基于单道心电记录仪的心电性能自动化检测系统  

Automatic Detection System of ECG Performance Based on Single Channel ECG Recorder

作　　者：洪伟 陆凌峰 游瑞元 HONG Wei;LU Lingfeng;YOU Ruiyuan(Shanghai Institute of Medical Device Testing,Shanghai,201318;BROADSIMS Inc.,Shenzhen,518111)

机构地区：[1]上海市医疗器械检验研究院,上海市201318 [2]博鑫资讯电子(深圳)有限公司,深圳市518111

出　　处：《中国医疗器械杂志》2021年第6期684-688,共5页Chinese Journal of Medical Instrumentation

摘　　要：针对YY 0885-2013《医用电气设备第2部分:动态心电图系统安全和基本性能专用要求》标准中的心电性能指标,传统的检测方法耗时、测试结果受人为因素影响大,提出一种自动化检测的方法,基于单道心电记录仪设计开发了一套心电性能自动化检验软件,结合标准测试设备搭建自动化检测系统,并采用MSA工具对该检测系统的重复性和稳定性进行分析,结果表明该检测系统可以接受,可提高检测效率。Aiming at the ECG performance indicators in the YY 0885-2013“Medical electrical equipment Part 2:Particular requirements for the safety including essential performance of ambulatory electrocardiographic systems”,the traditional detection methods are time-consuming and the test results are greatly affected by human factors.In this paper,an automated detection method is proposed.A set of automatic detection software for ECG performance is designed and developed based on a single-channel ECG recorder,and an automated detection system is set up in combination with standard testing equipment.And then,the MSA tool is used to analyze the repeatability and stability of the detection system,and the results show that the detection system is acceptable,and it can improve detection efficiency.

关 键 词：自动化 检测系统 心电性能 

分 类 号：R318[医药卫生—生物医学工程]