A-A-54496
The display shall indicate heart rate, pacing rate, output current, low battery status and alarm, ECG lead and pacer electrode fault, and a “battery charging” indicator display to allow the operator to determine if the unit is operating from AC line power or battery. The battery shall be a rechargeable, sealed lead acid type with an operating time of at least two hours.
The weight of the pacemaker shall be no more than 9 kilograms (20 pounds). The pacemaker shall have an alarm that sounds when an electrode becomes detached. It shall include a recorder with a frequency response of 0.5 to 30 Hz, plus or minus 3 dB. The pacemaker shall have a 1 mv calibration signal. The recorder shall be a single channel hot stylus type using 10 mm grid with thermal paper. The recorder shall operate with a 4 to 8 seconds delay.
The pacemaker shall have the capability to recharge its battery while in operation via line power.
The pacemaker shall be supplied with a case.
The pacemaker specifications shall meet all pertinent ANSI, AAMI, CSA, and ANSI/NFPA99 standards for patient and operator safety.
The pacemaker shall include all necessary auxiliary power cables and user operating directions. It shall be shielded against radio frequency interference (RFI). The pacemaker shall have an operating adjustable OPS detection sensitivity.
The electrical characteristics of the pacemaker shall be 120/230 volt, 50/60 Hz.
Workmanship. The cardiac pacemaker shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Each (EA). One cardiac pacemaker, as specified, constitutes one unit.
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