Abstract:
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.