Cardio Aid 360B Manual de Servicio

Innomed Medical Inc.

R-6487-2 Cardio-Aid 360-BBiphasic defibrillator

Service Manual

2/45 Cardio-Aid 360-B Service Manual

Contents

1. Recommended areas of use, operation concept ................................................................. 3 1.1. Brief description, main parameters ............................................................................ 3

1.1.1. STAR biphasic waveform ............................................................................... 3 1.2. Cases whereby the defibrillator can be used .............................................................. 3 1.3. Electrodes, recommended setups ............................................................................... 4 1.4. Environment of use .................................................................................................... 4 1.5. Who are entitled to operate the defibrillator?............................................................. 4 1.6. Abbreviations, expressions figuring in the description.............................................. 5 1.7. Special advantages of the Cardio-Aid 360-B device.............................................. 5

2. Technical data of the defibrillator ...................................................................................... 6 2.1. Applied standards ....................................................................................................... 6 2.2. Classifications ............................................................................................................ 6 2.3. General data................................................................................................................ 6 2.4. Display ....................................................................................................................... 7 2.5. LED-displays on the front board................................................................................ 7 2.6. Defibrillator ................................................................................................................ 8 2.7. Battery ........................................................................................................................ 9 2.8. ECG via pads or defibrillator paddles electrodes..................................................... 10 2.9. ECG via patient cable and ECG electrodes.............................................................. 10 2.10. ECG from external monitor.................................................................................. 11 2.11. Heart rate measurement from ECG signal ........................................................... 12 2.12. Pacer ..................................................................................................................... 12 2.13. SpO2 measurement .............................................................................................. 12 2.14. Non-invasive bloodpressure measurement (NIBP).............................................. 15 2.15. Printing ................................................................................................................. 15 2.16. Event storage ........................................................................................................ 16 2.17. Connection possibilities for data transfer............................................................. 16 2.18. Parameters of defibrillation impulse .................................................................... 17

3. Accessories, order information ........................................................................................ 20 4. The Cardio-Aid 360-B defibrillator maintanance, assigments..................................... 22

4.1. Cleaning of the device.............................................................................................. 22 4.2. Regular and periodic maintenance ........................................................................... 22 4.3. Battery handling, maintenance ................................................................................. 23

5. CA 360 B - Dismantling................................................................................................... 24 5.1. Removing the Assembled paddle holders. ............................................................... 25 5.2. Removing the Battery pack. ..................................................................................... 26 5.3. Removing the Rear cover assembly. ........................................................................ 27 5.4. Removing the front cover assembly......................................................................... 29 5.5. Dismantling the front cover assembly...................................................................... 30 5.6. Dismantling the internal assembled chassis. ............................................................ 32

6. Devices blockdiagramms ................................................................................................ 34 6.1. Electrical module interconnections: ......................................................................... 34 6.2. Mechanical structure: ............................................................................................... 35

Cardio-Aid 360-B Service Manual 3/45

1. Recommended areas of use, operation concept 1.1. 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.

1.1.1. 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.

1.2. 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 defibrillators 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.


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

1.3. 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.

1.4. 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.

1.5. 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.


1.6. 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 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 1.7. 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.


2. Technical data of the defibrillator 2.1. Applied standards

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.

2.2. 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 EN 55011 standard is: group no. 1, class B.

2.3. 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;

7.2 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 - 45C

Storage: -20 - 60C (


2.4. Display

Type Color TFT display with LED backlight Size 150 x 92mm color TFT display Resolution 800x480 pixel

Semi-automatic mode: 1 ECG curve Manual mode: two 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 1 lead (I II or 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

2.5. 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.


2.6. Defibrillator

Defibrillator impulse STAR (BTE) biphasic waveform, period of first phase depends on patients 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 (25C)

After 15 defibrillations

< 10 s(typically)

From mains (in voltage range of 100V~ - 240V~)

With charged battery

< 5 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)


Fully charged battery

< 17 s(typically)

From battery (25C)

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

2.7. Battery

Type NiMH battery 3000mAh

Nominal voltage 10,8 V (9 cells)

Operation time at 20C Monitoring: 4 hours or Defibrillation: 100 shocks at 270J, or 60 shocks at 360 J, or In case of pacing at 60bpm and at 100mA: 2 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 75C, which cuts the circuit in case of overwarming.

Lifetime In case of minimum 24 month normal use eg. one charging cycle per day


2.8. 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 SVSafety classification External defibrillator paddle: class CF

Defibrillator pads electrodes: class CF Internal defibrillator paddles: class CF

2.9. 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


Mains filter 50 or 60 Hz Gain x0.25, x0.5, x1, x2, x4, auto (default = x1) 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 200SVChecking of ECG electrode removal

Per electrode

Checking of ECG channel noise Per channel Classification Defibrillation-protected, class CF

2.10. 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 1000

mV/mV Connecting Via (20) ECG plug, with cable to be ordered from

manufacturer


2.11. 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

2.12. 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

2.13. 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


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 algorithms calculation of pulse rate is unaffected by the response mode setting. The data storage interval in the oximeters 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).


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 patients 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.


2.14. Non-invasive bloodpressure measurement (NIBP) Measurement method Oscillometric with scalar deflation Measurement range Adult: diastole 20200 mmHg

systole 40260 mmHg Neonatal: diastole 15100 mmHg systole 40130 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 15260 mmHg)

for cuff error or measurement error Defibrillation-protection 5 kV

2.15. Printing

Printing mode Manual or automatic Number of simultaneously printable curves

1

Printing time Selectable: 15, 20, 30s or 2 minutes 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


2.16. 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.

2.17. 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


2.18. Parameters of defibrillation impulse

U [V]

T [ms]

U1

U2

-U2

t1 t2t3

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


Delivered energy by the defibrillator as a function of patients chest impedance at the range between 2 360 J


3. 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)


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-5702-1 Assembled tested battery pack complete R-xxxx-x Service manual in paper copy or in PDF format


4. The Cardio-Aid 360-B defibrillator maintanance, assigments

4.1. 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.

4.2. 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. Hiba! A hivatkozsi forrs nem tallhat.. 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.


4.3. 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 Hiba! A knyvjelzC nem ltezik..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. 4.3): 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.


5. CA 360 B - Dismantling

This section provides information about the dismantling and re-assembly procedures for the CA 360 B. The CA 360 B is dismantled in steps braking the unit down into its major components.

Note! The necessary precautions against Electro Static Discharge (ESD) must be

taken. This applies to all handling of electrical components as well as printed circuit boards and all service involving dismantling the CA 360 B.

Note! Before starting dismantle operation you have to shoot down the device,

disconnect power cable and wait at least 2 minutes. Before handling High Voltage parts such as HV-capacitor, HV-circuit etc., ensure that there is no voltage using a high voltage probe (1000:1). High-voltage parts are identified with the Danger High-voltage symbol. Be very careful when connecting the high voltage probe- avoid touching the terminals and use proper insulation If voltage is present, leave the unit until the HV-capacitor is fully drained. If the capacitor remains charged it can be discharged by connecting a drain resistor e.g. 100kohm, 17W, directly over the HV capacitor terminals for min. 30 sec.Be very cautious when connecting the resistor and use proper insulation. When storing an HV-capacitor, always leave it in a short-circuit state. Re-assembling the CA 360 B taking care that the various rubber seals are seated correctly.

Important When ever an operation of dismantling and re-assembly of the CA 360 B is

carried out, a safety and performance check must be performed.

Tools needed: Torx screwdriver kit. Hexagon screwdriver kit Phillips screwdriver kit. Wire cutter


5.1. Removing the Assembled paddle holders.

Dismantling the CA 360 B Paddle holders remove the three screws marked with green arrows on the Paddle holders.

Note! Do not remove the smaller screw holding the metal plate on the Paddle holders


5.2. Removing the Battery pack.

The battery is located behind the left paddle/pads holder, seen from the front.

1. Turn off the CA 360 B and disconnect the main cable.

2. Remove the left paddle from the paddle holder.

3. Remove the left paddle holder (see instructions above)

4. Slacken the two screws on the battery.

Note! The screws are secured and can not fall out. 5. Remove the battery by pulling the white band.


5.3. Removing the Rear cover assembly.

Before you remove front and rear covers disconnect ECG cable, pacer cable/Defi cable, main cable and all other accessories. 1. Remove the Paddle holders by performing the procedure Removing the

Paddle holders 2. Remove the battery by performing the procedure Removing the battery.

3. Remove the eight screws in the rear cover.


4. Place the CA 360 B with the front cover facing downward.

Note! To avoid damaging the front panel, place the CA 360 B on a soft fabric or something similar. 5. Gently lift up the rear cover assembly until the connected printer cable

(optional) do not scretch. 6. Disconnect the printer cable.

7. Remove the rear cover assembly entirely.

Printer cable


5.4. Removing the front cover assembly.

1. Remove the nine screws marked with arrows in the front panel.

2. Carefully remove the front assembly from the black internal chassis until connected cables do not stretch.

3. Gently disconnect the keyboard cable, and the internal ECG cable.

keyboard cable

internal ECG cable


5.5. Dismantling the front cover assembly

1. Diconnect all cable from keyboard to the connector rack. (electrical ribbon cables, NIBP air cable.) By SPO2 option before disconnecting the SPO2 ribbon cable you have to release the cable supporter.

2. Remove the connector rack assembly by lifting and pushing it carefully up

toward from the front cover. 3. To romove the NIBP module carefully dislock the four pcb supports and

lift the NIBP module while disconnect the electrical plug. 4. To remove the ECG board, unscrew the four screws in the board.

Assembled connector rack

NIBP module

ECG module

pcb supports


4. To remove the keyboard, disconnect the display cables (a film cable and a power cable)

5. Remove the nine screws marked with arrows to dismantle the keyboard

circuit.

6. To remove the LCD, unscrew the four hexagon nut on the LCD fixing rail, lift the rails and remove the LCD.


5.6. Dismantling the internal assembled chassis.

1. To remove the power supply module, unscrew the seven screws on power supply circuit board, marked with arrows.

2. To remove the battery connector board, remove the one screw as shown,

and carefully disconnect the electrical plug on the board

3. To remove the DEFI test board unscrew the marked bolt, and pull out the board from its slot.

4. Remove the high voltage capacitors cutting the cable ties.

Note ! The defi board and the power supply board are connected to each other with a rigid multipin socket and plug. During remove operation you have to carefully disconnect this socket and plug. 5.

Battery connector board and fixing screw

Defi test board and fixing screw

HV capacitors

Rigid connection to defi board


To remove defi board, unscrew the seven screws on the board marked with arrows.

6. Carefully lift the defi board from the internal chassis.

Note ! The defi board and the power supply board are connected to each other with a rigid multipin socket and plug. If the power supply board is not removed before this step you have to carefully disconnect this socket and plug to remove defi board, see steps above!


6. Devices blockdiagramms 6.1. Electrical module interconnections:


6.2. Mechanical structure:


7. Troubleshooting What is to be done in case of defibrillator malfunction? The CA360-B defibrilltor stores every technical events under work with a timestamp into a servicelog file. If the defibrillator does not work due to an error, then the user has to make a note of the error circumstances and time and date of error appearance and has to read out the servicelog file mentioned above. The date and time of error appearance is important, because we can find the registry about that error in the log file according to the date and time. Please send this servicelog directory in compressed form with a note of the failure time and description to Innomed Medical. The Innomed Medical will give the solution in very short time. To read out the servicelog file the first step is to enter the service menu.

7.1. Entering service menu Service menu is protected, a code has to be entered. This is a simple method, it guards only involuntary entering. While turning the device on, enter the configurtaion menu:

Switch it on Innomed logo appears and 6 seconds later Action key flashes The device performs the self test and the Action key lights Push the Action key immediatelly Configuration menu appears

Now enter the Servicemenu

In the configuration menu You find the service menu Select it with \or]key and enter with key OK^ The digit 0 in the line turns to green Set it to 1 by key ] and confirm it with OK^ Push OK^ again and set 2 by ], confirm it with OK^ Push OK^ again and set 3 by ], confirm it with OK^ Service menu appears

7.2. Saving service data

If an error occurs data concerning the error can be obtained as follows:

1. Turn the device on 2. Enter configuration menu and then protected service menu (See 7.1 ) 3. Connect a pendrive to USB-A connector of the device (It is underneath on connector board

at the right side of the defibrillator.) 4. Select Save service data in "Logs and Reports Menu" within Service Settings menu.

The service data saving to the pendrive starts now. 5. When the text Storage State: Done appears in the last line of the window, the copy

is finished. Now unplug the pendrive and switch off the defibrillator.


6. Data is downloaded in a directory called sdata_yyyymmdd_z where: yyyy: year, mm: month, dd: day, z: ordinal number

This sdata directory shall be zipped and sent to Innomed with fault description.

7.3. Deleting error flags

There are some defi errors, which blocks the defibrillator, and it can work only after a service intervention. This blocking is made by error flags. In case of such error after service intervention the error flags must be cleared. The red error LED (beside display right side) flashing shows the blocked state. It can be terminated by deleting error flags.

Before deleting error flags, save the service data and error flags!

The steps of error flag deleting:

Enter configuration menu and then protected service menu (See 7.1 ) Select "Clear Flag" in Calibrations Menu/Defibrillator Calibration Menu within

Service Settings menu by OK^. Now the color of text Off changes green. Push the ] key, then the green text changes to On. Press OK^ which deletes the error flag on the defi board.

Select "Clear error flags" in "Calibrations Menu/Battery Calibration Menu" within Service Settings menu by OK^. Now the color of text Off changes green. Push the ] key, then the green text changes to On. Press OK^ which deletes error flag on the power board.

Leave the Service settings menu, switch off the defibrillator, and switch it on again. Check whether red flashing ceases.


8. The service menu of CA360-B defibrillator The service menu serves some informations about the hardware and software version of the device and gives some possibilities to check and calibrate it, to save some service informations, to clear error flags and to make software upgrade. Entering the service menu the next picture appears on screen:

8.1. Software Version Menu The > character signs at the end of line, that there is a submenu under this menu point and the OK^ key is for entering to this submenu. Entering this submenu You will find the identification numbers of applications and boot loader versions for all hw elements, voice prompts version, localization and config version numbers. When You make a service data saving, the saved file contains all these informations. You can leave this submenu by a key. To leave the Service Settings menu press the Menu Close key.

8.2. HW Serial Numbers and Versions Menu The > character signs at the end of line, that there is a submenu under this menu point and the OK^ key is for entering to this submenu. Entering this submenu You will find a list about the version number ans serial number of hw elements, and the device identification number. When You make a service data saving, the saved file contains all these informations. You can leave this submenu by a key. To leave the Service Settings menu press the Menu Close key.


8.3. Logs and Reports Menu This menu item gives the possibility to save the service data. See chapter 7.2.

8.4. Calibrations Menu In this menu point there are some possibilities to check the hardware elements, to measure some paramter, to clear error flags. You can leave all the submenu items listed below by akey. NIBP calibration menu

This will work in a later version. You can leave this submenu by a key. Defibrillator Calibration Menu

We can see here the status flags of the defi board, the error log flags, and here is the possibiliti to clear the defi board error flags. (See chapter 7.3 ) Warning! Alwais be very careful with erasing the error flag!

Defibrillator Online Data Menu Here You can find some online measured data from defi board, voltages, temperatures, impedances. They may be important, when there is some problem on defi board. You can check the impedance measung here. Close the defibrillator output with a resistor. below 200 the ImpImpDCLow line, beyond 200 the ImpImpDCHigh shows the correct impedance.

Keyboard online data menu This is same as the previous menuitem, but here we can find online measured data from keyboard.

Defi Tester Calibration Menu For later version

Impedance Calibration Menu For later version

Battery calibration menu Here we can read the status and error flags of the power board. Here is the possibility to erase the power board error flags. See chapter 7.3 .

Battery Online Data Menu In this menu the battery parameters are readable, temperature, currents, voltages, capacity, state. These parameters are measured only in the On state of the Online data. Move the cursor by ]\ keys to Online data line the press OK^. The color of Off text changes green. Press ] then OK^. Now the text is On in white color, and all the data are measured continously.

Important! Switch the Online data to Off state before You leave this menu point.

Select Device to Bridge This is for later versions.


8.5. Self Test Menu Here is a possibility to test the printer. If You push the OK^ key, the printer produces a short printout with the character generator of the printer. In later versions there will be more selftest possibilities.

8.6. Software Update Menu Before software update prepare a USB pendrive with the defibrillator software in the update directory and the licence file. The name of licence file is: licence_identification.lic, where identification stands for 12 character identifier, which contains letters and numbers. Enter the software update menu and connect the pendrive to the USB-A connector.

Select Software Packet Update with OK^.The device copies the software from the pendrive. Do not touch the defibrillator until the process ends and the device automatically enters the configuration menu.

Select Software Update Menu with OK^ again. Select Load Licence File with OK^.

The device copies the licence file from the pendrive. The process ends if Loading state: Done message appears in the last line of the window.

Quit this menu with a key In Software Update Menu upgrade the software where BAD message can be read by

pushing OK^ key. Defi Panel Software update starts, it is indicated by Download bar.

During downloading please ignore error messages on the display. Do not touch the defibrillator in this time.

At the end of download the service menu appears on screen. Select Software Update Menu again and the next software item indicated by BAD. Continue the process until the four BAD messages disappear. At the end of Power Panel Update, Please wait for the switching off message

appears. It takes approximately 15 seconds. After switching off, remove the pendrive then turn the device on. Enter configuration menu. Set the timer. Switch the device off.

At the next switching the defibrillator will work on the new software.

8.7. Software package ID This is only an information about the version number of the software package, this is not a selectable menu item.

8.8. DEVICE ID This is only an information about the device identification number, this is not a selectable menu item.


8.9. Licence Code

8.10. Service Menucode

1. Recommended areas of use, operation concept1.1. Brief description, main parameters1.1.1. STAR biphasic waveform

1.2. Cases whereby the defibrillator can be used1.3. Electrodes, recommended setups1.4. Environment of use1.5. Who are entitled to operate the defibrillator?1.6. Abbreviations, expressions figuring in the description1.7. Special advantages of the Cardio-Aid 360-B device

2. Technical data of the defibrillator2.1. Applied standards2.2. Classifications2.3. General data2.4. Display2.5. LED-displays on the front board2.6. Defibrillator2.7. Battery2.8. ECG via pads or defibrillator paddles electrodes2.9. ECG via patient cable and ECG electrodes2.10. ECG from external monitor2.11. Heart rate measurement from ECG signal2.12. Pacer2.13. SpO2 measurement2.14. Non-invasive bloodpressure measurement (NIBP)2.15. Printing2.16. Event storage2.17. Connection possibilities for data transfer2.18. Parameters of defibrillation impulse

3. Accessories, order information4. The Cardio-Aid 360-B defibrillator maintanance, assigments4.1. Cleaning of the device4.2. Regular and periodic maintenance4.3. Battery handling, maintenance

5. CA 360 B - Dismantling5.1. Removing the Assembled paddle holders.5.2. Removing the Battery pack.5.3. Removing the Rear cover assembly.5.4. Removing the front cover assembly.5.5. Dismantling the front cover assembly5.6. Dismantling the internal assembled chassis.

6. Devices blockdiagramms6.1. Electrical module interconnections:6.2. Mechanical structure:

7. Troubleshooting7.1. Entering service menu7.2. Saving service data7.3. Deleting error flags

8. The service menu of CA360-B defibrillator8.1. Software Version Menu8.2. HW Serial Numbers and Versions Menu8.3. Logs and Reports Menu8.4. Calibrations Menu8.5. Self Test Menu8.6. Software Update Menu8.7. Software package ID8.8. DEVICE ID8.9. Licence Code8.10. Service Menucode

Cardio Aid 360B Manual de Servicio

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Transcript of Cardio Aid 360B Manual de Servicio