1、 Part 10406: Device specialization Basic electrocardiograph (ECG) (1- to 3-lead ECG) Sponsored by the IEEE 11073 Standards Committee IEEE 3 Park Avenue New York, NY 10016-5997 USA 30 November 2011 IEEE Engineering in Medicine and Biology Society IEEE Std 11073-10406-2011Health informaticsPersonal he
2、alth device communication IEEE Std 11073-10406TM-2011 Health informaticsPersonal health device communication Part 10406: Device specialization Basic electrocardiograph (ECG) (1- to 3-lead ECG) Sponsor IEEE 11073TMStandards Committee of the IEEE Engineering in Medicine and Biology Society Approved 10
3、 September 2011 IEEE-SA Standards Board Approved 12 December 2012 American National Standards Institute Abstract: Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between personal basic electrocardiograph (ECG) devices
4、 and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability is established in this standard. Appropriate portions of existing standards including ISO/IEEE 11073 terminology and IEEE 11073-20601 informati
5、on models are leveraged. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability is specified. A common core of communication functionality for personal telehealth basic ECG (1- to 3-lead ECG) devices i
6、s defined. Monitoring ECG devices are distinguished from diagnostic ECG equipment with respect to including support for wearable ECG devices, limiting the number of leads supported by the equipment to three, and not requiring the capability of annotating or analyzing the detected electrical activity
7、 to determine known cardiac phenomena. This standard is consistent with the base framework and allows multifunction implementations by following multiple device specializations (e.g., ECG and respiration rate). Keywords: basic electrocardiograph (ECG) (1- to 3-lead ECG), IEEE 11073-10406, medical de
8、vice communication, personal health devices The Institute of Electrical and Electronics Engineers, Inc. 3 Park Avenue, New York, NY 10016-5997, USA Copyright 2011 by the Institute of Electrical and Electronics Engineers, Inc. All rights reserved. Published 30 November 2011. Printed in the United Sta
9、tes of America. IEEE is a registered trademarks in the U.S. Patent +1 978 750 8400. Permission to photocopy portions of any individual standard for educational classroom use can also be obtained through the Copyright Clearance Center. iv Copyright 2011 IEEE. All rights reserved Introduction This int
10、roduction is not part of IEEE Std 11073-10406-2011, Health informaticsPersonal health device communicationPart 10406: Device specializationBasic electrocardiograph (ECG) (1- to 3-lead ECG). Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establish
11、es a normative definition of the communication between personal basic electrocardiograph (ECG) devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of exi
12、sting standards including ISO/IEEE 11073 terminology and IEEE 11073-20601 information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of
13、 communication functionality for personal telehealth basic ECG (1- to 3-lead ECG) devices. Monitoring ECG devices are distinguished from diagnostic ECG equipment with respect to including support for wearable ECG devices, limiting the number of leads supported by the equipment to three, and not requ
14、iring the capability of annotating or analyzing the detected electrical activity to determine known cardiac phenomena. This standard is consistent with the base framework and allows multifunction implementations by following multiple device specializations (e.g., ECG and respiration rate). Notice to
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20、nce of amendments, corrigenda, or errata, visit the IEEE Standards Association web site at http:/ieeexplore.ieee.org/xpl/standards.jsp, or contact the IEEE at the address listed previously. v Copyright 2011 IEEE. All rights reserved For more information about the IEEE Standards Association or the IE
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25、, and the risk of infringement of such rights, is entirely their own responsibility. Further information may be obtained from the IEEE Standards Association. vi Copyright 2011 IEEE. All rights reserved Participants At the time this standard was submitted to the IEEE-SA Standards Board for approval,
26、the Personal Health Devices Working Group had the following membership: Douglas P. Bogia, Chair Lars Schmitt, Vice Chair Karsten Aalders Charles R. Abbruscato Nabil Abujbara Maher Abuzaid Jon Adams Manfred Aigner Jorge Alberola Murtaza Ali Prasad Alva Rolf Ambuehl David Aparisi Lawrence Arne Serafin
27、 Arroyo Muhammad Asim Merat Bagha Doug Baird David Baker Anindya Bakshi Ananth Balasubramanian Sunlee Bang M. Jonathan Barkley Gilberto Barrn David Bean John Bell Rudy Belliardi Daniel Bernstein George A. Bertos Ola Bjrsne Thomas Blackadar Marc Blanchet Thomas Bluethner Xavier Boniface Shannon Bouco
28、usis Kevin Braun Julius Broma Lyle G. Bullock, Jr. Bernard Burg Chris Burns Anthony Butt Jeremy Byford-Rew Satya Calloji Carole C. Carey Santiago Carot-Nemesio Randy W. Carroll Seungchul Chae Rahul Chauhan James Cheng Peggy Chien Silviu Chiricescu Chia-Chin Chong Saeed A. Choudhary Jinhan Chung John
29、 A. Cogan John T. Collins Cory Condek Todd H. Cooper David Cornejo Douglas Coup Nigel Cox Tomio Crosley Allen Curtis Ed Day Joost De Folter Sushil K. Deka Pedro de-las-Heras-Quiros Jim DelloStritto Matthew dEntremont Kent Dicks Hyoungho Do Amy Droitcour Xiaolian Duan Brian Dubreuil Jakob Ehrensvard
30、Fredrik Einberg Roger M. Ellingson Michihiro Enokida Javier Escayola Calvo Leonardo Estevez Roger Feeley Bosco T. Fernandes Morten Flintrup Joseph W. Forler Michael Fortner Russell Foster Eric Freudenthal Matthias Frohner Jing Gao Marcus Garbe Gracinda Garca Lago John Garguilo Rick Geimer Igor Gejdo
31、s Ferenc Gerbovics Nicolae Goga Julian Goldman Raul Gonzalez Gomez Chris Gough Channa Gowda Niclas Granqvist Charles Gropper Amit Gupta Jeff Guttmacher Rasmus Haahr Christian Habermann Mikey Hagerty Jerry Hahn Robert Hall Nathaniel Hamming Rickey L. Hampton Sten Hanke Kai Hassing Marc Daniel Haunsch
32、ild Mike Hayes Charles Henderson Jun-Ho Her Takashi Hibino Timothy L. Hirou Allen Hobbs Alex Holland Arto Holopainen Robert Hoy Frank Hsu Anne Huang Sen-Der Huang David Hughes Robert D. Hughes Jiyoung Huh Hugh Hunter Hitoshi Ikeda Yutaka Ikeda Philip O. Isaacson Atsushi Ito Praduman Jain Danny Joche
33、lson Chris Johnson Phaneeth Junga Akiyoshi Kabe Steve Kahle Tomio Kamioka Kei Kariya Andy Kaschl Junzo Kashihara Kohichi Kashiwagi Ralph Kent Kurt M. Kermes Ikuo Keshi Junhyung Kim Min-Joon Kim Minho Kim Taekon Kim Tetsuya Kimura Michael Kirwan Alfred Kloos Jeongmee Koh Jean-Marc Koller Patty Krantz
34、 Alexander Kraus Ramesh Krishna Falko Kuester vii Copyright 2011 IEEE. All rights reserved Rafael Lajara Pierre Landau Jaechul Lee Kyong Ho Lee Rami Lee Sungkee Lee Woojae Lee Yonghee Lee Kathryn A. Lesh Qiong Li Patrick Lichter Jisoon Lim Joon-Ho Lim John Lin Wei-Jung Lo Charles Lowe Sandra Martine
35、z Miguel Martnez de Espronceda Cmara Peter Mayhew Jim McCain Richard McPartland Chris Mcvay Lszl Meleg Ethan Metsger Jinsei Miyazaki Darr Moore Piotr Murawski Soundharya Nagasubramanian Jae-Wook Nah Alex Neefus Trong-Nghia Nguyen-Dobinsky Michael E. Nidd Tetsu Nishimura Jim Niswander Hiroaki Niwamot
36、o Thomas Norgall Yoshiteru Nozoe Brett Olive Charles Palmer Bud Panjwani Carl Pantiskas Mikey Paradis Jong-Tae Park Myungeun Park Soojun Park Phillip E. Pash TongBi Pei Soren Petersen Jeff Price Arif Rahman Tim Reilly Barry Reinhold Brian Reinhold Melvin I. Reynolds John G. Rhoads Jeffrey S. Robbins
37、 Scott Robertson Timothy Robertson David Rosales Bill Saltzstein Benedikt Salzbrunn Giovanna Sannino Jose A. Santos-Cadenas Stefan Sauermann John Sawyer Guillaume Schatz Alois Schloegl Paul S. Schluter Johannes Schmidt Lars Schmitt Mark G. Schnell Richard A. Schrenker Antonio Scorpiniti Jungmin Seo
38、Kwang Seok Seo Riccardo Serafin Sid Shaw Frank Shen Min Shih Mazen Shihabi Krishna Shingala Redmond Shouldice Marjorie Skubic Robert Smith Ivan Soh Motoki Sone Emily Sopensky Rajagopalan Srinivasan Andreas Staubert Nick Steblay Lars Steubesand John (Ivo) Stivoric Raymond Strickland Hermanni Suominen
39、 Lee Surprenant Ravi Swami Ray Sweidan Kunihiro Takiuchi Francis Tam Haruyuyki Tatsumi John W. Thomas Brad Tipler Jonas Tirn James Tomcik Janet Traub Jess Daniel Trigo Gary Tschautscher Masato Tsuchid Ken Tubman Yoshihiro Uchida Sunil Unadkat Philipp Urbauer Laura Vanzago Alpo Vrri Dalimar Velez Nav
40、een Verma Daniel von Bren Rudi Voon Isobel Walker David Wang Jerry P. Wang Yao Wang Yi Wang Steve Warren Fujio Watanabe Toru Watsuji Mike Weng Kathleen Wible Paul Williamson Jan Wittenber Jia-Rong Wu Will Wykeham Ariton Xhafa Ricky Yang Done-Sik Yoo Jason Zhang Zhiqiang Zhang Thomas Zhao Daidi Zhong
41、 Miha Zoubek Szymon Zysko viii Copyright 2011 IEEE. All rights reserved. The following members of the individual balloting committee voted on this standard. Balloters may have voted for approval, disapproval, or abstention. Thomas Blackadar Douglas P. Bogia Lyle G. Bullock, Jr. Randy W. Carroll Keit
42、h Chow Malcolm Clarke Randall Groves Kai Hassing Werner Hoelzl Robert D. Hughes Tetsushi Ikegami Atsushi Ito Piotr Karocki Laurie Kermes Greg Luri Wayne W. Manges Michael S. Newman Melvin I. Reynolds Bartien Sayogo Lars Schmitt Gil Shultz Kapil Sood Walter Struppler Mark Sturza Thomas Tullia John Ve
43、rgis Jan Wittenber Oren Yuen When the IEEE-SA Standards Board approved this standard on 10 September 2011, it had the following membership: Richard H. Hulett, Chair John Kulick, Vice Chair Robert Grow, Past Chair Judith Gorman, Secretary Masayuki Ariyoshi William Bartley Ted Burse Clint Chaplin Wael
44、 Diab Jean-Philippe Faure Alex Gelman Paul Houz Jim Hughes Joseph L. Koepfinger* David Law Thomas Lee Hung Ling Oleg Logvinov Ted Olsen Gary Robinson Jon Rosdahl Sam Sciacca Mike Seavey Curtis Siller Phil Winston Howard Wolfman Don Wright *Member Emeritus Also included are the following nonvoting IE
45、EE-SA Standards Board liaisons: Satish Aggarwal, NRC Representative Richard DeBlasio, DOE Representative Michael Janezic, NIST Representative Don Messina IEEE Standards Program Manager, Document Development Kathryn M. Bennett IEEE Standards Program Manager, Technical Program Development ix Copyright
46、 2011 IEEE. All rights reserved. Contents 1. Overview 1 1.1 Scope . 1 1.2 Purpose 1 1.3 Context 2 2. Normative references 2 3. Definitions, acronyms, and abbreviations 3 3.1 Definitions . 3 3.2 Acronyms and abbreviations . 3 4. Introduction to ISO/IEEE 11073 personal health devices 4 4.1 General 4 4
47、.2 Introduction to ISO/IEEE 11073-20601 modeling constructs . 4 4.3 Compliance with other standards . 5 5. Basic ECG (1- to 3-lead ECG) device concepts and modalities . 6 5.1 General 6 5.2 ECG waveform 6 5.3 R-R interval . 6 5.4 Heart rate . 7 6. Basic ECG (1- to 3-lead ECG) domain information model
48、 7 6.1 Overview . 7 6.2 Class extensions . 7 6.3 Object instance diagram 7 6.4 Types of configuration . 8 6.5 Profiles . 9 6.6 Medical device system object 11 6.7 Numeric objects . 15 6.8 Real-time sample array objects 18 6.9 Enumeration objects 19 6.10 PM-store objects 22 6.11 Scanner objects 29 6.
49、12 Class extension objects 32 6.13 Basic ECG (1- to 3-lead ECG) information model extensibility rules 32 7. Basic ECG (1- to 3-lead ECG) service model 32 7.1 General 32 7.2 Object access services 32 7.3 Object access event report services . 35 8. Basic ECG (1- to 3-lead ECG) communication model . 35 8.1 Overview . 35 8.2 Communications characteristics 36 8.3 Association procedure . 36 8.4 Configuring procedure . 38 8.5 Operating procedure 39 8.6 Time synchronization 40 x Copyright 2011 IEEE. All rights reserved. 9. Test associations . 40 9.1 Behav
