基于多参数监护仪的计量校准方法研究
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摘要
随着现代医疗技术和相关学科的不断发展,医用计量电子信息设备广泛在医院应用。由于多参数监护类设备能24小时对病人心电、心率、血压、体温、呼吸及血氧饱和度等生理参数的进行监测、分析和记录,已经成为医院使用的最多的仪器,因此多参数监护仪的计量校准方法研究在医院中起着越来越重要的作用。
本文针对医用多参数监护仪的测量技术、计量检测校准方法,主要包括计量软件系统方面进行了校准规范方面的研究。针对多参数监护仪的主要监护参数,如血氧饱和度、无创血压、呼吸末二氧化碳分压、有创心排量等目前还没有相应的国际国内计量检测标准、制造标准,本文结合自己多年的医用计量器具检测校准的工作实践和工作经验,通过大量的计量校准实验数据,重点研究了多参数监护仪主要监护参数的计量检测校准方法,为我国建立统一的多参数监护仪量值校准方法提供了依据。
研究完成的多参数监护仪的检测校准技术和方法能有效地检验监护参数测量的准确性和安全性,确保多参数监护仪准确、有效、安全、可靠。校准技术和方法已经在邵阳市计量部门的计量校准检测工作中得到了实施和应用,成为了邵阳地区医学计量的行业标准,进一步为我国的医学计量的行业发展奠定了基础。
With the develepment of modern medical technology and related disciplines, electronic signal equipments for medical measurement are widely used in the hospital. Multi-parameter monitoring equipment which can monitor, analyze and record 24 hours of the patient ECG, heart rate, blood pressure, body temperature, respiration and blood oxygen saturation and other physiological parameters has become the most important equipment used in the hospital, therefore the research of calibration method of multi-parameter monitor has played an increasingly important role in the hospital.
This thesis does the calibration standard research on measurement technology of medical multi-parameter patient monitor, metrology calibration method, mainly on the side of measuring software system. At present, some main monitoring parameters of the multi-parameter monitor such as oxygen saturation, noninvasive blood pressure, end respiratory carbon dioxide partial pressure, invasive cardiac output have not the appropriate domestic and international testing standards, manufacturing standards. Combined with my work experience on medical calibration of measuring instruments, the thesis focuses on the metrology calibration of monitoring parameters of the multi-parameter monitor through a large number of measurement and calibration test data, and provides a basis for our country to eastablish the calibration methods of multi-parameter monitor.
Completion of the study of multi-parameter monitor calibration techniques and methods of detection can effectively test the parameters in monitoring the accuracy and security, ensure multi-parameter monitor's accuracy, effectiveness, safety, reliability. The calibration technology and methods of multi-parameter monitor in the thesis which have been used in calibration testing work of Shaoyang measurement department, The calibration methods have become the industry standard of medical measurement in Shaoyang, and lay a foundation for the development of our country's medical measurement industry.
本文针对医用多参数监护仪的测量技术、计量检测校准方法,主要包括计量软件系统方面进行了校准规范方面的研究。针对多参数监护仪的主要监护参数,如血氧饱和度、无创血压、呼吸末二氧化碳分压、有创心排量等目前还没有相应的国际国内计量检测标准、制造标准,本文结合自己多年的医用计量器具检测校准的工作实践和工作经验,通过大量的计量校准实验数据,重点研究了多参数监护仪主要监护参数的计量检测校准方法,为我国建立统一的多参数监护仪量值校准方法提供了依据。
研究完成的多参数监护仪的检测校准技术和方法能有效地检验监护参数测量的准确性和安全性,确保多参数监护仪准确、有效、安全、可靠。校准技术和方法已经在邵阳市计量部门的计量校准检测工作中得到了实施和应用,成为了邵阳地区医学计量的行业标准,进一步为我国的医学计量的行业发展奠定了基础。
With the develepment of modern medical technology and related disciplines, electronic signal equipments for medical measurement are widely used in the hospital. Multi-parameter monitoring equipment which can monitor, analyze and record 24 hours of the patient ECG, heart rate, blood pressure, body temperature, respiration and blood oxygen saturation and other physiological parameters has become the most important equipment used in the hospital, therefore the research of calibration method of multi-parameter monitor has played an increasingly important role in the hospital.
This thesis does the calibration standard research on measurement technology of medical multi-parameter patient monitor, metrology calibration method, mainly on the side of measuring software system. At present, some main monitoring parameters of the multi-parameter monitor such as oxygen saturation, noninvasive blood pressure, end respiratory carbon dioxide partial pressure, invasive cardiac output have not the appropriate domestic and international testing standards, manufacturing standards. Combined with my work experience on medical calibration of measuring instruments, the thesis focuses on the metrology calibration of monitoring parameters of the multi-parameter monitor through a large number of measurement and calibration test data, and provides a basis for our country to eastablish the calibration methods of multi-parameter monitor.
Completion of the study of multi-parameter monitor calibration techniques and methods of detection can effectively test the parameters in monitoring the accuracy and security, ensure multi-parameter monitor's accuracy, effectiveness, safety, reliability. The calibration technology and methods of multi-parameter monitor in the thesis which have been used in calibration testing work of Shaoyang measurement department, The calibration methods have become the industry standard of medical measurement in Shaoyang, and lay a foundation for the development of our country's medical measurement industry.
引文
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[23]李建林.多参数监护仪的测量原理及正确使用方法[J].医疗装备,2008,(3)：13-14
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[33]王义山.多参数监护仪血压参数的检验校准方法探讨[J].中国计量,2008,(2)：81-82
[34]杨鹿.多参数监护仪应为强制检定的计量器具[J].计量与测试技术,2008,35(2)：60-61
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[38]梁宏谦.对多参数监护仪计量监督若干问题的探讨[J].中国计量,1999,38(1)：16-17
[39]王正.监护仪的基本测量原理及中央监护系统[J].医疗装备,2002,(5)：33-34
[40]FBC. MPS450 Multiparameter Simulator Operators Manua. FBC,2006, (1):1-14
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[42]贾建革.医学计量实用检测技术[M].北京中国计量出版社,2006,(3)：87-97
[43]CAO Yuzhen, DING Beisheng. Determining the saltation edges of the differential ECG by wavelet transform [J]. Journal of Tianjing University,2001,34(5): 601-604
[44]WANG Hongqiang, SUN Jixiang. Wavelet transform and data fusion based algorithm for precision detection of QRS complex in multi lead ECG signals[J]. Journal of National University of Defense Technology,1999,21(4): 87-90
[45]燕金元.关于几种无创测量血压方法的探讨[J].世界医疗器械,1998,4(7)：35-37
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[48]国家质量技术监督局戴孝华等.JJG692-1999数字式电子血压计(静态)检定规程.北京中国计量出版社,2008,(11)：11
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[2]Kevin H, and Zhang YT. Implementation of a WAP-based telemedicine system for patient monitoring. IEEE Transactions on Information Technology in Biomedicine, 2003,7(2):101-107
[3]Zhao XM, Fei DY, Dorn C, et al. A telemedicine system for wireless home healthcare based system for out-of-hospital follow-up of cardiac patients. IEEE Transactions on Information Technology in Biomedicine,2005,9(1):73-85
[4]Drazen JM, Campion EW. Severe Acute Respiratory Syndrome. N Engl J Med,2003, (348):1589
[5]World Health Organization. Cumulative Number of Reported Probable Cases. World Health Organization,2003, (4):23
[6]孙志奎,罗斌.医用多参数监护仪测量原理与日常维护[J].医疗装备,2007,20(3)：52-53
[7]郭勇.医学计量[M].北京中国计量出版社,2002,(2)：287-290
[8]夏黎明.多参数监护仪的基本性能及应用[J].医疗设备信息,2007,22(10)：56-57
[9]KY Kong, CY Ng, Kong. Web-Based Monitoring of real-time ECG date. IEEE Computers in Cardiology,2000,38(2):29-42
[10]丁康,曹铁生,段云友,袁丽君.呼吸和心动周期对正常人股总静脉血流频谱影响的初步研究[J].中华超声影像学杂志,2004,13(5)：348-349
[11]Hamilton PS, Tompkin WJ. Quantitative Investigation of QRS Detection Rules Using the MIT/BIH Arrhythmia Database. IEEE Trans BiomedEng,1991, (33): 57-87
[12]J.B.Martin, T.GDenis. A Micro-processor Dry-Electrode ECG Preamplifer. IEEE Trans on Biology and Medical Engineering,2000,47(2):155-162
[13]Alireza K, Ziarani, Adalbert Konrad. A nonlinear adaptive method of elimination of power line interference in ECG signals. IEEE Transaction Biomedical Engineering, 2002,49(6):540-547
[14]Harbin Wang, JinZhi Cheng. The Elimination of 50Hz Interference from the ECG Using Improved Levkov Method. Satellite Symposium of The 20th Annual International Conference of The IEEE Engineering in Medicine and Biology Society. Beijing,2004, (10):159-160
[15]Anna Esposito. An adaptive Learning algorithm for ECG noise and baseline drift removel. Neural nets,2003,37(3):139-147
[16]Hung TL, Van Arsdel WC. Automated Analysis of Rodent Threechannel Electocardiograms and Vectocardiograms. IEEE Trans,1985,32(1):56
[17]J.Y.Lee, E.Y. Choi. Blood Pressure Measurement Using Finger Cuff. Engineering in Medicine and Biology 27th Annual Conference,2005, (9):1-4
[18]Byra-Cook C., et al. Direct and Indirect Blood Pressure in Critical Care Patients. Nursing Research,1990,39(5):285-288
[19]Chin-Teng Lin. Reducinon of Interference in Oscillometric Arterial Blood Pressure Measurement Using Fuzzy Logic. IEEE Transactions on Biomedical Engineering, 2003,50(4):50
[20]朱培清,陈真诚.多参数监护仪无创血压测量特性的检测校准[J].工业计量,2009,19(5)：3-6
[21]McCormick PW, Melville S,Mark G,. G., et al. Regional cerebrovascular saturation measured by optical spectrospecopy in humans. Stroke,1991, (22):1-5
[22]Eiji Toba, Sadamu Sekiguchi. Non-Invasive Measurement System for Human Respiratory Condition and Body Temperature. Proceedings of the 1994 IEEE Intermational Conference on Multisensor Fusion and Integation for Intelligent Systems,1994, (11):2-5
[23]李建林.多参数监护仪的测量原理及正确使用方法[J].医疗装备,2008,(3)：13-14
[24]Rosell J, Webster J G Signal-to-motion artifact ratio versus frequency for impedance pneumograohy. IEEE Trans BMEI,1995, (42):321-323
[25]Javier R, Kevin P C, John G W. Reduction of motion artifactsusing a two-frequency impedance plethysmograph and adaptivefiltering. IEEE TransBME, 1995,(42):1044-1048
[26]王忠岳.经鼻呼气末二氧化碳监测用于臂丛神经阻滞的临床观察[J].中医正骨,2009,21(12)：59-60
[27]Eiji Toba, Sadamu Sekiguchi. Non-Invasive Measurement System for Human Respiratory Condition and Body Temperature. Proceedings of the 1994 IEEE Intermational Conference on Multisensor Fusion and Integation for Intelligent Systems,1994, (10):2-5
[28]中国医学会重症医学分会.中国重症加强治疗病房(ICU)建设与管理指南2006[J].中国危重病急救医学,2006,18(7)：387-388
[29]吴莹,谢家祺,张彩萍.智能多参数监护仪的特点及其临床应用[J].中国组织工程研究与临床康复,2009,(9)：1707-1710
[30]EN 60601-1-2006 [42] CENELEC. EN 60601-1-2006 Medical electrical equipment--Part 1:General requirements for basic safety and essential performance[S].北京标准出版社,2006,(10)：1-100
[31]苏佩秀.医用计量器具强制检定与提高医疗质量协调发展分析[J].中国医学装备,2008,5(3)：7-10
[32]Mauro Ursino, Cristina Cristalli. A mathematical study of some biomechanical factors affecting the oscillometric blood pressure measurement. IEEE TransBiomed Eng,1996, (43):761-778
[33]王义山.多参数监护仪血压参数的检验校准方法探讨[J].中国计量,2008,(2)：81-82
[34]杨鹿.多参数监护仪应为强制检定的计量器具[J].计量与测试技术,2008,35(2)：60-61
[35]中国计量出版社.中华人民共和国计量法[S].中国计量出版社,1986,(12)：10
[36]徐阳.多参数监护仪临床意义及周期检定的必要性[J].中国计量,2005,6(6)：36-37
[37]国家质检总局法规司.中华人民共和国强制检定的工作计量器具检定管理办法中国[G].北京计量出版社,2007,(12)：20
[38]梁宏谦.对多参数监护仪计量监督若干问题的探讨[J].中国计量,1999,38(1)：16-17
[39]王正.监护仪的基本测量原理及中央监护系统[J].医疗装备,2002,(5)：33-34
[40]FBC. MPS450 Multiparameter Simulator Operators Manua. FBC,2006, (1):1-14
[41]宁锉,刘晓军等.JJG 760-2003心电监护仪[S].中国计量出版社,2008,(11)：11
[42]贾建革.医学计量实用检测技术[M].北京中国计量出版社,2006,(3)：87-97
[43]CAO Yuzhen, DING Beisheng. Determining the saltation edges of the differential ECG by wavelet transform [J]. Journal of Tianjing University,2001,34(5): 601-604
[44]WANG Hongqiang, SUN Jixiang. Wavelet transform and data fusion based algorithm for precision detection of QRS complex in multi lead ECG signals[J]. Journal of National University of Defense Technology,1999,21(4): 87-90
[45]燕金元.关于几种无创测量血压方法的探讨[J].世界医疗器械,1998,4(7)：35-37
[46]胡良勇.吴洪景.动态无创血压监护仪检测校准方法的研究与应用[J].医疗保健器具,2006,(11)：20-23
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