Life-support policy, General policy, Examples of life-support devices – APC NetworkAIR Rack Air Removal Unit ACF102BLK User Manual

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NetworkAIR Rack Air Removal Unit Installation

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.

a

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