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Life-support policy, General policy, Examples of life-support devices – APC Switched Rack Power Distribution Unit (PDU) User Manual

Page 87: User ’s guide, Switched rack pdu

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USER

’S GUIDE

switched rack pdu

83

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.

aa

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.