A-A-54368
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 sweep speed shall be within plus or minus 10 percent of 25 mm/see and recorder chart speed within plus or minus 5 percent of 25 mm/sec.
ECG Amplifier Calibration test.
The accuracy of the 1 mV internal calibration pulse shall be measured by comparing the amplitude of this pulse to that of a calibrated 1 mV pulse applied to the patient cable from a pulse generator. It shall be accurate to plus or minus 15 percent.
ECG Amplifier Common Mode Rejection 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. 14easured common mode rejection shall be at least 80 dB with respect to chassis
ground with SK ohms imbalance between leads.
Defibrillator Overload Protection test.
Overload protection shall comply with those requirements specified in ANSI/AAMI EC 13.
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 value. This bandwidth maximum shall be 0.5 Hz to anywhere between 35 to 50 Hz inclusive, on the monitor and recorder, real time mode.
Defibrillator Energy Accuracy 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.
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