BS EN ISO/IEEE 11073-10404:2022 – TC:2023 Edition
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Tracked Changes. Health informatics. Device interoperability – Personal health device communication. Device specialization. Pulse oximeter
| Published By | Publication Date | Number of Pages |
| BSI | 2023 | 236 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | 30468207 |
| 147 | A-30455842 |
| 148 | undefined |
| 150 | European foreword Endorsement notice |
| 152 | Blank Page |
| 155 | Notice and Disclaimer of Liability Concerning the Use of IEEE Standards Documents Translations |
| 156 | Official statements Comments on standards Laws and regulations Data privacy Copyrights Photocopies |
| 157 | Updating of IEEE Standards documents Errata Patents IMPORTANT NOTICE |
| 164 | 1. Overview 1.1 Scope 1.2 Purpose 1.3 Context |
| 165 | 2. Normative references 3. Definitions, acronyms, and abbreviations 3.1 Definitions |
| 166 | 3.2 Acronyms and abbreviations 4. Introduction to ISO/IEEE 11073 personal health devices 4.1 General |
| 167 | 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 |
| 168 | 5. Pulse oximeter device concepts and modalities 5.1 General 5.2 Device types 5.3 General concepts 5.3.1 Noninvasive measurement |
| 169 | 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 |
| 170 | 5.4.2.2 Alternative expressions of SpO2 5.4.3 Pulse rate 5.4.4 Pulsatile occurrence 5.4.5 Plethysmogram |
| 171 | 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 |
| 172 | 6. Pulse oximeter DIM 6.1 Overview 6.2 Class extensions 6.3 Object instance diagram |
| 173 | 6.4 Types of configuration 6.4.1 General 6.4.2 Standard configuration 6.4.3 Extended configuration |
| 174 | 6.5 MDS object 6.5.1 MDS object attributes |
| 176 | 6.5.2 MDS object methods 6.5.3 MDS object events |
| 178 | 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 |
| 181 | 6.6.2.1 SpO2—Extended configuration 6.6.2.1.1 Threshold settings and status attributes |
| 182 | 6.6.2.2 SpO2—Standard configurations 6.6.2.3 SpO2—Methods, events, services 6.6.3 Pulse rate |
| 185 | 6.6.3.1 Pulse rate—Extended configuration 6.6.3.1.1 Threshold settings and status attributes |
| 186 | 6.6.3.2 Pulse rate—Standard configuration 6.6.3.3 Pulse rate—Methods, events, services 6.6.4 Pulsatile quality |
| 188 | 6.7 Real-time sample array (RT-SA) objects 6.7.1 Plethysmographic waveform |
| 189 | 6.8 Enumeration objects 6.8.1 General 6.8.2 Pulsatile occurrence |
| 190 | 6.8.3 Pulsatile characteristic |
| 192 | 6.8.4 Device and sensor annunciation conditions |
| 193 | 6.9 PM-store objects 6.9.1 General |
| 194 | 6.9.2 Persistent store model |
| 195 | 6.9.3 PM-store object attributes |
| 196 | 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 |
| 197 | 6.10 Scanner objects 6.10.1 General |
| 198 | 6.10.2 Periodic configurable scanner attributes |
| 199 | 6.10.3 Episodic configurable scanner attributes |
| 200 | 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 |
| 204 | 7.3 Object access EVENT REPORT services 8. Pulse oximeter communication model 8.1 Overview 8.2 Communications characteristics |
| 205 | 8.3 Association procedure 8.3.1 General 8.3.2 Agent procedure—Association request |
| 206 | 8.3.3 Manager procedure—Association response |
| 207 | 8.4 Configuring procedure 8.4.1 General 8.4.2 Pulse oximeter—Standard configuration 8.4.2.1 Agent procedure |
| 208 | 8.4.2.2 Manager procedure 8.5 Operating procedure 8.5.1 General 8.5.2 GET pulse oximeter MDS attributes |
| 209 | 8.5.3 Measurement data transmission 8.6 Time synchronization 9. Test associations 9.1 Behavior with standard configuration |
| 210 | 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 |
| 211 | 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 |
| 213 | 10.4.3 DIM MOC ICS 10.4.4 MOC attribute ICS |
| 214 | 10.4.5 MOC notification ICS 10.4.6 MOC nomenclature ICS |
| 215 | Annex A (informative) Bibliography |
| 216 | Annex B (normative) Additional ASN.1 definitions B.1 Device and sensor status bit mapping |
| 217 | Annex C (normative) Allocation of identifiers C.1 General C.2 Definitions of terms and codes |
| 218 | C.3 Systematic derivations of terms and codes |
| 219 | 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. |
| 221 | 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 |
| 222 | E.2.2.3 Association response E.2.3 Previously known extended configuration E.2.3.1 General E.2.3.2 Association request |
| 223 | E.2.3.3 Association response E.2.4 Standard configuration E.2.4.1 General E.2.4.2 Association request |
| 224 | 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 |
| 226 | 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 |
| 227 | 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 |
| 229 | E.5 Data reporting E.5.1 Confirmed measurement data transmission E.5.2 Response to confirmed measurement data transmission |
| 230 | E.6 Scanner example E.6.1 General E.6.2 Portion of configuration report describing a periodic configurable scanner |
| 231 | E.6.3 Measurement data transfer of a periodic configurable scanner |
| 232 | E.7 Disassociation E.7.1 Association release request E.7.2 Association release response |
| 233 | Annex F (informative) Revision history |
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