INTERNATIONAL
`STANDARD
`
`ISO/IEEE
`11073-30300
`
`First edition
` 2004-12-15
`
`Health informatics — Point-of-care
`medical device communication —
`Part 30300:
`Transport profile — Infrared wireless
`
`Informatique de santé — Communication entre dispositifs médicaux sur le
`site des soins —
`Partie 30300: Profil de transport — Faisceau infrarouge
`
`
`
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`© ISO/IEEE 2004
`
`Reference number
`ISO/IEEE 11073-30300:2004(E)
`
`C-001
`
`

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`C-002
`
`

`
` ISO/IEEE 11073-30300:2004(E)
`
`Health informatics — Point-of-care
`medical device communication —
`Part 30300:
`Transport profile — Infrared wireless
`
`Sponsor
`
`IEEE 1073™ Standard Committee
`
`of the
`
`IEEE Engineering in Medicine and Biology Society
`
`Approved 24 June 2004
`
`IEEE-SA Standards Board
`
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`ISO/IEEE 11073-30300:2004(E)
`
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`Abstract: This standard establishes a connection-oriented transport profile and physical layer
`suitable for medical device communications that use short-range infrared wireless. This standard
`defines communications services and protocols that are consistent with specifications of the
`Infrared Data Association (IrDA) and are optimized for point-of-care (POC) applications at or near
`the patient.
`
`Keywords: access point, bedside, device interfaces, infrared, Infrared Data Association, IrDA,
`legacy device, medical device, medical device communications, medical information bus, MIB,
`patient, Simple Network Time Protocol, SNTP, point-of-care, POC, point-of-care testing, POCT,
`wireless
`
`This ISO/IEEE document is an International Standard and is copyright-protected by ISO and the IEEE. Except as
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`Copyright © 2004 ISO/IEEE. All rights reserved.
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`ISO/IEEE 11073-30300:2004(E)
`
`IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating Committees of the
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`ISO/IEEE 11073-30300:2004(E)
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`ISO/IEEE 11073-30300:2004(E)
`
`ISO 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.
`
`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.
`
`A pilot project between ISO and the IEEE has been formed to develop and maintain a group of ISO/IEEE
`standards in the field of medical devices as approved by Council resolution 43/2000. Under this pilot
`project, IEEE is responsible for the development and maintenance of these standards with participation and
`input from ISO member bodies.
`
`Attention is drawn to the possibility that some of the elements of this International Standard may be the
`subject of patent rights. Neither ISO nor the IEEE shall be held responsible for identifying any or all such
`patent rights.
`
`ISO/IEEE 11073-30300:2004(E) was prepared by IEEE 1073 Committee of the IEEE Engineering in
`Medicine and Biology Society.
`
`Copyright © 2004 ISO/IEEE. All rights reserved.
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`ISO/IEEE 11073-30300:2004(E)
`
`IEEE Introduction
`
`This introduction is not part of ISO/IEEE 11073-30300:2004(E), Health informatics — Point-of-care medical device
`communication — Part 30300: Transport profile — Infrared wireless.
`
`ISO/IEEE 11073 standards enable communication between medical devices and external computer systems.
`They provide automatic and detailed electronic data capture of patient vital signs information and device
`operational data. The primary goals are to:
`— Provide real-time plug-and-play interoperability for patient-connected medical devices
`— Facilitate the efficient exchange of vital signs and medical device data, acquired at the point-of-care,
`in all health care environments
`
`“Real-time” means that data from multiple devices can be retrieved, time correlated, and displayed or
`processed in fractions of a second. “Plug-and-play” means that all the clinician has to do is make the
`connection — the systems automatically detect, configure, and communicate without any other human
`interaction.
`
`“Efficient exchange of medical device data” means that information that is captured at the point-of-care
`(e.g., patient vital signs data) can be archived, retrieved, and processed by many different types of
`applications without extensive software and equipment support, and without needless loss of information.
`The standards are especially targeted at acute and continuing care devices, such as patient monitors,
`ventilators, infusion pumps, ECG devices, etc. They comprise a family of standards that can be layered
`together to provide connectivity optimized for the specific devices being interfaced.
`
`Notice to users
`
`Patents
`
`Attention is called to the possibility that implementation of this standard may require 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. The IEEE shall not be responsible for identifying
`patents or patent applications for which a license may be required by to implement an IEEE standard or for
`conducting inquiries into the legal validity or scope of those patents that are brought to its attention.
`
`Errata
`
`Errata, if any, for this and all other standards can be accessed at the following URL: http://
`standards.ieee.org/reading/ieee/updates/errata/index.html. Users are encouraged to check this URL for
`errata periodically.
`
`Interpretations
`
`Current interpretations can be accessed at the following URL: http://standards.ieee.org/reading/ieee/interp/
`index.html.
`
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`ISO/IEEE 11073-30300:2004(E)
`
`Participants
`
`At the time this standard was completed, the working group of the IEEE 1073 Standard Committee had the
`following membership:
`
`Todd H. Cooper
`Kai Hassing
`Michael Krämer
`Simon Meij
`
`Paul Schluter, Chair and Editor
`
`Thomas Norgall
`Daniel Nowicki
`Melvin Reynolds
`Michael Spicer
`
`Lars Steubesand
`Andrew Sutton
`Alpo Värri
`Paul Woolman
`
`The following members of the individual balloting committee voted on this standard. Balloters may have
`voted for approval, disapproval, or abstention.
`
`Tamer Beser
`Thomas Canup
`Todd H. Cooper
`Nowicki Daniel
`Grace Esche
`W. Michael Gardiner
`
`Harald Greiner
`Jack Harrington
`Jörg Kampmann
`Robert Kennelly
`Yuan Ma
`Simon Meij
`S. Mark Poler
`
`Melvin Reynolds
`Ricardo Ruiz
`Michael Spicer
`Paul Schluter
`Rick Schrenker
`Lars Steubesand
`
`When the IEEE-SA Standards Board approved this standard on 24 June 2004, it had the following
`membership:
`
`Don Wright, Chair
`Steve M. Mills, Vice Chair
`Judith Gorman, Secretary
`
`Chuck Adams
`H. Stephen Berger
`Mark D. Bowman
`Joseph A. Bruder
`Bob Davis
`Roberto de Boisson
`Julian Forster*
`Arnold M. Greenspan
`
`*Member Emeritus
`
`Mark S. Halpin
`Raymond Hapeman
`Richard J. Holleman
`Richard H. Hulett
`Lowell G. Johnson
`Joseph L. Koepfinger*
`Hermann Koch
`Thomas J. McGean
`Daleep C. Mohla
`
`Paul Nikolich
`T. W. Olsen
`Ronald C. Petersen
`Gary S. Robinson
`Frank Stone
`Malcolm V. Thaden
`Doug Topping
`Joe D. Watson
`
`Also included are the following nonvoting IEEE-SA Standards Board liaisons:
`
`Satish K. Aggarwal, NRC Representative
`Richard DeBlasio, DOE Representative
`Alan Cookson, NIST Representative
`
`Don Messina
`IEEE Standards Project Editor
`
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`ISO/IEEE 11073-20101:2004(E)
`
`Contents
`
`1.
`
`Overview.............................................................................................................................................. 1
`
`2.
`
`3.
`
`4.
`
`5.
`
`1.1
`1.2
`1.3
`1.4
`
`Scope........................................................................................................................................ 2
`Purpose..................................................................................................................................... 2
`Standards compatibility ........................................................................................................... 2
`Audience .................................................................................................................................. 2
`
`References............................................................................................................................................ 3
`
`Definitions, acronyms, and abbreviations............................................................................................ 4
`
`3.1
`3.2
`
`Definitions ............................................................................................................................... 4
`Acronyms and abbreviations ................................................................................................... 7
`
`Goals for this standard ......................................................................................................................... 9
`
`Architecture ....................................................................................................................................... 10
`
`5.1
`5.2
`5.3
`
`5.4
`
`Topology................................................................................................................................ 10
`Protocol layering.................................................................................................................... 11
`IrDA primary and secondary roles......................................................................................... 12
`ISO/IEEE 11073-30200........................................................................................... 12
`5.3.1
`5.3.2
`PDA and local area network (LAN) AP (LAP)....................................................... 13
`5.3.3
`Common AP ............................................................................................................ 13
`Client-server models for medical device communication ..................................................... 14
`
`6.
`
`Physical layer..................................................................................................................................... 14
`
`6.1
`6.2
`
`IrDA transceiver power options............................................................................................. 15
`Signaling rates........................................................................................................................ 15
`
`7.
`
`Data link layer.................................................................................................................................... 16
`
`7.1
`
`7.2
`7.3
`
`IrDA primary and secondary roles......................................................................................... 17
`7.1.1
`ISO/IEEE 11073 ...................................................................................................... 17
`NCCLS POCT1 ....................................................................................................... 17
`7.1.2
`IrLAP frame........................................................................................................................... 17
`Procedure model .................................................................................................................... 18
`7.3.1
`Discovery ................................................................................................................. 18
`Negotiation and connection ..................................................................................... 18
`7.3.2
`7.3.3
`Information transfer ................................................................................................. 19
`7.3.4
`Disconnect ............................................................................................................... 19
`7.4 Minimum data link layer requirements.................................................................................. 19
`7.4.1 Minimum data link layer services............................................................................ 19
`Negotiation............................................................................................................... 20
`7.4.2
`7.4.3
`Link disconnect time................................................................................................ 20
`7.4.4
`Contention state ....................................................................................................... 20
`7.4.5
`Signaling speed........................................................................................................ 21
`7.4.6
`SIR interaction pulse (SIP) ...................................................................................... 21
`7.4.7
`Data size................................................................................................................... 21
`7.4.8
`Poll interval.............................................................................................................. 21
`
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`ISO/IEEE 11073-20101:2004(E)
`
`8.
`
`Network layer .................................................................................................................................... 22
`
`8.1
`8.2
`
`Discovery information ........................................................................................................... 22
`Information access requirements ........................................................................................... 24
`IASs ......................................................................................................................... 24
`8.2.1
`8.2.2
`Global identifier number.......................................................................................... 24
`8.2.3
`Interface type ........................................................................................................... 25
`8.2.4
`Port identifier number.............................................................................................. 25
`8.2.5
`SAPs......................................................................................................................... 25
`8.2.6
`Supported objects and attributes.............................................................................. 25
`8.2.7
`Extending the list of objects and attributes.............................................................. 27
`8.3 Minimum IrLMP multiplexer requirements .......................................................................... 27
`
`9.
`
`Transport layer................................................................................................................................... 28
`
`9.1 MTU....................................................................................................................................... 28
`9.2
`Transport service requirements.............................................................................................. 29
`9.3 MDDL service ....................................................................................................................... 29
`
`10.
`
`11.
`
`Time synchronization ........................................................................................................................ 29
`
`Labeling and conformance requirements........................................................................................... 30
`
`Labeling requirements ........................................................................................................... 30
`11.1
`11.2 Conformance requirements ................................................................................................... 31
`
`Annex A (informative) IrDA physical layer parameters ............................................................................... 32
`
`Annex B (informative) Overview of ISO/IEEE 11073-30200 ...................................................................... 36
`
`Annex C (informative) ISO/IEEE 11073-30200 cable-to-infrared adapter................................................... 39
`
`Annex D (informative) Marking guidelines .................................................................................................. 41
`
`Annex E (normative) IrDA conformance requirements ................................................................................ 44
`
`Annex F (normative) Networked APs for NCCLS POCT1 devices ............................................................. 47
`
`Annex G (informative) Networked APs for ISO/IEEE 11073 devices ......................................................... 54
`
`Annex H (informative) Compatibility with ISO/IEEE 11073-30200 and NCCLS POCT1.......................... 58
`
`Annex I (informative) Bibliography .............................................................................................................. 59
`
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`x
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`

`
`Health informatics — Point-of-care medical
`device communication —
`Part 30300:
`Transport profile — infrared wireless
`
`1. Overview
`
`This standard is divided into eleven clauses, as follows:
`— Clause 1 provides an overview of this standard.
`— Clause 2 lists references to other standards that are useful in applying this standard.
`— Clause 3 provides definitions and abbreviations.
`— Clause 4 provides goals for this standard.
`— Clause 5 provides an overview of network topology and layering.
`— Clause 6 provides a profile of the physical layer.
`— Clause 7 provides a profile of the data link layer.
`— Clause 8 provides a profile of the network layer.
`— Clause 9 provides a profile of the transport layer.
`— Clause 10 describes the optional time synchronization service.
`— Clause 11 provides labeling and conformance requirements.
`
`This standard also contains nine annexes, as follows:
`— Annex A describes the Infrared Data Association (IrDA) infrared physical layer.
`— Annex B provides an overview of the ISO/IEEE 11073-302001 cable-connected physical layer.
`— Annex C provides an example of an ISO/IEEE 11073-30200 cable-connected infrared adapter.
`— Annex D provides marking guidelines.
`— Annex E defines the IrDA profile specifications adapted from the IrDA implementation guidelines.
`— Annex F defines networked access points (APs) for NCCLS Point-of-Care Connectivity; Approved
`Standard (NCCLS POCT1) diagnostic devices.
`— Annex G provides guidelines for networked APs for ISO/IEEE 11073 devices.
`
`1Information on references can be found in Clause 2.
`
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`
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`001
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`

`
`ISO/IEEE 11073-30300:2004(E)
`
`HEALTH INFORMATICS — POINT-OF-CARE MEDICAL DEVICE COMMUNICATION
`
`— Annex H discusses lower layer compatibility with other medical communication standards.
`
`— Annex I provides bibliographical references.
`
`1.1 Scope
`
`The scope of this standard is to define an IrDA-based transport profile for medical device communication
`that uses short-range infrared, as a companion standard to ISO/IEEE 11073-30200, which specifies a cable-
`connected physical layer. This standard also supports use cases consistent with industry practice for
`handheld personal digital assistants (PDAs) and network APs that support IrDA-infrared communication.
`
`1.2 Purpose
`
`The purpose of this standard is to provide connection-oriented communication services and protocols con-
`sistent with IrDA specifications, using short-range infrared as the physical layer. This standard extends and
`complements ISO/IEEE 11073-30200, which specifies a cable-connected physical layer. The use of IrDA-
`infrared is appropriate for mobile and portable point-of-care (POC) clinical lab instruments (e.g., glucose
`meters) and other medical devices that require intermittent point-and-shoot connectivity to a data repository.
`
`This standard utilizes the work embodied in the Connectivity Industry Consortium (CIC) and
`NCCLS POCT1 device and AP interface specification (Appendix A), which is part of an overall effort to
`standardize communication for POC medical devices using a single transport protocol (IrDA Tiny Transport
`Protocol [TinyTP]) running over two physical layers: cable-connected and infrared.
`
`1.3 Standards compatibility
`
`This standard is one part of the family of ISO/IEEE 11073 standards. It is a companion standard to ISO/
`IEEE 11073-30200. Both standards describe connection-oriented communications services and protocols
`consistent with standards of the IrDA.
`
`Like ISO/IEEE 11073-30200, this standard is designed to be compatible with the ISO/IEEE 11073 upper
`layer standards such as the ISO/IEEE 11073-10000 and ISO/IEEE 11073-20000 families of standards. It is
`also fully compatible with (and is largely based on) Appendix A of the NCCLS POCT1 and is capable of
`supporting other upper layer medical device communication standards, such as the NCCLS POCT1 device
`messaging layer for POC diagnostic devices.
`
`Finally, this standard specifies and provides recommendations for how a network AP acts as a relay between
`the IrDA TinyTP connection to the medical device and a Transmission Control Protocol/Internet Protocol
`(TCP/IP) connection to a remote host on the network.2 This is an essential first step toward deploying the
`ISO/IEEE 11073 family of standards on the widely used TCP/IP and other standard Internet protocols.
`
`1.4 Audience
`
`The primary users of this standard are technical personnel who are creating or interfacing to a medical
`device communications system. Familiarity with the ISO/IEEE 11073 family of standards is recommended.
`Familiarity with communications and networking technologies is also recommended.
`
`2This standard provides a normative specification regarding network APs for NCCLS POCT1 devices in Annex F and informative
`guidance regarding network APs for ISO/IEEE 11073 devices. A future ISO/IEEE 11073 internetworking standard may include other
`profiles based on User Datagram Protocol/Internet Protocol (UDP/IP) as well as TCP/IP.
`
`2
`
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`002
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`

`
`PART 30300: TRANSPORT PROFILE — INFRARED WIRELESS
`
`ISO/IEEE 11073-30300:2004(E)
`
`2. References
`
`This standard shall be used in conjunction with the following publications. When the following standards
`are superceded by an approved revision, the revision shall apply.
`
`ANSI/TIA/EIA-232-F, Interface Between Terminal Equipment and Data Circuit-Terminating Equipment
`Employing Serial Binary Data Interchange.3
`
`ANSI/TIA/EIA-568-A, Commercial Building Telecommunications Cabling Standard.
`
`CENELEC EN 60825-1/A11 (amendment to CENELEC version of IEC 60825-1, Safety of Laser Products
`—Part 1: Equipment Classification, Requirements and User's Guide).4
`
`IEC 60417-1, Graphical Symbols for Use on Equipment—Part 1: Overview and Application.5
`
`IEC 60825-1, Safety of laser products—Part I: Equipment classification, requirements and user’s guide, as
`amended (reported at TC 76 Meeting, Frankfurt, Germany, October 31, 1997).
`
`IEEE Std 802.3™, IEEE Standard for Local Area Networks—Carrier Sense Multiple Access with Collision
`Detection (CSMA/CD) Access Method and Physical Layer Specifications.6, 7
`
`IEEE Std 1073™, I