Ves Matic 20 - Operator Manual

DIESSE DIAGNOSTICA SENESE SPAINSTRUCTIONS MANUAL VES-MATIC 20 / 20Plus New Automatic instrument for the determination of the erythrosedimentation rate (ESR) (patented)  Instructions Manual VES-MATIC 20 / 20Plus New DISTRIBUTOR DIESSE DIAGNOSTICA SENESE S.p.A. Via delle Rose 10 • 53035 Monteriggioni - Siena Phone +39-0577-58 71 11 • Fax +39-0577-31 86 90 www.diesse.it The information contained in this manual may be updated without prior warning. No part of this manual may be reproduced in any way or for any purpose, without written permission from Diesse Diagnostica Senese S.p.a. Printed in MAY 2001. Rev. 0.04 (08/11/01) ii  Instructions Manual VES-MATIC 20 / 20Plus New REVISION HISTORY REV. VERSION DATE APPR. CHANGE 0.00 1.05 14/05/01 Initial Revision 0.01 1.08 06/06/01 Initial Revision with Foto 0.02 1.10 03/07/01 Added instructions for Id Number input. 0.03 1.10 31/08/01 Review of instructions for Id Number input. 0.04 1.14 08/11/01 Delete of Sensor test. CheckDevive loading explanation. Corrected the explanation of ‘Sample ABSENT’ ‘Sample LOW’ and ‘EMPY’ messages.Added specs of monodirectional Protocol . VES-MATIC 20 / 20Plus New This manual applies to the following Ves-Matic 30 models: Models Description 10334/CE Ves-Matic 20 10332/CE Ves-Matic 20 with Internal Barcode Reader 10336/CE Ves-Matic 20 Plus with Internal Barcode Reader iii Rev. 0.04 (08/11/01)  Instructions Manual VES-MATIC 20 / 20Plus New CONTENTS CHAPTER 1 ....................................................................................................................................... 1 1.1. PRESENTATION OF THE UNIT........................................................................................... 2 1.2. WARRANTY........................................................................................................................... 2 1.3. LIMITED LIABILITY............................................................................................................. 3 1.4. APPLICABLE REGULATIONS............................................................................................. 3 1.5. TECHNICAL ASSISTANCE REQUESTS............................................................................. 3 1.6. REQUEST OF SPARE PARTS............................................................................................... 3 1.7. GLOSSARY............................................................................................................................. 4 CHAPTER 2 ....................................................................................................................................... 5 2.1. GENERAL CONFIGURATION OF THE UNIT WITH EXTERNAL CONNECTIONS ..... 6 2.2. BLOCK DIAGRAM ................................................................................................................ 8 2.3. TECHNICAL DESCRIPTION OF THE UNIT....................................................................... 9 2.4. TECHNICAL SPECIFICATIONS ........................................................................................ 10 2.5. MATERIAL SUPPLIED WITH THE UNIT......................................................................... 10 2.6. TRANSPORTATION INSTRUCTIONS .............................................................................. 11 2.7. INSTALLATION................................................................................................................... 12 2.8. CUSTOMER'S DUTIES ........................................................................................................ 13 2.9. INSTALLATION PROCEDURE .......................................................................................... 13 2.10. COMPOSITION OF THE UNIT AND DISPOSAL INSTRUCTIONS ............................... 14 CHAPTER 3 ..................................................................................................................................... 15 3.1. THE UNIT.............................................................................................................................. 16 3.2. WARNINGS .......................................................................................................................... 17 3.3. INDIVIDUAL PROTECTION MEANS ............................................................................... 17 CHAPTER 4 ..................................................................................................................................... 19 4.1. KEYBOARD COMMANDS ................................................................................................. 20 4.2. PREPARING THE SAMPLES.............................................................................................. 22 4.3. TURNING THE UNIT ON.................................................................................................... 22 4.4. MAIN MENU ........................................................................................................................ 24 4.5. DESCRIPTION OF THE TEST CYCLES ............................................................................ 24 4.6. DISPLAYING (AND PRINTING) THE STORED TESTS.................................................. 27 4.7. SETTING THE UNIT UP...................................................................................................... 28 4.7.1. CONFIGURING TEMPERATURE ADJUSTMENTS......................................................... 28 4.7.2. CONFIGURING THE PRINTER.......................................................................................... 28 4.7.3. CONFIGURING THE DISPLAY.......................................................................................... 29 Rev. 0.04 (08/11/01) iv  Instructions Manual VES-MATIC 20 / 20Plus New 4.7.4. CONFIGURING THE BAR CODE READER ..................................................................... 29 4.7.5. QUALITY CONTROL .......................................................................................................... 30 4.8. LOADING AND PROGRAMMING A WORK CYCLE ..................................................... 33 4.9. ENTERING THE ID NUMBER............................................................................................ 34 4.9.1 ENTERING THE ID. NUMBER MANUALLY................................................................... 36 4.10. UPDATING DATE AND TIME ........................................................................................... 37 CHAPTER 5 ..................................................................................................................................... 38 5.1. GENERAL RECOMMENDATIONS.................................................................................... 39 5.2. CLEANING THE UNIT ........................................................................................................ 39 5.3. REPLACING THE PAPER IN THE PRINTER.................................................................... 39 5.4. REPLACING THE CHECK DEVICE .................................................................................. 41 5.5. REPLACING THE FUSES.................................................................................................... 41 5.6. PERIODICAL INSPECTIONS.............................................................................................. 42 5.6.1. CHECKING THE SAFETY (MICROSWITCH) AND ACOUSTIC DEVICES.................. 43 5.6.2. INSPECTING THE SPRINGS .............................................................................................. 44 CHAPTER 6 ..................................................................................................................................... 46 6.1. SELF-DIAGNOSTICS........................................................................................................... 47 CHAPTER 7 ..................................................................................................................................... 50 7.1. CONNECTING A BAR CODE READER TO VES 20/30 INSTRUMENTATION............ 51 7.2. CONNECTION A HOST COMPUTER TO VES 20/30 INSTRUMENTATION................ 52 7.3. SPECIFICATIONS FOR THE BIDIRECTIONAL ASYNCHRONOUS SERIAL COMMUNICATION PROTOCOL................................................................................................... 53 7.4. VES20/30 SERIAL COMMANDS AND PARAMETER FORMAT ................................... 54 7.5. SPECIFICATION OF THE VES-MATIC 20/30 MONODIRECTIONAL COMMUNICATION PROTOCOL................................................................................................... 60 REFERENCES................................................................................................................................. 63 ENCLOSURE.................................................................................................................................... A ENCLOSURES A : EC DECLARATION OF COMPLIANCE ENCLOSURES B : WARRANTY ENCLOSURES C : TECHNICAL ASSISTANCE REQUEST ENCLOSURES D : SPARE PARTS REQUEST ENCLOSURES E : MANUAL METHOD FOR ESR DETERMINATION, BASED ON WESTERGREN'S TECHNIQUE ENCLOSURES F : PACKING LIST v Rev. 0.04 (08/11/01)  Instructions Manual VES-MATIC 20 / 20Plus New Rev. 0.04 (08/11/01) vi  Instructions Manual VES-MATIC 20 / 20Plus New CHAPTER 1 INTRODUCTION For safety reasons it is advisable to read carefully the recommendations and instructions contained in this manual before installing and using the unit. The manual should be kept together with the instrument for consultation when necessary. If VES-MATIC 20 / 20Plus New is sold or transferred, make sure that the manual is supplied the unit so that the new user receives all the necessary information regarding its functions and safety instructions. It is taken for granted that only authorised, competent personnel will operate the instrument. 1.1. PRESENTATION OF THE UNIT........................................................................................... 2 1.2. WARRANTY........................................................................................................................... 2 1.3. LIMITED LIABILITY............................................................................................................. 3 1.4. APPLICABLE REGULATIONS............................................................................................. 3 1.5. TECHNICAL ASSISTANCE REQUESTS............................................................................. 3 1.6. REQUEST OF SPARE PARTS............................................................................................... 3 1.7. GLOSSARY............................................................................................................................. 4 1 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New 1.1. PRESENTATION OF THE UNIT VES-MATIC 20 / 20Plus New is a benchtop analyser designed to simultaneously measure the erythrocyte sedimentation rate (ESR) in 20 blood samples (human or animal) (15 for Plus version). The ESR test procedure is performed automatically and the results are comparable to those attained with the Westergren method. The instrument operates by means of a microprocessor, which will be described in detail in the paragraphs that follow. 1.2. WARRANTY DIESSE DIAGNOSTICA SENESE S.p.A. subjects all its products to exhaustive quality control procedures; however, if defects are reported on the unit, please contact the local authorised Centre for Technical Assistance indicated at the time of the delivery of the unit. General regulations regarding the warranty DIESSE DIAGNOSTICA SENESE S.p.A. guarantees the VES-MATIC 20 / 20Plus New is free from material or manufacture defects, for a period of 12 months from the date of delivery (the shipping bill will be considered proof). If during the guarantee period the product should present any defect, the authorised Assistance Centres will repair it in their own laboratories, charging only transportation costs to the customer. Conditions: 1. The guarantee will be valid only if the certificate of guarantee is sent together with a copy of the delivery slip and the installation report, within 15 days of delivery of the instrument. 2. This product will not be considered defective in materials or manufacture, if the unit is adapted, modified or adjusted to make it compliant with national or local regulations differing from those for which the product was originally designed and manufactured. This guarantee will not cover such adaptations, modifications or adjustments or attempts to this end, even if correctly performed, nor will it cover any damage deriving from such interference. 3. This guarantee does not cover: - Periodical controls, maintenance and repair or replacement of parts due to normal wear Rev. 0.04 (08/11/01) 2  Instructions Manual VES-MATIC 20 / 20Plus New - Costs and risks of transportation, directly or indirectly related to the guarantee of this product, including transport from the centre of assistance to the customer. - Damages cause by negligence or an improper use of the product - Faulty operation of the unit due to modifications or repairs performed by unauthorised personnel - Damages caused by the installation of spare parts or pieces not approved by the manufacturer. THE WARRANTY CARD is contained in the ENCLOSURES. 1.3. LIMITED LIABILITY DIESSE DIAGNOSTICA SENESE S.p.A. shall not be held liable for damages caused by defects of manufacture or for the faulty operation of the unit, if this is used normally. It declines any other type of responsibility. (Directive 1999/34/EC that amends Directive 85/374/EEC implemented in Italy with D.P.R. n.224 of 24.5.1988 [D.L. n. 25 of 02/02/2001]). 1.4. APPLICABLE REGULATIONS The manufacturer, DIESSE DIAGNOSTICA SENESE S.p.A., declares that the company's activities are conducted in accordance with the manufacturing standards recommended by ISO 9000. The manufacturer declares that VES-MATIC 20 / 20Plus New has been designed, in terms of safety, as indicated in ENCLOSURE A (EC Declaration of compliance), in accordance with the provisions of the following Directives: 89/392/EEC 89/336/ECC 1.5. TECHNICAL ASSISTANCE REQUESTS If technical assistance should be required, contact the name of the Centre at the address indicated at the time of delivery of the unit; otherwise contact Diesse Diagnostica Senese S.p.A.. See ENCLOSURE C. 1.6. REQUEST OF SPARE PARTS The request for spare parts listed in the order form, see ENCLOSURE D, can be made by the customer (for other spare parts, consult the Maintenance Manual). 3 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New 1.7. GLOSSARY = ATTENTION, DANGEROUS SITUATION = DANGER, POTENTIALLY HAZARDOUS INFECTIVE SUBSTANCE = OBLIGATION TO PERFORM THE OPERATIONS DESCRIBED = PROHIBITION TO PERFORM THE OPERATION DESCRIBED = GENERAL INFORMATION = SPECIAL NOTE = PRINT DATA = CLEAN THE UNIT; THIS OPERATION MUST BE PERFORMED BY THE OPERATOR Rev. 0.04 (08/11/01) 4  Instructions Manual VES-MATIC 20 / 20Plus New CHAPTER 2 INSTALLATION This chapter provides all the information required to identify, install and operate the unit. The sections that follow provide information on the technical specifications and on the composition of the products, in accordance with European Directives, to guarantee a safe use of the unit and enable it to be correctly disposed of at the end of its working cycle. Its installation doesn't require the intervention of a qualified technician. 2.1. GENERAL CONFIGURATION OF THE UNIT WITH EXTERNAL CONNECTIONS ..... 6 2.2. BLOCK DIAGRAM ................................................................................................................ 8 2.3. TECHNICAL DESCRIPTION OF THE UNIT....................................................................... 9 2.4. TECHNICAL SPECIFICATIONS ........................................................................................ 10 2.5. MATERIAL SUPPLIED WITH THE UNIT......................................................................... 10 2.6. TRANSPORTATION INSTRUCTIONS .............................................................................. 11 2.7. INSTALLATION................................................................................................................... 12 2.8. CUSTOMER'S DUTIES ........................................................................................................ 13 2.9. INSTALLATION PROCEDURE .......................................................................................... 13 2.10. COMPOSITION OF THE UNIT AND DISPOSAL INSTRUCTIONS ............................... 14 5 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New 2.1. GENERAL CONFIGURATION OF THE UNIT WITH EXTERNAL CONNECTIONS DESCRIPTION OF THE REFERENCES: 1) Keyboard 2) Display 3) Paper holder with printer slot 4) Door of the sample-holder compartment 5) Cuvette-holder plate with 20 slots (15 slots for Plus version) 6) Numbered positions on the cuvette-holder 7) Housing for the replaceable check device Front View Rev. 0.04 (08/11/01) 6  Instructions Manual VES-MATIC 20 / 20Plus New DESCRIPTION OF THE REFERENCES: 8) Main switch (ON/OFF) 9) Fuses 10) Power cord 12) RS-232 connector for the external computer 11) Connector for external bar code reader 13) 485 connector 14) Forced ventilation fan Rear View 7 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New 2.2. BLOCK DIAGRAM (Detailed diagrams are illustrated in the Maintenance Manual) DESCRIPTION OF THE REFERENCES: 1- C.P.U. card 9- Keyboard 2- Card for the motor drivers 10- Printer interface 3- Feeder 11- Printer 4- Motors block 12- Internal Barcode Reader 5- Reading sensor unit 13- Door microswitch 6- Check-Device unit 14- Forced ventilation fan 7- Display/Keyboard interface 15- ON/OFF switch with mains filter 8- Display 16- External connections Rev. 0.04 (08/11/01) 8  Instructions Manual VES-MATIC 20 / 20Plus New 2.3. TECHNICAL DESCRIPTION OF THE UNIT CENTRAL UNIT This unit controls and processes the data received by sensors and manages all the peripherals. It also includes the FLASHEPROM which stores the program along with the EEPROM that stores read and processed data. OPTICAL READER UNIT This unit includes a photodiode + phototransistor pair. MOTORS TO TILT AND ROTATE THE CUVETTE-HOLDER PLATE One of the motors tilts the cuvette-holder plate by 90° while the other motor rotates it through a shaft in order to guarantee a consistent suspension of the red cells. MOTOR OF THE OPTICAL READER UNIT This motor lifts the optical reader unit to allow users to control the number of cuvettes present, the improperly placed cuvettes, the cuvettes containing an insufficient or excessive level of blood, or even to control the level of sedimentation. KEYBOARD This keyboard comprises 12 bifunctional buttons that can be used to enable the features of VES-MATIC 20 / 20Plus New. CUVETTE-HOLDER PLATE The radial section of the plate contains a ring with 20 numbered slots (15 for Plus version) designed to house the cuvettes. These are symmetrically tilted as compared to the rotation axis, so that the cuvettes are arranged along the cone generator. ACOUSTIC ALARM This alarm warns the operator during specific phases of the working cycle. The alarm issues a "beep" every time the keys on the keyboard are pressed. TEMPERATURE SENSOR This sensor, which measures the temperature, is located on the central unit next to the cuvette- holder plates. PRINTER The printer is used to print the final test results at the end of every working cycle. DISPLAY The monitor is used to display all the messages issued by the unit. 9 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New 2.4. TECHNICAL SPECIFICATIONS CENTRAL UNIT 8-BIT RISC technology with ultra-low dissipation; AND INTERFACES ATMEGA103 microprocessor CUVETTE-HOLDER With 20 numbered slots designed to house the cuvettes, with 15 numbered slots for Plus version OPTICAL READER Pair of opto-electric solid sate elements UNIT (photodiode + phototransistor) PRINTER Alphanumerical with 58 mm wide thermal paper, 36 cpl, speed of 20 mm/sec DISPLAY SUPER-TWISTED, liquid-crystal technology. Two lines, with 16 characters per line. POWER SUPPLY From 90 to 264 VAC (47 - 440 Hz) FUSES 2 x 1A ( 5 x 20 ) fast-acting ABSORBED 65 W max ELECTRIC POWER DIMENSIONS 490 x 330 x 365 mm ( l x h x p ) WEIGHT 10 Kg OPERATING From + 15°C to + 35°C TEMPERATURE STORAGE From + 5°C to + 45°C TEMPERATURE RELATIVE From 20 to 80% without condensation HUMIDITY ROTATION SPEED 1 revolution every 1.5 during the ordinary working cycle. OF THE PLATE 2.5. MATERIAL SUPPLIED WITH THE UNIT VES-MATIC 20 / 20Plus New is supplied with the following material: - INSTRUCTION MANUAL - Two 1A (5x20) spare fuses, FAST-ACTING - One power cord - Packing-list and installation report - Warranty card Rev. 0.04 (08/11/01) 10  Instructions Manual VES-MATIC 20 / 20Plus New 2.6. TRANSPORTATION INSTRUCTIONS VES-MATIC 20 / 20Plus New is a precision unit and must be handled as such. Inappropriate operations could damage the internal opto-electronic components and cause mechanical damages. Given the small dimensions and weight of the unit, this can even be transported manually using the necessary precautions to avoid excessive impacts or inclinations that could damage the unit. DIMENSIONS OF THE PACKAGING WIDTH cm 52 HEIGHT cm 44 DEPTH cm 62 GROSS WEIGHT kg 14 WEIGHT OF THE PACKAGING kg 4 It is advisable to store the original package with its internal components for future use (in particular, make sure that the package contains the polyurethane foam block that blocks in place the sample-holder plate). 11 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New 2.7. INSTALLATION This unit is designed to be used in a test laboratory. For safety requirements and due to the nature of the tests it performs, it is advisable to install the unit far from heat sources, in waterproof areas free from dust and on perfectly levelled surfaces that are not subject to impacts or vibrations. To protect the unit from overheating (due to the obstruction of the fan) and to be able to intervene promptly in emergency situations, it is necessary to maintain the required safety distances for the power cord. In particular, make sure that the rear of the unit is placed at a distance of 20 cm from the wall, that the front side is not obstructed and that a minimum distance of 10 cm is maintained on both the left and right side. For the same reason, it is forbidden to leave loose material on the unit. Never move the unit when it is running. If this operation cannot be avoided, check the conditions described in this section before using the unit for test purposes. If the use of the unit is not scheduled for a long period of time, it is advisable to disconnect it from the mains and cover it. Rev. 0.04 (08/11/01) 12  Instructions Manual VES-MATIC 20 / 20Plus New 2.8. CUSTOMER'S DUTIES The safety of the unit and of the operator cannot be guaranteed if the following conditions are not satisfied: - The mains should be "compatible" with the voltage and current specifications indicated on the metal nameplate placed on the rear of the unit. It is also advisable to periodically check the efficiency of the electric system. - The mains should be equipped with a ground connection, as per current law requirements. - The unit comes with an internal feeder designed to resist to the voltage variations indicated on the nameplate placed on the rear of the unit. If the line is very disturbed, use a saturated iron stabiliser (minimum 65 W). - Before connecting the unit with external devices (PC, BAR-CODE reader), check that these are compatible (see the manuals of the related devices) with the technical specifications set forth in Chapter 7. - Individual safety means (gloves, containers for the collection of used cuvettes, detergent solutions used to clean the unit) must always be made available. - Operators should be familiar with the procedures, prohibitions and warning described in this manual, in addition with safety regulations applicable in the workplace. - The unit should be installed according to the instructions given in the paragraph above. IT IS STRICTLY FORBIDDEN to: - Cover the rear orifices (fans) of the unit - Remove or change the safety and protection devices. 2.9. INSTALLATION PROCEDURE 1- Unpack the unit. 2- Check the material supplied with the unit (packing-list). 3- Install VES-MATIC 20 / 20Plus New (see 2.7.), removing the block that fixes the plate in place. (Polyurethane block for the plate) 4- Connect the unit to the mains (making sure that the conditions described in point 2.8. are met). 13 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New 5- Turn the unit on (see 4.3.). IN PRESENCE OF A FIRE OR OF A DANGER, TURN THE UNIT OFF AND DISCONNECT IT FROM THE MAINS 2.10. COMPOSITION OF THE UNIT AND DISPOSAL INSTRUCTIONS 1- VES-MATIC 20 / 20Plus New is made, in percentage, by: IRON 20% ALUMINIUM 20% COPPER 8% EPOXY and SILICA RESINS 6% PLASTIC MATERIALS 45% 2- To dispose the unit at the end of its working cycle, refer to the local applicable laws on waste disposal. Rev. 0.04 (08/11/01) 14  Instructions Manual VES-MATIC 20 / 20Plus New CHAPTER 3 OPERATION 3.1. THE UNIT.............................................................................................................................. 16 3.2. WARNINGS .......................................................................................................................... 17 3.3. INDIVIDUAL PROTECTION MEANS ............................................................................... 17 15 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New 3.1. THE UNIT VES-MATIC 20 / 20Plus New is a benchtop analyser designed and programmed to simultaneously measure the erythrocyte sedimentation rate (ESR) in 20 blood samples (in 15 blood samples for Plus version) directly in the cuvettes designed for this purpose. The ESR test procedure is performed completely automatically, and the results are comparable to those obtained by the Westergren method (Reference to bibliography 1-10). Results obtained at room temperature can be automatically converted to those that would be found at 18°C, according to Manley's normogram. VES-MATIC 20 / 20Plus New enables to attain results that are equivalent to those calculated using the Westergren's method (1 hour) in 25 minutes and to those calculated using the Westergren's method (2 hours) in 45 minutes, including the sample mixing. Clinical importance of ESR The unit provides information on the erythrocyte sedimentation rate (ESR), which represents the acute response phase of an inflammatory status and reflects the speed of sedimentation of the erythrocytes. The ESR value measured at a specific time is substantially influenced by the concentration of some proteins, in which the plasmatic concentration changes in presence of inflammatory conditions or of different pathologies (for example, neoplasias). The value is affected also by some properties of the erythrocytes and by anaemia (hematocrit). High values are found with multiple myeloma, leukaemia, lymphomas, breast and lung cancers, rheumatic arthritis, LES, lung failure. ESR values are also very high in presence of several kinds of infections and in particular in presence of liver metastasis, and in acute and chronic inflammatory diseases. Normal ESR values ESR values, for the first hour, are normally within 1 and 10 for men and within 1 and 15 for women. In pathological conditions, these value can increase up to 100 or above. Normal range for unit VES-MATIC 20 / 20Plus New MEN Up to 10 mm for the first hour Up to 20 mm for the second hour WOMEN Up to 15 mm for the first hour Up to 30 mm for the second hour Rev. 0.04 (08/11/01) 16  Instructions Manual VES-MATIC 20 / 20Plus New General operation of the unit The blood collected in the special cuvettes, in accordance with the instructions given in paragraph "PREPARATION OF THE SAMPLE", is carefully mixed by the instrument; the samples are then left to sediment for a given amount of time to allow the sedimentation to take place. The opto-electronic sensors automatically read the erythrocyte sedimentation level. The data are processed and then printed or displayed on the monitor. We would like to remind that in case of samples with an hematocrit value < 15% the instrument will print “SAMPLE LOW” or “EMPTY”. 3.2. WARNINGS Potentially infectious material is being handled. Follow the EUROPEAN DIRECTIVES no. 89/391/CEE, 89/656/CEE, 89/654/CEE, 89/655/CEE, 90/269/CEE, 90/270/CEE and 90/679/CEE. (In Italy these regulations were introduced by the Legislative Decree no. 626). DISCONNECT the instrument from the power supply before performing any technical operation, or in the case of malfunction of the instrument. Only use finger-tip pressure on the keys. Do not TOUCH the machine while it is operating (only use the keyboard to issue commands). Do not PLACE fingers or other objects between the plate and the outer casing. 3.3. INDIVIDUAL PROTECTION MEANS Observe all the necessary measures to ensure the safety of all the people working in the area where the unit is installed. Refer to local regulations. 17 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New Rev. 0.04 (08/11/01) 18  Instructions Manual VES-MATIC 20 / 20Plus New CHAPTER 4 OPERATING INSTRUCTIONS 4.1. KEYBOARD COMMANDS ................................................................................................. 20 4.2. PREPARING THE SAMPLES.............................................................................................. 22 4.3. TURNING THE UNIT ON.................................................................................................... 22 4.4. MAIN MENU ........................................................................................................................ 24 4.5. DESCRIPTION OF THE TEST CYCLES ............................................................................ 24 4.6. DISPLAYING (AND PRINTING) THE STORED TESTS.................................................. 27 4.7. SETTING THE UNIT UP...................................................................................................... 28 4.7.1. CONFIGURING TEMPERATURE ADJUSTMENTS......................................................... 28 4.7.2. CONFIGURING THE PRINTER .......................................................................................... 28 4.7.3. CONFIGURING THE DISPLAY.......................................................................................... 29 4.7.4. CONFIGURING THE BAR CODE READER ..................................................................... 29 4.7.5. QUALITY CONTROL .......................................................................................................... 30 4.8. LOADING AND PROGRAMMING A WORK CYCLE ..................................................... 33 4.9. ENTERING THE ID NUMBER............................................................................................ 34 4.9.1 ENTERING THE ID. NUMBER MANUALLY ................................................................... 36 4.10. UPDATING DATE AND TIME ........................................................................................... 37 19 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New 4.1. KEYBOARD COMMANDS The selected function is enabled only when the related key is pressed and released. For the Q.C. programme configuration only: during the manual entry of the ID number and the update of the Date and Time, the two-function keys automatically provide the related numerical values. = Numerical Value 1 - " 1 Print" + OK = To reprint the results of the last cycle performed. - " 1 Print" = To reprint the JOB LIST during the entry of the ID numbers. = Numerical Value 2 Enables the Line Feed on the printer in the Select Function Menu. = Numerical Value 3 = Numerical Value 4 Opens the Main Menu of the unit in the Select Function Menu (the Main Menu enables to select the tests that can be carried out with the unit, the configuration set-up and the database of the tests stored). = Numerical Value 5 Enables the scroll function during the display of the menus. = Numerical Value 6 Rev. 0.04 (08/11/01) 20  Instructions Manual VES-MATIC 20 / 20Plus New Enables the scroll function during the display of the menus. = Numerical Value 7 Updates the Date and Time in the Select Function Menu. = Numerical Value 8 = Numerical Value 9 = Numerical Value 0 Resumes the last test carried out, if interrupted in the Select Function Menu. The selection of this key during the display of the menus enables to view the pop-up menus and return to the initial menu item. The selection of this key during the entry of alphanumerical values enables to cancel the operation being performed. The selection of this key during the execution of a test enables to stop the functions of the unit and cancel the test. The selection of this key during the display of the pop-up menus enables to access the next menu. During the entry of alphanumerical values the key is used to enable and confirm the entry of data. It can also be used to start a cycle after the selection of a test. 21 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New 4.2. PREPARING THE SAMPLES Prepare the cuvettes in accordance with the instructions provided on the leaflet supplied with the package and follow the ICSH standards. The most important recommendations are given here below. Blood should be collected through a sampling of a maximum of 30 seconds, without excessive venous stasis. Blood can be collected both using a vacuum and a manual technique. Mix the blood soon after its collection by tilting the test probe at least twice. Suitability of the sample Sample are deemed suitable when: The test is performed within four hours from the collection The test is performed on a blood sample stored at 4° for a maximum of 12 hours. In this case, it is necessary to make sure that the temperature of the sample is equivalent to ambient temperature before it is actually inserted into the unit. Verify that the sample is not coagulated. If necessary, tilt the test sample before inserting it into the unit. Verify that the cuvette is perfectly SEALED. Filling the cuvette To guarantee a correct execution of the ESR test, VES-MATIC 20 / 20Plus New verifies that the sample probe is correctly filled by measuring the filling value and comparing it with the pre-set maximum and minimum tolerance values. If the test probe is too full, the unit prints error message "sample high"; otherwise it prints error message "sample low" if the level in the test probe is insufficient. In both cases, it is necessary to collect a new blood sample. 4.3. TURNING THE UNIT ON PROCEDURE: After installing the unit in accordance with the instructions set forth in Chapter 2, verify that the door of the plate is closed and set the switch on the rear of the unit to ON: Rev. 0.04 (08/11/01) 22  Instructions Manual VES-MATIC 20 / 20Plus New After being powered the unit displays the model and the related software version. VES MATIC 20 RELEASE X.XX After checking that the door of the sample-holder compartment is closed, it also runs an initial reset to check that all the internal components are in good working order. During the initial controls, it displays the following message: VES MATIC 20 BUSY If a problem occurs, it displays an error message (ERROR XXXX; (RES) TO RESTART). For information on the nature of the problem, see section Self-Diagnostics. At the end of the mechanical reset, the unit displays the number of tests that can be performed before replacing the Check Device. CHECK DEVICE XXXXX - The maximum number of tests that can be managed by the unit is 11999, along with the 4000 hits present on a Check Card, for a maximum total of 15999 hits for Check device. - If the counter of a Check Device needs to be replaced, the unit displays a flashing message. In this condition, it is not possible to start other tests, although the remaining functions are still enabled. The unit then displays the date and time set: DATE = dd/mm/yyyy TIME = hh:mm:ss At the end of this procedure, the unit is ready to perform all the functions selected: VES MATIC 20 SELECT FUNCTION 23 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New 4.4. MAIN MENU The Main Menu contains all the type of tests that can be performed with Ves-Matic 20 / 20Plus New, the results of the last (up to a maximum of 3) complete cycles carried out by the unit (*) and the Setup to configure the unit. To access the Main Menu, select under the Select Function Menu: To scroll the items displayed, use the arrow keys: e To exit from the Main Menu, press key: Items of the Main Menu: ANALISYS - ESR F1 ANALISYS - ESR F2 ANALISYS - ESR KINETICS F1 ANALISYS - ESR KINETICS F2 ANALISYS – STORED (*) SETUP- PARAM. SETTING 4.5. DESCRIPTION OF THE TEST CYCLES The sections here below describe the phases carried out by the unit during the six available cycles: ANALISI ESR F1 (Erythrosedimentation rate 1h) ANALISYS ESR F1 Data are supplied in accordance with Westergren's method over a one hour reading. Total duration of the test = 26 minutes. Rev. 0.04 (08/11/01) 24  Instructions Manual VES-MATIC 20 / 20Plus New Description of the examined test: - Cuvette test revolution (the test is stopped if no cuvette are present). - Translation of the plate and reading of the ID if the unit is equipped with an internal bar code. - Plate mixing in accordance with time and speed parameters set. - The first reference reading is taken after about 22 minutes - The second reference reading (which selects the highest value between the two reference readings) is taken after about 20 minutes. - The last reading is taken after 0 minutes, when the unit also calculates the results according to the set mode. ANALISI ESR F2 (Erythrosedimentation rate 2h) ANALISYS ESR F2 Data are supplied in accordance with Westergren's method over a one or two hour reading, together with Katz's index. Total duration of the test = 45 minutes Description of the examined test: - Cuvette test revolution (the test is stopped if no cuvette are present). - Translation of the plate and reading of the ID if the unit is equipped with an internal bar code. - Plate mixing in accordance with time and speed parameters set. - First reference reading - The second reference reading (which selects the highest value between the two reference readings) is taken after about 40 minutes from the end of the test. - The second reading it taken at 20 minutes from the end of the test. - The last reading is taken after 0 minutes, when the unit also calculates the results according to the set mode. 25 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New ANALISI ESR KINETICS F1 (Erythrosedimentation rate 1h) ANALISYS ESR KINETICS F1 Data are supplied in accordance with Westergren's method over a one hour reading. At the end of the test, the unit provides, for each sample, a graphic representation of the trend over time of the sedimentation rate of blood. Total duration of the test = 25 minutes Description of the examined test: - Cuvette test revolution (the test is stopped if no cuvette are present). - Translation of the plate and reading of the ID if the unit is equipped with an internal bar code. - Plate mixing in accordance with time and speed parameters set. - The first reference reading is taken after about 22 minutes - The second reference reading (which selects the highest value between the two reference readings) is taken after about 20 minutes. - 11 intermediate readings are taken at regular intervals. - The last reading is taken after 0 minutes, when the unit also calculates the results according to the set mode. ANALISI ESR KINETICS F2 (Erythrosedimentation rate 2h) ANALISYS ESR KINETICS F2 Data are supplied in accordance with Westergren's method over a one or two hour reading with Katz's index. At the end of the test, the unit provides, for each sample, a graphic representation of the trend over time of the sedimentation rate of blood. Data are supplied in accordance with Westergren's method with ad reading. Total duration of the test = 45 minutes Description of the examined test: - Cuvette test revolution (the test is stopped if no cuvette are present). - Translation of the plate and reading of the ID if the unit is equipped with an internal bar code. - Plate mixing in accordance with time and speed parameters set. - First reference reading - The second reference reading (which selects the highest value between the two reference readings) is taken after about 40 minutes from the end of the test. Rev. 0.04 (08/11/01) 26  Instructions Manual VES-MATIC 20 / 20Plus New - 23 intermediate readings are taken at regular intervals. - The last reading is taken after 0 minutes, when the unit also calculates the results according to the set mode. 4.6. DISPLAYING (AND PRINTING) THE STORED TESTS The unit is designed to store (under menu ANALYSIS STORED) the last 3 (in chronological order) test cycles, when performed, so that they can be displayed and/or printed at a later stage. If the unit is new or recently updated and does not therefore hold stored results, the programme displays the message "!!No test stored!!" returning to the Main Menu after about 2 seconds. Displaying the last 3 cycles: - Select "Analysis Stored" and confirm with OK (if the unit has carried out at least 1 test cycle) to display the following list: ANALISYS MEM:1/3 Num. Of stored analisys F1 06/12 11:20 Analisys type, Analisys Date and Time - Use the arrow keys to scroll the list and select the test to display among those stored. - Press OK to access the next menu. - At this point, the operator can decide to display the test results by selecting DISP or print them by selecting PRINT: - To return to the Main Menu, press ESC. 27 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New 4.7. SETTING THE UNIT UP To fully use the features of Ves-Matic 20 / 20 Plus, it is advisable to set it up as described below. 4.7.1. CONFIGURING TEMPERATURE ADJUSTMENTS The unit is generally able to determine the ESR value and adjust them to ambient temperature. However, the unit can also be programmed to adjust the value to a temperature of 18°C. It is advisable to use this function in laboratories with temperatures above 18°C. Conversion is carried out following Manley's procedure (Reference to bibliography: 11). To enable temperature adjustments - Access the Main Menu and select "Setup-Param.Setting". Then, confirm with OK. - The following message is displayed: TEMPERATURE CORRECTION OFF - Press OK to enable the function TEMPERATURE CORRECTION ON The set condition is enabled until it is changed and displayed (if this function is enabled) in the header of the printout. Repeat the procedure to disable temperature adjustment. 4.7.2. CONFIGURING THE PRINTER To disable the printer in presence of technical problems or if it sufficient to display the results only, follow the procedure described here below. - Access the Main Menu and select "Setup-Param.Setting". Then, confirm with OK. - Use the arrow keys to scroll down to item: PRINT RESULT ON - Press OK to disable the printer. Rev. 0.04 (08/11/01) 28  Instructions Manual VES-MATIC 20 / 20Plus New PRINT RESULT OFF The set condition is enabled until OK is again selected. (ON= Print enabled; OFF= Print disabled) 4.7.3. CONFIGURING THE DISPLAY To display the results, follow the procedure described here below: - Access the menu and select "Setup-Param.Setting". Then, confirm with OK. - Use the arrow keys to scroll down to item: DISPLAY RESULT OFF - Press OK to enable the function DISPLAY RESULT ON The set condition is enabled until OK is again selected. (ON= Display enabled; OFF= Display disabled) 4.7.4. CONFIGURING THE BAR CODE READER To enable the reading with the Bar Code Reader: - Access the menu and select "Setup-Param.Setting". Then, confirm with OK. - Use the arrow keys to scroll down to item: BARCODE OFF - Press OK once to enable the bar code reader inside the unit. BARCODE INTERNAL - Press OK once more to enable the external bar code reader. 29 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New BARCODE EXTERNAL The set condition is enabled until it is changed. Press Esc to return to the parent menu. 4.7.5. QUALITY CONTROL VES-MATIC 20 / 20Plus New enables to use the ESR control (Cod. 10430 4x9 Ml) blood, which identifies a test used to monitor the ESR values. Summary and principles of the method It is common laboratory practise to use stable controls to monitor analytical methods. ESR Control is constituted by stable material that offers the possibility of determining the accuracy and precision of the VES-Matic line instrumentation used to measure the ESR values. This material is diluted and handled as any other sample added with EDTA. Reagents ESR Control is a product that can be readily used for in-vitro diagnostic tests and is constituted by stabilised human erythrocytes suspended in a buffer that does not react with bacteria and fungi. Warning POTENTIALLY HAZARDOUS BIOLOGICAL MATERIAL ESR Control is designed FOR IN-VITRO DIAGNOSTIC USE only. The human components have tested negatively against anti-HIV and anti-HVC antibodies and against HBsAg. Always handle this material as potentially hazardous biological material. Stability and storage Store the bottles in a vertical position at a temperature of 2-30°C when they are not used. DO NOT FREEZE. Integral bottles are stable until the date of expire. After the opening of the packaging, products maintain their stability for at least 31 days at ambient temperature (18-30°C). Avoid exposing open bottles to light for long periods of time. Close all the bottles tightly to avoid the content from evaporating. Rev. 0.04 (08/11/01) 30  Instructions Manual VES-MATIC 20 / 20Plus New Directions for use IMPORTANT: it is very important to mix the ESR Control. 1. Remove the bottles from the refrigerator and leave them at ambient temperature (18 - 25°C) for 20 minutes, before mixing the product. 2. To agitate the control: a) Tilt the bottle until all the cells are re-suspended. Continue mixing for 30 seconds. Avoid the formation of foam. DO NOT USE A VORTEX. b) Examine the bottom of the bottle and verify that there are no suspended erythrocytes. If necessary, repeat the tilting. If the bottles have been stored for long periods of time, it may be necessary to mix the bottles for a longer interval of time. 3. Instructions for the use of the unit with Ves-Matic instrumentation Follow the manufacturer's instructions to fill the test probes. Avoid emptying the diluting agent from the test probe. Use the ESR Control in accordance with the instructions provided by the manufacturer of the instrumentation in use. 4. After every application, thoroughly clean the threading of the cap and of the bottle with absorbent material and immediately retighten the cap. Avoid exposing the open bottle to direct light. Bottles should be carefully closed after use to prevent the product from evaporating. Expected results, performance and specifications Refer to the data given in the leaflet. Setting the unit The QC is performed with a 1h ESR Cycle and a ESR 1h Kinetics Cycle. Procedure: To perform a Quality Check, it is necessary to enable this function under the Quality Control Setup Menu - Scroll the Main Menu down to item: QUALITY CONTROL SETUP and confirm with OK. 31 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New - This selection gives access to the QC Management Menu. The first item is QUALITY CONTROL OFF - Press OK to enable the QC (the set condition is enabled until it changed). - To enter the information needed to perform the QC (the lot number of the kit, the production date, the ESR values of the two serums), select the following items of the Quality Control Menu using the arrow keys 5 and 6. 1. Number of the production lot for ESR Blood LOTTO ______ 2. Date of production of the ESR Blood DATA ______ 3. Min-Max values of the ESR Normal Blood Sample NORMAL __ ___ 4. Min-Max values of the ESR Abnormal Blood Sample ABNORMAL __ ___ - To enter or change the parameters described above, follow the procedure detailed here below. - Press OK to start the entering procedure, from this moment the 5 and 6 key became the UP and DOWN arrows, and the 9 and 0 keys became the LEFT and RIGHT arrows. - Use the UP and DOWN arrows to change the character pointed and the LEFT/RIGHT arrows to select the character to change. - To end the editing session press ESC once, then pressing the ESC key yet, to confirm, the session will end, pressing OK to return to editing the code. - At the end press ESC to exit from the Menu. NOTE: if no data is set, the QC will be carried out using the default values. Rev. 0.04 (08/11/01) 32  Instructions Manual VES-MATIC 20 / 20Plus New 4.8. LOADING AND PROGRAMMING A WORK CYCLE After preparing the samples in accordance with the instructions given in paragraph 4.2, follow the procedure described here below. - Open the door as far as the upper stop. - Insert the samples in the slots. (entering the ID number with the external bar code; see paragraph 4.9.). In this phase, it is necessary to check the status of the springs the keep the cuvette in place and check that the cuvettes have been entered correctly. - After loading the unit, close the door and select the type of test that has to be carried out, as shown in the following Flow Diagram: 33 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New Note: it is always possible to cancel the test by pressing 'ESC' and confirming the cancellation with OK. While the test is in progress, the unit displays the type of test being performed and the time required to complete it. A special safety device stops the mechanical parts issuing an acoustic alarm every time the door is open during the operation of the unit. The displayed message is cancelled when the door is closed, although the acoustic alarm continues to be enabled. The message is cancelled after the door is closed, but the test cycle is interrupted. RESUME ANALYSIS To resume the last cancelled test, press in the Select Function Menu. This function is enabled only if the last test cycle has been intentionally (A) or accidentally (B) stopped. (A) Example: the door has been opened to insert new samples in the free slots, to correct the blood levels of the samples or the test has been cancelled to correct the previously entered data. (B) Example: due to external reasons, like a power failure. The programme creates a backup file that contains all the information of the samples examined, including the ID number acquired with the external bar code, the number of samples entered, etc.. This file is resumed every time the test is restarted. At the end of the test, the unit prints, if the printing feature is enabled, the following report: [Cycle: progressive number that identifies the number of test cycles carried out from when the unit has been turned on]. 4.9. ENTERING THE ID NUMBER Ves-Matic 20 / 20Plus New is designed to acquire the ID numbers [an alphanumerical number of a maximum of 13 digits] both through an internal and external bar code. These readers enable to associate to each tested sample the related ID number (ID). Rev. 0.04 (08/11/01) 34  Instructions Manual VES-MATIC 20 / 20Plus New It is possible to perform this operation following two procedures, according to the type of Barcode. A. Procedure recommended for the INTERNAL BAR CODE - Select and start a test cycle. - The unit carries out a test cycle, a translation, with plate in mixing position, and scans the identification numbers of the samples found. - If the unit is able to correctly read the codes of all the samples, it continues the test. - If the unit is unable to read the codes of all the inserted samples, it issues an acoustic alarm returning the plate to idle position. The display shows the first position with unreadable or missing code. At this point the operator can: 1. Decide not to take any action. After about one minute, the unit automatically resumes the test cycle from where it has been interrupted (displaying the countdown). 2. Manually enter the missing ID's (pressing OK to manually enter the ID number or ESC to go to the next position). 3. At the end of this operation, the cycle is resumed from where it had been interrupted. B. Procedure recommended for the EXTERNAL BAR CODE - Select and start a test cycle. - The user will be asked to confirm the ID's read (through the displayed message ‘Manual Loading ?’ ). - If the reading is disabled (pressing ESC), the unit resumes the test cycle normally. - If the reading is enabled (pressing OK) , the unit moves the sample-holder plate to position 1 next to the reading unit, positioning the sensor along half-way of its stroke. During this phase, the unit displays message: POS.1 ID= ************* issuing an acoustic signal. - The operator can read the ID (displayed) of the sample with the bar code reader. If after 10 seconds the instrument doesn’t receive the code from the reader the message ‘Edit or Retry ?’ will be displayed, pressing the DISP key the operator can enter the code manually (see ‘Entering the ID number Manually‘), instead pressing OK it is possible to repeat the reading with the bar code reader. To stop the 10 second timeout and enter the code manually press ESC, the message ‘Edit Barcode ?’ will be displayed, and then DISP. - At this point, the unit wait for the sample to be entered in the correct position, then issues a long acoustic signal moving to the next position. - The procedure will end automatically when the sample-holder plate is full. Otherwise it can be ended pressing ESC two times, the message ‘End Loading ?’. Press OK to end the procedeure. - At the end of the procedure, it is possible to press OK and upon request key OK to print the list of the entered ID's. 35 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New NOTE: if there are samples without ID, it is still possible to enter them in the position displayed. The unit issues a confirmation signal and moves to the next position without displaying the ID's. 4.9.1 ENTERING THE ID. NUMBER MANUALLY To enter the id number manually the unit must be set with the external barcode in the Parameter Setup Menu. - Select and start a test cycle. - The user will be asked to confirm the ID's read (through the displayed message ‘Manual Loading ?’ ). - If the reading is disabled (pressing ESC), the unit resumes the test cycle normally. - If the reading is enabled (pressing OK) , the unit moves the sample-holder plate to position 1 next to the reading unit, positioning the sensor along half-way of its stroke. During this phase, the unit displays message: POS.1 ID= ************* issuing an acoustic signal. - To enter the Id code manually press ESC once. The message ‘Edit Barcode ?’ will be displayed. Pressing DISP will open the editing session. EDITING SESSION - The display show the message ‘Input Barcode’ followed by 13 dots characters ‘.’. - Press OK to start the entering procedure manually, from this moment the 5 and 6 key became the UP and DOWN arrows, and the 9 and 0 keys became the LEFT and RIGHT arrows. - Use the UP and DOWN arrows to change the character pointed and the LEFT/RIGHT arrows to select the character to change. - To end the editing session press ESC once. The message ‘Are you sure ?’ will be displayed, then pressing the ESC key yet the session will end, pressing OK to return to editing the code. - At this point, the unit wait for the sample to be entered in the correct position, then issues a long acoustic signal moving to the next position. - The procedure will end automatically when the sample-holder plate is full. Otherwise it can be ended pressing ESC two times, the message ‘End Loading ?’ will be displayed. Press OK to end the procedeure. - At the end of the procedure, it is possible to press OK and upon request key OK to print the list of the entered ID's (JobList). Rev. 0.04 (08/11/01) 36  Instructions Manual VES-MATIC 20 / 20Plus New NOTE 1: the code will be maximum 13 characters long. If there era less than 13 characters the end of the code will be the first dot character (‘.’) found. All the characters following a dot will be discarded. Is it possible to change a character in a dot to clear it and break the code. NOTE2: if there are samples without ID, it is still possible to enter them in the position displayed. The unit issues a confirmation signal and moves to the next position without displaying the ID's. 4.10. UPDATING DATE AND TIME To update Date and Time, follow the procedure described here below: - Press key 7 in the Select Function Menu. - The following menu is displayed: DATE (dd/mm/yyyy) 10/05/2001 - Press ESC to enter a new date in the sequence Day/Month/Year. - Press OK to store the new entered data and change the time. (or press ESC once more to cancel the operation and return to the Select Function Menu). TIME HH : MM : SS 12 : 56 : 06 - Press ESC to enter a new time in the sequence Hours/Minutes/Seconds - Press OK to store the new entered data and change the time. (or press ESC once more to cancel the operation and return to the Select Function Menu). The date and time will be stored in the memory even if the unit is turned off. 37 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New CHAPTER 5 MAINTENANCE 5.1. GENERAL RECOMMENDATIONS ................................................................................... 39 5.2. CLEANING THE UNIT........................................................................................................ 39 5.3. REPLACING THE PAPER IN THE PRINTER ................................................................... 39 5.4. REPLACING THE CHECK DEVICE .................................................................................. 41 5.5. REPLACING THE FUSES ................................................................................................... 41 5.6. PERIODICAL INSPECTIONS ............................................................................................. 42 5.6.1. CHECKING THE SAFETY (MICROSWITCH) AND ACOUSTIC DEVICES ................. 43 5.6.2. INSPECTING THE SPRINGS .............................................................................................. 44 Rev. 0.04 (08/11/01) 38  Instructions Manual VES-MATIC 20 / 20Plus New 5.1. GENERAL RECOMMENDATIONS VES-MATIC 20 / 20Plus New has been designed and manufactured to reduce to the minimum ordinary and extraordinary maintenance. Before performing any operation: - Disconnect the unit from the mains - Use the individual protection means that are employed during the operation of the unit. - Check that the guards are in place and that the safety devices are enabled Use individual safety means to remove blood leakage that may have stained the external surface of the unit during the operating cycle. 5.2. CLEANING THE UNIT The external surface of the unit must be cleaned for safety purposes. Always use a mild and neutral detergent to perform this operation. To clean the interior of the unit, contact an authorised Service Centre. 5.3. REPLACING THE PAPER IN THE PRINTER Procedure: 1. Disconnect the unit from the mains. 2. Push the printer door inwards so that it can be opened by the snapping of the mechanism. 39 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New 3. Replace the existing paper roll with a new one. 4. Lift the print head using the side lever provided for this purpose. 5. Insert one end of the paper strip into the paper guide (2), cutting it straight with a pair of scissors (1) and making sure that its direction of rotation is correct (3). 6. Restart the unit. 7. Push the paper until it is picked-up automatically by the printer. 8. Lower the lever of the print head. 9. The paper continues to be fed until it projects from the front side. If the paper is not ejected, press button S2 (the button on the upper left of the control board). 10. Pull the paper outwards so that it can be cut. 11. Cut the paper projecting from the front part. 12. Close the door. Rev. 0.04 (08/11/01) 40  Instructions Manual VES-MATIC 20 / 20Plus New 5.4. REPLACING THE CHECK DEVICE All VES-MATIC 20 / 20Plus New units supplied to customers have already been inspected and preset to perform the first 4,000 samplings without the Check Device. Upon completing the first 4,000 samplings, it is necessary to install a new Check Device into the housing provided for this purpose. Procedure 1. Turn OFF the instrument. 2. Insert the Check Device card in the card-holder (located in the front side of the instrunent), keeping the golden contacts in the bottom side, and following the arrow printed on the card. 3. Turn ON the instrument. 4. When the message ‘Load Check Device ?’ will be displayed, press the OK key. The replacement operation should be carried out only when the unit is off. It is advisable to replace the Check-Device before it is completely unusable, that is when there are about forty tests to be carried out. 5.5. REPLACING THE FUSES This type of operation falls within the category of extraordinary maintenance and is the only operation that can be carried out by the operator. Contact the Technical Support for the extraordinary maintenance operations that are not described in this paragraph. Replace the fuses following the procedure outlined here below: 1. Turn the unit off and disconnect it from the mains. 41 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New 2. Use a flat screwdriver to remove the fuse-holder box. 3. Replace the faulty fuses with the new ones supplied with the unit. 4. Assemble the fuse-box and reconnect the unit to the mains. 5. Turn the unit on Contact the Technical Assistance, if the fuses burn once more when the unit is restarted. 5.6. PERIODICAL INSPECTIONS The inspections described here below should be carried out periodically to ensure the safety of the operator and the good working order of the machine. Rev. 0.04 (08/11/01) 42  Instructions Manual VES-MATIC 20 / 20Plus New 5.6.1. CHECKING THE SAFETY (MICROSWITCH) AND ACOUSTIC DEVICES This operation should be carried out when the unit is on but there are no parts moving. 1. Close the door and run a test cycle. 2. Reopen the door while the plate is moving. If the unit is operating correctly, the moving parts stop and the machine issues an acoustic alarm. NOTE: if this condition does not occur, contact the Technical Support. 43 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New 5.6.2. INSPECTING THE SPRINGS This operation should be performed when the unit is off. Insert a cuvette at about half of each slot without applying pressure. The springs are regarded efficient if the cuvette is able to maintain this position (1). If the cuvette is pushed by gravity right into the slot, the spring could be loosened or broken and must be replaced (2). Rev. 0.04 (08/11/01) 44  Instructions Manual VES-MATIC 20 / 20Plus New 45 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New CHAPTER 6 SELF-DIAGNOSTICS 6.1. SELF-DIAGNOSTICS .......................................................................................................... 47 Rev. 0.04 (08/11/01) 46  Instructions Manual VES-MATIC 20 / 20Plus New 6.1. SELF-DIAGNOSTICS Besides controlling the peripherals, the microprocessor also regularly controls the main components of the unit. When an anomaly occurs, the unit immediately stops the cycle in progress and sends an acoustic alarm, displaying at the same time the type of anomaly or problem occurred. The unit displays the following messages: MESSAGE AND PROBLEM CAUSE AND CORRECTIVE ACTION ERROR READING This message is displayed when the optical This problem can be caused both by electric reader unit movement is not completed within failures or by mechanical problems, that must the given limit. be removed. For electric problems, contact a qualified technician. Always check that the cuvettes are correctly inserted on the plates. ERROR PLATE This message is displayed when the full This problem can be caused both by electric rotation of the cuvette-holder plate does not failures or by mechanical problems, that must occur within the given limit. be removed. For electric problems, contact a qualified technician. TRANSLATION ERROR This message is displayed when the full This problem can be caused both by electric translation of the cuvette-holder plate is not failures or by mechanical problems, that must completed within the given interval. be removed. For electric problems, contact a qualified technician. CHECK-DEVICE EXHAUSTED This message is displayed when the Check Replace the Check Device with a new one. If Device needs to be replaced. the error persists, contact a qualified technician. ERROR PRINTER This message is displayed when a printer fault Contact a qualified technician occurs. 47 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New MESSAGE AND PROBLEM CAUSE AND CORRECTIVE ACTION SAMPLE ABSENT This message is printed when no samples are present or when in presence of samples with an hematocrit value < 15% SAMPLE EMPTY This message is printed when an empty cuvette is recognized by the instrument or when in presence of samples with an hematocrit value < 15%. SAMPLE LOW This message is printed when the sample Correctly fill the cuvette with the same blood level is too low. Or when in presence of sample following the instructions given on the samples with an hematocrit value < 15%. leaflet supplied with the cuvette package. (ex. use a small, well mixed, volume of the same sample assigned to the hemochrome test). Seal the cuvettes carefully and repeat the test. SAMPLE HIGH This message is printed when the sample Reduce the cuvette content following the level is too high. instructions given on the leaflet supplied with the cuvette package. Seal the cuvettes carefully and repeat the test. This message can also occur if the opto- Even in this case, it is necessary to contact a electronic elements are faulty. qualified technician. ANALYSIS ABORTED This message is printed if STOP is pressed during the working cycle. Every time an ERROR message occurs, it is always advisable to repeat the whole operation at least once to make sure that the error is not originated from external causes; for example, an interruption or temporary variation in the supply voltage. Turn the unit off and wait a few seconds. Restart the unit and resume the cycle as described above. Rev. 0.04 (08/11/01) 48  Instructions Manual VES-MATIC 20 / 20Plus New 49 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New CHAPTER 7 EXTERNAL CONNECTIONS For further explanations and information, consult the specific manuals of the devices to be connected. 7.1. CONNECTING A BAR CODE READER TO VES 20/30 INSTRUMENTATION ........... 51 7.2. CONNECTION A HOST COMPUTER TO VES 20/30 INSTRUMENTATION ............... 52 7.3. SPECIFICATIONS FOR THE BIDIRECTIONAL ASYNCHRONOUS SERIAL COMMUNICATION PROTOCOL .................................................................................................. 53 7.4. VES20/30 SERIAL COMMANDS AND PARAMETER FORMAT................................... 54 7.5. SPECIFICATION OF THE VES-MATIC 20/30 MONODIRECTIONAL COMMUNICATION PROTOCOL .................................................................................................. 60 Rev. 0.04 (08/11/01) 50  Instructions Manual VES-MATIC 20 / 20Plus New 7.1. CONNECTING A BAR CODE READER TO VES 20/30 INSTRUMENTATION The identification number of the samples (ID) can be entered manually or through the BAR CODE READER. 1. Before performing any connection, check that the presence of the following signals on the connector used for connection purposes (refer to the instruction manual of the bar code reader): EXTERNAL DB9 CONNECTOR SIGNAL 9 +5V 3 Data reception from bar code reader 5 GND 2. Connect instrument to external barcode TECHNICAL INFORMATION: The connection is performed using the 9-pin DB9 connector situated on the rear of the machine. The electric levels of signals are RS232. Communications are sent only from the bar code reader to the machine. The baud rate is 9600 bit/s, the data format has 8 data bits, 1 stop bit and no parity bit. The communication protocol is ASCII, the read bar code must end with a Carriage return character (0x0d). 51 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New 7.2. CONNECTION A HOST COMPUTER TO VES 20/30 INSTRUMENTATION Check that the connection cables are 3 wire connectors (Tx-Rx-Gnd) and are connected as follows (Standard Cable): VES CONNECTOR HOST-COMPUTER CONNECTOR Type DB9 Type DB9 Type DB25 2 2 3 3 3 2 5 5 7 Contact the Technical Assistance for the serial configuration. Rev. 0.04 (08/11/01) 52  Instructions Manual VES-MATIC 20 / 20Plus New 7.3. SPECIFICATIONS FOR THE BIDIRECTIONAL ASYNCHRONOUS SERIAL COMMUNICATION PROTOCOL Representation of the bytes transmitted on the serial line: STX BLK BLK LEN LEN ADD ADD COM COM D1 ... Dn ETX CHK CHK Each box represents 1 byte transmitted on the serial port. The pair of bytes will instead be packed in the memory and return to the value of 1 byte. STX : Character ASCII '>' 0x3E BLK : Block Number LEN : Number of characters, from D1 to Dn (included) If ADD=ADD+0x80, the end of the block is given by ETX and CHK is not controlled. ADD : Device ID (00 and FF = Reserved) Available range 01-7F COM : Command ID D1.Dn : Command related data ETX : Character ASCII 'CR' 0x0D CHK : CheckSum (XOR from STX to Dn included) The reply to the protocol will have to be part of the receiving device: ACK / NAK ADD ADD ETX ACK : Character ASCII 0x06 If the command block has been correctly interpreted according to the protocol specifications NAK : Character ASCII 0x15 If the command block is not compliant with protocol specifications ADD : Device ID If data transaction requires the use of more blocks, these will be numbered in progressive order starting from 0. Every transmission of more blocks should end with a block with a length equivalent to zero. 53 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New 7.4. VES20/30 SERIAL COMMANDS AND PARAMETER FORMAT Each command is interpreted and receives as reply ‘ACK’=[0x06]+ID+CR If a syntax error occurs or an incorrect command is issued, the reply will be ‘NACK’=[0x15]+ID+CR 0x01: Request of version Example: From Host >00000181+CR+00 Asks unit with ID ‘01‘ to run command ‘81’ (that is command ‘01’ without checksum control ) From ESR >00190101VES MATIC 20New Rel. 1.00+CR+10 0x02: Request list of stored tests The returned data field is formed by the number of tests stored in ASCII hex format (2 bytes) followed by15 byte separated by ‘;’ which specify the type, date and time of the test. Example: From Host >00000182+CR+00 Asks unit with ID ‘01‘ to run command ‘82’ (that is command ‘02’ without checksum control ) From ESR >0031010203F1 28/04 15:41;F2 28/04 15:49;F2K 28/04 16:13+CR+15 0x03: Request test transmission Example: From Host >0002018303+CR+00 Asks unit with ID ‘01‘ to run command ‘83’ (that is command ‘02’ without checksum control) with parameter ‘03’ indicating the number of tests that should be received. From ESR The reply can be formed by more blocks, depending on the quantity of information present in the test. Rev. 0.04 (08/11/01) 54  Instructions Manual VES-MATIC 20 / 20Plus New The unit transmits a 20 byte header with information regarding - Type of test 1 byte (0x01=F1, 0x02=F2, 0x03=F1K, 0x04=F2K) - ESR settings during the reception 1byte (X X BO BE BI FP FD FT where FT= temperature correction flag 1 is ON, FD=Displayed results flag, FP=Printed results flag, BI=Internal bar code selection flag, BE=External bar code selection flag, BO= Barcode deselection flag) - Number of samples 1 byte - Cycle 1byte - Temperature during test 1 byte - Test date 10 byte hex-ascii - Test time 5 byte hex-ascii Followed by a number of 40 byte fields equivalent to the "Number of samples" with the following format: - Position number 1 byte - Status flag 1 byte - Barcode 13 byte Hex-ascii - ESR results 24 byte - Katz index 1 byte Flag Status can acquire the following values: - 0x81 Abnormal cuvette - 0x82 High cuvette - 0x84 Low cuvette - 0x88 Empty cuvette - 0x00 Ordinary cuvette If the test carried out is of type F1, the ESR results will be equivalent to the first byte of the 24. The Katz index shall not be taken into account. If the test carried out is of type F2, the ESR results will be equivalent to the first two bytes of the 24. The Katz index will also be taken into account If the test carried out is of type F1K, the ESR results will be equivalent to the first 12 bytes of the 24. The Katz index shall not be taken into account If the test carried out is of type F2K, the ESR results will be within the first 24 bytes. The Katz index will also be taken into account. 55 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New 0x04: Command to request the unit status The unit status is constituted by 2 ASCII hex integers represented by means of two sets, each with 4 bytes. The first four bytes contain the following information: Bit value: Bit Code 0 Test type 1 Test type 2 Test type 3 Reset in progress 4 Check -Device expired 5 Open cover 6 Sample reading in progress 7 Mixing in progress 8 Centrifugation in progress 9 Test aborted 10 Error condition 11 -- 12 -- 13 -- 14 -- 15 -- The three Type of test bits 0,1 and 2 represent: • 0x01 F1 Normal • 0x02 F2 Normal • 0x03 F1 Kinetic • 0x04 F2 Kinetic The second group of 4 bytes represents the time in seconds needed to complete the test in progress. Example: From Host Send command >00000184+CR+00 00 Ask the unit with ID ‘01‘ to run command ‘0x84’ (that is command ‘0x04’ without checksum control) From ESR >00080104008105CD+CR+4D The status is codified as 0x0081, that is an ordinary F1 test in progress and a mixing stage in progress. The seconds needed to complete the test are 0x05CD, that is 1485 seconds. Rev. 0.04 (08/11/01) 56  Instructions Manual VES-MATIC 20 / 20Plus New 0x05: Reading the Setting register The unit returns the value of the setting register in 2 ASCII hex bytes. The register bit have a Boolean value (1=ON) Bit Code 0 Temperature correction 1 Displayed results 2 Printed results 3 Internal barcode 4 External barcode 5 Disabled barcode 6 -- 7 -- Example: From Host Send command >00000185+CR+00 00 Ask the unit with ID ‘01‘ to run command ‘0x85’ (that is command ‘0x05’ without check sum control) From ESR >0002010525+CR+3F Consequently: temperature correction is ON, Printed results is ON and the Barcode is disabled. 0x06: Writing in the Setting register This command enables to set the Setting register. Example: From Host >0002018682+CR+00 Ask the unit with ID ‘01‘ to run command ‘0x86’ with data field 0x82 (that is command ‘0x06’ without checksum control). This sets: Temperature correction OFF, Displayed results ON, Printed results OFF, Internal barcode ON. From ESR Replies ‘ACK’ for positive results; otherwise it replies ‘NACK' 57 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New 0x07: Start test The command enables to start and select the type of test. The type is codified as follows: Type Code 0x01 F1 Normal 0x02 F2 Normal 0x03 F1 Kinetic 0x04 F2 Kinetic Example: From Host Sends command >0002018703+CR+00 Ask the unit with ID ‘01‘ to run command ‘0x87’ with data field 0x03 (that is command ‘0x07’ without checksum control). This start the F1 kinetic test. From ESR Replies ‘ACK’ for positive results; otherwise it replies ‘NACK' 0x08: Block analysis The command enables to block the test in progress. Example: From Host Send command >00000188+CR+00 Ask the unit with ID ‘01‘ to run command ‘0x88’ (that is command ‘0x08’ without checksum control). From ESR Replies ‘ACK’ for positive results; otherwise it replies ‘NACK' 0x09: Read Barcode It reads the barcode stored in the requested position. Positions range from 0 to 19 for VES20. Example: From Host Send command >000201890D+CR+00 Ask the unit with ID ‘01‘ to run command ‘0x89’ (that is command ‘0x09’ without check sum control) with data field 0x0D, that is ask the barcode to be sent to position 13. From ESR >000D0109 . . . . . . . . . . . . . +6C Rev. 0.04 (08/11/01) 58  Instructions Manual VES-MATIC 20 / 20Plus New The units sends the 13 character code related to the requested barcode. 0x0A: Write barcode This command enables the write the barcode in the desired position during the test cycle. Positions range from 0 to 19 for VES20. Example: From Host Send command >000F018A07ABCDEFGHILMNO+CR+00 Ask unit with ID ‘01‘ to run command ‘0x8A’ (that is command ‘0x0A’ without checksum control) with data field 07ABCDEFGHILMNO. This enables to write the bar code “ABCDEFGHILMNO” in position 0x07. From ESR ‘ACK’ if the reply is positive; otherwise ‘NACK’ 0x0B: Read Date and Time This command enables to read the internal timer of the unit. The reply is formatted with 6 ASCII hex characters (12 byte) that refer to: hour, minutes, seconds, date, month and year. Example: From Host Send command >0000018B+CR+00 Ask unit with ID '01' to run command ‘0x8B’ (that is command ‘0x0B’ without checksum control). From ESR >000C010B0B14040C0C00+CR+4D The data field provides the following data: 11:20:04 hours with date 12/12/00 0x0C: Set date and time This command enables to set the internal timer of the unit. The command data field is formatted with 6 ASCII hex characters (12 byte) that refer to: hour, minutes, seconds, date, month and year. 59 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New Example: From Host Send command >000C018C0C00000F0601+CR+00 Ask unit with ID '01' to run command ‘0x8C’ (that is command ‘0x0C’ without checksum control) with data field 0C00001F0601. This enables to set the timer at 12:00:00 hours and with a 15/06/01 date . From ESR ‘ACK’ if the reply is positive; otherwise ‘NACK’ 0x0D: Read Check-Device The command returns the value of the formatted Check-Device as ASCII hex integer (4 byte). Example: From Host Send command >0000018D+CR+00 Ask unit with ID ‘01‘ to run command ‘0x8D’ (that is command ‘0x0D’ without checksum control). From ESR >0004010D0F99+CR+39 The Check-Device value is 0x0F99, that is 3993 7.5. SPECIFICATION OF THE VES-MATIC 20/30 MONODIRECTIONAL COMMUNICATION PROTOCOL When the instrument is switched on, the following string of 5 characters is send to the Host Computer [CR]Com> During performance of the analysis, the instrument transmits the hard-copy of the data sent to the printer with the following specifications. An echo is made of all the lines of the heading sent to the printer before the results are printed, terminating with the NULL and CR characters; lastly, a string of SPACE characters terminating with NULL and CR characters. Below are the lines containing the results, starting with CR character. Rev. 0.04 (08/11/01) 60  Instructions Manual VES-MATIC 20 / 20Plus New The records are therefore of 2 types: Type 1 STRING-NULL-CR Type 2 CR-STRING where: STRING : Sequence of 24 printable ASCII characters. CR: Carriage Return (ASCII 0x0D) NULL: Null (ASCII 0x00) SPACE: (ASCII 0x20) Example of display on the Host Computer: VES MATIC 20 (**) VES MATIC 20 PLUS **************************** (**) CYCLE------------------------------- 1 (**) SELECT --------------------------- F1 (**) TEMEPERATURE------------- OFF (**) Q.C.-------------------------------- ON (**) DATE(mm/dd/yy) ---------10/22/97 (**) TIME(hh:mm:ss) ----------10:21:33 (**) 1 = SAMPLE ABSENT (*) 2 = ----------------------------------- 1 (*) .. = ---------------------------------- -- (*) .. = ---------------------------------- -- (*) 20= SAMPLE LOW (*) 15= SAMPLE LOW (**) Lines of print of which a type 1 echo is made (*) Lines of print of which a type 2 echo is made 61 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New Example of program receive data from HOST-COMPUTER Below is an example of software (written in basic) apt to receive data from serial port during analysis EXAMPLE OF DATA 100 OPEN “com1:9600,n,8,1,cs,ds,cd” FOR RANDOM AS #1 ‘Open RS232 com1 110 OPEN “spool.txt” FOR OUTPUT AS #2 ‘Open capture file 120 IF NOT EOF(1) THEN ‘Start of loop 130 a$ = INPUT$(1,1) ‘Extracts characters 140 IF a$ = CHR(3) THEN GOSUB 200 ‘If character CR elaborates 150 PRINT #2,a$; ‘Update file 160 END IF ‘End of loop 170 IF INKEY$ = CHR$(27) THEN 190 ‘Exit if ESC pressed 180 GOTO 120 ‘Continue loop 200 REM Routine di elaborazione ... ... ... ... ... ... ... ... 500 RETURN Rev. 0.04 (08/11/01) 62  Instructions Manual VES-MATIC 20 / 20Plus New REFERENCES 1. Westergren A.: The Technique of the red cell sedimentation reaction. Am. Rev. Tuberc. 1926; 14: 94-101. 2. Silvestri M.G., Cozza E., Bertoli G., Federzoni C., Marzullo F.: Determinazione Automatica della velocità di Eritrosedimentazione. Assoc. Italiana Patologi Clinici XXXIV Congresso Nazionale 1984, Abstract. 3. De Franchis G., Carraro P., D'Osualdo A., Di Vito S.N., Paleari C.D.: Valutazione del Sistema Ves-Tec/VES-MATIC. Confronto con il Metodo ICSH. Il Patologo Clinico 1985; 4:120. 4. Jou J.M., Insa M.J., Aymeric M., Vives Corrons J.L.: Evaluación de un Sistema Totalmente Automático para realizar la Velocidad de Sedimentación Globular. Sangre 1988; 33 (6):474- 478. 5. Prischl F.C., Schwarzmeier J.D.: Automatisierte Bestimmung der Blutkor- perchensenkungsgeschwindigkeit (VES-MATIC): Einsatz im Krankenhaus. Berichte der OGKC 1988; 11:112-114. 6. Vatlet M., Brasseur M., Poplier M. et al.: Evaluation of the DIESSE VES-MATIC for the Automated Determination of the Erythrocyte Sedimentation Rate (ESR). Belgian Hematological Society Meeting 1989, Abstract. 7. Vallespì Solè T.: Valor Actual de la Velocidad de Sedimentación Globular. Lab 2000 1989; 19:5-14. 8. Fernández de Castro M., Fernández Calle P., Viloria A., Larrocha C., Jimenez M.C.: Valoración de un Sistema Alternativo Totalmente Automático para la Determinación de la Velocidad de Sedimentación Globular. Sangre 1989; 34 (1):4-9. 9. Koepke J.A., Caracappa P., Johnson L.: The Evolution of the Erythrocyte Sedimentation Rate Methodology. Labmedica 1990; Feb-Mar : 22-24. 10. Caswell M., Stuart J.: Assessment of DIESSE VES-MATIC automated system for measuring erythrocyte sedimentation rate. J. Clin. Pathol. 1991; 44: 946-949. 11. Manley R.W.: J. Clin. Pathol. 1957; 10: 354. 12. ICSH: Recommendation for Measurement of Erythrocyte Sedimentation Rate of Human Blood. Amer. J. Clin. Pathol. 1977; 68 (4): 505-507. 13. ICSH: Guidelines on Selection of Laboratory Tests for Monitoring the Acute Phase Response. J. Clin. Pathol. 1988; 41: 1203-1212. 63 Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New Rev. 0.04 (08/11/01) 64  Instructions Manual VES-MATIC 20 / 20Plus New ENCLOSURE ENCLOSURE A EC DECLARATION OF COMPLIANCE In accordance with Directive 89/392/EEC on machinery Diesse Diagnostica Senese S.p.A. DIESSE Diagnostica Senese S.p.A. with main office in Milan, via san Vittore 96/1 Hereby declares That the design, type of manufacture of the unit described here below and the version distributed on the market are compliant with the main safety requirements established in the relevant EC Directive. This declaration shall not be valid if: - Unauthorised modifications are made to the unit - The unit is used improperly - Unauthorised technical operations are made on the unit - Non original spare parts are used Product: Automatic unit for the determination of ESR values Type: VES-MATIC 20 / VES-MATIC 20 PLUS Technical data: 60-264 Vac (44 to 440 Hz) Is compliant In whole and in all its parts with the following EC Directive and related amendments: EC Directive on machinery (89/392/EEC) EC Directive on low voltage (73/23/EEC) EC Directive on electromagnetic compatibility (89/336/EEC) EC Directive on medical equipment (93/42/EEC) Corresponds In whole and in all its parts to the following harmonised standards and related amendments: - EN 292-1 - EN 292-2 - EN 61010 –1 Milan, The Managing Director A Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New ENCLOSURE C TECHNICAL ASSISTANCE REQUEST AUTHORISED TECHNICAL ASSISTANCE CENTRES: Data to be supplied in written form: 1 – Instrument data: MODEL TYPE DATE OF PURCHASE Y\N (warranty card) 2 – Customer data: NAME ADDRESS CITY COUNTRY ZIP 3 – Retailer data: NAME ADDRESS DEFECT OR FAULT REPORTED: Rev. 0.04 (08/11/01) B  Instructions Manual VES-MATIC 20 / 20Plus New ENCLOSURE D SPARE PARTS REQUEST AUTHORISED DISTRIBUTORS: COMPLETE A READABLE COPY OF THIS FORM AND SEND IT CUSTOMER ADDRESS CITY COUNTRY ZIP MODEL TYPE Y\N (warranty card) CODE DESCRIPTION PACKAGE Q.TY 20400170 1A FUSE (5X20), FAST-ACTING 10 pieces 21650030 CHECK DEVICE 1 piece 21810000 POWER CORD 1 piece 19900550 CUVETTE FOR SENS. TEST 1 piece 12300010 PAPER ROLL FOR PRINTER 4 pieces DATE SIGNATURE C Rev. 0.04 (08/11/01) Instructions Manual VES-MATIC 20 / 20Plus New ENCLOSURE E MANUAL METHOD FOR ESR DETERMINATION, BASED ON WESTERGREN'S TECHNIQUE To perform the ESR determination adopting Westergren's technique, follow the recommendations of the International Committee for Standardization in Haematology (ICSH) (Reference to bibliography: 12, 13), as summarised below. Materials - Blood collected no more than 3 hours earlier, with EDTA-K2 (1.5±0.25 mg per ml of blood) or with EDTA-K3 (1.7±0.3 mg per ml of blood). The hematocrit value must be between 30 and 36% (PCV – packed cell volume = 0.33 ± 0.03). - Anticoagulant/diluent solution composed of bihydrate trisodium citrate 109 mmol/L (3.28 g dissolved in 100 ml of distilled water). - Glass sedimentation tubes with the following dimensions: total length 300±1.5 mm, internal diameter 2.55±0.15 mm and ±0.05 mm uniformity, graduated scale 200±0.35 mm long divided in steps of 10 mm or less and with a maximum allowable error between two divisions of 0.2 mm. The tubes used for the test must be clean, dry and contain no detergent residuals. - Rack designed to maintain the tubes in a perfectly stable vertical position (±1°) to guarantee stability and prevent blood leaks from the tubes. Procedure Dilute the blood collected on EDTA, after careful but not vigorous mixing with citrate 109 mmol/L in the proportion 4+1 (e.g. 2 ml of blood + 0.5 ml of citrate); mix the blood and citrate thoroughly although not vigorously and aspirate into Westergren tubes; place the tubes in the rack, avoiding exposure to direct sun light, vibrations or impacts. After exactly 60 min, read the distance in mm between the lower meniscus of the plasma and the height of the sedimented erythrocytes. Rev. 0.04 (08/11/01) D