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Life-support policy, General policy, Examples of life-support devices – American Power Conversion AP9559 User Manual

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Basic Rack Power Distribution Unit

9

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.

I

n 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 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.