24 PDU: User’s Manual
Life-Support Policy
General policy American Power Conversion (APC) does not recommend the
use of any of its products in the following situations:
• 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 affect significantly
its safety or effectiveness.
•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.
a
a
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
and 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.
a