Policy with regards to using APC by Schneider Electric UPS on Life Support Products

Issue:
Policy with regards to using APC by Schneider Electric UPS on Life Support Products

Product:
Single Phase Back-UPS, Smart-UPS

Environment:
Global information about APC UPS units

Recommendation/Solution:

As a general policy, American Power Conversion (APC) does not recommend the use of any of its products 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 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:

1. the risks of injury or damage have been minimized
2. the customer assumes all such risks, and;
3. the liability of American Power Conversion is adequately protected under the circumstances.

Examples of devices considered to be life support devices are

• 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 both adults and infants
• anesthesia ventilators
• infusion pumps, and;
• any other device designated as critical by the U.S.F.D.A.

NOTE : Hospital grade wiring devices and reduced leakage currents that meet medical safety standards may be ordered as options on many APC UPS systems. APC does not claim that units with these modifications are certified or listed as such by APC or any other organization, therefore these units do not meet the requirements for use in direct patient care.

Gepubliceerd voor:Schneider Electric Belgium