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INTERNATIONAL ISO

STANDARD 19223

First edition
2019-07

Lung ventilators and related


equipment — Vocabulary and
semantics
Ventilateurs pulmonaires et équipement associé — Vocabulaire et
sémantique

Reference number
ISO 19223:2019(E)

© ISO 2019
ISO 19223:2019(E)

COPYRIGHT PROTECTED DOCUMENT


© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland

ii © ISO 2019 – All rights reserved


ISO 19223:2019(E)

Contents Page

Foreword ........................................................................................................................................................................................................................................ iv
Introduction..................................................................................................................................................................................................................................v
1 * Scope ............................................................................................................................................................................................................................. 1
2 Normative references ...................................................................................................................................................................................... 1
3 * Terms, definitions, symbols, and abbreviated terms ................................................................................................. 1
3.1 General artificial-ventilation terminology ...................................................................................................................... 2
3.2 Breath terminology ............................................................................................................................................................................. 9
3.3 Lung inflation terminology ........................................................................................................................................................ 13
3.4 * Time, phase and cycle terminology ................................................................................................................................ 18
3.5 * Rate terminology ............................................................................................................................................................................ 23
3.5.1 Preferred rate concepts........................................................................................................................................... 23
3.5.2 Secondary rate concepts — Rate terms for use if required for specific purposes 25
3.6 Pressure terminology ..................................................................................................................................................................... 26
3.7 Flow terminology............................................................................................................................................................................... 30
3.8 Volume terminology ........................................................................................................................................................................ 34
3.9 Initiation and termination terminology ......................................................................................................................... 38
3.10 * Baseline and PEEP terminology ........................................................................................................................................ 43
3.11 * Mode terminology ......................................................................................................................................................................... 48
3.12 * Bi-level terminology .................................................................................................................................................................... 60
3.13 Safety limits and alarm terminology ................................................................................................................................. 64
3.14 Gas port terminology ...................................................................................................................................................................... 67
Annex A (informative) Rationales and guidance................................................................................................................................... 69
Annex B (informative) Conceptual relationships between ventilator actions and types of breath .75
Annex C (informative) Illustrations of ventilation terms ............................................................................................................. 77
Annex D (informative) Classification of inflation-types ............................................................................................................ 109
Annex E (informative) Classification of ventilation-modes ................................................................................................... 114
Annex F (informative) Concepts relating to baseline airway pressures and PEEP as used in
this document ................................................................................................................................................................................................... 116
Annex G (informative) Conventions followed in this document ....................................................................................... 125
Annex H (informative) Implementation guidance for the vocabulary of this document ........................ 127
Annex I (informative) Equivalence declaration tables................................................................................................................ 129
Annex J (informative) Terminology — Alphabetized index of defined terms ..................................................... 132
Bibliography ......................................................................................................................................................................................................................... 139

© ISO 2019 – All rights reserved iii


ISO 19223:2019(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www.iso
.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 4, Vocabulary and semantics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv © ISO 2019 – All rights reserved


ISO 19223:2019(E)

Introduction
The characteristics of ventilation-modes of current automatic lung ventilators are often not well
understood. The current terminology used for their description is based on that introduced in the early
days of mechanical ventilation, but with the advances in ventilators, and ventilation-modes that have
evolved over recent years, the language used has been continuously adapted. In the absence of any
effective international coordinating action, this has inevitably led to increasing inconsistencies in the
way in which well-established terms and their derivatives are used.
To further compound the difficulties in understanding these complexities, some ventilator manufacturers
have created new proprietary terms to describe these alternative ways of ventilating patients, and
others have used existing terms with different meanings in different situations. This has led to patient
safety hazards, an example being that lung ventilator clinical orders (settings) for one model of ventilator
can be quite different from those required to get the same result from a different ventilator.
Recognizing these difficulties, ISO Technical Committee ISO/TC 121 requested its Subcommittee, SC 4,
to completely review the terminology and semantics for patient ventilation with a view to compiling a
standardized vocabulary that is applicable to current and, as far as possible, future practice. The primary
objective was to use as much existing terminology as possible, while clarifying its meaning and limiting
its potential for misuse by defining it more precisely. New terms were only introduced where there was
no alternative, either in order to name new concepts or where the misuse of existing vocabulary has
become so widespread that the term has become meaningless or unacceptably ambiguous. Importance
was placed on a vocabulary that would communicate a clear mental model of how the selected settings
would determine the interaction between the patient and the ventilator.
In order to achieve a vocabulary that is coherent, consistent and applicable to a range of fields such as
patient care, research, data collection and incident reporting, this document has been developed with the
participation, cooperation and assistance of members of other standards development organizations,
and of major international ventilator manufacturers. The applications include lung ventilators, medical
data systems facilitating clinical care and research, interoperability, incident reporting and equipment
maintenance.
The early work by the subcommittee in establishing how a standardized vocabulary should be
structured increasingly led to the conclusion that it would be necessary to revert to first principles.
It was recognized that much of the current terminology has its origins in the early use of automatic
ventilation, when the emphasis was inevitably on how best to save the lives of patients who could not
breathe for themselves and, consequently, only made basic provisions for the patient's own respiratory
activity. Since that time, ventilators have become increasingly interactive with the patient, such that it is
now necessary to consider their use from a ventilator-patient system perspective because it is no longer
possible, with any certainty, to predict ahead of time how that interaction will take place.
The terminology in this document is defined and used in a way that makes it capable of facilitating,
unambiguously, both the setting of a ventilator and how to describe and record the resultant ventilator-
patient interactions, continuously and at defined points within the course of ventilation. This includes
the result of the complex interactions that occur when additional breaths are taken during an assured-
inflation cycle, as can occur, for example, during APRV (airway pressure release ventilation).
This document seeks both to provide a consensus view and the basis for a coherent language for
describing ventilator function. Now that the fundamental concepts of artificial ventilation practice
within the scope of this document have matured, it has been possible to review the boundaries between
the various concepts of established ventilation-modes and the methods of artificially inflating a patient's
lungs and to formulate definitions that clarify the common elements and the distinctions. In particular,
the scopes of several concepts that were appropriate to earlier technology and practice have become
inadequate to encompass new developments and it was found necessary to subdivide them. Some of
their designating terms have, therefore, had to be deprecated, replaced or constrained using more
restrictive definitions, resulting in an inevitable reintroduction of some little-used legacy terms and
the need to create a few new terms.

© ISO 2019 – All rights reserved v


ISO 19223:2019(E)

The overall objective is to encourage a more disciplined use of ventilator vocabulary so that operators
trained in the application of this document will be able to move easily from one ventilator to another
and operate each one, with confidence, after a minimum amount of training. Although it is recognized
that change will not be immediate, it is expected that this discipline will feed through into scientific
publications, textbooks and training so that, over time, a standardized basic language of artificial
ventilation will become internationally established.
Examples of the application of this document are illustrated in the figures of Annexes C and F but these
are not intended to indicate a requirement, nor to impose any restriction on the design of artificial
ventilation devices.
Included with many of the terms are notes to entry that provide supplementary information, including
explanations of the semantics of the term along with their classification schemes. This format is not
only a requirement of ISO 704 but, unlike with such information in an annex, ensures that it remains
associated with the term when viewed on the free-to-access ISO Online Browsing Platform.
Some of the terms in this document are principally intended for technical documents, informatics and
related applications, and might have little applicability to ventilator labelling and instructions for use.
In this document, the following print types are used:
Definitions: roman type.
Material appearing outside of tables, such as notes, examples and references: smaller type.
Terms defined in Clause 3 of this document or as noted, apart from those in the form of acronyms or
initialisms or when used in headings or tables: italic type.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to the usage described in ISO/IEC Directives, Part 2,
Annex H. For the purposes of this document, the auxiliary verb
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
document,
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this document, and
— “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex A.
Colour coding is employed in most of the figures in Annexes B, C and F of this document to help
distinguish between some of the specific characteristics being illustrated. The coding used for each
figure, or set of figures, is provided either in its own specific key or in the introductory text of each
annex, as applicable.
NOTE The following figures and tables have been reproduced from Reference [34] with permission:

— Figures: B.1, C.1 to C.35 and F.1 to F.7;

— Tables: D.1 to D.3, E.1 and E.2.

vi © ISO 2019 – All rights reserved


INTERNATIONAL STANDARD ISO 19223:2019(E)

Lung ventilators and related equipment — Vocabulary and


semantics

1 * Scope
This document establishes a vocabulary of terms and semantics for all fields of respiratory care
involving mechanical ventilation, such as intensive-care ventilation, anaesthesia ventilation, emergency
and transport ventilation and home-care ventilation, including sleep-apnoea breathing-therapy
equipment. It is applicable
— in lung ventilator and breathing-therapy device standards,
— in health informatics standards,
— for labelling on medical electrical equipment and medical electrical systems,
— in medical electrical equipment and medical electrical system instructions for use and accompanying
documents,
— for medical electrical equipment and medical electrical systems interoperability, and
— in electronic health records.
This document is also applicable to those accessories intended by their manufacturer to be connected to
a ventilator breathing system or to a ventilator, where the characteristics of those accessories can affect
the basic safety or essential performance of the ventilator and ventilator breathing system.
NOTE This document can also be used for other applications relating to lung ventilation, including non-
electrical devices and equipment, research, description of critical events, forensic analysis and adverse event
(vigilance) reporting systems.

This document does not specify terms specific to breathing-therapy equipment, or to physiologic closed-
loop ventilation, high-frequency ventilation or negative-pressure ventilation; nor to respiratory support
using liquid ventilation or extra-corporeal gas exchange, or oxygen, except where it has been considered
necessary to establish boundaries between bordering concepts.

2 Normative references
There are no normative references in this document.

3 * Terms, definitions, symbols, and abbreviated terms


ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
NOTE For convenience, an index and a list of sources of all defined terms used in this document are provided
in Annex J.

© ISO 2019 – All rights reserved 1


ISO 19223:2019(E)

3.1 General artificial-ventilation terminology


3.1.1
ventilator
lung ventilator
DEPRECATED: respirator
medical device or medical electrical equipment intended to provide artificial ventilation
Note 1 to entry: In cases of possible ambiguity the full term, lung ventilator, should be used.

Note 2 to entry: See also ventilation (3.1.9).

[SOURCE: ISO 80601-2-12:2011, 201.3.222, modified — Definition split into two terms (see 3.1.1 and
3.1.10).]
3.1.2
airway
connected, gas-containing cavities and passages within the respiratory system, that conduct gas
between the alveoli and the oral and nasal orifices on the surface of the face, or the patient-connection
port if an airway device is used
Note 1 to entry: This is a well-established term that is commonly used in isolation in references to the airway of a
patient. Depending on the context, it is sometimes more helpful to use the qualified term, patient's airway.

Note 2 to entry: See also airway device (3.1.3).

3.1.3
airway device
device intended for use as an interface between the patient-connection port of a ventilator and the
patient's airway, and which has no auxiliary features on which the ventilator is dependent for its normal
operation
EXAMPLE Endotracheal tube; tracheotomy tube; face mask; supralaryngeal airway.

Note 1 to entry: The connection to the patient's airway can be at the face (non-invasive) or internal to the patient
(invasive).

Note 2 to entry: A face mask that intentionally vents respiratory gas to atmosphere by means of a bleed orifice
is a functional part of the ventilator breathing system and therefore not an airway device. With that arrangement,
the face seal of the mask becomes the patient-connection port and there is no patient-connection port connector,
nor an airway device.

Note 3 to entry: See also patient-connection port (3.14.5), airway (3.1.2) and ventilator breathing system (3.1.18).

3.1.4
airway resistance
drop in pressure between the patient-connection port and the alveoli per unit rate of airway flow
Note 1 to entry: The airway resistance is normally expressed as a single coefficient, with the implicit assumptions
that it is independent of the flow rate and of the direction of flow. In practice, these assumptions are typically
only approximately valid.

Note 2 to entry: See also airway (3.1.2).

3.1.5
respiratory system compliance
respiratory compliance
DEPRECATED: lung compliance
elastic characteristic of the lung expressed as the change in lung volume per unit change of airway
pressure in the absence of respiratory activity
Note 1 to entry: In addition to its direct reference, this term or its symbol, C rs, is used, in context or by qualification,
to designate this concept as a measured quantity (3.1.20).

2 © ISO 2019 – All rights reserved


ISO 19223:2019(E)

Note 2 to entry: The respiratory system compliance is normally expressed as a single coefficient, with the implicit
assumptions that it is independent of the volume of gas in the lung and of any hysteresis between increasing and
decreasing volumes. In practice, these assumptions are typically only approximately valid.

Note 3 to entry: Respiratory system compliance is typically determined by a static measurement once the airway
pressure has stabilized during an inspiratory pause. In mechanically ventilated patients it is typically determined
as either a static compliance or a dynamic compliance. There might be differences between the values obtained by
these different methods, not only due to the method itself but also due to viscoelastic effects, pressure balancing
throughout the slower compartments of the lungs and possible recruitment effects.

Note 4 to entry: It is sometimes more applicable to express this characteristic as lung elastance, which is simply
the inverse of respiratory system compliance.

Note 5 to entry: See also lung (3.1.16), airway pressure (3.6.1), respiratory activity (3.2.6), respiratory system
(3.1.17), inspiratory pause (3.4.12), pulmonary compliance (3.1.6), static compliance (3.1.7) and dynamic compliance
(3.1.8).

3.1.6
pulmonary compliance
elastic characteristic of the lungs expressed as the change in the lung volume per unit change of the
difference between the alveolar pressure and the pressure in the pleural space
Note 1 to entry: In addition to its direct reference, this term or its symbol, C L , is used, in context or by qualification,
to designate this concept as a measured quantity (3.1.20). The specific symbol, C L , has been adopted because of
its established usage in the scientific community to represent the ‘compliance of the lungs’.

Note 2 to entry: The pulmonary compliance is the compliance coefficient relating specifically to the lungs, as
distinct from the respiratory system compliance coefficient, which relates to the whole of the respiratory system
and, therefore, includes the compliance of the thoracic cage. For most patients it is not clinically necessary to
differentiate between the compliance of the lungs alone, and the compliance of the respiratory system, so the more
directly measurable respiratory system compliance provides sufficient information. If an impaired respiratory
system is indicated, the difference might be significant and can justify the more invasive and skilled procedure
required to obtain a measurement of pressure in the pleural space (the intrapleural pressure) and, thereby, that
of the pulmonary compliance.

Note 3 to entry: The difference between the alveolar pressure and the pleural pressure is typically referred to as
the transpulmonary pressure.

Note 4 to entry: The pulmonary compliance is normally expressed as a single coefficient, with the implicit
assumptions that it is independent of the volume of gas in the lungs, of any hysteresis between increasing and
decreasing volumes and of any variation of the pleural pressure within the pleural space. In practice, these
assumptions are typically only approximately valid.

Note 5 to entry: See also lung (3.1.16), airway pressure (3.6.1), respiratory system (3.1.17) and respiratory system
compliance (3.1.5).

3.1.7
static compliance
respiratory system compliance determined, under quasi-static conditions and while connected to a
ventilator, as the measured change in inspiratory volume per unit change in the measured plateau
inspiratory pressure relative to the measured total PEEP
Note 1 to entry: In addition to its direct reference, this term or its symbol, C stat , is used, in context or by
qualification, to designate this concept as a measured quantity (3.1.20).

Note 2 to entry: For the purposes of this measurement, quasi-static conditions are considered to occur during a
respiratory phase of low airway flow and no significant respiratory activity.

Note 3 to entry: Expressed as an equation: static compliance = inspiratory volume / (plateau pressure – total PEEP).
If the presence of auto-PEEP is not suspected or a value for total PEEP is not readily available, the set BAP may be
used as a substitute for total PEEP in this equation.

Note 4 to entry: See also respiratory system compliance (3.1.5), inspiratory volume (3.8.3), plateau inspiratory
pressure (3.6.4), total PEEP (3.10.6), auto-PEEP (3.10.7) and BAP (3.10.2).

© ISO 2019 – All rights reserved 3


ISO 19223:2019(E)

3.1.8
dynamic compliance
respiratory system compliance determined during normal mechanical ventilation
Note 1 to entry: In addition to its direct reference, this term or its symbol, C dyn, is used, in context or by
qualification, to designate this concept as a measured quantity (3.1.20).

Note 2 to entry: Dynamic compliance is a dynamically calculated value obtained during normal mechanical
ventilation by measuring the rate of change of inspiratory volume per unit change of airway pressure. A least
squares or other curve-fitting algorithm can be used, typically in conjunction with the equation of motion for
the respiratory system, to correct for any transient dynamic effects. When this term is used, the basis of the
calculation employed should be made available to the user.

3.1.9
ventilation
cyclical movement of a respirable gas into and out of the lungs
Note 1 to entry: This might be by external or spontaneous means, or by a combination of both.

Note 2 to entry: See also spontaneous breath (3.2.3), artificial ventilation (3.1.10), automatic ventilation (3.1.12),
mechanical ventilation (3.1.11), negative-pressure ventilation (3.1.14), positive-pressure ventilation (3.1.13) and
inflation (3.3.1).

3.1.10
artificial ventilation
intermittent elevation of the pressure in the patient's airway relative to that in the lungs by external
means with the intention of augmenting, or totally controlling, the ventilation of a patient
EXAMPLE Means used to provide artificial ventilation are manual resuscitation; mouth-to-mouth
resuscitation; automatic ventilation; mechanical ventilation.

Note 1 to entry: Common classifications of areas of application of artificial ventilation are: emergency; transport;
home-care; anaesthesia; critical care; rehabilitation.

Note 2 to entry: Classifications used to denote means used for artificial ventilation include: positive-pressure;
negative-pressure; gas-powered; operator-powered; electrically-powered.

Note 3 to entry: Negative-pressure ventilation elevates the relative pressure in the airway by intermittently
lowering the pressure in the lungs.

[SOURCE: ISO 80601-2-12:2011, 201.3.22, modified — Definition split into two terms (3.1.1 and 3.1.10).]
3.1.11
mechanical ventilation
artificial ventilation by means of a mechanical device
Note 1 to entry: This term has become the commonly used term for any form of artificial ventilation that involves
specifically designed equipment comprising mechanical parts only or mechanical and electrical/electronic parts.

Note 2 to entry: A mechanical ventilator can provide artificial ventilation automatically or by manual operation
and delivers either positive-pressure ventilation or negative-pressure ventilation.

3.1.12
automatic ventilation
continuous artificial ventilation by means of an automatic device
Note 1 to entry: Automatic ventilators deliver either positive-pressure ventilation or negative-pressure ventilation.

Note 2 to entry: This term can be used for the specific designation of the large class of mechanical ventilators
that are not manually operated. The designation includes all ventilators that operate without continuous human
intervention, extending from basic automatically-cycled resuscitators to ventilators providing physiological
closed-loop control.

4 © ISO 2019 – All rights reserved


ISO 19223:2019(E)

3.1.13
positive-pressure ventilation
PPV
DEPRECATED: IPPV
artificial ventilation achieved by the intermittent elevation of the airway pressure above any set BAP
Note 1 to entry: This is a general term for artificial ventilation achieved by the intermittent application of a raised
pressure to some part of the patient's airway in order to assist or control an increase in the volume of gas in the
lung. Each such intermittent elevation of the airway pressure constitutes an inflation.

Note 2 to entry: The original term for this means of applying artificial ventilation was intermittent positive-
pressure ventilation (IPPV) but since the almost universal adoption of the practice of retaining some level of
positive airway pressure at the end of expiration the ‘positive pressure’ is no longer intermittent because the
airway pressure is continuously positive. Although it is only possible to achieve positive-pressure artificial
ventilation by intermittently changing the airway pressure, whether it is by intermittent elevation or intermittent
release of the pressure, depends on the objective and settings. With its now wide acceptance in the practice of
artificial ventilation, the qualifying term ‘positive-pressure’ is, therefore, all that is required for its distinction.

Note 3 to entry: See also artificial ventilation (3.1.10), inflation (3.3.1), airway pressure (3.6.1), set (3.1.19), BAP
(3.10.2), airway (3.1.2), lung (3.1.16) and expiration (3.2.11).

3.1.14
negative-pressure ventilation
NPV
artificial ventilation achieved by intermittently changing a negative pressure applied to the exterior of
the patient's thorax
Note 1 to entry: This document does not include terms specific to negative-pressure ventilation.

Note 2 to entry: See also Clause 1.

3.1.15
NIV
non-invasive ventilation
positive-pressure ventilation without the use of an invasive airway device
Note 1 to entry: The connection to the patient is typically by means of a specially designed face or nasal mask.

Note 2 to entry: The provision of NIV does not, in itself, require dedicated ventilation-modes although some
might be more suited to its use, but it does typically require certain compensating measures, particularly those
relating to the possibility of increased and variable leakage. These can include, added, extended or deactivated
compensations, modified alarms limits, the deactivation of some alarms and the modification of inflation initiation
and termination criteria.

Note 3 to entry: On ventilators intended for NIV only, these compensations are classified as a permanently active
NIV adjunct. On ventilators where the compensations made to suit NIV are selectable as an option, although also
adjunctive in their actions, these have been typically classified as an NIV ventilator operational mode.

Note 4 to entry: See also positive-pressure ventilation (3.1.13), airway device (3.1.3), ventilator (3.1.1), ventilator
operational mode (3.11.1) and adjunct (3.11.4).

3.1.16
lung
each of the pair of compliant organs within the ribcage (thorax), bounded by the terminal bronchiole
and the visceral pleura, which during ventilation provide gas/blood interfaces that enable oxygen from
the gas to pass into the blood and carbon dioxide to be removed
Note 1 to entry: In specific reference to the pair of these organs, in this document the inflection ‘lungs’ is used.

© ISO 2019 – All rights reserved 5


ISO 19223:2019(E)

Note 2 to entry: In accordance with what has become common practice in the absence of a more suitable term,
this term in its singular form is also used in this document to reference the connected, respiratory-gas containing
cavities within the respiratory system, consisting of the airway and the lungs. Examples of this common practice
in applications that are outside the scope of this document are: lung function; lung disease; lung compliance; lung
mechanics; test lung. Other established examples are lung ventilator; lung elastance; lung protective strategy.

Note 3 to entry: Although there are no such references in this document, if in the application of this document
a need arises to refer to just ‘one of the lungs’ then, in order to avoid any possible ambiguity, it should always be
identified as such, or as the ‘left lung’ or ‘right lung’.

Note 4 to entry: See also ventilation (3.1.9) and breathe (3.2.2).

3.1.17
respiratory system
anatomical system related to breathing including the airway, lungs, chest wall, pleural space, brainstem
respiratory control centre, phrenic nerves, neuromuscular junctions, diaphragm and accessory muscles
of ventilation
3.1.18
ventilator breathing system
VBS
anaesthesia breathing system
pathways through which gas flows to or from the patient at respiratory pressures, bounded by the port
through which respirable gas enters, the patient-connection port and the gas exhaust port
Note 1 to entry: These pathways typically extend within and outside the body of the ventilator, with those outside
being operator-detachable.

Note 2 to entry: The port of entry of a respirable gas into the ventilator breathing system can be inside the body
of the ventilator and should not be confused with an external connection port into which respirable gas enters
before being reduced to respirable pressures.

Note 3 to entry: See also port (3.14.1), patient-connection port (3.14.5), exhaust port (3.14.2) and ventilator (3.1.1).

Note 4 to entry: The admitted term is included in this document for use in reference to the specific class of
ventilators that are configured to ventilate patients with an anaesthetic gas mixture. With this application, the
definition may be made more specific with ‘respirable gas’ becoming ‘anaesthetic gases and the ‘port through
which respirable gas enters’ becoming the ‘fresh-gas inlet’.

[SOURCE: ISO 4135:2001, 3.1.6 and 4.1.1, and ISO 80601-2-12:2011, 201.3.221, modified — Rephrased.]
3.1.19
set
allocated a specific value
EXAMPLE 1 A set pressure limit.

EXAMPLE 2 The set inspiratory pressure.

Note 1 to entry: Set is used in this document as a prefix to distinguish an intended value for a controlled ventilation
variable from a measured or actual value of the same quantity.

Note 2 to entry: The use of this term is not required if the distinction from a measured or actual value is evident
from the context of use.

Note 3 to entry: A set value might be determined directly by the operator or indirectly by selection of an algorithm
that determines the setting based on other settings or measurements.

Note 4 to entry: See also actual value (3.1.22) and the references to settings in Annexes A, C and D, and G.4.

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ISO 19223:2019(E)

3.1.20
measured
determined by a measuring device or system
Note 1 to entry: This term is used in this document as a prefix to distinguish the value of a quantity as determined
by a measuring device or system, from an actual value or set value of the same quantity.

Note 2 to entry: Measured values might be displayed or recorded as discrete values or as a continuous waveform.

Note 3 to entry: The use of this term is not required if the distinction from a set or actual value is evident from the
context of use.

Note 4 to entry: See also set (3.1.19), actual value (3.1.22) and G.4.

3.1.21
preset
one of a set of stored configuration parameter(s), including selection of algorithms and initial values for
use by algorithms, which affects or modifies the performance of the ventilator
Note 1 to entry: Presets are commonly configured by the manufacturer or a responsible organization.

Note 2 to entry: Access to a preset value is typically controlled by

— a tool,

— a responsible-organization password and a technical description, separate from the instructions for use,

— an individual operator password,

— voice recognition, or

— biometric means.

3.1.22
actual value
value of a quantity as it exists in fact
Note 1 to entry: This is the true value of a quantity, which might, or might not, be determinable by a
measuring device.

Note 2 to entry: The definitions of terms denoting quantities, in this document, denote the actual value of that
quantity. Set values are the means by which an operator informs the ventilator of the intended actual value, and
measured values are displays or records of the actual value, to the accuracy and resolution of the measuring system.

3.1.23
limit
point or level beyond which the value of a parameter may not pass without an action by the ventilator
Note 1 to entry: The action might be a notification or the implementation of means to prevent or mitigate a
hazardous situation.

Note 2 to entry: In this document, this term is restricted to the designation of safety constraints that provide
patient protection that is completely independent of the controlled ventilation parameters.

Note 3 to entry: An alarm system uses an alarm limit in determining an alarm condition.

Note 4 to entry: See also alarm system, alarm limit and alarm condition (Annex J) and safety limits and alarm
terminology (3.13).

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ISO 19223:2019(E)

3.1.24
normal use
operation, including routine inspection and adjustments by any operator, and stand-by, according to the
instructions for use
Note 1 to entry: Normal use should not be confused with intended use. While both include the concept of use as
intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates not
only the medical purpose, but also matters such as maintenance, transport.

[SOURCE: IEC 60601-1:2005+AMD1:2012, 3.71]


3.1.25
intended use
intended purpose
use for which a product, process or service is intended according to the specifications, instructions and
information provided by the manufacturer
[SOURCE: ISO/IEC Guide 63:2012, 2.5]
Note 1 to entry: Intended use should not be confused with normal use. While both include the concept of use as
intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates not
only the medical purpose, but also such matters as maintenance, service and transport.

3.1.26
normal condition
condition in which all means provided for protection against hazards are intact
[SOURCE: IEC 60601-1:2005+AMD1:2012, 3.70]
3.1.27
single fault condition
condition in which a single means for reducing a risk is defective or a single abnormal condition is present
[SOURCE: IEC 60601-1:2005+AMD1:2012, 3.116, modified — Restriction to electrical equipment only
was removed.]
3.1.28
accompanying document
document accompanying medical artificial ventilation equipment, a medical artificial ventilation system,
equipment or an accessory which contains information for the responsible organization or operator,
particularly regarding basic safety and essential performance
[SOURCE: IEC 60601-1:2005+AMD1:2012, 3.4, modified — Restriction to electrical equipment only was
removed.]
3.1.29
sleep-apnoea breathing-therapy equipment
medical equipment intended to alleviate the symptoms of a patient who suffers from sleep apnoea by
delivering a therapeutic breathing pressure to the patient
Note 1 to entry: Sleep-apnoea breathing-therapy equipment is primarily used in the home healthcare environment
by a lay operator without direct professional supervision.

[SOURCE: ISO 80601-2-70:2015, 201.3.212]

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3.2 Breath terminology


3.2.1
breath
increase in the volume of gas in the lungs resulting from an inward gas flow through the airway, paired
with a corresponding decrease in volume resulting from its expiration
Note 1 to entry: The inward flow might be caused by a positive-pressure inflation, a patient inspiratory effort, or a
combination of the two. Outward flow occurs whenever the pressure in the lung is higher than that at the patient-
connection port.

Note 2 to entry: A breath is composed of two principle phases: an inspiratory phase (3.4.9) or an inflation phase
(3.4.10), and an expiratory phase (3.4.2). Each of these can be subdivided into further phases. For example, the
inflation or inspiratory phase can be considered to include a termination phase and the expiratory phase can be
considered to include a trigger phase. An inflation phase can also be considered to include a plateau inspiratory-
pressure phase.

Note 3 to entry: The volume of gas that enters and leaves the lungs during a breath might differ due to physical
and/or compositional changes between inspired and expired gas, and leakages at the connection to the patient's
airway. Temporarily, it might also differ, breath-to-breath, in the event of, for example, dynamic hyperinflation or
specific patient actions.

Note 4 to entry: This definition accommodates the concept of additional breaths occurring within the period of
an assured-inflation cycle where the paired expiration of the volume generated by the assured inflation can occur
after one or more expirations of additional breaths.

Note 5 to entry: See also lung (3.1.16), inspiratory volume (3.8.3), expired tidal volume (3.8.4), tidal volume (3.8.1),
airway (3.1.2), inflation (3.3.1), inspiratory effort (3.2.7), plateau inspiratory pressure (3.6.4), patient-connection
port (3.14.5) and additional breath (3.2.8).

3.2.2
breathe
take gas into the lungs and then expire it
Note 1 to entry: Breathing is a spontaneous human activity that might be detected by a ventilator but, in this
document, is never considered to be a ventilator function.

Note 2 to entry: This term is typically used to designate this action as a continuously repeated physiological
process but it can be used to designate the taking of a single breath or even an inspiration or expiration.

Note 3 to entry: See also Reference [23] - Ventilators do not breathe.

3.2.3
spontaneous breath
breath initiated by the patient
Note 1 to entry: This definition is patient-centric and independent of a ventilator or sleep-apnoea breathing-
therapy equipment.

Note 2 to entry: The detection of a spontaneous breath by a medical device depends on the set detection threshold
of a relevant physiological parameter(s), which can include a parameter(s) that relates to the patient's intention
to breathe and not the actual movement of gas.

Note 3 to entry: The qualifier ‘spontaneous’ makes it clear that such breaths occur as a result of the patient's,
generally subconscious, physiological processes, and consequently have elements of unpredictability in initiation,
size and duration.

Note 4 to entry: From an artificial ventilation perspective, a spontaneous breath is also one to which the patient
has contributed at least a proportion of the work of inspiration. More specific terms, which provide an indication
of relative magnitude, are subsets of the general term and range from ‘breathing effort’ and ‘breathing activity’
to ‘natural breathing’. These are all parts or types of spontaneous breaths, as are spontaneous inspiration and
spontaneous expiration.

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ISO 19223:2019(E)

Note 5 to entry: See also breath (3.2.1), initiate (3.9.1), ventilator (3.1.1), sleep-apnoea breathing -therapy equipment
(3.1.29), breathe (3.2.2), inspiration (3.2.10), expiration (3.2.11) and natural breathing (3.2.4).

3.2.4
natural breathing
breathing with a workload within the range that a typical healthy person might expect to experience as
normal when not connected to a ventilator
Note 1 to entry: See also breathe (3.2.2), unassisted breath (3.2.12) and unrestricted breathing (3.2.5).

3.2.5
unrestricted breathing
unassisted breathing with any workload imposed on the patient by the ventilator not exceeding that
which could be experienced during natural breathing
Note 1 to entry: At present there is no standardized test specification to determine acceptable workloads imposed
on the patient by ventilators and related equipment in ventilation-modes where the patient is intended to breathe
without assistance, for example with CPAP or APRV. In the absence of such specifications, acceptability can only
be assessed subjectively or comparatively, and this term has been adopted to denote this subjective criterion. It
is expected that the introduction of this term will lead to the preparation of a corresponding test specification as
has been introduced for the work of breathing imposed by non-medical breathing equipment. The term is used
in this document as the criterion for assessing that the work imposed on a patient by such ventilation-modes is
not subjectively different from that which would be experienced by a typical person not requiring ventilatory
assistance, when breathing normally at rest in free air.

Note 2 to entry: See also breathe (3.2.2), unassisted breath (3.2.12), natural breathing (3.2.4), ventilation-mode
(3.11.2) and ventilation (3.1.9).

3.2.6
respiratory activity
activity of the patient's respiratory system related to the necessity to breathe
Note 1 to entry: This term typically serves as a reference to the minimum detectable form of the physiological
indications of the patient's respiratory intentions, which might be used to improve the interaction between the
ventilator and the patient. The term also serves as the reference to the level of effort to be supported during
effort-support (ES) inflations.

Note 2 to entry: This term may be used to express the activity during either of the phases of a breath, that is, a
patient inspiratory activity or a patient expiratory activity.

Note 3 to entry: Respiratory activity can be detected as a patient-generated change in flow or pressure of gas in
the airway, respiratory muscle activity, respiratory control-centre activity or other neural signals.

3.2.7
inspiratory effort
effort by the patient's respiratory muscles that contributes to the work of inspiration or that generates
detectable changes sufficient to cause a patient-trigger event
Note 1 to entry: This definition is patient-centric and independent of the ventilator or sleep-apnoea breathing-
therapy equipment.

Note 2 to entry: The detection of effort by the patient's respiratory muscles can be by measurements of
parameters such as airway pressure, airway flow, lung elastance or neural signals, or by EMG.

Note 3 to entry: See also breathe (3.2.2), effort-support (3.3.7) and D.2.7.

3.2.8
additional breath
breath that is additional to those resulting from assured inflations
Note 1 to entry: This concept is mainly relevant to ventilation-modes classified as Group 1 and 2 in this document
in which assured inflations are always delivered at the set rate.

Note 2 to entry: The additional breath rate is the total respiratory rate minus the set rate.

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Note 3 to entry: With assist/control (A/C) ventilation-modes, when a proportion of the inflations are patient-
triggered, it is usually not possible to identify any one breath as an additional breath; it is only possible to deduce
the number of additional breaths per minute by comparing the total respiratory rate (RR tot) with the set rate,
using the relationship shown in Note 2 to entry.

Note 4 to entry: All unassisted breaths in ventilation-mode Groups 1 and 2 are additional breaths.

Note 5 to entry: The concept of additional breaths facilitates the identification of an additional-breath rate
(3.5.2.3) and an additional minute volume (3.8.12).

Note 6 to entry: See also breath (3.2.1), assured inflation (3.3.11), ventilation-mode groups (3.11), set rate (3.5.1.1),
total respiratory rate (RRtot) (3.5.1.2), concurrent breath (3.2.9), unassisted breath (3.2.12), assisted breath (3.2.14)
and supported breath (3.2.13).

3.2.9
concurrent breath
additional breath, or phase of a breath, initiated during an inflation phase
EXAMPLE See Figures C.24, C.25 and C.35.

Note 1 to entry: The inspiratory phase of a concurrent breath can be unassisted or supported.

Note 2 to entry: This is a separate breath, or phase of a breath, following a change of airway flow direction or zero
airway flow, while the lung is still inflated. Complete unrestricted concurrent breaths are only possible with the
provision of ACAP or ACAPH.

Note 3 to entry: It is only the detection of the initiation of the inspiratory phase of a concurrent breath that
contributes to the total respiratory rate but the volume change that occurs during either concurrent phase is
included in the respective minute volume. [See spontaneous-breath rate (3.5.1.3)].

Note 4 to entry: See also additional breath (3.2.8), breath (3.2.1), initiate (3.9.1), inflation phase (3.4.10), inspiratory
phase (3.4.9), airway (3.1.2), lung (3.1.16), inflation (3.3.1), unrestricted breathing (3.2.5), ACAP (3.12.1), total
respiratory rate (3.5.1.2) and minute volume (3.8.6).

3.2.10
inspiration
DEPRECATED: inhalation
DEPRECATED: inhale
process of gas entering the lungs through the patient's airway
Note 1 to entry: An inspiration can be caused by an inspiratory effort, by an inflation or by a combination of both.

Note 2 to entry: See also inspiratory phase (3.4.9), inflation phase (3.4.10), airway (3.1.2) and expiration (3.2.11).

3.2.11
expiration
exhalation
process of gas leaving the lungs through the patient's airway and which terminates when inspiratory
flow next starts
Note 1 to entry: The admitted term, in its various grammatical forms, may be used instead of expiration
in reference to a patient action, wherever the use of certain grammatical forms of expiration might seem
inappropriate in the presence of patients. This admitted use is generally considered not to be necessary for
impersonal purposes such as in medical databases and computer records.

Note 2 to entry: See also airway (3.1.2), terminate (3.9.14) and inspiratory flow (3.7.1).

3.2.12
unassisted breath
spontaneous breath by a patient connected to a ventilator, with no assistance from an inflation
Note 1 to entry: An increase of airway pressure applied during the inspiratory phase of an unassisted breath,
with the declared intended use of compensating for any work of breathing imposed by an airway device or the
functioning of the ventilator, is not classed as an inflation in this document. See also tube compensation (3.6.11).

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Note 2 to entry: The patient's work of breathing when taking a spontaneous breath can be reduced by the provision
of ACAP or CPAP, but because no assistance is provided, such a breath is unassisted. See also ACAP (3.12.1).

Note 3 to entry: Unless demand flow is provided by the ventilation-mode selected, or by an ACAP adjunct, an
unassisted inspiration might require an unsustainable inspiratory effort.

Note 4 to entry: See also spontaneous breath (3.2.3), inflation (3.3.1), inspiratory phase (3.4.9), breathe (3.2.2),
CPAP (3.11.15), unassisted breath (3.2.12), intended use (3.1.25) and Figure C.2.

3.2.13
supported breath
spontaneous breath with assistance from a pressure-support or effort-support inflation-type
Note 1 to entry: See also pressure-support (3.3.6), effort-support (3.3.7), Annex B and Figures B.1, C.29, C.30
and F.6 a).

3.2.14
assisted breath
spontaneous breath with assistance from an inflation of the assured inflation-type but initiated by a
patient-trigger event
Note 1 to entry: An assisted breath is assisted by an inflation of the assured inflation-type but only occurs if
initiated before the next assured inflation is due to occur - which is at intervals determined by the set rate. Each
assisted breath, therefore, occurs at a rate higher than that set; a rate which is solely determined by the patient.

Note 2 to entry: A spontaneous breath that is supported by a pressure-support (PS) or effort-support (ES) inflation-
type, or by an assured inflation within a synchronization window, although also assisted, is separately identified by
the specific characteristic that distinguishes it from an assisted breath, namely, supported breath or synchronized
breath, respectively.

Note 3 to entry: See also spontaneous breath (3.2.3), patient-trigger event (3.6.9), assured inflation (3.3.11), set
rate (3.5.1.1), set (3.1.19), initiate (3.9.1), supported breath (3.2.13), synchronized breath (3.2.15), Annex B and
Figures B.1, and C.26 to C.28.

3.2.15
synchronized breath
spontaneous breath with assistance from an assured inflation, initiated by a patient-trigger event within
a synchronization window
Note 1 to entry: Synchronized breaths are assured to occur at the set rate.

Note 2 to entry: See also spontaneous breath (3.2.3), assured inflation (3.3.11), initiate (3.9.1), patient-trigger event
(3.9.6), synchronization window (3.9.8), set rate (3.5.1.1), assisted breath (3.2.14) and, Annex B and Figures C.14,
C.19, C.29, C.32 and C.33.

3.2.16
controlled breath
breath resulting from a ventilator-initiated assured inflation
Note 1 to entry: A controlled breath is always initiated by the ventilator and subsequently, in the absence of any
ensuing spontaneous breathing activity by the patient, generated entirely by the inflation waveform set or selected
by the operator. Controlled breaths, therefore, are assured to occur at the set rate.

Note 2 to entry: See also breath (3.2.1), ventilator-initiation (3.9.12), assured inflation (3.3.11), set (3.1.19), set rate
(3.5.1.1), Annex B and Figures B.1 and C.26 to C.28.

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3.3 Lung inflation terminology


3.3.1
inflation
positive-pressure inflation
ventilator inspiration
ventilator action intended to increase the volume of gas in the lungs by the application of an elevated-
pressure waveform to the patient-connection port until a specified termination criterion is met
Note 1 to entry: The elevation of the airway pressure, above the PEEP of the previous phase, during an inflation
and in the absence of total airway obstruction, generates an inspiratory flow that will either assist or totally
control the inflation of the patient's lungs. This action relieves some of or all the patient's work of breathing.

Note 2 to entry: If the inflation is pressure-regulated and the inspiratory phase is set to extend beyond the
inspiratory-flow time, then the lungs are held distended until the inflation is terminated. During this inspiratory
pause, concurrent breathing can be possible, to the extent determined by the specific ventilation-mode selected
and whether an ACAP adjunct is provided.

Note 3 to entry: Although, typically, there will be more than one inflation-termination criterion, for patient-safety
reasons, these will always include time-termination, intended as either a primary or secondary means.

Note 4 to entry: If an inflation is intended to be terminated by means additional to time, this should be indicated,
at least in the instructions for use, employing the inflation-type systematic naming and coding tables (see Annex D
and Tables D.1, D.2 and D.3).

Note 5 to entry: The elevated pressure waveform is implemented by either a flow-regulation function or a
pressure-regulation function.

Note 6 to entry: This is a context-sensitive term designating an intermittent elevated-pressure ventilator


parameter, as distinct from a negative-pressure ventilator inflation or a lung inflation resulting solely from a
patient's inspiratory effort. When used in its defined context, the preferred term is used by itself but in cases of
possible ambiguity, the qualified form, ‘positive-pressure inflation’, should be used.

Note 7 to entry: The admitted term ventilator inspiration is included to facilitate translation into languages that
do not have a translation for the word, inflation, as it is used in this context.

Note 8 to entry: See also ventilator (3.1.1), patient-connection port (3.14.5), terminate (3.9.14), PEEP (3.10.4),
breathe (3.2.2), pressure-regulation (3.3.9), concurrent breath (3.2.9), ACAP (3.12.1), flow-regulation (3.3.8),
positive-pressure ventilation (3.1.13) and negative-pressure regulation (3.1.14).

3.3.2
inflation-type
inflation characterized by its temporal delivery pattern following initiation, and its termination criteria
Note 1 to entry: Inflation-types are designated in this document by their property-class common names, wherever
possible. They are more precisely designated by the systematic coding scheme, which uses the abbreviations
of the common names, where available, but which also often includes designators of additional properties and
designates inflation-types with no common name yet attributed to them.

Note 2 to entry: A group of inflation-types that might be selected for a specific purpose is sometimes given a
purpose-class name, but such a name is not an alternative name for that inflation-type. As an example, a pressure-
control inflation-type might be selected to serve as the assured inflation within a ventilation-mode, but that only
makes it the assured ‘inflation-type’; a name that identifies its function within a ventilation-mode as being assured
to be delivered at least at the set rate but that does not change its pressure-control characteristics.

Note 3 to entry: For further information on inflation-type designations see Annex D and Tables D.1, D.2 and D.3.

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ISO 19223:2019(E)

3.3.3
volume-control
VC
inflation-type that generates inspiratory flow to a selected flow-waveform, for a set inspiratory-time, or
until the set volume has been delivered
Note 1 to entry: The selected inspiratory-flow waveform is typically that of a constant flow at a set value or of a
decreasing flow pattern, sometimes after a set rise time. The constant flow is maintained for the duration of the
inflation phase by means of a flow-regulation function.

Note 2 to entry: The flow-regulation function typically either maintains the set inspiratory flow or maintains an
inflation-to-inflation adjusted inspiratory flow with the intention that the set volume is delivered in the set time,
particularly when compensating for ventilator breathing system characteristics or an airway leak.

Note 3 to entry: See also inspiratory flow (3.7.1), set (3.1.19), inspiratory time (3.4.8), inflation phase (3.4.10), flow-
regulation (3.3.8), delivered volume (3.8.2), inspiratory volume (3.8.3), ventilator breathing system (3.1.18), airway
leak (3.7.11), Figures C.7, C.12, C.13, C.16, C.23 and C.27, Annex D and Tables D.1, D.2 and D.3.

3.3.4
pressure-control
PC
inflation-type that acts to generate a constant inspiratory pressure at a set level, after a set rise time
Note 1 to entry: After the set rise time, the set inspiratory pressure is typically maintained by means of a pressure-
regulation function.

Note 2 to entry: If the patient makes an inspiratory effort during a pressure-control inflation, this will result in a
corresponding increase in inspiratory flow, although not necessarily an increased delivered volume.

Note 3 to entry: If the patient makes an expiratory effort during a pressure-control inflation, the inspiratory
pressure could rise above that set, which might cause immediate termination of the inflation. The addition of ACAP
enables concurrent unrestricted expiration without termination.

Note 4 to entry: See also inspiratory pressure (3.6.2), set (3.1.19), rise time (3.3.10), pressure-regulation (3.3.9),
inspiratory effort (3.2.7), expiration (3.2.11), terminate (3.9.14), ACAP (3.12.1), concurrent breath (3.2.9),
unrestricted breathing (3.2.9), high-pressure relief limit (3.12.6), high-pressure termination limit (3.13.7),
Figures C.3 to C.5, C.8, C.9, C.11and C.22 to C.33, Annex D and Tables D.1, D.2 and D.3.

3.3.5
dual-control
type of inflation in which the regulated variable changes from pressure to flow, or vice versa, during an
inflation phase in accordance with the inflation algorithm
Note 1 to entry: A dual-control designation is incomplete without reference to the names of the inflation-types
that most closely represent the initial and secondary functions within the dual-control inflation. For examples see
Tables D.1 and D.2.

Note 2 to entry: Pressure limitations, as might be achieved by an inspiratory-pressure relief system or flow
limitations and, consequently, where the set delivered volume might not be achieved, are not considered to be
components of a dual-control inflation-type.

Note 3 to entry: See also pressure limit (3.13.1), D.2.8.3 and D.2.8.4.

3.3.6
pressure-support
PS
inflation-type that acts to generate a constant airway pressure, after a set rise time, and can be terminated
by patient respiratory activity; only made available for selection with ventilation-patterns where it
cannot be initiated other than in response to a patient-trigger event
Note 1 to entry: During and after the set rise time, the set inspiratory pressure is typically maintained by means of
a pressure-regulation function.

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Note 2 to entry: Pressure-support inflation-types are so named because they are specified and configured to be
used only to provide assistance to spontaneous breathing.

Note 3 to entry: Pressure-support inflations are typically flow-terminated but can be terminated by other means
that allow termination by patient respiratory activity.

Note 4 to entry: It is possible for flow-termination to be caused by the passive characteristics of the patient's
respiratory system alone, without any respiratory activity, in which case it is misleading to refer to the inflation
as having been terminated by the patient. Because current ventilators cannot make this distinction, in this
document, flow-terminated inflation-types are not referred to as being patient-terminated.

Note 5 to entry: As noted under inflation, pressure-support (PS) inflations are time-terminated if not terminated
within the set inspiratory time; a setting that can be preset or operator adjustable.

Note 6 to entry: By convention, inspiratory pressures for pressure-support (PS) inflations are usually set relative
to their related baseline airway pressure but, in this document, all such relative pressures are required to be
identified as such by the use of the differential symbol, Δ (3.6.6).

Note 7 to entry: For Group 2 ventilation-modes with an ACAP adjunct, a single pressure-support inflation setting can
be arranged to support breaths throughout the full assured-inflation cycle if its set inspiratory-pressure is higher
than the set inspiratory pressure for the assured inflation. Alternatively, there can be a second level of pressure-
support, relative to the set inspiratory pressure for the assured inflation, for the support of concurrent breaths.

Note 8 to entry: A pressure-control (PC) inflation that is flow-terminated is not classified as pressure-support (PS)
if used in ventilation-patterns where it can be ventilator-initiated, it is then classified as a pressure-control, flow-
terminated [PC(q)] inflation.

Note 9 to entry: See also terminate (3.9.14), initiate (3.9.1), time-termination (3.9.17), set (3.1.19), inspiratory time
(3.4.8), respiratory activity (3.2.6), baseline airway pressure (3.10.1), assured ventilation (3.11.6), flow-termination
(3.9.15), ACAP (3.12.1), concurrent breath (3.2.9), pressure-control (3.3.4), inflation (3.3.1), D.2.5, D.2.8.4, Tables D.1
and D.3, and Figures C.6, C.10 and C.29 to C.34.

3.3.7
effort-support
ES
inflation-type that generates an airway-pressure waveform that is intended to be proportional to a
patient's inspiratory effort
Note 1 to entry: The intention of this inflation-type is to unload a proportion of the work of breathing during an
inflation phase.

Note 2 to entry: The required airway-pressure waveform is typically calculated moment-by-moment by a


ventilator algorithm, using continuous measurements of parameters such as airway pressure, inspiratory flow,
lung elastance, neural signals or EMG; it is generated by means of a pressure-regulation function tracking the
calculated waveform.

Note 3 to entry: If the effort-support (ES) inflation is based on measurement of inspiratory flow, the support is most
commonly determined as independent proportions of the resistive or elastance components of the inspiratory effort.

Note 4 to entry: The unloading of a proportion of the work of breathing during an expiratory phase can be provided
by means of an adjunct under the control of an expiratory-control algorithm.

Note 5 to entry: The inflation is typically terminated when the inspiratory flow has declined to a termination-
flow threshold but as noted under inflation, effort-support (ES) inflations are time-terminated if not terminated by
other means within the set inspiratory time; a setting that can be preset or operator-adjustable.

Note 6 to entry: See also inspiratory effort (3.2.7), respiratory system compliance (3.1.5), airway resistance (3.1.4),
inflation (3.3.1), expiratory-control algorithm (3.10.5), terminate (3.9.14), preset (3.1.21), D.2.7 and Tables D.1
and D.3.

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ISO 19223:2019(E)

3.3.8
flow-regulation
function of the ventilator that varies the airway pressure as necessary with time to generate an intended
inspiratory-flow waveform irrespective of changes to the respiratory system parameters or of respiratory
activity
Note 1 to entry: See also airway pressure (3.6.1), respiratory system (3.1.17), respiratory activity (3.2.6), inspiratory
flow (3.7.1) and pressure-regulation (3.3.9).

3.3.9
pressure-regulation
function of the ventilator that regulates the airway pressure as necessary with time to generate an
intended airway-pressure waveform irrespective of changes to the respiratory system mechanics or of
concurrent unassisted inspirations
Note 1 to entry: See also concurrent breath (3.2.9), unassisted breath (3.2.12), pressure-control (3.3.4), pressure-
support (3.3.6) and flow-regulation (3.3.8).

3.3.10
rise time
indication of the time for the regulated parameter to rise to a set value following the initiation of an
inflation
Note 1 to entry: The rise time is often expressed as the slope of a ramp or as the time-constant of the rise although
neither of these terms depicts the actual typical trajectory of this pressure rise precisely.

Note 2 to entry: For pressure-regulation, this is the time to reach a set inspiratory pressure, for flow-regulation it is
the time to reach a set inspiratory flow.

Note 3 to entry: See also set (3.1.19), initiate (3.9.1), inflation (3.3.1) and Figures C.1 and C.9 to C.13.

3.3.11
assured inflation
inflation, of a selected type, which is assured to be initiated at intervals as determined by the selected
ventilation-pattern and the set rate
Note 1 to entry: The inflation-type selected for assured inflations is designated as an assured inflation-type.

Note 2 to entry: The operator has the assurance that, with Group 1 and 2 ventilation-modes, the selected assured
inflation-type will be delivered at either on average the set rate, or at least the set rate, depending upon the
selected ventilation-pattern. With Group 3 ventilation-modes, the selected assured inflation-type will be delivered
at the set rate in the absence of patient-trigger events occurring at a rate faster than that set.

Note 3 to entry: The pre-coordinated term, ‘assured’, is used in this document as the preferred synonym to the
legacy term, mandatory. It conveys the concept which mandatory is used to elicit in this document but avoids the
ambiguities which that term engenders. For the reasons explained in the rationale to 3.9.9, mandatory is only
used in this document when explaining the meaning of legacy ventilation-patterns that incorporate this term.

Note 4 to entry: The breath associated with an assured inflation is ‘synchronized’ or ‘controlled’.

Note 5 to entry: See also respiratory cycle (3.4.16) for the derivation of the post-coordinated term, assured-
inflation cycle.

Note 6 to entry: See also inflation (3.3.1), initiate (3.9.1), ventilation-pattern (3.11.3), set (3.1.19), rate (3.5.1.1),
assured inflation-type (3.3.12), assured-inflation cycle (3.4.18), ventilation-mode groups (3.11.5), assisted breath
(3.2.14), synchronized breath (3.2.15), controlled breath (3.2.16) and Figures B.1 and C.24 to C.33.

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3.3.12
assured inflation-type
inflation-type that has been selected for assured inflations
Note 1 to entry: In this document, inflation-types are classified either by their purpose, or by their properties
in terms of their characteristic waveform. This term is a purpose-classification, as distinct from the name of an
inflation-type, which is a property-classification.

Note 2 to entry: Although assured to be delivered at the set rate, the assured inflation-type can also be initiated
by a patient-trigger event in Group 1a ventilation-modes such as assist/control ventilation. Any such initiations can
lead to deliveries of the assured inflation-type at a rate greater than that assured by the set rate. It follows that
although all assured inflations are of the assured inflations-type, not all deliveries of the selected assured inflation-
type occur because they are assured.

Note 3 to entry: Assured inflation-types can be initiated either by the ventilator or by a patient-trigger event.

Note 4 to entry: See also inflation (3.3.1), assured inflation (3.3.11), inflation-type (3.3.2), initiate (3.9.1), ventilation-
mode groups (3.11.5), assist/control ventilation (3.11.8), SIMV (3.11.10) and Figures C.14 to C.20 and C.24 to C.33.

3.3.13
support inflation
inflation, of a selected type, that is intended to be terminated in response to the patient's respiratory
activity and for use in ventilation-modes where it can only be initiated in response to a patient-trigger event
Note 1 to entry: The inflation-type selected for support inflations is designated as a support inflation-type. Pressure-
support and effort-support inflation-types are typically selected as support inflation-types.

Note 2 to entry: With support inflations, there is no assurance of delivery; they are so named because they are
specified and configured to be used only to provide assistance to spontaneous breaths.

Note 3 to entry: Support inflations can be selected to support spontaneous breaths between assured inflations,
concurrent with assured inflations, or throughout complete assured-inflation cycles.

Note 4 to entry: It is not generally possible to refer to support inflations as ‘patient-terminated’ because, in the
absence of respiratory activity, they can, typically, also be terminated by the patient's passive lung without any
definitive indication of the distinction.

Note 5 to entry: The breath associated with a support inflation is ‘supported’. See supported breath (3.2.13).

Note 6 to entry: See also inflation (3.3.1), terminate (3.9.14), respiratory activity (3.2.6), support inflation-type
(3.3.14), spontaneous breath (3.2.3), assured inflation (3.3.11), assured-inflation cycle (3.4.18), lung (3.1.16) and
Figures C.21 and C.29 to C.34.

3.3.14
support inflation-type
inflation-type that has been selected for support inflations
Note 1 to entry: In this document, inflation-types are classified either by their purpose, or by their properties
in terms of their characteristic waveform. This term is a purpose classification to designate the group of
inflation-types that are solely used in ventilation-modes where they can only be initiated in response to a patient's
inspiratory effort and that are intended to be terminated in response to the patient's respiratory activity.

Note 2 to entry: See also inflation-type (3.3.2), support inflation (3.3.13), ventilation-mode (3.11.2), initiate (3.9.1),
inspiratory effort (3.2.7), terminate (3.9.14) and respiratory activity (3.2.6).

3.3.15
volume targeted
automatic inflation-to-inflation adjustment of the inflation settings, with the target of achieving a set
inspiratory volume for each breath
Note 1 to entry: The word ‘target’ is used because the inherent inflation-to-inflation delay, possible respiratory
activity and other limitations in the adjustment, result in less precise control of each inspiratory volume than is
achieved by direct feedback (for example, as is used for the pressure-regulation function) although the average
inspiratory volume will typically converge towards the set value.

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Note 2 to entry: This term is applicable to all inflations in which the delivery is pressure-regulated to a set value,
including those classified as pressure-support (PS), but not to those that respond to patient parameters according
to an alternative algorithm, for example, effort-support (ES). The concept is designated in the systematic coding
scheme by the use of the letters, vt, as a prescript to an appropriate inflation-type, for example, vtPC or vtPS. Such
a code becomes the generic classification for established proprietary terms such as, ‘PRVC’, ‘Volume Support’,
‘Volume Guarantee’, ‘VC+’ and ‘Autoflow ®1)’.

Note 3 to entry: See also inflation (3.3.1), set (3.1.19), inspiratory volume (3.8.3), breath (3.2.1), pressure-regulation
(3.3.9) pressure-support (3.3.6), effort-support (3.3.7), D.2.2 and Tables D.1 and D.2.

3.4 * Time, phase and cycle terminology


3.4.1
expiratory time
duration of an expiratory phase
[SOURCE: ISO 4135: 2001, 3.4.6, modified — Admitted term was removed.]
Note 1 to entry: In addition to its direct reference, this term may be used, in context or by qualification, to
designate this concept as a set quantity (3.1.19) or a measured quantity (3.1.20).

Note 2 to entry: The symbol, t E,, displayed in various character styles, is typically used to designate the expiratory
time setting, particularly where space is limited, such as on user interfaces.

Note 3 to entry: As a set quantity, the expiratory time is either the intended actual duration, the intended average
duration or the assured maximum duration of the expiratory phase of the assured inflation, depending on the
ventilation-mode selected.

Note 4 to entry: As a measured quantity, in ventilation-modes that facilitate simultaneous respiratory cycles, the
expiratory time is that of the longest respiratory cycle unless otherwise specified.

Note 5 to entry: The expiratory time is commonly set indirectly, for example, by means of a set rate and a set
inspiratory time.

Note 6 to entry: With expiratory phases alternatively labelled as BAP phases, expiratory time should be replaced
with the term BAP time. In ventilation-modes labelled as bi-level AV, the expiratory time may be identified either
by the term BAP time or time-low.

Note 7 to entry: For information on the use of symbols in the labelling of ventilation equipment see G.6 and H.2.

Note 8 to entry: See also expiratory phase (3.4.2), assured inflation (3.3.11), respiratory cycle (3.4.16), BAP phase
(3.10.3), BAP time (3.12.6), bi-level AV (3.12.4) and Figures C.22 to C.29, C.34 and F.4.

3.4.2
expiratory phase
interval from the start of expiratory flow to the start of inspiratory flow within a respiratory cycle
[SOURCE: ISO 4135: 2001, 3.4.5, modified — Applicability clarified.]
Note 1 to entry: If additional spontaneous breaths are possible, all or part of their expiratory phases can occur
within the expiratory phase of an assured-inflation cycle.

Note 2 to entry: In accordance with the conceptual framework of this document, the phase between inflations in
any respiratory cycle is the expiratory phase of that cycle. For ventilators with which there can be simultaneous
respiratory cycles, it might not be clear as to which of the cycles is being referenced unless it is specifically
associated with the assured-inflation cycle each time it is used. This is one of the reasons that the alternative
name, BAP phase, has been introduced into this document; an introduction that is particularly relevant for use
on ventilators that facilitate additional breaths in the phase between assured inflations. For further information
regarding these concepts, see 3.10, 3.11 and 3.12.

1) AutoFlow® is the trademark of a product supplied by Draeger Medical AG & Co. KG. This information is given
for the convenience of users of this document and does not constitute an endorsement by ISO of the product named.
Equivalent products may be used if they can be shown to lead to the same results.

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Note 3 to entry: If the patient generates flow that initiates an inflation, the inspiratory flow for the initiated inflation
cycle is taken as starting at the initiation of the inflation phase and any measurable flow in advance of that initiation
becomes the trigger flow. If necessary, depending upon the level of granularity required for a specific description of
this trigger flow, its duration can be considered to constitute a trigger phase. Because the change from the trigger
phase to the inflation phase is typically optimized at a level determined by operator settings, in this document it is
treated as having occurred during the final moments of the expiratory phase, unless otherwise stated.

This concept is consistent with the pragmatic view that the set inspiratory time should be taken to start at the
same point on the pressure rise-time waveform of an inflation, whether it is initiated by the ventilator or by a
patient-trigger event (see Figures C.3 and C.4) - also, that the main significance of the actual duration of the
expiratory phase is as a setting that determines a maximum interval between inflations; an aspect that becomes
much less critical whenever the patient determines a shorter interval.

If the patient generates inspiratory flow that does not cause a patient-trigger event, then its detectable
commencement is treated as the initiation of the inspiratory phase of the subsequent unassisted spontaneous breath.

Note 4 to entry: See also expiratory flow (3.7.5), inspiratory flow (3.7.1), assured-inflation cycle (3.4.18), BAP phase
(3.10.3), additional breath (3.2.8), spontaneous breath (3.2.3), respiratory cycle (3.4.16), assured-inflation cycle
(3.4.18), assured inflation (3.3.11), ventilator-initiation (3.9.12), patient-trigger event (3.9.6) and Figures C.2 to C.8,
C.23 to C.34 and F.5.

3.4.3
expiratory-flow time
duration of the interval from the start of expiratory flow to its cessation
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a measured quantity (3.1.20).

Note 2 to entry: In practice, it might be difficult to measure the actual flow time precisely because of the typically
asymptotic decline of the expiratory flow at this point in the expiratory phase but this term is unlikely to be used
in the description of situations where precision is critical.

Note 3 to entry: The expiratory-flow time and the expiratory time can be equal.

Note 4 to entry: See also expiratory flow (3.7.5) and expiratory time (3.4.1) and Figures C.1 and C.9 to C.13.

3.4.4
expiratory pause
portion of the expiratory phase from the end of expiratory flow to the start of inspiratory flow
[SOURCE: ISO 4135: 2001, 3.4.3, modified — Applicability clarified.]
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a measured quantity (3.1.20).

Note 2 to entry: See also expiratory phase (3.4.2), expiratory flow (3.7.5), inspiratory flow (3.7.1) and expiratory
hold (3.4.6).

3.4.5
expiratory-pause time
duration of an expiratory pause
[SOURCE: ISO 4135: 2001, 3.4.4]
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a measured quantity (3.1.20).

Note 2 to entry: See also expiratory pause (3.4.4).

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ISO 19223:2019(E)

3.4.6
expiratory hold
execution of a ventilator function intended to temporarily maintain a constant lung volume during a set
extension of the expiratory phase
Note 1 to entry: The maintenance of a constant lung volume is typically used to either facilitate the measurement
of auto-PEEP or to temporarily immobilize the torso (e.g., for diagnostic imaging).

Note 2 to entry: This function can be achieved by temporarily occluding the airway, by maintaining a pressure
at the patient-connection port or by other means. For the measurement of auto-PEEP, it is necessary to use an
expiratory hold achieved with an occluded airway.

Note 3 to entry: Both the initiation and the duration of the function are settings.

Note 4 to entry: See also lung (3.1.16), expiratory phase (3.4.2), expiratory-hold time (3.4.7), expiratory pause
(3.4.4) and initiate (3.9.1).

3.4.7
expiratory-hold time
duration of an expiratory hold
Note 1 to entry: The hold time can be set by selecting a time or determined by the duration of a manual input.

3.4.8
inspiratory time
duration of an inflation phase or inspiratory phase
[SOURCE: ISO 4135: 2001, 3.4.13, modified — Rephrased.]
Note 1 to entry: In addition to its direct reference, this term or its symbol, t I, may be used, in context or by
qualification, to designate this concept as a set quantity (3.1.19) or a measured quantity (3.1.20).

Note 2 to entry: The symbol, t I, displayed in various character styles, is typically used to designate the inspiratory
time setting, particularly where space is limited, such as on user interfaces.

Note 3 to entry: For information on the use of letter symbols in the labelling of ventilation equipment see A.4 - 3
and G.6.

Note 4 to entry: See also Figures C.1, C.9 to C.13, C.22 to C.34.

3.4.9
inspiratory phase
interval from the start of inspiratory flow to the start of expiratory flow during an unassisted breath
[SOURCE: ISO 4135:2001, 3.4.12, modified — Rephrased.]
Note 1 to entry: This term is restricted to the designation of unassisted inspirations because, when used in
relation to a breath in natural language, the verb inspire is closely associated with a patient action. In order to
avoid any inference of ‘ventilators breathing’, the intervals during which inflations are delivered are designated as
inflation phases.

Note 2 to entry: If additional spontaneous breaths are possible, their inspiratory phase can occur within the
inflation phase of an assured-inflation cycle.

Note 3 to entry: See also inflation phase (3.4.10), inspiratory flow (3.7.1), expiratory flow (3.7.5), unassisted breath
(3.2.12), inspiration (3.2.10), breath (3.2.1), ventilator (3.1.1), breathe (3.2.2), inflation (3.3.1), spontaneous breath
(3.2.3), assured-inflation cycle (3.4.18) and Figures C.2, C.24, C.25, C.30 to C.32 and C.34.

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3.4.10
inflation phase
interval from the start of the rise in airway pressure resulting from the initiation of an inflation to the
start of the expiratory flow resulting from its termination
Note 1 to entry: With some ventilation-modes, a concurrent breath can result in a concurrent inflation phase, for
example, it can initiate a pressure-support (PS) inflation that is concurrent with a pressure-control (PC) assured
inflation.

Note 2 to entry: Depending upon the level of granularity required for a specific description, an inflation phase can
be considered to include a termination phase.

Note 3 to entry: to entry See also inspiratory phase (3.4.9), airway pressure (3.6.1), initiate (3.9.1), inflation (3.3.1),
expiratory flow (3.7.5), terminate (3.9.14), breathe (3.2.2), concurrent breath (3.2.9) and Figures C.3 to C.8 and
C.23 to C.33.

3.4.11
inspiratory-flow time
duration of the interval from the start of inspiratory flow to its cessation
Note 1 to entry: In addition to its direct reference, this term may be used, in context or by qualification, to
designate this concept as a set quantity (3.1.19) or a measured quantity (3.1.20).

Note 2 to entry: This term becomes relevant as a separate concept with inflations where there is an inspiratory
pause. Where there is no inspiratory pause, it has the same value as the inspiratory time.

Note 3 to entry: See also Figures C.9 and C.12.

3.4.12
inspiratory pause
interval from the end of inspiratory flow to the start of expiratory flow within a respiratory cycle
[SOURCE: ISO 4135: 2001, 3.4.10, modified — Rephrased.]
Note 1 to entry: There is no inspiratory pause when the inspiratory flow ends with the transition to expiratory flow.

Note 2 to entry: See also inspiratory hold (3.4.14) and Figures C.9 and C.12.

3.4.13
inspiratory-pause time
duration of an inspiratory pause
[SOURCE: ISO 4135: 2001, 3.4.11]
Note 1 to entry: In addition to its direct reference, this term may be used, in context or by qualification, to
designate this concept as a set quantity (3.1.19) or a measured quantity (3.1.20).

Note 2 to entry: See also inspiratory pause (3.4.12) and Figures C.9 and C.12.

3.4.14
inspiratory hold
ventilator function intended to enable the respiratory pressures to temporarily equalize throughout the
lungs during a set extension of the end of an inflation or an inspiratory phase
Note 1 to entry: This function can be achieved by temporarily occluding the airway, by maintaining a pressure at
the patient-connection port or by other means.

Note 2 to entry: An inspiratory hold function is typically used to facilitate a separate clinical procedure, for
example, the measurement of lung parameters or a diagnostic imaging examination.

Note 3 to entry: The initiation of the function might be determined by a direct operator action or in conjunction
with the operation of other equipment.

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Note 4 to entry: See also inspiratory pause (3.4.12), ventilator breathing system (3.1.18), patient connection port
(3.14.5), delivered volume (3.8.2) and expired minute volume (3.8.9).

3.4.15
inspiratory-hold time
duration of an inspiratory hold
Note 1 to entry: The inspiratory-hold time might be determined by an elapsed time setting or by the duration of a
manual input.

Note 2 to entry: See also inspiratory hold (3.4.14).

3.4.16
respiratory cycle
cycle
complete sequence of respiratory events that leads to an increase, followed by a corresponding
decrease, of gas volume in the lung regardless of how it is generated
EXAMPLE 1 The sequence of respiratory events following the initiation of an assured inflation, through to the
subsequent initiation of the following assured inflation.

EXAMPLE 2 A pressure-support (PS) inflation phase followed by its expiratory phase.

Note 1 to entry: The term respiratory cycle has become a generic term for a complete breath cycle, whether it is
given some form of assistance, is unassisted or only results from an assured inflation. Its use addresses a problem
that arises because in common usage the word, breath, is often used to refer to either a single phase alone or a
complete breath cycle. It is also helpful in the consideration of the occurrence of additional breaths within an
assured-inflation cycle. The term ‘respiratory cycle’ is more concise than having to qualify the term breath in a way
that removes all ambiguity.

Note 2 to entry: This generic term is not intended for use as a universal substitute for any more specifically
applicable terms defined in this document. Its use should be restricted to the improvement of concision and
readability in instances such as those cited in Note 1 to entry.

Note 3 to entry: For an assured inflation, the respiratory cycle starts with its initiation and ends with the initiation
of the next inflation of the selected assured inflation-type. See also assured-inflation cycle (3.4.18).

Note 4 to entry: Additional, separate respiratory cycles can be initiated within an assured-inflation cycle - see also
additional breath (3.2.8).

Note 5 to entry: See also lung (3.1.16), breath (3.2.1), unassisted breath (3.2.12), spontaneous breath (3.2.3),
inspiratory phase (3.4.9), initiate (3.9.1), assured inflation (3.3.11), pressure-support (3.3.6), inflation phase (3.4.10),
expiratory phase (3.4.2), assured-inflation cycle (3.4.18) and Figure C.23.

3.4.17
respiratory cycle time
cycle time
duration of a respiratory cycle
Note 1 to entry: In addition to its direct reference, this term may be used, in context or by qualification, to
designate this concept as a set quantity (3.1.19) or a measured quantity (3.1.20).

Note 2 to entry: The set respiratory cycle time of an assured inflation (in minutes) is typically determined
indirectly as the reciprocal of the set rate. Respiratory cycle times are typically displayed in seconds, and rates as
per minute; the respiratory cycle time then becomes 60/set-rate.

Note 3 to entry: See also Figures C.15 to C.33.

3.4.18
assured-inflation cycle
respiratory cycle of an assured inflation
Note 1 to entry: In ventilation-modes such as SIMV, supported or unassisted additional breaths can be taken during
the expiratory phase of the assured-inflation cycle; also, during the inspiratory phase if an ACAP adjunct is provided.

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Note 2 to entry: In ventilation-modes alternatively labelled as bi-level AV, this cycle may be referred to as the bi-
level cycle.

Note 3 to entry: See also assured inflation (3.3.11), respiratory cycle (3.4.16), ventilation-mode (3.11.2), ACAP
(3.12.1), adjunct (3.11.4), bi-level AV (3.12.4) and Figures C.24 to C.33.

3.4.19
phase time ratio
I:E ratio
ratio of the inspiratory time to the expiratory time in a respiratory cycle
Note 1 to entry: In addition to its direct reference, this term or its symbol, I:E, may be used, in context or by
qualification, to designate this concept as a set quantity (3.1.19) or a measured quantity (3.1.20).

Note 2 to entry: By mathematical convention, a colon or a slash is used to designate a ratio between two values
so the addition of the word ‘ratio’ is not strictly necessary. However, its addition is widely practiced and is
considered to add to the readability of descriptive texts and lists, but in this document, its use is optional.

3.4.20
inspiratory-time fraction
t I:t TOT ratio
ratio of the inspiratory time to the respiratory cycle time
Note 1 to entry: In addition to its direct reference, this term or its symbol, t I:t TOT, displayed in various character
styles, may be used, in context or by qualification, to designate this concept as a set quantity (3.1.19) or a measured
quantity (3.1.20).

Note 2 to entry: This value can be expressed as a ratio, fraction or percentage.

Note 3 to entry: See also phase time ratio (3.4.19), inspiratory time (3.4.8) and respiratory cycle time (3.4.17).

3.5 * Rate terminology

3.5.1 Preferred rate concepts2)

3.5.1.1
set rate
DEPRECATED: f
DEPRECATED: frequency
number of assured inflations that are set to occur in a specified period of time, expressed as breaths
per minute
Note 1 to entry: In the absence of suitable standardization, manufacturers have devised their own abbreviations
to denote the various terms relating to respiratory rate for use on user interfaces, where space is often limited,
and in user manuals. In the case of set rate, it has become widely established custom and practice, when used
in context and without further qualification, to adopt the abbreviation, “Rate”, displayed in various character
styles. With the introduction of the term assured inflation in this document the adoption of the abbreviation AR
displayed in various character styles, to represent assured rate, would be appropriate as an alternative for this
purpose.

Note 2 to entry: The set rate can be determined by the operator either by a direct setting, or indirectly by means
of an algorithm (see Example 4).

Note 3 to entry: The set rate assures the operator that inflations of the selected assured inflation-type will be
delivered at intervals (in minutes) not exceeding, on average, the reciprocal of the set rate, although the actual
interval between any two successive inflations might not be constant.

2) The terms in this subclause are the designations for the preferred concepts relating to breath rate in this
document. Examples of alternative designations for admitted concepts are listed in 3.5.2.

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Note 4 to entry: The deprecated symbol, f, and the term that it represents, frequency, are deprecated as synonyms
for set rate in this document. Although having similar meanings, rate is the term more usually used in reference
to the number of instances occurring in a certain period of time, with no inference that the interval between
these instances is constant, whereas frequency has more of the connotation of occurring at constant intervals.

EXAMPLE 1 With an assist/control (A/C) ventilation-mode, the set rate is the assured minimum ventilator-
initiated inflation rate; with any patient-initiated (assist) inflations the total respiratory rate becomes higher. See
Figure C.17.

EXAMPLE 2 With an IMV (intermittent mandatory ventilation) mode, the set rate is the rate at which the assured
inflations are initiated. See Figure C.18.

EXAMPLE 3 With a SIMV (synchronized intermittent mandatory ventilation) mode, the set rate is the average
rate at which the assured inflations are initiated. See Figure C.19.

EXAMPLE 4 With one means of achieving a MMV (minimum minute volume) ventilation-mode, the mode-control
algorithm automatically adjusts the set rate downwards from its initial setting, as necessary to maintain the set
minute volume as a minimum.

3.5.1.2
total respiratory rate
total rate
number of respiratory cycles in a specified period of time, expressed as breaths per minute
Note 1 to entry: In addition to its direct reference, this term, and its abbreviation, RR tot , displayed in various
character styles, is only used, in context or by qualification, to designate this concept as a measured quantity
(3.1.20).

Note 2 to entry: The total respiratory rate is the spontaneous breath rate plus the ventilator-initiated inflation rate.

Note 3 to entry: Separate respiratory cycles initiated within assured-inflation cycles are counted as part of the total.

Note 4 to entry: See also additional breath (3.2.8), respiratory cycle (3.4.16), initiate (3.9.1) and assured-inflation
cycle (3.4.18).

3.5.1.3
spontaneous breath rate
spontaneous rate
ISO spontaneous-breath rate
total number of spontaneous breaths initiated in a specified period of time, expressed as breaths per minute
Note 1 to entry: In addition to its direct reference, this term, and its symbol, RR spont , displayed in various
character styles, is only used, in context or by qualification, to designate this concept as a measured quantity
(3.1.20).

Note 2 to entry: The spontaneous breath rate is the difference between the total respiratory rate and the ventilator-
initiated inflation rate.

Note 3 to entry: The detection of the beginning and end of a breath is dependent on the sensitivity of the ventilator
sensors and the thresholds of the detection algorithms. For further information concerning the reliability of
using the patient-triggered rate as a measure of the spontaneous-breath rate, see patient-trigger event (3.9.6).

Note 4 to entry: Because there is no dependent action required, as is the case with assisted breaths, the counting
of an unassisted spontaneous breath can be delayed until its inspiratory phase has terminated, thereby allowing a
higher level of discrimination between actual breaths and spurious events.

Note 5 to entry: Many legacy ventilators display and log the spontaneous breath rate as the unassisted breath rate
plus the supported breath rate. While true for CSV modes, this practice does not include the spontaneous breaths
that can initiate assured inflations, for example, in assist/control (A/C) ventilation and SIMV modes, making the
spontaneous breath rate measurement dependent on the ventilation-mode that has been selected. This practice is
considered to be misleading and is not supported in this document. The admitted term ISO spontaneous-breath
rate has been included for use where it is necessary to highlight this distinction as, for example, was necessary in
ISO/IEEE 11073-10101[22].

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Note 6 to entry: See also spontaneous breath (3.2.3), breath (3.2.1), initiate (3.9.1), unassisted breath (3.2.12),
ventilator-initiation (3.9.12) and patient-trigger event (3.9.6).

3.5.1.4
ventilator-initiated inflation rate
ventilator-initiated rate
number of inflations initiated by a timed signal within the ventilator in a specified period of time,
expressed as breaths per minute
Note 1 to entry: In addition to its direct reference, this term, and its symbol, RR vent , displayed in various character
styles, is only used, in context or by qualification, to designate this concept as a measured quantity (3.1.20).

Note 2 to entry: Ventilator-initiated inflations generate controlled breaths.

Note 3 to entry: In this document an inflation initiated by a patient-trigger event is classed as a patient-triggered
inflation; not as a ventilator-initiated inflation.

Note 4 to entry: See also inflation (3.3.1), breath (3.2.1), initiate (3.9.1), ventilator-initiation (3.9.12), controlled
breath (3.2.16), patient-trigger event (3.9.6) and assured inflation (3.3.11).

3.5.1.5
total inflation rate
total number of inflations initiated in a specified period of time, expressed as breaths per minute
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a measured quantity (3.1.20).

3.5.2 Secondary rate concepts — Rate terms for use if required for specific purposes 3)

3.5.2.1
assured inflation-type rate
number of assured inflation-type initiations in a specified period of time, expressed as breaths per minute
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a measured quantity (3.1.20).

Note 2 to entry: In Group 1a) and Group 2 ventilation-modes the assured inflation-type rate is assured to be equal to
the set rate; in Group 1b) ventilation-modes, the assured inflation-type rate is assured to be at least equal to the set
rate but will be higher if there are additional breaths.

3.5.2.2
unassisted breath rate
number of spontaneous breaths with no assistance from an inflation, initiated in a specified period of
time, expressed as breaths per minute
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a measured quantity (3.1.20).

Note 2 to entry: See also spontaneous breath (3.2.3) and unassisted breath (3.2.12)

3.5.2.3
additional breath rate
number of additional breaths initiated in a specified period of time, expressed as breaths per minute
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a measured quantity (3.1.20).

Note 2 to entry: The additional-breath rate is the difference between the total respiratory rate and the set rate.

3) 3.5.1 lists the five principal rate concepts that are necessary for the majority of mode descriptions. Situations
might arise where alternative rate concepts are required. Most of these may be formed as post-coordinated terms
comprising combinations of simpler terms already defined in this document. The four such terms entered in this
subclause are provided only as examples of possible post-coordinated terms.

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Note 3 to entry: See also additional breath (3.2.8), initiate (3.9.1), total respiratory rate (3.5.1.2) and set rate
(3.5.1.1).

3.5.2.4
concurrent unassisted-breath rate
number of unassisted spontaneous breaths initiated during assured-inflation phases in a specified period
of time, expressed as breaths per minute
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a measured quantity (3.1.20).

Note 2 to entry: See also unassisted breath (3.2.12), spontaneous breath (3.2.3) and concurrent breath (3.2.9).

3.6 Pressure terminology


3.6.1
airway pressure
pressure at the patient-connection port, relative to ambient pressure unless otherwise specified
Note 1 to entry: In addition to its direct reference, this term or its symbol p aw, displayed in various character
styles, is only used, in context or by qualification, to designate this concept as a measured quantity (3.1.20).

Note 2 to entry: The site(s) of actual measurement(s) may be anywhere in the ventilator breathing system,
providing that the indicated value is referenced to that at the patient-connection port.

Note 3 to entry: This is the generic term for this fundamental concept. Post-coordinated terms, for example, peak
inspiratory pressure and baseline airway pressure, are used in particular contexts.

Note 4 to entry: Although providing no explicit indication as to where along the patient's airway this pressure is
measured, this term, along with its symbol, has become widely adopted as referencing the pressure at the point at
which artificial-ventilation equipment is connected to the patient's airway or to an airway device. This is the final
site where a common and replicable pressure can be continuously monitored, conveniently, before breathing gas
enters the patient.

Note 5 to entry: A pressure measured in the patient's airway at a site other than at the patient-connection port is
referred to in this document as a respiratory pressure.

Note 6 to entry: The following terms are deprecated for use as synonyms for airway pressure: patient pressure;
proximal pressure; mouth pressure; pressure at the Y-piece; respiratory pressure; working pressure; inflation
pressure; delivered pressure; applied pressure; ventilator pressure. Some of these terms might be valid
synonyms but one of the objectives of a terminology standard is to select just one preferred term to represent a
given concept.

Note 7 to entry: See also patient-connection port (3.14.5), ventilator breathing system (3.1.18), airway (3.1.2),
artificial ventilation (3.1.10), respiratory system (3.1.17) and Annex C.

3.6.2
inspiratory pressure
support pressure
airway pressure during an inspiratory or inflation phase
Note 1 to entry: In addition to its direct reference, this term may be used, in context or by qualification, to
designate this concept as a set quantity (3.1.19) or a measured quantity (3.1.20).

Note 2 to entry: As a setting, the value of this quantity is the intended constant pressure level to be attained
following a set rise time. Inflation-types that are pressure-regulated to a constant level include pressure-control and
pressure-support.

Note 3 to entry: As a measurement, this is the general term for the pressure at any point in time during an
inspiratory or inflation phase. It will typically be qualified to indicate the point in the phase to which the
observation applies, examples being peak inspiratory pressure, plateau pressure and end-inspiratory pressure. It
may also be displayed as a waveform. See also G.4.

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Note 4 to entry: An inspiratory pressure (or support pressure) is always relative to ambient pressure, that is,
independent of the baseline airway pressure unless indicated otherwise by the differential symbol, Δ, as a prefix.
See 3.6.7.

Note 5 to entry: The term support pressure has been included as a special case of an inspiratory pressure that may
be used to denote the airway pressure during pressure-support inflations, primarily because its setting is often
used alongside a setting for a pressure-control inflation on a user interface and in this way can be easily separately
identified.

Note 6 to entry: The symbols, pI or psupp, displayed in various character styles, are typically used to designate
these pressure settings, particularly where space is limited, such as on user interfaces.

Note 7 to entry: The following terms are deprecated as synonyms for the term inspiratory pressure: delivered
pressure; plateau pressure; pressure limit; respiratory pressure; working pressure; target pressure; end-
inspiratory pressure; insufflation pressure.

Note 8 to entry: See also airway pressure (3.6.1), inspiratory phase (3.4.9), inflation phase (3.4.10), set (3.1.19), rise
time (3.3.10), pressure-regulation (3.3.9), baseline airway pressure (3.10.1), plateau inspiratory pressure (3.6.4),
pressure limit (3.13.1), end-inspiratory pressure (3.6.8), Δ inspiratory pressure (3.6.7) and Figures C.3 to C.13 and
C.22 to C.34.

3.6.3
peak inspiratory pressure
peak pressure
highest airway pressure reached during a previous respiratory cycle
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a measured quantity (3.1.20).

Note 2 to entry: Peak inspiratory pressure is always referenced to the ambient pressure.

Note 3 to entry: In this document, the use of peak inspiratory pressure or peak pressure to denote a setting is
deprecated.

Note 4 to entry: See also airway pressure (3.6.1), respiratory cycle (3.4.16), inspiratory pressure (3.6.2) and
Figures C.9 to C.13, C.23 and C.27.

3.6.4
plateau inspiratory pressure
plateau pressure
airway pressure during an inspiratory pause when the flow at the patient-connection port is zero
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a measured quantity (3.1.20). The corresponding set value is that of the inspiratory
pressure.

Note 2 to entry: Methods used to determine plateau pressure include assessment of the inspiratory pressure and
inspiratory flow waveforms, the application of an inspiratory hold manoeuvre, whether manual or automated, or
by applying a least squares curve-fitting analysis to the inspiratory pressure waveform.

Note 3 to entry: With a pressure-control inflation, unless the airway pressure reaches a constant level during the
inflation phase, there will be no plateau pressure and, therefore, no valid measurement can be made.

Note 4 to entry: Concurrent patient respiratory activity or leaks can destabilize the pressure level.

Note 5 to entry: When given sufficient time at its stabilized level and there is no airway flow due to respiratory
activity, gas distributes throughout the lungs as far as is possible and the plateau inspiratory pressure typically
will be an indication of the end-inspiratory average alveolar pressure.

Note 6 to entry: Although it will often have the same value, this term is not a synonym for end-inspiratory pressure.

Note 7 to entry: See also inspiratory pressure (3.6.2), inspiratory hold (3.4.14), inspiratory pause (3.4.12), end-
inspiratory pressure (3.6.8), concurrent breath (3.2.9) and Figure C.12.

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3.6.5
inspiratory-pressure relief
means of limiting the maximum inspiratory pressure to the set level by discharging excess inspiratory
flow to the atmosphere
Note 1 to entry: The intended maximum inspiratory pressure level is determined by the set pressure limit.

Note 2 to entry: This form of pressure limitation will often result in the delivered volume falling below that set as
the set relief-pressure is approached. Awareness of this characteristic is important for operators of the simple
gas-powered ventilators that typically use such pressure-limitation means and in which there is no independent
measurement of the inspiratory volume or the expired tidal volume.

Note 3 to entry: See also set (3.1.19) and pressure limit (3.13.1).

3.6.6
Δ
delta
difference between two quantities
Note 1 to entry: This symbol is used in this document as a prefix to denote that the qualified parameter is
referenced to another parameter. In particular, it is used in this document to qualify an inspiratory or expiratory
pressure to denote when it is referenced to a baseline airway-pressure level instead of to the default, ambient
pressure level.

Note 2 to entry: In verbal communication, Δ, as used in this document, is expressed as either ‘delta’ or ‘differential’.

Note 3 to entry: See also Δ inspiratory pressure (3.6.7), inspiratory pressure (3.6.2), expiratory pressure (3.6.9),
baseline airway pressure (3.10.1) and Figures C.1, C.9, C.10, C.29, C.30 and C.33.

3.6.7
Δ inspiratory pressure
Δ pressure
Δ support pressure
differential airway pressure relative to baseline airway pressure during an inflation phase
Note 1 to entry: In addition to its direct reference, this term or an appropriate symbol may be used, in context or
by qualification, to designate this concept as a set quantity (3.1.19) or a measured quantity (3.1.20).

Note 2 to entry: There is currently no agreed convention as to whether an inspiratory pressure is always to be
expressed as an absolute quantity relative to ambient pressure or an absolute quantity for one group of inflation-
types and relative for another. This has unacceptable patient-safety implications that need to be addressed in a
vocabulary of lung ventilation. The symbol, Δ, is currently sometimes used as a prefix to make this distinction, and
that convention has been adopted as a requirement in this document. Without a prefix, or any other indication,
respiratory pressures are always to be considered to be relative to ambient pressure. The addition of a Δ prefix,
is used to indicates a pressure that is relative to the set BAP level. In ventilation-modes where there is a second,
higher, baseline airway pressure, then the prefix for a pressure relative to that higher-pressure level becomes Δ H.
These prefixes are applicable to relevant terms, symbols and displayed values but not to inflation-types.

Note 3 to entry: The sum of the set BAP level and the Δ inspiratory pressure equals the inspiratory pressure. This
applies to both settings and measurements of this parameter.

Note 4 to entry: See also Δ (3.6.6) and Figures C.1, C.9, C.10, C.29, C.30 and C.33.

3.6.8
end-inspiratory pressure
airway pressure at the point when inflation termination is initiated
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a measured quantity (3.1.20).

Note 2 to entry: This pressure is displayed or recorded as the last measured value of the inspiratory pressure
before the initiation of inflation termination.

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Note 3 to entry: This pressure might be coincident with the peak inspiratory pressure or the end of an inspiratory
pressure plateau and hence have the same value.

Note 4 to entry: The end-inspiratory pressure is always recorded and displayed as an airway pressure, that is, as
relative to ambient pressure, unless indicated otherwise by the differential symbol, Δ, as a prefix.

Note 5 to entry: See also airway pressure (3.6.1), inflation phase (3.4.10), initiate (3.9.1), terminate (3.9.14), peak
inspiratory pressure (3.6.3), plateau inspiratory pressure (3.6.4), Δ inspiratory pressure (3.6.7) and Figure C.9 to C.13.

3.6.9
expiratory pressure
respiratory pressure during an expiratory phase
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a measured quantity (3.1.20).

Note 2 to entry: In this document, an expiratory pressure is taken to be an airway pressure unless used in a
compound (post-coordinated) term, in which case the new name or its definition can indicate an alternative
measurement reference site or reference pressure level.

Note 3 to entry: As a measurement, this is the general term for the pressure at any point in time during an
expiratory phase. It will typically be qualified to indicate the point in the phase or the site to which the observation
applies. It may also be displayed as a waveform.

Note 4 to entry: The expiratory pressure is always relative to ambient pressure, that is, independent of the baseline
airway pressure unless indicated otherwise by the differential symbol, Δ, as a prefix.

Note 5 to entry: See also airway pressure (3.6.1), Figure C.9 to C.12, A.4 – 3, and G.4.

3.6.10
expiratory pressure-relief
means that relieves expiratory pressure at the initiation of and throughout the expiratory phase by
allowing expiratory flow to pass through to the exhaust port with minimal resistance when above the
BAP level, but which inhibits that flow below the BAP level
Note 1 to entry: Separate valves providing this function (often referred to as PEEP valves) are, typically, standard
accessories with bag-valve-mask ventilators.

Note 2 to entry: With this function acting alone during a BAP phase, an unassisted inspiration might incur
additional work of breathing, and if there is a leak in the ventilator breathing system or at the connection to the
patient, the airway pressure might fall towards the ambient pressure, which will result in a loss of the intended
PEEP. Such consequences can be mitigated by the provision of a bias flow or prevented by the provision of demand
flow or an ACAP adjunct, active at the BAP level.

3.6.11
tube compensation
TC
airway-pressure offset feature provided by a ventilator during the inspiratory phase of an unassisted or
supported spontaneous breath, or during an expiratory phase, specifically for the intended purpose of
compensating, at least in part, for any added airway resistance imposed by an airway device
Note 1 to entry: Tube compensation is not classified as an inflation-type because its intention is to provide
compensation for an artificially imposed resistive load and not to unload some of the patient's work of breathing.

Note 2 to entry: The assistive offset is typically calculated by the ventilator, based on information entered by the
operator, for example, the inside diameter of an endotracheal tube.

Note 3 to entry: The assistive offset is not intended to compensate for the effects of lung stiffness.

Note 4 to entry: To achieve compensation during the expiratory phase of a breath the airway pressure may be
reduced below the baseline airway pressure for part of the expiratory phase but this document does not sanction
the intentional application of sub-ambient pressures to the patient-connection port.

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Note 5 to entry: See also airway pressure (3.6.1), inspiratory phase (3.4.9), unassisted breath (3.2.12), supported
breath (3.2.13), spontaneous breath (3.2.3), expiratory phase (3.4.2), baseline airway pressure (3.10.1) and patient-
connection port (3.14.5).

3.7 Flow terminology


3.7.1
inspiratory flow
DEPRECATED: peak flow
DEPRECATED: flow limit
flow of gas delivered to the patient through the patient-connection port during an inspiratory or
inflation phase
Note 1 to entry: In addition to its direct reference, this term may be used, in context or by qualification, to
designate this concept as a set quantity (3.1.19) or a measured quantity (3.1.20).

Note 2 to entry: In the absence of suitable standardization, the abbreviation, “Flow”, displayed in various character
styles, is typically used by manufacturers to designate the constant inspiratory flow setting, particularly on user
interfaces where space is often limited, and in user manuals.

Note 3 to entry: Where an inflation serves to augment a patient's spontaneous breath then, conceptually,
inspiratory flow can be seen as being comprised of a component of demand flow resulting from the patient's
inspiratory efforts and a component of flow due solely to the raised pressure of the inflation. However, currently,
most ventilators cannot separate these two components and so the unattributed inclusive term, inspiratory flow,
has been adopted in this document for general use. The term demand flow is included in this document for use
when there is a necessity to make reference to the flow resulting solely from the patient's inspiratory efforts as a
separate concept.

Note 4 to entry: The set inspiratory flow will be a good representation of the actual flow that generates the tidal
volume when it all enters the patient's respiratory tract. This is frequently not the case due to, for example, leakage
at the patient/airway device interface [particularly in neonatal and NIV (non-invasive ventilation)] and from the
operator-detachable part of the ventilator breathing system. With these conditions, a more reliable indication of
the actual flow that will enter the respiratory tract will be provided if the inspiratory flow is leak-compensated
relative to that set.

Note 5 to entry: For further information on the semantics of measured quantities and the term inspiratory flow in
this document see A.4 -3, G.3, G.4 and Annex H.

Note 6 to entry: See also inspiratory effort (3.2.7), demand flow (3.7.10), tidal volume (3.8.1), delivered volume
(3.8.2), inspiratory volume (3.8.3) and the Figures of Annex C.

3.7.2
peak inspiratory flow
highest flow of gas delivered to the patient through the patient-connection port during an inspiratory or
inflation phase
Note 1 to entry: In addition to its direct reference, this term may be used, in context or by qualification, to
designate this concept as a measured value but in this document, is not used to designate this concept as a set
value (3.1.19).

Note 2 to entry: See also Figures C.1, C.2 and C.9 to C.11.

3.7.3
inspiratory-termination flow
termination flow
inspiratory flow threshold at which the termination of a flow-terminated inflation-type is initiated
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a set quantity (3.1.19).

Note 2 to entry: This threshold flow is typically expressed as either a set inspiratory-termination flow or a set
percentage of the peak inspiratory flow.

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Note 3 to entry: For labelling purposes a further abbreviation, such as, Term’n flow %, can be appropriate

Note 4 to entry: See also inspiratory flow (3.7.1), flow-termination (3.9.15), termination (3.9.14), peak inspiratory
flow (3.7.2), initiate (3.9.1), and Figures C.6 and C.10.

3.7.4
end-inspiratory flow
inspiratory flow at the point when inflation termination is initiated
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a measured quantity (3.1.20).

Note 2 to entry: This flow is that measured before the inspiratory-flow waveform trajectory transitions towards
zero in response to a termination signal; the inflation phase itself does not terminate until the commencement of
expiratory flow.

Note 3 to entry: The measured value can be expected to be closer to the actual value if the measurement is leak-
compensated.

Note 4 to entry: See also inspiratory-termination flow (3.7.3), terminate (3.9.14), inspiratory flow (3.7.1), initiate
(3.9.1), inflation phase (3.4.10) and Figure C.5.

3.7.5
expiratory flow
flow from the patient through the patient-connection port during an expiratory phase
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a measured quantity (3.1.20).

Note 2 to entry: The integral of the measured expiratory flow will be a good representation of the expired tidal
volume when there is no gas loss. This is frequently not the case due, for example, to leakage at the patient/airway
device interface [particularly in neonatal and NIV (non-invasive ventilation)]. With these conditions, a more
reliable indication of the actual expired tidal volume will be provided if the expiratory flow is leak-compensated.

Note 3 to entry: See also patient-connection port (3.14.5), expiratory phase (3.4.2), expired tidal volume (3.8.4),
leakage tidal volume (3.8.5), airway device (3.1.3), NIV (3.1.15) and the Figures of Annex C.

3.7.6
end-expiratory flow
expiratory flow at the point of initiation of an inflation or an inspiration
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a measured quantity (3.1.20).

Note 2 to entry: This flow, if any, is that measured before the expiratory-flow waveform trajectory transitions
towards zero in response to either an inflation-initiation signal or the initiation of an unassisted breath.

Note 3 to entry: As a measured value, end-expiratory flow is an indication of auto-PEEP that has not fully dissipated
and, therefore, that the pressure in the lungs might be higher than the intended minimum.

Note 4 to entry: The measured value might be closer to the actual value if the measurement is leak-compensated.

Note 5 to entry: See also Figures C.8 and C.31.

3.7.7
bias flow
flow that passes through the ventilator breathing system to the exhaust port but is not intended to
contribute to the work of lung ventilation
Note 1 to entry: In addition to its direct reference, this term may be used to designate this concept, in context or
by qualification, as a set value (3.1.20).

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Note 2 to entry: The term bias flow is used to refer to an intended low-level flow that passes right through the
ventilator breathing system with the purpose of improving the responsiveness and accuracy of the ventilator’s
control and detection systems, and of minimising the rebreathing of expired gas. It is typically only maintained
during an expiratory phase but can be maintained throughout a respiratory cycle.

3.7.8
continuous flow
gas flowing continuously through the ventilator breathing system, with a proportion intermittently
passing to the patient's lung whenever the airway pressure is raised by the ventilator or an operator
action, or flow is demanded by a patient's inspiratory effort
Note 1 to entry: In addition to its direct reference, this term may be used to designate this concept, in context or
by qualification, as a set value (3.1.20).

Note 2 to entry: A constant, continuous flow in the inspiratory limb of the ventilator breathing system is commonly
used in the artificial ventilation of neonatal and paediatric patients.

Note 3 to entry: The airway pressure can be intermittently raised to a set pressure-limited inspiratory pressure, for
example, by the use of an adjustable pressure-relief valve operating in parallel with either the timed occlusions of
an expiratory valve, or the manual occlusions of a normally-open exhaust port.

Note 4 to entry: See also ventilator breathing system (3.1.18), lung (3.1.16), airway pressure (3.6.1), inspiratory
effort (3.2.7), set (3.1.19), artificial ventilation (3.1.10), pressure-limited (3.13.2) and exhaust port (3.14.2).

3.7.9
decreasing flow pattern
DEPRECATED: decelerating-flow pattern
airway-flow waveform with a continuously decreasing flow
Note 1 to entry: This term is applicable to the description of

— a selectable inspiratory-flow waveform pattern following an initial rise,

— the inspiratory-flow waveform pattern of a pressure-regulated inflation following an initial rise, and

— a typical expiratory-flow waveform.

Note 2 to entry: A decreasing flow pattern is assumed to be nominally linear unless otherwise indicated. In most
applications, the precise linearity of such a waveform is not critical and so this term is appropriate to describe
a range of waveforms that includes those that might have minor nonlinearities, providing these are essentially
inconsequential.

Note 3 to entry: If the decreasing flow pattern is other than nominally linear this should be indicated – preferably
by the addition of an appropriate descriptive term, thereby creating a new post-coordinated term.

Note 4 to entry: An example of a typical nonlinear pattern is illustrated in Figure 1, which is designated, for
example, as a concave decreasing flow pattern. This a typical flow-waveform pattern resulting from a pressure-
regulated inflation following an initial rise, or of a typical expiration. Although not a common feature, this term
is alternatively applicable to the description of a selectable inspiratory flow waveform pattern of this form for a
volume-control (VC) inflation; a selectable pattern intended to merge some of the benefits of a pressure-control
(PC) inflation waveform with those of volume-control.

Note 5 to entry: A concave decreasing flow pattern is typical of the airway flow waveform observed in situations
where the applied pressure difference across the airway resistance is changing due to the charging or discharging
of the compliant lung. Such a pattern is sometimes referred to as an exponential waveform although there is
generally too much nonlinearity in the system for that to be even approximately the case.

Note 6 to entry: Although a commonly used term, ‘decelerating-flow pattern’ is an incorrect designation for any
form of decreasing flow pattern in that the rate of flow of a gas, which is essentially a measure of its velocity,
cannot be ‘decelerated’; it is only a volume of the gas that can be accelerated and decelerated - not the ‘velocity’ of
that gas.

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Key
1 inspiratory flow
2 time
3 concave decreasing flow pattern

Figure 1 — Example of a decreasing flow pattern

3.7.10
demand flow
flow generated by a ventilator solely to meet the flow demand of the patient while acting to maintain the
airway pressure at its intended value
Note 1 to entry: In addition to its direct reference, this term may be used, in context or by qualification, to
designate this concept as a measured quantity (3.1.20).

Note 2 to entry: This term denotes the specific subset of inspiratory flow that is solely due to the patient's
spontaneous inspiratory efforts when connected to a ventilator. In certain contexts, a term for this distinction
is helpful but where this is unimportant the concept can be assumed to be included within the scope of the
generalized term, inspiratory flow (see Notes to 3.7.1).

Note 3 to entry: During unassisted breathing, the intention is that the demand flow will meet the patient's flow
demands in a manner that allows unrestricted breathing at the applicable BAP level. This can involve the use
of a function that temporarily elevates the airway pressure slightly, with the intention of compensating for the
possible pressure drop across an airway device or for the inevitable pressure drop that is necessary for the
pressure-regulation function to provide flow in proportion to the demand. Alternatively, it can be provided by
the provision of ACAP, an adjunct that facilitates unrestricted breathing by the generation of demand flow in
proportion to the patient's demand, with no dependency on a patient-trigger event.

Note 4 to entry: Where spontaneous breaths are given assistance by an inflation, the flow through the patient-
connection port during the inflation phase will be the sum of that due to the raised pressure of the inflation
and that due to the flow demand resulting from the patient's inspiratory effort. Because there is currently no
reliable way to separate these two components, in this document the total of the flow generated is denoted by the
inclusive, general term, inspiratory flow.

Note 5 to entry: Because a demand flow function is required to provide flow in proportion to the demand it is
necessary for it to be independent of any set trigger level.

Note 6 to entry: See also airway pressure (3.6.1), inspiratory flow (3.7.1), unrestricted breath (3.2.5), BAP (3.10.2),
airway device (3.1.3), pressure-regulation (3.3.9), ACAP (3.12.1), patient-trigger event (3.9.6), spontaneous breath
(3.2.3), inflation (3.3.1), inspiratory effort (3.2.7), set (3.1.19) and trigger level (3.9.5).

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3.7.11
airway leak
loss of respiratory gas from its pathway between the patient-connection port interface and the lungs
Note 1 to entry: In addition to its direct reference, this term may be used, in context or by qualification, to
designate this concept as a measured quantity (3.1.20).

Note 2 to entry: Loss of gas at the interface between a mask or endotracheal tube and the patient is considered to
be an airway leak, as is also loss of gas at the patient-connection port interface.

Note 3 to entry: An airway leak can be expressed as a flow rate or a volume and during an inspiratory, inflation or
expiratory phase, or during a period of time.

Note 4 to entry: See also patient-connection port (3.14.5), airway (3.1.2), inspiratory phase (3.4.9), inflation phase
(3.4.10) and expiratory phase (3.4.2).

3.7.12
ventilator breathing system leak
VBS leak
loss of gas from the ventilator breathing system
Note 1 to entry: In addition to its direct reference, this term may be used, in context or by qualification, to
designate this concept as a measured value (3.1.20).

Note 2 to entry: With this definition, this leak does not include any loss of gas at or beyond the interface at the
patient-connection port.

Note 3 to entry: The term may be applied to the total ventilator breathing system leakage or, more specifically,
to any leakage that influences the displayed values of delivered volume or expired minute volume. Any such
implications should be disclosed by the manufacturer.

Note 4 to entry: Relevant international standards generally require that ventilator breathing system leakage
should not exceed a specified rate of flow, expressed at BTPS (body temperature and pressure, saturated).

Note 5 to entry: See also ventilator breathing system (3.1.18), patient-connection port (3.14.5), delivered volume
(3.8.2) and expired minute volume (3.8.9).

3.8 Volume terminology


3.8.1
tidal volume
volume of gas that enters and leaves the lung during a breath
Note 1 to entry: In addition to its direct reference, this term or its symbol, V T, displayed in various character
styles, may be used, in context or by qualification, to designate this concept as a set quantity (3.1.19). As a
measured quantity, it is only used to designate this concept when expressed as a compensated value.

Note 2 to entry: In practice, the volumes that enter and leave the lung are typically measured as delivered (or
inspiratory) volumes and expired tidal volumes because, even without leakage, these two quantities will only be
nominally equal due to physical and/or compositional changes of the gas and normal physiological variation in
end-expiratory lung volume. Leakages between the point at which the flow towards the patient is measured and
the lung, such as occur at the connection to the patient's airway, will increase these discrepancies.

Note 3 to entry: Without leakage compensation the measured expired tidal volume will be a better representation
of the actual tidal volume because leakage is less during expiration than during delivery due to the lower mean
airway pressure. Where leakage compensation is in operation, the actual delivered and inspiratory volumes are
typically greater than the set tidal volume, but the compensated tidal volume provides a better representation of
the actual tidal volume.

Note 4 to entry: With ventilation equipment where no inspiratory or expired volume measurements are available
the actual tidal volume might deviate from the set value as a result of the factors referred to in Note 2 to this entry.

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3.8.2
delivered volume
net volume of gas delivered to the gas output port during an inspiratory or inflation phase
Note 1 to entry: In addition to its direct reference, this term or its symbol, V Del, displayed in various character
styles, may only be used, in context or by qualification, to designate this concept as a measured quantity (3.1.20).

Note 2 to entry: The delivered volume is a good representation of the actual tidal volume when all of the delivered
volume enters the patient's respiratory tract. This is frequently not the case due to, for example, leakage around
the endotracheal tube or face mask [particularly in neonatal and NIV (non-invasive ventilation)]. However, where
the actual delivered volume is leak-compensated relative to that set the setting is considered to be a sufficiently
reliable indication of the tidal volume for it to be so labelled.

Note 3 to entry: The delivered volume is defined as a net volume because it is the actual volume delivered minus
any volume that passes through the expiratory valve as a consequence of a bias flow.

Note 4 to entry: See also gas output port (3.14.3), inflation (3.3.1), inspiratory phase (3.4.9), tidal volume (3.8.1), set
(3.1.19), expiration (3.2.11) and bias flow (3.7.7).

3.8.3
inspiratory volume
volume of gas delivered through the patient-connection port during an inspiratory or inflation phase
Note 1 to entry: In addition to its direct reference, this term or its symbol, V I, displayed in various character
styles, may only be used, in context or by qualification, to designate this concept as a measured quantity (3.1.20).

Note 2 to entry: This is the concept designated by 'delivered volume', in ISO 4135:2001,3.4.2; a term that has not
been widely adopted to date. It is a concept relevant to where measurements of volume made close to the patient-
connection port, such as is typically the case with self-contained, multi-parameter patient monitors, as distinct
from the redefined delivered volume, which is applicable to ventilators where the inspiratory flow is determined or
measured within the body of the ventilator. The closer site of measurement means that this quantity only differs
from the actual volume entering the lung by the amount of any volume loss occurring at the connection to the
patient's airway.

Note 3 to entry: See also patient-connection port (3.14.5), inspiratory phase (3.4.9), inflation phase (3.4.10),
delivered volume (3.8.2), inspiratory flow (3.7.1) and tidal volume (3.8.1).

3.8.4
expired tidal volume
volume of gas leaving the lung through the patient-connection port during an expiratory phase
Note 1 to entry: In addition to its direct reference, this term or its symbol, V TE , displayed in various character
styles, is used, in context or by qualification, to designate this concept as a measured quantity (3.1.20).

Note 2 to entry: Where there is concurrent breathing, although the ventilator can determine the inspiratory
volumes of the additional breaths their expirations will most often be inevitably combined with that from the
assured inflation, which is typically displayed with no separate attributions.

Note 3 to entry: This term would be appropriate to designate this concept, in context or by qualification, as a
set target value for this quantity but this is typically not currently practiced because of other factors that would
have to be taken into account.

Note 4 to entry: See also lung (3.1.16), patient-connection port (3.14.5), expiratory phase (3.4.2), concurrent breath
(3.2.9), inspiratory volume (3.8.3), additional breath (3.2.8), assured inflation (3.3.11) and set (3.1.19).

3.8.5
leakage tidal volume
volume of gas lost between the measurement of the volume passing to the patient and the measurement
of the corresponding expired tidal volume, due to leakage during a respiratory cycle
Note 1 to entry: In addition to its direct reference, this term or its symbol, V TLeak , displayed in various character
styles, is used, in context or by qualification, to designate this concept as a measured quantity (3.1.20).

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Note 2 to entry: This leakage is typically estimated based on a comparison of the measured volume passing to the
patient with the measured expired tidal volume, and the mean inspiratory and expiratory pressures.

Note 3 to entry: See also respiratory cycle (3.4.16), airway leak (3.7.11), expired tidal volume (3.8.4), inspiratory
pressure (3.6.2) and expiratory pressure (3.6.9).

3.8.6
minute volume
DEPRECATED: V̇
volume of gas either passing to or leaving the lung during inspiratory or inflation phases, or expiratory
phases, respectively, expressed as a volume per minute
Note 1 to entry: In addition to its direct reference, this term or its symbol, V M, displayed in various character
styles, may be used, in context or by qualification, to designate this concept as a set quantity (3.1.19). As a
measured quantity, it is only used to designate this concept when expressed as a compensated value.

Note 2 to entry: Unless otherwise qualified, this term designates the volume either passing to or leaving the lung
during all of the respective inspiratory or inflation phases, or expiratory phases that have occurred during the
period of measurement. This term is appropriately qualified when used to denote the minute volumes resulting
from specific types of inflations or breaths [for an example, see assured minute volume (3.8.11)].

Note 3 to entry: While a minute volume is expressed as a volume per minute, the actual measurement period
will typically be that of a specified number of complete respiratory cycles or of a time other than one minute, in
order to provide a more consistent average value. The term by itself suggests that its value is that of a volume but
experience has indicated that users prefer the assurance of it being expressed as an average flow rate, that is, as
a volume/min.

Note 4 to entry: In practice, the volumes that enter and leave the lung per minute are typically measured as
delivered or inspiratory minute volumes and expired minute volumes because, even without leakage, these two
quantities will only be nominally equal due to physical and/or compositional changes of the gas and normal
physiological variations in end-expiratory lung volume. Leakages between the point at which the flow towards
the patient is measured and the lung, such as occur at the connection to the patient's airway, will increase these
discrepancies.

Note 5 to entry: Without leakage compensation, the measured expired minute volume is expected to be a better
representation of the actual minute volume because leakage is less during expiration than during delivery due to
the lower mean airway pressure. Where leakage compensation is in operation the actual delivered and inspiratory
minute volumes are typically greater than the set minute volume but the compensated minute volume provides a
better representation of the actual minute volume.

Note 6 to entry: With ventilation equipment where no inspiratory or expired minute volume measurements are
available the actual minute volume might deviate from the set value as a result of the factors referred to in Note 2
to this entry.

Note 7 to entry: See also lung (3.1.16), respiratory cycle (3.4.16), delivered minute volume (3.8.7), inspiratory
minute volume (3.8.8), expired minute volume (3.8.9), inspiratory volume (3.8.3) and expiration (3.2.11).

Note 8 to entry: The symbol, V̇ , is sometimes used as a designation for minute volume. This is incorrect because
V̇ is a symbol for the differential of volume with time, that is, dV/dt, which is an instantaneous flow rate. Minute
volume is the integral of a varying flow rate and so reflects the average rate of flow. For correct representation
this would require the addition of ‘ ˉ ’ above the V̇ , which presents typological difficulties.

3.8.7
delivered minute volume
net volume of gas delivered to the gas output port during all inflation and inspiratory phases, expressed
as a volume per minute
Note 1 to entry: In addition to its direct reference, this term or its symbol, V MDel, displayed in various character
styles, may only be used, in context or by qualification, to designate this concept as a measured quantity (3.1.20).

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Note 2 to entry: Delivered minute volume is also referred to as minute volume when all of the delivered volume
enters the patient's respiratory tract. This is frequently not the case due to, for example, leakage at the patient/
ventilator interface [particularly in neonatal and NIV (non-invasive ventilation)]. However, where the displayed
minute volume of gas delivered is leak-compensated the observation is considered to be a sufficiently reliable
indication of the minute volume for it to be so labelled.

Note 3 to entry: See also ventilator breathing system (3.1.18), inflation phase (3.4.10), inspiratory phase (3.4.9),
minute volume (3.8.6), delivered volume (3.8.2) and NIV (3.1.15).

3.8.8
inspiratory minute volume
volume of gas delivered through the patient-connection port during all inflation and inspiratory phases,
expressed as a volume per minute
Note 1 to entry: In addition to its direct reference, this term or its symbol, V MI, displayed in various character
styles, may only be used, in context or by qualification, to designate this concept as a measured quantity (3.1.20).

Note 2 to entry: This is the concept designated by delivered ventilation, in ISO 4135:2011,3.4.1; a term that has
not been widely adopted to date. It is a concept relevant to measurements of volume made close to the patient-
connection port, such as is typically the case with self-contained, multi-parameter patient monitors, as distinct
from the redefined delivered minute volume (3.8.7), which is applicable to ventilators where the inspiratory flow
is determined or measured within the body of the ventilator. Having the site of measurement closer to the patient
means that this quantity only differs from the actual volume entering the lung per minute by the amount of any
leakage minute volume occurring at the connection to the patient's airway.

Note 3 to entry: See also minute volume (3.8.6), patient-connection port (3.14.5), delivered minute volume (3.8.7),
inspiratory flow (3.7.1), lung (3.1.16), leakage minute volume (3.8.10), airway (3.1.2) and expired minute volume
(3.8.9).

3.8.9
expired minute volume
DEPRECATED: expired ventilation
volume of gas leaving the lung through the patient-connection port during all expiratory phases,
expressed as a volume per minute
Note 1 to entry: In addition to its direct reference, this term or its symbol, V ME , displayed in various character
styles, is used, in context or by qualification, to designate this concept as a measured quantity (3.1.20).

Note 2 to entry: See also expired tidal volume (3.8.4), minute volume (3.8.6) and inspiratory minute volume (3.8.8).

3.8.10
leakage minute volume
volume of gas lost between the measurement of the volumes passing to the patient and the measurement
of the corresponding expired minute volumes, due to leakage during a specified time or number of
respiratory cycles, expressed as a volume per minute
Note 1 to entry: In addition to its direct reference, this term or its symbol, V MLeak , displayed in various character
styles, is used, in context or by qualification, to designate this concept as a measured quantity (3.1.20).

Note 2 to entry: This leakage is typically estimated based on a comparison of the known delivered flows/volume
with the measured expiratory flows/volume, and the mean inspiratory and expiratory pressures.

3.8.11
assured minute volume
minute volume due to the ventilation set rate
EXAMPLE 1 The minute volume resulting from all the assured inflations in an SIMV mode.

EXAMPLE 2 The minute volume resulting from the set number of assured inflations in an assist/control (A/C)
ventilation-mode.

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Note 1 to entry: In addition to its direct reference, this term or its symbol, V MAssd, displayed in various character
styles, is used, in context or by qualification, to designate this concept as a set quantity (3.1.19) for ventilation-
modes with volume-control or volume-targeted inflation-types. It is a measured quantity (3.1.20) for ventilation-
modes with pressure-control inflation-types.

Note 2 to entry: The assured minute volume is the minute volume resulting only from inflations assured to be
delivered at intervals determined by the set rate.

Note 3 to entry: The volume of gas delivered at the set rate is only assured when volume-control inflation-types are
selected for that delivery. The average volume of gas delivered can be assured by the selection of volume-targeted
pressure-control inflation-types. With pressure-control inflation-types, only the rate of delivery is assured, and the
volume of gas in each delivery can deviate from that initially set, which means that the actual minute volume
resulting from the assured inflations can only be determined by measurement.

Note 4 to entry: Where leakage-compensated measurements of this quantity are available these may be used in
the place of expired minute volume measurements.

Note 5 to entry: See also ventilation (3.1.9), rate (3.5.1.1), ventilation-mode (3.11.2), volume targeted (3.3.15),
inflation-type (3.3.2), assured inflation (3.3.11) and mandatory (3.9.9).

3.8.12
additional minute volume
minute volume that is additional to the assured minute volume
EXAMPLE 1 The volume resulting from all unassisted and supported breaths.

EXAMPLE 2 The volume resulting from the number of inflations in excess of the set number per minute in
assist/control (A/C) ventilation-modes.

Note 1 to entry: In addition to its direct reference, this term or its symbol, V MAddn, displayed in various character
styles, is used, in context or by qualification, to designate this concept as a measured quantity (3.1.20).

Note 2 to entry: This is the minute volume resulting from any unassisted breaths and from inflations delivered in
addition to the set rate.

Note 3 to entry: In assist/control (A/C) ventilation-modes, the additional minute volume is determined as the
additional-breath-rate/total-respiratory-rate proportion of the expired minute volume resulting from inflations.

Note 4 to entry: Where leakage-compensated measurements of this quantity are available these may be used in
the place of expired minute volume measurements.

Note 5 to entry: See also minute volume (3.8.6), assured minute volume (3.8.11), unassisted breath (3.2.12),
supported breath (3.2.13), assist/control ventilation (3.11.8), rate (3.5.1.1), total respiratory rate (3.5.1.2), expired
minute volume (3.8.9) and inflation (3.3.1).

3.9 Initiation and termination terminology


3.9.1
initiate
cause a process or action to begin
Note 1 to entry: This word has been adopted in this document as the general term to designate the concept of
causing a process or action to begin. This is to counter a tendency to use the word ‘trigger’ for this purpose; a
trend that removes the ability of that term to differentiate its own special meaning from that of a simple timed
switching action. In this document, an inflation can be initiated by, for example:

— a patient-trigger event;

— a timed signal;

— a manual input;

— a conditional termination of an expiratory phase;

— a signal from a remote device.

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Note 2 to entry: In this document, an inflation that is initiated by a timed signal may be referred to as being
ventilator-initiated.

Note 3 to entry: A conditional termination of an expiratory phase is typically achieved by establishing an


expiratory-flow threshold at which the next inflation is initiated. An initiation of this type is sometimes used, for
example, to optimize the expiratory time in an APRV (airway pressure release ventilation) mode. Such a threshold
flow is typically expressed as either a set expiratory flow or a set percentage of the peak expiratory-flow.

Note 4 to entry: See also trigger (3.9.2), ventilator-initiation (3.9.12), patient-trigger event (3.9.6), terminate
(3.9.14) and APRV (3.11.14).

3.9.2
trigger
DEPRECATED: time trigger
DEPRECATED: manual trigger
DEPRECATED: remote trigger
function that detects that the measured value(s) of a parameter(s) that can be attributed to the patient
has reached the threshold value required to initiate another event
Note 1 to entry: This is the definition of the basic concept of a trigger function, as the term is used in this document.
In practice, some such functions might monitor the value of more than one parameter and make use of dedicated
detection algorithms in order that sensitive settings can be used with a minimum risk of auto-triggering.

Note 2 to entry: This term is used to differentiate that class of inflation initiation signals that depend upon the
attainment of a threshold by the measured value of a patient parameter, and hence involve a sensitivity setting,
from those generated directly by the operation of simple timed, manual or remote, binary-switch functions.

Note 3 to entry: See also initiate (3.9.1), auto-trigger (3.9.10), inflation (3.3.1) and patient-trigger event (3.9.6).

3.9.3
flow trigger
trigger that detects when changes of flow in the ventilator breathing system reach a set threshold level
Note 1 to entry: This is a classification for the means of detecting a patient's inspiratory effort in generating a
patient-trigger event. As explained in Note 1 to 3.9.2, in practice, some such functions might monitor the value of
more than one parameter and make use of dedicated detection algorithms in order that a sensitive setting can
be used with minimal risk of auto-triggering. In a flow-trigger algorithm, flow will be the dominant parameter in
determining attainment of the threshold level.

Note 2 to entry: The change of flow detected might be a change in a bias flow or a change in the flow through the
patient-connection port.

Note 3 to entry: See also trigger (3.9.2), ventilator breathing system (3.1.18), inspiratory effort (3.2.7), patient-
trigger event (3.9.6), pressure trigger (3.9.4), auto-trigger (3.9.10), bias flow (3.7.7) and patient-connection port
(3.14.5).

3.9.4
pressure trigger
trigger that detects when pressure changes in the ventilator breathing system reach a set threshold level
Note 1 to entry: This is a classification for the means of detecting a patient's inspiratory effort in generating a
patient-trigger event. As explained in Note 1 to 3.9.2, in practice some such functions might monitor the value
of more than one parameter and make use of dedicated detection algorithms in order that a sensitive setting
can be used with minimal risk of auto-triggering. In a pressure-trigger algorithm, pressure will be the dominant
parameter in determining attainment of the threshold level.

Note 2 to entry: The change of pressure detected may be a change in a measured pressure or a change in a rate of
a pressure change.

Note 3 to entry: See also trigger (3.9.2), ventilator breathing system (3.1.18), inspiratory effort (3.2.7), patient-
trigger event (3.9.6), flow trigger (3.9.3) and bias flow (3.7.7).

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3.9.5
trigger level
threshold value for a trigger function
Note 1 to entry: This term is used, in context or by qualification, only to designate this concept as a set value
(3.1.20).

Note 2 to entry: The level might be labelled in units of pressure or flow, or with a simple sensitivity scale.

3.9.6
patient-trigger event
trigger-event
signal used to initiate an inflation, resulting from a measured value(s) of a parameter(s) that can be
attributed to the patient reaching a threshold value
Note 1 to entry: Typical patient respiratory parameters that are monitored for this purpose are airway pressure,
flow or volume, and electromyography signals (EMG). Far less commonly used parameters are chest-wall motion
and transthoracic impedance. The detection algorithm may involve more than one of these parameters.

Note 2 to entry: An inflation initiated by a patient-trigger event may be referred to as being patient triggered or by
the method of detection, for example, pressure triggered, flow triggered, etc.

Note 3 to entry: The interval from the instant the patient initiates an inspiratory flow until the point where the
inspiratory pressure starts to increase in response to a patient-trigger event can be referred to as the trigger phase.
Because the change from the trigger phase to the inflation phase is typically optimized at a level determined by
operator settings, in this document it is treated as having occurred during the final moments of the expiratory
phase, unless otherwise stated. See also expiratory phase 3.4.2 and Figures C.3, C.6 and C.7.

Note 4 to entry: The initiation of an inflation by means of a manual input is not a manual trigger event; it is a
manual initiation.

Note 5 to entry: It is important that users are made aware that a patient-trigger event might result from the detection
of a spurious perturbation on a measurement, especially if the threshold value is set at too sensitive a level.

Note 6 to entry: See also initiate (3.9.1), inflation (3.3.1), airway pressure (3.6.1), measured (3.1.20), trigger (3.9.2),
pressure trigger (3.9.4), flow trigger (3.9.3), auto-trigger (3.9.10) and breath stacking (3.9.11).

3.9.7
breath synchronization
timing adjustment of each initiation and/or termination of an assured inflation in order to match the
pattern of any spontaneous inspiratory and/or expiratory efforts, while still maintaining the set rate
Note 1 to entry: Any such initiation timing adjustment will typically alter the respiratory cycle time of the assured
inflation, breath to breath, but the average initiation rate will be maintained at the set rate.

Note 2 to entry: See also initiate (3.9.1), terminate (3.9.14), assured inflation (3.3.11), inspiratory effort (3.2.7) set
rate (3.5.1.1) and D.2.6.

3.9.8
synchronization window
time interval following the scheduled initiation or termination, of an assured inflation during which
actual initiation or termination can be synchronized with any respiratory activity of the patient
Note 1 to entry: See also breath synchronization (3.9.7), initiate (3.9.1), terminate (3.9.14), assured inflation
(3.3.11), respiratory activity (3.2.6), Annex B and Figures B.1, C.19, C.29 and C.33.

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3.9.9
mandatory
required to occur
Note 1 to entry: This term is defined as used in this document, with a specific meaning of the word mandatory,
which in natural language has a spectrum of meanings. It has become firmly established in the vocabulary of
artificial ventilation but, because of its ambiguity, it can denote either ‘total control’ or, as in this definition,
‘required to occur’. In early artificial ventilation practice, it was usual for all aspects of the patient's ventilation to
be taken over by the ventilator and so every breath could be described as mandatory in its broadest sense. Since
then, with the introduction of patient triggering and the concept of support for spontaneous breathing, only a small
percentage of patients currently have their ventilation totally controlled. However, there remains a mandatory
component to all forms of artificial ventilation but a key aspect for an operator when setting a contemporary
ventilator is being assured that, when a selected inflation-type is delivered within the selected ventilation-pattern,
it will provide at least a minimum level of assistance and, in the case of apnoea, that the ventilation will be totally
controlled.

These developments have led manufacturers to increasingly restrict the use of the term ‘mandatory’ to the context
of ventilation that is assured to occur by the programmed delivery of a selected inflation-type, in predetermined
patterns, at a rate that is independent of the patient's respiratory activity. This is the only sense in which the term
mandatory is used in this document; which is mainly in the explanation of the classical mode names such as CMV
(continuous mandatory ventilation), IMV (intermittent mandatory ventilation) and SIMV (synchronized intermittent
mandatory ventilation). For other purposes, wherever possible, the term assured is used in its place.

Note 2 to entry: See also artificial ventilation (3.1.10), ventilation (3.1.9), ventilator (3.1.1), inflation (3.3.1), assured
inflation (3.3.11), inflation-type (3.3.2), respiratory activity (3.2.6) and assured minute volume (3.8.11).

3.9.10
auto-trigger
DEPRECATED: auto-cycle
initiation of an inflation as a result of a false patient-trigger event
Note 1 to entry: A false patient-trigger event can be caused, for example, by external perturbations such as a
movement of the breathing tube or a cardiac impulse creating pneumatic disturbances.

3.9.11
breath stacking
initiation of another inflation by either the ventilator or a patient-trigger event, before the previous
breath has been fully expired
Note 1 to entry: This situation might be caused, for example, by auto-triggering or by the expiratory time being set
too short; it causes an accumulation of gas in the lungs and associated auto-PEEP.

Note 2 to entry: Breath stacking is the generalized term for more than one breath in succession being initiated
before completion of expiration. The specific case of breath stacking where only a second breath is initiated
prematurely is commonly referred to as double-triggering.

3.9.12
ventilator-initiation
initiation of an inflation by means of a timed signal generated after a set interval
3.9.13
remote inflation-initiation
initiation of an inflation by means of a recognized signal caused by an event external to the ventilator
EXAMPLE 1 A signal from another medical device.

EXAMPLE 2 A synchronization signal from X-ray equipment.

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3.9.14
terminate
DEPRECATED: cycle
bring to an end
Note 1 to entry: In this document this term is used in reference to the ending of inflation phases. The means of
termination of an inflation phase constitutes the secondary classification of inflation-types. The termination of an
expiratory phase is caused by the initiation of an inspiration or inflation.

Note 2 to entry: The term ’cycle’ is currently commonly used in some countries with the meaning of ‘terminate’
but it is, in fact, an abbreviation of ‘cycle-off’’. These terms originated when ventilators simply cycled between
‘on’ and ‘off’. Typically, ventilators are now equipped with a variety of different means to terminate and initiate
an inflation and the term ‘cycle’ is considered to be misleading in this context; it also causes confusion with the
common and scientific meaning of the term ‘cycle’ as used in this document.

Note 3 to entry: See also inspiratory-termination flow (3.7.3), flow-termination (3.9.15), pressure-termination
(3.9.16), time-termination (3.9.17) and D.2.8.2.

3.9.15
flow-termination
DEPRECATED: flow cycling
termination of a pressure-regulated inflation when the inspiratory flow has satisfied the prevailing
inspiratory-termination flow criterion
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a set quantity (3.1.20).

Note 2 to entry: This method of termination provides the means for the patient's respiratory activity to be used to
influence the duration of an inflation phase in order to improve the match of the duration with the patient's own
breathing pattern. See pressure-support for an example of an inflation-type that is typically pressure-regulated and
flow-terminated.

Note 3 to entry: Patient-safety considerations dictate that a time-termination be provided as a backup where flow-
termination is intended to be the primary means of termination. This time-termination can be preset, operator-
adjustable or set by an algorithm.

Note 4 to entry: Flow-terminated pressure-support inflation-types have often been referred to as patient-
terminated. The use of that term is deprecated in this document unless the ventilator is able to specifically
indicate that the termination is due to the patient's respiratory activity and neither due to the inevitable decline in
inspiratory flow as the passive lungs are inflated in the absence of any such activity, nor due to time-termination.

Note 5 to entry: See also terminate (3.9.14), inflation (3.3.1), inspiratory flow (3.7.1), inspiratory-termination flow
(3.7.3), respiratory activity (3.2.6), pressure-support (3.3.6), inflation-type (3.3.2), pressure-regulation (3.3.9),
time-termination (3.9.17), preset (3.1.21), end-inspiratory flow (3.7.4) and D.2.5.

3.9.16
pressure-termination
DEPRECATED: pressure cycling
termination of an inflation phase when the inspiratory pressure attains a set level
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a set quantity (3.1.20).

Note 2 to entry: The set level can be either the primary termination criterion for the inflation-type or a set safety
limit for the protection of the patient during normal condition or under a single fault condition.

Note 3 to entry: See also terminate (3.9.14), normal condition (3.1.26), single fault condition (3.1.27), limit (3.1.23),
pressure limited (3.13.2), adjustable pressure limit (3.13.9), pressure-control (3.3.4) and D.2.8.1.

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3.9.17
time-termination
DEPRECATED: time cycling
termination of an inflation phase after a set elapsed time
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a set quantity (3.1.20).

Note 2 to entry: Patient-safety considerations dictate that all inflation-types have a directly or indirectly set time-
termination. Typically, this can be the operator-selected primary means of termination or it can be a preset back-
up to an alternative primary means of termination.

Note 3 to entry: See also terminate (3.9.14), inflation phase (3.4.10), set (3.1.19) preset (3.1.21) and initiate (3.9.1).

3.10 * Baseline and PEEP terminology


3.10.1
baseline airway pressure
baseline pressure
reference airway-pressure level that may be above the ambient pressure by a set amount and at which a
patient breathes when unassisted and upon which inflations are superimposed
Note 1 to entry: The setting for the amount by which the baseline airway pressure is offset is designated by the
acronym BAP (3.10.2).

Note 2 to entry: The baseline airway-pressure level for humans breathing without a ventilator is that of the ambient
environment. Most ventilators have the capability for the patient to be ventilated and be able to breathe, with
a baseline airway-pressure level(s) that is artificially raised relative to the ambient pressure. In addition to the
baseline at ambient pressure, this document utilizes baselines at the set BAP level (see Note 3 to entry), at the set
inspiratory-pressure level of an assured inflation (see Note 5 to entry) and also, at the set level in CPAP ventilation-
modes (see Note 7 to entry). With ventilation-modes designated as bi-level AV the baseline at the inspiratory
pressure level may be designated as BAPH.

Note 3 to entry: Baseline airway pressures at the set BAP level become the reference level for

— any inflation cycles initiated from that baseline,

— an ACAP adjunct if active at that level,

— the expiratory-control algorithm for any inflation cycles initiated from that baseline,

— the intended minimum alveolar pressure level throughout expiratory phases of inflations initiated from that
baseline, and

— the intended PEEP (positive end-expiratory pressure) at the patient-connection port.

Note 4 to entry: The adoption of the concept of a baseline airway pressure at a set BAP level, to replace that of
a PEEP setting that only determines a positive pressure at the end of each expiratory phase, is increasingly
necessary because of the growing number of ventilators that incorporate an ACAP adjunct. These are able to
generate required airway-pressure waveforms irrespective of both inspiratory and expiratory flow and during
both inspiratory and expiratory phases of an assured inflation. With such an adjunct activated the patient is able
to inspire and expire at any time at any BAP level. Such inspirations can be unassisted or supported and intended
expiratory-pressure waveforms are maintained under the control of an expiratory-control algorithm. Unassisted
inspirations are enabled by the provision of demand flow that is proportional to the patient's demands, with no
dependency on a patient-trigger event. The functionality that such features enable requires a vocabulary that
encompasses the concept of one or more continuous baseline airway pressures in addition to one that only
specifies an intended airway pressure at the end of an expiratory phase.

Note 5 to entry: If an ACAP adjunct is provided during a pressure-control (PC) assured-inflation, the set inspiratory
pressure level becomes the baseline for:

— any concurrent support inflations initiated from that baseline,

— the ACAP adjunct at that level, and

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— the expiratory-control algorithm for any inflation cycles initiated from that baseline.

Note 6 to entry: Ventilation-modes in which ACAP is always active, at both the BAP and inspiratory pressure levels,
may alternatively be labelled as bi-level AV.

Note 7 to entry: In a CPAP ventilation-mode, the baseline at the set CPAP level becomes the reference level for the
ACAP adjunct that enables continuous unrestricted breathing at that constant level.

Note 8 to entry: Examples of airway-pressure baselines are shown as orange-coloured broken lines in the Figures
in Annex C.

Note 9 to entry: See also airway pressure (3.6.1), set (3.1.19), breathe (3.2.2), unassisted breath (3.2.12), inflation
(3.3.1), BAP (3.10.2), bi-level AV (3.12.4), BAP H (3.12.7), CPAP (3.11.15), initiate (3.9.1), expiratory-control algorithm
(3.10.5), PEEP (3.10.4), ventilation (3.1.9), ventilation-mode (3.11.2), ACAP (3.12.1), adjunct (3.11.4), supported
breath (3.2.13), unrestricted breathing (3.2.5), Annexes C and F and Figures C.4, C.5, C.8 and C.9 to C.13.

3.10.2
BAP
pressure-low
PEEP
quantity by which the baseline airway pressure is set to be positively offset from the ambient pressure
Note 1 to entry: The acronym BAP is employed in this document for the designation this concept as a set quantity
(3.1.19) and in reference to baselines at a set airway-pressure level. The full term (see 3.10.1) is used in reference
to the concept and its function. For examples of this usage see the notes to subclauses relating to baseline airway
pressure and the relevant subclauses in 3.10 and 3.12.

Note 2 to entry: In ventilation-modes with more than one baseline airway pressure, BAP is the setting for that at
the lowest level.

Note 3 to entry: The admitted term, pressure-low, is included in this edition of this document based on its common
current usage, in combination with pressure-high, in the labelling of bi-level AV ventilation-modes and the possible
need for a longer transition time for the changeover to the use of the term BAP, should this prove necessary. It
may be represented by an appropriate letter symbol, for example, p L .

Note 4 to entry: Although, in the absence of a commonly accepted alternative term, the use of the term, ‘PEEP’
as an abbreviation of positive end-expiration pressure, has been implicitly extended to encompass that of the
setting for the baseline airway pressure at the same pressure level, this has never been formalized. The term,
itself, explicitly states that it is specifically related to the ‘end’-expiration pressure, and since its introduction it
has gradually acquired a range of meanings relating to that parameter alone. For these reasons, and because the
increasing implementation of ACAP adjuncts has made the concept of a baseline airway pressure more important as
a separate concept, the term BAP, the acronym for the more explicitly appropriate term, baseline airway pressure,
has been adopted in this document as the preferred term for the designation of the setting for this concept.

However, in addition to its retention as the preferred term for the designation of the positive end-expiratory
pressure as a measurement, as defined in 3.10.4, PEEP is retained in this edition of this document to also designate
this separate concept of the set level for the baseline airway pressure, as an admitted term. This temporary
retention is to provision for a longer transition time in the changeover to the use of the preferred term, BAP,
should this prove necessary. It might also continue to be a more appropriate term for a setting on basic ventilators
and resuscitators, where the concept of a baseline airway pressure is not relevant, and the setting of the positive
end-expiratory pressure is the only necessity.

Note 5 to entry: See also baseline airway pressure (3.10.1), set (3.1.19), ventilation-mode (3.11.2), BAPH (3.12.7),
PEEP (3.10.4), pressure-high (3.12.7) and the Figures of Annex C.

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3.10.3
BAP phase
pressure-low phase
alternative name for the phase between assured inflations, in particular on ventilators where unassisted
or supported spontaneous inspirations are facilitated during that phase in at least one of the selectable
ventilation-modes on that ventilator
Note 1 to entry: Although this is also the expiratory phase of the assured-inflation cycle, unless that association is
made clear each time it is used, if there are additional respiratory cycles there is ambiguity as to which expiratory
phase is being referred to. The use of the term, BAP phase, therefore adds concision. This is particularly relevant
with SIMV and bi-level AV ventilation-modes that might use extended BAP phases of up to 30 seconds or more.

Note 2 to entry: This phase is designated as the BAP phase because, although the conceptual baseline at this
set level is continuous, it is only required as a continuous reference following termination and up till the point
of initiation of an assured-inflation phase. If additional breaths concurrent with an assured inflation are possible,
these will be superimposed on a higher baseline, at the inspiratory-pressure level, which may be alternatively
labelled as BAPH.

Note 3 to entry: The reason for labelling all expiratory phases as BAP phases on ventilators with at least one
ventilation-mode, where that is applicable, is to ensure consistent labelling on any one device. The term may
also be applied to the expiratory phases of other classes of inflation if the resulting consistency is assessed as
improving usability.

Note 4 to entry: The admitted term, pressure-low phase, is the typical alternative name for this phase when its set
pressure level is designated by its alternative name, pressure-low.

Note 5 to entry: See also expiratory phase (3.4.2), unassisted breath (3.2.12), supported breath (3.2.13),
spontaneous breath (3.2.3), initiate (3.9.1), additional breath (3.2.8), assured-inflation cycle (3.4.18), respiratory
cycle (3.4.16), BAP H (3.12.7), pressure-low (3.10.2), bi-level AV (3.12.4), ventilation-mode (3.11.2) and Figures C.23
to C.33 and F.1 to F.6.

3.10.4
PEEP
positive end-expiratory pressure
<actual and measured value> respiratory pressure at the end of an expiratory phase
Note 1 to entry: In addition to its direct reference, this term or its acronym, is used in this document to designate
this concept as a measured quantity. Without qualification, the quantity is always that at the patient-connection
port and relative to ambient pressure. When used as part of a post-coordinated term it may be attributed to other
measurement sites or reference pressure levels. The term, in its acronym form only, is also an admitted term for
the designation of the set value of the baseline airway-pressure level (which encompasses the setting for the end-
expiratory pressure), thereby acting as a synonym for BAP. For further information on PEEP as an admitted term
for this purpose see 3.10.2.

Note 2 to entry: As a measured quantity, the qualification ‘positive’ is not strictly necessary but its use is retained
because it places emphasis on one of the main purposes for which PEEP is used, that is, retaining at least a
minimum ‘positive’ pressure in the alveoli in order to guard against their collapse.

Note 3 to entry: Since its early use, this term has been used to designate this concept as both a setting and
measured value with very little clarity as to which. As the term for a measurement it has been post-coordinated to
form terms such as auto-PEEP, intrinsic PEEP, alveolar PEEP, total PEEP, dynamic intrinsic PEEP, static intrinsic
PEEP, dynamic total PEEP and applied PEEP. The term extrinsic PEEP has also been used to designate the PEEP
at the patient-connection port but it is usually not clear whether that is for the set or the actual value. Although,
ideally both will have the same value the actual value is not dependent on the set value alone and might have a
higher or lower value, depending on other factors such as the expiratory time, any ventilator breathing system or
airway device leakage, or patient respiratory activity. An inspection of current ventilator labelling demonstrates
that there is very little consistency in the way these various forms of the term are used and what they designate.

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In practice, on modern electronically-controlled ventilators, there is still only the need for one term for the
designation of the intended PEEP but a need for an increasing number of terms to designate the various measured
outcomes that can be displayed. With the increased significance of the concept of a baseline airway pressure on
such ventilators (for further information see 3.10.1), and because the intended PEEP is simply a specific point
on that baseline, there is now a strong case for using the set BAP as the designator for both. This then leaves
the acronym PEEP, along with its various post-coordinations, free to designate only measured quantities on
those ventilators where there are one or more measured values to be displayed or recorded. However, on basic
ventilators and resuscitators, where the concept of baselines is not relevant, and where no independent measured
PEEP values are displayed or recorded, then it is logical to retain PEEP as the designator for the set value. These
considerations are the basis for the notation adopted in this document.

Note 4 to entry: The measured value of this quantity informs the operator as to how closely the actual airway
pressure at the end of expiration corresponded with the set BAP value.

Note 5 to entry: See BAP (3.10.2) for further information on the context in which PEEP is used in this document.

Note 6 to entry: See also measured (3.1.20), set (3.1.19), patient-connection port (3.14.5), airway pressure (3.6.1),
baseline airway pressure (3.10.1), expiratory pressure (3.6.9), actual value (3.1.22), total PEEP (3.10.6), auto-PEEP
(3.10.7), Post-coordinated terms G.1, Annex F and the Figures of Annex C.

3.10.5
expiratory-control algorithm
algorithm that determines the expiratory-pressure waveform of an expiratory phase
Note 1 to entry: The algorithm used for a specific ventilation-mode is specified by the manufacturer.

Note 2 to entry: The expiratory-control algorithm takes the relevant baseline airway pressure as its reference
throughout the corresponding phases. See Note 1 to baseline airway pressure (3.10.1).

Note 3 to entry: The main purpose of this algorithm is that of managing the expiratory-pressure waveforms
following inflations and unassisted inspirations in order to achieve a required objective(s) throughout each
expiratory phase.

Note 4 to entry: A basic expiratory-control algorithm can be no more than that of switching the expiratory valve
to its open state, leaving the expiratory flow waveform and the minimum expiratory pressure to be determined by
an expiratory pressure-relief function (commonly known as a PEEP valve), which is set to the required BAP level.
This relieves expiratory pressure by allowing expiratory flow to pass through to the exhaust port with minimal
resistance when it is above the BAP level, but which inhibits expiratory flow below that level. However, with this
arrangement, once the expiratory flow has ceased, any leakage from the ventilator breathing system or from an
airway device can cause the pressure to continue to fall so that by the end of expiration the measured airway
pressure, PEEP, could be below that set.

Note 5 to entry: Typically, expiratory-control algorithms are used to continuously control the expiratory-pressure
waveform during expirations in order to achieve an optimum rate of pressure decay. This can involve, for
example, achieving faster deflation of the lungs by temporarily reducing the airway pressure below the baseline
airway-pressure level in early expiration but bringing it back up to baseline airway pressure early enough to ensure
that the pressure in the lungs never decreases below the baseline airway-pressure level during that phase.

Note 6 to entry: With an expiratory-control algorithm acting in isolation during a BAP phase, an unassisted
inspiration might result in additional work of breathing; also, if there is a leak in the ventilator breathing system or
at the connection to the patient, the airway pressure might fall towards the ambient pressure, which will result in
a loss of the intended PEEP. Such consequences can be mitigated by the provision of a bias flow or prevented by
the provision of an ACAP adjunct, active at the BAP level.

Note 7 to entry: An increasing number of ventilators now use an expiratory-control algorithm to coordinate their
inspiratory and expiratory control functions in a way that generates required expiratory-pressure waveforms
irrespective of both inspiratory and expiratory flow. This can then be used in combination with the pressure-
regulation function to assure the maintenance of a constant pressure throughout even extended inspiratory and
expiratory phases of pressure-regulated assured inflations, thereby providing an ACAP (assured constant airway
pressure) adjunct.

Note 8 to entry: See also baseline airway pressure (3.10.1), expiratory-pressure (3.6.9), expiratory phase (3.4.2),
expiratory flow (3.7.5), unassisted breath (3.2.12), supported breath (3.2.13), expiratory pressure-relief (3.6.10),
BAP (3.10.2), PEEP (3.10.4), ACAP (3.12.1), A.4 – 3.12, Annex F and Figures F.3, F.6 and F.7.

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3.10.6
total PEEP
tPEEP
DEPRECATED: intrinsic PEEP
stabilized airway pressure at the end of an expiratory-hold procedure that temporarily occludes the
airway, in the absence of any respiratory activity.
Note 1 to entry: In addition to its direct reference, this term is only used in this document, in context or by
qualification, to designate this concept as a measured quantity (3.1.20).

Note 2 to entry: As the pressure at the patient-connection port falls during expiration, there is lag in the
corresponding rate of fall of the alveolar pressure, mainly due to airway resistance and flow limitation factors.
Usually, by the end of the expiratory phase, the alveolar pressure will equalize with the pressure at the patient
connection-port. However, when there is a short expiratory time or with a diseased lung, the average alveolar
pressure at the end of the expiratory phase can still be higher than the measured expiratory pressure, as the
pressures might not have had sufficient time to equilibrate. The amount by which this average alveolar pressure
exceeds the measured PEEP (positive end-expiratory pressure) cannot be measured directly, but its presence and
order of magnitude is commonly ascertained by the use of an expiratory-hold procedure.

Note 3 to entry: The airway-pressure measurement at the end of an expiratory-hold procedure is the average of
that of the pressurized gas in the alveoli that has been able to distribute uniformly throughout the lung during
the expiratory-hold time, but it might not fully include the contribution of any trapped alveolar gas. An accurate
measurement during this procedure is dependent upon the use of an expiratory-hold time that is sufficient to allow
pressure stabilization and on the absence of any respiratory activity during the hold.

Note 4 to entry: In the absence of any auto-PEEP, a measured total PEEP has the same value as the measured PEEP
for the same expiration and, therefore, has no relevance, other than to show that there is no auto-PEEP.

Note 5 to entry: Because of the diverse nature of a diseased lung there is currently no universally agreed definition
of what constitutes total PEEP in an artificially ventilated patient although there appears to be a consensus that
the value measured at the end of an expiratory-hold procedure during which there is no respiratory activity is the
most reliable. This has, therefore, been adopted as the reference method for the determination of the value of this
quantity in this document although a substantially equivalent value can be determined by other methods.

Note 6 to entry: See also airway pressure (3.6.1), expiratory-hold (3.4.6), airway (3.1.2), patient-connection port
(3.14.5), lung (3.1.16), expiratory pressure (3.6.9), auto-PEEP (3.10.7), PEEP (3.10.4), baseline airway pressure
(3.10.2), artificial ventilation (3.1.10), respiratory activity (3.2.6) and Annex F.

Note 7 to entry: Although sometimes used as a synonym for total PEEP, intrinsic PEEP is deprecated for use in
this document because, although the adjective ‘intrinsic’ implies that term is denoting the totality of the PEEP
within the lungs, there is a clear lack of consensus in medical publications and in manufacturers’ labelling as to
whether it should be used to denote the total PEEP or only the auto-PEEP portion of total PEEP.

3.10.7
auto-PEEP
AP
DEPRECATED: intrinsic PEEP
portion of the stabilized airway pressure above that set for the end-expiratory pressure, at the end of an
expiratory-hold procedure that temporarily occludes the airway and in the absence of any respiratory
activity
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a measured quantity (3.1.20)

Note 2 to entry: As the pressure at the patient-connection port falls during expiration, in the absence of respiratory
efforts there is an unavoidable lag in the corresponding rate of fall of the alveolar pressure, mainly due to airway
resistance and other flow-limiting factors. Normally, the effects of this lag will have fully dissipated by the end
of the expiratory phase, but with shorter expiratory times or with a diseased lung, the average alveolar pressure
might still be above the setting for the end-expiratory pressure at the end of the expiratory phase. It is this
additional pressure that was originally designated as auto-PEEP but as it is a quantity that cannot be measured
directly it is defined in this document in terms of the measurements obtained from an expiratory hold procedure.

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Note 3 to entry: If there is insufficient expiratory time for the expiratory pressure to reach its baseline airway-
pressure level before the end of the expiratory phase then the measured PEEP will be greater than that intended
by the BAP setting.

Note 4 to entry: This concept, although originally described using the name auto-PEEP, has since been referred
to as intrinsic PEEP, occult PEEP, inadvertent PEEP, endogenous PEEP and internal PEEP. In the absence of
standardization, and with inadequate transparency in the meaning of these alternative names, there has been
little consensus as to whether they are synonyms of auto-PEEP or of total PEEP, whereas the ‘auto’ in auto-PEEP
provides a clear disassociation from the ‘set’ portion of total PEEP.

Because of its common use in the related scientific literature, the letter symbol for intrinsic PEEP, PEEPi, is
also sometimes used to denote auto-PEEP, on the basis that the two terms are synonyms. This practice is not
deprecated, providing it is a true synonym for auto-PEEP, although it is considered that the term auto-PEEP is
sufficiently concise that the use of a letter symbol that might cause some confusion, is not justified.

The abbreviation AP is included as an admitted term in this document so that it can be used in descriptive text
requiring repeated use of the term, but it is not advocated for user-interface labelling.

Note 5 to entry: As with respiratory system compliance, a value for auto-PEEP can also be obtained during normal
uninterrupted ventilation. A typical means is the measurement of the change of airway pressure that is necessary
to cause the transition from residual expiratory flow to the commencement of inspiratory flow. This measured
value has become known as dynamic PEEP (PEEPi, dyn). However, although not deprecated, this method is not
considered to be sufficiently established to justify a separate entry in this edition of this document.

Note 6 to entry: See also total PEEP (3.10.6), PEEP (3.10.4), baseline airway pressure (3.10.1) and Figures F.1 to F.4.

3.11 * Mode terminology


3.11.1
ventilator operational mode
operational mode
way in which a ventilator is set to operate
EXAMPLE Standby; calibration; ventilator breathing system check; start-up procedure.

Note 1 to entry: NIV also becomes an operational mode if it is selectable as an option.

Note 2 to entry: In the absence of the selection of a specific alternative operational mode(s), when ventilation
is started, typically after a ventilator setup routine, a ventilator will commence ventilation using its intended
ventilation-mode and as configured by the operator’s settings and selections.

Note 3 to entry: See also ventilator (3.1.1), set (3.1.19), ventilator breathing system (3.1.18) and NIV (3.1.15).

3.11.2
ventilation-mode
specified manner in which a ventilator performs its ventilatory function when connected to a patient
Note 1 to entry: Although a large number of ventilation-modes have been described since mechanical ventilation
was introduced, all can be seen to be comprised of two key features. These are, the method employed to make
the necessary contribution to the inflation of the patient's lungs and the patterns with which these contributions
occur, based on elapsed time or relative to any respiratory activity of the patient. Increasingly, these two features
have been separately identified, classified and taught, and this practice has been formalized in this document,
the development of which led to the adoption of the terms inflation-type and ventilation-pattern for their separate
designation.

More recently, the introduction of microprocessor controls has led to the construction of adult ventilators with
a built-in facility for a patient to be able to make unrestricted expirations, as well as inspirations, at any time,
including during an inflation at a constant pressure level - a feature previously confined to infant ventilators. This
feature is separately identified in this document as an ACAP adjunct.

Note 2 to entry: In this document, specific classification schemes have been introduced for ventilation-modes,
inflation-types, ventilation-patterns and ventilation-mode adjuncts. These serve, not only to facilitate their
identification and relationships, but as a basis for systematic naming and coding. For further information see
Annexes D and E.

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Note 3 to entry: Some ventilation-modes, or specific setting protocols for such modes, have a particular feature(s)
that has been seen to justify an alternative name; a name that places emphasis on that feature. Names of such
modes, which may be generic or proprietary, are classified as alternative mode names (3.11.20). Examples of such
generic ventilation-mode names are bi-level AV and APRV (airway pressure release ventilation).

Note 4 to entry: Other ventilation-modes incorporate an additional supervisory function that is considered to
distinguish it from the underlying pattern-based ventilation-mode to the extent that it too justifies a separate
identity. Such a ventilation-mode is separately classified as a superordinate mode. Most of such ventilation-modes
have proprietary names but an example of a generic ventilation-mode of this type is MMV.

Note 5 to entry: If a ventilator is set to automatically switch between alternative ventilation-modes when
specified conditions are fulfilled, independent of whether an alarm condition is generated, in this document this
arrangement may also be given a superordinate mode name. However, its systematic coding will require that both
ventilation-modes are identified and that their systematic codes are linked by arrow symbols, as used to indicate
dual-control inflation-types, for example, CSV-PS → CMV-VC. (See D.2.8.3, D.2.8.4 and Table D.3 for dual-control
inflation-types).

Note 6 to entry: Although alternative and superordinate mode names, whether generic or proprietary, are adopted
or permitted by this document as indicators of the additional or supervisory feature, they will not provide a
complete description of the ventilation-mode without reference to the systematic code of the pattern-based
ventilation-mode on which it is based, along with an explanation of the alternative or additional feature.

Note 7 to entry: See also ventilator (3.1.1), ventilation (3.1.9), respiratory activity (3.2.6), ventilation-pattern
(3.11.3), inflation-type (3.3.2), adjunct (3.11.4), ventilation-mode group (3.11.5), alternative mode name (3.11.20),
superordinate mode (3.11.21), systematic ventilation-mode name (3.11.19) and Tables E.1 and E.2.

3.11.3
ventilation-pattern
specified temporal pattern of sequenced interactions between a ventilator and the patient, including
which, when and by what, selected inflation-types are initiated
Note 1 to entry: The ventilation-pattern also determines which inflation-types are appropriate for use with that
pattern.

Note 2 to entry: Ventilation-patterns are invariably too complex to fully classify using a few simple words. It has
therefore become customary to identify them by means of short descriptive names or by easily remembered
associated abbreviations or acronyms although, because of a lack of standardization, the meanings attached to
these identifiers have become very variable. However, in most cases the name has not been restricted to use with
a specific inflation-type and it is therefore equally suitable to name just the ventilation-pattern. In this document,
well established, non-proprietary ventilation-mode acronyms, or their names, have been adopted wherever
possible as the generic names for the principle ventilation-patterns associated with them.

Note 3 to entry: When a named ventilation-pattern is selected, the features specified for that pattern in this
document will be made available for setting and described in the instructions for use. However, it is necessary to
recognize that, with some modern ventilators, particularly those with an ACAP adjunct, it is inevitable that some
ventilation-modes can be set in such a way that they generate specific pressure or flow waveforms that could also
be obtained with specific settings of a ventilation-mode with a different ventilation-pattern selected.

Note 4 to entry: The names or codes used to identify ventilation-patterns in this document are only used as
systematic names or codes for ventilation-modes that conform to the definitions provided in this document. A
ventilation-pattern that does not conform in this way should be described in terms of the most similar ventilation-
pattern, with an explanation of the differences.

Note 5 to entry: A specified ventilation-pattern, together with a specified inflation-type(s) and the type of any
ventilation-mode adjunct, constitutes the core, systematic name of any ventilation-mode used for positive-pressure
ventilation. In referring to groups of ventilation-modes that make use of the same ventilation-pattern, the acronym
(or name) of that shared ventilation-pattern may be used for the designation of each of those ventilation-mode
groups, as illustrated, for example, in Note 4 to entry of 3.11.5.2 (although acronyms or names of shared inflation-
types may not be used in the same way).

Note 6 to entry: A ventilation-pattern is independent of the inflation-type(s) selected and of the set values for
parameters such as the set rate, inspiratory pressure and phase time ratio.

Note 7 to entry: See also inflation-type (3.3.2), ventilation-mode (3.11.2), adjunct (3.11.4), Annexes E, H and I, and
Tables E.1 and E.2.

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3.11.4
adjunct
ventilation-mode adjunct
function of a ventilator, which provides ancillary actions to a ventilation-mode
EXAMPLE 1 ACAP.

EXAMPLE 2 Tube compensation.

EXAMPLE 3 Leak compensations.

EXAMPLE 4 Ventilator breathing system compliance compensation.

Note 1 to entry: NIV is also classified as an adjunct if it is permanently active.

Note 2 to entry: A ventilation-mode adjunct can be, for example, permanently active, operator-initiated or
configured by the responsible organization or manufacturer to become active when a particular ventilation-mode
is selected. Additional properties that are selectable by the operator in order to modify a specific ventilation-
pattern or inflation-type are considered to be optional variations, not ventilation-mode adjuncts.

Note 3 to entry: The ancillary actions are adjunctive in that they only make changes that supplement the intended
effect of the selected ventilation-modes and their settings.

Note 4 to entry: See also ventilation-mode (3.11.2), adjunct (3.11.4) and NIV (3.1.15).

3.11.5
* ventilation-mode group
group of ventilation-modes that share fundamental features with respect to the characteristics of their
ventilation-patterns
Note 1 to entry: The systematic grouping described in this subclause has been introduced with the intent of
helping with the discussion, understanding, memorization and teaching of how the various ventilation-modes
relate to each other in terms of their functional characteristics.

Note 2 to entry: The characterization of ventilation-modes into groups in the labelling of ventilators is not
a requirement for conformity with this document but where the groupings described in this document are
employed, they are required to be in accord with those descriptions.

Note 3 to entry: See also Rationale A.4 - 3.11.5, ventilation-mode (3.11.2), ventilation-pattern (3.11.3) and
Tables E.1 and E.2.

3.11.5.1
ventilation-mode Group 1
group of ventilation-modes sharing ventilation-patterns in which only one inflation-type can be selected
at a time, this being assured to be initiated at least at the set rate
Note 1 to entry: The inflation-type selected is also referred to in this document by its generic, purpose-
classification, that is, assured inflation-type.

Note 2 to entry: See also inflation-type (3.3.2), assured inflation (3.3.11), initiate (3.9.1), set (3.1.19), set rate
(3.5.1.1) and assured inflation-type (3.3.12).

3.11.5.1.1
ventilation-mode Group 1a
subset of Group 1 ventilation-modes with no provision for the selected inflation-type to be initiated by a
patient-trigger event
EXAMPLE CMV (continuous mandatory ventilation) mode.

Note 1 to entry: With Group 1a modes, there is no assurance that spontaneous breaths (3.2.3) will be facilitated
except where ACAP (3.12.1) is provided as an adjunct (3.11.4).

Note 2 to entry: See also patient-trigger event (3.9.6) and CMV (3.11.7).

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3.11.5.1.2
ventilation-mode Group 1b
subset of Group 1 ventilation-modes in which the selected inflation-type is assured to be initiated at
successive intervals determined by the set rate if not initiated within such an interval by a patient-
trigger event.
EXAMPLE Assist/control (A/C) ventilation-mode.

Note 1 to entry: In the absence of patient-trigger events, assured inflations are initiated at intervals of 1/set-rate
minutes. Patient-trigger events can initiate the selected assured inflation-type at a rate greater than that assured
by the set rate. It follows that although all assured deliveries are of the assured inflations-type, not all deliveries of
the selected assured inflation-type occur because they are assured.

Note 2 to entry: See also assist/control ventilation (3.11.8), assured inflation-type (3.3.12) and assured inflation-
type rate (3.5.2.1).

3.11.5.2
ventilation-mode Group 2
group of ventilation-modes sharing ventilation-patterns in which an inflation-type is selected to be
initiated at the set rate; between these assured inflations spontaneous breathing is possible, which can be
either unassisted or supported by a selected support inflation-type
Note 1 to entry: On ventilators with an ACAP adjunct any inspiration occurring concurrently with a pressure-
control assured inflation, can be supported by either the selected support inflation-type if its inspiratory pressure
is set to be greater than that of the assured inflation, or by a second selected support inflation-type.

Note 2 to entry: The inflation-type selected to be initiated at the set rate is also referred to in this document by its
generic, purpose-classification, that is, assured inflation-type (3.3.12).

Note 3 to entry: The inflation-type selected to support any spontaneous breaths not assisted by an assured inflation
is also referred to in this document by its generic, purpose-classification, that is, support inflation-type (3.3.14).
This grouping does not preclude the possibility for the selected support inflation-type to be set to provide zero
support in order to facilitate unrestricted breathing between assured inflations.

Note 4 to entry: Group 2 ventilation-modes include those based on the well-established ventilation-patterns used in
IMV (intermittent mandatory ventilation) and SIMV (synchronized intermittent mandatory ventilation) modes. The
scope of any ventilation-mode in this group is independent of whether spontaneous breaths are set to be supported
or not between the assured inflations or whether these inflations are assured to be initiated at an unusual set rate,
for example, at only once per minute, in order to recruit the patient's lungs.

Note 5 to entry: See also rate (3.5.1.1), unassisted breath (3.2.12) and supported breath (3.2.13), support inflation
(3.3.13), assured inflation (3.3.11), assured inflation cycle (3.4.18), ACAP (3.12.1) and adjunct (3.11.4).

3.11.5.2.1
ventilation-mode Group 2a
subset of Group 2 ventilation-modes with no provision for the assured inflations to be initiated by a
patient-trigger event
EXAMPLE IMV (intermittent mandatory ventilation) mode.

3.11.5.2.2
ventilation-mode Group 2b
subset of Group 2 ventilation modes with the initiation of each assured inflation being synchronized with
any spontaneous breathing while maintaining the set rate
EXAMPLE SIMV (synchronized intermittent mandatory ventilation) mode.

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3.11.5.3
ventilation-mode Group 3
group of ventilation-modes sharing ventilation-patterns in which every patient-trigger event initiates
a selected inflation-type; if a patient-trigger event does not occur within a set time interval a second
selected inflation-type is initiated by the ventilator
Note 1 to entry: The ventilation-modes in this Group are typically used in ventilators intended for patients that
are not ventilator-dependent but need some support with each breath and might need assured ventilation during
short periods of apnoea.

Note 2 to entry: Group 3 ventilation-modes include those based on the ventilation-pattern used in S/T (spontaneous/
timed) ventilation-modes.

3.11.5.4
ventilation-mode Group 4
group of ventilation-modes sharing ventilation-patterns that enable continuous unrestricted breathing or
continuous supported breathing, always with a constant baseline airway pressure at the set BAP level
Note 1 to entry: In this group of ventilation-modes no inflation is assured to be initiated. If apnoea ventilation is
provided for instances of apnoea then this is classified in this document as an automatic change of ventilation-mode.

Note 2 to entry: Group 4 ventilation-modes include those based on the well-established ventilation-patterns used
in CSV (continuous spontaneous ventilation) and CPAP (continuous positive airway pressure) ventilation-modes.

Note 3 to entry: See also unrestricted breathing (3.2.5), supported breath (3.2.13), baseline airway pressure
(3.10.1), pressure-support (3.3.6), effort-support (3.3.7), CSV (3.11.12) and CPAP (3.11.15).

3.11.5.4.1
ventilation-mode Group 4a
subset of Group 4 ventilation-modes with provision to support each inspiratory activity that exceeds a
threshold value
EXAMPLE CSV (continuous spontaneous ventilation) mode.

Note 1 to entry: The support provided in Group 4a ventilation-modes can be by means of pressure-support (PS)
or effort-support (ES) inflation-types. With pressure-support the threshold value will be a set value, with effort-
support the threshold will be the minimum value resolvable by the ventilator.

3.11.5.4.2
ventilation-mode Group 4b
subset of Group 4 ventilation-modes with no provision to support any inspiratory activity
EXAMPLE CPAP (continuous positive airway pressure) ventilation-mode.

3.11.6
* assured ventilation
mandatory ventilation
patient ventilation by assured inflations
Note 1 to entry: The duration of an assured ventilation episode can be that of a single breath or of a sequence of
breaths, ending when a non-synchronising patient-trigger event occurs.

Note 2 to entry: The term assured ventilation is used in this document to better represent the core concept of the
classical ventilation-modes, CMV (continuous mandatory ventilation), IMV (intermittent mandatory ventilation) and
SIMV (synchronized intermittent mandatory ventilation). Mandatory ventilation is retained as an admitted term
for this concept in order to provide a link between the use of the word mandatory in the ventilation-mode name
and the more relevant interpretation of its meaning in this document, that is, the assurance provided by its being
required to occur. [See also mandatory (3.9.9)]

Note 3 to entry: It is only assured inflation-types delivered at the set rate that contribute to assured ventilation.
Assured inflation-types that are patient-triggered, and that increase the rate above that set, are not assured
inflations and do not contribute to assured ventilation. (See also assured inflation-type (3.3.12).

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Note 4 to entry: With some Group 2 ventilation-modes, for example, SIMV, the assured inflations are assured to be
delivered at the set rate but are also required to be synchronized with any spontaneous breaths. This is achieved
by the use of a synchronization window that is opened at equal intervals. The actual initiation of that inflation
is then either patient-triggered within that window or ventilator-initiated when the window is terminated. This
ensures that the assured inflations will be delivered at the set rate although there might be small variations in the
inflation-to-inflation interval as a consequence of the synchronization.

Note 5 to entry: It is the intent to deprecate the admitted term mandatory ventilation, other than when used as
part of a ventilation-mode name, in future editions of this document.

3.11.7
CMV
continuous mandatory ventilation
DEPRECATED: continuous mechanical ventilation
DEPRECATED: controlled mechanical ventilation
DEPRECATED: IPPV
DEPRECATED: CPPV
name of a ventilation-pattern in which a selected inflation-type is assured to be initiated at intervals
determined by the set rate, with no facility for any inflation to be initiated by a patient-trigger event
Note 1 to entry: The selected inflation-type is classed as the assured inflation-type and every inflation may be
referred to as an assured inflation.

Note 2 to entry: The interval determined by the set rate is 1/set-rate minutes.

Note 3 to entry: This is the characteristic ventilation-pattern of Group 1a ventilation-modes. See Figures C.15 and
C.16 for schematic illustrations of this pattern.

Note 4 to entry: The abbreviation, CMV, related to this concept is retained because it is well established, although
a number of different names have been associated with it. In this document, it is used only for a ventilation-
pattern that does not respond to patient-trigger events of any magnitude (that is, its function is the same as assist/
control (A/C) ventilation with its trigger function off).

Note 5 to entry: Although not now widely used on critical care ventilators, ventilation-modes with this pattern are
still used on some simpler resuscitation and transport and emergency ventilators.

Note 6 to entry: On ventilators with an ACAP adjunct it is possible to set a ventilation-mode with this pattern so
that it resembles one with an IMV (intermittent mandatory ventilation) pattern. In such a case, the manufacturer’s
description of the ventilation-mode determines its appropriate designation.

Note 7 to entry: See also ventilation-pattern (3.11.3), inflation (3.3.1), inflation-type (3.3.2), assured inflation-type
(3.3.12) trigger (3.9.2), Figures C.15, C.16, and C.22 to C.25.

3.11.8
assist/control ventilation
A/C ventilation
A/C
name of a ventilation-pattern in which a selected inflation-type is assured to be initiated at intervals
determined by the set rate, unless initiated by an earlier patient-trigger event
Note 1 to entry: With this ventilation-pattern, the selected inflation-type is classed as the assured inflation-type as
the operator is assured that it will be initiated at least at the set rate. However, any patient-trigger event will result
in a total inflation rate in excess of that set and give rise to additional breaths and additional minute volume. It is
usually not then possible to identify any one of the resulting breaths as an additional breath; it is only possible to
deduce the number of additional breaths per minute by comparing the total inflation rate with the set rate.

Note 2 to entry: The interval determined by the ventilator set rate is, 1/set-rate minutes.

Note 3 to entry: This ventilation-pattern name is descriptive of its function in that every patient-trigger event
initiates the generation of an assisted breath whereas a controlled breath is generated if no patient-trigger event
occurs within the interval determined by the set rate.

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Note 4 to entry: The preferred terms are those advocated for use in a written format, with the forward slash
being a key element by indicating that with this ventilation-pattern the ventilator will either assist a spontaneous
breath or control the generation of a breath in the absence of a patient-trigger event. However, the term is typically
spoken as ‘assist control ventilation’.

Note 5 to entry: This is the characteristic ventilation-pattern of Group 1b ventilation-modes. See Figure C.17 for a
schematic illustration of this pattern.

Note 6 to entry: See also ventilation-pattern (3.11.3), ventilator (3.1.1), initiate (3.9.1), patient-trigger event (3.9.6),
assured inflation-type (3.3.12), assured inflation (3.3.11), additional breath (3.2.8), additional minute volume
(3.8.12), total inflation rate (3.5.1.5), assisted breath (3.2.14), controlled breath (3.2.16), spontaneous breath
(3.2.3) and Figures C.17 and C.26 to C.28.

3.11.9
IMV
intermittent mandatory ventilation
name of a ventilation-pattern in which a selected inflation-type is always initiated at a constant interval,
as determined by the ventilator set rate; between these assured deliveries, unrestricted breathing is
possible or spontaneous inspirations may be supported by a second selected inflation-type
Note 1 to entry: The inflation-type selected for delivery at the set rate is classed as the assured inflation-type and
the second inflation-type selected is classed as a support inflation-type.

Note 2 to entry: On ventilators with an ACAP adjunct any inspirations occurring concurrently with a pressure-
control assured inflation-type, may be assisted by either the selected support inflation-type or by an additional,
third selected inflation-type (which can also be referred to as the second support inflation-type).

Note 3 to entry: This is the characteristic ventilation-pattern of Group 2a ventilation-modes. See Figure C.18 for a
schematic illustration of this pattern.

Note 4 to entry: It is possible to set ventilation-modes conforming to this pattern so that they resemble modes
with a CMV (continuous mandatory ventilation)-pattern on ventilators with an ACAP adjunct. In such cases the
manufacturer’s description of the ventilation-mode determines its appropriate designation.

Note 5 to entry: See also ventilation-pattern (3.11.3), initiate (3.9.1), set (3.1.19), set rate (3.5.1.1), unrestricted
breath (3.2.5), ventilation-mode group (3.11.5), Annex B, and Figures C.18, C.31 and C.32.

3.11.10
SIMV
synchronized intermittent mandatory ventilation
name of a ventilation-pattern in which a selected inflation-type is initiated at the set rate but with
each initiation being synchronized with any spontaneous breathing; between these assured inflations
unrestricted breathing is possible or spontaneous inspirations may be supported by a second selected
inflation-type
Note 1 to entry: Synchronization is achieved by the use of a synchronization window, which provides time for the
initiation of the assured inflation to be in phase with any preceding spontaneous breath in order to minimize the
possibility of breath stacking. It achieves this by allowing either direct patient initiation during the synchronization
window or time for expiration of any spontaneous breath not completed.

Note 2 to entry: The synchronization window is configured so that the initiation of each inflation is synchronized
with any spontaneous breathing while maintaining the assured average rate of delivery as determined by the
set rate.

Note 3 to entry: The inflation-type selected for delivery at the set rate is classed as the assured inflation-type and
the second inflation-type selected is classed as a support inflation-type.

Note 4 to entry: On ventilators with an ACAP adjunct any inspirations occurring concurrently with a pressure-
control assured inflation-type, may be assisted by either the selected support inflation-type or by an additional,
third selected inflation-type (which can also be referred to as the second support inflation-type).

Note 5 to entry: This is the characteristic ventilation-pattern of Group 2b ventilation-modes. See Figure C.19 for a
schematic illustration of this pattern.

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Note 6 to entry: See also ventilation-pattern (3.11.3), unrestricted breathing (3.2.5), assured inflation (3.3.11),
set rate (3.5.1.1), assured-inflation type (3.3.12), support inflation (3.3.13), synchronization window (3.9.8), ACAP
(3.12.1), breath stacking (3.9.11), IMV (3.11.9), Annex A, Annex B and Figures C.19, C.29, C.30 and C.33.

3.11.11
S/T ventilation
S/T
spontaneous/timed ventilation
name of a ventilation-pattern in which every patient-trigger event initiates an inflation of the selected
support inflation-type; if a patient-trigger event does not occur within a set time interval assured
ventilation is provided by a second selected inflation-type that is initiated by the ventilator
Note 1 to entry: The inflation-type selected for patient initiation is also referred to in this document by its generic,
purpose-classification, that is, either a support inflation-type or an effort-support inflation-type.

Note 2 to entry: The inflation-type selected for providing assured ventilation can have the same settings as that
selected for patient initiation but will typically be, for example, a PC, vtPC or PC(q) inflation-type.

Note 3 to entry: In the absence of patient-trigger events, assured inflations will be delivered at intervals of 1/set-
rate minutes.

Note 4 to entry: Patient-trigger events cause an increase in the total inflation rate above that determined by the
set rate.

Note 5 to entry: This is the characteristic ventilation-pattern of Group 3 ventilation-modes. See Figure C.20 for a
schematic illustration of this pattern.

Note 6 to entry: Ventilation-modes with a single inflation-type other than a support inflation-type, that can be
initiated by either a patient-trigger event or the ventilator, are classified as assist/control (A/C) ventilation-modes.

Note 7 to entry: See also ventilation-pattern (3.11.3), patient-trigger event (3.9.6), initiate (3.9.1), support inflation-
type (3.3.14), assured ventilation (3.11.6), assured inflation (3.3.11), set rate (3.5.1.1), total inflation rate (3.5.1.5),
assured inflation-type (3.3.12), assist/control ventilation (3.11.8) and Figure C.20.

3.11.12
CSV
continuous spontaneous ventilation
SPONT
name of a ventilation-pattern that enables continuous supported breathing with a continuously constant
baseline airway pressure
Note 1 to entry: With CSV, although each spontaneous breath can be assisted by a support inflation no assured
ventilation is provided.

Note 2 to entry: With pressure-support set to ‘zero’, or its minimum setting, ventilation-modes using this ventilation-
pattern might appear to function in a similar manner to the CPAP ventilation-pattern but because pressure-support
is still selected it cannot be designated as CPAP. In this document, a ventilation-mode classification is independent
of the setting used.

Note 3 to entry: A CSV ventilation-mode may be reidentified as a CPAP mode on the user interface if the pressure-
support is deselected, providing it acts to maintain the airway pressure at its constant level in a manner that is
independent of any trigger setting. The set level may then either retain the label BAP on the user interface or
become relabelled as CPAP.

Note 4 to entry: This is the characteristic ventilation-pattern of Group 3a ventilation-modes. See Figure C.21 for a
schematic illustration of this ventilation-pattern.

Note 5 to entry: See also supported breath (3.2.13), support inflation (3.3.13), assured ventilation (3.11.6), CPAP
(3.11.15) and Figures C.21, C.34 and F.7 b).

Note 6 to entry: Ventilation-modes using this ventilation-pattern are commonly labelled on user interfaces with
abbreviations of ‘spontaneous’, such as ‘SPONT’, ‘SPN’ and ‘SPON’.

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3.11.13
MMV
minimum minute volume
DEPRECATED: mandatory minute volume
generic name of a superordinate-mode that provides assurance to the operator that the patient will
receive at least the set minute volume in accordance with the selected ventilation-mode algorithm
EXAMPLE 1 Ventilation-mode using an SIMV ventilation-pattern where the set rate is adjusted by the MMV
algorithm to maintain the set minute volume until the lower limit of the setting is reached.

EXAMPLE 2 Ventilation-mode using an SIMV ventilation-pattern where the set rate and the set tidal volume
parameters are both continually automatically adjusted in relation to each other in accordance with an
established minimum respiratory work of breathing equation and lung protective strategy algorithms, while
maintaining the operator-set minimum minute volume whenever safely possible.

Note 1 to entry: It is possible for the patient to demand minute volumes in excess of the set value.

Note 2 to entry: This is not to be confused with ‘mandatory minute ventilation’, which was the first implementation
of a ventilation-mode that was described by this abbreviation. That implementation was an adaptation of a
ventilator intended for use during anaesthesia in the operating room and did not provide for spontaneous
ventilation in excess of the set minute volume. It was not, therefore, suitable in that form for unattended or
longer-term ventilation. Subsequent developments of the concept have eliminated that restriction and led to its
replacement by various forms of ‘minimum minute volume’ ventilation (see Examples 1 and 2).

Note 3 to entry: This is a superordinate mode name because it does not describe a ventilation-pattern; it is simply
a named ventilatory objective. This objective can be implemented with more than one pattern-based mode but
in each case necessarily involving the operator transferring the responsibility for the adjustment of certain
parameter settings to the ventilation-mode algorithm. Intrinsic to such algorithms, is the automatic adjustment of
certain initial settings over time, according to the respiratory activity of the patient.

Note 4 to entry: See also superordinate mode (3.11.21), respiratory activity (3.2.6), set (3.1.19), minute volume
(3.8.6), ventilation-pattern (3.11.3), ventilation-mode (3.11.2) and set rate (3.5.1.1).

3.11.14
* APRV
airway pressure release ventilation
alternatively named specific setting protocol of a bi-level AV ventilation-mode in which the patient is
intended to take unrestricted breaths during an extended assured-inflation phase at the BAPH level and
in which the BAP phase is intended to be set to terminate as soon as the alveolar pressure has had time
to descend to the BAP level
Note 1 to entry: APRV is an alternative name for a specific setting protocol for ventilation-modes such as IMV-PC
<ACAP> or IMV-PC{S} <ACAP>; settings that give extreme inverse phase time ratios (t H:t L) such that the patient
takes unrestricted breaths at a relatively high baseline airway pressure while being artificially ventilated by short
intermittent airway pressure releases.

Note 2 to entry: Ventilators supporting this protocol can offer means of setting an appropriate duration for the
alveolar pressure to have time to descend to the BAP level that include a time setting or based on the elapsed time
for the expiratory flow, the expiratory pressure or an EMG signal to reduce by a set amount or to a set level. If the
necessarily extreme inverse phase time ratios are made available, it is possible to achieve the intended function of
APRV by making specific settings on any of a range of bi-level AV modes, of which IMV-PC <ACAP> is an example.

Note 3 to entry: The terminology used in this entry is that which is appropriate for the labelling of a bi-level AV
ventilation-mode to be set to an APRV protocol.

Note 4 to entry: Ventilation-modes in which the settings and features have been configured with the specific
intention of facilitating this setting protocol may be labelled as APRV as an alternative mode name, although,
as with all alternative mode names, the full specification is incomplete without a disclosure of the underlying
systematic ventilation-mode name.

Note 5 to entry: See also bi-level AV (3.12.4), assured-inflation (3.3.11), inflation phase (3.4.10), BAP H (3.12.7), BAP
phase (3.10.3), terminate (3.9.14), unrestricted breathing (3.2.5), phase time ratio (3.4.19), baseline airway pressure
(3.10.1), artificial ventilation (3.1.10), airway pressure (3.6.1), Figures C.31 and C.32, and A.4 - 3.11.14.

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3.11.15
CPAP
continuous positive airway pressure
ventilation-mode or sleep-apnoea breathing-therapy mode in which the patient breathes continuously at a
set airway-pressure level, above ambient pressure
Note 1 to entry: CPAP is intended to maintain the airway pressure at its set value apart from the inevitable minor
deviations that are necessary for it to perform its function. Although there are currently no tests for acceptable
levels for such deviations, they are expected to neither add to nor subtract from the patient's perceived work of
breathing to a greater extent than could be experienced during natural breathing.

Note 2 to entry: This definition excludes the use of the term to describe ventilation-modes where spontaneous
inspirations are supported by intermittently elevated pressures other than with the intention to compensate for
any actual or perceived imposed work of breathing.

Note 3 to entry: Because, as used for this ventilation-mode, the concept of a CPAP level coincides with that of a
baseline airway pressure the setting could be designated as for either concept but as the intention of the operator
selecting this ventilation-mode will be to achieve a specific CPAP level, this becomes an acceptable admitted term
to designate the set quantity.

Note 4 to entry: Although at the periphery of the spectrum of what constitutes a ventilation-mode, CPAP is
included in this document because it is commonly made available on typical critical care ventilators for use as
part of a continuum of a patient's treatment without the necessity to change to another device.

Note 5 to entry: It is possible for a ventilation-mode resembling CPAP to be realized on a ventilator by the use of
CSV (continuous spontaneous ventilation) with the pressure-support (PS) set to ‘zero’ or ‘none’ but CSV set in this
way is not equivalent to CPAP if its performance in response to a spontaneous inspiration is dependent on the
setting of an appropriate trigger level.

Note 6 to entry: On ventilators equipped with ACAP, this adjunct will enable unrestricted breathing whenever
CPAP is selected.

Note 7 to entry: CPAP is a Group 4b ventilation-mode. Because no inflation-type is selected this ventilation-mode
is identical to its ventilation-pattern and there is no necessity to distinguish between them. The systematic
ventilation-mode name becomes, therefore, simply, CPAP. On ventilators where CPAP is enabled by means of an
ACAP adjunct the systematic code is CPAP <ACAP>.

Note 8 to entry: When used for sleep-apnoea breathing-therapy, CPAP is not classed as a ventilation-mode - it
becomes a sleep-apnoea breathing-therapy mode. Although the principle clinical intention of such a therapy mode
is to maintain a positive pressure in the patient's airway during sleep in order prevent airway obstruction by the
soft tissues in the throat it has become a common practice to reduce this pressure during expiration, principally
to improve patient acceptability. Ventilation-modes with this feature are typically identified with names that
allude to this use of two levels of positive airway pressure. The generic name adopted for the designation of such a
breathing-therapy mode in this document is bi-level PAP.

Note 9 to entry: See also natural breathing (3.2.4), unrestricted breath (3.2.5), baseline airway pressure (3.10.1),
pressure-support (3.3.6), breathing-therapy mode (3.11.22), CSV (3.11.12), ventilation-mode Group 4b (3.11.5.4.2),
ACAP (3.12.1), bi-level PAP (3.12.5), A.4 - 3.12, and Figure C.2.

3.11.16
apnoea ventilation
apnea ventilation
safety provision by which the ventilator automatically switches to a predetermined ventilation-mode
that generates controlled breaths whenever a hypoventilation alarm condition occurs or when a breath
is not detected during a specified period of time
Note 1 to entry: A second preferred term for this concept is included in this document because each spelling of
the key base word, apnoea, is universally used in specific spheres of influence; both within and outside of the
scope of this document.

Note 2 to entry: See also controlled breath (3.2.16), alarm condition (Annex J), and backup ventilation (3.11.17).

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3.11.17
backup ventilation
property of a ventilation-mode where the normal function is for the ventilator to automatically deliver
an inflation of a predetermined inflation-type when a breath is not detected during a set period
Note 1 to entry: An alarm condition is not generated when a backup ventilation inflation is delivered.

3.11.18
fail-safe ventilation
DEPRECATED: apnea ventilation
DEPRECATED: apnoea ventilation
DEPRECATED: backup ventilation
safety provision by which the ventilator automatically switches to a predetermined alternative
ventilation-mode intended to maintain patient safety in the event of a component, sensor or function
becoming inoperable
Note 1 to entry: Such provisions could be necessitated by a ventilator component failure such as pressure sensor
failure or a microprocessor failure.

Note 2 to entry: The automatic initiation of fail-safe ventilation usually generates a technical alarm condition.

Note 3 to entry: See also apnoea ventilation (3.11.16).

3.11.19
systematic ventilation-mode name
systematic mode name
methodically derived designation for any specific ventilation-mode based on its ventilation-pattern, the
inflation-type(s) used and any active adjuncts
Note 1 to entry: The concept of a systematic ventilation-mode name has been introduced into this document to
provide the basis for a unique coding system with the capability of identifying any ventilation-mode that is within
the scope of this document to the high level of granularity facilitated by the relevant definitions and tables in this
document. In the case of a superordinate mode or the use of an alternative mode name, it is used to identify the
ventilation-pattern based ventilation-mode that underlies its operation.

Note 2 to entry: The systematic ventilation-mode name may be represented either by its full name or in its coded
form but the conciseness of the coded form makes it more suitable for general use.

Note 3 to entry: See Tables E.1 and E.2 for illustrations of the structure of the systematic ventilation-mode name
and typical examples of both the systematic name and its associated code.

Note 4 to entry: The inclusion of any active ventilation-mode adjuncts can be indicated by either a global checkbox
covering all, or just specifically specified, ventilation-modes available on that ventilator or as an addition to any
individual code, enclosed between angled brackets (for example, <ACAP>).

Note 5 to entry: Wherever possible and appropriate, it is the abbreviations provided for any terms in this document
that should be employed in the formation of the systematic code for any specific ventilation-mode. Examples of
systematic ventilation-mode names in a coded form are A/C-VC, SIMV-VC\PS, IMV-PC\PS <ACAP> and CSV-PS.

Note 6 to entry: See also ventilation-pattern (3.11.3), inflation-type (3.3.2), adjunct (3.11.4), ACAP (assured constant
airway pressure) (3.12.1), Annexes D and E, Tables D.1, D.2 and D.3, Tables E.1 and E.2, and Tables I.1 and I.3.

3.11.20
alternative mode name
alternative ventilation-mode name
name used to identify a ventilation-mode, or a specific setting protocol for a ventilation-mode, which
is an alternative to the systematic ventilation-mode name, with the intention of placing emphasis on a
particular characteristic feature of that ventilation-mode or the manner in which it might be used
EXAMPLE 1 Bi-level AV (bi-level artificial ventilation).

EXAMPLE 2 APRV (airway pressure release ventilation).

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Note 1 to entry: The alternative name can be used to identify a single ventilation-mode, or several ventilation-
modes with the same characteristic feature or features.

Note 2 to entry: The alternative name can be either a standardized generic name or a proprietary name.

Note 3 to entry: The specification of an alternatively named ventilation-mode is incomplete without reference to
its systematic ventilation-mode name.

Note 4 to entry: The selection of a ventilation-pattern and inflation-types is fundamental to all ventilation-
modes but some such modes have overriding, clinically significant, combinations of features that have been
considered to justify their own generic or proprietary name. Such ventilation-modes sometimes use higher-
order or interventional control algorithms in order to achieve additional objectives, for example, a ventilation
strategy or procedure, and which have therefore been identified solely by a name relating only to that objective.
In other instances, specific combinations of ventilation-pattern, inflation-type(s) and range of settings have been
characterized by a name that puts emphasis on a particular ventilation concept. Although this practice can be
useful as a shorthand reference such ventilation-mode names do not currently provide a complete description.
A ventilation-mode selected on a ventilator using vocabulary conforming to that of this document will enable
identification of the standardized selected ventilation-pattern and selected inflation-type(s).

3.11.21
superordinate mode
one of a group of ventilation-modes that has a significant feature in addition to those of the underlying
ventilation pattern-based mode, and by which it is separately identified
Note 1 to entry: The additional feature is typically a supervisory function that is set to adjust the settings of the
controls of the ventilator automatically, with the intention of achieving a progressive care plan with the patient.

Note 2 to entry: The specification of a superordinate mode is incomplete without reference to the systematic
ventilation-mode name of the underlying ventilation-mode on which its operation depends.

Note 3 to entry: Examples of proprietary superordinate-mode names are SmartCare ®4), Automode®5) and ASV®6).

Note 4 to entry: See also alternative mode name (3.11.20) and systematic ventilation-mode name (3.11.19).

3.11.22
breathing-therapy mode
respiratory mode of a device that delivers a respirable gas at therapeutic breathing pressures to the
patient's airway with a primary intention other than to support a proportion of the patient's work of
breathing
EXAMPLE 1 Sleep-apnoea therapy.

EXAMPLE 2 CPAP.

EXAMPLE 3 High flow oxygen therapy.

EXAMPLE 4 Bi-level PAP.

Note 1 to entry: See also CPAP - Note 8 to entry (3.11.15), bi-level PAP (3.12.5), ventilation-mode (3.11.2), breath
(3.2.1) and airway (3.1.2).

4) SmartCare® is the trademark of a product supplied by Dräger Medical AG & Co. KG. This information is given
for the convenience of users of this document and does not constitute an endorsement by ISO of the product named.
Equivalent products may be used if they can be shown to lead to the same results.
5) Automode® is the trademark of a product supplied by Maquet Critical Care AB. This information is given for
the convenience of users of this document and does not constitute an endorsement by ISO of the product named.
Equivalent products may be used if they can be shown to lead to the same results.
6) ASV® is the trademark of a product supplied by Hamilton Medical AG. This information is given for the
convenience of users of this document and does not constitute an endorsement by ISO of the product named.
Equivalent products may be used if they can be shown to lead to the same results.

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ISO 19223:2019(E)

3.12 * Bi-level terminology


3.12.1
ACAP
assured constant airway pressure
built-in adjunct that enables unrestricted breathing by acting to maintain the airway pressure at its set
value, irrespective of inspiratory or expiratory flows, or specified permitted leakage, whenever it is
intended to be at a constant level
Note 1 to entry: This adjunct is intended to maintain the airway pressure at its set value apart from the inevitable
minor deviations that are necessary for it to perform its function. Although there are currently no standardized
tests for acceptable levels for such deviations, they are expected to neither add to nor subtract from the patient's
perceived work of breathing to a greater extent than might be experienced during natural breathing.

Note 2 to entry: If the ventilator is connected to the patient with an airway device with sufficient resistance to
hinder unrestricted breathing its effect can be offset if the operator selects a tube compensation (TC) function.

Note 3 to entry: The concept of an ACAP adjunct is that of a function that is built into the design of a ventilator. A
typical implementation of ACAP on a gas-powered ventilator might involve the use of a proportional expiratory
valve under the continuous control of an expiratory-control algorithm. When this is controlled in unison with
the control of a proportional inspiratory valve it becomes possible to generate the required pressure waveform,
irrespective of the possibly rapidly changing inspiratory and expiratory flows of natural breathing, during both
the inflation and expiratory phases of an assured-inflation cycle. This enables the patient to inspire and expire
at any time, at any BAP level, unassisted or supported. Unassisted inspirations are enabled by the provision of
demand flow that is proportional to the patient's demands, with no dependency on a patient-trigger event.

The additional functionality provided by ACAP is denoted with the term ‘open system’ by one manufacturer. This
is helpful in communicating a sense of its basic function in allowing free breathing to atmosphere but an ACAP
adjunct additionally facilitates the same free breathing with airway pressures maintained at constant levels above
that of the atmosphere. In most cases this is achieved without the use of a truly open system.

This adjunct can also be provided by a ventilator that uses alternative proportional gas control or pressure
generation elements.

Note 4 to entry: ACAP is typically configured to be active whenever appropriate for the selected ventilation-mode.

Note 5 to entry: Examples of instances of where ACAP is active, if provided, are

— during the intended constant-pressure portion of the waveform of a pressure-control (PC) assured inflation,

— after the expiratory pressure has stabilized at its BAP level during the expiratory phases of assured-inflation
cycles and between any support inflations,

— between any support inflations during CSV and continuously when pressure-support (PS) is set to ‘zero’ or
‘off’, and

— during CPAP ventilation-modes.

Note 6 to entry: The constant pressure levels at which ACAP is active become the baseline airway pressures for
that activity.

Note 7 to entry: For unassisted breaths, an ACAP adjunct facilitates unrestricted breathing by the generation of
demand flow in proportion to the patient's demands, without any trigger threshold, during inspiration and by the
provision of minimal resistance during expiration.

Note 8 to entry: Although this adjunct might not be required to maintain the baseline airway pressures if pressure-
support is provided during an expiratory phase, it will serve to prevent the pressure dropping below the set BAP
level towards the end of expiration due, for example, to any ventilator breathing system or airway leaks. It also
allows unrestricted breathing below the set trigger level, or when any pressure-support (PS) is switched off.

Note 9 to entry: Some of the functions of ACAP might also be achievable by using specific settings with certain
ventilation-modes but, although such settings can be described as providing an equivalent function to ACAP,
because its function is dependent on set values such an arrangement does not constitute an ACAP adjunct.
If equivalence is claimed, the means used to facilitate unrestricted breathing should be described in the
accompanying documents.

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Note 10 to entry: Group 2 ventilation-modes with a pressure-control inflation-type selected and an ACAP adjunct,
facilitate unrestricted inspirations and expirations at both pressure levels of the assured-inflation cycle and may,
therefore, be designated by the alternative mode name, bi-level AV.

Note 11 to entry: See also adjunct (3.11.4), ACAP L (3.12.2), ACAP H (3.12.3), unrestricted breathing (3.2.5), natural-
breathing (3.2.4), tube compensation (3.6.11), assured-inflation (3.3.11), support inflation (3.3.13), trigger level
(3.9.5), baseline airway pressure (3.10.1), BAP (3.10.2), bi-level AV (3.12.4), demand flow (3.7.10), D.2.8.5, Annex A.4
- 3.12, Annexes D, E and F, Tables D.1, E.1 and E.2, and Figures C.24, C.25, C.28, C.29 to C.33 and F.7.

3.12.2
ACAPL
ACAP-low
adjunct that enables unrestricted breathing by acting to maintain the expiratory pressure at the set BAP
level, irrespective of inspiratory or expiratory flows, or specified permitted leakage, after the expiratory
pressure has decreased to the BAP level during the expiratory phases of assured-inflation cycles and
between any support inflations
Note 1 to entry: As an adjunct that is only active during the expiratory phases of assured-inflation cycles, ACAP L
can be the most appropriate for use, for example, with a ventilation-mode using a flow-regulated inflation-type as
the assured inflation.

Note 2 to entry: This adjunct is intended to maintain the airway pressure at its set value apart from the inevitable
minor deviations that are necessary for ACAPL to perform its function. Although there are currently no
standardized tests for acceptable levels, with ACAPL , such deviations are expected to neither add to nor subtract
from the patient's perceived work of breathing to a greater extent than could be experienced during natural
breathing.

Note 3 to entry: Where provided, ACAPL is typically preselected to be active wherever appropriate - depending
on the ventilation-mode that has been selected.

Note 4 to entry: For unassisted breaths, an ACAPL adjunct typically facilitates unrestricted breathing at the BAP
level, by the generation of demand flow in proportion to the patient's demands, without any trigger threshold,
during inspiration and by the provision of minimal resistance during expiration.

Note 5 to entry: Although this adjunct might not be required to maintain the baseline airway pressure if pressure-
support (PS) is provided during an expiratory phase, it will serve to prevent the pressure dropping below the
set baseline airway pressure towards the end of expiration due, for example, to any ventilator breathing system
or airway leaks. It also allows natural breathing below the set trigger level, or when any pressure-support (PS) is
switched off.

Note 6 to entry: Some of the functions of ACAPL might also be achievable with the use of specific settings with
certain ventilation-modes but, although such settings might resemble an equivalent function to ACAP L , because its
function is dependent on set values such an arrangement does not constitute an ACAPL adjunct. If equivalence is
claimed, the means used to facilitate unrestricted breathing should be described in the accompanying documents.

Note 7 to entry: See also: adjunct (3.11.4), unrestricted breathing (3.2.5), set (3.1.19), BAP (3.10.2), baseline airway
pressure (3.10.1), demand flow (3.7.10), flow regulation (3.3.8), assured inflation (3.3.11), assured-inflation cycle
(3.4.18) and Figures C.23 and F.6.

3.12.3
ACAPH
ACAP-high
mode adjunct that maintains the airway pressure at its set assured-inflation inspiratory-pressure level,
irrespective of inspiratory or expiratory flows, whenever it is intended to be constant at that level
Note 1 to entry: Note to 1 entry: This adjunct is provided for use only during the inflation phases of pressure-
regulated assured-inflation cycles. ACAPH is not applicable during inflations with flow-regulated inflation-types,
for example, volume-control, because the inspiratory pressure is not intended to be at a constant level during such
inflations. If additional inspiratory flow is provided on demand with a volume-control inflation-type, this is classed
as a dual-control inflation not volume-control with ACAP.

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Note 2 to entry: This adjunct is intended to maintain the airway pressure at its set value with the exception of the
inevitable minor deviations that are necessary for ACAPH to perform its function. Although there are currently
no standardized tests for acceptable levels, with ACAPH, such deviations are expected to neither add to nor
subtract from the patient's perceived work of breathing to a greater extent than could be experienced during
natural breathing.

Note 3 to entry: Where provided, ACAPH is typically preselected to be active wherever appropriate, depending on
the ventilation-mode that has been selected.

Note 4 to entry: For unassisted breaths, an ACAPH adjunct facilitates unrestricted breathing by the generation of
demand flow in proportion to the patient's demands, without any trigger threshold, during inspiration and by the
provision of minimal resistance during expiration.

Note 5 to entry: Some of the functions of ACAPH might also be achievable by using specific settings with certain
ventilation-modes but, although such settings might resemble an equivalent function to ACAP H, because its
function is dependent on set values such an arrangement does not constitute an ACAPH adjunct. If equivalence is
claimed, the means used to facilitate unrestricted breathing should be described in the accompanying documents.

Note 6 to entry: See also adjunct (3.11.4), baseline airway pressure (3.10.1), dual-control (3.3.5), assured inflation
(3.3.11) and D.2.8.5.

3.12.4
bi-level AV
bi-level artificial ventilation
bi-level
alternative name for Group 2 ventilation-modes with a pressure-control assured inflation-type and ACAP
as an adjunct, where the intention is to place emphasis on the facility for unrestricted breathing at both
baseline airway-pressure levels of the assured-inflation cycle
Note 1 to entry: With the provision of ACAP, unrestricted breathing is possible at two alternating pressure levels,
thereby adding to the ventilation provided by the assured pressure-control (PC) inflations.

Note 2 to entry: It is common practice to also adopt an alternative naming scheme for the set and measured
quantities that are affected by this intended change of emphasis. Figures in Annex C that illustrate ventilation-
modes that can be alternatively designated as bi-level AV also show how the alternative terms, standardized for
that purpose, are used. Preferred and admitted terms for these quantities are listed in following entries in 3.12.

Note 3 to entry: This is the generic name for a class of ventilation-modes based on one originally introduced with
the proprietary name BIPAP®7) (which is not to be confused with the proprietary name BiPAP ®8), a breathing-
therapy mode).

Note 4 to entry: See also Group 2 ventilation-modes (3.11.5.2), ACAP (3.12.1), bi-level PAP (3.12.5), APRV (3.11.14),
and Figures C.30 to C33.

7) BIPAP® is a trademark owned by RIC Investments, LLC and used under license on a product supplied by Draeger
Medical AG & Co. KG. This information is given for the convenience of users of this document and does not constitute
an endorsement by ISO of the product named. Equivalent products may be used if they can be shown to lead to the
same results.
8) BiPAP® is the trademark of a product supplied by Respironics Inc. This information is given for the convenience
of users of this document and does not constitute an endorsement by ISO of the product named. Equivalent products
may be used if they can be shown to lead to the same results.

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3.12.5
bi-level PAP
bi-level positive airway pressure
BPAP
sleep-apnoea breathing-therapy mode in which there are two therapeutic positive pressure levels at the
patient-connection port during the respiratory cycle
[SOURCE: ISO 80601-2-70:2015, 201.3.203, modified — Rephrased.]
Note 1 to entry: The two levels of positive airway pressure (PAP) invoked by the various names that have been
given to this breathing-therapy mode are typically identified by the terms IPAP (inspiratory positive airway
pressure) and EPAP (expiratory positive airway pressure), with IPAP representing the set inspiratory pressure
level during the patient's inspiratory phase and EPAP the set baseline airway pressure (BAP) during the patient's
expiratory phase.

Note 2 to entry: This is the generic name for a breathing-therapy mode previously identified by the proprietary
name BiPAP®8) (which is not to be confused with the proprietary name BIPAP ®7), a ventilation-mode).

Note 3 to entry: Although classed as a breathing-therapy mode, this mode has been included in this edition of
this document in order to highlight one of the conceptual boundaries between equipment intended for artificial
ventilation and that intended for breathing therapy.

Note 4 to entry: See also breathing-therapy mode (3.11.22), respiratory cycle (3.4.16), airway pressure (3.6.1),
inspiration (3.2.10), expiration (3.2.11), set (3.1.19), inspiratory pressure (3.6.2), baseline airway pressure (3.10.1),
BAP (3.10.2), expiratory phase (3.4.2), bi-level AV (3.12.4) and CPAP (3.11.15).

3.12.6
BAP time
time-low
duration of a BAP, or pressure-low, phase
Note 1 to entry: In addition to its direct reference, this term may be used, in context or by qualification, to
designate this concept as a set quantity (3.1.19) or a measured quantity (3.1.20).

Note 2 to entry: This term is only relevant to ventilation-modes labelled as bi-level AV and is only used in
combination with the term BAPH (pressure-high) for the designation of the higher baseline airway pressure; it may
be represented by an appropriate letter symbol, for example, t L (or t BAP).

Note 3 to entry: See also baseline airway pressure (3.10.1), BAP H (3.12.2), bi-level AV (3.12.4), time-high (3.12.9)
and Figures C.22 to C.33 and F.5.

3.12.7
BAPH
pressure-high
alternatively named higher baseline airway-pressure level in ventilation-modes labelled as bi-level AV
Note 1 to entry: In addition to its direct reference, this term may be used, in context or by qualification, to
designate this concept as a set quantity (3.1.19).

Note 2 to entry: The preferred term is spoken as, BAP-high.

Note 3 to entry: The admitted term is included in this edition of this document based on its common current
usage and the possible need for a longer transition time for the changeover to the use of the term BAP H, should
this prove necessary; it may be represented by an appropriate letter symbol, for example, p H.

Note 4 to entry: The use of this alternative term, or its admitted synonym, in ventilation-modes labelled as bi-level
AV is optional.

Note 5 to entry: See also BAP (3.10.2), bi-level AV (3.12.4) and Figures C.32, C.33, and F.7a.

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3.12.8
BAPH phase
pressure-high phase
alternatively named assured-inflation phase in ventilation-modes labelled as bi-level AV
Note 1 to entry: The admitted term is included in this edition of this document based on its common current
usage and the possible need for a longer transition time for the changeover to the use of the term BAP H phase,
should this prove necessary.

Note 2 to entry: The preferred term is spoken as, BAP-high phase.

Note 3 to entry: The admitted term may be represented by an appropriate letter symbol, for example, p H phase.

Note 4 to entry: The use of this alternative term, or its admitted synonym, in ventilation-modes labelled as bi-level
AV is optional.

Note 5 to entry: See also bi-level AV (3.12.4), BAP (3.10.2) and Figures C.32, C.33, and F.7a.

3.12.9
BAPH time
time-high
alternatively named duration of a BAPH, or pressure-high, phase
Note 1 to entry: In addition to its direct reference, this term may be used, in context or by qualification, to
designate this concept as a set quantity (3.1.19) or a measured quantity (3.1.20).

Note 2 to entry: This term is only relevant to ventilation-modes labelled as bi-level AV and is only used in
combination with the term BAPH (or pressure-high) for the designation of the higher baseline airway pressure; it
may be represented by an appropriate letter symbol, for example, t H, t BH or t BAPH.

Note 3 to entry: With inflations that provide synchronized termination, the measured duration, averaged over
several respiratory cycles, will be determined by the set time-high, even though the duration of any individual
BAPH (or pressure-high) phase can vary from the set rate as allowed by the synchronization algorithm.

Note 4 to entry: The use of this alternative term, or its admitted synonym, in ventilation-modes labelled as bi-level
AV is optional.

Note 5 to entry: See also bi-level AV (3.12.4), baseline airway pressure (3.10.1), BAP H (3.12.7), BAP H phase (3.12.8),
time-low (3.12.6), breath synchronization (3.9.7), D.2.6, Annex F and Figures C.32 and C.33, and F.7.

3.13 Safety limits and alarm terminology


3.13.1
pressure limit
airway-pressure limit
airway-pressure threshold value for the initiation of an action to protect the patient during normal use
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a set quantity (3.1.19).

Note 2 to entry: This is a general, pre-coordinated term that is the basic definition for high and low limitation
functions and for associated functions such as defining alarm conditions and other means of protection.

Note 3 to entry: The limit is to be taken to be for a rising pressure unless specified otherwise. This not only
accords with common usage but also avoids a possible confusion resulting from the use of the word ‘high’, which
is used in the limit and alarm terms in this document with a meaning of ‘higher than intended’, as distinct from
‘the opposite of low’.

Note 4 to entry: See also normal use (3.1.24), limit (3.1.23) and deprecated terms for inspiratory pressure (3.6.2).

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3.13.2
pressure-limited
inspiratory pressure limited to the set pressure limit during normal use, by means of an inspiratory-
pressure relief function
Note 1 to entry: This limitation is typically used in conjunction with volume-control inflation-types where the
intention is to limit the maximum pressure that can be generated at the patient-connection port during normal use.

Note 2 to entry: An inspiratory-pressure-relief function spills excess regulated flow to atmosphere, if necessary
to avoid the inspiratory pressure exceeding the set level. This can result in a possibly un-quantified loss of the
delivered volume. See also inspiratory-pressure relief (3.6.5).

Note 3 to entry: The term pressure-limited may be represented by an appropriate letter symbol, for example, p Lim.

Note 4 to entry: The initiation of this pressure-limitation is typically associated with an alarm condition.

Note 5 to entry: See also normal use (3.1.24), inspiratory-pressure relief (3.6.5), airway pressure (3.6.1), alarm
condition (Annex J), D.2.3 and Figure C.13 for an example of a pressure-limited inflation.

3.13.3
maximum limited pressure
maximum limited airway-pressure
DEPRECATED: maximum circuit pressure limit
highest airway pressure that can occur during normal use or under single fault condition
Note 1 to entry: In addition to its direct reference as a requirement, this term is only used, in context or by
qualification, to designate this concept as a set quantity (3.1.19).

Note 2 to entry: As with all unqualified airway pressures, this limited pressure is that at the patient-connection
port and relative to ambient pressure.

Note 3 to entry: As this is the highest-level precaution against excessive pressures being applied to the patient's
airway this pressure limit is typically preset by the manufacturer but can be made adjustable by the responsible
organization to a lower pressure level.

[SOURCE: ISO 80601-2-12:2011, 201.3.214, modified — Addition of preferred and deprecated terms.]
3.13.4
maximum working airway-pressure
maximum working pressure
highest airway pressure that can be generated by the ventilator during intended use and normal condition
Note 1 to entry: This information is usually documented in the instructions for use as it is valuable in determining
if a ventilator is suitable for use with patients with an impaired lung.

Note 2 to entry: This maximum pressure is typically determined by the manufacturer.

Note 3 to entry: See also airway pressure (3.6.1), intended use (3.1.25) and normal condition (3.1.26).

3.13.5
high-airway-pressure limit
airway pressure threshold value at which a protection device prevents any further rise in the airway
pressure
Note 1 to entry: The protection device can maintain the airway pressure at a level close to the threshold value,
reduce the airway pressure to the set BAP or terminate the inflation phase. One or more of these alternatives will
be required by the Particular Standard that covers the class of ventilator to which the term might be applied.

Note 2 to entry: The set limit can be:

— independently adjustable;

— connected to an adjustable pressure limit;

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ISO 19223:2019(E)

— connected to the high airway pressure-alarm limit;

— related to the set inspiratory pressure.

Note 3 to entry: See also protection device (3.13.10) and inspiratory-pressure relief (3.6.5)

3.13.6
high-pressure relief limit
high-airway-pressure relief limit
airway pressure threshold value used by a ventilator to determine when a protection device prevents any
further rise in airway pressure during normal use
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a set quantity (3.1.19).

Note 2 to entry: As with all unqualified airway pressures, this limited pressure is that at the patient-connection
port and relative to ambient pressure.

Note 3 to entry: During an inflation, the high inspiratory-pressure relief protection device is intended to maintain
the airway pressure at the threshold value, without terminating the inflation.

Note 4 to entry: Activation of this form of airway pressure limitation can cause a drop in the inspiratory volume.
Operator awareness of this characteristic can be important for patient safety.

Note 5 to entry: The set limit can be independently adjustable, linked with an adjustable pressure limit, related to
the set inspiratory pressure or determined by an algorithm.

Note 6 to entry: The set limit can be associated with an alarm limit.

Note 7 to entry: See also protection device (3.13.10), normal use (3.1.24), alarm limit (Annex J) and high-pressure
termination limit (3.13.7).

3.13.7
high-pressure termination limit
high-airway-pressure termination limit
airway pressure threshold value used by a ventilator to determine when a protection device terminates
the current inflation phase during normal use
Note 1 to entry: This form of airway pressure limitation can often result in the delivered volume falling below that
set. Operator awareness of this characteristic is important for patient safety.

Note 2 to entry: As with all unqualified airway pressures, this limited pressure is that at the patient-connection
port and relative to ambient pressure.

Note 3 to entry: The threshold value can be independently adjustable or connected to an adjustable pressure limit,
may be related to the set inspiratory pressure or determined by an algorithm.

Note 4 to entry: This function can be associated with an alarm condition. Particular standards typically have
specific requirements.

Note 5 to entry: This limit may have the same as or a different threshold from the high airway pressure-alarm
condition. Particular standards typically have specific requirements.

Note 6 to entry: See also protection device (3.13.10), high-pressure relief limit (3.13.7), limit (3.1.23), alarm
condition (Annex J) and Figure C.11.

3.13.8
maximum settable inspiratory pressure
highest inspiratory pressure that can be set by the operator
Note 1 to entry: In addition to its direct reference, this term is only used, in context or by qualification, to
designate this concept as a set quantity, which will typically be preset by the manufacturer or the responsible
organization

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Note 2 to entry: As with all unqualified airway pressures, this inspiratory pressure is that at the patient-connection
port and relative to ambient pressure unless prefixed with ‘delta’ or the symbol Δ.

Note 3 to entry: See also inspiratory pressure (3.6.2), set (3.1.19), preset (3.1.21) and Δ inspiratory pressure (3.6.7).

3.13.9
adjustable pressure limit
adjustable airway pressure limit
APL
operator-set limitation on the airway pressure under normal condition
EXAMPLE APL valve on anaesthesia breathing system.

Note 1 to entry: See also limit (3.1.23), normal condition (3.1.26) and ventilator breathing system (3.1.18).

3.13.10
protection device
part or function of a ventilation device that, without intervention by the operator, protects the patient
from hazardous output due to incorrect delivery of energy or substances
[SOURCE: ISO 80601-2-12:2011, 201.3.220, modified — Rephrased.]

3.14 Gas port terminology


3.14.1
port
opening(s) for the passage of a fluid through a specified interface
Note 1 to entry: Typical interfaces where ports occur are

— where gas enters a medical device,

— where operator-detachable tubing is connected to a medical device, and

— where a ventilator breathing system is connected to the patient or to an airway device.

Note 2 to entry: A port can be in the form of a specific connector or designed to not allow connection with any
connector.

3.14.2
exhaust port
port of the medical equipment or device from which gas is discharged to the atmosphere during normal
use, either directly or via an anaesthetic gas scavenging system.
[SOURCE: ISO 80601-2-12:2011, 201.3.205, modified — Restriction to electrical equipment only was
removed.]
3.14.3
gas output port
port of the ventilator through which gas is delivered at respiratory pressures to an operator-detachable
part of the ventilator breathing system
[SOURCE: ISO 4135:2001, 3.2.8, modified — Rephrased.]
3.14.4
gas return port
port of the ventilator through which gas is returned at respiratory pressures through an operator-
detachable part of the ventilator breathing system, from the patient-connection port
[SOURCE: ISO 80601-2-12:2011, 201.3.210, modified — Adapted for ventilators.]

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3.14.5
patient-connection port
port of a ventilator breathing system intended for connection to an airway device
[SOURCE: ISO 80601-2-12:2011, 201.3.218, modified — Rephrased.]
Note 1 to entry: The patient-connection port is the end of the ventilator breathing system proximal to the patient.

Note 2 to entry: The patient-connection port is typically in the form of a suitable for connection to an airway
device such as a tracheal or tracheostomy tube, a face mask, or a supralaryngeal airway, or to a test apparatus.

Note 3 to entry: Current particular standards typically specify that the patient-connection port is required to be
in the form of a specific standardized connector(s), for example, a connector(s) conforming to ISO 5356-1.

Note 4 to entry: In ventilators designed to provide NIV (non-invasive ventilation) and where the ventilation function
is dependent upon a design feature of a component that connects the ventilator to the patient's airway, then the
patient-connection port typically becomes the contact line of the seal to the patient's face and there is no patient-
connection-port connector.

Note 5 to entry: See also port (3.14.1), ventilator breathing system (3.1.18), airway device (3.1.3), NIV (3.1.15) and
airway (3.1.2).

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Annex A
(informative)

Rationales and guidance

A.1 General guidance


This annex provides rationales for the important clauses of this document and is intended for those
who are familiar with its subject but who have not participated in its development. An understanding
of the reasons for the main requirements is essential for its proper application. Furthermore, as clinical
practice and technology change, it is expected that rationales for the present requirements will facilitate
any revision of this document necessitated by those developments.

A.2 Mental model of ventilation as the basis of this document


The Introduction summarizes the factors that led to a comprehensive review of the vocabulary of
artificial ventilation and the preparation of this document. A key definition in the review was that of
ventilation-mode because the concepts behind it are fundamental to the conceptual structure underlying
the terminology presented in this document. An explanation of how the definitions associated with
that key term were derived is, therefore, an essential background to understanding that underlying
structure.
Early devices for delivering automatic ventilation by means of intermittent positive pressure,
operated to a fixed cyclical pattern with a range of settings for just the basic parameters. However,
with the increasing flexibility offered by electronic control systems, more and more permutations and
combinations of the basic elements of gas delivery were devised – to the point where, in the absence
of an internationally standardized vocabulary, it was no longer practical to provide every possible
ventilation-pattern with a meaninfgul unique name.
Today, more than 100 different names for in excess of 30 mutually exclusive ventilation-modes make
it impossible to teach and learn which mode to use in which clinical situation. Consequently, most
users have only been taught just a few of these ventilation-modes. Also, it has become very difficult to
relate different manufacturers’ modes to each other – a problem significantly compounded by a lack of
consistency in the terminology used to describe them.
An analysis of the structure of these ventilation-modes reveals that they all require the selection of
both the regulated parameter used to inflate the lungs and a pattern that determines when and what
inflations occur; functions that can be conveniently referred to as the inflation-type and the ventilation-
pattern. It also becomes clear that, conceptually and from a clinical perspective, in most cases the choice
of inflation-type is largely independent of the choice of ventilation-pattern.
In the vocabulary of this document, this concept has been formalized, with the ventilation-mode
becoming a composite of these two independent, operator-selectable elements: the inflation-type
determines how the pressure or flow at the patient-connection port will be regulated during an inflation,
once initiated, and the ventilation-pattern determines how the ventilator will respond to patient-trigger
events and what it will cause to be delivered, when, irrespective of the patient’s respiratory activity.
This is seen to be a logical step because most of the clinically distinctive characteristics of the classical
modes, which still form the foundation of modern ventilation-modes, are those that relate to the time-
pattern of interactive events between the ventilator and the patient; characteristics which are largely
independent of the delivery-regulation means.

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In practice, many manufacturers have already, at least partially, intuitively introduced such a separation
in the way in which they have labelled their ventilator user interfaces and structured their instructions
for use.
From this perspective, it is pertinent to note that part of the confusion with respect to ventilation-
modes has resulted from manufacturers labelling their modes with names that feature just one of these
attributes; some modes might be labelled SIMV – a ventilation-pattern, and others VCV – an inflation-
type. In accordance with this document both of these ventilation-mode labels are incomplete: the correct
ventilation-mode designation requires an indication of both the ventilation-pattern and the inflation-
type(s) being used, with the examples becoming SIMV-PC or SIMV-VC and CMV-VC.
The above approach reduces the number of pre-coordinated names required significantly as any of a
number of inflation-types can be independently selected for use with each ventilation-pattern: instead of
M x N different ventilation-mode names to learn there become just M ventilation-patterns plus N inflation-
types. Ventilator operation can therefore be described as if made up from elements of a construction set.
As an example, it enabled a list of 58 ventilation-mode names, taken from manufacturers’ literature, to be
reduced to just 8 ventilation-patterns and 8 inflation-types – each of which can be placed into one of an
even smaller number of easily remembered groups.
This format, with its focus on the pattern to which inflations are initiated and on the type of inflation
that is delivered, is independent of which ventilation-pattern and inflation-type combination can be used
with which setting, and for which clinical intention. Its structure not only reduces the number of items
to be remembered but also makes them much easier to teach, learn, remember and recognize, thereby
improving ventilator usability.
With this perception of what constitutes a ventilation-mode in current practice, in order to understand
how these ventilation-modes relate to each other the committee found it to be helpful to create a
classification system that groups them in terms of what they have in common and in what way they differ.
It was considered that present trends are likely to increasingly disconnect the functional classification
of ventilation patterns from clinical intentions and that ventilation-mode classifications should be based
on function alone. When this was done, only four basic groupings, with two further subgroups, were
required. These classifications enable teaching to be in terms of the common characteristics of, and
mutual differences between, the ventilation-patterns in each group, and the appropriate settings for
each of these ventilation-patterns for different clinical intentions.
Additionally, with only four basic families of inflation-types, instructions for their use can be centred on
the clinical considerations of the alternative methods of generating an inflation, and of its termination.
These instructions can be largely independent of the ventilation-pattern with which it will be used
although some instruction might be necessary where the selected inflation-type could affect the clinical
intention of the resultant ventilation-modes. Although, conceptually, around 20 standardized types
of inflation could be made available for operator selection to accompany each ventilation-pattern, in
practice, manufacturers will only offer the much more limited range of combinations most likely to be
used in clinical practice.
From this perspective, it can be seen that, in the past, many ‘new’ ventilation-modes that have been
introduced, with their own proprietary names, have in fact only been an easily described sub-set of a
standard inflation-type.
With regard to the naming of these ventilation-patterns and inflation types, there has been full
recognition that existing users already have a pertinent vocabulary which they use in the day-to-
day operation of current ventilators. The confusions have arisen because, in the absence of any
comprehensive international agreement, there are invariably several terms in use for each concept and
in other cases a single term is being used for a range of concepts with only some similarities.
Because almost all the concepts defined in this document are based on current good practice, and
therefore fall within the general range of meanings associated with each of these existing terms it was
considered to be more appropriate to retain these terms, wherever possible, and use this document to
give them a standardized definition rather than attempt to introduce a completely new term for every
concept.

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It was seen that with this approach, users will be able to operate ventilators conforming to this
document in the same way as at present - with no more difficulty than in moving between different
ventilators - with the advantage that once learnt, it will increasingly be directly applicable to more and
more ventilators as time progresses. In addition, the named ventilation-patterns and inflation-types in
this document are classified into coherent groups, so those users interested in the differences between
ventilation-modes will find that these are always explained from the same reference points. These
classifications also form the basic framework for the unique identification, by name and code, of any
ventilation-mode within the scope of this document.
Another challenge that the members of the committee and others have encountered when teaching
ventilator theory, has been how to distinguish between what the ventilator is doing and what is
happening to the patient. In this document, a ventilator can generate breaths by cyclically inflating the
patient's lungs, but it is only a patient who can breathe.
A further question might be as to where the trigger function for patient-initiation fits into these
classifications. In some previous classification proposals, initiation was considered to be a property
of the inflation-type and so the triggering-function was also included in these properties. In the
classification system of this document, the initiation of an inflation is a property of the ventilation-
pattern, which provides rules defining how the ventilator responds to various inputs. Logically,
therefore, the ventilation-pattern is simply responding to a signal from a ventilator detection function
indicating that the measurement of a patient parameter(s) has attained a set threshold value. With this
concept, the trigger function becomes just another ventilation monitoring function that provides a signal
to the ventilator control system. In practice, most major manufacturers already treat patient-triggering
in this way, that is, as an independently-selectable, settable monitoring function which provides a signal
when the monitored parameter reaches a set level, for use by the selected ventilation-pattern algorithm
as required.

A.3 Guidance followed in the writing of this document


This document is based on the guidance and requirements specified in ISO 704 and ISO 10241-1.

A.4 Rationales for particular clauses and subclauses


The numbering of the following rationales corresponds to the numbering of the clauses in this
document. The numbering is, therefore, not consecutive.
1 Scope
Terms pertaining specifically to breathing-therapy equipment and high-frequency ventilation have not,
in general, been specified in this edition of this document as their scope is still evolving with continuing
developments in those technologies and their applications. The only exceptions are where it was
considered necessary to establish boundaries between bordering concepts. It is the intention of the
committee to include such terms in a future amendment or edition of this document.
3 Terms, definitions, symbols, and abbreviated terms
As stated in ISO 704 and ISO 10241-1, a primary function of a standardized terminology is to indicate
preferred, admitted, and deprecated terms. In subject fields where there has been no effective
standardized terminology, such as is the case with artificial ventilation, it is inevitable that there is
frequently more than one term in common use for the designation of a given concept.
However, in choosing a preferred term in this document it was recognized that there was often the
need to make a compromise between the conflicting requirements of the avoidance of ambiguity and
the need for conciseness. In this document, the form of the preferred term, whether the full form of
an abbreviation, was selected with priority given to the one that is most generally used. Guidance for
corresponding letter symbols is sometimes also provided in notes to entries - for use in appropriate
contexts.

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Where a term is listed as ‘deprecated’, this means that it is deprecated as a synonym for the preferred
term, although some such terms are used as preferred terms for the designation of other concepts.
In accordance with ISO 10241-1:2011, 6.4.4, the definitions of terms in Clause 3 of this document
are intensional definitions. Such definitions are required to consist of a single phrase specifying the
concept being designated, and if possible, to reflect the position of the concept in the concept system;
containing only information that makes the concept unique. A definition given without an indication
of its applicability is to be taken as representing the general meaning of the term. Any additional
descriptive information deemed necessary is included in notes to entry or in examples. Notes to
terminology entries follow different rules from those integrated into other text in a standard; they
provide additional information that supplements the terminological data in the definitions.
Because a ventilator is a device that, typically, interacts with a patient in accordance with inputs from an
operator, certain of the concepts of artificial ventilation are of quantities with a value that might be either
the actual value or the intended value as set, directly or indirectly, by an operator. In these instances, the
definition is used to represent the general meaning of the term. If it is, or can be, used to represent either
a set value or an actual value or both, this is stated in a note to entry. An actual value exists as a concept
whether it can be measured or not and is, therefore, unaffected by the accuracy of measurement or the
method by which it might be displayed or recorded. For this reason, the vocabulary of this document
only addresses actual values, set values and measured values as concepts. It is for particular standards
to specify any requirements regarding measurement accuracy and units of measurement.
The terminological entries in Clause 3 are primarily arranged in a systematic order, with a secondary
alphabetical order. An alphabetically arranged list of terms is provided in Annex J.
For further information concerning set, measured and actual values, and on how this document is
intended to be applied, particularly with respect to context and qualification, and concerning some of
the conventions followed in Clause 3, see informative Annexes G and H.
3.4 Time, phase and cycle terminology
The use of terms relating to gas entering and leaving the patient's lungs is fundamental to a vocabulary
of artificial ventilation. In normal speech in English, terms such as inspire, inhale, exhale and expire in
their various inflected forms are used for that purpose but each has connotations that makes it less
than ideal in at least one of its forms. In particular, inhalation has become associated with drug abuse
and many clinicians consider it to be inappropriate to speak of the patient expiring, in the presence of
the patient or those close to them. However, one of the basic objectives of a terminology standard is,
wherever possible, to have only one term to represent each concept. After much discussion, the terms
inspiration and expiration were selected for this document but with the recognition that the use of
alternative terms can be more appropriate in potentially sensitive situations.
3.5 Rate terminology
The ventilation rate terms in this subclause have been grouped into two further subclauses. The first of
these groups comprises the terms that are commonly used on the user interfaces of ventilators.
The second group comprises those that might be required for specific purposes such as in technical
descriptions, clinical papers or data logging. Potentially, there are many such terms but most can be
formed as post-coordinations of simpler terms already defined in this document. Four such terms have
been entered in 3.5.2, as examples, but, as with some other terms in this document, the purpose of this
group is solely to provide guidance in the case of needing to express a respiratory rate in terms of one
of a range of related concepts. There is no implied requirement that manufacturers should make use of
any one of these terms in their labelling or accompanying documents.
3.10 Baseline and PEEP terminology
See Annex F, for a rationale for these topics.
3.11 Mode terminology
See A.2.

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3.11.5 Ventilation-mode group


The systematic grouping described in this subclause was introduced during the preparation of this
document. Its value in helping with the discussion, understanding, memorization and teaching of how
the various ventilation-modes related to each other regarding their functional characteristics, led to the
decision to retain it.
Ventilation-mode groups have been introduced in this document solely to provide a means of classifying
ventilation-modes in a way that can assist with the understanding and teaching of how the large numbers
of such modes currently in use are related to each other. There is no requirement for manufacturers
to include reference to these groups in product labelling but where this grouping is referred to it is
required to be in accordance with this document.
Four ventilation-mode groups have been specified, according to their ventilation-patterns. Each
ventilation-mode within the scope of this document falls into one of these groups, the defining
characteristics of which are given in 3.11.5. All alternatively-named modes and superordinate modes also
fall into one of these groups, as determined by the underlying ventilation-pattern employed.
3.11.6 Assured ventilation
The admitted term, mandatory ventilation, is included in this document because it became firmly
established over several decades by its use in the ventilation-mode names, CMV, IMV and SIMV. In the
early implementations of these ventilation-modes both the initiation and the delivery were imposed on
the patient but with the modern approach to artificial ventilation, which allows patients to contribute
to their own ventilation as much as they are able, the term only makes sense when used to convey the
concept of the assured initiation of a selected inflation-type. This is the only sense in which it is used
in this document. However, because the word mandatory is ambiguous when used as a term in this
context, in that it can be taken to mean either of these, and because this ambiguity has allowed it to
be used to give the appearance of unifying a range of different concepts, the word is only used in this
document in reference to the legacy ventilation-patterns that have it incorporated into their names. For
other purposes, natural language phrases such as ‘assured to be’ are used to convey the defined concept
wherever possible, in preference to the term mandatory or any of its inflected forms.
In the related semantics, the delivery of an inflation causes mandatory ventilation of the patient's lungs
but only in the sense that the selected inflation-type is assured to be initiated - not that the inflation-type
selected will necessarily deliver an assured volume.
3.11.14 APRV (airway pressure release ventilation)
The rational for the introduction of this ventilation-mode, and for its name, was to allow patients
with acute oxygenation failure to breathe with better coordination, improved gas exchange and less
barotrauma. The periodic release and near immediate subsequent build-up of airway pressure was
intended to assist the patient's own breathing efforts while not allowing the lungs to collapse.
Although that rational describes the essential concept of APRV it is recognized that, with this ventilation-
mode selected, many manufacturers now permit the operator to set the BAP phase-time (t L) to values far
in excess of any expected expiratory-flow times. The justification for this is that the ongoing treatment
of a patient requiring APRV during an initial acute period might well involve the progressive adjustment
of the two BAP levels and also the two phase times, both as individual values and their differentials, in
order to provide a step-less continuity of treatment - working towards a single decreasing level of CPAP,
without the discontinuity involved in changing over to a different ventilation-mode.
3.12 Bi-level terminology
The terminology in this document has been developed taking account of the additional functionality
of ventilators incorporating an ACAP adjunct. This is an advanced regulation function that, unlike
conventional pneumatic regulators, maintains a set airway pressure, irrespective of the direction of
the airway flow. It is used not only to enhance the regulation of the airway pressure during pressure-
control inflations but also to maintain the required pressure between assured inflations. This makes it
possible for the patient to breathe at any time, both concurrently with an assured inflation and during
the expiratory phases between assured inflations, with a minimal imposed addition to the patient's work

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of breathing. The set airway pressure for this regulation function can be continuously constant, as when
used with CPAP, or in the form of a varying pressure waveform with constant portions as is typically
generated by either the inflation-type algorithm during inflation phases or the expiratory-control
algorithm during BAP (or expiratory) phases. During BAP phases, it maintains a constant pressure when
there is no pressure-support, available or selected, and in the presence of any leakage.
On ventilators equipped with this increased functionality, manufacturers have either labelled their
ventilation-modes as bi-level modes, with corresponding terminology for the settings and displays, or
have retained the classical terminology for their ventilation-modes, settings and displays, accompanied
by a statement indicating that the patient is free to breathe at any time.
As both approaches appear to have advantages and disadvantages, and as there is not yet any clear
consensus as to which is better from a human factors perspective, this document includes terms
suitable for both approaches. These terms are in most cases presented in this document as alternatives,
but it is expected that they will always be used consistently and in context, according to the ventilation-
mode designation adopted by the manufacturer.
It is anticipated that in future editions of this document more specific guidance will be given on the
application of such terms.

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Annex B
(informative)

Conceptual relationships between ventilator actions and types


of breath

Figure B.1 is a diagrammatical representation of how the terminology of this document is used to
describe patient-ventilator interactions and the relationship between increases in the volume of gas in
the lung and inflations. In a sequence, these interactions lead to the generation a series of breaths of a
single or changing type.
In this document, breaths are defined from the patient perspective. Five types of breath are designated
by the type of inspiratory assistance that might be provided by various means of artificial ventilation.
Breaths can be either initiated by the patient or ventilator-initiated after an elapsed time without any
respiratory activity being detected, as determined by the ventilation-pattern that has been selected. The
following combinations of patient and ventilator actions determine the type of breath that results.
a) If there is no respiratory activity then the selected assured inflation-type will be ventilator-initiated
and will act to increase the volume of gas in the lung until one of the inflation termination criteria
has been reached, at which point the ventilator will allow the gas in the lung to discharge until the
next breath initiation occurs. This sequence of events results in a controlled breath.
b) If respiratory activity occurs during an expiratory phase of, or concurrent with, an assured inflation,
but the selected ventilation-pattern is not programmed to initiate the next inflation, then the
ventilator might either respond to the patient demand by supplying demand flow, which matches the
demand with little imposed increase in the work of breathing, or might have an unspecified delivery,
which could cause a significant increase in the work of breathing. Either ventilator response results
in an unassisted breath.
c) If a patient-trigger event occurs during an expiratory phase and the ventilation-pattern is
programmed to initiate the next assured inflation-type, then its resulting delivery will assist any
further inspiratory effort. The volume of gas in the lung will increase until respiratory pressures
equalize or one of the inflation termination criteria is reached. When one of the inflation termination
criteria is reached the ventilator will allow the gas in the lung to discharge until the next breath
initiation occurs. This sequence of events results in an assisted breath.
d) If a patient-trigger event occurs during a synchronization window at the end of an expiratory phase,
then the next assured inflation-type will be initiated and this will assist any further inspiratory
effort. The volume of gas in the lung will increase until respiratory pressures equalize or one of the
inflation termination criteria is reached. When one of the inflation termination criteria is reached
the ventilator will allow the gas in the lung to discharge until the next breath initiation occurs. This
sequence of events results in a synchronized breath.
e) If a patient-trigger event occurs during an expiratory phase, or concurrent with an assured inflation,
and the selected ventilation-pattern is programmed to initiate the next support inflation-type, then
its resulting delivery will support any further inspiratory effort. The volume of gas in the lung will
increase until respiratory pressures equalize or one of the inflation termination criteria is reached,
at which point the ventilator will allow the gas in the lung to discharge until the next breath initiation
occurs. This sequence of events results in a supported breath.
It will be clear that the sequence in which any of these specific combinations, and the resultant breaths,
occur depends on the pattern of respiratory activity and the ventilation-mode that has been selected.

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Key
1 assured inflation-type 9 controlled
2 support inflation-type 10 synchronized
3 demand flow 11 assisted
4 time 12 supported
5 patient-trigger event 13 unassisted
6 patient-trigger event 14 increase in volume of gas in lung
7 patient demand 15 unspecified delivery
8 synchronization window
connections showing the relationship for ventilation-modes
ventilator delivery
where the patient is able to increase the assured inflation-type
functions
delivery rate above that set
connections showing the relationship for ventilation-modes
means of delivery
where patient trigger events do not increase the average
initiation
assured inflation-type delivery rate above that set
outcome assured rate
unscheduled more than assured rate

Figure B.1 — Diagrammatical representation of the concepts of the relationship between


breath- and inflation-related terms in the vocabulary of this document

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Annex C
(informative)

Illustrations of ventilation terms

An important aspect identified in the development of this document is that part of the present confusion
in the use of ventilation terminology is the lack of distinction between the setting perspective and the
outcome perspective.
Most current representations of ventilation-patterns and inflations are based on typical waveforms as
seen on user-interface displays, which is inevitably an outcome perspective. This is a helpful approach
when describing the interpretation of the function of a specific ventilator but inevitably such a display
introduces indeterminate artefacts, and these can detract from the clarity of a formal diagrammatical
representation of the changes of state that are actually set to occur.
Although set flow changes can be made to occur almost instantaneously this is not possible with
pressure changes because of the resistance and compliance characteristics of a patient's respiratory
system. With such changes at the initiation and termination of an inflation, where conceptually the
set value causes a step change, the actual responses are less immediate. In particular, with pressure-
regulation, rise times are typically operator-adjustable to enable the avoidance of excessive overshoots
and subsequent oscillations.
As appropriate, therefore, the diagrammatic representations of both settings and measurements for
typical ventilation waveforms shown in the figures in this annex, and Annex F, are sometimes that of
an idealized form of the input into the ventilator control system and an idealized patient, or sometimes
that of typical actual waveforms as measured at the patient-connection port. They are sometimes
combinations of both, depending on the feature that is intended to be highlighted. Figure C.1 has been
specifically included to illustrate typical idealized waveforms with the addition of typical artefacts,
shown using broken lines, and employing the colour coding detailed in the note to that figure.
Additionally, some of the figures in this annex and Annex F illustrate waveforms that result from
unusual settings of ventilation-modes based on classically named ventilation-patterns - although these
settings are within the range made available for use with such modes on currently manufactured
ventilators. These unusual waveforms are not shown with any intention of advocating the use of such
settings for a particular treatment, but to demonstrate how actual waveforms can be very different
from those that are typically provided to illustrate a ventilation-mode function. Such illustrations
highlight that the ventilation waveforms that can be generated with a specific classical pattern-based
mode, but with unusual settings, are not necessarily all unique and some could overlap those that can be
generated with another of the classical patterns.
Colour coding is employed in the figures of this annex, and of Annex F, for the reasons explained in the
Introduction of this document. Unless otherwise stated, blue is used to represent set parameters and
green to represent actual or measured parameters; orange broken lines are used to represent baseline
airway-pressure levels. Waveforms with no specific coding are shown in grey. Additional colours are
used for other purposes in specific figures. Figures C.14 to C.21 and C.35 have their own keys for their
particular use of colours.

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a) Flow-regulated inflations

b) Pressure-regulated inflations

Key
1 airway pressure 9 set inspiratory flow
2 ambient pressure 10 expiratory flow time
3 inspiratory pressure 11 expiratory-flow waveform
4 BAP 12 rise time
5 PEEP 13 set Δ inspiratory pressure (if PC);
6 inspiratory time (setting if VC or PC measurement if PS) set Δ support pressure (if PS)
7 inspiratory flow 14 peak inspiratory flow
8 expiratory flow

NOTE For this figure only, the colour coding is used to separately identify those portions of the waveforms
that are due to settings and those due to measurements. The continuous blue traces are used to represent the
idealized waveforms of the ventilator output and the continuous green traces to represent typical actual flows
and pressures.

Figure C.1 — Representative ventilation-patterns and inflation-types illustrating the format


used in the figures in this annex and Annex F

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Key
1 airway pressure 6 inspiratory phase
2 CPAP 7 expiratory phase
3 inspiratory flow 8 peak expiratory flow
4 expiratory flow 9 ambient pressure
5 peak inspiratory flow 10 inevitable pressure deviations

Figure C.2 — The inspiratory and expiratory phases of an unassisted breath, taken with the
airway pressure maintained at a set CPAP level

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Key
1 airway pressure 6 BAP
2 inspiratory pressure 7 inspiratory flow
3 expiratory phases 8 expiratory flow
4 inflation phase 9 ambient pressure
5 trigger phase

Figure C.3 — The inflation and expiratory phases of a patient-triggered, pressure-control (PC)
inflation

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Key
1 airway pressure 6 expiratory phase
2 inspiratory pressure 7 BAP
3 inspiratory flow 8 baseline airway pressure
4 expiratory flow 9 ambient pressure
5 inflation phase

Figure C.4 — The inflation and expiratory phases of a ventilator-initiated, pressure-control


(PC) inflation

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Key
1 airway pressure 6 expiratory phase
2 inspiratory pressure 7 BAP
3 inspiratory flow 8 baseline airway pressure
4 expiratory flow 9 ambient pressure
5 inflation phase 10 end-inspiratory flow

Figure C.5 — The inflation and expiratory phases of a ventilator-initiated, pressure-control


(PC) inflation, time-terminated before the cessation of inspiratory flow

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Key
1 airway pressure 6 BAP
2 support pressure 7 inspiratory flow
3 expiratory phases 8 expiratory flow
4 inflation phase 9 inspiratory-termination flow
5 trigger phase 10 ambient pressure

Figure C.6 — The inflation and expiratory phases of a patient-triggered, pressure-support (PS)
inflation

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Key
1 airway pressure 6 BAP
2 PEEP 7 inspiratory flow
3 expiratory phases 8 expiratory flow
4 inflation phase 9 inspiratory flow
5 trigger phase 10 ambient pressure

Figure C.7 — The inflation and expiratory phases of a patient-triggered, volume-control (VC)
inflation

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Key
1 airway pressure 6 expiratory phases
2 inspiratory pressure 7 BAP
3 inspiratory flow 8 baseline airway pressure
4 expiratory flow 9 ambient pressure
5 inflation phase 10 end-expiratory flow

Figure C.8 — The inflation and expiratory phases of a ventilator-initiated, pressure-control


(PC) inflation with end-expiratory flow

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Key
1 airway pressure 13 inspiratory time
2 rise time 14 inspiratory flow
3 inspiratory-pressure waveform 15 expiratory flow
4 instantaneous inspiratory-pressure 16 peak inspiratory flow
5 inspiratory pressure 17 inspiratory-flow time
6 peak inspiratory pressure 18 expiratory-flow waveform
7 Δ inspiratory pressure 19 peak expiratory flow
8 end-inspiratory pressure 20 expiratory-flow time
9 expiratory-pressure waveform 21 inspiratory-pause time
10 instantaneous expiratory pressure 22 baseline airway pressure
11 BAP 23 ambient pressure
12 PEEP

Figure C.9 — Illustrations of the application of defined ventilation terms in designating key
features of typical inflation waveforms — Typical airway-pressure and flow waveforms for a
pressure-control (PC) inflation

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Key
1 airway pressure 12 PEEP
2 rise time 13 inspiratory time
3 inspiratory-pressure waveform 14 inspiratory flow
4 instantaneous inspiratory-pressure 15 expiratory flow
5 inspiratory pressure 16 peak inspiratory flow
6 peak inspiratory pressure 17 expiratory-flow waveform
7 Δ support pressure 18 peak expiratory flow
8 end-inspiratory pressure 19 expiratory-flow time
9 expiratory-pressure waveform 20 termination flow
10 instantaneous expiratory pressure 21 baseline airway pressure
11 BAP 22 ambient pressure

Figure C.10 — Illustrations of the application of defined ventilation terms in designating key
features of typical inflation waveforms — Typical airway-pressure and flow waveforms for a
pressure-support (PS) inflation

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Key
1 airway pressure 9 inspiratory flow
2 rise time 10 expiratory flow
3 inspiratory-pressure 11 peak inspiratory flow
4 Δ inspiratory pressure 12 inspiratory time
5 high-pressure termination limit 13 peak expiratory flow
6 end-inspiratory pressure 14 baseline airway pressure
7 BAP 15 ambient pressure
8 PEEP

Figure C.11 — Illustrations of the application of ventilation terms in designating key features
of typical inflation waveforms — Typical airway-pressure and flow waveforms for a pressure-
terminated, pressure-control (PC) inflation

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Key
1 airway pressure 12 rise time (if applicable)
2 inspiratory-pressure waveform 13 inspiratory flow
3 plateau inspiratory pressure 14 inspiratory-pause time
4 expiratory-pressure waveform 15 expiratory flow
5 instantaneous expiratory pressure 16 inspiratory-flow time
6 PEEP 17 expiratory-flow waveform
7 instantaneous inspiratory pressure 18 peak expiratory flow
8 peak inspiratory pressure 19 expiratory-flow time
9 BAP 20 baseline airway pressure
10 inspiratory time 21 ambient pressure
11 inspiratory flow

Figure C.12 — Illustrations of the application of ventilation terms in designating key features of
typical inflation waveforms — Typical airway-pressure and flow waveforms for volume-control
(VC) inflation with inspiratory pause

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Key
1 airway pressure 9 expiratory flow
2 inspiratory-pressure waveform 10 inspiratory flow
3 peak inspiratory pressure 11 inspiratory-flow waveform
4 pressure limit 12 peak expiratory flow
5 PEEP 13 expiratory-flow waveform
6 BAP 14 inspiratory time
7 rise time (if applicable) 15 baseline airway pressure
8 inspiratory flow 16 ambient pressure

Figure C.13 — Illustrations of the application of ventilation terms in designating key features
of typical inflation waveforms — Typical airway-pressure and flow waveforms for a pressure-
limited volume-control (VC) inflation

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Figure C.14 — Ventilation-patterns: Key to Figures C.15 to C.21

Key
1 setting perspective 6 respiratory cycle time (1/set-rate)
2 function of the ventilation-pattern in initiating 7 time
inflations 8 inspiratory flow
3 typical consequent airway-flow waveforms 9 expiratory flow
4 airway pressure
5 representations of pressure-control, assured
inflation-types

Figure C.15 — Ventilation-patterns: Diagrammatic illustrations of the function of the CMV-


pattern in the initiation of inflations, with pressure-control (PC) as the selected inflation-type

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Key
1 setting perspective 6 representations of volume-control, assured
2 typical consequent airway-pressure waveforms inflation-types
3 typical consequent airway-flow waveforms 7 time
4 function of the ventilation-pattern in initiating 8 inspiratory flow
inflations 9 expiratory flow
5 airway pressure 10 respiratory cycle time (1/set-rate)

Figure C.16 — Ventilation-patterns: Diagrammatic illustrations of the function of the CMV-


pattern in the initiation of inflations, with volume-control (VC) as the selected inflation-type

Key
1 setting perspective 5 respiratory cycle time (1/set-rate)
2 function of the ventilation-pattern in initiating 6 time
inflations 7 airway pressure
3 typical consequent airway-flow waveforms 8 inspiratory flow
4 representations of pressure-control, assured 9 expiratory flow
inflation-types

Figure C.17 — Ventilation patterns: Diagrammatic illustrations of the function of the assist/
control (A/C) ventilation-pattern in the initiation of inflations

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Key
1 setting perspective 5 representations of pressure-support inflation-types
2 function of the ventilation-pattern in 6 respiratory cycle time (1/set-rate)
initiating inflations 7 airway pressure
3 typical consequent airway-flow waveforms 8 inspiratory flow
4 representations of pressure-control, assured 9 expiratory flow
inflation-types 10 time

Figure C.18 — Ventilation patterns: Diagrammatic illustrations of the function of the IMV-
pattern in the initiation of inflations

Key
1 setting perspective 6 respiratory cycle time (1/set-rate)
2 function of the ventilation-pattern in initiating 7 airway pressure
inflations 8 inspiratory flow
3 typical consequent airway-flow waveforms 9 expiratory flow
4 representations of pressure-control, assured 10 time
inflation-types 11 synchronization window
5 representations of pressure-support inflation-types

Figure C.19 — Ventilation patterns: Diagrammatic illustrations of the function of the SIMV-
pattern in the initiation of inflations

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Key
1 setting perspective 6 respiratory cycle time (1/set-rate)
2 function of the ventilation-pattern in initiating 7 airway pressure
inflations 8 inspiratory flow
3 typical consequent airway-flow waveforms 9 expiratory flow
4 representations of pressure-support inflation-types 10 time
5 representations of assured inflation-types

Figure C.20 — Ventilation patterns: Diagrammatic illustrations of the function of the S/T
ventilation-pattern in the initiation of inflations

Key
1 setting perspective 5 representations of pressure-support inflation-types
2 function of the ventilation-pattern in initiating 6 time
inflations 7 inspiratory flow
3 typical consequent airway-flow waveforms 8 expiratory flow
4 airway pressure

Figure C.21 — Ventilation patterns: Diagrammatic illustrations of the function of the CSV-
pattern in the initiation of inflations

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Key
1 airway pressure 6 inspiratory time
2 ambient pressure 7 expiratory time or BAP time
3 inspiratory pressure 8 cycle time (1/set-rate)
4 PEEP 9 inspiratory flow
5 BAP 10 expiratory flow

Figure C.22 — Typical airway-pressure and flow waveforms for a CMV-PC ventilation-mode

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Key
1 airway pressure 10 expiratory flow
2 ambient pressure 11 inflation phase
3 peak inspiratory pressure 12 expiratory phase or BAP phase
4 PEEP 13 respiratory cycle
5 BAP 14 inspiratory phase
6 inspiratory time 15 unassisted breath
7 expiratory time or BAP time 16 expiratory phase
8 cycle time (1/set-rate) 17 inspiratory flow
9 inspiratory flow

Figure C.23 — Typical airway-pressure and flow waveforms for a CMV-VC <ACAPL>
ventilation-mode

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Key
1 airway pressure 10 expiratory phase or BAP phase
2 ambient pressure 11 assured-inflation cycle
3 inspiratory pressure 12 inspiratory flow
4 PEEP 13 expiratory flow
5 BAP 14 concurrent breath
6 inspiratory time 15 inspiratory phase
7 expiratory time or BAP time 16 unassisted breath
8 respiratory cycle time (1/set-rate) 17 concurrent expiration
9 assured-inflation phase 18 concurrent inspiration

Figure C.24 — Typical airway-pressure and flow waveforms for a


CMV-PC <ACAP> ventilation-mode, set with extended phase times

NOTE Figures C.24 and C.25 illustrate unusual settings of this ventilation-mode which are possible with the
range of settings available on currently manufactured ventilators. As explained in the introduction to this annex
(C.1), such illustrations are not shown with the intention of advocating such settings, but to demonstrate how
actual waveforms can be very different from those normally provided to illustrate a ventilation-mode function.
Such illustrations highlight that the ventilation waveforms that can be generated with a specific classical
ventilation-pattern based ventilation-mode, but with unusual settings, are not necessarily all unique and some
could overlap those that can be generated with another of these ventilation-modes.

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Key
1 airway pressure 9 assured-inflation phase
2 ambient pressure 10 expiratory phase or BAP phase
3 inspiratory pressure 11 assured-inflation cycle
4 PEEP 12 inspiratory flow
5 BAP 13 expiratory flow
6 inspiratory time 14 inspiratory phases
7 expiratory time or BAP time 15 concurrent breath
8 respiratory cycle time (1/set-rate) 16 expiratory phases

Figure C.25 — Typical airway-pressure and flow waveforms for a


CMV-PC <ACAP> ventilation-mode, set with an extreme inverse I:E ratio

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Key
1 airway pressure 11 respiratory cycle time
2 ambient pressure 12 assured-inflation phase
3 assist inflation (of the assured-inflation type) 13 assist-inflation phase
4 assured inflation 14 expiratory phase or BAP phase
5 PEEP 15 assured cycle
6 BAP 16 assist-inflation cycle
7 inspiratory pressure 17 inspiratory flow
8 inspiratory time 18 expiratory flow
9 expiratory time or BAP time 19 assisted breath
10 respiratory cycle time (1/set-rate) 20 controlled breath

Figure C.26 — Typical airway-pressure and flow waveforms for an A/C-PC ventilation-mode

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Key
1 airway pressure 10 assist-inflation phase
2 ambient pressure 11 expiratory phase or BAP phase
3 assured inflation 12 assist-inflation cycle
4 inspiratory flow 13 inspiratory flow
5 PEEP 14 expiratory flow
6 BAP 15 assisted breath
7 inspiratory time 16 controlled breath
8 expiratory time or BAP time 17 peak inspiratory pressure
9 respiratory cycle time (1/set-rate) 18 assured-inflation cycle

Figure C.27 — Typical airway-pressure and flow waveforms for an


A/C–VC ventilation-mode

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Key
1 airway pressure 12 assured-inflation cycle
2 ambient pressure 13 assist-inflation cycle
3 inspiratory pressure 14 inspiratory flow
4 BAP 15 expiratory flow
5 PEEP 16 controlled breath
6 inspiratory time 17 unrestricted breath
7 expiratory time or BAP time 18 assisted breath
8 respiratory-cycle time (1/set-rate) 19 concurrent unrestricted expiration
9 assured-inflation phase followed by unassisted inspiration
10 expiratory phase or BAP phase 20 flow trigger level
11 assist-inflation phase

Figure C.28 — Typical airway-pressure and flow waveforms for an


A/C–PC <ACAP> ventilation-mode

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Key
1 airway pressure 14 BAP time
2 Δ inspiratory pressure 15 support-inflation phase
3 support inflations 16 expiratory phase
4 assured inflations 17 assured-inflation phase
5 Δ support pressure 18 BAP phase
6 PEEP 19 assured-inflation cycle
7 BAP 20 support-inflation cycle
8 synchronization window 21 assured-inflation expiratory flow time
9 support-inflation inspiratory time 22 assured-inflation expiratory pause time
10 expiratory time (of support-inflation cycle) 23 supported breath
11 support-inflation cycle time 24 flow-trigger level
12 inspiratory time (of assured inflation-type) 25 inspiratory flow
13 respiratory cycle time (1/set-rate) 26 expiratory flow

Figure C.29 — Typical airway-pressure and flow waveforms for an


SIMV-PC\PS ventilation-mode

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Key
1 airway pressure 14 assured-inflation cycle time
2 inspiratory pressure 15 assured-inflation phase
3 Δ support pressure 16 BAP phase of assured-inflation cycle
4 ΔH support pressure 17 assured-inflation cycle
5 assured inflations 18 inspiratory flow
6 support inflations 19 expiratory flow
7 PEEP 20 concurrent supported breath
8 BAP 21 unassisted breath
9 support inflation 22 flow-trigger level
10 expiratory phase (of support-inflation cycle) 23 inspiratory phase
11 support-inflation cycle 24 expiratory phase
12 inspiratory time 25 unrestricted concurrent expirations
13 BAP time

NOTE Synchronization windows are not illustrated in this figure.

Figure C.30 — Typical airway-pressure and flow waveforms for variations on an SIMV-PC\PS\PS
<ACAP> ventilation-mode, with typical settings for a bi-level AV mode

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Key
1 airway pressure 11 assured-inflation cycle
2 ambient pressure 12 inspiratory flow
3 inspiratory pressure 13 expiratory flow
4 PEEP 14 inspiratory phase
5 BAP 15 expiratory phase
6 inspiratory time 16 concurrent unassisted breath
7 BAP time 17 assured inflations
8 respiratory cycle time (1/set-rate) 18 incomplete expiration, typically intentionally
9 assured-inflation phase achieved by use of insufficient expiratory time
10 BAP phase

Figure C.31 — Typical airway-pressure and flow waveforms for variations on an IMV-PC\PS\PS
<ACAP> ventilation-mode, with typical APRV settings

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Key
1 airway pressure 10 bi-level AV cycle
2 ambient pressure 11 inspiratory flow
3 BAPH or pH 12 expiratory flow
4 PEEP 13 inspiratory phase
5 BAP or pL 14 expiratory phase
6 BAPH time or tH 15 concurrent unassisted breath
7 BAP time or tL 16 assured inflations
8 BAPH phase 17 synchronized termination (typical)
9 BAP phase 18 respiratory cycle time (1/set-rate)

Figure C.32 — Typical airway pressure and flow waveforms for variations on an IMV-PC\PS\PS
<ACAP> ventilation-mode, with a PC{S} assured inflation-type, both support-pressures set to
zero and optionally labelled as intended for APRV (airway pressure release ventilation)

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Key
1 airway pressure 13 support-inflation phase
2 BAPH or pH 14 expiratory phase
3 ΔH support pressure 15 support-inflation cycle
4 Δ support pressure 16 assured-inflation cycle
5 BAP or pL 17 inspiratory flow
6 PEEP 18 expiratory flow
7 synchronization window 19 supported concurrent inspirations
8 respiratory cycle time (1/set-rate) (if support available or selected)
9 BAPH time or tH 20 unassisted breath
10 BAP time or tL 21 flow-trigger level
11 BAPH phase 22 ambient pressure
12 BAP phase

Figure C.33 — Typical airway pressure and flow waveforms for variations on an SIMV-PC\PS\PS
<ACAP> mode, with a PC{S} assured inflation-type and optionally labelled as a bi-level AV mode

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Key
1 airway pressure 7 expiratory phase
2 ambient pressure 8 support-inflation cycle
3 Δ support pressure 9 inspiratory flow
4 PEEP 10 expiratory flow
5 BAP 11 expiratory time
6 inspiratory phase 12 inspiratory time

Figure C.34 — Typical airway pressure and flow waveforms for a CSV-PS ventilation-mode

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Key
1 airway pressure
2 inspiratory flow
3 ambient pressure
4 inspiratory time

Figure C.35 — Characteristics of a concurrent breath

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Annex D
(informative)

Classification of inflation-types

D.1 General
The principle individual terms relating to currently available inflation-types are defined in 3.3. However,
there are many possible variations on these waveforms and Tables D.1 and D.2 have been included in
order to demonstrate how the defined inflation-types, and their known variations, are systematically
identified by both name and associated code. Table D.3 has been included to demonstrate the structure
of the schematic coding scheme that has been used and to provide a template for the schematic coding
of future inflation-types and those that are not already specifically designated. Although Table D.3 also
includes examples of systematic codes, for a more complete list see Tables D.1 and D.2.
Following convention, the primary classification of inflation-types in this document has been founded
on the two basic ventilation parameters that can be conveniently regulated - pressure and flow – along
with a hierarchy of letters used to codify how an inflation will be managed, after initiation.
The core elements of the systematic naming and encoding scheme are those that have been universally
adopted in current ventilation terminology, and which are defined in 3.3, that is, volume-control (VC),
pressure-control (PC) and pressure-support (PS), although the name effort-support (ES) has also been
added to enable the classification of certain newer developments. In this document, these names, each
in isolation, represent an inflation-type that, once initiated in accordance with the selected ventilation-
pattern, regulate the delivered flow or pressure to the set value or pattern until terminated by time,
flow, pressure, volume or other criteria.
Significant variations from the defined conditions for each name are designated by the attachment
of a supplements to the name or code. In the case of a code, the attachment is made using leading
lower-case letters and contained trailing letters – the containment being by means of round brackets
for termination parameters, curly brackets for conditional termination means and square brackets
for additional regulation parameters. Relevant suffixes and prefixes are a necessary part of the full
coded form of the systematic ventilation-mode name that should always be declared in a ventilator’s
accompanying documents. For other purposes, they are not always needed provided the selection of the
represented function is otherwise indicated in the accompanying documents or by a separate indication
on the user interface.
In the particular case of volume-control (VC) inflations, although these are always flow-regulated six
alternative means that have been used to achieve the required gas delivery are listed in Tables D.1 and
D.2. Because no particular names have evolved to make a distinction between these alternative means
and they all control the gas delivery largely independently of the patient no further supplementary
coding has been introduced in this document to specifically designate those distinctions. However,
it is expected that manufacturers will explain the means utilized in achieving volume-control on their
ventilators in their accompanying documents, using the vocabulary of this document.
In these classifications, wherever the primary means of inflation termination is shown to be other than
by time, safety considerations dictate that there will always be some sort of ultimate time limit on every
inflation. This might be a factory-set default or an operator-settable value with a limit on the maximum
setting, but such secondary time limits are not included in the coding in order to keep them as concise
as possible.
Provision has also been made to accommodate the possibility of switching between regulated
parameters during an inflation phase.

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D.2 Supplementary explanatory notes for the systematic coding scheme defined
in the applicable entries of Clause 3 and tabulated in Tables D.1, D.2 and D.3.
D.2.1
volume-control (See also 3.3.3)
Inflation-types that are all flow-regulated to a constant value (or a specified decreasing flow pattern) and
time-terminated, which, by convention, have been identified under their more generally applicable name
of volume-control, with the abbreviation, VC. There are various ways of achieving a required tidal volume
within these restraints and most of these have their distinctive characteristics individually described
in separate rows in Table D.1. In practical use, the differences will typically be evident from the method
by which the volume is set but will be of secondary significance to most operators. For this reason
and following current practice, in this document all these listed alternative possibilities are taken
to fall within the scope of this name [volume-control (VC)]. However, the specific characteristics that
identify the differences as explained in this document should be always described in the accompanying
documents.
Inflation-types that are flow-regulated to a constantly decreasing value and time-terminated, which, by
convention, have also been identified under their more generally applicable name of volume-control,
with the abbreviation, VC, are identified with the prefix df or cdf.
All volume-control inflations delivering leak compensated volumes may be identified with the suffix LC
although this is not necessary if this feature has been separately identified as an adjunct.

D.2.2
volume-targeted (See also 3.3.15 and 3.3.9)
Inflation-types, which unlike volume-control (VC), do not control the delivered volume directly but which
target a set volume by adjusting the inspiratory settings of a pressure-regulated inflation, typically
inflation-to-inflation, depending on measurements of previous deliveries.

D.2.3
pressure-limited volume-control (See also 3.13.2, 3.3.3 and 3.3.9)
Variant of volume-control (VC) in which, when the inspiratory pressure attains a set level during normal
operation, excess regulated flow is spilt to atmosphere, if this is necessary to avoid the inspiratory
pressure exceeding the set level. This can result in a possibly un-quantified loss of the delivered volume.
This variant is indicated by the addition of the trailing code [p LIM]. As this loss is part of the normal
operation of this inflation-type an alarm condition might not be generated, but if there is any loss of
delivered volume patient safety considerations dictate that it should be indicated. If the pressure is
limited by pressure-regulation, then the code becomes VC→PC (see 3.3.5).

D.2.4
pressure-control (See also 3.3.4)
Inflation-type that, after an initial rise time, is pressure-regulated to a constant value and time-terminated.
By convention, it has been identified with the name pressure-control, with the abbreviation, PC.

D.2.5
pressure-support or flow-terminated pressure-control (See also 3.3.6, 3.9.15 and 3.3.4)
Pressure-control (PC) inflation-type that is intended to be terminated by patient respiratory activity
reducing the flow to a set flow level before the set time-termination, and which is only used with
ventilation-patterns in which it can only be initiated by a patient-trigger event, has become identified

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with the name pressure-support, with the abbreviation, PS. If used with a ventilation- pattern in which it
could be time-initiated its code reverts to that of a variant of PC, that is, PC(q).

D.2.6
synchronized-termination (See also 3.9.7, 3.9.8 and 3.12.9)
Pressure-control inflation-type, intended for use with ACAP or ACAPH adjuncts, where the patient
can expire spontaneously during the set inflation phase without terminating the delivery. It then uses
a synchronization window to modulate the actual termination point of each inflation to coincide with
the patient’s expiratory activity (3.2.6). The presence of this feature is indicated by the conditional-
termination variation trailing code {S}, spoken as ‘pressure-control with synchronized-termination’.

D.2.7
effort-support (See also 3.3.7)
Variant of a pressure-support inflation-type that is pressure-regulated to a non-constant waveform that
is dependent upon the instantaneous value of a patient variable(s) that indicates the patient effort at
that point in time, with the intention of providing support to the breathing that is always proportion
to the respiratory effort. The variables used are typically either those relating to the loads imposed by
airway resistance and the lung elastance or the neural signals that determine respiratory effort. The
concept is identified with the name effort-support, with the abbreviation, ES. The full systematic name
for an effort-support inflation-type will include a reference to which of these indicators of specific patient
efforts are supported, that is, change in lung volume [v], airway flow [q], change in lung volume and
airway flow [q+v], or the electromyographic activity of the diaphragm and intercostal muscles [EMG].

D.2.8
Note There are currently no agreed names to designate these following, additional regulation parameters,
other than the use of a verbal description. D.2.8.1 to D.2.8.5 provide cross references to their corresponding
entries in Table D.3.

D.2.8.1

flow-regulated, pressure-terminated (See also 3.3.8 and 3.9.16)


Flow-regulated inflation that is pressure-terminated and with which, as a consequence, there is no
direct correlation between the setting and the delivered volume. It is not, therefore, a variant of VC and
is classified as a flow-regulated, pressure-terminated inflation-type. This inflation-type is not currently
used in mainstream ventilators but is still sometimes used in low-cost, gas-powered resuscitators.
These devices are commonly known as ‘pressure-cycled resuscitators’, on the basis that each phase
change is initiated when a measured airway-pressure in the ventilator breathing system reaches a set
level, although they are sometimes flow- or time-terminated.

D.2.8.2

volume-terminated, pressure-control (See also 3.3.4 and 3.9.14)


Variant of a pressure-control inflation-type in which the inflation is terminated after a set volume has
been delivered. As a variant, it is coded as PC(v).

D.2.8.3

dual-control (See also 3.3.5)


Hybrid inflation-type that starts with the first inflation-type but under specified conditions will be
changed to an alternative type during the course of the delivery. These changes may be conditionally
bi-directional or unidirectional as indicated by the coupling arrows.

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D.2.8.4

volume-assured pressure-support (See also 3.3.5 and 3.3.6)


Specific example of dual-control in which a pressure-support (PS) inflation-type is extended by the
maintenance of the termination flow if the delivered volume has not by then attained the set volume-
assured value. The transition to constant flow can alternatively be initiated earlier in the phase if the
control algorithm anticipates that the set minimum value will not otherwise be attained. This example
of dual-control is commonly referred to as "volume assured pressure support", with the acronym VAPS,
but its abbreviated systematic designation is PC→VC.

D.2.8.5

pressure-control with ACAP or ACAPH (See also 3.3.4 and 3.12.1)


Conceptually, this is a pressure-control (PC) assured inflation-type on a ventilator provided with an
ACAP adjunct that is active at the higher, inspiratory-pressure baseline airway-pressure level (BAP H). It
facilitates concurrent expirations in addition to unrestricted inspirations.

Table D.1 — Coding scheme for inflation-types

Table D.2 — Coding scheme for variants of Volume-control Inflation-types

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Table D.3 — Systematic coding scheme for inflation-types

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Annex E
(informative)

Classification of ventilation-modes

The principal individual terms relating to currently available ventilation-modes and how these are
combined to arrive at a systematic name and code are defined and explained in 3.11. The rationale to
that subclause gives further explanation. Tables E.1 and E.2 have been included in this document in
order to provide typical examples of how these individual concepts are combined to provide a scheme
that enables the large number of possible ventilation-modes to be uniquely classified by means of a
systematic name and code.
As has been explained in previous sections of this document, the primary means of classification of
ventilation-modes in this document is by the ventilation-pattern that has been selected. This allows
their convenient arrangement into four basic groups, with two further subgroups, according to shared
characteristics, as defined in 3.11.3. As made clear in the entries to 3.11, the use of these groups is
not a necessary condition for conformance with this document, but it does provide a helpful primary
classification.
The secondary means of classification is by the dominant inflation-type that has been selected, which
will typically be either the only inflation-type or the assured inflation-type.
The third, and the successive, means of classification is by the inflation-type that has been selected to
provide assistance to any spontaneous breathing between assured inflations, and then by any additional
inflation-types or phases where they are made active.
Additional classifications are by adjuncts that are permanent features of the ventilator and by adjuncts
that are available only by selection.
Each row in Tables E.1 and E.2 represents a specific ventilation-mode. The two left hand columns serve
to segregate these examples into the ventilation-mode groups, as defined in 3.11.5. Within each group,
these ventilation-modes are listed according to the above criteria, and by the classification of inflation-
types as described in 3.3 and further detailed in Annex D.
The third column lists the systematic code for the typical examples of possible specific ventilation-modes
within each group. Examples involving all the characteristic ventilation-patterns of each group are
included along with typically associated inflation-types but, as is indicated by the number of entries in
Tables D.1 and D.2, the possible combinations of these two features is far greater than shown. However,
the intention is to demonstrate the pattern of use, not to include every possibility.
The fifth column lists the full systematic name of each of the ventilation-modes. The comparison of these
names with the associated systematic code demonstrates the practicality and conciseness achieved
with the adoption of the code as the primary means of ventilator-mode identification.
If the ventilator provides an ACAP adjunct, this adds a further level of classification. For reasons of table-
size limitations and because the provision of ACAP facilitates the use of other additional features, the
examples of ventilation-modes that include ACAP have been separated into a second table, E.2.
Although, for individual codes, the provision of ACAP is denoted by an appendage within angled
brackets, that is as <ACAP>, the fourth column of Table E.2 shows how, because of their global effect
when built into a specific model of ventilator, adjuncts may be indicated by means of a global entry.
The applicability of each type of ACAP in the global entries to any one of the example ventilation-mode
entries is indicated by a note that is referenced in the third column of Table E.2. This is the method that
is recommended for use in manufacturer’s equivalence tables (see example Tables I.1 and I.2).

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Other typical features and applicable notes are also shown as global entries, with linking references in
the ‘Additional notes’ columns.

Table E.1 — Typical examples of ventilation-mode systematic coding scheme for ventilators
without an ACAP adjunct

Table E.2 — Typical examples of ventilation-mode systematic coding scheme for ventilators
with an ACAP adjunct

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Annex F
(informative)

Concepts relating to baseline airway pressures and PEEP as used


in this document

Inherent in the concept of a ventilation-pattern that determines how and when inflations are delivered
is the determination of what happens between inflations. Typically, there are clinical requirements to
ventilate patients with an elevated baseline airway pressure and this requires the use of specific control
elements and appropriate algorithms, particularly when provision is made for unrestricted, unassisted
breathing, both between, and concurrent with, assured inflations. Figures F.1 – F.4 illustrate the
applications of the terminology in this document that relate to this phase.
Figures F.1 – F.4 show the typical expiratory-phase waveforms that could be expected with four specific
usage scenarios. These were chosen to illustrate the effects of settings, patient parameters and control
algorithms on pressures during, and at the end of, time-terminated expiratory phases. For the purposes
of these explanations all these figures are based on the use of the same basic CMV-PC mode setting.
As the pressure at the patient-connection port falls during an expiration, there is an unavoidable lag in
the corresponding rate of fall of the alveolar pressure. This is mainly due to airway resistance and flow
limitation factors. Normally, the effects of this lag will have fully dissipated by the end of the expiratory
phase, but with shorter expiratory times or with a diseased lung, the average alveolar pressure might
still be above the measured expiratory pressure at the end of the expiratory phase. The amount by which
this average alveolar pressure exceeds the measured positive end-expiratory pressure, PEEP, cannot be
measured directly but its presence and order of magnitude is commonly ascertained by the use of an
expiratory-hold procedure. The airway pressure measured at the end of this procedure is the average of
that of the pressurized gas in the alveoli that has been able to distribute uniformly throughout the lungs
during the expiratory-hold time, although it might not fully include the contribution of any trapped gas
to the true average pressure.
Figure F.1 illustrates the normal situation where the alveolar pressure does lag the expiratory pressure
while there is expiratory flow but once the expiratory pressure reaches a constant value at the set BAP
level and expiratory flow has ceased, an expiratory hold procedure would show that the alveolar gas had
ceased distributing and that both the average pressure of the gas that had distributed and the total
PEEP were at the measured PEEP level.
Figure F.2 illustrates a typical situation that can occur when ventilating a diseased lung with airflow
obstruction and flow limitation. In this case, the expiratory pressure has reached a constant value at
the set BAP but the effects of the lag have not fully dissipated by the end of the expiratory phase. An
expiratory hold procedure would show that the alveolar gas had not ceased distributing and that the
average pressure of the gas, designated as total PEEP (tPEEP), was greater than the measured PEEP by
the amount designated as auto-PEEP.
Figure F.3 again illustrates a typical situation that can occur when ventilating a diseased lung with
airflow obstruction and flow limitation. However, in this case an expiratory-control algorithm has been
used to determine an optimum expiratory pressure waveform on a ventilator with the ability to maintain
such a waveform by utilizing the facilities of an ACAP or ACAPL adjunct, or an equivalent function. The
waveform has been initially taken below the set BAP level in order to discharge gas from the ventilator
breathing system and the patient's upper airways as quickly as possible before bringing it back up to the
assured level while the pressure in the lower airways is still declining. The effect is to decrease the lag
in the later stages of the expiration and to thereby reduce the auto-PEEP.
Figure F.4 illustrates a typical situation that can occur if the set expiratory time is too short, such that
there is insufficient time for the gas in the lungs to fully discharge before the next inflation is initiated.
This is more likely to occur at the higher set rates as might be appropriate for younger patients or if

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there is excessive resistance in the expiratory limb of the ventilator breathing system. In this case, the
measured PEEP does not reach the baseline airway-pressure level, leading to an increase in the measured
total PEEP. Although this portion of total PEEP is more apparent to the operator it is still within the
scope of the definition of auto-PEEP because it is clearly part of the proportion of total PEEP above that
intended by the setting.
Typically, there will be no difference between PEEP and the set BAP, but where a difference arises the
operator should be aware of the possible implications. A positive difference might indicate too short
an expiratory time or a restriction in the expiratory pathway of the ventilator breathing system (for
example, a contaminated filter). A negative difference might indicate that the pressure in the lungs
is being allowed to drop below the intended minimum level due to uncompensated leakage from the
ventilator breathing system or at the connections of an airway device.
Figure F.5 illustrates a typical expiratory phase of an assured inflation in a Group 2 ventilation-mode,
which may be alternatively referred to as a BAP phase. This alternative name is not only more concise
and less ambiguous but leads naturally into the terminology of bi-level AV (where both levels would be
indicated by orange broken lines as in the Figures of C.30 to C33 and F.7 a).
Figures F.6 and F.7 illustrate the function of an expiratory-control algorithm.
F.6 a) shows its function during the BAP phase of the pressure-control, assured inflation of a Group 2
ventilation-mode when each patient inspiration is supported by a pressure-support inflation, whereas
F.6 b) shows the same BAP phase but with either no support or with the support reduced to its ‘off’ or
‘zero’ level.
F.7 a) shows its function when supported spontaneous breathing is enabled during an inflation phase in a
bi-level AV mode - a phase which may be alternatively referred to as a BAPH phase.
F.7 b) shows the function of the expiratory-control algorithm in a CSV mode with pressure-support.
In each of these illustrations the expiratory-pressure waveforms are as determined by the expiratory-
control algorithm and the volume of gas to be discharged. They are maintained by the built-in
functionality of an ACAP adjunct that is active at the BAP level - or an equivalent pressure-regulation
function. However, it should be noted that the range of waveforms, and how closely they are maintained,
is likely to be impaired with the use of some equivalent pressure-regulation functions.
The colour coding used in this annex is the same as that explained in the introduction to Annex C, with
the addition of lime green to identify the projected typical average alveolar pressure waveforms.

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Key
1 airway pressure 5 BAP
2 ambient pressure 6 PEEP
3 typical, measured expiratory-pressure waveform 7 total PEEP
4 projected typical average alveolar pressure waveform 8 BAP phase

Figure F.1 — Illustration of the application of BAP and PEEP terminology — Typical ideal
expiratory-airway-pressure waveforms with no auto-PEEP

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Key
1 airway pressure 6 PEEP
2 ambient pressure 7 total PEEP
3 typical, measured expiratory-pressure waveform 8 BAP phase
4 projected typical average alveolar pressure waveform 9 auto-PEEP
5 BAP

Figure F.2 — Illustration of the application of BAP and PEEP terminology


— Typical expiratory-airway-pressure waveforms with an impaired lung

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Key
1 airway pressure 6 PEEP
2 ambient pressure 7 total PEEP
3 typical, measured expiratory-pressure waveform 8 BAP phase
4 projected typical average alveolar pressure waveform 9 auto-PEEP
5 BAP

Figure F.3 — Illustration of the application of BAP and PEEP terminology — Typical expiratory-
airway-pressure waveforms with an impaired lung but with an expiratory-control algorithm
programmed to enhance initial evacuation of the gas in the upper airways by increasing the
initial pressure differential.

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Key
1 airway pressure 6 PEEP
2 ambient pressure 7 total PEEP
3 typical, measured expiratory-pressure waveform 8 BAP phase
4 projected typical average alveolar pressure waveform 9 auto-PEEP
5 BAP

Figure F.4 — Illustration of the application of BAP and PEEP terminology — Typical expiratory-
airway-pressure waveforms on a ventilator with inadequate set expiratory time or excessive
expiratory-limb resistance (e.g., due to kinked tube or increased resistance filter)

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Key
1 airway pressure 9 expiratory phase
2 ambient pressure 10 support-inflation cycle
3 displayed expiratory-pressure waveform (typical) 11 BAP phase
4 inspiratory pressure 12 inspiratory flow
5 PEEP 13 expiratory flow
6 BAP 14 unassisted spontaneous inspiration
7 BAP time 15 spontaneous inspirations with pressure-support
8 support-inflation phase

Figure F.5 — The BAP phase

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a) Function of the expiratory-control algorithm during a BAP phase with supported breaths

b) Function of the expiratory-control algorithm during a BAP phase with unassisted breaths

Key
1 airway pressure 8 pressure-support inflations to assist
2 ambient pressure spontaneous inspirations
3 BAP 9 baseline airway pressure
4 PEEP 10 BAP phase
5 typical expiratory-pressure waveforms, following an 11 the expiratory-control algorithm also generates
assured inflation, as determined by the expiratory- the constant pressure-support portion of the
control algorithm intended expiratory-pressure waveform of the
6 typical expiratory-pressure waveforms, following assured inflation, which the ACAP L adjunct acts
support-inflations, as determined by the expiratory to maintain in order to enable unrestricted
-control algorithm breathing when pressure- support is absent or
7 assured inflation turned off, and to compensate for leakage

Figure F.6 — Illustrations of the function of the expiratory-control algorithm on ventilators


with an ACAPL adjunct (or an equivalent function) during BAP phases

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a) Function of the expiratory-control algorithm during an assured-inflation phase

b) Function of the expiratory-control algorithm in a CSV mode

Key
1 airway pressure 8 typical expiratory-pressure waveforms, following
2 ambient pressure support-inflations, as determined by the expiratory
3 BAP control algorithm
4 PEEP 9 baseline airway pressure
5 inspiratory pressure or BAPH 10 inspiratory phase or BAPH phase
6 assured inflation
7 pressure-support inflations to assist
spontaneous inspirations

Figure F.7 — Illustrations of the function of the expiratory-control algorithm on ventilators


with an ACAP adjunct (or an equivalent function)

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Annex G
(informative)

Conventions followed in this document

G.1 Post-coordinated terms


The notes to some definitions refer to post-coordinated terms. These are terms formed by the
combination of two defined terms, or of a defined term with a natural language word, to form a new
compound term. Usually, the additional term or word qualifies the base term by reference to an
alternative site, pressure level or point of occurrence within a respiratory cycle. It can place a restriction
on the applicability of the base term. Some of the most commonly used post-coordinated terms are
defined in their own right but users of this document are free to create other post-coordinated terms
providing the combination does not conflict with the meaning of any of the other terms defined in this
document.

G.2 Use of hyphens


Where hyphens are used in compound terms in the vocabulary of this document, their use is considered
to be good practice in the interests of readability and the minimization of possible ambiguity but that
use is not normative.

G.3 Flows and pressures


In natural language, the word ‘flow’ denotes a steady movement of a body of fluid in the same general
direction but to be precise when designating a quantified flow in isolation, the addition of the word
‘rate’ is necessary.
Similarly, the word ‘pressure’ in reference to a gas, denotes a continuous physical force exerted against
the walls of its container. For it to be used to denote a quantity, the addition of a term such as ‘level’ is
necessary.
In practice, when used as artificial ventilation terms these additions seldom add meaning as the context
of use is sufficient in itself. Therefore, with the need for brevity, particularly when used on user
interfaces and in instructions for use, in the vocabulary of this document, the term ‘flow’ is taken to
encompass the concept of a rate of flow and the term ‘pressure’ is taken to encompass the concept of
the pressure level. Where this is seen to create an ambiguity, or in applications where the use of correct
English is considered to be the priority, the terms ‘rate’ or ‘level’ may be added, respectively, where
appropriate.

G.4 Measurements
References to measured values in this document are to be taken as referring to values obtained from
measurement systems, with the understanding that the actual measurement signal(s) might have
been appropriately processed to remove artefacts such as result from transients and ‘noise’, while
maintaining a declared accuracy; also, that the site(s) of a measurement can be away from the site to
which the measurement is referenced.
As a measurement, without further qualification or context, a recorded or displayed discrete value of a
quantity is typically that of a measurement at a point in time relative to a respiratory cycle or a specified
elapsed time. As the actual value of a quantity generally varies with time, even if regulated to a set
value, a displayed or recorded measured value generally has little meaning unless related to a specific

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point(s) in a respiratory cycle(s), either by a qualifying term or by the context of use. An example of
context is a displayed waveform, which is clearly a continuous display of the actual measured value with
progress of time. An example of a qualified term is peak inspiratory pressure where the displayed value
is the highest measured value recorded during a specified interval.
Although the definition of many terms relating to quantities in the vocabulary of this document
specify a site at which it applies, there is no requirement that measurements are made at that site. In
practice, the site of actual measurement(s) can be anywhere in the ventilator breathing system providing
the indicated value and its attributes are referenced to the specified site. The displayed or recorded
measured value may also be a calculated value based on the results of more than one measurement at
different sites.
As stated in Annex A.4 (3), the terms relating to quantities in this document are conceptual and are
independent of any specific system of units of measurement. It is for particular standards to specify
any requirements regarding measurement accuracy, the applicability and appropriateness of the
measurement methods that might be adopted, and units of measurement.

G.5 Multiplicity of terms


Artificial ventilation can be described at many levels of granularity, depending on the objective of the
description. This document is based on a comprehensive conceptual model of such ventilation, which
can lead to an apparently confusing multiplicity of terms relating to certain aspects of that function
when listed in an all-encompassing vocabulary. It should be emphasized that there is no requirement
for manufacturers to adopt every one of these terms, nor be required to provide their own equivalent to
each one, in the labelling of any specific ventilator.

G.6 The use of letter symbols to represent defined terms


It is not within the primary scope of this document to specify requirements for symbols to be used
as alternatives to a defined term. Letter symbols are typically used where space is limited, such as
on a user interface, but for many terms, currently used symbols are very diverse. Some manufacturers
attempt to follow the guidance and examples for mathematical signs and symbols to be used in natural
sciences and technology given in the ISO 80000 series but this guidance is not comprehensive.
Letter symbols have only been included as possible alternative terms in this document where there
appears to be a general consensus relating to their use in representing the principal terms. The general
form shown is recommended but, as stated in Annex H, not a requirement. Where they are reproduced
by users of this document they may be in fonts and styles to suit the application, except for letters
designating quantities. These should always be in an italic style in accordance with the relevant parts
of ISO 80000.

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Annex H
(informative)

Implementation guidance for the vocabulary of this document

H.1 Recommendations for initial introduction


It is recognized that the full international adoption of a standardized vocabulary cannot occur
immediately after its publication and that time will have to be allowed for each user to adapt to at least
some changes from the vocabulary they currently use. However, care has been taken in the preparation
of this document to minimize the changes that will be faced by most users in the general use of
ventilators, and it is anticipated that it will be less challenging than is the case presently when moving
from one manufacturer’s ventilator to that of another.
It is expected that, initially, the vocabulary specified in this document will be publicized by means of
dedicated articles and presentations, as well as being adopted both by authors when writing articles in
medical journals and textbooks, and by those teaching and training.
The committee firmly advocates that manufacturers should also participate in this initial introduction
by preparing documentation that identifies all the terms used for the labeling of their current ventilators
that are different from the term used to designate the same concept in this document and lists them
with the standardized term alongside. Any terms used to designate a concept that is similar to but
differs from a concept designated in this document should also be listed along with that standardized
designation, but should be accompanied by a brief description of the divergence.
For all ventilation-modes that can be selected on a ventilator, the full coded form of the systematic
ventilation-mode name as specified in this document should be listed alongside the labeled name used
on the ventilation equipment. These listings should be supplemented by brief descriptions of the basic
ventilation-modes that are available on the ventilator using the vocabulary of this document. Any
ventilation-mode that cannot be adequately specified with any of the coding scheme options specified in
this document should be listed using the nearest systematic code but with an associated note giving a
brief description of the difference(s).
Preferably, this information should be made available to users and operators in the form of a glossary
and as part of, or as a supplement to, the accompanying documents.
For further guidance on the implementation of these recommendations see H.2 and the text and tables
of Annexes D, E, and I.

H.2 Implementation on ventilator labelling


The following informative guidelines are provided to indicate how it is intended that this document
should be used in the labeling of ventilation equipment following its initial introduction as outlined above.
First, it should be accentuated that the vocabulary specified in this document is intended to contribute
to the effectiveness and safety of the practice of artificial ventilation by providing the basis for a
coherent language covering current and foreseeable future practice. It has been structured so that it
is sufficiently adaptable to facilitate the description of novel deviations although it is recognized that
some future innovations might require the use of terms and concepts not covered by this edition of this
document. It should also be highlighted that the terms, names and acronyms used in this document
have been described in a manner that formalizes their interpretation to the extent that it minimizes
ambiguity and provides a rigid usage discipline for formal data handling and informatics, whilst still
enabling phraseology that is suitable for user instructions and clinical dialog.

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In the application of this document, the full term should always be used wherever it is considered to
be important that any ambiguity is to be avoided and where there is no trade-off with conciseness, for
example, in the formulation of databases. However, in many applications the context of use can make
some of the parts of a compound preferred term redundant, in which case abbreviations, symbols and
permitted terms may be used, as appropriate. In the particular case of terms representing set, measured
or actual values, qualifications such as ‘set’ or ‘measured’ may be omitted where the meaning is obvious
from the context of use.
Also, where space is particularly limited, such as on a typical user interface, or conciseness is necessary,
it is permissible to use abbreviations or symbols to represent preferred terms, providing the context
makes it self-evident as to whether they relate to set, measured or actual values. Such abbreviations or
symbols may be those shown in this document, or may be appropriate alternatives, providing that, in all
cases, their meanings and their equivalence to the related preferred term is made available to the user.
As examples of where abbreviations or symbols may be used, in a section on a user interface designated
for ‘settings’ the input key for inspiratory flow may be marked simply as ‘Flow’, and that for inspiratory
time with an appropriate symbol such as ‘t I’.
As pointed out in G.6, symbols are not within the primary scope of this document and have only been
included in Notes to entries, as possible alternatives, where there appears to be an existing general
consensus relating to their use in representing a defined concept. Their inclusion is only for guidance
and their format and use is not a normative requirement. For further information and recommendations
refer to G.6.
Even with these considerations, the exclusive use of the terms listed in this document might still be too
formal for some applications and the intention is that in conformance with this document manufacturers
will be able to still retain their proprietary names and acronyms and substitute their own phraseology
in preparing instructions for use, subject to the following principles:
a) The standardized term should be used in preference to any other where it is applicable.
b) The standardized terms may be used in a variety of post co-ordinations and with any alternative
grammatical forms provided that the meaning conveyed is in accordance with the definitions of the
terms and concepts in this document.
c) Where proprietary and registered, names and acronyms for ventilation-modes and control
algorithms are used they should be explained in terms of the concepts defined in this document in
an appropriate section of, or supplement to, the instructions for use.
d) The meaning conveyed by any proprietary term that might be introduced following the publication
of this document, where applicable, should be the same as that described in this document for the
same concept or combination of concepts.
e) Text prepared by the manufacturer and others to explain and describe artificial ventilation may use
their own phraseology in expressing the concepts involved but the underlying concepts defined in
this document are to be adhered to.
f) Descriptions of artificial ventilation practice not directly covered by this document may use a
manufacturer's own phraseology and explain its own naming structures in expressing the concepts
involved but this should be in a form that is easily understood by those trained in the vocabulary of
this document.
g) New terms, conforming with this document under the permitted exceptions b) to f), should be
chosen and used in a manner that avoids any conflicts that could cause confusion to those trained
in the vocabulary in this document.

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Annex I
(informative)

Equivalence declaration tables

Table I.1 — Recommended layout for a manufacturer’s ventilation-mode equivalence table


(Example)
Ventilation-mode a
Alternative Additional
(Typical examples list- Systematic codec
mode nameb notes
ed below)
VC-CMV CMV-VC 1
PCV + assist control A/C-PC
BiLevel bi-level AV SIMV-PC\PS 2
P-SIMV SIMV-PC\PS
APRV APRV IMV-PC 3
SPN-PPS CSV-ES 4

Additional notes (Examples)


Note 1 ACAPL is provided to allow unrestricted breathing throughout the
BAP phase.
Note 2 ACAP is provided to allow unrestricted breathing at any time.
Note 3 Option of expiratory-flow initiation of next assured inflation.
Note 4 The effort-support can be set to be proportional to flow and/or
volume.
Note 5 The pressure-support settings are adapted with the features of an
NIV adjunct.
a This column will list the manufacturer’s own descriptions of the ventilation modes-
available on the subject ventilator.
b This column will list any alternative mode names listed in this document, where
applicable.
c This column will list the corresponding systematic ventilation-mode code as specified
in this document.
NOTE This table is an example only and its content might not represent any currently
available ventilator.

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Table I.2 — Illustrative examples of manufacturer’s modes entered into an


equivalence table with supplementary notes
Mode name
(Typical examples of manu- Alternative See
Systematic code
facturers’ designations are mode name Note:
listed below)
VC-CMV CMV-VC 2
PC-CMV + VG CMV-vtPC 2
VCV + assist control A/C-VC 2
(S)CMV A/C-VC
P-CMV A/C-PC
Assist control ventilation
A/C-PC
(A/C) + pressure breath
PC-AC A/C-PC 1
PCV + assist control A/C-PC
PC-AC + VG A/C-vtPC
PC-APRV APRV IMV-PC 1&3
APRV APRV IMV-PC 1&3
VC-SIMV SIMV-VC\PS 2
SIMV (VC) + PS SIMV-VC\PS
SIMV SIMV-VC\PS 1
SIMV (PC) + PS SIMV-PC\PS
P-SIMV SIMV-PC\PS
VC-SIMV + AutoFlow ®1)/VG SIMV-vtPC\PS 2
SIMV (PRVC) + PS SIMV-vtPC\PS 1
PC-SIMV+ VG SIMV-vtPC\PS 1
APVsimv SIMV-vtPC\PS
SIMV + PRVC + PSV breaths SIMV-vtPC\PS
SIMV + (VC+) + PS SIMV-vtPC\PS
BiLevel bi-level AV SIMV-PC\PS 1
SIMV-PC{S}\
DuoPAP®9) bi-level AV 1
PS(x2)
SIMV-PC{S}\
BiLevel bi-level AV 1
PS(x2)
bi-level AV/ SIMV-PC{S}\
APRV/BIPHASIC 1
APRV PS(x2)
PC-BIPAP®7) bi-level AV SIMV-PC\PS 1
VC-MMV MMV-VC\PS SIMV-VC\PS 6
ASV®6) MMV-vtPC\PS SIMV-vtPC\PS 7
SPN-CPAP/PS CSV-PS 2
Pressure-support (NIV) CSV-PS 5
SPN-CPAP/VS CSV-vtPS
SPN-PPS CSV-ES 4
CPAP CPAP 1
9 DuoPAP® is the trademark of a product supplied by Hamilton
Medical AG. This information is given for the convenience of users
of this document and does not constitute an endorsement by ISO of
the product named. Equivalent products may be used if they can be
shown to lead to the same results.

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Table I.2 — (continued)


Supplementary notes
Note: Further levels of classification and deviations
1 ACAP is provided to allow unrestricted breathing at
any time.
2 ACAPL is provided to allow the possibility of unre-
stricted, unsupported breathing during BAP phases
(irrespective of any PS trigger settings in modes that
include PS).
3 Option of expiratory-flow initiation of next assured
inflation.
4 The effort-support can be set to be proportional to
flow and/or volume.
5 The pressure-support settings are adapted as appro-
priate for NIV.
6 Achieves MMV by continuous automatic adjustment of
the set rate.
7 Achieves MMV by continuous automatic adjustment of
tidal volume and set rate as determined by minimum
work of breathing equation.

Table I.3 — Typical illustrative examples of entries to manufacturer’s adjunct equivalence table
Adjuncts
Typical
Typical manufacturers’ designations Standardized designation
availability
"Open system" Permanently
ACAP
"Patient may breathe freely" available
"Allowing spontaneous breathing during the expirato- Permanently
ACAPL
ry phase" available
"Patient breathes spontaneously at the high pres- Permanently
ACAPH
sure-level" available
ATC
Tube compensation (TC) Selectable
AAC, Artificial Airway Compensation
Breathing system compliance compensation None Selectable
Breathing system leakage compensation None Selectable
Leak compensation None Selectable

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Annex J
(informative)

Terminology — Alphabetized index of defined terms

Preferred terms, admitted terms and terms in other documents

Term Normative Status Source


A/C preferred term (2nd) 3.11.8
A/C ventilation preferred term (3rd) 3.11.8
ACAP preferred term 3.12.1
ACAPH preferred term 3.12.3
ACAP-high admitted term 3.12.3
ACAPL preferred term 3.12.2
ACAP-low admitted term 3.12.2
accompanying document preferred term 3.1.28;
IEC 60601-1:2005+AMD1:2012—3.4, modified
actual value preferred term 3.1.22
additional breath preferred term 3.2.8
additional breath rate preferred term 3.5.2.3
additional minute volume preferred term 3.8.12
adjunct preferred term (1st) 3.11.4
adjustable airway pressure limit preferred term (2nd) 3.13.9
adjustable pressure limit preferred term (1st) 3.13.9
airway preferred term 3.1.2
airway device preferred term 3.1.3
airway leak preferred term 3.7.11
airway pressure preferred term 3.6.1
airway pressure release ventilation preferred term (2nd) 3.11.14
airway resistance preferred term 3.1.4
alarm condition preferred term IEC 60601-1-8 2006+A1:2012—3.1
alarm limit preferred term IEC 60601-1-8 2006+A1:2012—3.3
alarm system preferred term IEC 60601-1-8 2006+A1:2012—3.11
alternative mode name preferred term (1st) 3.11.20
alternative ventilation-mode name preferred term (2nd) 3.11.20
AP admitted term 3.10.7
APL preferred term (3rd) 3.13.9
apnea ventilation preferred term (2nd) 3.11.16
apnoea ventilation preferred term (1st) 3.11.16
APRV preferred term (1st) 3.11.14
artificial ventilation preferred term 3.1.10
assist/control ventilation preferred term (1st) 3.11.8
assisted breath preferred term 3.2.14
assured constant airway pressure admitted term 3.12.1

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Term Normative Status Source


assured inflation preferred term 3.3.11
assured-inflation cycle preferred term 3.4.18
assured inflation-type preferred term 3.3.12
assured inflation-type rate preferred term 3.5.2.1
assured minute volume preferred term 3.8.11
assured ventilation preferred term 3.11.6
assured-inflation cycle preferred term 3.4.18
auto trigger preferred term 3.9.10
automatic ventilation preferred term 3.1.12
auto-PEEP preferred term 3.10.7
backup ventilation preferred term 3.11.17
BAP preferred term 3.10.2
BAP phase preferred term 3.10.3
BAP time preferred term 3.12.6
BAPH preferred term 3.12.7
BAPH phase preferred term 3.12.8
BAPH time preferred term 3.12.9
baseline airway pressure preferred term (1st) 3.10.1
baseline pressure preferred term (2nd) 3.10.1
bias flow preferred term 3.7.7
bi-level admitted term 3.12.4
bi-level artificial ventilation preferred term (2nd) 3.12.4
bi-level AV preferred term (1st) 3.12.4
bi-level PAP preferred term (1st) 3.12.5
bi-level positive airway pressure preferred term (2nd) 3.12.5
BPAP admitted term 3.12.5
breath preferred term 3.2.1
breath stacking preferred term 3.9.11
breath synchronization preferred term 3.9.7
breathe preferred term 3.2.2
breathing-therapy mode preferred term 3.11.22
CMV preferred term (1st) 3.11.7
concurrent breath preferred term 3.2.9
concurrent unassisted-breath rate preferred term 3.5.2.4
continuous flow preferred term 3.7.8
continuous mandatory ventilation preferred term (2nd) 3.11.7
continuous positive airway pressure preferred term (2nd) 3.11.15
continuous spontaneous ventilation preferred term (2nd) 3.11.12
controlled breath preferred term 3.2.16
CPAP preferred term (1st) 3.11.15
CSV preferred term (1st) 3.11.12
cycle time preferred term (2nd) 3.4.17
decreasing flow pattern preferred term 3.7.9
delivered minute volume preferred term 3.8.7
delivered volume preferred term 3.8.2

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Term Normative Status Source


Δ preferred term (1st) 3.6.6
delta preferred term (2nd) 3.6.6
Δ inspiratory pressure preferred term (1st) 3.6.7
Δ pressure preferred term (3rd) 3.6.7
demand flow preferred term 3.7.10
AP admitted term 3.10.7
dual-control preferred term 3.3.5
dynamic compliance preferred term 3.1.8
effort-support preferred term (1st) 3.3.7
end-expiratory flow preferred term 3.7.6
end-inspiratory flow preferred term 3.7.4
end-inspiratory pressure preferred term 3.6.8
ES preferred term (2nd) 3.3.7
exhaust port preferred term 3.14.2
expiration preferred term 3.2.11
expiratory flow preferred term 3.7.5
expiratory hold preferred term 3.4.6
expiratory pause preferred term 3.4.4
expiratory phase preferred term 3.4.2
expiratory pressure preferred term 3.6.9
expiratory pressure-relief preferred term 3.6.10
expiratory time preferred term 3.4.1
expiratory-control algorithm preferred term 3.10.5
expiratory-flow time preferred term 3.4.3
expiratory hold preferred term 3.4.6
expiratory-hold time preferred term 3.4.7
expiratory-pause time preferred term 3.4.5
expired minute volume preferred term 3.8.9
expired tidal volume preferred term 3.8.4
fail-safe ventilation preferred term 3.11.18
flow trigger preferred term 3.9.3
flow-regulation preferred term 3.3.8
flow-termination preferred term 3.9.15
gas output port preferred term 3.14.3
gas return port preferred term 3.14.4
harm preferred term IEC 60601-1:2005+AMD1:2012—3.38
hazardous situation preferred term ISO 14971:2007—2.4
high-airway-pressure limit preferred term 3.13.5
high-airway-pressure relief limit preferred term (2nd) 3.13.6
high-airway-pressure termination limit preferred term (2nd) 3.13.7
high-pressure relief limit preferred term (1st) 3.13.6
high-pressure termination limit preferred term (1st) 3.13.7
I:E ratio preferred term (2nd) 3.4.19
IMV preferred term (1st) 3.11.9
inflation preferred term (1st) 3.3.1

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Term Normative Status Source


inflation phase preferred term 3.4.10
inflation-type preferred term 3.3.2
initiate preferred term 3.9.1
inspiration preferred term 3.2.10
inspiratory effort preferred term 3.2.7
inspiratory flow preferred term (1st) 3.7.1
inspiratory hold preferred term 3.4.14
inspiratory minute volume preferred term 3.8.8
inspiratory pause preferred term 3.4.12
inspiratory phase preferred term 3.4.9
inspiratory pressure preferred term (1st) 3.6.2
inspiratory time preferred term 3.4.8
inspiratory volume preferred term 3.8.3
inspiratory-flow time preferred term 3.4.11
inspiratory-hold time preferred term 3.4.15
inspiratory-pause time preferred term 3.4.13
inspiratory-pressure relief preferred term 3.6.5
inspiratory-termination flow preferred term (1st) 3.7.3
inspiratory time fraction preferred term (1st) 3.4.20
intended use preferred term 3.1.25;
ISO/IEC Guide 63:2012—2.5;
ISO 14971:2007—2.5
intermittent mandatory ventilation preferred term (2nd) 3.11.9
leakage minute volume preferred term 3.8.10
leakage tidal volume preferred term 3.8.5
limit preferred term 3.1.23
lung preferred term 3.1.16
lung ventilator admitted term 3.1.1
mandatory preferred term 3.9.9
manufacturer preferred term IEC 60601-1:2005+AMD1:2012—3.55
maximum limited airway-pressure preferred term (2nd) 3.13.3
maximum limited pressure preferred term (1st) 3.13.3
maximum settable inspiratory press preferred term 3.13.8
maximum working airway-pressure preferred term (1st) 3.13.4
maximum working pressure preferred term (2nd) 3.13.4
measured preferred term 3.1.20
medical electrical equipment preferred term IEC 60601-1:2005+AMD1:2012—3.63
medical electrical system preferred term IEC 60601-1:2005+AMD1:2012—3.64
mechanical ventilation preferred term 3.1.11
minimum minute volume preferred term (2nd) 3.11.13
minute volume preferred term 3.8.6
MMV preferred term (1st) 3.11.13
natural breathing preferred term 3.2.4
negative-pressure ventilation preferred term (1st) 3.1.14
NIV preferred term (1st) 3.1.15

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Term Normative Status Source


non-invasive ventilation preferred term (2nd) 3.1.15
normal condition preferred term 3.1.26;
IEC 60601-1:2005+AMD1:2012 —3.70
normal use preferred term 3.1.24;
IEC 60601-1:2005+AMD1:2012 —3.71
NPV preferred term (2nd) 3.1.14
operator preferred term IEC 60601-1:2005+AMD1:2012—3.73
patient preferred term IEC 60601-1:2005+AMD1:2012—3.76
patient-connection port preferred term 3.14.5
patient-trigger event preferred term (1st) 3.9.6
PC preferred term (2nd) 3.3.4
peak inspiratory flow preferred term 3.7.2
peak inspiratory pressure preferred term (1st) 3.6.3
peak pressure preferred term (2nd) 3.6.3
PEEP preferred term (1st) 3.10.4
PEEP, <set value> admitted term 3.10.2
phase time ratio preferred term (1st) 3.4.19
plateau inspiratory pressure preferred term (1st) 3.6.4
plateau pressure preferred term (2nd) 3.6.4
port preferred term 3.14.1
normal condition preferred term 3.1.26
normal use preferred term 3.1.24
positive end-expiratory pressure preferred term (2nd) 3.10.4
positive-pressure inflation preferred term (2nd) 3.3.1
positive-pressure ventilation preferred term (1st) 3.1.13
preset preferred term 3.1.21
pressure limit preferred term 3.13.1
pressure limited preferred term 3.13.2
pressure trigger preferred term 3.9.4
pressure-control preferred term (1st) 3.3.4
pressure-high admitted term 3.12.7
pressure-high phase admitted term 3.12.8
pressure-limited preferred term 3.13.2
pressure-low admitted term (1st) 3.10.2
pressure-low phase admitted term 3.10.3
pressure-regulation preferred term 3.3.9
pressure-support preferred term (1st) 3.3.6
pressure-termination preferred term 3.9.16
protection device preferred term 3.13.10
PS preferred term (2nd) 3.3.6
pulmonary compliance preferred term 3.1.6
remote inflation-initiation preferred term 3.9.13
respiratory activity preferred term 3.2.6
respiratory compliance preferred term (2nd) 3.1.5
respiratory cycle preferred term 3.4.16

136 © ISO 2019 – All rights reserved


ISO 19223:2019(E)

Term Normative Status Source


respiratory cycle time preferred term (1st) 3.4.17
respiratory system preferred term 3.1.17
respiratory system compliance preferred term (1st) 3.1.5
responsible organization preferred term IEC 60601-1:2005+AMD1:2012—3.101
rise time preferred term 3.3.10
S/T preferred term (2nd) 3.11.11
S/T ventilation preferred term (1st) 3.11.11
set preferred term 3.1.19
set rate preferred term 3.5.1.1
SIMV preferred term (1st) 3.11.10
single fault condition preferred term 3.1.27
sleep-apnoea breathing-therapy preferred term 3.1.29
equipment
SPONT admitted tem 3.11.12
spontaneous breath preferred term 3.2.3
spontaneous breath rate preferred term (1st) 3.5.1.3
spontaneous rate preferred term (2nd) 3.5.1.3
spontaneous/timed ventilation preferred term (3rd) 3.11.11
static compliance preferred term 3.1.7
superordinate mode preferred term 3.11.21
support inflation preferred term 3.3.13
support inflation-type preferred term 3.3.14
support pressure, <pressure support> preferred term (2nd) 3.6.2
supported breath preferred term 3.2.13
synchronization window preferred term 3.9.8
synchronized breath preferred term 3.2.15
synchronized intermittent mandatory preferred term (2nd) 3.11.10
ventilation
systematic ventilation-mode name preferred term (1st) 3.11.19
TC preferred term (2nd) 3.6.11
terminate preferred term 3.9.14
t I:t TOT ratio preferred term (2nd) 3.4.20
tidal volume preferred term 3.8.1
time-high admitted term 3.12.9
time-low admitted term 3.12.6
time-termination preferred term 3.9.17
total inflation rate preferred term 3.5.1.5
total PEEP preferred term 3.10.6
total rate preferred term (2nd) 3.5.1.2
total respiratory rate preferred term (1st) 3.5.1.2
tPEEP admitted term 3.10.6
trigger preferred term 3.9.2
trigger-event preferred term (2nd) 3.9.6
trigger level preferred term 3.9.5
tube compensation preferred term (1st) 3.6.11

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Term Normative Status Source


unassisted breath preferred term 3.2.12
unassisted breath rate preferred term 3.5.2.2
unrestricted breathing preferred term 3.2.5
VBS preferred term (2nd) 3.1.18
VC preferred term (2nd) 3.3.3
ventilation preferred term 3.1.9
ventilation-mode preferred term 3.11.2
ventilation-mode group preferred term 3.11.5
ventilation-mode Group 1 preferred term 3.11.5.1
ventilation-mode Group 1a preferred term 3.11.5.1.1
ventilation-mode Group 1b preferred term 3.11.5.1.2
ventilation-mode Group 2 preferred term 3.11.5.2
ventilation-mode Group 2a preferred term 3.11.5.2.1
ventilation-mode Group 2b preferred term 3.11.5.2.2
ventilation-mode Group 3 preferred term 3.11.5.3
ventilation-mode Group 4 preferred term 3.11.5.4
ventilation-mode Group 4a preferred term 3.11.5.4.1
ventilation-mode Group 4b preferred term 3.11.5.4.2
ventilation-pattern preferred term 3.11.3
ventilator preferred term 3.1.1
ventilator breathing system preferred term (1st) 3.1.18
ventilator breathing system leak preferred term (1st) 3.7.12
ventilator inspiration preferred term (3rd) 3.3.1
ventilator operational mode preferred term 3.11.1
ventilator-initiated rate preferred term (2nd) 3.5.1.4
ventilator-initiated inflation rate preferred term (1st) 3.5.1.4
ventilator-initiation preferred term 3.9.12
volume targeted preferred term 3.3.15
volume-control preferred term (1st) 3.3.3

138 © ISO 2019 – All rights reserved


ISO 19223:2019(E)

Bibliography

[1] ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
[2] ISO/IEC TR 10000-1, Information technology — Framework and taxonomy of International
Standardized Profiles — Part 1: General principles and documentation framework
[3] ISO 10241-1, Terminological entries in standards — Part 1: General requirements and examples of
presentation
[4] ISO 10241-2, Terminological entries in standards — Part 2: Adoption of standardized
terminological entries
[5] ISO 80000 (all parts), Quantities and units
[6] IEC 60027 (all parts), Letter symbols to be used in electrical technology
[7] ISO/TS 8000-1, Data quality — Part 1: Overview
[8] ISO/IEC Guide 51, Safety aspects — Guidelines for their inclusion in standards
[9] ISO 690, Information and documentation — Guidelines for bibliographic references and citations to
information resources
[10] IEC 60601-1:2005+AMD1:2012, Medical electrical equipment — Part 1: General requirements for
basic safety and essential performance
[11] ISO 80601-2-12:2011+Cor.1:2011, Medical electrical equipment — Part 2-12: Particular
requirements for basic safety and essential performance of critical care ventilators
[12] ISO 80601-2-72, Medical electrical equipment — Part 2-72: Particular requirements for basic safety
and essential performance of home healthcare environment ventilators for ventilator-dependent
patients
[13] ISO 10651-3, Lung ventilators for medical use — Part 3: Particular requirements for emergency and
transport ventilators
[14] ISO 10651-4, Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
[15] ISO 80601-2-79, Medical electrical equipment — Part 2-79: Particular requirements for basic safety
and essential performance of ventilatory support equipment for ventilatory impairment
[16] ISO 80601-2-80, Medical electrical equipment — Part 2-80: Particular requirements for basic safety
and essential performance of ventilatory support equipment for ventilatory insufficiency
[17] ISO 17510, Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
[18] ISO 80601-2-67, Medical electrical equipment — Part 2-67: Particular requirements for basic safety
and essential performance of oxygen-conserving equipment
[19] ISO 26782, Anaesthetic and respiratory equipment — Spirometers intended for the measurement of
time forced expired volumes in humans
[20] ISO 23747, Anaesthetic and respiratory equipment — Peak expiratory flow meters for the
assessment of pulmonary function in spontaneously breathing humans
[21] ISO 80601-2-13:2011+Amd1:2015+Amd2:2018, Medical electrical equipment — Part 2-13:
Particular requirements for basic safety and essential performance of an anaesthetic workstation
[22] ISO/IEEE 11073-10101:2004+Amd1:2017, Health informatics — Point-of-care medical device
communication — Part 10101: Nomenclature

© ISO 2019 – All rights reserved 139


ISO 19223:2019(E)

[23] Morley C.J., Keszler M. Ventilators do not breathe. Archives of Disease in Childhood. Fetal and
Neonatal Edition, 2012, 97(6), F392-4 [viewed 2019-03-01] available at doi:10.1136/fetalneonatal
-2012-302137. ISSN 0003-9888
[24] Marini J.J. Dynamic hyperinflation and auto-positive end-expiratory pressure: lessons learned
over 30 years. American Journal of Respiratory and Critical Care Medicine, 2011, Oct 1;184(7):756-
62. ISSN 0003-0805
[25] Creating a Culture of Safety--Priority Issues from the 2014 AAMI/FDA
Summit On Ventilator Technology https://s3.amazonaws.com/rdcms
-aami/files/production/public/FileDownloads/Summits/Ventilator/2014 _Ventilator_Summit
_Report .pdf [viewed 2019-03-01]
[26] IEC 60601-1-8:2006+AMD1:2012, Medical electrical equipment — Part 1-8: General requirements
for basic safety and essential performance — Collateral standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical systems
[27] ISO 704:2009, Terminology work — Principles and methods
[28] ISO 860, Terminology work — Harmonization of concepts and terms
[29] Minotra D., Dain S.L., Burns C.M. Protocol for Usability Testing and Validation of the ISO Draft
International Standard 19223 for Lung Ventilators. JMIR Research Protocols 2017;6(9): e166.
ISSN 1929-0798
[30] ISO 4135:20019), Anaesthetic and respiratory equipment — Vocabulary
[31] ISO 80601-2-70:2015, Medical electrical equipment — Part 2-70: Particular requirements for basic
safety and essential performance of sleep apnoea breathing therapy equipment
[32] ISO 14971:2007, Medical devices — Application of risk management to medical devices
[33] ISO/IEC Guide 63:2012, Guide to the development and inclusion of safety aspects in International
Standards for medical devices
[34] Jones N.S., Dain S.L., Illustrated Handbook of Ventilator Vocabulary. Available at http:
//ventilatorvocabulary.online

9) On publication of this document, this document will supersede the equivalent vocabulary in ISO 4135. It is
intended that ISO 4135 will then be appropriately revised, restricting its scope to deal only with terms outside the
scope of this document.

140 © ISO 2019 – All rights reserved


ISO 19223:2019(E)

ICS 01.040.11; 11.040.10
Price Group A

© ISO 2019 – All rights reserved

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