©1999 Trace Engineering
Trace Engineering, Inc., does not recommend the use of any of its products in life support applications or
direct patient care. This especially applies to situations where the products failure or malfunction can be
reasonably expected to cause the failure or malfunction of the life support device, or to significantly affect its
safety or effectiveness.
Examples of life support devices include: 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.
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 (c) the liability of Trace Engineering, Inc., is ad-
equately protected under the circumstances.
8.0 LIFE SUPPORT APPLICATIONS-POLICY
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