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

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

devices

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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Switched Rack PDU Installation and Quick-Start Manual

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American Power Conversion P D U, AP8841 Life-Support Policy, General policy, Examples of life-support, Devices