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IEEE 11073 10418 2011

IEEE 11073 10418 2011

$75.29

Health informatics–Personal health device communication Part 10418: Device specialization–International Normalized Ratio (INR) monitor

Published By Publication Date Number of Pages
IEEE 2011 69
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New IEEE Standard – Active. A normative definition of communication between personal telehealth International Normalized Ratio (INR) devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) is established in this standard in a manner that enables plug-and-play interoperability. Work done in other ISO/IEEE 11073 standards is leveraged, including existing terminology, information profiles, application profile standards, and transport standards. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability is specified. A common core of functionality of INR devices is defined in this standard. In the context of personal health devices, the measurement of the prothrombin time (PT) that is used to assess the level of anticoagulant therapy and its presentation as the International Normalized Ratio compared to the prothrombin time of normal blood plasma is referred to in INR monitoring. Applications of the INR monitor include the management of the therapeutic level of anticoagulant used in the treatment of a variety of conditions. The data modeling and its transport shim layer according to ISO/IEEE 11073-20601:2010 are provided by this standard, and the measurement method is not specified.

PDF Catalog

PDF Pages PDF Title
1 IEEE Std 11073-10418-2011 Front Cover
3 Title Page
6 Introduction
Notice to users
Laws and regulations
Copyrights
Updating of IEEE documents
Errata
7 Interpretations
Patents
8 Participants
11 Contents
13 Important Notice
1. Overview
1.1 Scope
14 1.2 Purpose
1.3 Context
2. Normative references
15 3. Definitions, acronyms, and abbreviations
3.1 Definitions
3.2 Acronyms and abbreviations
16 4. Introduction to ISO/IEEE 11073 personal health devices
4.1 General
4.2 Introduction to ISO/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
17 4.2.5 Implementing the models
4.3 Compliance with other standards
5. INR monitor device concepts and modalities
5.1 General
18 5.2 Prothrombin time
5.3 Quick value
5.4 International Sensitivity Index (ISI)
5.5 International Normalized Ratio
19 5.6 Control calibration
5.7 Batch/code number
5.8 Device and sensor status
5.9 Device alarm conditions
5.10 INR value out of bounds
5.11 Extended capabilities
5.12 Target level for INR
20 5.13 Current level of medication
5.14 Recommended new level of medication
5.15 Context information
6. International Normalized Ratio monitor domain information model
6.1 Overview
6.2 Class extensions
6.3 Object instance diagram
22 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
23 6.5.2 MDS object methods
24 6.5.3 MDS object events
25 6.5.4 Other MDS services
6.5.4.1 GET service
26 6.5.4.2 SET service
6.6 Numeric objects
6.6.1 General
27 6.6.2 International Normalized Ratio
28 6.6.3 Control calibration
29 6.6.4 Prothrombin time
6.6.5 Quick value
30 6.6.6 International Sensitivity Index
6.6.7 Target level for INR
31 6.6.8 Current level of medication
6.6.9 Recommended new level of medication
32 6.7 Real-time sample array objects
6.8 Enumeration objects
6.8.1 General
33 6.8.2 Device and sensor status
34 6.8.3 Context tester
35 6.8.4 Batch code
36 6.9 PM-store objects
6.9.1 General
6.9.2 Persistent store model
37 6.9.3 PM-store object attributes
38 6.9.4 PM-store object methods
6.9.5 PM-store object events
6.9.6 PM-store object services
6.9.6.1 GET service
39 6.9.7 PM-segment objects
6.10 Scanner objects
6.11 Class extension objects
6.12 INR monitor information model extensibility rules
40 7. INR monitor service model
7.1 General
7.2 Object access services
42 7.3 Object access event report services
8. INR monitor communication model
8.1 Overview
8.2 Communications characteristics
43 8.3 Association procedure
8.3.1 General
8.3.2 Agent procedureā€”association request
1) The agent shall support protocol-version2. Support for any other version may be indicated by setting additional bits. When protocols higher than protocol-version2 are used, the agent shall continue to use only features as specified in this standard. Whe(
2) At least the MDERs shall be supported (i.e., encoding-rules = 0x8000).
3) The version of the nomenclature used shall be set to nom-version1 (i.e., nomenclature-version = 0x80000000).
4) The field functional-units may have the test association bits set but shall not have any other bits set.
5) The field system-type 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 INR monitor with which it is associating and, optionally, to implement a simple acce(
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 INR monitor specialization, then the field indicating the data request modes (data-req-mode-capab) supported by the INR monitor agent shall be set to data-req-supp-init-agent.
9) If the agent supports only the INR monitor 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 procedureā€”association response
44 1) A manager following this specialization shall support protocol-version2. A manager may support additional higher protocol versions and select them if offered by an agent.
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 MDERs.
3) The version of the nomenclature used shall be set to nom-version1 (i.e., nomenclature-version = 0x80000000).
4) The field functional-units shall have all bits reset except for those relating to a test association.
5) The field system-type 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 field dev-config-id shall be manager-config-response (0).
8) The field data-req-mode-capab shall be 0.
9) If the agent supports only the INR specialization, data-req-init-agent-count shall be set to 0 and data-req-init-manager-count shall be set to 0.
8.4 Configuring procedure
8.4.1 General
8.4.2 INR monitorā€”standard configuration
8.4.2.1 Agent procedure
45 8.4.2.2 Manager procedure
46 8.5 Operating procedure
8.5.1 General
8.5.2 GET INR monitor MDS attributes
8.5.3 Measurement data transmission
8.6 Time synchronization
9. Test associations
47 9.1 Behavior with standard configuration
9.2 Behavior with extended configurations
10. Conformance
10.1 Applicability
10.2 Conformance specification
48 10.3 Levels of conformance
10.3.1 General
10.3.2 Conformance level 1: Base conformance
10.3.3 Conformance level 2: Extended nomenclature (ASN.1 and/or ISO/IEEE 11073-10101:2004 [B8])
10.4 Implementation conformance statements
10.4.1 General format
49 10.4.2 General implementation conformance statement
51 10.4.3 DIM MOC implementation conformance statement
52 10.4.4 MOC attribute ICS
10.4.5 MOC notification implementation conformance statement
53 10.4.6 MOC nomenclature conformance statement
54 Annex A (informative) Bibliography
55 Annex B (normative) Any additional ASN.1 definitions
56 Annex C (normative) Allocation of identifiers
59 Annex D (informative) Message sequence examples
61 Annex E (informative) Protocol data unit examples

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IEEE 11073 10418 2011
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