IEEE 11073-10406-2023

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IEEE Standard for Health Informatics–Device Interoperability Part 10406: Personal Health Device Communication–Device Specialization–Basic Electrocardiography (ECG) (1‐ to 3‐lead ECG) (Approved Draft)

Published By	Publication Date	Number of Pages
IEEE	2023	74

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Description

Revision Standard – Active. 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 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 information 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 is 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 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).

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PDF Pages	PDF Title
1	IEEE Std 11073-10406™-2023 Front cover
4	Important Notices and Disclaimers Concerning IEEE Standards Documents
8	Introduction
9	Participants
12	Contents
14	1. Overview 1.1 Scope 1.2 Purpose
15	1.3 Context 1.4 Word usage 2. Normative references
16	3. Definitions, acronyms, and abbreviations 3.1 Definitions
17	3.2 Acronyms and abbreviations 4. Introduction to ISO/IEEE 11073 personal health devices 4.1 General
18	4.2 Introduction to ISO/IEEE 11073-20601 modeling constructs 4.2.1 General 4.2.2 Domain information model 4.2.3 Service model 4.2.4 Communication model 4.2.5 Implementing the models 4.3 Compliance with other standards
19	5. Basic ECG (1- to 3-lead ECG) device concepts and modalities 5.1 General 5.2 ECG waveform 5.3 R-R interval 5.4 Heart rate
20	6. Basic ECG (1- to 3-lead ECG) domain information model 6.1 Overview 6.2 Class extensions 6.3 Object instance diagram
21	6.4 Types of configuration 6.4.1 General
22	6.4.2 Standard configuration 6.4.3 Extended configuration 6.5 Profiles 6.5.1 General 6.5.2 Simple ECG profile 6.5.3 Heart rate profile
24	6.6 Medical device system object 6.6.1 MDS object attributes
25	6.6.2 Tick-Resolution attribute 6.6.3 MDS object methods
26	6.6.4 MDS object events
27	6.6.5 Other MDS services 6.6.5.1 GET service
28	6.6.5.2 SET service 6.7 Numeric objects 6.7.1 General 6.7.2 Heart rate
31	6.7.3 R-R interval 6.8 Real-time sample array objects 6.8.1 General
32	6.8.2 ECG waveform
33	6.9 Enumeration objects 6.9.1 General 6.9.2 Device status
34	6.9.3 Context Data Trigger
35	6.10 PM-store objects 6.10.1 General
36	6.10.2 Persistent store model
37	6.10.3 Periodic
38	6.10.4 Aperiodic
39	6.10.5 PM-store object methods 6.10.6 PM-store object events
40	6.10.7 PM-store object services 6.10.7.1 General 6.10.7.2 GET service 6.10.7.3 SET service 6.10.8 PM-segment objects 6.10.8.1 Periodic session
41	6.10.8.2 Aperiodic session
42	6.11 Scanner objects 6.11.1 General
43	6.11.2 Periodic configurable scanner attributes
44	6.11.3 Episodic configurable scanner attributes 6.12 Class extension objects
45	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 services
48	7.3 Object access event report services 8. Basic ECG (1- to 3-lead ECG) communication model 8.1 Overview 8.2 Communications characteristics
49	8.3 Association procedure 8.3.1 General 8.3.2 Agent procedure—association request
50	8.3.3 Manager procedure—association response
51	8.4 Configuring procedure 8.4.1 General 8.4.2 Basic ECG (1- to 3-lead ECG)—standard configuration 8.4.2.1 Agent procedure
52	8.4.2.2 Manager procedure 8.5 Operating procedure 8.5.1 General 8.5.2 GET basic ECG (1- to 3-lead ECG) MDS attributes 8.5.3 Measurement data transmission
53	8.6 Time synchronization 9. Test associations 9.1 Behavior with standard configuration 9.2 Behavior with extended configurations 10. Conformance 10.1 Applicability
54	10.2 Conformance specification 10.3 Levels of conformance 10.3.1 General 10.3.2 Conformance level 1: Base conformance 10.3.3 Conformance level 2: Extended nomenclature (ASN.1 and/or ISO/IEEE 11073-10101) 10.4 Implementation conformance statements (ICSs) 10.4.1 General format
55	10.4.2 General ICS
56	10.4.3 DIM MOC ICS
57	10.4.4 MOC attribute ICS
58	10.4.5 MOC notification ICS 10.4.6 MOC nomenclature ICS
59	Annex A (informative) Bibliography
60	Annex B (normative) Any additional ASN.1 definitions B.1 Bit mappings for device, lead, and signal status
61	Annex C (normative) Allocation of identifiers
62	Annex D (informative) Message sequence examples
64	Annex E (informative) Protocol data unit examples E.1 General E.2 Association information exchange E.2.1 General E.2.2 Extended configuration E.2.2.1 General E.2.2.2 Association request
65	E.2.2.1 Association response E.2.3 Previously known extended configuration E.2.3.1 General E.2.3.2 Association request
66	E.2.3.3 Association response E.2.4 Standard configuration E.2.4.1 General E.2.4.2 Association request
67	E.2.4.3 Association response E.3 Configuration information exchange E.3.1 General
68	E.3.2 Extended configuration E.3.2.1 General E.3.2.2 Remote operation invoke event report configuration
69	E.3.2.3 Remote operation response event report configuration E.3.3 Known configuration E.3.3.1 General E.3.3.2 Remote operation invoke event report configuration E.3.3.3 Remote operation response event report configuration
70	E.3.4 Standard configuration E.3.4.1 General E.3.4.2 Remote operation invoke event report configuration E.3.4.3 Remote operation response event report configuration E.4 GET MDS attributes service E.4.1 General E.4.2 Get all MDS attributes request E.4.3 Get response with all MDS attributes
72	E.5 Data reporting E.5.1 Unconfirmed measurement data transmission E.6 Disassociation E.6.1 Association release request E.6.2 Association release response
73	Annex F (informative) Revision history

Additional information

Standard Title	IEEE Standard for Health Informatics–Device Interoperability Part 10406: Personal Health Device Communication–Device Specialization–Basic Electrocardiography (ECG) (1‐ to 3‐lead ECG) (Approved Draft)
Published Code	IEEE
Publication Date	2023
Pages Count	74

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