Life-Support Policy
General policy | As a general policy, American Power Conversion (APC) does |
| not recommend the use of any of its products in |
| applications where failure or malfunction of the APC product |
| can be reasonably expected to cause failure of the |
| device or to significantly affect its safety or effectiveness. APC |
| does not recommend the use of any of its products 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 |
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 both |
| adults and infants, anesthesia ventilators, infusion pumps and |
| any other devices designated as “critical” by the U.S. FDA. |
| |
| 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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