Requirements analysis on defibrillation protection testing and marking of multi-parameter monitor
10.7687/j.issn1003-8868.2017.12.124
- VernacularTitle:多参数监护仪除颤防护测试与标记要求分析
- Author:
Wen-Zhong ZHANG
1
;
Ji-Guang LIU
;
Jing LI
;
Zhen-Jin DENG
;
Qin XU
Author Information
1. 广东省医疗器械质量监督检验所
- Keywords:
multi-parameter monitor;
medical electrical equipment;
defibrillation;
protection;
standard
- From:
Chinese Medical Equipment Journal
2017;38(12):124-126,151
- CountryChina
- Language:Chinese
-
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.