Para Systems Life Support Policy
English
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.
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