Research and Practice of Quality Control Management of Digital Electrocardiograph
MAI Dacheng1a,2, XIAO Xiang1b, LAO Wanyi3, HUANG Jin3, CHEN Yuanpeng3, WANG Yongsheng1a,2
1. a. Department of Equipment; b. Office of Administrative, Guangzhou Panyu Central Hospital, Guangzhou Guangdong 511400,
China; 2. Guangdong Primary Hospital Medical Device Management Branch, Guangzhou Guangdong 510515, China; 3. Electrical
Science Office, Guangzhou Panyu Quality and Technical Supervision and Testing Institute, Guangzhou Guangdong 511400, China
Abstract：Objective To study and formulate the independent quality control and detection method of digital electrocardiograph
in line with the application scenario of medical institutions, combined with the clinical application needs and concerned indicators
of digital electrocardiograph, to guarantee the function of digital electrocardiogram machine and improve the qualified rate of
strong detection of measurement. Methods Taking the analysis of the forced inspection of digital electrocardiograph in the Quality
and Technical Supervision and testing institute of the district in recent three years as the starting point, combined with manual
inspection, simulator and other detection tools, qualitative detection and quantitative detection were carried out from the seven
dimensions of instrument appearance, daily management and startup inspection, internal calibration voltage error, input voltage
range, weighting coefficient error, waveform recognition ability and amplitude time parameter measurement, ECG measurement
error. Results Through the quality control test management measures of digital electrocardiographs, the number of unqualified
digital electrocardiographs in our hospital decreased from 10 in 2019 to 1 in 2021. On the basis of ensuring the effectiveness of the
test results, the quality control test time was shortened from (43±6) min to (21±4) min (P<0.05) by simplifying the test content and
combining the control test method with the quality control test report. Conclusion The quality control of digital electrocardiograph
can find the hidden dangers of digital electrocardiograph and solve them in advance, so as to ensure the performance of the equipment
and meet the needs of clinical diagnosis, and provide a strong guarantee for clinical accurate monitoring of patients’ physiological
parameters.
麦达成1a,2，肖翔1b，劳婉仪3，黄劲3，陈远鹏3，王永胜1a,2. 数字心电图机质控管理研究与实践[J]. 中国医疗设备, 2022, 37(12): 119-123.
MAI Dacheng1a,2, XIAO Xiang1b, LAO Wanyi3, HUANG Jin3, CHEN Yuanpeng3, WANG Yongsheng1a,2. Research and Practice of Quality Control Management of Digital Electrocardiograph. China Medical Devices, 2022, 37(12): 119-123.
