BS EN ISO/IEEE 11073-10420:2022:2023 Edition
$215.11
Health informatics. Device interoperability – Personal health device communication. Device specialization. Body composition analyzer
| Published By | Publication Date | Number of Pages |
| BSI | 2023 | 86 |
Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between personal body composition analyzer agents and managers (e.g., cell phones, personal computers, personal health appliances, set-top boxes) is established by this document 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 to restrict optionality in base frameworks in favor of interoperability. This document defines a common core of communication functionality for personal telehealth body composition analyzers. In this context, the phrase “body composition analyzer” is used broadly to cover analyzing devices that measure body impedances and compute the various body components including body fat from the impedance.
PDF Catalog
| 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 |
| 19 | 1. Overview 1.1 Scope 1.2 Purpose 1.3 Context |
| 20 | 1.4 Word usage 2. Normative references |
| 21 | 3. Definitions, acronyms, and abbreviations 3.1 Definitions |
| 22 | 3.2 Acronyms and abbreviations 4. Introduction to ISO/IEEE 11073 personal health devices 4.1 General |
| 23 | 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 |
| 24 | 5. Body composition analyzer concepts and modalities 5.1 General 5.2 Body fat 5.3 Body height 5.4 Body weight |
| 25 | 5.5 Body mass index 5.6 Fat free mass 5.7 Soft lean mass 5.8 Body water 5.9 Basal metabolic rate 5.10 Bioimpedance analysis method 5.11 Body muscle |
| 26 | 6. Body composition analyzer 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 |
| 28 | 6.4.3 Extended configuration 6.5 Medical device system (MDS) object 6.5.1 MDS object attributes |
| 29 | 6.5.2 MDS object methods |
| 31 | 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 Body fat |
| 33 | 6.6.3 Body height 6.6.4 Body weight |
| 43 | 6.6.5 Body mass index |
| 44 | 6.6.6 Fat free mass |
| 45 | 6.6.7 Soft lean mass |
| 46 | 6.6.8 Body water |
| 47 | 6.6.9 Basal metabolic rate |
| 48 | 6.6.10 Body muscle |
| 49 | 6.7 Real-time sample array objects 6.8 Enumeration objects 6.8.1 General 6.8.2 Bioimpedance analysis method |
| 50 | 6.9 PM-store objects 6.10 Scanner objects 6.11 Class extension objects 6.12 Body composition analyzer DIM extensibility rules 7. Body composition analyzer service model 7.1 General 7.2 Object access services |
| 51 | 7.3 Object access event report services |
| 53 | 8. Body composition analyzer communication model 8.1 Overview 8.2 Communications characteristics 8.3 Association procedure 8.3.1 General |
| 54 | 8.3.2 Agent procedure—association request a) The version of the association procedure used by the agent shall be set to assoc-version1 (i.e., assoc-version = 0x80000000). b) The DataProtoList structure element of the data protocol identifier shall be set to data-proto-id-20601 (i.e., data-proto-id = 0x5079). c) The data-proto-info field shall contain a PhdAssociationInformation structure which shall contain the following parameter values: 1) The version of the data exchange protocol shall be set to protocol-version4 (i.e., protocol-version = 0x10000000). Support for any other version may be indicated by setting additional bits. When protocols lower than protocol-version4 are used, the … 2) At least the MDER encoding rules shall be supported (i.e., encoding-rules = 0x8000). 3) The protocol version bits and nomenclature version bits shall consist of valid combinations of bits as defined in Table 16. 4) The functional-units field may have the test association bits set but shall not have any other bits set. 5) The system-type field shall be set to sys-type-agent (i.e., system-type = 0x00800000). 6) The system-id field shall be set to the value of the System-Id attribute of the MDS object of the agent. The manager may use this field to determine the identity of the body composition analyzer with which it is associating and, optionally, to impl… 7) The dev-config-id field shall be set to the value of the Dev-Configuration-Id attribute of the MDS object of the agent. 8) If the agent supports only the body composition analyzer specialization, then the field indicating the data request modes (data-req-mode-capab) supported by the body composition analyzer agent shall be set to data-req-supp-init-agent. 9) If the agent supports only the body composition analyzer specialization, then data-req-init-manager-count shall be set to zero, and data-req-init-agent-count shall be set to 1. 8.3.3 Manager procedure—association response a) The result field shall be set to an appropriate response from those defined in IEEE Std 11073-20601. For example, if all other conditions of the association protocol are satisfied, accepted is returned when the manager recognizes the dev-config-id … b) In the DataProtoList structure element, the data protocol identifier shall be set to data-proto-id-20601 (i.e., data-proto-id = 0x5079). c) The data-proto-info field shall be filled in with a PhdAssociationInformation structure, which shall contain the following parameter values: |
| 55 | 1) The manager following this specialization shall support protocol-version4. The manager may support additional protocol versions and select them if the agent offers them. When protocols lower than protocol-version4 are used, the manager shall use on… 2) The manager shall respond with a single selected encoding rule that is supported by both agent and manager. The manager shall support at least the MDER encoding rules. 3) The manager shall select a valid combination of protocol version and nomenclature version as defined in Table 16. 4) The functional-units field shall have all bits reset except for those relating to a test association. 5) The system-type field shall be set to sys-type-manager (i.e., system-type = 0x80000000). 6) The system-id field shall contain the unique system id of the manager device, which shall be a valid EUI-64 type identifier. 7) The dev-config-id field shall be manager-config-response (0). 8) The data-req-mode-capab field shall be 0. 9) The data-req-init-*-count field shall be 0. 8.4 Configuring procedure 8.4.1 General 8.4.2 Body composition analyzer—standard configuration 8.4.2.1 Agent procedure |
| 57 | 8.4.2.2 Manager procedure 8.5 Operating procedure 8.5.1 General 8.5.2 GET body composition analyzer MDS attributes |
| 58 | 8.5.3 Measurement data transmission 8.6 Time synchronization 9. Test associations 9.1 General 9.2 Behavior with standard configuration |
| 59 | 9.3 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 |
| 60 | 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 |
| 62 | 10.4.3 DIM MOC ICS 10.4.4 MOC attribute ICS |
| 63 | 10.4.5 MOC notification ICS |
| 64 | 10.4.6 MOC nomenclature ICS |
| 65 | Annex A (informative) Bibliography |
| 66 | Annex B (normative) Any additional ASN.1 definitions |
| 67 | Annex C (normative) Allocation of identifiers |
| 68 | Annex D (informative) Message sequence examples a) When the user connects the medication monitor, the manager does not recognize 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 P… b) As a consequence of this, the agent negotiates its configuration information to the manager. After getting confirmation from the manager accepting the agent’s configuration, the agent device is ready to send measurements. Both devices enter the Ope… 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. Note that the manager may request the MDS object attributes as soon as the agent enters the Ass… d) As a next step, the user of the agent device takes a single measurement. The measurement data is transmitted to the manager using a confirmed event report. After having successfully received the measurement data, the manager sends a confirmation to… e) The user ends the measurement session (e.g., by pushing a proper button on the device, or just by not using the device for a duration longer than a certain time period). As a consequence, the agent disassociates from the manager by sending an assoc… f) When the agent requests to associate to the manager for the next measurement session (e.g., the next day), the result in the manager’s response is accepted, as it already knows the agent’s configuration from the previous measurement session. Both d… g) Finally, the last two steps shown are similar as in item e) and item f). The user takes a single confirmed measurement followed by releasing the association. |
| 70 | 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 |
| 71 | E.2.2.3 Association response E.2.3 Previously known extended configuration E.2.3.1 General E.2.3.2 Association request |
| 72 | E.2.3.3 Association response E.2.4 Standard configuration E.2.4.1 General E.2.4.2 Association request |
| 73 | 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 |
| 77 | 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 |
| 78 | 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 |
| 80 | E.5 Data reporting E.5.1 Confirmed measurement data transmission E.5.2 Response to confirmed measurement data transmission |
| 81 | E.6 Disassociation E.6.1 Association release request E.6.2 Association release response |
| 82 | Annex F (informative) Revision history |
| 83 | Blank Page |
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