R-5656-02-V02_CA360B_DFU_eng_20120320



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Innomed Medical Inc.Cardio-Aid ® 360-B Biphasic defibrillator Direction for use R-5656-02-V02 User manual Cardio-Aid ® 360-B User’s manual R-5656-02-V02 3/89 Contents 1. Introduction, Warnings............................................................................................ 7 2. Recommended areas of use, operation concept....................................................... 9 2.1. Brief description, main parameters ......................................................................... 9 2.1.1. STAR® biphasic waveform.................................................................................... 9 2.2. Cases whereby the defibrillator can be used ........................................................... 9 2.3. Electrodes, recommended setups .......................................................................... 10 2.4. Environment of use ............................................................................................... 10 2.5. Who are entitled to operate the defibrillator?........................................................ 10 2.6. Abbreviations, expressions figuring in the description......................................... 10 2.7. Special advantages of the Cardio-Aid ® 360-B device........................................... 11 3. The Cardio-Aid ® 360-B defibrillator maintanance, assigments............................ 12 3.1. Cleaning of the device........................................................................................... 12 3.2. Regular and periodic maintenance ........................................................................ 12 3.3. Battery handling, maintenance .............................................................................. 13 3.4. Classifications ....................................................................................................... 13 4. Symbols, controls and their functions ................................................................... 14 4.1. Symbols applied on the device.............................................................................. 14 4.2. A CA360-B defibrillator control elements and their functions............................. 16 5. Turning on and off the device ............................................................................... 18 6. Use of the electrodes ............................................................................................. 20 6.1. Defibrillator electrodes.......................................................................................... 20 6.1.1. Disposable defibrillator pacing electrodes ............................................................ 20 6.1.2. Defibrillator paddle electrode................................................................................ 22 6.1.3. Internal defibrillator electrode............................................................................... 23 6.2. ECG patient cable.................................................................................................. 25 6.2.1. 10-lead ECG cable................................................................................................. 25 6.2.2. 3-lead ECG cable................................................................................................... 26 6.2.3. 5-lead ECG cable................................................................................................... 26 6.2.4. ECG from external monitor................................................................................... 26 7. User menu.............................................................................................................. 27 7.1. SEMI AUTO......................................................................................................... 27 7.2. MANUAL mode.................................................................................................... 27 7.3. PACING mode ...................................................................................................... 29 7.4. ECG mode ............................................................................................................. 29 8. Printing.................................................................................................................. 30 9. CA360-B defibrillator alarm system..................................................................... 31 9.1. Concepts connection with ALARM...................................................................... 31 9.2. Curing of alarm system......................................................................................... 32 10. Auxiliary supplies of the defibrillator ................................................................... 34 10.1. QRS recognition and QRS voice........................................................................... 34 10.2. Oxygen saturation (SpO2) measurement .............................................................. 34 10.2.1. Preparing the measurement: .................................................................................. 34 10.2.2. Patient preparation:................................................................................................ 35 10.3. Use of non-invasive blood pressure measurement ................................................ 36 10.3.1. Measurement method: ........................................................................................... 36 10.3.2. Preparing the measurement ................................................................................... 36 4/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 10.3.2.1. Cuff size....................................................................................................... 36 10.3.2.2. Placing the cuff ............................................................................................ 37 11. Therapeutical modes.............................................................................................. 38 11.1. AED mode............................................................................................................. 38 11.2. Manual defibrillation............................................................................................. 45 11.2.1. Asynchronous manual defibrillation ..................................................................... 45 11.2.2. Synchronized cardioversion .................................................................................. 47 11.2.3. Internal defibrillation............................................................................................. 50 11.3. Using of pacemaker.............................................................................................. 50 11.3.1. Quick guideline ..................................................................................................... 51 12. ECG mode ............................................................................................................. 54 12.1. Viewing of ECG.................................................................................................... 54 12.2. Printing in ECG mode ........................................................................................... 56 13. Use of the cofiguration menu................................................................................ 57 13.1. Entering the configuration menu........................................................................... 57 13.2. Handling of the configuration menu ..................................................................... 57 13.3. Elements of the configuration menu ..................................................................... 58 13.3.1. Language selection................................................................................................ 58 13.3.2. Use of defaults....................................................................................................... 58 13.3.3. Alarm settings........................................................................................................ 59 13.3.3.1. Global alarm settings ................................................................................... 59 13.3.3.2. Asystole........................................................................................................ 59 13.3.3.3. Heart rate alarm............................................................................................ 59 13.3.3.4. SpO2 alarm.................................................................................................. 59 13.3.3.5. Pulse alarm................................................................................................... 60 13.3.3.6. NIBP systole, diastole and mean value alarm.............................................. 60 13.3.4. Device setups......................................................................................................... 60 13.3.4.1. Voice menu .................................................................................................. 60 13.3.4.2. Date and time ............................................................................................... 60 13.3.4.3. Date and time format ................................................................................... 60 13.3.4.4. LCD brightness ............................................................................................ 61 13.3.4.5. User identification........................................................................................ 61 13.3.4.6. Mains frequency........................................................................................... 61 13.3.5. Energy settings ...................................................................................................... 62 13.3.5.1. Viewing of delivered energy........................................................................ 62 13.3.5.2. Manual energy – external............................................................................. 62 13.3.5.3. Manual energy- internal ............................................................................... 62 13.3.5.4. Semi-automatic energy – first shock............................................................ 62 13.3.5.5. Semi-automatic energy – second shock....................................................... 63 13.3.5.6. Semi-automatic energy – third shock .......................................................... 63 13.3.6. Mode settings ........................................................................................................ 63 13.3.6.1. Defibrillation mode when turning on........................................................... 63 13.3.6.2. Pacing mode................................................................................................. 63 13.3.6.3. Pace current.................................................................................................. 64 13.3.6.4. Pace rate....................................................................................................... 64 13.3.6.5. Wake-up selftest (automatic selftest)........................................................... 64 13.3.6.6. Wake-up start time (time of automatic selftest)........................................... 65 13.3.6.7. Demo mode.................................................................................................. 65 13.3.7. Signal setup menu ................................................................................................. 65 13.3.7.1. ECG menu.................................................................................................... 65 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 5/89 13.3.7.2. Speed menu.................................................................................................. 66 13.3.8. Periphery setup menu ............................................................................................ 66 13.3.8.1. Automatic printing....................................................................................... 66 13.3.8.2. Printing time................................................................................................. 66 13.3.8.3. Printing speed............................................................................................... 67 13.3.8.4. Printing event report .................................................................................... 67 13.3.8.5. Multichannel printing................................................................................... 67 13.3.8.6. External ECG amplifier ............................................................................... 67 13.3.9. Data saving............................................................................................................ 67 13.3.10. Delete saved data................................................................................................... 68 13.3.11. Service menu ......................................................................................................... 68 14. Technical data of the defibrillator ......................................................................... 69 14.1. Applied standard.................................................................................................... 69 14.2. General data........................................................................................................... 69 14.3. Display................................................................................................................... 70 14.4. LED-displays on the front board........................................................................... 70 14.5. Defibrillator ........................................................................................................... 71 14.6. Battery ................................................................................................................... 72 14.7. ECG via pads or defibrillator paddles electrodes.................................................. 73 14.8. ECG via patient cable and ECG electrodes........................................................... 73 14.9. ECG from external monitor................................................................................... 74 14.10. Heart rate measurement from ECG signal ............................................................ 75 14.11. Pacer ...................................................................................................................... 75 14.12. SpO2 measurement................................................................................................ 75 14.13. Non-invasive bloodpressure measurement (NIBP) ............................................... 78 14.14. Printing.................................................................................................................. 78 14.15. Event storage ......................................................................................................... 79 14.16. Connection possibilities for data transfer .............................................................. 79 14.17. Parameters of defibrillation impulse ..................................................................... 80 15. Accessories, order information.............................................................................. 84 16. Elimination of useless electronic devices as waste ............................................... 86 17. Guidelines and manufacturer statements – electromagnetic compatibility........... 86 6/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 This user’s manual can be used for the CA360-B devices with the software of version number 1.0 or upwards. Innomed Medical Inc. reserves the right for unannounced modifications for the sake of device development. The full or partial copy of this direction for use can only be made with the written permission of our company. All brand names and logos are the officially registered properties of the respective companies. All rights reserved! Budapest, 22.02. 2012. The device is manufactured and distributed by: Innomed Medical Medical Developing and Manifacturing Inc. 1146 Budapest, Szabó József utca 12. (1) 460-9200 Fax: (1) 460-9222 www. innomed.hu [email protected] Cardio-Aid ® 360-B User’s manual R-5656-02-V02 7/89 1. Introduction, Warnings Always check the seals and expiration dates of all the disposable defibrillation and monitoring electrodes. Important! Before unpacking the unit you should be thoroughly familiar with the functions of the defibrillator, with their operation and with this user’s manual. Important! The device can only be used with the accessories listed in this user’s manual, ideal operation is only guaranteed with them. Innomed assumes full responsibility for safety, reliability and performance of this device, in case: • The equipment is used by qualified personnel in accordance with the user’s manual. • Only the accessories listed in the user’s manual are used. • Assembly, modifications or repairs were carried out by your Innomed service center, and parts and components used have been approved by Innomed. • Electrical installations comply with local regulations. Important! Since the waveform (duration and amplitude) from the defibrillator depends on patient impedance, defibrillator charging must only start after the electrodes have been placed on the patient. If charging starts with open defibrillator electrodes, charging will start but will not finish and the device emits visual and audible warning. If the defibrillator electrodes are placed on the patient, the device performs the impedance measurement and finishes charging, and it will only get ready for shock after this. Pushing the shock key the energy is delivered. Remove the electrodes only after the shock delivered. Important! The defibrillator electrodes should be placed on the patient, so that the distance between them are at least 5 cm and there is no gel on the body surface between the two electrodes, saying that no gel-bridge should be formed between the two electrodes, which conducts the current during defibrillation. (see section no. 6.1.2) Important! In semi-automatic mode the defibrillator operates according to ERC2010 guideline. Please read carefully the section titled “Using defibrillator in semi- automatic mode”. 8/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 Important! The defibrillator is using biphasic waveform. In case of VF / VT the recommended energy of first shock is 200 J, according to ERC 2010 guideline. Important! 360 J energy can be set on the device. This is quite a high value, please use it carefully. Such a high energy can only be indicated in case of especially heavy weight in case of biphasic waveform. Important! During the installation and operation of the device please mind the information referring to electromagnetic compatibility, summarized in section no. 17. Important! Be aware that some portable radio frequency communication equipments can interfere with the operation of the device. Important! In case any electronic device is connected to the patient with no defibrillator protection in the input, then it must be removed from the patient for the duration of shocking. The defibrillator electrodes must be well separated from other electrodes and metal surfaces placed on the patient. Inplanted pacemaker, ICD, CRT device should not get into the directionline of the defibrillation energy proximity (between the two pads or the two paddles). Attention! The use of the defibrillator in the presence of flammable agents or in an oxygen enritched atmosphere can cause explosion hazard. Cardio-Aid ® 360-B User’s manual R-5656-02-V02 9/89 2. Recommended areas of use, operation concept 2.1. Brief description, main parameters The defibrillator is an instrument serving for stopping the ventricular fibrillation, it is able to change the electric operation of the heart, by applying a high energy impulse. In case of ventricular tachycardia, the defibrillator is able to restore the normal operation, by applying synchronous defibrillation. In case of sinus tachycardia, bradycardia or strong arrythmia, the device is able to normalize the heart operation, in pacing mode. With the adequate electrodes, it is possible to use the device, in case of heart operation, by the impulse delivered directly to the heart. Besides the energy delivery (defibrillation and pacing) the defibrillator can make ECG, and it can measure some other physiological parameters (eg. HR, SPO2, NIBP). In case of external (transcutaneous) defibrillation, the delivered energy can be 2-360 J in 15 steps, in case of internal defibrillation it can be 1-50 J, also in 15 steps. In defibrillation mode the device performs STAR ® biphasic waveform, and in pacing mode it performs rectangular current impulse. 2.1.1. STAR® biphasic waveform It has been prooved about the STAR biphasic waveform during clinical researches made according to FDA guidelines, that it is one of the most effective waveforms for stopping ventricular fibrillation. STAR (BTE) biphasic waveform characteristics: the period of first phase is depending on patient impedance, 3 – 11 ms, the period of second phase is fixed 3,2ms. The amplitude of the signal depends on the set energy and on patient impedance. 2.2. Cases whereby the defibrillator can be used In manual mode • Applying asynchronous shock for the treatment of ventricular fibrillation with the assistance of external defibrillator paddles or pads or internal paddles. • Applying synchronized shock in case of atrial fibrillation, ventricular tachycardia (cardioversion), with the assistance of external defibrillator electrodes (pads/paddles). • ECG, HR, SpO2, NIBP monitoring. Semi-automatic mode • The device assists the operator by voice and text (step by step) instructions appearing on the display, in the device operation. The device automatically performs the necessary operations, it charges the defibrillator’s energy, and it gives an instruction for the delivery of shock. • Applying of asynchronous shock, in case of recognized fibrillating heart muscle (according to AHA). • ECG, HR monitoring. 10/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 In pacing mode • External pacer, in ’demand’ and in ’fixed’ modes. • ECG, HR, SpO2, NIBP monitoring. In ECG mode • ECG monitoring on 1, 3, 7, or 12 channels • HR, SpO2, NIBP monitoring 2.3. Electrodes, recommended setups The defibrillator paddle electrode of the device can be transformed into pediatric or adult electrodes by only a single rotation, the adhesive defibrillator electrodes and the internal electrodes are available in adult and pediatric sizes as well. The defibrillator can be used for adult and pediatric population. Its application is not recommended for children under the age of 1. For children between the ages 1-8 and under the weight of 25 kg, the application of 2 – 4 J/kg energy is recommended. 2.4. Environment of use The CA360-B defibrillator was primarily made for hospital and clinical use, but it can also be applied during surgeries and by general practitioners as well. In AED mode even a skilled policeman or fireman can operate the device. The device was made for continuous use, but because of the high energy, it must be considered that any defibrillation with greater frequency than two shocks delivery/minute, is only allowed for a short time. 2.5. Who are entitled to operate the defibrillator? The CA360-B defibrillator in semi-automatic mode can be operated by non-professional persons as well, as the defibrillator gives instructions to the operator. Even in such cases, it is advisable that the device should be operated by a person, who has been trained for the use of semi-automatic defibrillators. In case of manual, synchronous and asynchronous defibrillation and in fixed and demand pacing mode, the device can only be operated by a skilled person – physician. 2.6. Abbreviations, expressions figuring in the description The abbreviations figuring in the description are mostly from the English special literature, but they are generally known and can be used in case of other languages as well. In spite of this, it is advisable to give a summary about the used abbreviations and about the expressions figuring in the description. CA Cardiac Arrest, stopping of the heart CRT Cardiac Resynchronisation Therapy ICD Implantable Cardioverter Defibrillator PM Pacemaker CPR CardioPulmonary Resuscitation Cardio-Aid ® 360-B User’s manual R-5656-02-V02 11/89 BLS Basic Life Support, basic level resuscitation AALS Adult Advanced Life Support, lifesaving procedure in case of adults, according to ERC 2010 PALS Pediatric Advanced Life Support, lifesaving procedure in case of children, according to ERC 2010 ROSC Return of Spontaneous Circulation AED Automated External Defibrillator BTE Biphasic Truncated Exponential waveform FDA Food and Drug Administration VT Ventricular Tachycardia VF Ventricular Fibrillation HR Heart Rate NIBP Non-Invasive Blood Pressure SpO2 Oxygen Saturation STAR ® Self-Tracking Active Response, denomination of the applied waveform Pads electrode Disposable, adhesive defibrillator-pacing electrode with gel on it (see section no. 4.1.1) Paddle electrode defi-paddle electrode (see section no. 4.1.2 ) Internal defi paddle electrode spoon electrode for direct defibrillation of the heart (see section no. 4.1.3) Default basic setup by manufacturer Dump status The high-voltage capacitors were discharged by an internal circuit 2.7. Special advantages of the Cardio-Aid ® 360-B device • 100%adaptation of ERC 2010 BLS-AED recommendation • It supports the effort of minimizing CPR interruptions and unintended deliveries of shock, which can cause the injury of the person performing resuscitation. With the defibrillator it is possible to start charging before placing the paddle electrodes on the chest. In this case there is no electric shock hazard, CPR can be continued. When placing the electrode on the chest, charging is finished in quite a short time and the shock can be delivered. • According to the recommendation of ERC 2010 the first shock can be set to a minimum level of 150 J. • In order to reach high efficiency, we set the energy of CA360-B in AED mode to 200- 200-270 J, this way most of the time the delivery of the first shock already stops the fibrillation. 12/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 3. The Cardio-Aid ® 360-B defibrillator maintanance, assigments 3.1. Cleaning of the device Warning! Do not use any aggressive, acidic chemical for cleaning the device, even if they are diluted. Do not use any surface damaging granular material or flammable detergent. Do not sterilize the device and its accessories, only in case it figures in the instructions of the accessory. Clean the defibrillator and the cables with soft cloth or sponge, not with aggressive detergent. During cleaning, make sure that no liquid should enter into the connectors of the device. Pay special attention when cleaning the tube of the blood pressure measurement cuff, because if any water gets into the tube, entering inside the device during the operation of the blood pressure measurement device, it can damage the valve and the compressor. For cleaning you can use alcoholic solution, ammonium solution with water, peroxide solution or any non-aggressive domestic detergents dropped on a dampened sponge. 3.2. Regular and periodic maintenance Continuously make sure that the device and its accessories should be clean and undamaged. Gel and other materials sticked to it, must be cleaned off from the electrodes. The undamaged status of the electrode cables (cable insulation, breaking) must be regularly checked. The battery condition must be followed with attention, if the device indicates the running down of battery, it must be connected to the mains, in order to be replaced. After some years of operation the battery capacity can reduce to that extent that it cannot guarantee the operation conditions described in the technical data. In such cases the device gives an alarm, the battery must be replaced. Battery replacement can only be carried out by a skilled person. Periodically (in 1-2 years) the main parameters of defibrillator must be checked and if needed a calibration must be made. The calibration can only be made by a skilled service person with adequate qualifications. The continuous and reliable operation can be ensured by the allowance of a wake-up test. If we set it, then the defibrillator will automatically turn on once in a day and it will carry out some test examinations. Operation of the wake-up self-test is detailed in section no. 13.3.6.5. This test ensures a continuous check-up, in case of errors or operation faults it will immediately give an alarm. The expected lifetime of the device is 8 years. Cardio-Aid ® 360-B User’s manual R-5656-02-V02 13/89 3.3. Battery handling, maintenance The CA360-B defibrillator works with 3000mAh, NiMH type battery. A fully charged battery would allow minimum 4-hour monitoring, the delivery of 100 shocks at the energy of 270J or 2-hour pacing. The battery capacity level can always be seen on the battery indicator, the explanation of the indicator can be seen in the table of page 14. The defibrillator is equipped with an intelligent battery charger circuit, which carries out all the battery related tasks, therefore the operator does not have to worry about it. If the battery capacity level symbol on the screen indicates the low level of battery, then the defibrillator must be connected to the mains power by a mains cable, by this way charging is started. The charging process is shown by the battery charger LED (18) (see section no. 3.3): The device, connected to the mains, indicates its charging capacity level by flashing signals. In case of being completely charged, the LED is continuously enlighted. In case the device is not connected to the mains, the light of the LED is off. After being connected to the mains, the defibrillator still complies with all the safety requirements, so it can be used without any restrictions. The defibrillator, connected to the mains, is able to operate even with completely empty battery or without battery as well. Warning! Even if the defibrillator is out of use, it still has to be connected to the mains, once in every 3 month, to avoid complete run down of the battery. The lifetime of the battery, in case of normal use, is minimum 2 years. During operation and with time the battery capacity reduces, under a certain critical level the defibrillator indicates the necessity of battery replacement. 3.4. Classifications The CA360-B defibrillator is classified as II.b. according to the rule no. 9 described in the point III./3.1 of the supplement no. IX of the 93/42/EEC board directive amended by Directive 2007/47/EC. From the aspect of electromagnetic compatibility the classification of the CA360-B defibrillator, according to the MSz EN 55011 standard is: group no. 1, class B. 14/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 4. Symbols, controls and their functions 4.1. Symbols applied on the device Input Alarm system enabled Main fuse position Alarm system disabled CF type equipment Alarm suspended Defibrillator-protected CF type equipment Alarm voice set to mute Attention! See the enclosed documentation! Alarm voice switched on set to low voice BF type equipment Alarm voice switched on set to medium voice Dangerous voltage Alarm voice switched on set to laud voice Event No information about the battery Printing Battery capacity < 25% Disarm Battery capacity > 25% Lead selection Battery capacity > 50% Size selection Battery capacity > 75% Error detected by the system Battery capacity > 90% On/off switch Battery error Denomination of manufacturer IP 32 Environment-proof Alternating current SN Serial number of the device Error in the high-voltage system Attention! Consult the user’s manual Cardio-Aid ® 360-B User’s manual R-5656-02-V02 15/89 The equipment is safe, the high-voltage unit is not charged High-voltage capacitors discharged (dump status) Stop-watch symbol, it indicates the time passed since turning on Defibrillator is ready for shock delivery, it is charged In the right lower corner of the screen time can be seen: hour:minute Shock counter symbol, next to it the number of delivered shocks can be seen EKG Line filter EKG muscle filter Asystole alarm Ventricular Fibrillation Alarm or Shockable rithm alarm 16/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 4.2. A CA360-B defibrillator control elements and their functions 22 23 30 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 17/89 Functions of control elements: # Key Function 1 Turning on by keeping the key pressed for half a second Turning off by keeping the key pressed for half a second 2 Lead selector (LEAD) Selects between ECG leads 3 EVENT It stores one ECG curve and data in the internal memory 4 PRINT Starts or stops printing 5 SEMI AUTO Semi-automatic mode 6 MANUAL Manual mode 7 PACING Pacing mode 8 NIBP Starts blood pressure measurement 9 FREEZE It is freezing the screen picture 10 ALARM It switches the alarm on and off in manual and pacing modes. 11 a, b, c Soft Key – 3 pcs. software driven keys Control elements of changing functions, the actual function is displayed over the key. The keys are marked from left to right with the identifications 11a, 11b, 11c. 12 MENU Menu control keys, navigation inside the menu. POKQRS 13 ECG ECG mode – 12-lead ECG 15 DISARM Disarming. Dumps the energy internally 16 Amplifier selector It sets the amplifier of the ECG curve 17 Action key The event to be carried out appears on the screen (analysis, charging, delivery of shock, …) 18 Battery status display Yellow LED. It is not enlighted if the defibrillator is not connected to the mains. It is blinking or continuously enlighted when there is charging. 19 Ready Operation status indicator Green flashing: the defibrillator is ready to use Red flashing: the defibrillator detected error No light, no flashing: the defibrillatoris not ready to use 20 ECG conncetor Patient cable connector (ECG cable) 21 Defi electrode connector Defibrillator electrodes connector 22 Printer 58 mm thermal printer 23 Paddle holder Defi paddle support 24 NIBP Blood pressure measurement cuff connector 25 SpO2 SpO2 sensor connector (Nellcor) 26 HEAD Multiparameter measuring head connector (option) 27 USB A USB Host connector 28 USB B USB device connector 29 LAN Connection to local network 30 Mains connector 100-240V~ 50/60Hz mains cable connector Hereinafter in the description, the control elements and connectors will be referred to with their denominations, by putting before them in brackets the # number given in the above table. Eg. (22) Printer 18/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 5. Turning on and off the device The defibrillator can be turned on and off by the key (1) . When turning on, the control elements must be pressed for about half a second, this way the device will switch on, the next picture will appear and the device selftest will be started. After the running of selftest – which takes about 15 seconds – the defibrillator will be ready for operation, it will set the mode selected in configuration menu (see section no. 13.3.6.1). Cardio-Aid ® 360-B User’s manual R-5656-02-V02 19/89 Turning off can be made by the (1) key in any state of the defibrillator. For this the key has to be pressed for about 2 seconds, in order to avoid accidental turning off. When the defibrillator recognizes the turning off command, the following figure is going to appear on the screen: Hereby the device saves the information and events collected during the operation. During the time of saving the (11b) key can be pressed, this way the saving process can be interrupted, the defibrillator will switch off immediatelly. 20/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 6. Use of the electrodes 6.1. Defibrillator electrodes 6.1.1. Disposable defibrillator pacing electrodes The pacing electrode is a disposable, adhesive, pregelled electrode, which can be immediately used after opening the packaging and removing the protective foil. This electrode is suitable for defibrillation, for transcutaneous stimulation and for ECG signal leading. Hereinafter this type of electrode is going to be referred as pads electrode. Warning! Before use, check the expiration date indicated on the packaging. Plug the cable by pressing it firmly into the connector, situated on the front of the unit Connect the defibrillator electrodes to the cable Place the electrodes on the patient according to the figure indicated on the electrode, or according to other aspects (injury, implanted pacemaker, etc.). Placing of electrodes in case of right- side pacemaker implant. Cardio-Aid ® 360-B User’s manual R-5656-02-V02 21/89 Sterno-Apicalis electrode placement: (right edge of sternum and around theapex) Place the LL (Left Lateral) electrode on the side of the body, under the left breast, and the RA electrode has to be placed on the right side, under the collar-bone. Anterior-Posterior placement can be used for non-invasive pacing, for manual defibrillation and for synchronous cardioversion, but it is not suitable in AED mode and for ECG monitoring. The Anterior (positive electrode, Y or LL) electrode should be on the left side of the body, under the breast, the Posterior (RA) electrode should be on the left side of the back, behind the heart. After you have placed the electrodes, select the desired energy by the energy selector keys (11a) (11b), situated on the front panel, then start charging by the (17) Action key, and if you detect shockable rhythm, you can deliver the shock by the Action key (17). Warning! Make sure that, in order to avoid electric shock, during defibrillaton nobody touches the patient, the conductor liquids in connection with the patient (gel, blood, saline solution) and the metal objects in connection with the patient, like for instance the frame of bed or stretcher. These touches are providing undesirable ways for the defibrillating current. Use of the disposable pacing electrode is indicated in the following cases: Transcutaneous pacer-stimulation Semiautomatic defibrillation „Hands-free” (the operator does not hold the paddle, the electrode is sticked to the patient) defibrillation in manual mode See serial numbers and reorder information in section no. 15. Attention! The defibrillator measures the patient impedance before delivery of shock. In case it is out of the range 20 - 200, the defibrillator will indicate error and it will not deliver the shock. The cause of very low impedance might be the presence of too much current conductor liquid (gel, physiological saline solution, …) on patient’s body. In this case it must be wiped off. In case of too high impedance the electrode might be too dry, or it might be expired. Impedance can be reduced by changing or gelling the electrode. 22/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 6.1.2. Defibrillator paddle electrode Control elements on the defibrillator paddles: The energy selection (1), charging (2) shock delivery (3) can be controlled directly from the keys of the paddles. For shock delivery (defibrillation) the 3d keys of both the right and the left paddles have to be pressed at the same time. Put gel on the electrodes, then place them on patient’s chest: the Apex electrode should be pressed on the side of the body, under the left breast, the Sternum electrode should be pressed on the right side, under the collar-bone. Select the adequate energy by the key marked by1, charge the device by pressing the key marked by 2, and if you detect shockable rhythm, then press the keys marked by 3 from both paddles together at the same tyme, this way shock is delivered. Plug the cable firmly into the front of the unit By rotating the plate, the adult defibrillator paddle can be transformed into pediatric paddle 1 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 23/89 Warning! The defibrillator measures the patient impedance before delivery of shock. In case it is out of the range 20 - 200, the defibrillator will indicate error and it will not deliver the shock. The cause of very low impedance might be the presence of too much current conductor liquid (gel, physiological saline solution, …) on patient’s body. In this case it must be wiped off. In case of too high impedance the electrode might be too dry, or it might be expired. Impedance can be reduced by changing or gelling the electrode. Warning! Make sure that, in order to avoid electric shock, during defibrillaton nobody touches the patient, the conductor liquids in connection with the patient (gel, blood, saline solution) and the metal objects in connection with the patient, like for instance the frame of bed or stretcher. These touches are providing undesirable ways for the defibrillating current. Cleaning: Do not let the gel get dried on the paddle electrodes, because it can make the electrodes to get spoiled early. After use, but at least once in a day wipe the paddle electrodes clean by some paper towels. Attention! During cleaning, the device must be turned off. For paddle electrode ordering information see section no. 15. 6.1.3. Internal defibrillator electrode The internal defibrillator electrode can be used during heart operations, when the chest of the patient is open, the defibrillator impulse can be delivered directly to the heart. Handling Sterilize the internal defibrillator electrodes before use. Plug the defibrillator cable firmly into the socket (21) on the front of the unit. Use the defibrillator spoons carefully, and regularly check them for damage. Do not disassemble, unless you wish to replace certain parts of the electrode. When replacing the spoon do not overtighten. Non-autoclavable connector Autoclavable parts (defibrillator spoon, handle and cable) Do not bend the cable or wind it around the electrodes. Store the electrodes as illustrated here. 24/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 Warning! Make sure that, in order to avoid electric shock, during defibrillaton nobody touches the patient, the conductor liquids in connection with the patient (gel, blood, saline solution) and the metal objects in connection with the patient, like for instance the frame of bed or stretcher. These touches are providing undesirable ways for the defibrillating current. Disassembly To disassemble the autoclavable cable from the non-autoclavable connector, remove the cable from the defibrillator, by pulling at the plug only (never pull at the cable or the strain relief to remove the cable). Press the release button on the connector to remove the cables from the connector. Cleaning Do not clean the paddles in a dishwasher – because it can lead to mechanical wear- instead rub them gently by hand before sterilizing them. The above parts can be steam-autoclaved. Recommended temperature: 134ºC (maximum 140ºC, 284ºF) Pressure: 2.2 bar (32 PSI) Duration: 3.5 minutes Extraction drying: 7-8 minutes Reorder information There are 3 different sizes of internal spoons. See reorder information in section no. 15. Cardio-Aid ® 360-B User’s manual R-5656-02-V02 25/89 6.2. ECG patient cable Three different types of ECG cable can be connected to the device. The applied ECG cable is automatically recognized by the device, and it will set the screen picture accordingly, and it will decide which leads can be selected by the lead selector keys. 6.2.1. 10-lead ECG cable ECG electrodes must be placed in a way that they should ensure good contact, in order to get a record without any noise. In case of using disposable electrodes, the expiration date indicated on the packaging must be checked, and they can only be used in case their expiration date is still valid. In case of using clip and suction electrodes, gel should be applied, in order to get a good contact. Placement of electrodes in case of standard and Cabrera leads: For ordering information see section no. 15. R L F N R: right hand L: left hand N: right leg F: left leg V1: in the IV. rib space at the right edge of the sternum V2: in the IV. rib space at the left edge of the sternum V3: in the midpoint between V2 and V4 leads V4: in the V. rib space, on the mediclavicular line V5: in the V. rib space, on the frontal armpit line V6: in the V. rib space, on the middle armpit line 26/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 6.2.2. 3-lead ECG cable This cable can be used in case there is no need for chest leads, when you only want to see the I, II, III leads by 3 pcs adhesive electrodes. Placement of electrodes can be seen on the following figure: For ordering information see section no. 15. 6.2.3. 5-lead ECG cable This cable is for monitoring limb leads (I, II, III, aVR, aVL, aVF) and one chest lead. With this cable, 3 simultaneously measured leads (I, II, Vx) and 4 calculated (III, aVR, aVL, aVF) leads can be monitored. It depends on the placement of the white color electrode, which chest lead can be seen. We can see the chest lead of where we place the electrode. For ordering information see section no. 15. . 6.2.4. ECG from external monitor There is a possibility to connect ECG signal from an external ECG monitor, e.g. diagnostic ECG or patient monitor. So if ECG electrodes already are on the patient, it is not necessary to connect more electrodes. The output voltage of external ECG monitotmust be in ±10 V range, this signal must be connected to the (20) ECG input connector by a cable, available from manufacturer.The delay of monitor output signal may be max 10 ms, this is the responsibility of user. The sensitivity of monitor may be 100 mV/mV or 1000 mV/mV. In the configuration menu (see section 13.3.8.6) the real sensitivity must be adjusted. 1: Red 2: Yellow 3: Green 1: Red 2: Yellow 3: Green 4: Black 5: White Cardio-Aid ® 360-B User’s manual R-5656-02-V02 27/89 7. User menu During the operation of the defibrillator it is continuously needed to use the user menu, for the selection of parameters and curves to be viewed, for alarm limit settings, and for the setup of sound, curve running speed and other parameters. Therefore, before describing the defibrillator modes, we briefly present the use and options of the user menu. After turning on, the defibrillator enters into the mode set in the configuration menu (see section no. 13.3.6.1) and it is ready for operation. The user menu appears on the screen with the next figure by pressing OKQkey in that modes, where it is enabled: 7.1. SEMI AUTO In semiautomatic mode the user menu is disabled, all the parameters are set, there is no need for any user interventions, the defibrillator instructions have to be followed. In case we would like to use the user menu, we need to change to manual mode. 7.2. MANUAL mode User menu can be controlled by the (12) menu keys, if changing of any setting is necessary. For entering the menu, press the key labelled (12) OKQ, this way the menu appears. If next to the name of the menu the > sign appears, it shows that a submenu also belongs to this menu. Entering the submenu is also made by pressing the OKQbutton. 28/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 The settable parameters are found in the bottom line of the menu. The parameter to be modified can be selected by the (12) Pand Rkeys, and we can start the modification by the OKQkey. By pressing the OKQkey, the color of the parameter will change from white to green, this shows the possibility that it can be modified. The modification can be made by the Pand Rkeys, then it can be validated by the Skey. This way the color of the parameter will turn to white again. To return to the previous menu level, also the Skey has to be pressed. Immediate exit from the menu can be made by the (11c) Menu Close key. Parts of the menu: Speed menu Here the curve running speed of different curves viewed on the display can be seen. Sound menu The sound of speech (low, medium, laud), the alarm sound, sound of pressing the keys and the QRS sound (mute, low, medium, laud). Filters menu The filters of ECG channels (baseline filter, muscle filter, line filter) can be switched on and off, and the breakpoint frequency of the muscle filter is selectable. Alarm limits menu For measured parameters it is possible to set alarm limits: HR lower and upper limit, SpO2 % lower and upper limit, NIBP Systole, Diastole and medium value lower and upper limits can be set one by one. It is possible to set the lower and upper limits of the pulse, measured by SPO2 sensor. NIBP menu The non-invasive blood pressure measurement device can measure adult and pediatric blood pressure, it can make manual, repeated and continuous measurements. Operation of the NIBP menu: In case of selecting pediatric blood pressure measurement mode, pediatric cuff has to be applied, which is inflated and deflated slower by the control unit. In case of adult mode selection, normal adult cuff and normal speed are applied. Measurement interval selection: in AUTO mode, the device repeats the measurement, according to the time selected here. If the AUTO measurement is disabled then blood pressure measurement can only be started by the (8) NSTART key (manual measurement). Alarm menu Set Factory Default Alarm Settings: this way the default alarm settings will be mounted, included alarm limits and all other alarm parameters. Alarm volume: setting of alarm volume. Selectable volumes: mute, low, medium, high. Other settings Default Layout: the factory default display layout – paramaters and curves – are settable here. LCD Brightness: 1 – 10 brightness value is seleztable here. 10 is the maximum, 1 is the minimum brightness. Further menu option is the selection of parameter fields and the curve viewing fields function. It can be done if it is not in menu state. If you press the Ror the Pkey then the background of one of the parameter fields or curve viewing fields will turn to dark-blue and will start blinking, indicating this way that the field can be modified. Select the field to be modified by the Por Rkey, then enter the menu by the OKQbutton. Here you can select the parameter to be displayed and in case of curves, the running speed. In parameter selection, you can also select the alarm limits and status. By standing with the cursor on the parameter selection, pressing the OKQbutton you can enter the selection mode. Then the color of the parameter will turn to green, and by the Pand down keys you can select from the optional parameters. You can acknowledge the selection by the OKQbutton. You can exit from the menu by the Skey. Here the (11c) Menu Close key also works. Cardio-Aid ® 360-B User’s manual R-5656-02-V02 29/89 7.3. PACING mode The operation of user menu is completely the same with the one described about manual mode. 7.4. ECG mode Structure of the menu, started by the OKQbutton is the same with the one described in MANUAL and PACING modes. Also functions of the three parameter fields can be set in the way written above, selecting the field by the Pand Rkeys, then entering the actual menu by the OKQbutton. In ECG mode it is not possible to select curves for viewing. In case of 10 lead patient cable always twelve leads, in case of 5 lead patient cable always 7 leads are on display. One rhythm curve can be seen under ECG leads, which can be switched off. If you switch it off, then the space for viewing the 12 ECG leads will be increased with this space. The rhythm curve can be switched on and off by the (11a) key of variable functions, of which function in ECG mode is ’Change layout’. By pressing this key, the’ECG layout option’ menu appears, in which the rhythm curve can be switched on and off. By pressing the OKQbutton, the color of the setup (on or off) will turn to green, then setup can be changed by the P, R keys. By pressing the OKQbutton the color of selected setup will turn to white again, and it is possible to exit from the menu by the OK Qor the (11c) Menu close keys. 30/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 8. Printing The CA360-B defibrillator is equipped with a thermo-printer, printing on a 58-mm wide paper. Printing can be started or stopped by the (4) PRINT button. Manually started printing: in this case the operation can be stopped by pressing the (4) PRINT button, or it will stop automatically after the time is set in time setup line (section no. 13.3.8.2), in the service menu ‘periphery setups’ point. This interval can be 16, 20, 32 or 120 seconds. Printing speed can also be set in the configuration menu, according to the description of section no. 13.3.8.3. Attention! In AED mode printing is not possible. If printing is needed after the use of AED, you must enter the MANUAL mode, and here you can start printing by pressing the (4) PRINT button. Printing paper loading, replacement: (22) Printer is to be found on the left side of the defibrillator. Printer door can be opened by pressing the printer door eject button, according to the following figure. The paper roll has to be placed here, so that when closing the door the thermal side should be upside. Place the paper inside carefully, so that it should not get crumpled or get stuck when closing the printer door. The automatic printing and event report printing are enabled or disabled in configuration menu (chapter 13.3.8.1 and 13.3.8.4) The automatic print starts at events – alarm os shocking – the length is 8 seconds with 2 seconds pre-delay. The shocking is a special event , the length of it is 12 seconds with 4 seconds pre-delay. Printer eject button Cardio-Aid ® 360-B User’s manual R-5656-02-V02 31/89 9. CA360-B defibrillator alarm system The alarm system of the CA360-B defibrillator is able to receive alarms of technical and physiological origin. The reason of technical alarm can also be of two types. One of them is the fault of the device, which is detected by the defibrillator’s internal test. (eg. battery error, defibrillator board error, measurement error, etc.). The other type of error is related to the sensors, eg. removed electrodes, noisy ECG signal, removed SPO2 peripheric sensor, blood pressure cuff error, etc. Alarm type of physiological origin is possible, if any measured parameter gets out of the previously set alarm limits. 9.1. Concepts connection with ALARM • Priority The priority can be at high, medium, low or basic level (notification). The signal of the alarm (voice and visual signals) depends on the priority level. Technical alarms are of basic priority, for each physiological alarm it is possible to set the priority. • Latching alarm If the alarm is set to latching, then the alarm status will only be over if the operator has acknowledged the alarm by the (10) Alarm button. In case of non-latching alarms, when the reason of the alarm has ended, the alarm status also ends. The latching or non-latching alarm mode can be selected in the alarm menu. • Global disabling of alarm Physiological alarms can be globally disabled, in case of technical alarms this disabling cannot be validated. Alarms can be disabled individually as well from the menu. • Delaying in case of occurring or ceasing an alarm In case one of the parameters overcomes the alarm limit, the alarm system does not alert immediately, this way we can avoid that short changes, noises would cause alarm. The delay depends on the parameters, but it is not a settable value. In case of ending of the alarm reason, the delaying occures the same way. If during this time the alarm reason reappears, the alarm event does not end. Delaying time can be 0 as well, typically in case of technical alarms. Delay times are not settable. The status of the alarm system and the alarm sound are indicated by the symbols of table no. 3.1. (Alarm system switched off, enabled or paused and voice signal switched off or sound.) • Suspension If an alarm event happens, the operator can pause the alarm by the (10) ALARM button. In case the alarm reason does not end, then after pausing time is over, alarm will be validated again. Not all alarms can be paused, physiological alarms are typically pausable. Pausing time can be set from the menu. • The technical alarms are of low priority, they cannot be disabled globally, their delaying is 0 s. Reason of the technical alarms always appears on the display during the alarm, it informs the operator about the reason of the alarm. (Eg. noisy ECG signal, patient cable is missing, NIBP cuff error,…) 32/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 9.2. Curing of alarm system The alarm system is cured in user menu, configuration menu and in function by the (10) ALARM key. In the user menu (see chapter 7.2 we can set the default alarm settings and the alarm sound volume. The alarm limits are settable by selecting the parameter fields, as it is described in chapter 7.2. Here we can set the alarm status applied to actual phisiological parameter too. In the configuration menu all the alarm parameters are settable. Describe of the parameters and the settable values are in chapter 13.3.3. Using of (10) ALARM key: If the alarm system is switched on but there is no alarm event, then at pressing the (10) ALARM key the (11c) soft key gets the „Alarm Off” function for some seconds. If this key is pressed, the alarm system is off, this is signed in the upper left corner of the display by an icon . If we do not touch this key, it gets back the original function. If the alarm system is ON state and there is a real alarm event, by pressing the (10)ALARM key the soft keys get the functions: (11a) Acknowledge, (11b) Suspend, (11c) Alarm Off. If we use the (11a) Acknowledge key, we clear the stored alarm events. This is the manual acknowledge. If we use the (11b)Suspend key, the alarm will be suspended for the time, set in the configuration menu. The icon on screen sign this. When the suspend time is over, the alarm will be active again. By the (11c)Alarm Off key the alarm system can be switched off. If we do not touch these keys, after some seconds they get back their original functions. If there is suspended alarm event, the (11a) key gets the Suspend Off function. If the alarm system is in OFF state, by pressing the (10)ALARM key the alarm system goes to ON state. The alarm sound volume is settable in the user menu/Volume/Alarm sound volume menu item(see chapter 7.2). The possible levels: MUTE, LOW, MEDIUM, HIGH. Cardio-Aid ® 360-B User’s manual R-5656-02-V02 33/89 Table of physiological parameters, able to cause the alarm, and related settings: 34/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 10. Auxiliary supplies of the defibrillator In all modes of the defibrillator works the QRS recognition and – except AED mode – works the non-invasive blood pressure measurement and SPO2 monitoring. Therefore before the therapeutical and monitoring modes, we overview the use of these services. . 10.1. QRS recognition and QRS voice In all modes of defibrillator works a QRS recognition algorithm, which analyses the ECG channel selected for display. When the QRS recognition ahorithm identifies a QRS wave, it gives a beep sound, so the rithm is sensible by ear. The QRS volume adjustable in user menu (chapter 7.2.) and configuration menu (chapter 13.3.4.1) too. If the SpO2 sensor is on the patient too, the pitch of QRS sound depends on oxigen saturation. If the saturation decreases, the pitch decreases too, so the changing of oxigen saturation is sensible by ear. 10.2. Oxygen saturation (SpO2) measurement For oxygen saturation measurement in the CA360-B defibrillator, a Covidien (Nellcor) module equipped with finger clip sensor is applied. By the finger clip sensor the oxygen saturation can be continuously measured in %, the pulse wave can be monitored in MANUAL and PACING modes, and from the pusle wave, the pulse number can be defined as well. The pulse number received from the SPO2 module, on the display and in the description as well, is referred to as ‘Pulse’. In MANUAL mode, on the left side of the display, in the field under the ECG channel the pulse wave monitoring with settable running speed can be selected. The SPO2 % and the pulse number is selectable in one of the right side parameter fields, and alarm limit values can also be set to them, which will be displayed on the bottom of the parameter field. In PACING mode the operation is similar to the one in MANUAL mode, the pulse wave, the SPO2 % and the pulse number can be viewed and the running speed of pulse wave can be set. In ECG mode, the SPO2 % and the pulse number displaying and alarm limit setting can be selected into one of the parameter fields on the right side. In the parameter fields the HR and NIBP value and alarm limits are selectable in every mode. 10.2.1. Preparing the measurement: Connect the extension cable of the sensor to the (25) SpO2 connector, located on the right side of the device. If the defibrillator is on, then by the above, the module is ready for operation. The red light of the LED in the finger clip indicates that the sensor has been connected. Only use fingerclips recommended by Innomed! Cardio-Aid ® 360-B User’s manual R-5656-02-V02 35/89 10.2.2. Patient preparation: Before using the finger clip, if necessary, cut the patient’s finger nails and remove fingernail conditioning materials from fingernails, because it can give a false measurement. Place the clip on patient’s nail, in a way that the LED shining with red light should be over the patient’s nail. Do not use the blood pressure measurement cuff and the finger clip sensor on the same hand, as it can cause false alarms. Too much external lights can interfere with the measurement, in this case it is recommended to cover the hand with the fingerclip. After the finger clip has been placed on patient, monitoring starts automatically, the SPO2 % value and the pulse wave are displayed. Warning Check the finger clip at least every four hours. If you see any changes on the finger, or the quality of pulse wave deteriorates, for the reliability of the measurement, put the clip on another finger, and check patient’s circulation. Warning any types of interference known to influence the function or accuracies of the pulse oximeter equipment; In case of simultaneous applied photodynamic therapy please take into account the light emission parameters of the finger clip. 36/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 10.3. Use of non-invasive blood pressure measurement Warning The non-invasive bloodpressure measurement does not work in AED mode, so if after a successful resuscitation you would like to measure blood pressure by the device, then you have to change to manual mode by pressing the (6) Manual button. The non-invasive blood pressure measurement device is suitable for adult and pediatric blood pressure measurement. It can be used in auto and manual modes as well. In manual mode a blood pressure measurement can be started by pressing the (8) NSTART button once. In automatic mode the measurement can be continuous (STAT) or a periodically repeating measurement settable in the menu. Automatic mode can be started and stopped by pressing the (8) NSTART button once. Warning Repeated measuring (in every 1-2 min) is allowed only for short duration (5-10 min.) to avoid any harm of patient! The continuous automatic measurement is made in a way that after the cuff deflation the next measurement immediately starts. This continuous automatic measurement is allowed to last for max. 5 min. only, but it can be stopped anytime by by pressing the (8) NSTART button. 10.3.1. Measurement method: Connect the blood pressure cuff tube to the (24) NIBP connector, and fix the cuff on patient’s upper arm, according to the instructions. (In case of using SPO2 sensor, it should not be on the same hand where the cuff is placed.) By this the blood pressure measurement device is ready for operation. Blood pressure measurement can be started by pressing the (8) NSTART button. The module inflates the cuff pressure above the value of the systole pressure. Then the internal pressure of the cuff will gradually decrease, meanwhile the module is analyzing the pressure waves caused by the pulse, and from this it calculates the arterial systolic, diastolic and main pressure values. The device is able to measure blood pressure, both in adult and neonatal modes. 10.3.2. Preparing the measurement The most important thing is patient preparation for measurements. In case patient is not at rest, it is very likely that the outcome of the measurement will be a false or unsuccessful result. Therefore it is very important to inform the patient, so that during the measurement he should keep his arm laid on the bed, at rest, stretched. 10.3.2.1. Cuff size For exact measurement it is important to select the right sized cuff. The cuff’s inflating part has to reach around the limbs in 50-80 % and its width must be around 2/3 of the upper arm’s length. If any marking is to be found on the cuff, then it has to be decided Cardio-Aid ® 360-B User’s manual R-5656-02-V02 37/89 accordingly, whether its size is suitable or not. In case there is no any suitable sized cuff available, then you should rather choose a larger than a smaller one. 10.3.2.2. Placing the cuff The deflated cuff should be wrapped tightly fitting around patient’s upper arm, but not by overtightening it. Warning Make sure that the marked center of the inflatable part is above the patient’s artery, according to the instructions of the cuff. It is very important that the cuff should not be placed on any joint (elbow, knee), and the limb must be stretched in order to avoid any false measurement. The cuff should not be put on the same arm of the patient, where the pulse oximeter finger clip is placed, as it interferes with the clip’s measurement, which can cause false alarm. During measurement, please do not squeeze the cuff hose, avoid pinching the tubes. Regularly check that the measurement does not deteriorate the patient's circulation, check the affected limb. The result appears in the right side parameter field. If no parameter field has been marked for NIBP viewing, the device will remember the result of the last measurement, and if we highlight one field for the viewing of NIBP, then the result of last measurement will appear there. 38/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 11. Therapeutical modes The therapeutical modes of the defibrillator are AED mode, the manual modes and the pacemaker mode. 11.1. AED mode The device assists the operator by voice and text instructions appearing on the display, in the device operation. The device automatically performs the necessary operations, it charges the defibrillator’s energy accumulator, and it gives an instruction for the delivery of shock. The CA360-B defibrillator in semi-automatic mode can be operated by non-professional persons as well, as the defibrillator is giving the instructions to the operator. Even in such cases as well it is advisable that the device should be operated by a person, who has been trained for the use of semi-automatic defibrillators The displayed and the vocally spoken text has been created, so that the steps of the operator will always be completely obvious, so that non-professional operator should not have to make any decisions and the device would support the operator in all his actions. The ERC2010 puts a strong emphasis on the importance of chest compression, chest compression must only be paused for a very short time, during the time of analysis and shock delivery. Resuscination process can only be stopped if signs of the ROSC Return Of Spontaneous Circulation (breathing, opening of eyes, maybe speech…) have clearly returned. The energy level of the first shock should be 150 – 200 J for adults, according to ERC 2010 recommendation (STAR biphasic waveform), about the further shocks, for increasing the efficiency, the energy level can be raised. Warning! In AED mode the operator does not set the energy levels directly, it is only possible in the configuration menu. (See section no. 13.) For children (between the age of 1-8 and under the weight of 25 kg) it is advisable to use 2-4 J/kg energy. Warning! Make sure that, in order to avoid electric shock, during defibrillation, nobody touches the patient, the conductor liquids in connection with the patient (gel, blood, saline solution) and metal objects in connection with the patient, like for instance the frame of bed or stretcher. These touches are providing undesirable ways for the defibrillating current. Cardio-Aid ® 360-B User’s manual R-5656-02-V02 39/89 After turning on the defibrillator, in AED mode, the following screen picture is displayed: On the upper line of the screen the actual function of the (17) Action key is displayed. In this case it means the abortion of CPR. It is necessary if the operator wants to fit another action into the process of resuscitation, eg. analysis. In the line below it, the actual phase of resuscination can be seen. In the present case it is the CPR. The line running under the text indicates the passing of time. The line below it is the alarm field, in the picture it indicates shockable rhythm. In the graphic field the ECG signal received from the electrodes can be seen, next to it the heart rate parameter appears, which can be measured during resuscination and calculated from the ECG signal. In the line under the graphic field the symbol indicating the defibrillator’s status (in this case the safe status) can be seen, the time passed since turning on in hours:minutes: seconds format, and the shock counter are displayed, which shows 0 on the figure. In the bottom line the symbol indicating the battery status, the (11 a, b and c) software controlled fields, indicating the key functions, are displayed. In the present case only the (11c) key has any functions, this way it is possible to indicate that the spontaneous circulation has returned. On the right lower courner the time is displayed in hours: minutes format. On the following figure it can be seen that the defibrillator has already recognized the shockable rhythm, the 2 minutes phase of the CPR has finished, or the operator has aborted it, and the defibrillator has automatically started the charging. The charging process is indicated by the line next to the state indicating symbol. The upper line is empty, as the (17) action key has no any functions during the charging. In the second line the actual function is displayed: Charging… 40/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 The following screen picture shows the state when the defibrillator is charged and it is in a state ready for delivering shock. The upper line of the screen indicates, that shocking can be started by the (17) Action key. In this case the operator either delivers the shock, or if necessary, he aborts the charged state by the Disarm button. Cardio-Aid ® 360-B User’s manual R-5656-02-V02 41/89 Steps of using the AED: 1. Make sure that the patient and the rest of the persons present are safe (safe environment). 2. If the victim is unconscious, and has no respiration, call for help laudly, arrange to get the defibrillator to the scene. 3. Immediately start the resuscination (CPR): make sure that the respiratory tracts are free. Then repeat continuously until the defibrillator arrives: 30 compressions on the middle of the chest (on the sternum) in 4-5 cm depth, followed by 2 blow-ins. Aim for 100 times chest compressions per minute. 4. As soon as the defibrillator arrives on the scene, turn it on by the (1) power on button. After the running of self-test (about 15 seconds) the defibrillator is ready for operation. If necessary, select the semi-automatic mode by pressing the (5) SEMI AUTO button. The selection is indicated by the LED beside the key. -Place the electrodes according to the figure or the defibrillator manual (paddle or defibrillator pacing electrode). Do not place the electrodes near pacemaker or ECG electrodes. -If there are several lifesavers at present, the resuscination (30 compressions, followed by two blow ins) must be continued during defibrillator installation as well. –After turning the defibrillator on, follow the verbal instructions or the instructions on the display. -Make sure that nobody touches patient, while the defibrillator performs the analysis. The ECG analysis starts automatically. 5. If the defibrillator detects a shockable rhythm, it charges automatically and gets into a shock-ready state. When the defibrillator gives an instruction for shocking: -Make sure that nobody is touching the patient, and the metal, current conductor materials (stretcher, gel, physiological saline solutions, etc.) in connection with the patient should be removed. -Press the shock button. -After shock, continue resuscination according to instructions of the defibrillator. 6. In case the defibrillator does not recommend shock, immediately continue the resuscination. (30 compressions, followed by two blow-ins) The process can be stopped if normal breathing has obviously returned. 42/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 Semi-automatic defibrillation protocol * The defibrillator continuously performs the rhythm identifying analysis. If it finds shockable rhythm, it indicates the possibility of shocking, but if before delivery of shock the analyzer detects non-shockable rhythm, then it will disable the shock and will instruct to continue CPR. * 150-270J biphasic for 2 min. Patient unresponsive No pulse, no breathing CPR 30:2 Until AED attached CPR 30:2 for 2 min. Continue until the victim starts to wake up: to move, open eyes and to breath normally CPR 30:2 for 2 min. AED assesses rhythm No shock advised Shock advised * 1 shock 150-270 J Cardio-Aid ® 360-B User’s manual R-5656-02-V02 43/89 Questions and answers for the semi-automatic defibrillation protocol: • How to start the semi-automatic defibrillation process? The semi-automatic protocol starts automatically, if the defibrillator is switched to semi-automatic mode, and the electrodes are placed according to the instructions. For more details, see the section titled, The steps of using of AED (page 41) • Is it necessary to perform CPR before defibrillation? Yes, it is necessary. The immediate CPR increases survival chances. It is advisable to perform chest compression and blow-in the proportion of 30:2, until the defibrillator arrives at the scene, and patient is prepared for defibrillation. From this point the defibrillator instructions should be followed in semi-automatic mode. • What should happen if the patient recovers? If signs of circulation are clear, then enable the Abort CPR function by pressing the (17) Action key. This way the Pulse present text will appear above the (11c) key, and the text Analysis appears beside the (17) Action key. If the Pulse present key is pressed, then the process of resuscination will be aborted, the text Pulse present mode will appear on the display, and the defibrillator will change to monitoring mode. VF detection and the HR alarms will be working, they are warning the operator if any changes happen in patient’s sate. Then by the (17) Action key the process can be restarted, the text „Press action button for analysing” is warning us about this. The resuscination process can also be aborted by changing to Manual mode by the ((6) MANUAL key). Alarms also work in Manual mode, if they are enabled, this is how they indicate the changing of state. In case of patient’s state deteriorating, process can be restarted by the (5) SEMI AUTO button. • How to abort and restart the resuscination process, analysis? During CPR, the CPR phase can be aborted by pressing the (17) Action key. Then by pressing the key again, the device will get to analysis state, then from this point the process will be continued normally. If after aborting the CPR , no analysis will be initiated, then after some time the analysis will automatically restart by the (17) Action key. Then the device restarts the CPR phase. The resuscitation process can be aborted by the ‘Sign of Life’ or by the MANUAL keys. • What happens if the (15) Disarm button is pressed? If the device finds patient’s rhythm to be non-shockable rhythm, then it will automatically perform disarming. If the defibrillator is in a charged state, it can perform disarming. • What happens if one of the electrodes falls off? During CPR the device does not check electrode fall-off. If the electrode falls off during analysis, or the process cannot be normally continued, because of any other reasons, then the device is warning about the problem. After solving this problem the resuscination process continues by itself. • Why is it that the device does not recognize electrode fall-off during CPR? During CPR the device does not examine the state of cables and electrodes, as because of their faultiness it is not allowed to stop the CPR. Besides this, chest compression might lead to false detection, therefore there is no electrode check during CPR. • Which energy should be selected for shocking? The energy level of first shock should be 150 – 200 J (STAR biphasic waveform), for further shocks, energy level can be raised, but it is not necessary by all means. 3 energy levels can be set for semi-automatic defibrillation in the menu. When switching to semi-automatic mode, the first level is selected. Stepping to the next level happens during shock. If before shock the analysis detects non-shockable rhythm, then the shock will be skipped, and the possible following shock will be delivered at the 44/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 previous energy level. The default values are 200 J, 200 J, 270 J, but of course these can be changed by user in the configuration menu. • Use of semi-automatic mode by defibrillator paddles: If possible in semi-automatic mode defi electrodes should be used, but defibrillation is also possible by defi paddles. In this case defi paddles should only be placed on the chest, if instructed by the device, according to analysis. Then within 1-2 seconds charging process will stop, and the device will give instruction for shock delivery. • When should ECG electrodes be used as well? The use of ECG electrodes provides better quality signals, but it increases preparation time and it complicates the process. In case of using self-adhesive defibrillator electrodes, these are giving quite good quality of signals for ECG analysis, so no electrode is needed. When using defibrillator paddles, by all means means ECG electrodes must be placed, without this, the semi-automatic protocol does not start. • What to do if there is no electrode gel or gel pad available? Wetting of defibrillator paddles is very important from the aspect of obtaining a good contact, the lack of gel can cause lower energy delivery and the burning of skin. If the electrode gel is missing, any wetting assists the deibrillation (clean water, any kind of liquid), but do not use creams, and generally oily materials, because they only worsen contact • How does the defibrillator select energy of shock? In semi-automatic mode the defibrillator shocks with the preset (in the configuration menu) energy levels. The firs, second and third shock energy levels can be set separately. For these, it is advisable to set increasing values, in order to increase the efficiency of the shocks. According to the energy step-back protocol, if the result of an analysis is non-shockable rhythm, then the possible following shock (if needed) is delivered at unchanged energy level. Automatic ECG analysis The Cardio-Aid 360-B defibrillator incorporates an automatic VF/VT detection system. This detection system is always enabled in semi-automatic mode. In semi-automatic mode, the “Possible shockable rhythm” warning message appears together with a voice prompt. The operator will be prompted not to touch the patient while the final analysis is performed. In manual and pacing modes „Shockable rhythm” is displayed as a warning message. Definition of shockable rhythm: • Ventricular fibrillation (VF) • Ventricular tachycardia with broad QRS (VT) >180 bpm Cardio-Aid ® 360-B User’s manual R-5656-02-V02 45/89 11.2. Manual defibrillation 11.2.1. Asynchronous manual defibrillation In case of manual defibrillation the operator decides individually on the energy level and on performing the defibrillation. In the simplest case, defibrillation can be performed very quickly by the following steps. 1. Turning on the defibrillator: turn on the defibrillator by the (1) power on button. After running the self-test, the defibrillator will get to the operation-ready state in about 15 seconds. During this time free patient’s chest and plug the electrode cable to the 21 connector and place the electrodes on patient’s chest. 2. Set the desired energy by the Energy+/- key to be found on the paddle electrode, or in case of pads electrode, by the soft key buttons signed by no.11. 3. Decide according to the ECG curve on the defibrillator’s display, whether the rhythm appearing is shockable or not, and if it is shockable rhythm then start charging by the charge key signed no. 2, to be found on the paddle electrode (Apex). In case of using defibrillator electrode, charging can be started by the 17 Action key. Charging process is shown by a voice signal and by a line running on the display. Warning!!! Charging only completes, if electrodes are placed on patient’s chest during charging, as for charging, patient impedance value is necessary. (See STAR waveform description section no. 2.1.1). If charging has been started, without the electrodes being on the patient, then charging will not be completed, the device will give a voice and also a visual signal about it. 4. If you still view that the rhythm is shockable, then by pressing the keys marked by no. 3 together, on the electrodes Apex and Sternum, you can deliver the shock. In case of defibrillator electrode, shock can be started by the 17 Action key. In case you think that what you see is a non-shockable rhythm, you can abort the shock-ready state by pressing the (15) DISARM button. If you do not press the (15) DISARM button, but you do not deliver the shock, then after 30 seconds the defibrillator automatically stops the shock-ready state. Screen picture in manual defibrillation mode: 46/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 In case of using pads electrode, charging can be started by the (17) Action key, as it can be seen on the right side, on the upper line of the screen. In case of using defibrillator paddle electrodes, charging can be started by the key marked by no. 2, located on the paddle, with the label Charge. On the left side of the upper line, the value of selected energy level is displayed. Warning! Make sure that, in order to avoid electric shock, during defibrillaton nobody touches the patient, the conductor liquids in connection with the patient (gel, blood, saline solution) and metal objects in connection with the patient, like for instance the frame of bed or stretcher. These touches are providing undesirable ways for the defibrillating current. During defibrillation no oxygen should be on the patient. In case of asynchronous manual defibrillation (3- or 5-lead) patient cable can be used, in order to obtain better quality ECG signal. When using patient cable, the ECG is of better quality, more detailed, but the electrode placement makes preparation time to be longer, which can be critical. Cardio-Aid ® 360-B User’s manual R-5656-02-V02 47/89 11.2.2. Synchronized cardioversion Quick guideline • Turn on the device and after the running of self-test, select manual mode by key no. 6. The selection is indicated by the LED beside the key. • Connect the ECG cable to the device (20 ECG connector) and place the ECG electrodes on patient’s chest, according to the description of section no. 6.2. If needed, set the ECG lead by key no. 2 and the sensitivity by key no. 16. • Connect the gel-pad electrode according to the description of section no. 6.1.1 or the paddle electrode, according to section no. 6.1.2. Stick the pads electrodes on, or put gel on paddle electrodes and push them on patient’s chest. • By the key no. 11c, labelled „Sync Menu”, enter the Sync menu, then by the (12) P, Rkeys select Latching Mode or Non-Latching Mode, synchronized mode, and validate it by the 12 OKQbutton. Then on the upper line of the screen the text Sync On appears, and the selected Latched or Non-Lathed mode text will be displayed. Important! In latched mode, after delivering the synchronized shock the defibrillator will remain in Sync mode, while in non-latched mode, after delivering the synchronized shock, the device will return to asynchronous manual mode. • Select energy by the keys 11a and 11b, or by the Energy button located on the Sternum paddle electrode. Attention! In case of synchronized cardioversion, generally less energy is needed, for an adult, 80-110J can already be effective. • If the device indicates that it has recognized the QRS, start charging by the 17 Action key, or by the key, marked by 2, to be found on the Apex paddle electrode. When charging is completed, it is indicated by the device on the display and by voice signal as well. • For shocking, press the 17 Action key, or press together at the same time the keys marked by 3, on the Apex and Sternum electrodes, and keep them pressed. After you have pressed them, the device is waiting for the next QRS, and when it appears, it deliveres the shock. If keys are released before QRS appearance, then there will be no shock. Synchronized cardioversion by defibrillator paddles is only possible if the ECG signal is coming from a separate ECG electrode, or from an external source of signals. Important! In case of synchronous cardioversion, when pressing the shock buttons, immediately a clicking sound can be heard, which is the sound of safety relays, and it does not mean delivery of shock. Shock buttons must be still kept on being pressed, until shock is delivered, which can also be followed on the display of the device. Make sure that in order to avoid electric shock, nobody touches the patient during delivering shock. 48/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 QRS detection is shown on the display of the device. Over the detected QRS, at the R peak, a marker line appears and a letter ‘S’, which indicates the synchronized point. In synchronous mode the defibrillator delivers the shock within 40 ms, following the marker. This way user can check on the display that the device detects the QRS correctly. The above figure appears in the ECG field of the display, the markers beside the ‘S’ are showing the places of R peaks. If there is no suitable heart activity for the synchronizer, when pressing the shock buttons, the text “There is no shockable rhythm’ might appear on the screen. Shocking is obstructed if: • No QRS complexes can be detected on the selected lead. • The amplitude of the signal is too low. • ECG electrodes have been placed incorrectly, or they are not connected well. Synch mode automatically switches off if: • Changing from manual to semi-automatic mode. • ECG plug is removed. • When changing to pacing mode. • In case of synchronized shock, if the defibrillator is set to synchronous ‘non-latching’, in the Synch menu. When using external ECG, ECG delaying from the external ECG source should be less than 10 ms. See section 6.2.4. Cardio-Aid ® 360-B User’s manual R-5656-02-V02 49/89 On the following figure, the screen picture appearing when switching to manual mode can be seen. We are viewing the set energy level and state of the synchronized defibrillation. In case of Sync off, there is asynchronous defibrillation, it can be changed in the Sync menu. Beside the text Sync, the actual function of the (17) Action button is displayed. Under it, messages, alarm reasons can be seen, then ECG and pulse waves and different parameters are displayed. Under the graphic field, symbols indicating the alarm and the battery state can be seen. The text SAFE indicates that the defibrillator is not charged, it is not in a shock-ready state. Next to it, the time passed since turning on and the shock counter can be seen. In the bottom line, the actual functions of 11a, 11b, 11c keys with variable functions are displayed, increasing of energy, decreasing of energy and entering in sync menu. In the right lower courner, time is displayed in hours: minutes format. 50/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 11.2.3. Internal defibrillation The internal defibrillation is made during heart operation, in case of opened chest, with energy delivered directly to the heart. In this case internal defibrillator electrode has to be used, according to the description of section no. 6.1.3. The defibrillator recognizes that an internal defibrillator electrode has been connected, and it sets the energy selection possibility into the range of 1-50 J. In case of internal defibrillation, higher energy than 50 J cannot be used. Quick guideline 1. Turn on the device by the 1 power on button. After running self-test (15 seconds) the device is ready for operation. If necessary, switch the device to MANUAL mode by the key no. 6. The mode is indicated by the LED beside the key. 2. Select energy level by the 11a 11b keys. In case of internal defibrillation, the energy can be set to the range of 1 – 50 J. 3. Touch the heart by the internal electrodes. 4. Start charging by the 17 Action key. 5. If charging is completed, shocking can be started by the 17 Action key. Warning! Make sure that, in order to avoid electric shock, during defibrillation nobody should touch the patient. Adequate maintenance, cleaning and sterilization of electrodes are important, as it has already been detailed in section no. 6.1.3. 11.3. Using of pacemaker The non-invasive or transcutaneous pacer gives electronic impulse to the heart, in order to create cardiac depolarization and miocardial contraction. The use of pacer can be necessary in the following cases: • P-asystole (there is P wave beside AV blocking) • Symptomatic bradycardia • Tachycardia (antitachycardia stimulation) In case of asystole, if there is complete electronic silence, the use of pacer is contraindicated, in this case resuscitation must be continued by chest compression and by medicines, according to the descriptions of AALS and PALS of any ERC guidelines. If there is P wave but there is no ventricular contraction because of the complete AV blocking, then operation with pacer is recommended. In case of tachycardia, overdrive pacing can be used, here the pacer frequency, over the actual heart rate has to be applied, and should be decreased gradually, till the normal level. In case of symphtomatic bradycardia, threatening AV blocking, P-asystole, standby pacing has to be applied (demand mode). Pacer can work in two modes, in fixed and in demand modes. In fixed mode, the pacer is continuously giving the impulses, with the set frequency and amplitude, independently from spontaneous heart rate. This mode should be used in case of P-asystole and tachycardia overdrive. In demand mode, the pacer only gives impulse, if no spontaneous QRS comes, during the cycle, corresponding to the set basis frequency (RR distance). Cardio-Aid ® 360-B User’s manual R-5656-02-V02 51/89 The pacer provides square pulses with settable amplitude and frequency and with fixed width of 40 ms impulse. Amplitude can be set between 20 – 200 mA and the frequency between 30 – 200 ppm. During pacer stimulation, pediatric and adult size pacer (pads) electrodes can be used. For the use of pacer, in some certain cases ECG electrodes also have to be placed on the patient, in order to obtain good quality ECG signals for development and evaluation. Primary condition of demand mode, the sure, unnoisy QRS detection, in case of spontaneous activity. This is not stable enough, in case of two-lead ECG. The (electronic) noise, identified as QRS, can cause missed pacer stimulations, which can potencially be life-threatening, therefore for safe operation, the use of ECG electrodes is obligatory. During fixed stimulation, it is not necessary to detect QRS, therefore it is allowed to use pacer, without ECG electrodes as well. Warning! If You change the defi mode from AED or Manual to Pacemaker mode, and the capacitors are charged, before the start of pacemaker the capacitors must be discharged. In this case in the upper line of display appears a status bar showing the process of discharge and a “PLEASE WAIT” sign. When the discharging finished, a “PACER START” sign appears, and You can start the pacemaker. The discharging procedure takes maximum 20 seconds. 11.3.1. Quick guideline 1. Turn on the device by the 1 power on button. After running self-test (15 seconds) the device is ready for operation. If necessary, switch the device to PACING mode by the key no. 7. The mode is indicated by the LED beside the key. 2. Place ECG electrodes according to the description in section no. 6.2.2 or 6.2.3 and the gel-pad electrodes, according to section no. 6.1.1 (Anterior-Posterior placement). 3. Select pacer stimulation mode – fixed or demand – by pressing the button no. 11. The actual pacing mode will be displayed in the upper line of the display. 4. Setting of pacer rhythm: press the11b Frequency button, this way, functions of 11a 11b 11c keys will change: Increasing of frequency, decreasing of frequency and closing of menu. 5. Start stimulation by pressing the (17) Action key (Start pacer). This way the pacer is started, in the upper line of the display, the text „Pacer Stop” will appear. 6. Increase pacer current above efficiency level. Press the (11c) Set Current key, this way, functions of the three soft keys will change. By the (11b) Current+, (11a) Current- keys, the amplitude of pacer impulse can be set, by the 11c Menu closing key it is possible to return to the previous menu level. (The power of current can also be set if the pacer is in switched off state, at this point if current changing key is pressed longer, changing will speed up.) Keep the current with about 10 % over the limit level. The limit level is generally 40 – 80 mA, depending on the placement of electrodes. Both current and frequency can be set also during pacer operation, but in this case the changing does not speed up even if the key is pressed longer. (safety function). If there is not any pads electrodes available, for a while it is allowed to perform pacing by defibrillator paddles, but in this case the use of ECG electrode is obligatory. 52/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 Warning! Using of pacer by defibrillator paddles can only be allowed for a while, until the pads electrodes are placed on the patient, or transarterial pacer is introduced. Warning! During stimulation by transcutaneous pacer, most of the patients feel pains. Based on patient’s state, physitian operating the device should consider the application of pain killers for the patient. Screen picture in pacer mode: In the upper line, on the left side of the display the mode of pacer (Fixed or Demand) can be seen. Besides, the set pace rate and pace current values are displayed. Function of the (17) Action key in this state is the starting of pacer. After starting, the function of this key will change to stop pacing. Attention! In case of running pacemaker to switch the defi to an other mode (AED, Manual or ECG) or to switch it off is impossible. First You have to stop the pacemaker by (17) action key. The VF detector works also, when the pacemaker run. If the VF detector realises ventricular fibrillation, a VF alarm appears. In this case also You have to stop the pacemaker, then You can step to defibrillator mode (AED or Manual). Cardio-Aid ® 360-B User’s manual R-5656-02-V02 53/89 Defibrillator/pacer electrodes in pacer mode: Using the paddle electrodes in pacer mode is possible only when ECG cable is connected, and ECG electrodes are on the patient. In case of paddle electrode there is no possibility to choose the “Demand” mode, the pacemaker can work only in “Fix” mode. Using pad electrodes in pacer mode, the defibrillator requires ECG cable too, but the “Demand” mode is coosable in this case. When You connect the pad electrode cable, the (11a) soft key gets the “Pacer Mode” function. When You push it, You can choose the “Fix” or “Demand” mode. 54/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 12. ECG mode Defibrillator can be switched to ECG mode by the (13) key labelled ECG. Change of mode is indicated by the LED enlighted beside the key. In ECG mode, the defibrillator performs ECG function, completed with the options of SpO2 and NIBP measurement. 12.1. Viewing of ECG ECG signal can be captured from 3-lead, 5-lead or 10-lead patient cables or from external ECG device. (See chapter 6.2.4) Screen in case of 10 lead ECG cable: Sharing of screen: On the lower part of the screen, the functions of variable function keys are displayed. In basic situation these are Change Layout, Speed and Filter. On the left side of the screen, the ECG field is located. The sructure of this field depends on the type of the patient cable. Cardio-Aid ® 360-B User’s manual R-5656-02-V02 55/89 In case of 3-lead patient cable, one ECG channel can be seen. The viewed channel, which may be I, II, or III, can be selected by the (2) lead selector key. Screen in case of 3 lead ECG cable: In case of 5-lead patient cable, 7 channels can be viewed. These are I, II, III, aVR, aVL, aVF, and Vx. Display of the leads cannot be influenced by the lead selector key, but the rithm channel is selectable by this key. Screen in case of 5 lead ECG cable: 56/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 In case of 10-lead standard patient cable, the standard 12 channels appear in the ECG field. These are I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5 and V6. The (2) Lead selector key is for select the rithm channel here. Amplitude of the curves viewed in the ECG field, can be set by the (16) ECG amplifyer key to the values of ¼, ½, 1 or 2 cm/mV. We can enter the speed setting menu by the (11b) Speed key, for setting of curve running speed. Here the following speeds can be set: 5, 10, 25 or 50 mm/s for ECG and 5 or 10 mm/s for rithm. Setting method: by pressing the Speed key, the speed menu opens. Put the selector sign on the ECG speed line, by the P, Rkeys, then select the function by the OKQbutton. Color of the actual speed value will turn to green, and at this point you can change the speed values by the P, Rkeys. Acknowledge selection by the OKQbutton, this way, color of the set speed value will change back to the original one, and selection is validated. Menu can be closed by the (11b) Menu Close or (11c) Menu Back button. After closing, functions of variable function keys will change back to the original state. Adjust of rithm curve speed is the same. The (11c) Filter key is for setting of ECG filters. By this, you can enter the Filter menu. Here the muscle filter and the mains filter can be switched on or off. The muscle filter can be given the 25, 30,35, 40 Hz or the switched off value. The mains filter can be switched on and off, mains frequency can be set in the configuration menu. You can exit from the Filter menu by the (11b) Menu Close or (11c) Menu Back key, at this point the functions of variable function keys will change back to the original state. A 0,05Hz base line filter is in ECG amplifier, this is not a switchable filter, it is always switched on. Under the ECG field, a narrow field can be seen, where rhythm curve can be viewed. For the setting of this, press the (11a) Change layout key. In the opening rhythm curve menu window, rhythm curve can be switched on and off by the OKQthen the P, R, finally by the OKQ and Menu closing buttons. In case of using 5- or 10-lead patient cable, the lead of rhythm channel can be selected by the (2) Lead selection button. 12.2. Printing in ECG mode In ECG mode, printing can be started by the (4) PRINT button. Then a heading will be printed, including a pointed place for patient’s name, date, mode and printing parameters. After this, printing of curves starts. The channel selected for rhythm will be printed with the set parameters. On both edges of the paper, actual parameters will be printed (HR, SpO2 %, NIBP). Cardio-Aid ® 360-B User’s manual R-5656-02-V02 57/89 13. Use of the cofiguration menu In configuration menu, all the main parameters of the defibrillator can be set, these will be remembered by the device, and until any new changes, it will operate with these values. 13.1. Entering the configuration menu We can enter the configuration menu when turning on the device. Turn on the device by the (1) power on button. First a login figure will appear, then after about 6 seconds a voice signal can be heard. After another few seconds, the text ‘Self-test completed’ will appear, and the (17) Action key will be enlightened. At this point the Action key has to be pressed, this way configuration menu will appear, and the text ‘Menu close’ will appear on the bottom of the display, over the (11c) key. We can exit from the menu by the S, or the ’Menu close’ keys. After exiting, the defibrillator immediately enters the selected mode and it will get to an operation-ready state. 13.2. Handling of the configuration menu The menu handling keys are the P, R, Sand OKQkeys, signed by (12) in section no. 4.2 , we will make a reference to them in the followings. If the defibrillator is in menu state, then also the soft keys, signed by 11b and 11c are for menu controlling, at this time, they are labelled as Menu Back and Menu Close. Menu Back is equal to the Skeys, the Menu Close is for immediate exiting from the menu. Inside the menu, we can move by the Pand Rkeys, we can stand on the desired menu point by them. If beside the name of a menu point the „>” sign appears, it means that this menu point has a submenu. From menu elements, the actual one is indicated by dark background. This sign can be moved upward and downward by the Pand Rkeys. Press OKQbutton, by moving the sign on the desired menu point, this way the menu point is selected. If a menu point with no submenu is selected, then by pressing OKQ, it will be possible to change the parameters. At this point the color of parameter will turn to green, and it can be changed by the P, Rkeys. After setting the adequate parameter, by pressing the OKQ button, the parameter will be validated, its color will turn to white again. Then we can select another menu line by the P, Rbuttons or by the Skeys, or by the (11c) Menu Back key, we can step one level upwards in the menu system. If we are on the upper level of the menu, then by these keys we are closing the menu, we are returning to the therapeutical or monitoring mode of the defibrillator. If we are in a lower level, by the (11b) Menu Close key we can immediately close the menu, skipping the intermediary levels. 58/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 13.3. Elements of the configuration menu When entering the configuration menu, the following figure appears on the screen: 13.3.1. Language selection In this menu point the language of display and of speech can be changed together. When entering the menu, the label of actual language can be seen. By pressing the OKQbutton, the color of language label will turn to green and it can be changed by the P, Rkeys. If you have selected the desired language, by pressing the OKQbutton, this language will be validated, the menu will appear again, already in the selected language. The list of available languages is continuously growing, so we rather not list them here. The label representing the languages, always appears on the given language, so it can be certainly available for the person selecting the language. 13.3.2. Use of defaults Here it is possible to reset defaults. Meaning all the parameters of the device – alarm limits, sensitivity, channel selection, highlighting parameter fields, sharing of screen, etc. By standing on this menu point by the selector sign, pressing the OKQbutton, the color of the label ‘No’ beside the menu point will turn to green. Then by the P, Rkeys we can choose between ‘Yes’ and ‘No’. If we have changed our mind and we prefer not to change the default, then by selecting ‘No’, we should press OKQ, and the original presets will remain. If we choose ‘Yes’, then by pressing OKQ, the defaults will be validated, the color of the label ‘Yes’ will change back to white, indicating that the order has been completed, then the label will change to ‘No’, indicating that settings can be reset from different menus. Cardio-Aid ® 360-B User’s manual R-5656-02-V02 59/89 13.3.3. Alarm settings A submenu belongs to this menu point. We can enter the submenu by pressing the OKQ button. The first item is the Default Alarm Setting. Select this, the factory default alarm settings come into force. This applies to alarm limits and any other alarm parameters. Hereafter we review the alarm settings belonging to alarm parameters. 13.3.3.1. Global alarm settings Also a submenu belongs to this item. We can enter the submenu by pressing the OKQbutton. The firs item is the Status. It may be ON or OFF. In ON state the alarm system is active, all the alarm event evokes alarm, which is not disabled in its unique menu item. In OFF state only the event makes alarm, which are not swichable off by general disable. (eg. Asystole or ventricular fibrillation) The next item is the alarm volume, here You can choose the volume of alarm sound. The selectable levels are MUTE, LOW, MEDIUM, HIGH. 13.3.3.2. Asystole Status may be ON or OFF, this enables or disables the alarm from this parameter. Limit Value is the time is seconds from the last detected QRS, when asystole alarm happens. This tine may be 2, 3 or 4 seconds. Acknowledge Type may be MANUAL or AUTO. In MANUAL mode the alarm is active after ceasing of alarm reason. The alarm will end only acknowledging by user. In AUTO mode the alarm stops after ceasing of alarm reason. Priority may be HIGH, MEDIUM, LOW or MESSAGE. The features of alarm marking (sound and picture on screen) depends on this setting. Suspend Time (minute). It may be 0, 1, 2, 3, 4 or 5 minutes. The operator can pause the alarm sign for this time. In case the alarm reason does not end, after suspend time is over alarm will be validated again. Store item shows what will be stored into event diary in case of alarm. Printing item shows what will be printed in case of alarm. The last 2 items are not settable. 13.3.3.3. Heart rate alarm The parameters settable here are the same as in previous chapter. There is no Limit parameter here, but there are low and high limit of heart rate. These parameters are settable in BPM (beat/minute). The low limit may be 30 – 100 BPM, the high limit may be 50 – 300 BPM. The high limit is always higher than low limit. 13.3.3.4. SpO2 alarm The parameters settable here are the same as in previous chapter. The low and high limits here are in SpO2%. The low limit may be 50 – 100 %, the high limit may be 90 – 100 %. The high limit is always higher than low limit. 60/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 13.3.3.5. Pulse alarm The parameters settable here are the same as in previous chapter. The pulse alarm is on pulse number in pulse/minute measured by SpO2 sensor. The low limit may be 30 – 100 %, the high limit may be 50 – 300 %. The high limit is always higher than low limit. 13.3.3.6. NIBP systole, diastole and mean value alarm The parameters settable here are the same as in previous chapter. These three alarm settings are the same. The alarm limits are settable in mmHg. The alarm limits are: Systole: low limit 20 – 150 mmHg high limit 90 – 260 mmHg Diastole: low limit 20 – 110 mmHg high limit 90 – 260 mmHg Mean value: low limit 20 – 130 mmHg high limit 90 – 260 mmHg The high limit is always higher than low limit. 13.3.4. Device setups A submenu belongs to this menu point. We can enter the submenu by pressing the OKQ button. Here the following parameters can be set: 13.3.4.1. Voice menu To this submenu point also belongs a submenu, where we can enter by pressing OKQ. Here we can set the intensity of speech voice, alarm voice, keyboard voice and QRS voice. By the P, Rkey, step on the line of volume, you would like to set, then select the parameter by the OKQbutton. This way the color of actual value will turn to green, and it can be changed by the P, Rkeys. The selected volume can be low, medium or mute. About the speech volume, switching off is not possible, as the voice instructions are always needed. If we have set the desired volume, we can validate it by pressing OKQ. This way the color of the label will change back to the original color, and setting will be validated. Setting of volume happens the same way in each lines of the voice menu. From voice menu we can go back to tool settings menu, by the Sor the Menu Back keys, or we can exit from menu mode by the Menu Close key. 13.3.4.2. Date and time Here we can set the date (day month year) and time (hours minutes seconds). Method of setting: we are selecting the parameter to be set by the P, Rkeys, then we are validating the selection by pressing the OKQbutton. This way the color of parameter to be set will turn to green, and it can be set by the P, Rbuttons. Set the desired value, then validate it by pressing OKQ. Validation is indicated by the changed color. The program ensures that only correct date can be set. From ‘Date and time’ menu we can go back to tool settings menu by the Sor the Menu Back buttons, or we can exit menu mode by the Menu Close button. 13.3.4.3. Date and time format Here we can choose between the 12- or 24-hour time displays. Step on the date and time format menu line by the P, Rkeys, then validate the selection by the OKQbutton, this way the color of actual format will turn to green. You can choose between the 12- or 24-hour formats by the P, Rkeys. The selection can be validated by the OKQbutton, it is indicated by the changing of the color, from this point, the format selected here is valid. Cardio-Aid ® 360-B User’s manual R-5656-02-V02 61/89 From Date and time format menu we can go back to tool settings menu by the Sor the Menu Back keys, or we can exit menu mode by the Menu Close button. 13.3.4.4. LCD brightness In this menu point LCD brightness can be set. Entering the menu by the OKQbutton, brightness value can be set between 0 and 10. 0 is the lowest brightness, it can only be used in a very dark place. The maximum brightness can be obtained at the value of 10. In an averagely enlightened place, at the brightness value of 5, clear display can be obtained. The set brightness can be validated by the OKQbutton. From the LCD brightness menu, it is possible to go back to tool settings menu by the Sor the Menu Back keys, or we can exit menu mode by the Menu Close button. 13.3.4.5. User identification Here a label can be written, for the identification of the user. When an event or a log file is read from the defibrillator, this will identify the data package. How to set it: move the selector sign by the P, Rkeys to the ‘User ID’ line, then press the OKQbutton. This way the color of actual ID will turn to green and it indicates that the first character can be changed. Changing of characters can be made by the P, Rbuttons. The capital and small characters, numbers, the sign / and the space can be selected. The role of space becomes important, if we want to type shorter ID than the actual one, in this case the unnecessary characters can be deleted by space. The space can be found at the end of the capital alphabet, after the letter Z. After the selection of the desired character, we can step on the next character by the OKQ key, and it can be set in the same way. If we get to the end of the text and we press another OKQbutton there, the new ID will be validated. If without validation, we are exiting by the Menu Back key, then the previous ID will remain valid. Possibility for fast clear of user identifier: write space on the first two characters of user identifier then press OKQ. The total user identifier will be cleared. 13.3.4.6. Mains frequency For filtering out mains noises, the device is equipped with a notch filter, which is tuned to mains frequency. In this menu point it is possible to select mains frequency. The device can be operated by 50 or 60 Hz mains frequency, so 50 or 60 Hz notch filter can be selected here. How to set it: stand the selector sign on the line, mains frequency, by the P, Rkeys, and press the OKQbutton. This way the label of the actual mains frequency will turn to green, indicating that this value can be modified. By the P, Rkeys, 50 Hz or 60 Hz can be selected. Selection can be validated by the OKQbutton. By this label color will change back to the original color. 62/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 13.3.5. Energy settings Initial energy values can be selected here. We can enter this menu point by pressing the OKQ button. Here the following parameters can be set: 13.3.5.1. Viewing of delivered energy In case of enabling, the viewing of delivered energy, after delivery of shock, the value of actually delivered shock will appear on the display. If this option is disabled, then only the value of selected energy will be viewed on the display. Step on this menu point by the selector sign, by using the P, Rkeys, and select menu point by the OKQbutton. This way color of the actual parameter will turn to green, indicating the possibility of changing. At this point the ‘Enabling’ and ‘Disabling’ settings can be selected by the P, Rkeys. Validation is made by pressing the OKQbutton, this way the parameter color will change back to the original color, and setting will be validated. 13.3.5.2. Manual energy – external Here we can select the initial value of the energy, when turning on, in MANUAL defibrillation mode, in case of external shock delivery. (Application of paddle or pads electrodes). Stand on this menu point by using the P, Rkeys, and select menu point by pressing the OKQbutton. This way color of the actual parameter will turn to green, indicating the possibility of changing. At this point, energy can be selected by the P, Rkeys between 2 and 360 J. Validation is made by pressing the OKQbutton, this way the parameter color will change back to the original color, and setting will be validated. 13.3.5.3. Manual energy- internal Here we can select the initial value of the energy, when turning on, in MANUAL defibrillation mode, in case of internal defibrillation. (Application of internal defibrillator electrode). Stand on this menu point by using the P, Rkeys and select menu point by pressing the OKQbutton. This way color of the actual parameter will turn to green, indicating the possibility of changing. Then energy can be selected by the P, Rkeys, between 1 and 50 J. Validation is made by pressing the OKQbutton, this way the parameter color will change back to the original color, and setting will be validated. 13.3.5.4. Semi-automatic energy – first shock In case of semi-automatic defibrillation, the energy level of first, second and third shocks can be set separately. In case of failure of the first shock, the shock should be repeated at the same or at a little bit higher energy level. That is why it is necessary to set separately the energy of the three shocks. In this menu point, the energy of first shock can be set. Stand on this menu point by using the P, Rkeys and select menu point by pressing the OKQbutton. This way color of the actual parameter will turn to green, indicating the possibility of changing. Then energy can be selected by the P, Rkeys, between 2 and 270 J. Validation is made by pressing the OKQbutton, this way the parameter color will change back to the original color, and setting will be validated. Cardio-Aid ® 360-B User’s manual R-5656-02-V02 63/89 13.3.5.5. Semi-automatic energy – second shock Its setting process is completely the same with the one of the first shock setting. Usual setting is the energy of first shock or one step higher. In case first shock has failed (ventricular fibrillation is not over or it returned very fast), then after 2 minutes of CPR the second shock delivery will be made at this energy level. (ERC 2010 BLS-AED guideline) 13.3.5.6. Semi-automatic energy – third shock Its setting process is completely the same with the one of the first shock setting. Usual setting is the energy of second shock or one step higher than that. In case second shock has failed (ventricular fibrillation is not over or it returned very fast), after another 2 minutes of CPR, third shock delivery will be made at this energy level. (ERC 2010 BLS-AED recommendation) 13.3.6. Mode settings 13.3.6.1. Defibrillation mode when turning on When turning on, the defibrillator can start in manual or semi-automatic mode. We can select in this menu point, which one to be validated. Stand on this menu point by using the P, R keys and select menu point by pressing the OKQbutton. This way color of the actual parameter will turn to green, indicating the possibility of changing. Then by the P, Rkeys MANUAL and SEMI AUTO modes can be changed. Validation is made by pressing the OKQbutton, this way the parameter color will change back to the original color, and setting will be validated. When turning on, the defibrillator will operate in the mode we selected here. If we want to use the defibrillator in another mode, then after turning on, we can select another mode by pushing a button. 13.3.6.2. Pacing mode The pacer in the defibrillator can operate in two modes, in fixed or in demand modes. (See section no. 11.3). In this menu point we can select, that after turning on, when selecting pacing mode, in which mode the pacing should be. Stand on this menu point by using the P, Rkeys and select menu point by pressing the OKQbutton. This way color of the actual parameter will turn to green, indicating the possibility of changing. Then by the P, Rkeys, Fixed and Demand modes can be selected. Validation is made by pressing the OKQbutton, this way the parameter color will change back to the original color, and setting will be validated. If we switch to pacing mode, the mode selected here will be set, and if we would like to change it, then by the key labelled (11a) Pacing mode, we can change the mode easily by a button touch. 64/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 13.3.6.3. Pace current Here the value of pace current can be set, when turning on. The value when turning on is usually 0 mA, but as the general limit value is 40 mA or higher, the defibrillator allows to set a higher initial current, this way pacing can be started faster, current does not or only slightly have to be set. Stand on this menu point by using the P, Rkeys and select menu point by pressing the OKQbutton. This way color of the actual parameter will turn to green, indicating the possibility of changing. Then the value of current can be changed in the range between 0 – 200 mA, by the P, Rkeys. Validation is made by pressing the OKQbutton, this way the parameter color will change back to the original color, and setting will be validated. If we switch to pacing mode, this value of current will be selected, but it can be very easily changed according to the description of section no. 11.3. 13.3.6.4. Pace rate Here we can set the value of pace rate, when turning on. Stand on this menu point by using the P, Rkeys and select menu point by pressing the OKQbutton. This way color of the actual parameter will turn to green, indicating the possibility of changing. Then the value of current can be changed in the range of 30 – 200 pulse/minute, by the P, Rkeys. Validation is made by pressing the OKQbutton, this way the parameter color will change back to the original color, and setting will be validated. If we switch to pacing mode, this frequency will be selected, but it can be very easily changed according to the description of section no 11.3. 13.3.6.5. Wake-up selftest (automatic selftest) Wake-up selftest is an automatic selftest, which, in case it is enabled, is running at a time when the defibrillator is very likely to be out of use. At the time defined by the user (see section no. 13.3.6.6) the device automatically switches on and it runs some certain tests. If the outcome of the test is positive, the device will switch off, and after next turning on, it will work without error message in order. If the selftest detects an error, the device will give an error signal by red blinking LED, and when next turning on, it will display a message about the type of error that has been detected by the test. The automatic selftest only makes tests of very low energy demand, so that it will not finish the battery. It does not check, for instance the printing, the backlight and the high-voltage charging circuit, as these are tasks of high- energy demand. It is important to mention, that the selftest also checks the battery, and under 50 % energy level it indicates, that battery must be charged. The enabling or disabling of wake-up selftest is made in this menu point. Stand on this menu point by using the P, R keys and select menu point by pressing the OKQbutton. This way color of the actual parameter will turn to green, indicating the possibility of changing. Then enabling or disabling can be selected by the P, Rkeys. Validation is made by pressing the OKQbutton, this way the parameter color will change back to the original color, and setting will be validated. Cardio-Aid ® 360-B User’s manual R-5656-02-V02 65/89 13.3.6.6. Wake-up start time (time of automatic selftest) In this menu point the starting time of automatic selftest, described in section no. 13.3.6.5 can be set. It is advisable to choose a time, when the device is very likely to be switched off, generally some time during the night. If the defibrillator is turned on, the automatic selftest will not start, even if it has been enabled. It does not cause any confusion, as in turned on state the defibrillator is checking itself. Stand on this menu point by using the P, Rkeys and select menu point by pressing the OKQbutton. This way color of the actual parameter will turn to green, indicating the possibility of changing. Then the time of selftest, which can only be a complete hour, can be selected by the P, Rkeys. After setting the time validation is made by pressing the OKQbutton, this way the parameter color will change back to the original color, and setting will be validated. If the automatic selftest is enabled, then selftest will be made at the time set here. 13.3.6.7. Demo mode In demo mode the device is providing ECG pulsewave signal, and it measures heart rate and SPO2 %. These signals can be viewed in each mode of the defibrillator. Demo mode can be enabled or disabled in this menu point. Stand on this menu point by using the P, Rkeys and select menu point by pressing the OKQbutton. This way color of the actual parameter will turn to green, indicating the possibility of changing. Then we can choose to switch the demo mode on or off, by the P, Rkeys. Validation is made by pressing the OKQbutton, this way the parameter color will change back to the original color, and setting will be validated. After exiting from the menu, curves and the parameters measured on them can be viewed in any modes of the defibrillator. The DEMO label appearing on the display is warning us about the fact, that the viewed signals are not received from sensors but they are artificial ones. If the device is turned off, when next turning on, demo mode will be switched off. 13.3.7. Signal setup menu A submenu belongs to this menu point. We can enter submenu by pressing the OKQbutton, where alarm limits, curve speeds and other parameters can be set. From the submenu we can go back to the previous level by the Sor the (11c) Menu Back keys. The following parameters can be set in this menu point: 13.3.7.1. ECG menu In the ECG menu, the set channel, the amplification, and the color-coding of ECG channels, when turning on the device, can be set. The selected ECG lead, when turning on, can be I, II, III, aVR, aVL, aVF, V1(Vx),V2, V3, V4, V5, V6. It can be set in the default ECG lead menu line. Take the selector sign by the P, Rkeys on the ‘Default ECG lead’ line, and select menu point by the OKQbutton. This way the color of actual parameter will turn to green, indicating that the parameter can be set. The desired lead can be selected by the P, Rkeys, then selection can be confirmed by pressing the OKQbutton. The ECG amplification valid, when turning on the device has to be set the same way. Here 0.25x, 0.5x, 1x, 2x sensitivity can be set in cm/mV, then selection should be validated by pressing the OKQbutton. Auto ECG gain means the device automaticly select the optimal sensitivity of ECG. This service switchable on and off in this menu item. 66/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 In the next point the viewing color of the ECG can be set. Colored and non-colored scheme can be chosen. In case of colored scheme, ECG channels will be viewed by the color-coding described in the standard, while in case of monochrome scheme, the ECG channels will be viewed by the same colors. Validation of selection happens by the OKQbutton in this case as well. 13.3.7.2. Speed menu In speed menu, the running speed of curves viewed on the display can be set. In the menu, the list of curves to be viewed can be seen. By the P, Rkey, stand on the label of the curve, of which speed you would like to set. Select the line by the OKQbutton, then the color of actual parameter will turn to green, indicating the possibility of changing. The desired running speed can be selected by the P, Rkeys, then validate the selection by pressing the OKQbutton. The selectable ECG speeds are: 5, 10, 25, 50 mm/s, the selectable SpO2 curve speeds are 5, 10, 25 mm/s. 13.3.8. Periphery setup menu A submenu belongs to this menu point. We can enter the submenu by pressing the OKQ button, where settings related to printing can be made, and here the sensitivity, referring to the external ECG amplifyer can be set as well. From the submenu we can go back to the previous level by the Sor the (11c) Menu Back keys. The following parameters can be set in this menu point: 13.3.8.1. Automatic printing If automatic printing is enabled, then in case any event happens, printing will automatically start, the actual parameter values and the event generating the printing will be written down, and ECG curve will be printed, in a way that the 2 seconds period before and 6 seconds after the event can also be seen on the paper. The event generating the printing can be delivery of shock, or any kind of alarm (HR, SpO2, VF, etc.). Take the selector sign on the ‘Automatic printing’ line by the P, Rkeys, and select menu point by the OKQbutton. Then the color of actual parameter will turn to green, indicating that it can be set. Enabling or disabling can be changed by the P, Rbuttons. Selection can be confirmed by the OKQbutton. 13.3.8.2. Printing time Printing can be started by the (4) PRINT button. Then the device prints a heading including the actual parameters, then it will start printing the ECG curve. Generally it is enough to print a 15 seconds period, but in some certain cases, printing a longer period is useful. In this menu point, we can set how many seconds of ECG should be included in the printout. By the (4) PRINT button, printing can be stopped at any time, but if it is not stopped, then after the time set here, it will automatically stop. It can be useful from the aspect of saving paper. Take the selector sign on the line ‘Printing time’ by theP, Rkeys, and select menu point by the OKQ button. Then the color of actual parameter will turn to green, indicating that it can be set. Periods can be changed by the P, Rkeys. Selection can be 16 s, 20 s, 32 s or 2 minutes printing. Confirm selection by the OKQbutton. If you select continuous printing, and you do not stop the printing already started, then it will be continued until the paper finishes. Cardio-Aid ® 360-B User’s manual R-5656-02-V02 67/89 13.3.8.3. Printing speed Printing speed can be 25 or 50 mm/s, it can be defined in this menu point. Take the selector sign on the line ‘Printing speed’ by the P, Rkeys, and select menu point by pressing the OKQbutton. Then the color of actual parameter will turn to green, indicating that it can be set. Speed can be selected by the P, Rkeys. Confirm selection by the OKQbutton. 13.3.8.4. Printing event report The event report printing is enabled or disabled in this menu point. If it is enabled, at switching off the defibrillator prints out the event report from the last event to backwards. The user can stop the printing by pushing the (11b) soft key “ABORT”, then the printing stops and the defi is switching off. 13.3.8.5. Multichannel printing When it is disabled, the printer works in single channel mode. If enabled, 3 ECG channel will be printed to paper. 13.3.8.6. External ECG amplifier The defibrillator cannot view and evaluate only the ECG signal received from the ECG electrode and amplified, but it is also able to receive and develop the signals recorded and amplified by other devices. In this case, the signal of the external device can be connected to the (20) ECG connector of the defibrillator by a cable, obtainable from the manufacturer. As the external device is providing already amplified signals, but in the defibrillator the ECG has to be viewed and evaluated with correct amplitude, therefore the defibrillator has to know the sensitivity of the external ECG amplifyer. This value can be set in this menu point. Sensitivity of the external ECG amplifyer can be read from the external device, or it can be found in its user’s manual. This value has to be set in the ‘External ECG amplifier’ menu point. Take the selector sign on the line ‘External ECG amplifier’ by the P, Rkeys, and select menu point by pressing the OKQbutton. Then the color of actual parameter will turn to green, indicating that it can be set. Select amplification by the P, Rkeys, from the 1V/mV or 0,1V/mV options. Confirm selection by the OKQbutton. 13.3.9. Data saving Here is the possibility to save the stored data and service log files to a USB pendrive. Connect the pendrive to the (27) USB-A connector on the right side of defi, then select the Data Saving menu point. The defi realises the connected pendrive and save the files to it, then signs the end of saving. Attention! Wait the end of storing action. The defibrillator will give a “Storage State: Done” message at the end of storing. Then You can leave the submenu by Skey and remove the USB pendrive. If the event report is long, the storing may take a few minutes. The saved data may study and evaluate by Innobase CA360B software on PC. 68/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 13.3.10. Delete saved data The data stored by Data Saving action may delete by this command. It is practical to perform a Delete saved data action, because without deleting these data will storedat the next storing action too. Attention! The “Delete Saved Data” command immediately goes to action by pressing OKQ key. Here also wait the “Deleting State: Done” message before leaving the submenu. 13.3.11. Service menu The service menu was made for technical service personnel, user of the defibrillator should not use this service. Incorrect use of service menu might threaten the safe operation of the device, therefore unintended entry in the system is prevented by the use of password. Password is known by the service person, this way he can enter the service menu, where he can get information about the software and hardware versions and serial numbers, he can get access and download error and service lists, he can check and calibrate the defibrillator units. Detailed description of the use of service menu can be found in the service manual. Cardio-Aid ® 360-B User’s manual R-5656-02-V02 69/89 14. Technical data of the defibrillator 14.1. Applied standard EN60601-1: 1990+A1: 1993+A11: 1993+A12: 1993+A2: 1995+A13: 1996 General safety and basic operation requirements EN60601-1-2:2007 Electromagnetic compatibility EN60601-2-4:2003 Safety requirements of defibrillators EN60601-2-25: 1995+A1:1999 Safety requirements of single and multi-channel electrocardiographs, including basic requirements of operation EN60068-2-27: 2009 Basic environmental testing procedures Bump tests EN60529: 1991+ A1:2000 Degrees of protection provided by enclosures (IP code) The device complies with the ERC 2010 guidelines. 14.2. General data Size 360 x 280 x 250 mm (width x height x depth) Weight 6.5 kg with pads electrodes, battery, pacer and printer; 7 kg with defibrillator paddles Power 100-240 VAC, 50/60 Hz Capacity @100VAC: max. 1,3 A; max. 130 VA @240VAC: max. 0,5 A; max. 120 VA Temperature Operating: 0 - 45ºC Storage: -20 - 60ºC (<168h) Humidity Operating: 30 – 95% relative humidity, non-condensing Storage: 30 – 95% relative humidity, non-condensing Operation and storage pressure 550 – 1060hPa Classification Class I / Internally powered equipment Environmental stability Water protection: Drip-proof equipment (IP32) Mode of operation Continuous monitoring and pacer stimulation, Defibrillation at 270 J energy for 2 minutes every 12 seconds, for long period an average of 2 shocks/minute. 70/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 14.3. Display Type Color TFT display with LED backlight Size 150 x 92mm color TFT display Resolution 800x480 pixel Semi-automatic mode: 3 ECG curve Manual mode: three selectable curves with individually settable curve speed Pacing mode: three selectable curves with individually settable curve speed Number of viewable curves ECG mode: with 3-lead cable 3 lead (I, II, III) can be selected with 5-lead cable cable 7 leads with 10-lead cable 12 leads simultaneous viewing + rhythm curve switchable on and off ECG window At 4.4 s 25mm/s curve running speed Curve speed 5, 10, 25, 50 mm/s Sensitivity 0,25 0,5 1 2 4 cm/mV or Auto Frequency transmission to the display 2 Hz – 25 Hz 14.4. LED-displays on the front board Battery capacity LED Indicates the battery capacity. Connected to the mains, the device indicates its battery capacity by flashes: in case of empty battery one flash in each 4 seconds, at 50% capacity two flashes in every 4 seconds, at 90% capacity three flashes in every 4 seconds. In case of being fully charged, the LED is enlightened continuously. If the device is not connected to the mains, the LED is not enlightened. State indicator LED Dual-colored indicator, green and red. The LED flashing in green indicates, that the device can work correctly (one flash in each 4 seconds). If the selftest (turning on test or wake-up test) detects error, the LED will be flashing twice in red color, every 4 seconds. Cardio-Aid ® 360-B User’s manual R-5656-02-V02 71/89 14.5. Defibrillator Defibrillator impulse STAR (BTE) biphasic waveform, period of first phase depends on patient’s chest (measured between the two paddles) impedance, 3 – 11 ms, period of second phase is fixed 3,2ms. The amplitude of the signal depends on set energy and on patient impedance. External defibrillator paddles or pads electrodes 2-5-7-10-20-30-40-50- 60-80-100-150-200-270- 360J Delivered energy at 50 ohm loading Internal paddles 1-2-3-4-5-6-7-8-9-10- 15-20-30-40-50J Energy accuracy ±1J or ±5%, which is higher, in case of shocks delivered at any energy level, for 50 ohm loading. Energy availabilty Automatic disabling of shocking 30 seconds after being charged. Impedance range during external defibrillation In case of impedance higher than 200 ohm and lower than 20 ohm the defibrillator disables shocking. Impedance range during internal defibrillation In case of impedance higher than 50 ohm and lower than 15 ohm the defibrillator disables shocking. Synchronous shock delaying Typically 40 ms (max. 60 ms) from top of QRS to the top of discharge curve. Synchronous marker „S” signal, by vertical line Fully charged battery < 7 s (typically) From battery (25ºC) After 15 defibrillations < 10 s (typically) From mains (in voltage range of 100V~ - 240V~) With charged battery < 4 s (typically) 90V~ mains voltage In case of completely empty battery < 15s (typically) Charging time to 270 J in manual mode Time passed from power on to charge- ready state for maximum energy < 20s (typically) 72/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 Fully charged battery < 17 s (typically) From battery (25ºC) After 15 defibrillations < 20 s (typically) From mains (in voltage range of 100V~ - 240V~) With charged battery < 15 s (typically) 90V~ mains voltage In case of completely empty battery < 25 s (typically) Maximum time passed from enabling of rhythm recognition (including analysis time) till shock-ready state, at maximum energy level, in semi- automatic mode. Time passed from power on to charge- ready state for maximum energy < 40 s (typically) VF / VT recognition Complies or better than the AAMI DF-39 requirement. Recognizes broad QRS VT > at 180bpm 14.6. Battery Type NiMH battery 3000mAh Nominal voltage 10,8 V (9 cells) Operation time at 20ºC Monitoring: 4,5 hours, or Defibrillation: >200 shocks at 200 J, or >100 shocks at 270J, or > 60 shocks at 360 J, or Pacing at 60bpm and at 160mA :> 3 hours Charging time in case of completely empty battery 2,5 hours Battery protection against overwarming The battery housing is equipped with a thermal fuse of 75°C, which cuts the circuit in case of overwarming. Lifetime In case of minimum 24 month normal use eg. one charging cycle per day Cardio-Aid ® 360-B User’s manual R-5656-02-V02 73/89 14.7. ECG via pads or defibrillator paddles electrodes Mode Differential Input signal range ± 5 mV DC tolerance ± 400 mV Frequency response(-3dB) 2-60 Hz Gain x0.25, x0.5, x1, x2, x4, auto (default = x1) Input-related noise Max. 30 uVpp ECG input impedance Min. 20 Mohm CMRR Min. 100 dB Recovery time after overdriveing < 5 s Pacemaker tolerance Max. 700 mV / 2 ms Pacemaker detection Min. 2 mV / 0,25 ms Max. 700 mV / 2 ms Defibrillator tolerance Max. 400 J Patient impedance measurement range 10-200 ohm Signal delay (in correlation with viewing) Max 20 ms Sampling frequency 400 Hz AD resolution 5 uV / bit QRS-detection limit level 200 dV Safety classification External defibrillator paddle: class CF Defibrillator pads electrodes: class CF Internal defibrillator paddles: class CF 14.8. ECG via patient cable and ECG electrodes 3-lead cable: I. II. III. 5-lead cable: I. II. III. aVR aVL aVF Vx Viewable leads 10-lead cable: I. II. III. aVR aVL aVF V1 … V6 Input signal range ± 10 mV DC tolerance ± 320 mV Frequency response (-3dB) 0,05 – 150 Hz Baseline filter (-3dB) 0,5 Hz Muscle filter (-3dB) settable: 25, 30, 35, 40 Hz 74/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 Mains filter 50 or 60 Hz Attenuation: > 20 dB Gain x0.25, x0.5, x1, x2, x4, auto (default = x1) Baseline recovery time after shock < 5 s at 270 J Input-related noise Max. 20 uVpp ECG input impedance Min. 20 Mohm CMRR (by mains filter) Min. 120 dB Recovery time after overload < 5s Pacemaker tolerance Max. 700 mV / 2 ms Pacemaker detection Min. 2 mV / 0,25 ms Max. 700 mV / 2 ms Defibrillator tolerance Max. 400 J With baseline filter: 2 s Signal delay (in correlation with viewing) Without baseline filter: 10 ms Blocking Automatic Sampling frequency 8 kHz AD resolution 0,25 uV / bit, 24 bit QRS-detection limit level 200dV Checking of ECG electrode removal Per electrode Checking of ECG channel noise Per channel Classification Defibrillation-protected, class CF 14.9. ECG from external monitor Dinamic range ± 10V (with 1V/mV signal) With baseline filter: 2 s Signal delay (in correlation with viewing) Without baseline filter: 10 ms Sensitivity Settable from the menu: 100 mV/mV or 1000 mV/mV ±5% Connecting Via (20) ECG plug, with cable to be ordered from manufacturer Cardio-Aid ® 360-B User’s manual R-5656-02-V02 75/89 14.10. Heart rate measurement from ECG signal Measurement range 15 – 300 bpm Accuracy of measurement ± 2 bpm vagy ± 1 % Resolution of displaying 1 bpm Alarms Lower and upper limits can be set 14.11. Pacer Mode „Demand” (VVI) or „Fixed” (VOO) Pulse type Rectangular, constant current Pulse duration 40 ms ± 5% Pulse amplitude 20 – 200 mA ± 5%. Pulse amplitude step ± 1 mA Pace rhythm 30 – 200 bpm ± 5%. Pace rhythm step ± 1 bpm Output voltage Max. 250V 14.12. SpO2 measurement Sensor Fingerclip SpO2 measurement range 1 – 100% Accuracy of SpO2 measurement Over 70% ±2% Resolution of SpO2 displaying 1 % Pulse number measurement range 20 – 300 bpm ±3 bpm Resolution of pulse displaying 1 bpm Alarms Lower and upper limits of SpO2% and rhythm Defibrillator-protection 5 kV Light emission of the finger clip: 660 nm (red) 900 nm (infrared) Typically less, than 15 mW 76/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 Data Update Period, Effect of Data Averaging, and Other Signal Processing: OxiMax Algorithm The advanced signal processing of the OxiMax algorithm automatically extends the amount of data required for measuring SpO2 and pulse rate depending on the measurement conditions. During normal measurement conditions in the Normal Mode, the SpO2 averaging time is six (6) to seven (7) seconds or approximately three (3) seconds in Fast Mode. Equivalently, the typical pulse rate averaging time is approximately five seconds, independent of response mode. The OxiMax algorithm automatically extends the dynamic averaging time required beyond seven (7) seconds during degraded or difficult measurement conditions caused by low perfusion, signal artifact, ambient light, electrocautery, other interference, or a combination of these factors, which results in an increase in the dynamic averaging beyond the minimum as set by the response mode. If the resulting dynamic averaging time exceeds 20 seconds for SpO2, the algorithm sets the pulse search bit while continuing to update SpO2 and Pulse Rate values every second. As such measurement conditions extend, the amount of data required may continue to increase. If the dynamic averaging time reaches 40 seconds, and/or 50 seconds for pulse rate, a low priority alarm state results: the algorithm sets the Pulse Timeout bit and the module reports a zero saturation indicating a loss- of-pulse condition which should result in an audible alarm. Response Mode For systems featuring the Fast Mode (NELL-1, NELL-2), this setting dictates the response time (two (2) to four (4) seconds in Fast Mode and six (6) to seven (7) seconds in Normal Mode) applied by the OxiMax algorithm in its calculation of SpO2. The OxiMax algorithm’s calculation of pulse rate is unaffected by the response mode setting. The data storage interval in the oximeter’s trend memory is decreased automatically to two (2) seconds when the oximeter is set to operate in the Fast Mode (the storage interval is four (4) seconds in the Normal Mode). Cardio-Aid ® 360-B User’s manual R-5656-02-V02 77/89 Test Considerations and Oximeter Accuracy Functional Testers and Patient Simulators Some models of commercially available bench top functional testers and patient simulators can be used to verify the proper functionality of Nellcor pulse oximeters, sensors, and cables. Reference the individual testing device's operator's manual for the procedures specific to the model of tester used. While such devices may be useful for verifying that the pulse oximeter sensor, cabling, and oximeter are functional, they are incapable of providing the data required to properly evaluate the accuracy of a system's SpO2 measurements. Fully evaluating the accuracy of the SpO2 measurements requires, at a minimum, accommodating the wavelength characteristics of the sensor and reproducing the complex optical interaction of the sensor and the patient’s tissue. These capabilities are beyond the scope of known bench top testers. SpO2 measurement accuracy can only be evaluated in vivo by comparing pulse oximeter readings with values traceable to SaO2 measurements obtained from simultaneously sampled arterial blood using a laboratory CO-oximeter. Many functional testers and patient simulators have been designed to interface with the pulse oximeter's expected calibration curves and may be suitable for use with Nellcor oximeters and/or sensors. Not all such devices, however, are adapted for use with the Nellcor OxiMax digital calibration system. While this will not affect use of the simulator for verifying system functionality, displayed SpO2 measurement values may differ from the setting of the test device. For a properly functioning oximeter, this difference will be reproducible over time and from oximeter to oximeter within the performance specifications of the test device. Accuracy with Low Perfusion Reading accuracy in the presence of low perfusion (detected IR pulse modulation amplitude between 0.03% and 1.5%) was validated using signals supplied by a patient simulator. SpO2 and pulse rate values were varied across the monitoring range over a range of weak signal conditions and compared to the known true saturation and pulse rate of the input signals. 78/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 14.13. Non-invasive bloodpressure measurement (NIBP) Measurement method Oscillometric with scalar deflation Measurement range Adult: diastole 20…200 mmHg systole 40…260 mmHg Neonatal: diastole 15…100 mmHg systole 40…130 mmHg Accuracy of pressure transducer ±3 mmHg Modes Manual, Continuous and Periodical (2 - 480 minutes) Displayed values Diastole, systole, arterial pressure, time of last measurement. Alarms For lower and upper limits (between 15…260 mmHg) for cuff error or measurement error Defibrillation-protection 5 kV 14.14. Printing Printing mode Manual or automatic Number of simultaneously printable curves 3 Printing time Selectable: 15, 20, 30 or 120 s Speed 25 mm/s Paper Thermal, non-rastered 58mm x 30m roll Printer head resolution In the direction of amplitude: 8 dots/mm On time axis: 8 dots/mm Preprinting of curves 8s Cardio-Aid ® 360-B User’s manual R-5656-02-V02 79/89 14.15. Event storage Events generating storage Delivery of shock, related to alarm of physiological parameters (limit crossing, sensor errors), manual event indication by the (3) event button Number of storable events 200 Data, parameters stored in events Device state, measured parameters HR, SpO2%, NIBP, cause of event, shock energy, state of ECG filters Curves stored in the event Curves monitored during event, ECG, pulsewave, SpO2% Viewing of stored events In case of printing enabled event viewer, started from user menu, events will be printed, starting from the last event in chronological order backwards. Events can be saved via USB connector on pendrive, then they can be viewed on PC. 14.16. Connection possibilities for data transfer LAN connection For technical service and program upgrade USB host connection For technical service and program upgrade USB device connection For later use 80/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 14.17. Parameters of defibrillation impulse U [V] T [ms] U1 U2 -U2 t1 t2 t3 Phase 1 Phase 2 -U3 U1 Voltage at the beginning of first phase U2 Voltage at the end of first phase -U2 Voltage at the beginning of second phase -U3 Voltage at the end of second phase t1 Duration of first phase t2 Break between the first and the second phases t3 Duration of second phase parameters of STAR biphasic waveform Cardio-Aid ® 360-B User’s manual R-5656-02-V02 81/89 82/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 Delivered energy by the defibrillator as a function of patient’s chest impedance at the range between 2 – 360 J Cardio-Aid ® 360-B User’s manual R-5656-02-V02 83/89 84/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 15. Accessories, order information Part number Description K25528-4 Internal defibrillator paddles set, adult. Straight, 65mm in diameter. 2 spoons, 2 handles, 2 cables, 1 internal defibrillator paddles connector. K25529-2 Internal defibrillator paddles set, pediatric. Straight, 40mm in diameter. 2 spoons, 2 handles, 2 cables, 1 internal defibrillator paddles connector. F25531-8 Internal defibrillator paddles set, neonatal size. Straight, 25.4mm in diameter. 2 spoons, 2 handles, 2 cables, 1 internal defibrillator paddles connector. FF32773-B Internal defibrillator paddle 65mm Adult P007152 Internal defibrillator paddle 40 mm Pediatric FF33603-A Internal defibrillator paddle 25,5 mm Neonatal F25527-6 Internal defibrillator paddle connector. F25530-0 Cable for internal defibrillator paddles, 2 pcs. FF20437-9 External defibrillator paddles set, complete. K20438-8 Cable for defibrillator pads electrode KEG260 Electrode gel, 260g KP58S-5 Recording paper 58mm x 20 m non-rastered, 5 rolls. K49576-4 Defibrillator / pacer controller, R2 connector. K7955 Adult defibrillator-electrode R2//F7955 FIAB 1 pair K7955P Pediatric defibrillator pads-electrode R2//F7955P FIAB 1 pair K7955-10 Adult defibrillator pads-electrode R2/F7955 FIAB 1 box = 10 pcs. K7955P-10 Pediatric defibrillator pads-electrode R2/F7955P FIAB 1 box = 10 pcs. R-5651-1 ECG patient cable with 3 leads and clips, def. protected R-5650-1 ECG patient cable with 5 leads and clips, def. protected R-5649-1 ECG patient cable with 10 leads and clips and with V-lead selector. KFS50 FS-50 disposable ECG electrode (30 pcs/pack) SKINTACT R-xxxx-x Cable for external ECG-source connection. End of the cable is opened towards the external device KDEFSPFU Nellcor adult pulseoxymeter sensor (DS-100A) KDEFSPFUH Nellcor pulseoxymeter cable (DOC-10) R-4198-1 NIBP Cuff normal (23-33 cm) Cardio-Aid ® 360-B User’s manual R-5656-02-V02 85/89 Part number Description R-4198-2 NIBP Cuff extra sized (31-40 cm ) R-4198-3 NIBP Cuff pediatric (17-26 cm) R-4198-4 NIBP Cuff infant (13-19 cm) R-4198-5 NIBP Cuff neonatal (7-13 cm) KITMANT NIBP Cuff extension tube KITMANCST3 Extension tube for neonatal NIBP cuff R-xxxx-x Complete battery pack for CA360-B defibrillator R-xxxx-x Service manual in paper copy or in PDF format 86/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 16. Elimination of useless electronic devices as waste (Applyable in the selective waste collection system of the European Union and other European countries.) This symbol on the product or on its packaging indicates that this product should not be treated as household waste. Please hand it over at the collection point for the collection of electrical and electronic waste. 17. Guidelines and manufacturer statements – electromagnetic compatibility Guideline and manufacturer statement – electromagnetic interference emission The CA360-B defibrillator was made for the use in the electromagnetic environment defined below. The buyer or user of CA360-B has to make sure that it should work in such environment. Interference emission test Conformance Electromagnetic environment - guideline RF emissions CISPR 11 Group 1 The CA360-B defibrillator only uses RF energy for its internal operations. Therefore RF interference emisson is very low, and not likely to interfere with the electronic devices in its vicinity. RF emissions CISPR 11 Class B Harmonic current emissions IEC 61000-3-2 Class B Voltage fluctuations/flicker emissions IEC 61000-3-3 Conforms A CA360-B defibrillator can be used in households and in establishments directly connected to the public low-voltage power supply network that supplies domestic buildings. Cardio-Aid ® 360-B User’s manual R-5656-02-V02 87/89 Guideline and manufacturer statement – electromagnetic interference tolerance The CA360-B defibrillator was made for the use in the electromagnetic environment defined below. The buyer or user of CA360-B has to make sure that it should work in such environment. Interference tolerance test Test level Conformance level Electromagnetic environment- guideline Electrostatic discharge (ESD) IEC 61000-4-2 ± 6 kV contact ± 8 kV air discharge ± 6 kV contact ± 8 kV air discharge Floor should be wood, concrete or ceramic title. If floor is covered with synthetic material, the relative humidity should be at least 30 %. Fast electric transients/ burst IEC 61000-4-4 ± 2 kV on power supply lines ± 1 kV on input and output lines ± 2 kV on power supply lines ± 1 kV on input and output lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 ± 1 kV differential mode ± 2 kV common mode ± 1 kV differential mode ± 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines acc. IEC 61000-4-11 < 5% U T (>95% dip in U T ) for 0,5 cycles, 40% U T (60% dip in U T ) for 0,5 cycles, 70% U T (30% dip in U T ) for 25 cycles, < 5% U T (>95% dip in U T ) for 5 s < 5% U T (>95% dip in U T ) for 0,5 cycles, 40% U T (60% dip in U T ) for 0,5 cycles, 70% U T (30% dip in U T ) for 25 cycles, < 5% U T (>95% dip in U T ) for 5 s Mains power quality should be that of a typical commercial or hospital environment. Mains frequency (50/60 Hz) magnetic fields IEC 61000-4-8 10 A/m 10 A/m Mains frequency magnetic fields should be at the same level with the characteristics of a typical commercial or hospital environment. Note: U T is the AC mains voltage prior to application of the test level. 88/89 Cardio-Aid ® 360-B User’s manual R-5656-02-V02 Guideline and manufacturer statement – electromagnetic interference tolerance The CA360-B defibrillator was made for the use in the electromagnetic environment defined below. The buyer or user of CA360-B has to make sure that it should work in such environment. Interference tolerance test Test level Conformity level Electromagnetic environment- guideline Portable and mobile RF communication devices cannot be used within the protection range of CA360-B defibrillator, defined by the transmitter frequency function. Recommended protective distance Conducted RF IEC 61000-4-6 3 V eff 150 kHz–80 MHz outside the ISM bands 10 V eff 150 kHz–80 MHz In the ISM bands a 3 V 10 V/m d = P 2 . 1 d = P 2 . 1 Radiated RF IEC 61000-4-3 10 V/m 80 MHz – 2.5 GHz 10 V/m d = P 2 . 1 80 MHz – 800 MHz d = P 3 . 2 800 MHz – 2.5 GHz Where P is the maximum output power rating of the transmitter in Watts (W) according to the transmitter manufacturer, and d is the recommended separation distance in meters (m). b Field strength from fixed RF transmitters c , as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range d Interference may occur in the vicinity of equippments marked with the following symbol: 1. NOTE: in case of 80 MHz and 800 MHz the higher frequency range applies. 2. NOTE: This guideline cannot be applied in each situation. Electromagnetic propagation is influenced by the absorption and reflection from buildings, objects and people. a The ISM (industrial, scientific and medical engineering) bands between 150 kHz and 80 MHz are as follows: 6,765 MHz-6,795 MHz; 13,553 MHz-13,567 MHz; 26,957 MHz-27,283 MHz and 40,66 Mhz- 40,70 MHz b. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz, and between 80 Mhz and 2,5 GHz are necessary to reduce the likelihood of caused interferences by mobile/portable telecommunication devices, in case they are taken too close to patient by mistake. Therefore a complementary 10/3 constant was put in the calculations, which are for the defining of recommended separation distances of transmitters, operating in these frequency ranges. c. Field strength from fixed transmitters, such as base station for radio (cellular/wireless) telephones and mobile radios, amateur radios, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To get to know the electromagnetic environment due to fixed transmitters, an electromagnetic site survey is necessary. If the measured field strength, in the location where the CA360-B defibrillator is operated, exceeds the applicable RF compliance level, the intended operation of the defibrillator should be reviewed. If abnormal performance is observed, additional measures might be necessary, such as turning or relocating the CA360-B defibrillator. d Over the frequency ranges between 150 kHz and 80 MHz, field strength should be less than 3 V/m. Cardio-Aid ® 360-B User’s manual R-5656-02-V02 89/89 Recommended separation distances between portable and mobile RF telecommunication devices and the CA360-B defibrillator The CA360-B defibrillator was made for the operation in a controlled RF interference environment. The buyer or operator of CA360-B defibrillator can help prevent electromagnetic interference by defining the separation distance between the portable and mobile RF telecommunication devices (transmitters) and the CA360-B defibrillator, by defining, calculated according to the followings, by the highest output power of the telecommunication device. Highest given output power of transmitter W Separation distance based on transmitter frequency m 150 kHz – 80 MHz d = P 2 . 1 80 MHz – 800 MHz d = P 2 . 1 800 MHz – 2.5 GHz d = P 3 . 2 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m), can be estimated by using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in Watts (W), given by the transmitter manufacturer. 1. NOTE: In case of 80 MHz and 800 MHz separation distance belonging to the higher frequency range should be applied.. 2. NOTE: The ISM (industrial, scientific and medical engineering) bands between 150 kHz and 80 MHz are as follows: 6,765 MHz-6,795 MHz; 13,553 MHz-13,567 MHz; 26,957 MHz-27,283 MHz and 40,66 Mhz-40,70 MHz 3. NOTE: A complementary 10/3 constant was put in the calculations, which are for the defining of recommended separation distances of transmitters, operating in the ISM frequency ranges between 150 kHz and 80 MHz and between 80 Mhz and 2,5 GHz, to reduce the likelihood of caused interferences by mobile/portable telecommunication devices, in case they are taken too close to patient by mistake. 4. NOTE: This guideline cannot be applied in each situation. Electromagnetic propagation is influenced by the absorption and reflection from buildings, objects and people.
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