Substantiation of medical and technical requirements for noninvasive spectrophotometric diagnostic devices

Andrey V. Dunaev; Evgeny A. Zherebtsov; Dimitrii A. Rogatkin; Neil A. Stewart; Sergei G. Sokolovski; Edik U. Rafailov

doi:10.1117/1.JBO.18.10.107009

28 October 2013 Substantiation of medical and technical requirements for noninvasive spectrophotometric diagnostic devices

Andrey V. Dunaev, Evgeny A. Zherebtsov, Dimitrii A. Rogatkin, Neil A. Stewart, Sergei G. Sokolovski, Edik U. Rafailov

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Funded by: European Community’s Seventh Framework Programme

Journal of Biomedical Optics, Vol. 18, Issue 10, 107009 (October 2013). https://doi.org/10.1117/1.JBO.18.10.107009

Abstract

A scientific approach to the formulation of medical and technical requirements (MTRs) for noninvasive spectrophotometric diagnostic devices using optical technologies such as laser Doppler flowmetry and absorption spectroscopy is proposed. The theoretical modeling framework, metrological certification, and testing of these devices are still in the early stages of development. The theoretical estimation of the received signal levels for wavelengths between 514 and 940 nm is highly dependent on the blood volume level in the subject tissue. The proposed approach allows, in particular, the calculation of technical and metrological performance constraints of the instruments, such as the ranges of the sensitivity and power-related signal-to-noise ratios for different spectral channels and different biomedical (biochemical and physiological) parameters. Substantiation of specialized MTRs for the noninvasive spectrophotometric diagnostic devices can enable them to develop to the level of standardized measurement techniques.

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Andrey V. Dunaev, Evgeny A. Zherebtsov, Dimitrii A. Rogatkin, Neil A. Stewart, Sergei G. Sokolovski, and Edik U. Rafailov "Substantiation of medical and technical requirements for noninvasive spectrophotometric diagnostic devices," Journal of Biomedical Optics 18(10), 107009 (28 October 2013). https://doi.org/10.1117/1.JBO.18.10.107009

Published: 28 October 2013

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