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APC公司有关救生及生命保障设备的应用指南

发布日期: 04 十月 2012

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警告!救生设备

在由于 APC 产品的失效或故障会导致救生设备失效或明显影响其安全性或有效性的情况下,American Power Conversion Corporation 及其世界范围的关系企业和附属公司 (“APC”) 不建议在救生应用中使用任何其产品。APC 不允许在直接的病人护理中使用任何其产品。APC 不会有意出售其产品用于这些应用。

所谓救生设备包括但不限于新生儿用氧分析器、神经刺激器(不管是否用于麻醉、止痛或其它目的)、自体输血设备、血泵、去纤颤器、心律检波器和警报器、起博器、血液透析系统、腹膜透析系统、新生儿呼吸保育器、用于成人和婴儿的呼吸辅助器、麻醉呼吸器、输液泵以及任何被 U.S.F.D.A (美国食品和药物管理局)指定为“危急 (CRITICAL)”的其它设备。

医院级别配线设备和符合医疗安全标准的低泄漏电流可以在很多 APC 的 UPS 系统中作为可选部分订购,APC 并不表示这样修改过的设备为APC或其它机构所认证或评定的,因此这些设备并不满足直接病人护理的要求。

WARNING! Life Support

American Power Conversion Corporation, its affiliates and subsidiaries world-wide, (“APC”) do not recommend the use of any of their products in life
support applications where failure or malfunction of the APC product can be reasonably expected to cause failure of the life support device or to
significantly affect its safety or effectiveness. APC does not permit the use of any of its products in direct patient care. APC will not knowingly sell its
products for use in such applications.

Examples of devices considered to be life support devices include, but are not limited to, neonatal oxygen analysers, nerve stimulators (whether used for
anaesthesia, 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, anaesthesia ventilators, infusion pumps, and any
other device designated as “critical” by the U.S.F.D.A.

Hospital grade wiring devices and reduced leakage currents that meet medical safety standards may be ordered as options on many APC UPS systems. APC
does not claim that units with these modifications are certified or listed as such by APC or any other organization, therefore these units do not meet the
requirements for use in direct patient care.

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