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MasterSwitch Power Distribution Unit User’s Guide 45
Product Information
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.
•
I
n 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 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.