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Life-support policy, General policy, Examples of life- support devices – APC Network Management Card none User Manual

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Network Management Card User’s Guide

63

Product Information

Life-Support Policy

General policy

As a general policy, American Power Conversion (

APC

) does not

recommend the use of any of its products 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 significantly
affect its safety or effectiveness.

APC

does not recommend the use of

any of its products 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 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.