ISO/IEEE 11073-10407:2022
Health informatics — Device interoperability — Part 10407: Personal health device communication — Device specialization — Blood pressure monitor
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 blood pressure monitor devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and 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 blood pressure monitors.
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Notice and Disclaimer of Liability Concerning the Use of IEEE Standards Documents
Translations
Official statements
Comments on standards
Laws and regulations
Copyrights
Photocopies
Updating of IEEE Standards documents
Errata
Patents
1. Overview
1.1 Scope
1.2 Purpose
1.3 Word usage
1.4 Context
2. Normative references
3. Definitions, acronyms, and abbreviations
3.1 Definitions
3.2 Acronyms and abbreviations
4. Introduction to ISO/IEEE 11073 personal health devices
4.1 General
4.2 Introduction to 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
5. Blood pressure monitor device concepts and modalities
5.1 General
5.2 Systolic and diastolic pressure
5.3 Mean arterial pressure
5.4 Pulse rate
5.5 Blood pressure measurement status
6. Blood pressure monitor domain information model
6.1 Overview
6.2 Class extensions
6.3 Object instance diagram
6.4 Types of configuration
6.4.1 General
6.4.2 Standard configuration
6.4.3 Extended configuration
6.5 Medical device system object
6.5.1 MDS object attributes
6.5.2 MDS object methods
6.5.3 MDS object events
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 Blood pressure measurement
6.6.3 Pulse rate
6.7 Real-time sample array objects
6.8 Enumeration objects
6.8.1 General
6.8.2 Blood pressure measurement status
6.9 PM-store objects
6.10 Scanner objects
6.11 Class extension objects
6.12 Blood pressure monitor information model extensibility rules
7. Blood pressure monitor service model
7.1 General
7.2 Object access services
7.3 Object access event report services
8. Blood pressure monitor communication model
8.1 Overview
8.2 Communication characteristics
8.3 Association procedure
8.3.1 General
8.3.2 Agent procedure—association request
8.4 Configuring procedure
8.4.1 General
8.4.2 Blood pressure monitor—standard configuration
8.4.2.1 Agent procedure
8.4.2.2 Manager procedure
8.5 Operating procedure
8.5.1 General
8.5.2 GET blood pressure monitor MDS attributes
8.5.3 Measurement data transmission
8.6 Time synchronization
9. Test associations
9.1 General
9.2 Behavior with standard configuration
9.3 Behavior with extended configurations
10. Conformance
10.1 Applicability
Annex A (informative) Bibliography
10.4.2 General implementation conformance statement
10.4.3 DIM MOC implementation conformance statement
10.4.4 MOC attribute implementation conformance statement
10.4.5 MOC notification implementation conformance statement
10.4.6 MOC nomenclature conformance statement
Annex A (informative) Bibliography
Annex B (normative) Additional ASN.1 definitions
B.1 Device and sensor status bit mapping
Annex C (normative) Allocation of identifiers
Annex D (informative) Message sequence examples
a) When the user connects the blood pressure 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 correspondi...
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. 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 a proper button on the device or just by not using the device for duration longer than a certain time period). As a consequence, the agent disassociates from the manager by sending an associat...
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 d) and item e). The user takes a single confirmed measurement followed by releasing the association.
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
E.2.2.3 Association response
E.2.3 Previously known extended configuration
E.2.3.1 General
E.2.3.2 Association request
E.2.3.3 Association response
E.2.4 Standard configuration
E.2.4.1 General
E.2.4.2 Association request
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
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
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
E.5 Data reporting
E.5.1 Confirmed measurement data transmission
E.5.2 Response to confirmed measurement data transmission
E.6 Disassociation
E.6.1 Association release request
E.6.2 Association release response
Annex F (informative) Revision history
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Notice and Disclaimer of Liability Concerning the Use of IEEE Standards Documents
Translations
Official statements
Comments on standards
Laws and regulations
Copyrights
Photocopies
Updating of IEEE Standards documents
Errata
Patents
1. Overview
1.1 Scope
1.2 Purpose
1.3 Word usage
1.4 Context
2. Normative references
3. Definitions, acronyms, and abbreviations
3.1 Definitions
3.2 Acronyms and abbreviations
4. Introduction to ISO/IEEE 11073 personal health devices
4.1 General
4.2 Introduction to 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
5. Blood pressure monitor device concepts and modalities
5.1 General
5.2 Systolic and diastolic pressure
5.3 Mean arterial pressure
5.4 Pulse rate
5.5 Blood pressure measurement status
6. Blood pressure monitor domain information model
6.1 Overview
6.2 Class extensions
6.3 Object instance diagram
6.4 Types of configuration
6.4.1 General
6.4.2 Standard configuration
6.4.3 Extended configuration
6.5 Medical device system object
6.5.1 MDS object attributes
6.5.2 MDS object methods
6.5.3 MDS object events
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 Blood pressure measurement
6.6.3 Pulse rate
6.7 Real-time sample array objects
6.8 Enumeration objects
6.8.1 General
6.8.2 Blood pressure measurement status
6.9 PM-store objects
6.10 Scanner objects
6.11 Class extension objects
6.12 Blood pressure monitor information model extensibility rules
7. Blood pressure monitor service model
7.1 General
7.2 Object access services
7.3 Object access event report services
8. Blood pressure monitor communication model
8.1 Overview
8.2 Communication characteristics
8.3 Association procedure
8.3.1 General
8.3.2 Agent procedure—association request
8.4 Configuring procedure
8.4.1 General
8.4.2 Blood pressure monitor—standard configuration
8.4.2.1 Agent procedure
8.4.2.2 Manager procedure
8.5 Operating procedure
8.5.1 General
8.5.2 GET blood pressure monitor MDS attributes
8.5.3 Measurement data transmission
8.6 Time synchronization
9. Test associations
9.1 General
9.2 Behavior with standard configuration
9.3 Behavior with extended configurations
10. Conformance
10.1 Applicability
Annex A (informative) Bibliography
10.4.2 General implementation conformance statement
10.4.3 DIM MOC implementation conformance statement
10.4.4 MOC attribute implementation conformance statement
10.4.5 MOC notification implementation conformance statement
10.4.6 MOC nomenclature conformance statement
Annex A (informative) Bibliography
Annex B (normative) Additional ASN.1 definitions
B.1 Device and sensor status bit mapping
Annex C (normative) Allocation of identifiers
Annex D (informative) Message sequence examples
a) When the user connects the blood pressure 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 correspondi...
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. 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 a proper button on the device or just by not using the device for duration longer than a certain time period). As a consequence, the agent disassociates from the manager by sending an associat...
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 d) and item e). The user takes a single confirmed measurement followed by releasing the association.
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
E.2.2.3 Association response
E.2.3 Previously known extended configuration
E.2.3.1 General
E.2.3.2 Association request
E.2.3.3 Association response
E.2.4 Standard configuration
E.2.4.1 General
E.2.4.2 Association request
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
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
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
E.5 Data reporting
E.5.1 Confirmed measurement data transmission
E.5.2 Response to confirmed measurement data transmission
E.6 Disassociation
E.6.1 Association release request
E.6.2 Association release response
Annex F (informative) Revision history
Blank Page