Reporting of Test Results 4 Testing and Maintenance
71
Test and Inspection Matrix - Checks with Patient Monitor
Test Bl oc k Na me Test or Inspection to be performed Expected Test Result What to Record
on Service
Record
Visual Check Check for any mechanical damage and all
external leads and accessories. Is the device
free of damage and are all accessories properly
set up?
Expected answer is "yes".
If so, visual test is passed.
V: P or
V: F
where P=Pass and
F=Fail
Power On Check 1. Switch on gas analyzer and patient monitor
and check for any INOP messages after the
warmup phase. Make sure that the gas
analyzer is not in Standby.
2. Wait for 12 minutes and make sure that no
INOP messages appear (except “GM No
Breath”, “GM Alarm Suppress”, “GM Cal
running” and “GM Zero running”).
3. Ensure that the displayed values
correspond to the ambient air (21% O
2
3%,
0% all other gases).
Expected result: No INOP
messages and correct ambient air
values. If so, Power On test is
passed.
PO: P or
PO: F
where P=Pass and
F=Fail
Normal Operation
Check
Enter Monitoring mode on the patient
monitor and check that all gas analyzer
related waves and numerics are present and
correspond to the user’s configuration.
Expected answer is "yes". If so,
performance normal operation
check is passed.
NO: P or
NO: F
where P=Pass and
F=Fail
Fan Check Check that the fan runs smoothly. Expected answer is "yes". FA: P or
FA: F
where P=Pass and
F=Fail
Mounting Integrity
Te s t
Perform the Mounting Integrity Test All quick mount screws are
tight. No damage to quick or fix
mount. No damage to threading
of G1/G5.
MI: P or
MI: F
where P=Pass and
F=Fail
Safety (1) Perform Safety Test (1): Protective Earth
resistance
With mains cable:
Maximum impedance (X1 ):
<= 300 mOhms)
S(1):P/X1 or
S(1):F/X1
where P=Pass and
F=Fail
Safety (2) Perform Safety Test (2): Equipment Leakage
Current -Normal Condition.
With mains cable:
Maximum leakage current (X1):
<= 100A
S(2):P/X1 or
S(2):F/X1
where P=Pass and
F=Fail
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