A-A-54369
The system’s modules either used separately or together as an integral unit shall, as a minimum, comply with all applicable sections and requirements (not addressed herein), of the following publications (current editions):
* ANSI/AAMI DF2 - American National Standard for Cardiac Defibrillator Devices.
* UL 544- Standard for Safety of Electric Medical and Dental Equipment.
* NFPA 99 - Standard for Health Care Facilities.
* American Heart Association, AHA publication titled “Recommendations for Standardization of Specifications for Instruments in Electrocardiography and Vectorcardiography.”
All equipment must be capable of enduring environments the equipment is expected to experience in shipment, storage, service and use.
Atmospheric pressure – 19.5 in Hg to 30.1 in Hg
Relative Humidity (R.H.) – 95 percent (non-condensing)
Temperature:
Operational – 32°F to 114°F
Storage - -23°F to 149°F
All units shall be easily cleaned with available hospital cleansing solutions and adequately protected from moisture. The unit shall be of a rugged construction capable of withstanding hazards of normal use in a hospital setting such as shock and impact, frequently encountered in the hospital environment.
The total weight of the ECG Monitor/Recorder and Defibrillator, including the batteries, paddles, etc., shall not exceed forty (40) pounds.
ECG Monitor/Recorder:
1. Input. The unit shall be capable of providing an ECG through the defibrillator paddles or via a five (5) lead patient cable having a six (6) pin cable connector conforming to AAMI ECG - 5/83, Standard for ECG Connectors.
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