10
Life-Support Policy
General policy 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
deviceor to significantly affect its safety or effectiveness. APC
does not recommend the use of any of its products in direct
patientcare. APC will not knowingly sell its products for use in
such applications unless itreceives 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)t he liability of American Power Conversion is adequately
protected underthe circumstances.
Examples of
life-support
devices
Thet erm life-supportdevice includes but is not limited to:
neonataloxygen analyzers, nerve stimulators (whether used for
anesthesia, pain relief,or other p urposes), autotransfusion
devices, blood pumps,d efibrillators, arrhythmiadetectors and
alarms, pacemakers,hemodialysis systems, peritoneal dialysis
systems, neonatal ventilator incubators, ventilators for both
adults and infants,a nesthesia ventilators, infusion pumps and
any other devices designated as “critical”by the U.S.FDA.
Hospital-gradewiring and leakage current protection may be
ordered asoptions onmany APC U PS systems. APC does not
claimthat unitswith these modifications are certified orlisted
asHospital Grade by APC or any other organization. Therefore
theseunits do not meet the requirements for use in direct
patient care.