Hong Wei, Lu Lingfeng, You Ruiyuan
Shanghai Institute of Medical Device Testing, Shanghai, 201318.
BROADSIMS Inc., Shenzhen, 518111.
Zhongguo Yi Liao Qi Xie Za Zhi. 2021 Nov 30;45(6):684-688. doi: 10.3969/j.issn.1671-7104.2021.06.019.
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.
针对YY 0885-2013《医用电气设备 第2部分：动态心电图系统安全专用要求 包括基本性能》中的心电图性能指标，传统检测方法耗时且检测结果受人为因素影响较大。本文提出一种自动检测方法。基于单通道心电图记录仪设计并开发了一套心电图性能自动检测软件，并结合标准测试设备搭建了自动检测系统。然后，使用MSA工具分析检测系统的重复性和稳定性，结果表明该检测系统是可接受的，且能够提高检测效率。
