Life Support Policy - Para systems ETR500 User Manual

Life Support Policy

As a general policy, we do not recommend the use of any of our products in life
support applications where failure or malfunction of the product can be reason-
ably expected to cause failure of the life support device or to significantly affect
its safety or effectiveness. We do not recommend the use of any of our prod-
ucts in direct patient care. We will not knowingly sell our products for use in
such applications unless it receives in writing assurances satisfactory to us
that (a) the risks of injury or damage have been minimized, (b) the customer
assumes all such risks, and (c) our liability is adequately protected under the
circumstances.
Examples of devices considered to be life support devices are neonatal oxygen
analyzers, nerve stimulators (whether used for anesthesia, pain relief, or other
purposes), auto transfusion devices, blood pumps, defibrillators, arrhythmia
detectors and alarms, pacemakers, hemodialysis systems, peritoneal dialysis
systems, neonatal ventilator incubators, ventilators for both adults and infants,
anesthesia ventilators, and infusion pumps as well as any other devices desig-
nated as "critical" by the United States FDA.
Hospital grade wiring devices and leakage current may be ordered as options
on many of our UPS systems. We do not claim that units with this modification
are certified or listed as Hospital Grade by us or any other organization. There-
fore, these units do not meet the requirements for use in direct patient care.
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