APC REMOTE POWER-OFF DEVICE AP9830 - Manual (Page 29)

26 Remote Power-Off Device — Installation and Quick Start
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.
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.