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多导睡眠测量仪质量控制检测与性能评估

黄靖 杨利 段傲文 徐力 杜振伟 龙恒宇 魏安海 潘克新

中国医学装备2024,Vol.21Issue(5):123-127,5.
中国医学装备2024,Vol.21Issue(5):123-127,5.DOI:10.3969/j.issn.1672-8270.2024.05.024

多导睡眠测量仪质量控制检测与性能评估

Quality control testing and performance evaluation of polysomnography

黄靖 1杨利 1段傲文 1徐力 1杜振伟 1龙恒宇 2魏安海 3潘克新1

作者信息

  • 1. 陆军军医大学大坪医院医学工程科 重庆 400042
  • 2. 石家庄医学高等专科学校口腔医学系 石家庄 050062
  • 3. 重庆大学微电子与通信工程学院 重庆 400044
  • 折叠

摘要

Abstract

Objective:To research the quality control and testing methods of polysomnography and to ensure its safe and effective performance.Methods:A quality control testing method was designed for the main indicators of EEG signal,EMG signal,ECG signal,and pulse oxygen saturation of polysomnography.In August 2023,two polysomnography instruments of the same brand and different models(marked as Test Equipment A and Test Equipment B)in clinical use in Daping Hospital,Army Medical University were selected.The quality control testing of polysomnography instrument was conducted by using electroencephalogram calibration instrument and vital sign simulator to evaluate the reliability of the performance of polysomnography.Results:A quality control testing method was developed for quality control testing of polysomnography aiming at the repeatability of the indicated values of EEG signals,EMG signals,ECG signals,and pulse oxygen saturation of polysomnography.Except for the output value of 2 mV of the voltage measurement simulator of test equipment B,the relative error of the recorded data was-11%,and the parameters were out of tolerance,and the rest of the test data of test equipment A and test equipment B met the maximum limit output value of the national metrology verification regulations and the technical requirements of the equipment manufacturer.Conclusion:The quality control detection method of polysomnography can evaluate the performance parameters of the selected testing equipment A and testing equipment B,and provide technical support for the quality control detection and safe use of such equipment.

关键词

多导睡眠测量仪/电压测量/时间间隔/幅频特性/波形频率/质量控制

Key words

Polysomnography/Voltage measurement/Time interval/Amplitude frequency characteristic/Waveform frequency/Quality control

分类

医药卫生

引用本文复制引用

黄靖,杨利,段傲文,徐力,杜振伟,龙恒宇,魏安海,潘克新..多导睡眠测量仪质量控制检测与性能评估[J].中国医学装备,2024,21(5):123-127,5.

中国医学装备

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1672-8270

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