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1、American National Standard ANSI/AAMI EC71:2001/(R)2007 AAMI Association for the Advancement of Medical Instrumentation Standard communications protocol for computer-assisted electrocardiography The Objectives and Uses of AAMI Standards and Recommended Practices It is most important that the objectiv
2、es and potential uses of an AAMI product standard or recommended practice are clearly understood. The objectives of AAMIs technical development program derive from AAMIs overall mission: the advancement of medical instrumentation. Essential to such advancement are (1) a continued increase in the saf
3、e and effective application of current technologies to patient care, and (2) the encouragement of new technologies. It is AAMIs view that standards and recommended practices can contribute significantly to the advancement of medical instrumentation, provided that they are drafted with attention to t
4、hese objectives and provided that arbitrary and restrictive uses are avoided. A voluntary standard for a medical device recommends to the manufacturer the information that should be provided with or on the product, basic safety and performance criteria that should be con- sidered in qualifying the d
5、evice for clinical use, and the measurement techniques that can be used to determine whether the device conforms with the safety and performance criteria and/or to compare the per- formance characteristics of different products. Some standards em- phasize the information that should be provided with
6、 the device, including performance characteristics, instructions for use, warnings and precautions, and other data considered important in ensuring the safe and effective use of the device in the clinical environment. Recommending the disclosure of performance characteristics often necessitates the
7、development of specialized test methods to facilitate uniformity in reporting; reaching consensus on these tests can represent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establishment of minimum safety and performance criteria, refe
8、ree tests must be provided and the reasons for establishing the criteria must be documented in the rationale. A recommended practice provides guidelines for the use, care, and/or processing of a medical device or system. A recommended practice does not address device performance per se, but rather p
9、rocedures and practices that will help ensure that a device is used safely and effectively and that its performance will be maintained. Although a device standard is primarily directed to the manufac- turer, it may also be of value to the potential purchaser or user of the device as a fume of refere
10、nce for device evaluation. Similarly, even though a recommended practice is usually oriented towards health care professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also, some recommended practices, while not addressing
11、device performance criteria, provide guidelines to industrial personnel on such subjects as sterilization processing, methods of collecting data to establish safety and efficacy, human engineering, and other processing or evaluation techniques; such guidelines may be useful to health care profession
12、als in understanding industrial practices. In determining whether an AAMI standard or recommended practice is relevant to the specific needs of a potential user of the document, several important concepts must be recognized: All AAMI standards and recommended practices are voluntary (unless, of cour
13、se, they are adopted by government regulatory or procurement authorities). The application of a standard or recom- mended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommended practice reflects the collective expertise of a
14、committee of health care professionals and industrial representatives, whose work has been reviewed nationally (and sometimes internationally). As such, the consensus recommendations embodied in a standard or recommended practice are intended to respond to clinical needs and, ultimately, to help ens
15、ure patient safety. A standard or recommended practice is limited, however, in the sense that it responds generally to perceived risks and conditions that may not always be relevant to specific situations. A standard or recommended practice is an important reference in responsible decision-making, b
16、ut it should never replace responsible decisionmaking. Despite periodic review and revision (at least once every five years), a standard or recommended practice is necessarily a static document applied to a dynamic technology. Therefore, a standards user must carefully review the reasons why the doc
17、ument was initially developed and the specific rationale for each of its provisions. This review will reveal whether the document remains relevant to the specific needs of the user. Particular care should be taken in applying a product standard to existing devices and equipment, and in applying a re
18、commended practice to current procedures and practices. While observed or potential risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard, professional judgment must be used in applying these criteria to existing equip- ment. No single s
19、ource of information will serve to identify a particular product as “unsafe“. A voluntary standard can be used as one resource, but the ultimate decision as to product safety and efficacy must take into account the specifics of its utilization and, of course, cost-benefit considerations. Similarly,
20、a recommended practice should be analyzed in the context of the specific needs and resources of the individual institution or firm. Again, the rationale accompanying each AAMI standard and recommended practice is an excellent guide to the reasoning and data underlying its provision. In summary, a st
21、andard or recommended practice is truly useful only when it is used in conjunction with other sources of information and policy guidance and in the context of professional experience and judgment. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standa
22、rds and recommended practices must be made in writing, to the Manager for Technical Development. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Board. The interpretation will become official and r
23、epresentation of the Association only upon exhaustion of any appeals and upon publication of notice of interpre- tation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterization or explanation
24、 of a standard or recommended practice which has not been developed and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National StandardANSI/AAMI EC71:2001/(R)2007 Standard communications prot
25、ocol for computer-assisted electrocardiography Developed by Association for the Advancement of Medical Instrumentation Approved 11 May 2001 and reaffirmed 24 August 2007 by American National Standards Institute, Inc. Abstract:This standard specifies the content and structure of information for inter
26、change between digital electrocardiographs (ECG carts) and computer ECG management systems, as well as other computer systems where ECG-related data can be stored. Standard data formats are specified for demographics, ECG rhythm data, reference beats, global measurements, and interpretation. Practic
27、al compression of the ECG rhythm data is also standardized. This standard also specifies the two-way digital transmission of remote requests and results between digital ECG carts and heterogeneous computer systems (hosts). It specifies conventions required for cart-to-host and cart-to-cart interchan
28、ge of patient data. Compliance with this standard is defined separately for data format, query messaging, and data transport. Keywords:electromedical equipment, diagnostic, monitoring, communications protocol, computer-assisted ECG, ECG AAMI Standard This Association for the Advancement of Medical I
29、nstrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect preclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or using products,
30、processes, or procedures not conforming to the standard. AAMI standards are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise,
31、 or withdraw this standard no later than 5 years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI. All AAMI standards, recommended practices, technical information reports, and other types of technical documents develope
32、d by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible
33、 for enforcement of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 2002 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocop
34、ying, storage, or transmission, electronically or otherwise, of all or any part of this document without the prior written permission of the Association for the Advancement of Medical Instrumentation is strictly prohibited by law. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copi
35、es of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission r
36、egarding the use of all or any part of this document, contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1570201625 Contents Page Committee representationvi Foreword .vii Introduction and fie
37、ld of applicationviii 1Scope 1 2Normative references 1 3Definitions . 2 3.1 Description of terms specific to this standard 2 3.2 Description of other technical terms related to this standard. 2 3.3 Description of general medical informatics terms 2 4Abbreviations 2 5Definition of the data contents a
38、nd format within the standard ECG communications protocol 4 5.1 General considerations 4 5.2 Specifications for the data structure. 4 5.3 Specification of the pointer section Section 0 . 8 5.4 Specification of the header information Patient data / ECG acquisition data Section 1. 9 5.5 Specification
39、of the Huffman tables Section 2 22 5.6 Specification of the ECG lead definition Section 3 24 5.7 Specification of QRS locations, reference beat subtraction zones, and protected areas Section 4 . 27 5.8 Specification of the encoded type 0 reference beat data Section 5 29 5.9 Specification of the rhyt
40、hm data Section 6 31 5.10Specification of the global measurements Section 7. 33 5.11Specifications for the storage of full text electro-cardiographic interpretive statements Section 8 38 5.12Specifications for storing manufacturer specific interpretive statements and data related to the overreading
41、trail Section 9. 39 5.13Specification of the lead measurement block Section 10 40 5.14Specifications for the storage of the universal ECG interpretive statement codes Section 11 43 6Minimum requirements for encoding and compression of the electrocardiographic signal data. 45 6.1 Scope and field of a
42、pplication 45 6.2 Introduction 45 6.3 ECG compression methodology 45 6.4 Main results from the investigations on ECG data compression in the SCP ECG project. 47 6.5 Minimum requirements for ECG data compression . 47 6.5.1Categories of compression schemes. 48 6.5.2Minimum requirements for ECG data en
43、coding and compression1) 48 7Definition of a minimum set of control and query messages for the interchange of ECG data. 49 7.1 Introduction 49 7.2 Message formats 49 7.2.1Identification data interchange (Message type = “I“). 50 7.2.2Request (Message type = “R“). 51 7.2.3Status (Message type = “S“) 5
44、5 7.2.4Advisory (Message type = “A“) 55 7.2.5Done (Message type = “D“) . 55 7.2.6Numbered Notes for clauses 7.2.1 7.2.5 56 7.2.7Minimum Functionality. 58 7.3 State diagrams. 59 7.3.1Establishment of Session State Diagram 59 7.3.2Query Messaging System State Diagram 60 7.4 Message sequence examples61
45、 7.4.1ECG Transfer.61 7.4.2Patient List Request.61 7.4.3ECG List Request 62 7.4.4ECG Report Request .62 7.5 Use of advisory messages .63 8Standard low-level ECG-cart to host transport protocol 64 8.1 Scope.64 8.2 Datalink and physical functional layers 64 8.3 Physical functional layer.64 8.3.1Genera
46、l description64 8.3.2Local connections 64 8.3.3Remote connection64 8.4 Data link functional layer65 8.4.1General description65 8.4.2Transmit machine.65 8.4.3Receive machine66 8.4.4Format of the data blocks 67 8.4.5CRC error detection algorithm .68 8.6.4State Transition Diagrams (STD).69 8.4.7Communi
47、cation scenario .73 ANNEX A A.0 Introduction .74 A.1 Scope74 A.2 References and definitions74 A.3 Values.75 A.4 Control characters.76 A.5 Character set encoding.77 A.6 Language code .83 A.7 Method for handling unsupported character sets83 A.8 Summary of the escape sequences described in this annex f
48、or the encoding of free text in SCP-ECG83 A.9 Examples of encoded text strings .84 ANNEX B B.0 Introduction .85 B.1 Compliance specification 85 B.2 Testing/validation of SCP-ECG data format compatibility.90 B.3 Coding of SCP-ECG compliance 92 ANNEX C C.0 Introduction.93 C.1 Principles of “High“ SCP-
49、ECG data compresison.93 C.2 Equations for SCP-ECG data compression95 C.3 Numerical examples for SCP-ECG data compression114 C.4 Test set of ECGs for conformance testing 118 ANNEX D D.0 Introduction. 120 D.1 Constraints . 120 D.2 Composition of the code and general syntax rules. 120 D.3 Acronyms for ECG interpretive statements 124 D.4 Overreading of measurement results . 136 ANNEX E Glossary.139 ANNEX F F.0 National standards 141 F.1 References from the ECG standards literature. 141 F.2 Specific references with respect to ECG date compression. 142 vi 2002
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