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Life-support policy, General policy, Examples of life-support devices – APC SMARTSLOT DP300E User Manual

Page 32: Examples of life-support devices 26

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Life-Support Policy

General policy

As a general policy,

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
affect significantly 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

Life-support devices include but are not limited to neonatal
oxygen analyzers, nerve stimulators (whether used for anes-
thesia, 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 both adults and infants, anesthesia ventilators, and infu-
sion pumps as well as any other devices designated as
“critical” by the

U.S. FDA

.

Hospital-grade wiring devices and leakage current protec-
tion 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 require-
ments for use in direct patient care.