support device or to affect significantly its safety or effectiveness.
• In direct patient care.
APC will not knowingly sell its products for use in such applications unless it receives in writing assurances satisfactory to APC that (a) the risks of injury or damage have been minimized, (b) the customer assumes all such risks, and (c) the liability of APC is adequately protected under the circumstances.
Examples of life-support devices
The term life-support device includes but is not limited to 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 adults and infants), anesthesia ventilators, infusion pumps, and any other devices designated as “critical” by the U.S. FDA.
Hospital-grade wiring devices and leakage current protection may be ordered as options on many APC UPS systems. APC does not claim that units with these modifications are certified or listed as hospital- grade by APC or any other organization. Therefore these units do not meet the requirements for use in direct patient care.
Environmental Manager: Main Module | 29 |