified by: • A Visual alarm with a Red light with a flashing pattern of 4-4 modulation (one flash of 4/8 second, followed by a 4/8 second pause). • An Audible alarm with a 4-4 modulation that has a high pitch, modulated tone. • A Message on the top of the Touch Screen preceded by an exclamation (!) mark and followed by the words: “data error”. A Alarms not related to the safety of the patient, caused by internal machine processes, requiring operator intervention to remove the cause, returning the process data to the operating limits. They may be identified by: • A Visual alarm with a Red light with a flashing pattern of 4-4 modulation (one flash of 4/8 second, followed by a 4/8 second pause). • An Audible alarm with a 4-4 modulation that has a high pitch, modulated tone. • A Message on the top of the Touch Screen. B Alarms not related to the safety of the patient, caused directly by an operator error on the machine controls or caused by machine conditions requiring operator intervention. These require operator intervention. They may be recognized by: • A Visual alarm with a Yellow light with a flashing pattern of 1-7 modulation (a flash of 1/8 second followed by a pause of 7/8 second). • An Audible alarm with a 1-7 modulation that has a low pitch if the Standard buzzer is installed or that has a high pitch if the Magnetic buzzer is installed, modulated tone. • A Message on the top of the Touch Screen. W Indication of disturbances not related to the safety of the patient and due to conditions not recognized by the Protection Module. These disturbances may revert to normal without operator intervention. They may be identified by: • A Visual alarm with a Yellow light with a flashing pattern of 1-7 modulation (a flash of 1/8 second followed by a pause of 7/8 second). • An Audible alarm with a modulation of 1-7 and a high pitch, modulated tone. • A Message on the top of the Touch Screen, preceded by W! E Alarms which are not related to the safety of the patient, and are caused by control errors that may revert to normal without the need for operator intervention. They usually require the intervention of a Service technician. They may be identified by: • A Visual alarm with a Yellow light with a flashing pattern of 1-7 modulation (a flash of 1/8 second and followed by a pause of 7/8 second). • Audible alarm with a modulation of 1-7 and a high pitch, modulated tone. • A Message indication on the top of the Touch Screen. Rev. B SECTION 8 - ALARMS AND SIGNALS 8-3 D Indication related to a machine state requiring the attention of the operator. These are not related to the safety of the patient or to an error condition. They may be identified by: • A Visual alarm with a Yellow light with a flashing pattern of 1-7 modulation (a flash of 1/8 second followed by a pause of 7/8 second). • An Audible alarm with a modulation of 1-7 and a low pitch if the Standard buzzer is installed or that has a high pitch if the Magnetic buzzer is installed, modulated tone. • A Message on the top of the Touch Screen. C Alarms which are not related to the safety of the patient and are due to transitory control errors which usually revert to normal without operator intervention. If these errors persist, the machine is probably not functioning properly and Service must be notified. They may be identified by: • A Visual alarm with Yellow light with a flashing pattern of 1-7 modulation (a flash of 1/8 second followed by a pause of 7/8 second). • A Message on the top of the Touch Screen. The operator can therefore identify the class of alarm with the aid of the three types of indicators available and then take appropriate action. Note All the alarms are coded numerically. The relevant code is displayed on the Touch Screen with the alarm message. Note The PHOENIX machine is able to send a signal to a remote alarm device, to indicate an audible alarm, only in case of occurrence of alarms in the classes P, Pd, A, W, E. LEVELS OF OPERATOR INTERVENTION When an alarm condition occurs, the operator may be able to manually deal with the problem, depending on its class. The specific actions to take are described for each individual alarm. Three types of intervention are possible: 1) OVERRIDE When an alarm is activated, the operator can try to solve the problem by stopping the autonomous operations being carried out by the machine and reaching a specific safe state. This can be done by pressing the OVERRIDE button on the Main Control Panel. When the LED on the OVERRIDE button comes on, release the OVERRIDE button. During the OVERRIDE state, the LED is on. Rev. B 8-4 PHOENIX OPERATOR MANUAL The OVERRIDE state lasts 2 minutes. During this period: • Some of the safety mechanisms are disabled (as pointed out in the description of each alarm). • The Audible alarm stops. • The Visual alarm remains ON as long as the fault persists. • The Message remains on the Touch Screen with the description of the cause of the alarm. • The Message is preceded by the icon representing the OVERRIDE condition: ! Venous Pressure • Every 20 seconds the Audible and Visual alarms are repeated. If one or more additional faults cause an alarm during the OVERRIDE state, the description relative to each fault is added to the superimposed window. In this case the operator can intervene with the OVERRIDE button. All the new alarms are set to the OVERRIDE state. The timer relative to the duration of the OVERRIDE state is reset to zero each time the button is pressed so this state remains for 2 minutes from the last time the button was pressed. OVERRIDE is removed: • Automatically when the time has elapsed. • Manually before the time has elapsed, by pressing the OVERRIDE button until the LED goes off and then releasing the button. When the OVERRIDE state has been removed, any remaining alarms are reactivated, along with their respective descriptive messages. Note In some specific alarm cases, the OVERRIDE button has different effects. The alarm condition is RESET and the alarm message disappears from the screen. These cases are marked with in the following list. Note The selection of the OVERRIDE button has no effect on the alarms that occur while the machine is performing one of the following T1Tests: Board CPU, EPROM CRC, Comparator, Board RAM, Battery, Buzzer Lamp, Voltages (24V), Venous Clamp. WARNING The selection of the OVERRIDE button has effect on all the alarms that are active and can be set to the OVERRIDE state (refer to the “Alarms List” in this section for the list of alarms that can be set to the OVERRIDE state). In the Alarm Area of the screen only two alarm messages can be displayed; if there are more than two alarms active, the additional alarms may be viewed on the Machine view by pressing the Machine Navigation key. Rev. B SECTION 8 - ALARMS AND SIGNALS 8-5 WARNING During OVERRIDE, the user is responsible for monitoring the parameters that are being overridden. 2) MUTE By pressing the MUTE button on the Main Control Panel, the operator can temporarily (2 min) deactivate the audible alarm. During the MUTE state: • The LED on the MUTE button remains on. • The Audible alarm is deactivated. • The Visible alarm remains. • The message remains on the Touch Screen with the description of each alarm. The MUTE state is removed: • Automatically when the time has elapsed. • Manually by pressing the MUTE button until the LED starts to flash. • When a new alarm is activated. 3) RESTART In certain alarm conditions, the view relative to the current phase of the process disappears from the Touch Screen and the RESTART key becomes available to allow an exit from the alarm condition. A suggestion on how to solve the problem appears in the Operator Message area. When the fault has been removed and RESTART pressed, normal operation is resumed. The current view reappears on the Touch Screen. WARNING If the first time the RESTART key is selected, the machine returns to the RESTART condition, wait at least ten seconds before pressing the RESTART key again. WARNING In some Protection alarms, the audible alarm is active only after DIALYSIS is initiated. WARNING Press the RESTART key only after having removed the cause requiring the “RESTART”, as described on the Touch Screen. Never press the RESTART key more than 2 or 3 times if the problem has not been identified that will remove the cause of “RESTART”. Rev. B 8-6 PHOENIX OPERATOR MANUAL 8.1.1 Operator Guidelines for responding to Alarms on the PHOENIX machine In case of an alarm condition, the Operator should perform the following actions: 1. Press the MUTE Button to silence the Audible Alarm, if desired. 2. Observe the Alarm Message in the Alarm Area at top of the Touchscreen. Alarms are referenced by number. The number is located on the Right Side of the Alarm Message. 3. Determine the cause of the Alarm. If uncertain about the cause or appropriate response to the alarm, refer to Alarms Troubleshooting, in this section, for possible causes and solutions. 4. Correct the cause of the Alarm and then press the OVERRIDE Button. The Alarm or Alarms that are present will be overridden for 2 minutes. 5. In some cases it may be necessary to restore the previous operating conditions to properly troubleshoot an Alarm. In these cases the OVERRIDE Button may be pressed prior to correcting the cause of the Alarm. WARNING During OVERRIDE, the user is responsible for monitoring the parameters that are being overridden. Note For some Alarm Conditions a RESTART Key will appear on the Touchscreen. These Alarms are cleared by pressing the RESTART Key, rather than pressing the OVERRIDE Button. Note If the Overridden Alarms reoccur during the 2-minute OVERRIDE period they will not cause a new Alarm. Note If other new Alarms occur during the OVERRIDE period, the PHOENIX machine will generate audible and visual alarms. Note Each time the OVERRIDE Button is pressed the OVERRIDE period is reset to 2 minutes. Rev. B SECTION 8 - ALARMS AND SIGNALS 8-7 8.1.1.1 OVERRIDING Arterial and Venous Pressure Alarms Following an Arterial or Venous Pressure Alarm (code #155 and #305), pressing the OVERRIDE Button will restart the Blood Pump at the previous speed. During the OVERRIDE period, the overridden Arterial and/or Venous Pressure Alarms will not recur until the 2-minute period has elapsed. However, after 30 seconds the previously memorized alarm windows will be displayed on the Pressure Bar Graphs. If the Pressure Pointers move outside of the alarm windows, the corresponding alarm messages and the Override Icon will be displayed in the Alarm Area. The Blood Pump will continue to operate because the Alarms are in an Override condition. An audible alarm will also occur, if it has not been previously muted. When the Pressure Pointers return within the alarm windows the alarm messages will no longer appear. Additional, supplementary Arterial and Venous Pressure Limit Alarms are always present and active: • “! ART PRESSURE LIMIT” (code #306), which occurs when the pressure reaches the value set for the MIN ART PRESSURE parameter. • “! VEN PRESSURE LIMIT” (code #154), which occurs when the pressure reaches the value set in the Configuration Menu for the VEN PRES LIMIT parameter. However the Operator must consider that during the time when the Arterial or Venous Pressure Alarms are OVERRIDDEN and before an ! ART PRESSURE LIMIT#306 alarm, or a ! VEN PRESSURE LIMIT #154 alarm occurs: • The patient’s vascular access may be exposed to pressure extremes. • Restriction of blood flow to the Arterial Chamber may result in emptying of the Chamber prior to the Redundant Alarm occurring. WARNING It is the Operator’s responsibility to determine and to correct the cause of the Arterial or Venous Pressure Alarm (#155 and #305) PRIOR to pressing the OVERRIDE Button. Note Pressing the OVERRIDE button will “spread the alarm windows” for 30 sec. Rev. B 8-8 PHOENIX OPERATOR MANUAL 8.1.1.2 Operator Actions required after pressing the OVERRIDE Button for Arterial and Venous Pressure Alarms After pressing the OVERRIDE Button the Operator should remain at the machine and observe the Arterial and Venous Pressure Pointers. The Operator should also wait for the memorized Arterial and Venous Pressure Alarm Windows to reappear around the Pressure Pointers and then determine if the needle position, the Blood Pump speed or the alarm windows are appropriate. If required, the Arterial or Venous Alarm Windows may be adjusted by pressing the SET Button and then highlighting the appropriate Pressure Bar Graph. The CONFIRM Button is then pressed to adjust the Alarm Windows, followed by pressing the SET button to return to the Home Screen. The newly memorized alarm widows will appear around the pressure pointers. If the pressures are stable and within the alarm windows the Operator may press and hold the OVERRIDE Button until the orange LED to the right of the button is no longer illuminated. This will cancel the Override condition. Alternatively the Operator may observe the machine until the 2-minute Override period is completed. 8.1.2 Alphabetic List of Alarms Below is a list of all the alarms in alphabetic order, indicating: • The message that appears on the Touch Screen. • The Attribute (if any) • The Numerical Code • The Class • The OVERRIDE button availability Rev. B SECTION 8 - ALARMS AND SIGNALS 8-9 ALARM MESSAGE CODE ATTRIBUTE CLASS OVERRIDE ! AIR & FOAM DETECTOR 4 AIR BUBBLE P YES T0 FAILURE PARTIAL ! ART PRESSURE ALARM 305 MAXIMUM P YES MINIMUM UNDEFIN ! ART PRESSURE LIMIT 306 P NO ! ARTERIAL PUMP 10 MAXIMUM P YES MINIMUM UNDEFIN LINE PRES ! AUTOEMPTYING: MAX ACTIVATION TIME 294 P YES ! BIC CONDUCTIVITY 23 MAXIMUM P NO MINIMUM ! BLOOD DETECTED DURING PRIME 342 P NO ! BLOOD LEAKAGE 28 P YES ! BLOOD PUMP DIRECTION 340 P YES ! BYPASS WRONGLY EXTENDED 302 P NO ! CONCENTRATE CANS 40 HIGH PH P NO LOW PH A PUMP B PUMP A+B PUMPS ! CONDUCTIVITY PROFILE 210 CURVE P YES TIMING SET VAL ! CONTROL SYSTEM OUT OF ORDER 274 P NO ! DIALYSATE FLOW 44 MAXIMUM P YES MINIMUM UNDEFIN ! DIASCAN MEASUREMENT FAILED : 251 P YES ! FINAL CONDUCTIVITY 62 MAXIMUM P NO MINIMUM ! PI PO MAX 114 P NO ! PI PO MIN 115 P NO ! PROTECTIVE CARD COMM. TIMEOUT 120 P NO ! PROTECTIVE MSG TRANSFER ERROR 39 PD NO ! SN COMMUTATION 125 P YES ! T1 TEST FAILED 133 P NO ! TEMPERATURE 134 MAXIMUM P NO MINIMUM UNDEFIN Rev. B 8-10 PHOENIX OPERATOR MANUAL ALARM MESSAGE CODE ATTRIBUTE CLASS OVERRIDE ! TEMPERATURE EXCESSIVE VALUE 136 P NO ! UF MASS BALANCE 144 VALVES P YES D1-2/P2 NO CALIB ! UF RATE ERROR 145 LOW P YES HIGH VESSEL ! VEN PRESSURE ALARM 155 MAXIMUM P YES MINIMUM UNDEFIN ! VEN PRESSURE LIMIT 154 P YES PARTIAL SEE NOTE 2 ! VOLTAGES INCORRECT 160 P NO ! WEIGHT LOSS RATE PROFILE 212 CURVE P YES TIMING SET VAL !ART PRESSURE DATA ERROR 307 PD NO !AUTOEMPTYING DATA ERROR 277 PD NO !BICARB 6.6% COND DATA ERROR 19 PD NO !BICARB 8.4% COND DATA ERROR 20 PD NO !BICART COND DATA ERROR 263 PD NO !BLD DATA ERROR 26 PD NO !BLOOD FLOW DATA ERROR 27 PD NO !BYPASS ALARM DATA ERROR 36 PD NO !CONDUCTIVITY DATA ERROR 41 PD NO !DATA ERROR 43 PD NO !DIALYSAT FLOW DATA ERROR 45 PD NO !DIALYSIS TIME DATA ERROR 239 PD NO !DIASCAN FREQ. DATA ERROR 257 PD NO ! LONG POWER FAILURE 80 P YES !MAX BLOOD FLOW DATA ERROR 312 PD NO !PAUSE THERAPY DATA ERROR 313 PD NO !S/N MAX PRESSURE DATA ERROR 209 PD NO !S/N MIN PRESSURE DATA ERROR 208 PD NO ! SHORT POWER FAILURE 124 P YES Rev. B SECTION 8 - ALARMS AND SIGNALS 8-11 ALARM MESSAGE CODE ATTRIBUTE CLASS OVERRIDE !TEMPERATURE DATA ERROR 135 PD NO !TOT WEIGHT L DATA ERROR 240 PD NO !UF DATA ERROR 143 PD NO !VEN PRES LIMIT DATA ERROR 152 PD NO !VENOUS PRES DATA ERROR 150 PD NO !WLR MINIMUM DATA ERROR 164 PD NO > GENERAL SAFE STATE < 64 P NO See warning at end of section. A CONNECTOR POSITION 2 B NO ACE CAN IS EMPTY 1 A YES ART PRESSURE LIMIT 11 A NO ART PUMP POSITION 13 C YES ART SENSOR ERROR 6 A NO ARTERIAL CLAMP POSITION 7 A NO ARTERIAL COVER IS OPEN 8 B NO B CONNECTOR POSITION 18 B NO BAD BLOOD LINE POSITION 219 A YES BAD HYDRAULIC CONDITION 14 E NO BICARB CAN IS EMPTY 24 A YES BICART CONNECTOR POSITION 22 B NO BICART IS EMPTY 21 A YES BIOSLAVE MSG TRANSFER ERROR 297 C NO BIOSLAVE CARD COMM. TIMEOUT 296 E NO BLOOD CARD COMMUNICATION 295 E NO TIMEOUT BLOOD CARD MSG TRANFER ERROR 130 C NO BLOOD MODULE<->MASTER DISK 259 A YES MISMATCH BLOOD PUMP JAMMED 12 C YES BLOOD PUMP NOT IN START POSITION 29 E YES BPM NOT CONNECTED 255 A YES Rev. B 8-12 PHOENIX OPERATOR MANUAL ALARM MESSAGE CODE ATTRIBUTE CLASS OVERRIDE BPM: AID REQUEST 30 A YES BPM: MEASUREMENT NOT MADE 32 A YES BPM: SYSTEM FAILURE 31 A YES BT1 LEVEL ERROR 33 E NO BT1 MALFUNCTIONING 299 C NO BT2 LEVEL ERROR 34 E NO BT2 MALFUNCTIONING 268 C NO BTP LEVEL ERROR 35 E NO CENTR. ACID CONNECTOR POSITION 271 B NO CENTR. BICARB CONNECTOR POSITION 272 B NO CENTRYNET STATION OFFLINE 322 D NO CENTRYNET: DUPLICATE STATION 321 D NO CENTRYNET: INCOMPLETE DATA 323 E YES COLLECTION CENTRYNET: STATION ID ERROR 325 D NO D1 OUT OF ORDER 300 C NO D2 OUT OF ORDER 301 C NO DIAL CONNECTOR POSITION 65 B NO DIALYSER SAFETY PRESSURE 68 D NO DIASCAN INITIAL CALIBRATION FAILED 244 B YES DIASCAN: INCORRECT MEASUREMENT 246 C YES DIASCAN: LIMIT LOW CLEARANCE 249 B YES DIASCAN: MEAS. IMPOSSIBLE (ALARM) 270 B YES DIASCAN: MEASUREM. IMPOSSIBLE (SET) 269 B YES DIASTOLIC PRESSURE ALARM 46 A YES DISINF CONNECTOR POSITION 47 B NO E2PROM BIOSLAVE ERROR 50 E NO E2PROM BLOOD ERROR 48 E NO E2PROM HYDR ERROR 49 E NO END DIA - TOTAL WL 53 B NO Rev. B SECTION 8 - ALARMS AND SIGNALS 8-13 ALARM MESSAGE CODE ATTRIBUTE CLASS OVERRIDE END DIA - DIFF TIME REACHED 339 B NO END DIA - TIMEOUT 51 B NO END DIA - TOTAL BLOOD 52 B NO END HEPARIN 55 A NO END OF DIALYSATE PREPARATION 57 D NO END OF HEPARIN TIME 58 B NO END OF WASHBACK PROCEDURE 332 C YES ERROR ON CALIBRATION TOOL 279 B NO ERROR ON HEATER PROTECTION 59 A NO ERROR ON TOTAL WEIGHT LOSS 60 B NO FIXED DATA 63 C NO FORECAST DIAL. DOSE NOT MATCH 354 E YES PRESCRIP. >> GENERAL SYSTEM FAILURE << System xxx / / Blocking HEART RATE ALARM 66 A YES HEATING SYSTEM NOT STARTED 67 B NO HEPARIN PUMP DIRECTION ERROR 69 E NO HEPARIN SPEED ERROR 70 C NO HEPARINISATION NOT STARTED 71 B YES HIGH LEVEL IN DIS TANK 72 E NO HIGH LEVEL IN UF VESSEL 73 E NO HYD CARD MSG TRANSFER ERROR 131 C NO HYDRAULIC CARD COMM. TIMEOUT 304 E YES KT-KT/V TARGET ACHIEVED 355 YES LOW LEVEL IN DIS TANK 82 E NO LOW LEVEL IN UF VESSEL 83 E NO LOW PRESSURE IN DEGASSER 84 E NO LOW TEMPERATURE LIMIT REACHED 81 C NO MAX PI PRESSURE 87 A NO MAX PO PRESSURE 88 A NO Rev. B B .8-14 PHOENIX OPERATOR MANUAL ALARM MESSAGE CODE ATTRIBUTE CLASS OVERRIDE MAX TEMPERATURE LIMIT 90 B NO MIN PI PRESSURE 94 A NO MIN PO PRESSURE 95 A NO NO POWER 353 A NO NO WATER 100 A NO OUTPUT OVERPRESSURE 206 A NO P1 PUMP OUT OF ORDER 104 E NO P2 PUMP OUT OF ORDER 106 B NO PA AUTOCALIBRATION NOT PERFORMED 107 E NO PA PUMP OUT OF ORDER 108 B NO PB AUTOCALIBRATION NOT PERFORMED 109 E NO PB PUMP OUT OF ORDER 110 B NO PC PUMP FAILURE 111 E NO PH MAXIMUM ALARM 112 E NO PH MINIMUM ALARM 113 E NO PI PRESSURE SENSOR ERROR 116 E NO PO PRESSURE SENSOR ERROR 118 E NO PRIME VOLUME COMPLETED 54 C YES PUF AUTOCALIBRATION NOT PERFORMED 121 E NO PUF PUMP OUT OF ORDER 122 B NO S/N: VEN PRESSURE NOT CHANGING 351 A YES S/N: VENOUS PRESSURE UNRELIABLE 352 B NO START DIALYSIS DELAYED 129 B NO SYSTOLIC PRESSURE ALARM 132 A YES TIME OUT PROC 190 E NO TIMEOUT ERROR ON PROCESS CLOSING 335 C NO TIMEOUT ERROR ON PROCESS SELECTION 333 C NO TIMEOUT ON PA AUTOCALIBRATION 139 E NO TIMEOUT ON PB AUTOCALIBRATION 140 E NO Rev. B .ALARMS AND SIGNALS 8-15 ALARM MESSAGE CODE ATTRIBUTE CLASS OVERRIDE TIMEOUT ON PUF AUTOCALIBRATION 141 E NO TOTAL HEPARIN INFUSED ERROR 338 B YES TRANSMEMBRANE PRESSURE 142 C NO/YES SEE NOTE 1 ULTRAFILTER : TMP TOO HIGH 237 B YES ULTRAFILTER IS PACKED 138 B NO ULTRAFILTER MAX PRESSURE 146 C NO ULTRAFILTER PRESSURE SENSOR 147 C NO ULTRAFILTER: LOWER SWITCH 61 B NO ULTRAFILTER: UPPER SWITCH 38 B NO VEN PRESSURE OUT OF RANGE 153 A NO VEN SENSOR ERROR 159 A NO VENOUS CLAMP POSITION 148 A NO W! STILL IN MINIMUM UF 189 W YES W! AD CONVERTER 165 W YES W! AIR & FOAM DETECTOR 264 W YES W! ANALOG HIVAR 166 W YES W! ART PRESSURE SENSOR ERROR 317 W YES W! BLD CALIBRATION PHASE 167 W YES W! BLD FAST RECOVERY 168 W YES W! BLD LED EXCESSIVE VALUE 169 W YES W! BLD RECEIVER EXCESSIVE VALUE 170 W YES W! BLOOD IN THE VENOUS LINE 308 W YES W! BLOOD PUMP STOPPED BY ABD 318 W YES W! BLOOD SENSED IN VENOUS LINE 359 W YES W! COMMUNICATION CRC ERROR 327 W YES W! DAC EXCURSION 172 W YES W! DRIFT ON FLOWMETERS 343 W YES W! E2PROM CRC 173 W YES W! LOW ART FLOW FOR TOO LONG 204 W YES Rev. SECTION 8 . the alarm can be reset. Rev. if the parameter is set to YES. CALCULATION NOT RELIABLE 220 W YES W! UNKNOWN MESSAGE TYPE 185 W YES W! UNRECOGNIZED SOFTWARE EXEC 182 W YES W! VENOUS LINE NOT FITTED 205 W YES W! VOLTAGES INCORRECT 187 W YES W! WAIT FOR PRESSURE TEST EXECUTION 319 W YES W! WAIT TO CONTINUE 188 W YES SEE NOTE 3 WAIT FOR CONFIRMATION 283 E YES WHF DOOR POSITIONING 326 B NO Note 1 If the parameter TMP ALARM is set to NO in the Config menu. the alarm cannot be overridden. B .8-16 PHOENIX OPERATOR MANUAL ALARM MESSAGE CODE ATTRIBUTE CLASS OVERRIDE W! MASS BALANCE NOT RELIABLE 309 W YES W! PA AUTOCALIBRATION FAILED 176 W YES W! PATIENT SENSOR SATURATION 273 W YES W! PB AUTOCALIBRATION FAILED 177 W YES W! PDR PRESSURE SENSOR ERROR 252 W YES W! PI PRESSURE SENSOR 178 W YES W! PO PRESSURE SENSOR 179 W YES W! PUF AUTOCALIBRATION FAILED 180 W YES W! PV PRESSURE SENSOR 181 W YES W! RAM ERROR 175 W YES W! SET VALUE OUT OF RANGE 250 W YES W! STILL IN BYPASS 171 W YES W! STILL IN PAUSE THERAPY 329 W YES W! T1 TEST FAILED 183 W YES W! T1TESTS DISABLED 203 W NO W! TEMPERATURE SENSOR 184 W YES W! U.F. Rev. Note 3 To RESET the alarm condition. SECTION 8 . press the OVERRIDE button then press the CONFIRM button. otherwise the safety activation is not removed. B .ALARMS AND SIGNALS 8-17 Note 2 OVERRIDE only has an effect if the measured venous pressure is less than +450 mmHg. • The Blood Pump is stopped. the machine must be switched OFF. This is a latching alarm and in order to reset it. The operator is warned by: • An alarm window with the message: →> GENERAL SAFE STATE < ← • An Operator Message in the help window: You Must Switch Off The Machine • A Visual alarm. If this test passes. • The Venous Clamp is closed. the following message is displayed: ! Voltages Incorrect If a General Safe State is due to a Temperature elevated value alarm. after the Blood Pump restart. • The Ultrafiltration Pump is stopped. the following message is displayed: ! T1 Test Failed If a General Safe State is due to incorrect voltage. The machine is stopped and the patient isolated. The GENERAL SAFE STATE is a shutdown alarm and the treatment is stopped. with a flashing red light of a 6-2 modulation (two flashes lasting 3/8 of a second with an intervening pause of 1/8 of a second) • A high volume Audible alarm of 6-2 modulation. i. the Protection Module generates a > GENERAL SAFE STATE < alarm and the following steps are taken: • The Dialysate Flow through the dialyser is stopped. the following message is displayed: ! Temperature Excessive Value WARNING When the Blood Pump stops due to an alarm condition: • The venous pressure alarm window lower limit is automatically set to +10 mmHg and the upper limit is set to the VEN PRES LIMIT parameter value decreased of 50 mmHg (see Section 2 . if the safe state is not correctly configured. the machine remains in the safe state until the cause of the alarm is removed (as indicated in the Suggested Action). Rev. the Protection Module checks that the actions relating to the specific safe state are performed correctly by the machine. B . If a General Safe State occurs as a result of a T1 test failure.Configuration Description. in this manual). Otherwise. These values are maintained for all the time the Blood Pump is OFF and for 30 sec. • The arterial pressure alarm window lower limit is automatically set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg and the upper limit is set to +150 mmHg.e. • A numerical code relative to the specific safe state that was not correctly configured (see below).8-18 PHOENIX OPERATOR MANUAL WARNING In each alarm condition critical to the safety of the patient (Class P alarms). • Blood has been detected and all the relevant safety systems are activated. Rev. The Patient Sensor Icons are: • No blood has been detected • Blood has been detected but the operational test has failed.ALARMS AND SIGNALS 8-19 WARNING The machine is supplied with a special device called the Patient Sensor which has the task of setting some class P alarms in an automatic OVERRIDE state when DIALYSIS has not yet started. B . the relevant safety systems are locked until the presence of blood is detected to allow a smooth start to the process. Not all the relevant safety systems are activated. SECTION 8 . by highlighting the symbol in correspondence to the safe requests which are active only after either the Patient Sensor has detected blood in the venous line. This condition of the Patient Sensor is indicated by an Icon in the Icon Area on the Touch Screen. or after the DIALYSIS Action key has been pressed. For each Class P alarm. for each alarm in this section. since the patient’s blood has not yet reached the venous line in the Patient Sensor. the possibility of an automatic OVERRIDE by the Patient Sensor and the related effects are indicated. Note In this section the icon is used to indicate the possibility to set the alarm to the OVERRIDE state. Therefore. in numerical order. In DESCALING: The Acid/Acetate Pump PA has been driven at maximum speed for over 25 seconds and the wrong solution has been detected for DESCALING to be performed. Supply appropriate concentrate to the empty. Verify the Concentrate connector is well connected to the Concentrate Wand.A – Special Procedures. 6.2 Numerical List of Alarms and relevant description Below is a description. use. the vinegar container is relevant inlet connector and press the empty. If the VINEGAR DESCAL Action key has 3.8-20 PHOENIX OPERATOR MANUAL 8. ACE CAN IS EMPTY 1 Reason In DIALYSIS: The Acid/Acetate Pump (PA) has been driven at maximum speed for for Alarm over 25 seconds due to the conductivity not reaching the set value. Press OVERRIDE to continue. OVERRIDE button to restart uptake of vinegar into the machine. Acid/Acetate Concentrate container is 1. Supply appropriate vinegar solution to the been selected. relevant inlet connector following the Acid/Acetate Concentrate Container Change procedure (see Section 5. Rev. Supply appropriate concentrate/vinegar to selected the Acid/Acetate container is the relevant inlet connector and press the empty. The correct DESCALING procedure has not 5. in this manual). 5. Check and if necessary change the Concentrate Wand. Verify the correct solution. Massive air leak from the Acid/Acetate 2. B . If the DESCALING Action key has been 4. of all the alarms listed in the previous table. Acid/Acetate Concentrate connector not 6. depending on been selected for the descaling solution in the DESCALING procedure selected. OVERRIDE button to restart uptake of concentrate to the machine. 2. fitted into the proper Wand. Actions Possible Suggested Cause Action 1. Press OVERRIDE to continue. Call for Service if the problem persists. Machine The Acid/Acetate Pump PA stops. Acid/Acetate Concentrate Wand. 4. 3. In DIALYSIS: during the preparation phase. Possible Suggested Cause Action 1. or not fully inserted into relation to the machine phase. B . its Rinse Port. the machine will automatically go into Bypass. SECTION 8 . Acid/Acetate Concentrate Connector is in 1.ALARMS AND SIGNALS 8-21 A CONNECTOR POSITION 2 Reason The Acid/Acetate Concentrate connector is not in the correct location for the for Alarm phase of the machine. Verify the right connector position in the wrong position. Machine In ADR: the machine will stop and wait for the connector position to be Actions corrected. Call for Service if the problem persists. Rev. the machine will not proceed: during the treatment phase. related to the ABD sensor. Open the venous access line clamp. Press the MUTE button to silence the below the Air Bubble Detector). 1. Air or foam in the venous line (inside or a. clamp the venous dialyser line between the dialyser and the expansion chamber. c. Close the venous access line clamp. Air Bubble 2.) d. has failed. Clamp the venous dialyser line between the dialyser and the venous chamber. #4 with Attribute Air Bubble. Open the white cap on the venous access line of the Cartridge and attach a sterile 10-20 ml syringe to the venous access line of the Cartridge. Possible Suggested Cause Action 1. (If in SINGLE NEEDLE mode connect the syringe to the access port on the post dialyser expansion chamber) Remove the syringe and replace the white cap on the venous access line. Aspirate until the venous pressure is between –50 and -150 mmHg. (If in SINGLE NEEDLE mode. The Venous Line Clamp and the Air Bubble Detector will deactivate for 30 Rev. Press the OVERRIDE button to open the Venous Line Clamp. e. b. B . T0 Failure The T0 Test. f.8-22 PHOENIX OPERATOR MANUAL ! AIR & FOAM DETECTOR 4 Attribute 1. Procedure to clear the alarm. alarm. Actions Closes the Venous Line Clamp. Avoid a negative pressure over -150 mmHg. Ultrafiltration Pump is reduced to its minimum value. Machine Stops the Blood Pump. Manually clamp the venous line below the venous line clamp and any visible air bubbles. T0 Failure Reason Air Bubble for Alarm The presence of air is detected in the venous line at the Air Bubble Detector. Close the door of the Air Bubble Detector. h. Move the venous line position a few Bubble Detector. Follow the procedure to clear this alarm described above. Proceed as follows: Venous Line is scratched under the Air a. Rev. centimeters. Air is drawn automatically into the venous chamber. 5. Note 1 The Venous Line Clamp is not automatically opened if the venous pressure is not lower than +10mmHg. #4 with Attribute T0 Failure. Follow the procedure to clear the alarm described above. b. 3.) i. Proceed as follows: Decreased Sensitivity of the Air Bubble a. If the problem persists call for Service 5. 2. g. 4. (or in between the dialyser and the post-dialyser expansion chamber for SINGLE NEEDLE. b. SECTION 8 . repeat the procedure from step b. adjust the blood level in the Cartridge chambers 2. If needed. Slowly open the clamp on the venous line. Follow the procedure to clear this alarm described above. Detector. #4 with Attribute Air Bubble. #4 with Attribute Air Bubble. Press the RESUME button to restart the blood pump at the previous value. 3. (See Warning 2) j.ALARMS AND SIGNALS 8-23 seconds. If air bubbles remain. b. B . Proceed as follows: Air Bubble Detector door is open. If the problem persists call for Service Call for Service if the problem persists. Re-position the venous line. 4.(See Note 1 and Warning 1). Proceed as follows: Failure in the electronic board. #4 with AttributeAir Bubble. take note of the values displayed for the parameters ABD DIAGNOSTIC in the MACHINE view: this information could be helpful for the service technician. a. a. When the alarm #4 occurs. Remove the clamp on the venous dialyser line between the dialyser and the venous chamber. Follow the procedure to clear this alarm described above. even if the Patient Sensor has not detected blood. Note Check for Air bubbles starting from PATIENT CONNECT. • Ensure the blood levels in the Cartridge chambers are at the target level. follow the guidelines below: • Follow the priming procedure carefully. • Ensure arterial line is connected securely and leak-free. WARNING 2 RESUME has no effect if the venous line is not inserted in the Venous Line Clamp (in this case the alarm #205 appears). Note To prevent an !AIR IN BLOOD (#4) alarm. B . Rev.8-24 PHOENIX OPERATOR MANUAL WARNING 1 Do not open the clamp in between the dialyser and the venous chamber (in DOUBLE NEEDLE mode) or in between the dialyser and the post-dialyser expansion chamber (in SINGLE NEEDLE mode) because the positive pressure at the blood side of the dialyser could push air bubbles to the patient. • Carefully manage the extracorporeal accesses when administrating medication. ALARMS AND SIGNALS 8-25 ART SENSOR ERROR 6 Reason The control system has detected a large spike or a large rapid change while for Alarm monitoring the Arterial Pressure Sensor. Call for Service if the problem persists. B . Actions The Ultrafiltration Pump speed is reduced to its minimum value. Temporary problem. Possible Suggested Cause Action 1. SECTION 8 . Machine The Blood Pump is stopped. 1. Wait a few seconds for the alarm to be cleared. Rev. Machine The Blood Pump stops. 1. Possible Suggested Cause Action 1.8-26 PHOENIX OPERATOR MANUAL ARTERIAL CLAMP POSITION 7 Reason The optical switch on the Arterial Line Clamp indicates that the clamp is open for Alarm when it should be closed or it is closed when it should be open. Rev. This alarm only applies to single needle machines. B . Arterial Line Clamp dirty. Carefully clean the Arterial Line Clamp with a cloth dipped in a disinfectant solution. Arterial Line Clamp obstructed. Call for Service if the problem persists. 2. Only the arterial line should be inserted into the clamp. Actions The Ultrafiltration Pump speed is reduced to its minimum value. 2. Verify the Arterial Line Clamp is free from obstruction. The magnet is dirty. Carefully clean the magnet placed behind the Blood Pump Door with a cloth dipped in a disinfectant solution. Possible Suggested Cause Action 1. B . Note The check for the front cover of the Blood Pump is enabled at the beginning of PRIME. Call for Service if the problem persists. Actions The Ultrafiltration Pump speed is reduced to its minimum value. for Alarm Machine The Blood Pump is stopped. Closes the Venous Line Clamp. 1. Blood Pump Cover is open.ALARMS AND SIGNALS 8-27 ARTERIAL COVER IS OPEN 8 Reason The Blood Pump Cover is open. Close the Blood Pump Cover. 2. Be sure the Blood Pump Cover is securely latched. Rev. 2. SECTION 8 . Check the venous line position. The venous line is not inserted inside the Air 2. set value.8-28 PHOENIX OPERATOR MANUAL ! ARTERIAL PUMP 10 Attribute 1. Undefin There is an error in the reading from the encoder on the Blood Pump or the rotor position sensors. Machine Stops the Blood Pump. Rev. 2. Maximum 3. Actions Closes the Venous Line Clamp. Call for Service if the problem persists. Line Pres The venous line is not inserted inside the Air Bubble Detector housing. Ultrafiltration Pump is reduced to its minimum value. Possible Suggested Cause Action 1. Minimum 2. Line Pres Reason Minimum for Alarm The actual flow of the Blood Pump is less than the set value or the minimum permitted value. Maximum The actual flow of the Blood Pump is higher than the set value or the maximum permitted value. The Blood Pump speed is different from the 1. Undefin 4. Bubble Detector housing. B . Press OVERRIDE to restart the Blood Pump. The alarm clears when the arterial pressure is in the proper range. Arterial pressure decreased somewhat 2. clamps. Possible Suggested Cause Action 1. B .e. SECTION 8 . anticoagulant hemoconcentration and/or inadequate dosage. blood flow rate. arterial line. kinks. 2. Restriction of blood flow from the arterial 1. Call for Service if the problem persists. Rev. for Alarm Machine The Blood Pump is stopped. Actions The Ultrafiltration Pump speed is reduced to its minimum value. clotted arterial needle. heparinization of the patient and a resulting pressure drop increase for a given needle at a fixed blood flow rate.ALARMS AND SIGNALS 8-29 ART PRESSURE LIMIT 11 Reason The arterial pressure is beyond the upper or lower limit of the sensor. Attention should be given to re-evaluating during a treatment due to needle size. i. poor flow from the patient’s arterial access. Check for restriction of blood flow in the access or in the arterial line. Press OVERRIDE to restart the Blood Pump. Call for Service if the problem persists. Cartridge. 2. Machine The Blood Pump is stopped. Cartridge Blood Set Pump segment is 1. Possible Suggested Cause Action 1. The Blood Pump Rotor is jammed. Rev. B . 2.8-30 PHOENIX OPERATOR MANUAL BLOOD PUMP JAMMED 12 Reason The Blood Pump Rotor is jammed and will not turn or the blood slave board does for Alarm not see the signal from the Blood Pump board. Verify the Blood Pump Rotor is not obstructed. Press OVERRIDE to restart the Blood Pump. Verify the correct placement of the jamming the Rotor of the Blood Pump. Actions The Ultrafiltration Pump speed is reduced to its minimum value. for Alarm or the machine is not sensing a Cartridge Blood Set. Call for Service if the problem persists. Press OVERRIDE to clear the alarm. Verify the Blood Pump Rotor is not obstructed. B . Actions Possible Suggested Cause Action 1. the venous line into the Air Bubble Detector and the Venous Line Clamp. Verify the Cartridge position. SECTION 8 . 2. Rev. The arterial proper position. The venous and arterial lines are not in their 1.ALARMS AND SIGNALS 8-31 ART PUMP POSITION 13 Reason The Blood Pump Rotor could not be positioned by the Blood Board while in IDLE. The Blood Pump Rotor is jammed. Manually position the Blood Pump Rotor to a horizontal position. line should be placed in the Arterial Line Clamp (if present). 2. Machine None. Press OVERRIDE to clear the alarm. WARNING When the patient is connected. Press RESTART to continue. 3. Drain Line is kinked or occluded. Dialysate Lines kinked. Dialysate Connectors in the wrong position. re-check carefully all the possible causes of the alarm then press again the RESTART key. Call for Service if the problem persists. if the first selection of the RESTART key doesn’t clear the alarm. 2. Actions Possible Suggested Cause Action 1. See the for Alarm operator message box for more details. Verify the Dialysate Connectors are well connected in the correct position for the current operation of the machine. Press RESTART to continue. Press RESTART to continue. Verify that the Dialysate Lines are not kinked. B . 1. 4. Verify adequate water supply to machine. No water. Press RESTART to continue. Rev.8-32 PHOENIX OPERATOR MANUAL BAD HYDRAULIC CONDITION 14 Reason Problem or configuration issue with the hydraulic portion of the machine. Never press the RESTART key more than 2 or 3 times if the problem that is causing the “RESTART” condition has not been identified. Verify that the Drain Line is not kinked or occluded. 4. Machine The machine goes into a RESTART condition. 2. 3. its rinse port. during the treatment phase. Bicarbonate Concentrate Connector is in 1. the machine will not proceed. B . the machine will automatically go into bypass. Rev. Call for Service if the problem persists. Possible Suggested Cause Action 1. Verify the right connector position in the wrong position or not fully inserted into relation with the machine phase. Machine In ADR: the machine will stop and wait for the connector position to be Actions corrected. In DIALYSIS: during the preparation phase. SECTION 8 .ALARMS AND SIGNALS 8-33 B CONNECTOR POSITION 18 Reason The Bicarbonate Concentrate Connector is not in the correct position for the phase for Alarm of the machine. restart the Main Board.6% COND parameter. If the alarm persists. Call for Service if the problem persists. A data difference was detected inside the 1. In Set mode. Rev. for the BIC 6. for the BIC 6. Machine None Actions Possible Suggested Cause Action 1.8-34 PHOENIX OPERATOR MANUAL ! BICARB 6.6% COND the machine. B . restore the parameter to the double image of the Protective System in correct value.6% COND DATA ERROR 19 Reason A data difference was detected inside the double image of the Protection System for Alarm in the Main Board. parameter. for the BIC 8.ALARMS AND SIGNALS 8-35 ! BICARB 8. SECTION 8 .4% COND the machine. for the BIC 8. Machine None Actions Possible Suggested Cause Action 1. B . restart the Main Board. In Set mode. Rev. If the alarm persists. parameter.4% COND parameter. Call for Service if the problem persists.4% COND DATA ERROR 20 Reason A data difference was detected inside the double image of the Protection System for Alarm in the Main Board. A data difference was detected inside the 1. restore the parameter to the double image of the Protection System in correct value. BiCart cartridge is almost empty. Press OVERRIDE to restart uptake of bicarbonate. Verify the correct position of the BiCart in its holder. Machine The Bicarbonate Pump stops. due to the conductivity not reaching the set value. Replace the BiCart according to the directions in the operator manual. B . Rev. 2. Actions Possible Suggested Cause Action 1. 1. 2. BiCart cartridge in wrong position. Call for Service if the problem persists. Press OVERRIDE to restart uptake of bicarbonate.8-36 PHOENIX OPERATOR MANUAL BICART IS EMPTY 21 Reason The Bicarbonate Pump is being driven to maximum speed for greater than 25 for Alarm seconds. In DIALYSIS: During the dialysate preparation phase. Call for Service if the problem persists. or not closed securely. Machine In ADR: The machine stops and waits for both Holder Arms to be moved to Actions the correct position. the machine will go into bypass when one of the two Holder Arms is in the incorrect position. BiCart Holder Arms are in the wrong 1. Holder Arms in relation to the machine phase. the machine will not proceed. B . Possible Suggested Cause Action 1. Rev. During the treatment phase. Verify the correct position of the BiCart position.ALARMS AND SIGNALS 8-37 BICART CONNECTOR POSITION 22 Reason The BiCart Holder Arms are not in the required position for the current operating for Alarm phase. SECTION 8 . Bicarbonate Concentrate Connector not 2. 2. Change Bicarbonate Concentrate Wand. replace as directed in the Operator’s Manual. proper wand. BiCart. Rev. 4.8-38 PHOENIX OPERATOR MANUAL ! BIC CONDUCTIVITY 23 Attribute 1. Verify the connector is well fitted to the well fitted to the Concentrate Wand. BiCart not well positioned in its holder. the machine will go into BYPASS. Maximum Reason Minimum for Alarm Value of Bicarbonate Conductivity is lower than the value set by the operator or the permitted minimum. Concentrate Wand. 4. Machine During a dialysis treatment. Massive air leak from the Bicarbonate 3. B . 3. If BiCart are almost empty. Verify adequate levels of Concentrates. Call for Service if the problem persists. Bicarbonate Concentrate container or 1. Minimum 2. Maximum Value of Bicarbonate Conductivity is higher than the value set by the operator or the permitted maximum. Actions Possible Suggested Cause Action 1. Ensure the BiCart is securely placed in its holder. 2. Change Bicarbonate Concentrate Wand. Press OVERRIDE to continue. Machine The Bicarbonate Pump is shut off. Bicarbonate Concentrate Connector not 2. proper wand. Bicarbonate Concentrate Container is 1. Massive air leak from the Bicarbonate 3. B . Verify the connector is well fitted to the well fitted to the Concentrate Wand. Call for Service if the problem persists. Supply appropriate concentrate to the empty. Actions Possible Suggested Cause Action 1. SECTION 8 . Rev.ALARMS AND SIGNALS 8-39 BICARB CAN IS EMPTY 24 Reason The Bicarbonate Pump has been driven at the maximum speed for greater than 30 for Alarm seconds due to a loss in Bicarbonate Conductivity. 3. relevant inlet connector and press OVERRIDE to restart uptake of bicarbonate. Press OVERRIDE to continue. Concentrate Wand. In Set mode. A data difference was detected inside the 1. Call for Service if the problem persists. B .8-40 PHOENIX OPERATOR MANUAL ! BLD DATA ERROR 26 Reason A data difference was detected inside the double image of the Protection System for Alarm in the Main Board. Machine None Actions Possible Suggested Cause Action 1. restart the Main Board. restore the parameter to the double image of the Protection System in correct value. for the BLD SENS the machine. for the BLD SENS parameter. Rev. If the alarm persists. parameter. Actions Possible Suggested Cause Action 1. Rev.ALARMS AND SIGNALS 8-41 ! BLOOD FLOW DATA ERROR 27 Reason A data difference was detected inside the double image of the Protection System for Alarm in the Main Board. Call for Service if the problem persists. If the Main Board. for the BLOOD FLOW parameter. A data difference was detected inside the 1. SECTION 8 . for the BLOOD FLOW the alarm persists. B . Re-enter a different blood flow rate. then double image of the Protection System in restore the parameter to the correct value. parameter. Machine None. restart the machine. 8-42 PHOENIX OPERATOR MANUAL ! BLOOD LEAKAGE 28 Reason The machine has detected a blood leak into the hydraulic circuit either at a level of for Alarm 0.30 ml/min or at a rate of 0.45 ml/min (HIGH or LOW sensitivity set value). Machine Stops the Blood Pump. Actions Closes the Venous Line Clamp. Ultrafiltration Pump is reduced to its minimum value. Possible Suggested Cause Action 1. Dialyser is leaking blood into the hydraulic 1. Test the dialysate for the presence of blood. circuit. If the results are positive, replace the dialyser and the Cartridge Blood Set. Follow the correct procedure to replace the extracorporeal circuit. Before starting a new dialysis treatment perform an ADR disinfection. 2. The Blood Leak Sensor is dirty. 2. Test the dialysate for the presence of blood. If the results are negative consider reducing the sensitivity of the sensor to its low value to complete the treatment (BLD SENS parameter). Press OVERRIDE. 3. The Blood Leak Sensor is dirty and the 3. If the dialysate tested negative for the sensitivity is set to LOW. presence of blood, the Blood Leak Sensor parameter is set to LOW and the alarm persists, stop the treatment. As soon as possible perform a chemical disinfection to clean the Blood Leak Sensor. 4. Massive air leak from the Dialysate 4. Verify the Dialysate Connectors do not leak. Connectors. Put the machine in BYPASS and verify that the Dialysate Connectors are well fitted to the dialyser. Remove from BYPASS. Press OVERRIDE. Call for Service if the problem persists. WARNING If the ”!Blood Leakage” # 28 alarm occurs and the identified cause is “Dialyser is leaking blood into the hydraulic circuit”, perform an ADR disinfection before starting a new dialysis treatment. Presence of blood in dialysate might result in a possible contamination of the hydraulic circuit with bacteria or viruses. If the ADR disinfection is not correctly performed before starting a new dialysis treatment, blood into the hydraulic circuit may cause cross- contamination problems resulting in patient injury or death. Rev. B SECTION 8 - ALARMS AND SIGNALS 8-43 BLOOD PUMP NOT IN START POSITION 29 Reason A problem was encountered during the initial reset phase that would not allow the for Alarm Blood Pump to position itself correctly. Machine None. Actions Possible Suggested Cause Action 1. The Blood Pump Cover is open or not 1. Verify the Blood Pump Cover is closed, completely closed. press OVERRIDE to clear the alarm or restart the machine. Call for Service if the problem persists. Rev. B 8-44 PHOENIX OPERATOR MANUAL BPM: AID REQUEST 30 Reason Incorrect calibration of the BPM device. for Alarm Machine Blood pressure monitoring is stopped and the measurement is not available. Actions Possible Suggested Cause Action 1. Temporary blockage of the device 1. Press OVERRIDE to clear the alarm. Do not perform any other measurements. In DIALYSIS, wait for the end of the treatment, turn OFF the machine, wait a few seconds and turn it ON again. From the IDLE view try a blood pressure measurement. Call for Service if the problem persists. Rev. B SECTION 8 - ALARMS AND SIGNALS 8-45 BPM: SYSTEM FAILURE 31 Reason The BPM is not taking measurements because of high or low pressure detected in for Alarm the cuff. Machine Blood pressure monitoring is stopped and the measurement is not available. Actions Possible Suggested Cause Action 1. Tubing is kinked or disconnected. 1. Verify that the external tubing is connected and there are no leaks or kinks. Press OVERRIDE and retry the measurement. 2. The patient moved his arm too many times 2. Press OVERRIDE and retry the during the measurement. The BPM was measurement. unable to measure the blood pressure. 3. The external Blood Pressure Cuff tubing or 3. Replace the cuff tubing and the cuff with a the cuff itself is leaking. new one. 4. There is a communication problem between 4. Repeat the measurement. the cuff and the machine. Call for Service if the problem persists Rev. B 8-46 PHOENIX OPERATOR MANUAL BPM: MEASUREMENT NOT MADE 32 Reason The blood pressure monitor was unable to take a blood pressure measurement. for Alarm Machine Blood pressure monitoring is stopped and the measurement is not available. Actions Possible Suggested Cause Action 1. The patient moved during the measurement. 1. Press OVERRIDE and retry the The BPM was unable to detect the systolic measurement. or diastolic pressure. 2. Incorrect position of the cuff. 2. Check the position of the cuff. Press OVERRIDE and retry the measurement. 3. The external blood pressure cuff tubing or 3. Replace the cuff tubing and the cuff with a the cuff itself is leaking. new one. Press OVERRIDE to clear the alarm. 4. Tubing is kinked or disconnected. 4. Verify that all of the external tubing is connected and there are no leaks or kinks. Press OVERRIDE and retry the measurement. Call for Service if the problem persists Rev. B SECTION 8 - ALARMS AND SIGNALS 8-47 BT1 LEVEL ERROR 33 Reason LD1 Level Sensor failed its test during dialysis preparation or an ADR process. The for Alarm level sensor may have detected air, failed or needs to be cleaned. Machine In ADR: The Time Out Proc (#190) alarm is generated which causes the Actions machine to stop the procedure and to go to a RESTART condition. In DIALYSIS: None. Possible Suggested Cause Action 1. Massive air leak from an empty concentrate 1. Check for empty Acid/Acetate, BiCart or container. Bicarbonate Container. The alarm clears before patient connection. 2. Dirty LD1 Level Detector. 2. Perform a RINSE or a Chemical Disinfection to clean the sensor of deposits. 3. Concentrate Line is not in the proper 3. Verify proper placement of the Concentrate position for the current phase of the Line for the current phase of the machine. machine. 4. BiCart Holder Arms are not in the fully 4. Place the BiCart Holder Arms in the closed closed position. position. Call for Service if the problem persists. Rev. B 8-48 PHOENIX OPERATOR MANUAL BT2 LEVEL ERROR 34 Reason LD2 Level Sensor failed its test during dialysis preparation or a cleaning process. for Alarm The Level Sensor may have detected air, failed or needs to be cleaned. Machine In ADR: None. Actions In DIALYSIS: None. Possible Suggested Cause Action 1. Massive air leak from an empty Concentrate 1. Check for empty Acid/Acetate, BiCart or Container. Bicarbonate Container. The alarm stays until the end of the treatment. 2. Dirty LD2 Level Detector. 2. Perform a RINSE or a Chemical Disinfection to clean the sensor of deposits. 3. Concentrate Line is not in the proper 3. Verify that the Concentrate Lines are in the position for the current phase of the proper position for the current phase of the machine. machine. 4. BiCart Holder Arms are not in the fully 4. Move the BiCart Holder Arms to the closed closed position. position to clear this alarm and to allow cleaning of the complete circuit. Call for Service if the problem persists. Rev. B SECTION 8 - ALARMS AND SIGNALS 8-49 BTP LEVEL ERROR 35 Reason LP Level Sensor failed its test during dialysis preparation or an ADR process. The for Alarm level sensor may have detected air, failed or needs to be cleaned. Machine In ADR: the Time Out Proc (#190) alarm is generated which causes the Actions machine to stop the procedure and to go to a RESTART condition. In DIALYSIS: None. Possible Suggested Cause Action 1. Dirty LP Level Detector. 1. Perform a RINSING or a Chemical Disinfection to clean the sensor of deposits. Call for Service if the problem persists. Rev. B 8-50 PHOENIX OPERATOR MANUAL ! BYPASS ALARM DATA ERROR 36 Reason A data difference was detected inside the double image of the Protection System for Alarm in the Main Board, for the BYPASS ALARM parameter. Machine None. Actions Possible Suggested Cause Action 1. A data difference was detected inside the 1. Return to IDLE view, in Configuration menu double image of the Protective System in restore the parameter to the correct value. If the Main Board, for the BYPASS ALARM the alarm persists, restart the machine. parameter. Call for Service if the problem persists. Rev. B SECTION 8 - ALARMS AND SIGNALS 8-51 ULTRAFILTER: UPPER SWITCH 38 Reason The Ultrafilter Upper Microswitch (SWFS) located on the rear of the machine is for Alarm indicating a problem condition. Machine In ADR: The machine goes into the RESTART condition. Actions In Dialysate preparation: The machine will not continue until the microprocessor sees the correct signal from the switch. In DIALYSIS: The machine bypasses the dialyser. Possible Suggested Cause Action 1. In Dialysate preparation: incorrect position 1. Carry out the following operations: of the Ultrafilter or Bypass fitting. • If an ultrafilter is installed, verify that it is correctly mounted covering both micro switches. • If an ultrafilter is not installed, verify that the clean dialysate bypass fitting is installed correctly on the lower bracket. 2. Incorrect ULTRAFIL. USE parameter. 2. Verify that the correct ULTRAFIL. USE parameter value is in memory. Call for Service if the problem persists. Rev. B 8-52 PHOENIX OPERATOR MANUAL ! PROTECTIVE MSG TRANSFER ERROR 39 Reason A communication problem has been detected in the transmission of data between for Alarm the Master Module and the Protection Module. Machine None. Actions Possible Suggested Cause Action 1. A communication problem has been 1. Wait for a few seconds for the alarm to detected in the transmission of data clear. between the Master Module and the • If it does not clear, enter the last safety Protection Module. related parameter which failed to restore the communication. • If it does not clear, turn the machine off, then back on and continue with the procedure being performed. Call for Service if the problem persists. Rev. B SECTION 8 - ALARMS AND SIGNALS 8-53 ! CONCENTRATE CANS 40 Attribute 1. LOW PH 2. HIGH PH 3. A Pump 4. B Pump 5. A+B PUMPS Reason LOW PH for Alarm The measured pH is lower than the permitted value. HIGH PH The measured pH is higher than the permitted value. A PUMP;B PUMP; A+B PUMPS A discrepancy is indicated between the conductivity of the dialysate both for the dialysate flow and the rotation speed of the associated Pump/Pumps. The actual Pump(s) speed does not match with the actual concentrate(s) used. Machine Bypasses the dialyser. Actions Note Autocalibration of the Pumps is possible from the beginning of dialysate preparation to phase 8, and from phase 9 on, each time the alarm occurs with the A Pump, B Pump or A+B Pumps attribute. Note PB autocalibration is only available with liquid bicarbonate. Possible Suggested Cause Action 1. Machine has run out of concentrates. 1. Replace the empty container, then wait a few seconds for the machine to stabilize. 2. If the attribute is A Pump or B Pump or A+B 2. Verify that the correct concentrate type is Pumps, concentrate type was/were changed connected to the machine. Verify that the and the PA/PB/PA+PB conductivity is stable, then perform a autocalibration/autocalibrations was/were PA/PB/PA+PB autocalibration/ not performed. autocalibrations. 3. Air leak from a Concentrate 3. Verify there are no air leaks from the Connector/BiCart. Concentrate Connectors/BiCart. 4. The Concentrate Connector has 4. Rinse accumulated debris from the accumulated debris or salt crystals. Connector. 5. The Concentrate Line is not properly 5. Verify that the Concentrate Lines are connected to the Concentrate Container securely connected and that no air bubbles are being draw into the lines. Rev. B 8-54 PHOENIX OPERATOR MANUAL 6. The solution in the Concentrate Container is 6. Stop the dialysis preparation and replace the not a solution correct for haemodialysis Cartridge Blood Set and the dialyser with a treatments (see Section 9 – Specification, in new Cartridge Blood Set and a new dialyser. this manual). Run a complete RINSE procedure. Replace the solution with the correct solution and then restart the dialysis preparation. 7. The solution in the Concentrate Container is 7. Verify that the solution is the correct not correct or is dilute. concentrate and/or replace the solution with the correct solution. 8. The Acid Concentrate Connector is not 8. Verify that the Acid Connector is securely securely connected to its Rinse Port. (If connected to its Rinse Port. using concentrate from a central delivery system) 9. Ensure that the correct type of dialysate has 9. In SETUP, select the correct concentrate been selected on the Dialysate Select view. type. Call for Service if the problem persists. Rev. B SECTION 8 - ALARMS AND SIGNALS 8-55 ! CONDUCTIVITY DATA ERROR 41 Reason A data difference was detected inside the double image of the Protection System for Alarm in the Main Board, for the CONDUCTIVITY parameter. Machine None. Actions Possible Suggested Cause Action 1. A data difference was detected inside the 1. In Set mode, restore the parameter to the double image of the Protective System in correct value. If the alarm persists, restart the Main Board, for the CONDUCTIVITY the machine. parameter. Call for Service if the problem persists. Rev. B In Config the operator must restore the stored in the Protection Module. for Alarm Machine None. parameters not related to the safety of the patient. A difference was detected when data was 1. B . Call for Service if the problem persists. Actions Possible Suggested Cause Action 1.8-56 PHOENIX OPERATOR MANUAL ! DATA ERROR 43 Reason A difference was detected when data was stored in the Protection Module. If not cleared. turn the machine OFF. then back ON and continue with the procedure being performed. Rev. UNDEFIN The machine is unable to measure dialysate flow. for Alarm MINIMUM The actual flow of the dialysate is lower than the set flow or minimum permitted flow. Perform a Descaling or a Chemical flowmeters of the machine. Unstable dialysate flow has been detected 1.ALARMS AND SIGNALS 8-57 ! DIALYSATE FLOW 44 Attribute 1. Call for Service if the problem persists. 2. B . Machine Machine bypasses the dialyser. Maximum 3. There are deposits or debris inside the 2. Press OVERRIDE to continue with the by the machine. Disinfection. Minimum 2. SECTION 8 . treatment. MAXIMUM The actual flow of the dialysate is higher than the set flow or maximum permitted flow. Rev. Actions Possible Suggested Cause Action 1. Undefin Reason The actual flow of the dialysate is different from the set value. for the DIALYSATE FL. restore the parameter to the double image of the Protection System in correct value. In Set mode. parameter. parameter. Call for Service if the problem persists. Actions Possible Suggested Cause Action 1. Machine None. for the DIALYSATE FL. A data difference was detected inside the 1. the Main Board. B . Rev.8-58 PHOENIX OPERATOR MANUAL ! DIALYSAT FLOW DATA ERROR 45 Reason A data difference was detected inside the double image of the Protection System for Alarm in the Main Board. The cuff is improperly applied. 4. 2. 3. Refer to your internal policy and consider changing the Maximum or Minimum limit of this alarm in SET mode for this patient. The diastolic pressure is out of the range set 1. 2. Retry measurement. The patient moved during the reading. SECTION 8 . Retry in configuration. Take a comparison blood pressure properly. Call for Service if the problem persists. Machine None. Check cuff application.ALARMS AND SIGNALS 8-59 DIASTOLIC PRESSURE ALARM 46 Reason The diastolic pressure measurement made by the BPM device is outside the limits for Alarm set by the operator in configuration. Press OVERRIDE to reset the alarm. B . The blood pressure cuff is not working 4. repeat measurement. Rev. Actions Possible Suggested Cause Action 1. the measurement and compare it with a manual blood pressure cuff. 3. measurement with a correctly calibrated manual sphygmomanometer. into its Rinse Port. Call for Service if the problem persists. Rev. Verify the connector is in the proper is in the wrong position.8-60 PHOENIX OPERATOR MANUAL DISINF CONNECTOR POSITION 47 Reason The Disinfectant Connector is not in the proper position for the phase of the for Alarm machine. The Disinfectant or Concentrate Connector 1. Machine In ADR: the machine will stop and wait until the connector is put in the Actions proper position. In DIALYSIS: none Possible Suggested Cause Action 1. B . or not fully inserted position in relation to the machine phase. ALARMS AND SIGNALS 8-61 E2PROM BLOOD ERROR 48 Reason Problem detected with the calibration coefficients in the Blood board EEPROM. B . for Alarm Default coefficients will be used to run the machine. Call for Service if the problem persists. Actions Possible Suggested Cause Action 1. Rev. Discontinue the treatment. Blood board EEPROM. Error with calibration parameters in the 1. Machine None. SECTION 8 . Actions Possible Suggested Cause Action 1. Hydraulic board EEPROM.8-62 PHOENIX OPERATOR MANUAL E2PROM HYDR ERROR 49 Reason Problem detected with the calibration coefficients in the Hydraulic board EEPROM. Call for Service if the problem persists. B . Discontinue the treatment. for Alarm Default coefficients will be used to run the machine. Rev. Error with calibration parameters in the 1. Machine None. Actions Possible Suggested Cause Action 1. SECTION 8 . B . Machine None. Call for Service if the problem persists. Rev. Error with calibration parameters in the 1.ALARMS AND SIGNALS 8-63 E2PROM BIOSLAVE ERROR 50 Reason Problem detected with the calibration coefficients in the Bioslave board EEPROM. for Alarm Default coefficients will be used to run the machine. Discontinue the treatment. Bioslave board EEPROM. Note If the DIALYSIS TIME is increased following the occurrence of this alarm. Additional DIALYSIS TIME may be needed. Machine None.TIMEOUT 51 Reason This message signals the operator that the DIALYSIS TIME is complete. the DIFFUSION TIME parameter will not be updated. Actions Note This alarm doesn’t occur when Profiling is active. 2. Increase the set DIALYSIS TIME to lengthen the treatment. Disconnect patient. Rev. This is only for Alarm used if TIME has been selected as the condition to end the dialysis treatment (END DIALYSIS parameter).8-64 PHOENIX OPERATOR MANUAL END DIA . Possible Suggested Cause Action 1. 2. B . even if the alarm condition has been reached. 1. DIALYSIS TIME is complete. Additional dialysis is needed even though 2. This is only used if “T BL” has been selected as the condition to end the dialysis treatment (END DIALYSIS parameter). Machine None. The total blood has been processed.TOTAL BLOOD 52 Reason This message signals the operator that the amount of the blood selected to be for Alarm dialysed is complete. 1. Increase the set blood volume to lengthen the blood volume has been processed.ALARMS AND SIGNALS 8-65 END DIA . SECTION 8 . Disconnect patient. Possible Suggested Cause Action 1. the treatment. Rev. B . Actions Note This alarm doesn’t occur when Profiling is active. even if the alarm condition has been reached. 2. WLR MINIMUM key. Rev. Increase the set TOT WEIGHT L to the TOT WEIGHT L programmed has been lengthen the treatment. then deselect the removed.8-66 PHOENIX OPERATOR MANUAL END DIA . This is only used if TWL has been selected as the condition to end the dialysis treatment (END DIALYSIS parameter). Machine The hourly weight loss of the patient is automatically set to the minimum Actions value. Disconnect patient. even if the alarm condition has been reached. Note This alarm doesn’t occur when Profiling is active. Additional dialysis is needed even though 2. complete. Possible Suggested Cause Action 1. The TOT WEIGHT L programmed is 1. B . 2.TOTAL WL 53 Reason This message signals the operator that the patient’s weight removal has been for Alarm completed. which for Alarm has passed through the dialyser. Machine Blood Pump stops.ALARMS AND SIGNALS 8-67 PRIME VOLUME COMPLETED 54 Reason The Blood Pump has finished priming. Rev. 2. 1. Priming is complete. Additional priming is required. 2. B . Repress PRIME and select a priming procedure. The quantity of physiological solution. is equal to that selected by the operator during the PRIME process. Actions Possible Suggested Cause Action 1. SECTION 8 . Press OVERRIDE to clear the alarm and proceed with set up. Turn off the heparin program and use the RIGHT arrow button on the Heparin Control Panel to decrease pressure then use the LEFT arrow button to ensure the heparin syringe plunger clamp is in contact with the syringe plunger. Ensure that the syringe is properly placed in the syringe holder. Rev. refill the syringe. perform a manual bolus if desired. Restart the program. place it back on the pump. 2. Open the Heparin Line Clamp. B . perform a manual bolus if desired. Call for Service if the problem persists. Incorrect position of the syringe. 4. Blocked heparin line. perform a manual bolus if desired. 3. Heparin syringe is empty.8-68 PHOENIX OPERATOR MANUAL END HEPARIN 55 Reason The heparin syringe is at the end of its travel. Actions Possible Suggested Cause Action 1. 1. Restart the program. 2. Turn off the heparin program. Restart the program and verify the machine is delivering the correct heparin quantity. Verify the Heparin Line Clamp is closed on the heparin line of the 4 position line clamp. Machine Stops the Heparin Pump. 4. Verify the Heparin Line Clamp is open. Defective syringe. for Alarm Heparin Line Clamp is not open. 3. refill a new syringe. Verify the Heparin Line Clamp is open. place it back on the pump. Turn off the heparin program. Rev. Dialysate preparation is complete. SECTION 8 . B . Machine is ready to prime a dialyser. 1.ALARMS AND SIGNALS 8-69 END OF DIALYSATE PREPARATION 57 Reason The dialysate preparation process is complete. Actions Possible Suggested Cause Action 1. If set to OFF. Select the appropriate keys to prime the dialyser. this alarm will not occur. Note In CONFIGURATION of the machine it is possible to turn this ALARM OFF (END PRE ALARM parameter). for Alarm Machine The machine waits for the dialyser to be primed. lower than the previous one.8-70 PHOENIX OPERATOR MANUAL END OF HEPARIN TIME 58 Reason The programmed PRE STOP TIME has been reached. Actions Possible Suggested Cause Action 1. B . Heparin infusion is complete. Select the HEPARIN view. 2. 1. The patient needs more heparin. Deactivate the heparin program to clear the alarm. 2. If set to OFF. Set a new value for the PRE STOP TIME. Rev. for Alarm Machine Stops the Heparin Pump. this alarm will not occur. Note In CONFIGURATION of the machine it is possible to turn this ALARM off. in this manual) if in treatment. perform a Fast Recovery of the Dialysis process (see Section 5.A .ALARMS AND SIGNALS 8-71 ERROR ON HEATER PROTECTION 59 Reason The alarm appears if the Heater malfunctions or if there is a problem in the for Alarm protection circuit of the heater. 1. SECTION 8 . B . Call for Service if the problem persists.Special Procedures. Rev. Error in the heating system. Turn the machine OFF. Actions Possible Suggested Cause Action 1. Machine The Heater is turned off. To match the current dialysis treatment with Total Fluid Removed and the programmed the Target Loss. 3. Alarms or operations set with the TOT WEIGHT L. Operator placed the machine in Minimum 4. The UF Rate has not been confirmed after 1.8-72 PHOENIX OPERATOR MANUAL ERROR ON TOTAL WEIGHT LOSS 60 Reason There is greater than a 100 gram difference between the actual total fluid removed for Alarm and the programmed TOT WEIGHT L. To match the current DIALYSIS treatment DIALYSIS mode. Call for Service if the problem persists. calculated. a COMPENSATION Action key will appear in PROFILE view. mode and CONFIRM the new UF Rate calculated. Select the COMPENSATION Action key for a new profile rate to be established so that the TOT WEIGHT L may be achieved. Machine None. Confirm the UF Rate by selecting SET from the TOT WEIGHT L has been set. To match the current DIALYSIS treatment UF for too long or the machine remained in with the TOT WEIGHT L. after blood detection. B . 4. Rev. the HOME view. enter the SET PATIENT CONNECT. If UF Profiling is activated. enter the SET the Minimum UF Rate for too long. Actions Possible Suggested Cause Action 1. enter SET mode and TOT WEIGHT L. 2. TOT WEIGHT L. mode and CONFIRM the new UF rate for too long. Select the COMPENSATION Action key for a new profile rate to be established so that the TOT WEIGHT L may be achieved. a COMPENSATION Action key will appear in PROFILE view. The operator changed the CONFIRM the UF Rate calculated. If UF Profiling is activated. selecting UF Rate and pressing CONFIRM (the machine calculates the UF Rate for the TIME and TOT WEIGHT L values). There is a difference between the actual 2. but forgot to CONFIRM the new UF Rate. Interruption in the operation of the 3. If an Ultrafilter is installed. verify that the clean dialysate bypass fitting is installed correctly on the lower bracket. USE parameter. Incorrect ULTRAFIL. In Dialysate preparation: incorrect position 1. In DIALYSIS: The machine bypasses the dialyser. Possible Suggested Cause Action 1. SECTION 8 . USE parameter value is entered in Config. B . Call for Service if the problem persists. Actions In Dialysate preparation: The machine will not continue until the microprocessor sees the correct signal from the switch. 2.ALARMS AND SIGNALS 8-73 ULTRAFILTER: LOWER SWITCH 61 Reason The ultrafilter lower microswitch (SWBY) is indicating a problem condition. 2. microswitches. for Alarm Machine In ADR: The machine goes into the RESTART condition. Verify that the correct ULTRAFIL. Rev. If an Ultrafilter is not installed. verify that it is of the Ultrafilter or bypass fitting located correctly mounted covering both behind the machine. 5. Call for Service if the problem persists. Massive air leak from the Concentrate 3. Change Concentrate Wand. Minimum 2. salt crystals. When using Central Delivery Acid. concentrate and dilution. the 6. Maximum Reason The conductivity of the dialysate is above or below the allowed limit. Wait for the concentrate Wand(s). B . stability of the dialysate flow.8-74 PHOENIX OPERATOR MANUAL ! FINAL CONDUCTIVITY 62 Attribute 1. Rinse Port. Wait for Wand. Actions Possible Suggested Cause Action 1. Rinse accumulated debris from the Connector(s) has accumulated debris or Connector(s). 3. Verify that the Acid/Acetate or Bicarbonate Acid/Acetate or Bicarbonate Connector is Connector is properly positioned in its not securely connected to its Rinse Port. The Acid/Acetate or Bicarbonate 4. relevant inlet connector. stability of the dialysate flow. Rev. Supply appropriate concentrate to the Container is empty. Wait for stability of the dialysate flow. Verify that the solution is the correct Concentrate Container. Inappropriate solution in the Acid/Acetate 5. Acid/Acetate or Bicarbonate Concentrate 2. 4. 2. for Alarm Machine In DIALYSIS: the machine will bypass the dialyser. Verify the Connector(s) are properly Connector(s) are not properly positioned to positioned to the proper wand(s). Acid/Acetate or Bicarbonate Concentrate 1. 6. SECTION 8 - ALARMS AND SIGNALS 8-75 FIXED DATA 63 Reason This alarm will display if the operator selects Disinfection (HEAT or CHEMICAL) or for Alarm RINSE modes and does not start the mode. Machine The machine will not proceed. Actions Possible Suggested Cause Action 1. The operator did not start the process to be 1. Turn OFF the machine and turn it ON. performed. Repeat the process to perform. Rev. B 8-76 PHOENIX OPERATOR MANUAL > GENERAL SAFE STATE < 64 Reason THIS IS A SPECIAL ALARM. A FULL DESCRIPTION APPEARS IN THE WARNING for Alarm AT THE END OF THE PRECEDING SUB-SECTION. SEE THE POSSIBLE CAUSE FOR DIFFERENT INDICATIONS. Machine 1. Bypasses the dialyser. Actions 2. Stops the Ultrafiltration Pump. 3. Stops the Blood Pump. 4. Closes the Venous Line Clamp. 5. Audible alarm cannot be muted or overridden. Possible Suggested Cause Action 1. A safety condition has not been satisfied 1. Turn off the machine. See the Fast when an alarm occurred. Recovery of the Dialysis process in the Section 5.A - Special Procedures. If the alarm reoccurs, disconnect the patient and turn off the machine. 2. A T1 Test failed during preparation. 2. Verify that the dialysate Connectors are well fitted to the machine. Verify the Cartridge is not blocking the Blood Pump Rotor. Turn the machine OFF, then try again to start up. Call for Service if the problem persists. Note If this alarm occurs during a treatment, the operator restarts the machine and the Patient Sensor detects blood, the machine will allow the operator to do a Fast Recovery of the Dialysis process (See the Fast Recovery of the Dialysis process procedure in the Section 5.A - Special Procedures). This enables the user to bypass many of the T1 tests so that the machine can continue the treatment from Patient Connect. Rev. B SECTION 8 - ALARMS AND SIGNALS 8-77 DIAL CONNECTOR POSITION 65 Reason The flow sensor (LFD) has detected an incorrect flow through the Dialysate for Alarm Connectors for the current phase. Machine The machine will go to a RESTART condition. Actions Possible Suggested Cause Action 1. Dialysate Connectors in the wrong 1. Correctly connect the dialyser Connectors position. to the Bypass Connectors or to the dialyser depending upon the phase of the machine at that time, then press RESTART. 2. Dialysate Connectors not properly 2. Verify the Dialysate Connectors are positioned. properly positioned to the dialyser or to the machine, depending upon the phase of the machine at that time. Press RESTART to restart the current operation of the machine. 3. Massive air leak. 3. Verify the presence of air in the external Dialysate line (TO/FROM). Press RESTART to restart the current operation of the machine. Call for Service if the problem persists. Rev. B 8-78 PHOENIX OPERATOR MANUAL Heart Rate Alarm 66 Reason The BPM heart rate measurement is outside the limits set by the operator. for Alarm Machine None. Actions Possible Suggested Cause Action 1. The BPM heart rate measurement is outside 1. Press OVERRIDE to clear the alarm. Verify the limits set by the operator. the heart rate with a manual measurement, compare it with the BPM heart rate. If both readings are close, consider changing the heart rate limits for this patient in the SET mode from the BPM view. 2. The cuff is improperly applied. 2. Check cuff application, repeat measurement. 3. The patient moved during the 3. Retry measurement. measurement. 4. The blood pressure cuff is not working 4. Take a manual pulse rate. Replace the properly or has a leak. tubing and cuff if necessary. Call for Service if the problem persists. Rev. B SECTION 8 - ALARMS AND SIGNALS 8-79 HEATING SYSTEM NOT STARTED 67 Reason This alarm displays if the hydraulic flowpath temperature falls below 90°C for 5 for Alarm minutes during HEAT Disinfection. Machine The machine will go to a RESTART condition. Actions Possible Suggested Cause Action 1. The hydraulic flowpath temperature falls 1. Press RESTART to reset to normal operating below 90°C for 5 minutes during HEAT conditions. If the alarm occurs again, turn Disinfection. OFF the machine and then ON. Repeat the ADR procedure. Call for Service if the problem persists. Rev. B 8-80 PHOENIX OPERATOR MANUAL DIALYSER SAFETY PRESSURE 68 Reason The transmembrane pressure difference of the blood side to the dialysate side is for Alarm larger than the value set by the operator for the HD SAFE THRE. Machine None. Actions Possible Suggested Cause Action 1. The HD SAFE THRE. is incorrect for the 1. Verify that the correct HD SAFE THRE. dialyser used. value was selected and entered in Config for the dialyser used. 2. The blood flow rate is too high for the 2. Verify the correctness of the patient current dialyser in the current operating prescription (ultrafiltration rate). Consider condition. decreasing the blood flow if this operation is not in disagreement with the patient prescription to decrease the venous pressure and avoid hemoconcentration. 3. The ultrafiltration is too high for the current 3. Verify the correctness of the patient dialyser in the current operating condition. prescription (ultrafiltration rate). 4. The transmembrane pressure is too high. 4. Consider increasing the dialysate flow to increase the dialysate pressure. 5. The extracorporeal circuit is clotting (low 5. Check the extracorporeal circuit for flux dialyser). clotting. Refer to your internal policy. Call for Service if the problem persists. Rev. B SECTION 8 - ALARMS AND SIGNALS 8-81 HEPARIN PUMP DIRECTION ERROR 69 Reason The Heparin Pump motor is rotating in the wrong direction. for Alarm Machine Stops the Heparin Pump. Actions Possible Suggested Cause Action 1. The Heparin Pump motor is rotating in the 1. Deactivate the heparin program. Activate it wrong direction. again. If the problem persists deactivate the heparin program. Call for Service if the problem persists. Rev. B 8-82 PHOENIX OPERATOR MANUAL HEPARIN SPEED ERROR 70 Reason Actual Heparin Pump infusion rate is incorrect. for Alarm Machine Stops the Heparin Pump. Actions Possible Suggested Cause Action 1. Actual Heparin Pump infusion rate is 1. Deactivate the heparin program. Activate it incorrect. again. If the problem persists, deactivate the heparin program. 2. Blocked heparin line or the clamp is closed. 2. Verify that the heparin clamp on the 4 Position Line Clamp is open and the heparin line is open. Call for Service if the problem persists. Rev. B SECTION 8 - ALARMS AND SIGNALS 8-83 HEPARINISATION NOT STARTED 71 Reason The machine is in DIALYSIS, sensing blood at the Patient Sensor and the Heparin for Alarm Pump has not been turned ON. Machine None. Actions Possible Suggested Cause Action 1. Heparin infusion was not started at the 1. In heparin view, start the heparin program beginning of the treatment. and press OVERRIDE to clear the alarm. 2. No heparin program is needed. 2. Press OVERRIDE to clear the alarm. Note In Config, the HEPARIN ALARM parameter can be configured to NO or YES. If set to NO, the Heparinisation Not Started alarm is turned off and will not appear. Rev. B 8-84 PHOENIX OPERATOR MANUAL HIGH LEVEL IN DIS TANK 72 Reason The state of the high level sensor in the disinfectant tank is not as required for the for Alarm current phase. Machine In ADR: The Time Out Proc (#190) alarm is displayed and the machine Actions stops. In Dialysis: None. Possible Suggested Cause Action 1. In ADR: the disinfectant container is empty. 1. Check the level of the disinfectant container. Press RESTART to proceed with the current process. 2. In ADR: disinfectant connector not 2. Verify the Disinfectant Connector is attached to the Disinfectant Wand. properly positioned to the Disinfectant Wand. Press RESTART to proceed with the current process. 3. In dialysis preparation: the machine had 3. Run a complete RINSE procedure. been shut off when the tank was full or not completely rinsed out. 4. In dialysis preparation: the Level Sensor is 4. Stop the dialysis preparation and run a dirty or defective. complete RINSE procedure. If the problem persists call for Service. 5. In DIALYSIS: If the Visual and Audible 5. Wait for the end of the treatment. After alarms are triggered press OVERRIDE. WASHBACK, try to perform a RINSE procedure. Call for Service if the problem persists. Rev. B SECTION 8 - ALARMS AND SIGNALS 8-85 HIGH LEVEL IN UF VESSEL 73 Reason Problem indicated with the High Level Sensor in the UF burette. for Alarm Machine In ADR: The Time Out Proc (#190) alarm is displayed and the machine Actions stops. In Dialysis: None. Possible Suggested Cause Action 1. In ADR: Error detected by the High Level 1. Press RESTART to restart the process. Sensor in the UF burette. Call for Service if the problem persists. Rev. B 8-86 PHOENIX OPERATOR MANUAL ! LONG POWER FAILURE 80 Reason An interruption of the AC supply voltage for more than 20 seconds. for Alarm Machine Stops the Blood Pump. Actions Closes the Venous Line Clamp. Ultrafiltration pump is reduced to its minimum value. Bypasses dialyser. Note This alarm occurs only if the Battery Backup Kit is not installed. WARNING When AC power is interrupted, a continuous audible alarm is turned ON. Possible Suggested Cause Action 1. Loss of AC power. 1. When power is restored, press OVERRIDE to restart the dialysis treatment. 2. The plug has been disconnected, or the 2. Verify the plug is properly positioned in the main switch (beside the socket) has been socket and the switch is turned on. Press turned off. OVERRIDE to restart the dialysis treatment. Call for Service if the problem persists. Rev. B SECTION 8 - ALARMS AND SIGNALS 8-87 LOW TEMPERATURE LIMIT REACHED 81 Reason This alarm appears if, in Chemical Disinfection with heating, the hydraulic flowpath for Alarm temperature falls below 33°C. Machine The process time will stop until the temperature measured in the hydraulic Actions circuit reaches 36°C. Possible Suggested Cause Action 1. Temporary drop of the temperature. 1. No Action is required. The machine should heat automatically. Call for Service if the problem persists. Rev. B 8-88 PHOENIX OPERATOR MANUAL LOW LEVEL IN DIS TANK 82 Reason The state of the Low Level Sensor in the Disinfectant Tank is not as required for the for Alarm current phase. Machine In ADR: The Time Out Proc (#190) alarm is displayed and the machine Actions stops. In Dialysis: None Possible Suggested Cause Action 1. In ADR: the Disinfectant Container is 1. Check that an adequate amount of empty. disinfectant is present in the Disinfectant Container. Press RESTART to proceed with the current process. 2. In ADR: the Disinfectant Connector is not 2. Verify that the Disinfectant Connector is attached to the Disinfectant Wand or the properly connected to the Disinfectant Wand is not positioned properly for the Wand and that the Wand is submerged in level of disinfectant present. the disinfectant. Press RESTART to proceed with the current process. 3. In dialysis preparation the machine was 3. Run a complete RINSE procedure. shut off when the tank was full or not completely rinsed out. 4. In dialysis preparation: the Level Sensor is 4. Stop the dialysis preparation and run a dirty or defective. complete RINSE procedure. If the problem persists call for Service. 5. In DIALYSIS: If the Visual and Audible 5. Wait for the end of the treatment. After alarms occur, press OVERRIDE. WASHBACK, try to perform a RINSE procedure. Call for Service if the problem persists. Rev. B sensor in the UF burette. Call for Service if the problem persists. In ADR: Error detected by the low level 1.ALARMS AND SIGNALS 8-89 LOW LEVEL IN UF VESSEL 83 Reason Problem indicated with the Low Level Sensor in the UF Burette for Alarm Machine In ADR: The Time Out Proc (#190) alarm is displayed and the machine Actions stops. SECTION 8 . Press RESTART to restart the process. Possible Suggested Cause Action 1. In Dialysis: None. Rev. B . Call for Service if the problem persists. Problem in the degassing loop. the machine stops and goes into a RESTART Actions condition. re-check carefully all the possible causes of the alarm then press again the RESTART key.8-90 PHOENIX OPERATOR MANUAL LOW PRESSURE IN DEGASSER 84 Reason Low flow as seen by LFP (for more than 6 seconds) is indicated in the degassing for Alarm portion of the hydraulics. Never press the RESTART key more than 2 or 3 times if the problem that is causing the “RESTART” condition has not been identified. WARNING When the patient is connected. Possible Suggested Cause Action 1. Machine The heater is turned OFF. Rev. B . if the first selection of the RESTART key doesn’t clear the alarm. Press RESTART to restart the process. 1. SECTION 8 . External Dialysate Lines are kinked. Dialysate Line. re- check carefully all the possible causes of the alarm then press again the RESTART key. Massive presence of air inside the hydraulic 4. proper position for the current phase of the machine. Verify the presence of air in external circuit. Dialysate Connectors in the wrong 1. depending upon the phase of the machine at that time. current dialyser. 5. 3. 6. Procedures. the UF Pump is driven at the current value. Dialysate Connectors in the proper 2. If the pressure is greater than 500 mmHg. Change the dialyser if necessary 7. 2. In ADR: If the pressure is greater than 500 mmHg the machine will stop the hydraulic module pumps and the UF Pump.A – Special venous seal. Perform a diaphragm Neutralization between the Cartridge Blood Set and the procedure (See Section 5. to the dialyser or to the machine. 4. reducing the blood flow if this operation is not in disagreement with the patient prescription. 8. WARNING When the patient is connected. Verify the correctness of the patient overpressure on the hydraulic side of the prescription (ultrafiltration rate). Check for clotting or clogging in the blood dialyser. Verify external Dialysate Lines are not kinked. producing a 5. side of the dialyser. The blood flow is too high. but not well inserted. Incorrect placement of the diaphragm 8. Call for Service if the problem persists. Consider machine. Never press the RESTART key more than 2 or 3 times if the problem that is causing the “RESTART” condition has not been identified. then press RESTART. Machine In DIALYSIS: Actions If the pressure is greater than 450 mmHg. Verify Dialysate Connectors are well fitted position. then press RESTART. Rev.ALARMS AND SIGNALS 8-91 MAX PI PRESSURE 87 Reason The hydraulic pressure sensor PI has detected a higher pressure than what is for Alarm allowed at the dialyser inlet connector. Possible Suggested Cause Action 1. in this manual). Verify Dialysate Connectors are in the position. 3. The machine goes into the RESTART. the UF Pump is driven at the current value and the machine goes into the RESTART phase. B . if the first selection of the RESTART key doesn’t clear the alarm. then press RESTART. then press RESTART. Clotting or clogging in the blood side of the 6. The dialysate flow rate is not correct for the 7. Consider reducing the dialysate flow rate. current dialyser. Dialysate Connectors in the proper 2. re- check carefully all the possible causes of the alarm then press again the RESTART key. B . 4. The blood flow is too high. dialysate line. Verify Dialysate Connectors are in the position. Verify the correctness of the patient overpressure on the hydraulic side of the prescription (ultrafiltration rate). Verify external dialysate lines are not kinked. the UF Pump is driven at the current value. if the first selection of the RESTART key doesn’t clear the alarm. If the pressure is greater than 500 mmHg. the UF Pump is driven at the current value and the machine goes into the RESTART phase. Check for clotting or clogging in the blood dialyser. Possible Suggested Cause Action 1.A – Special venous seal. but not well inserted. Clotting or clogging in the blood side of the 6. producing a 5. 5. Replace the dialyser if necessary. Consider reducing the dialysate flow rate. The machine goes into the RESTART. WARNING When the patient is connected. Incorrect placement of the diaphragm 8. 2. Verify Dialysate Connectors are well fitted position. reducing the blood flow if this operation is not in disagreement with the patient prescription. Perform a diaphragm Neutralization between the Cartridge Blood Set and the procedure (See Section 5. to the dialyser or to the machine. Massive presence of air inside the hydraulic 4. 8. Machine In DIALYSIS: Actions If the pressure is greater than 450 mmHg. then press RESTART. The dialysate flow rate is not correct for the 7. 3. Verify the presence of air in the external circuit. proper position for the current phase of the machine. Call for Service if the problem persists. then press RESTART. then press RESTART. External dialysate lines are kinked. Never press the RESTART key more than 2 or 3 times if the problem that is causing the “RESTART” condition has not been identified. Dialysate Connectors in the wrong 1. Procedures. 6. 7. in this manual). Rev. depending upon the phase of the machine at that time.8-92 PHOENIX OPERATOR MANUAL MAX PO PRESSURE 88 Reason The pressure sensor Po has detected a higher pressure than what is allowed at the for Alarm dialyser outlet connector. 3. then press RESTART. side of the dialyser. In ADR: If the pressure is greater than 500 mmHg the machine will stop the hydraulic module pumps and the UF Pump. Consider machine. B . Incoming water temperature is too high. In DIALYSIS ⇒ 46°C (114. Rev. 2. 3. Wait for the temperature to drop. 1. In Chemical Disinfection ⇒ 42°C (107.8°F) 2. 2. Actions Possible Suggested Cause Action 1. Verify a previous RESTART condition. In Heat or Heat Citric Disinfection⇒ 110°C (230°F) Machine The heater is turned OFF. Check the incoming water temperature (See the Specifications section). Call for Service if the problem persists. The machine had a RESTART condition. Verify patient safety. the heater is automatically turned on. 3.6°F) 3.ALARMS AND SIGNALS 8-93 MAX TEMPERATURE LIMIT 90 Reason The temperature measured by TP is greater than the following maximum values: for Alarm 1. Discontinue DIALYSIS and call for Service. The machine has malfunctioned. SECTION 8 . proper position for the current phase of the machine. Machine In DIALYSIS: Actions When the Dialysate flow is greater than 400 ml/min and the pressure is lower than -350 mmHg. 3. 6. Rev. 5. side of the dialyser. then press RESTART. B . Replace the dialyser if necessary. The UF Rate is too high for the dialyser 5. 3. Verify the Dialysate Connectors are in the position. dialysate line. When the Dialysate flow is lower than or equal to 400 ml/min and the pressure is lower than -250 mmHg. then press RESTART. then press RESTART. the UF Pump is stopped and the machine goes into the RESTART condition. 7. Check the proper UF Rate for the dialyser used. Possible Suggested Cause Action 1. 2. re-check carefully all the possible causes of the alarm then press again the RESTART key. if the first selection of the RESTART key doesn’t clear the alarm. Dialysate Connectors in the wrong 1. Verify the external dialysate lines are not kinked. Clotting or clogging in the blood side of the 6. If the pressure is lower than -450 mmHg. Verify the Dialysate Connectors are well position. but not well inserted. WARNING When the patient is connected. The dialysate flow is not correct for the 7. Consider reducing the dialysate flow rate. depending upon the phase of the machine at that time. 4. used. Verify the presence of air in the external circuit. External dialysate lines are kinked. then press RESTART. Call for Service if the problem persists. the UF Pump is stopped. Never press the RESTART key more than 2 or 3 times if the problem that is causing the “RESTART” condition has not been identified. fitted to the dialyser or to the machine. Massive presence of air inside the hydraulic 4. Check for clotting or clogging in the blood dialyser. Consider reducing the blood flow if this operation is not in disagreement with the patient prescription then press RESTART. Dialysate Connectors in the proper 2. In ADR: The pumps in the hydraulic module are stopped and the machine goes into the RESTART condition.8-94 PHOENIX OPERATOR MANUAL MIN PI PRESSURE 94 Reason The pressure sensor Pi has detected a lower pressure (approximately -350 mmHg) for Alarm than what is allowed at the inlet of the dialyser. the UF Pump is stopped and the machine goes into bypass. current dialyser. Check for clotting or clogging in the blood dialyser. then press RESTART. Clotting or clogging in the blood side of the 6. External dialysate lines are kinked. then press RESTART. then press RESTART. Consider reducing the dialysate flow rate. 3. side of the dialyser. Check the proper UF Rate for the dialyser used. WARNING When the patient is connected. If the pressure is lower than -450 mmHg. Massive presence of air inside the hydraulic 4. the UF Pump is stopped and the machine goes into the RESTART condition. dialysate line. The UF Rate is too high for the dialyser 5. When the Dialysate flow is lower than or equal to 400 ml/min and the pressure is lower than -250 mmHg. current dialyser. Dialysate Connectors in the proper 2. Replace the dialyser if necessary. then press RESTART. SECTION 8 . 5. Dialysate Connectors in the wrong 1. 7. In ADR: The pumps in the hydraulic module are stopped and the machine goes into the RESTART condition. B . Verify the presence of air in the external circuit. 6. depending upon the phase of the machine at that time. the UF Pump is stopped and the machine goes into bypass. Call for Service if the problem persists. if the first selection of the RESTART key doesn’t clear the alarm. 2. used. Consider reducing the blood flow if this operation is not in disagreement with the patient prescription. then press RESTART.ALARMS AND SIGNALS 8-95 MIN PO PRESSURE 95 Reason The pressure sensor Po has detected a lower pressure (approximately -350 mmHg) for Alarm than what is allowed at the outlet of the dialyser. re-check carefully all the possible causes of the alarm then press again the RESTART key. Verify the Dialysate Connectors are well position. Possible Suggested Cause Action 1. The dialysate flow rate is not correct for the 7. Verify the Dialysate Connectors are in the position. Machine In DIALYSIS: Actions When the Dialysate flow is greater than 400 ml/min and the pressure is lower than -350 mmHg. but not well inserted. 3. Verify the external dialysate lines are not kinked. 4. proper position for the current phase of the machine. - Rev. fitted to the dialyser or to the machine. the UF Pump is stopped. Never press the RESTART key more than 2 or 3 times if the problem that is causing the “RESTART” condition has not been identified. 4. The water valve is closed. 4. Note In DIALYSIS press RESTART to continue the treatment after the problem is fixed. 3. 2. for Alarm Machine All hydraulic module pumps are stopped. The incoming water filter is clogging. Possible Suggested Cause Action 1. The inlet water is disconnected. Verify the water valve is open.8-96 PHOENIX OPERATOR MANUAL NO WATER 100 Reason No water in the hydraulic circuit. Verify that there is adequate water pressure system. B . Water pressure is low. In ADR the machine restarts automatically. Call for Service if the problem persists. A clogged filter will decrease the amount of water flowing through the system. Rev. 3. Pressure drop in the RO distribution 1. in the RO distribution system 2. Connect the inlet water to proper water valve. Actions In DIALYSIS: the machine bypasses the dialyser. Check the water filter in the machine for clogging. 4. Press RESTART to restart the current the pump P1. In DIALYSIS: failure on the command that 2. 2.ALARMS AND SIGNALS 8-97 P1 PUMP OUT OF ORDER 104 Reason The encoder on P1 does not indicate the proper response to the command to run for Alarm P1. turn it ON again and repeat the procedure to perform. Recovery of the Dialysis process procedure in the Special Procedures section. operation of the machine. Turn OFF the machine. thus indicating malfunctioning. If the alarm does not clear see the Fast drives the pump P1. If it is not possible to modify the patient prescription. stop the treatment and call for Service. Actions In DIALYSIS: None. SECTION 8 . In ADR: failure on the command that drives 3. In ADR: if the machine does not restart. Possible Suggested Cause Action 1. 3. B . Call for Service if the problem persists. or P1 pump does not guarantee the dialysate flow set value. wait a few seconds. In DIALYSIS: P1 pump does not work 1. this operation is not in disagreement with the patient prescription. at the end of the treatment call for Service. Consider completing the treatment by properly in order to guarantee the dialysate setting the dialysate flow to 500 ml/min if flow set value. Rev. 4. Machine In ADR: The machine stops and goes into a RESTART condition. 8-98 PHOENIX OPERATOR MANUAL P2 PUMP OUT OF ORDER 106 Reason The encoder on P2 does not indicate the proper response to the command to run for Alarm P2. Turn OFF the machine.A Special Procedures. If the alarm does not clear see the Fast drives the P2 Pump. Recovery of the Dialysis process procedure in the Section 5. Actions In DIALYSIS: None. In DIALYSIS: failure of the command that 1. Rev. 2. In ADR: if the machine does not restart. Possible Suggested Cause Action 1. thus indicating malfunctioning. In ADR: failure of the command that drives 2. turn it ON again and repeat the procedure to perform. Machine In ADR: The machine stops and goes into a RESTART condition. 3. wait a few seconds. Press RESTART to restart the current the P2 Pump. 3. operation of the machine. B . Call for Service if the problem persists. ALARMS AND SIGNALS 8-99 PA AUTOCALIBRATION NOT PERFORMED 107 Reason The self calibration of the PA pump has not been performed due to a problem in for Alarm the EEPROM of the Protective board. Rev. SECTION 8 . Repeat the PA autocalibration. Pump failed. Actions Possible Suggested Cause Action 1. B . Machine None. The autocalibration of the Acid/Acetate 1. Call for Service if the problem persists. In ADR. B . Rev. Acid/Acetate Pump failed. Call for Service if the problem persists.8-100 PHOENIX OPERATOR MANUAL PA PUMP OUT OF ORDER 108 Reason The PA Pump does not respond to commands. does not fix the problem. wait a few seconds. Actions In DIALYSIS: None. turn it ON again and repeat the procedure to perform. press RESTART to restart the current operation of the machine. Turn OFF the machine. for Alarm Machine In ADR: The machine stops and goes into a RESTART condition. Possible Suggested Cause Action 1. In ADR. 2. 1. Acid/Acetate Pump failed but RESTART 2. B . The autocalibration of the Bicarbonate 1. Rev. Machine None. Actions Note This alarm only occurs when using liquid bicarbonate concentrate. SECTION 8 . Pump failed. Possible Suggested Cause Action 1. Repeat the PB autocalibration. Call for Service if the problem persists.ALARMS AND SIGNALS 8-101 PB AUTOCALIBRATION NOT PERFORMED 109 Reason The self calibration of the PB Pump has not been performed due to a problem in for Alarm the EEPROM of the protective board. B . not fix the problem. In ADR. Bicarbonate Pump failed but RESTART does 2. Turn OFF the machine. 1.8-102 PHOENIX OPERATOR MANUAL PB PUMP OUT OF ORDER 110 Reason The PB Pump does not respond to commands. press RESTART to restart the current operation of the machine. turn it ON again and repeat the procedure to perform. Bicarbonate Pump failed. Possible Suggested Cause Action 1. 2. Rev. Actions In DIALYSIS: None. Call for Service if the problem persists. wait a few seconds. for Alarm Machine In ADR: The machine stops and goes into a RESTART condition. 3. Recovery of the Dialysis process procedure in the Section 5.Special Procedures. If the alarm does not clear see the Fast drives the PC Pump. In ADR: if the machine does not restart. Turn OFF the machine. B . SECTION 8 . In ADR: failure of the command that drives 2. SECTION 8 . 3. operation of the machine. Rev. In DIALYSIS: failure of the command that 1. Possible Suggested Cause Action 1.ALARMS AND SIGNALS 8-103 8. turn it ON again and repeat the procedure. 2. thus indicating a malfunction. Press RESTART to restart the current the PC Pump. wait a few seconds.ALARMS AND SIGNALS PC PUMP FAILURE 111 Reason The encoder on the PC does not indicate the proper response to the command to for Alarm run the PC. Machine In ADR: The machine stops and goes into a RESTART condition.A . Actions In DIALYSIS: None. Call for Service if the problem persists. B . value in relation to the chemical being used for that process. the machine will go to a RESTART Actions condition.8-104 PHOENIX OPERATOR MANUAL PH MAXIMUM ALARM 112 Reason This alarm only occurs during Chemical or Heat Citric Disinfection. Verify that the chemical is the correct type maximum SET in the parameters. Press RESTART to restart the current operation of the machine. The pH Max parameter value is not correct 2. Machine In Chemical or Citric Disinfection. 2. Possible Suggested Cause Action 1. to be used. Rev. The pH value for Alarm measured is greater than the maximum SET in the parameters. Call for Service if the problem persists. Consider changing the pH Max parameter for the chemical being used. If the problem persists. The pH value measured is greater than the 1. discontinue the process. The pH value measured is lower than the 1. the machine will go to a RESTART Actions condition. Possible Suggested Cause Action 1. SECTION 8 . Rev. to be used. value in relation to the chemical being used for that process. If the problem persists. The pH value for Alarm measured is less than the minimum SET in the parameters.ALARMS AND SIGNALS 8-105 PH MINIMUM ALARM 113 Reason This alarm only occurs during Chemical or Heat Citric Disinfection. Consider changing pH Min parameter for the chemical used. discontinue the process. The pH Min parameter value is not correct 2. 2. Press RESTART to restart the current operation of the machine. B . Call for Service if the problem persists. Machine In Chemical or Citric Disinfection. Verify that the chemical is the correct type maximum SET in the parameters. Consider reducing the Blood Pump speed if this operation is not in disagreement with the patient prescription. Actions Note In case of high pressure detected by Pi or by Po. Rev. Verify the presence of air in the external circuit. Check for clotting or clogging in the blood Cartridge Blood Set. Procedures. Massive presence of air inside the hydraulic 3. Perform a diaphragm Neutralization between the Cartridge Blood Set and the procedure (See Section 5. 4. for Alarm Machine None. 6. in this manual). Moreover. proper position and are well fitted to the dialyser or to the machine. Dialysate Connectors not in the proper 1. Change the dialyser and the Cartridge Blood Set if necessary.A – Special venous seal. B . Dialysate line. side of the dialyser or in the Cartridge Blood Set. Possible Suggested Cause Action 1. Verify the Dialysate Connectors are well fitted to the dialyser or to the machine. depending upon the phase of the machine at that time. the #87 alarm (in case of high pressure detected by Pi) or the #88 alarm (in case of high pressure detected by Po) often occurs just before the #114 alarm appearance. Verify the correctness of the patient prescription (ultrafiltration rate). the machine goes into RESTART condition and the RESTART window becomes available. Clotting or clogging in the dialyser and/or 5. 5. The dialysate flow rate is not correct for the 6. Consider reducing the dialysate flow rate. 7. 3. 2. Call for Service if the problem persists. The UF Rate is too low. 4. if the pressure detected becomes highter than +500 mmHg. 2. Verify the Dialysate Connectors are in the position or not well inserted. External Dialysate Lines are kinked. Verify the external Dialysate Lines are not kinked. Refer also to the #87 or #88 alarm description to exit from the alarm condition. Incorrect placement of the diaphragm 7.8-106 PHOENIX OPERATOR MANUAL ! PI PO MAX 114 Reason The dialyser inlet/outlet pressure has exceeded the maximum limit of +480 mmHg. current dialyser. Refer also to the #94 or #95 alarm description to exit from the alarm condition. The UF Rate is too high for the dialyser 4. 2. side of the dialyser or in the Cartridge Blood Set. Clotting or clogging in the dialyser or the 5. Replace if necessary. Moreover. Possible Suggested Cause Action 1. 5. Verify the presence of air in the external circuit. for Alarm Machine Ultrafiltration is stopped. 4. Rev. 6. Check for clotting or clogging in the blood Cartridge Blood Set. current dialyser. Dialysate Lines. Verify the correctness of the patient used. Verify the external Dialysate Lines are not kinked. the machine goes into RESTART condition and the RESTART window becomes available. Verify the Dialysate Connectors are well fitted to the dialyser or to the machine.ALARMS AND SIGNALS 8-107 ! PI PO MIN 115 Reason The dialyser inlet/outlet pressure is below the minimum limit of -350 mmHg. B . Actions Note In case of low pressure detected by Pi or by Po. Call for Service if the problem persists. prescription (ultrafiltration rate). Consider increasing the dialysate flow rate. Massive presence of air inside the hydraulic 3. Verify the Dialysate Connectors are in the position or are not inserted well. 3. The dialysate flow rate is not correct for the 6. Dialysate Connectors not in the proper 1. External Dialysate Lines are kinked. the #94 alarm (in case of low pressure detected by Pi) or the #95 alarm (in case of low pressure detected by Po) often occurs just before the #115 alarm appearance. 2. proper position and are well fitted to the dialyser or to the machine. if the pressure detected becomes lower than -450 mmHg. Consider increasing the Blood Pump speed if this operation is not in disagreement with the patient prescription. SECTION 8 . depending upon the phase of the machine at that time. the dialyser. Machine None. B .8-108 PHOENIX OPERATOR MANUAL PI PRESSURE SENSOR ERROR 116 Reason A problem was detected with the Inlet Dialyser Pressure Sensor due to an for Alarm unplugged Sensor or to an out of range reading. Actions Possible Suggested Cause Action 1. Call for Service if the problem persists. No action is required. Rev. Problem detected with the Inlet Sensor of 1. Rev. the dialyser. Machine None. Problem detected with the Outlet Sensor of 1.ALARMS AND SIGNALS 8-109 PO PRESSURE SENSOR ERROR 118 Reason A problem was detected with the Outlet Dialyser Pressure Sensor due to an for Alarm unplugged Sensor or to an out of range reading. Call for Service if the problem persists. SECTION 8 . Actions Possible Suggested Cause Action 1. B . No action is required. A - Special Procedures. The machine blocks and goes into > 2. See the Fast Recovery of the Dialysis GENERAL SAFE STATE <. Note This alarm is usually followed by a > GENERAL SAFE STATE < alarm. Actions Stops the Ultrafiltration Pump. 2. Rev. communication system. can not be silenced by pressing the MUTE button. TIMEOUT 120 Reason The Protection System is not able to communicate with the Main computer Board. Possible Suggested Cause Action 1. Stops the Blood Pump. which signals the #120 alarm condition. B . Closes the Venous Line Clamp. Call for Service if the problem persists. Wait few seconds for stability of the system.8-110 PHOENIX OPERATOR MANUAL ! PROTECTIVE CARD COMM. If the condition persists. Temporary instability of the communication 1. for Alarm Machine Bypasses the dialyser. Note The Audible alarm. stop DIALYSIS. process procedure in the Section 5. necessary. The Autocalibration of the Ultrafiltration 1. Machine None. Actions Possible Suggested Cause Action 1. Repeat the PUF Autocalibration. B . If Pump failed. turn OFF the machine. SECTION 8 . Rev. Call for Service if the problem persists.ALARMS AND SIGNALS 8-111 PUF AUTOCALIBRATION NOT PERFORMED 121 Reason The Ultrafiltration Pump Autocalibration was not performed due to a problem in for Alarm the EEPROM of the Protective board. Rev. In ADR: press RESTART to restart the current operation of the machine. does not fix the problem. 1. Call for Service if the problem persists. 2. Ultrafiltration Pump failed. B . Turn OFF the machine. Actions In DIALYSIS: None. for Alarm Machine In ADR: The machine stops and goes into a RESTART condition. turn it ON again and repeat the procedure.8-112 PHOENIX OPERATOR MANUAL PUF PUMP OUT OF ORDER 122 Reason The Ultrafiltration Pump does not respond to commands. Possible Suggested Cause Action 1. wait a few seconds. Ultrafiltration Pump failed but RESTART 2. turned off. 1. Actions Note This alarm occurs only if the Battery Backup Kit is not installed. The plug has been disconnected. Verify that the plug is properly positioned breaker switch (beside the socket) has been in the socket and the switch is turned on. Call for Service if the problem persists. B . Loss of AC power less than 20 seconds.ALARMS AND SIGNALS 8-113 ! SHORT POWER FAILURE 124 Reason A drop in AC voltage for less than 20 seconds. Rev. Press OVERRIDE to restart the dialysis treatment. 2. Possible Suggested Cause Action 1. Press OVERRIDE to restart the dialysis treatment. WARNING When AC power drops out. a continuous audible alarm is turned on. SECTION 8 . for Alarm Machine Bypasses the dialyser. or the 2. The leaking. 6. The venous line is kinked. for Alarm Machine Stops the Blood Pump.8-114 PHOENIX OPERATOR MANUAL ! SN COMMUTATION 125 Reason The maximum run time for a cycle in Single Needle mode has elapsed. Possible Suggested Cause Action 1. A previous alarm stopped the Blood Pump. 3. Press OVERRIDE to restart the pump and chambers were adjusted while the Blood clear the alarm. 10. consider changing the venous limits. cannot reinfuse the blood to the patient after clamp commutation. A combination of Blood Pump speed. expansion chambers. Arterial and/or venous lines are not in their 9. The machine 4. 2. Verify that there is no clotting in the Set. change venous high and low trip points. Press OVERRIDE to restart the pump and clear the alarm. The blood levels in the arterial and venous 7. 8. Increase the Blood Pump speed. causing the stroke to be too long. Rev. B . 2. 4. 7. The patient is moving around. Increase the Blood Pump speed. Place the line(s) in the clamp(s). 9. Press OVERRIDE to restart the Pump and clear the alarm. 10. Clotting is occuring in the Cartridge Blood 5. or venous limits set by the operator. Call for Service if the problem persists. Adjust the levels inside the chamber will fill up over time. 5. clear the alarm. 6. Slowly adjust the arterial Pump was running. Cartridge Blood Set. The expansion chambers may be leaking 1. Verify the venous line is not kinked. The Blood Pump speed is too low for the 3. or decrease the UF RATE has caused the SN cycle time to RATE to reduce the SN cycle time to within exceed the allowed cycle time. Actions Closes the Venous Line Clamp. Press OVERRIDE to restart the pump and clear the alarm. the allowed time limit. and UF the venous trip points. and venous chamber blood levels. Press OVERRIDE to restart the pump and clamps. Verify the expansion chambers are not air. A change was made to the UF RATE. 8. using a syringe. Ultrafiltration is reduced to its minimum value. 2. Problems during patient connection 2. start the treatment. SECTION 8 . Rev.ALARMS AND SIGNALS 8-115 START DIALYSIS DELAYED 129 Reason The Patient Sensor has detected blood for at least 5 minutes and the DIALYSIS for Alarm Action key on the PATIENT CONNECT view has not been pressed. Machine None. at least 5 minutes and the DIALYSIS Action key on the PATIENT CONNECT view has not been pressed. B . Select the DIALYSIS Action key. The Patient Sensor has detected blood for 1. Actions Possible Suggested Cause Action 1. Fix problems in patient connection. then postponed the start of dialysis. If alarm does not clear and the machine 2. for Alarm Machine None. Wait a few seconds for the alarm to be cleared.Special Procedures. 1. B . See the Fast Recovery of the Dialysis process stops functioning. 2. procedure in the Section 5. Call for Service if the problem persists. Temporary communication problem. Rev.A . Actions Possible Suggested Cause Action 1.8-116 PHOENIX OPERATOR MANUAL BLOOD CARD MSG TRANFER ERROR 130 Reason The Main computer and the Blood Slave Board are not communicating. A - Special Procedures. 1. process procedure in the Section 5. Temporary communication problem.ALARMS AND SIGNALS 8-117 HYD CARD MSG TRANSFER ERROR 131 Reason The Main computer Board and the hydraulic modules are not communicating. for Alarm Machine None. SECTION 8 . Call for Service if the problem persists. B . 2. Wait a few seconds for the alarm to be cleared. If alarm does not clear and the machine 2. Actions Possible Suggested Cause Action 1. See the Fast Recovery of the Dialysis stops functioning. Rev. 2. measurement. Actions Possible Suggested Cause Action 1. 4. The patient’s systolic pressure is out of the 1. If the readings are not similar. Retry the measurement. Replace the cuff and tubing and retry the properly. Press OVERRIDE to reset the alarm. Rev. Verify range set in configuration. The blood pressure cuff is not working 4. 2. 3. The cuff is improperly applied. Take a comparison blood pressure reading with a correctly calibrated manual sphygmomanometer. Machine None. call for Service. the measurement with a manual blood pressure cuff. Retry the measurement.8-118 PHOENIX OPERATOR MANUAL SYSTOLIC PRESSURE ALARM 132 Reason The systolic pressure measurement taken by the BPM device is outside the limits for Alarm set by the operator in the Configuration view. Call for Service if the problem persists. B . 3. Patient moved during the measurement. Press OVERRIDE to reset the alarm. Press OVERRIDE to reset the alarm. Check and/or reapply the cuff on the patient’s extremity. Retry the measurement. Refer to your internal policy. Call for Service if the problem persists. but the venous line was out of Bubble Detector. Rev. Repeat Dialysate preparation. Verify that the Dialysate Connectors are properly positioned to their Bypass Ports. 2. note the T1 test failed and call for Service. SECTION 8 . B . A Fast Recovery of the Dialysis process was 2. If the T1 test fails again. 1.ALARMS AND SIGNALS 8-119 ! T1 TEST FAILED 133 Reason One of the automatic T1 tests of the machine’s components and processes has for Alarm failed. the Dialysis process procedure is required. disconnect the patient. A new Fast Recovery of the Air Bubble Detector. If the blood is clotting. Machine GENERAL SAFE STATE Actions Possible Suggested Cause Action 1. The venous line must stay inside the Air performed. A T1 test failed during preparation. to a previous RESTART condition.Specifications). 3. Actions Possible Suggested Cause Action 1. B . A temporary instability of dialysate flow due 1. the Section 9 . Call for Service if the problem persists.8-120 PHOENIX OPERATOR MANUAL ! TEMPERATURE 134 Attribute MINIMUM MAXIMUM UNDEFIN Reason Minimum for Alarm The measured temperature is -2°C lower than the set value or the minimum permitted value (34°C). If the machine temperature remains high or and has not yet reached operating low for more than 10 minutes. Check the incoming water temperature (See exceeded safe limits. dialysis. The temperature of the dialysate has 2. Wait for stability of the system. Machine Bypasses the dialyser. 2. The machine has recently been turned on 3. Maximum The measured temperature is +2°C above than the set value or the maximum permitted value (39. Discontinue dialysis. 4. Undefin The machine is unable to measure the temperature. Rev.5°C). The machine has an internal malfunction 4. discontinue temperature. Actions Possible Suggested Cause Action 1. for the TEMPERATURE the machine. restart the Main Board. 2. Call for Service if the problem persists. for the TEMPERATURE parameter. A data difference was detected inside the 1.ALARMS AND SIGNALS 8-121 ! TEMPERATURE DATA ERROR 135 Reason A data difference was detected inside the double image of the Protection System for Alarm in the Main Board. parameter. Machine None. SECTION 8 . In SET mode. The machine has an internal malfunction. If the alarm persists. 2. Rev. Discontinue DIALYSIS. restore the parameter to the double image of the Protection System in correct value. B . 1°C for at least 5 minutes. exceeded safe limits. B . 3. 3.Specifications). 2. Check the incoming water temperature. The temperature measured by the Hydraulic Probe was greater than 107°C for at least 5 minutes. The temperature measured by the Hydraulic Probe was greater than 80°C with a variation of less than 0. process procedure in the Section 5. Not in DIALYSIS: The protection probe (TPS) temperature was greater than 105°C for at least 30 seconds. Discontinue DIALYSIS. See the Fast Recovery of the Dialysis made the dialysate flow rate unstable. Call for Service if the problem persists. Machine GENERAL SAFE STATE Actions Possible Suggested Cause Action 1. In dialysis: a previous RESTART condition 1. The machine has an internal malfunction. Rev.A - Special Procedures.8-122 PHOENIX OPERATOR MANUAL ! TEMPERATURE EXCESSIVE VALUE 136 Reason In DIALYSIS: for Alarm The protection probe (TPS) temperature was greater than 50°C for at least 30 seconds. If the problem persists disconnect the patient. (See the Section 9 . The temperature of the dialysate has 2. Rev. Call for Service if the problem persists. Machine In DIALYSIS and ADR: Actions The machine goes into a RESTART condition. SECTION 8 . When the treatment is complete. The Clean Dialysate Ultrafilter is plugged. replace the Ultrafilter according to the procedure. If treatment has started.ALARMS AND SIGNALS 8-123 ULTRAFILTER IS PACKED 138 Reason The pressure drop across the Clean Dialysate Ultrafilter is higher than the for Alarm maximum permitted value. Possible Suggested Cause Action 1. B . 1. the dialysis process in progress can be continued by decreasing the dialysate flow rate. and then repeat the PA Autocalibration. for Alarm Machine None.8-124 PHOENIX OPERATOR MANUAL TIMEOUT ON PA AUTOCALIBRATION 139 Reason The PA Pump Autocalibration has failed due to the timeout of the Main Board. Wait a few seconds for stability of the Autocalibration or the machine has run out machine. Rev. Turn the machine OFF and then back ON Autocalibration. 2. Container. Actions Possible Suggested Cause Action 1. If needed reboot the machine and repeat the PA Autocalibration. Power failure during PA Pump 3. then repeat the PA Autocalibration. 3. inserted in the proper Wand. and perform PA Autocalibration again. Conductivity is not stable during the 2. Concentrates were changed during the 1. B . Verify the Acid/Acetate Connector is well Autocalibration. Call for Service if the problem persists. If needed reboot the machine and repeat the PA Autocalibration. verify the stability of Acid/Acetate conductivity. check for the correct Acid/Acetate of concentrates. B . and then repeat the PB Autocalibration. Verify the Bicarbonate Connector is well Autocalibration. verify the stability of the Bicarbonate Conductivity. Wait a few seconds for the machine to Autocalibration or the machine has run out stabilize. Rev. Actions Note This alarm will only occur if Liquid Bicarbonate is being used. Possible Suggested Cause Action 1. turn the machine OFF and then back ON and repeat the PB Autocalibration. and perform the PB Autocalibration again. 2. If needed turn the machine OFF and then back ON and repeat the PB Autocalibration. inserted in the proper Wand. Concentrate. Call for Service if the problem persists. then repeat the PB Autocalibration. Conductivity is not stable during the 2. SECTION 8 . 3. check for the correct Bicarbonate of concentrates. Concentrates were changed during the 1. If needed. Turn the machine OFF and then back ON Autocalibration.ALARMS AND SIGNALS 8-125 TIMEOUT ON PB AUTOCALIBRATION 140 Reason The PB Pump Autocalibration has failed due to the timeout of the Main Board. Power failure during PB Pump 3. for Alarm Machine None. Call for Service if the problem persists. restart the Dialysis Autocalibration failed. for Alarm Machine None. preparation and the PUF Autocalibration. The tubing segment in the PUF Peristaltic 1. and needs to be stretched. and then Pump is new. Turn the machine OFF and then back ON Autocalibration. Power failure during PUF Pump 3. In a previous RESTART condition the 2. From IDLE view. Perform a RINSING procedure.8-126 PHOENIX OPERATOR MANUAL TIMEOUT ON PUF AUTOCALIBRATION 141 Reason The PUF Pump Autocalibration has failed due to the timeout of the Main Board. 3. B . Actions Possible Suggested Cause Action 1. 2. repeat the PUF Autocalibration. Rev. and perform the PUF Autocalibration again. 4. when the alarm appears once. Check that the Dialysate Lines are not kinked or clamped. The Cartridge Blood Set is not well 6. Readjust the alarm limit. parameter in the Config menu. SECTION 8 . B . it will be displayed on the Touch Screen as long as the alarm condition persists. Correct the action which caused the Blood Pump to stop and restart the Blood Pump. prescription (ultrafiltration rate). 3. Verify the correctness of the patient treatment. Perform the Diaphragm Neutral Position Procedure (See Section 5. 4. 6. it can be reset and then does not appear again. Possible Suggested Cause Action 1. TMP THRESHOLD parameter does not 2. The TMP icon and visual alarm are displayed if the TMP ALARM is set YES or NO. Note The Transmembrane Pressure alarm is not active if the machine is in Single Needle mode. The Pressure Sensor cannot read pressure pod diaphragm are not collapsed. 2. if the parameter is set to YES. Rev. Consider changing the limit of this comply with the specification of the dialyser. Consider increasing the Blood Pump speed if this operation is not in disagreement with the patient prescription. TMP. Actions Note If the parameter TMP ALARM is set to NO in the configuration process. verify the positioned or a pressure pod diaphragm has Cartridge Blood Set position. Dialyser not correct for the current 1. 3. If the alarm condition persists.A Special Procedures) if required. Verify that the collapsed. The Dialysate Lines are blocked. The Alarm limit is set too close to the actual 5.ALARMS AND SIGNALS 8-127 TRANSMEMBRANE PRESSURE 142 Reason The difference between the venous pressure and the Pi Pressure Transducer has for Alarm reached the TMP THRESHOLD parameter set by the user. Comply with the specifications of the dialyser. Machine None. Blood Pump is stopped. properly. 5. Call for Service if the problem persists. it is not possible to override the alarm. If the alarm persists.8-128 PHOENIX OPERATOR MANUAL ! UF DATA ERROR 143 Reason A data difference was detected inside the double image of the Protection System for Alarm in the Main Board. confirm the parameter to the double image of the Protective System in correct value. Call for Service if the problem persists. for the WEIGHT LOSS/H parameter. Rev. for the WEIGHT LOSS/H the machine. A data difference was detected inside the 1. Actions Possible Suggested Cause Action 1. Machine None. restart the Main Board. In SET mode. parameter. B . B . Press OVERRIDE. 2. Actions Note This alarm will only be displayed after the Patient Sensor detects blood or the DIALYSIS Action key is pressed. NO CALIB: The machine could not perform an alignment of the D2 flowmeter during the treatment. Call for Service if the problem persists. D1-D2: Error in the Ultrafiltration Mass Balance in the Hydraulic Module. and the Ultrafiltration Mass Balance could be incorrect. Press OVERRIDE to clear the alarm. If the attribute is D1-D2 or P2 Pump the 2. D1-D2 10. the machine has 3. P2 Pump: Error in the Ultrafiltration Mass Balance in the Hydraulic Module. alignment. As soon as possible perform DESCALING. Valves 9. Machine Bypasses the dialyser. Rev. If the attribute is No Calib. SECTION 8 . 3. No Calib Reason VALVES: for Alarm Error in the Ultrafiltration Mass Balance in the Hydraulic Module. If the problem persists disconnect the machine needs to be descaled. due to incorrect valves control. due to incorrect P2 Pump flow or P2 reading.ALARMS AND SIGNALS 8-129 ! UF MASS BALANCE 144 Attribute 8. patient. due to incorrect flowmeter reading. The machine not performed a flowmeter alignment for 25 automatically will perform a flowmeter minutes. P2 Pump 11. A RESTART condition has resulted in the 1. Possible Suggested Cause Action 1. machine detecting a Ultrafiltration Mass Balance error. VESSEL Reason 1. Press OVERRIDE to restart the Ultrafiltration adds approximately 2 liters/hour to the UF Pump. Actions Note This alarm will only be displayed after the Patient Sensor detects blood or the DIALYSIS Action key is pressed. Rev. If the alarm persists disconnect the patient. Pi and Po pressures are high. Press OVERRIDE to restart the Ultrafiltration Rate of the machine too often. LOW 2. 3. as the Total Fluid Removal value may not be reliable. Rate to lower the pressure.8-130 PHOENIX OPERATOR MANUAL ! UF RATE ERROR 145 Attibute 1. Vessel: There was an error detected in the calculation of the volume or the emptying time of the UF burette. B . Call for Service if the problem persists. 2. The machine 2. 2. LOW: for Alarm The measured ultrafiltration is lower than the rate set by the operator or the permitted limit. HIGH: The measured ultrafiltration is higher than the rate set by the operator or the permitted limit. HIGH 3. This is a Pump. Possible Suggested Cause Action 1. may be affected by this error. The operator changed the Ultrafiltration 1. Machine Ultrafiltration Rate is set to zero. The Total Weight Loss calculation temporary acquiring error. If this occurs often the alarm could be triggered. SECTION 8 . Press RESTART to restart the current operation of the machine. replace the Ultrafilter according to the procedure. depending upon the phase of the machine at that time. 2. Correctly connect the dialyser Connectors to the Bypass Connectors or to the dialyser depending upon the phase of the machine at that time. positioned to the dialyser or to the machine. the dialysis process in progress can be continued by decreasing the dialysate flow rate. 2. B . 3. Dialysate Connectors in the wrong position.ALARMS AND SIGNALS 8-131 ULTRAFILTER MAX PRESSURE 146 Reason The PFS Pressure Sensor (PFS Sensor is related to the Clean Dialysate Ultrafilter) for Alarm has registered a measurement which exceeds the maximum permitted value. Dialysate Connectors not properly 3. 1. If in treatment. The Clean Dialysate Ultrafilter is plugged. When the treatment is complete. Call for Service if the problem persists. Possible Suggested Cause Action 1. Verify the Dialysate Connectors are properly positioned. then press RESTART. Machine In DIALYSIS and ADR: Actions The machine goes into a RESTART condition. Rev. Rev. Actions Possible Suggested Cause Action 1.8-132 PHOENIX OPERATOR MANUAL ULTRAFILTER PRESSURE SENSOR 147 Reason A problem was detected with the Pre Ultrafilter Pressure Sensor (PFS) due to an for Alarm unplugged connector or to an out of range reading. Never press the RESTART key more than 2 or 3 times if the problem that is causing the “RESTART” condition has not been identified. B . operation of the machine. Call for Service if the problem persists. if the first selection of the RESTART key doesn’t clear the alarm. Press RESTART to restart the current Sensor. re-check carefully all the possible causes of the alarm then press again the RESTART key. WARNING When the patient is connected. Machine None. Problem detected with the Pre Ultrafilter 1. Verify the Venous Line Clamp is free from obstruction. Carefully clean the Venous Line Clamp (see Section 6 . 2. Call for service if the problem persists. 1. 3. Actions Possible Suggested Cause Action 1. or it is closed when it should be open.ALARMS AND SIGNALS 8-133 VENOUS CLAMP POSITION 148 Reason The Optical Switch in the Venous Line Clamp indicates that the clamp is open for Alarm when it should be closed. The machine has an internal malfunction. Venous Line Clamp is dirty. 3. in this manual). 2. Venous Line Clamp is obstructed.Clean/Disinfect. Call for Service if the problem persists. B . SECTION 8 . Only the venous line should be inserted into the clamp. Machine None. Rev. A data difference was detected inside the 1. B . Actions Possible Suggested Cause Action 1. in Config restore the double image of the Protection System in parameter to the correct value.8-134 PHOENIX OPERATOR MANUAL ! VENOUS PRES DATA ERROR 150 Reason A data difference was detected inside the double image of the Protection System for Alarm in the Main Board. Call for Service if the problem persists. and turn the machine OFF. for the VEN P parameter. Return to IDLE view. then back ON again. for the VEN P parameter. Machine None. persists. Rev. If the alarm the Main Board. B . If the alarm persists. Actions Possible Suggested Cause Action 1. SECTION 8 . for the VEN PRES LIMIT parameter. Machine None. parameter. turn the the Main Board. In SET mode. then turn it ON again.ALARMS AND SIGNALS 8-135 ! VEN PRES LIMIT DATA ERROR 152 Reason A data difference was detected inside the double image of the Protection System for Alarm in the Main Board. for the VEN PRES LIMIT machine OFF. Rev. Call for Service if the problem persists. A data difference was detected inside the 1. restore the parameter to the double image of the Protective System in correct value. 8-136 PHOENIX OPERATOR MANUAL VEN PRESSURE OUT OF RANGE 153 Reason The measured venous pressure is outside the range of values permitted by the for Alarm Sensor. Ultrafiltration is reduced to the minimum value. Call for Service if the problem persists. heparinization of the patient.e. 2. Venous pressure has increased somewhat 2. Check for restriction of blood flow in the venous access or in the venous line. clotted venous needle. kinks. poor flow to the patient’s venous access. clamps. Restriction of blood flow to the patient’s 1. Possible Suggested Cause Action 1. venous line. i. Actions Closes the Venous Line Clamp. blood flow rate and haemoconcentration and/or inadequate anticoagulant dosage. resulting in a pressure increase for a given needle at a fixed blood flow rate. The alarm clears when the venous pressure is in the proper range. B . Attention should be given to re-evaluating during a treatment due to needle size. Rev. Machine Stops the Blood Pump. e. clotted venous needle. When this is the case. Attention should be given to re-evaluating during a treatment due to needle size. venous line. Possible Suggested Cause Action 1. Venous pressure has increased somewhat 2. to clear the ! VENOUS PRESSURE HIGH LIMIT #154 alarm. poor flow to the patient’s venous access. B . Actions Closes the Venous Line Clamp. Call for Service if the problem persists. Rev. The alarm clears when the venous pressure is in the proper range. see Note Ultrafiltration is reduced to the minimum value. heparinization of the patient. Restriction of blood flow to the patient’s 1. resulting in a Press OVERRIDE to open the Venous pressure increase for a given needle at a Clamp. kinks. clamps. if the problem that is causing the alarm condition has not been identified and removed. Note The following message appears in the window: Decrease the Venous Pressure ! Override will only open the Venous Line Clamp if the venous pressure is > VEN PRES LIMIT but lower than +450 mmHg. blood flow rate and haemoconcentration and/or inadequate anticoagulant dosage.ALARMS AND SIGNALS 8-137 ! VEN PRESSURE LIMIT 154 Reason The Venous Pressure Sensor measured a value that is greater than the VEN PRES for Alarm LIMIT value set by the operator in the Configuration menu. Check for restriction of blood flow in the venous access or in the venous line. i. 2. The alarm clears when the venous fixed blood flow rate. pressure is in the proper range. Press OVERRIDE to open the Venous Clamp. SECTION 8 . WARNING Never press the OVERRIDE button. the following message is displayed: Push OVERRIDE To Open The Venous Clamp. Machine Stops the Blood Pump. MAXIMUM: The Venous Pressure Sensor has measured a pressure value that is higher than the maximum permitted range selected by the operator and displayed in the pressure graph. Machine Stops the Blood Pump. Carefully check patient’s line connections. venous line. if the problem that is causing the alarm condition has not been identified and removed. If needed select in SET the graph of the pressure causing the alarm and press CONFIRM Possible Suggested Cause Action 1. MINIMUM: for Alarm The Venous Pressure Sensor has measured a pressure value that is lower than +10 mmHg or which is lower than the minimum range selected by the operator and displayed in the pressure graph. 3. venous line may have 1. to clear the ! Ven Pressure Alarm #155 alarm. MAXIMUM 3. graph and press CONFIRM. Press OVERRIDE to restart the Blood Pump. Ultrafiltration is reduced to the minimum value. WARNING Never press the OVERRIDE button. Press OVERRIDE to restart the Blood Pump. UNDEFIN: Error in venous pressure acquisition. Carefully check patient’s line connections.A – Special venous seal. check for kinked 2. Actions Closes the Venous Line Clamp. 2. 2. In SET mode. Press Override to restart the Pump. Perform a Diaphragm Neutral Position between the Cartridge Blood Set and the Procedure (See Section 5. in this manual). Call for Service if the problem persists. MINIMUM 2. Procedures. Incorrect placement of the diaphragm 3. select the venous pressure set.8-138 PHOENIX OPERATOR MANUAL ! VEN PRESSURE ALARM 155 Attribute 1. If <10 mmHg. B . Note The following message appears in the Operator Messages Area: Check blood line and patient's access. Press OVERRIDE to restart the Blood Pump. If high venous pressure. 4. UNDEFIN Reason 1. Press OVERRIDE to restart the Blood Pump. The venous pressure window needs to be 4. Rev. 3. become disconnected from the patient. Call for Service if the problem persists. Rev. Ultrafiltration is reduced to its minimum value. Wait a few seconds for the alarm to be cleared. Actions Closes the Venous Line Clamp. Possible Suggested Cause Action 1. Temporary problem. SECTION 8 . Machine Stops the Blood Pump. 1.ALARMS AND SIGNALS 8-139 VEN SENSOR ERROR 159 Reason The control system has detected a large spike or a large rapid change while for Alarm monitoring the Venous Pressure Sensor. B . A . Rev. procedure in the Section 5. Machine GENERAL SAFE STATE Actions Possible Suggested Cause Action 1. Call for Service if the problem persists. Difference between the Protection 1.Special Procedures.8-140 PHOENIX OPERATOR MANUAL ! VOLTAGES INCORRECT 160 Reason The Protection Module detects a difference between the reference values and the for Alarm Power Supply voltages after Patient Connection. B . See Fast Recovery of the Dialysis process references and the Power Supply voltages. Discontinue treatment if the problem persists. Call for Service if the problem persists. Machine None. Rev. SECTION 8 . Actions Possible Suggested Cause Action 1. turn the machine OFF. in Config menu restore double image of the Protection System in the parameter to the correct value. Return to IDLE view.ALARMS AND SIGNALS 8-141 ! WLR MINIMUM DATA ERROR 164 Reason A data difference was detected inside the double image of the Protection System for Alarm in the Main Board. ON again. B . for the WLR MINIMUM parameter. If the the Main Board. then parameter. A data difference was detected inside the 1. for the WLR MINIMUM alarm persists. Rev. Press OVERRIDE to clear the alarm. B .8-142 PHOENIX OPERATOR MANUAL W! AD CONVERTER 165 Reason Malfunction of analog/digital converter on the Protective Board. 1. Temporary acquiring problem. Actions Possible Suggested Cause Action 1. Call for Service if the problem persists. for Alarm Machine None. B . discontinue the treatment. and turn the machine OFF. Call for Service if the problem persists.ALARMS AND SIGNALS 8-143 W! ANALOG HIVAR 166 Reason Protection Module unable to monitor the Temperature or Pressure Sensors. Rev. Actions Possible Suggested Cause Action 1. Wait a few seconds for the alarm to be cleared. Temporary acquiring problem. for Alarm Machine None. SECTION 8 . If the alarm persists. 1. Press OVERRIDE. The did not occur at the correct phase. Machine None. Actions Possible Suggested Cause Action 1. The calibration of the Blood Leak Detector 1.8-144 PHOENIX OPERATOR MANUAL W! BLD CALIBRATION PHASE 167 Reason The calibration of the Optical Sensor for the Blood Leak Detector did not occur at for Alarm the correct time. Rev. This Blood Leak Detector will calibrate. B . alarm usually occurs during a Fast Recovery of the Dialysis process. Press OVERRIDE to clear the alarm. After a Fast Recovery of the Dialysis 1. the value of the Blood Leak Blood Leak Detector will use a default Detector has not been set.ALARMS AND SIGNALS 8-145 W! BLD FAST RECOVERY 168 Reason A Fast Recovery of the Dialysis process procedure has been performed by the for Alarm operator and the EEPROM calibration value for the Blood Leak Detector has not been set. Actions Possible Suggested Cause Action 1. SECTION 8 . The process. B . Machine None. parameter. Rev. Press OVERRIDE to clear the alarm. B . An excessive control voltage at the Blood 1. Perform a Chemical Disinfect procedure to Leak Detector transmitter Optical Sensor is clean the Sensor. because of deposits on the detector. Call for Service if the problem persists.8-146 PHOENIX OPERATOR MANUAL W! BLD LED EXCESSIVE VALUE 169 Reason Excessive control voltage at the Blood Leak Detector transmitter Optical Sensor. Actions Possible Suggested Cause Action 1. present. Rev. for Alarm Machine None. receiver of the Optical Sensor. Press OVERRIDE to clear the alarm. B . SECTION 8 . Actions Possible Suggested Cause Action 1. Machine None. due to Perform a Chemical Disinfect procedure to deposits on the detector. An excessively high value is present at the 1. Rev. clean the Sensor. Call for Service if the problem persists.ALARMS AND SIGNALS 8-147 W! BLD RECEIVER EXCESSIVE VALUE 170 Reason An excessively high value is present at the receiver of the Optical Sensor. resulting for Alarm in loss of Blood Leak Detector sensitivity. Proceed with DIALYSIS.8-148 PHOENIX OPERATOR MANUAL W! STILL IN BYPASS 171 Reason The machine has been in PATIENT CONNECT for more than 7 minutes or in the for Alarm WASHBACK phase for more than 8 minutes. by pressing the DIALYSIS Action key. The machine remained in WASHBACK for 2. Rev. Press OVERRIDE or continue the treatment too long. Actions Note This message remains on the Touch Screen for a few seconds and then disappears automatically. 2. Machine None. The machine remained in PATIENT 1. CONNECT for too long. B . Possible Suggested Cause Action 1. SECTION 8 . Temporary acquiring problem.ALARMS AND SIGNALS 8-149 W! DAC EXCURSION 172 Reason Protection Module unable to monitor Temperature or Pressure Sensors. Press OVERRIDE to clear the alarm. Actions Possible Suggested Cause Action 1. 1. B . Call for Service if the problem persists. Rev. for Alarm Machine None. Actions Possible Suggested Cause Action 1. The calibration parameters of the EEPROM 1. Rev. have been lost. Machine None. Retry dialysis preparation. The calibration data has been lost and standard defaults are used. B . Turn the machine OFF and then ON again.8-150 PHOENIX OPERATOR MANUAL W! E2PROM CRC 173 Reason The control memory CRC test performed by the Protection System for the correct for Alarm number related to the calibration data has failed. Call for Service if the problem persists. Protection Slave Board memory problem. 1. Rev. for Alarm Machine None. SECTION 8 . Actions Possible Suggested Cause Action 1. Retry Dialysate preparation. Turn the machine OFF and then ON again. B .ALARMS AND SIGNALS 8-151 W! RAM ERROR 175 Reason Error in reading Protection Module memory. Call for Service if the problem persists. When the Acid/Acetate conductivity is stable. inserted well to the proper Concentrate Wand. and then repeat the PA Autocalibration. 2. Power failure during PA Autocalibration. Conductivity is not stable during the PA 2. for Alarm Machine None. verify the correct Acid/Acetate Concentrates are being used. Turn the machine OFF and then ON again and repeat the PA Autocalibration. Concentrates were changed during the 1. Rev. B . Actions Possible Suggested Cause Action 1. Call for Service if the problem persists.8-152 PHOENIX OPERATOR MANUAL W! PA AUTOCALIBRATION FAILED 176 Reason Acid/Acetate Pump Autocalibration by the Protection System has failed. 3. repeat the PA Autocalibration. Wait a Autocalibration procedure or the machine few seconds for the machine to stabilize. If needed turn the machine OFF and then ON again and repeat the PA Autocalibration. If needed. Press OVERRIDE to clear the alarm. turn the machine OFF and then ON again and repeat the PA Autocalibration. Verify the Acid/Acetate Connector is Autocalibration procedure. has run out of concentrates. 3. Verify the Bicarbonate Connector is inserted Autocalibration. Power failure during PB Autocalibration. When the Bicarbonate conductivity is stable. Rev. Concentrates were changed during the 1. of concentrates. Wait a Autocalibration or the machine has run out few seconds for the machine to stabilize. (This alarm for Alarm will only occur when Liquid Bicarbonate is used. well to the proper Concentrate Wand. turn the machine OFF and then ON again and repeat the PB Autocalibration. repeat the PB Autocalibration. verify the correct Bicarbonate Concentrate is being used. If needed turn the machine OFF and then ON again. Conductivity is not stable during PB 2. Actions Possible Suggested Cause Action 1.ALARMS AND SIGNALS 8-153 W! PB AUTOCALIBRATION FAILED 177 Reason Bicarbonate Pump Autocalibration by the Protection System has failed. Call for Service if the problem persists.) Machine None. Press OVERRIDE to clear the alarm. and repeat the PB Autocalibration. If needed. and then repeat the PB Autocalibration. Turn the machine OFF and then ON again and repeat the PB Autocalibration. 3. 3. B . SECTION 8 . 2. Machine None. Temporary problem.8-154 PHOENIX OPERATOR MANUAL W! PI PRESSURE SENSOR 178 Reason A large pressure spike or a large rapid change were detected from the Pi Pressure for Alarm Sensor. Rev. Call for Service if the problem persists. Actions Possible Suggested Cause Action 1. B . 1. Wait a few seconds for the alarm to be cleared. Wait a few seconds for the alarm to be cleared. B . Temporary problem. Machine None.ALARMS AND SIGNALS 8-155 W! PO PRESSURE SENSOR 179 Reason A large pressure spike or a large rapid change were detected from the Po Pressure for Alarm Sensor. SECTION 8 . Actions Possible Suggested Cause Action 1. 1. Call for Service if the problem persists. Rev. 2. Rev. and repeat the PUF Autocalibration. preparation and repeat the PUF Autocalibration. B . Turn the machine OFF and then ON again Autocalibration. Actions Possible Suggested Cause Action 1.8-156 PHOENIX OPERATOR MANUAL W! PUF AUTOCALIBRATION FAILED 180 Reason Ultrafiltration Pump Autocalibration by the Protection System has failed. restart Dialysate Autocalibration. Return to IDLE view. The Ultrafiltration Pump has failed the PUF 1. Power failure during the PUF 2. for Alarm Machine None. Call for Service if the problem persists. Rev. Actions Possible Suggested Cause Action 1. 1. SECTION 8 . Temporary problem. Wait a few seconds for the alarm to be cleared. Press OVERRIDE.ALARMS AND SIGNALS W! PV PRESSURE SENSOR 181 Reason A large pressure spike or a large rapid pressure change was detected by the for Alarm Venous Pressure Sensor. SECTION 8 . B . Call for Service if the problem persists. Machine None.ALARMS AND SIGNALS 8-157 8. Actions Possible Suggested Cause Action 1. B . The Protection module detects an error in 1. Press OVERRIDE to clear the alarm. execution of the software.8-158 PHOENIX OPERATOR MANUAL W! UNRECOGNIZED SOFTWARE EXEC 182 Reason Execution error in program management of the Protection Module. for Alarm Machine None. Call for Service if the problem persists. Rev. ALARMS AND SIGNALS 8-159 W! T1 TEST FAILED 183 Reason Failure of one of the T1 tests which does not stop the machine (see Section 5. then back ON and restarting is the operator’s responsibility to carefully Dialysis preparation. A T1 test related to: Temperature. restart Dialysis preparation to recheck the or Blood Leak Detector failed during failed T1 test. in this manual).B - for Alarm Test Procedures. SECTION 8 . Turn the machine OFF. 2. It machine OFF. Machine None. B . Rev. The T1 test failed following turning the 2. It is NOT advisable to continue treatment. 1. Call for Service if the problem persists. check the parameters involved in the failed test if the decision is made to continue treatment despite the test failure. preparation. Actions Possible Suggested Cause Action 1. then back ON. and Acid/Acetate or Bicarbonate Conductivity. Call for Service if the problem persists. B .8-160 PHOENIX OPERATOR MANUAL W! TEMPERATURE SENSOR 184 Reason A large temperature spike or a large rapid temperature change was detected by for Alarm the TPS Temperature Sensor. Actions Possible Suggested Cause Action 1. Machine None. Temporary problem. Press OVERRIDE. Rev. Wait a few seconds for the alarm to be cleared. 1. Actions Possible Suggested Cause Action 1. discontinue treatment. Rev. 1. B .ALARMS AND SIGNALS 8-161 W! UNKNOWN MESSAGE TYPE 185 Reason The Protection Module does not recognize the data sent. Temporary problem. If the alarm persists. for Alarm Machine None. SECTION 8 . turn the machine OFF and then back ON. Wait a few seconds for the alarm to be cleared. Press OVERRIDE. Call for Service if the problem persists. a Class P signal (see Class P alarms section). Call for Service. Possible Suggested Cause Action 1. Actions In DIALYSIS: Alarm 160 occurs causing a GENERAL SAFE STATE. do not proceed into DIALYSIS. B . which causes a GENERAL SAFE STATE and consequently stops the machine. If the alarm persists until the end of the preparation. Rev. Power supply failure during preparation.8-162 PHOENIX OPERATOR MANUAL W! VOLTAGES INCORRECT 187 Reason The Protection Module detects a difference between the reference values and the for Alarm supply voltages. WARNING After patient connection this signal becomes #160. Machine None before Blood detection (patient not connected). 1. in this manual). WARNING It is not advisable to continue treatment.ALARMS AND SIGNALS 8-163 W! WAIT TO CONTINUE 188 Reason Failure of a machine control test (T1 test) with a request for the operator to confirm for Alarm if normal operation is to be continued despite T1 test failure (see Section 5. but to notify Service as to which test failed. Rev. Actions Possible Suggested Cause Action 1. It is the operator’s responsibility to carefully monitor the parameters involved in the failed test if the decision is made to continue treatment despite the test failure. 1. B . Press OVERRIDE then CONFIRM to proceed despite failure of T1 test.Test procedures. T1 test failed. SECTION 8 . Call for Service if the problem persists.B . Machine None. The TOT WEIGHT L or UFR may need to be adjusted to avoid Fluid Removal alarms. for Alarm Machine None. 2. Actions Note This message remains on the Touch Screen for a few seconds and then disappears automatically. treatment. Deselect the WLR MINIMUM Action key to longer than 4 minutes. Possible Suggested Cause Action 1. An alarm condition sets WLR MINIMUM for 2. Rev. B . Correct the alarm condition to continue the longer than 4 minutes.8-164 PHOENIX OPERATOR MANUAL W! STILL IN MINIMUM UF 189 Reason The machine has been in WLR MINIMUM for longer than 4 minutes. reset the Ultrafiltration Rate to its set value. It is displayed every 4 minutes if the condition remains. WLR MINIMUM Action key selected for 1. Rev. for Alarm Machine In ADR: Actions Machine stops and goes to the RESTART phase. B . SECTION 8 . An alarm has occurred that stopped the 1. Possible Suggested Cause Action 1. Call for Service if the problem persists. alarm condition. Press the RESTART key after correcting the procedure.ALARMS AND SIGNALS 8-165 TIME OUT PROC 190 Reason Service processes are stopped due to a time out. Rev. Press OVERRIDE to use the machine in test has been temporarily disabled. A Service Technician must re-enable the T1 Tests before using the machine for a patient treatment. Possible Suggested Cause Action 1. WARNING If the W! T1Tests Disabled #203 alarm appears. B . starting from the selection of the Dialysate Type until the end of the FINAL RINSE process. It is displayed every 5 minutes for all the dialysis treatment. the machine must not be used for a patient treatment. Call for Service if the problem persists. vitro for service testing.8-166 PHOENIX OPERATOR MANUAL W! T1TESTS DISABLED 203 Reason T1 Test has been hardware disabled. Actions Note This message remains on the Touch Screen for 5 seconds and then disappears automatically. for Alarm Machine The T1 Test will not be executed. The machine is being serviced and the T1 1. A Service Technician must re-enable the T1 Test before using the machine for a patient treatment. for more than 4 minutes. Machine None. Actions Note This message remains on the Touch Screen for a few seconds and then disappears automatically. Press OVERRIDE to clear the alarm. Increase Blood Pump speed to more than 50 ml/min. SECTION 8 .ALARMS AND SIGNALS 8-167 W! LOW ART FLOW FOR TOO LONG 204 Reason Operator has set the Blood Pump to a value less than 50 ml/min for more than 4 for Alarm minutes. Rev. Blood Pump speed is less than 50 ml/min 1. It is displayed every 4 minutes if the condition remains. B . Possible Suggested Cause Action 1. Call for Service if the problem persists. If an “! AIR & FOAM DETECTOR” #4 alarm occurs when the venous Actions line is not correctly placed in the Air Bubble Detector. B . Venous line is not inserted correctly into the 1.8-168 PHOENIX OPERATOR MANUAL W! VENOUS LINE NOT FITTED 205 Reason The venous line has been incorrectly inserted in the Venous Line Clamp or inside for Alarm the Air Bubble Detector housing. Venous line is not inserted correctly into the 2. Check the venous line position. line into the Venous Line Clamp. Machine None. Remove and correctly re-insert the venous Venous Line Clamp. 2. it is not possible to clear the alarm. Rev. Air Bubble Detector housing. When the RESUME key is pressed the Blood Pump doesn’t start and the Venous Line Clamp closes. Possible Suggested Cause Action 1. including the Ultrafiltration Pump. B . Obstruction or kinking in the drain hose. 1. Call for Service if the problem persists.ALARMS AND SIGNALS 8-169 OUTPUT OVERPRESSURE 206 Reason The Hydraulic Module Drain Pressure Switch (SWP1) is sensing HIGH pressure in for Alarm the drain. Rev. Possible Suggested Cause Action 1. SECTION 8 . Verify the drain hose is not kinked or obstructed in any way. Machine The machine goes into Bypass and all Hydraulic Module Pumps are Actions stopped. If the Main Board. Actions Possible Suggested Cause Action 1. the alarm persists. in Configuration menu double image of the Protection System in restore the parameter to the correct value. Rev. Machine None. for the SN P parameter.8-170 PHOENIX OPERATOR MANUAL ! S/N MIN PRESSURE DATA ERROR 208 Reason A data difference was detected inside the double image of the Protection System for Alarm in the Main Board. restart the machine. A data difference was detected inside the 1. B . for the SN P parameter. Call for Service if the problem persists. Return to IDLE view. for the SN P parameter. If the Main Board. SECTION 8 . restart the machine. the alarm persists.ALARMS AND SIGNALS 8-171 ! S/N MAX PRESSURE DATA ERROR 209 Reason A data difference was detected inside the double image of the Protection System for Alarm in the Main Board. Actions Possible Suggested Cause Action 1. B . Machine None. A data difference was detected inside the 1. Rev. for the SN P parameter. in Configuration menu double image of the Protection System in restore the parameter to the correct value. Call for Service if the problem persists. Return to IDLE view. B . incoherent condition in the Conductivity Before starting the following dialysis Profiling execution. treatments. The Protection Module detected an 1. for Alarm TIMING: The Conductivity Profile timing has caused a Protection Module data error. SET VAL: The Conductivity Curve scanning set value has caused a Protection Module data error. Possible Suggested Cause Action 1. Press OVERRIDE to clear the alarm. Note This alarm will only be displayed after the Patient Sensor detects blood or the DIALYSIS Action key is pressed. Machine Machine goes into Bypass.8-172 PHOENIX OPERATOR MANUAL ! CONDUCTIVITY PROFILE 210 Reason CURVE: The Conductivity Profile has caused a Protection Module data error. check and if necessary re-set the profiling curves in Config/PROFILE. Rev. Actions Disables Conductivity Profiling. check and if necessary re-set the profiling curves in Config/PROFILE. incongruent condition in the UF Profiling Before starting the following dialysis execution. TIMING: The Ultrafiltration Profile timing has caused a Protection Module data error. B . Possible Suggested Cause Action 1. Note This alarm will only be displayed after the Patient Sensor detects blood or the DIALYSIS Action key is pressed. The Protection Module detected an 1. Machine Ultrafiltration is reduced to the minimum. Actions Ultrafiltration Rate profiling is disabled. Rev.ALARMS AND SIGNALS 8-173 ! WEIGHT LOSS RATE PROFILE 212 Reason CURVE: for Alarm The Ultrafiltration Profile has caused a Protection Module data error. SET VAL: The Ultrafiltration Curve scanning set value has caused a Protection Module data error. SECTION 8 . treatments. Press OVERRIDE to clear the alarm. configured for the current phase of the machine. Verify the Cartridge Blood Set is correctly configured for the Autoemptying Procedure.8-174 PHOENIX OPERATOR MANUAL BAD BLOOD LINE POSITION 219 Reason The machine detects an incorrect configuration of the Cartridge Blood Set during for Alarm the Autoemptying Procedure. Call for Service if the problem persists. Machine Stops the Blood Pump. B . The operator has clamped one of the lines 1. Actions Possible Suggested Cause Action 1. Rev. 2. The Cartridge Blood Set is not correctly 2. Verify that clamps are open on the Cartridge on the Cartridge Blood Set. Blood Set. Refer to alarm number 145 for further troubleshooting information.A - Special Procedures. Actions Possible Suggested Cause Action 1. SECTION 8 . B . The Ultrafiltration Pump (PUF) 2. Machine None. The occurred too many times during DIALYSIS. Fluid Removed data displayed may not be accurate. CALCULATION NOT RELIABLE 220 Reason The “! UF RATE ERROR: VESSEL” #145 alarm has occurred too many times during for Alarm DIALYSIS. directions for this procedure in Section 5. Press OVERRIDE to clear the alarm. Rev.F. The “! UF RATE ERROR: Vessel” alarm has 1.ALARMS AND SIGNALS 8-175 W! U. Perform PUF Autocalibration. Call for Service if the problem persists. Disconnect the patient. 2. See the Autocalibration is required. Press OVERRIDE to clear the alarm. Press OVERRIDE to clear the alarm. ultrafilter needs to be replaced. B . 2. Machine In DIALYSIS: None. From correct ULTRAF PRES parameter. The end of life. Call for Service if the problem persists. The operator set a value lower than the 2. Actions Possible Suggested Cause Action 1. Rev. on Config menu. The ultrafilter is approaching its expected 1. IDLE view.8-176 PHOENIX OPERATOR MANUAL ULTRAFILTER : TMP TOO HIGH 237 Reason Transmembrane Pressure has reached 90% of the maximum value set by the for Alarm operator. verify the correct value for the ULTRAF PRES parameter. SECTION 8 . In Set Mode. parameter. restore the parameter to the double image of the Protection System in correct value. B . Rev.ALARMS AND SIGNALS 8-177 ! DIALYSIS TIME DATA ERROR 239 Reason A data difference was detected inside the double image of the Protection System for Alarm in the Main Board. restart the Main Board. A data difference was detected inside the 1. for the DIALYSIS TIME parameter. Actions Possible Suggested Cause Action 1. If the alarm persists. for the DIALYSIS TIME the machine. Call for Service if the problem persists. Machine None. If the alarm persists. Machine None.8-178 PHOENIX OPERATOR MANUAL ! TOT WEIGHT L DATA ERROR 240 Reason A data difference was detected inside the double image of the Protection System for Alarm in the Main Board. restart the Main Board. for the TOT WEIGHT L the machine. parameter. Call for Service if the problem persists. Rev. Actions Possible Suggested Cause Action 1. In Set Mode. A data difference was detected inside the 1. B . restore the parameter to the double image of the Protection System in correct value. for the TOT WEIGHT L parameter. During Autocalibration avoid alarms and caused Autocalibration to fail. available for the current treatment. for Alarm Machine In DIALYSIS: None. B . The 2. An conductivity alarm or user intervention 1. Call for Service if the problem persists. Actions DIASCAN Monitoring System is disabled. The Autocalibration was out of range. SECTION 8 .ALARMS AND SIGNALS 8-179 DIASCAN INITIAL CALIBRATION FAILED 244 Reason Initial DIASCAN Autocalibration has failed. The DIASCAN Monitoring System is not available for the current treatment. Rev. 2. The not able to measure the correct DIASCAN Monitoring System is not conductivity. Possible Suggested Cause Action 1. modifications to Dialysate conductivity and flow rate in SET. Check if DIASCAN performs two auto- DIASCAN conductivity measuring system is calibrations during the next treatment. B . Call for Service if the problem persists.8-180 PHOENIX OPERATOR MANUAL DIASCAN: INCORRECT MEASUREMENT 246 Reason A DIASCAN measurement could not be completed. in the Kt/V view. Avoid user interventions or conductivity Diascan measurement. Actions Possible Suggested Cause Action 1. alarms during Diascan measurement. Rev. 2. The Diascan conductivity measuring system 2. for Alarm Machine None. Switch off the DIASCAN Monitoring System is not properly working. An alarm or user intervention cancelled the 1. Let the blood flow rate stabilize before performing other procedures to clear the alarm. SECTION 8 . 2. Rev. for Alarm Machine None. Clearance threshold incorrect for this 4. Change the clearance threshold alarm level. increased. patient. Determine reason for clotting and replace the dialyser. 2. 4. B . 3. Problem with patient’s access or needle 3.ALARMS AND SIGNALS 8-181 DIASCAN: LIMIT LOW CLEARANCE 249 Reason The last measured value of the Clearance is lower than the fixed threshold. The level of recirculation is placement. The Dialyser is clotting. Actions Possible Suggested Cause Action 1. 1. Check patient’s access for correct needle placement. The blood flow rate was changed. The Protection System has detected a 1.8-182 PHOENIX OPERATOR MANUAL W! SET VALUE OUT OF RANGE 250 Reason The Protection System has detected a control set-value that is out of range. B . Rev. for Alarm Machine None. Actions Possible Suggested Cause Action 1. Press OVERRIDE to clear the alarm. control set-value that is out of range. Press OVERRIDE to clear the alarm. 2.ALARMS AND SIGNALS 8-183 ! DIASCAN MEASUREMENT FAILED : 251 Reason The Protection System has detected a violation of a DIASCAN safety criterion. The DIASCAN conductivity measuring 1. Rev. Possible Suggested Cause Action 1. Call for Service if the problem persists. Machine Machine goes into Bypass. Duration: Conductivity Step duration too long. SECTION 8 . Switch off the DIASCAN Monitoring System in the kT/V view. Frequen: Too many repetitions of the Conductivity Step. system has failed. 3. DIASCAN is not reliable for the current treatment. Actions Note This alarm will only be displayed after the Patient Sensor detects blood or the DIALYSIS Action key is pressed. B . SET VALUE: Conductivity Step amplitude too high or too low. for Alarm 1. 1. Temporary problem. Wait a few seconds for the alarm to be cleared. Rev. Actions Possible Suggested Cause Action 1. B . Machine None.8-184 PHOENIX OPERATOR MANUAL W! PDR PRESSURE SENSOR ERROR 252 Reason A large pressure spike or a large rapid change in pressure was detected by the for Alarm Drain Pressure Sensor. Call for Service if the problem persists. 1. Press OVERRIDE to clear the alarm. B . The machine does not detect the BPM. Rev. turn the machine OFF then back ON again and retry a measurement. During DIALYSIS the BPM is not available. Call for Service if the problem persists. From IDLE. Actions Possible Suggested Cause Action 1.ALARMS AND SIGNALS 8-185 BPM NOT CONNECTED 255 Reason The BPM is disconnected inside the machine. for Alarm Machine None. SECTION 8 . Actions Possible Suggested Cause Action 1. A data difference was detected inside the 1. in SET double image of the Protection System in Mode. DATA ERROR 257 Reason A data difference was detected inside the double image of the Protection System for Alarm in the Main Board. In the Config/PROFILE/kT/V view. Call for Service if the problem persists.8-186 PHOENIX OPERATOR MANUAL ! DIASCAN FREQ. Machine None. B . for the INTERMEASUREM parameter to the correct value. restore the INTERMEASUREM the Main Board. Rev. persists. If the alarm parameter. for the INTERMEASUREM parameter. restart the machine. discontinue the treatment. During a Fast Recovery of the Dialysis 1. Rev. SECTION 8 .ALARMS AND SIGNALS 8-187 BLOOD MODULE<->MASTER DISK MISMATCH 259 Reason An incongruent condition has been detected between the Blood board for Alarm configuration and the dialysis mode during a Fast Recovery of the Dialysis process. Call for Service if the problem persists. Board configuration and the Dialysis mode. B . The Fast Recovery of the Dialysis process is process the machine detected an not available. Machine The dialysis process is not available. incongruent condition between the Blood Perform a RINSE to reset the alarm. Actions Possible Suggested Cause Action 1. restore the double image of the Protection System in parameter to the correct value. for the BICART COND parameter. in SET Mode. Machine None. Actions Possible Suggested Cause Action 1. Rev. If the alarm the Main Board.8-188 PHOENIX OPERATOR MANUAL ! BICART COND DATA ERROR 263 Reason A data difference was detected inside the double image of the Protection System for Alarm in the Main Board. Call for Service if the problem persists. for the BICART COND persists. A data difference was detected inside the 1. From Home view. ON again. B . turn the machine OFF then back parameter. Machine Stops the Blood Pump. Possible Suggested Cause Action 1.ALARMS AND SIGNALS 8-189 W! AIR & FOAM DETECTOR 264 Reason During Dialysate preparation. ignore it. Stop Dialysate preparation and return to wet. SECTION 8 . Call for Service if the problem persists. Actions WARNING OVERRIDE has no effect if the venous line is not inserted into the Venous Line Clamp (in which case the alarm number 205: “W! Venous Line Not Fitted“ appears). Remove the venous line from the Air Bubble Detector and carefully clean the Patient Sensor and the surface of the Air Bubble Detector around the Patient Sensor using a soft cloth. Rev. the IDLE view. B . the Patient Sensor has detected blood in the venous for Alarm line and the Air Bubble Detector has detected air in the venous line. If the alarm persists. Carefully clean the venous line using a soft cloth. Reinsert the venous line in the Air Bubble Detector and restart the Dialysate preparation. Note If the alarm is displayed only for a few seconds before the machine detects blood. refer to the troubleshooting procedure described below. Air in venous line or Patient Sensor dirty or 1. 8-190 PHOENIX OPERATOR MANUAL BT2 MALFUNCTIONING 268 Reason LD2 Level Sensor malfunctioning. Rev. Possible Suggested Cause Action 1. (Patient connection Actions forward). This alarm is only triggered during treatment. Call for Service if the problem persists. It appears only if a certain sequence of “! UF for Alarm Mass Balance” alarms (code number 144) occur. Verify the Dialysate Connectors are well position. Machine None. connected in the correct position and that there are no air leaks. B . Dialysate Connectors are in the wrong 1. A changed during the measurement. Rev. Avoid changing blood or dialysate flow rates during DIASCAN readings. DIASCAN measurement will not be obtained at this interval. Press OVERRIDE to clear the alarm. Actions Possible Suggested Cause Action 1. SECTION 8 . The blood or dialysate flow rate was 1. Machine None.ALARMS AND SIGNALS 8-191 DIASCAN: MEASUREM. B . IMPOSSIBLE (SET) 269 Reason The set-value for blood or dialysate flow rate has been changed during the for Alarm measurement. Machine went into Bypass due to an alarm. Rev. for Alarm Machine None. obtained at this interval.8-192 PHOENIX OPERATOR MANUAL DIASCAN: MEAS. Press OVERRIDE to clear the alarm. an alarm occurred and the machine went into Bypass. 1. Avoid placing the machine in BYPASS during DIASCAN readings. Actions Possible Suggested Cause Action 1. A or the operator put the machine into DIASCAN measurement will not be Bypass. IMPOSSIBLE (ALARM) 270 Reason During the measurement. B . ALARMS AND SIGNALS 8-193 CENTR. ACID CONNECTOR POSITION 271 Reason The Central Acid Inlet Connector is not in the correct position for the current for Alarm operating phase of the machine. Rev. Perform a complete ADR procedure in order to have the SETUP Action key displayed in the IDLE view. The Central Acid Inlet Connector is not in 1. In DIALYSIS: The machine stops during the preparation phase. Note If the machine has stopped during an ADR procedure when the alarm occurs. The machine goes into Bypass during the treatment phase. operating phase of the machine. Verify the correct configuration of the the correct position for the current machine. Call for Service if the problem persists. Possible Suggested Cause Action 1. B . SECTION 8 . Machine In ADR: Actions The machine stops and waits for the Connector to be correctly positioned. the SETUP Action key is not available. 8-194 PHOENIX OPERATOR MANUAL CENTR. The Central Bicarbonate Inlet Connector is 1. Possible Suggested Cause Action 1. current operating phase of the machine. Perform a complete ADR procedure in order to have the SETUP Action key displayed in the IDLE view. B . Machine In ADR: Actions The machine stops and waits for the Connector to be correctly positioned. In DIALYSIS: The machine stops during the preparation phase. the SETUP Action key is not available. Note If the machine has stopped during an ADR procedure when the alarm occurs. Rev. The machine goes into Bypass during the treatment phase. BICARB CONNECTOR POSITION 272 Reason The Central Bicarbonate Inlet Connector is in the incorrect position required for for Alarm the current operating phase of the machine. Call for Service if the problem persists. Verify the correct configuration of the not in the correct position required for the machine. Rev. SECTION 8 . Call for Service. for Alarm Machine None. The Patient Sensor is malfunctioning. B . 1.ALARMS AND SIGNALS 8-195 W! PATIENT SENSOR SATURATION 273 Reason The Protection System detects the maximum allowed value for the Patient Sensor. Service is required. Actions Possible Suggested Cause Action 1. Turn the machine OFF. Recovery of the Dialysis process procedure in the Section 5. Possible Suggested Cause Action 1.8-196 PHOENIX OPERATOR MANUAL ! CONTROL SYSTEM OUT OF ORDER 274 Reason The Control System is not able to communicate with the Protection System. for Alarm Machine GENERAL SAFE STATE Actions Note The Audible alarm. in this manual. B . Call for Service if the problem persists.A . The control system is no more working 1. can not be silenced by pressing the MUTE button.Special Procedures. which signals the #274 alarm condition. Rev. See the Fast correctly. restore the parameter to the double image of the Protection System in correct value. Call for Service if the problem persists. In Config. SECTION 8 . parameter. restart the Main Board.ALARMS AND SIGNALS 8-197 ! AUTOEMPTYING DATA ERROR 277 Reason A data difference was detected inside the double image of the Protection System for Alarm in the Main Board. B . Actions Possible Suggested Cause Action 1. A data difference was detected inside the 1. for the AutoEmptying parameter. for the AutoEmptying the machine. If the alarm persists. Machine None. Rev. Actions Possible Suggested Cause Action 1. Rev. B .8-198 PHOENIX OPERATOR MANUAL ERROR ON CALIBRATION TOOL 279 Reason The machine has detected a problem during the P2 Autocalibration. for Alarm This alarm can occurr only during Service calibration. can occurr only in calibration environment. No troubleshooting is required. Machine The machine does not proceed with the P2 Autocalibration. this alarm the P2 Autocalibration. The machine has detected a problem during 1. Machine The machine stops and waits for confirmation. Pump. SECTION 8 . The machine is waiting for the operator to 1. Actions Possible Suggested Cause Action 1. B .ALARMS AND SIGNALS 8-199 WAIT FOR CONFIRMATION 283 Reason The machine is waiting for the operator to confirm an Autocalibration of the PA or for Alarm PB Pump. Check for correct concentrates and press confirm an Autocalibration of the PA or PB CONFIRM to proceed. Rev. Actions Venous Line Clamp closes. 3. Machine Stops the Blood Pump.8-200 PHOENIX OPERATOR MANUAL ! AUTOEMPTYING: MAX ACTIVATION TIME 294 Reason The maximum volume of blood has passed through the Blood Pump during the for Alarm AutoEmptying procedure. Verify the position of the venous line in the in the Patient Sensor. 2. The Patient Sensor is dirty. The Autoempting procedure is stopped after Autoempting procedure. Rev. Carefully clean the Patient Sensor. The venous line is not correctly positioned 2. Patient Sensor. Press OVERRIDE then an additional 100 ml will be infused. 3. using a soft cloth. Call for Service if the problem persists. The Patient Sensor detects blood during the 1. B . Possible Suggested Cause Action 1. 400 ml. A - Special Procedures. Call for Service if the problem persists. Actions Possible Suggested Cause Action 1. Too much information is going to the See the Fast Recovery of the Dialysis Blood Slave Microprocessor at one time. Machine None. Wait a few seconds for the alarm to clear. process procedure in the Section 5.ALARMS AND SIGNALS 8-201 BLOOD CARD COMMUNICATION TIMEOUT 295 Reason There was a communication problem detected between the Blood Slave Board for Alarm and the Main board. Board. B . Rev. SECTION 8 . Temporary data overload of the Blood Slave 1. Too much information is going to the See the Fast Recovery of the Dialysis process Bio Slave Microprocessor at one time. Temporary data overload of the Bio Slave 1. Board.Special Procedures. TIMEOUT 296 Reason There was a communication problem detected between the Bio Slave Board and for Alarm the Main Board. Machine None. Rev. Wait a few seconds for the alarm to clear. Actions Possible Suggested Cause Action 1.A .8-202 PHOENIX OPERATOR MANUAL BIOSLAVE CARD COMM. procedure in the Section 5. B . Call for Service if the problem persists. for Alarm Machine None. 2. B . SECTION 8 . Call for Service if the problem persists. See the Fast Recovery of the Dialysis stops functioning. Temporary communication problem. Actions Possible Suggested Cause Action 1. 1. Rev. Wait a few seconds for the alarm to be cleared. process procedure in the Section 5.ALARMS AND SIGNALS 8-203 BIOSLAVE MSG TRANSFER ERROR 297 Reason The Main computer and the Bio Slave Board are not communicating. If alarm does not clear and the machine 2.A - Special Procedures. B . Dirty LD1 level detector. Actions Possible Suggested Cause Action 1.8-204 PHOENIX OPERATOR MANUAL BT1 MALFUNCTIONING 299 Reason LD1 Level Sensor Failure. Rev. Call for Service if the problem persists. for Alarm Machine None. Perform a RINSING or a Chemical Disinfection to clean the sensor of deposits. 1. for Alarm Machine None. Rev. SECTION 8 . Debris has clogged the gears in the flow 1. Perform a DESCALING. completely blocked. If the flowmeter is meter. B .ALARMS AND SIGNALS 8-205 D1 OUT OF ORDER 300 Reason The D1 flowmeter does not respond to changes in the dialysate flow. Actions Possible Suggested Cause Action 1. Call for Service if the problem persists. ADR cannot start. Debris has clogged the gears in the flow 1. B . ADR cannot start. completely blocked. If the flowmeter is meter. Call for Service if the problem persists.8-206 PHOENIX OPERATOR MANUAL D2 OUT OF ORDER 301 Reason The D2 flowmeter does not respond to changes in the dialysate flow. Actions Possible Suggested Cause Action 1. Perform DESCALING. Rev. Machine None. Possible for Alarm Mass Balance alarms may precede this alarm. ALARMS AND SIGNALS 8-207 ! BYPASS WRONGLY EXTENDED 302 Reason The machine is in Bypass for more than 6 minutes. SECTION 8 . Possible Suggested Cause Action 1. See the Fast Recovery of the Dialysis process procedure in the Section 5. 2. Take the machine out of Bypass by pressing during the treatment. the BYPASS Action key. either automatically or the for Alarm operator has selected BYPASS. B . Bypass has been selected and not cleared 1. The machine is stuck in bypass.A - Special Procedures. Machine None. Actions In DIALYSIS: The alarm is active when the machine is in DIALYSIS mode with blood detected in the venous line. 2. Rev. The alarm will be displayed on the Touch Screen 6 minutes after the machine is in BYPASS. A - one time. Special Procedures. Slave Board.8-208 PHOENIX OPERATOR MANUAL HYDRAULIC CARD COMM. Rev. B . Machine None. TIMEOUT 304 Reason There was a communication problem detected between the Hydraulic Slave Board for Alarm and the Main Board. Wait a few seconds for the alarm to clear. Call for Service if the problem persists. Temporary data overload of the Hydraulic 1. Actions Possible Suggested Cause Action 1. Too much information is going See the Fast Recovery of the Dialysis to the Hydraulic Slave Microprocessor at process procedure in the Section 5. Machine Stops the Blood Pump. MINIMUM. Press OVERRIDE to restart the Blood Pump. Check the arterial line and the patient’s arterial access for kinks. Carefully check Cartridge connections and disconnected from the patient. 3. observing the arterial pressure. The arterial line may have become 2. 2. i. clamped or restricted. poor flow from the patient’s arterial access. Press OVERRIDE to restart the Blood Pump. In SET Mode. clamps or other restrictions. if this operation is not in disagreement with the patient prescription. the patient’s access site. SECTION 8 . Press OVERRIDE to restart the Blood Pump. Venous Line Clamp closes. Press Override to restart the Pump. UNDEFIN Reason MINIMUM: The Arterial Pressure Sensor has measured a pressure value which is for Alarm lower than the minimum range selected by the operator and displayed on the Arterial Pressure Bar Graph. select the Arterial Pressure set. B . The arterial pressure window needs to be 1. clotted arterial needle. Actions Reduces the Ultrafiltration Rate to its minimum.e.ALARMS AND SIGNALS 8-209 ! ART PRESSURE ALARM 305 Attribute 1. 3. Note The following message appears in the operator messages area: Check blood line and patient's access. Rev. UNDEFIN: Error in the arterial pressure acquisition. Arterial line is kinked. 3. If needed select in SET the graph of the pressure causing the alarm and press CONFIRM Possible Suggested Cause Action 1. 2. MAXIMUM. Bar Graph and press CONFIRM. Consider slowly increasing the blood flow. MAXIMUM: The Arterial Pressure Sensor has measured a pressure value which is higher than the maximum permitted range selected by the operator and displayed on the Arterial Pressure Bar Graph. to clear the ! Art Pressure Alarm #305 alarm.A . if the problem that is causing the alarm condition has not been identified and removed.8-210 PHOENIX OPERATOR MANUAL 4. Loss of diaphragm pressure between the 4. Press OVERRIDE to restart the Blood Pump. WARNING Never press the OVERRIDE button. Procedures.Special cone. Call for Service if the problem persists. Rev. B . see the Section 5. Perform a Diaphragm Neutral Position Cartridge Blood Set and the arterial pressure Procedure. i. Press OVERRIDE to restart the Blood Pump. B . Venous Line Clamp closes. the patient’s access site. Machine Stops the Blood Pump. Arterial pressure decreased somewhat 4. Blood Pump speed is too fast. SECTION 8 . Check the arterial line and the patient’s arterial access for kinks. Actions Reduces the Ultrafiltration Rate to its minimum. clamped or restricted. The arterial line may have become 1. 4. 2. if the problem that is causing the alarm condition has not been identified and removed. Press OVERRIDE to restart the Blood Pump. 3. clamps or other restrictions. resulting in a Press OVERRIDE to restart the Blood reduced pressure for a given needle at a Pump. fixed blood flow rate.e.ALARMS AND SIGNALS 8-211 ! ART PRESSURE LIMIT 306 Reason Arterial pressure is lower than the MIN ART PRESSURE value set by the operator in for Alarm the Configuration menu. WARNING Never press the OVERRIDE button. Attention should be given to re-evaluating during a treatment due to needle size. to clear the ! Art Pressure Limit #306 alarm. Possible Suggested Cause Action 1. Carefully check Cartridge connections and disconnected from the patient. 2. Call for Service if the problem persists. Arterial line is kinked. anticoagulant haemoconcentration and/or inadequate dosage. heparinization of the patient. 3. poor flow from the patient’s arterial access. Rev. Press OVERRIDE to restart the Blood Pump. Consider decreasing the blood flow if this operation is not in disagreement with the patient prescription. blood flow rate. clotted arterial needle. Protection System in the Main Board. Machine None. From Set Mode. restart the machine. restore the parameter to P parameter inside the double image of the the correct value. A data difference was detected for the ART 1. Actions Possible Suggested Cause Action 1. Rev.8-212 PHOENIX OPERATOR MANUAL ! ART PRESSURE DATA ERROR 307 Reason A data difference was detected for the ART P parameter inside the double image for Alarm of the Protection System in the Main Board. B . Call for Service if the problem persists. If the alarm persists. remove the venous line from the Air Bubble Detector and carefully clean the Patient Sensor and the surface of the Air Bubble Detector around the Patient Sensor using a soft cloth. attached to the patient’s access. Switch the machine OFF.ALARMS AND SIGNALS 8-213 W! BLOOD IN THE VENOUS LINE 308 Reason The Patient Sensor detected blood in the venous line. If the alarm occurs during PRIME or RECIRCULATION. 2. The Patient Sensor is dirty or wet. clean the Patient Sensor following the procedure described above. Possible Suggested Cause Action 1. Reinsert the venous line in the Air Bubble Detector and then switch the machine ON. which signals the #308 alarm condition. before starting a new dialysis session. the machine is forced to the PATIENT CONNECT view. Verify that the venous line is appropriately venous line. Note In case of blood detected in the venous line during PRIME. has a low pitch modulated tone. the Audible alarm. Press OVERRIDE to continue. B . If the alarm occurs during Dialysate preparation and the Blood Pump is running. Refer also to the #342 alarm description to exit from the alarm condition. Rev. At the end of the current dialysis treatment. also the #342 alarm occurs together with the #308 alarm. 2. Call for Service if the problem persists. The Patient Sensor detected blood in the 1. SECTION 8 . it is not possible to proceed. Actions Note If the Standard buzzer is installed on the machine. for Alarm Machine Stops the Blood Pump. The ! UF Mass Balance #144 alarm has 1. If an external scale is not being used. B . If an external scale is being used.8-214 PHOENIX OPERATOR MANUAL W! MASS BALANCE NOT RELIABLE 309 Reason The “! UF Mass Balance” #144 alarm has occurred too many times during the for Alarm dialysis treatment. refer to the weight measured by the scale to check the value of the TOTAL FLUID REMOVED. Each time thereafter this alarm will display along with the “! UF Mass Balance” #144 alarm. Call for Service if the problem persists. Rev. the TOTAL FLUID REMOVED displayed on video is no more reliable. Determine the cause of the ! UF Mass occurred 10 times or continues to display Balance alarm (#144) then press OVERRIDE during a treatment. to continue. Possible Suggested Cause Action 1. this alarm is Actions displayed. Machine After the ! UF Mass Balance #144 alarm recurs 10 times. Refer to Alarm number 144 for additional troubleshooting information. WARNING After the ! UF Mass Balance (#144) recurs 10 times. discontinue DIALYSIS. restart the machine. Rev. in Config. A data difference was detected for the MAX 1. SECTION 8 . Board. B .ALARMS AND SIGNALS 8-215 ! MAX BLOOD FLOW DATA ERROR 312 Reason A data difference was detected for the MAX BLOOD FLOW parameter inside the for Alarm double image of the Protection System in the Main Board. If the alarm image of the Protection System in the Main persists. Call for Service if the problem persists. Machine None. Actions Possible Suggested Cause Action 1. restore the BLOOD FLOW parameter inside the double parameter to the correct value. From IDLE view. the Main Board. Rev. Machine None. Call for Service if the problem persists. If the alarm double image of the Protection System in persists.8-216 PHOENIX OPERATOR MANUAL ! PAUSE THERAPY DATA ERROR 313 Reason A data difference was detected for the PAUSE THERAPY parameter inside the for Alarm double image of the Protection System in the Main Board. Actions Possible Suggested Cause Action 1. From IDLE view. restart the machine. in Config. A data difference was detected for the 1. B . restore the PAUSE THERAPY parameter inside the parameter to the correct value. Temporary problem. Press OVERRIDE. Machine None. Actions Possible Suggested Cause Action 1. Rev. Wait a few seconds for the alarm to clear.ALARMS AND SIGNALS 8-217 W! ART PRESSURE SENSOR ERROR 317 Reason A large pressure spike or a large rapid change in pressure was detected by the for Alarm Arterial Pressure Sensor. Call for Service if the problem persists. SECTION 8 . B . 1. Restart the Blood Pump by performing the 30 seconds following an ! Air & Foam procedure to clear the alarm (instructions are Detector #4 alarm. The Blood Pump has not been restarted for 1. Rev. found in the description for the ! Air & Foam Detector #4 alarm. B . in this section).8-218 PHOENIX OPERATOR MANUAL W! BLOOD PUMP STOPPED BY ABD 318 Reason The Blood Pump has not been restarted for 30 seconds following an ! Air & Foam for Alarm Detector #4 alarm. Actions Possible Suggested Cause Action 1. Machine Blood Pump is off. The venous line must be inserted in the Air incorrectly during the Venous/Arterial Bubble Detector and the door closed. 1. Close the Blood Pump Cover. using a soft cloth dipped in Ethyl Alcohol (90%) or in Isopropyl Alcohol (70%). SECTION 8 . Possible Suggested Cause Action 1. The magnet is dirty. Blood Pump Cover must be closed.ALARMS AND SIGNALS 8-219 W! WAIT FOR PRESSURE TEST EXECUTION 319 Reason The machine cannot proceed with the Arterial and Venous T1 Test because the for Alarm pressures are not close to 0 mmHg. Carefully clean the magnet located behind the Blood Pump Cover. Open the arterial and venous from 0 mmHg. B . Machine The machine will stop at this point and not proceed any further into the Actions test. The Pressure Test during the T1 test. Be sure the Blood Pump Cover is securely latched. Clamp the Cartridge saline line. arterial and it is possible to have a pressure different venous lines. Rev. 4. access lines to the atmosphere. 3. The pressures displayed on the Touch Screen should decrease toward 0 mmHg. 3. Blood Pump Cover is open. The Cartridge Blood Set was installed 2. Call for Service if the problem persists. 2. 4. If the Cartridge Blood Set is filled with saline. Reposition the Cartridge Blood Set and restart the T1 test. Note In the alarm name. Main Board internal error. 2. Call for Service if the problem persists. Machine GENERAL SAFE STATE. switch the machine OFF and then back ON. See the Fast Recovery of the Dialysis process Procedure in Section 5. IDLE. 1. If this alarm occurs during ADR. Possible Suggested Cause Action 1. for Alarm Main Board blockage. B .A – Special Procedures. If this alarm occurs during DIALYSIS. Main Board internal error. perform a Fast Recovery of the Dialysis process. Rev. "xxx" means the internal code related to the alarm condition. 2.8-220 PHOENIX OPERATOR MANUAL >> GENERAL SYSTEM FAILURE << System Blocking XXX Reason THIS IS A SPECIAL ALARM. SETUP and PRIME. Actions Touchscreen blocked. Note This alarm is not functional if the CentryNet option is not installed. the network controller will retain any data that it has collected until the station comes back online. The “CentryNet: Station ID Error“ alarm also appears.ALARMS AND SIGNALS 8-221 CENTRYNET: DUPLICATE STATION 321 Reason The station number entered into the machine is in use(duplicated) by another for Alarm machine on the network. Note A treatment cannot be started or ended on the Phoenix machine until the CentryNet: Duplicate Station has cleared. Verify the other stations. Note If the alarm persists. the CentryNet option must be switched OFF. Change the STATION ID for the machine that is incorrect. Rev. Actions Automatically resets when the error condition is corrected. B . Machine None to the patient system. matches the posted STATION ID in the clinic. The user is responsible for manually collecting data until the cause of the alarm can be corrected. Possible Suggested Cause Action 1. SECTION 8 . or when the CentryNet option is turned OFF (CentryNet = NO). If a treatment is in progress. Check that the STATION ID on the machine been assigned to another machine. correcting any duplication. The same STATION ID number has already 1. Polling timer limit may need changing to been exceeded. The user is responsible for manually collecting data until the cause of the alarm can be corrected. The CentryNet Network Controller is not 2.8-222 PHOENIX OPERATOR MANUAL CENTRYNET STATION OFFLINE 322 Reason The network controller has failed to successfully poll a particular station on the for Alarm network (the machine did not receive a poll within the expected polling time). the network controller will retain any data that it has collected until the station comes back online. The Offline Timeout (polling timer) limit has 3. Verify all configuration items relating to CentryNet. 1. Note If the alarm persists. Note A treatment cannot be started or ended on the Phoenix machine until the CentryNet Station Offline error has cleared. B . Note This alarm is not functional if the CentryNet option is not installed. 2. Machine None to the patient system. The icon changes to indicate Off-Line. the CentryNet option must be switched OFF. Automatically resets when the error condition Actions is corrected. If a treatment is in progress. Rev. Possible Suggested Cause Action 1. accommodate the number of machines and quantity of data being collected. A configuration setting is incorrect. Call for Service if the problem persists. or when the CentryNet option is turned OFF (CentryNet = NO). Communication section) for instructions. 3. Add the station to the network (see the programmed for this station. START COLLECT/STOP COLLECT keys are not active. using the machine without CentryNet. Switch the CentryNet option OFF and take records for this treatment due to an internal records manually for that treatment. etc. 4. Verify all cable connections are RINSE. CentryNet back ON for the next treatment and determine if the problem has corrected itself. Call for Service if the problem persists. DESCALE. verify the network controller is has not yet been collected by the Network collecting data.) and all data from that treatment intact. the STATION OFFLINE 5. The station is off-line. Possible Suggested Cause Action 1. Turn Phoenix problem. Controller.ALARMS AND SIGNALS 8-223 CENTRYNET: INCOMPLETE DATA COLLECTION 323 Reason An attempt to end a treatment (STOP COLLECT) has been made before all records in for Alarm the database have been collected by the network controller. the network controller will retain any data that it has collected until the station comes back online. Continue alarm condition will eventually occur. Wait a few minutes until data collection is pressed and all data from the current complete and then press STOP COLLECT treatment has not yet been collected by the again. Note A treatment cannot be started or ended on the Phoenix machine until the CentryNet: Incomplete Data Collection error has cleared. the CentryNet option must be switched OFF. Network Controller. B . The treatment has ended in the normal 1. Refer to the CentryNet Station Offline #322 alarm message and troubleshooting advice. 5. or when the CentryNet option is turned OFF (CentryNet = NO). Switch the CentryNet option OFF. The STOP COLLECT Action key has been 2. Wait for the network controller to finish polling machine. FINAL complete. other machines. If a treatment is in progress. The user is responsible for manually collecting data until the cause of the alarm can be corrected. Automatically resets when error condition is Actions corrected. 3. Machine None to the patient system. 2. Note This alarm is not functional if the CentryNet option is not installed. Rev. The network controller is polling another 3. Note If the alarm persists. Wait a few minutes until data collection is fashion (WASHBACK. SECTION 8 . CentryNet is unable to collect a number of 4. 4. or the machine has not been assigned to that station (awaiting assignment). B . Make sure the STATION ID matches the CentryNet. Note A treatment cannot be started or ended on the Phoenix machine until the CentryNet: Station ID Error has cleared.8-224 PHOENIX OPERATOR MANUAL CENTRYNET: STATION ID ERROR 325 Reason A poll has been received by Phoenix. Call for Service if the problem persists. is being established The alarm will self-clear. the network controller will retain any data that it has collected until the station re-links with CentryNet. 1. or has changed. communication process to be completed. 3. STATION ID assignment has been lost at 5. Verify all configuration items relating to CentryNet. Change the STATION ID for one machine. 2. Check that the STATION ID on the alarming the CentryNet: Duplicate Station (Alarm machine matches the posted STATION ID in #321) message appears on screen. the clinic. No action necessary. reboot the Phoenix to reinitialize the STATION ID assignment. the option must be switched OFF. 3. A configuration setting is incorrect. Possible Suggested Cause Action 1. Two stations have the same STATION ID. If a treatment is in progress. Note This alarm is not functional if the CentryNet option is not installed. Either the machine. or when the CentryNet option is turned OFF (CentryNet = NO). The alarm will self-clear. or the CentryNet option. Wait for processed. Note If the alarm persists. but the network controller machine ID does not for Alarm match the Phoenix machine ID for that station. Rev. No action necessary. correcting any duplication 5. If not in a treatment. physical location in the clinic. Wait for has just been turned on and communication communication process to be completed. A new STATION ID is currently being 2. Machine None to the patient system. The user is responsible for manually collecting data until the cause of the alarm can be corrected. 4. Automatically resets when error condition is Actions corrected. Actions Possible Suggested Cause Action 1. Rev. Machine The machine stops and waits for the WHO Door to be closed. SECTION 8 . B . Call for Service if the problem persists.ALARMS AND SIGNALS 8-225 WHF DOOR POSITIONING 326 Reason The Waste Handling Option Door is open during an operational phase that for Alarm requires the WHO Door to be closed. Verify that the Door is closed. The Waste Handling Option Door is open 1. when it should be closed. the data using the selection procedure. Press OVERRIDE to clear the alarm. The Protective system detected an incorrect 1. Actions Possible Suggested Cause Action 1. Confirm message from the Control system. Rev. The message has been lost and the last correct message is used. B . Machine None.8-226 PHOENIX OPERATOR MANUAL W! COMMUNICATION CRC ERROR 327 Reason The Protection test for the correct reading of the message sent by the Control for Alarm System has failed. ALARMS AND SIGNALS 8-227 W! STILL IN PAUSE THERAPY 329 Reason The operator has maintained the selection of PAUSE THERAPY for more than 5 for Alarm minutes (approx). Press OVERRIDE to clear the alarm. Machine None. B . Rev. SECTION 8 . treatment. The operator has maintained the selection 1. of PAUSE THERAPY for more than 5 Deselect PAUSE THERAPY to continue the minutes. Possible Suggested Cause Action 1. Actions Note This message remains on the Touch Screen for a few seconds and then disappears automatically. Press OVERRIDE to continue. Machine The Blood Pump stops. or end the that has passed through the dialyser is equal treatment. B . WASHBACK (RINSEBACK VOLUME parameter). The quantity of physiological saline solution 1. Actions Possible Suggested Cause Action 1. Consider changing in Config the to the RINSEBACK VOLUME SET by the quantity of physiological solution for operator. Rev.8-228 PHOENIX OPERATOR MANUAL END OF WASHBACK PROCEDURE 332 Reason The quantity of physiological saline solution that has passed through the dialyser is for Alarm equal to the RINSEBACK VOLUME set by the operator. can occur only during the manufacturer tests. B . Machine NONE. Rev. SECTION 8 . for Alarm This alarm can occur only during the manufacturer tests. No troubleshooting is required. Failure of the communication between 1. this alarm BOM and the machine.ALARMS AND SIGNALS 8-229 TIMEOUT ERROR ON PROCESS SELECTION 333 Reason Failure of the communication between BOM and the machine. The alarm will be used only during the manufacturer tests. Actions Possible Suggested Cause Action 1. Possible Suggested Cause Action 1. Note This alarm can occurr only during the machine Calibration procedures. No troubleshooting is required. B . for Alarm Machine The machine doesn’t transfer data to the On Board Calibration Actions environment.8-230 PHOENIX OPERATOR MANUAL TIMEOUT ERROR ON PROCESS CLOSING 335 Reason Internal communication error. Internal communication error. this alarm can occur only during the machine calibration procedures. Rev. 1. SECTION 8 . The Heparin Pump is still malfunctioning. The Heparin Pump is malfunctioning. Verify that the machine has delivered the correct initial bolus if required. B . 1. 2. Call for Service if the problem persists. Press OVERRIDE to clear the alarm. Deactivate the Heparin program to clear the alarm. 2. Verify the total amount of heparin delivered.ALARMS AND SIGNALS 8-231 TOTAL HEPARIN INFUSED ERROR 338 Reason The Heparin Pump is malfunctioning or it is not delivering the correct amount of for Alarm heparin. Machine None. Rev. Actions Possible Suggested Cause Action 1. Note If the DIALYSIS TIME is increased following the occurrence of this alarm. Actions Note This alarm doesn’t occur when Profiling is active. Note The alarm will self-clear if the DIALYSIS TIME parameter value is increased. This for Alarm alarm will occur only if DIFFUSION TIME has been selected as the treatment end point for the END DIALYSIS parameter. Additional DIALYSIS TIME may be needed. B . Increase the set DIALYSIS TIME to lengthen the treatment.8-232 PHOENIX OPERATOR MANUAL END DIA . 2. even if the alarm condition has been reached. DIFFUSION TIME is complete. Machine None. Disconnect patient.DIFF TIME REACHED 339 Reason This message signals the operator that the DIFFUSION TIME is complete. 1. Possible Suggested Cause Action 1. the DIFFUSION TIME parameter will not be updated. Rev. 2. Call for Service if the problem persists. The > GENERAL SAFE STATE < 64 alarm will direction due to an internal malfunction. the Blood for Alarm Pump is not turning in the correct direction for the current machine operating phase. The blood pump is not turning in the correct 1. Machine GENERAL SAFE STATE Actions Possible Suggested Cause Action 1. when all the machine safety systems are activated. Rev.ALARMS AND SIGNALS 8-233 BLOOD PUMP DIRECTION 340 Reason During DIALYSIS. SECTION 8 . occur. Refer to alarm number 64 for further troubleshooting information. B . the #308 alarm will also occur together with the #342 alarm. for Alarm Machine Stops the Blood Pump. The Patient Sensor is dirty or wet. Rev. before starting a new dialysis session. Actions Ultrafiltration Rate is set to zero. B . Venous Line Clamp closes. Call for Service if the problem persists. Possible Suggested Cause Action 1. The machine is forced to the PATIENT CONNECT view. 1. At the end of the current dialysis treatment. Note If blood is detected in the venous line during PRIME. The Patient Sensor detected blood in the venous line. clean the Patient Sensor and the surface of the Air Bubble Detector around the Patient Sensor using a soft cloth.8-234 PHOENIX OPERATOR MANUAL ! BLOOD DETECTED DURING PRIME 342 Reason During PRIME. Also refer to the #308 alarm description to exit from the alarm condition. Restart the dialysis preparation.ALARMS AND SIGNALS 8-235 W! DRIFT ON FLOWMETERS 343 Reason The D1/D2 flowmeter test. Test failed due to a problem on the 2. If the problem persists. has for Alarm failed due to a drift of the flowmeters. If the problem persists. Call for Service if the problem persists. the dialysis preparation and return to IDLE view. Press OVERRIDE to clear the alarm. There are deposits or debris inside the 1. Machine None. Press OVERRIDE to clear the alarm. then restart the dialysis preparation. for the maximum amount of time. the dialysis preparation and return to IDLE view. Rev. 2. Possible Suggested Cause Action 1. Stop flowmeter(s). Perform a DESCALING or a Chemical Disinfection to clean the flowmeters of deposits. turn the machine OFF and call for Service. or perform acid based chemical disinfect now. B . Actions Note The following message appears in the Operator Messages Area: Flow Balance alarm MAY occur during Tx Recommend Descale at the end of Tx. Stop flowmeters of the machine. SECTION 8 . turn the machine OFF and call for Service. performed during the dialysis preparation phase. Press OVERRIDE to restart the Blood Pump and clear the alarm. Machine Stops the Blood Pump. Actions Closes the Venous Line Clamp. Procedures. Note OVERRIDE has no effect if the machine doesn’t detect a variation in the venous pressure value.8-236 PHOENIX OPERATOR MANUAL S/N: VEN PRESSURE NOT CHANGING 351 Reason In Single Needle Mode. Incorrect placement of the diaphragm 4. The Blood lines are kinked. Arterial and/or venous lines are not in their 5. Possible Suggested Cause Action 1. Verify that there is no clotting in the Set. Rev. Call for Service if the problem persists. Press OVERRIDE to restart the Blood Pump clamps. the venous pressure remains stable during the arterial for Alarm cycle. Perform a Diaphragm Neutral Position between the Cartridge Blood Set and the Procedure (See Section 5. Place the line(s) in the clamp(s). clamps or other restrictions.A – Special venous seal. Press OVERRIDE to restart the Blood Pump and clear the alarm. 2. 3. 4. 3. B . Cartridge Blood Set. access for kinks. Press OVERRIDE to restart the Blood Pump and clear the alarm. Press OVERRIDE to restart the Blood Pump and clear the alarm. Clotting is occurring in the Cartridge Blood 2. clamped or 1. and clear the alarm. 5. Check the Blood lines and the patient’s restricted. The patient is moving around. in this manual). Actions Note This message remains on the Touch Screen for all the dialysis treatment until the EMPTYING Action key confirmation. Possible Suggested Cause Action 1. Machine None.ALARMS AND SIGNALS 8-237 S/N: VENOUS PRESSURE UNRELIABLE 352 Reason The “S/N: Ven Pressure Not Changing” #351 alarm has occurred 3 times during for Alarm the dialysis treatment. Call for Service if the problem persists. SECTION 8 . Refer to dialysis treatment. Rev. Determine the cause of the alarm then #351 alarm has occurred 3 times during the press OVERRIDE to continue. B . The “S/N: Ven Pressure Not Changing” 1. Alarm number 351 for additional troubleshooting information. during the Dialysate Preparation phase until Patient Connection. Note In Rinsing or Disinfection. once the AC Power Supply returns: . Machine In RINSE: None. 4. during the treatment phase. Switch OFF the machine. 2. B .The interrupted process automatically restarts and no operator intervention is required. Perform WASHBACK to return blood to the DIALYSIS. DIALYSIS. if the “No Power #353" alarm is displayed for more than 3 minutes. DIALYSIS. Note If the power failure lasts for less than 3 minutes.8-238 PHOENIX OPERATOR MANUAL NO POWER 353 Reason The AC supply voltage has been interrupted in a machine equipped with the for Alarm BATTERY BACKUP KIT. Interruption of the AC supply voltage in 4. . during EMPTYING or DESCALING. Switch OFF the machine. Actions In DISINFECTION and in DIALYSIS: the heater is turned off. Interruption of the AC supply voltage in RINSE 1. or DISINFECTION. Interruption of the AC supply voltage in 2. Interruption of the AC supply voltage in 3. patient and then switch OFF the machine.The “No Power #353" alarm disappears. Switch OFF the machine. the machine will be automatically switched OFF. Possible Suggested Cause Action 1. Rev. 3. consistency Check Treat. Check patient’s access for correct needle placement. B . Determine reason for clotting and replace the dialyser. Verify that the dialyser selected is adequate to to meet Target Dose. (The parameter TARGET Kt/V THRESH is SET in the IDLE mode in the Config\kT/V view. Actions Note The following message appears in the Operator Messages Area: Check Clearance/Blood Flow R. Dialyser is not providing sufficient Clearance 3. dialysate connector is not connected to the Press OVERRIDE to clear the alarm. Time/Prescription consistency Enter SET Mode to modify the Target. DOSE NOT MATCH PRESCRIP. 5. 6. The DIALYSIS TIME set is not consistent with 6. Verify that the patient prescription is correct. Press OVERRIDE to clear the alarm. the TARGET KT/V programmed. Press OVERRIDE to clear the alarm. SECTION 8 . 1.”#354 alarm will occur only if the TARGET Kt/V THRESH parameter is set to a value different from 0 and the TARGET KT or the TARGET KT/V parameter value has been confirmed/entered. inlet dialysate port of the dialyser). operation is not in disagreement with the patient prescription. Dialysate connectors are reversed (blue 5.) Machine None. 2. estimated by the machine. 3. TARGET KT and/or the TARGET KT/V Consider increasing the blood flow rate if this programmed. then Press OVERRIDE to cancel the message Note The “FORECAST DIAL. Press OVERRIDE to clear the alarm. flow if this operation is not in disagreement with the patient prescription. Verify that the patient prescription is correct. 354 Reason The Forecast Kt/V (or Kt). Press OVERRIDE to clear the alarm. Correctly connect the dialysate connectors. The level of recirculation is placement. The Dialyser is clotting. 4. Possible Suggested Cause Action 1. deliver the Prescribed dialysis dose. The blood flow rate is not consistent with the 4. Consider increasing the DIALYSIS TIME if this operation is not in disagreement with the patient prescription. Consider decreasing the blood increased. is lower than the TARGET for Alarm Kt/V THRESH Percentage. Press OVERRIDE to clear the alarm. DOSE NOT MATCH PRESCRIP. Problem with patient’s access or needle 2. Rev.ALARMS AND SIGNALS 8-239 FORECAST DIAL. Rev. Verify that the patient prescription is correct.8-240 PHOENIX OPERATOR MANUAL 7. B . TARGET KT/V value programmed or consider setting a lower value for the TARGET Kt/V THRESH parameter. programmed is not consistent with the patient Consider changing the TARGET KT and/or the prescription. Press OVERRIDE to clear the alarm. The TARGET KT and/or the TARGET KT/V 7. If set to NO. the Kt-Kt/V Target Achieved alarm is turned off and will not appear. B . Press OVERRIDE to clear the alarm. percentage of the TARGET KT/V value. Actions Note In Config. it can be reset by pressing the OVERRIDE button and then it does not appear again during the same dialysis treatment. Machine None. Press OVERRIDE to clear the alarm.DISTRIB VOLUME. Rev. the fixed percentage of the TARGET KT value.DIALYSIS TIME .DRY WEIGHT . SECTION 8 . The KT/V is greater than or equal to the fixed 2. Possible Suggested Cause Action 1. The Depurated Vol is greater than or equal to 1. If set to YES. 2.TARGET KT/V .TARGET KT . the TARGET Kt/V Reached parameter can be configured to NO or YES. If DISTRIB VOLUME and DRY WEIGHT parameter values have been confirmed: The KT/V is greater than or equal to the TARGET KT/V value. The Kt-Kt/V Target Achieved alarm will appear again during the same dialysis treatment only after a modification of at least one of the following parameter values: . when the alarm appears once.ALARMS AND SIGNALS 8-241 KT-KT/V TARGET ACHIEVED 355 Reason If DISTRIB VOLUME and DRY WEIGHT parameter values have not been for Alarm confirmed: The Depurated Vol is greater than or equal to the TARGET KT value. The Patient Sensor detected blood in the 1. Press CONFIRM to clear the alarm.Press CONFIRM Possible Suggested Cause Action 1. attached to the patient’s access. The operator is allowed to remove the venous line from the Air Bubble Detector to clean and dry the Patient Sensor and the venous line for a maximum of three times. B . Or: . Actions Note When the alarm appears also the following superimposed window is displayed: If the line has blood in it. Call for Service if the problem persists.Remove venous line from patient sensor .Put venous line back in the patient sensor . 2. 2. Follow the instructions given in the superimposed window: remove the venous line from the Air Bubble Detector and carefully clean the venous line. sensor slot .8-242 PHOENIX OPERATOR MANUAL W! BLOOD SENSED IN VENOUS LINE 359 Reason The Patient Sensor detected blood in the venous line during priming of the blood for Alarm side of the dialyser and the Blood Pump was running. Then reinsert the venous line in the Air Bubble Detector. Machine Stops the Blood Pump. The Patient Sensor is dirty or wet. Note If the Patient Sensor continues to detect blood after performing the cleaning and drying procedure described in the superimposed window. Verify that the “No blood detected” Patient Sensor Icon is displayed in the Icon Area on the Touch Screen and then press CONFIRM to clear the alarm. press CONFIRM. the W! Blood sensed in venous line #359 alarm message will reoccur together with the superimposed window. the Patient Sensor and the surface of the Air Bubble Detector around the Patient Sensor using a soft cloth. Rev. Verify that the venous line is appropriately venous line.Clean and dry venous line & pt. SPECIFICATIONS 9. according to the IEC 60601-1 international electrical safety standard. SECTION 9 . or anesthetic mixtures with air or with oxygen or nitrous oxide.1 General specifications Name PHOENIXTM Haemodialysis Equipment. Version The machine can be installed according to one of the following power supply versions: N° Zone Power supply 1 Europe 220 V 50/60 Hz 2 Europe.9 in) 930 mm (36. As a result the Phoenix machine is not recommended for use in direct cardiac applications. Note The Phoenix machine is classified as Class I APPLIED PART B device.9 SPECIFICATIONS 9. US 115 V 60 Hz Dimensions Parameter Dimension Height 1440 mm (56.5 lb) Non-combustible plastic materials for external panels and electronic keyboard cover (in compliance with CSA standard C22.4 in) with “IV Pole” Width 610 mm (24. Rev.7 in) 1970 mm (77. South America 230 V 50/60 Hz 3 UK 240 V 50/60 Hz 4 North America.3 in²) 567300 mm² (879. 6 "self-extinguishing").2 no.5 in) with “Chemical Container Shelf” Total floor surface covered by base 433100 mm² (671.0 in) with “Dialyser holder” in working position Depth of base 710 mm (27.3 in²) Dry weight 120 kg (264. B . Applied Part Type B (EN 60601-1) • Class IIb (MDD 93/42/EEC) • Protection Class: IPX1 (drip-proof equipment) • Not suitable for use in the presence of flammable anesthetics. • Continuous operation. Equipment Classification • Class I. Refer to. to keep a minimum distance of 10 m (33 ft) from the equipment. Automatic turn-off Can only be enabled for rinsing and disinfection phases. thus it has an adequate degree of protection against electromagnetic disturbances. at least. covers the equipment. and be compliant with. refer to Appendix A in this manual). in this manual. B . WARNING The PHOENIX system conforms to IEC 60601-1-2 standard on Electromagnetic Compatibility. The compatibility of the PHOENIX machine with the other accessories and disposables listed in this Operator Manual has been verified during product validation. Electromagnetic Environment Requirements The PHOENIX machine needs specials precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Appendix A.A. Rev. However.9-2 PHOENIX OPERATOR MANUAL Ambient requirements and storage conditions State Temperature Humidity Operational +10°C to +40°C (50°F to 104°F) 30 to 85 % rh Storage -20°C to +70°C (-4°F to 158°F) 10 to 95 % rh (non-condensing) Atmospheric pressure range State Pressure Operational 700 to 1060 hPa Storage 500 to 1060 hPa WARNING Storage under 0°C (32°F) is not recommended unless the hydraulic circuit has been emptied (see Maintenance section of the Service Manual). CE Marking The PHOENIX machine has been developed to conform to the requirements of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. it is not recommended to use cellular phones (hand-held) in the dialysis room or. to prevent any problems. (For additional information about special precaution regarding EMC. The CE marking by the manufacturer GAMBRO DASCO S. local standards and guidelines.p. B . Collateral standard: Programmable electrical medical systems (Equivalent to EN 60601-1-4) CSA C22-2 N° 601-1-M90 MEDICAL ELECTRICAL EQUIPMENT. CEI 62/98 (Equivalent to EN 60601-2-16) BS 5724-2-16 IEC 60601-1-2 MEDICAL ELECTRICAL EQUIPMENT Part 1. General Requirements for Safety Independent internationally recognized experts have rigorously checked conformity with these standards.SPECIFICATIONS 9-3 Conformity with international rules The PHOENIX machine has been developed to conform to the following electrical safety standards: IEC 60601-1 MEDICAL ELECTRICAL EQUIPMENT Part 1. Collateral standard: Safety Requirements for Medical Electrical System. 2. General Requirements for Safety CAN/CSA C22-2N°601-2-16-92 MEDICAL ELECTRICAL EQUIPMENT Part 2. (Equivalent to EN 60601-1-1) IEC 60601-1-4 MEDICAL ELECTRICAL EQUIPMENT Part 1. Dielectric strength: verified in compliance with clause 20 of IEC 601-1 (UL 2601-1). General Requirements for Safety 1. UL 2601-1 MEDICAL ELECTRICAL EQUIPMENT. General Requirements for Safety. Patient Leakage Current (normal condition): max 5uA (115V). General Requirements for Safety. max 10 uA (230/240V). SECTION 9 . General VDE 0750-1 Requirements for Safety (Equivalent to EN 60601-1) CEI 62/5 BS 5724-1 UL 2601-1 IEC 60601-2-16 MEDICAL ELECTRICAL EQUIPMENT Part 2. <300uA as required by the UL 2601-1 Standard (typically between 170 and 220 uA) (230V). Particular VDE 0750-206 requirements for safety of haemodialysis equipment. Particular requirements for safety of haemodialysis equipment. 1. Collateral standard: Electromagnetic compatibility - Requirements and tests (Equivalent to EN 60601-1-2) IEC 60601-1-1 MEDICAL ELECTRICAL EQUIPMENT Part 1. Leakage current and dielectric strength Earth Leakage Current: <300uA as required by the UL 2601-1 Standard (typically between 80 and 130 uA) (115V). Rev. 9-4 PHOENIX OPERATOR MANUAL Note The above measurements are applicable when all standard and optional accessories designed for the PHOENIX are connected. Power failure If there is a power failure. Note Both versions are fitted with a three-pin plug which includes a Ground. Electrical Power Supply – two standard versions: N° Volts % Range Hertz Amps 1 230/240 ±10 50/60 10 Note 1 2 115 ±10 60 16 or 12 (without heat disinfection) Note 1 It is possible to operate the machine with a 220 or 240 volt power supply. However. selection of voltage requires an internal service configuration. The values programmed and the modes set remain in the machine’s memory for 4 minutes. WARNING The correct installation of a MEDICAL ELECTRICAL SYSTEM requires that each SYSTEM component be individually connected to the main power. It is strongly recommended: NOT TO USE MULTIPLE PORTABLE SOCKET- OUTLETS. Rev. they must comply with the IEC 60601-1-1 Standard and must NOT BE PLACED ON THE FLOOR. However. WARNING Possible hazards may arise from equipment (other than the accessories listed below) being connected to machine. B . an audible alarm is triggered and the yellow lamp is illuminated. which may cause the permitted leakage current to be exceeded. WARNING Wait at least 5 seconds after switching OFF the machine before turning it ON again. if using multiple portable socket-outlets. 2 lb) Note The telescopic pin adjustment must be done without bags on the hooks • Concentrate/Disinfectant Wands • Chemical Container Shelf (maximum load: 16 Kg or 35. Rev. B .3 lb) WARNING Do not stand on Chemical Container Shelf. • pH Probe Assembly • Blood Pump Crank • BPM Cuff • Single Needle Holder • Operator’s Manual • Installation Checklist Accessories • BPM (Blood Pressure Monitoring System) • Central Concentrate Supply Kit • DIASCAN Kit • Single Needle Kit • CentryNet serial interface board (RS 485) • CWP Adapter Kit • Clean Dialysate • Remote Alarm • Battery Backup Kit Note Refer to your local representative to verify if your machine is already equipped with the BATTERY BACKUP Kit.SPECIFICATIONS 9-5 Shipping List The machine packaging contains a shipping list with the following components: • Water Inlet Hose and Drain Hose • Connection Set • Sampling Connector • Dialysate Connectors and Lines • Intravenous Pole (maximum load: 6 Kg or 13. SECTION 9 . Blood Pressure Monitoring System in this manual). The Computer Connection Accessories may be used to connect the machine to a Personal Computer to interface with the Communication System (see Section 7 – Communication System in this manual).0. the brake is released. All external equipments connected to the PHOENIX machine must be compliant with IEC 60950. The BPM port is the pneumatic connection used for the BPM option (see Section 5. Wheels and portability The PHOENIX system is maneuvered by 4 double wheels and one brake which is at the front of the concentrate container shelf. The other connectors are currently not used. WARNING The PHOENIX machine is provided with ports for connecting it with an external personal computer or a communication network. Note A two-color plate status indicator. To avoid jolting. when green is visible. the brake is ON. The brake is foot-operated: to brake. Rev. indicates whether the brake is ON or OFF. When red is visible.9-6 PHOENIX OPERATOR MANUAL Interface connectors See Fig 9. move the machine carefully using the rear handle. Software revision This manual revision is related to the software revision root 3. B . press the left side of the pedal completely down. fitted behind the brake pedal. The machine is supplied with a standard 10 Base T Ethernet connection.C . press the right side of the pedal completely down. check that the brake is released and remove infusion bags or any other weights or hanging objects from the IV pole or from the concentrate container shelf. WARNING Before moving the machine.36. to release the brake. SECTION 9 . it may be present or not in the Interface Connectors Panel) Computer Connection Remote alarm External water valve (not used) Fig 9.SPECIFICATIONS 9-7 Hour Meter (Depending on the machine version.0 Interface Connectors Rev. B . Color Code Concentrate Connectors Front: Bicarbonate Connector : Blue Acetate/Acid Connector : White/Red Disinfectant Connector : Yellow Rear: Two permanent lines :Yellow/No-Coloured connected to disinfectant containers on the back of the machine.0 psig) Flow 1.2. Examples include: reverse osmosis.5 to 87. deionization.4 in) Maximum distance to the drain 3 m (118. Mantain an air clearance between the drain connector of the machine and the drain itself.2 °C (50°F to 90 °F) Filtration (by internal filter) 250 μm RMS Drain Maximum height above floor level: 1 m (39. Temperature: +95 °C max (203 °F max) Make the connection. Rev. Refer to the local standards or to the AAMI RD62 "Water treatment equipment for hemodialysis applications" standard. Main requirements Incoming water Required value Pressure 100 to 600 kPa (14.1 Water supply Incoming water Water treated for the haemodialysis process should be obtained using purification processes.1 in) Drain flow : 1.2 Hydraulic section 9. Water Quality Requirements.9-8 PHOENIX OPERATOR MANUAL 9.1 l/min Temperature 10°C to 32. as described in applicable local and international standards. ion exchange or any other system approved by the person responsible for the dialysis facility.1 l/min max. with an external pressure connector to avoid back flow. B . WARNING It is the responsibility of the user to determine the correspondence between the dialysate conductivity. Rev. The concentrate supply pressure range at which the machine operates is 0 to 1 bar (0 to 14. WARNING Attention must be given to the safety hazards related to incorrect choice of dialysate concentrates. B .g. SECTION 9 .17 mS/cm Average accuracy ± 1.5% of the selected value Alarms ± 5% of the selected value Protection system type Monitoring of the dialysate electrical conductivity Note When the Final Conductivity value set is changed. the Protection System verifies the congruency of the variation during the transition period. some graphs and tables are given as examples of the correspondence between dialysate conductivity and dialysate solute content of those particular dialysate concentrates. and the dialysate solute content. Note For the dialysate concentrates listed in this manual. Total conductivity of the dialysate Permitted values 13 .5 psi).2. Note Concentrate is drawn into the machine by a peristaltic pump. displayed by the machine. The concentrate temperature must be between 5 °C (41°F) and 30 °C (86°F). This can be done by taking dialysate samples at different conductivity values (e. verified by clinical laboratory results. for each dialysate concentrate used for dialysis treatment.2 Dialysate WARNING It is recommended to use concentrates which conform to the requirements of the local standards or of the AAMI RD61 "Concentrates for hemodialysis" standard or of the European Pharmaceutical standards. The control of alarm thresholds and dialysate conductivity precision is of major medical importance in ensuring a safe dialysis treatment.14.SPECIFICATIONS 9-9 9. 13.15 mS/cm) and sending them to a laboratory for analysis. 9-10 PHOENIX OPERATOR MANUAL Conductivity of the Bicarbonate Solution Both BiCart® (sodium bicarbonate cartridge .6%. the NaHCO3 concentration must be at least of 70.see specific instruction sheet) and a solution of sodium bicarbonate can be used with the PHOENIX machine. will be described in the following tables.4% Bicarbonate Concentrate type: Ion Concentrate Concentrate (g/l) (mEq/l) NaHCO3 (Sodium bicarbonate) 84.22 70 CaCl2 2H2O (Calcium chloride) 7.4% • Bicarbonate Concentrate Nominal composition of 8. Rev.00 1000 • Acid Concentrate Four different types of acid concentrate are considered: (a) Nominal composition of 1:34 (35X) Acid Concentrate type (containing 4mEq/l acetic acid when properly diluted to make dialysate): Salt Concentrate Concentrate (g/l) (mEq/l) NaCl (Sodium chloride) 204. Two different types of solution of sodium bicarbonate. 9.3) and Table (f) refer to this acid composition. 9. Type 1: BIC 8. B .4% dialysis treatment contains only NaHCO3 (sodium bicarbonate).72 105 MgCl2 6H2O (Magnesium chloride) 2. namely BIC 8.4% and BIC 6.1 and Fig.41 140 Table (a) The following graphs and the related tables (Figs.25 CH3COOH (Acetic acid) 8. selected for a BIC 8.00 g/l so that the machine reaches a correct value of dialysate conductivity. Note If the bicarbonate concentrate.67 26.54 3500 KCl (Potassium chloride) 5. (c) Nominal composition of 1:34 (35X) Acid Concentrate type (containing 3mEq/l acetic acid when properly diluted to make dialysate): Salt Concentrate Concentrate (g/l) (mEq/l) NaCl (Sodium chloride) 204.43 33. SECTION 9 . 9.31 105 Table (c) Rev.67 26.54 3500 KCl (Potassium chloride) 5.22 70 CaCl2 2H2O (Calcium chloride) 7.SPECIFICATIONS 9-11 (b) Nominal composition of 1:44 (45X) Acid Concentrate type (containing 4mEq/l acetic acid when properly diluted to make dialysate): Salt Concentrate Concentrate (g/l) (mEq/l) NaCl (Sodium chloride) 262.81 180 Table (b) The following graphs and the related tables (Figs. 9.92 135 MgCl2 6H2O (Magnesium chloride) 3.72 105 MgCl2 6H2O (Magnesium chloride) 2.1 and Fig. B .71 90 CaCl2 2H2O (Calcium chloride) 9.25 CH3COOH (Acetic acid) 6.3) and Table (f) refer to this acid composition.98 4500 KCl (Potassium chloride) 6.75 CH3COOH (Acetic acid) 10. the audible and visual alarms are triggered.7 mS/cm.75 CH3COOH (Acetic acid) 8. B .1 mS/cm Alarms: ±5% of set value WARNING When the conductivity of the dialysate exceeds the alarm threshold. Rev.7 and 3. WARNING Bicarbonate value in Final Dialysate depends on both the Final conductivity and the Bicarbonate conductivity settings.98 4500 KCl (Potassium chloride) 6. with steps of 0.1 mS/cm.43 33. to reduce the possible formation of bicarbonate precipitates. Conductivity values of between 2.11 135 Table (d) Note For Acid Concentrate selection.71 90 CaCl2 2H2O (Calcium chloride) 9. may be selected.9-12 PHOENIX OPERATOR MANUAL (d) Nominal composition of 1:44 (45X) Acid Concentrate type (containing 3mEq/l acetic acid when properly diluted to make dialysate): Salt Concentrate Concentrate (g/l) (mEq/l) NaCl (Sodium chloride) 262. these are the minimum quantities of acetic acid recommended for use in a solution. It is the responsibility of the user to set conductivity in accordance with the type of concentrate used to obtain the desired value of bicarbonate in the final dialysate. Average accuracy: ±0.92 135 MgCl2 6H2O (Magnesium chloride) 3. 6 % • Bicarbonate Concentrate Nominal composition of 6.480 128.44 KCl (Potassium chloride) 5. 9.2 and Fig.4%.850 147. B . Rev.SPECIFICATIONS 9-13 Type 2: BiCart® Use of BiCart®: For the nominal composition of Acid Concentrate Type refers to the tables (a) and (b) above.490 73. who are specially trained for haemodialysis treatments. WARNING Carefully read the BiCart® Instructions for Use before using the device.740 36.83 (36.95 785. 9.79 CH3COOH (Acetic acid) 8.53 402. using the PHOENIX Operator’s Manual (see Section 5 – Dialysis Operation in this manual). for Type 1: BIC 8.11 NaCl (Sodium chloride) 23.96 MgCl2 6H2O (Magnesium chloride) 3.6% Bicarbonate Concentrate type: Ion Concentrate Concentrate (g/l) (mEq/l) NaHCO3 (Sodium bicarbonate) 65.38 Table (e) The following graphs and the related tables (Figs. SECTION 9 .190 2946.63 CaCl2 2H2O (Calcium chloride) 9.83X) Acid Concentrate type: Salt Concentrate Concentrate (g/l) (mEq/l) NaCl (Sodium chloride) 172.3) and Table (g) refer to this acid composition.64 • Acid Concentrate Nominal composition of 1:35. Type 3: BIC 6. BiCart® may only be used by staff. 6% 1:35.0 mS/cm. the audible and visual alarms are triggered. Conductivity values of between 4.83 (36.9-14 PHOENIX OPERATOR MANUAL Note For Acid Concentrate selection.6 and 6. these are the minimum quantities of acetic acid recommended for use in a solution.83X) Examples of Correspondence between Conductivity Settings and Dialysate Solute Content The following graphs and tables are given as examples of the correspondence between dialysate conductivity and dialysate solute content for some of the particular dialysate concentrates listed in this section. Selection Guide for Bicarbonate Concentrate: Bicarbonate Concentrate Type Acid Concentrate Type BIC 8. Average accuracy: ±0. Rev. to reduce the possible formation of bicarbonate precipitates. Changes in the concentrate formula will result in changes of the dialysate solute content so if a different formula is used these graphs and tables may not be representative. with steps of 0.4% 1:34 (35X) 1:44 (45X) BiCart 1:34 (35X) 1:44 (45X) BIC 6.1 mS/cm. B . may be selected.1 mS/cm Alarms ±5% of set value WARNING When the conductivity of the dialysate exceeds the alarm threshold. 5 3.0 33.1 3 2.3 3.6 3.4 3.0 35.9 2.2 (mS/cm) 13.0 40.0 32.6 (mS/cm) Fig 9.7 mS/cm and the Final Conductivity to 13 mS/cm. Note Bicarbonate values displayed in the above graph/table are calculated with an approximation of ± 1 mEq/l.2 3.0 mS/cm 40 (mEq/l) 3.0 mS/cm.0 41.8 2.0 Bicarbonate value in Final Dialysate mEq/l Bicarbonate Bicarbonate Final Conductivity value need Conductivity 30 (mEq/l) 2.4% solution is used (with Acid Concentrate of the type containing 4mEq/l acetic acid when properly diluted to make dialysate). the bicarbonate value in final dialysate will be approximately 42 mEq/l.8 (mS/cm) 35 (mEq/l) 3. the Bicarbonate value in Final Dialysate will be increased by approximately 1 mEq/l.0 31.0 36.0 mS/cm when the acid concentrate used are the acid concentrate listed in Table(a) and Table (b).7 28.0 37. SECTION 9 .5 mEq/l from the above graph/table. B . bicarbonate value in final dialysate will be reduced by approximately 1. They represent typical values obtained setting Final conductivity to 13.0 39.0 29. For example. using this concentrate and setting the Bicarbonate Conductivity to 3. Note If Final conductivity is set to 17.0 38.0 34.0 30. The above graph and table show the effects on Bicarbonate value in Final Dialysate following adjustments in Bicarbonate Conductivity. Rev.1 Bicarbonate value in Final Dialysate versus Bicarbonate Conductivity when the BIC. Note If the Acid Concentrate used is of the type containing 3mEq/l acetic acid (when properly diluted to make dialysate).SPECIFICATIONS 9-15 How to set Conductivity to get a desired Bicarbonate value in Final Dialysate Bicarbonate Conductivity mS/cm 3.7 3. 8. 00 5. Rev.0 mS/cm.2 Bicarbonate value in Final Dialysate versus Bicarbonate Conductivity when the BIC.5 mEq/l from the above graph/table.6% solution is used.0 31.40 5. Note Bicarbonate values displayed in the above graph/table are calculated with an approximation of ± 1 mEq/l.6 (mS/cm) 35 (mEq/l) 5.0 mS/cm 40 (mEq/l) 5.0 34.3 (mS/cm) 13.50 5.80 4.0 Bicarbonate value in Final Dialysate mEq/l Bicarbonate Bicarbonate Final Conductivity value need Conductivity 30 (mEq/l) 4. The above graph and table show the effects on Bicarbonate value in Final Dialysate following adjustments in Bicarbonate Conductivity.30 5.0 35. Note If Final conductivity is set to 17.0 41.0 36. bicarbonate values in final dialysate will be reduced by approximately 1.0 32.10 5.70 5.0 39.0 38.9-16 PHOENIX OPERATOR MANUAL How to set Conductivity to get a desired Bicarbonate value in Final Dialysate 6.90 Bicarbonate Conductivity mS/cm 5. 6.70 4.80 5.9 (mS/cm) Fig 9.0 33. They represent typical values obtained setting Final conductivity to 13.0 40. B .20 5.60 30.0 mS/cm and when the acid concentrate used is the acid concentrate listed in Table(e).60 5.00 4.0 37.90 4. 5 Final Conductivity mS/cm 16.0 mS/cm.3 (mS/cm) 140 (mEq/l) 3.0 13.5 14.0 16.0 15.0 145.4% / Bic 6.9 (mS/cm) 155 (mEq/l) 15. SECTION 9 .6% Sodium value need Bicarbonate conductivity Final Conductivity 135 (mEq/l) 13.6%) and setting Bicarbonate conductivity to 6.7 mS/cm (Bic 8. B .SPECIFICATIONS 9-17 How to set Conductivity to get a desired Sodium value in Final Dialysate 17.0 130.3 (mS/cm) 150 (mEq/l) 14. Note Sodium values displayed in the above graph/table are calculated with an approximation of ± 2 mEq/l. or • The acid concentrate listed in Table(e) (for Bic 6.0 135.0 160.8 (mS/cm) 145 (mEq/l) 6.0 14.0 140.0 Sodium value in Final Dialysate mEq/l Bic 8.0 170.5 15.0 150.3 Sodium value in Final Dialysate / Final Dialysate Conductivity.5 13.4%)/ 13.0 165. Rev.4% or BiCart) and setting Bicarbonate conductivity to 3.0 mS/cm (Bic 6.4 (mS/cm) 160 (mEq/l) 15. They represent typical values obtained when is used: • The acid concentrate listed in Table(a) or in Table (b) (for Bic 8.7 mS/cm.9 (mS/cm) Fig 9.6%) 14. The above graph and table show the effects on Sodium value in Final Dialysate following adjustments in Final Dialysate Conductivity.0 155. sodium values in final dialysate will be reduced by approximately 3 mEq/l from the above graph/table. the Sodium value in Final Dialysate will be increased by approximately 1 mEq/l. sodium values in final dialysate will be reduced by approximately 3 mEq/l from the above graph/table. Rev. B .6% type is used.4% type is used. If the bicarbonate concentrate of the 6.7 mS/cm. when setting the Bicarbonate conductivity to 4.6 mS/cm.9-18 PHOENIX OPERATOR MANUAL Note If the bicarbonate concentrate of the 8. Note If the Acid Concentrate used is of the type containing 3mEq/l acetic acid (when properly diluted to make dialysate). when setting the Bicarbonate conductivity to 2. 0 2.1 1.8 2.0 mS/cm 3.1 2.22 15.85 3.6 0.0 0.2 1. Rev. K+ and Mg++ ions concentration varies in the Final dialysate as shown in the following tables: BIC 8.7 mS/cm 3.6% concentrate: Final Conductivity Bicarbonate Ca++ K+ Mg++ Conductivity (mEq/l) (mEq/l) (mEq/l) 4.05 4.6 0.37 6.02 17.5 2.7 mS/cm 2.0 mS/cm 3.80 2.29 Table (g) Note Ca++.6 1.5 2. K+ and Mg++ ions concentration in the Final dialysate Both when varying the Bicarbonate Conductivity and when varying the Final Conductivity.7 mS/cm 2.1 mS/cm 2.0 mS/cm 5.66 2.90 6.8 0.9 1.8 0.4% concentrate: Final Conductivity Bicarbonate Ca++ K+ Mg++ Conductivity (mEq/l) (mEq/l) (mEq/l) 2.SPECIFICATIONS 9-19 Ca++.1 mS/cm 3.0 2.7 mS/cm 4. the Ca++.9 1.3 mS/cm 4.7 mS/cm 3.7 1.6 mS/cm 5.0 mS/cm 5.0 mS/cm 2.88 15.0 mS/cm 4.9 2.6 mS/cm 4.6% concentrate type The following table shows the effects on Ca++.1 mS/cm 4.0 mS/cm 3.2 mEq/l.5 2.0 mS/cm 5.82 4.6 mS/cm 3.73 13.7 mS/cm 3.5 0.8 1. SECTION 9 .1 0.3 mS/cm 4.4 2.1 2.4 1.3 0.8 2.45 17.3 1.2 0. K+ and Mg++ values in Final Dialysate following adjustments in Bicarbonate Conductivity when using a BIC 8. K+ and Mg++ values in Final Dialysate following adjustments in Bicarbonate Conductivity when using a BIC 6.9 0.99 3.98 13.0 0.3 mS/cm 3.2 2. K+ and Mg++ values displayed in the above tables are calculated with an approximation of ± 0.0 mS/cm 3.95 Table (f) BIC 6.3 2.7 1.7 2.14 6.4% concentrate type The following table shows the effects on Ca++. B .71 3.6 1. 5 mg/l (ppm) . +32 °C (89.8°F)/-1. +41 °C (105.5 °C (103.6°F) min.6°F). Protection system type: monitoring of the dialysate temperature WARNING When the temperature of the dialysate exceeds the alarm threshold.1°F) Accuracy: +1. the audible and visual alarms are triggered.0 °C (+1. Partial pressure of Oxygen: less than 100 mmHg at 40 °C (104°F) or dissolved gas in dialysate less than 4.8°F) max. B . Rev.2°F) to +39. Dialysate Deaeration Method of Deaeration: heating in combination with vacuum pumping.9-20 PHOENIX OPERATOR MANUAL Dialysate Temperature Range: +34 °C (93.5°C (-2.7°F) Alarms: ±2 °C (3. Dialysate Flow Possible values: 350 to 800 ml/min with steps of 50 ml/min Accuracy: ±5% Dialysate Pressure Permitted values: -350 to +450 mmHg Accuracy: ±25 mmHg WARNING When the pressure of the dialysate exceeds the alarm threshold. the audible and visual alarms are triggered. Rev.5 to 8. A safety system is present to prevent concentrate exchange errors. the audible and visual alarms are triggered. by generating an alarm in case the pumps speeds are measured outside a range of -10% to +30% of the reference value. WARNING When the pH of the dialysate exceeds the alarm threshold.5 to 7.3 pH units Range in Bicarbonate mode: 6. Dialysate Pump Monitoring for Concentrate Exchange The reference values for the speed of the acid/acetate and bicarbonate peristaltic pumps are defined during the corresponding calibration processes and represent the 100% functioning point.0 to 8. B . SECTION 9 .SPECIFICATIONS 9-21 Dialysate pH The pH of the dialysate is displayed on the screen.8 (depending on service configuration) pH units Range in Acetate mode 6.2 pH units only during the preparation phase in BiCart dialysis.2 pH units Note The range for pH is 6.6 or 7. Accuracy: ±0. ) Polyetheretherketone (Peek) Polyetheretherketone and Carbon Fiber (Peek + CF) Polyetheretherketone and Glass Fiber (Peek + GF) Polyfluorovinylidene (PVDF) Polyphenysulphide (PPS) Polypropylene (PP) Polysulfone (PSU) Polytetrafluoro Ethylene (PTFE) Polyvinil Cloruro (PVC) Silicon Rubber (SI) Stainless Steel (AISI SS316) Titanium (Ti) 9.4 Descaling Machine descaling can be carried out using: • The same concentrate solution used for the dialysis procedure (in case of Bicarbonate Dialysis). concentrates and water Ceramic Ethylene Propylene Diene Monomer (EPDM) Ethylene Propylene Monomer (EPM) Fiberglas Reinforced Polyamide (PA + GF -Glass Fiber-) Fiberglas Reinforced Polypropylene (PP + CF -Carbon Fiber-) Fluoroelastomer (FKM) Glass (GLA) Graphite (C) High Density Polyethylene (HDPE) Liquid Cristal Polymer (LCP) Nitril Butil Rubber (NBR) Polyester Thermoplastic Elastomer (PTE -Santoprene.2.9-22 PHOENIX OPERATOR MANUAL 9.2. • A 5% Acetic Acid Solution.3 Materials in contact with dialysate. B . • A Vinegar Solution containing at least a 5% concentration of Acetic Acid. Rev. Actril® and Renalin®.g.: • Bleach® • Instrunet HD™ (*) • Amuchina™ Peracetics Active ingredient: Peracetic Acid from 0. Acetoper™.5 Disinfection WARNING Contact with cleaning and/or disinfection chemicals may pose a risk of burns. Rev.000 ppm.06% to 4% Some commercial products are e.g. skin irritation or other adverse reactions. Peresal™.: • Actril® (*) • Dialox™ (*) • Renalin™ (*) • Acetoper™ (*) • Peresal™ (*) Aldehydes Active ingredient: Formaldehyde Solution at 37-40% or association of different aldehydes. 48 hrs for: formaldehyde solution and Steridial™.2. chlorine dioxide or active chlorine. Some commercial products are e. Some commercial products are e.: • Steridial™ WARNING To prevent damaging the machine. do not leave disinfectant solution in the machine for periods over the following limits: 4 hrs for: Amuchina™. Always follow the chemical manufacturer's instructions when handling these products or cleaning spills. 24 hrs for: Dialox™. which can be classified by their active ingredient. One week for: Sodium Hypochlorite at Bacteriostatic strength (1:750 dilution).SPECIFICATIONS 9-23 9.g.000 to 60. SECTION 9 . Oxidating Chlorine Active ingredient: Sodium Hypochlorite with active chlorine from 50. Instrunet HD™ and Sodium Hypochlorite at Disinfectant strength (1:25 dilution). B . Disinfectants that may be used for chemical disinfection The machine can withstand different chemical solutions. substituting Acetic Acid solution at 30% v/v (add 120 ml of pure Acetic Acid to 280 ml of water to obtain 400 ml of solution) for the chemical disinfectant.9-24 PHOENIX OPERATOR MANUAL Note Chemicals marked with the symbol (∗) carry out a combined action of disinfection and descaling. it is important that only citric acid is used and no other disinfectants. Note If Bicarbonate Dialysis is carried out. the temperature of the inlet water of the machine must be less than 95°C. Centralized Heat Disinfection System The Centralized Heat Disinfection System may be used. Rev. an Acetic Acid cleaning must be performed at least twice a week (in the case of two normal dialysis sessions per day) to remove the calcium and magnesium carbonate residuals which may have precipitated in the hydraulic circuit. Contact your Local Representative to determine if other chemical agents may be used for disinfection. To do this. follow the instructions for the disinfection process and automatic rinsing (see Section 6 – Clean/Disinfect in this manual). Chemical agents that can be used for Heat Citric Disinfection The machine can withstand the following chemical solutions: • Citric Acid at a concentration of 50% Citric Acid WARNING In the Heat Citric Disinfection phase. B . WARNING When the Centralized Heat Disinfection System is used. The UF Flow Rate accuracy is ±2%. When this alarm is activated the Ultrafiltration Pump is stopped.6 Ultrafiltration system Total Target Weight Loss The maximum Total Programmable Target Weight Loss is 30 kg to be obtained in a linear Treatment Time of up to 8 hours. the minimum value that can be set for the WEIGHT LOSS/H parameter is 0.2 kg/h. UF Flow Rate The minimum UF Rate can be configured (see Section 2 . 0.0 Kg/h.5 Kg/h WLEFBS=±50 g/h WLEUFR=±10 g/h WLE=±60 g/h Rev.100.0 kg/h. SECTION 9 .2. Note If the WLR MIN ALARM parameter is set to 0.SPECIFICATIONS 9-25 9. or 0.200. 0. Protection System Type: monitoring of ultrafiltration volume. WARNING If the difference between the actual flow of the Ultrafiltration Pump and the set UFR is greater than ±20% with a UF Rate greater than 0. an audible and visual alarm is triggered.100 Kg/h. to 0. Flow Balance System Dialysis fluid flowing into the dialyser and dialysis fluid flowing out from the dialyser are balanced in order to guarantee that the only fluid removed from the patient is equal to what is pumped by the UF Pump.0. B .300 kg/h.Configuration Description in this manual). The Flow Balance System (per hour) accuracy is: • ±35 g/h at a dialysate flow=350 ml/min • ±50 g/h at a dialysate flow=500 ml/min • ±80 g/h at a dialysate flow=800 ml/min Maximum Weight Loss Error (g/h) The maximum Weight Loss Error (per hour) can be calculated with the following formula: WLE = WLEUFR + WLEFBS where: WLE = maximum Weight Loss Error WLEUFR = UFR error related to the UF Flow Rate accuracy WLEFBS = Flow Balance System error related to the Flow Balance System accuracy Example: at dialysate flow=500 ml/min and UFR= 0. The maximum UF Rate is 4. Maximum Threshold: value set for the VEN PRESS LIMIT parameter Delay time: about 1 s. High Sensitivity: • Normalized Blood Loss: 0. Operating range of the sensitivity controlled by setting the BLD SENS. A Safety Test of the Blood Leak Detector System is automatically performed each time the machine enters the Dialysate Preparation phase. Low Sensitivity: • Normalized Blood Loss: 0. B . Out of Range Alarms • Note: in Single Needle mode only the Out of Range Alarms are active Minimum Threshold: +10 mmHg Delay time: about 1 s. Automatic electronic compensation is performed before starting the DIALYSIS mode. in Double Needle Alarms mode.30 ml/min of fresh whole human or bovine blood with a hematocrit of 32%. • Normalized Blood Loss: 0. Operating range: +10 to the value set for the VEN PRESS LIMIT parameter.2. Tolerance: ±10 mmHg. Delay time: about 2 s.7 Detection of Extracorporeal Blood Loss Blood Loss Detection in the event of membrane rupture (Blood Leak Detector) Elapsed Time before an alarm: less than 1 min. the Blood Leak alarm may be delayed. WARNING In the "UF only" process or with the hydraulic circuit in BYPASS.9-26 PHOENIX OPERATOR MANUAL 9. Detection Method: Optical Infrared System.38 ml/min of fresh whole human or bovine blood with a hematocrit of 32%. • Normalized Blood Loss: 0. due to the operating conditions and dialyser characteristics. Blood Loss to the Environment (Venous Pressure Monitoring) Venous Pressure Accuracy: ± 20 mmHg or ±10% of set value. Parameter.45 ml/min of fresh whole human or bovine blood with a hematocrit of 25%. whichever is Sensor greater Venous Pressure -40. Conditions: Dialysate Flow of about 800 ml/min (max specified dialysate flow). A Safety Test of the Venous Pressure Monitoring System is automatically performed each time the machine enters the Dialysate Preparation phase Rev. +70 mmHg with respect to set value.35 ml/min of fresh whole human or bovine blood with a hematocrit of 25%. When a venous needle disconnects from its access. Its lower value is set to +10 mmHg. • adjust properly the venous pressure alarm window: the venous pressure alarm lower limit should be set as closely as practical to the actual patient’s venous pressure value without generating excessive nuisance alarms.SPECIFICATIONS 9-27 WARNING Modification of the Blood Flow Rate causes a fluctuation in the Venous Pressure and therefore an alarm may be triggered. SECTION 9 . Its lower value is set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg. to prevent such an effect. B . To reduce the risk of needles disconnection: • ensure that venous needle and line are firmly secured to the access site area according to your clinic's protocol. WARNING Modification of Blood Flow Rate causes a fluctuation in the Arterial Pressure and therefore an alarm may be triggered.Configuration Description in this manual). WARNING Monitoring of the Venous Pressure could not always detect the disconnection of a venous needle from its access site. Rev. to prevent such an effect. the Alarm Window is automatically set wider for 30 seconds. • inspect frequently the patient's access. which may result in extracorporeal blood loss to the environment. WARNING A dedicated warning (W! Low Art Flow For Too Long #204) exists in order to avoid blood loss due to coagulation resulting from interruption of blood flow. the Alarm Window is automatically set wider for 30 seconds. WARNING In WASHBACK (see Section 5 . Following a change in the Blood Flow Rate. Following a change in the Blood Flow Rate. while the upper value is set to +150 mmHg. pressure at the venous monitoring side may only decrease by the pressure maintained within the patient’s access site. This pressure drop may be less than the width of the machine’s venous pressure alarm window: in this particular case the disconnection of a venous needle from its access site is not detectable by the machine. • ensure that the patient's access is visible at all times during the dialysis treatment.Dialysis Operation in this manual) the limits of the Venous Pressure alarm window are automatically set to -50 and +250 mmHg and the limits of the Arterial Pressure window are set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg and +150 mmHg. even if pressure alarms and alarm windows are properly set. while the upper limit is set to the VEN PRES LIMIT parameter value decreased of 50 mmHg (see Section 2 . WARNING The manufacturer recommends the use of a dialyser with dialysate and blood connections that comply with ISO 8637. see Configuration).2. Rev. 36 min or 20. The Manufacturer does not assume responsibility or liability for use of blood line other than the Gambro/Hospal Cartridge Blood Set. Dialysis • Acetate • Bicarbonate with Liquid Concentrates or BiCart Disinfection Heat Hot water: >85°C (185°F) Process Time: may be set to 18.8 Operating Modes WARNING The use of the Gambro/Hospal Cartridge Blood Set designed for Phoenix machine has been tested and validated to provide safe and proper functioning of the system. It is the responsibility of the user to validate that other blood lines provide safe and effective performance. Therefore the total duration of the Heat Disinfection Process is about 10 minutes more than the Disinfection Time selected. B . Note Further information on suitable blood lines can be obtained by contacting your local representative. the Hydraulic Circuit is cooled with fresh water. After the Contact Time. The Manufacturer has not validated the use of blood lines other than those specified in this manual. 40 min if the Clean Dialysate system is installed (with the DISINF TIME parameter in Config.9-28 PHOENIX OPERATOR MANUAL 9. Note Do not use plate-type dialyser. if an Automatic Rinsing is not required. For additional information contact your local representative. B . the Hydraulic Circuit is rinsed and cooled with fresh water. for the END PROCESS MODE parameter in Config. descaling and disinfection of the machine. performed after the Chemical Disinfection. for the END PROCESS MODE parameter in the Config view. The value may be Set to None or Bact. see Section 2 – Configuration Description). may be set by selecting Rins. (with the DISINF TIME parameter in Config. Automatic verification of the volume of Citric Acid pumped by the device. Automatic verification of the volume of disinfectant pumped by the device. Note It is recommended to alternate the disinfection methods and/or the disinfectants. An Automatic Rinsing Process. The effectiveness of rinsing to obtain the maximum permitted levels of disinfectant residuals (measured at a point in the hydraulic circuit just prior to the dialyser connection) was tested by Gambro Dasco Quality Control and it conforms to international standards. Chemical Disinfection Time: may be set from 15 to 30 min or from 28 to 43 min if END PROCESS MODE is set to Bact. SECTION 9 . Rev. Automatic filling with Disinfectant (about 180 ml).SPECIFICATIONS 9-29 Heat Citric Hot water: >80°C (176°F) Process Time: 24 min or 28 min if the Clean Dialysate system is installed Automatic filling with citric acid (about 180 ml). A Bacteriostatic Disinfection Process may be set: select Bact. in order to optimize cleaning. After the Contact Time. The total duration of the Heat Citric Disinfection Process is about 30 minutes. see Section 2 – Configuration Description in this manual). The effectiveness of Rinsing (measured at a point in the hydraulic circuit just prior to the dialyser connection) conforms to international standards for residual concentrations of disinfectant: • Formaldehyde less than 1. from the manufacturer’s quality control department. Rev.9-30 PHOENIX OPERATOR MANUAL Rinsing This phase is mandatory after Chemical Disinfection. upon request. Note The test procedures for the measurement of disinfection and rinsing efficiency are available.5 ppm Time may be set at a value between 15 and 50 minutes or between 19 and 50 minutes if the Clean Dialysate system is installed (RINSING TIME parameter .0 ppm • Sodium Hypochlorite less than 0. B . WARNING Verify the absence of disinfectant residuals before connecting the dialyser. The following is the current list of Gambro/Hospal Cartridge® Blood Set models that have been validated for use with the Phoenix® Hemodialysis Delivery System.SPECIFICATIONS 9-31 9. Rev.1 Operating Modes Blood Circulation in Dialysis Mode • Double Needle • Single Needle (optional) Blood Lines The blood lines are positioned in a way designed to ensure a simple and effective system. B .3.Dialysis Operation.3 Extracorporeal Circulation 9. Refer to Chapter 5. Cartridge Blood Set The Gambro/Hospal Cartridge® Blood Sets are the only extracorporeal blood circuit for hemodialysers that may be used with the Phoenix® Hemodialysis Delivery System.0 . SECTION 9 . in this manual for the mounting procedure for the Cartridge Blood set. C . Before installing a Gambro/Hospal Cartridge Blood Set.Low Weight 003429-500 Single Needle Conversion Kit WARNING It is the responsibility of the physician to ensure that the appropriate Gambro/Hospal Cartridge Blood Set is selected for the weight of the patient being treated. carefully read the Cartridge Blood Set Instructions for Use.9-32 PHOENIX OPERATOR MANUAL Code Application 6032536 Single Needle Conversion Kit 6184071 Double Needle Double Needle 6186803 (with prime line attached) 6186886 Double Needle 6187439 Single Needle 6187660 Double Needle Single Needle 6187686 (with prime line attached) 6187694 Double Needle 6188320 Double Needle Double Needle 6280598 (with prime line attached) 003409-410 Single Needle (with prime line attached) 003410-500 Double Needle 003410-510 Double Needle (with prime line attached) 003410-710 Double Needle (with prime line attached and injection port on prime line) 003412-500 Double Needle . Rev. Note Contact your Local Service Representative for the Gambro/Hospal Cartridge Blood Sets technical data in order to choose the most appropriate Gambro/Hospal Cartridge Blood Set for your usage. SPECIFICATIONS 9-33 WARNING The use of the Gambro/Hospal Cartridge Blood Set designed for Phoenix machine has been tested and validated to provide safe and proper functioning of the system. for example. Max Blood Flow (at 70 rpm): 580 ml/min (with Gambro/Hospal Cartridge Blood Set models that have been validated for use) Rev. • A Protective System to prevent overloads. SECTION 9 . • A light on the Blood Pump Control Panel is illuminated when the Pump is turning (or when it is about to turn. C . Technical characteristics of the Blood Pump Speed of Pump Head: 0 to 70 rpm approx. after an automatic stop caused by an alarm).3. • Blood Pump stop and automatic closure of the Venous Line Clamp if air or foam is detected while blood is sensed. 9. It is peristaltic and it is comprised of: • An Electronic Speed Control System to keep the speed constant. independent of load variations. The Manufacturer has not validated the use of blood lines other than those specified in this manual. • A Safety Control when the Blood Pump Door is open. It is the responsibility of the user to validate that other blood lines provide safe and effective performance. • A Pump Direction Monitor.2 Blood Pumps Blood Pump The Blood Module has one pump specifically designed for dialysis. • A handle for manual turning of the blood pump. The Manufacturer does not assume responsibility or liability for use of blood line other than the Gambro/Hospal Cartridge Blood Set. is higher (less negative) than –150 mmHg. The blood flow actual value is estimated by means of a mathematical algorithm taking into account the pump segment characteristics of HOSPAL/GAMBRO Cartridge Blood Set. The actual value is usually lower than the set value due to the negative pressure in the access line at the inlet to the pump. The accuracy of the blood flow actual value is typically within ±16% in the following conditions: • the pressure before the pump. is higher (less negative) than –150 mmHg. the current pump speed and the pressure values in the extra- corporeal circuit. Rev. The actual value is usually lower than the set value due to the negative pressure in the access line at the inlet to the pump. Blood Flow Accuracy (Single Needle Mode) The machine display shows: • The blood flow set value (displayed as “BLOOD FLOW”). • The blood flow actual value (displayed as “BLOOD FLOW”). The negative pressure is caused by the rotation of the pump itself and pressure drop linked to the motion of blood in the line. The accuracy on the estimate. given by the pressure in the arterial chamber of the cartridge. The actual value coincides with the set value when the pump inlet pressure (arterial pressure) is zero. using HOSPAL/GAMBRO Cartridge Blood Set. Note Due to a natural decrease of the pump segment performance during the dialysis treatment. The negative pressure is caused by the rotation of the pump itself and pressure drop linked to the motion of blood in the line. is lower (more negative) than -150 mmHg. given by the pressure in the arterial chamber of the cartridge. • The blood flow actual value (displayed as “BLOOD FLOW”). The blood flow actual value is the actual blood flow rate in the extra-corporeal circuit. the ±10% accuracy on the blood flow actual value estimation may not be guaranteed. in the Section 01 for a detailed description of how to calculate the blood flow actual value in Single Needle Mode). The blood flow actual value is the actual blood flow rate in the extra-corporeal circuit. The blood flow set value represents the theoretical blood flow rate in the extra- corporeal circuit calculated from the speed of the blood pump rotor and the geometric characteristics of the pump segment. The blood flow set value represents the theoretical blood flow rate in the extra- corporeal circuit calculated from the speed of the blood pump rotor and the geometric characteristics of the pump segment. is typically within ±10% in the following conditions: • the pressure before the pump. given by the pressure in the arterial chamber of the cartridge. B . if the pressure before the pump. The blood flow actual value is calculated by using the blood pump activation time and the blood pump speed value (refer to the “Parameter modification” paragraph.9-34 PHOENIX OPERATOR MANUAL Blood Flow Accuracy (Double Needle Mode) The machine display shows: • The blood flow set value (displayed as “BLOOD FLOW”). 5 to 9. The bolus is injected when the MAN BOLUS Action key is pressed. SECTION 9 . Alarms • If the set value is > 300 ml/min ± 10% • If the set value is <= 300 ml/min ± 30 ml/min in Double Needle ± 105 ml/min in Single Needle Note Data relating to haemolysis is available upon request. The blood recirculation rate is not due to the single needle Cartridge Blood Set characteristics. 9. Manual Bolus: bolus quantity programmed.9 ml/h in steps of 0. Heparin Pump Specifications • Maximum Capacity 30 ml • Maximum Delivery Rate in Linear Mode 10 ml/h • Possible Delivery Rate in Linear Mode 0/0.5 to 10 ml/h Automatic Bolus: bolus quantity and internal time are programmed. if the pressure before the pump.3. Rev.3 Heparin Pump The PHOENIX machine can be supplied with a syringe type infusion pump which delivers heparin with either a standard 10 to 20 ml or a 20 to 30 ml syringe.2 ml/h • Maximum pressure +900 mmHg The delivery of heparin (see Heparinization Section) may be: Linear: 0/0. (Istantaneous flow) In Single Needle mode the stroke volume for each cycle is approximately 60 ml. given by the pressure in the arterial chamber of the cartridge. the ±16% on the blood flow actual value calculation may not be guaranteed. Note In Single Needle mode. is lower (more negative) than -150 mmHg.SPECIFICATIONS 9-35 Note Due to a natural decrease of the pump segment performance during the dialysis treatment.1 ml/h • Accuracy ±5 % or ±0. B . Blood Flow set Double Needle 10 to 580 ml/min Single Needle (option) 10 to 580 ml/min. the blood recirculation rate at the level of the vascular access is influenced by the needle type or catheter used. 941 in) DISPOMED 30 22.6 mm (0.618 in) BD 10 10 14.9 mm (0. then setting the DIAMETER parameter.831 in) MONJECT 12 12 15.6 mm (0. 0.7 mm (0. The user should periodically check the correlation between the stated and the actual diameters.787 in) PIC 20 LL 20 19.1 mm (0.1 mm (0. first ANOTHER for the Syringe Type parameter.622 in) WARNING These diameters have been taken from samples from many countries and are correct at the time of printing.4 mm (0.1 mm (0.770 in) PENTA 20 20 20.567 in) TERUMO 10 10 15.752 in) ICO MONOSTERIL 20 19.6 mm (0. This will happen regardless of the type of heparin programming selected.9-36 PHOENIX OPERATOR MANUAL Note If the HEPARIN PR Action key is selected before blood is detected. B . Note It is possible to define a syringe that is not present on the list.7 mm (0.752 in) BD 20 PLASTIPAK 20 19.929 in) ICO GAMMA PLUS 30 23. Rev.0 mm (0.752 in) TERUMO 20 20 20.787 in) MONOJECT 20 20 20.4 ml of heparin is injected into the Cartridge to prime the heparin line. the manufacturer cannot be held responsible for changes in syringe dimensions that may occur. in Config.1 mm (0.3 mm (0.1 mm (0.878 in) PENTA 30 30 21. Syringes that may be used for Heparin Infusion Syringe name Volume (ml) Internal diameter TERUMO 30 23. However. Note The syringe infusion pump described above must be used only for the infusion of heparin.941 in) BD 30 PLASTIPAK 30 21.8 mm (0. by setting.9 mm (0.0 mm (0.850 in) PIC 30 LL 30 23.854 in) ICO GAMMA PLUS 20 19.909 in) 3S (BERTONI) 30 23. 3. 3. through programming of the rate and timing of heparinization. Patient Sensor before the Venous Line Clamp Before blood detection by the Patient Sensor or before the selection of the DIALYSIS Action key. Heparin Bolus Injection Characteristics. Rev. 2. Single Needle .SPECIFICATIONS 9-37 9. Linear or Bolus heparinization. SECTION 9 .4 Automatic Functions 1.One Pump (optional): arterial/venous cycles occur through automatic blood pump transition when preprogrammed venous pressure thresholds are reached. the class P alarms are bypassed (see Section 8 . B .Alarms and Signals in this manual) to allow easier filling of the extracorporeal and dialysate circuits. 4. 5 Main Surveillance Devices 1) Monitoring of Arterial Pressure.3. Monitoring the pre-pump arterial pressure is required to protect the patient from high negative arterial pressures between the patient and the blood pump. B . See Subsection “Blood Loss to the Environment”. according to set venous pressure values: • Normal operating conditions: from 100 to 400 mmHg • Safety Alarm: over +450 mmHg WARNING The user must take precautions against the hazard of cross-contamination between patients by using only extracorporeal circuits with hydrophobic filters on the pressure ports and by disinfecting the accessible surfaces of the equipment. 2) Monitoring of Venous Pressure. Rev. the signal received by the detector is modified in proportion to the volume of air present. An ultrasonic wave band crosses the fluid in the blood line. When air is present in the line. an arterial pressure alarm is triggered. 4) Monitoring of the Commutation Pressure in Single Needle mode (optional) The Venous Pressure Sensor is used to measure the blood pressure in the Venous Chamber for blood pump activation and deactivation in Single Needle mode. Accuracy: ±20 mmHg or ± 10%. The alarm threshold can be fixed between the value set for the MIN ART PRESSURE parameter and +150 mmHg on the Touch Screen. Accuracy: Able to detect a single bubble with a volume approximately of 20 μl. whichever is greater. • A Transducer which carries out the auto-test approximately every 250 ms. If the pressure falls below a set value. which causes the Venous Line Clamp to close and the Blood Pump to stop. The blood module has an Air Bubble Detector consisting of: • An Ultrasonic Device located in the Air Detector Housing. the microprocessor triggers a signal. When the signal goes above a fixed threshold. The arterial pressure sensor is used to measure pre-pump arterial pressure. with the blood flow at the maximum allowed value.9-38 PHOENIX OPERATOR MANUAL 9. 3) Ultrasonic Air Bubble Detector. • A Visual and an Audible alarm which is activated if air is detected. Rev.SPECIFICATIONS 9-39 9.Optional with Single Needle Feature 2) Venous Line Clamp The Venous Line Clamp. • Closure in Single Needle to reduce recirculation. SECTION 9 .6 Safety system actuators 1) Arterial Clamp .3. located below the air bubble detector. and to assure that the Blood Pump is stopped. in this manual). The Venous Line Clamp is fitted with a position sensor to ensure proper functioning of the clamp. B . performs the following tasks: • Automatic closure when required by an alarm as part of a specific safety state (see Section 8 .Alarms and Signals. by placing the machine in a Safe State. Rev. • Activity of Diascan system • Control System Communication checking • Correct Sequence of T1 Tests • Power Failure • Long Bypass • Autoemptying If. on encountering a fault. as required by international regulations. an independent safety chain is implemented. the protection system places the machine in a General Safe State: 1 The Venous Line Clamp is activated. For each of these conditions. 2 The Power Supply to all other actuators. The conditions controlled are: • Final Dialysate Conductivity • Blood Pump • Bicarbonate Dialysate conductivity • Presence of blood in the Hydraulic Circuit • Concentrate Container Error • Dialysate Flow • Error in the Single Needle mode (optional) • Maximum Dialyser Pressure at the Dialyser Inlet and Outlet • Minimum Dialyser Pressure at the Dialyser Inlet and Outlet • Heater Protection • Voltage Drop of greater than 20 seconds and less than 4 minutes • Voltage Drop of less than 20 seconds • Presence of Air in the Venous Line • Profiling of Final Conductivity Activity • Profiling of Ultrafiltration Rate Activity • Temperature of the Dialysate • Ultrafiltration Flow • Ultrafiltrate Mass Balance • Venous Pressure higher than the maximum permitted • Venous Pressure outside the interval selected or less than the minimum permitted • Arterial Pressure lower than the minimum permitted • Arterial Pressure outside the interval selected or more than the maximum permitted • Incorrect Voltage • Activity in Profiling Mode. B . the relevant safety state is not correctly configured.4 Protection System The Protection System has the function of controlling fault conditions which may be dangerous for the patient. is turned OFF. except those for visual and audible alarms.9-40 PHOENIX OPERATOR MANUAL 9. install or use the machine before having read the manual carefully. SECTION 9 . Moving Parts WARNING Turn the Blood pump OFF before touching the Blood Pump Rotor. Do not touch the blocking system. WARNING Do not assemble. The machine could be damaged if handled in an improper way. Electrical Protection WARNING Do not remove the panels. checking or maintenance operation. paying special attention to the notes and observations. Disposal of Energy Cells The PHOENIX machine contains energy cells (batteries).SPECIFICATIONS 9-41 9. follow local regulations for proper disposal. If necessary.5 General Safety Controls Use The PHOENIX Haemodialysis System must be used under the supervision of a physician. B . Earth Check that the PHOENIX machine is properly grounded. Use and Maintenance Read this manual carefully. When replacing these components. ask qualified staff to open the panels. Disconnect the machine from the main power supply before every cleaning. Rev. Risks of Explosion WARNING Do not use this machine near flammable gas or flammable anaesthetic mixtures with air. with oxygen or with nitrous oxide. Handling and Transport WARNING Carefully move the machine by using the handle on the rear panel. Pay attention to the fact that some components of the machine (display. it may be returned directly to the local representative/distributor who has supplied it. When discarding electromedical equipment used at or through healthcare facilities. recycling and recovery of potentially still useable materials and components and to reduction of the potential risks to the environment and human health. When discarding electromedical equipment used in private households.) may contain toxic substances which. Rev.9-42 PHOENIX OPERATOR MANUAL Disposal of discarded equipment Discarded electromedical equipment may not be disposed of together with municipal waste but must be collected separately in order to guarantee ecologically correct disposal to prevent dispersion of potential pollutants into the environment.returned free of charge to the distributor at the time of purchasing new equipment . if released into the environment. B . it may be: . batteries. Users who return electromedical equipment to the subjects identified above actively contribute to reuse. etc. pose a risk to the health of living organisms and the environment itself.sent to the specialized collection centres free of charge. circuit boards. Abusive disposal of discarded equipment may be punishable by law. including Preventive Maintenance Checklists. For a complete description of all the components to be replaced and the calibrations and checks to be performed refer to the Preventive Maintenance Checklist provided with each Preventive Maintenance kit and to the calibration/test procedures described in the Phoenix Service Manual. Operation Frequency Change the O-rings Every 4000 hours Change the BIC/ACE/Sterilant/Dialysate connectors Every 4000 hours Change the Safety valve Every 4000 hours Replace the UF.SPECIFICATIONS 9-43 9. The Manufacturer makes available Preventive Maintenance Kits. B . SECTION 9 . air. as well as frequency and duration of use determine the maintenance frequency. Every 4000 hours Change the Pressure Ports gaskets Every 4000 hours EVC and EVD valve body Every 4000 hours Replace the WHO Connector Cap Every 4000 hours HLS and LLS level sensors Every 4000 hours pH sensor Every 4000 hours During these operations the technician should verify the following: • Leakage in the hydraulic circuit • Leakage in the blood circuit • Correct grounding and hearth leakage current • Power Supply voltages • Correct closing of the clamps • Blood Pump Rotor occlusion • ABD alarm simulation • Power failure simulation • Arterial and Venous Pressure pods • WHO door Rev. The ambient conditions. hydraulic Filters Every 4000 hours Replace the O-rings in the BiCart holder arms Every 4000 hours Change the Peristaltic Pump Inserts and recalibrate the machine.6 Technician Maintenance WARNING The manufacturer does not accept any responsibility for damage caused by any operation carried out on the machine by unauthorized staff. To keep the machine in good and safe working order. Below is a list of the main operations and verifications required during the Technical Preventive Maintenance program. to complete the Technical Preventive Maintenance. updated at the date of printing of this manual. however when a maximum of 4. preventive maintenance must be performed by authorized service technicians.000 hours of use has elapsed (or at least once a year) technical preventive maintenance is required. 2 ohm maximum Between earth ground in IEC 601. the water line should be disinfected and rinsed. a DESCALING Procedure must performed. B . If machine is stored for more than 7 days.9-44 PHOENIX OPERATOR MANUAL Periodic Safety Inspection A safety inspection of the PHOENIX machine is required at least once a year. WARNING Before replacing or checking any component in the Hydraulic Circuit. WARNING Stagnant water may contaminate the machine. Only trained and qualified technicians are approved to perform the safety inspection procedures. The inspection consists of the following tests: Parameter Performance Conditions Earth leakage current Low voltage model < 300 uA (typically < 130 uA) Normal condition High voltage model < 300 uA (typically < 220 uA) Normal condition Ground Integrity Test per 0. Rev.1. or as stipulated by local requirements. para 18f mains plug and any accessible conductive part. p.The equipment is used in accordance with the published instructions for use. contact the Service Representative in your country and request additional information or assistance. DOES NOT ASSUME RESPONSIBILITY OR LIABILITY FOR ANY DAMAGES RESULTING FROM THE OPERATION OR PERFORMANCE OF ANY DEVICE. While the unit is within the stated warranty period. OR THE EFFECT OF SUCH WORK ON MACHINE OPERATION AND PERFORMANCE. Rev.The electrical installation of the relevant room complies with all applicable local electrical codes and IEC requirements. -.All equipment modifications are authorized in writing by GAMBRO DASCO S. ITS LIABILITY HEREBY BEING LIMITED SOLELY TO REPAIR OR REPLACEMENT. INCLUDING ANY IMPLIED WARRANTY OF SALEABILITY OR SUITABILITY OF USE AND OF ANY OTHER OBLIGATION ON THE PART OF THE MANUFACTURER. GAMBRO DASCO S. are warranted against defects in workmanship and materials. OR ANY INJURY CAUSED BY SUCH DEVICE AFTER REPAIRS HAVE BEEN ATTEMPTED BY ANYONE OTHER THAN QUALIFIED PERSONS BELONGING TO THE SERVICE REPRESENTATIVE IN YOUR COUNTRY. or if there are any additions or deletions that you feel will improve the manual. -. DOES NOT RECOGNISE THE OWNER OF A PRODUCT AS AN AUTHORISED SERVICE REPRESENTATIVE. Any unauthorized work will immediately void the warranty.P. THE WARRANTY ON THIS MACHINE WILL BE VOIDED BY ANY SUCH ATTEMPTED REPAIR AND NO PARTS OR LABOR COSTS INCURRED BY THE OWNER WILL BE REIMBURSED BY THE MANUFACTURER.A. and repairs are carried out by appropriately qualified persons. IMPORTANT NOTE SINCE GAMBRO DASCO S. THIS WARRANTY IS IN LIEU OF ANY OTHER EXPRESSED OR IMPLIED WARRANTIES.P. and/or its affiliates accept responsibility for the safety. GAMBRO DASCO S.. no service repairs on this machine should be attempted.p. calibrations.P. reliability.p.Operational procedures.A.A. If any information in this manual is found to be in error. WARRANTY I WARRANTY WARRANTY All products manufactured by Gambro Dasco S. and -. THE MANUFACTURER. HAS NO CONTROL OVER THE MANNER IN WHICH SERVICE OR MAINTENANCE WORK IS CONDUCTED BY PERSONS OTHER THAN TRAINED PERSONNEL BELONGING TO THE SERVICE REPRESENTATIVE IN YOUR COUNTRY. B .A.A. please forward your comments to the Service Representative in your country.A. If additional information or assistance is required or the information provided is not sufficient. and carried out by appropriately qualified persons. and performance of this equipment only if: -. GAMBRO DASCO S. UNDER NO CIRCUMSTANCES WILL THE MANUFACTURER BE LIABLE FOR INDIRECT OR CONSEQUENTIAL DAMAGES OF ANY KIND. The Manufacturer does not assume responsibility or liability for use of not genuine spare parts and for use/mounting of those components not in accordance with the official Instruction for Use accompanying those components. improvements will be made available at reasonable prices. Where possible. WARNING This manual contains a number of references to accessories and disposables for use with the Phoenix machine. in this manual). The Manufacturer has not validated the use of accessories or disposables other than those specified in this manual.p. Do not attempt to assemble. or operate the machine until all the contents of this manual are thoroughly understood. Gambro Dasco S. It is the responsibility of the user to validate that other accessories or disposables provide safe and effective performance.A is committed to continuously improving this product.A. Whoever receives this manual accepts that drawings and information contained herein must not be disclosed to others without the express written permission of Gambro Dasco S. NOTE This manual contains a number of references to spare parts for use with PHOENIX. Depending on the circumstances. The PHOENIX has been tested and validated for use with spare parts listed in this manual. The improvement process may result in modifications to both the product specifications and consequently to the equipment produced in the future. Any such improvement shall not be construed as corrections of any perceived deficiency.p.II PHOENIX OPERATOR MANUAL NOTE The PHOENIX Haemodialysis machine was designed and has been built to comply with the product specifications listed in this manual (See Section 09 – Specifications. use of not genuine spare parts and use/mounting of those components not in accordance with the above mentioned Instruction for Use may reduce the Manufacturer’s warranties for the Phoenix Hemodialysis System.A. The Manufacturer does not assume responsibility or liability for use of accessories or disposable other than those specified in this manual. install. Rev. B . NOTE This publication contains information which is the property of Gambro Dasco S.p. The Phoenix machine has been tested and validated for use with the accessories and disposables listed in this manual. These changes or improvements may or may not be applicable or usable with previously produced equipment. B . its RF Group 1 emissions are very low and CISPR 11 are not likely to cause any interference in nearby electronic equipment. Electromagnetic Emission test Compliance environment . RF emission The PHOENIX is suitable for Class B use in all establishments. CISPR 11 including domestic Harmonic emissions establishments and those Not applicable IEC 61000-3-2 directly connected to the public low-voltage power Voltage fluctuations / flicker supply network that supplies emissions Not applicable buildings used for domestic IEC 61000-3-3 purposes. Rev. Therefore. The customer or the user of the PHOENIX should assure that it is used in such an environment.guidance The PHOENIX uses RF energy only for its internal RF emission function. For PHOENIX equipment with a rated mains voltage less than to 220V.A APPENDIX A: Guidelines and Manufacturer’s Declaration – Electromagnetic Emissions and Immunity Appendix A: Guidelines and Manufacturer’s Declaration – Electromagnetic Emissions and Immunity Guidance and manufacturer’s declaration – electromagnetic emissions The PHOENIX is intended for use in the electromagnetic environment specified below. Therefore. CISPR 11 including domestic Harmonic emissions establishments and those Class A IEC 61000-3-2 directly connected to the public low-voltage power Voltage fluctuations / flicker supply network that supplies emissions Complies buildings used for domestic IEC 61000-3-3 purposes.guidance The PHOENIX uses RF energy only for its internal RF emission function. The customer or the user of the PHOENIX should assure that it is used in such an environment. For PHOENIX equipment with a rated mains voltage greater than or equal to 220V. RF emission The PHOENIX is suitable for Class B use in all establishments. Rev. Electromagnetic Emission test Compliance environment . its RF Group 1 emissions are very low and CISPR 11 are not likely to cause any interference in nearby electronic equipment. B .A-2 PHOENIX OPERATOR MANUAL Guidance and manufacturer’s declaration – electromagnetic emissions The PHOENIX is intended for use in the electromagnetic environment specified below. (>95 % dip in UT) (>95 % dip in UT) for 5 s for 5 s Power frequency Power frequency magnetic fields should be at levels (50/60 Hz) magnetic 3 A/m 3 A/m characteristic of a typical field location in a typical IEC 61000-4-8 commercial or hospital environment. ±2 KV for power supply ± 2 KV for power supply Mains power quality Electrical fast lines lines should be that of a transient / burst ±1 KV for input / output ± 1 KV for input / output typical commercial or IEC 61000-4-4 hospital environment. NOTE UT is the a.5 cycles Mains power quality should be that of a typical commercial or 40 % UT 40 % UT hospital environment. ±6 KV contact ± 6 KV contact If floors are covered discharge (ESD) ±8 KV air ± 8 KV air with synthetic material. IEC 61000-4-2 the relative humidity should be at least 30%. lines lines Mains power quality Surge ±1 KV line(s) to line(s) ± 1 KV differential mode should be that of a IEC 61000-4-5 ±2 KV lines(s) to earth ± 2 KV common mode typical commercial or hospital environment. If Voltage dips. APPENDIX A: GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS AND IMMUNITY A-3 Guidance and manufacturer’s declaration – electromagnetic emissions The PHOENIX is intended for use in the electromagnetic environment specified below. Electrostatic concrete or ceramic tile. Rev. short (60 % dip in UT) (60 % dip in UT) the user of the interruptions and for 5 cycles for 5 cycles PHOENIX requires voltage variations on continued operation power supply input during power mains lines 70 % UT 70 % UT interruptions. B . Electrostatic concrete or ceramic tile. it is IEC 61000-4-11 (30 % dip in UT) (30 % dip in UT) recommended that the PHOENIX be powered for 25 cycles for 25 cycles from an uninterruptible power supply or a <5 % UT <5 % UT battery. ±6 KV contact ± 6 KV contact If floors are covered discharge (ESD) ±8 KV air ± 8 KV air with synthetic material. mains voltage prior to application of the test level.c. The customer or the user of the PHOENIX should assure that it is used in such an environment. IEC 61000-4-2 the relative humidity should be at least 30%. <5 % UT <5 % UT (>95 % dip in UT) (>95 % dip in UT) for 0.5 cycle for 0. Floors should be wood. Floors should be wood. Electromagnetic propagation is affected by absorption and reflection from structures. Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz. a Field strengths from fixed transmitters.5 GHz transmitter manufacturer and d is the recommended separation distance in metres (m). If abnormal performance is observed.A-4 PHOENIX OPERATOR MANUAL Guidance and manufacturer’s declaration – electromagnetic immunity The PHOENIX is intended for use in the electromagnetic environment specified below. To asses the electromagnetic environment due to fixed transmitters. should be less than the compliance level in each frequency range b. such as reorienting or relocating the PHOENIX. additional measures may be necessary. The customer or the user of the PHOENIX should assure that it is used in such an environment.5 GHz IEC 61000-4-6 150 KHz to 80 MHz where P is the maximum output power rating of Radiated RF 3 V/m 3 V/m the transmitter in watts (W) according to the IEC 61000-4-3 80 MHz to 2. Recommended separation distance d = 1. b Over the frequency range 150 KHz to 80 MHz. amateur radio. such as base stations for radio (cellular/cordless) telephones and land mobile radios. Rev.3 P 800 MHz to 2. If the measured field strength in the location in which the PHOENIX is used exceeds the applicable RF compliance level above. B . as determined by an electromagnetic site survey a. Field strengths from fixed RF transmitters. field strength should be less than 3 V/m. than the recommended separation distance calculated from the equation applicable to frequency of the transmitter. the higher frequency range applies. objects and people. NOTE 2 These guidelines may not apply in all situations. AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.2 P 80 MHz to 800 MHz Conducted RF 3 Vrms 3 Vrms d = 2. an electromagnetic site survey should be considered. the PHOENIX should be observed to verify normal operation.guidance level Portable and mobile RF communications equipment should be used no closer to any part of the PHOENIX including cables.2 P d = 1. Compliance Immunity test IEC 60601 test level Electromagnetic environment . B .5 W d = 1. Rev. APPENDIX A: GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS AND IMMUNITY A-5 Recommended separation distances between portable and mobile RF communications equipment and the PHOENIX The PHOENIX is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. object and people.8 7.2 P d = 2.2 2. the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter. Rated maximum Separation distances according to frequency of transmitter output power of transmitter 150 KHz to 80 MHz 80 MHz to 800 800 MHz to 2.23 0.2 P MHz GHz d = 1. according to the maximum output power of the communications equipment.1 0.73 1 1. NOTE 1 At 80 MHz and 800 MHz.3 100 12 12 23 For transmitters rated at maximum output power not listed above. The customer or the user of the PHOENIX can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PHOENIX as recommended below.12 0.8 3. Electromagnetic propagation is affected by absorption and reflection from structures.3 10 3.2 1.12 0. the separation distance for the higher frequency range applies.3 P 0. where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.01 0.38 0. NOTE 2 These guidelines may not apply in all situations.38 0. B .A-6 PHOENIX OPERATOR MANUAL This page is left intentionally blank Rev. switch ON the machine again. then the SETUP Action key. then active in IDLE. SETUP SELECTION Situation Remedy “W! SET VALUE OUT OF RANGE” # Press OVERRIDE to clear the alarm. wait 5 seconds and and/or Action keys not available in switch ON the machine again. Switch OFF the machine. GENERAL EVENTS Situation Remedy Machine stuck during software loading Switch OFF the machine. 1. Machine stuck after the selection of Switch OFF the machine. wait 5 seconds. Audible buzzer and flashing red light Switch OFF the machine.B APPENDIX B: Special Troubleshooting The situations described below are exceptional events. wait 5 seconds and keys in a fast sequence. 3. switch ON the machine again. This table provides instructions in order to solve these problems and prevent them (when possible) from occurring again. wait 5 seconds then switch ON the machine. do not touch the screen until the IDLE view is displayed. Rev. wait 5 seconds. To prevent this situation. 250 alarm occurs after the selection of the SETUP Action key. Machine stuck after selecting Action Switch OFF the machine. IDLE Situation Remedy Machine stuck in IDLE. switch ON the machine. do not press the Action keys too quickly. IDLE. To prevent this situation. B . 2. at the machine switch ON. Action key not responding at first Select the Action key again. touch. TREATMENT Situation Remedy “END OF HEPARIN TIME” # 58 alarm To clear the alarm. beginning of treatment. activate the heparin displayed even if the heparin program is not program and then deactivate it. environment (when Profiling is activated). after patient ID has been already entered. Rev. (TIMING)” # 210 alarms displayed after the wait 5 seconds. PRIME Situation Remedy Machine stuck when starting a second Perform another prime. With CentryNet communication system Do not touch the Action key. Blood pump running at minimum rate Manually increase the BLOOD FLOW to instead of at the prescribed rate at the the prescribed value. Profile curves have not been activated. “!WEIGHT LOSS RATE PROFILE (TIMING)” Press OVERRIDE to clear the alarm. PATIENT ID Action key still entered will not be effective. deactivate Profiling. activated. 5. PATIENT CONNECTION Situation Remedy PAT CONNECT Action key present even if Activate the profile curves. If the # 212 and “!CONDUCTIVITY PROFILE alarm persists. switch OFF the machine. 6.B-2 PHOENIX OPERATOR MANUAL 4. any data activated. present in Report Page. machine again. B . priming with the “PRIME VOLUME COMPLETED” # 54 alarm displayed on the screen. then switch ON the deactivation of the related profile. DIALYSIS TIME parameter not shown in SET If DIALYSIS TIME s to be modified. 2. Put on the gloves. 1). If chemicals in the hydraulic circuit come in contact with skin. NOT Performed Correctly”. Switch On the machine. 1 Before disconnecting any component in the hydraulic circuit. Performed Correctly”.“Chemical Proc. .ty 3 • A pair of gloves q. ensure that the hydraulic circuit is not containing chemicals. 3.1). if one of the following messages appears: . B . .2). Material / Instruments needed for the installation • Ethyl Alcohol q. they might cause chemical injuries. 4. information related to the status of the last machine process appear on the Touch Screen display (see Fig. WARNING Fig. the software program is loaded.“Chemical Proc. Disconnection of the three Ultrafilter Bypass connector lines (section C. Connection of the Ultrafilter Bypass connector (section C. At Power ON. C APPENDIX C: Ultrafilter Bypass Connector Installation This section describes: 1. 2.“Rinsing NOT Performed Correctly”.1 Disconnection of the three Ultrafilter Bypass connector lines Setup instructions 1. Rev.ty 5 ml • Clamp q.ty 1 C. Perform a Rinse process. B . 8. 2). Filtrate Outlet Line Dialysate Inlet Line Ultrafilter Bypass connector Fig. 2 Rev. Close the water inlet. Switch Off the machine. Line 7.C-2 PHOENIX OPERATOR MANUAL 5. 6. Unplug the power cord from power Deaeration supply. Follow the instructions below to disconnect the three Ultrafilter Bypass connector’s lines from the Ultrafilter Bypass connector (see Fig. Snap safety clip Fig. 6 Rev. 3 Snap safety clip springs Upper Ultrafilter Bypass connector port Fig. Press the Deaeration Line‘s snap safety clip springs then unhook the snap safety clip from the upper Deaeration Ultrafilter Bypass connector port (see Line Figures 3 and 4). B . 5 Fig. 6). 5 and Fig. APPENDIX C: ULTRAFILTER BYPASS CONNECTOR INSTALLATION C-3 Disconnection of the Deaeration Line from the Ultrafilter Bypass connector 9. Grey Deaeration Line ring Fig. Slide the Deaeration Line’s snap safety clip along the Deaeration Line and insert the snap safety clip into the grey Deaeration Line ring (see Fig. 4 10. Luer lock Fig. 7).C-4 PHOENIX OPERATOR MANUAL 11. 8). Deaeration Line Fig. Disconnect the Deareation Line from the upper Ultrafilter Bypass connector port by pulling upwards the Deaeration Line’s Luer lock (seeFig. 7 12. B . Clamp the Deaeration Line to avoid water spillage (see Fig. 8 Rev. APPENDIX C: ULTRAFILTER BYPASS CONNECTOR INSTALLATION C-5 Disconnection of the Dialysate Inlet Line from the Ultrafilter Bypass connector 13. 9 Snap safety clip springs Fig. Slide the Dialysate Inlet Line’s snap safety clip along the Dialysate Inlet Line and insert the snap safety clip into the grey Dialysate Inlet Line ring (see Fig. 11 Fig. 11 and Fig. Dialysate Snap Inlet Line safety clip Fig. Press the Dialysate Inlet Line ‘s snap safety clip springs then unhook the snap safety clip from the lower Ultrafilter Bypass connector port (see Figures 9 and 10). Grey Dialysate Inlet Line ring Fig. B . 12 Rev. 12). 10 14. Dialysate Inlet Line Fig. 14). 14 Disconnection of the Filtrate Outlet Line from the Ultrafilter Bypass connector 17. 13 16. B . Disconnect the Dialysate Inlet Line from the lower Ultrafilter Bypass connector port pulling downwards the Dialysate Inlet Line’s Luer lock (see Fig. Clamp the Filtrate Outlet Line to avoid water spillage (see Fig. 13).C-6 PHOENIX OPERATOR MANUAL 15. Filtrate Outlet Line Fig. 15). Clamp the Dialysate Inlet Line to avoid water spillage (see Fig. 15 Rev. Luer lock Fig. Press the Filtrate Outlet Line’s pinch safety clip springs (Fig. Fig. 16 Pinch safety clip Fig. 16) then unhook Pinch safety the pinch safety clip from the middle clip Ultrafilter Bypass connector port (see springs Fig. 17). Filtrate Outlet Line Fig. B . Disconnect the Filtrate Outlet Line from the middle Ultrafilter Bypass connector port. APPENDIX C: ULTRAFILTER BYPASS CONNECTOR INSTALLATION C-7 18. (see Fig. 18). 17 19. 18 Rev. 19 Rev. 19). Remove the Ultrafilter Bypass connector clip from the lower fixing clip (see Fig. Lower fixing clip Fig. B .C-8 PHOENIX OPERATOR MANUAL Removal of the Ultrafilter Bypass connector Upper fixing 20. Fig. Fig. APPENDIX C: ULTRAFILTER BYPASS CONNECTOR INSTALLATION C-9 C. 1). 3 Rev. 1 Lower fixing clip Fig. Do not insert the new Ultrafilter Bypass connector connector into the lower fixing clip (see Fig.2 Connection of the Ultrafilter Bypass connector Connection of the Deaeration Line to the Ultrafilter Bypass connector New 1. Bypass 2. since it is necessary to handle the Ultrafilter Bypass connector. therefore the upper and lower ports are equivalent). 3) with Ethyl Bypass Alcohol (the Ultrafilter Bypass connector is connector port symmetric. Spray the upper Ultrafilter Bypass Ultrafilter connector port (see Fig. 2). 2 Upper 3. B . Take the new Ultrafilter Bypass connector Ultrafilter (see Fig. 6 Rev. 6). 5 5. Deaeration Line Fig. Fig. B . Insert completely the Deaeration Line’s Luer lock into the upper Ultrafilter Bypass connector port (see Figures 4 and 5). Luer Note lock Ensure that the Deaeration Line is not twisted or kinked. 4 Upper Ultrafilter Bypass connector port Fig. Unclamp the Deaeration Line (see Fig.C-10 PHOENIX OPERATOR MANUAL Deaeration Line 4. 7 Snap 7. 9). Disconnect the snap safety clip from the safety clip grey Deaeration Line ring (see Fig. B . Ribs Ribs Fig. Fig. 8 8. APPENDIX C: ULTRAFILTER BYPASS CONNECTOR INSTALLATION C-11 Snap 6. 8). Hook the snap safety clip to the Ultrafilter Snap Bypass connector and make sure to hear a safety clip “click” sound when it is firmly inserted (see Fig. 7). Position each of the two Deaeration Line’s safety snap safety clip springs in the housing clip between the two ribs of the Ultrafilter Bypass connector (see Fig. Fig. 9 Rev. therefore the upper and lower ports are equivalent).C-12 PHOENIX OPERATOR MANUAL 9. 11) with Ethyl Alcohol (the Ultrafilter Bypass connector is symmetric. 10-B Ultrafilter Bypass connector. 11 Rev. Spray the lower Ultrafilter Bypass connector port (see Fig. 10-A Fig. Ensure that the snap safety clip is properly hooked to the Ultrafilter Bypass connector: The Deaeration Line’s snap safety clip has to be fully inserted in its housing in order to avoid line disconnection. (Fig.) Connection of the Dialysate Inlet Line to the Ultrafilter Bypass connector 10. 10-A shows a good installation Fig. 10-B shows a bad installation due to the gap between the GOOD BAD Deaeration Line’s snap safety clip and the Fig. Lower Ultrafilter Bypass connector port Fig. B . Unclamp the Dialysate Inlet Line (see Fig. Insert completely the Dialysate Inlet Line’s Luer lock (see Fig. Note Ensure that the Dialysate Inlet Line is not twisted or kinked. B . 14 Rev. 14). 13). Luer lock Dialysate Inlet Line Fig. APPENDIX C: ULTRAFILTER BYPASS CONNECTOR INSTALLATION C-13 11. 12 Lower Ultrafilter Bypass connector port Fig. 12) into the lower Ultrafilter Bypass connector port (Fig. 13 12. Dialysate Inlet Line Fig. B . Position each of the two Dialysate Inlet Line’s snap safety clip springs in the housing between the two ribs of the Ribs Ultrafilter Bypass connector (see Fig. 15). 16). Ribs Snap safety clip spring Fig.C-14 PHOENIX OPERATOR MANUAL 13. Disconnect the snap safety clip from the grey Dialysate Inlet Line ring (see Fig. 15 14. Snap safety clip Fig. 16 Rev. 19 Rev. 18-B shows a bad GOOD BAD installation due to the gap between the Fig. Hook the snap safety clip to the Ultrafilter Bypass connector and make sure to hear a “click” sound when it is firmly inserted (see Fig. 18-A shows a good installation. Snap safety clip Fig. 18-A Fig.) Connection of the Filtrate Outlet Line to the Ultrafilter Bypass connector Middle Ultrafilter 17. Ensure that the snap safety clip is properly hooked to the Ultrafilter Bypass connector: The Dialysate Inlet Line’s snap safety clip has to be fully inserted in its housing in order to avoid line disconnection. Fig. B . 17 16. 17). 18-B Dialysate Inlet Line’s snap safety clip and the Ultrafilter Bypass connector. 19) with Ethyl connector Alcohol. (Fig. Spray the middle Ultrafilter Bypass Bypass connector port (see Fig. APPENDIX C: ULTRAFILTER BYPASS CONNECTOR INSTALLATION C-15 15. port Fig. Filtrate Outlet Line Fig. 21 Rev. 20 Pinch safety clip 19. Fully insert the Filtrate Outlet Line onto the middle Ultrafilter Bypass connector port (see Fig. 20). B . Hook the pinch safety clip to the middle Ultrafilter Bypass connector port (see Fig. 21) Fig.C-16 PHOENIX OPERATOR MANUAL 18. 22 21. Unclamp the Filtrate Outlet Line (see Fig. Filtrate Outlet Line Fig. 23). Fig. B . Ensure that the pinch safety clip is securely inserted onto the middle Ultrafilter Bypass connector port in order to avoid line disconnection (see Fig. 22). 23 Rev. APPENDIX C: ULTRAFILTER BYPASS CONNECTOR INSTALLATION C-17 Pinch safety clip 20. Insert the Ultrafilter Bypass connector in the lower fixing clip present on the machine panel (see the yellow arrow in Fig. (Please refer to the Operator’s Manual. Switch On the machine. 26. Only if the Heat Disinfection is not available. Plug the Power Cord to power supply. switch Off the machine and repeat the connection procedure of the improper connections. 25. Lower fixing clip Fig. Open the water inlet. 27. 24). During the Rinse process complete the “Final Check” checklist as described at page 19 of this Appendix C. 28. Perform a Rinse procedure to check for leaks in the hydraulic circuit. 24. B . perform a Chemical Disinfection procedure to disinfect the hydraulic circuit prior to performing a dialysis treatment (Please refer to Section 06 in this manual for a detailed description of the Heat and Chemical Disinfection procedures). 24 Machine disinfection 23. Rev. Section 06 for a detailed description of the Rinse procedure).C-18 PHOENIX OPERATOR MANUAL 22. Perform a Heat Disinfection procedure. In case a fluid leakage occurs during the Final Check. …Check that the Deaeration Line is not twisted or kinked (see Fig. Refer to Figure 25 …Check that the Ultrafilter Bypass connector is properly installed into the lower fixing clip located on the machine panel as shown in Fig. …Check that the snap safety clip is correctly hooked to the Ultrafilter A Bypass connector (see Fig. 26. point A). 26. point A). Refer to Figure 26 …Check that no leaks are present in the Deaeration Line (see Fig. 26 Rev. 1. 25 2. APPENDIX C: ULTRAFILTER BYPASS CONNECTOR INSTALLATION C-19 Final Check Fill in the checklist below to verify if the Ultrafilter Bypass connector replacement procedure has been correctly performed. 26. To correctly perform the installation procedure all the flags must be checked. 25. point A). Fig. Lower fixing clip Fig. B . B point B). 27. 28. C Fig.C-20 PHOENIX OPERATOR MANUAL 3. B . 28. point C). Refer to Figure 27 …Check that no leaks are present in the Dialysate Inlet Line (see Fig. 27. point B). 27. …Check that the pinch safety clip is correctly connected to the Ultrafilter Bypass connector(see Fig. …Check that the Dialysate Inlet Line is not twisted or kinked (see Fig. …Check that the snap safety clip is correctly connected to the Ultrafilter Bypass connector (see Fig. Refer to Figure 28 …Check that no leaks are present in the Filtrate Outlet Line (see Fig. 27 4. point C) . 28 Rev. Fig. point B).