Getemed VitaGuard 300, VitaGuard 310, VitaGuard 2000, VitaGuard 2100, VitaGuard 3000 Test procedure

Service Manual - Test Procedure

VitaGuard®

Projekt ID: 0027

VG 3100 / VG 2100 / VG 310

8 Equipment and Materials

The equipment listed below marked R is the equipment used by getemed AG. Similar
models from other manufacturers can be used as long as the performance is similar.
The model numbers of the equipment listed with getemed AG as manufacturer
correspond with the ordering (REF) numbers, should the distributor wish to purchase
the equipment from getemed.

Equipment Model / REF Manufacturer

Power adapter NA 3000-2 7344 1101 getemed AG
ECG patient cable 7341 1001 getemed AG
Masimo SpO2 cable PC08 70257 getemed AG, Masimo
Masimo SpO2 Sensor DC I 70254 getemed AG, Masimo
PC Interface cable (USB-Kabel) 7341 2001 getemed AG
VitaWin software VitaWin 3 getemed AG
R 1A / 3-6V power supply HM7042 Hameg
R Digital Multimeter Model 87 Fluke
R ECG/Respiration patient simulator 214B DNI Nevada Inc.
R SpO2 patient simulator Oxitest Plus DNI Nevada Inc.
R Stop watch - ­R Safety tester Unimet 1000 ST Bender
R Test PC with Windows 2000 or XP - -

0027-TD-0027-Rev C

9 Procedure

The procedure is divided into 4 sections:

· Visual inspection of the monitor

· Functional measurements

· Safety inspection

· Visual inspection of accessories

For easy reference, the numbers of this procedure correspond with the numbers in
the test report.

Before beginning the test procedure, the revision stand of the monitor should be
checked. The distributor should contact getemed on a regular basis at

[e-mail] in order to determine if changes are necessary.

Should the monitor under test show any signs of malfunction, then it must be returned
immediately to getemed AG for inspection.

The test reports must be archived for at least 10 years and made available to
getemed AG on request.

The distributor shall maintain a database showing when a monitor was last tested and
by whom.

The remaining part of section 9 explains how to perform the test procedure. To
correspond with the test report, numbering will begin with 9.7.1.

0027-TD-0027-Rev C-B5.1-Service Manual 18 Month Regular Inspection Test Procedure English.doc

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Service Manual - Test Procedure

VitaGuard®

Projekt ID: 0027

VG 3100 / VG 2100 / VG 310

9.7.1 Visual inspection of the monitor

The first section of the test report is the visual inspection of the monitor.

9.7.1-1 Labels

All three labels listed in box 1 must be readable and free from damage. If this is the
case, then box 1 can be ticked-off with o.k.

The following labels are readable and not damaged:

· Top label with keys (key panel)

1

· Label on the back of the monitor with serial number and
safety warnings; warning label in battery compartment.

· Label stripe at the front marking all inputs

9.7.1-2 Connectors

The connectors listed in box 2 must be fitted tightly. The connector pins must be
visually inspected to ensure that none of them are damaged. If this is the case, then
box 2 can be ticked-off with o.k.

The following connectors are fitted tightly and not damaged:

· ECG input (VG 3100 and VG 2100 only)

· NA 3000-2 power supply input

2

· SpO2 input (VG 3100 and VG 310 only)

· USB input

· AUX input

9.7.1-3 Casing and LCD display

0027-TD-0027-Rev C

o.k.

o.k.

The monitor casing must not be cracked or have any significant scratches. The LCD­display must also be free from damage. If this is the case, then box 3 can be ticked­off with o.k.

3 The monitor casing and the LCD display are not damaged. o.k.

9.7.2 Functional measurements

The second section of the test report involves measuring parameters and performing
functional tests.

The external power adapter NA 3000-2 used must be modified to measure the current
flowing to the monitor. To do this, cut the positive wire going to the monitor and attach
two 4 mm connector jack plugs to the loose ends. These can then be inserted into a
multimeter.

It is assumed that the default settings are selected before beginning the test
procedure.

0027-TD-0027-Rev C-B5.1-Service Manual 18 Month Regular Inspection Test Procedure English.doc

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Service Manual - Test Procedure

VitaGuard®

Projekt ID: 0027

VG 3100 / VG 2100 / VG 310

0027-TD-0027-Rev C

VitaGuard

Monitor

Comp.

Battery

Digital-

Multimeter

(1)

Power supply

3-6V / 2A

Digital-

Multimeter

NA 3000-2

SpO2­Sensor
and
simulator

(3)

SpO2 ECG

Power

AUX

(4)

Patient

simulator

(2)

Figure 1 – Current Measurement Set-Up

VitaGuard

Monitor

Battery

Comp.

SpO2 ECG Power

AUX

Power supply

3-6V / 1A

SpO2
Simulator

Patient­Simulator

Figure 2 – Alarm Measurement Set-Up

VitaGuard

Monitor

Battery

Comp.

SpO2 ECG

USB

Power AUX

Power supply

3-6V / 1A

PC
VitaWin

Figure 3 – PC Measurement Set-Up

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