Getemed VitaGuard 300, VitaGuard 310, VitaGuard 2000, VitaGuard 2100, VitaGuard 3000 Test report
...Page 1
Service Manual - Test Report
VitaGuard®
Projekt ID: 0027
VG 3100 / VG 2100 / VG 310
1 Purpose
This report documents the tests carried out on the VitaGuard® monitor by the
distributor when performing the regular 18-month inspection or prior to delivering the
monitor for use.
2 Test Item
VitaGuard®
Serial Number (SN):
3 Reference
1. Test Procedure Document 0027-TD-0027-Rev C
4 Investigators
Test engineer:
Other engineers / technicians:
5 Company
0027-TD-0028-Rev C
VG 3100 o VG 2100 o VG 310
o
6 Location
Distributor address:
7 Test plan
7.1 Visual inspection of the monitor
Nr
Measurement / Action Range Value
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
The following connectors are fitted tightly and not damaged:
• ECG input (VG 3100 and VG 2100 only)
•
2
NA 3000-2 power supply input
•
SpO2 input (VG 3100 and VG 310 only)
• USB input
•
AUX input
3 The monitor casing and the LCD display are not damaged. o.k.
o.k.
o.k.
0027-TD-0028-Rev C-B5.1-Service Manual 18 Month Regular Inspection Test Report English.doc Page 1 of 3
Page 2
Service Manual - Test Report
VitaGuard®
Projekt ID: 0027
VG 3100 / VG 2100 / VG 310
7.2 Functional measurements
Nr
Current Consumption with Ubat = 6V
1 Current from batteries when monitor switched off < 200 µA
2a Current from batteries VG 2100 40 ... 55 mA
b when switched on VG 3100 (SpO2 on) 60... 83 mA
(from SN 801050395)
c
d
(from SN 801040001 to SN 801050394) VG 310 (SpO
3 Current from battery when NA 3000-2 connected < 5 µA
4 Current from NA 3000-2 when monitor switched off 4,5 ... 6 mA
5a Current from NA3000-2 VG 2100 107 ... 125 mA
b when monitor switched on VG 3100 (SpO2 on) 125 ... 140 mA
c
(from SN 801050395) VG 310 (SpO
d
(from SN 801040001 to SN 801050394) * VG 310 (SpO
6 Green LED lights when NA 3000-2 connected o.k.
7 LCD backlight switches on when NA 3000-2 connected o.k.
8 Automatic change-over between batteries and NA 3000-2 o.k.
9 Automatic change-over when NA 3000-2 pulled from socket o.k.
Battery Control
10 Battery symbol full 6.0V
11 Battery symbol empty 4,5 ... 4,7 V
12 Internal battery “very good” o.k.
General
13 Parameters stay stored when monitor switched off o.k.
14 LED’s activated upon start-up, LCD display o.k. o.k.
15 Buzzer sounds loud and clear o.k.
Respiration section (VG 3100 and VG 2100 only)
16 Apnea alarm after 12 s 10 … 14 s
17 Apnea alarm stays active for further 15 s o.k.
18
Basal impedance = 500 Ω 400 ... 600 Ω
19
Basal impedance = 1000 Ω 900 ... 1100 Ω
20 Warning when red electrode removed o.k.
Heart Rate (HR) Section (VG 3100 and VG 2100 only)
21 Heart rate from 30 – 240 /min
22 Bradycardia alarm when HR = 40 /min 4 ... 8 s
23 Tachycardia alarm when HR = 240 /min 13 … 17 s
24 Heart rate when signal amplitude = 0.5 mV o.k.
25 Alarm when no signal present 3 ... 5 s
SpO2-Section (VG 3100 and VG 310 only)
26 Sensor off: Warning and technical alarm o.k.
27 SpO2 set to 97%, 90%, 80% with PR = 100 bpm o.k.
28 PR set to 90 bpm and 120 bpm, with SpO2 = 80% o.k.
29 SpO2 alarm when SpO2 = 70% 8 ... 12 s
30 SpO2 alarm when SpO2 = 90% 8 ... 12 s
Measurement / Action Range Value
VG 310 (SpO2 on) 55... 63 mA
0027-TD-0028-Rev C
on) 60 ... 75 mA
2
on) 120 ... 128 mA
2
on) 125 ... 135 mA
2
HR ± 2 /min
0027-TD-0028-Rev C-B5.1-Service Manual 18 Month Regular Inspection Test Report English.doc Page 2 of 3
Page 3
Service Manual - Test Report
VitaGuard®
Projekt ID: 0027
VG 3100 / VG 2100 / VG 310
PC Interface
31 Read and analyse stored episodes, check time o.k.
32 Read compliance protocol o.k.
33 Reset monitor o.k.
7.3 Safety inspection in accordance with EN 60601-1, Class II, CF
Nr
Automatic test passed (Yes/No) Yes
7.4 Visual inspection of accessories
Nr
1 Visual inspection of ECG cable o.k.
2 Visual inspection of power adapter NA 3000-2 o.k.
3 Visual inspection of SpO2 cable (PC08 or PC12) o.k.
4 Visual inspection of user manual o.k.
5 Visual inspection of packaging o.k.
8 Analysis and recommendations
Part Result Recommendation
7.1
7.2
7.3
7.4
Decision:
Monitor suitable for further use: yes
Date
:____________________
Measurement / Action Range Value
Measurement / Action Range Value
no
o
Signature
:______________________
0027-TD-0028-Rev C
o
0027-TD-0028-Rev C-B5.1-Service Manual 18 Month Regular Inspection Test Report English.doc Page 3 of 3
Loading...