Life-support policy, General policy, Examples of life-support devices – APC AP9924 User Manual

Page 18

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16

Wire Harness: 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.

• 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 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.

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