Cardio Aid 360B Manual de Servicio

Innomed Medical Inc.

Cardio-Aid R-6487-2

360-B

Biphasic defibrillator 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?................................... defibrillator?.......................................................... .......................... ... 4 1.6. Abbreviations, expressions figuring in the description ........................................... .............................................. ... 5

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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.................................................... data........................................................................... .............................................. ..................................... .............. 6 2.4. Display ........................................... .................................................................. ............................................... ............................................... ............................. ...... 7 2.5. LED-displays on the front board ........................................... .................................................................. ..................................... .............. 7 2.6. Defibrillator Defibrill ator ............................................ ................................................................... .............................................. ............................................. ...................... 8 2.7. Battery ............................................ .................................................................... ............................................... .............................................. ............................. ...... 9 2.8. ECG via pads or defibrillator paddles electrodes ............................................. ..................................................... ........ 10 2.9. ECG via patient cable and ECG electrodes.......................................... electrodes.............................................................. .................... 10 2.10. ECG from external monitor........................ 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)...................... (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.

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The Cardio-Aid 360-B defibrillator defibrillator maintanance, assigments ..................................... ..................................... 22 4.1. Cleaning of the device.................... device ............................................ ............................................... .............................................. ........................... .... 22 4.2. Regular and periodic maintenance ............................................ ................................................................... ............................... ........ 22 4.3. Battery handling, maintenance .............................................. ..................................................................... ................................... ............ 23 5. CA 360 B - Dismantling......................... 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....................... assembly. ............................................. .............................................. ........................... .... 29 5.5. Dismantling the front cover assembly....................................... assembly.............................................................. ............................... ........ 30 5.6. Dismantling the internal assembled chassis. ............................................ ............................................................ ................ 32 6. Device’s blockdiagramms .............................................. ..................................................................... .............................................. ........................... .... 34 6.1. Electrical module interconnections: .............................................. ..................................................................... ........................... .... 34 6.2. Mechanical structure: ............................................. .................................................................... .............................................. ........................... .... 35

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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?................................... defibrillator?.......................................................... .......................... ... 4 1.6. Abbreviations, expressions figuring in the description ........................................... .............................................. ... 5

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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.................................................... data........................................................................... .............................................. ..................................... .............. 6 2.4. Display ........................................... .................................................................. ............................................... ............................................... ............................. ...... 7 2.5. LED-displays on the front board ........................................... .................................................................. ..................................... .............. 7 2.6. Defibrillator Defibrill ator ............................................ ................................................................... .............................................. ............................................. ...................... 8 2.7. Battery ............................................ .................................................................... ............................................... .............................................. ............................. ...... 9 2.8. ECG via pads or defibrillator paddles electrodes ............................................. ..................................................... ........ 10 2.9. ECG via patient cable and ECG electrodes.......................................... electrodes.............................................................. .................... 10 2.10. ECG from external monitor........................ 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)...................... (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.

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The Cardio-Aid 360-B defibrillator defibrillator maintanance, assigments ..................................... ..................................... 22 4.1. Cleaning of the device.................... device ............................................ ............................................... .............................................. ........................... .... 22 4.2. Regular and periodic maintenance ............................................ ................................................................... ............................... ........ 22 4.3. Battery handling, maintenance .............................................. ..................................................................... ................................... ............ 23 5. CA 360 B - Dismantling......................... 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....................... assembly. ............................................. .............................................. ........................... .... 29 5.5. Dismantling the front cover assembly....................................... assembly.............................................................. ............................... ........ 30 5.6. Dismantling the internal assembled chassis. ............................................ ............................................................ ................ 32 6. Device’s blockdiagramms .............................................. ..................................................................... .............................................. ........................... .... 34 6.1. Electrical module interconnections: .............................................. ..................................................................... ........................... .... 34 6.2. Mechanical structure: ............................................. .................................................................... .............................................. ........................... .... 35

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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 of sinus tachycardia, bradycardia or strong arrythmia, 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 paramete rs (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 fixe d 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 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.

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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, wel l, as the t he 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 operated by a skilled person – physician.

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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 CRT ICD PM CPR BLS AALS

Cardiac Arrest, stopping of the heart Cardiac Resynchronisation Therapy Implantable Cardioverter Defibrillator Pacemaker CardioPulmonary Resuscitation Basic Life Support, basic level resuscitation 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

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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 200200-270 J, this way most of the time the delivery of the first shock already stops the fibrillation.

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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: @240VAC:

Temperature

Operating: 0 - 45ºC

max. 1,3 A; max. 0,5 A;

max. 130 VA max. 120 VA

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.

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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

State indicator LED

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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 enli ghtened continuously. If the device is not connected to the mains, the LED is not enlightened. 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.


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2.6. 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.

Delivered energy at 50 ohm loading

External defibrillator paddles or pads electrodes

2-5-7-10-20-30-40-5060-80-100-150-200-270360J

Internal paddles

1-2-3-4-5-6-7-8-9-1015-20-30-40-50J

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

Charging time to 270 J in manual mode

From (25ºC)

battery

Fully charged battery

<7s (typically)

After 15 < 1 0 s defibrillations (typically) From mains (in voltage range of 100V~ 240V~)

With battery

90V~ voltage

In case of < 15s completely empty (typically) battery

mains

Time passed from power on to chargeready state for maximum energy

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charged < 5 s (typically)

< 20s (typically)

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Maximum time passed from enabling of rhythm recognition (including analysis time) till shock-ready state, at maximum energy level, in semiautomatic mode.

VF / VT recognition

From (25ºC)

battery Fully battery

charged < 1 7 s (typically)

After 15 < 2 0 s defibrillations (typically) From mains (in voltage range of 100V~ 240V~)

With battery

90V~ voltage

mains

In case of completely empty battery

Time passed from power on to chargeready state for maximum energy

< 40 s (typically)

Complies or requirement.

better

than

charged < 1 5 s (typically)

the

<25s (typically)

AAMI

DF-39

Recognizes broad QRS VT > at 180bpm

2.7. Battery Type

NiMH battery 3000mAh

Nominal voltage

10,8 V (9 cells)

Operation time at 20ºC

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 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

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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

<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

Patient impedance measurement range

10-200 ohm

Signal delay viewing)

Max 20 ms

(in

correlation

with

Sampling frequency

400 Hz

AD resolution

5 uV / bit

QRS-detection limit level

200 SV

Safety 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. Viewable leads

5-lead cable: I. II. III. aVR aVL aVF Vx 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

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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

Signal delay (in correlation with viewing)

With baseline filter: 2 s

Blocking

Automatic

Sampling frequency

8 kHz

AD resolution

0,25 uV / bit, 24 bit

QRS-detection limit level

200SV

Checking removal

Per electrode

of

ECG

electrode

Without baseline filter: 10 ms

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)

Signal delay (in correlation with viewing)

With baseline filter: 2 s

Sensitivity

Settable from the menu: 100 mV/mV … 1000 mV/mV

Connecting

Via (20) ECG plug, with cable to be ordered from manufacturer

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Without baseline filter: 10 ms

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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 range

20 – 300 bpm

number

measurement

±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

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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 lossof-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).

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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.

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2.14. 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

Modes

Manual, Continuous and Periodical (2 - 480 minutes)

Displayed values

Diastole, systole, measurement.

Alarms

For lower and upper limits (between 15…260 mmHg) for cuff error or measurement error

Defibrillation-protection

5 kV

mmHg

arterial

pressure,

time

of

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

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8s

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last

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

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2.18. Parameters of defibrillation impulse U [ V] U1

U2 Phase 1

t3 t1

t2

T [ms] Phase 2 -U3

-U2

U1 U2 -U2 -U3 t1 t2 t3

Voltage at the beginning of first phase Voltage at the end of first phase Voltage at the beginning of second phase Voltage at the end of second phase Duration of first phase Break between the first and the second phases Duration of second phase parameters of STAR biphasic waveform

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Delivered energy by the defibrillator as a function of patient’s chest impedance at the range between 2 – 360 J

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3. Accessories, order information Part number

K25528-4

Description

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)

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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

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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 mat erial 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 hivatkozási forrás nem található.. 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.

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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 könyvjelzC nem létezik.. 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.

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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

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

Note!

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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.

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5.3. Removing the Rear cover assembly. Before you remove front and rear covers disconnect ECG cable, p acer 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.

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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

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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

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5.5. Dismantling the front cover assembly 1.

Diconnect all cable from keyboard to the connector rack. (el ectrical ribbon cables, NIBP air cable.) By SPO2 option before disconnecting the SPO2 ribbon cable you have to release the cable s upporter.

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.

pcb supports

Assembled connector rack

NIBP module ECG module

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4.

To remove the keyboard, disconnect the display cables (a film c able 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.


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5.6. Dismantling the internal assembled chassis.

Note !

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 it’s slot.

4.

Remove the high voltage capacitors cutting the cable ties.

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. Defi test board and fixing screw 5.

HV capacitors Battery connector board and fixing screw

Rigid connection to defi board

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To remove defi board, unscrew the seven screws on the board marked with arrows. 6.

Carefully lift the defi board from the internal chassis.

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!

Note !

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6. Device’s blockdiagramms 6.1. Electrical module interconnections:

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6.2. Mechanical structure:

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7. Troubleshooting What is to be done in case of defibrillator malfunction? The CA360-B defibrillátor 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 us er 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 defibrillat or.

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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.

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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 fil e contains all these informations. You can leave this submenu by a key. To leave the Service Settings menu press the Menu Close key.

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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 paraméter, to clear error flags. You can leave all the submenu items listed below by a key. 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 fro m 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 defibrill ator 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.

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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 softwar e package, this is not a selectable menu item.

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

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Cardio Aid 360B Manual de Servicio

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