SIST EN ISO 10651-4:2002
(Main)Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
This European Standard specifies requirements for operator-powered resuscitators intended for use with all age groups and which are portable and intended to provide lung ventilation to individuals whose breathing is inadequate. Operator-powered resuscitators for infants and children are designated according to body mass range and approximate age equivalent.
Lungenbeatmungsgeräte - Teil 4: Anforderungen an anwenderbetriebene Wiederbelebungsgeräte (Handbeatmungsgeräte) (ISO 10651-4:2002)
Diese Europäische Norm legt Anforderungen an anwenderbetriebene, tragbare Wiederbelebungsgeräte
(Handbeatmungsgeräte) fest, die zur Anwendung an Menschen aller Altersstufen und zur Lungenbeat-
mung bei Personen mit unzureichender Atemtätigkeit vorgesehen sind. Anwenderbetriebene Wiederbe-
lebungsgeräte für Kleinkinder und Kinder sind entsprechend dem Bereich des Körpergewichts und dem
ungefähren Alter festlegt.
Elektrisch- oder gasbetriebene Wiederbelebungsgeräte sind in dieser Norm nicht enthalten.
ANMERKUNG Anhang B enthält Begründungen zu diesem Teil dieser Europäischen Norm. Die Abschnitte und
Unterabschnitte mit einer entsprechenden Begründung sind mit dem Buchstaben R) hinter der Abschnittsnummer
gekennzeichnet.
Ventilateurs pulmonaires - Partie 4: Exigences relatives aux ressuscitateurs a puissance motrice manuelle (ISO 10651-4:2002)
La présente norme européenne spécifie les exigences relatives aux ressuscitateurs portatifs a puissance motrice manuelle destinés a etre utilisés pour tous les groupes d'âges, conçus pour assurer la ventilation des poumons de sujets dont la respiration est insuffisante. Les ressuscitateurs a puissance motrice manuelle pour enfants en bas âge et enfants doivent etre conçus en fonction du poids du sujet et de l'âge approximatif correspondant.
Pljučni ventilatorji - 4. del: Posebne zahteve za naprave za oživljanje, ki jih upravlja operater (ISO 10651-4:2002)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10651-4:2002
01-november-2002
3OMXþQLYHQWLODWRUMLGHO 3RVHEQH]DKWHYH]DQDSUDYH]DRåLYOMDQMHNLMLKXSUDYOMD
RSHUDWHU ,62
Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO
10651-4:2002)
Lungenbeatmungsgeräte - Teil 4: Anforderungen an anwenderbetriebene
Wiederbelebungsgeräte (Handbeatmungsgeräte) (ISO 10651-4:2002)
Ventilateurs pulmonaires - Partie 4: Exigences relatives aux ressuscitateurs a puissance
motrice manuelle (ISO 10651-4:2002)
Ta slovenski standard je istoveten z: EN ISO 10651-4:2002
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 10651-4:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10651-4:2002
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SIST EN ISO 10651-4:2002
EUROPEAN STANDARD
EN ISO 10651-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2002
ICS 11.040.10
English version
Lung ventilators - Part 4: Particular requirements for operator-
powered resuscitators (ISO 10651-4:2002)
Ventilateurs pulmonaires - Partie 4: Exigences relatives aux Lungenbeatmungsgeräte - Teil 4: Anforderungen an
ressuscitateurs à puissance motrice manuelle (ISO 10651- anwenderbetriebene Wiederbelebungsgeräte
4:2002) (Handbeatmungsgeräte) (ISO 10651-4:2002)
This European Standard was approved by CEN on 7 April 2001.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10651-4:2002 E
worldwide for CEN national Members.
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SIST EN ISO 10651-4:2002
EN ISO 10651-4:2002 (E)
Contents
Page
Foreword.3
1 Scope .4
2 Normative references .4
3 Terms and definitions.4
4 Connectors .6
5 Operational requirements .6
6 Ventilatory requirements.7
7 Storage and operating conditions.9
8 Requirements for resuscitator, or parts, supplied sterile .9
9 Marking .9
10 Information to be provided by the manufacturer in operating and maintenance instructions .10
Annex A (normative) Test methods.12
Annex B (informative) Rationale .22
Annex ZA (informative) Clauses of this European Standard addressing Essential Requirements or
other provisions of EU Directives. .25
Bibliography .27
2
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SIST EN ISO 10651-4:2002
EN ISO 10651-4:2002 (E)
Foreword
This document (EN ISO 10651-4:2002) has been prepared by Technical Committee CEN/TC 215 "Respiratory and
anaesthetic equipment", the secretariat of which is held by BSI, in collaboration with Technical Committee ISO/TC
121 "Anaesthetic and respiratory equipment".
This European Standard shall be given the status of a national standard, either by publication of an identical text or
by endorsement, at the latest by September 2002, and conflicting national standards shall be withdrawn at the
latest by September 2002.
This document has been prepared under a mandate given to CEN by the European Commission and the European
Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this document.
Annex A is normative and form part of this European Standard.
Annex B is for information only.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard : Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,
Sweden, Switzerland and the United Kingdom.
3
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SIST EN ISO 10651-4:2002
EN ISO 10651-4:2002 (E)
1 Scope
This European Standard specifies requirements for operator-powered resuscitators intended for use with all age
groups and which are portable and intended to provide lung ventilation to individuals whose breathing is
inadequate. Operator-powered resuscitators for infants and children are designated according to body mass range
and approximate age equivalent.
Electrically- and gas-powered resuscitators are not covered by this European Standard.
NOTE Annex B contains rationale statements for this Part of this European Standard. The clauses and subclauses which
R)
have corresponding rationale statements are marked with after their number.
2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other publications. These
normative references are cited at the appropriate places in text and the publications are listed hereafter. For dated
references, subsequent amendments to or revisions of any of these publications apply to this European Standard
only when incorporated in it by amendment or revision. For undated references the latest edition of the publication
referred to applies (including amendments).
EN 148-1, Respiratory protective devices - Threads for facepieces –Part 1: Standard thread connection.
EN 556: 1994+A1:1998, Sterilization of medical devices - Requirements for terminally-sterilized medical devices to
be labelled “STERILE”.
EN 737-1, Medical gas pipeline systems - Part 1: Terminal units for compressed medical gases and vacuum.
EN 868-1, Packaging materials and systems for medical devices which are to be sterilized - Part 1: General
requirements and test methods .
EN 1041, Information supplied by the manufacturer with medical devices.
EN 1281-1, Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets.
prEN 13544-2:2000, Respiratory therapy equipment – Part 2 : Specifications for tubing and connectors.
EN ISO 4135:1996, Anaesthesiology – Vocabulary (ISO 4135 :1995).
3 Terms and definitions
For the purposes of this part of EN ISO 10651, the terms and definitions given in EN ISO 4135:1996 and the
following terms and definitions apply.
NOTE Some of the definitions have been taken from EN ISO 4135, but they are included in this European Standard for
convenience; other definitions, which are given in EN ISO 4135, for apparatus in general, have been modified slightly for the
purposes of this European Standard as they apply specifically to resuscitators.
3.1
reverse leakage
volume of expired gas which does not pass through the expiratory port but returns to the resuscitator
3.2
bag inlet valve
valve activated by the subatmospheric pressure in the compressible unit of the resuscitator to refill the
compressible unit with gas at ambient pressure
3.3
bag refill valve
valve, with no manual trigger, activated by the sub-atmospheric pressure in the compressible unit of the
resuscitator to refill the compressible unit from a pressurized gas source
4
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SIST EN ISO 10651-4:2002
EN ISO 10651-4:2002 (E)
3.4
compressible unit
that part of an operator-powered resuscitator e.g. a bag or bellows that, when compressed by the operator, delivers
a volume of gas
3.5
delivered oxygen concentration
average concentration of oxygen in the gas delivered from the resuscitator
3.6
delivered volume, V
del
volume of gas, expressed in millilitres, leaving the resuscitator through the patient connection port during the
inspiratory phase
3.7
forward leakage
volume of gas produced by the resuscitator during the inspiratory phase which does not pass through the patient
port to the patient but passes to the atmosphere
3.8
minute volume, V
volume of gas per minute entering or leaving the patient’s lungs
3.9
operator-powered resuscitator
resuscitation device in which ventilation of the lungs is produced by the operator compressing the compressible
unit of the device
NOTE Hereinafter called "resuscitator".
3.10
patient connection port
that opening through which gas flows to and from the patient
3.11
patient connection port connector
connector at the patient connection port which connects directly to a face mask or an appropriate mating airway
device
3.12
patient valve
valve in the breathing system that directs gas into the lungs for the inspiratory phase and into the atmosphere
during the expiratory phase
3.13
pressure limiting system
means for limiting the maximum delivery pressure
3.14
resuscitator deadspace, V
D,app
that volume of previously exhaled gas which is delivered from the resuscitator in the succeeding inspiratory phase
3.15
tidal volume, V
T
volume of gas, expressed in millilitres, entering or leaving the patient or the lung model during the inspiratory or
expiratory phase
3.16
ventilatory cycle
ventilation cycle comprising the inspiratory phase plus the expiratory phase of breathing
5
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SIST EN ISO 10651-4:2002
EN ISO 10651-4:2002 (E)
4 Connectors
4.1 Patient connection port connector
The patient connection port connector of the resuscitator shall be a 15 mm female and 22 mm male coaxial
connector complying with EN 1281-1.
4.2 ) Expiratory port connector for breathing gases
R
If an expiratory port connector is provided, it shall be one of the following :
a) a 30 mm male conical connector complying with EN 1281-1 or ;
b) a permanent connection or propriatory connector incompatible with EN 1281-1 and EN 737-1 ;
and with a means to prevent connection with internal lumen to any breathing attachment.
4.3 Face mask connectors
If provided with the resuscitator, face masks shall have either a 22 mm female connector or a 15 mm male
connector which shall mate with the corresponding connectors specified in EN 1281-1.
4.4 R) Bag refill valve connectors
If a conical connector is provided for attachment of a bag refill valve, it shall be a unique 32 mm female design. The
dimensions of this connector, when submitted to the test gauge given in Figure A.1, shall fit within the tolerance
steps.
4.5 Bag inlet valve connectors
Bag inlet valve connectors shall not be compatible with connectors dimensioned in accordance with EN 1281-1.
The bag inlet valve should be designed to minimize the risk of unintentional connection of breathing attachments
which might block the valve
4.6 Threaded gas filter connectors
If the resuscitator is fitted with a threaded gas filter connection, it shall comply with EN 148-1.
4.7 Oxygen tube connector and pressure gauge connector
The oxygen tube connector, if provided, shall comply with prEN 13544-2:2000. The pressure gauge connector (if
provided) shall not be compatible with tubing fitting the oxygen tube connector.
5 Operational requirements
5.1 General
All test performance requirements in this European Standard shall be satisfied when the resuscitator is operated by
one person.
5.2 R) Dismantling and reassembly
A resuscitator intended to be dismantled by the user, e.g. for cleaning, etc. should be designed so as to minimize
the risk of incorrect reassembly when all parts are mated.
The manufacturer shall recommend a functional test of operation to be carried out after reassembly (see 10.2d)).
6
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5.3 R) Patient valve function after contamination with vomitus
After the resuscitator has been tested in accordance with the test described in A.4.3, it shall meet the requirements
specified in 6.2, 6.4, 6.7.1 and 6.7.2.
NOTE It is preferable that the valve housing be constructed so that operation of the mechanism can be observed by the
operator, e.g. through a transparent housing. Observation of the functioning mechanism of the patient valve can assist the
operator in detecting abnormal operation.
5.4 Mechanical shock
5.4.1 R) Drop test
The resuscitator shall meet, at room temperature, the requirements specified in 6.2, 6.4 and 6.7.1, following the
drop test described in A.4.4.
5.5 Immersion in water
After immersion in water by the method described in A.4.5, the resuscitator shall comply with the requirements
specified in 6.2, 6.4, 6.7.1 and 6.7.2.
5.6 R) Bag refill valves
Bag refill valves for use with resuscitators shall not have provision for manual operation.
5.7 Materials of construction
All gas conducting parts shall be from materials selected to take into account the chemical and physical properties
of any substances that the manufacturer declares can be administered by the resuscitator
6 Ventilatory requirements
6.1 R) Supplementary oxygen and delivered oxygen concentration
When tested by the method described in A.4.6 in accordance with the requirements of its classification (see 6.7.1)
a resuscitator shall provide a minimum delivered oxygen concentration of at least 35 % (V/V) when connected to an
oxygen source supplying not more than 15 l/min and, in addition, shall be capable of providing an oxygen
V/V
concentration of at least 85 % ( ) (see note). The manufacturer shall state the range of delivered oxygen
concentrations at representative flows, i.e. 2 l/min, 4 l/min, 6 l/min, 8 l/min, etc.
NOTE The 85 % (V/V) requirement can be accomplished with the use of an attachment.
6.2 R) Expiratory resistance
In the absence of positive end-expiratory pressure devices, and when tested by the method described in A.4.7, the
pressure generated at the patient connection port shall not exceed 0,5 kPa ( 5 cmH 0). (See also 10.2 c) 8)).
2
6.3 R) Inspiratory resistance
When tested by the method described in A.4.8, the pressure at the patient connection port shall not exceed 0,5 kPa
( 5 cmH 0) below atmospheric pressure. (See also 10.2 c) 8)).
2
6.4 R) Patient valve malfunction
When tested by the method described in A.4.9, an inadvertent positive expiratory pressure greater than 0,6 kPa
( 6 cmH O) shall not be created at an added input flow of up to 30 l/min when this flow is added in accordance
2
with the manufacturer’s instructions.
7
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SIST EN ISO 10651-4:2002
EN ISO 10651-4:2002 (E)
6.5 R) Patient valve leakage - Forward leakage
If forward leakage is a design feature, it shall be so stated in the instruction manual.
6.6 R) Resuscitator deadspace and rebreathing
When tested by the method described in A.4.10, the resuscitator deadspace shall not exceed 5 ml + 10 % of the
minimal delivered volume specified for the classification of the resuscitator (see 6.7.1).
Excessive rebreathing should not occur during spontaneous breathing.
6.7 R) Ventilation performance
6.7.1 R) Minimum delivered volume (V )
del
When tested as described in A.4.11 using the compliance, resistance, frequency and I:E ratio given in Table 1, the
minimum delivered volume shall be as given in Table 1.
6.7.2 R) Pressure limitation
6.7.2.1 For resuscitators designated for use with a body mass less than 10 kg, a pressure-limiting system shall
be provided so that the airway pressure does not exceed 4,5 kPa ( 45 cmH 0) under the test conditions described
2
in A.4.12. However, it shall be possible to generate an airway pressure of at least 3 kPa ( 30 cm H O).
2
NOTE An override mechanism can be provided.
6.7.2.2 If a pressure-limiting system is provided for a resuscitator designated for use with patients of over
10 kg body mass, the pressure at which it operates shall be stated in the instruction manual [see 10.2 c)9)]. Any
pressure-limiting device provided that limits pressure to below 6 kPa ( 60 cmH 0) shall be equipped with an
2
override mechanism. If provided with a locking mechanism, pressure override mechanisms shall be so designed
that the operating mode, i.e. on or off, is readily apparent to the user by obvious control position, flag, etc.
Compliance is tested by visual inspection.
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EN ISO 10651-4:2002 (E)
Table 1 — Test conditions for ventilatory performance
Patient Body Compliance Resistance Inspiration: Frequency f Minimum
a
delivered
mass B
Expiration Breaths/min
volume V
Del
ratio
Kg l/kPa kPa/(l/s) ± 20 % ± 10 % ml
B 5 0,01 40 1:1 60 20
0,1 2 1:2 25 150
5 < B 10
1)
0,2 2 1:2 20
10 < B 40 15 B
B > 40 0,2 2 1:2 20 600
a
B = Body mass, in kilograms, designated by the manufacturer in the manual.
7 Storage and operating conditions
7.1 Storage
The resuscitator and the resuscitator kit (if provided) shall, after storage at temperatures of - 40 °C and + 60 °C and
at any relative humidity between 40 % r.h. and 95 % r.h., comply with clause 6 except 6.6 (deadspace).
7.2 R) Operating conditions
When tested by the method described in A.4.13, the resuscitator shall comply with clause 6 throughout the range of
relative humidity from 15 % r.h. to 95 % r.h either :
throughout the temperature range from - 18 °C to + 50 °C ; or
if a specific operating range is given (see 9.2 and 10) throughout the temperature range declared by the
manufacturer.
8 Requirements for resuscitator, or parts, supplied sterile
8.1 Sterility assurance
Resuscitators or parts supplied and marked as “STERILE” shall satisfy requirement 4.1 of EN 556:1994+A1:1998
for the assurance of sterility needed to make the claim of being sterile.
8.2 Packaging for resuscitators or parts supplied sterile
The packaging shall serve as an effective barrier to the penetration of micro-organisms and particulate material in
accordance with EN 868-1.
The packaging shall not be capable of reclosure without clearly revealing that it has been opened.
9 Marking
9.1 General
Marking of resuscitators, or parts if applicable, packages, inserts and information to be supplied by the
manufacturer shall comply with EN 1041.
NOTE Some requirements of 9 can be met by the use of appropriate symbols as given in EN 980.
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9.2 Indication of operating conditions
If the resuscitator cannot function as specified in 7.2 between - 18 °C and + 50 °C, a warning shall be marked on
the device.
NOTE Examples of warnings are :
“only for use between . °C and . °C ; or a symbol as shown in Figure 1.
Figure 1 — Example of symbol for showing operation condition between - 10 °C and + 50 °C
9.3 Indication of pressure-limiting system setting
If the resuscitator is supplied with a pressure-limiting system set at one fixed pressure, the nominal pressure setting
at which the system is activated shall be marked on the resuscitator.
10 Information to be provided by the manufacturer in operating and maintenance
instructions
10.1 General
The manufacturer shall provide instructions for use and maintenance. The size and shape of these instructions for
use should be such that they can be enclosed with or attached to the resuscitator container.
10.2 Contents
In addition of EN 1041 the instructions for use and maintenance shall include the following information, where
applicable :
a) a warning to the effect that incorrect operation of the resuscitator can be hazardous ;
b) instructions on how to make the resuscitator operational in all intended modes of operation ;
c) a specification detailing the following information for the resuscitator and its recommended accessories if
applicable :
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EN ISO 10651-4:2002 (E)
1) the body mass range for which the resuscitator is suitable for use ;
2) operating environmental limits ;
3) storage environmental limits ;
4) any substances, other than air, which can be administered by the resuscitator (e.g. oxygen, volatile
anaesthetic agents) ;
5) delivered oxygen concentrations under various test conditions ;
6) delivered volume range ;
7) resuscitator deadspace, backward leakage and forward leakage ;
8) expiratory resistance and inspiratory resistance, and the resistance imposed by any recommended
accessory ;
9) the end-expiratory pressure generated by the resuscitator in normal use, if greater than 0,2 kPa
( 2 cmH 0) ;
2
10) details of the pressure-limiting system and override mechanism operation, if any ;
11) accuracy of controls or indicating devices, if any, supplied with the resuscitator ;
12) external dimensions of the resuscitator and, if provided, the resuscitator case ;
13) mass of the resuscitator and, if provided, the resuscitator case ;
d) instructions for the dismantling and reassembly of components for cleaning (including cleaning of any vomitus)
and sterilization (if applicable), and details of a functional test of operation to be carried out after reassembly.
NOTE These instructions can be given, if possible, with a schematic also ;
e) recommended methods of cleaning and disinfection or sterilization of the resuscitator, its components and its
accessories if applicable ;
f) functional test for operation to be carried out prior to use ;
g) list of operator-replaceable parts ;
h) maintenance requirements ;
i) guidance regarding use in hazardous or explosive atmospheres, including a warning that if the resuscitator will
entrain or permit the patient to inhale gas from the atmosphere, its use in contaminated environments can be
hazardous unless entrainment is prevented. If applicable, a description of how to prevent such entrainment or
inhalation, e.g. by the use of a filter ;
j) warnings that in the presence of high oxygen concentrations there is danger from smoking or naked flames
and that oil or grease should not be used with the resuscitator ;
k) for sterile resuscitators or parts, the method of sterilization used.
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Annex A
(normative)
Test methods
A.1 General test conditions
The ambient temperature for the duration of the tests shall be between 20 °C and 25 °C, except where otherwise
stated. The relative humidity shall be within the range from 45 % r.h. to 75 % r.h., except where otherwise stated.
A.2 Apparatus
A.2.1 General
Typical test apparatus is shown in Figures A.1 to A.5 ; alternative test apparatus of equivalent or greater accuracy
may be used.
A.2.2 Test lung (see Figures A.4 and A.5 for examples), with appropriate compliance and resistance
characteristics (see Tables A.1 and A.2).
A.2.3 Resistors, if not provided with the test lung.
A.2.4 Apparatus for the measurement and the recording of pressure, flow and volume.
A.2.5 Apparatus for the measurement of temperatures.
A.2.6 Apparatus for the measurement of deadspaces (see Figure A.3 for typical example).
A.2.7 Graduated cylinder, of at least 200 ml capacity.
A.2.8 Oxygen analyzer.
A.2.9 Water reservoir, sufficiently large to permit complete immersion of the resuscitator.
A.2.10 Environmental chamber, capable of maintaining temperatures from - 40 °C ± 1 °C to + 70 °C ± 1 °C and
relative humidity from 15 % r.h. to 95 % r.h. for periods of up to 7 days.
A.3 Conditioning and reference conditions
A.3.1 Conditioning of resuscitator and test apparatus
Unless otherwise specified in particular tests, place the resuscitator and test apparatus in the test location and
allow sufficient time for the resuscitator and apparatus to reach equilibrium with ambient conditions.
A.3.2 Reference conditions
Correct all test readings to the reference conditions of Normal Temperature and Pressure, Dry (NTPD) (20 °C,
1)
1 atm , 0 % relative humidity).
1) 1 atm = 101 325 Pa = 760 mmHg.
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A.4 Test procedures
A.4.1 Bag refill valve connectors
Using a 32 mm male gauge (see Figure A.1), measure the internal diameter of the connector.
A.4.2 Dismantling and reassembly
Verify by inspection of the resuscitator and accompanying documents that a functional test has been provided to
test operation after reassembly.
A.4.3 Valve function after contamination with vomitus
A.4.3.1 Test material
Simulated vomitus, prepared by mixing two parts of baby meal beef with vegetable and one part water.
A.4.3.2 Procedure
Warm the simulated vomitus to (37 ± 3) °C and pour 175 ml into the patient connection port. Then cycle the
resuscitator at a rate of 30 breaths/min for resuscitators suitable for use with patients of a body mass up to 10 kg,
or at a rate of 12 breaths/min for all other models. Perform this test with the resuscitator connected to the test lung
(A.2.2). Continue to cycle the resuscitator for 30 s. Clear the resuscitator of the mixture according to the
manufacturer’s instructions and verify the resuscitator’s performance.
NOTE Some of the test solution can spill over when poured into the patient connection port.
A.4.4 Drop test
Stabilize the resuscitator at the minimum functioning temperature recommended by the manufacturer.
Drop the resuscitator from a height of 1 m onto a concrete floor in the worst case orientation. For the purpose of
this test, the resuscitator shall be a complete unit, but without the face mask and attached accessories.
Repeat the test 6 times.
A.4.5 Immersion in water
Arrange the resuscitator in its ready-for-use condition and drop it from a height of 1 m into the water reservoir
(A.2.9). Take the resuscitator out after 10 s and remove the water by shaking and/or squeezing for not more than
20 s. Begin ventilating the test lung (A.2.2) immediately.
A.4.6 Supplementary oxygen and delivered oxygen concentration
Connect the resuscitator to the test lung (A.2.2) set at C 20 and R 20 characteristics (see Tables A.1 and A.2).
Connect an oxygen analyzer (A.2.8) at a site in the compliance chamber as far away as possible from the patient
connection port. Ventilate the test lung at a frequency of 12 breaths/min and a tidal volume of 600 ml. Introduce
input oxygen flows of no more than 15 l/min. Continue this procedure until a stable value for oxygen concentration
is achieved. Use only one hand with maximum allowable hand dimensions given in Figure A.2 to compress the
compressible unit.
A.4.7 Expiratory resistance
For resuscitators suitable for use with patients with a body mass of up to 10 kg, connect the patient connection port
to an air source and introduce air at a flow of 5 l/min. Record the pressure generated at the patient connection port.
For all other resuscitators, connect the patient connection port to the air source and introduce air at a flow of
50 l/min. Record the pressure generated at the patient connection port.
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A.4.8 Inspiratory resistance
For resuscitators suitable for use with patients with a body mass of up to 10 kg, connect the patient connection port
to a vacuum source producing an air flow of 5 l/min. Record the pressure generated at the patient connection port.
For all other resuscitators, connect the patient connection port to a vacuum source producing an air flow of
50 l/min. Record the pressure generated at the patient connection port.
A.4.9 Patient valve malfunction
Connect the resuscitator to the test lung (A.2.2) set at C 20 and R 20 characteri
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