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-,-,-IEEE P1073.1.3.11 / D3.0Draft Standard forMedical Device Communications -Medical Device Data Language (M
5、DDL)Virtual Medical Device, Specialized CapnometerPrepared 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 Capnometer VirtualMedical Device. It establi
6、shes 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, Capnometer, Respirat
7、ion RateNOTE: 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 is an unapproved draft of a proposed IEEE Standar
8、d, 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 the IEEE Copyright Administrator.Permission is also
9、 granted for member bodies and technical committees of ISO and IEC to reproduce this documentfor purposes of developing a national position. Other entities seeking permission to reproduce portions of thisdocument for these or other uses must contact the IEEE Standards Department for the appropriate
10、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 Engineers, Inc. Provided by IHS under license with IEEEN
11、ot for ResaleNo reproduction or networking permitted without license from IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYDraft 3 - P1073.1.3.11 Medical Device Communications, CapnometerCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.2Introdu
12、ctionThis is a draft copy of the IEEE 1073 CapnometerVMD 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 this standard consists of:Ken Fuchs, ChairDan Nowicki GE Mar
13、quette Medical SystemsJan Wittenber AgilentWard Silver Medtronic Physio-ControlKen Fuchs Siemens Medical SystemsDennis Harding SpacelabsKen Hall SpacelabsTodd Cooper RealsoftPop Tufty Protocol SystemsJohn Villaire Protocol SystemsRick Schrenker Massachusetts General HospitalSpecial thanks to Kai Has
14、sing 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 new upper layerdocuments are generated.Review and Feedbac
15、k 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 Electrical and Electronics Engineers, Inc. Provided by IH
16、S under license with IEEENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYDraft 3 - P1073.1.3.11 Medical Device Communications, CapnometerCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft,
17、subject to change.3Revision HistoryRevisionNumberDate RemarksDraft 1 December 13, 1998 Initial Draft FormatDraft 2 February 1, 1999 Incorporate comments from Orlando meeting,add attribute guidelinesDraft 3 October 31, 1999 Incorporate inputs from Vital Signs Meetingheld at Siemens Danvers.Copyright
18、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 - P1073.1.3.11 Medical Device Communications, CapnometerCopyright 1
19、999 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 DOMAIN INFORMATIO
20、N MODEL .115.1 MEDICAL SUBJECT MODEL .115.2 APPLICATION PROFILES AND THE GENERAL VMD116 CAPNOMETER VMD DOMAIN INFORMATION MODEL136.1 GENERAL OVERVIEW .136.2 EXTENDING THE CAPNOMETER VMD136.3 CAPNOMETER VMD DOMAIN INFORMATION MODEL136.4 VMO ATTRIBUTES156.4.1 Type156.4.2 Label String.156.5 VMD ATTRIBU
21、TES166.5.1 VMD Status .166.5.2 VMD-Model166.5.3 Instance Number .166.5.4 Product Specification.166.5.5 Compatibility ID176.5.6 Parameter Group.176.5.7 Position .176.5.8 Operating Hours 176.5.9 Operating Cycles .176.5.10 Measurement Princple .177 CARBON DIOXIDE CHANNEL .18Copyright The Institute of E
22、lectrical 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 - P1073.1.3.11 Medical Device Communications, CapnometerCopyright 1999 IEEE. All Righ
23、ts Reserved.This is an unapproved IEEE Standards Draft, subject to change.57.1 CARBON DIOXIDE CHANNEL ATTRIBUTES.187.1.1 Channel Status187.1.2 Measurement Principle.187.2 CARBON DIOXIDE - METRIC ATTRIBUTES.197.2.1 Metric Specification197.2.2 Metric Status197.2.3 Metric Calibration Error! Bookmark no
24、t defined.7.3 CARBON DIOXIDE NUMERIC ATTRIBUTES217.3.1 Compound Observed Value.217.3.2 Summary Carbon Dioxide Numeric 237.4 CARBON DIOXIDE REAL-TIME SAMPLE ARRAY ATTRIBUTES247.4.1 Sample Array Attributes .247.4.2 Sample Array Specification 247.4.3 Scale and Range Specification247.4.4 Sample Array Ob
25、served Value.257.4.5 Carbon Dioxide Real-Time Sample Array Attributes .267.4.6 Sample Period.267.4.7 Summary Carbon Dioxide RT Sample Array.278 RESP-CO2 CHANNEL .288.1 RESP-CO2 CHANNEL ATTRIBUTES.288.1.1 Channel Status288.1.2 Measurement Principle.288.2 RESP-CO2 METRIC ATTRIBUTES.298.2.1 Metric Spec
26、ification298.2.2 Metric Status298.3 RESP-CO2 NUMERIC ATTRIBUTES318.3.1 Observed Value.318.3.2 Summary Resp-CO2 Numeric328.4 RESP-CO2 APNEA NUMERIC ATTRIBUTES338.4.1 Observed Value.338.4.2 Summary Resp-CO2 Apnea Numeric.349 CAPNOMETER VMD ALERT STATUS .359.1 VMD ALERT STATUS ATTRIBUTES.359.1.1 Capnom
27、eter VMD Physio Alert IDs.359.1.2 Capnometer VMD Technical Alert IDs.3510 CAPNOMETER VMD MODES OF OPERATION39Copyright 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-,-,
28、-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYDraft 3 - P1073.1.3.11 Medical Device Communications, CapnometerCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.610.1 CAPNOMETER VMD DEVICE MODES 3910.2 CAPNOMETER VMD DEVICE FINITE STATE MACHINE.3911
29、CONFORMANCE MODEL 4011.1 APPLICABILITY.4011.2 CONFORMANCE SPECIFICATION.4011.3 LEVELS OF CONFORMANCE.4011.3.1 Conformance Level 1.4011.3.2 Conformance Level 2.4011.3.3 Conformance Level 3.4111.4 IMPLEMENTATION CONFORMANCE STATEMENTS.4111.4.1 General Format4111.4.2 General Implementation Conformance
30、Statement4111.4.3 DIM MOC Implementation Conformance Statement4211.4.4 MOC Attribute Implementation Conformance Statement.4311.4.5 MOC Notification Implementation Conformance Statement.4412 DATA BANDWIDTH CONSIDERATIONS 4512.1 OVERVIEW.4512.2 CAPNOMETER SCENARIO45Copyright The Institute of Electrica
31、l 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 - P1073.1.3.11 Medical Device Communications, CapnometerCopyright 1999 IEEE. All Rights Reser
32、ved.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 a consistentobject model across the vast area of Medical Devices and Medical Systems. A major aim is toprovide adequate information and guidance
33、in order to maximize the probability of successfulinteroperability of medical devices. To achieve this it is necessary to provide a detaileddescription of the various Medical Devices along with specific object and data models. Theinteroperability of these medical devices in the patient bedside envir
34、onment, primarily betweenthe bedside and the patient care information systems, will play a major part in the future ofmedical informatics.A general overview of the entire IEEE 1073 series of standards can be found in the IEEE 1073Standard for Medical Device Communications Overview and Framework docu
35、ment. The IEEE1073.1.3.11 standard (this document) concentrates specifically on the domain of theCapnometer VMD. The VMD represents the clinical/medical aspects of a complete medicaldevice. This document focuses on those aspects, while other IEEE 1073.1.x standardsdemonstrate how to incorporate this
36、 and/or other VMDs to create compliant and completemedical devices.The structure and organization of the Capnometer VMD is based on the Object Oriented Designand Modeling information contained in the Domain Information Model section of the Vital SignsInformation Representation document developed by
37、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 documents.1.1 ScopeThe scope of this standard is the dom
38、ain of Capnometer Virtual Medical Devices, which is asubset 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 transferred to and from the Capnometer VMD. The i
39、mpact of the Application Profile Model that governs the selected specificationoptions available within the various communication standards. 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 P1
40、073.1 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 ApplicationProfiles (MDAP) series that defines the various options available within the IEEE
41、1073 family ofstandards.1.2 PurposeThe purpose of this standard is to define the overall model for a Capnometer VMD that supportsthe IEEE 1073 series of standards. It does this by describing the associated Domain InformationModel, the Data Model, and the Dynamic Model if appropriate.Issues relating
42、to the Communications Stack and the Application Profiles are covered in otherIEEE 1073 documents, which describe how to include the Capnometer VMD as part of a MedicalCopyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reprodu
43、ction or networking permitted without license from IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYDraft 3 - P1073.1.3.11 Medical Device Communications, CapnometerCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.8Device System (MDS). This docu
44、ment also includes a list of associated Definitions andAbbreviations.1.3 ApplicabilityThe information in this document is applicable to the domain of software design and developmentfor IEEE 1073 compatible Capnometer VMDs, as well as the integration of these CapnometerVMDs into IEEE 1073 compatible
45、Medical Device Systems.1.4 AudienceThis document is primarily targeted at Medical Domain System Software Architects andProgrammers as well as the acute care bedside medical equipment integration specialists. Thisdocument may also be useful to the Healthcare Information Systems specialists involved i
46、narchiving and real-time data presentation.1.5 OrganizationThe 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 storedin the Medical Data Information Base (MDIB).The definitions of Capnomete
47、r VMD specific variables and attributes as well as theirrelationships.The Conformance Statement requirementsThe 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 base
48、d 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 communication interface is based on the IEEE 1073.4.x series and1073.3.x series of stan
49、dards.The communications concepts are leveraged on the ISO/OSI series of standards.The Domain Information Model is aligned and harmonized with the CEN/TC251/PT5-021document covering the domain of Capnometer Representation.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-,-,
