1、 IEEE Standard for Wearable, Cuffless Blood Pressure Measuring Devices Sponsored by the Standards Committee IEEE 3 Park Avenue New York, NY 10016-5997 USA IEEE Engineering in Medicine and Biology Society IEEE Std 1708-2014IEEE Std 1708-2014 IEEE Standard for Wearable, Cuffless Blood Pressure Measuri
2、ng Devices Sponsor Standards Committee of the IEEE Engineering in Medicine and Biology Society Approved 21 August 2014 IEEE-SA Standards Board Abstract: IEEE Std 1708 establishes a normative definition of wearable cuffless blood pressure (BP) measuring devices and the objective performance evaluatio
3、n of this kind of device. The standard is independent of the form of the device or the vehicle to which the device is attached or in which it is embedded. The standard is applicable to all types of wearable BP measurement devices including epidermal and unobtrusive BP devices that have different mod
4、es of operation (e.g., to measure short-term, long-term, snapshot, continuous, beat(s)-to-beat(s) BP, or BP variability). This standard is, however, limited to evaluation of devices that do not use a cuff during measurement and do not cover evaluation of all sphygmomanometers that are used with an o
5、ccluding or inflatable cuff for the indirect determination of BP on the upper arm or wrist. This standard provides guidelines for manufacturers to qualify and validate their products, potential purchasers or users to evaluate and select prospective products, and health care professionals to understa
6、nd the manufacturing practices on wearable BP devices. Keywords: blood pressure measuring devices, cuffless, epidermal, hypertension, IEEE 1708, performance evaluation, unobtrusive, wearable The Institute of Electrical and Electronics Engineers, Inc. 3 Park Avenue, New York, NY 10016-5997, USA Copyr
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36、EE. All rights reserved. vi Participants At the time this IEEE standard was completed, the Wearable Cuffless Blood Pressure Monitors Working Group had the following membership: Yuan-Ting Zhang, Chair Carole Carey, Vice Chair Todd Cooper Guy Dumont Young Huh S. Johnson Emil Jovanov Yongming Kim Ikka
37、Korhonen J. Liu Nigel Lovell S. Luo Ratko Magjarevi Jens Muehlsteff K. S. Park C. Poon E. Solane Kenji Sunagawa H. L. Tai Toshiyo Tamura Z. H. Wang Z. Y. Wu I. R. F. Yan Kenichi Yumakoshi The following members of the individual balloting committee voted on this standard. Balloters may have voted for
38、 approval, disapproval, or abstention. Arthur Astrin Christopher Biernacki Lyle Bullock Keith Chow Todd Cooper Sourav Dutta Kenneth Fuchs Randall Groves Voicu Groza Kai Hassing Werner Hoelzl Noriyuki Ikeuchi Atsushi Ito Piotr Karocki JongMuk Lee Vincent Lipsio Greg Luri Iulian Profir Sergio Rapuano
39、Bartien Sayogo Veselin Skendzic Kapil Sood Walter Struppler Chandrasekaran Subramaniam John Vergis Oren Yuen Yuanting Zhang Daidi Zhong When the IEEE-SA Standards Board approved this standard on 21 August 2014, it had the following membership: John Kulick, Chair Jon Walter Rosdahl, Vice Chair Richar
40、d H. Hulett, Past Chair Konstantinos Karachalios, Secretary Peter Balma Farooq Bari Ted Burse Clint Chaplin Stephen Dukes Jean-Philippe Faure Gary Hoffman Michael Janezic Jeffrey Katz Joseph L. Koepfinger* David J. Law Hung Ling Oleg Logvinov Ted Olsen Glenn Parsons Ron Petersen Adrian Stephens Pete
41、r Sutherland Yatin Trivedi Phil Winston Don Wright Yu Yuan *Member Emeritus Also included are the following nonvoting IEEE-SA Standards Board liaisons: Richard DeBlasio, DOE Representative Michael Janezic, NIST Representative Julie Alessi IEEE-SA Content Publishing Kathryn Bennett IEEE-SA Technical
42、Community ProgramsCopyright 2014 IEEE. All rights reserved. vii Introduction This introduction is not part of IEEE Std 1708-2014, IEEE Standard for Wearable, Cuffless Blood Pressure Measuring Devices. Hypertension is an important public-health challenge worldwide B12. In 2000, the estimated global n
43、umber of adults with hypertension was 972 million, 26.4% of the adult population B12. Hypertension is important not only because of its high frequency but also because it is a major modifiable risk factor for cardiovascular and kidney disease B12. It was reported by WHO report 2002 B2 that about 62%
44、 of strokes and 49% of heart attacks are caused by hypertension; 7.1 million die from hypertension, which is about 13% of the global fatality in total B35. Despite the risk people with hypertension may face, lack of awareness makes the situation difficult to control. The Joint National Committee 7th
45、 report (JNC 7) B5 stated that the percentage of persons in whom hypertension is properly controlled (BP 2), v denotes the degrees of freedom and ()denotes the Gamma function. As the value of v grows, the generalized t distribution approaches the normal distribution. IEEE Std 1708-2014 IEEE Standard
46、 for Wearable, Cuffless Blood Pressure Measuring Devices Copyright 2014 IEEE. All rights reserved. 15 Compared to normal distribution, generalized t distribution introduced another parameter, degree of freedom, which controls the shape of the probability density function in terms of the heights of p
47、eak and the thickness of tail. This property makes the t distribution prominent at identifying outliers. We assumed that the error distributions of the devices follow either a normal distribution or generalized t distribution of a certain degree of freedom. CP5, CP10, and CP15can then be estimated f
48、rom the reported MD and SD by the following equations: 22()21CP ( , , )2xuLgdLLu d L e dxd =(A. 2) if it is a normal distribution, and 112221()()2CP ( , , , ) (1 )( 2)( ) ( 2)2vLtLLvdtuu d v L dtvdvv += +(A. 3) if it is a generalized t distribution, where L = 5, 10, 15 mmHg as required by BHS protoc
49、ol B21, d denotes SD. We restricted the selection of v to be within 3 and 30 since at distribution with v 30, it can be approximated by a normal distribution. The BHS grading for each device was then estimated from the calculated CP5, CP10, and CP15. The evaluation results of 40 devices B39 were collected from literature where the MD, SD, CP5,CP10,and CP15of the error distribution and the BHS grading for each device on the measurement of SBP and DBP were reported. To determine the degree of freedom that matched best to the real underl
