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中国医疗器械杂志 2020, Vol. 44 Issue (4) :315-318    DOI: 10.3969/j.issn.1671-7104.2020.04.007
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眼后节光学相干断层扫描仪轴向分辨率的检测装置研制和测量不确定度分析
王敬涛1,贾晓航1,彭建华1,胡一平1,骆超2,蔡明2
1 浙江省医疗器械检验研究院,杭州市,310018
2 执鼎医疗科技(杭州)有限公司,杭州市,310053
Development of Axial Resolution Testing Device for Optical Coherence Tomograph for the Posterior Segment of the Human Eye and Measurement Uncertainty Analysis
WANG Jingtao1, JIA Xiaohang1, PENG Jianhua1, HU Yiping1, LUO Chao2, CAI Ming2
1 Zhejiang Institute of Medical Device Supervision and Testing, Hangzhou, 310018
2 ZD Medical (Hangzhou) Co. Ltd., Hangzhou, 310053

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摘要 通过分析眼后节光学相干断层扫描仪的轴向分辨率理论计算模型,设计并研制了一套用于测量其轴向分辨 率的检测装置。针对一台商业化的眼后节光学相干断层扫描仪,理论计算其轴向分辨率为5.07 μm,实际 测量值为5.45 μm。对检测装置进行不确定度评定,结果为(5.45±0.10) μm,检测装置所引入的测量误差 很小;同时,利用该检测装置测得的轴向分辨率满足设备的指标要求(≤6 μm)。
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关键词光学相干断层扫描技术   轴向分辨率   计量学   不确定度评定     
Abstract: Based on the analysis of the theoretical calculation model of axial resolution of optical coherence tomograph for the posterior segment of the human eye, a set of testing device for measuring its axial resolution is designed and developed. In view of a commercial ophthalmic optical coherence tomograph in clinical use, its axial resolution is calculated to be 5.07 μm theoretically, and the actual measurement value is 5.45 μm. The uncertainty of the detection device is evaluated and the result is (5.45±0.10) μm. The measurement error introduced by the testing device is very small. Meanwhile, the axial resolution measured by the testing device meets the requirements of the instrument(≤6 μm).
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Received 2019-10-28;
Fund:

浙江省科技计划项目(2018F10040)

Corresponding Authors: 骆超     Email: luo.chao@zd-med.com
About author: 王敬涛,E-mail: wangjingtao@mdst.org.cn
引用本文:   
王敬涛1,贾晓航1,彭建华1,胡一平1,骆超2,蔡明2.眼后节光学相干断层扫描仪轴向分辨率的检测装置研制和测量不确定度分析[J]  中国医疗器械杂志, 2020,V44(4): 315-318
WANG Jingtao1, JIA Xiaohang1, PENG Jianhua1, HU Yiping1, LUO Chao2, CAI Ming2.Development of Axial Resolution Testing Device for Optical Coherence Tomograph for the Posterior Segment of the Human Eye and Measurement Uncertainty Analysis[J]  Chinese Journal of Medical Instrumentation, 2020,V44(4): 315-318
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