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air resuscitation
Australian Standard

Ancillary devices for expired


AS 4259—1995
This Australian Standard was prepared by Committee HT/5, Resuscitators and
Ventilators. It was approved on behalf of the Council of Standards Australia on
21 September 1994 and published on 5 January 1995.

The following interests are represented on Committee HT/5:


Australasian College for Emergency Medicine
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Australian and New Zealand College of Anaesthetists


Australian Chamber of Commerce and Industry
Australian College of Paediatrics
Australian Red Cross Society
Australian Resuscitation Council
Commonwealth Department of Human Services and Health
Department of Health and Community Services, Vic.
Department of Mineral Resources, N.S.W.
Medical Industry Association of Australia
Metal Trades Industry Association of Australia
Royal Australian College of General Practitioners
Royal Life Saving Society — Australia
St John Ambulance, Australia
Surf Life Saving Association of Australia

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This Standard was issued in draft form for comment as DR 93197.


AS 4259—1995

Australian Standard
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Ancillary devices for expired


air resuscitation

First publi shed as AS 4259—1995.

PUBLISHED BY STANDARDS AUSTRALIA


(STANDARDS ASSOCIATION OF AUSTRALIA)
1 THE CRESCENT, HOMEBUSH, NSW 2140
ISBN 0 7262 9343 1
AS 4259—1995 2

PREFACE

This Standard was prepared by the Standards Australia Committee HT/5 on Resuscitators and
Ventilators after a request by the Commonwealth Department of Human Services and Health
which was concerned about the existence of some potentially hazardous devices.
The objective of this Standard is to enable ancillary devices for expired air resuscitation to
be used safely and effectively, especially in emergency situations.
The apparatus and test methods specified in the Appendices are not intended to exclude the
use of other measuring devices or methods yielding results of an accuracy equal to or greater
than those specified. In case of dispute, the methods given in this Standard will be the
reference methods, with tolerances of 10 percent of the values given unless otherwise stated.
Any suprastructures or attachments necessary for the use of the ancillary device should be
included in the test methods.
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The terms ‘normative’ and ‘informative’ have been used in this Standard to define the
application of the appendix to which they apply. A ‘normative’ appendix is an integral part
of a Standard, whereas an ‘informative’ appendix is only for information and guidance.

 Copyri ght STANDARDS AUSTRALIA


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payment provided such programs are used exclusively in-house by the creators of the programs.
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3 AS 4259—1995

CONTENTS

Page

FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1 SCOPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2 REFERENCED DOCUMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3 DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4 SIZE/SIZE DESIGNATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
5 MATERIALS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
6 DESIGN OF COMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
7 CONNECTORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
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8 PORTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
9 OPERATIONAL REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
10 PERFORMANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
11 INFORMATION TO BE SUPPLIED BY THE MANUFACTURER . . . . . . . . . . 14
12 PACKAGING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
13 MARKING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
14 RATIONALE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

APPENDICES
A BASIC COMPONENTS AND SUPRASTRUCTURE . . . . . . . . . . . . . . . . . . . 17
B METHOD OF TEST FOR RESISTANCE OF A BUCCAL PORTION TO
COMPRESSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
C METHOD OF TEST FOR VENTILATION PERFORMANCE . . . . . . . . . . . . 24
D METHOD OF TEST FOR EXPIRATORY RESISTANCE FOR THE PATIENT 25
E METHOD OF TEST FOR EXPIRATORY (INFLATION) RESISTANCE FOR
RESCUER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
F METHOD OF TEST FOR INSPIRATORY RESISTANCE FOR A
SPONTANEOUSLY BREATHING PATIENT . . . . . . . . . . . . . . . . . . . . . . . 27
G METHOD OF TEST FOR FUNCTION OF ANCILLARY DEVICE
AFTER CONTAMINATION WITH STOMACH CONTENTS . . . . . . . . . . . . 28
H METHOD OF TEST FOR FUNCTION AFTER IMMERSION IN WATER . . . 29
I METHOD OF TEST FOR ATTEMPTED DISPLACEMENT OF A
UNIDIRECTIONAL OR BIDIRECTIONAL VALVE BY A FINGER . . . . . . . 30
J METHOD FOR MEASUREMENT OF APPARATUS DEAD SPACE . . . . . . . 31
K METHOD OF TEST FOR FUNCTION AFTER DISMANTLING
AND REASSEMBLY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
L METHOD FOR DETERMINING RESISTANCE TO DISENGAGEMENT
OF PARTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
M METHOD FOR DETERMINING FUNCTION OF THE ANCILLARY DEVICE
AFTER DROPPING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
N METHOD FOR DETERMINING FUNCTION AFTER THE APPLICATION
OF A POTENTIALLY DEFORMING WEIGHT . . . . . . . . . . . . . . . . . . . . . . 35
AS 4259—1995 4

Page

O METHOD FOR DETERMINING MEAN DELIVERED


OXYGEN CONCENTRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
P CHARACTERISTICS OF ANCILLARY DEVICES FOR EXPIRED
AIR RESUSCITATION AND THEIR ADDITIONAL PARTS . . . . . . . . . . . . 38
Q RATIONALE STATEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
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5 AS 4259—1995

FOREWORD

This Standard sets criteria by which the safety and potential effectiveness of ancillary devices
for expired air resuscitation (EAR) may be judged. Such devices are being offered with
increasing frequency by manufacturers as instruments for use in alternative techniques to
direct mouth-to-mouth or mouth-to-nose resuscitation.
At the time of preparation of the Standard, there are no published reports of cross-infection
by the human immuno-deficiency virus (HIV) or hepatitis B virus (HBV) during expired air
resuscitation or its teaching, although there have been a small number of possible instances
of cross-infection with other microorganisms (meningococcus, mycobacterium tuberculosis,
herpes simplex, Salmonella and Shigella ). Despite this lack of evidence for cross-infection
during mouth-to-mouth resuscitation, there exists concern amongst some health professionals
and some members of the general public that cross-infection with HIV during EAR is
possible. Surprisingly, little concern has been expressed about cross-infection with the HBV
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despite its greater infectivity.


There is evidence that some potential rescuers would prefer to provide EAR using an
ancillary device rather than by direct mouth-to-mouth or mouth-to-nose contact. There is no
evidence that devices which contain a one-way valve or a filter reduce the risk of, or prevent,
cross-infection. On the other hand, some valves or filters may increase resistance to inflation
of the lungs and to exhalation, making expired air resuscitation difficult and increasing the
risk of distension of the stomach or air trapping within the lungs. Devices which can be
passed through the mouth beyond the teeth or gums, or through the nose into the pharynx,
have the potential to increase the risk of airway obstruction by pushing the tongue backwards
into the posterior pharynx or by inducing laryngospasm or vomiting. Such devices may even
increase the risk of cross-infection by causing bleeding in the airway. Blood is a more likely
medium for transmission of HIV than saliva.
Ventilation of the lungs should not be delayed because no ancillary device is available. Such
devices are not necessary for effective performance of expired air resuscitation. They do not
ensure the maintenance of a clear airway and, on occasions, may make it more difficult to
achieve a clear airway.
For the safe use of some ancillary devices, advanced levels of training are needed. The
Australian Resuscitation Council’s policy statements recommend the availability of training
in the mouth-to-mask technique of expired air resuscitation for individuals over 10 years of
age, but it is the Council’s recommendation that the use of pharyngeal airways should be
taught only to those undertaking training in advanced life support.
Because of the variety of ancillary devices available, it is not intended that this Standard
prescribe an exact design with narrow limits of dimensions and physical characteristics which
could possibly diminish serviceability and future development but it is intended that it set
standard testing protocols and criteria which buyers can use for comparison of devices and
which manufacturers may use as a basic reference guide to design and development.
AS 4259—1995 6

STANDARDS AUSTRALIA

Australian Standard
Ancillary devices for expired air resuscitation

1 SCOPE This Standard specifies safety and performance requirements for ancillary
devices for expired air resuscitation of adults and children without intubation of the trachea.
The Standard also covers overlays which are similar to faceshields but are not intended for
use on humans, although intended for simulated expired air resuscitation on manikins.
Devices which have short airways intended to lie on the tongue but not reach the pharynx
are not included as they are less likely than oropharyngeal airways to achieve a clear airway
but may produce similar complications. Devices designed for oesophageal intubation are not
included because of the severity of the complications which may attend their use. Laryngeal
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masks and combined pharyngeal-tracheal airways are not included because studies which
evaluate their efficacy for expired air resuscitation in emergency settings have not yet been
concluded.

2 REFERENCED DOCUMENTS The following documents are referred to in this


Standard:
AS
2496 Breathing attachments for anaesthetic purposes for human use
ISO
5364 Oropharyngeal airways
8382 Resuscitators intended for use with humans

3 DEFINITIONS For the purpose of this Standard, the definitions below apply.
3.1 Adult —an individual whose body mass is 40 kg or greater.
3.2 Ancillary device for expired air resuscitation — a device which enables the
administration of expired air resuscitation to a patient without contact of the rescuer’s mouth
with the mouth or nose of the patient.
NOTE: Appendix A gives information on the basic components and suprastructure of ancillary
devices for expired air resuscitation.
3.3 Apparatus dead space— that volume of previously exhaled gas from the patient that
is redelivered to the patient in the succeeding inflation phase.
3.4 Backward leak — the passage of the patient’s expired air or body fluids into the
mouthpiece past a valve or filter which is intended to prevent such passage.
3.5 Bidirectional valve —a valve which is intended to direct the rescuer’s expired air into
the patient during the inflation phase, and the patient’s expired air to atmosphere during the
expiratory phase.
3.6 Buccal portion— the part of an ancillary device which is intended to lie between the
teeth or gums of the patient (see also Clause 3.19).
3.7 Child— an individual whose body mass is greater than 10 kg but less than 40 kg.
3.8 Connector — a fitting which joins two or more components together.
3.9 Exhaust port — an opening, other than the rescuer’s port, in the device, through which
the patient’s expired air and any supplemental oxygen passes to atmosphere.

COPYRIGHT
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AS 4259-1995, Ancillary devices for expired air


resuscitation
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