5: Performance Verification Performance Verification Procedures
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ECG Check
This section describes how to check the operation of the ECG functions. Each of the ECG checks
assumes the device and the simulator are still set up as they were at the end of the previous ECG check.
Setup
1 Set up the simulator:
a Connect a Therapy cable and ECG cable to the Efficia DFM100.
b Connect the ECG simulator to both the Therapy cable and the 3- or 5-lead ECG cable.
c Set the simulator for normal sinus rhythm (NSR), 1 mV amplitude, and 30 bpm.
2 Set up the Efficia DFM100:
Tu r n t h e T h e r a p y K n o b t o Monitor.
Check ECG Display, HR, Leads Off
1 Check the waveform.
Using the Lead Select button, verify that the display shows a clear waveform for all Leads and Pads.
2 Check the Heart Rate (HR).
Verify that the Heart Rate (HR) displayed is correct.
3 Check the alarms.
a Verify that the heart rate alarm sounds (assuming 30 bpm is below the configured lower limit).
b Set the simulator to 60 bpm.
Verify that the heart rate alarm stops.
4 Check the Leads Off condition.
a Using the Lead Select button, select Pads (or Paddles).
b Disconnect the ECG simulator from the Therapy cable and verify that the display shows a
dashed line in place of the waveform and that the device sounds an alert and displays the Press
“I, II..” Button to Select Another ECG Lead message
c If you are testing a 3-lead cable, use the Lead Select button to select Lead II.
NOTE: If you are testing anything other than a 3-lead ECG cable, make sure an ECG waveform appears
in Wave Sectors 1 and 2.
d If you are testing a 5-lead cable, select the V or V/C lead (depending on the electrode
configuration).
e Disconnect each of the ECG electrodes from the simulator one at a time, and verify that the
display shows a dashed line in place of the waveform when that electrode is disconnected.
f Verify that the device sounds an alert and displays the V Off, Check Limb Leads or Press “I,
II..” Button to Select Another ECG Lead message.
5 Repeat the above test, setting the simulator for normal sinus rhythm (NSR), 1 mV amplitude, at
200 bpm.
Verify that the heart rate alarm sounds (assuming 200 bpm is above the configured upper limit).
Check ECG Printing
1 Reconnect the simulator to the device as described in the Setup section above.
2 Press the Print button to print a strip.
a Verify that it shows a normal ECG with a clean baseline.
b Verify that the date, time, and configuration information printed at the top of the strip are
correct.