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

The term life-support device includes but is not limited to

life-support

neonatal oxygen analyzers, nerve stimulators (whether used for

devices

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.

APC Redundant Switch: Installation and Operation Manual

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American Power Conversion Redundant Switch operation manual Life-Support Policy