GS Corpuls3 Safety tests

Document name
and location:

S:\Reparaturen\STK_Protokolle\STK_c³_with_test_instruction
_EN.docx

Release
identification:

Software version 2.1.0
Creation date:

2013-05-07

Release date:

2013-05-15

Originator name:

Carsten Fuchs

Release name:

Udo Franke

corpuls

³

Safety Technical Test, Test instruction and test report 1/16

Warning

Implementation of Safety Technical Tests implies the occurrence of high voltages
which may result in severe injuries or death. Only authorized qualified personnel are
permitted to carry out Safety Technical Tests.

Attention

Safety Technical Tests should only be carried out by authorized personnel with
calibrated measuring equipment and simulators.

Description

Manufacturer or supplier

Model

Part no.

Safety analyzer to perform protec­tive earthing-, device leakage
current-, isolation resistance
measurement and high voltage test

EKU Elektronik GmbH,
D-56291 Leiningen
MTP 6000 (or comparable)

Defibrillator/Pacer analyzer

Fluke Biomedical Division,
Everett, WA 98203, U.S.
Impulse 7000 (or comparable)

Multi parameter/ECG simulator

Fluke Biomedical Division
PS420 (or comparable)

Digital multimeter

Fluke Corporation
Series 80V (or comparable)

Digital fine manometer

GREISINGER electronic GmbH,
D-93128 Regenstauf
GMH 3160-07 (or comparable)

Mains charger with magnetic plug,
12 volts DC / 9 amp.

GS Elektromedizinische Geräte
G. Stemple GmbH,
D-86916 Kaufering

04501.120

Test cable set for Safety Technical

Test Patient Box corpuls³

W0029.14100

Test cable set for Safety Technical

Test Defibrillator Unit corpuls³

W0029.24100

Test cable for Safety Technical

Test Display Unit corpuls³ with LAN

W0029.34100

Paddle holder for leakage current

and H/V testing, corpuls³

W0029.031263

Paddle for leakage current and high

voltage testing corpuls³

(2 pcs. required)

W0029.04326

Test cable Safety Technical Test
Charger with magnetic plug
corpuls³

W0029.04501

Safety Technical Test

For legal requirements and periods of Safety Technical Tests see chapter 9.4.1 of
Operators Instruction.

Implementation of Safety Technical Tests is only accepted when carried out according to
both, this test instruction and the Operators Instruction, and at least documented
according to this test report.

Test equipment, adapters and facilities

Document name
and location:

S:\Reparaturen\STK_Protokolle\STK_c³_with_test_instruction
_EN.docx

Release
identification:

Software version 2.1.0
Creation date:

2013-05-07

Release date:

2013-05-15

Originator name:

Carsten Fuchs

Release name:

Udo Franke

corpuls

³

Safety Technical Test, Test instruction and test report 2/16

Adapter for leakage current test
Masimo Rainbow® Module

W4212.00002

T-connector cable

04325.09

1

Check of external mechanical intactness of the device

1.1

Check of mechanical intactness. The device must neither have form cracks
nor fractures. In case of damage, present the device to an authorized
national or local GS representative for repair. Swivel the complete device
about 30°. The mechanisms must neither be too rough-running nor
automatically tilting.

1.2

Check covers and fasteners for completeness.

1.3

Check of shock paddles intactness. The paddles must be free from form
cracks in their synthetic material; the helix cable, the electrode plates and
the safety electrodes must be free of any damage; rubber caps of the
buttons must be available and undamaged, labels must be available. The
connector must easily and surely be lockable with the therapy cable. The
electrode surfaces should be free of gel leftovers and other contamination.

1.4

Check of attached cables and sensors. Check cleading of cables and
sensors for insulating damage; if necessary remove paste-on labels
installed by the operator. Continued use of broken cables and sensors is
forbidden.

1.5

Check printer assembly, lid and locking mechanism. The printer lid should
easily release and lock.

1.6

Check of labels, warning and safety instruction plates for completeness and
readability. Check of type plates for readability. Note the serial numbers of
each single component to be tested in the test report sheet.

1.7

Check interlocking mechanisms between the single components. Therefore
unlock and relock the components. The interlocking mechanism must be
free of damage.

1.8

Check the magnetic connector contact panels of the of the single
components for damage and pollution. Clean the panels if necessary.

1.9

Shaking test. Shake each of the single components to detect loose parts
inside.

Warning

Do not open the device! Inner parts may be under high voltage. Disregarding may
cause severe injuries or death! In case of defect contact your authorized national or
local GS representative for inspection and potential repair.

Test instruction for Safety Technical Test

Document name
and location:

S:\Reparaturen\STK_Protokolle\STK_c³_with_test_instruction
_EN.docx

Release
identification:

Software version 2.1.0
Creation date:

2013-05-07

Release date:

2013-05-15

Originator name:

Carsten Fuchs

Release name:

Udo Franke

corpuls

³

Safety Technical Test, Test instruction and test report 3/16

2

Protection against electrical shock hazard

Attention

During following measurements, all single components must be separated from
electrical power supply (power supply pack). Take the batteries out of the single
components!

Attention

Performance of both the leakage current measuring of application parts (item 2.6)
and the high voltage test (item 2.7) requires the application of the specified GS­specific adapters and facilities. Using other adapters and facilities may result in
device damage and termination of warranty rights!

2.1

Check of protective earthing of the external power supply pack (IEC
62353:2007, item 5.3.2.2, image 1, protection class I). Connect the mains
plug to the safety tester and measure with the probe at the minus pole of
the corpuls magnet connector using the test cable P/N W0029.04501 to
activate the switch inside the male connector. Testing current must be not
less than 200 mA and must not exceed a limit of 10 A. This step must not
be done for power supplies with part number 04500.1202 and 04501.1201.

2.2

Measuring of device leakage current of external power supply pack (IEC
62353:2007, item 5.3.3.2.3, image 4, protection class I) (direct
measurement).

2.3

Measuring of insulation resistance of the external power supply pack (IEC
62353:2007, item 5.3.4, image 9). Testing voltage 500 V (DC).

2.4

Measuring of line resistance between potential equalization plug and minus
pins of power contact field of the Defibrillator Unit (by using a Hirschmann
clip or an alligator clip). Remove cover if required. Testing current must be
not less than 200 mA and must not exceed a limit of 10 A. The potential
equalization plug may be covert by a plastic cover.

2.5

Measuring of line resistance between safety electrodes of connected shock
paddles and potential equalization plug by using a resistance measuring
gauge. Testing current must not exceed a limit of 1 A.

2.6

Measuring of leakage current of application parts (IEC 62353:2007, item

5.3.3.3.1, image 6, protection class I). Application parts at which is not
currently measured, must be grounded (to the potential equalization plug of
the Defibrillator Unit or to minus contact of the corpuls magnet connector of
the Patient Box). Measure between:

2.6.1

High voltage output of therapy cable/therapy socket with connected
shock paddles and potential equalization plug (connect the shock
paddles to the therapy cable/therapy socket and put on the adapter
P/N w0029.031263).

2.6.2

High voltage output of therapy cable/therapy socket with connected
T-connector cable (P/N 04325.09) and potential equalization plug.
The measuring is only required if internal shock electrodes (shock
spoons) are applied.

2.6.3

High voltage output of test signal connector and potential
equalization plug.

Document name
and location:

S:\Reparaturen\STK_Protokolle\STK_c³_with_test_instruction
_EN.docx

Release
identification:

Software version 2.1.0
Creation date:

2013-05-07

Release date:

2013-05-15

Originator name:

Carsten Fuchs

Release name:

Udo Franke

corpuls

³

Safety Technical Test, Test instruction and test report 4/16

2.6.4

Short-wired test contact pins of the paddle trays and potential
equalization plug (if the test contact pins were replaced by
accessory bags Part no. 04322.50 and 04322.51, the original
condition must be restored for the time of measurement).

2.6.5

ECG inputs (4-pole and 6-pole connected) and minus contact of the
corpuls magnet connector of the Patient Box.

2.6.6

SpO

2

input and minus contact of the corpuls magnet connector of

the Patient Box.

2.6.7

CO

2

input and minus contact of the corpuls magnet connector of the

Patient Box.

2.6.8

Input Temp1 and minus contact of the corpuls magnet connector of
the Patient Box.

2.6.9

Input Temp2 and minus contact of the corpuls magnet connector of
the Patient Box.

2.6.10

Input IBP1 and minus contact of the corpuls magnet connector of
the Patient Box.

2.6.11

Input IBP2 and minus contact of the corpuls magnet connector of
the Patient Box.

2.6.12

CPR input and minus contact of the corpuls magnet connector of
the Patient Box.

2.6.13

LAN connector and minus contact of the corpuls magnet connector
of the Display Unit.

2.7

High voltage test of application parts (IEC 60601-2-4:2002, item 20, image

107). Application parts at which is not currently measured, must be
grounded (to the potential equalization plug of the Defibrillator Unit or to
minus contact of the corpuls magnet connector of the Patient Box). Set the
current limiter of the high voltage generator to 500 µA. No high voltage
flashover must appear; no release of the current limiter. Apply 5 kV (DC) for
30 sec each between:

2.7.1

High voltage output of therapy cable/therapy socket with connected
shock paddles and potential equalization plug (connect the shock
paddles to the therapy cable and put on the adapter P/N
w0029.031263).

2.7.2

High voltage output of test signal connector and potential
equalization plug.

2.7.3

Short-wired test contact pins of the paddle trays and potential
equalization plug (if the test contact pins were replaced by
accessory bags Part no. 04322.50 and 04322.51, the original
condition must be restored for the time of measurement).

2.7.4

ECG inputs (4-pole and 6-pole connected) and minus contact of the
corpuls magnet connector of the Patient Box.

2.7.5

SpO

2

input and minus contact of the corpuls magnet connector of

the Patient Box.

2.7.6

CO

2

input and minus contact of the corpuls magnet connector of the

Patient Box.

2.7.7

Input Temp1 and minus contact of the corpuls magnet connector of
the Patient Box.

2.7.8

Input Temp2 and minus contact of the corpuls magnet connector of
the Patient Box.

Document name
and location:

S:\Reparaturen\STK_Protokolle\STK_c³_with_test_instruction
_EN.docx

Release
identification:

Software version 2.1.0
Creation date:

2013-05-07

Release date:

2013-05-15

Originator name:

Carsten Fuchs

Release name:

Udo Franke

corpuls

³

Safety Technical Test, Test instruction and test report 5/16

2.7.9

Input IBP1 and minus contact of the corpuls magnet connector of
the Patient Box.

2.7.10

Input IBP2 and minus contact of the corpuls magnet connector of
the Patient Box.

2.7.11

CPR input and minus contact of the corpuls magnet connector of
the Patient Box.

2.7.12

LAN connector and minus contact of the corpuls magnet connector
of the Display Unit.

3

General functions (charging, network connection)

For all following checks reinstall the batteries to the single components. The
single components will automatically switch on. Shutdown the single components
by operating the PWR on/off buttons and reassemble them to a compact device.

3.1

Switch on the compact device by operating the PWR button of the Display
Unit. Wait for boot-up (approx. 20 sec) then check network status.

3.2

Separate Defibrillator Unit, and then separate Patient Box from Display Unit
(modular mode). Check network status.

3.3

Check network status on the LCD of Patient Box.

3.4

Connect power supply pack to corpuls magnet connector of Defibrillator
Unit. Check charging control lamp of Defibrillator Unit.

3.5

Connect power supply pack to corpuls magnet connector of Patient Box.
Check charging control lamp of Patient Box.

3.6

Reassemble Patient Box with Display Unit (semi-modular mode). Check
charging control lamp of Display Unit.

3.7

Connect power supply pack to corpuls magnet connector of the Display
Unit. Check charging control lamp of Display Unit.

3.8

Reassemble all single components to a compact device; connect power
supply pack to corpuls magnet connector of Defibrillator Unit. Check
charging control lamp of Display Unit.

4

Device function Display Unit

For following tests operate the device in modular mode.

4.1

Check acoustics and keyboard of the Display Unit. Push every button of the
keyboard. The speaker must answer with a tone.

4.2

Check printer functionality. Select menu item “Test page“.

4.3

Check alarm and printer stop in case of lack of paper. Remove paper reel
and start printer operation.

4.4

Check visual alarm indication. In case of an alarm, the alarm lamp in the
jogdial must light up.

4.5

Check GSM function. Install SIM and establish a connection to a fax
recipient. Transmit a diagnosis ECG to the fax recipient.

4.6

Check the Health Insurance Card Reader. Insert an applicable card into the
card reader slot; patient’s data must appear on the screen.

4.7

Check the LAN function. Compare the MAC address of the device with the
papers of the device. Connect the device to a DHCP server. Dial the
assigned IP address of the device using the ping networking utility.