American Power Conversion AP9312TH Life-Support Policy, General policy, Examples of, life-support

Life-Support Policy

General policy	As a general policy, American Power Conversion (APC) does
	not recommend the use of any of its products in the following
	situations:
	• 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 significantly
	affect its safety or effectiveness.
	• 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	The term life-support device includes but is not limited to
life-support	neonatal oxygen analyzers, nerve stimulators (whether used for
devices	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
	or 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 this 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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