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多参数监护仪除颤防护测试与标记要求分析

张文忠 刘继广 李婧 邓振进 徐勤

医疗卫生装备2017,Vol.38Issue(12):124-126,151,4.
医疗卫生装备2017,Vol.38Issue(12):124-126,151,4.DOI:10.7687/j.issn1003-8868.2017.12.124

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

张文忠 1刘继广 2李婧 3邓振进 4徐勤5

作者信息

  • 1. 510663广州,广东省医疗器械质量监督检验所
  • 2. 518057广东深圳,国家医用诊断仪器工程技术研究中心
  • 3. 430075武汉,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
  • 4. 410001长沙,湖南省医疗器械与药用包装材料(容器)检测所
  • 5. 518057广东深圳,深圳出入境检验检疫局
  • 折叠

摘要

Abstract

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

Key words

multi-parameter monitor/medical electrical equipment/defibrillation/protection/standard

分类

医药卫生

引用本文复制引用

张文忠,刘继广,李婧,邓振进,徐勤..多参数监护仪除颤防护测试与标记要求分析[J].医疗卫生装备,2017,38(12):124-126,151,4.

基金项目

国家科技支撑计划(2015BAI10B00) (2015BAI10B00)

医疗卫生装备

OACSTPCD

1003-8868

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