ANSI P1073.1.3.5 D04-2000 Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device Specialized - Defibrillator Device《医疗装置通信用标准草案.专用虚.pdf

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-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYP1073.1.3.5 Medical Device Communications, DefibrillatorsCopy

5、right 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.P1073.1.3.5 Defibrillators1IEEE P1073.1.3.5Standard forMedical Device Communications -Medical Device Data Language (MDDL)Virtual Medical Device, Specialized -Defibrillator DeviceDraft 0.04January 17, 2

6、000Editor - Ward SilverSponsor:Engineering in Medicine and Biology SocietyCopyright 1997 by the Institute of Electrical and ElectronicsEngineers, Inc.345 East 47th StreetNew York, NY 10017, USAAll rights reservedThis is an unapproved draft of a proposed IEEE Standard, subject to change. Permission i

7、s hereby grantedfor IEEE Standards Committee participants to reproduce this document for purposes of IEEE standardizationactivities. Permission is also granted for member bodies and technical committees of ISO and IEC toreproduce this document for purposes of developing a national position. Other en

8、tities seeking permissionto reproduce this document for standardization or other uses, must contact the IEEE Standards Departmentfor the appropriate license. Use of information contained in this unapproved draft is at your own risk.IEEE Standards DepartmentCopyright and Permissions445 Hoes Lane, P.

9、O. Box 1331Piscataway, NJ 08855-1331, 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 ONLYP1073.1.3.5 Medical Devi

10、ce Communications, DefibrillatorsCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.P1073.1.3.5 Defibrillators2Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproductio

11、n or networking permitted without license from IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYP1073.1.3.5 Medical Device Communications, DefibrillatorsCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.P1073.1.3.5 Defibrillators3Revision Histor

12、yRevision Number Date RemarksRev 0.01 December 31, 1997 Initial Draft FormatRev 0.02 September 1, 1998 Incorporates review comments from Jan 98 mtg.Rev 0.03 January 14, 1999 Incorporates review comments from Sep 98 mtg.Rev 0.03A January 24, 1999 Additional late changes prior to Jan 99 mtg.Rev 0.03B

13、January 29, 1999 Incorporates review comments from Jan 99 mtg.Rev 0.04 January 17, 2000 Incorporates review commentsCopyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permitted without license from

14、IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYP1073.1.3.5 Medical Device Communications, DefibrillatorsCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.P1073.1.3.5 Defibrillators4Copyright The Institute of Electrical and Electronics Engineer

15、s, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYP1073.1.3.5 Medical Device Communications, DefibrillatorsCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE St

16、andards Draft, subject to change.P1073.1.3.5 Defibrillators5ForewordThis is the fourth Draft copy of the IEEE-1073 Defibrillator Device Standard and incorporatesrecommended changes from other editors and reviewers.Non-trivial changes include:1) Distinction between Semi-automatic Mode and Automatic M

17、ode (section 6.1.1 and various locations)2) Added data item for Paddles Type based on the enumerations in the SCP-ECG standard. (section 6.2)3) Added distinction between Selected vs. Delivered Pacing Energy. (section 6.2)4) CEN codes added for parameters matching those in CEN/TC 251/PT5-021/N97-63 V

18、ital SignsInformation Representation, Annex A, Pre-final version Oct 97. (section 6.2)5) New section on compliance following that of the latest revisions of the Vital Signs documents. (section9.3 and 9.4)Remaining open issues:1) Whether pacing functions should be retained within the defibrillator VM

19、D or moved to a pacing VMD oftheir own. This should get some discussion during the balloting process.2) Should the parameters without matching CEN codes be retained or should equivalent items with CEN codesbe substituted?3) Alignment with any changes to the conformance model.Copyright The Institute

20、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 ONLYP1073.1.3.5 Medical Device Communications, DefibrillatorsCopyright 1999 IEEE. All Rights

21、Reserved.This is an unapproved IEEE Standards Draft, subject to change.P1073.1.3.5 Defibrillators6The sub-committee currently working on the development of this standard consists of:Ward Silver Medtronic Physio-Control Corporationwsilverphysio-Bill Hawley Intermountain Health CJan Wittenber Hewlett

22、PAll parts of this document are subject to further discussion and may be changed significantly in the future asthe associated IEEE 1073 upper layer documents are revised, and new upper layer documents are generated.Review and Feedback on the content of this document is solicited and should be addres

23、sed to the Editor.Ward SilverMedtronic Physio-Control Corporation11811 Willows Rd. NEP.O. Box 97006Redmond, WA 98073-9706wsilverphysio-(425) 867-4352 (Voice)(425) 867-4462 (Fax)Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for Resale

24、No reproduction or networking permitted without license from IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYP1073.1.3.5 Medical Device Communications, DefibrillatorsCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.P1073.1.3.5 Defibrillators7I

25、ntroductionThe primary purpose of the IEEE 1073 series of standards is to provide a consistent object model across thevast area of Medical Devices, Systems, and Sub-Systems. To achieve this it is necessary to provide a detaileddescription of the various Medical Devices along with the modeling techni

26、que used to describe these devices.The interoperability of these medical devices in the patient bedside environment, primarily between thebedside and the patient care information systems, will play a major part in the future of medical informatics.A general overview of the entire IEEE 1073 series of

27、 standards can be found in the IEEE 1073 Standard forMedical Device Communications Overview and Framework document. The IEEE 1073.1.3.1 standard (thisdocument) concentrates specifically on the domain of Defibrillator Devices.The structure and organization of the Defibrillator Device is based on the

28、Object Oriented Design andModeling information contained in the Domain Information Model section of the Vital Signs InformationRepresentation document developed by the associated CEN/TC 251/PT5-021 committee. This Object modelin turn is primarily based on the Object Oriented analysis approach of Coa

29、d and Yourdon. In this documentthe Object Oriented design tools used are based on the UML (Unified Modeling Language) Rational Rose tooldeveloped by the Rational Software Company.The definitions and terminology used in this Defibrillator Device document relies heavily on that establishedby the SCP-E

30、CG Protocol standard. (CEN prENV1064:1993 v1.0). As the SCP-ECG standard evolves, it isexpected that the IEEE-1073 Defibrillator VMD definitions and structure will follow changes to thisstandard. Acceptance of defibrillator behavior or terminology new to the CEN/TC 251/PT5-021 Vital Signscommittee m

31、ay require joint efforts by the IEEE-1073 committee, CEN, and the AAMI working groupreviewing the SCP-ECG standard. It should be assumed by the reader of this document, unless otherwisestated, that terms and concepts used here are in compliance with existing IEEE-1073 methodology and withthe SCP-ECG

32、 v1.0 standard.The upper layer language discussed in this document is based on the IEEE P1073.1.x (MDDL) series ofdocuments. The profiles are derived from the associated IEEE P1073.2.x (MDAP) series of documents.The communications related sections of this standard draw heavily on the ISO Open System

33、s InterconnectSeven Layer Basic Reference Model in addition to the various Medical Information Bus sub-sets of thesedocuments as described in the IEEE P1073.x series of documents. Reliable data delivery, particularly in thearea of patient safety related information, has been a primary concern in the

34、 development of all thesestandards, and every effort has been made to identify potential problem areas and provide for a robust systemoperation.Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking per

35、mitted without license from IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYP1073.1.3.5 Medical Device Communications, DefibrillatorsCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.P1073.1.3.5 Defibrillators8Copyright The Institute of Electri

36、cal 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 ONLYP1073.1.3.5 Medical Device Communications, DefibrillatorsCopyright 1999 IEEE. All Rights Reserved.T

37、his is an unapproved IEEE Standards Draft, subject to change.P1073.1.3.5 Defibrillators9Table of Contents1. GENERAL131.1 SCOPE 131.2 PURPOSE.131.3 APPLICABILITY.131.4 AUDIENCE.131.5 ORGANIZATION141.6 CONVENTIONS.142. NORMATIVE REFERENCES153. DEFINITIONS174. ABBREVIATIONS215. DEFIBRILLATOR DEVICE DOM

38、AIN INFORMATION MODEL235.1 GENERAL OVERVIEW 235.2 SUBJECT MODEL OVERVIEW.255.2.1 System Subject Model265.2.2 Medical Subject Model275.2.3 Alert Subject Model285.2.4 Extended Services Subject Model.295.2.5 Communication Subject Model .305.2.6 Control Subject Model316. DATA MODEL .326.1 DEFIBRILLATOR

39、DEVICE SPECIFIC DATA CONSTRUCTS .326.1.1 Defibrillator device modes of operation .336.1.2 Defibrillator Device profiles supported346.1.3 Defibrillator Device current operational state.346.2 PARAMETER DEFINITIONS 377. DYNAMIC MODEL.397.1 MDS FINITE STATE MACHINE407.2 APPLICATION PROFILES417.3 THE MIN

40、IMUM DEFIBRILLATOR DEVICE427.3.1 Initial Start-up Communication Sequence.427.3.2 Defibrillator Device Modes447.3.3 Minimum Defibrillator Device Object Diagram .467.3.4 Minimum Defibrillator Periodic Scanner Definition.497.3.5 Defibrillator Device Alerts.508. COMMUNICATION STACK .518.1 PDU FORMATS 52

41、9. CONFORMANCE MODEL559.1 APPLICABILITY.559.2 CONFORMANCE SPECIFICATION.559.3 LEVELS OF CONFORMANCE.569.3.1 Conformance Level 156Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permitted without

42、license from IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYP1073.1.3.5 Medical Device Communications, DefibrillatorsCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.P1073.1.3.5 Defibrillators109.3.2 Conformance Level 2569.3.3 Conformance Lev

43、el 3569.4 IMPLEMENTATION CONFORMANCE STATEMENTS 569.4.1 General Format.569.4.2 General Implementation Conformance Statement .579.4.3 DIM MOC Implementation Conformance Statement589.4.4 MOC Attribute Implementation Conformance Statement599.4.5 MOC Notification Implementation Conformance Statement .60

44、10. ANNEX A - CEN OBJECT CLASS ATTRIBUTES6110.1 OBJECT CLASS ATTRIBUTES6110.1.1 Top6110.1.2 VMS.6210.1.3 MDS 6310.1.4 Hydra MDS.6410.1.5 Log6410.1.6 Event Log .6410.1.7 Battery .6410.1.8 VMO6510.1.9 VMD6610.1.10 Channel6710.1.11 Metric.6810.1.12 Numeric7010.1.13 Sample Array.7110.1.14 Real Time Samp

45、le Array 7210.1.15 Time Sample Array .7310.1.16 Distribution Sample Array .7410.1.17 Enumeration7510.1.18 P-M Store7610.1.19 P-M Segment7710.1.20 Alert.7810.1.21 Alert Status .7810.1.22 Alert Monitor.7910.1.23 SCO.8010.1.24 Operation8010.1.25 Select Item Operation 8110.1.26 Set Value Operation8110.1

46、.27 Set String Operation .8210.1.28 Toggle Flag Operation8210.1.29 Activate Operation8210.1.30 Limit Alert Operation8310.1.31 Scanner.8410.1.32 Configurable Scanner8410.1.33 Episodic Configurable Scanner.8410.1.34 Periodic Configurable Scanner .8510.1.35 Fast Periodic Configurable Scanner 8510.1.36

47、Unconfigurable Scanner.8510.1.37 Context Scanner .8510.1.38 Alert Scanner.8610.1.39 Operating Scanner8611. ANNEX B - USE CASE MODELS 8811.1 REDUCTION OF CLINICAL USE CASES TO KERNEL PROFILES 8811.1.1 Connection to Stationary Patient 8811.1.2 Ambulatory Use .8811.1.3 Transport Use .8911.1.4 Device Re

48、placement.8911.1.5 Remote/Ambulance Use89Copyright 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 ONLYP1073.1.3.5 Medical Devi

49、ce Communications, DefibrillatorsCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.P1073.1.3.5 Defibrillators1111.1.6 Home Therapy .8911.1.7 Maintenance and Configuration Support8911.1.8 Archival Support8911.1.9 Implanted Defibrillator .9011.1.10 System Management 9011.1.11 Alarmin