Life-Support Policy
General policy | As a general policy, American Power Conversion (APC) does |
| not recommend the use of any of its products in the following |
| situations: |
| • |
| the APC product can be reasonably expected to cause |
| failure of the |
| affect its safety or effectiveness. |
| • 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 adults |
| or infants), anesthesia ventilators, infusion pumps, and any |
| other devices designated as “critical” by the U.S. FDA. |
| |
| may be ordered as options on many APC UPS systems. APC |
| does not claim that units with this modifications are certified or |
| listed as |
| Therefore these units do not meet the requirements for use in |
| direct patient care. |
20
