ANSI IEEE 11073-10421-2010 Health informatics Personal health device communication Part 10421 Device specialization Peak expiratory flow monitor (peak flow)《健康信息学.个人保健设备通信.设备规范.峰呼气.pdf

1、 Part 10421: Device specialization Peak expiratory flow monitor (peak flow) Sponsored by the IEEE 11073 Standards Committee IEEE 3 Park Avenue New York, NY 10016-5997 USA 19 November 2010IEEE Engineering in Medicine and Biology Society IEEE Std 11073-10421-2010Health informaticsPersonal health devic

2、e communication IEEE Std 11073-10421TM-2010 Health informaticsPersonal health device communication Part 10421: Device specialization Peak expiratory flow monitor (peak flow) Sponsor IEEE 11073TMStandards Committee of the IEEE Engineering in Medicine and Biology Society Approved 30 September 2010 IEE

3、E-SA Standards Board Approved 1 June 2011 American National Standards InstituteAbstract: Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication is established in this standard between personal telehealth peak expiratory flow mon

4、itor devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. Appropriate portions of existing standards are leveraged, including ISO/IEEE 11073 terminology, information models, applica

5、tion profile standards, and transport standards. The use of specific term codes, formats, and behaviors is specified in telehealth environments restricting optionality in base frameworks in favor of interoperability. A common core of communication functionality is defined for personal telehealth pea

6、k expiratory flow monitor devices. Keywords: forced expiratory volume, medical device communication, peak expiratory flow, peak expiratory flow monitor, peak flow, personal health devices The Institute of Electrical and Electronics Engineers, Inc. 3 Park Avenue, New York, NY 10016-5997, USA Copyrigh

7、t 2010 by the Institute of Electrical and Electronics Engineers, Inc. All rights reserved. Published 19 November 2010. Printed in the United States 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 educatio

8、nal classroom use can also be obtained through the Copyright Clearance Center. iv Copyright 2010 IEEE. All rights reserved. Introduction This introduction is not part of IEEE Std 11073-10421-2010, Health informaticsPersonal health device communicationPart 10421: Device specializationPeak expiratory

9、flow monitor (peak flow). ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. This document uses the optimized framework created in IEEE Std 11073-20601-2008aand describes a specific, interoperable communication approach for weighing scales. These sta

10、ndards align with, and draw upon, the existing clinically focused standards to provide support for communication of data from clinical or personal health devices Notice to users Laws and regulations Users of these documents should consult all applicable laws and regulations. Compliance with the prov

11、isions of this standard does not imply compliance to any applicable regulatory requirements. Implementers of the standard are responsible for observing or referring to the applicable regulatory requirements. IEEE does not, by the publication of its standards, intend to urge action that is not in com

12、pliance with applicable laws, and these documents may not be construed as doing so. Copyrights This document is copyrighted by the IEEE. It is made available for a wide variety of both public and private uses. These include both use, by reference, in laws and regulations, and use in private self-reg

13、ulation, standardization, and the promotion of engineering practices and methods. By making this document available for use and adoption by public authorities and private users, the IEEE does not waive any rights in copyright to this document. Updating of IEEE documents Users of IEEE standards shoul

14、d be aware that these documents may be superseded at any time by the issuance of new editions or may be amended from time to time through the issuance of amendments, corrigenda, or errata. An official IEEE document at any point in time consists of the current edition of the document together with an

15、y amendments, corrigenda, or errata then in effect. In order to determine whether a given document is the current edition and whether it has been amended through the issuance of amendments, corrigenda, or errata, visit the IEEE Standards Association web site at http:/ieeexplore.ieee.org/xpl/standard

16、s.jsp, or contact the IEEE at the address listed previously. For more information about the IEEE Standards Association or the IEEE standards development process, visit the IEEE-SA web site at http:/standards.ieee.org. Errata Errata, if any, for this and all other standards can be accessed at the fol

17、lowing URL: http:/standards.ieee.org/reading/ieee/updates/errata/index.html. Users are encouraged to check this URL for errata periodically. aFor information on references, see Clause 2. v Copyright 2010 IEEE. All rights reserved. Interpretations Current interpretations can be accessed at the follow

18、ing URL: http:/standards.ieee.org/reading/ieee/interp/ index.html. Patents Attention is called to the possibility that implementation of this standard may require use of subject matter covered by patent rights. By publication of this standard, no position is taken with respect to the existence or va

19、lidity of any patent rights in connection therewith. The IEEE is not responsible for identifying Essential Patent Claims for which a license may be required, for conducting inquiries into the legal validity or scope of Patents Claims or determining whether any licensing terms or conditions provided

20、in connection with submission of a Letter of Assurance, if any, or in any licensing agreements are reasonable or non-discriminatory. Users of this standard are expressly advised that determination of the validity of any patent rights, and the risk of infringement of such rights, is entirely their ow

21、n responsibility. Further information may be obtained from the IEEE Standards Association. vi Copyright 2010 IEEE. All rights reserved. Participants At the time this standard was submitted to the IEEE-SA Standards Board for approval, the Personal Health Device Working Group had the following members

22、hip: Douglas P. Bogia, Chair Ananth Balasubramanian, Vice Chair Karsten Aalders Charles R. Abbruscato Nabil Abujbara Maher Abuzaid Jon Adams Manfred Aigner Murtaza Ali Rolf Ambuehl Lawrence Arne Serafin Arroyo Kevin Arruda Muhammad Asim Merat Bagha Doug Baird David Baker Anindya Bakshi Ananth Balasu

23、bramanian Sunlee Bang M. Jonathan Barkley Gilberto Barrn David Bean John Bell Rudy Belliardi Yazid Benazzouz George A. Bertos Ola Bjrsne Thomas Blackadar Marc Blanchet Thomas Bluethner Xavier Boniface Shannon Boucousis Julius Broma Lyle G. Bullock, Jr. Bernard Burg Chris Burns Anthony Butt Jeremy By

24、ford-Rew Satya Calloji Carole C. Carey Santiago Carot-Nemesio Randy W. Carroll Rahul Chauhan James Cheng Maria Cherkaoui Peggy Chien Silviu Chiricescu Jiho Choi Chia-Chin Chong Saeed A. Choudhary Jinhan Chung Malcolm Clarke Rick A. Cnossen John A. Cogan Moshe Cohen John T. Collins Cory Condek Todd H

25、. Cooper Nigel Cox Tomio Crosley Jeremy Cummin Allen Curtis Kathryn Cush Rupert Dance Jess Daniel Trigo Sushil K. Deka Pedro de-las-Heras-Quiros Jim DelloStritto Matthew dEntremont Kent Dicks Hyoungho Do Amy Droitcour Brian Dubreuil Jakob Ehrensvard Fredrik Einberg Roger M. Ellingson Michihiro Enoki

26、da Javier Escayola Calvo Leonardo Estevez Roger Feeley Bosco T. Fernandes Gear Fisher Julie N. Fleischer Roger Florkowski Joseph W. Forler Russell Foster Eric Freudenthal Matthias Frohner Miguel Galarraga Jing Gao Marcus Garbe Gracinda Garca Lago Juan Garca-Prieto Cuesta John Garguilo Rick Geimer Ig

27、or Gejdos Ferenc Gerbovics Nicolae Goga Julian Goldman Raul Gonzalez Gomez Chris Gough Channa Gowda Niclas Granqvist Charles Gropper Amit Gupta Jeff Guttmacher Christian Habermann Mikey Hagerty Jerry Hahn Robert Hall Rickey L. Hampton Sten Hanke Kai Hassing Marc Daniel Haunschild Mike Hayes Mike Hay

28、es Charles Henderson Timothy L. Hirou Allen Hobbs Alex Holland Arto Holopainen Robert Hoy Frank Hsu Anne Huang Sen-Der Huang David Hughes Robert D. Hughes Nick Hunn Hugh Hunter Hitoshi Ikeda Yutaka Ikeda Philip O. Isaacson Atsushi Ito Praduman Jain Ho-In Jeon Danny Jochelson Chris Johnson Phaneeth J

29、unga Akiyoshi Kabe Steve Kahle Tomio Kamioka Kei Kariya Andy Kaschl Junzo Kashihara Kohichi Kashiwagi Ralph Kent Kurt M. Kermes Ikuo Keshi Minho Kim Min-Joon Kim Taekon Kim Tetsuya Kimura Michael Kirwin Alfred Kloos Jeongmee Koh Jean-Marc Koller Thomas Kottler vii Copyright 2010 IEEE. All rights res

30、erved. Patty Krantz Alexander Kraus Ramesh Krishna Falko Kuester Pierre Landau Rami 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 Martinez Miguel Martnez de Espronceda Cmara Dennis Mathews Peter Mayhew Jim McCain R

31、ichard McPartland Lszl Meleg Jinsei Miyazaki Darr Moore Joe Morrissey Piotr Murawski Soundharya Nagasubramanian Jae-Wook Nah Alex Neefus Michael E. Nidd Tetsu Nishimura Jim Niswander Hiroaki Niwamoto Thomas Norgall Yoshiteru Nozoe Brett Olive Charles Palmer Bud Panjwani Carl Pantiskas Mikey Paradis

32、Jong-Tae Park Soojun Park Phillip E. Pash TongBi Pei Soren Petersen Arnie Pittler Carol Primdahl Arif Rahman Barry Reinhold Brian Reinhold Melvin I. Reynolds Jeffrey S. Robbins Scott Robertson Timothy Robertson David Rosales Bill Saltzstein Jose A. Santos-Cadenas Stefan Sauermann John Sawyer Paul S.

33、 Schluter Johannes Schmidt Lars Schmitt Mark G. Schnell Richard A. Schrenker Antonio Scorpiniti Kwang Seok Seo Riccardo Serafin Sid Shaw Frank Shen Min Shih Mazen Shihabi Tommy Shing Krishna Shingala Redmond Shouldice Robert Smith Ivan Soh Motoki Sone Emily Sopensky Andreas Staubert Nick Steblay Lar

34、s Steubesand John (Ivo) Stivoric Raymond Strickland Hermanni Suominen Lee Surprenant Ravi Swami Ray Sweidan Kunihiro Takiuchi Francis Tam Haruyuyki Tatsumi Brad Tipler Jonas Tirn James Tomcik Janet Traub Gary Tschautscher Masato Tsuchid Ken Tubman Yoshihiro Uchida Sunil Unadkat Philipp Urbauer Laura

35、 Vanzago Alpo Vrri Daniel von Bren Rudi Voon Isobel Walker Jrg Walter David Wang Jerry P. Wang Yao Wang Steve Warren Fujio Watanabe Toru Watsuji Jeff Webber Paul Williamson Jan Wittenber Jia-Rong Wu Will Wykeham Ariton Xhafa Ricky Yang Done-Sik Yoo Jason Zhang Thomas Zhao Daidi Zhong Szymon Zysko Th

36、e following members of the individual balloting committee voted on this standard. Balloters may have voted for approval, disapproval, or abstention. Christopher Biernacki Thomas Blackadar Douglas P. Bogia Nancy Bravin Lyle Bullock Randy W. Carroll Peng Chen Keith Chow Malcolm Clarke Richard Doyle So

37、urav Dutta Randall Groves Kai Hassing Werner Hoelzl Atsushi Ito Piotr Karocki Daniel Levesque William Lumpkins G. Luri Wade Midkiff Melvin Reynolds Bartien Sayogo Lars Schmitt Gil Shultz James E. Smith Kapil Sood Lars Steubesand Jan Wittenber Oren Yuen viii Copyright 2010 IEEE. All rights reserved.

38、When the IEEE-SA Standards Board approved this standard on 30 September 2010, it had the following membership: Robert M. Grow, Chair Richard H. Hulett, Vice Chair Steve M. Mills, Past Chair Judith Gorman, Secretary Karen Bartleson Victor Berman Ted Burse Clint Chaplin Andy Drozd Alexander Gelman Jim

39、 Hughes Young Kyun Kim Joseph L. Koepfinger* John Kulick David J. Law Hung Ling Oleg Logvinov Ted Olsen Ronald C. Petersen Thomas Prevost Jon Walter Rosdahl Sam Sciacca Mike Seavey Curtis Siller Don Wright *Member Emeritus Also included are the following nonvoting IEEE-SA Standards Board liaisons: S

40、atish 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 Developmentix Copyright 2010 IEEE. All rights reserved. C

41、ontents 1. Overview 1 1.1 Scope . 1 1.2 Purpose 2 1.3 Context 2 2. Normative references 2 3. Definitions, acronyms, and abbreviations 2 3.1 Definitions . 3 3.2 Acronyms and abbreviations . 3 4. Introduction to ISO/IEEE 11073 personal health devices 4 4.1 General 4 4.2 Introduction to ISO/IEEE 11073-

42、20601 modeling constructs . 4 5. Peak expiratory flow monitor device concepts and modalities. 5 5.1 General 5 5.2 PEF 5 6. Peak expiratory flow monitor domain information model . 7 6.1 Overview . 7 6.2 Class extensions . 7 6.3 Object instance diagram 7 6.4 Types of configuration . 9 6.5 Medical devi

43、ce system object 9 6.6 Numeric objects . 13 6.7 Real-time sample array objects 20 6.8 Enumeration objects 20 6.9 PM-store objects 22 6.10 Scanner objects 22 6.11 Class extension objects 22 6.12 Peak expiratory flow monitor information model extensibility rules 22 7. Peak expiratory flow monitor serv

44、ice model 22 7.1 General 22 7.2 Object access services 22 7.3 Object access event report services . 23 x Copyright 2010 IEEE. All rights reserved. 8. Peak expiratory flow monitor communication model 24 8.1 Overview . 24 8.2 Communications characteristics 24 8.3 Association procedure . 24 8.4 Configu

45、ring procedure . 26 8.5 Operating procedure 28 8.6 Time synchronization 29 9. Test associations . 29 9.1 Behavior with standard configuration 29 9.2 Behavior with extended configurations . 30 10. Conformance 30 10.1 Applicability 30 10.2 Conformance specification 30 10.3 Levels of conformance 30 10.

46、4 Implementation conformance statements 31 Annex A (informative) Bibliography . 36 Annex B (normative) Any additional ASN.1 definitions . 37 Annex C (normative) Allocation of identifiers . 38 Annex D (informative) Message sequence examples . 39 Annex E (informative) Protocol data unit examples 41 1

47、Copyright 2010 IEEE. All rights reserved. Health informaticsPersonal health device communication Part 10421: Device specialization Peak expiratory flow monitor (peak flow) IMPORTANT NOTICE: This standard is not intended to ensure safety, security, health, or environmental protection. Implementers of

48、 the standard are responsible for determining appropriate safety, security, environmental, and health practices or regulatory requirements. This IEEE document is made available for use subject to important notices and legal disclaimers. These notices and disclaimers appear in all publications contai

49、ning this document and may be found under the heading “Important Notice” or “Important Notices and Disclaimers Concerning IEEE Documents.” They can also be obtained on request from IEEE or viewed at http:/standards.ieee.org/IPR/disclaimers.html. 1. Overview 1.1 Scope The scope of this standard is to establish a normative definition of communication between personal telehealth peak flow monitoring devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-