A-A-54369
ECG amplifier CMRR test. Common mode rejection is measured by comparing the amplitude of a 1 mV differential signal applied to the monitor to the amplitude of a higher voltage sinusoidal signal of 60 Hz applied between the junction of the leads and ground. Measured common mode rejection shall be at least 100 db with respect to chassis ground with 5 k ohms imbalance between leads.
Defibrillator energy accuracv test. Connect the defibrillator paddles to a defibrillator analyzer equipped with a 50 ohm resistive load. Charge the defibrillator to a preselected energy level, then discharge into the analyzer. Repeat for each available energy level setting. Measure and record data. Measured energy must be within plus or minus 15 percent (or 4 joules, whichever is greater) of the selected energy.
Defibrillator charge time test. Using a stopwatch, measure the time between activation of the charge control and full charge indication for the first and last of 10 sequential charges and discharges all at 320 joules or above. This time shall not exceed 10 seconds.
Synchronized discharge test. Connect a signal generator to the ECG monitor. Measure the time between the leading edge of square pulse and the leading edge of the defibrillator’s synchronized discharge pulse. This time can be displayed automatically on a defibrillator analyzer if so equipped, or measured directly from an oscilloscope, and shall be within 30 milliseconds.
ECG monitor and recorder frequency response test. Apply a 1 mV peak to peak differential sinusoidal signal to the patient cable, and vary the frequency. The bandwidth is defined-by the upper and lower frequencies at which the trace deflection amplitude decreases to 0.707 times the maximum value. This bandwidth shall be 0.5 Hz to 30 Hz on the cardioscope and 0.05 to 100 Hz on the recorder.
Humidity test. Place the unit in test chamber such that leakage current and delivered energy accuracy test can be performed external to the chamber.
Adjust the temperature of the chamber to 820F.
Permit sufficient time for the temperature “inside the unit” to stabilize prior to proceeding.
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