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4、atalog/drafts.html. Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEELicensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/25/2007 03:07:13 MDTNo reproduction or networking permitted without license from IHS -,-,- IEEE P1073.1.3
5、.11 / D3.0 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized Capnometer Prepared by Vital Signs Monitoring Working Group of the IEEE 1073 Committee Sponsor: Engineering in Medicine and Biology Society (EMBS) Abstract: This stan
6、dard establishes a model for the implementation of the Capnometer Virtual Medical Device. It establishes a Design Model and specifies how this Model should be implemented. It also provides guidance concerning bandwidth requirements as well as how to specify conformance with this standard. Keywords:
7、bedside, VMD, Channel, medical device, medical device communications, MIB, patient, Capnometer, Respiration Rate NOTE: This draft is for review only and should not be distributed without permission of the editor. Copyright 1999 by the Institute of Electrical and Electronics Engineers, Inc. 345 East
8、47th Street New York, NY 10017, USA All Rights Reserved. This is an unapproved draft of a proposed IEEE Standard, subject to change. Permission is hereby granted for IEEE Standards Committee participants to reproduce this document for purposes of IEEE standardization activities. If this document is
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10、ce portions of this document for these or other uses must contact the IEEE Standards Department for the appropriate license. Use of information contained in this unapproved draft is at your own risk. IEEE Standards Department Copyright and Permissions 445 Hoes Lane, P.O. Box 1331 Piscataway, NJ 0885
11、5-1331, USA Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEELicensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/25/2007 03:07:13 MDTNo reproduction or networking permitted without license from IHS -,-,- UNAPPROVED DRAFT PUBLI
12、SHED FOR COMMENT ONLY Draft 3 - P1073.1.3.11 Medical Device Communications, Capnometer Copyright 1999 IEEE. All Rights Reserved. This is an unapproved IEEE Standards Draft, subject to change. 2 Introduction This is a draft copy of the IEEE 1073 CapnometerVMD Standard. The information and data presen
13、ted here is intended to provide a foundation on which the final document can be built. The subcommittee currently working on the development of this standard consists of: Ken Fuchs, Chair Dan NowickiGE Marquette Medical Systems Jan WittenberAgilent Ward SilverMedtronic Physio-Control Ken FuchsSiemen
14、s Medical Systems Dennis HardingSpacelabs Ken HallSpacelabs Todd CooperRealsoft Pop TuftyProtocol Systems John VillaireProtocol Systems Rick SchrenkerMassachusetts General Hospital Special thanks to Kai Hassing of Agilent, Boeblingen Germany for his input into this document. All parts of this docume
15、nt are subject to further discussion and may be changed significantly in the future as the associated IEEE 1073 upper layer documents are revised, and new upper layer documents are generated. Review and Feedback on the content of this is document is solicited and should be addressed to the Editor: K
16、en Fuchs Siemens Medical Systems 16 Electronics Ave., Danvers, MA 01923 Phone:978/907-7686 Fax:978/774-8342 Email:ken.fuchsieee.org Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEELicensee=NASA Technical Standards 1/9972545001 Not for Resa
17、le, 04/25/2007 03:07:13 MDTNo reproduction or networking permitted without license from IHS -,-,- UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLY Draft 3 - P1073.1.3.11 Medical Device Communications, Capnometer Copyright 1999 IEEE. All Rights Reserved. This is an unapproved IEEE Standards Draft, subject
18、 to change. 3 Revision History Revision Number DateRemarks Draft 1December 13, 1998Initial Draft Format Draft 2February 1, 1999Incorporate comments from Orlando meeting, add attribute guidelines Draft 3October 31, 1999Incorporate inputs from Vital Signs Meeting held at Siemens Danvers. Copyright The
19、 Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEELicensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/25/2007 03:07:13 MDTNo reproduction or networking permitted without license from IHS -,-,- UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLY Dra
20、ft 3 - P1073.1.3.11 Medical Device Communications, Capnometer Copyright 1999 IEEE. All Rights Reserved. This is an unapproved IEEE Standards Draft, subject to change. 4 Table of Contents 1GENERAL .7 1.1SCOPE7 1.2PURPOSE7 1.3APPLICABILITY.8 1.4AUDIENCE.8 1.5ORGANIZATION.8 1.6CONVENTIONS8 2NORMATIVE R
21、EFERENCES9 3DEFINITIONS 10 4ABBREVIATIONS10 5GENERAL VMD DOMAIN INFORMATION MODEL.11 5.1MEDICAL SUBJECT MODEL.11 5.2APPLICATION PROFILES AND THE GENERAL VMD11 6CAPNOMETER VMD DOMAIN INFORMATION MODEL13 6.1GENERAL OVERVIEW.13 6.2EXTENDING THE CAPNOMETER VMD13 6.3CAPNOMETER VMD DOMAIN INFORMATION MODE
22、L13 6.4VMO ATTRIBUTES15 6.4.1Type15 6.4.2Label String.15 6.5VMD ATTRIBUTES16 6.5.1VMD Status.16 6.5.2VMD-Model16 6.5.3Instance Number .16 6.5.4Product Specification.16 6.5.5Compatibility ID17 6.5.6Parameter Group.17 6.5.7Position .17 6.5.8Operating Hours 17 6.5.9Operating Cycles .17 6.5.10 Measureme
23、nt Princple .17 7CARBON DIOXIDE CHANNEL .18 Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEELicensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/25/2007 03:07:13 MDTNo reproduction or networking permitted without license from
24、IHS -,-,- UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLY Draft 3 - P1073.1.3.11 Medical Device Communications, Capnometer Copyright 1999 IEEE. All Rights Reserved. This is an unapproved IEEE Standards Draft, subject to change. 5 7.1CARBON DIOXIDE CHANNEL ATTRIBUTES.18 7.1.1Channel Status18 7.1.2Measure
25、ment Principle.18 7.2CARBON DIOXIDE - METRIC ATTRIBUTES.19 7.2.1Metric Specification19 7.2.2Metric Status19 7.2.3Metric Calibration Error! Bookmark not defined. 7.3CARBON DIOXIDE NUMERIC ATTRIBUTES21 7.3.1Compound Observed Value.21 7.3.2Summary Carbon Dioxide Numeric 23 7.4CARBON DIOXIDE REAL-TIME S
26、AMPLE ARRAY ATTRIBUTES24 7.4.1Sample Array Attributes .24 7.4.2Sample Array Specification 24 7.4.3Scale and Range Specification24 7.4.4Sample Array Observed Value.25 7.4.5Carbon Dioxide Real-Time Sample Array Attributes .26 7.4.6Sample Period.26 7.4.7Summary Carbon Dioxide RT Sample Array.27 8RESP-C
27、O2 CHANNEL .28 8.1RESP-CO2 CHANNEL ATTRIBUTES.28 8.1.1Channel Status28 8.1.2Measurement Principle.28 8.2RESP-CO2 METRIC ATTRIBUTES.29 8.2.1Metric Specification29 8.2.2Metric Status29 8.3RESP-CO2 NUMERIC ATTRIBUTES31 8.3.1Observed Value.31 8.3.2Summary Resp-CO2 Numeric32 8.4RESP-CO2 APNEA NUMERIC ATT
28、RIBUTES33 8.4.1Observed Value.33 8.4.2Summary Resp-CO2 Apnea Numeric.34 9CAPNOMETER VMD ALERT STATUS .35 9.1VMD ALERT STATUS ATTRIBUTES.35 9.1.1Capnometer VMD Physio Alert IDs.35 9.1.2Capnometer VMD Technical Alert IDs.35 10CAPNOMETER VMD MODES OF OPERATION39 Copyright The Institute of Electrical an
29、d Electronics Engineers, Inc. Provided by IHS under license with IEEELicensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/25/2007 03:07:13 MDTNo reproduction or networking permitted without license from IHS -,-,- UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLY Draft 3 - P1073.1.3.11 Medical
30、 Device Communications, Capnometer Copyright 1999 IEEE. All Rights Reserved. This is an unapproved IEEE Standards Draft, subject to change. 6 10.1CAPNOMETER VMD DEVICE MODES39 10.2CAPNOMETER VMD DEVICE FINITE STATE MACHINE.39 11CONFORMANCE MODEL 40 11.1APPLICABILITY.40 11.2CONFORMANCE SPECIFICATION.
31、40 11.3LEVELS OF CONFORMANCE.40 11.3.1 Conformance Level 1.40 11.3.2 Conformance Level 2.40 11.3.3 Conformance Level 3.41 11.4IMPLEMENTATION CONFORMANCE STATEMENTS.41 11.4.1 General Format41 11.4.2 General Implementation Conformance Statement41 11.4.3 DIM MOC Implementation Conformance Statement42 1
32、1.4.4 MOC Attribute Implementation Conformance Statement.43 11.4.5 MOC Notification Implementation Conformance Statement.44 12DATA BANDWIDTH CONSIDERATIONS 45 12.1OVERVIEW.45 12.2CAPNOMETER SCENARIO45 Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license
33、 with IEEELicensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/25/2007 03:07:13 MDTNo reproduction or networking permitted without license from IHS -,-,- UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLY Draft 3 - P1073.1.3.11 Medical Device Communications, Capnometer Copyright 1999 IEEE. All
34、 Rights Reserved. This is an unapproved IEEE Standards Draft, subject to change. 7 1 General One of the primary purposes of the IEEE 1073 series of standards is to provide a consistent object model across the vast area of Medical Devices and Medical Systems. A major aim is to provide adequate inform
35、ation and guidance in order to maximize the probability of successful interoperability of medical devices. To achieve this it is necessary to provide a detailed description of the various Medical Devices along with specific object and data models. The interoperability of these medical devices in the
36、 patient bedside environment, primarily between the bedside 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 standards can be found in the IEEE 1073 Standard for Medical Device Communications O
37、verview and Framework document. The IEEE 1073.1.3.11 standard (this document) concentrates specifically on the domain of the Capnometer VMD. The VMD represents the clinical/medical aspects of a complete medical device. This document focuses on those aspects, while other IEEE 1073.1.x standards demon
38、strate how to incorporate this and/or other VMDs to create compliant and complete medical devices. The structure and organization of the Capnometer VMD is based on the Object Oriented Design and Modeling information contained in the Domain Information Model section of the Vital Signs Information Rep
39、resentation document developed by the associated CEN/TC 251/PT5-021 committee. This Object model in turn is primarily based on the UML Object Oriented design and analysis approach. The upper layer language discussed in this document is based on the IEEE P1073.1.x (MDDL) series of documents. 1.1 Scop
40、e The scope of this standard is the domain of Capnometer Virtual Medical Devices, which is a subset of the general group of Virtual Medical Devices (VMDs). It specifically addresses: The Object Oriented Design and Analysis of the virtual Capnometer device. The Data Model of the information transferr
41、ed to and from the Capnometer VMD. The impact of the Application Profile Model that governs the selected specification options available within the various communication standards. The Dynamic Model of the Virtual Medical Device. Conformance issues for the Virtual Medical Device implementation. The
42、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 Application Profile Model is also based on the IEEE P1073.2 Medical Device Application Profiles (MDAP) series that defines t
43、he various options available within the IEEE 1073 family of standards. 1.2 Purpose The purpose of this standard is to define the overall model for a Capnometer VMD that supports the IEEE 1073 series of standards. It does this by describing the associated Domain Information Model, the Data Model, and
44、 the Dynamic Model if appropriate. Issues relating to the Communications Stack and the Application Profiles are covered in other IEEE 1073 documents, which describe how to include the Capnometer VMD as part of a Medical Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided b
45、y IHS under license with IEEELicensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/25/2007 03:07:13 MDTNo reproduction or networking permitted without license from IHS -,-,- UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLY Draft 3 - P1073.1.3.11 Medical Device Communications, Capnometer Copyr
46、ight 1999 IEEE. All Rights Reserved. This is an unapproved IEEE Standards Draft, subject to change. 8 Device System (MDS). This document also includes a list of associated Definitions and Abbreviations. 1.3 Applicability The information in this document is applicable to the domain of software design
47、 and development for IEEE 1073 compatible Capnometer VMDs, as well as the integration of these Capnometer VMDs into IEEE 1073 compatible Medical Device Systems. 1.4 Audience This document is primarily targeted at Medical Domain System Software Architects and Programmers as well as the acute care bed
48、side medical equipment integration specialists. This document may also be useful to the Healthcare Information Systems specialists involved in archiving and real-time data presentation. 1.5 Organization The organization of this document is broken down into several major sections as follows: The Data Model that covers Capnometer VMD specific information that can be stored in the Medical Data Information Base (MDIB). The definitions of Capnometer VMD specific variables and attributes as well as their relationships. The Conformance Statement