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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