TY - JOUR
T1 - Substantiation of medical and technical requirements for noninvasive spectrophotometric diagnostic devices
AU - Dunaev, Andrey V.
AU - Zherebtsov, Evgeny A.
AU - Rogatkin, Dmitrii A.
AU - Stewart, Neil A.
AU - Sokolovski, Sergei G.
AU - Rafailov, Edik U.
N1 - Funding Information:
This work partially was supported by the European Community’s Seventh Framework Programme (FP7-People-2009-IAPP) under Grant Agreement no. 251531 MEDILASE.
PY - 2013/10/28
Y1 - 2013/10/28
N2 - 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.
AB - 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.
KW - laser Doppler flowmetry
KW - medical and technical requirements
KW - medical devices
KW - noninvasive medical spectrophotometry
KW - tissue blood volume
KW - tissue reflectance oximetry
UR - http://www.scopus.com/inward/record.url?scp=84892642673&partnerID=8YFLogxK
UR - https://www.spiedigitallibrary.org/journals/journal-of-biomedical-optics/volume-18/issue-10/107009/Substantiation-of-medical-and-technical-requirements-for-noninvasive-spectrophotometric-diagnostic/10.1117/1.JBO.18.10.107009.full?SSO=1
U2 - 10.1117/1.JBO.18.10.107009
DO - 10.1117/1.JBO.18.10.107009
M3 - Article
C2 - 24165744
AN - SCOPUS:84892642673
SN - 1083-3668
VL - 18
JO - Journal of Biomedical Optics
JF - Journal of Biomedical Optics
IS - 10
M1 - 107009
ER -