A-A-54369
e. Calibration. Momentary 1 millivolt signal to preamplifier.
f. Leakage current. The unit shall have an electrically isolated patient input circuit and leakage currents in accordance with the latest edition of ANSI/AAMI ES1, Safe Current Limits for Electromedical Apparatus.
4. Recorder. The recorder shall be an integral part of the monitor module. A stand-alone instrument requiring interconnecting cabling, or integral with the defibrillator module, shall not be acceptable. The recorder stylus position shall be adjustable and capable of being changed by the operator. The recorder display shall have the following characteristics:
a. Paper size. 1.97 in width x 100 ft, 0.04 in x 0.2 in ruled squares.
b. Paper speed. 1 in/second
c. Low warning. Visual end of roll marking shall appear on paper no less than three feet (3 ft) from the end.
d. Recorder modes. Real time and delayed by approximately 5 seconds.
e. Frequency response. 0.05 HZ to 100 Hz (real), 0.5Hz to 40 Hz (delay).
5. Heart rate meter. The heart rate meter shall have the following characteristics:
a. Rate detector: Operate with patient-generated R-wave; positive or negative polarity.
b. Rate display: 3 digit LED or equivalent digital display.
c. Range: At least 30 to 240 beats/minute, 5 percent accuracy.
d. Alarm range: Adjustable, minimum range 30 to 240 BPM: high and low settings.
e. Update frequency: 2-5 seconds - shall not be affected by activation of freeze control, if provided.
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