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USER’S GUIDE
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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 devices
The term life-support device includes but is not limited to neonatal 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.