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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
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摘要 目的:研究多导睡眠测量仪质量控制检测方法,确保其使用中性能的安全性与有效性。方法:针对多导睡眠测量仪的脑电信号、肌电信号、心电信号和脉搏血氧饱和度主要指标参数,设计质量控制检测方法。选取2023年8月陆军军医大学大坪医院临床在用的2台同品牌不同型号的多导睡眠测量仪(标记为测试设备A和测试设备B),采用心脑电图机检定仪和生命体征模拟仪进行多导睡眠测量仪质量控制检测,评估多导睡眠测量仪性能的可靠性。结果:针对多导睡眠测量仪的脑电信号、肌电信号、心电信号和脉搏血氧饱和度示值重复性制定质量控制检测方法进行多导睡眠测量仪质量控制检测,记录数据除测试设备B电压测量模拟仪输出值2 mV时,相对误差为-11%,出现参数超差,测试设备A和测试设备B的其余检测数据均满足国家计量检定规程和设备生产厂家技术要求的最大极限输出值。结论:多导睡眠测量仪质量控制检测方法能够对选取的测试设备A和测试设备B多导睡眠测量仪进行性能参数评估,为该类设备质量控制检测和使用安全提供技术支持。 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.
作者 黄靖 杨利 段傲文 徐力 杜振伟 龙恒宇 魏安海 潘克新 Huang Jing;Yang Li;Duan Aowen;Xu Li;Du Zhenwei;Long Hengyu;Wei Anhai;Pan Kexin(Department of Medical Engineering,Daping Hospital,Army Medical University,Chongqing 400042,China;Department of Stomatology,Shijiazhuang Medical College,Shijiazhuang 050062,China;School of Microelectronics and Communication Engineering,Chongqing University,Chongqing 400044,China)
出处 《中国医学装备》 2024年第5期123-127,共5页 China Medical 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 Polysomnography Voltage measurement Time interval Amplitude frequency characteristic Waveform frequency Quality control
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