Environmental Manager: Main Module 29
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 th at (a) the risks of
injury or damage have been minimized, (b) the
customer assumes all such risks, and (c) the liability
of APC 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 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
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.