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作 者:江晓 李作家[2] Jiang Xiao;Li Zuojia(Guangzhou Nanda Kangdexin Testing Technology Co.,Ltd,Guangzhou Guangdong 510000,China;Nanfang Hospital,Southern Medical University,Guangzhou Guangdong 510000,China)
机构地区:[1]广州南大康德信检测技术有限责任公司,广东广州510000 [2]南方医科大学南方医院,广东广州510000
出 处:《医疗装备》2023年第22期38-40,共3页Medical Equipment
摘 要:目的提出一种可用于胎儿监护仪宫缩压探头参数的校准方法。方法借鉴现有胎儿监护仪其他参数的校准方法和指标要求,设计宫缩压探头参数的校准方法。基于该方法对3个不同厂家的6台胎儿监护仪进行宫缩压探头参数(包括非线性误差、重复性、温度漂移)校准,并分析该方法对宫缩压非线性误差的不确定度。结果6台胎儿监护仪的宫缩压探头理论值为25%、50%、75%的非线性误差分别为-2.6%~3.3%、-4.0%~3.0%、-4.3%~3.3%,满足YY/T 0449-2018《超声多普勒胎儿监护仪》的指标要求(≤±10%);重复性范围为0.5%~1.0%;温度漂移范围为-1~0 mmHg(1 mmHg=0.133 kPa);宫缩压非线性误差的不确定度范围为1.1%~1.4%。结论该方法能有效评估胎儿监护仪的宫缩压探头参数,其非线性误差的不确定度小于最大允许误差(±10%)的1/3,可用于临床仪器的校准。Objective To propose a calibration method for the parameters of uterine contraction pressure probes in fetal monitors.Methods With the reference of calibration methods and indicator requirements for other parameters of existing fetal monitors,the calibration method for the parameters of the uterine contraction pressure probe was designed.Based on this method,the calibration of the parameters of the uterine contraction pressure probe(including nonlinear error,repeatability,and temperature drift)for six fetal monitors from three different manufacturers was carried out,and the uncertainty of the nonlinear error of uterine contraction pressure for this method was analyzed.Results The nonlinear errors of the uterine contraction pressure probes of six fetal monitors at theoretical values of 25%,50%,and 75%were-2.6%to 3.3%,-4.0%to 3.0%,and-4.3%to 3.3%,respectively,which met the index requirements of YY/T 0449-2018"Ultrasonic Doppler Fetal Monitor"(no more than±10%).The repeatability range was 0.5%to 1.0%;The temperature drift range was-1~0 mmHg;The uncertainty range of the non-linear error of uterine contraction pressure was 1.1%to 1.4%.Conclusion The parameters of the uterine contraction pressure probe of the fetal monitor can be effectively evaluated through this method.The uncertainty of its nonlinear error is less than 1/3 of the maximum allowable error(±10%),indicating that it can be used for calibration analysis of clinical instruments.
关 键 词:宫缩压参数 胎儿监护仪 非线性误差 重复性 温度漂移
分 类 号:TH77[机械工程—仪器科学与技术]
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