Ambu Silicone Face Masks Manual

Ambu®Silicone Face Masks
Silicone masks with inflated cuff
Directions for use

2
English
Directions for use 3
Deutsch
Bedienungsanleitung 9
Dansk
Brugsanvisning 15
∂ÏÏËÓÈο
Οδηγίες χρήσης 21
Español
Manual de instrucciones 27
Suomi
Käyttöohje 33
Français
Mode díemploi 39
Italiano
Manuale díuso 45
Nederlands
Gebruiksaanwijzing 51
Norsk
Brukerveiledning 57
Português
Manual de instruções 63
Svenska
Instruktionshandbok 69
Ambu®are registered trademarks of Ambu A/S, Denmark.
Ambu A/S is certified according to ISO 9001 and ISO 13485.

UK
3
1. Warnings/precautions
Caution:
• U.S. federal law restricts this device to sale by or on the order of
a physician (USA only).
• For use by CPR trained personnel only. The proper application of
a face mask to obtain a tight seal should be trained in particular.
Make sure that such personnel are made familiar with the
contents of this manual.
2. Description
Ambu®Silicone Face Masks sizes 0A, 0 (with boring), 0, 2, 3/4, 5 and 6 with
inflated cushion are designed for use with manual resuscitators, automatic resuscitators
and ventilators.
Size 0A with a 15mm ISO connector
The mask is transparent. The cuff of the 0A model is filled with foam and the inflation
is not adjustable.
Sizes 0, 2, 3 /4, 5 and 6 with a 22 mm ISO connector
The mask domes are transparent. The soft cuff is inflatable and the cuff inflation
may be adjusted.
Directions for use
Ambu®Silicone Face Masks
Silicone masks with inflated cuff

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Size 0 with boring
The model 0 with boring is designed for use with the Ambu®Mark III and the
Ambu®Mark IV resuscitator on small children down to three years of age/
approx. 15 kg of body weight. The leakage from the boring is designed to limit the
ventilation pressure to approx. 4 kPa (40 cm H2O) and shall not be used for
any other application than that.
3. Operating instructions
Ventilation with a face mask
Apply the mask firmly to the patient’s face to achieve a tight seal. Hold the mask tight
against the face while maintaining the correct head tilt to keep the airway open.
It is very important to thoroughly train correct application of the
face mask before any attempt is made to use a resuscitator.

UK
5
4. Cleaning - disinfecting - sterilising
Detergents and chemical disinfectants
Numerous brands of detergents and chemical disinfectants are available. Use only
brands that are compatible with the mask materials to avoid reduction in the lifetime
of the materials. See list of materials on page 6. Follow the instructions of the
manufacturer of the detergent or chemical disinfectant for dilution and exposure time.
Substances containing phenol should be avoided.
Information on selected detergents and chemical disinfectants verified for compatibility
with the mask materials is available on request from the local Ambu representative or
Ambu A/S.
Note: If residuals of detergents or disinfectants are allowed to dry on the mask
materials, surfaces may become impaired and the product lifetime may become reduced.
The cleaning, disinfecting and sterilising process
The following steps are generally recommended. Select proper methods for the mask
parts in question according to the table above.
The table shows applicable methods for cleaning, disinfecting and sterilising.
zApplicable
Not applicable
Methods
Cleaning Disinfecting - sterilising
Washing Disinfecting Auto-
claving
Mask Manual washing Washing machine (WM) W.M. heat disinfecting Boiling Chemical 121º C 138º C
After
each use
Silicone face masks sizes 0,
2, 3/4 & 5 zzzzzzz
Silicone face mask with
foam filled cuff size 0A zzzz

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4.1. Disassembly of the mask (recommended)
Unbutton or remove mask cuff from dome.
Caution!
Before autoclaving remove stopper from the inflation tube.
4.2. Cleaning of parts
Manual washing or automatic washing machine
Wash the parts in warm water using a detergent suitable for the mask materials cf.
paragraph 5. Rinse all parts thoroughly in clean water to remove all detergent residues.
If surface cleaning and/or disinfecting of the outer surfaces of the mask are carried out,
make sure that the detergent and/or disinfectant is compatible with the materials of the
mask and be sure to remove the detergent/disinfectant by rinsing with water. If residues
are allowed to dry on the mask, the lifetime of the materials may be reduced.
An automatic washing machine with a programme designed for washing anaesthesia
breathing equipment may be used.
Disassembled mask with stopper
removed from the inflation tube.
Disassembled mask

UK
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4.3. Disinfecting and/or sterilising
Select heated or chemical disinfection according to local standards for disinfection and
the table of applicable methods.
Washing machine - Heat disinfecting programme
Automatic washing machines designed for medical equipment will normally include
program cycles for heat disinfection.
Boiling
Use clean water, heat and boil parts for e.g. 10 minutes to disinfect.
Chemical disinfecting
Follow the instructions of the manufacturer of the chemical disinfectant for dilution
and exposure time. After exposure of the mask parts to the chemical disinfectant, rinse
thoroughly in clean water to remove all residues.
Autoclaving
Use standard autoclaving equipment adjusted for max. 138°C.
Caution!
Before autoclaving remove stopper from the inflation tube.
4.4. Drying and cooling
Leave the parts to dry and/or cool completely before reassembling the mask.
4.5. Inspection of parts
After cleaning, disinfecting and/or sterilising carefully inspect all parts for damage or
excessive wear and replace, if necessary. Some methods may cause discolouration of
rubber parts without impact on their lifetime. In case of materials deterioration e.g.
cracking, the parts should be replaced.
4.6. Assembling
Reassemble the mask.

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0086
5. Specifications
Weight
Size 0A: app. 28 g. Size 3/4: app. 78 g.
Size 0 with boring: app. 39 g. Size 5: app. 80 g.
Size 0: app. 38 g. Size 6: app. 105 g.
Size 2: app. 63 g.
Operating temperature range: -40ºC to 50ºC (-40ºF to 122ºF)
Storage temperature range: -40ºC to 70ºC (-40ºF to 158ºF)
Parts Materials
Mask cuff size 0A: Silicone rubber with foam filling
Mask dome: Polysulphone
Mask cuff: Silicone rubber
Mask connector: Silicone rubber
Parts list
Cat. No. Size Connector
Blue
000 313 000 Face mask, size 0A 15 mm ISO connector
000 314 000 Face mask, size 0 with boring 22 mm ISO connector
000 315 000 Face mask, size 0 22 mm ISO connector
000 316 000 Face mask, size 2 22 mm ISO connector
000 312 000 Face mask, size 3/4 22 mm ISO connector
000 317 000 Face mask, size 5 22 mm ISO connector
000 319 000 Face mask, size 6 22 mm ISO connector
Note:
These directions for use may be updated without futher notice.
Copies of the current version are available from the manufacturer.

DE
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Bedienungsanleitung
Ambu®Silikon-Gesichtsmasken
Mit transparentem Dom und regulierbarem Cuff
1. Warnhinweise/Vorsichtsmaßnahmen
Achtung:
• Laut US-Bundesrecht darf dieses Gerät nur von einem Arzt selbst
oder auf dessen Anordnung verkauft werden (nur USA).
• Diese Maske darf nur von Personen verwendet werden, die zur
kardiopulmonalen Wiederbelebung ausgebildet sind. Die korrekte
Verwendung einer Gesichtsmaske, so daß eine dichte Versiegelung
erreicht wird, muss besonders geübt werden. Es ist sicherzustellen,
dass das betreffende Personal mit dem Inhalt dieses Anleitung
vertraut ist.
2. Beschreibung
Die Ambu®Silikon-Gesichtsmasken mit selbstfüllendem Maskencuff eignen sich
ideal für die Anwendung mit manuellen und automatischen Beatmungssystemen.
Größe 0A mit einem 15 mm ISO Konnektor
Die Maske ist durchsichtig. Der Cuff des 0A-Modells ist mit Schaum gefüllt, und das
Inflationsvolumen kann nicht eingestellt werden.
Größe 0, 2, 3/4, 5 und 6 mit 22 mm ISO Konnektor
Die Maskendome sind transparent. Der Maskencuff ist selbstfüllend und druckregulierbar.

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Größe 0 mit Bohrung
Das Modell 0 mit Bohrung ist für die Anwendung mit den Ambu®Mark III- und
Ambu®Mark IV-Beatmungsbeuteln für Kleinkinder im Mindestalter von ca.
drei Jahren mit mindestens 15 kg Körpergewicht ausgelegt. Die Leckage von der
Bohrung begrenzt den Beatmungsdruck auf ca. 4 kPa (40 cm H2O) und darf nicht
für andere Zwecke verwendet werden.
3. Bedienung
Beatmung mit einer Gesichtsmaske
Setzen Sie die Maske auf das Gesicht des Patienten, so daß sie luftdicht abschließt.
Halten Sie die Maske dicht auf dem Gesicht und achten Sie gleichzeitig auf ein kor-
rektes Kopfüberstrecken, um die Atemwege frei zu halten.
Vor der Anwendung eines Beatmungsbeutels muß das korrekte
Aufsetzen der Gesichtsmaske ausführlich geübt werden.