IEEE 11073-10404-2022

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IEEE/ISO International Standard–Health informatics–Device interoperability–Part 10404: Personal health device communication–Device specialization–Pulse oximeter (Published)

Published By	Publication Date	Number of Pages
IEEE	2022	86

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Description

Adoption Standard – Active. Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of communication between personal telehealth pulse oximetry devices and compute engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. 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 communication functionality for personal telehealth pulse oximeters.

PDF Catalog

PDF Pages	PDF Title
4	Blank Page
7	Notice and Disclaimer of Liability Concerning the Use of IEEE Standards Documents Translations
8	Official statements Comments on standards Laws and regulations Data privacy Copyrights Photocopies
9	Updating of IEEE Standards documents Errata Patents IMPORTANT NOTICE
16	1. Overview 1.1 Scope 1.2 Purpose 1.3 Context
17	2. Normative references 3. Definitions, acronyms, and abbreviations 3.1 Definitions
18	3.2 Acronyms and abbreviations 4. Introduction to ISO/IEEE 11073 personal health devices 4.1 General
19	4.2 Introduction to IEEE 11073-20601 modeling constructs 4.2.1 General 4.2.2 Domain information model (DIM) 4.2.3 Service model 4.2.4 Communication model 4.2.5 Implementing the models 4.3 Compliance with other standards
20	5. Pulse oximeter device concepts and modalities 5.1 General 5.2 Device types 5.3 General concepts 5.3.1 Noninvasive measurement
21	5.3.2 Acquisition modes 5.3.2.1 General 5.3.2.2 Spot-check 5.3.2.3 Continuous monitoring 5.3.2.4 Stored-and-forwarded measurements 5.4 Collected data 5.4.1 General 5.4.2 Percentage of arterial haemoglobin oxygen saturation 5.4.2.1 SpO2
22	5.4.2.2 Alternative expressions of SpO2 5.4.3 Pulse rate 5.4.4 Pulsatile occurrence 5.4.5 Plethysmogram
23	5.4.6 Pulsatile quality and signal characterization 5.5 Derived data 5.5.1 Limit indications 5.5.2 Pulsatile status 5.5.3 Device and sensor status 5.6 Stored data 5.7 Device configurations
24	6. Pulse oximeter DIM 6.1 Overview 6.2 Class extensions 6.3 Object instance diagram
25	6.4 Types of configuration 6.4.1 General 6.4.2 Standard configuration 6.4.3 Extended configuration
26	6.5 MDS object 6.5.1 MDS object attributes
28	6.5.2 MDS object methods 6.5.3 MDS object events
30	6.5.4 Other MDS services 6.5.4.1 GET service 6.5.4.2 SET service 6.6 Numeric objects 6.6.1 General 6.6.2 SpO2
33	6.6.2.1 SpO2—Extended configuration 6.6.2.1.1 Threshold settings and status attributes
34	6.6.2.2 SpO2—Standard configurations 6.6.2.3 SpO2—Methods, events, services 6.6.3 Pulse rate
37	6.6.3.1 Pulse rate—Extended configuration 6.6.3.1.1 Threshold settings and status attributes
38	6.6.3.2 Pulse rate—Standard configuration 6.6.3.3 Pulse rate—Methods, events, services 6.6.4 Pulsatile quality
40	6.7 Real-time sample array (RT-SA) objects 6.7.1 Plethysmographic waveform
41	6.8 Enumeration objects 6.8.1 General 6.8.2 Pulsatile occurrence
42	6.8.3 Pulsatile characteristic
44	6.8.4 Device and sensor annunciation conditions
45	6.9 PM-store objects 6.9.1 General
46	6.9.2 Persistent store model
47	6.9.3 PM-store object attributes
48	6.9.4 PM-store object methods 6.9.5 PM-store object events 6.9.6 PM-store object services 6.9.7 PM-segment objects
49	6.10 Scanner objects 6.10.1 General
50	6.10.2 Periodic configurable scanner attributes
51	6.10.3 Episodic configurable scanner attributes
52	6.11 Class extension objects 6.12 Pulse oximeter information model extensibility rules 7. Pulse oximeter service model 7.1 General 7.2 Object access services
56	7.3 Object access EVENT REPORT services 8. Pulse oximeter communication model 8.1 Overview 8.2 Communications characteristics
57	8.3 Association procedure 8.3.1 General 8.3.2 Agent procedure—Association request
58	8.3.3 Manager procedure—Association response
59	8.4 Configuring procedure 8.4.1 General 8.4.2 Pulse oximeter—Standard configuration 8.4.2.1 Agent procedure
60	8.4.2.2 Manager procedure 8.5 Operating procedure 8.5.1 General 8.5.2 GET pulse oximeter MDS attributes
61	8.5.3 Measurement data transmission 8.6 Time synchronization 9. Test associations 9.1 Behavior with standard configuration
62	9.2 Behavior with extended configurations 10. Conformance 10.1 Applicability 10.2 Conformance specification 10.3 Levels of conformance 10.3.1 General 10.3.2 Conformance Level 1: Base conformance
63	10.3.3 Conformance Level 2: Extended nomenclature (ASN.1 and/or IEEE 11073-10101) 10.4 Implementation conformance statements (ICSs) 10.4.1 General format 10.4.2 General ICS
65	10.4.3 DIM MOC ICS 10.4.4 MOC attribute ICS
66	10.4.5 MOC notification ICS 10.4.6 MOC nomenclature ICS
67	Annex A (informative) Bibliography
68	Annex B (normative) Additional ASN.1 definitions B.1 Device and sensor status bit mapping
69	Annex C (normative) Allocation of identifiers C.1 General C.2 Definitions of terms and codes
70	C.3 Systematic derivations of terms and codes
71	Annex D (informative) Message sequence examples a) When the user connects the pulse oximeter, the manager does not yet know the agent’s configuration and sends a response to the agent’s Association Request with the result accepted-unknown-config. See E.2.2.2 and E.2.2.3 for the corresponding PDU ex… b) As a consequence of the previous action, the agent negotiates its configuration information to the manager. After getting confirmation that the manager accepts the agent’s configuration, the agent device is ready to send measurements. Both devices … c) Subsequently, the manager may request the MDS object attributes of the agent by sending a data message with the “Remote Operation Invoke \| Get” command. As a response, the agent reports its MDS object attributes to the manager using a data message … d) As a next step, the user of the agent device takes a single measurement. The measurement data are transmitted to the manager using a confirmed event report. After having successfully received the measurement data, the manager sends a confirmation t… e) The user ends the measurement session (e.g., by pushing the appropriate button on the device or by simply not using the device for a duration longer than a certain time period). As a consequence, the agent disassociates from the manager by sending … f) When the agent requests to associate to the manager for the next measurement session (e.g., the next day), the manager responds that it has accepted the configuration, as it already knows the agent’s configuration from the previous measurement sess… g) Finally, the last two steps shown are similar to step d) and step e). The user takes a single confirmed measurement followed by releasing the association.
73	Annex E (informative) PDU 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
74	E.2.2.3 Association response E.2.3 Previously known extended configuration E.2.3.1 General E.2.3.2 Association request
75	E.2.3.3 Association response E.2.4 Standard configuration E.2.4.1 General E.2.4.2 Association request
76	E.2.4.3 Association response E.3 Configuration information exchange E.3.1 General E.3.2 Extended configuration E.3.2.1 General E.3.2.2 Remote operation invoke event report configuration
78	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
79	E.3.3.3 Remote operation response event report configuration 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 medical device system attributes request E.4.3 Get response with all MDS attributes
81	E.5 Data reporting E.5.1 Confirmed measurement data transmission E.5.2 Response to confirmed measurement data transmission
82	E.6 Scanner example E.6.1 General E.6.2 Portion of configuration report describing a periodic configurable scanner
83	E.6.3 Measurement data transfer of a periodic configurable scanner
84	E.7 Disassociation E.7.1 Association release request E.7.2 Association release response
85	Annex F (informative) Revision history

Additional information

Standard Title	IEEE/ISO International Standard–Health informatics–Device interoperability–Part 10404: Personal health device communication–Device specialization–Pulse oximeter (Published)
Published Code	IEEE
Publication Date	2022
Pages Count	86

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