Life Support Policy
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. FD
Copyright
Trace Engineering Co., Inc.
Telephone (360) 435-8826
Part Number 3471
5916 195th Street, NE
Fax (360) 435-2229
Released: Thursday, April 29, 1999
Arlington, WA 98223 USA
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