GE Healthcare

Technical
Information Letter
DCAR

Ref:
Ref. Note: 2042412-001 Date: January 09, 2009
Product Group: Defibrillator Revision 2
Number:
Product(s): CardioServ all versions, Basic, Pacer Revision NA
and SpO2 Notes:
Affected Hardware and Software Affected NA
Part(s): Product Code:
Tracking NA Billing NA
Number: Number:
Subject: Functional Checkouts Source (ECO NA
or iTrak):

The information contained in this document is CONFIDENTIAL INFORMATION and IS INTENDED ONLY FOR THE USE OF
EMPLOYEES OF GENERAL ELECTRIC COMPANY, IT’S SUBSIDIARIES, AFFILIATES OR DESIGNEES. Distribution or copying
of this document by non-employees or non-designees is strictly prohibited without the express written consent of
General Electric Company or subsidiary thereof.

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.
Problem
Need to meet FDA guidelines for objective evidence when writing Service Debrief Comments for work and
testing performed.

Solution
Clarify the scripts to debrief a Service Dispatch in the service system. This Technical Bulletin specifies the
Functional Checks to be performed for each Service Work performed.

Procedure
Use these scripts in the Service Comments when debriefing a Service Dispatch.

 For a replaced FRU, use the following debrief script:

”Equipment passed all required checkouts per Technical Bulletin 2042412-001 and is ready for use.”

 Electrical safety tests, when performing electrical safety checks use the following text.
Electrical safety checks meet allowable limits as stated in Technical Bulletin 2042412-001 and is
ready for use.

You must record the electrical safety check values in your debrief.

Functional Checkout Procedures

The checkout procedures on the following pages apply to all CardioServ product codes. Checkout procedure
shows some of the checkout steps optional because of product variants (Basic, Pacer, SpO2)
The procedure shows these options as “ if applicable”

Follow the checkout procedure appropriate to the repair being performed.

The information contained in this document is CONFIDENTIAL INFORMATION and IS INTENDED ONLY FOR THE USE OF
EMPLOYEES OF GENERAL ELECTRIC COMPANY, IT’S SUBSIDIARIES, AFFILIATES OR DESIGNEES. Distribution or copying
of this document by non-employees or non-designees is strictly prohibited without the express written consent of
General Electric Company or subsidiary thereof.

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 GE Healthcare

Section 1 – Functional Checkout Procedures

Every repair and planned maintenance shall be made following the appropriate repairs procedures as
outlined in the manufacturer’s manual for the system. For systems under the manufacturers warranty the
repair may be performed by the OEM service representative, however final functional checkout of the system
is the responsibility of the GE service representative onsite at the time.

1.1 Procedure after repair and planned maintenance:

Checkout
Procedure
Description Tools
Details
Section 2 / 3
Visual Inspection 1,2,7 2,1
Power on 1,2 2,2
Check Hardware 1,3,5,8 2,3
Check Software 1,2 2,4
Thermal printer 1,2 2,5
Defibrillation 1,4,5 2,6
ECG 1,5 2,7
Pacing 1,5 2,8
SpO2 1,6 2,9
Safety Tests 1,3 3

The information contained in this document is CONFIDENTIAL INFORMATION and IS INTENDED ONLY FOR THE USE OF
EMPLOYEES OF GENERAL ELECTRIC COMPANY, IT’S SUBSIDIARIES, AFFILIATES OR DESIGNEES. Distribution or copying
of this document by non-employees or non-designees is strictly prohibited without the express written consent of
General Electric Company or subsidiary thereof.

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 GE Healthcare

Section 2 – Functional Checkout Procedure Details

Tools (check calibration dates of the tools)
1. Applicable Service and/or Operator Manual as needed
2. Anti-static wrist strap
3. Safety tester
4. Stop watch
5. Defib / Pacing tester
6. SpO2 Sensor / SRC-Max Simulator
7. Lint free cloth
8. Accu Service Unit (ASU)

1. Visual Inspection
a. Inspect the parts for excess wear and or any visual signs of damage.
b. Check the device case for cracks or any other visual damage
c. Inspect plugs, cords, cables and connectors for bent prongs or pins
d. Inspect keys and controls for damage
e. Check label plate is readable
f. Check Paddles for cracks or any other visual damage (if applicable)
g. If system box has been opened, check that interior is free of excessive dust build-up, if
necessary use commercially available compressed air to clean following the manufacturers
instructions.
h. Clean if necessary
i. Expected Result: No visual damage and wear detected Pass/Fail

2. Power On
a. Power on device on mains
Expected Result: CardioServ boots and shows the FW-Version, mains and battery LED light up
(Battery LED only if battery available) Pass/Fail
b. Power on device on battery
Expected Result: CardioServ boots and shows the FW-Version Pass/Fail

3. Check Hardware
a. Screen
Power on CardioServ
Expected Result: Screen shows Defib home screen Pass/Fail
b. Speaker
Power on CardioServ
Expected Result: Beeps while boot up Pass/Fail
c. Keyboard Test with keyboard test function (F1+F5 and than F3+F4)
Open keyboard test function
Press all buttons on device and paddles
Expected Result: Keyboard operates Pass/Fail
d. Energy switch: Set to all possible positions
Expected Result: all selected energies are displayed Pass/Fail
e. Battery: Recommended battery test is in the ASU, if not available operate on battery power.
Discharge with 360 Joule into Defib tester, please make sure that after every 10 discharges
you have to wait 30min, because of temperature.
Expected Result: 30 discharges possible per battery Pass/Fail

The information contained in this document is CONFIDENTIAL INFORMATION and IS INTENDED ONLY FOR THE USE OF
EMPLOYEES OF GENERAL ELECTRIC COMPANY, IT’S SUBSIDIARIES, AFFILIATES OR DESIGNEES. Distribution or copying
of this document by non-employees or non-designees is strictly prohibited without the express written consent of
General Electric Company or subsidiary thereof.

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 GE Healthcare

4. Check Software
Power on CardioServ
Expected Result: FW version is displayed and language setting
is ok and display contrast is properly set Pass/Fail

5. Thermal Printer Test

Power on CardioServ
Press print button
Expected Result: Print Out with Text and ECG with 25mm/s Pass/Fail

6. Defibrillation
a. Select all possible Energy levels and defibrillate in defib tester, enter measured values.

Attention, there are different acceptable limits for the devices Version 3 and older and the
new Version 4 CardioServ

Selected Energy Acceptable Limits (J) Acceptable Measured Energy

(J) CS V3 and older Limits (J) CS V4 (J)
and older
2 1–3 1–3
5 4–6 4–6
7 6–8 6–8
10 8.– 12 9 – 11
20 18 – 22 19 – 21
30 27 – 33 29 – 31
50 45 – 55 49 – 51
70 63 – 77 n.a.
100 92 – 108 97 – 103
150 140 – 160 146 – 154
200 188 – 212 194 – 206
300 285 – 315 291 – 309
360 340 – 380 350 – 370

Expected Result: Delivered Energy within the limits Pass/Fail

b. Automatically internal discharge

Charge 100 J , do not discharge
Expected Result: Energy discharged internally within 30s Pass/Fail

c. Synchronized defibrillation
Charge 100 J , set defib tester for sync. Defibrillation, deliver shock
Expected Result: Shock delivered according to ECG rhythm and sync time is within
60ms range Pass/Fail

7. Check ECG
Power on CardioServ
Apply ECG Cable (3 or 5 lead)
Switch all available Channels
a. Apply simulator 60bpm

The information contained in this document is CONFIDENTIAL INFORMATION and IS INTENDED ONLY FOR THE USE OF
EMPLOYEES OF GENERAL ELECTRIC COMPANY, IT’S SUBSIDIARIES, AFFILIATES OR DESIGNEES. Distribution or copying
of this document by non-employees or non-designees is strictly prohibited without the express written consent of
General Electric Company or subsidiary thereof.

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 GE Healthcare

Expected Result: ECG shown on the screen

Heart rate between 58 … 62 bpm Pass/Fail
b. Apply simulator 60bpm
Remove electrode
Expected Result: Electrode alarm occurs Pass/Fail
c. Apply simulator 120bpm
Hart rate upper limit 100bpm
Activate HR-Alarm and tone
Expected Result: Alarm occurs and beeps Pass/Fail

8. Pacing (if applicable)

Power on CardioServ, switch Pacer on, connect to pacer tester
a. Select Fix mode, use following settings, enter measured values

Selected Acceptable Limits Measured

Rate 60 bpm 57 … 63 bpm
Pulse with 38 … 42ms
Rate 200 bpm 190 … 210 bpm
Pulse with 19 … 21ms
Amplitude 200 mA 180 … 220 mA
Rate100 bpm 95 … 105 bpm
Pulse with 19 … 21ms
Amplitude 100 mA 90 … 110 mA

b. Select demand mode 90bpm and simulator 60 bpm

Expected Result: no pacing pulse delivered Pass/Fail

9. SpO2 (if applicable)

Power on CardioServ
Apply Spo2 Sensor or SRC-Max simulator (75% and 90%)
Measure your Pulse rate and Saturation
Expected Result: SpO2 measurements shown on the screen
Values in acceptable limits (Sat 90 … 100%)
With simulator 75 %and 90% Pass/Fail
b. Apply SpO2 sensor
SpO2 upper limit 85 %
Activate SpO2-Alarm and tone
Expected Result: Alarm occurs and beeps Pass/Fail

The information contained in this document is CONFIDENTIAL INFORMATION and IS INTENDED ONLY FOR THE USE OF
EMPLOYEES OF GENERAL ELECTRIC COMPANY, IT’S SUBSIDIARIES, AFFILIATES OR DESIGNEES. Distribution or copying
of this document by non-employees or non-designees is strictly prohibited without the express written consent of
General Electric Company or subsidiary thereof.

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 GE Healthcare

______________________________________________________________________________________________

Section 3 - Electrical Safety Checks

Perform electrical safety checks when indicated. Record measurement values in your debrief.
Note: The following values apply to 120/240VAC.

Leakage Leakage
Unit Under Test
Current Limits Current Limits
Step Condition Enter Result in micro amps in micro amps
measured (uA) (uA)
values
Acc. UL Acc. IEC
Earth Leakage Current
A in uA

1. Forward Polarity NC Pass/Fail 500 500

2. Neutral open, Forward Polarity SFC Pass/Fail 1000 1000

3. Neutral open, Reverse Polarity SFC Pass/Fail 1000 1000

4. Reverse Polarity NC Pass/Fail 500 500

B Enclosure Leakage Current in uA

1. Forward Polarity NC Pass/Fail 100 100

2. Neutral open, Forward Polarity SFC Pass/Fail 300 500
3. Ground open, Forward Polarity SFC Pass/Fail 300 500
4. Ground open, Reverse Polarity SFC Pass/Fail 300 500

5. Neutral open, Reverse Polarity SFC Pass/Fail 300 500

6. Reverse Polarity NC Pass/Fail 100 100

C Patient Leakage Current, * in uA
1. Forward Polarity NC Pass/Fail 10 10
2. Neutral open, Forward Polarity SFC Pass/Fail 50 50
3. Ground open, Forward Polarity SFC Pass/Fail 50 50
4. Ground open, Reverse Polarity SFC Pass/Fail 50 50
5. Neutral open, Reverse Polarity SFC Pass/Fail 50 50
6. Reverse Polarity NC Pass/Fail 10 10
Patient Leakage Current
D Mains on applied part in uA
(All SIP/SOPs Grounded)
Forward Polarity
1. SFC Pass/Fail 50 50
Neutral / Ground closed
Reverse Polarity
2. SFC Pass/Fail 50 50
Neutral / Ground closed
Resistance Resistance
E Ground Continuity in m
in  in 
AC mains power cord ground
prong to exposed metal surface Less than Less than
1. N/A Pass/Fail
300m 300m
(i.e. ground lug)

NC = Normal Condition SFC = Single Fault Condition N/A = Not Applicable

* patient leakage current on paddles limit is 100µA

The information contained in this document is CONFIDENTIAL INFORMATION and IS INTENDED ONLY FOR THE USE OF
EMPLOYEES OF GENERAL ELECTRIC COMPANY, IT’S SUBSIDIARIES, AFFILIATES OR DESIGNEES. Distribution or copying
of this document by non-employees or non-designees is strictly prohibited without the express written consent of
General Electric Company or subsidiary thereof.

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