Performance Verification Procedures 5: Performance Verification
169
NOTE: Test internal paddles (IEC Type CF) only if the device is used for internal defibrillation.
1 Connect a set of external paddles to the device.
a Make sure the metal surfaces of the paddles and slide-on adapters are clean and dry. Also make
sure the slide-on adapters are clean, shiny, and making good contact to the paddle surface.
b Put the paddles in the paddle tray.
2 Tu r n t h e T h e r a p y K n o b t o Monitor.
3 Verify that the PCI is not lit.
4 Take one paddle out of the paddle tray.
5 Verify that one red LED of the PCI flashes.
6 Replace paddle in tray and remove other paddle.
7 Verify that one red LED of the PCI flashes.
8 Take both paddles from the paddle tray and hold them firmly together, face to face (metal to metal).
Be sure the paddles are clean and are making good contact with one another.
9 Verify that all LEDs on the PCI are lit.
Safety Tests
This section discusses tests of the Efficia DFM100’s electrical safety. The Philips Safety test designation
for each test is provided for reference of Philips service personnel.
This section is organized into the following topics:
Te st Not e s . . . . . . . . . . . . . . . . . . . p. 169
Te st Met h o d . . . . . . . . . . . . . . . . . . p. 169
AC Mains (Ground Leakage) . . . . . . . . . . . . . . . p. 171
Chassis (Enclosure) Leakage . . . . . . . . . . . . . . . p. 171
Patient Lead Leakage . . . . . . . . . . . . . . . . p. 171
Test Notes
Efficia DFM100 complies with the international electrical safety standards:
– IEC 60601, Medical Electrical Equipment, General Requirements for Safety
To successfully complete Efficia DFM100 safety testing, please note the following:
• Use the procedures called out by the manufacturer of the safety analyzer in use.
• Only test the AC Mains (line) voltage used in the customer’s facility — there is no need to test both
120 V AC and 240 V AC.
• Test both Normal and Reverse Polarity line connections for each test, and record the worst case value.
• If a chassis reference point is needed for the testing, connect to the inside metal shaft on the ECG
Out (Sync) jack. (This is not earth ground).
Test Method
In order to establish a systematic maintenance plan, we recommend all safety tests and records shall be
made under the following circumstances: Upon reception of the Efficia DFM100, every year, and the
Efficia DFM100 is opened for repair.
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