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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