American Power Conversion AP9554 Power Supply User Manual


 
11
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
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
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 both
adults and infants, anesthesia ventilators, infusion pumps and
any other devices designated as criticalby the
U.S
.
FDA
.
Hospital-grade wiring 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.