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Innomed Medical Inc.: Cardio-Aid 360-B Biphasic Defibrillator Service Manual
Innomed Medical Inc.: Cardio-Aid 360-B Biphasic Defibrillator Service Manual
Cardio-Aid 360-B
Contents
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.
In manual mode
Applying asynchronous shock for the treatment of ventricular fibrillation with the assistance
of external defibrillator paddles or pads or internal paddles.
Applying synchronized shock in case of atrial fibrillation, ventricular tachycardia
(cardioversion), with the assistance of external defibrillator electrodes (pads/paddles).
ECG, HR, SpO2, NIBP monitoring.
Semi-automatic mode
The device assists the operator by voice and text (step by step) instructions appearing on the
display, in the device operation. The device automatically performs the necessary
operations, it charges the defibrillator’s energy, and it gives an instruction for the delivery
of shock.
Applying of asynchronous shock, in case of recognized fibrillating heart muscle (according to
AHA).
ECG, HR monitoring.
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
2.2. Classifications
The CA360-B defibrillator is classified as II.b. according to the rule no. 9 described in the
point III./3.1 of the supplement no. IX of the 93/42/EEC board directive amended by
Directive 2007/47/EC.
From the aspect of electromagnetic compatibility the classification of the CA360-B
defibrillator, according to the EN 55011 standard is: group no. 1, class B.
2.4. Display
2.6. Defibrillator
Maximum time passed from enabling From battery Fully charged < 1 7 s
of rhythm recognition (including (25ºC) battery (typically)
analysis time) till shock-ready state, at
After 15 < 2 0 s
maximum energy level, in semi-
defibrillations (typically)
automatic mode.
From mains With charged < 1 5 s
(in voltage range battery (typically)
of 100V~ -
240V~)
90V~ mains In case of <25s
voltage completely empty (typically)
battery
Time passed from < 40 s (typically)
power on to charge-
ready state for
maximum energy
VF / VT recognition Complies or better than the AAMI DF-39
requirement.
Recognizes broad QRS VT > at 180bpm
2.7. Battery
Mode Differential
Input signal range ± 5 mV
DC tolerance ± 400 mV
Frequency response(-3dB) 2-60 Hz
Gain x0.25, x0.5, x1, x2, x4, auto (default = x1)
Input-related noise Max. 30 uVpp
ECG input impedance Min. 20 Mohm
CMRR Min. 100 dB
Recovery time after overdriveing <5s
Pacemaker tolerance Max. 700 mV / 2 ms
Pacemaker detection Min. 2 mV / 0,25 ms
Max. 700 mV / 2 ms
Defibrillator tolerance Max. 400 J
Patient impedance measurement range 10-200 ohm
Signal delay (in correlation with Max 20 ms
viewing)
Sampling frequency 400 Hz
AD resolution 5 uV / bit
QRS-detection limit level 200 SV
Safety classification External defibrillator paddle: class CF
Defibrillator pads electrodes: class CF
Internal defibrillator paddles: class CF
Mains filter 50 or 60 Hz
Gain x0.25, x0.5, x1, x2, x4, auto (default = x1)
Input-related noise Max. 20 uVpp
ECG input impedance Min. 20 Mohm
CMRR (by mains filter) Min. 120 dB
Recovery time after overload < 5s
Pacemaker tolerance Max. 700 mV / 2 ms
Pacemaker detection Min. 2 mV / 0,25 ms
Max. 700 mV / 2 ms
Defibrillator tolerance Max. 400 J
Signal delay With baseline filter: 2 s
(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 200SV
Checking of ECG electrode Per electrode
removal
Checking of ECG channel noise Per channel
Classification Defibrillation-protected, class CF
2.12. Pacer
2.13. SpO2 measurement
Sensor Fingerclip
SpO2 measurement range 1 – 100%
Accuracy of SpO2 measurement Over 70% ±2%
Resolution of SpO2 displaying 1%
Pulse number measurement 20 – 300 bpm ±3 bpm
range
Resolution of pulse displaying 1 bpm
Alarms Lower and upper limits of SpO2% and rhythm
Defibrillator-protection 5 kV
Light emission of the finger clip: 660 nm (red)
900 nm (infrared)
Typically less, than 15 mW
Data Update Period, Effect of Data Averaging, and Other Signal Processing:
OxiMax Algorithm The advanced signal processing of the OxiMax
algorithm automatically extends the amount of data
required for measuring SpO2 and pulse rate
depending on the measurement conditions. During
normal measurement conditions in the Normal Mode,
the SpO2 averaging time is six (6) to seven (7)
seconds or approximately three (3) seconds in Fast
Mode. Equivalently, the typical pulse rate averaging
time is approximately five seconds, independent of
response mode.
The OxiMax algorithm automatically extends the
dynamic averaging time required beyond seven (7)
seconds during degraded or difficult measurement
conditions caused by low perfusion, signal artifact,
ambient light, electrocautery, other interference, or a
combination of these factors, which results in an
increase in the dynamic averaging beyond the
minimum as set by the response mode.
If the resulting dynamic averaging time exceeds 20
seconds for SpO2, the algorithm sets the pulse search
bit while continuing to update SpO2 and Pulse Rate
values every second.
As such measurement conditions extend, the amount
of data required may continue to increase. If the
dynamic averaging time reaches 40 seconds, and/or
50 seconds for pulse rate, a low priority alarm state
results: the algorithm sets the Pulse Timeout bit and
the module reports a zero saturation indicating a loss-
of-pulse condition which should result in an audible
alarm.
Response Mode For systems featuring the Fast Mode (NELL-1,
NELL-2), this setting dictates the response time (two
(2) to four (4) seconds in Fast Mode and six (6) to
seven (7) seconds in Normal Mode) applied by the
OxiMax algorithm in its calculation of SpO2.
The OxiMax algorithm’s calculation of pulse rate is
unaffected by the response mode setting. The data
storage interval in the oximeter’s trend memory is
decreased automatically to two (2) seconds when the
oximeter is set to operate in the Fast Mode (the
storage interval is four (4) seconds in the Normal
Mode).
2.15. Printing
2.16. Event storage
U [ V]
U1
U2
Phase 1
t3
t1 t2 T [ms]
Phase 2
-U3
-U2
Delivered energy by the defibrillator as a function of patient’s chest impedance at the range
between 2 – 360 J
®
4. The Cardio-Aid 360-B defibrillator
maintanance, assigments
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.
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.
The CA 360 B is dismantled in steps braking the unit down into its major
components.
Note! The necessary precautions against Electro Static Discharge (ESD) must be
taken. This applies to all handling of electrical components as well as printed
circuit boards and all service involving dismantling the CA 360 B.
Note! Before starting dismantle operation you have to shoot down the device,
disconnect power cable and wait at least 2 minutes. Before handling High
Voltage parts such as HV-capacitor, HV-circuit etc., ensure that there is no
voltage using a high voltage probe (1000:1). High-voltage parts are identified
with the “Danger High-voltage” symbol. Be very careful when connecting the
high voltage probe- avoid touching the terminals and use proper insulation If
voltage is present, leave the unit until the HV-capacitor is fully drained. If the
capacitor remains charged it can be discharged by connecting a drain resistor
e.g. 100kohm, 17W, directly over the HV capacitor terminals for min. 30 sec.
Be very cautious when connecting the resistor and use proper insulation. When
storing an HV-capacitor, always leave it in a short-circuit state. Re-assembling
the CA 360 B taking care that the various rubber seals are seated correctly.
Tools needed:
• Torx screwdriver kit.
• Hexagon screwdriver kit
• Phillips screwdriver kit.
• Wire cutter
Dismantling the CA 360 B Paddle holders remove the three screws marked
with green arrows on the Paddle holders.
Note! Do not remove the smaller screw holding the metal plate on the Paddle holders
The battery is located behind the left paddle/pads holder, seen from the front.
1. Turn off the CA 360 B and disconnect the main cable.
Note! The screws are secured and can not fall out.
Before you remove front and rear covers disconnect ECG cable, pacer
cable/Defi cable, main cable and all other accessories.
1. Remove the Paddle holders by performing the procedure “Removing the
Paddle holders”
2. Remove the battery by performing the procedure “Removing the battery”.
4. Place the CA 360 B with the front cover facing downward.
Note! To avoid damaging the front panel, place the CA 360 B on a soft fabric or
something similar.
5. Gently lift up the rear cover assembly until the connected printer cable
(optional) do not scretch.
Printer cable
1. Remove the nine screws marked with arrows in the front panel.
2. Carefully remove the front assembly from the black internal chassis until
connected cables do not stretch.
3. Gently disconnect the keyboard cable, and the internal ECG cable.
keyboard
cable
internal ECG
cable
2. Remove the connector rack assembly by lifting and pushing it carefully up
toward from the front cover.
3. To romove the NIBP module carefully dislock the four pcb supports and
lift the NIBP module while disconnect the electrical plug.
4. To remove the ECG board, unscrew the four screws in the board.
pcb supports
Assembled
connector rack
NIBP
module
ECG
module
4. To remove the keyboard, disconnect the display cables (a film cable and a
power cable)
5. Remove the nine screws marked with arrows to dismantle the keyboard
circuit.
6. To remove the LCD, unscrew the four hexagon nut on the LCD fixing rail,
lift the rails and remove the LCD.
1. To remove the power supply module, unscrew the seven screws on power
supply circuit board, marked with arrows.
2. To remove the battery connector board, remove the one screw as shown,
and carefully disconnect the electrical plug on the board
3. To remove the DEFI test board unscrew the marked bolt, and pull out the
board from it’s slot.
4. Remove the high voltage capacitors cutting the cable ties.
Note ! The defi board and the power supply board are connected to each other with a
rigid multipin socket and plug. During remove operation you have to carefully
disconnect this socket and plug.
Defi test board and
fixing screw
5.
HV
capacitors
Battery connector
board and fixing
screw
Rigid
connection to
defi board
To remove defi board, unscrew the seven screws on the board marked with
arrows.
6. Carefully lift the defi board from the internal chassis.
Note ! The defi board and the power supply board are connected to each other with a
rigid multipin socket and plug. If the power supply board is not removed before
this step you have to carefully disconnect this socket and plug to remove defi
board, see steps above!
7. Troubleshooting
What is to be done in case of defibrillator malfunction?
The CA360-B defibrillátor stores every technical events under work with a timestamp into a
servicelog file. If the defibrillator does not work due to an error, then the user has to make a
note of the error circumstances and time and date of error appearance and has to read out the
servicelog file mentioned above. The date and time of error appearance is important, because
we can find the registry about that error in the log file according to the date and time.
Please send this servicelog directory in compressed form with a note of the failure time and
description to Innomed Medical. The Innomed Medical will give the solution in very short
time.
To read out the servicelog file the first step is to enter the service menu.
This sdata directory shall be zipped and sent to Innomed with fault description.
Before deleting error flags, save the service data and error flags!
• Enter configuration menu and then protected service menu (See 7.1 )
• Select "Clear Flag" in Calibrations Menu/Defibrillator Calibration Menu within
Service Settings menu by OK ^. Now the color of text Off changes green. Push the
] key, then the green text changes to On. Press OK ^ which deletes the error flag on
the defi board.
• Select "Clear error flags" in "Calibrations Menu/Battery Calibration Menu" within
Service Settings menu by OK ^. Now the color of text Off changes green. Push the
] key, then the green text changes to On. Press OK ^ which deletes error flag on the
power board.
• Leave the Service settings menu, switch off the defibrillator, and switch it on again.
• Check whether red flashing ceases.
Important! Switch the Online data to ’Off’ state before You leave this menu point.
Enter the software update menu and connect the pendrive to the USB-A connector.
Select Software Packet Update with OK ^.
The device copies the software from the pendrive. Do not touch the defibrillator until
the process ends and the device automatically enters the configuration menu.
Select Software Update Menu with OK ^ again.
Select Load Licence File with OK ^.
The device copies the licence file from the pendrive. The process ends if “Loading
state: Done” message appears in the last line of the window.
Quit this menu with a key
In Software Update Menu upgrade the software where “BAD” message can be read by
pushing OK ^ key.
Defi Panel Software update starts, it is indicated by Download bar.
During downloading please ignore error messages on the display. Do not touch the
defibrillator in this time.
At the end of download the service menu appears on screen.
Select Software Update Menu again and the next software item indicated by BAD.
Continue the process until the four BAD messages disappear.
At the end of Power Panel Update, “Please wait for the switching off …” message
appears. It takes approximately 15 seconds.
After switching off, remove the pendrive then turn the device on.
Enter configuration menu.
Set the timer.
Switch the device off.
At the next switching the defibrillator will work on the new software.
8.8. DEVICE ID
This is only an information about the device identification number, this is not a selectable
menu item.
8.10. Service Menucode