EN ISO 11073-10404:2011

SLOVENSKI STANDARD
01-maj-2011
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10404. del:
Specialne naprave - Pulzni oksimeter (ISO/IEEE 11073-10404:2010)
Health informatics - Personal health device communication - Part 10404: Device
specialization - Pulse oximeter (ISO/IEEE 11073-10404:2010)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10404: Gerätespezifikation - Pulsoximeter (ISO/IEEE 11073-10404:2010)
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Ta slovenski standard je istoveten z: EN ISO 11073-10404:2011
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic 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 11073-10404
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2011
ICS 35.240.80
English Version
Health informatics - Personal health device communication -
Part 10404: Device specialization - Pulse oximeter (ISO/IEEE
11073-10404:2010)
Informatique de santé - Communication entre dispositifs de Medizinische Informatik - Kommunikation von Geräten für
santé personnels - Partie 10404: Spécialisation des die persönliche Gesundheit - Teil 10404:
disposititfs - Oxymètre de pouls (ISO/IEEE 11073- Gerätespezifikation - Pulsoximeter (ISO/IEEE 11073-
10404:2010) 10404:2010)
This European Standard was approved by CEN on 23 April 2010.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10404:2011: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
The text of ISO/IEEE 11073-10404:2010 has been prepared by Technical Committee ISO/TC 215 "Health
informatics" of the International Organization for Standardization (ISO) and has been taken over as
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 September 2011, and conflicting national standards shall be
withdrawn at the latest by September 2011.
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 organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-10404:2010 has been approved by CEN as a EN ISO 11073-10404:2011 without
any modification.
INTERNATIONAL ISO/IEEE
STANDARD 11073-10404
First edition
2010-05-01
Health informatics — Personal health
device communication —
Part 10404:
Device specialization — Pulse oximeter
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10404: Spécialisation des disposititfs — Oxymètre de pouls

Reference number
ISO/IEEE 11073-10404:2010(E)
©
ISO 2010
©
IEEE 2010
ISO/IEEE 11073-10404:2010(E)
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ii © IEEE 2010 – All rights reserved

ISO/IEEE 11073-10404:2010(E)
Contents Page
Foreword. v
Introduction.vii
1. Overview. 1
1.1 Scope. 1
1.2 Purpose. 1
1.3 Context. 2
2. Normative references . 2
3. Definitions, acronyms, and abbreviations. 2
3.1 Definitions. 2
3.2 Acronyms and abbreviations. 3
4. Introduction to ISO/IEEE 11073 personal health devices. 3
4.1 General. 3
4.2 Introduction to IEEE 11073-20601 modeling constructs. 4
5. Pulse oximeter device concepts and modalities . 4
5.1 General. 4
5.2 Device types. 5
5.3 General concepts. 5
5.4 Collected data. 6
5.5 Derived data. 8
5.6 Stored data . 8
5.7 Device configurations . 8
6. Pulse oximeter DIM. 9
6.1 Overview. 9
6.2 Class extensions . 9
6.3 Object instance diagram. 9
6.4 Types of configuration . 10
6.5 MDS object . 11
6.6 Numeric objects . 14
6.7 Real-time sample array (RT-SA) objects . 24
6.8 Enumeration objects. 25
6.9 PM-store objects . 29
6.10 Scanner objects . 33
6.11 Class extension objects . 37
6.12 Pulse oximeter information model extensibility rules. 37

© IEEE 2010 – All rights reserved iii

ISO/IEEE 11073-10404:2010(E)
7. Pulse oximeter service model . 37
7.1 General. 37
7.2 Object access services. 37
7.3 Object access EVENT REPORT services. 40
8. Pulse oximeter communication model. 41
8.1 Overview. 41
8.2 Communications characteristics. 41
8.3 Association procedure. 42
8.4 Configuring procedure . 43
8.5 Operating procedure. 45
8.6 Time synchronization. 46
9. Test associations . 46
9.1 Behavior with standard configuration . 46
9.2 Behavior with extended configurations. 46
10. Conformance. 46
10.1 Applicability. 46
10.2 Conformance specification. 47
10.3 Levels of conformance. 47
10.4 Implementation conformance statements (ICSs) . 48
Annex A (informative) Bibliography. 52
Annex B (normative) Additional ASN.1 definitions . 53
Annex C (normative) Allocation of identifiers . 55
Annex D (informative) Message sequence examples . 57
Annex E (informative) PDU examples . 59
iv © IEEE 2010 – All rights reserved

ISO/IEEE 11073-10404:2010(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 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 11073-10404 was prepared by the 11073 Committee of the Engineering in Medicine
and Biology Society of the IEEE (as IEEE Std 11073-10404-2008). 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. Both parties are responsible for the
maintenance of this document.
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: Domain information model
— Part 10404: Device specialization — Pulse oximeter
— Part 10407: Device specialization — Blood pressure monitor
© IEEE 2010 – All rights reserved v

ISO/IEEE 11073-10404:2010(E)
— Part 10408: (Point-of-care medical device communication) Device specialization —
Thermometer
— Part 10415: (Point-of-care medical device communication) Device specialization — Weighing
scale
— Part 10417: Device specialization — Glucose meter
— Part 10471: (Point-of-care medical device communication) Device specialization —
Independant living activity hub
— Part 20101: (Point-of-care medical device communication) Application profiles — Base
standard
— Part 20601: (Point-of-care medical device communication) 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
vi © IEEE 2010 – All rights reserved

ISO/IEEE 11073-10404:2010(E)
Introduction
ISO/IEEE 11073 standards enable communication between medical devices and external computer
a
systems. This standard uses the optimized framework created in IEEE Std 11073-20601™-2008 and
describes a specific, interoperable communication approach for pulse oximeters. These standards align
with, and draw upon, the existing clinically focused standards to provide support for communication of data
from clinical or personal health devices.

a
For information on references, see Clause 2.
© IEEE 2010 – All rights reserved vii

INTERNATIONAL STANDARD ISO/IEEE 11073-10404:2010(E)

Health informatics—Personal health device
communication—
Part 10404:
Device specialization—Pulse oximeter
IMPORTANT NOTICE: This standard is not intended to ensure safety, security, health, or
environmental protection in all circumstances. 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 communication between personal telehealth pulse oximeter devices
and compute engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a
manner that enables plug-and-play (PnP) interoperability. It leverages appropriate portions of existing
standards including ISO/IEEE 11073 terminology, information models, application profile standards, and
transport standards. 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 pulse oximeters.
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 compute engines (e.g., cell phones, personal computers,
personal health appliances, 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 2010 – All rights reserved

ISO/IEEE 11073-10404:2010(E)
1.3 Context
See IEEE Std 11073-20601-2008 for an overview of the environment within which this standard is
written.
This standard, IEEE Std 11073-10404-2008, defines the device specialization for the pulse oximeter, being
a specific agent type, and provides a description of the device concepts, its capabilities, and its
implementation according to this standard.

This standard is based on IEEE Std 11073-20601-2008, which in turn draws information from both
ISO/IEEE 11073-10201:2004 [B3] and ISO/IEEE 11073-20101:2004 [B4]. The medical device encoding
rules (MDER) used within this standard are fully described in IEEE Std 11073-20601-2008.

This standard reproduces relevant portions of the nomenclature found in ISO/IEEE 11073-10101:2004 [B2]
and adds new nomenclature codes for the purposes of this standard. Between this standard and
IEEE Std 11073-20601-2008, all required nomenclature codes for implementation are documented.
NOTE—In this standard, ISO/IEEE P11073-104zz is used to refer to the collection of device specialization standards
that utilize IEEE Std 11073-20601-2008, 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.

IEEE Std 11073-20601-2008, Health informatics—Personal health device communication—Part 20601:
Application profile—Optimized Exchange Profile.
See Annex A for all informative material referenced by this standard.
3. Definitions, acronyms, and abbreviations
3.1 Definitions
For the purposes of this standard, the following terms and definitions apply. The Authoritative Dictionary
of IEEE Standards [B1] should be referenced 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, a class describes the attributes, methods, and events that objects
instantiated from the class utilize.
3.1.3 compute engine: See: manager.
3.1.4 device: A physical apparatus implementing either an agent or manager role.
3.1.5 handle: An unsigned 16-bit number that is locally unique and identifies one of the object instances
within an agent.
Information on references can be found in Clause 2.
The numbers in brackets correspond to the numbers in 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.
IEEE publications are available from the Institute of Electrical and Electronics Engineers, 445 Hoes Lane, Piscataway, NJ 08854,
USA (http://standards.ieee.org/).
© IEEE 2010 – All rights reserved

ISO/IEEE 11073-10404:2010(E)
3.1.6 manager: A node receiving data from one or more associated agent systems. Examples of managers
include a cellular phone, health appliance, set top box, or a computer system.
3.1.7 obj-handle: See: handle.
3.1.8 object: In object-oriented modeling, a particular instantiation of a class. The instantiation realizes
attributes, methods, and events from the class.
3.1.9 personal health device: A device used in personal health applications.
3.1.10 personal telehealth device: See: personal health device.
3.1.11 plethysmogram, plethysmographic, or photoplethysmographic waveform: Sequence of samples
related to the sequential time-varying light absorption due to effects of pulsatile blood flow.
3.1.12 SpO : Percentage oxygen saturation of haemoglobin as measured by a pulse oximeter, where this
measurement is an estimate of the fraction of functional haemoglobin (or hemoglobin) in arterial blood that
is saturated with oxygen.
NOTE—For more information about SpO , see ISO 9919 [B6].
3.2 Acronyms and abbreviations
APDU application protocol data unit
ASN.1 Abstract Syntax Notation One
DIM domain information model
ECG electrocardiograph
EUI-64 extended unique identifier (64 bits)
ICS implementation conformance statement
ID identifier
MDC medical device communication
MDER medical device encoding rules
MDS medical device system
MOC managed object class
OID object identifier
PDU protocol data unit
PHD personal health device
PnP plug-and-play
RT-SA real-time sample array
SpO percentage oxygen saturation of haemoglobin
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 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 healthcare information systems. See
IEEE Std 11073-20601-2008 for a description of the guiding principles for this series of ISO/IEEE 11073
personal health device standards.

IEEE Std 11073-20601-2008 supports the modeling and implementation of an extensive set of personal
health devices. IEEE Std 11073-10404-2008 (this standard) defines aspects of the pulse oximeter device. It
describes all aspects necessary to implement the application layer services and data exchange protocol
between an ISO/IEEE 11073 personal health device pulse oximetry agent and a manager. This standard

© IEEE 2010 – All rights reserved

ISO/IEEE 11073-10404:2010(E)
defines a subset of the objects and functionality contained in IEEE Std 11073-20601-2008, extending and
adding 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-
20601-2008, are normatively defined in Annex C.
4.2 Introduction to IEEE 11073-20601 modeling constructs
4.2.1 General
The ISO/IEEE 11073 series of standards, and in particular IEEE Std 11073-20601-2008, 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 11073-20601-2008 for a detailed description of the modeling constructs.
4.2.2 Domain information model (DIM)
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 manager is defined by the
application protocol in IEEE Std 11073-20601-2008.
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 manager. Protocol messages within the
ISO/IEEE 11073 series of standards are defined in ASN.1. The messages defined in IEEE Std 11073-
20601-2008 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 11073-20601-
2008.
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.
5. Pulse oximeter device concepts and modalities
5.1 General
This clause presents the general concepts of pulse oximeter equipment. In the context of personal health
devices in the ISO/IEEE 11073 family of standards, a pulse oximeter, also called an oximeter, provides a
noninvasive estimate of functional oxygen of arterial haemoglobin (SpO ) from a light signal interacting
© IEEE 2010 – All rights reserved

ISO/IEEE 11073-10404:2010(E)
with tissue, by using the time-dependent changes in tissue optical properties that occur with pulsatile blood
flow (see Draft Guidance for Industry and FDA Staff [B5]). Applying the Beer-Lambert law of light
absorption through such an arterial network, the fraction of oxygenation of arterial haemoglobin can be
estimated. This estimate, normally expressed as a percentage by multiplying that fraction by 100, is known
as SpO . Occasionally, this estimate may be referenced as %SpO . ISO 9919 [B6] contains additional
2 2
information applicable to pulse oximetry.
5.2 Device types
Pulse oximeter systems with applicability in the personal health space may take on a variety of
configurations and sensor compositions, and their configurations have suitability in different personal
health application spaces. Pulse oximeter equipment comprises a pulse oximeter monitor, a pulse oximeter
probe, and a probe cable extender, if provided. Some oximeters are all-in-one assemblies, where the optical
probe, processing, and display components are in a single package. Other oximeters may consist of separate
sensor and processing/display components. Still others may place the sensor and signal processing in one
component, and send that information into an external component for display and storage. In addition, other
configurations may add storage capability into the system. This implies that different information models
may be best suited for each particular device configuration.
5.3 General concepts
5.3.1 Noninvasive measurement
The scope of this specialization covers the intended use of pulse oximeter equipment, which includes, but is
not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate. This standard is not
applicable to pulse oximeter equipment intended for use in laboratory research applications or to oximeters
that require a blood sample (see ISO 9919 [B6]). This standard does not cover measurement of oxygenation
via blood extraction. This standard is not applicable to pulse oximeter equipment solely intended for foetal
use.
The sensing mechanism may use either transmissive or reflective methods to measure blood oxygenation.
In addition, blood oxygenation is usually determined as a ratio of the absorbance of two different
wavelengths of light, although more wavelengths may be used.
5.3.2 Acquisition modes
5.3.2.1 General
Pulse oximeters are used to measure SpO within a variety of use scenarios.
5.3.2.2 Spot-check
In a spot-check scenario, a user may simply want to take a single, fully processed reading for transmission
to a manager. For example, the user would attach the oximeter, whereupon the agent would take an
oximetry and pulse rate reading. The agent would then begin communication with a manager and send that
single reading. The manager may acknowledge the transmission so the agent can subsequently disassociate
and return to its prior state.
5.3.2.3 Continuous monitoring
A continuous monitoring situation involves the pulse oximeter device measuring the user’s oxygenation for
some period of time greater than that needed to acquire a single measurement. Multiple measurements may
be taken to acquire trending information.
© IEEE 2010 – All rights reserved

ISO/IEEE 11073-10404:2010(E)
5.3.2.4 Stored-and-forwarded measurements
Stored-and-forwarded measurements could be considered as a specialized, continuous monitoring
application where the pulse oximetry device is not always in communication with a manager, and the
oximeter records data over several minutes or hours. In this case, oximetry data are stored in the device for
the duration of the study session and subsequently transferred to the manager at an appropriate time. This
measurement communication style is distinct from the situation where temporarily stored measurements are
transferred when the communication link is restored.
5.4 Collected data
5.4.1 General
This subclause describes the nature of the data that have been collected based on the acquisition modes
described in 5.3.2.
5.4.2 Percentage of arterial haemoglobin oxygen saturation
5.4.2.1 SpO
Every oximeter sends at least one expression of SpO . This is the primary measurement of a pulse oximeter.
It is important to note that this measurement is determined through various signal processing techniques
and can be expressed in different ways. Each method and expression has its applicability in particular
application spaces (e.g., vital signs monitoring and diagnostic sleep studies). Often the reported SpO has
been processed with a variety of techniques in order to present the data for use in a number of ways.

In response to the various physiological phenomena and situations, SpO measurements may be expressed
in a variety of ways. Additional modalities for expressing SpO are often used that are better suited to
expose or suppress various physiological or environmental phenomena, as seen in 5.4.2.2. The following
subclause outlines three expressions of SpO that may be used by a device manufacturer to convey blood
oxygenation level.
It is also conceivable that pulse oximeter equipment may deliver a single SpO that is determined by one of
these modalities. Furthermore, several of these distinct expressions may be transmitted concurrently during
a measurement session. The manager, upon receiving this collection of information, may choose to display
another subset of these expressions. It is required for a pulse oximeter agent to support at least one instance
of this measurement.
5.4.2.2 Alternative expressions of SpO
One case of SpO measurement involves a user wearing a sensor during unintentional or moderate activity.
The result of this activity may be intermittent loss of signal acquisition. The most common expression of
SpO may be too sensitive to these effects and could result in a fluctuating (and, therefore, misleading)
reading. An SpO measurement modality known as “slow-response” modality has a characteristic that
“smoothes out” a series of measurements in some fashion, perhaps by changing an averaging parameter or
by employing a different algorithm. This modality is defined in this standard.

During a sleep study, an apnea event results in a rapid desaturation of blood oxygenation. This SpO
measurement can be expressed by a “fast-response” modality that uses a technique that more effectively
captures such events. The technique may vary among device manufacturers, but a distinct expression able
to capture these rapid changes is defined in this standard.

© IEEE 2010 – All rights reserved

ISO/IEEE 11073-10404:2010(E)
The terms slow-response and fast-response are relative to a particular implementation and are not intended
to show a comparison across devices or vendors. Note that these are descriptive terms intentionally left
unspecific to allow more flexible interpretations within a particular implementation.

A pulse oximeter will often send SpO measurements periodically; e.g., once every second. In addition,
pulse oximeters may begin outputting measurements as soon as it has a reasonable estimate of functional
haemoglobin oxygenation. Subsequent measurements may, in some fashion, converge on the oximeter’s
best estimate. An additional modality, the “spot-check” modality, fulfills the desire to be able to perform
and display a single SpO measurement that is also its best estimate of functional haemoglobin oxygenation.
In other words, a spot-check is not simply the first measurement, but the first best measurement. The
specific manner in which this measurement is produced is specific to the pulse oximeter implementation.
Once that measurement is transmitted, the measurement session is complete.
5.4.3 Pulse rate
The heart rate measured by a pulse oximeter is produced by a heartbeat, but also requires ejection of blood
by the heart and generation of an arterial and tissue pressure wave that is detectable by
photoplethysmographic means. Therefore, the pulse rate may be a less reliable measure of heart rate than
that of directly measuring by electrocardiograph (ECG). As described in 5.4.2.1 and 5.4.2.2, the reported
value or values may be determined in a variety of ways, and corresponding modalities of “slow-response,”
“fast-response,” and “spot-check” are defined for pulse rate measurements. It is required for a pulse
oximeter agent to support at least one instance of this feature.
5.4.4 Pulsatile occurrence
If a precisely timestamped occurrence of a pulse is transmitted to a manager, that information can be used
in conjunction with other reported physiological events to derive another physiological measurement. Other
application spaces may wish to indicate pulsatile occurrence with less precision for purposes of displaying,
for instance, a flashing heart icon. It is not required for a pulse oximeter agent to support this feature.
5.4.5 Plethysmogram
There are applications where it is desired to visualize the sequence of samples related to the time-varying
light absorption due to the effects of pulsatile blood flow. Often these samples are taken from a single
wavelength light source, usually the wavelength less affected by changes in oxygen saturation. It is not
required for a pulse oximeter agent to support this feature.
5.4.6 Pulsatile quality and signal characterization
Pulse oximeter manufacturers have many ways to characterize the quality of the pulsatile wave.
Unfortunately, no industry-wide standard currently exists to quantify the characteristics of the signal.
However, signal amplitude metrics among the different vendors provide quantities that can be found to
have a linear relationship. One notable characteristic is the amplitude of the signal modulation. Other
methods to characterize the quality of the pulsatile wave may be employed. It is not required for a pulse
oximeter to support this feature.
© IEEE 2010 – All rights reserved

ISO/IEEE 11073-10404:2010(E)
5.5 Derived data
5.5.1 Limit indications
Pulse oximeters may implement indicators based on monitoring physiological values as falling outside
predefined limits. The commonly implemented indicators include reaching the thresholds of a high or low
SpO , or reaching the thresholds of a high or low pulse rate.
5.5.2 Pulsatile status
Pulse oximeters may provide status indications of certain characteristics of a pulsatile wave or irregul
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