SIST EN ISO 11073-10406:2013

SLOVENSKI STANDARD
01-februar-2013
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10406. del:
Specialne naprave - Osnovni elektrokardiograf (EKG) (od 1- do 3-odvodni EKG)
(ISO/IEEE 11073-10406:2012)
Health informatics - Personal health device communication - Part 10406: Device
specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-
10406:2012)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10406: Gerätespezifikation - Basiselektrokardiogramm (EKG) (EKG mit 1 bis 3
Ableitungen) (ISO/IEEE 11073-10406:2012)
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Ta slovenski standard je istoveten z: EN ISO 11073-10406:2012
ICS:
11.040.50 Radiografska oprema Radiographic equipment
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 11073-10406
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2012
ICS 35.240.80
English Version
Health informatics - Personal health device communication -
Part 10406: Device specialization - Basic electrocardiograph
(ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012)
Informatique de santé - Communication entre dispositifs de Medizinische Informatik - Kommunikation von Geräten für
santé personnels - Partie 10406: Spécialisation des die persönliche Gesundheit - Teil 10406:
dispositifs - Électrocardiographe de base (ECG) (ECG 1 à Gerätespezifikation - Basiselektrokardiogramm (EKG)
3) (ISO/IEEE 11073-10406:2012) (EKG mit 1 bis 3 Ableitungen) (ISO/IEEE 11073-
10406:2012)
This European Standard was approved by CEN on 30 November 2012.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10406:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 11073-10406:2012) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretariat of
which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by June 2013, and conflicting national standards shall be withdrawn at
the latest by June 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-10406:2012 has been approved by CEN as a EN ISO 11073-10406:2012 without
any modification.
INTERNATIONAL ISO/IEEE
STANDARD 11073-10406
First edition
2012-12-01
Health informatics — Personal health
device communication —
Part 10406:
Device specialization — Basic
electrocardiograph (ECG)
(1- to 3-lead ECG)
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10406: Spécialisation des dispositifs — Électrocardiographe de
base (ECG) (ECG 1 à 3)
Reference number
ISO/IEEE 11073-10406:2012(E)
©
IEEE 2012
ISO/IEEE 11073-10406:2012(E)
©  IEEE 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO or IEEE at the respective
address below.
ISO copyright office Institute of Electrical and Electronics Engineers, Inc.
Case postale 56  CH-1211 Geneva 20 3 Park Avenue, New York  NY 10016-5997, USA
Tel. + 41 22 749 01 11 E-mail stds.ipr@ieee.org
Fax + 41 22 749 09 47 Web www.ieee.org
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © IEEE 2012 – All rights reserved

ISO/IEEE 11073-10406:2012(E)
Contents
1. Overview . 1
1.1 Scope . 1
1.2 Purpose . 1
1.3 Context . 2
2. Normative references. 2
3. Definitions, acronyms, and abbreviations . 3
3.1 Definitions . 3
3.2 Acronyms and abbreviations . 3
4. Introduction to ISO/IEEE 11073 personal health devices . 4
4.1 General . 4
4.2 Introduction to ISO/IEEE 11073-20601 modeling constructs. 4
4.3 Compliance with other standards. 5
5. Basic ECG (1- to 3-lead ECG) device concepts and modalities. 6
5.1 General . 6
5.2 ECG waveform. 6
5.3 R-R interval . 6
5.4 Heart rate . 7
6. Basic ECG (1- to 3-lead ECG) domain information model.7
6.1 Overview . 7
6.2 Class extensions. 7
6.3 Object instance diagram . 7
6.4 Types of configuration. 8
6.5 Profiles. 9
6.6 Medical device system object. 11
6.7 Numeric objects. 15
6.8 Real-time sample array objects. 18
6.9 Enumeration objects . 19
6.10 PM-store objects. 22
6.11 Scanner objects. 29
6.12 Class extension objects. 32
6.13 Basic ECG (1- to 3-lead ECG) information model extensibility rules . 32
7. Basic ECG (1- to 3-lead ECG) service model . 32
7.1 General . 32
7.2 Object access services. 32
7.3 Object access event report services . 35
8. Basic ECG (1- to 3-lead ECG) communication model.35
8.1 Overview . 35
8.2 Communications characteristics . 36
8.3 Association procedure . 36
8.4 Configuring procedure. 38
8.5 Operating procedure . 39
8.6 Time synchronization . 40

© IEEE 2012 – All rights reserved iii

ISO/IEEE 11073-10406:2012(E)
9. Test associations. 40
9.1 Behavior with standard configuration. 40
9.2 Behavior with extended configurations . 41
10. Conformance . 41
10.1 Applicability . 41
10.2 Conformance specification . 41
10.3 Levels of conformance . 42
10.4 Implementation conformance statements . 42
Annex A (informative) Bibliography . 47
Annex B (normative) Any additional ASN.1 definitions . 48
Annex C (normative) Allocation of identifiers. 49
Annex D (informative) Message sequence examples. 50
Annex E (informative) Protocol data unit examples . 52

iv © IEEE 2012 – All rights reserved

ISO/IEEE 11073-10406:2012(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating
Committees of the IEEE Standards Association (IEEE-SA) Standards Board. The IEEE develops its standards
through a consensus development process, approved by the American National Standards Institute, which
brings together volunteers representing varied viewpoints and interests to achieve the final product.
Volunteers are not necessarily members of the Institute and serve without compensation. While the IEEE
administers the process and establishes rules to promote fairness in the consensus development process, the
IEEE does not independently evaluate, test, or verify the accuracy of any of the information or the soundness
of any judgments contained in its standards.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is called to the possibility that implementation of this standard may require the use of subject matter
covered by patent rights. By publication of this standard, no position is taken with respect to the existence or
validity of any patent rights in connection therewith. ISO/IEEE is not responsible for identifying essential
patents or patent claims for which a license may be required, for conducting inquiries into the legal validity or
scope of patents or patent claims or determining whether any licensing terms or conditions provided in
connection with submission of a Letter of Assurance or a Patent Statement and Licensing Declaration Form, if
any, or in any licensing agreements are reasonable or non-discriminatory. Users of this standard are expressly
advised that determination of the validity of any patent rights, and the risk of infringement of such rights, is
entirely their own responsibility. Further information may be obtained from ISO or the IEEE Standards
Association.
ISO/IEEE 11073-10406 was prepared by the IEEE 11073 Standards Comittee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073-10406-2011). It was adopted by Technical Committee
ISO/TC 215, Health informatics, in parallel with its approval by the ISO member bodies, under the “fast-track
procedure” defined in the Partner Standards Development Organization cooperation agreement between ISO
and IEEE. IEEE is responsible for the maintenance of this document with participation and input from ISO
member bodies.
ISO/IEEE 11073 consists of the following parts, under the general title Health informatics — Personal health
device communication (text in parentheses gives a variant of subtitle):
 Part 10101: (Point-of-care medical device communication) Nomenclature
 Part 10201: (Point-of-care medical device communication) Domain information model
 Part 10404: Device specialization — Pulse oximeter
 Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
 Part 10407: Device specialization — Blood pressure monitor
 Part 10408: Device specialization — Thermometer

© IEEE 2012 – All rights reserved v

ISO/IEEE 11073-10406:2012(E)
 Part 10415: Device specialization — Weighing scale
 Part 10417: Device specialization — Glucose meter
 Part 10420: Device specialization — Body composition analyzer
 Part 10421: Device specialization — Peak expiratory flow monitor (peak flow)
 Part 10471: Device specialization — Independant living activity hub
 Part 10472: Device specialization — Medication monitor
 Part 20101: (Point-of-care medical device communication) Application profiles — Base standard
 Part 20601: Application profile — Optimized exchange protocol
 Part 30200: (Point-of-care medical device communication) Transport profile — Cable connected
 Part 30300: (Point-of-care medical device communication) Transport profile — Infrared wireless
 Part 30400: (Point-of-care medical device communication) Interface profile — Cabled Ethernet
 Part 90101: (Point-of-care medical device communication) Analytical instruments — Point-of-care test
 Part 91064: (Standard communication protocol) Computer-assisted electrocardiography
 Part 92001: (Medical waveform format) — Encoding rules [Technical Specification]

vi © IEEE 2012 – All rights reserved

ISO/IEEE 11073-10406:2012(E)
Introduction
This introduction is not part of IEEE Std 11073-10406-2011, Health informatics—Personal health device
communication—Part 10406: Device specialization—Basic electrocardiograph (ECG) (1- to 3-lead ECG).
Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard
establishes a normative definition of the communication between personal basic electrocardiograph (ECG)
devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes)
in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing
standards including ISO/IEEE 11073 terminology and IEEE 11073-20601 information models. It specifies
the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in
base frameworks in favor of interoperability. This standard defines a common core of communication
functionality for personal telehealth basic ECG (1- to 3-lead ECG) devices. Monitoring ECG devices are
distinguished from diagnostic ECG equipment with respect to including support for wearable ECG devices,
limiting the number of leads supported by the equipment to three, and not requiring the capability of
annotating or analyzing the detected electrical activity to determine known cardiac phenomena. This
standard is consistent with the base framework and allows multifunction implementations by following
multiple device specializations (e.g., ECG and respiration rate).

© IEEE 2012 – All rights reserved vii

ISO/IEEE 11073-10406:2012(E)
Health informatics — Personal health device
communication —
Part 10406:
Device specialization — Basic electrocardiograph (ECG)
(1- to 3-lead ECG)
IMPORTANT NOTICE: This standard is not intended to ensure safety, security, health, or
environmental protection. Implementers of the standard are responsible for determining appropriate
safety, security, environmental, and health practices or regulatory requirements.
This IEEE document is made available for use subject to important notices and legal disclaimers.
These notices and disclaimers appear in all publications containing this document and may
be found under the heading “Important Notice” or “Important Notices and Disclaimers
Concerning IEEE Documents.” They can also be obtained on request from IEEE or viewed at
http://standards.ieee.org/IPR/disclaimers.html.
1. Overview
1.1 Scope
Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard
establishes a normative definition of the communication between personal basic electrocardiograph (ECG)
devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes)
in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing
standards including ISO/IEEE 11073 terminology and IEEE Std 11073-20601 information models. It
specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting
optionality in base frameworks in favor of interoperability. This standard defines a common core of
communication functionality for personal telehealth basic ECG (1- to 3-lead ECG) devices. Monitoring
ECG devices are distinguished from diagnostic ECG equipment with respect to including support for
wearable ECG devices, limiting the number of leads supported by the equipment to three, and not requiring
the capability of annotating or analyzing the detected electrical activity to determine known cardiac
phenomena. This standard is consistent with the base framework and allows multifunction implementations
by following multiple device specializations (e.g., ECG and respiration rate).
1.2 Purpose
This standard addresses a need for an openly defined, independent standard for controlling information
exchange to and from personal health devices and managers (e.g., cell phones, personal computers,
personal health appliances, and set top boxes). Interoperability is key to growing the potential market for
these devices and enabling people to be better informed participants in the management of their health.

© IEEE 2012 – All rights reserved 1

ISO/IEEE 11073-10406:2012(E)
1.3 Context
See IEEE Std 11073-20601a-2010 for an overview of the environment within which this standard is
written.
This standard defines the device specialization for the basic ECG (1- to 3-lead ECG), being a specific agent
type, and it provides a description of the device concepts, its capabilities, and its implementation according
to this standard.
TM
This standard is based on IEEE Std 11073-20601a -2010 and ISO/IEEE 11073-20601:2010, which in turn
draw information from both ISO/IEEE 11073-10201:2004 [B7] and
ISO/IEEE 11073-20101:2004 [B8]. The medical device encoding rules (MDERs) used within this standard
are fully described in ISO/IEEE 11073-20601:2010.
This standard reproduces relevant portions of the nomenclature found in ISO/IEEE 11073-10101:2004 0
and adds new nomenclature codes for the purposes of this standard. Among this standard,
ISO/IEEE 11073-20601:2010, and IEEE Std 11073-20601a-2010, all required nomenclature codes for
implementation are documented.
NOTE 1—IEEE Std 11073-20601a-2010 is an amendment to ISO/IEEE 11073-20601:2010. It contains new material
and corrections and does not copy the content of ISO/IEEE 11073-20601:2010. Throughout this standard, a reference
to IEEE Std 11073-20601a-2010 refers to the document that is obtained after applying this new material and
corrections to ISO/IEEE 11073-20601:2010.
NOTE 2—In this standard, ISO/IEEE 11073-104zz is used to refer to the collection of device specialization standards
that utilize IEEE Std 11073-20601a-2010, where zz can be any number from 01 to 99, inclusive.
2. Normative references
The following referenced documents are indispensable for the application of this document (i.e., they must
be understood and used, so that each referenced document is cited in text and its relationship to this
document is explained). For dated references, only the edition cited applies. For undated references, the
latest edition of the referenced document (including any amendments or corrigenda) applies.
TM
IEEE Std 11073-20601a -2010, Health informatics—Personal health device communication—Application
4,5
profile—Optimized Exchange Protocol—Amendment 1.
ISO/IEEE 11073-20601:2010, Health informatics—Personal health device communication—Application
profile—Optimized Exchange Protocol.
See Annex A for all informative material referenced by this standard.

Information on references can be found in Clause 2.
The numbers in brackets correspond to those of the bibliography in Annex A.
Notes in text, tables, and figures are given for information only and do not contain requirements needed to implement the standard.
The IEEE standards or products referred to in this clause are trademarks of the Institute of Electrical and Electronics Engineers, Inc.
IEEE publications are available from the Institute of Electrical and Electronics Engineers, 445 Hoes Lane, Piscataway, NJ 08854-
4141, USA (http://standards.ieee.org/).
ISO/IEEE publications are available from the ISO Central Secretariat, 1, ch. de la Voie-Creuse, Case postale 56, CH-1211, Geneva
20, Switzerland (http://www.iso.ch/). ISO/IEEE publications are also available in the United States from the Institute of Electrical and
Electronics Engineers, 445 Hoes Lane, Piscataway, NJ 08854-4141, USA (http://standards.ieee.org/).
© IEEE 2012 – All rights reserved
ISO/IEEE 11073-10406:2012(E)
3. Definitions, acronyms, and abbreviations
3.1 Definitions
For the purposes of this document, the following terms and definitions apply. The IEEE Standards
Dictionary: Glossary of Terms & Definitions should be consulted for terms not defined in this clause.
3.1.1 agent: A node that collects and transmits personal health data to an associated manager.
3.1.2 class: In object-oriented modeling, it describes the attributes, methods, and events that objects instantiated
from the class utilize.
3.1.3 device: A term used to refer to a physical apparatus implementing either an agent or a manager role.
3.1.4 electrode: An electrical sensor in contact with a specified part of the body. Two or more electrodes are
used to detect heart action voltage. See: lead.
3.1.5 handle: An unsigned 16-bit number that is locally unique and identifies one of the object instances within
an agent.
3.1.6 lead: Commonly refers to two different things: It may be used to refer to the combination of an electrode
and associated lead wire, used for a certain ECG recording. Alternatively, it may be used to refer to the
signal obtained by tracing the voltage between two electrodes or linear combinations thereof. The latter
definition is used throughout this standard.
3.1.7 lead wire: A cable connected between an electrode and the agent device.
3.1.8 manager: A node receiving data from one or more agent systems. Some examples of managers include a
cellular phone, health appliance, set top box, or computer system.
3.1.9 obj-handle: See: handle.
3.1.10 object: In object-oriented modeling, a particular instantiation of a class. The instantiation realizes
attributes, methods, and events from the class.
3.1.11 personal health device: A device used in personal health applications.
3.1.12 personal telehealth device: See: personal health device.
3.2 Acronyms and abbreviations
APDU application protocol data unit
ASN.1 Abstract Syntax Notation One
DIM domain information model
ECG electrocardiogram or electrocardiograph
EKG elektrokardiogramm (German)
EUI-64 extended unique identifier (64 bits)
ICS implementation conformance statements

The IEEE Standards Dictionary: Glossary of Terms & Definitions is available at http://shop.ieee.org/.

© IEEE 2012 – A ll rights reserved
ISO/IEEE 11073-10406:2012(E)
MDC medical device communication
MDER medical device encoding rules
MDS medical device system
MOC managed object class
PDU protocol data unit
PHD personal health device
RT-SA real-time sample array
VMO virtual medical object
VMS virtual medical system
4. Introduction to ISO/IEEE 11073 personal health devices
4.1 General
This standard and the remainder of the series of ISO/IEEE 11073 personal health device (PHD) standards
fit in the larger context of the ISO/IEEE 11073 series of standards. The full suite of standards enables
agents to interconnect and interoperate with managers and with computerized health-care information
systems. See IEEE Std 11073-20601a-2010 for a description of the guiding principles for this series of
ISO/IEEE 11073 Personal Health Device standards.
IEEE Std 11073-20601a-2010 supports the modeling and implementation of an extensive set of personal
health devices. This standard defines aspects of the basic ECG (1- to 3-lead ECG) device. It describes all
aspects necessary to implement the application layer services and data exchange protocol between an
ISO/IEEE 11073 PHD basic ECG (1- to 3-lead ECG) agent and a manager. This standard defines a subset
of the objects and functionality contained in IEEE Std 11073-20601a-2010 and extends and adds
definitions where appropriate. All new definitions are given in Annex B in Abstract Syntax Notation One
(ASN.1). Nomenclature codes referenced in this standard, which are not defined in
IEEE Std 11073-20601a-2010, are normatively defined in Annex C.
4.2 Introduction to ISO/IEEE 11073-20601 modeling constructs
4.2.1 General
The ISO/IEEE 11073 series of standards, and in particular IEEE Std 11073-20601a-2010, is based on an
object-oriented systems management paradigm. The overall system model is divided into three principal
components: the domain information model (DIM), the service model, and the communication model. See
IEEE Std 11073-20601a-2010 for a detailed description of the modeling constructs.
4.2.2 Domain information model
The DIM is a hierarchical model that describes an agent as a set of objects. These objects and their
attributes represent the elements that control behavior and report on the status of the agent and data that an
agent can communicate to a manager. Communication between the agent and the manager is defined by the
application protocol in the IEEE Std 11073-20601a-2010.
© IEEE 2012 – All rights reserved
ISO/IEEE 11073-10406:2012(E)
4.2.3 Service model
The service model defines the conceptual mechanisms for the data exchange services. Such services are
mapped to messages that are exchanged between the agent and the manager. Protocol messages within the
ISO/IEEE 11073 series of standards are defined in ASN.1. The messages defined in
IEEE Std 11073-20601a-2010 can coexist with messages defined in other standard application profiles
defined in the ISO/IEEE 11073 series of standards.
4.2.4 Communication model
In general, the communication model supports the topology of one or more agents communicating over
logical point-to-point connections to a single manager. For each logical point-to-point connection, the
dynamic system behavior is defined by a connection state machine as specified in
IEEE Std 11073-20601a-2010.
4.2.5 Implementing the models
An agent implementing this standard shall implement all mandatory elements of the information, service,
and communication models as well as all conditional elements where the condition is met. The agent
should implement the recommended elements, and it may implement any combination of the optional
elements. A manager implementing this standard shall utilize at least one of the mandatory, conditional,
recommended, or optional elements. In this context, “utilize” means to use the element as part of the
primary function of the manager device. For example, a manager whose primary function is to display data
would need to display a piece of data in the element in order to utilize it.
4.3 Compliance with other standards
Devices that comply with this standard may also be required to comply with other domain- and device-
specific standards that supersede the requirements of this standard with respect to issues including safety,
reliability, and risk management. A user of this standard is expected to be familiar with all other such
standards that apply and to comply with any higher specifications thus imposed. Typically, medical devices
will comply with the IEC 60601-1:2005 0 base standards with respect to electrical and mechanical safety
and any device-specific standard as might be defined in the IEC 60601-2 [B2] series of standards. Software
aspects may apply through standards such as IEC 62304:2006/EN 62304:2006 [B3]. Devices that comply
with this standard implement higher layers of network software and utilize lower layers as appropriate to
the application. The requirements on performance of such applications and conformance are defined
elsewhere and are outside the scope of this standard. Moreover, the use of any medical equipment is subject
to risk assessment and risk management appropriate to the application. Some relevant examples are ISO
14971:2007 [B5] and IEC 80001-1:2010 [B4]. The requirements of such risk assessment and risk
management and conformance are outside the scope of this standard.
© IEEE 2012 – All rights reserved
ISO/IEEE 11073-10406:2012(E)
5. Basic ECG (1- to 3-lead ECG) device concepts and modalities
5.1 General
This clause presents the general concepts of basic ECG (1- to 3-lead ECG) devices. In general, an ECG
device with associated lead wires and electrodes measures the electrical activity of the heart. More
precisely, it measures the electrical potential differences between electrodes placed on the person’s body,
reflecting the sum of the electrical activities of muscle fibers. These electrical activities are related to the
myocardial muscle but also include artifacts caused by electrical activities of other muscle fibers after
movement. In the context of personal health devices in this family of standards, a basic ECG (1- to 3-lead
ECG) is used for the purpose of acquiring and recording 1 to 3 channel (leads) electrocardiographic
waveforms or analyzing the acquired signals to measure heart rate.
The electrical potential is measured by means of a system of conducting wires attached to a person using
electrodes. The electrodes are placed on specific locations on the surface of the person’s body. There are
different lead measurement systems for placing the electrodes on the person’s body.
5.2 ECG waveform
ECG waveforms represent a continuous stream of measured electrical potential differences within a certain
time period. ECG waveforms are typically used for cardiac rhythm monitoring.
5.3 R-R interval
Figure 1 illustrates the basic ECG signal and specific waveforms that may occur, for example, during atrial
depolarization (P wave), ventricular depolarization (QRS complex), and ventricular repolarization (ST-T
wave). The R-R interval (interbeat interval) is an instantaneous measurement defined as the time between
the maximums of two consecutive R-waves (early ventricular depolarization), and it is typically indicated
in milliseconds or an internal oscillator count. The latter is used in order to simplify implementations or to
support higher accuracy by avoiding round off errors and is referred to as ticks and defined as ticks per
second in this standard. Conceptually the R-R interval measurement is implemented by means of a detector
that registers the time instant of each individual R peak and subsequently calculates the interval in between
them.
Figure 1 —Basic form of ECG signal
© IEEE 2012 – All rights reserved
ISO/IEEE 11073-10406:2012(E)
5.4 Heart rate
Heart rate is defined as the number of heartbeats per unit of time. Typically, this value is quoted as beats
per minute, although often a period less than 1 min is used to determine the number of beats that have
occurred, and the value is normalized. A heart rate measurement based on a single beat interval is termed
the instantaneous heart rate. The instantaneous heart rate is defined as the inverse of a single R-R value,
subject to a proper normalization factor accounting for the conversion from beats per millisecond to beats
per minute. The instantaneous heart rate is often fluctuating and is therefore filtered (averaged) reducing
higher frequency content for the purposes of display.
6. Basic ECG (1- to 3-lead ECG) domain information model
6.1 Overview
This clause describes the domain information model of the basic ECG (1- to 3-lead ECG).
6.2 Class extensions
In this standard, no class extensions are defined with respect to IEEE Std 11073-20601a-2010.
6.3 Object instance diagram
The metric object instance diagram of the basic ECG (1- to 3-lead ECG) domain information model,
defined for the purposes of this standard, is shown in Figure 2.
The objects of the DIM, as shown in Figure 2, are described in 6.6 through 6.11. This includes the medical
device system (MDS) object (see 6.6), the numeric objects (see 6.7), the RT-SA objects (see 6.8), the
enumeration objects (see 6.9), the PM-store objects (see 6.10), and the scanner objects (see 6.11). See 6.13
for rules for extending the basic ECG (1- to 3-lead ECG) information model beyond elements as described
in this standard. Each clause that describes an object of the basic ECG (1- to 3-lead ECG) contains the
following information:
⎯ The nomenclature code used to identify the class of the object. One example where this code is
used is the configuration event, where the object class is reported for each object. This allows
the manager to determine whether the class of the object being specified is a numeric, real-time
sample array, enumeration, scanner, or PM-store class.
⎯ The attributes of the object. Each object has attributes that represent and convey information on
the physical device and its data sources. Each object has a Handle attribute that identifies the
object instance within an agent. Attribute values are accessed and modified using methods such
as GET and SET. Attribute types are defined using ASN.1. The ASN.1 definitions for new
attribute types specific to this standard are in Annex B, and the ASN.1 definitions for existing
attribute types referenced in this standard are in IEEE Std 11073-20601a-2010.
⎯ The methods available on the object.
⎯ The potential events generated by the object. The data are sent to the manager using events.
⎯ The available services such as getting or setting attributes.
© IEEE 2012 – All rights reserved
ISO/IEEE 11073-10406:2012(E)
The attributes for each class are defined in tables that specify the name of the attribute, its value, and its
qualifier. The qualifiers mean: M — Attribute is Mandatory, C — Attribute is Conditional and depends on
the condition stated in the Remark or Value column (if IEEE Std 11073-20601a-2010 is referenced, then it
contains the conditions), R — Attribute is Recommended, NR — Attribute is Not Recommended, and O —
Attribute is Optional. Mandatory attributes shall be implemented by an agent. Conditional attributes shall
be implemented if the condition applies and may be implemented otherwise. Recommended attributes
should be implemented by the agent. Not recommended attributes should not be implemented by the agent.
Optional attributes may be implemented by the agent. For attributes with qualifiers set to R or NR,
underlying requirements stated in the Remark and Value column in IEEE Std 11073-20601a-2010 shall be
followed.
The attributes can be either static, meaning that they shall remain unchanged after the configuration is
agreed upon, or dynamic, meaning that the attribute may change at some point after configuration.

Figure 2 —Basic ECG (1- to 3-lead ECG)—domain information model
6.4 Types of configuration
6.4.1 General
As specified in IEEE Std 11073-20601a-2010, there are two styles of configuration available. Subclauses
6.4.2 and 6.4.3 briefly introduce standard and extended configurations.
6.4.2 Standard configuration
Standard configurations are defined in the IEEE 11073-104zz specializations (such as this standard) and are
assigned a well-known identifier (Dev-Configuration-Id). The usage of a standard configuration is
negotiated at association time between the agent and the manager. If the manager recognizes and selects to
operate using the configuration, then the agent can send measurements immediately. If the manager does
not recognize the configuration, the agent provides the configuration prior to transmitting measurement
information. The DIM of the standard configuration defined in this standard is described in 6.5.3.
© IEEE 2012 – All rights reserved
ISO/IEEE 11073-10406:2012(E)
6.4.3 Extended configuration
In extended configurations, the agent’s configuration is not predefined in a standard. The agent determines
the objects, attributes, and values that will be used in a configuration and assigns a configuration identifier.
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