多参数监护仪除颤防护测试与标记要求分析  

Requirements analysis on defibrillation protection testing and marking of multi-parameter monitor

作　　者：张文忠[1] 刘继广 李婧 邓振进 徐勤[5] 

机构地区：[1]广东省医疗器械质量监督检验所,广州510663 [2]国家医用诊断仪器工程技术研究中心,广东深圳518057 [3]国家食品药品监督管理局湖北医疗器械质量监督检验中心,武汉430075 [4]湖南省医疗器械与药用包装材料(容器)检测所,长沙410001 [5]深圳出入境检验检疫局,广东深圳518057

出　　处：《医疗卫生装备》2017年第12期124-126,151,共4页Chinese Medical Equipment Journal

基　　金：国家科技支撑计划(2015BAI10B00)

摘　　要：目的:探讨多参数监护仪除颤防护测试和标记的要求,以期帮助制造商理解相关标准,更合理地设计产品。方法:阐述监护仪除颤防护测试的背景原理,分析相关标准对除颤防护的测试及标记要求,对临床实际应用监护仪时的除颤防护流程进行研究。结果:如果多参数监护仪不满足除颤防护要求,在医疗中被错误使用,轻则导致设备损坏,重则导致患者除颤治疗失败甚至死亡,同时也会有引发医护人员电击事故的危险。结论:除颤防护是多参数监护仪重要的性能,只有在产品设计时全面理解标准要求、充分考虑合理可预见的临床应用场景,才能有效降低设备使用风险。Objective To study the requirements for defibrillation protection testing and marking of the multi-parameter monitor to facilitate the manufacturer to understand related standards and design products rationally. Methods The background and principle were described for defibrillation protection testing of the monitor. The requirements of related standards were analyzed for defibrillation protection testing and marking, and the defibrillation protection flow was explored during the clinical application of the monitor. Results The multi-parameter monitor might be damaged in case of the monitor's deficiencies in the the defibrillation protection, even patient's failure in the defibrillation protection or death might occur, and the electrical shock could be caused also to medical staffs. Conclusion The defibrillation protection is of great significance for the multi-parameter monitor, and considerations have to be posed on standards requirements and the monitor's clinical application so as to decrease its use risks.

关 键 词：多参数监护仪 医用电气设备 除颤 防护 标准 

分 类 号：R197.39[医药卫生—卫生事业管理]