1、NOTICETHIS DOCUMENT IS AN UNAPPROVED IEEE STANDARDSDRAFT, SUBJECT TO CHANGE. THE IEEE SHALL NOT BELIABLE FOR ANY DAMAGES RESULTING FROM YOUR USEOF THIS UNAPPROVED IEEE STANDARDS DRAFT.The IEEE makes no guaranties or warranties as to the results to be obtainedfrom purchasing and using this unapproved
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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-,-,-Copyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.1
5、IEEE P1073.1.3.6 / D6.0Draft Standard forMedical Device Communications -Medical Device Data Language (MDDL)Virtual Medical Device, Specialized -ECGPrepared byVital Signs Monitoring Working Group of the IEEE 1073 CommitteeSponsor:Engineering in Medicine and Biology Society (EMBS)Abstract: This standa
6、rd establishes a model for the implementation of the ECG Virtual MedicalDevice. It establishes a Design Model and specifies how this Model should be implemented. Italso provides guidance concerning bandwidth requirements as well as how to specify conformancewith this standard.Keywords: bedside, ECG,
7、 VMD, Channel, medical device, medical device communications, MIB,patient, Heart Rate, Respiration, Arrhythmia, Ischemia, STNOTE: 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.3
8、45 East 47th StreetNew York, NY 10017, USAAll Rights Reserved.This 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
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11、1, USACopyright 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 6 - P1073.1.3.6 Medical Device Communications, ECGCop
12、yright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.2IntroductionThis is a draft copy of the IEEE 1073 ECG VMD Standard. The information and data presented hereis intended to provide a foundation on which the final document can be built.The subcommitte
13、e currently working on the development of this standard consists of:Ken Fuchs, ChairDan Nowicki GE Marquette Medical SystemsJan Wittenber AgilentWard Silver Medtronic Physio-ControlDennis Harding SpacelabsKen Hall SpacelabsTodd Cooper RealsoftPop Tufty Protocol SystemsJohn Villaire Protocol SystemsR
14、ick Schrenker 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 r
15、evised, and new upper layerdocuments are generated.Review and feedback on the content of this is document is solicited and should be addressed tothe Chair:Ken FuchsSiemens Medical Systems16 Electronics Ave.,Danvers, MA 01923Phone: 978/907-7686Fax: 978/774-8342Email: ken.fuchsieee.orgCopyright The In
16、stitute 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 6 - P1073.1.3.6 Medical Device Communications, ECGCopyright 1999 IEEE. All
17、Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.3Revision HistoryRevisionNumberDate RemarksRev 0.01 December 13, 1998 Initial Draft FormatRev 0.02 December 31, 1998 Incorporate comments from K. HassingRev 0.03 January 11, 1999 Incorporate additional comments from K.Hass
18、ingRev 0.04 February 1, 1999 Incorporate comments from Orlando meetingRev 0.05 April 20, 1999Rev 0.06 July 15, 1999 Revised after Danvers meeting on Vital SignsdocumentsCopyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo repro
19、duction or networking permitted without license from IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYDraft 6 - P1073.1.3.6 Medical Device Communications, ECGCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.4Table of Contents1 OVERVIEW .81.1 SC
20、OPE.81.2 PURPOSE.81.3 APPLICABILITY.91.4 AUDIENCE.91.5 ORGANIZATION91.6 CONVENTIONS .92 NORMATIVE REFERENCES103 DEFINITIONS.114 ABBREVIATIONS .115 GENERAL VMD DOMAIN INFORMATION MODEL125.1 MEDICAL SUBJECT MODEL.125.2 APPLICATION PROFILES AND THE GENERAL VMD .126 ECG VMD DOMAIN INFORMATION MODEL.146.
21、1 GENERAL OVERVIEW.146.2 EXTENDING THE ECG VMD.146.3 ECG VMD DOMAIN INFORMATION MODEL.146.4 VMO ATTRIBUTES186.4.1 Type186.4.2 Label String186.5 VMD ATTRIBUTES186.5.1 VMD Status.196.5.2 VMD-Model.196.5.3 Instance Number196.5.4 Product Specification.196.5.5 Compatibility ID196.5.6 Parameter Group196.5
22、.7 Position.206.5.8 Operating Hours.206.5.9 Operating Cycles .206.5.10 Measurement Principle207 ECG CHANNEL .217.1 ECG CHANNEL ATTRIBUTES.217.1.1 Channel Status.217.1.2 Measurement Principle217.2 ECG METRIC ATTRIBUTES227.2.1 Metric Specification .22Copyright The Institute of Electrical and Electroni
23、cs 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 6 - P1073.1.3.6 Medical Device Communications, ECGCopyright 1999 IEEE. All Rights Reserved.This is an unapprov
24、ed IEEE Standards Draft, subject to change.57.2.2 Metric Status 227.3 ECG REAL-TIME SAMPLE ARRAY ATTRIBUTES247.3.1 Sample Array Attributes.247.3.2 ECG Real-Time Sample Array Attributes.277.3.3 Summary - ECG RT Sample Array 288 HEART RATE CHANNEL 298.1 HEART RATE CHANNEL ATTRIBUTES 298.1.1 Channel St
25、atus.298.1.2 Measurement Principle298.2 HEART RATE METRIC ATTRIBUTES .308.2.1 Metric Specification .308.2.2 Metric Status 308.2.3 VMO Source List318.3 HEART RATE NUMERIC ATTRIBUTES328.3.1 Observed Value .328.3.2 Summary Heart Rate Numeric339 ISCHEMIA CHANNEL.349.1 ISCHEMIA CHANNEL ATTRIBUTES.349.1.1
26、 Channel Status.349.1.2 Measurement Principle349.2 ISCHEMIA METRIC ATTRIBUTES359.2.1 Metric Specification .359.2.2 Metric Status 359.3 ISCHEMIA NUMERIC ATTRIBUTES 379.3.1 Observed Value .379.3.2 Summary Ischemia Numeric.389.4 ISCHEMIA TIME SAMPLE ARRAY ATTRIBUTES399.4.1 Sample Array Attributes.399.4
27、.2 Ischemia Time Sample Array Attributes.409.4.3 Summary Ischemia Time Sample Array .4010 ARRHYTHMIA CHANNEL.4210.1 ARRHYTHMIA CHANNEL ATTRIBUTES 4210.1.1 Channel Status.4210.1.2 Measurement Principle4210.2 ARRHYTHMIA METRIC ATTRIBUTES .4310.2.1 Metric Specification .4310.2.2 Metric Status 4310.3 AR
28、RHYTHMIA COUNT NUMERIC ATTRIBUTES4510.3.1 Observed Value .45Copyright 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
29、 6 - P1073.1.3.6 Medical Device Communications, ECGCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.610.3.2 Summary Arrhythmia Count Numeric .4610.4 ARRHYTHMIA STATUS ENUMERATION ATTRIBUTES.4710.4.1 Enum Observed Value.4710.4.2 Summary Arrhythmia
30、 Rhythm Status Enumeration.5411 ECG MEASUREMENTS CHANNEL.5511.1 ECG MEASUREMENTS CHANNEL ATTRIBUTES5511.1.1 Channel Status.5511.1.2 Measurement Principle5511.2 ECG MEASUREMENTS METRIC ATTRIBUTES.5611.2.1 Metric Specification .5611.2.2 Metric Status 5611.3 ECG MEASUREMENTS NUMERIC ATTRIBUTES .5811.3.
31、1 Observed Value .5811.3.2 Summary ECG Measurements Numeric 6012 RESP-ECG CHANNEL.6212.1 RESP-ECG CHANNEL ATTRIBUTES.6212.1.1 Channel Status.6212.1.2 Measurement Principle6212.2 RESP-ECG METRIC ATTRIBUTES6312.2.1 Metric Specification .6312.2.2 Metric Status 6312.3 RESP-ECG NUMERIC ATTRIBUTES 6512.3.
32、1 Observed Value .6512.3.2 Summary Resp-ECG Numeric6612.4 RESP-ECG APNEA NUMERIC ATTRIBUTES 6712.4.1 Observed Value .6712.4.2 Summary Resp-ECG Apnea Numeric 6812.5 RESP-ECG REAL-TIME SAMPLE ARRAY ATTRIBUTES6912.5.1 Sample Array Attributes.6912.5.2 RESP-ECG Real-Time Sample Array Attributes7112.5.3 S
33、ummary - RESP-ECG RT Sample Array .7113 ECG VMD ALERT STATUS .7213.1 VMD ALERT STATUS ATTRIBUTES7213.1.1 ECG VMD Physio Alert IDs7213.1.2 ECG VMD Technical Alert IDs 7414 ECG VMD MODES OF OPERATION.7714.1 ECG VMD DEVICE MODES .7714.2 ECG VMD DEVICE FINITE STATE MACHINE 7715 CONFORMANCE MODE.78Copyri
34、ght 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 6 - P1073.1.3.6 Medical Device Communications, ECGCopyright 1999
35、IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.715.1 APPLICABILITY.7815.2 CONFORMANCE SPECIFICATION7815.3 LEVELS OF CONFORMANCE .7815.3.1 Conformance Level 1 .7815.3.2 Conformance Level 2 .7815.3.3 Conformance Level 3 .7915.4 IMPLEMENTATION CONFORMANCE STATEM
36、ENTS.7915.4.1 General Format7915.4.2 General Implementation Conformance Statement 7915.4.3 DIM MOC Implementation Conformance Statement .8015.4.4 MOC Attribute Implementation Conformance Statement8115.4.5 MOC Notification Implementation Conformance Statement .8216 DATA BANDWIDTH CONSIDERATIONS8316.1
37、 OVERVIEW.8316.2 ECG SCENARIO .83Copyright 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 6 - P1073.1.3.6 Medical De
38、vice Communications, ECGCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.81 OverviewOne of the primary purposes of the IEEE 1073 series of standards is to provide a consistent objectmodel across the vast area of Medical Devices and Medical System
39、s. A major aim is to provideadequate information and guidance in order to maximize the probability of successfulinteroperability of medical devices. To achieve this it is necessary to provide a detailed descriptionof the various Medical Devices along with specific object and data models. The interop
40、erability ofthese medical devices in the patient bedside environment, primarily between the bedside and thepatient care information systems, will play a major part in the future of medical informatics.A general overview of the entire IEEE 1073 series of standards can be found in the IEEE 1073Standar
41、d for Medical Device Communications Overview and Framework document. The IEEE1073.1.3.6 standard (this document) concentrates specifically on the domain of the ECG VMD.The VMD represents the clinical/medical aspects of a complete medical device. This documentfocuses on those aspects, while other IEE
42、E 1073.1.x standards demonstrate how to incorporatethis and/or other VMDs to create compliant and complete medical devices.The structure and organization of the ECG VMD is based on the Object Oriented Design andModeling information contained in the Domain Information Model section of the Vital Signs
43、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. The upper layer language discussed in this document is based on the IEEEP1073.1.x (MDDL) series of documen
44、ts.1.1 ScopeThe scope of this standard is the domain of ECG Virtual Medical Devices, which is a subset of thegeneral group of Virtual Medical Devices (VMDs). It specifically addresses: The Object Oriented Design and Analysis of the virtual ECG device. The Data Model of the information transferred to
45、 and from the ECG VMD. The impact of the Application Profile Model that governs the selected specificationoptions available within the various communication standards. Conformance issues for the Virtual Medical Device implementation.The Data Model in turn is based on the IEEE P1073.1 Medical Device
46、Data Language (MDDL) seriesof standards that defines the semantics and syntax of the information exchanged.The Application Profile Model is also based on the IEEE P1073.1 Medical Device Data Language(MDDL) Profiles series that defines the various options available within the IEEE 1073 family ofstand
47、ards.1.2 PurposeThe purpose of this standard is to define the overall model for a ECG VMD that supports the IEEE1073 series of standards. It does this by describing the associated Domain Information Model, theData Model, and the Dynamic Model if appropriate.Issues relating to the Communications Stac
48、k and the Application Profiles are covered in other IEEE1073 documents, which describe how to include the ECG VMD as part of a Medical DeviceSystem (MDS). This document also includes a list of associated Definitions and Abbreviations.Copyright The Institute of Electrical and Electronics Engineers, I
49、nc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYDraft 6 - P1073.1.3.6 Medical Device Communications, ECGCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.91.3 ApplicabilityThe information in this document is app
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