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

Test Procedure

VitaGuard® VG2000 / VG3000 / VG300

Projekt ID: 9204 H1

1 Approvals

Department Name Signature Date
Author
Engineering
Quality Assurance

Valid from: 10.12.2001
Copy to: FE X VK PF QB Others

Revision Author Dept. Datum Design Change Nr.

A R. Downes FE 27.02.01
B R. Downes FE 20.12.01

2 Scope

This document is valid for distributors that satisfy the following conditions:

• the company is certified in accordance with DIN ISO 9003

• the engineers/technicians performing the tests have been training to do so by

getemed AG.

18-Month Regular Inspection

9204-TP-0001-Rev B

3 Purpose

This document describes the tests that should be carried out at least once every 18
months or after the monitor has been returned to the distributor by the user.

4 Reference

1. 9204-TR-0001-Rev B Test Report Document to be copied for each monitor.

5 Investigators

Responsible Technician:
Other technicians:

6 Location

Address of the distributor

7 Start and End Dates

Begin: Start date of test
End: Maximum of 2 hours after starting

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Test Procedure

VitaGuard® VG2000 / VG3000 / VG300

Projekt ID: 9204 H1

18-Month Regular Inspection

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 numbers, should the distributor wish to purchase the
equipment from getemed.

Equipment Model Manufacturer

Power adapter NA2000-2 72126 getemed AG
ECG patient cable 70263 getemed AG
Masimo SpO2 cable PC08 70257 getemed AG, Masimo
Masimo SpO2 Sensor DC I 70254 getemed AG, Masimo
External alarm unit EA1000 70003 getemed AG
Cable for EA1000 70004 getemed AG
PC Interface cable 70262 getemed AG
VitaWin software VitaWin 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

Resistor Box 1-3000Ω ±1%
R Stop watch - ­R Safety tester Unimet 1000 ST Bender
R

Two 4.7kOhm ±1% resistors
R Test PC with Windows 95 or higher - -

9204-TP-0001-Rev B

Mini-Ohm Dekade Präzisionsmesstechnik

- -

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 will be notified of any changes as they occur and informed as
to whether these changes should be implemented in older monitors.

Should the monitor under test shows 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 data bank 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.

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Test Procedure

VitaGuard® VG2000 / VG3000 / VG300

Projekt ID: 9204 H1

18-Month Regular Inspection

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 four 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,

• Label on the back of the monitor with serial number and

1

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.

2

9.7.1-3 Casing and LCD display

safety warnings,

• Label stripe at the front marking all inputs,

• Label marking direction of batteries inside the battery

compartment.

The following connectors are fitted tightly and not damaged:

• ECG/PC input,

• power supply input,

• SpO2 input,

• ext. Alarm input (VG3000 and VG300 only).

9204-TP-0001-Rev B

o.k.

o.k.

The monitor casing must not be cracked or have any significant scratches. Special
case must be given to the corners and the areas around the connectors. 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 NA2000-2 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 4mm connector jack plugs to the loose ends. These can then be inserted into a
multimeter.

For measurements with the resistor box, the red and yellow leads form the ECG
patient cable are connected to the resistor box. The black lead is taken from the
center point of two 4.7kOhm resistors connected between red and yellow in order to
avoid an open-lead warning from the black electrode.

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Test Procedure

VitaGuard® VG2000 / VG3000 / VG300

Projekt ID: 9204 H1

18-Month Regular Inspection

9204-TP-0001-Rev B

VG2000/3000/300

Monitor

Comp.

Battery

Digital-

Multimeter

(1)

Power supply

3-6V / 2A

Digital-

Multimeter

NA2000-2

SpO2­Sensor
and
simulator

(3)

SpO2 ECG

Power

EA 1000

(4)

Patient

simulator

(2)

Figure 1 – Current Measurement Set-Up

VG2000/3000

Monitor

Battery

Comp.

SpO2 ECG Power EA 1000

Power supply

3-6V / 2A

Resistor box

Figure 2 – Basal Impedance Measurement Set-Up

VG2000/3000/300

Monitor

Battery

Comp.

SpO2 ECG

Power

EA 1000

Power supply

3-6V / 1A

SpO2
Simulator

Patient­Simulator

ext. alarm
EA1000

Figure 3 – Alarm Measurement Set-Up

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