R-5656-02-V02 CA360B DFU Eng 20120320

Innomed Medical Inc.
Cardio-Aid
360-B
Biphasic defibrillator
Direction for use
R-5656-02-V02
User manual
Cardio-Aid
360-B Users manual R-5656-02-V02 3/89

Contents

1. Introduction, Warnings............................................................................................ 7
2. Recommended areas of use, operation concept....................................................... 9
2.1. Brief description, main parameters ......................................................................... 9
2.1.1. STAR biphasic waveform.................................................................................... 9
2.2. Cases whereby the defibrillator can be used ........................................................... 9
2.3. Electrodes, recommended setups .......................................................................... 10
2.4. Environment of use ............................................................................................... 10
2.5. Who are entitled to operate the defibrillator?........................................................ 10
2.6. Abbreviations, expressions figuring in the description......................................... 10
2.7. Special advantages of the Cardio-Aid
360-B device........................................... 11
3. The Cardio-Aid
360-B defibrillator maintanance, assigments............................ 12

3.1. Cleaning of the device........................................................................................... 12
3.2. Regular and periodic maintenance ........................................................................ 12
3.3. Battery handling, maintenance .............................................................................. 13
3.4. Classifications ....................................................................................................... 13
4. Symbols, controls and their functions ................................................................... 14
4.1. Symbols applied on the device.............................................................................. 14
4.2. A CA360-B defibrillator control elements and their functions............................. 16
5. Turning on and off the device ............................................................................... 18
6. Use of the electrodes ............................................................................................. 20
6.1. Defibrillator electrodes.......................................................................................... 20
6.1.1. Disposable defibrillator pacing electrodes ............................................................ 20
6.1.2. Defibrillator paddle electrode................................................................................ 22
6.1.3. Internal defibrillator electrode............................................................................... 23
6.2. ECG patient cable.................................................................................................. 25
6.2.1. 10-lead ECG cable................................................................................................. 25
6.2.2. 3-lead ECG cable................................................................................................... 26
6.2.3. 5-lead ECG cable................................................................................................... 26
6.2.4. ECG from external monitor................................................................................... 26
7. User menu.............................................................................................................. 27
7.1. SEMI AUTO......................................................................................................... 27
7.2. MANUAL mode.................................................................................................... 27
7.3. PACING mode ...................................................................................................... 29
7.4. ECG mode ............................................................................................................. 29
8. Printing.................................................................................................................. 30
9. CA360-B defibrillator alarm system..................................................................... 31
9.1. Concepts connection with ALARM...................................................................... 31
9.2. Curing of alarm system......................................................................................... 32
10. Auxiliary supplies of the defibrillator ................................................................... 34
10.1. QRS recognition and QRS voice........................................................................... 34
10.2. Oxygen saturation (SpO2) measurement .............................................................. 34
10.2.1. Preparing the measurement: .................................................................................. 34
10.2.2. Patient preparation:................................................................................................ 35
10.3. Use of non-invasive blood pressure measurement ................................................ 36
10.3.1. Measurement method: ........................................................................................... 36
10.3.2. Preparing the measurement ................................................................................... 36
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360-B Users manual R-5656-02-V02

10.3.2.1. Cuff size....................................................................................................... 36
10.3.2.2. Placing the cuff ............................................................................................ 37
11. Therapeutical modes.............................................................................................. 38
11.1. AED mode............................................................................................................. 38
11.2. Manual defibrillation............................................................................................. 45
11.2.1. Asynchronous manual defibrillation ..................................................................... 45
11.2.2. Synchronized cardioversion .................................................................................. 47
11.2.3. Internal defibrillation............................................................................................. 50
11.3. Using of pacemaker.............................................................................................. 50
11.3.1. Quick guideline ..................................................................................................... 51
12. ECG mode ............................................................................................................. 54
12.1. Viewing of ECG.................................................................................................... 54
12.2. Printing in ECG mode ........................................................................................... 56
13. Use of the cofiguration menu................................................................................ 57
13.1. Entering the configuration menu........................................................................... 57
13.2. Handling of the configuration menu ..................................................................... 57
13.3. Elements of the configuration menu ..................................................................... 58
13.3.1. Language selection................................................................................................ 58
13.3.2. Use of defaults....................................................................................................... 58
13.3.3. Alarm settings........................................................................................................ 59
13.3.3.1. Global alarm settings ................................................................................... 59
13.3.3.2. Asystole........................................................................................................ 59
13.3.3.3. Heart rate alarm............................................................................................ 59
13.3.3.4. SpO2 alarm.................................................................................................. 59
13.3.3.5. Pulse alarm................................................................................................... 60
13.3.3.6. NIBP systole, diastole and mean value alarm.............................................. 60
13.3.4. Device setups......................................................................................................... 60
13.3.4.1. Voice menu .................................................................................................. 60
13.3.4.2. Date and time ............................................................................................... 60
13.3.4.3. Date and time format ................................................................................... 60
13.3.4.4. LCD brightness ............................................................................................ 61
13.3.4.5. User identification........................................................................................ 61
13.3.4.6. Mains frequency........................................................................................... 61
13.3.5. Energy settings ...................................................................................................... 62
13.3.5.1. Viewing of delivered energy........................................................................ 62
13.3.5.2. Manual energy external............................................................................. 62
13.3.5.3. Manual energy- internal ............................................................................... 62
13.3.5.4. Semi-automatic energy first shock............................................................ 62
13.3.5.5. Semi-automatic energy second shock....................................................... 63
13.3.5.6. Semi-automatic energy third shock .......................................................... 63
13.3.6. Mode settings ........................................................................................................ 63
13.3.6.1. Defibrillation mode when turning on........................................................... 63
13.3.6.2. Pacing mode................................................................................................. 63
13.3.6.3. Pace current.................................................................................................. 64
13.3.6.4. Pace rate....................................................................................................... 64
13.3.6.5. Wake-up selftest (automatic selftest)........................................................... 64
13.3.6.6. Wake-up start time (time of automatic selftest)........................................... 65
13.3.6.7. Demo mode.................................................................................................. 65
13.3.7. Signal setup menu ................................................................................................. 65
13.3.7.1. ECG menu.................................................................................................... 65
Cardio-Aid
360-B Users manual R-5656-02-V02 5/89

13.3.7.2. Speed menu.................................................................................................. 66
13.3.8. Periphery setup menu ............................................................................................ 66
13.3.8.1. Automatic printing....................................................................................... 66
13.3.8.2. Printing time................................................................................................. 66
13.3.8.3. Printing speed............................................................................................... 67
13.3.8.4. Printing event report .................................................................................... 67
13.3.8.5. Multichannel printing................................................................................... 67
13.3.8.6. External ECG amplifier ............................................................................... 67
13.3.9. Data saving............................................................................................................ 67
13.3.10. Delete saved data................................................................................................... 68
13.3.11. Service menu ......................................................................................................... 68
14. Technical data of the defibrillator ......................................................................... 69
14.1. Applied standard.................................................................................................... 69
14.2. General data........................................................................................................... 69
14.3. Display................................................................................................................... 70
14.4. LED-displays on the front board........................................................................... 70
14.5. Defibrillator ........................................................................................................... 71
14.6. Battery ................................................................................................................... 72
14.7. ECG via pads or defibrillator paddles electrodes.................................................. 73
14.8. ECG via patient cable and ECG electrodes........................................................... 73
14.9. ECG from external monitor................................................................................... 74
14.10. Heart rate measurement from ECG signal ............................................................ 75
14.11. Pacer ...................................................................................................................... 75
14.12. SpO2 measurement................................................................................................ 75
14.13. Non-invasive bloodpressure measurement (NIBP) ............................................... 78
14.14. Printing.................................................................................................................. 78
14.15. Event storage ......................................................................................................... 79
14.16. Connection possibilities for data transfer .............................................................. 79
14.17. Parameters of defibrillation impulse ..................................................................... 80
15. Accessories, order information.............................................................................. 84
16. Elimination of useless electronic devices as waste ............................................... 86
17. Guidelines and manufacturer statements electromagnetic compatibility........... 86
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This users manual can be used for the CA360-B devices with the software of version number
1.0 or upwards.
Innomed Medical Inc. reserves the right for unannounced modifications for the sake of device
development.
The full or partial copy of this direction for use can only be made with the written permission
of our company.
All brand names and logos are the officially registered properties of the respective companies.
All rights reserved!

Budapest, 22.02. 2012.

The device is manufactured and distributed by:
Innomed Medical
Medical Developing and Manifacturing Inc.
1146 Budapest, Szab Jzsef utca 12.
(1) 460-9200 Fax: (1) 460-9222
www. innomed.hu
innomed@innomed.hu
Cardio-Aid
360-B Users manual R-5656-02-V02 7/89

1. Introduction, Warnings
Always check the seals and expiration dates of all the disposable defibrillation and
monitoring electrodes.

Important!
Before unpacking the unit you should be thoroughly familiar with the functions
of the defibrillator, with their operation and with this users manual.

Important!
The device can only be used with the accessories listed in this users manual,
ideal operation is only guaranteed with them.

Innomed assumes full responsibility for safety, reliability and performance of this device, in
case:
The equipment is used by qualified personnel in accordance with the users manual.
Only the accessories listed in the users manual are used.
Assembly, modifications or repairs were carried out by your Innomed service center,
and parts and components used have been approved by Innomed.
Electrical installations comply with local regulations.

Important!
Since the waveform (duration and amplitude) from the defibrillator depends on
patient impedance, defibrillator charging must only start after the electrodes
have been placed on the patient. If charging starts with open defibrillator
electrodes, charging will start but will not finish and the device emits visual and
audible warning. If the defibrillator electrodes are placed on the patient, the
device performs the impedance measurement and finishes charging, and it will
only get ready for shock after this. Pushing the shock key the energy is delivered.
Remove the electrodes only after the shock delivered.
Important!
The defibrillator electrodes should be placed on the patient, so that the distance
between them are at least 5 cm and there is no gel on the body surface between the
two electrodes, saying that no gel-bridge should be formed between the two
electrodes, which conducts the current during defibrillation. (see section no. 6.1.2)
Important!
In semi-automatic mode the defibrillator operates according to ERC2010
guideline. Please read carefully the section titled Using defibrillator in semi-
automatic mode.
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Important!
The defibrillator is using biphasic waveform. In case of VF / VT the
recommended energy of first shock is 200 J, according to ERC 2010 guideline.
Important!
360 J energy can be set on the device. This is quite a high value, please use it
carefully. Such a high energy can only be indicated in case of especially heavy
weight in case of biphasic waveform.
Important!
During the installation and operation of the device please mind the information
referring to electromagnetic compatibility, summarized in section no. 17.
Important!
Be aware that some portable radio frequency communication equipments can
interfere with the operation of the device.
Important!
In case any electronic device is connected to the patient with no defibrillator
protection in the input, then it must be removed from the patient for the duration
of shocking.
The defibrillator electrodes must be well separated from other electrodes and
metal surfaces placed on the patient. Inplanted pacemaker, ICD, CRT device
should not get into the directionline of the defibrillation energy proximity
(between the two pads or the two paddles).
Attention!
The use of the defibrillator in the presence of flammable agents or in an oxygen
enritched atmosphere can cause explosion hazard.
Cardio-Aid
360-B Users manual R-5656-02-V02 9/89

2. Recommended areas of use, operation concept
2.1. Brief description, main parameters

The defibrillator is an instrument serving for stopping the ventricular fibrillation, it is able to
change the electric operation of the heart, by applying a high energy impulse. In case of
ventricular tachycardia, the defibrillator is able to restore the normal operation, by applying
synchronous defibrillation. In case of sinus tachycardia, bradycardia or strong arrythmia, the
device is able to normalize the heart operation, in pacing mode.
With the adequate electrodes, it is possible to use the device, in case of heart operation, by the
impulse delivered directly to the heart.
Besides the energy delivery (defibrillation and pacing) the defibrillator can make ECG, and it
can measure some other physiological parameters (eg. HR, SPO2, NIBP).
In case of external (transcutaneous) defibrillation, the delivered energy can be 2-360 J in 15
steps, in case of internal defibrillation it can be 1-50 J, also in 15 steps.
In defibrillation mode the device performs STAR
biphasic waveform, and in pacing mode it

performs rectangular current impulse.

2.1.1. STAR biphasic waveform
It has been prooved about the STAR

biphasic waveform during clinical researches made
according to FDA guidelines, that it is one of the most effective waveforms for stopping
ventricular fibrillation.
STAR

(BTE) biphasic waveform characteristics: the period of first phase is depending on
patient impedance, 3 11 ms, the period of second phase is fixed 3,2ms. The amplitude of the
signal depends on the set energy and on patient impedance.

2.2. Cases whereby the defibrillator can be used

In manual mode
Applying asynchronous shock for the treatment of ventricular fibrillation with the
assistance of external defibrillator paddles or pads or internal paddles.
Applying synchronized shock in case of atrial fibrillation, ventricular tachycardia
(cardioversion), with the assistance of external defibrillator electrodes (pads/paddles).
ECG, HR, SpO2, NIBP monitoring.
Semi-automatic mode
The device assists the operator by voice and text (step by step) instructions appearing on
the display, in the device operation. The device automatically performs the necessary
operations, it charges the defibrillators energy, and it gives an instruction for the delivery
of shock.
Applying of asynchronous shock, in case of recognized fibrillating heart muscle
(according to AHA).
ECG, HR monitoring.
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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

2.3. Electrodes, recommended setups

The defibrillator paddle electrode of the device can be transformed into pediatric or adult
electrodes by only a single rotation, the adhesive defibrillator electrodes and the internal
electrodes are available in adult and pediatric sizes as well.
The defibrillator can be used for adult and pediatric population. Its application is not
recommended for children under the age of 1. For children between the ages 1-8 and under
the weight of 25 kg, the application of 2 4 J/kg energy is recommended.

2.4. Environment of use

The CA360-B defibrillator was primarily made for hospital and clinical use, but it can also be
applied during surgeries and by general practitioners as well. In AED mode even a skilled
policeman or fireman can operate the device.
The device was made for continuous use, but because of the high energy, it must be
considered that any defibrillation with greater frequency than two shocks delivery/minute, is
only allowed for a short time.

2.5. Who are entitled to operate the defibrillator?

The CA360-B defibrillator in semi-automatic mode can be operated by non-professional
persons as well, as the defibrillator gives instructions to the operator. Even in such cases, it is
advisable that the device should be operated by a person, who has been trained for the use of
semi-automatic defibrillators.
In case of manual, synchronous and asynchronous defibrillation and in fixed and demand
pacing mode, the device can only be operated by a skilled person physician.

2.6. Abbreviations, expressions figuring in the description

The abbreviations figuring in the description are mostly from the English special literature,
but they are generally known and can be used in case of other languages as well.

In spite of this, it is advisable to give a summary about the used abbreviations and about the
expressions figuring in the description.

CA Cardiac Arrest, stopping of the heart
CRT Cardiac Resynchronisation Therapy
ICD Implantable Cardioverter Defibrillator
PM Pacemaker
CPR CardioPulmonary Resuscitation
Cardio-Aid
360-B Users manual R-5656-02-V02 11/89

BLS Basic Life Support, basic level resuscitation
AALS Adult Advanced Life Support, lifesaving procedure in case of
adults, according to ERC 2010

PALS Pediatric Advanced Life Support, lifesaving procedure in case
of children, according to ERC 2010

ROSC Return of Spontaneous Circulation
AED Automated External Defibrillator
BTE Biphasic Truncated Exponential waveform
FDA Food and Drug Administration
VT Ventricular Tachycardia
VF Ventricular Fibrillation
HR Heart Rate
NIBP Non-Invasive Blood Pressure
SpO2 Oxygen Saturation
STAR
Self-Tracking Active Response, denomination of the applied

waveform

Pads electrode Disposable, adhesive defibrillator-pacing electrode with gel on
it (see section no. 4.1.1)

Paddle electrode defi-paddle electrode (see section no. 4.1.2 )
Internal defi paddle electrode spoon electrode for direct defibrillation of the heart (see
section no. 4.1.3)

Default basic setup by manufacturer
Dump status The high-voltage capacitors were discharged by an internal
circuit
2.7. Special advantages of the Cardio-Aid
360-B device

100%adaptation of ERC 2010 BLS-AED recommendation
It supports the effort of minimizing CPR interruptions and unintended deliveries of shock,
which can cause the injury of the person performing resuscitation. With the defibrillator it
is possible to start charging before placing the paddle electrodes on the chest. In this case
there is no electric shock hazard, CPR can be continued. When placing the electrode on
the chest, charging is finished in quite a short time and the shock can be delivered.
According to the recommendation of ERC 2010 the first shock can be set to a minimum
level of 150 J.
In order to reach high efficiency, we set the energy of CA360-B in AED mode to 200-
200-270 J, this way most of the time the delivery of the first shock already stops the
fibrillation.

12/89 Cardio-Aid

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

3.1. Cleaning of the device

Warning!
Do not use any aggressive, acidic chemical for cleaning the device, even if they
are diluted. Do not use any surface damaging granular material or flammable
detergent. Do not sterilize the device and its accessories, only in case it figures in
the instructions of the accessory.
Clean the defibrillator and the cables with soft cloth or sponge, not with aggressive detergent.
During cleaning, make sure that no liquid should enter into the connectors of the device. Pay
special attention when cleaning the tube of the blood pressure measurement cuff, because if
any water gets into the tube, entering inside the device during the operation of the blood
pressure measurement device, it can damage the valve and the compressor.
For cleaning you can use alcoholic solution, ammonium solution with water, peroxide
solution or any non-aggressive domestic detergents dropped on a dampened sponge.

3.2. Regular and periodic maintenance

Continuously make sure that the device and its accessories should be clean and undamaged.
Gel and other materials sticked to it, must be cleaned off from the electrodes. The undamaged
status of the electrode cables (cable insulation, breaking) must be regularly checked.
The battery condition must be followed with attention, if the device indicates the running
down of battery, it must be connected to the mains, in order to be replaced.
After some years of operation the battery capacity can reduce to that extent that it cannot
guarantee the operation conditions described in the technical data. In such cases the device
gives an alarm, the battery must be replaced. Battery replacement can only be carried out by a
skilled person.
Periodically (in 1-2 years) the main parameters of defibrillator must be checked and if needed
a calibration must be made. The calibration can only be made by a skilled service person with
adequate qualifications.
The continuous and reliable operation can be ensured by the allowance of a wake-up test. If
we set it, then the defibrillator will automatically turn on once in a day and it will carry out
some test examinations. Operation of the wake-up self-test is detailed in section no. 13.3.6.5.
This test ensures a continuous check-up, in case of errors or operation faults it will
immediately give an alarm.
The expected lifetime of the device is 8 years.

Cardio-Aid
360-B Users manual R-5656-02-V02 13/89

3.3. Battery handling, maintenance

The CA360-B defibrillator works with 3000mAh, NiMH type battery. A fully charged battery
would allow minimum 4-hour monitoring, the delivery of 100 shocks at the energy of 270J or
2-hour pacing.
The battery capacity level can always be seen on the battery indicator, the explanation of the
indicator can be seen in the table of page 14.
The defibrillator is equipped with an intelligent battery charger circuit, which carries out all
the battery related tasks, therefore the operator does not have to worry about it. If the battery
capacity level symbol on the screen indicates the low level of battery, then the defibrillator
must be connected to the mains power by a mains cable, by this way charging is started. The
charging process is shown by the battery charger LED (18) (see section no. 3.3): The device,
connected to the mains, indicates its charging capacity level by flashing signals.
In case of being completely charged, the LED is continuously enlighted. In case the device is
not connected to the mains, the light of the LED is off.
After being connected to the mains, the defibrillator still complies with all the safety
requirements, so it can be used without any restrictions.
The defibrillator, connected to the mains, is able to operate even with completely empty
battery or without battery as well.

Warning!
Even if the defibrillator is out of use, it still has to be connected to the mains, once
in every 3 month, to avoid complete run down of the battery.
The lifetime of the battery, in case of normal use, is minimum 2 years. During operation and
with time the battery capacity reduces, under a certain critical level the defibrillator indicates
the necessity of battery replacement.

3.4. Classifications

The CA360-B defibrillator is classified as II.b. according to the rule no. 9 described in the
point III./3.1 of the supplement no. IX of the 93/42/EEC board directive amended by
Directive 2007/47/EC.
From the aspect of electromagnetic compatibility the classification of the CA360-B
defibrillator, according to the MSz EN 55011 standard is: group no. 1, class B.

14/89 Cardio-Aid

4. Symbols, controls and their functions
4.1. Symbols applied on the device

Input Alarm system enabled
Main fuse position Alarm system disabled
CF type equipment Alarm suspended
Defibrillator-protected CF type
equipment
Alarm voice set to mute
Attention! See the enclosed
documentation!
Alarm voice switched on set to
low voice
BF type equipment Alarm voice switched on set to
medium voice
Dangerous voltage Alarm voice switched on set to
laud voice
Event No information about the
battery
Printing Battery capacity < 25%
Disarm Battery capacity > 25%
Lead selection Battery capacity > 50%
Size selection Battery capacity > 75%
Error detected by the system Battery capacity > 90%
On/off switch Battery error
Denomination of manufacturer IP 32 Environment-proof
Alternating current SN Serial number of the device
Error in the high-voltage
system

Attention! Consult the users
manual
Cardio-Aid
360-B Users manual R-5656-02-V02 15/89

The equipment is safe, the
high-voltage unit is not
charged
High-voltage capacitors
discharged (dump status)
Stop-watch symbol, it indicates
the time passed since turning
on
Defibrillator is ready for shock
delivery, it is charged
In the right lower corner of the
screen time can be seen:
hour:minute
Shock counter symbol, next to it
the number of delivered shocks
can be seen
EKG Line filter EKG muscle filter
Asystole alarm
Ventricular Fibrillation Alarm
or Shockable rithm alarm
16/89 Cardio-Aid

4.2. A CA360-B defibrillator control elements and their
functions

22
23
30
Cardio-Aid
360-B Users manual R-5656-02-V02 17/89

Functions of control elements:

# Key Function
1
Turning on by keeping the key pressed for half a second
Turning off by keeping the key pressed for half a second
2 Lead selector (LEAD) Selects between ECG leads
3 EVENT It stores one ECG curve and data in the internal memory
4 PRINT Starts or stops printing
5 SEMI AUTO Semi-automatic mode
6 MANUAL Manual mode
7 PACING Pacing mode
8 NIBP Starts blood pressure measurement
9 FREEZE It is freezing the screen picture
10 ALARM It switches the alarm on and off in manual and pacing modes.
11 a,
b, c
Soft Key 3 pcs.
software driven keys
Control elements of changing functions, the actual function is displayed over
the key. The keys are marked from left to right with the identifications 11a,
11b, 11c.
12 MENU Menu control keys, navigation inside the menu. POKQRS
13 ECG ECG mode 12-lead ECG
15 DISARM Disarming. Dumps the energy internally
16 Amplifier selector It sets the amplifier of the ECG curve
17 Action key
The event to be carried out appears on the screen (analysis, charging,
delivery of shock, )
18 Battery status display
Yellow LED. It is not enlighted if the defibrillator is not connected to the
mains. It is blinking or continuously enlighted when there is charging.
19 Ready
Operation status indicator
Green flashing: the defibrillator is ready to use
Red flashing: the defibrillator detected error
No light, no flashing: the defibrillatoris not ready to use
20 ECG conncetor Patient cable connector (ECG cable)
21 Defi electrode connector Defibrillator electrodes connector
22 Printer 58 mm thermal printer
23 Paddle holder Defi paddle support
24 NIBP Blood pressure measurement cuff connector
25 SpO2 SpO2 sensor connector (Nellcor)
26 HEAD Multiparameter measuring head connector (option)
27 USB A
USB Host connector
28 USB B
USB device connector
29 LAN
Connection to local network
30 Mains connector 100-240V~ 50/60Hz mains cable connector
Hereinafter in the description, the control elements and connectors will be referred to with
their denominations, by putting before them in brackets the # number given in the above
table. Eg. (22) Printer
18/89 Cardio-Aid

5. Turning on and off the device

The defibrillator can be turned on and off by the key (1) . When turning on, the control
elements must be pressed for about half a second, this way the device will switch on, the next
picture will appear and the device selftest will be started. After the running of selftest which
takes about 15 seconds the defibrillator will be ready for operation, it will set the mode
selected in configuration menu (see section no. 13.3.6.1).

Cardio-Aid
360-B Users manual R-5656-02-V02 19/89

Turning off can be made by the (1) key in any state of the defibrillator. For this the key has
to be pressed for about 2 seconds, in order to avoid accidental turning off. When the
defibrillator recognizes the turning off command, the following figure is going to appear on
the screen:

Hereby the device saves the information and events collected during the operation. During the
time of saving the (11b) key can be pressed, this way the saving process can be interrupted,
the defibrillator will switch off immediatelly.
20/89 Cardio-Aid

6. Use of the electrodes
6.1. Defibrillator electrodes

6.1.1. Disposable defibrillator pacing electrodes
The pacing electrode is a disposable, adhesive, pregelled electrode, which can be immediately
used after opening the packaging and removing the protective foil. This electrode is suitable
for defibrillation, for transcutaneous stimulation and for ECG signal leading. Hereinafter this
type of electrode is going to be referred as pads electrode.

Warning!
Before use, check the expiration date indicated on the packaging.
Plug the cable by pressing it
firmly into the connector,
situated on the front of the unit
Connect the defibrillator
electrodes to the cable
Place the electrodes on the patient
according to the figure indicated
on the electrode, or according to
other aspects (injury, implanted
pacemaker, etc.).
Placing of electrodes in case of
right- side pacemaker implant.
Cardio-Aid
360-B Users manual R-5656-02-V02 21/89

Sterno-Apicalis electrode placement: (right edge of sternum and around theapex)
Place the LL (Left Lateral) electrode on the side of the body, under the left breast, and the RA
electrode has to be placed on the right side, under the collar-bone.
Anterior-Posterior placement can be used for non-invasive pacing, for manual defibrillation
and for synchronous cardioversion, but it is not suitable in AED mode and for ECG
monitoring. The Anterior (positive electrode, Y or LL) electrode should be on the left side of
the body, under the breast, the Posterior (RA) electrode should be on the left side of the back,
behind the heart.

After you have placed the electrodes, select the desired energy by the energy selector keys
(11a) (11b), situated on the front panel, then start charging by the (17) Action key, and if you
detect shockable rhythm, you can deliver the shock by the Action key (17).

Warning!
Make sure that, in order to avoid electric shock, during defibrillaton nobody
touches the patient, the conductor liquids in connection with the patient (gel,
blood, saline solution) and the metal objects in connection with the patient, like for
instance the frame of bed or stretcher. These touches are providing undesirable
ways for the defibrillating current.
Use of the disposable pacing electrode is indicated in the following cases:
Transcutaneous pacer-stimulation
Semiautomatic defibrillation
Hands-free (the operator does not hold the paddle, the electrode is sticked to the patient) defibrillation
in manual mode

See serial numbers and reorder information in section no. 15.

Attention!
The defibrillator measures the patient impedance before delivery of shock. In case
it is out of the range 20 - 200, the defibrillator will indicate error and it will
not deliver the shock.
The cause of very low impedance might be the presence of too much current
conductor liquid (gel, physiological saline solution, ) on patients body. In this
case it must be wiped off.
In case of too high impedance the electrode might be too dry, or it might be
expired. Impedance can be reduced by changing or gelling the electrode.
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6.1.2. Defibrillator paddle electrode

Control elements on the defibrillator paddles:

The energy selection (1), charging (2) shock delivery (3) can be controlled directly from the
keys of the paddles.
For shock delivery (defibrillation) the 3d keys of both the right and the left paddles have to be
pressed at the same time.

Put gel on the electrodes, then place them on patients chest: the
Apex electrode should be pressed on the side of the body, under
the left breast, the Sternum electrode should be pressed on the
right side, under the collar-bone.
Select the adequate energy by the key marked by1, charge the
device by pressing the key marked by 2, and if you detect
shockable rhythm, then press the keys marked by 3 from both
paddles together at the same tyme, this way shock is delivered.

Plug the cable
firmly into the
front of the unit
By rotating the plate, the
adult defibrillator paddle
can be transformed into
pediatric paddle
1
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Warning!
The defibrillator measures the patient impedance before delivery of shock. In case
it is out of the range 20 - 200, the defibrillator will indicate error and it will
not deliver the shock.
The cause of very low impedance might be the presence of too much current
conductor liquid (gel, physiological saline solution, ) on patients body. In this
case it must be wiped off.
In case of too high impedance the electrode might be too dry, or it might be
expired. Impedance can be reduced by changing or gelling the electrode.
Warning!
Cleaning: Do not let the gel get dried on the paddle electrodes, because it can make the
electrodes to get spoiled early. After use, but at least once in a day wipe the paddle electrodes
clean by some paper towels.

Attention!
During cleaning, the device must be turned off.
For paddle electrode ordering information see section no. 15.
6.1.3. Internal defibrillator electrode
The internal defibrillator electrode can be used during heart operations, when the chest of the
patient is open, the defibrillator impulse can be delivered directly to the heart.

Handling
Sterilize the internal defibrillator electrodes before use.
Plug the defibrillator cable firmly into the socket (21) on the front of the unit.
Use the defibrillator spoons carefully, and regularly check them for damage. Do not
disassemble, unless you wish to replace certain parts of the electrode. When replacing the
spoon do not overtighten.
Non-autoclavable
connector
Autoclavable parts
(defibrillator spoon,
handle and cable)
Do not bend the cable or wind it around the
electrodes. Store the electrodes as illustrated here.
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Warning!
Disassembly
To disassemble the autoclavable cable from the non-autoclavable connector, remove the
cable from the defibrillator, by pulling at the plug only (never pull at the cable or the strain
relief to remove the cable). Press the release button on the connector to remove the cables
from the connector.

Cleaning
Do not clean the paddles in a dishwasher because it can lead to mechanical wear- instead
rub them gently by hand before sterilizing them. The above parts can be steam-autoclaved.

Recommended temperature: 134C (maximum 140C, 284F)
Pressure: 2.2 bar (32 PSI)
Duration: 3.5 minutes
Extraction drying: 7-8 minutes

Reorder information
There are 3 different sizes of internal spoons. See reorder information in section no. 15.

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6.2. ECG patient cable

Three different types of ECG cable can be connected to the device. The applied ECG cable is
automatically recognized by the device, and it will set the screen picture accordingly, and it
will decide which leads can be selected by the lead selector keys.

6.2.1. 10-lead ECG cable
ECG electrodes must be placed in a way that they should ensure good contact, in order to get
a record without any noise. In case of using disposable electrodes, the expiration date
indicated on the packaging must be checked, and they can only be used in case their
expiration date is still valid. In case of using clip and suction electrodes, gel should be
applied, in order to get a good contact.
Placement of electrodes in case of standard and Cabrera leads:

For ordering information see section no. 15.

R L
F N
R: right hand
L: left hand
N: right leg
F: left leg
V1: in the IV. rib space at the right
edge of the sternum
V2: in the IV. rib space at the left
edge of the sternum
V3: in the midpoint between V2
and V4 leads
V4: in the V. rib space, on the
mediclavicular line
frontal armpit line
middle armpit line
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This cable can be used in case there is no need for chest leads, when you only want to see the
I, II, III leads by 3 pcs adhesive electrodes. Placement of electrodes can be seen on the
following figure:


This cable is for monitoring limb leads (I, II, III, aVR, aVL, aVF) and one chest lead. With
this cable, 3 simultaneously measured leads (I, II, Vx) and 4 calculated (III, aVR, aVL, aVF)
leads can be monitored. It depends on the placement of the white color electrode, which chest
lead can be seen. We can see the chest lead of where we place the electrode.

.
6.2.4. ECG from external monitor
There is a possibility to connect ECG signal from an external ECG monitor, e.g. diagnostic
ECG or patient monitor. So if ECG electrodes already are on the patient, it is not necessary to
connect more electrodes. The output voltage of external ECG monitotmust be in 10 V range,
this signal must be connected to the (20) ECG input connector by a cable, available from
manufacturer.The delay of monitor output signal may be max 10 ms, this is the responsibility
of user. The sensitivity of monitor may be 100 mV/mV or 1000 mV/mV. In the configuration
menu (see section 13.3.8.6) the real sensitivity must be adjusted.
1: Red
2: Yellow
3: Green
1: Red
2: Yellow
3: Green
4: Black
5: White
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7. User menu
During the operation of the defibrillator it is continuously needed to use the user menu, for the
selection of parameters and curves to be viewed, for alarm limit settings, and for the setup of
sound, curve running speed and other parameters. Therefore, before describing the
defibrillator modes, we briefly present the use and options of the user menu.
After turning on, the defibrillator enters into the mode set in the configuration menu (see
section no. 13.3.6.1) and it is ready for operation.

The user menu appears on the screen with the next figure by pressing OKQkey in that
modes, where it is enabled:

7.1. SEMI AUTO

In semiautomatic mode the user menu is disabled, all the parameters are set, there is no need
for any user interventions, the defibrillator instructions have to be followed. In case we
would like to use the user menu, we need to change to manual mode.

7.2. MANUAL mode

User menu can be controlled by the (12) menu keys, if changing of any setting is necessary.
For entering the menu, press the key labelled (12) OKQ, this way the menu appears. If next
to the name of the menu the > sign appears, it shows that a submenu also belongs to this
menu. Entering the submenu is also made by pressing the OKQbutton.
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The settable parameters are found in the bottom line of the menu. The parameter to be
modified can be selected by the (12) Pand Rkeys, and we can start the modification by the
OKQkey. By pressing the OKQkey, the color of the parameter will change from white to
green, this shows the possibility that it can be modified. The modification can be made by the
Pand Rkeys, then it can be validated by the Skey. This way the color of the parameter
will turn to white again. To return to the previous menu level, also the Skey has to be
pressed. Immediate exit from the menu can be made by the (11c) Menu Close key.
Parts of the menu:
Speed menu Here the curve running speed of different curves viewed on the display
can be seen.
Sound menu The sound of speech (low, medium, laud), the alarm sound, sound of
pressing the keys and the QRS sound (mute, low, medium, laud).
Filters menu The filters of ECG channels (baseline filter, muscle filter, line filter) can
be switched on and off, and the breakpoint frequency of the muscle filter
is selectable.
Alarm limits menu For measured parameters it is possible to set alarm limits: HR lower and
upper limit, SpO2 % lower and upper limit, NIBP Systole, Diastole and
medium value lower and upper limits can be set one by one. It is possible
to set the lower and upper limits of the pulse, measured by SPO2 sensor.
NIBP menu The non-invasive blood pressure measurement device can measure adult
and pediatric blood pressure, it can make manual, repeated and
continuous measurements.
Operation of the NIBP menu:
In case of selecting pediatric blood pressure measurement mode,
pediatric cuff has to be applied, which is inflated and deflated slower by
the control unit. In case of adult mode selection, normal adult cuff and
normal speed are applied.
Measurement interval selection: in AUTO mode, the device repeats the
measurement, according to the time selected here.
If the AUTO measurement is disabled then blood pressure measurement
can only be started by the (8) NSTART key (manual measurement).
Alarm menu Set Factory Default Alarm Settings: this way the default alarm settings
will be mounted, included alarm limits and all other alarm parameters.
Alarm volume: setting of alarm volume. Selectable volumes: mute, low,
medium, high.
Other settings Default Layout: the factory default display layout paramaters and
curves are settable here.
LCD Brightness: 1 10 brightness value is seleztable here. 10 is the
maximum, 1 is the minimum brightness.
Further menu option is the selection of parameter fields and the curve viewing fields function.
It can be done if it is not in menu state. If you press the Ror the Pkey then the background
of one of the parameter fields or curve viewing fields will turn to dark-blue and will start
blinking, indicating this way that the field can be modified.
Select the field to be modified by the Por Rkey, then enter the menu by the OKQbutton.
Here you can select the parameter to be displayed and in case of curves, the running speed. In
parameter selection, you can also select the alarm limits and status. By standing with the
cursor on the parameter selection, pressing the OKQbutton you can enter the selection mode.
Then the color of the parameter will turn to green, and by the Pand down keys you can
select from the optional parameters. You can acknowledge the selection by the OKQbutton.
You can exit from the menu by the Skey. Here the (11c) Menu Close key also works.
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7.3. PACING mode

The operation of user menu is completely the same with the one described about manual
mode.

7.4. ECG mode

Structure of the menu, started by the OKQbutton is the same with the one described in
MANUAL and PACING modes. Also functions of the three parameter fields can be set in the
way written above, selecting the field by the Pand Rkeys, then entering the actual menu by
the OKQbutton. In ECG mode it is not possible to select curves for viewing. In case of 10
lead patient cable always twelve leads, in case of 5 lead patient cable always 7 leads are on
display.
One rhythm curve can be seen under ECG leads, which can be switched off. If you switch it
off, then the space for viewing the 12 ECG leads will be increased with this space. The
rhythm curve can be switched on and off by the (11a) key of variable functions, of which
function in ECG mode is Change layout. By pressing this key, theECG layout option menu
appears, in which the rhythm curve can be switched on and off. By pressing the OKQbutton,
the color of the setup (on or off) will turn to green, then setup can be changed by the P, R
keys. By pressing the OKQbutton the color of selected setup will turn to white again, and it
is possible to exit from the menu by the OK Qor the (11c) Menu close keys.

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8. Printing

The CA360-B defibrillator is equipped with a thermo-printer, printing on a 58-mm wide
paper.
Printing can be started or stopped by the (4) PRINT button.
Manually started printing: in this case the operation can be stopped by pressing the (4) PRINT
button, or it will stop automatically after the time is set in time setup line (section no.
13.3.8.2), in the service menu periphery setups point. This interval can be 16, 20, 32 or 120
seconds. Printing speed can also be set in the configuration menu, according to the description
of section no. 13.3.8.3.

Attention!
In AED mode printing is not possible. If printing is needed after the use of AED,
you must enter the MANUAL mode, and here you can start printing by pressing
the (4) PRINT button.
Printing paper loading, replacement:
(22) Printer is to be found on the left side of the defibrillator. Printer door can be opened by
pressing the printer door eject button, according to the following figure. The paper roll has to
be placed here, so that when closing the door the thermal side should be upside. Place the
paper inside carefully, so that it should not get crumpled or get stuck when closing the printer
door.

The automatic printing and event report printing are enabled or disabled in configuration
menu (chapter 13.3.8.1 and 13.3.8.4) The automatic print starts at events alarm os shocking
the length is 8 seconds with 2 seconds pre-delay. The shocking is a special event , the length
of it is 12 seconds with 4 seconds pre-delay.
Printer eject button
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9. CA360-B defibrillator alarm system

The alarm system of the CA360-B defibrillator is able to receive alarms of technical and
physiological origin. The reason of technical alarm can also be of two types. One of them is
the fault of the device, which is detected by the defibrillators internal test. (eg. battery error,
defibrillator board error, measurement error, etc.). The other type of error is related to the
sensors, eg. removed electrodes, noisy ECG signal, removed SPO2 peripheric sensor, blood
pressure cuff error, etc.
Alarm type of physiological origin is possible, if any measured parameter gets out of the
previously set alarm limits.

9.1. Concepts connection with ALARM

Priority
The priority can be at high, medium, low or basic level (notification). The signal of the
alarm (voice and visual signals) depends on the priority level. Technical alarms are of
basic priority, for each physiological alarm it is possible to set the priority.
Latching alarm
If the alarm is set to latching, then the alarm status will only be over if the operator has
acknowledged the alarm by the (10) Alarm button. In case of non-latching alarms,
when the reason of the alarm has ended, the alarm status also ends. The latching or
non-latching alarm mode can be selected in the alarm menu.
Global disabling of alarm
Physiological alarms can be globally disabled, in case of technical alarms this
disabling cannot be validated. Alarms can be disabled individually as well from the
menu.
Delaying in case of occurring or ceasing an alarm
In case one of the parameters overcomes the alarm limit, the alarm system does not
alert immediately, this way we can avoid that short changes, noises would cause
alarm. The delay depends on the parameters, but it is not a settable value. In case of
ending of the alarm reason, the delaying occures the same way. If during this time the
alarm reason reappears, the alarm event does not end. Delaying time can be 0 as well,
typically in case of technical alarms. Delay times are not settable. The status of the
alarm system and the alarm sound are indicated by the symbols of table no. 3.1.
(Alarm system switched off, enabled or paused and voice signal switched off or
sound.)
Suspension
If an alarm event happens, the operator can pause the alarm by the (10) ALARM
button. In case the alarm reason does not end, then after pausing time is over, alarm
will be validated again.
Not all alarms can be paused, physiological alarms are typically pausable. Pausing
time can be set from the menu.
The technical alarms are of low priority, they cannot be disabled globally, their
delaying is 0 s. Reason of the technical alarms always appears on the display during
the alarm, it informs the operator about the reason of the alarm. (Eg. noisy ECG
signal, patient cable is missing, NIBP cuff error,)

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9.2. Curing of alarm system

The alarm system is cured in user menu, configuration menu and in function by the (10)
ALARM key.
In the user menu (see chapter 7.2 we can set the default alarm settings and the alarm sound
volume.
The alarm limits are settable by selecting the parameter fields, as it is described in chapter 7.2.
Here we can set the alarm status applied to actual phisiological parameter too.
In the configuration menu all the alarm parameters are settable. Describe of the parameters
and the settable values are in chapter 13.3.3.

Using of (10) ALARM key:
If the alarm system is switched on but there is no alarm event, then at pressing the (10)
ALARM key the (11c) soft key gets the Alarm Off function for some seconds. If this key is
pressed, the alarm system is off, this is signed in the upper left corner of the display by an
icon . If we do not touch this key, it gets back the original function.

If the alarm system is ON state and there is a real alarm event, by pressing the (10)ALARM
key the soft keys get the functions: (11a) Acknowledge, (11b) Suspend, (11c) Alarm Off.
If we use the (11a) Acknowledge key, we clear the stored alarm events. This is the manual
acknowledge. If we use the (11b)Suspend key, the alarm will be suspended for the time, set in
the configuration menu. The icon on screen sign this. When the suspend time is over, the
alarm will be active again. By the (11c)Alarm Off key the alarm system can be switched off.
If we do not touch these keys, after some seconds they get back their original functions.
If there is suspended alarm event, the (11a) key gets the Suspend Off function.

If the alarm system is in OFF state, by pressing the (10)ALARM key the alarm system goes to
ON state.

The alarm sound volume is settable in the user menu/Volume/Alarm sound volume menu
item(see chapter 7.2). The possible levels: MUTE, LOW, MEDIUM, HIGH.

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Table of physiological parameters, able to cause the alarm, and related settings:

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10. Auxiliary supplies of the defibrillator
In all modes of the defibrillator works the QRS recognition and except AED mode works
the non-invasive blood pressure measurement and SPO2 monitoring. Therefore before the
therapeutical and monitoring modes, we overview the use of these services. .

10.1. QRS recognition and QRS voice

In all modes of defibrillator works a QRS recognition algorithm, which analyses the ECG
channel selected for display. When the QRS recognition ahorithm identifies a QRS wave, it
gives a beep sound, so the rithm is sensible by ear. The QRS volume adjustable in user menu
(chapter 7.2.) and configuration menu (chapter 13.3.4.1) too.
If the SpO2 sensor is on the patient too, the pitch of QRS sound depends on oxigen
saturation. If the saturation decreases, the pitch decreases too, so the changing of oxigen
saturation is sensible by ear.

10.2. Oxygen saturation (SpO2) measurement

For oxygen saturation measurement in the CA360-B defibrillator, a Covidien (Nellcor)
module equipped with finger clip sensor is applied. By the finger clip sensor the oxygen
saturation can be continuously measured in %, the pulse wave can be monitored in MANUAL
and PACING modes, and from the pusle wave, the pulse number can be defined as well. The
pulse number received from the SPO2 module, on the display and in the description as well, is
referred to as Pulse.
In MANUAL mode, on the left side of the display, in the field under the ECG channel the
pulse wave monitoring with settable running speed can be selected. The SPO2 % and the
pulse number is selectable in one of the right side parameter fields, and alarm limit values can
also be set to them, which will be displayed on the bottom of the parameter field.
In PACING mode the operation is similar to the one in MANUAL mode, the pulse wave, the
SPO2 % and the pulse number can be viewed and the running speed of pulse wave can be set.
In ECG mode, the SPO2 % and the pulse number displaying and alarm limit setting can be
selected into one of the parameter fields on the right side.
In the parameter fields the HR and NIBP value and alarm limits are selectable in every mode.

10.2.1. Preparing the measurement:
Connect the extension cable of the sensor to the (25) SpO2 connector, located on the right
side of the device. If the defibrillator is on, then by the above, the module is ready for
operation. The red light of the LED in the finger clip indicates that the sensor has been
connected.
Only use fingerclips recommended by Innomed!

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10.2.2. Patient preparation:
Before using the finger clip, if necessary, cut the patients finger nails and remove fingernail
conditioning materials from fingernails, because it can give a false measurement.
Place the clip on patients nail, in a way that the LED shining with red light should be over
the patients nail.
Do not use the blood pressure measurement cuff and the finger clip sensor on the same hand,
as it can cause false alarms.
Too much external lights can interfere with the measurement, in this case it is recommended
to cover the hand with the fingerclip.
After the finger clip has been placed on patient, monitoring starts automatically, the SPO2 %
value and the pulse wave are displayed.
Warning
Check the finger clip at least every four hours. If you see any changes on the
finger, or the quality of pulse wave deteriorates, for the reliability of the
measurement, put the clip on another finger, and check patients circulation.
Warning
any types of interference known to influence the function or accuracies of the
pulse oximeter equipment;
In case of simultaneous applied photodynamic therapy please take into account
the light emission parameters of the finger clip.
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10.3. Use of non-invasive blood pressure measurement

Warning
The non-invasive bloodpressure measurement does not work in AED mode, so if
after a successful resuscitation you would like to measure blood pressure by the
device, then you have to change to manual mode by pressing the (6) Manual
button.
The non-invasive blood pressure measurement device is suitable for adult and pediatric blood
pressure measurement. It can be used in auto and manual modes as well.
In manual mode a blood pressure measurement can be started by pressing the (8) NSTART
button once.
In automatic mode the measurement can be continuous (STAT) or a periodically repeating
measurement settable in the menu. Automatic mode can be started and stopped by pressing
the (8) NSTART button once.

Warning
Repeated measuring (in every 1-2 min) is allowed only for short duration (5-10
min.) to avoid any harm of patient!
The continuous automatic measurement is made in a way that after the cuff deflation the next
measurement immediately starts. This continuous automatic measurement is allowed to last
for max. 5 min. only, but it can be stopped anytime by by pressing the (8) NSTART button.

10.3.1. Measurement method:
Connect the blood pressure cuff tube to the (24) NIBP connector, and fix the cuff on patients
upper arm, according to the instructions. (In case of using SPO2 sensor, it should not be on
the same hand where the cuff is placed.) By this the blood pressure measurement device is
ready for operation.
Blood pressure measurement can be started by pressing the (8) NSTART button. The module
inflates the cuff pressure above the value of the systole pressure. Then the internal pressure of
the cuff will gradually decrease, meanwhile the module is analyzing the pressure waves
caused by the pulse, and from this it calculates the arterial systolic, diastolic and main
pressure values.
The device is able to measure blood pressure, both in adult and neonatal modes.

10.3.2. Preparing the measurement
The most important thing is patient preparation for measurements. In case patient is not at
rest, it is very likely that the outcome of the measurement will be a false or unsuccessful
result. Therefore it is very important to inform the patient, so that during the
measurement he should keep his arm laid on the bed, at rest, stretched.
10.3.2.1. Cuff size
For exact measurement it is important to select the right sized cuff. The cuffs inflating
part has to reach around the limbs in 50-80 % and its width must be around 2/3 of the
upper arms length. If any marking is to be found on the cuff, then it has to be decided
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accordingly, whether its size is suitable or not. In case there is no any suitable sized cuff
available, then you should rather choose a larger than a smaller one.
10.3.2.2. Placing the cuff
The deflated cuff should be wrapped tightly fitting around patients upper arm, but not by
overtightening it.

Warning
Make sure that the marked center of the inflatable part is above the patients
artery, according to the instructions of the cuff.
It is very important that the cuff should not be placed on any joint (elbow, knee),
and the limb must be stretched in order to avoid any false measurement. The cuff
should not be put on the same arm of the patient, where the pulse oximeter finger
clip is placed, as it interferes with the clips measurement, which can cause false
alarm.
During measurement, please do not squeeze the cuff hose, avoid pinching the
tubes.
Regularly check that the measurement does not deteriorate the patient's
circulation, check the affected limb.
The result appears in the right side parameter field. If no parameter field has been marked for
NIBP viewing, the device will remember the result of the last measurement, and if we
highlight one field for the viewing of NIBP, then the result of last measurement will appear
there.

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11. Therapeutical modes
The therapeutical modes of the defibrillator are AED mode, the manual modes and the
pacemaker mode.

11.1. AED mode
The device assists the operator by voice and text instructions appearing on the display, in the
device operation. The device automatically performs the necessary operations, it charges the
defibrillators energy accumulator, and it gives an instruction for the delivery of shock.
The CA360-B defibrillator in semi-automatic mode can be operated by non-professional
persons as well, as the defibrillator is giving the instructions to the operator. Even in such
cases as well it is advisable that the device should be operated by a person, who has been
trained for the use of semi-automatic defibrillators
The displayed and the vocally spoken text has been created, so that the steps of the operator
will always be completely obvious, so that non-professional operator should not have to make
any decisions and the device would support the operator in all his actions.
The ERC2010 puts a strong emphasis on the importance of chest compression, chest
compression must only be paused for a very short time, during the time of analysis and shock
delivery.
Resuscination process can only be stopped if signs of the ROSC Return Of Spontaneous
Circulation (breathing, opening of eyes, maybe speech) have clearly returned.
The energy level of the first shock should be 150 200 J for adults, according to ERC 2010
recommendation (STAR biphasic waveform), about the further shocks, for increasing the
efficiency, the energy level can be raised.
Warning! In AED mode the operator does not set the energy levels directly, it is only
possible in the configuration menu. (See section no. 13.)
For children (between the age of 1-8 and under the weight of 25 kg) it is advisable to use 2-4
J/kg energy.

Warning!
Make sure that, in order to avoid electric shock, during defibrillation, nobody
blood, saline solution) and metal objects in connection with the patient, like for
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After turning on the defibrillator, in AED mode, the following screen picture is displayed:

On the upper line of the screen the actual function of the (17) Action key is displayed. In
this case it means the abortion of CPR. It is necessary if the operator wants to fit another
action into the process of resuscitation, eg. analysis. In the line below it, the actual phase of
resuscination can be seen. In the present case it is the CPR. The line running under the text
indicates the passing of time. The line below it is the alarm field, in the picture it indicates
shockable rhythm. In the graphic field the ECG signal received from the electrodes can be
seen, next to it the heart rate parameter appears, which can be measured during
resuscination and calculated from the ECG signal. In the line under the graphic field the
symbol indicating the defibrillators status (in this case the safe status) can be seen, the time
passed since turning on in hours:minutes: seconds format, and the shock counter are
displayed, which shows 0 on the figure. In the bottom line the symbol indicating the battery
status, the (11 a, b and c) software controlled fields, indicating the key functions, are
displayed. In the present case only the (11c) key has any functions, this way it is possible
to indicate that the spontaneous circulation has returned. On the right lower courner the
time is displayed in hours: minutes format.

On the following figure it can be seen that the defibrillator has already recognized the
shockable rhythm, the 2 minutes phase of the CPR has finished, or the operator has aborted
it, and the defibrillator has automatically started the charging. The charging process is
indicated by the line next to the state indicating symbol. The upper line is empty, as the
(17) action key has no any functions during the charging. In the second line the actual
function is displayed: Charging
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The following screen picture shows the state when the defibrillator is charged and it is in a
state ready for delivering shock. The upper line of the screen indicates, that shocking can be
started by the (17) Action key. In this case the operator either delivers the shock, or if
necessary, he aborts the charged state by the Disarm button.

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Steps of using the AED:

1. Make sure that the patient and the rest of the persons present are safe (safe
environment).
2. If the victim is unconscious, and has no respiration, call for help laudly, arrange to get
the defibrillator to the scene.
3. Immediately start the resuscination (CPR): make sure that the respiratory tracts are
free. Then repeat continuously until the defibrillator arrives: 30 compressions on the
middle of the chest (on the sternum) in 4-5 cm depth, followed by 2 blow-ins. Aim for
100 times chest compressions per minute.
4. As soon as the defibrillator arrives on the scene, turn it on by the (1) power on button.
After the running of self-test (about 15 seconds) the defibrillator is ready for
operation. If necessary, select the semi-automatic mode by pressing the (5) SEMI
AUTO button. The selection is indicated by the LED beside the key.
-Place the electrodes according to the figure or the defibrillator manual (paddle or
defibrillator pacing electrode). Do not place the electrodes near pacemaker or ECG
electrodes.
-If there are several lifesavers at present, the resuscination (30 compressions, followed
by two blow ins) must be continued during defibrillator installation as well.
After turning the defibrillator on, follow the verbal instructions or the instructions on
the display.
-Make sure that nobody touches patient, while the defibrillator performs the
analysis. The ECG analysis starts automatically.
5. If the defibrillator detects a shockable rhythm, it charges automatically and gets into a
shock-ready state.
When the defibrillator gives an instruction for shocking:
-Make sure that nobody is touching the patient, and the metal, current conductor
materials (stretcher, gel, physiological saline solutions, etc.) in connection with
the patient should be removed.
-Press the shock button.
-After shock, continue resuscination according to instructions of the defibrillator.
6. In case the defibrillator does not recommend shock, immediately continue the
resuscination.
(30 compressions, followed by two blow-ins)
The process can be stopped if normal breathing has obviously returned.
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Semi-automatic defibrillation protocol

* The defibrillator continuously performs the rhythm identifying analysis. If it finds
shockable rhythm, it indicates the possibility of shocking, but if before delivery of shock the
analyzer detects non-shockable rhythm, then it will disable the shock and will instruct to
continue CPR.

*
150-270J biphasic
for 2 min.

Patient unresponsive
No pulse, no breathing
CPR 30:2
Until AED attached
CPR 30:2
for 2 min.
Continue until the victim
starts to wake up:
to move, open eyes and
to breath normally
CPR 30:2
for 2 min.
AED
assesses
rhythm
No shock
advised
Shock advised
*
1 shock
150-270 J
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Questions and answers for the semi-automatic defibrillation protocol:
How to start the semi-automatic defibrillation process?
The semi-automatic protocol starts automatically, if the defibrillator is switched to
semi-automatic mode, and the electrodes are placed according to the instructions.
For more details, see the section titled, The steps of using of AED (page 41)
Is it necessary to perform CPR before defibrillation?
Yes, it is necessary. The immediate CPR increases survival chances. It is advisable to
perform chest compression and blow-in the proportion of 30:2, until the defibrillator
arrives at the scene, and patient is prepared for defibrillation. From this point the
defibrillator instructions should be followed in semi-automatic mode.
What should happen if the patient recovers?
If signs of circulation are clear, then enable the Abort CPR function by pressing the
(17) Action key. This way the Pulse present text will appear above the (11c) key, and
the text Analysis appears beside the (17) Action key. If the Pulse present key is
pressed, then the process of resuscination will be aborted, the text Pulse present mode
will appear on the display, and the defibrillator will change to monitoring mode. VF
detection and the HR alarms will be working, they are warning the operator if any
changes happen in patients sate. Then by the (17) Action key the process can be
restarted, the text Press action button for analysing is warning us about this.
The resuscination process can also be aborted by changing to Manual mode by the ((6)
MANUAL key). Alarms also work in Manual mode, if they are enabled, this is how they
indicate the changing of state. In case of patients state deteriorating, process can be
restarted by the (5) SEMI AUTO button.
How to abort and restart the resuscination process, analysis?
During CPR, the CPR phase can be aborted by pressing the (17) Action key. Then by
pressing the key again, the device will get to analysis state, then from this point the
process will be continued normally. If after aborting the CPR , no analysis will be
initiated, then after some time the analysis will automatically restart by the (17) Action
key. Then the device restarts the CPR phase. The resuscitation process can be aborted
by the Sign of Life or by the MANUAL keys.
What happens if the (15) Disarm button is pressed?
If the device finds patients rhythm to be non-shockable rhythm, then it will
automatically perform disarming. If the defibrillator is in a charged state, it can
perform disarming.
What happens if one of the electrodes falls off?
During CPR the device does not check electrode fall-off. If the electrode falls off
during analysis, or the process cannot be normally continued, because of any other
reasons, then the device is warning about the problem. After solving this problem the
resuscination process continues by itself.
Why is it that the device does not recognize electrode fall-off during CPR?
During CPR the device does not examine the state of cables and electrodes, as because
of their faultiness it is not allowed to stop the CPR. Besides this, chest compression
might lead to false detection, therefore there is no electrode check during CPR.
Which energy should be selected for shocking?
The energy level of first shock should be 150 200 J (STAR biphasic waveform), for
further shocks, energy level can be raised, but it is not necessary by all means.
3 energy levels can be set for semi-automatic defibrillation in the menu. When
switching to semi-automatic mode, the first level is selected. Stepping to the next level
happens during shock. If before shock the analysis detects non-shockable rhythm, then
the shock will be skipped, and the possible following shock will be delivered at the
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previous energy level. The default values are 200 J, 200 J, 270 J, but of course these
can be changed by user in the configuration menu.
Use of semi-automatic mode by defibrillator paddles:
If possible in semi-automatic mode defi electrodes should be used, but defibrillation is
also possible by defi paddles. In this case defi paddles should only be placed on the
chest, if instructed by the device, according to analysis. Then within 1-2 seconds
charging process will stop, and the device will give instruction for shock delivery.
When should ECG electrodes be used as well?
The use of ECG electrodes provides better quality signals, but it increases preparation
time and it complicates the process. In case of using self-adhesive defibrillator
electrodes, these are giving quite good quality of signals for ECG analysis, so no
electrode is needed. When using defibrillator paddles, by all means means ECG
electrodes must be placed, without this, the semi-automatic protocol does not start.
What to do if there is no electrode gel or gel pad available?
Wetting of defibrillator paddles is very important from the aspect of obtaining a good
contact, the lack of gel can cause lower energy delivery and the burning of skin. If the
electrode gel is missing, any wetting assists the deibrillation (clean water, any kind of
liquid), but do not use creams, and generally oily materials, because they only worsen
contact
How does the defibrillator select energy of shock?
In semi-automatic mode the defibrillator shocks with the preset (in the configuration
menu) energy levels. The firs, second and third shock energy levels can be set
separately. For these, it is advisable to set increasing values, in order to increase the
efficiency of the shocks. According to the energy step-back protocol, if the result of an
analysis is non-shockable rhythm, then the possible following shock (if needed) is
delivered at unchanged energy level.

Automatic ECG analysis
The Cardio-Aid 360-B defibrillator incorporates an automatic VF/VT detection system. This
detection system is always enabled in semi-automatic mode.
In semi-automatic mode, the Possible shockable rhythm warning message appears together
with a voice prompt. The operator will be prompted not to touch the patient while the final
analysis is performed.
In manual and pacing modes Shockable rhythm is displayed as a warning message.
Definition of shockable rhythm:
Ventricular fibrillation (VF)
Ventricular tachycardia with broad QRS (VT) >180 bpm

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11.2. Manual defibrillation

11.2.1. Asynchronous manual defibrillation
In case of manual defibrillation the operator decides individually on the energy level and on
performing the defibrillation. In the simplest case, defibrillation can be performed very
quickly by the following steps.

1. Turning on the defibrillator: turn on the defibrillator by the (1) power on button. After
running the self-test, the defibrillator will get to the operation-ready state in about 15
seconds. During this time free patients chest and plug the electrode cable to the 21
connector and place the electrodes on patients chest.
2. Set the desired energy by the Energy+/- key to be found on the paddle electrode, or in
case of pads electrode, by the soft key buttons signed by no.11.
3. Decide according to the ECG curve on the defibrillators display, whether the rhythm
appearing is shockable or not, and if it is shockable rhythm then start charging by the
charge key signed no. 2, to be found on the paddle electrode (Apex). In case of using
defibrillator electrode, charging can be started by the 17 Action key. Charging process
is shown by a voice signal and by a line running on the display. Warning!!! Charging
only completes, if electrodes are placed on patients chest during charging, as for
charging, patient impedance value is necessary. (See STAR waveform description
section no. 2.1.1). If charging has been started, without the electrodes being on the
patient, then charging will not be completed, the device will give a voice and also a
visual signal about it.
4. If you still view that the rhythm is shockable, then by pressing the keys marked by no.
3 together, on the electrodes Apex and Sternum, you can deliver the shock. In case of
defibrillator electrode, shock can be started by the 17 Action key.
In case you think that what you see is a non-shockable rhythm, you can abort the
shock-ready state by pressing the (15) DISARM button. If you do not press the (15)
DISARM button, but you do not deliver the shock, then after 30 seconds the
defibrillator automatically stops the shock-ready state.
Screen picture in manual defibrillation mode:
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In case of using pads electrode, charging can be started by the (17) Action key, as it can be
seen on the right side, on the upper line of the screen. In case of using defibrillator paddle
electrodes, charging can be started by the key marked by no. 2, located on the paddle, with the
label Charge. On the left side of the upper line, the value of selected energy level is displayed.

Warning!
blood, saline solution) and metal objects in connection with the patient, like for
ways for the defibrillating current. During defibrillation no oxygen should be on
the patient.
In case of asynchronous manual defibrillation (3- or 5-lead) patient cable can be used, in order
to obtain better quality ECG signal. When using patient cable, the ECG is of better quality,
more detailed, but the electrode placement makes preparation time to be longer, which can be
critical.

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11.2.2. Synchronized cardioversion

Quick guideline
Turn on the device and after the running of self-test, select manual mode by key no. 6.
The selection is indicated by the LED beside the key.
Connect the ECG cable to the device (20 ECG connector) and place the ECG
electrodes on patients chest, according to the description of section no. 6.2. If
needed, set the ECG lead by key no. 2 and the sensitivity by key no. 16.
Connect the gel-pad electrode according to the description of section no. 6.1.1 or the
paddle electrode, according to section no. 6.1.2. Stick the pads electrodes on, or put
gel on paddle electrodes and push them on patients chest.
By the key no. 11c, labelled Sync Menu, enter the Sync menu, then by the (12) P,
Rkeys select Latching Mode or Non-Latching Mode, synchronized mode, and
validate it by the 12 OKQbutton. Then on the upper line of the screen the text Sync
On appears, and the selected Latched or Non-Lathed mode text will be displayed.
Important!
In latched mode, after delivering the synchronized shock the defibrillator will
remain in Sync mode, while in non-latched mode, after delivering the
synchronized shock, the device will return to asynchronous manual mode.
Select energy by the keys 11a and 11b, or by the Energy button located on the
Sternum paddle electrode.
Attention!
In case of synchronized cardioversion, generally less energy is needed, for an
adult, 80-110J can already be effective.
If the device indicates that it has recognized the QRS, start charging by the 17 Action
key, or by the key, marked by 2, to be found on the Apex paddle electrode. When
charging is completed, it is indicated by the device on the display and by voice signal
as well.
For shocking, press the 17 Action key, or press together at the same time the keys
marked by 3, on the Apex and Sternum electrodes, and keep them pressed. After you
have pressed them, the device is waiting for the next QRS, and when it appears, it
deliveres the shock. If keys are released before QRS appearance, then there will be no
shock.

Synchronized cardioversion by defibrillator paddles is only possible if the ECG signal is
coming from a separate ECG electrode, or from an external source of signals.
Important!
In case of synchronous cardioversion, when pressing the shock buttons,
immediately a clicking sound can be heard, which is the sound of safety relays,
and it does not mean delivery of shock. Shock buttons must be still kept on being
pressed, until shock is delivered, which can also be followed on the display of the
device. Make sure that in order to avoid electric shock, nobody touches the patient
during delivering shock.

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QRS detection is shown on the display of the device. Over the detected QRS, at the R peak, a
marker line appears and a letter S, which indicates the synchronized point. In synchronous
mode the defibrillator delivers the shock within 40 ms, following the marker. This way user
can check on the display that the device detects the QRS correctly.

The above figure appears in the ECG field of the display, the markers beside the S are
showing the places of R peaks.

If there is no suitable heart activity for the synchronizer, when pressing the shock buttons,
the text There is no shockable rhythm might appear on the screen.

Shocking is obstructed if:
No QRS complexes can be detected on the selected lead.
The amplitude of the signal is too low.
ECG electrodes have been placed incorrectly, or they are not connected well.
Synch mode automatically switches off if:
Changing from manual to semi-automatic mode.
ECG plug is removed.
When changing to pacing mode.
In case of synchronized shock, if the defibrillator is set to synchronous non-latching, in
the Synch menu.
When using external ECG, ECG delaying from the external ECG source should be less than
10 ms. See section 6.2.4.

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On the following figure, the screen picture appearing when switching to manual mode can be
seen.

We are viewing the set energy level and state of the synchronized defibrillation. In case of
Sync off, there is asynchronous defibrillation, it can be changed in the Sync menu. Beside the
text Sync, the actual function of the (17) Action button is displayed. Under it, messages,
alarm reasons can be seen, then ECG and pulse waves and different parameters are displayed.
Under the graphic field, symbols indicating the alarm and the battery state can be seen. The
text SAFE indicates that the defibrillator is not charged, it is not in a shock-ready state. Next
to it, the time passed since turning on and the shock counter can be seen. In the bottom line,
the actual functions of 11a, 11b, 11c keys with variable functions are displayed, increasing of
energy, decreasing of energy and entering in sync menu. In the right lower courner, time is
displayed in hours: minutes format.

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11.2.3. Internal defibrillation
The internal defibrillation is made during heart operation, in case of opened chest, with
energy delivered directly to the heart. In this case internal defibrillator electrode has to be
used, according to the description of section no. 6.1.3.
The defibrillator recognizes that an internal defibrillator electrode has been connected, and it
sets the energy selection possibility into the range of 1-50 J. In case of internal defibrillation,
higher energy than 50 J cannot be used.

Quick guideline
1. Turn on the device by the 1 power on button. After running self-test (15 seconds) the
device is ready for operation. If necessary, switch the device to MANUAL mode by
the key no. 6. The mode is indicated by the LED beside the key.
2. Select energy level by the 11a 11b keys. In case of internal defibrillation, the energy
can be set to the range of 1 50 J.
3. Touch the heart by the internal electrodes.
4. Start charging by the 17 Action key.
5. If charging is completed, shocking can be started by the 17 Action key.

Warning!
Make sure that, in order to avoid electric shock, during defibrillation nobody
should touch the patient.
Adequate maintenance, cleaning and sterilization of electrodes are important, as it has already
been detailed in section no. 6.1.3.

11.3. Using of pacemaker

The non-invasive or transcutaneous pacer gives electronic impulse to the heart, in order to
create cardiac depolarization and miocardial contraction.
The use of pacer can be necessary in the following cases:
P-asystole (there is P wave beside AV blocking)
Symptomatic bradycardia
Tachycardia (antitachycardia stimulation)
In case of asystole, if there is complete electronic silence, the use of pacer is contraindicated,
in this case resuscitation must be continued by chest compression and by medicines,
according to the descriptions of AALS and PALS of any ERC guidelines. If there is P wave
but there is no ventricular contraction because of the complete AV blocking, then operation
with pacer is recommended.
In case of tachycardia, overdrive pacing can be used, here the pacer frequency, over the actual
heart rate has to be applied, and should be decreased gradually, till the normal level.
In case of symphtomatic bradycardia, threatening AV blocking, P-asystole, standby pacing
has to be applied (demand mode).
Pacer can work in two modes, in fixed and in demand modes. In fixed mode, the pacer is
continuously giving the impulses, with the set frequency and amplitude, independently from
spontaneous heart rate. This mode should be used in case of P-asystole and tachycardia
overdrive. In demand mode, the pacer only gives impulse, if no spontaneous QRS comes,
during the cycle, corresponding to the set basis frequency (RR distance).
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The pacer provides square pulses with settable amplitude and frequency and with fixed width
of 40 ms impulse. Amplitude can be set between 20 200 mA and the frequency between 30
200 ppm.
During pacer stimulation, pediatric and adult size pacer (pads) electrodes can be used. For the
use of pacer, in some certain cases ECG electrodes also have to be placed on the patient, in
order to obtain good quality ECG signals for development and evaluation. Primary condition
of demand mode, the sure, unnoisy QRS detection, in case of spontaneous activity. This is
not stable enough, in case of two-lead ECG. The (electronic) noise, identified as QRS, can
cause missed pacer stimulations, which can potencially be life-threatening, therefore for safe
operation, the use of ECG electrodes is obligatory. During fixed stimulation, it is not
necessary to detect QRS, therefore it is allowed to use pacer, without ECG electrodes as well.

Warning!
If You change the defi mode from AED or Manual to Pacemaker mode, and the
capacitors are charged, before the start of pacemaker the capacitors must be
discharged. In this case in the upper line of display appears a status bar showing
the process of discharge and a PLEASE WAIT sign. When the discharging
finished, a PACER START sign appears, and You can start the pacemaker. The
discharging procedure takes maximum 20 seconds.
11.3.1. Quick guideline
1. Turn on the device by the 1 power on button. After running self-test (15 seconds) the
device is ready for operation. If necessary, switch the device to PACING mode by the
key no. 7. The mode is indicated by the LED beside the key.
2. Place ECG electrodes according to the description in section no. 6.2.2 or 6.2.3 and
the gel-pad electrodes, according to section no. 6.1.1 (Anterior-Posterior placement).
3. Select pacer stimulation mode fixed or demand by pressing the button no. 11. The
actual pacing mode will be displayed in the upper line of the display.
4. Setting of pacer rhythm: press the11b Frequency button, this way, functions of 11a
11b 11c keys will change: Increasing of frequency, decreasing of frequency and
closing of menu.
5. Start stimulation by pressing the (17) Action key (Start pacer). This way the pacer is
started, in the upper line of the display, the text Pacer Stop will appear.
6. Increase pacer current above efficiency level. Press the (11c) Set Current key, this
way, functions of the three soft keys will change. By the (11b) Current+, (11a)
Current- keys, the amplitude of pacer impulse can be set, by the 11c Menu closing key
it is possible to return to the previous menu level. (The power of current can also be
set if the pacer is in switched off state, at this point if current changing key is pressed
longer, changing will speed up.)
Keep the current with about 10 % over the limit level. The limit level is generally 40
80 mA, depending on the placement of electrodes.
Both current and frequency can be set also during pacer operation, but in this case the
changing does not speed up even if the key is pressed longer. (safety function).
If there is not any pads electrodes available, for a while it is allowed to perform pacing by
defibrillator paddles, but in this case the use of ECG electrode is obligatory.

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Warning!
Using of pacer by defibrillator paddles can only be allowed for a while, until the
pads electrodes are placed on the patient, or transarterial pacer is introduced.
Warning!
During stimulation by transcutaneous pacer, most of the patients feel pains. Based
on patients state, physitian operating the device should consider the application of
pain killers for the patient.
Screen picture in pacer mode:

In the upper line, on the left side of the display the mode of pacer (Fixed or Demand) can be
seen. Besides, the set pace rate and pace current values are displayed. Function of the (17)
Action key in this state is the starting of pacer. After starting, the function of this key will
change to stop pacing.

Attention!
In case of running pacemaker to switch the defi to an other mode (AED, Manual
or ECG) or to switch it off is impossible. First You have to stop the pacemaker by
(17) action key.
The VF detector works also, when the pacemaker run. If the VF detector realises
ventricular fibrillation, a VF alarm appears. In this case also You have to stop the
pacemaker, then You can step to defibrillator mode (AED or Manual).
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Defibrillator/pacer electrodes in pacer mode:

Using the paddle electrodes in pacer mode is possible only when ECG cable is connected, and
ECG electrodes are on the patient. In case of paddle electrode there is no possibility to choose
the Demand mode, the pacemaker can work only in Fix mode.
Using pad electrodes in pacer mode, the defibrillator requires ECG cable too, but the
Demand mode is coosable in this case. When You connect the pad electrode cable, the
(11a) soft key gets the Pacer Mode function. When You push it, You can choose the Fix
or Demand mode.

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12. ECG mode

Defibrillator can be switched to ECG mode by the (13) key labelled ECG. Change of mode is
indicated by the LED enlighted beside the key.
In ECG mode, the defibrillator performs ECG function, completed with the options of SpO2
and NIBP measurement.

12.1. Viewing of ECG

ECG signal can be captured from 3-lead, 5-lead or 10-lead patient cables or from external
ECG device. (See chapter 6.2.4)

Screen in case of 10 lead ECG cable:
Sharing of screen:
On the lower part of the screen, the functions of variable function keys are displayed. In basic
situation these are Change Layout, Speed and Filter.

On the left side of the screen, the ECG field is located. The sructure of this field depends on
the type of the patient cable.
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In case of 3-lead patient cable, one ECG channel can be seen. The viewed channel, which
may be I, II, or III, can be selected by the (2) lead selector key.

In case of 5-lead patient cable, 7 channels can be viewed. These are I, II, III, aVR, aVL, aVF,
and Vx. Display of the leads cannot be influenced by the lead selector key, but the rithm
channel is selectable by this key.

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In case of 10-lead standard patient cable, the standard 12 channels appear in the ECG field.
These are I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5 and V6. The (2) Lead selector key is
for select the rithm channel here. Amplitude of the curves viewed in the ECG field, can be set
by the (16) ECG amplifyer key to the values of , , 1 or 2 cm/mV. We can enter the speed
setting menu by the (11b) Speed key, for setting of curve running speed.
Here the following speeds can be set: 5, 10, 25 or 50 mm/s for ECG and 5 or 10 mm/s for
rithm.
Setting method: by pressing the Speed key, the speed menu opens. Put the selector sign on the
ECG speed line, by the P, Rkeys, then select the function by the OKQbutton. Color of the
actual speed value will turn to green, and at this point you can change the speed values by the
P, Rkeys. Acknowledge selection by the OKQbutton, this way, color of the set speed value
will change back to the original one, and selection is validated. Menu can be closed by the
(11b) Menu Close or (11c) Menu Back button. After closing, functions of variable function
keys will change back to the original state. Adjust of rithm curve speed is the same.
The (11c) Filter key is for setting of ECG filters. By this, you can enter the Filter menu. Here
the muscle filter and the mains filter can be switched on or off.
The muscle filter can be given the 25, 30,35, 40 Hz or the switched off value.
The mains filter can be switched on and off, mains frequency can be set in the configuration
menu.
You can exit from the Filter menu by the (11b) Menu Close or (11c) Menu Back key, at this
point the functions of variable function keys will change back to the original state.
A 0,05Hz base line filter is in ECG amplifier, this is not a switchable filter, it is always
switched on.

Under the ECG field, a narrow field can be seen, where rhythm curve can be viewed. For the
setting of this, press the (11a) Change layout key. In the opening rhythm curve menu window,
rhythm curve can be switched on and off by the OKQthen the P, R, finally by the OKQ
and Menu closing buttons. In case of using 5- or 10-lead patient cable, the lead of rhythm
channel can be selected by the (2) Lead selection button.

12.2. Printing in ECG mode
In ECG mode, printing can be started by the (4) PRINT button. Then a heading will be
printed, including a pointed place for patients name, date, mode and printing parameters.
After this, printing of curves starts. The channel selected for rhythm will be printed with the
set parameters. On both edges of the paper, actual parameters will be printed (HR, SpO2 %,
NIBP).

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13. Use of the cofiguration menu

In configuration menu, all the main parameters of the defibrillator can be set, these will be
remembered by the device, and until any new changes, it will operate with these values.

13.1. Entering the configuration menu

We can enter the configuration menu when turning on the device. Turn on the device by the
(1) power on button. First a login figure will appear, then after about 6 seconds a voice signal
can be heard. After another few seconds, the text Self-test completed will appear, and the
(17) Action key will be enlightened. At this point the Action key has to be pressed, this way
configuration menu will appear, and the text Menu close will appear on the bottom of the
display, over the (11c) key.
We can exit from the menu by the S, or the Menu close keys. After exiting, the defibrillator
immediately enters the selected mode and it will get to an operation-ready state.

13.2. Handling of the configuration menu

The menu handling keys are the P, R, Sand OKQkeys, signed by (12) in section no. 4.2 ,
we will make a reference to them in the followings. If the defibrillator is in menu state, then
also the soft keys, signed by 11b and 11c are for menu controlling, at this time, they are
labelled as Menu Back and Menu Close. Menu Back is equal to the Skeys, the Menu Close
is for immediate exiting from the menu.
Inside the menu, we can move by the Pand Rkeys, we can stand on the desired menu point
by them. If beside the name of a menu point the > sign appears, it means that this menu
point has a submenu.
From menu elements, the actual one is indicated by dark background. This sign can be moved
upward and downward by the Pand Rkeys. Press OKQbutton, by moving the sign on the
desired menu point, this way the menu point is selected.
If a menu point with no submenu is selected, then by pressing OKQ, it will be possible to
change the parameters. At this point the color of parameter will turn to green, and it can be
changed by the P, Rkeys. After setting the adequate parameter, by pressing the OKQ
button, the parameter will be validated, its color will turn to white again. Then we can select
another menu line by the P, Rbuttons or by the Skeys, or by the (11c) Menu Back key, we
can step one level upwards in the menu system. If we are on the upper level of the menu, then
by these keys we are closing the menu, we are returning to the therapeutical or monitoring
mode of the defibrillator. If we are in a lower level, by the (11b) Menu Close key we can
immediately close the menu, skipping the intermediary levels.

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13.3. Elements of the configuration menu

When entering the configuration menu, the following figure appears on the screen:

13.3.1. Language selection
In this menu point the language of display and of speech can be changed together. When
entering the menu, the label of actual language can be seen. By pressing the OKQbutton, the
color of language label will turn to green and it can be changed by the P, Rkeys. If you
have selected the desired language, by pressing the OKQbutton, this language will be
validated, the menu will appear again, already in the selected language. The list of available
languages is continuously growing, so we rather not list them here. The label representing the
languages, always appears on the given language, so it can be certainly available for the
person selecting the language.

13.3.2. Use of defaults
Here it is possible to reset defaults. Meaning all the parameters of the device alarm limits,
sensitivity, channel selection, highlighting parameter fields, sharing of screen, etc.
By standing on this menu point by the selector sign, pressing the OKQbutton, the color of
the label No beside the menu point will turn to green. Then by the P, Rkeys we can
choose between Yes and No. If we have changed our mind and we prefer not to change the
default, then by selecting No, we should press OKQ, and the original presets will remain. If
we choose Yes, then by pressing OKQ, the defaults will be validated, the color of the label
Yes will change back to white, indicating that the order has been completed, then the label
will change to No, indicating that settings can be reset from different menus.

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13.3.3. Alarm settings
A submenu belongs to this menu point. We can enter the submenu by pressing the OKQ
button. The first item is the Default Alarm Setting. Select this, the factory default alarm
settings come into force. This applies to alarm limits and any other alarm parameters.
Hereafter we review the alarm settings belonging to alarm parameters.

13.3.3.1. Global alarm settings
Also a submenu belongs to this item. We can enter the submenu by pressing the OKQbutton.
The firs item is the Status. It may be ON or OFF. In ON state the alarm system is active, all
the alarm event evokes alarm, which is not disabled in its unique menu item. In OFF state
only the event makes alarm, which are not swichable off by general disable. (eg. Asystole or
ventricular fibrillation)
The next item is the alarm volume, here You can choose the volume of alarm sound. The
selectable levels are MUTE, LOW, MEDIUM, HIGH.

13.3.3.2. Asystole
Status may be ON or OFF, this enables or disables the alarm from this parameter.
Limit Value is the time is seconds from the last detected QRS, when asystole alarm happens.
This tine may be 2, 3 or 4 seconds.
Acknowledge Type may be MANUAL or AUTO. In MANUAL mode the alarm is active
after ceasing of alarm reason. The alarm will end only acknowledging by user. In AUTO
mode the alarm stops after ceasing of alarm reason.
Priority may be HIGH, MEDIUM, LOW or MESSAGE. The features of alarm marking
(sound and picture on screen) depends on this setting.
Suspend Time (minute). It may be 0, 1, 2, 3, 4 or 5 minutes. The operator can pause the
alarm sign for this time. In case the alarm reason does not end, after suspend time is over
alarm will be validated again.
Store item shows what will be stored into event diary in case of alarm.
Printing item shows what will be printed in case of alarm.
The last 2 items are not settable.

13.3.3.3. Heart rate alarm
The parameters settable here are the same as in previous chapter. There is no Limit parameter
here, but there are low and high limit of heart rate. These parameters are settable in BPM
(beat/minute). The low limit may be 30 100 BPM, the high limit may be 50 300 BPM.
The high limit is always higher than low limit.

13.3.3.4. SpO2 alarm
The parameters settable here are the same as in previous chapter. The low and high limits here
are in SpO2%. The low limit may be 50 100 %, the high limit may be 90 100 %. The high
limit is always higher than low limit.

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13.3.3.5. Pulse alarm
The parameters settable here are the same as in previous chapter. The pulse alarm is on pulse
number in pulse/minute measured by SpO2 sensor. The low limit may be 30 100 %, the
high limit may be 50 300 %. The high limit is always higher than low limit.

13.3.3.6. NIBP systole, diastole and mean value alarm
The parameters settable here are the same as in previous chapter. These three alarm settings
are the same. The alarm limits are settable in mmHg. The alarm limits are:
Systole: low limit 20 150 mmHg high limit 90 260 mmHg
Diastole: low limit 20 110 mmHg high limit 90 260 mmHg
Mean value: low limit 20 130 mmHg high limit 90 260 mmHg
The high limit is always higher than low limit.

13.3.4. Device setups
button. Here the following parameters can be set:

13.3.4.1. Voice menu
To this submenu point also belongs a submenu, where we can enter by pressing OKQ. Here
we can set the intensity of speech voice, alarm voice, keyboard voice and QRS voice. By the
P, Rkey, step on the line of volume, you would like to set, then select the parameter by the
OKQbutton. This way the color of actual value will turn to green, and it can be changed by
the P, Rkeys. The selected volume can be low, medium or mute. About the speech volume,
switching off is not possible, as the voice instructions are always needed. If we have set the
desired volume, we can validate it by pressing OKQ. This way the color of the label will
change back to the original color, and setting will be validated. Setting of volume happens the
same way in each lines of the voice menu. From voice menu we can go back to tool settings
menu, by the Sor the Menu Back keys, or we can exit from menu mode by the Menu Close
key.

13.3.4.2. Date and time
Here we can set the date (day month year) and time (hours minutes seconds). Method of
setting: we are selecting the parameter to be set by the P, Rkeys, then we are validating the
selection by pressing the OKQbutton. This way the color of parameter to be set will turn to
green, and it can be set by the P, Rbuttons. Set the desired value, then validate it by
pressing OKQ. Validation is indicated by the changed color.
The program ensures that only correct date can be set. From Date and time menu we can go
back to tool settings menu by the Sor the Menu Back buttons, or we can exit menu mode by
the Menu Close button.

13.3.4.3. Date and time format
Here we can choose between the 12- or 24-hour time displays. Step on the date and time
format menu line by the P, Rkeys, then validate the selection by the OKQbutton, this way
the color of actual format will turn to green. You can choose between the 12- or 24-hour
formats by the P, Rkeys. The selection can be validated by the OKQbutton, it is indicated
by the changing of the color, from this point, the format selected here is valid.
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From Date and time format menu we can go back to tool settings menu by the Sor the Menu
Back keys, or we can exit menu mode by the Menu Close button.

13.3.4.4. LCD brightness
In this menu point LCD brightness can be set. Entering the menu by the OKQbutton,
brightness value can be set between 0 and 10. 0 is the lowest brightness, it can only be used in
a very dark place. The maximum brightness can be obtained at the value of 10. In an
averagely enlightened place, at the brightness value of 5, clear display can be obtained. The
set brightness can be validated by the OKQbutton. From the LCD brightness menu, it is
possible to go back to tool settings menu by the Sor the Menu Back keys, or we can exit
menu mode by the Menu Close button.

13.3.4.5. User identification
Here a label can be written, for the identification of the user. When an event or a log file is
read from the defibrillator, this will identify the data package. How to set it: move the selector
sign by the P, Rkeys to the User ID line, then press the OKQbutton. This way the color
of actual ID will turn to green and it indicates that the first character can be changed.
Changing of characters can be made by the P, Rbuttons. The capital and small characters,
numbers, the sign / and the space can be selected. The role of space becomes important, if we
want to type shorter ID than the actual one, in this case the unnecessary characters can be
deleted by space. The space can be found at the end of the capital alphabet, after the letter Z.
After the selection of the desired character, we can step on the next character by the OKQ
key, and it can be set in the same way. If we get to the end of the text and we press another
OKQbutton there, the new ID will be validated. If without validation, we are exiting by the
Menu Back key, then the previous ID will remain valid. Possibility for fast clear of user
identifier: write space on the first two characters of user identifier then press OKQ. The total
user identifier will be cleared.

13.3.4.6. Mains frequency
For filtering out mains noises, the device is equipped with a notch filter, which is tuned to
mains frequency. In this menu point it is possible to select mains frequency. The device can
be operated by 50 or 60 Hz mains frequency, so 50 or 60 Hz notch filter can be selected here.
How to set it: stand the selector sign on the line, mains frequency, by the P, Rkeys, and
press the OKQbutton. This way the label of the actual mains frequency will turn to green,
indicating that this value can be modified. By the P, Rkeys, 50 Hz or 60 Hz can be selected.
Selection can be validated by the OKQbutton. By this label color will change back to the
original color.

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13.3.5. Energy settings
Initial energy values can be selected here. We can enter this menu point by pressing the OKQ
button. Here the following parameters can be set:

13.3.5.1. Viewing of delivered energy
In case of enabling, the viewing of delivered energy, after delivery of shock, the value of
actually delivered shock will appear on the display. If this option is disabled, then only the
value of selected energy will be viewed on the display. Step on this menu point by the selector
sign, by using the P, Rkeys, and select menu point by the OKQbutton. This way color of
the actual parameter will turn to green, indicating the possibility of changing. At this point the
Enabling and Disabling settings can be selected by the P, Rkeys. Validation is made by
pressing the OKQbutton, this way the parameter color will change back to the original color,
and setting will be validated.

13.3.5.2. Manual energy external
Here we can select the initial value of the energy, when turning on, in MANUAL
defibrillation mode, in case of external shock delivery. (Application of paddle or pads
electrodes). Stand on this menu point by using the P, Rkeys, and select menu point by
pressing the OKQbutton. This way color of the actual parameter will turn to green,
indicating the possibility of changing. At this point, energy can be selected by the P, Rkeys
between 2 and 360 J. Validation is made by pressing the OKQbutton, this way the parameter
color will change back to the original color, and setting will be validated.

13.3.5.3. Manual energy- internal
Here we can select the initial value of the energy, when turning on, in MANUAL
defibrillation mode, in case of internal defibrillation. (Application of internal defibrillator
electrode). Stand on this menu point by using the P, Rkeys and select menu point by
indicating the possibility of changing. Then energy can be selected by the P, Rkeys,
between 1 and 50 J. Validation is made by pressing the OKQbutton, this way the parameter
color will change back to the original color, and setting will be validated.

13.3.5.4. Semi-automatic energy first shock
In case of semi-automatic defibrillation, the energy level of first, second and third shocks can
be set separately. In case of failure of the first shock, the shock should be repeated at the same
or at a little bit higher energy level. That is why it is necessary to set separately the energy of
the three shocks. In this menu point, the energy of first shock can be set. Stand on this menu
point by using the P, Rkeys and select menu point by pressing the OKQbutton. This way
color of the actual parameter will turn to green, indicating the possibility of changing. Then
energy can be selected by the P, Rkeys, between 2 and 270 J. Validation is made by
pressing the OKQbutton, this way the parameter color will change back to the original color,
and setting will be validated.

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13.3.5.5. Semi-automatic energy second shock
Its setting process is completely the same with the one of the first shock setting. Usual setting
is the energy of first shock or one step higher. In case first shock has failed (ventricular
fibrillation is not over or it returned very fast), then after 2 minutes of CPR the second shock
delivery will be made at this energy level.
(ERC 2010 BLS-AED guideline)

13.3.5.6. Semi-automatic energy third shock
Its setting process is completely the same with the one of the first shock setting. Usual setting
is the energy of second shock or one step higher than that. In case second shock has failed
(ventricular fibrillation is not over or it returned very fast), after another 2 minutes of CPR,
third shock delivery will be made at this energy level.
(ERC 2010 BLS-AED recommendation)

13.3.6. Mode settings
13.3.6.1. Defibrillation mode when turning on
When turning on, the defibrillator can start in manual or semi-automatic mode. We can select
in this menu point, which one to be validated. Stand on this menu point by using the P, R
keys and select menu point by pressing the OKQbutton. This way color of the actual
parameter will turn to green, indicating the possibility of changing. Then by the P, Rkeys
MANUAL and SEMI AUTO modes can be changed. Validation is made by pressing the
OKQbutton, this way the parameter color will change back to the original color, and setting
will be validated. When turning on, the defibrillator will operate in the mode we selected here.
If we want to use the defibrillator in another mode, then after turning on, we can select
another mode by pushing a button.

13.3.6.2. Pacing mode
The pacer in the defibrillator can operate in two modes, in fixed or in demand modes.
(See section no. 11.3). In this menu point we can select, that after turning on, when selecting
pacing mode, in which mode the pacing should be. Stand on this menu point by using the P,
Rkeys and select menu point by pressing the OKQbutton. This way color of the actual
parameter will turn to green, indicating the possibility of changing. Then by the P, Rkeys,
Fixed and Demand modes can be selected. Validation is made by pressing the OKQbutton,
this way the parameter color will change back to the original color, and setting will be
validated. If we switch to pacing mode, the mode selected here will be set, and if we would
like to change it, then by the key labelled (11a) Pacing mode, we can change the mode easily
by a button touch.

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13.3.6.3. Pace current
Here the value of pace current can be set, when turning on. The value when turning on is
usually 0 mA, but as the general limit value is 40 mA or higher, the defibrillator allows to set
a higher initial current, this way pacing can be started faster, current does not or only slightly
have to be set. Stand on this menu point by using the P, Rkeys and select menu point by
indicating the possibility of changing. Then the value of current can be changed in the range
between 0 200 mA, by the P, Rkeys. Validation is made by pressing the OKQbutton,
validated. If we switch to pacing mode, this value of current will be selected, but it can be
very easily changed according to the description of section no. 11.3.

13.3.6.4. Pace rate
Here we can set the value of pace rate, when turning on. Stand on this menu point by using
the P, Rkeys and select menu point by pressing the OKQbutton. This way color of the
actual parameter will turn to green, indicating the possibility of changing. Then the value of
current can be changed in the range of 30 200 pulse/minute, by the P, Rkeys. Validation
is made by pressing the OKQbutton, this way the parameter color will change back to the
original color, and setting will be validated. If we switch to pacing mode, this frequency will
be selected, but it can be very easily changed according to the description of section no 11.3.

13.3.6.5. Wake-up selftest (automatic selftest)
Wake-up selftest is an automatic selftest, which, in case it is enabled, is running at a time
when the defibrillator is very likely to be out of use. At the time defined by the user (see
section no. 13.3.6.6) the device automatically switches on and it runs some certain tests. If the
outcome of the test is positive, the device will switch off, and after next turning on, it will
work without error message in order. If the selftest detects an error, the device will give an
error signal by red blinking LED, and when next turning on, it will display a message about
the type of error that has been detected by the test. The automatic selftest only makes tests of
very low energy demand, so that it will not finish the battery. It does not check, for instance
the printing, the backlight and the high-voltage charging circuit, as these are tasks of high-
energy demand. It is important to mention, that the selftest also checks the battery, and under
50 % energy level it indicates, that battery must be charged. The enabling or disabling of
wake-up selftest is made in this menu point. Stand on this menu point by using the P, R
keys and select menu point by pressing the OKQbutton. This way color of the actual
parameter will turn to green, indicating the possibility of changing. Then enabling or
disabling can be selected by the P, Rkeys. Validation is made by pressing the OKQbutton,
validated.

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13.3.6.6. Wake-up start time (time of automatic selftest)
In this menu point the starting time of automatic selftest, described in section no. 13.3.6.5 can
be set. It is advisable to choose a time, when the device is very likely to be switched off,
generally some time during the night. If the defibrillator is turned on, the automatic selftest
will not start, even if it has been enabled. It does not cause any confusion, as in turned on state
the defibrillator is checking itself. Stand on this menu point by using the P, Rkeys and
select menu point by pressing the OKQbutton. This way color of the actual parameter will
turn to green, indicating the possibility of changing. Then the time of selftest, which can only
be a complete hour, can be selected by the P, Rkeys. After setting the time validation is
made by pressing the OKQbutton, this way the parameter color will change back to the
original color, and setting will be validated. If the automatic selftest is enabled, then selftest
will be made at the time set here.

13.3.6.7. Demo mode
In demo mode the device is providing ECG pulsewave signal, and it measures heart rate and
SPO2 %. These signals can be viewed in each mode of the defibrillator. Demo mode can be
enabled or disabled in this menu point. Stand on this menu point by using the P, Rkeys and
select menu point by pressing the OKQbutton. This way color of the actual parameter will
turn to green, indicating the possibility of changing. Then we can choose to switch the demo
mode on or off, by the P, Rkeys. Validation is made by pressing the OKQbutton, this way
the parameter color will change back to the original color, and setting will be validated. After
exiting from the menu, curves and the parameters measured on them can be viewed in any
modes of the defibrillator. The DEMO label appearing on the display is warning us about the
fact, that the viewed signals are not received from sensors but they are artificial ones. If the
device is turned off, when next turning on, demo mode will be switched off.

13.3.7. Signal setup menu
A submenu belongs to this menu point. We can enter submenu by pressing the OKQbutton,
where alarm limits, curve speeds and other parameters can be set. From the submenu we can
go back to the previous level by the Sor the (11c) Menu Back keys. The following
parameters can be set in this menu point:

13.3.7.1. ECG menu
In the ECG menu, the set channel, the amplification, and the color-coding of ECG channels,
when turning on the device, can be set. The selected ECG lead, when turning on, can be I, II,
III, aVR, aVL, aVF, V1(Vx),V2, V3, V4, V5, V6. It can be set in the default ECG lead menu
line. Take the selector sign by the P, Rkeys on the Default ECG lead line, and select menu
point by the OKQbutton. This way the color of actual parameter will turn to green,
indicating that the parameter can be set. The desired lead can be selected by the P, Rkeys,
then selection can be confirmed by pressing the OKQbutton. The ECG amplification valid,
when turning on the device has to be set the same way. Here 0.25x, 0.5x, 1x, 2x sensitivity
can be set in cm/mV, then selection should be validated by pressing the OKQbutton. Auto
ECG gain means the device automaticly select the optimal sensitivity of ECG. This service
switchable on and off in this menu item.
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In the next point the viewing color of the ECG can be set. Colored and non-colored scheme
can be chosen. In case of colored scheme, ECG channels will be viewed by the color-coding
described in the standard, while in case of monochrome scheme, the ECG channels will be
viewed by the same colors. Validation of selection happens by the OKQbutton in this case as
well.

13.3.7.2. Speed menu
In speed menu, the running speed of curves viewed on the display can be set. In the menu, the
list of curves to be viewed can be seen. By the P, Rkey, stand on the label of the curve, of
which speed you would like to set. Select the line by the OKQbutton, then the color of actual
parameter will turn to green, indicating the possibility of changing. The desired running speed
can be selected by the P, Rkeys, then validate the selection by pressing the OKQbutton.
The selectable ECG speeds are: 5, 10, 25, 50 mm/s, the selectable SpO2 curve speeds are 5,
10, 25 mm/s.

13.3.8. Periphery setup menu
button, where settings related to printing can be made, and here the sensitivity, referring to the
external ECG amplifyer can be set as well. From the submenu we can go back to the previous
level by the Sor the (11c) Menu Back keys. The following parameters can be set in this
menu point:
13.3.8.1. Automatic printing
If automatic printing is enabled, then in case any event happens, printing will automatically
start, the actual parameter values and the event generating the printing will be written down,
and ECG curve will be printed, in a way that the 2 seconds period before and 6 seconds after
the event can also be seen on the paper. The event generating the printing can be delivery of
shock, or any kind of alarm (HR, SpO2, VF, etc.). Take the selector sign on the Automatic
printing line by the P, Rkeys, and select menu point by the OKQbutton. Then the color of
actual parameter will turn to green, indicating that it can be set. Enabling or disabling can be
changed by the P, Rbuttons. Selection can be confirmed by the OKQbutton.

13.3.8.2. Printing time
Printing can be started by the (4) PRINT button. Then the device prints a heading including
the actual parameters, then it will start printing the ECG curve. Generally it is enough to print
a 15 seconds period, but in some certain cases, printing a longer period is useful. In this menu
point, we can set how many seconds of ECG should be included in the printout. By the (4)
PRINT button, printing can be stopped at any time, but if it is not stopped, then after the time
set here, it will automatically stop. It can be useful from the aspect of saving paper. Take the
selector sign on the line Printing time by theP, Rkeys, and select menu point by the OKQ
button. Then the color of actual parameter will turn to green, indicating that it can be set.
Periods can be changed by the P, Rkeys. Selection can be 16 s, 20 s, 32 s or 2 minutes
printing. Confirm selection by the OKQbutton. If you select continuous printing, and you do
not stop the printing already started, then it will be continued until the paper finishes.

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13.3.8.3. Printing speed
Printing speed can be 25 or 50 mm/s, it can be defined in this menu point. Take the selector
sign on the line Printing speed by the P, Rkeys, and select menu point by pressing the
OKQbutton. Then the color of actual parameter will turn to green, indicating that it can be
set. Speed can be selected by the P, Rkeys. Confirm selection by the OKQbutton.

13.3.8.4. Printing event report
The event report printing is enabled or disabled in this menu point. If it is enabled, at
switching off the defibrillator prints out the event report from the last event to backwards. The
user can stop the printing by pushing the (11b) soft key ABORT, then the printing stops and
the defi is switching off.

13.3.8.5. Multichannel printing
When it is disabled, the printer works in single channel mode. If enabled, 3 ECG channel will
be printed to paper.

13.3.8.6. External ECG amplifier
The defibrillator cannot view and evaluate only the ECG signal received from the ECG
electrode and amplified, but it is also able to receive and develop the signals recorded and
amplified by other devices. In this case, the signal of the external device can be connected to
the (20) ECG connector of the defibrillator by a cable, obtainable from the manufacturer. As
the external device is providing already amplified signals, but in the defibrillator the ECG has
to be viewed and evaluated with correct amplitude, therefore the defibrillator has to know the
sensitivity of the external ECG amplifyer. This value can be set in this menu point. Sensitivity
of the external ECG amplifyer can be read from the external device, or it can be found in its
users manual. This value has to be set in the External ECG amplifier menu point. Take the
selector sign on the line External ECG amplifier by the P, Rkeys, and select menu point by
pressing the OKQbutton. Then the color of actual parameter will turn to green, indicating
that it can be set. Select amplification by the P, Rkeys, from the 1V/mV or 0,1V/mV
options. Confirm selection by the OKQbutton.

13.3.9. Data saving
Here is the possibility to save the stored data and service log files to a USB pendrive. Connect
the pendrive to the (27) USB-A connector on the right side of defi, then select the Data
Saving menu point. The defi realises the connected pendrive and save the files to it, then signs
the end of saving. Attention! Wait the end of storing action. The defibrillator will give a
Storage State: Done message at the end of storing. Then You can leave the submenu by
Skey and remove the USB pendrive.
If the event report is long, the storing may take a few minutes.
The saved data may study and evaluate by Innobase CA360B software on PC.

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13.3.10. Delete saved data
The data stored by Data Saving action may delete by this command. It is practical to perform
a Delete saved data action, because without deleting these data will storedat the next storing
action too.
Attention! The Delete Saved Data command immediately goes to action by pressing OKQ
key. Here also wait the Deleting State: Done message before leaving the submenu.

13.3.11. Service menu
The service menu was made for technical service personnel, user of the defibrillator should
not use this service. Incorrect use of service menu might threaten the safe operation of the
device, therefore unintended entry in the system is prevented by the use of password.
Password is known by the service person, this way he can enter the service menu, where he
can get information about the software and hardware versions and serial numbers, he can get
access and download error and service lists, he can check and calibrate the defibrillator units.
Detailed description of the use of service menu can be found in the service manual.
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14. Technical data of the defibrillator
14.1. Applied standard

EN60601-1: 1990+A1: 1993+A11: 1993+A12: 1993+A2: 1995+A13: 1996
General safety and basic operation requirements
EN60601-1-2:2007 Electromagnetic compatibility
EN60601-2-4:2003 Safety requirements of defibrillators
EN60601-2-25: 1995+A1:1999 Safety requirements of single and multi-channel
electrocardiographs, including basic requirements of
operation
EN60068-2-27: 2009 Basic environmental testing procedures Bump tests
EN60529: 1991+ A1:2000 Degrees of protection provided by enclosures (IP code)
The device complies with the ERC 2010 guidelines.

14.2. General data

Size 360 x 280 x 250 mm (width x height x depth)
Weight 6.5 kg with pads electrodes, battery, pacer and printer;
7 kg with defibrillator paddles
Power
100-240 VAC, 50/60 Hz
Capacity
@100VAC: max. 1,3 A; max. 130 VA
@240VAC: max. 0,5 A; max. 120 VA
Temperature Operating: 0 - 45C
Storage: -20 - 60C (<168h)
Humidity Operating: 30 95% relative humidity, non-condensing
Storage: 30 95% relative humidity, non-condensing
Operation and storage
pressure
550 1060hPa
Classification Class I / Internally powered equipment
Environmental
stability
Water protection: Drip-proof equipment (IP32)
Mode of operation

Continuous monitoring and pacer stimulation,
Defibrillation at 270 J energy for 2 minutes every 12 seconds,
for long period an average of 2 shocks/minute.
70/89 Cardio-Aid

14.3. Display

Type Color TFT display with LED backlight
Size 150 x 92mm color TFT display
Resolution 800x480 pixel
Semi-automatic mode: 3 ECG curve
Manual mode: three selectable curves with individually
settable curve speed
Pacing mode: three selectable curves with individually
settable curve speed
Number of viewable curves
ECG mode:
with 3-lead cable 3 lead (I, II, III) can be selected
with 5-lead cable cable 7 leads
with 10-lead cable 12 leads
simultaneous viewing
+ rhythm curve switchable on and off
ECG window At 4.4 s 25mm/s curve running speed
Curve speed 5, 10, 25, 50 mm/s
Sensitivity 0,25 0,5 1 2 4 cm/mV or Auto
Frequency transmission to
the display
2 Hz 25 Hz
14.4. LED-displays on the front board

Battery capacity LED
Indicates the battery capacity. Connected to the mains, the
device indicates its battery capacity by flashes:
in case of empty battery one flash in each 4 seconds,
at 50% capacity two flashes in every 4 seconds,
at 90% capacity three flashes in every 4 seconds.
In case of being fully charged, the LED is enlightened
continuously.
If the device is not connected to the mains, the LED is not
enlightened.
State indicator LED
Dual-colored indicator, green and red. The LED flashing in
green indicates, that the device can work correctly (one flash in
each 4 seconds). If the selftest (turning on test or wake-up test)
detects error, the LED will be flashing twice in red color, every 4
seconds.
Cardio-Aid
360-B Users manual R-5656-02-V02 71/89

14.5. Defibrillator

Defibrillator impulse STAR
(BTE) biphasic waveform, period of first

phase depends on patients chest (measured between
the two paddles) impedance, 3 11 ms, period of
second phase is fixed 3,2ms. The amplitude of the
signal depends on set energy and on patient
impedance.

External defibrillator
paddles or pads
electrodes
2-5-7-10-20-30-40-50-
60-80-100-150-200-270-
360J
Delivered energy at 50 ohm loading
Internal paddles 1-2-3-4-5-6-7-8-9-10-
15-20-30-40-50J
Energy accuracy 1J or 5%, which is higher, in case of shocks
delivered at any energy level, for 50 ohm loading.
Energy availabilty Automatic disabling of shocking 30 seconds after
being charged.
Impedance range during external
defibrillation
In case of impedance higher than 200 ohm and lower
than 20 ohm the defibrillator disables shocking.
Impedance range during internal
defibrillation
In case of impedance higher than 50 ohm and lower
than 15 ohm the defibrillator disables shocking.
Synchronous shock delaying Typically 40 ms (max. 60 ms) from top of QRS to the
top of discharge curve.
Synchronous marker S signal, by vertical line

Fully charged
battery
< 7 s
(typically)
From battery
(25C)

After 15
defibrillations
< 10 s
(typically)
From mains
(in voltage range
of 100V~ -
240V~)
With charged
battery
< 4 s
(typically)
90V~ mains
voltage
In case of
completely empty
battery
< 15s
(typically)
Charging time to 270 J in manual
mode
Time passed from
power on to charge-
ready state for
maximum energy
< 20s (typically)
72/89 Cardio-Aid

Fully charged
battery
< 17 s
(typically)
From battery
(25C)
After 15
defibrillations
< 20 s
(typically)
From mains
(in voltage range
of 100V~ -
240V~)
With charged
battery
< 15 s
(typically)
90V~ mains
voltage
In case of
completely empty
battery
< 25 s
(typically)
Maximum time passed from enabling
of rhythm recognition (including
analysis time) till shock-ready state, at
maximum energy level, in semi-
automatic mode.
Time passed from
power on to charge-
ready state for
maximum energy
< 40 s (typically)
VF / VT recognition Complies or better than the AAMI DF-39
requirement.
Recognizes broad QRS VT > at 180bpm
14.6. Battery

Type NiMH battery 3000mAh

Nominal voltage 10,8 V (9 cells)

Operation time at 20C Monitoring: 4,5 hours, or
Defibrillation:
>200 shocks at 200 J, or
>100 shocks at 270J, or
> 60 shocks at 360 J, or
Pacing at 60bpm and at 160mA :> 3 hours
Charging time in case of
completely empty battery
2,5 hours
Battery protection against
overwarming
The battery housing is equipped with a thermal fuse
of 75C, 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 Users manual R-5656-02-V02 73/89

14.7. ECG via pads or defibrillator paddles electrodes

Mode Differential
Input signal range 5 mV
DC tolerance 400 mV
Frequency response(-3dB) 2-60 Hz
Gain x0.25, x0.5, x1, x2, x4, auto (default = x1)
Input-related noise Max. 30 uVpp
ECG input impedance Min. 20 Mohm
CMRR Min. 100 dB
Recovery time after overdriveing < 5 s
Pacemaker tolerance Max. 700 mV / 2 ms
Pacemaker detection Min. 2 mV / 0,25 ms
Max. 700 mV / 2 ms
Defibrillator tolerance Max. 400 J
Patient impedance measurement range 10-200 ohm
Signal delay (in correlation with
viewing)
Max 20 ms
Sampling frequency 400 Hz
AD resolution 5 uV / bit
QRS-detection limit level 200 dV
Safety classification External defibrillator paddle: class CF
Defibrillator pads electrodes: class CF
Internal defibrillator paddles: class CF
14.8. ECG via patient cable and ECG electrodes

3-lead cable: I. II. III.
5-lead cable: I. II. III. aVR aVL aVF Vx Viewable leads
10-lead cable: I. II. III. aVR aVL aVF V1 V6
Input signal range 10 mV
DC tolerance 320 mV
Frequency response (-3dB) 0,05 150 Hz
Baseline filter (-3dB) 0,5 Hz
Muscle filter (-3dB) settable: 25, 30, 35, 40 Hz
74/89 Cardio-Aid

Mains filter 50 or 60 Hz Attenuation: > 20 dB
Gain x0.25, x0.5, x1, x2, x4, auto (default = x1)
Baseline recovery time after
shock
< 5 s at 270 J
Input-related noise Max. 20 uVpp
ECG input impedance Min. 20 Mohm
CMRR (by mains filter) Min. 120 dB
Recovery time after overload < 5s
Pacemaker tolerance Max. 700 mV / 2 ms
Pacemaker detection Min. 2 mV / 0,25 ms
Max. 700 mV / 2 ms
Defibrillator tolerance Max. 400 J
With baseline filter: 2 s Signal delay
(in correlation with viewing)
Without baseline filter: 10 ms
Blocking Automatic
Sampling frequency 8 kHz
AD resolution 0,25 uV / bit, 24 bit
QRS-detection limit level 200dV
Checking of ECG electrode
removal
Per electrode
Checking of ECG channel noise Per channel
Classification Defibrillation-protected, class CF
14.9. ECG from external monitor

Dinamic range 10V (with 1V/mV signal)
With baseline filter: 2 s Signal delay
(in correlation with viewing)
Without baseline filter: 10 ms
Sensitivity Settable from the menu: 100 mV/mV or
1000 mV/mV 5%
Connecting Via (20) ECG plug, with cable to be ordered from
manufacturer
Cardio-Aid
360-B Users manual R-5656-02-V02 75/89

14.10. Heart rate measurement from ECG signal

Measurement range 15 300 bpm
Accuracy of measurement 2 bpm vagy 1 %
Resolution of displaying 1 bpm
Alarms Lower and upper limits can be set
14.11. Pacer

Mode Demand (VVI) or Fixed (VOO)
Pulse type Rectangular, constant current
Pulse duration 40 ms 5%
Pulse amplitude 20 200 mA 5%.
Pulse amplitude step 1 mA
Pace rhythm 30 200 bpm 5%.
Pace rhythm step 1 bpm
Output voltage Max. 250V
14.12. SpO2 measurement

Sensor Fingerclip
SpO2 measurement range 1 100%
Accuracy of SpO2 measurement Over 70% 2%
Resolution of SpO2 displaying 1 %
Pulse number measurement
range
20 300 bpm 3 bpm
Resolution of pulse displaying 1 bpm
Alarms Lower and upper limits of SpO2% and rhythm
Defibrillator-protection 5 kV
Light emission of the finger clip: 660 nm (red)
900 nm (infrared)
Typically less, than 15 mW
76/89 Cardio-Aid

Data Update Period, Effect of Data Averaging, and Other Signal Processing:
OxiMax Algorithm The advanced signal processing of the OxiMax
algorithm automatically extends the amount of data
required for measuring SpO2 and pulse rate
depending on the measurement conditions. During
normal measurement conditions in the Normal Mode,
the SpO2 averaging time is six (6) to seven (7)
seconds or approximately three (3) seconds in Fast
Mode. Equivalently, the typical pulse rate averaging
time is approximately five seconds, independent of
response mode.
The OxiMax algorithm automatically extends the
dynamic averaging time required beyond seven (7)
seconds during degraded or difficult measurement
conditions caused by low perfusion, signal artifact,
ambient light, electrocautery, other interference, or a
combination of these factors, which results in an
increase in the dynamic averaging beyond the
minimum as set by the response mode.
If the resulting dynamic averaging time exceeds 20
seconds for SpO2, the algorithm sets the pulse search
bit while continuing to update SpO2 and Pulse Rate
values every second.
As such measurement conditions extend, the amount
of data required may continue to increase. If the
dynamic averaging time reaches 40 seconds, and/or
50 seconds for pulse rate, a low priority alarm state
results: the algorithm sets the Pulse Timeout bit and
the module reports a zero saturation indicating a loss-
of-pulse condition which should result in an audible
alarm.
Response Mode For systems featuring the Fast Mode (NELL-1,
NELL-2), this setting dictates the response time (two
(2) to four (4) seconds in Fast Mode and six (6) to
seven (7) seconds in Normal Mode) applied by the
OxiMax algorithm in its calculation of SpO2.
The OxiMax algorithms calculation of pulse rate is
unaffected by the response mode setting. The data
storage interval in the oximeters trend memory is
decreased automatically to two (2) seconds when the
oximeter is set to operate in the Fast Mode (the
storage interval is four (4) seconds in the Normal
Mode).
Cardio-Aid
360-B Users manual R-5656-02-V02 77/89

Test Considerations and Oximeter Accuracy
Functional Testers and Patient
Simulators
Some models of commercially available bench top
functional testers and patient simulators can be used
to verify the proper functionality of Nellcor pulse
oximeters, sensors, and cables. Reference the
individual testing device's operator's manual for the
procedures specific to the model of tester used.
While such devices may be useful for verifying that
the pulse oximeter sensor, cabling, and oximeter are
functional, they are incapable of providing the data
required to properly evaluate the accuracy of a
system's SpO2 measurements.
Fully evaluating the accuracy of the SpO2
measurements requires, at a minimum,
accommodating the wavelength characteristics of the
sensor and reproducing the complex optical
interaction of the sensor and the patients tissue.
These capabilities are beyond the scope of known
bench top testers.
SpO2 measurement accuracy can only be evaluated in
vivo by comparing pulse oximeter readings with
values traceable to SaO2 measurements obtained
from simultaneously sampled arterial blood using a
laboratory CO-oximeter.
Many functional testers and patient simulators have
been designed to interface with the pulse oximeter's
expected calibration curves and may be suitable for
use with Nellcor oximeters and/or sensors. Not all
such devices, however, are adapted for use with the
Nellcor OxiMax digital calibration system. While this
will not affect use of the simulator for verifying
system functionality, displayed SpO2 measurement
values may differ from the setting of the test device.
For a properly functioning oximeter, this difference
will be reproducible over time and from oximeter to
oximeter within the performance specifications of the
test device.
Accuracy with Low Perfusion Reading accuracy in the presence of low perfusion
(detected IR pulse modulation amplitude between
0.03% and 1.5%) was validated using signals
supplied by a patient simulator. SpO2 and pulse rate
values were varied across the monitoring range over a
range of weak signal conditions and compared to the
known true saturation and pulse rate of the input
signals.
78/89 Cardio-Aid

14.13. Non-invasive bloodpressure measurement (NIBP)

Measurement method Oscillometric with scalar deflation
Measurement range Adult: diastole 20200 mmHg
systole 40260 mmHg
Neonatal: diastole 15100 mmHg
systole 40130 mmHg
Accuracy of pressure transducer 3 mmHg
Modes Manual, Continuous and Periodical (2 - 480 minutes)
Displayed values Diastole, systole, arterial pressure, time of last
measurement.
Alarms For lower and upper limits (between 15260 mmHg)
for cuff error or measurement error
Defibrillation-protection 5 kV
14.14. Printing

Printing mode Manual or automatic
Number of simultaneously
printable curves
3
Printing time Selectable: 15, 20, 30 or 120 s
Speed 25 mm/s
Paper Thermal, non-rastered 58mm x 30m roll
Printer head resolution In the direction of amplitude: 8 dots/mm
On time axis: 8 dots/mm
Preprinting of curves 8s
Cardio-Aid
360-B Users manual R-5656-02-V02 79/89

14.15. Event storage

Events generating storage Delivery of shock, related to alarm of physiological
parameters (limit crossing, sensor errors),
manual event indication by the (3) event button
Number of storable events 200
Data, parameters stored in
events
Device state, measured parameters
HR, SpO2%, NIBP, cause of event, shock energy, state
of ECG filters
Curves stored in the event Curves monitored during event, ECG, pulsewave,
SpO2%
Viewing of stored events In case of printing enabled event viewer, started from
user menu, events will be printed, starting from the last
event in chronological order backwards.
Events can be saved via USB connector on pendrive,
then they can be viewed on PC.
14.16. Connection possibilities for data transfer

LAN connection For technical service and program upgrade
USB host connection For technical service and program upgrade
USB device connection For later use
80/89 Cardio-Aid

14.17. Parameters of defibrillation impulse

U [V]
T [ms]
U1
U2
-U2
t1 t2
t3
Phase 1
Phase 2
-U3

U1 Voltage at the beginning of first phase
U2 Voltage at the end of first phase
-U2 Voltage at the beginning of second phase
-U3 Voltage at the end of second phase
t1 Duration of first phase
t2 Break between the first and the second phases
t3 Duration of second phase

parameters of STAR biphasic waveform

Cardio-Aid
360-B Users manual R-5656-02-V02 81/89

82/89 Cardio-Aid

Delivered energy by the defibrillator as a function of patients chest impedance at the range
between 2 360 J
Cardio-Aid
360-B Users manual R-5656-02-V02 83/89

84/89 Cardio-Aid

15. Accessories, order information

Part number Description
K25528-4 Internal defibrillator paddles set, adult. Straight, 65mm in diameter.
2 spoons, 2 handles, 2 cables, 1 internal defibrillator paddles
connector.
K25529-2 Internal defibrillator paddles set, pediatric. Straight, 40mm in diameter.
connector.
F25531-8 Internal defibrillator paddles set, neonatal size. Straight, 25.4mm in
diameter.
connector.
FF32773-B Internal defibrillator paddle 65mm Adult
P007152 Internal defibrillator paddle 40 mm Pediatric
FF33603-A Internal defibrillator paddle 25,5 mm Neonatal
F25527-6 Internal defibrillator paddle connector.
F25530-0 Cable for internal defibrillator paddles, 2 pcs.
FF20437-9 External defibrillator paddles set, complete.
K20438-8 Cable for defibrillator pads electrode
KEG260 Electrode gel, 260g
KP58S-5 Recording paper 58mm x 20 m non-rastered, 5 rolls.
K49576-4 Defibrillator / pacer controller, R2 connector.
K7955 Adult defibrillator-electrode R2//F7955 FIAB 1 pair
K7955P Pediatric defibrillator pads-electrode R2//F7955P FIAB 1 pair
K7955-10 Adult defibrillator pads-electrode R2/F7955 FIAB 1 box = 10 pcs.
K7955P-10 Pediatric defibrillator pads-electrode R2/F7955P FIAB 1 box = 10 pcs.
R-5651-1 ECG patient cable with 3 leads and clips, def. protected
R-5650-1 ECG patient cable with 5 leads and clips, def. protected
R-5649-1 ECG patient cable with 10 leads and clips and with V-lead selector.
KFS50 FS-50 disposable ECG electrode (30 pcs/pack) SKINTACT
R-xxxx-x Cable for external ECG-source connection. End of the cable is opened
towards the external device
KDEFSPFU Nellcor adult pulseoxymeter sensor (DS-100A)
KDEFSPFUH Nellcor pulseoxymeter cable (DOC-10)
R-4198-1 NIBP Cuff normal (23-33 cm)
Cardio-Aid
360-B Users manual R-5656-02-V02 85/89

Part number Description
R-4198-2 NIBP Cuff extra sized (31-40 cm )
R-4198-3 NIBP Cuff pediatric (17-26 cm)
R-4198-4 NIBP Cuff infant (13-19 cm)
R-4198-5 NIBP Cuff neonatal (7-13 cm)
KITMANT NIBP Cuff extension tube
KITMANCST3 Extension tube for neonatal NIBP cuff
R-xxxx-x Complete battery pack for CA360-B defibrillator
R-xxxx-x Service manual in paper copy or in PDF format

86/89 Cardio-Aid

16. Elimination of useless electronic devices as waste

(Applyable in the selective waste collection system of the European Union and other
European countries.)
This symbol on the product or on its packaging indicates
that this product should not be treated as household
waste. Please hand it over at the collection point for the
collection of electrical and electronic waste.

17. Guidelines and manufacturer statements
electromagnetic compatibility

Guideline and manufacturer statement electromagnetic interference emission
The CA360-B defibrillator was made for the use in the electromagnetic environment
defined below. The buyer or user of CA360-B has to make sure that it should work in
such environment.
Interference emission
test
Conformance Electromagnetic environment - guideline
RF emissions
CISPR 11
Group 1 The CA360-B defibrillator only uses RF energy for its
internal operations. Therefore RF interference emisson
is very low, and not likely to interfere with the
electronic devices in its vicinity.
RF emissions
CISPR 11
Class B
Harmonic current
emissions
IEC 61000-3-2
Class B
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
Conforms
A CA360-B defibrillator can be used in households
and in establishments directly connected to the public
low-voltage power supply network that supplies
domestic buildings.
Cardio-Aid
360-B Users manual R-5656-02-V02 87/89

Guideline and manufacturer statement electromagnetic interference tolerance
such environment.
Interference
tolerance test
Test level Conformance level Electromagnetic
environment- guideline
Electrostatic
discharge (ESD)
IEC 61000-4-2
6 kV contact
8 kV air
discharge
6 kV contact
8 kV air
discharge
Floor should be wood, concrete or
ceramic title. If floor is covered
with synthetic material, the relative
humidity should be at least 30 %.
Fast electric
transients/ burst
IEC 61000-4-4
2 kV on power
supply lines
1 kV on input and
output lines
2 kV on power
supply lines
1 kV on input and
output lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
1 kV differential
mode
2 kV common mode
1 kV differential
mode
2 kV common mode
environment.
Voltage dips,
short
interruptions
and voltage
variations on power
supply input lines
acc.
IEC 61000-4-11

< 5% U
T
(>95% dip in
U
T
) for 0,5 cycles,
40% U
T
(60% dip in
U
T
) for 0,5 cycles,
70% U
T
(30% dip in
U
T
) for 25 cycles,
< 5% U
T
(>95% dip in
U
T
) for 5 s
< 5% U
T
(>95% dip in
U
T
) for 0,5 cycles,
40% U
T
(60% dip in
U
T
) for 0,5 cycles,
70% U
T
(30% dip in
U
T
) for 25 cycles,
< 5% U
T
(>95% dip in
U
T
) for 5 s
environment.
Mains frequency
(50/60 Hz) magnetic
fields
IEC 61000-4-8
10 A/m 10 A/m Mains frequency magnetic fields
should be at the same level with
the characteristics of a typical
commercial or hospital
environment.
Note: U
T
is the AC mains voltage prior to application of the test level.
88/89 Cardio-Aid

Guideline and manufacturer statement electromagnetic interference tolerance
such environment.
Interference
tolerance test
Test level Conformity
level
Electromagnetic environment-
guideline
Portable and mobile RF communication
devices cannot be used within the
protection range of CA360-B
defibrillator, defined by the transmitter
frequency function.

Recommended protective distance
Conducted RF
IEC 61000-4-6

3 V
eff

150 kHz80 MHz
outside the ISM bands

10 V
eff

150 kHz80 MHz
In the ISM bands
a

3 V
10 V/m
d = P 2 . 1
d = P 2 . 1
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz 2.5 GHz
10 V/m
d = P 2 . 1 80 MHz 800 MHz
d = P 3 . 2 800 MHz 2.5 GHz
Where P is the maximum output power
rating of the transmitter in Watts (W)
according to the transmitter manufacturer,
and d is the recommended separation
distance in meters (m).
b

Field strength from fixed RF transmitters
c
,
as determined by an electromagnetic site
survey, should be less than the
compliance level in each frequency range
d
Interference may occur in the vicinity of
equippments marked with the following
symbol:
1. NOTE: in case of 80 MHz and 800 MHz the higher frequency range applies.
2. NOTE: This guideline cannot be applied in each situation. Electromagnetic propagation is influenced by
the absorption and reflection from buildings, objects and people.
a
The ISM (industrial, scientific and medical engineering) bands between 150 kHz and 80 MHz are as
follows: 6,765 MHz-6,795 MHz; 13,553 MHz-13,567 MHz; 26,957 MHz-27,283 MHz and 40,66 Mhz-
40,70 MHz
b.
The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz, and between 80 Mhz
and 2,5 GHz are necessary to reduce the likelihood of caused interferences by mobile/portable
telecommunication devices, in case they are taken too close to patient by mistake. Therefore a
complementary 10/3 constant was put in the calculations, which are for the defining of recommended
separation distances of transmitters, operating in these frequency ranges.
c.
Field strength from fixed transmitters, such as base station for radio (cellular/wireless) telephones and
mobile radios, amateur radios, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To get to know the electromagnetic environment due to fixed transmitters, an
electromagnetic site survey is necessary. If the measured field strength, in the location where the CA360-B
defibrillator is operated, exceeds the applicable RF compliance level, the intended operation of the
defibrillator should be reviewed. If abnormal performance is observed, additional measures might be
necessary, such as turning or relocating the CA360-B defibrillator.
d
Over the frequency ranges between 150 kHz and 80 MHz, field strength should be less than 3 V/m.
Cardio-Aid
360-B Users manual R-5656-02-V02 89/89

Recommended separation distances between portable and mobile RF telecommunication
devices and the CA360-B defibrillator
The CA360-B defibrillator was made for the operation in a controlled RF interference environment. The
buyer or operator of CA360-B defibrillator can help prevent electromagnetic interference by defining the
separation distance between the portable and mobile RF telecommunication devices (transmitters) and the
CA360-B defibrillator, by defining, calculated according to the followings, by the highest output power of
the telecommunication device.
Highest given
output power of
transmitter
W
Separation distance based on transmitter frequency
m
150 kHz 80 MHz
d = P 2 . 1
80 MHz 800 MHz
d = P 2 . 1
800 MHz 2.5 GHz
d = P 3 . 2
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in meters (m), can be estimated by using the equation applicable to the frequency of the transmitter, where
P is the maximum output power rating of the transmitter in Watts (W), given by the transmitter
manufacturer.
1. NOTE: In case of 80 MHz and 800 MHz separation distance belonging to the higher frequency range
should be applied..
2. NOTE: The ISM (industrial, scientific and medical engineering) bands between 150 kHz and 80 MHz
are as follows: 6,765 MHz-6,795 MHz; 13,553 MHz-13,567 MHz; 26,957 MHz-27,283 MHz and 40,66
Mhz-40,70 MHz
3. NOTE: A complementary 10/3 constant was put in the calculations, which are for the defining of
recommended separation distances of transmitters, operating in the ISM frequency ranges between 150
kHz and 80 MHz and between 80 Mhz and 2,5 GHz, to reduce the likelihood of caused interferences by
mobile/portable telecommunication devices, in case they are taken too close to patient by mistake.
4. NOTE: This guideline cannot be applied in each situation. Electromagnetic propagation is influenced by
the absorption and reflection from buildings, objects and people.

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