American Power Conversion AP7922 Life-Support Policy, General policy, Examples of life-support

Life-Support Policy

General policy	American Power Conversion (APC) does not recommend the use of any
	of its products in the following situations:
	•	In life-support applications where failure or malfunction of the
		APC product can be reasonably expected to cause failure of the
		life-support device or to affect significantly its safety or
		effectiveness.
	•	In direct patient care.
	APC will not knowingly sell its products for use in such applications
	unless it receives in writing assurances satisfactory to APC that (a) the
	risks of injury or damage have been minimized, (b) the customer
	assumes all such risks, and (c) the liability of American Power
	Conversion is adequately protected under the circumstances.
Examples of life-support	The term life-support device includes but is not limited to neonatal
devices	oxygen analyzers, nerve stimulators (whether used for anesthesia, pain
	relief, or other purposes), autotransfusion devices, blood pumps,
	defibrillators, arrhythmia detectors and alarms, pacemakers,

hemodialysis systems, peritoneal dialysis systems, neonatal ventilator incubators, ventilators (for adults and infants), anesthesia ventilators, infusion pumps, and any other devices designated as “critical” by the U.S. FDA.

Hospital-grade wiring devices and leakage current protection may be ordered as options on many APC UPS systems. APC does not claim that units with these modifications are certified or listed as hospital-grade by APC or any other organization. Therefore these units do not meet the requirements for use in direct patient care.

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