摘要
目的血液净化设备血压测量模块在实际临床使用过程中,存在血压测量值波动较大及血压测量值准确性不确定的现象。为此,本文针对血液净化设备血压测量模块进行计量检测,评估其临床使用中的准确性。方法基于血液净化设备血压测量模块的设计原理,依据国内《JJG 692—2010无创自动测量血压计检定规程》,并参考美国高血压学会颁布的BHS标准,以及美国国家标准学会与美国医疗器械促进协会联合颁布的ANSI/AAMI标准,利用ProSim 8生命体征模拟仪,对血液净化设备血压测量模块进行血压示值重复性(收缩压、舒张压)及血压示值准确性(收缩压、舒张压)检测。检测涉及威高日机装及费森尤斯2种品牌的4种机型,共计27台血液净化设备。结果参与本次检测的血液净化设备血压测量模块的血压示值重复性合格率均为100%;血压示值准确性具有随标准血压设定值的增高而降低的趋势,不同机型的血压测量模块在血压类型(收缩压/舒张压)、血压示值区间、血压示值误差数值等方面表现出各自的特点,且存在一定比例的血压示值准确性不合格率。结论在实际临床使用过程中,血液净化设备血压测量模块具有血压示值重复性好,血压示值准确性存在一定问题的特点。因此,关注并定期开展血液净化设备血压测量模块计量检测工作,对于及时发现血压测量模块使用问题,为临床工作中准确进行患者血压监测提供设备和技术保证是非常有必要的。
Objective During the actual clinical use of blood pressure monitor on blood purification equipment,there exists the phenomenon that the blood pressure indication fluctuates greatly and the accuracy of blood pressure indication is uncertain.Therefore,this article focuses on metrological verification for blood pressure monitor on blood purification equipment,to evaluate its accuracy in clinical practice.Methods Based on the design principle of blood pressure monitor on blood purification equipment,in accordance with the domestic“verification regulation of non-invasive automated sphygmomanometers:JJG693—2010”,and reference to the BHS standard issued by the American Society of Hypertension,as well as the ANSI/AAMI standard jointly issued by the American National Standards Institute and the American Association for the Promotion of Medical Devices,ProSim 8 vital signs simulator is used to measure the blood pressure monitor on blood purification equipment,including blood pressure indication repeatability(systolic pressure,diastolic pressure)and blood pressure indication accuracy(systolic pressure,diastolic pressure).The metrological verification involves 4 types of 2 brands(WEGO Nikkiso and Fresenius Medical Care),with a total of 27 blood pressure monitor on blood purification equipment.Results The qualified rate of blood pressure indication repeatability is 100%for blood pressure monitor on blood purification equipment which participating in this study.The accuracy of blood pressure indication tends to decrease with the increase of the standard blood pressure setting value.Different types of blood pressure monitors show their own characteristics in blood pressure type(systolic pressure/diastolic pressure),blood pressure indication section and blood pressure indication error value.Also there is a certain proportion of unqualified rate of blood pressure indication accuracy.Conclusions In the actual clinical use,the blood pressure monitor on blood purification equipment has the characteristics of blood pressure indication in good repeatability and some problems in the accuracy.Therefore,it is necessary to pay attention to the regularly metrological verification of blood pressure monitor on blood purification equipment,in order to timely discover the problems in the use of blood pressure monitor and provide equipment and technical assurance for accurate patient blood pressure monitoring in clinical work.
作者
李颖
王充
高艳均
张东亮
LI Ying;WANG Chong;GAO Yanjun;ZHANG Dongliang(Department of Nephrology,Beijing Jishuitan Hospital,Capital Medical University,Beijing 100035;Department of Medical Engineering,Beijing Jishuitan Hospital,Capital Medical University,Beijing 100035)
出处
《北京生物医学工程》
2024年第2期187-193,共7页
Beijing Biomedical Engineering
基金
首都医科大学附属北京积水潭医院院级科研基金(ZR-202214、HL-202207)资助。
关键词
血液净化设备
血压测量模块
计量检测
准确性
重复性
blood purification equipment
blood pressure monitor
metrological verification
accuracy
repeatability
