Test And Inspection Matrix
Performance Verification 9
Table 2 Test and Inspection Reporting
Test
1
1. Details of the tests are included later in this chapter.
Expected Results
What to Record
2
2. When authorized Philips Medical Systems personnel service the instru-
ment. The results are reported back to Philips. The collected data form a
database to be used in product development. It is not necessary for hospi-
tal personnel to report these results.
Visual: Inspect exterior
of monitor for damage
No Visual Damage V:P or V:F
Power-On Self-Test Displays Normal Monitoring
Screen Configuration and emits
tones
PO:P or PO:F
Basic Pneumatic
Leakage Test (NBP
test)
After 1 minute at approximately
250 mmHg, pressure drops no
more than 6 mmHg.
BPL: Px6
Where x6 =Pressure
Drop in mmHg
NiBP Accuracy Test 250 mmHg; ±5 mmHg
PN:P/X1…X4 (or X5
3
)
PN:F/X1…X4 (or X5
3
)
Record Pressure in
mmHg = X1
3. In the case of the NiBP Deflation Rate Test, applicable to the A3 only.
NiBP Leakage Test After 1 Minute at 250 mmHg,
pressure drops no more than
6 mmHg
Record Pressure
Drop in mmHg = X2
NiBP Inflation Rate
Test
Monitor Reports NiBP = 280
mmHg in <6 seconds
Record Time to
280 mmHg in
Seconds = X3
NiBP Overpressure
Test
Overpressure Deflation is
activated at a value between
280 mmHg to 330 mmHg
Record value in
mmHg at which
Overpressure
Deflation occurs =X4
NiBP Deflation Rate
Test (A3 only)
Monitor reports NiBP >10
mmHg and <190 mmHg
Record value in
mmHg on monitor at
1 min = X5
Safety Performance
Tests
All Safety Performance Tests
are in range of Table 5 to
Table 12
S:P or S:F
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