A-A-54369
Strain relief test. Gradually apply a 35 lb. pull in a direction that would be the most likely to pull the cord from the enclosure and maintain for one minute. The strain relief is not acceptable if there is such movement of the cord as to indicate that stress is being transmitted to terminals, splices or interior wiring.
Air clearance spacing test. Measurements shall be made using an appropriate measuring instrument, to verify isolated patient connected circuitry is spaced at least 1/8 inch from non-isolated circuitry.
Defibrillator paddle insulation test. Apply aluminum foil to the entire gripping surface of one paddle with sufficient pressure to make it conform to the surface.
With the paddles connected to the defibrillator, connect the high potential lead of a 60 Hz (or 50 Hz, if preferred) high potential test source to the aluminum foil. Connect low-potential or ground lead to the paddle electrode. Slowly adjust the peak voltage amplitude of the test source to equal 1.5 times the maximum voltage occurring on the defibrillator energy stored capacitor. Maintain the voltage for 1 minute.
Repeat this test with the low-potential lead connected to the other paddle electrode.
There shall be no voltage breakdown, and the 60 Hz leakage current shall not exceed 250 UA peak (177 UA rms); if a 50 Hz test source is used, the current shall not exceed 210 UA peak (148 UA rms).
ECG monitor/recorder sweep/chart speed test. Measure the monitor sweep speed and the recorder paper speed by applying a signal of known frequency to the patient cable. Monitor and recorder chart sweep speed shall be within plus or minus 10 percent and plus or minus 5 percent of 25 mm/see respectively.
ECG amplifier calibration test. The accuracy of the 1 mV internal calibration pulse shall be measured by comparing the amplitude of this pulse to a pulse applied to the patient cable from a pulse generator. It shall be accurate to plus or minus 15 percent.
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