ISO/IEEE INTERNATIONAL STANDARD 11073-10406 First edition 2012-12-01 Health informatics Personal health device communication - Part 10406: Device specialization Basic electrocardiograph (ECG) (1- to 3-lead ECG) Informatique de sante Communication entre dispositifs de santé personnels- Partie 10406: Spécialisation des dispositifs Electrocardiographe de base (ECG) (ECG 1a 3) Reference number ISO ISO/IEEE 11073-10406:2012(E) IEEE IFFF2012 IS0/IEEE 11073-10406:2012(E) COPYRIGHTPROTECTEDDOCUMENT IEEE2012 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO or IEEE at the respective address below. ISO copyright office Institute of Electrical and Electronics Engineers, Inc. Case postale 56. CH-1211 Geneva 20 3Park Avenue, NewYork·NY 10016-5997,USA Tel. + 41 22 749 01 11 E-mail [email protected] Fax + 4122 749 0947 Web www.ieee.org E-mail [email protected] Web www.iso.org Published in Switzerland @ IEEE 2012 - All riahts reserved ISO/IEEE 11073-10406:2012(E) Contents 1.Overview. 1.1 Scope 1.2Purpose 1.3 Context 2. Normative references.. 3. Definitions, acronyms, and abbreviations . 3.1 Definitions.. 3.2 Acronyms and abbreviations .. 4. Introduction to ISO/IEEE 11073 personal health devices . 4.1 General ... 4.2 Introduction to ISO/IEEE 11073-20601 modeling constructs . 4..3 Compliance with other standards..... 5. Basic ECG (1- to 3-lead ECG) device concepts and modalities. 5.1 General . 5.2 ECG waveform 5.3 R-R interval 5.4Heart rate 6.Basic ECG (1-to 3-leadECG)domain information model.. 6.1Overview.. 6.2Class extensions 6.3 Object instance diagram 6.4 Types of configuration.. 6.5 Profiles.. 6.6 Medical device system object 6.7Numeric objects 6.8 Real-time sample array objects 18 6.9Enumerationobjects 6.10 PM-store objects . 6.11Scannerobjects 29 6.12Class extension objects 32 6.13 Basic ECG (1- to 3-lead ECG) information model extensibility rules ... 7. Basic ECG (1- to 3-lead ECG) service model 7.1 General ..... 7.2 Object access servic 32 7.3 Object access event report services 35 8. Basic ECG (1- to 3-lead ECG) communication model 35 8.1Overview. 35 8.2Communicationscharacteristics 36 8.3 Association procedure . 36 8.4 Configuring procedure. 38 8.5 Operating procedure . 39 8.6 Time synchronization 40 riahts reserved ili ISO/IEEE11073-10406:2012(E) 9. Test associations.. 9.1 Behavior with standard configuration.. 40 9.2 Behavior with extended configurations 41 10.Conformance 10.1 Applicability... 10.2 Conformance specification 10.3 Levels of conformance .... 42 10.4 Implementation conformance statements 42 Annex A (informative) Bibliography .. 47 Annex B (normative) Any additional ASN.1 definitions ..48 Annex C (normative) Allocation of identifiers. 49 Annex D (informative) Message sequence examples. Annex E (informative) Protocol data unit examples 52 @IEEE2012-All riahts reserved ISO/IEEE11073-10406:2012(E) Foreword IsoO (the International Organization for Standardization) is a worldwide federation of national standards bodies (IsO member bodies). The work of preparing International Standards is normally carried out through IsO technical committees. Each member body interested in a subject for which a technical committee has been non-governmental, in liaison with isO, also take part in the work. IsoO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating Committees of the IEEE Standards Association (IEEE-SA) Standards Board. The IEEE develops its standards through a consensus development process, approved by the American National Standards Institute, which brings together volunteers representing varied viewpoints and interests to achieve the final product. Volunteer