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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:
• 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.
• 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 adults
or infants), anesthesia ventilators, infusion pumps, and any
other devices designated as “critical” by the
U.S. FDA
.
Hospital-grade wiring devices and leakage current protection
may be ordered as options on many
APC UPS
systems.
APC
does not claim that units with this 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.