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ENV 13734 : DRAFT 2000

Current
Current

The latest, up-to-date edition.

HEALTH INFORMATICS - VITAL SIGNS INFORMATION REPRESENTATION
Published date

01-12-2013

Foreword
Introduction
1 Scope
2 Normative References
3 Definitions
4 Abbreviations
5 Requirements
6 Communication Parties and Roles
7 Domain Information Model
   7.1 General
        7.1.1 Modelling Concept
        7.1.2 Scope of the Domain Information Model
        7.1.3 Approach
        7.1.4 Extension of the Model
   7.2 Subject Diagram - Overview
   7.3 Model for the Medical Subject
        7.3.1 Virtual Medical Object
        7.3.2 Virtual Medical Device
        7.3.3 Channel
        7.3.4 Metric
        7.3.5 Numeric
        7.3.6 Sample Array
        7.3.7 Real Time Sample Array
        7.3.8 Time Sample Array
        7.3.9 Distribution Sample Array
        7.3.10 Enumeration
        7.3.11 Persistent Metric (PM)-Store
        7.3.12 Persistent Metric (PM)-Segment
   7.4 Model for the Alert Subject
        7.4.1 Alert
        7.4.2 Alert Status
        7.4.3 Alert Monitor
   7.5 Model for the System Subject
        7.5.1 VMS
        7.5.2 MDS
        7.5.3 Simple MDS
        7.5.4 Hydra MDS
        7.5.5 Composite Single Bed MDS
        7.5.6 Composite Multiple Bed MDS
        7.5.7 Log
        7.5.8 Event Log
        7.5.9 Battery
   7.6 Model for the Control Subject
        7.6.1 Service and Control
        7.6.2 Operation
        7.6.3 Select Item Operation
        7.6.4 Set Value Operation
        7.6.5 Set String Operation
        7.6.6 Toggle Flag Operation
        7.6.7 Activate Operation
        7.6.8 Limit Alert Operation
   7.7 Model for the Extended Services Subject
        7.7.1 Scanner
        7.7.2 Configurable Scanner
        7.7.3 Episodic Configurable Scanner
        7.7.4 Periodic Configurable Scanner
        7.7.5 Fast Periodic Configurable Scanner
        7.7.6 Unconfigurable Scanner
        7.7.7 Context Scanner
        7.7.8 Alert Scanner
        7.7.9 Operating Scanner
        7.7.10 Discriminator
   7.8 Model for the Communication Subject
        7.8.1 Communication Controller
        7.8.2 Specialized Communication Controller
   7.9 Model for the Archival Subject
        7.9.1 Multipatient Archive
        7.9.2 Patient Archive
        7.9.3 Session Archive
        7.9.4 Physician
        7.9.5 Session Test
        7.9.6 Session Notes
        7.9.7 Ancillary
   7.10 Model for the Patient Subject
        7.10.1 Patient Demographics
   7.11 Domain Information Model - Dynamic Model
        7.11.1 General
        7.11.2 MDS Communication Finite State Machine
        7.11.3 Dynamic Object Relations
8 Domain Information Model - Object Definitions
   8.1 General
        8.1.1 Notation
        8.1.2 Common Data Types
   8.2 Top Object
        8.2.1 Attributes
        8.2.2 Behaviour
        8.2.3 Notifications
   8.3 Objects in the Medical Subject
        8.3.1 Virtual Medical Object
        8.3.2 Virtual Medical Device
        8.3.3 Channel Object
        8.3.4 Metric
        8.3.5 Numeric
        8.3.6 Sample Array
        8.3.7 Real Time Sample Array
        8.3.8 Time Sample Array
        8.3.9 Distribution Sample Array
        8.3.10 Enumeration
        8.3.11 PM-Store
        8.3.12 PM-Segment
   8.4 Objects in the Alert Subject
        8.4.1 Alert
        8.4.2 Alert Status
        8.4.3 Alert Monitor
   8.5 Objects in the System Subject
        8.5.1 Virtual Medical System
        8.5.2 Medical Device System
        8.5.3 Simple MDS
        8.5.4 Hydra MDS
        8.5.5 Composite Single Bed MDS
        8.5.6 Composite Multiple Bed MDS
        8.5.7 Log
        8.5.8 Event Log
        8.5.9 Battery
   8.6 Objects in the Control Subject
        8.6.1 Service and Control Object
        8.6.2 Operation
        8.6.3 Select Item Operation
        8.6.4 Set Value Operation
        8.6.5 Set String Operation
        8.6.6 Toggle Flag Operation
        8.6.7 Activate Operation
        8.6.8 Limit Alert Operation
   8.7 Objects in the Extended Services Subject
        8.7.1 Scanner
        8.7.2 Configurable Scanner
        8.7.3 Episodic Configurable Scanner
        8.7.4 Periodic Configurable Scanner
        8.7.5 Fast Periodic Configurable Scanner
        8.7.6 Unconfigurable Scanner
        8.7.7 Context Scanner
        8.7.8 Alert Scanner
        8.7.9 Operating Scanner
        8.7.10 Discriminator
   8.8 Objects in the Communication Subject
   8.9 Objects in the Archival Subject
        8.9.1 Multipatient Archive
        8.9.2 Patient Archive
        8.9.3 Session Archive
        8.9.4 Physician
        8.9.5 Session Test
        8.9.6 Session Notes
   8.10 Objects in the Patient Subject
        8.10.1 Patient Demographics
9 Service Model for Communicating Systems
   9.1 General
   9.2 Communicating Systems
   9.3 General Service Model Overview
        9.3.1 Conceptual Architecture of Communicating Systems
        9.3.2 Operational Services
        9.3.3 Notification Services
        9.3.4 Services Used by a Manager System
        9.3.5 Services Used by an Agent System
        9.3.6 Services Used by a Hybrid System
   9.4 General Object Management Services Definition
        9.4.1 Event Report
        9.4.2 GET
        9.4.3 SET
        9.4.4 ACTION
        9.4.5 CREATE
        9.4.6 DELETE
10 The Medical Data Information Base
11 Conformance Model
   11.1 Applicability
   11.2 Conformance Specification
   11.3 Implementation Conformance Statements
        11.3.1 General Format
        11.3.2 General Implementation Conformance Statement
        11.3.3 Service Support Implementation Conformance
               Statement
        11.3.4 DIM MOC Implementation Conformance Statement
        11.3.5 MOC Attribute Implementation Conformance Statement
        11.3.6 MOC Behaviour Implementation Conformance Statement
        11.3.7 MOC Notification Implementation Conformance
               Statement
        11.3.8 Levels of Conformance
Annex A - Normative, Medical data information base (MDIB)
          nomenclature, data dictionary and codes
   A.1 Overview of Annex A
        A.1.1 Introduction
        A.1.2 Code Assignment to the MDIB Elements
   A.2 Data Dictionary and Codes for Object Oriented Modelling
        Elements
        A.2.1 Introduction
        A.2.3 Object-Oriented Modelling Elements: Inventory
               Tables
   A.3 Nomenclature, Data Dictionary and Codes for Vital Signs
        Instrumentation/Devices
        A.3.1 Introduction
        A.3.2 Base Concepts
        A.3.3 First Set of Differentiating Criteria
        A.3.4 Second Set of Differentiating Criteria
        A.3.5 Third Set of Differentiating Criteria
        A.3.6 Attributes
        A.3.7 Code Table
   A.4 Terminology and Codes for Units of Measurement
        A.4.1 Introduction
        A.4.2 Orders of Magnitude Discriminator
        A.4.3 Units outside of SI
        A.4.4 Units of Measurement
   A.5 Nomenclature, Data Dictionary and Codes for Metrics
        (Measurements and Enumerations)
        A.5.1 Nomenclature for ECG Measurements
        A.5.2 Nomenclature for ECG Enumerations
        A.5.3 Nomenclature, Data Dictionary and Codes for
               Haemodynamic Monitoring Measurements
        A.5.4 Nomenclature, Data Dictionary and Codes for
               Respiratory Measurements
        A.5.5 Nomenclature, Data Dictionary and Codes for
               common Blood Gas, Blood, Urine and other fluid
               Chemistry Measurements
        A.5.6 Nomenclature, Data Dictionary and Codes for
               Fluid Output Measurements
        A.5.7 Nomenclature ,Data Dictionary and Codes for Pumps
        A.5.8 Nomenclature, Data Dictionary and Codes for
               Neurological Monitoring Measurements
        A.5.9 Nomenclature, Data Dictionary and Codes for
               Neurophysiologic Enumerations
        A.5.10 Nomenclature, Data Dictionary and Codes for
               Stimulation Modes
        A.5.11 Nomenclature, Data Dictionary and Codes for
               Miscellaneous Measurements
   A.6 Nomenclature, Data Dictionary and Codes for Body Sites
        A.6.1 Introduction
        A.6.2 Sites for neurophysiological signal monitoring:
               location near peripheral nerves
        A.6.3 Sites for neurophysiological signal monitoring:
               location near muscles
        A.6.4 Nomenclature, Data Dictionary and Codes for sites
               for EEG-electrode placement on the head
        A.6.5 Sites for EOG signal monitoring
        A.6.6 Nomenclature, Data Dictionary and Codes for General
               Neurological Sites for monitoring measurements and
               drainage
        A.6.7 Nomenclature, Data Dictionary and Codes for Body
               sites for Cardiovascular Measurements
        A.6.8 Nomenclature, Data Dictionary and Codes for
               miscellaneous body sites used in vital signs
               monitoring and measurement
        A.6.9 Nomenclature, Data Dictionary and Codes for
               Qualifiers of Body Sites Locations
   A.7 Nomenclature, Data Dictionary and Codes for Alerts
        A.7.1 Introduction
        A.7.2 Diagnostic Pattern Events
        A.7.3 Device and environment related Events
   A.8 Nomenclature, Data Dictionary and Codes for External
        Nomenclatures
        A.8.1 Introduction
        A.8.2 External Nomenclature
Annex B - Informative Scenarios
   B.1 Overview
        B.1.2 Introduction
        B.1.3 Application to the Scope of the Vital Signs
               Standard
   B.2 Scenario 1 - Data Logger - Single Device
        B.2.1 Overview
        B.2.2 Examples
        B.2.3 Data Requirements
        B.2.4 Communications Requirements
   B.3 Scenario 2 - Data Logger - Multiple Devices
        B.3.1 Overview
        B.3.2 Examples
        B.3.3 Data Requirements Introduced
        B.3.4 Communication Requirements Introduced
   B.4 Scenario 3 - Real-Time Data Display
        B.4.1 Overview
        B.4.2 Examples
        B.4.3 Data Requirements Introduced
        B.4.4 Communication Requirements Introduced
   B.5 Scenario 4 - Patient Alarm Monitoring
        B.5.1 Overview
        B.5.2 Example
        B.5.3 Data Requirements Introduced
        B.5.4 Communication Requirements Introduced
   B.6 Scenario 5 - Remote Control
        B.6.1 Overview
        B.6.2 Examples
        B.6.3 Data Requirements Introduced
        B.6.4 Communication Requirements
   B.7 Scenario 6 - Patient Viewing Interoperability
        B.7.1 Overview
        B.7.2 Examples
        B.7.3 Data Requirements Introduced
        B.7.4 Communication Requirements Introduced
   B.8 Scenario 7 - Patient Monitoring Interoperability
        B.8.1 Overview
        B.S.2 Examples
        B.S.3 Data Requirements Introduced
        B.8.4 Communication Requirements Introduced
   B.9 Scenario 8 - Patient Data Exchange (Off-line)
        B.9.1 Overview
        B.9.2 Examples
        B.9.3 Data Requirements Introduced
        B.9.4 Communication Requirements Introduced
   B.10 Scenario 9 - Patient Data Exchange (On-line/Interactive)
        B.10.1 Overview
        B.10.2 Examples
        B.10.3 Data Requirements Introduced
        B.10.4 Communication Requirements Introduced
Annex C - Informative Communicating Systems Example
   C.1 General
        C.1.1 Disclaimers
        C.1.2 Purpose
        C.1.3 Organization
        C.1.4 Sample Application
   C.2 The Manager/Agent Framework
   C.3 Local Agent Initialization
   C.4 Association
   C.5 Configuration
        C.5.1 MDS Create Event
        C.5.2 Context Scanner
   C.6 Using the GET Service
   C.7 Using Scanner Objects for Automated Attribute Access
Annex D - Informative Nomenclature Building for the Medical
          Data Information Base and the Data
Dictionary
   D.1 Introduction
   D.2 Categorial Structures and Descriptors
   D.3 Possible Uses and Advantages from the Approach of
        Categorial Structures
   D.4 Target Categories in the MDIB
Annex E - Informative, Further References

Gives a common representation of all application entities present in the application processes within the various devices independent of the syntax. It addresses the definition and structuring of information referred in communication between application entities.

Committee
TC 251
DocumentType
Draft
PublisherName
Comite Europeen de Normalisation
Status
Current

Standards Relationship
DIN V ENV 13734:2001-06 Identical
I.S. ENV 13734:2000 Identical
DD ENV 13734:2000 Identical
NEN NVN ENV 13734 : 2001 Identical
UNE-ENV 13734:2002 Identical
NBN ENV 13734 : 2001 Identical
PN ENV 13734 : 2003 Identical
UNI ENV 13734 : 2001 Identical

CR 14300 : 2002 HEALTH INFORMATICS - INTEROPERABILITY OF HEALTHCARE MULTIMEDIA REPORT SYSTEMS
S.R. CWA 15849:2008 CODING OF INFORMATION AND TRACEABILITY OF HUMAN TISSUES AND CELLS
I.S. CR 14300:2002 HEALTH INFORMATICS - INTEROPERABILITY OF HEALTHCARE MULTIMEDIA REPORT SYSTEMS
DD ENV 13735:2001 Health informatics. Interoperability of patient connected medical devices
CEN/TS 14271 : 2003 HEALTH INFORMATICS - FILE EXCHANGE FORMAT FOR VITAL SIGNS
06/30150535 DC : 0 EN 15521 - HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGIES OF HUMAN ANATOMY
I.S. CEN TS 14271:2003 HEALTH INFORMATICS - FILE EXCHANGE FORMAT FOR VITAL SIGNS
DD CEN/TS 14271:2003 Health informatics. File exchange format for vital signs
07/30168606 DC : 0 BS ISO 11073-91064 - HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 91064: STANDARD COMMUNICATION PROTOCOL - COMPUTER-ASSISTED ELECTROCARDIOGRAPHY
AMEDP-37 : 2012 DEVELOPMENT AND IMPLEMENTATION OF TELECONSULTATION SYSTEMS
ISO/IEEE 11073-10101:2004 Health informatics Point-of-care medical device communication Part 10101: Nomenclature
BS EN ISO 11073-10101 : 2005 HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 10101: NOMENCLATURE

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