Minuteman SMARTSINE, User Manual

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Para Systems Life Support Policy
As a general policy, Para Systems Inc. (Para Systems) does not recommend
the use of any of its products in life support applications where failure or
malfunction of the Para Systems product can be reasonably expected to cause
failure of the life support device or to significantly affect its safety or
effectiveness. Para Systems does not recommend the use of any of its
products in direct patient care. Para Systems will not knowingly sell its
products for use in such applications unless it receives in writing assurances
satisfactory to Para Systems that (a) the risks of injury or damage have been
minimized, (b) the customer assumes all such risks, and (c) the liability of
Para Systems 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), 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
designated as “critical” by the United States FDA.
Hospital grade wiring and low leakage current devices may be ordered as
options on many Para Systems UPS systems. Para Systems does not claim
that units with this modification are certified or listed as Hospital Grade by Para
Systems or any other organization. Therefore, these units do not meet the
requirements for use in direct patient care.