Within the context of the ISO/IEEE 11073 family of standards for device communication, this document 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 document defines a common core of communication functionality for personal telehealth pulse oximeters.

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PDF Pages	PDF Title
2	undefined
4	European foreword Endorsement notice
6	Blank Page
9	Notice and Disclaimer of Liability Concerning the Use of IEEE Standards Documents Translations
10	Official statements Comments on standards Laws and regulations Data privacy Copyrights Photocopies
11	Updating of IEEE Standards documents Errata Patents IMPORTANT NOTICE
18	1. Overview 1.1 Scope 1.2 Purpose 1.3 Context
19	2. Normative references 3. Definitions, acronyms, and abbreviations 3.1 Definitions
20	3.2 Acronyms and abbreviations 4. Introduction to ISO/IEEE 11073 personal health devices 4.1 General
21	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
22	5. Pulse oximeter device concepts and modalities 5.1 General 5.2 Device types 5.3 General concepts 5.3.1 Noninvasive measurement
23	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
24	5.4.2.2 Alternative expressions of SpO2 5.4.3 Pulse rate 5.4.4 Pulsatile occurrence 5.4.5 Plethysmogram
25	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
26	6. Pulse oximeter DIM 6.1 Overview 6.2 Class extensions 6.3 Object instance diagram
27	6.4 Types of configuration 6.4.1 General 6.4.2 Standard configuration 6.4.3 Extended configuration
28	6.5 MDS object 6.5.1 MDS object attributes
30	6.5.2 MDS object methods 6.5.3 MDS object events
32	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
35	6.6.2.1 SpO2—Extended configuration 6.6.2.1.1 Threshold settings and status attributes
36	6.6.2.2 SpO2—Standard configurations 6.6.2.3 SpO2—Methods, events, services 6.6.3 Pulse rate
39	6.6.3.1 Pulse rate—Extended configuration 6.6.3.1.1 Threshold settings and status attributes
40	6.6.3.2 Pulse rate—Standard configuration 6.6.3.3 Pulse rate—Methods, events, services 6.6.4 Pulsatile quality
42	6.7 Real-time sample array (RT-SA) objects 6.7.1 Plethysmographic waveform
43	6.8 Enumeration objects 6.8.1 General 6.8.2 Pulsatile occurrence
44	6.8.3 Pulsatile characteristic
46	6.8.4 Device and sensor annunciation conditions
47	6.9 PM-store objects 6.9.1 General
48	6.9.2 Persistent store model
49	6.9.3 PM-store object attributes
50	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
51	6.10 Scanner objects 6.10.1 General
52	6.10.2 Periodic configurable scanner attributes
53	6.10.3 Episodic configurable scanner attributes
54	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
58	7.3 Object access EVENT REPORT services 8. Pulse oximeter communication model 8.1 Overview 8.2 Communications characteristics
59	8.3 Association procedure 8.3.1 General 8.3.2 Agent procedure—Association request
60	8.3.3 Manager procedure—Association response
61	8.4 Configuring procedure 8.4.1 General 8.4.2 Pulse oximeter—Standard configuration 8.4.2.1 Agent procedure
62	8.4.2.2 Manager procedure 8.5 Operating procedure 8.5.1 General 8.5.2 GET pulse oximeter MDS attributes
63	8.5.3 Measurement data transmission 8.6 Time synchronization 9. Test associations 9.1 Behavior with standard configuration
64	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
65	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
67	10.4.3 DIM MOC ICS 10.4.4 MOC attribute ICS
68	10.4.5 MOC notification ICS 10.4.6 MOC nomenclature ICS
69	Annex A (informative) Bibliography
70	Annex B (normative) Additional ASN.1 definitions B.1 Device and sensor status bit mapping
71	Annex C (normative) Allocation of identifiers C.1 General C.2 Definitions of terms and codes
72	C.3 Systematic derivations of terms and codes
73	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.
75	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
76	E.2.2.3 Association response E.2.3 Previously known extended configuration E.2.3.1 General E.2.3.2 Association request
77	E.2.3.3 Association response E.2.4 Standard configuration E.2.4.1 General E.2.4.2 Association request
78	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
80	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
81	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
83	E.5 Data reporting E.5.1 Confirmed measurement data transmission E.5.2 Response to confirmed measurement data transmission
84	E.6 Scanner example E.6.1 General E.6.2 Portion of configuration report describing a periodic configurable scanner
85	E.6.3 Measurement data transfer of a periodic configurable scanner
86	E.7 Disassociation E.7.1 Association release request E.7.2 Association release response
87	Annex F (informative) Revision history

Published By	Publication Date	Number of Pages
BSI	2023	90


PDF Format	Searchable	Printable	Preview Now

Status	Definitive
Pages	90
Publication Date	2023-01-09
ISBN	978 0 539 22274 6
Standard Number	BS EN ISO/IEEE 11073-10404:2022
Title	Health informatics. Device interoperability – Personal health device communication. Device specialization. Pulse oximeter
Identical National Standard Of	ISO /IEEE 11073-10404, EN ISO /IEEE 11073-10404
Replaces	BS EN ISO 11073-10404:2011
Descriptors	Diagnostic equipment (medical), Diagnostic instruments (medical), Medical electrical equipment, Medical equipment, Medical informatics, Medical technology, Medical electronics, Medical radiology
Publisher	BSI
Committee	IST/35
ICS Codes	35.240.80 - IT applications in health care technology

BS EN ISO/IEEE 11073-10404:2022:2023 Edition

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