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?............................................................. 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
Removing the Rear cover assembly. ........................................................................ 27
5.3.
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. 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
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
performs rectangular current impulse.
®
biphasic waveform, and in pacing mode it
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 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.
Cardio-Aid® 360-B Service Manual
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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, 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.
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Cardio-Aid® 360-B Service Manual
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
®
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.
Cardio-Aid® 360-B Service Manual
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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
Electromagnetic compatibility
EN60601-1-2:2007
Safety requirements of defibrillators
EN60601-2-4:2003
Safety requirements of single and multi-channel
EN60601-2-25: 1995+A1:1999
electrocardiographs, including basic requirements of
operation
Basic environmental testing procedures Bump tests
EN60068-2-27: 2009
Degrees of protection provided by enclosures (IP code)
EN60529: 1991+ A1:2000
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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Cardio-Aid® 360-B Service Manual
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
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.
Dual-colored indicator, green and red. The LED flashing in
green indicates, that the device can work correctly (one flash in
each 4 seconds). If the selftest (turning on test or wake-up test)
detects error, the LED will be flashing twice in red color, every 4
seconds.
Cardio-Aid® 360-B Service Manual
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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)
Cardio-Aid® 360-B Service Manual
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
Cardio-Aid® 360-B Service Manual
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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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Cardio-Aid® 360-B Service Manual
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
Cardio-Aid® 360-B Service Manual
Without baseline filter: 10 ms
11/45
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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Cardio-Aid® 360-B Service Manual
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).
Cardio-Aid® 360-B Service Manual
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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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Cardio-Aid® 360-B Service Manual
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
Cardio-Aid® 360-B Service Manual
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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Cardio-Aid® 360-B Service Manual
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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Cardio-Aid® 360-B Service Manual
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
Cardio-Aid® 360-B Service Manual
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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 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
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.
Note!
Do not remove the smaller screw holding the metal plate on the Paddle holders
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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, 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.
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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. (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.
pcb supports
Assembled
connector rack
NIBP
module
ECG
module
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Cardio-Aid® 360-B Service Manual
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.
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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.
Note !
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!
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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 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.
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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 file 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 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.
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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 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.
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8.9. Licence Code
8.10. Service Menucode
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