5: Performance Verification Test and Inspection Matrix
154
Functional Checks: In normal Clinical Mode, perform the following functional checks:
ECG (E) Using an ECG simulator, perform Leads
ECG and Pads cable ECG test. See “ECG
Check” on page 164.
If all checks pass, and all data within limits:
• Waveform clear on display
• HR correct on display and matches defib
analyzer at 2 data points: 30 and 200 bpm
• HR alarm works
• Leads off indicators perform as expected
• Cycles through different views
then ECG test passes.
E:x
Example E:p
SpO
2
(Sp) Using the SpO
2
sensor, perform SpO
2
check. See “SpO
2
Check” on page 165.
If pleth wave is clear, pulse rate is displayed,
and saturation reads between 95% -100%,
then SpO
2
check passes.
SP:x
Example Sp:p
NBP
Measurement
(NM)
Take a blood pressure measurement on
yourself or another person. See “NBP
Check” on page 165.
If you are able to complete a measurement,
the NBP check passes.
NM:x
Example: NM:p
Synchronized
Cardioversion
(SC)
Using an ECG simulator and defibrillator
analyzer, perform the “Synchronized
Cardioversion Test” on page 168.
If all checks pass, and all data within limits:
• Sync markers appear on the display, at the
peak or on the falling side of the QRS
• Shock delivered on next QRS
• Shock delivered 6 J ± 2 J
• If applicable, strip prints with the correct
information on it
• Delay between the peak of the QRS and
the delivered shock is <
30 ms
• If clinicians use an external monitor as the
ECG source, verify that the external
monitor and the device combination will
deliver a synchronized shock within 60 ms
of the peak of the R-wave.
then Synchronized cardioversion test passes.
SC:x
Example SC:p
Pacing Test
(P)
Using a defibrillator analyzer, perform the
“Pacer Test” on page 167.
• (70 ppm) 30 mA
• (180 ppm) 160 mA
If all checks pass, and all data within limits:
•30mA±5mA
•160mA±16mA
then Pacing test passes.
P:x
Example P:p
Table 33 Test and Inspection Matrix (Continued)
Tes t Gr o up
Name
Test or Inspection to Perform Expected Test Results Data to Record
x = p (pass)
or f (fail)