ANSI P1073.1.3.10 D3.0-1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device Specialized – Cardiac Output《医疗装置通信用标准草案.专用虚拟医疗.pdf

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4、tml.Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-IEEE P1073.1.3.10 / D3.0Draft Standard forMedical Device Communications -Medical Device Data Language (M

5、DDL)Virtual Medical Device, Specialized Cardiac OutputPrepared byVital Signs Monitoring Working Group of the IEEE 1073 CommitteeSponsor:Engineering in Medicine and Biology Society (EMBS)Abstract: This standard establishes a model for the implementation of the Cardiac OutputVirtual Medical Device. It

6、 establishes a Design Model and specifies how this Model should beimplemented. It also provides guidance concerning bandwidth requirements as well as how tospecify conformance with this standard.Keywords: bedside, VMD, Channel, medical device, medical device communications, MIB,patient, Blood Temper

7、ature, Cardiac Output, Temperature, Injectate TemperatureNOTE: This draft is for review only and should not be distributed without permission of theeditor.Copyright 1999 by the Institute of Electrical and Electronics Engineers, Inc.345 East 47th StreetNew York, NY 10017, USAAll Rights Reserved.This

8、is an unapproved draft of a proposed IEEE Standard, subject to change. Permission is hereby granted for IEEEStandards Committee participants to reproduce this document for purposes of IEEE standardization activities. If thisdocument is to be submitted to ISO or IEC, notification shall be given to th

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10、he IEEE Standards Department for the appropriate license. Use ofinformation contained in this unapproved draft is at your own risk.IEEE Standards DepartmentCopyright and Permissions445 Hoes Lane, P.O. Box 1331Piscataway, NJ 08855-1331, USACopyright The Institute of Electrical and Electronics Enginee

11、rs, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYDraft 3 - P1073.1.3.10 Medical Device Communications, Cardiac OutputCopyright 1999 IEEE. All Rights Reserved.This is an unappr

12、oved IEEE Standards Draft, subject to change.2IntroductionThis is a draft copy of the IEEE 1073 Cardiac Output VMD Standard. The information and datapresented here is intended to provide a foundation on which the final document can be built.The subcommittee currently working on the development of th

13、is standard consists of:Ken Fuchs, ChairDan Nowicki GE Marquette Medical SystemsJan Wittenber AgilentWard Silver Medtronic Physio-ControlKen Fuchs Siemens Medical SystemsDennis Harding SpacelabsKen Hall SpacelabsTodd Cooper RealsoftPop Tufty Protocol SystemsJohn Villaire Protocol SystemsRick Schrenk

14、er Massachusetts General HospitalSpecial thanks to Kai Hassing of Agilent, Boeblingen Germany for his input into this document.All parts of this document are subject to further discussion and may be changed significantly inthe future as the associated IEEE 1073 upper layer documents are revised, and

15、 new upper layerdocuments are generated.Review and Feedback on the content of this is document is solicited and should be addressed tothe Editor:Ken FuchsSiemens Medical Systems16 Electronics Ave.,Danvers, MA 01923Phone: 978/907-7686Fax: 978/774-8342Email: ken.fuchsieee.orgCopyright The Institute of

16、 Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYDraft 3 - P1073.1.3.10 Medical Device Communications, Cardiac OutputCopyright 1999 IEEE. Al

17、l Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.3Revision HistoryRevisionNumberDate RemarksDraft 1 March 15, 1999 Initial Draft FormatDraft 2 May 5, 1999 Incorporate feedback from Toronto meetingDraft 3 October 31, 1999 Incorporate feedback from Vital Signs Meeting.Co

18、pyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYDraft 3 - P1073.1.3.10 Medical Device Communications, Cardiac Outpu

19、tCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.4Table of Contents1 GENERAL .71.1 SCOPE71.2 PURPOSE 71.3 APPLICABILITY.81.4 AUDIENCE .81.5 ORGANIZATION.81.6 CONVENTIONS82 NORMATIVE REFERENCES93 DEFINITIONS 104 ABBREVIATIONS105 GENERAL VMD DOMAI

20、N INFORMATION MODEL .115.1 MEDICAL SUBJECT MODEL .115.2 APPLICATION PROFILES AND THE GENERAL VMD116 CARDIAC OUTPUT VMD DOMAIN INFORMATION MODEL136.1 GENERAL OVERVIEW .136.2 EXTENDING THE CARDIAC OUTPUT VMD136.3 CARDIAC OUTPUT VMD DOMAIN INFORMATION MODEL 136.4 VMO ATTRIBUTES156.4.1 Type156.4.2 Label

21、 String.156.5 VMD ATTRIBUTES166.5.1 VMD Status .166.5.2 VMD-Model166.5.3 Instance Number .166.5.4 Product Specification.166.5.5 Compatibility ID166.5.6 Parameter Group.176.5.7 Position .176.5.8 Operating Hours 176.5.9 Operating Cycles .176.5.10 Measurement Principle.177 INTERMITTENT CARDIAC OUTPUT C

22、HANNEL.18Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYDraft 3 - P1073.1.3.10 Medical Device Communications, Ca

23、rdiac OutputCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.57.1 INTERMITTENT CARDIAC OUTPUT - CHANNEL ATTRIBUTES.187.1.1 Channel Status187.1.2 Measurement Principle.187.2 INTERMITTENT CARDIAC OUTPUT - METRIC ATTRIBUTES.197.2.1 Metric Specificat

24、ion197.2.2 Metric Status197.3 INTERMITTENT CARDIAC OUTPUT NUMERIC ATTRIBUTES217.3.1 Observed Value.217.3.2 Summary Intermittent Cardiac Output Numeric 227.4 INJECTATE TEMPERATURE NUMERIC ATTRIBUTES .237.4.1 Observed Value.237.4.2 Summary Injectate Temperature Numeric247.5 BLOOD TEMPERATURE NUMERIC A

25、TTRIBUTES 257.5.1 Observed Value.257.5.2 Summary Blood Temperature Numeric 267.6 BLOOD TEMPERATURE SAMPLE ARRAY ATTRIBUTES277.6.1 Sample Array Attributes .277.6.2 Sample Array Specification 277.6.3 Scale and Range Specification277.6.4 Sample Array Observed Value.277.6.5 Blood Temperature Time Sample

26、 Array Attributes .287.6.6 Absolute Time Stamp.28Is Required287.6.7 Sample Period.287.6.8 Sweep Speed287.6.9 Summary - Blood Temperature Time Sample Array.298 CONTINUOUS CARDIAC OUTPUT CHANNEL.308.1 CONTINUOUS CARDIAC OUTPUT - CHANNEL ATTRIBUTES.308.1.1 Channel Status308.1.2 Measurement Principle.30

27、8.2 CONTINUOUS CARDIAC OUTPUT - METRIC ATTRIBUTES.318.2.1 Metric Specification318.2.2 Metric Status318.3 CONTINUOUS CARDIAC OUTPUT NUMERIC ATTRIBUTES338.3.1 Observed Value.338.3.2 Summary Continuous Cardiac Output Numeric348.4 BLOOD TEMPERATURE NUMERIC ATTRIBUTES 358.4.1 Observed Value.35Copyright T

28、he Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYDraft 3 - P1073.1.3.10 Medical Device Communications, Cardiac OutputCopyrigh

29、t 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.68.4.2 Summary Blood Temperature Numeric 369 CARDIAC OUTPUT VMD ALERT STATUS .379.1 VMD ALERT STATUS ATTRIBUTES.379.1.1 Cardiac Output VMD Physio Alert IDs.379.1.2 Cardiac Output VMD Technical Alert IDs 37

30、10 CARDIAC OUTPUT VMD MODES OF OPERATION4210.1 CARDIAC OUTPUT VMD DEVICE MODES.4210.2 CARDIAC OUTPUT VMD DEVICE FINITE STATE MACHINE.4211 CONFORMANCE MODEL 4311.1 APPLICABILITY.4311.2 CONFORMANCE SPECIFICATION.4311.3 LEVELS OF CONFORMANCE.4311.3.1 Conformance Level 1.4311.3.2 Conformance Level 2.431

31、1.3.3 Conformance Level 3.4411.4 IMPLEMENTATION CONFORMANCE STATEMENTS.4411.4.1 General Format4411.4.2 General Implementation Conformance Statement4411.4.3 DIM MOC Implementation Conformance Statement4511.4.4 MOC Attribute Implementation Conformance Statement.4611.4.5 MOC Notification Implementation

32、 Conformance Statement.4712 DATA BANDWIDTH CONSIDERATIONS 4812.1 OVERVIEW.4812.2 CARDIAC OUTPUT SCENARIO48Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-UN

33、APPROVED DRAFT PUBLISHED FOR COMMENT ONLYDraft 3 - P1073.1.3.10 Medical Device Communications, Cardiac OutputCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.71 GeneralOne of the primary purposes of the IEEE 1073 series of standards is to provide

34、 a consistentobject model across the vast area of Medical Devices and Medical Systems. A major aim is toprovide adequate information and guidance in order to maximize the probability of successfulinteroperability of medical devices. To achieve this it is necessary to provide a detaileddescription of

35、 the various Medical Devices along with specific object and data models. Theinteroperability of these medical devices in the patient bedside environment, primarily betweenthe bedside and the patient care information systems, will play a major part in the future ofmedical informatics.A general overvi

36、ew of the entire IEEE 1073 series of standards can be found in the IEEE 1073Standard for Medical Device Communications Overview and Framework document. The IEEE1073.1.3.10 standard (this document) concentrates specifically on the domain of the CardiacOutput VMD. The VMD represents the clinical/medic

37、al aspects of a complete medical device.This document focuses on those aspects, while other IEEE 1073.1.x standards demonstrate howto incorporate this and/or other VMDs to create compliant and complete medical devices.The structure and organization of the Cardiac Output VMD is based on the Object Or

38、ientedDesign and Modeling information contained in the Domain Information Model section of the VitalSigns Information Representation document developed by the associated CEN/TC 251/PT5-021committee. This Object model in turn is primarily based on the UML Object Oriented design andanalysis approach.

39、The upper layer language discussed in this document is based on the IEEEP1073.1.x (MDDL) series of documents.1.1 ScopeThe scope of this standard is the domain of Cardiac Output Virtual Medical Devices, which is asubset of the general group of Virtual Medical Devices (VMDs). It specifically addresses

40、: The Object Oriented Design and Analysis of the virtual Cardiac Output device. The Data Model of the information transferred to and from the Cardiac Output VMD. The impact of the Application Profile Model that governs the selected specificationoptions available within the various communication stan

41、dards. The Dynamic Model of the Virtual Medical Device. Conformance issues for the Virtual Medical Device implementation.The Data Model in turn is based on the IEEE P1073.1 Medical Device Data Language (MDDL)series of standards that defines the semantics and syntax of the information exchanged.The A

42、pplication Profile Model is also based on the IEEE P1073.2 Medical Device ApplicationProfiles (MDAP) series that defines the various options available within the IEEE 1073 family ofstandards.1.2 PurposeThe purpose of this standard is to define the overall model for a Cardiac Output VMD thatsupports

43、the IEEE 1073 series of standards. It does this by describing the associated DomainInformation Model, the Data Model, and the Dynamic Model if appropriate.Issues relating to the Communications Stack and the Application Profiles are covered in otherIEEE 1073 documents, which describe how to include t

44、he Cardiac Output VMD as part of aMedical Device System (MDS). This document also includes a list of associated Definitions andAbbreviations.Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permit

45、ted without license from IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYDraft 3 - P1073.1.3.10 Medical Device Communications, Cardiac OutputCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.81.3 ApplicabilityThe information in this document is

46、 applicable to the domain of software design and developmentfor IEEE 1073 compatible Cardiac Output VMDs, as well as the integration of these CardiacOutput VMDs into IEEE 1073 compatible Medical Device Systems.1.4 AudienceThis document is primarily targeted at Medical Domain System Software Architec

47、ts andProgrammers as well as the acute care bedside medical equipment integration specialists. Thisdocument may also be useful to the Healthcare Information Systems specialists involved inarchiving and real-time data presentation.1.5 OrganizationThe organization of this document is broken down into

48、several major sections as follows:The Data Model that covers Cardiac Output VMD specific information that can bestored in the Medical Data Information Base (MDIB).The definitions of Cardiac Output VMD specific variables and attributes as well astheir relationships.The Conformance Statement requireme

49、ntsThe Data Bandwidth requirements and model.1.6 ConventionsThe conventions used in this document are based on the following concepts:The concepts of the abstract data language structure are based on the IEEE 1073.1.xseries of standards.The application profiles defined are based on the IEEE 1073.2.x series of standards.The Transport interface is based on the IEEE 1073.3.x series of standards.The Physical communi