反射式脉搏血氧模拟器设计与应用  

Design and Application of a Simulator of Reflective Pulse Oximetry

作　　者：王浩[1] 李佳戈[1] 孟祥峰[1] WANG Hao;LI Jiage;MENG Xiangfeng(Division of Active Medical Device and Medical Optics,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院光机电室,北京102629

出　　处：《中国医疗设备》2021年第2期22-25,共4页China Medical Devices

基　　金：国家质量基础的共性技术研究与应用项目(2016YFF0201001)。

摘　　要：目的为满足反射式脉搏血氧仪类产品的质控需求,设计了一款反射式脉搏血氧模拟器。方法根据反射式脉搏血氧仪的工作原理,设计并搭建了基于液体循环的模拟器,对模拟液光谱成分、吸光度等指标进行了测量;在具体产品的测试中,对模拟器的脉搏准确率、稳定性等指标进行了进一步的验证。结果在辐射发射试验中,检品所记录的总血红蛋白浓度与人体数据较为接近,均为16~18 g/dL之间,变异系数为0.3%;脉率预设值为60、90、120次/min,脉率误差分别为0.50%、0.67%、0.25%,均能够满足测试需求。结论本文设计的反射式血氧模拟器有助于对反射式血氧产品进行质量评价。Objective To meet the needs of quality control of reflective pulse oximeter,a reflective pulse oximeter was designed.Methods A liquid-circulating simulator was designed and fabricated according to the mechanism of reflective pulse oximeter;Key parameters were measured such as spectral components and optical absorbance.In the test of specific oximetry products,the pulse accuracy,stability and other indicators of the simulator were further verified.Results In the radiation emission test,the total hemoglobin concentration recorded by the samples was close to the human body data,ranging from 16 g/dL to 18 g/dL,and the coefficient of variation was 0.3%.The preset value of pulse rate was 60,90 and 120 times/min,and the error of pulse rate was 0.50%,0.67%and 0.25%,respectively,which can meet the test requirements.Conclusion The reflective oximetry simulator designed in this paper is helpful to evaluate the quality of reflective oximetry products.

关 键 词：反射式脉搏血氧仪 体模 脉率 质量控制 

分 类 号：R197.39[医药卫生—卫生事业管理] TH773[医药卫生—公共卫生与预防医学]