APC AP9612TH Datenblatt PDF herunterladen (Seite 17)

Environmental Monitoring Card 13

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

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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