Trace Engineering LEGEND II Manual page 90

As a general policy, Trace Engineering, Inc. does not recommend the use of any of its products in life
support applications where failure or malfunction of the Trace Engineering product can be reasonably
expected to cause failure of the life support device or to significantly affect its safety or effectiveness.
Trace Engineering, Inc. does not recommend the use of any of its products in direct patient care.
Trace Engineering, Inc. will not knowingly sell its products for use in such applications unless it
receives in writing assurances satisfactory to Trace Engineering, Inc. that (a) the risks of injury or
damage have been minimized, (b) the customer assumes all such risks, and the liability of Trace
Engineering, Inc. 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), autotransfusion 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 designated as "critical" by
the U.S. FDA.
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