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 P1073.1.3.7 / D4.0Draft Standard forMedical Device Communications -Medical Device Data Language (MD
5、DL)Virtual Medical Device, Specialized Blood PressurePrepared 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 Blood Pressure VirtualMedical 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 Pressur
7、e, Fluid Pressure, Non-Invasive Blood Pressure, Invasive Blood Pressure,Pulse 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, USA
8、All 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 is to be submitted to ISO or IEC, notifica
9、tion shall be given to the IEEE Copyright Administrator.Permission is also 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
10、other uses must contact the 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 Electrica
11、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 4 - P1073.1.3.7 Medical Device Communications, Blood PressureCopyright 1999 IEEE. All Rights Re
12、served.This is an unapproved IEEE Standards Draft, subject to change.2IntroductionThis is a draft copy of the IEEE 1073 Blood Pressure 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
13、on the development of this 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 Prot
14、ocol SystemsRick 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 do
15、cuments are revised, and 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.orgCo
16、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 4 - P1073.1.3.7 Medical Device Communications, Blood Pressure
17、Copyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, 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 May 4, 19
18、99 Incorporate comments from Toronto meeting,add attribute guidelinesDraft 4 June 28, 1999 Incorporate inputs from Vital Signs Meetingheld at Siemens Danvers.Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or
19、networking permitted without license from IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYDraft 4 - P1073.1.3.7 Medical Device Communications, Blood PressureCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.4Table of Contents1 GENERAL .71.1 SCO
20、PE71.2 PURPOSE 71.3 APPLICABILITY.81.4 AUDIENCE .81.5 ORGANIZATION.81.6 CONVENTIONS82 NORMATIVE REFERENCES83 DEFINITIONS 104 ABBREVIATIONS105 GENERAL VMD DOMAIN INFORMATION MODEL .115.1 MEDICAL SUBJECT MODEL .115.2 APPLICATION PROFILES AND THE GENERAL VMD116 BLOOD PRESSURE VMD DOMAIN INFORMATION MOD
21、EL136.1 GENERAL OVERVIEW .136.2 EXTENDING THE BLOOD PRESSURE VMD .136.3 BLOOD PRESSURE VMD DOMAIN INFORMATION MODEL136.4 VMO ATTRIBUTES156.4.1 Type156.4.2 Label 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 Compatibilit
22、y ID176.5.6 Parameter Group.176.5.7 Position .176.5.8 Operating Hours 176.5.9 Operating Cycles .176.5.10 Measurement Principle.177 INVASIVE BLOOD PRESSURE CHANNEL187.1 INVASIVE BLOOD PRESSURE CHANNEL ATTRIBUTES 187.1.1 Channel Status187.1.2 Measurement Principle.187.2 INVASIVE BLOOD PRESSURE METRIC
23、ATTRIBUTES 197.2.1 Metric Specification197.2.2 Metric Status197.2.3 Metric Calibration .207.3 INVASIVE BLOOD PRESSURE NUMERIC ATTRIBUTES .217.3.1 Compound Observed Value.217.3.2 Summary - Invasive Blood Pressure Numeric277.4 WEDGE PRESSURE NUMERIC ATTRIBUTES .287.4.1 Compound Observed Value.287.4.2
24、Summary Wedge Pressure Numeric 297.5 INVASIVE BLOOD PRESSURE REAL-TIME SAMPLE ARRAY ATTRIBUTES .30Copyright 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
25、 DRAFT PUBLISHED FOR COMMENT ONLYDraft 4 - P1073.1.3.7 Medical Device Communications, Blood PressureCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.57.5.1 Sample Array Attributes .307.5.2 Sample Array Specification 307.5.3 Scale and Range Specif
26、ication307.5.4 Sample Array Observed Value.317.5.5 Invasive Blood Pressure Real-Time Sample Array Attributes327.5.6 Sample Period.327.5.7 Summary - Invasive Blood Pressure RT Sample Array328 PULSE RATE (BP) CHANNEL348.1 PULSE RATE (BP) CHANNEL ATTRIBUTES348.1.1 Channel Status348.1.2 Measurement Prin
27、ciple.348.2 PULSE RATE (BP) METRIC ATTRIBUTES358.2.1 Metric Specification358.2.2 Metric Status358.2.3 VMO Source List368.3 PULSE RATE (BP) NUMERIC ATTRIBUTES.378.3.1 Absolute Time Stamp.378.3.2 Observed Value.378.3.3 Summary Pulse Rate Numeric.389 NON-INVASIVE BLOOD PRESSURE CHANNEL399.1 NON-INVASIV
28、E BLOOD PRESSURE CHANNEL ATTRIBUTES.399.1.1 Channel Status399.1.2 Measurement Principle.399.2 NON-INVASIVE BLOOD PRESSURE METRIC ATTRIBUTES.409.2.1 Metric Specification409.2.2 Metric Status419.3 NON-INVASIVE BLOOD PRESSURE NUMERIC ATTRIBUTES429.3.1 Compound Observed Value.429.3.2 Summary Non-Invasiv
29、e Blood Pressure Numeric .439.4 CUFF PRESSURE NUMERIC ATTRIBUTES449.4.1 Observed Value.449.4.2 Summary Non-Invasive Blood Pressure Numeric .4510 BLOOD PRESSURE VMD ALERTS .4610.1 VMD ALERT STATUS ATTRIBUTES.4610.1.1 Blood Pressure VMD Physio Alert IDs 4610.1.2 Blood Pressure VMD Technical Alert Ids
30、4611 BLOOD PRESSURE VMD MODES OF OPERATION4911.1 BLOOD PRESSURE VMD DEVICE MODES4911.2 BLOOD PRESSURE VMD DEVICE FINITE STATE MACHINE 4912 CONFORMANCE MODEL 5012.1 APPLICABILITY.5012.2 CONFORMANCE SPECIFICATION.5012.3 LEVELS OF CONFORMANCE.5012.3.1 Conformance Level 1.5012.3.2 Conformance Level 2.50
31、12.3.3 Conformance Level 3.5112.4 IMPLEMENTATION CONFORMANCE STATEMENTS.5112.4.1 General Format5112.4.2 General Implementation Conformance Statement5112.4.3 DIM MOC Implementation Conformance Statement52Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under licen
32、se with IEEENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYDraft 4 - P1073.1.3.7 Medical Device Communications, Blood PressureCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to
33、 change.612.4.4 MOC Attribute Implementation Conformance Statement.5312.4.5 MOC Notification Implementation Conformance Statement.5413 DATA BANDWIDTH CONSIDERATIONS 5513.1 OVERVIEW.5513.2 BLOOD PRESSURE SCENARIO .55Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS
34、 under license with IEEENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYDraft 4 - P1073.1.3.7 Medical Device Communications, Blood PressureCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft
35、, 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 in order to maximize the probability of succes
36、sfulinteroperability 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 environment, primarily betweenthe bedside and the p
37、atient 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 document. The IEEE1073.1.3.7 standard (this docume
38、nt) concentrates specifically on the domain of the BloodPressure 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 demonstrate howto incorporate this and/or other VMDs to create compliant and
39、complete medical devices.The structure and organization of the Blood Pressure VMD is based on the Object OrientedDesign and Modeling information contained in the Domain Information Model section of the VitalSigns Information Representation document developed by the associated CEN/TC 251/PT5-021commi
40、ttee. 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 domain of Blood Pressure Virtual Medical
41、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 Blood Pressure device. The Data Model of the information transferred to and from the Blood Pressure VMD. The impact of the Application P
42、rofile 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 P1073.1 Medical Device Data
43、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 1073 family ofstandards.1.
44、2 PurposeThe purpose of this standard is to define the overall model for a Blood Pressure VMD thatsupports 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
45、Stack and the Application Profiles are covered in otherIEEE 1073 documents, which describe how to include the Blood Pressure VMD as part of aCopyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEENot for ResaleNo reproduction or networking permit
46、ted without license from IHS-,-,-UNAPPROVED DRAFT PUBLISHED FOR COMMENT ONLYDraft 4 - P1073.1.3.7 Medical Device Communications, Blood PressureCopyright 1999 IEEE. All Rights Reserved.This is an unapproved IEEE Standards Draft, subject to change.8Medical Device System (MDS). This document also inclu
47、des 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 Blood Pressure VMDs, as well as the integration of these BloodPressure VMDs into IEEE 1073 compatible Medical
48、 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 inarchiv
49、ing 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 Blood Pressure VMD specific information that can bestored in the Medical Data Information Base (MDIB).The definitions of Blood Pressure VMD specific variables and attributes as well astheir relationships.The Conformance Statement requirementsThe Data Ban
