APC AP9218 User Manual
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Product Information

Life-SupportPolicy

General policy

American Power Conversion (APC) does not recommend the use of any

 

of its products in the following situations:

 

• In life-supportapplications where failure or malfunction of the

 

APC product can be reasonably expected to cause failure of the

 

life-supportdevice 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-

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

support 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 or infants), anesthesia ventilators,

 

infusion pumps, and any other devices designated as “critical” by the

 

U.S. FDA.

 

Hospital-gradewiring 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-gradeby

 

APC or any other organization. Therefore these units do not meet the

 

requirements for use in direct patient care.

MasterSwitch Power Distribution Unit User’s Guide

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