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Analytic Systems does not recommend the use of its products in life support applications where failure or malfunction of this product can be reasonably expected to cause failure of the life support device or to significantly affect its safety or effectiveness. Analytic Systems does not recommend the use of any of its products in direct patient care.
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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