5: Performance Verification Performance Verification Procedures
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4 Check the output on the defibrillator analyzer. The output should read 180 + 1.5% ppm and
140 +
14 mA.
Synchronized Cardioversion Test
This section describes how to check the synchronized cardioversion function.
NOTE: Whenever possible, we recommend that clinicians perform synchronized cardioversion procedures while
directly monitoring the patient through the Efficia DFM100’s electrodes or lead inputs.
If clinicians use an external monitor as the ECG source, you must verify that the external monitor and
the Efficia DFM100 combination will deliver a synchronized shock within 60 ms of the peak of the
R-wave. Use a 1 mV QRS complex with a QRS width of 40 ms. This performance cannot be guaranteed
with all commercially available monitors.
Setup
1 Set up the defibrillator analyzer.
a Connect the ECG cable and the Pads cable to the Efficia DFM100.
b Connect the ECG cable to the analyzer.
c Connect the Pads cable to the analyzer.
d Set the analyzer to take a energy measurement, waveform NSR, 1 mV amplitude, 60 bpm).
e Set the analyzer to take a synchronized measurement, waveform NSR, 1 mV amplitude,
60 bpm).
2 Set up the Efficia DFM100.
a Turn the Therapy Knob to 1-10 J.
b Press the Sync button. Check that a Sync message appears in the upper right corner of
Wave Sector 1.
Check Display, Shock, Print
1 Check the displayed waveform.
Verify that sync markers appear on the display, at or near the peak of the QRS complex. Adjust the
size of the displayed ECG as needed to view it more clearly.
TIP: To adjust the size of the displayed ECG, navigate the following menus:
Menu –> Displayed Waves –> select Wave1 or Wave 2 –> I, II, or III –> select size.
2 Check shock delivery.
a Select an energy of 6 J.
b Press the Charge button.
c Press and hold the Shock button until the shock is delivered (at next QRS).
d Verify on the defibrillator analyzer that the shock was delivered, and was 6 ± 2 J. (see step d in
set up the defibrillator analyzer.)
e If the device is configured to do so, verify that it prints a strip with the correct information on it
(waveform, text, shock).
f Verify on the defibrillator analyzer that the delay between the peak of the QRS and the delivered
shock was <
30 ms. (see step e in set up the defibrillator analyzer.)
Paddles Safety Check
This section describes how to test the paddles to ensure they are connected correctly. This test checks the
Patient Contact Indicator (PCI) function of the paddles. The PCI measurement is used to detect Pads
Off and Paddles Off, and to illuminate the PCI LEDs on PCI-equipped paddle sets. If all results are as
described, the device passes that portion of the test.
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