A-A-51867A
Condensed operating instructions and warning placards shall be mounted on the unit.
13. To prevent patient burns, The dispersive electrodes (disposable and reusable) shall disperse the return current over an adequately large area. A reusable dispersive electrode shall be supplied which shall resist scratching and be easily to clean. The electrodes shall not be adversely affected by surgical prep solutions or physiological fluids.
14. The unit shall have a dispersive electrode monitoring system to monitor the contact quality between the patient and the dispersive electrode.
15. A detection system shall be provided to monitor the electrical continuity of the current oath from dispersive electrode to the ESU. If a break occurs in this pathway, the ESU shall de-energize and activate a fault indicator until the unit is manually reset for normal operation.
16. The unit shall be convection cooled. A fan, which must be thermally activated, may be incorporated to provide adequate component cooling and to dissipate internal heat. If a fan is provided placement of ventilation openings shall deflect exhaust air downward and away from the sterile field. Position of vents shall not allow accidental contact with electrical connections or components, and shall be designed to restrict entry of spilled fluids.
17. Overcurrent protection for the ESU, preferably in the form of a circuit breaker, is required. If a fuse is used, a spare must be provided and clearly labeled as to function and rating. Circuit breakers must be protected from other objects impinging against in.
Unit shall meet UL 544 and ANSI/AAMI HF-16 Standards. All items shall conform to the applicable requirements of nationally recognized standards for the safety of medical equipment of the issue in effect on the date of solicitation. All items shall be approved as conforming to such a standard by an independent, nationally recognize testing laboratory.
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