ResMed AirFit F20 User manual

User guide
Full face mask
User guide
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QuietAir
QuietAir

i
Fitting / Anlegen / Ajustement / Applicazione / Opzetten /Tillpassning /
Sovittaminen /Tilpasning /Tilpasning / Paigaldamine / Colocación /
Colocação / Τοποθέτηση της μάσκας / MaskeninTakılması / Zakładanie /
Felhelyezés / Fixarea măştii / Поставяне / Nasazení masky /
Namještanje / Mátun / Uzlikšana / Užsidėjimas / Nasadzovanie /
Namestitev / Установка маски / 装着 /  / המאתה / 

ii
Adjustment / Anpassen / Ajustement / Regolazione / Afstellen /
Justering / Säätäminen / Justering / Justering / Kohendamine / Ajuste /
Ajuste / Προσαρμογή / Ayarlama / Regulacja / Beállítás / Ajustare /
Регулиране / Úprava masky / Podešavanje / Stilling / Regulēšana /
Koregavimas / Prispôsobenie / Prilagoditev / Регулировка / 調整 /
 / ןונווכ / 

iii
Removal / Abnehmen / Retrait / Rimozione / Afnemen / Borttagning /
Pois ottaminen / Fjernelse / Fjerning / Eemaldamine / Retirada /
Remoção / Αφαίρεση / Çıkarma / Zdejmowanie / Eltávolítás / Îndepărtare
/ Сваляне / Sejmutí masky / Uklanjanje / Fjarlægja / Noņemšana /
Nuėmimas / Snímanie / Odstranjevanje / Снятие маски / 取り外し /
 /הרסה / 

iv
Disassembly / Auseinanderbau / Démontage / Smontaggio /
Demonteren / Demontering / Purkaminen / Adskillelse / Demontering /
Osadeks lahtivõtmine / Desmontaje / Desmontagem /
Αποσυναρμολόγηση / Sökme / Demontaż / Szétszerelés / Dezasamblare /
Разглобяване / Demontáž / Rastavljanje / Sundurtekning / Izjaukšana /
Išardymas / Rozobratie / Razstavljanje / Разборка / 分解方法 /
 / קוריפ /   

v
Reassembly / Zusammenbau / Remontage / Riassemblaggio / Opnieuw
monteren / Montering / Kokoaminen / Samling / Montering / Uuesti
kokkupanek / Nuevo montaje / Nova montagem / Επανασυναρμολόγηση /
Yeniden montaj / Składanie / Ismételt összeszerelés / Reasamblare /
Повторно сглобяване / Opětovné sestavení / Ponovno sastavljanje / Að
setja aftur saman / Atkārtota salikšana / Pakartotinis surinkimas /
Opätovné zostavenie / Ponovno sestavljanje / Повторная сборка / 再組
立方法 /   / שדחמ הבכרה /   

vi
Cleaning the vent / Luftauslassönung reinigen / Nettoyage de l’orifice
de ventilation / Pulizia del foro per l’esalazione / De ventilatieopening
schoonmaken / Rengöra ventilöppningarna / Ilma-aukon
puhdistaminen / Rengøring af lufthullet / Rengjøre
ventileringsåpningen / Õhuava puhastamine / Limpieza de la
ventilación / Limpeza do respiradouro / Καθαρισμός ανοίγματος
εξαερισμού / Hava deliğini temizleme / Czyszczenie odpowietrznika / A
szellőzőnyílás tisztítása / Curăţarea orificiului / Почистване на
отдушника / Čištění ventilačního otvoru / Čišćenje odušnika / Að þrífa
loftgatið / Ventilācijas atveres tīrīšana / Oro angos valymas / Čistenie
ventilu / Čiščenje izhoda za zrak / Очистка вентиляционного
отверстия / 呼気排出孔のクリーニング /    / רורוואה חתפ יוקינ
   /

English 1
ENGLISH
Thank you for choosing the AirFit™ F20 Non Magnetic full face mask.
Using this guide
Please read the entire guide before use. When following instructions,
refer to the images at the front of the guide.
Intended use
The AirFit F20 Non Magnetic is a non-invasive accessory used for
channeling airflow (with or without supplemental oxygen) to a patient
from a positive airway pressure (PAP) device such as a continuous
positive airway pressure (CPAP) or bilevel system.
The AirFit F20 Non Magnetic is:
•to be used by patients weighing more than 30 kg for whom positive
airway pressure therapy has been prescribed
•intended for single-patient reuse in the home environment and multi-
patient reuse in the hospital/institutional environment.
QuietAir elbow
The QuietAir elbow is intended for single-patient reuse in both home and
hospital/institutional environments.
Clinical benefits
The clinical benefit of vented masks is the provision of effective therapy
delivery from a therapy device to the patient.
Intended patient population/medical conditions
Obstructive pulmonary diseases (eg, Chronic Obstructive Pulmonary
Disease), restrictive pulmonary diseases (eg, diseases of the lung
parenchyma, diseases of the chest wall, neuromuscular diseases), central
respiratory regulation diseases, obstructive sleep apnoea (OSA) and
obesity hypoventilation syndrome (OHS).

2
GENERAL WARNINGS
•The mask must be used under qualified supervision for users who
are unable to remove the mask by themselves. The mask may not
be suitable for those predisposed to aspiration.
•The mask must be fitted with the supplied elbow (containing the
valve and vent assembly) to ensure safe and functional usage
unless otherwise specified. Do not use the mask if the valve or
vent assembly is damaged or missing.
•The mask contains safety features in the elbow, which are the
valve and vent, to enable normal breathing and exhaust exhaled
breath. Occlusion of the valve and vent needs to be prevented to
avoid having an adverse effect on the safety and quality of the
therapy. Regularly inspect the valve and vent to ensure they are
kept clean, undamaged and clear of blockages. The mask should
not be worn if the valve is damaged as it will not be able to
perform its safety function. The elbow should be replaced if the
valve is damaged, distorted or torn. The vent holes and valve
should be kept clear.
•The mask should only be used with CPAP or bilevel devices
recommended by a physician or respiratory therapist.
•Avoid connecting flexible PVC products (eg, PVC tubing) directly
to any part of the mask. Flexible PVC contains elements that can
be damaging to the materials of the mask, and may cause the
components to crack or break.
•The mask should not be used unless the device is turned on. Once
the mask is fitted, ensure the device is blowing air.
Explanation: CPAP and bilevel devices are intended to be used
with special masks (or connectors) which have venting to allow
continuous flow of air out of the mask. When the device is turned
on and functioning properly, new air from the device flushes the
exhaled air out through the mask holes. When the device is
turned off, the mask valve opens to atmosphere allowing fresh air
to be breathed. However, a higher level of exhaled air may be
rebreathed when the device is off. This applies to most full face
masks for use with CPAP and bilevel devices.
•Follow all precautions when using supplemental oxygen.
•Oxygen flow must be turned off when the CPAP or bilevel device
is not operating, so that unused oxygen does not accumulate
within the device enclosure and create a risk of fire.

English 3
GENERAL WARNINGS
•Oxygen supports combustion. Oxygen must not be used while
smoking or in the presence of an open flame. Only use oxygen in
well ventilated rooms.
•At a fixed rate of supplemental oxygen flow, the inhaled oxygen
concentration varies, depending on the pressure settings, patient
breathing pattern, mask, point of application and leak rate. This
warning applies to most types of CPAP or bilevel devices.
•The technical specifications of the mask are provided for your
clinician to check that they are compatible with the CPAP or
bilevel device. If used outside specification or if used with
incompatible devices, the seal and comfort of the mask may not
be effective, optimum therapy may not be achieved, and leak, or
variation in the rate of leak, may affect the CPAP or bilevel device
function.
•Discontinue using this mask if you have ANY adverse reaction to
the use of the mask, and consult your physician or sleep therapist.
•Using a mask may cause tooth, gum or jaw soreness or aggravate
an existing dental condition. If symptoms occur, consult your
physician or dentist.
•The F20 line of full face CPAP masks are not intended to be used
simultaneously with nebulizer medications that are in the air path
of the mask/tube.
•As with all masks, some rebreathing may occur at low CPAP
pressures.
•Refer to your CPAP or bilevel device manual for details on
settings and operational information.
•Remove all packaging before using the mask.
•For any serious incidents that occur in relation to this device,
these should be reported to ResMed and the competent authority
in your country.
Using your mask
When using your mask with ResMed CPAP or bilevel devices that have
mask setting options, refer to the Technical specifications section in this
user guide for the correct setting.
For a full list of compatible devices for this mask, see the Mask/Device
Compatibility List on www.resmed.com/downloads/masks. If you do not
have internet access, please contact your ResMed representative.

4
Use a standard conical connector if pressure readings and/or
supplemental oxygen are required.
Fitting
1. Lift and pull both mask clips away from the frame.
2. Ensure that the ResMed logo on the headgear is facing outwards and
is upright. With both lower headgear straps released, hold the mask
against your face and pull the headgear over your head.
3. Bring the lower straps below your ears, and attach the mask clip to
the frame.
4. Undo the fastening tabs on the upper headgear straps. Pull the straps
evenly until the mask is stable and positioned as shown in the
illustration. Reattach the fastening tabs.
5. Undo the fastening tabs on the lower headgear straps. Pull the straps
evenly until the mask is stable and sits comfortably on the chin.
Reattach the fastening tabs.
6. Connect the device air tubing to the elbow. Attach the elbow to the
mask by pressing the side buttons and pushing the elbow into the
mask, ensuring it clicks in on both sides.
7. Your mask and headgear should be positioned as shown in the
illustration.
Adjustment
If necessary, slightly adjust the position of the mask for the most
comfortable fit. Ensure that the cushion is not creased and the headgear
is not twisted.
1. Turn on your device so that it is blowing air.
Adjustment tips:
With air pressure applied, pull the mask away from your face to
allow the cushion to inflate and reposition onto your face.
To resolve any leaks at the upper part of the mask, adjust the
upper headgear straps. For the lower part, adjust the lower
headgear straps.
Adjust only enough for a comfortable seal. Do not overtighten as
this may cause discomfort.

English 5
Removal
1. Lift and pull both mask clips away from the frame.
2. Pull the mask away from your face and back over your head.
Disassembly
If the mask is connected to your device, disconnect the device air tubing
from the elbow.
1. Undo the fastening tabs on the upper headgear straps. Pull the straps
out of the frame.
Tip: Keep the mask clips attached to the lower headgear straps to
easily distinguish the upper and lower straps when reassembling.
2. Remove the elbow from the mask by pressing the side buttons and
pulling the elbow away.
3. Hold the side of the frame between the upper and lower arms. Gently
pull the cushion away from the frame.
Reassembly
1. Attach the cushion to the frame by aligning the circular openings and
pushing together until retained.
2. With the ResMed logo on the headgear facing outside and upright,
thread the upper headgear straps into the frame slots from the inside.
Fold them over to secure.
Cleaning your mask at home
It is important to follow the steps below to get the best performance out
of your mask.

6
WARNING
•As part of good hygiene, always follow cleaning instructions and
use a mild liquid detergent. Some cleaning products may damage
the mask, its parts and their function, or leave harmful residual
vapours that could be inhaled if not rinsed thoroughly.
•Regularly clean your mask and its components to maintain the
quality of your mask and to prevent the growth of germs that can
adversely affect your health.
•Visible criteria for product inspection: If any visible deterioration
of a system component is apparent (cracking, discoloration, tears
etc.), the component should be discarded and replaced.
Daily/After each use:
1. Disassemble the mask according to the disassembly instructions.
2. Rinse the frame, elbow and cushion under running water. Clean with a
soft brush until dirt is removed.
3. Soak the components in warm water (approximately 30°C) with a mild
liquid detergent for up to ten minutes.
4. Shake the components in the water.
5. Brush the moving parts of the elbow and around the vent holes.
6. Brush the areas of the frame where the arms connect, and inside and
outside the frame where the elbow connects.
7. Rinse the components under running water.
8. Leave the components to air dry out of direct sunlight. Make sure to
squeeze the arms of the frame to ensure that excess water is
removed.
Weekly:
1. Disassemble the mask. The mask clips can remain attached to the
headgear during cleaning.
2. Handwash the headgear in warm water (approximately 30°C) with
mild liquid detergent.
3. Rinse the headgear under running water. Inspect to ensure the
headgear is clean and detergent free. Wash and rinse again, if
necessary.
4. Squeeze the headgear to remove excess water.
5. Leave the headgear to air dry out of direct sunlight.

English 7
Reprocessing the mask between patients
Reprocess this mask when using between patients. Cleaning and
disinfection instructions are available on
www.resmed.com/downloads/masks. If you do not have internet access,
please contact your ResMed representative.
Troubleshooting
Problem/possible cause
Solution
Mask is uncomfortable.
Headgear straps are too tight. The cushion membrane is designed to inflate
against your face to provide a comfortable seal
with low headgear tension. Adjust straps evenly.
Ensure that the headgear straps are not too tight
and that the cushion is not creased.
Mask could be the wrong size. Talk to your clinician to have your face size
checked. Note that sizing across different masks
is not always the same.
Mask is too noisy.
Elbow incorrectly installed or
incorrect assembly of the mask
system.
Remove the elbow from your mask, then
reassemble according to the instructions. Check
that the mask is correctly assembled according to
the instructions.
Vent is dirty. Use a soft bristle brush to clean the vent.
Mask leaks around the face.
Cushion membrane is creased. Mask
is incorrectly positioned or adjusted. Refit your mask according to the instructions. Ensure that you position the cushion correctly on
your face before pulling headgear over your
head. Do not slide the mask down your face
during fitting as this may lead to creasing of the
cushion.
Mask could be the wrong size Talk to your clinician to have your face size
checked. Note that sizing across different masks
is not always the same.

8
Technical specifications
Pressure-flow
curve
The mask contains passive venting to protect against rebreathing. As
a result of manufacturing variations, the vent flow rate may vary.
Pressure
(cm H2O)
Flow
(L/min)
3
19
13
42
22
57
31
70
40
82
Therapy pressure:
3 to 40 cm H2O
Resistance with Anti Asphyxia Valve (AAV) closed to atmosphere:
Drop in pressure measured (nominal)
at 50 L/min
0.2 cmH2O
at 100 L/min
0.6 cmH
2
O
Resistance with Anti Asphyxia Valve (AAV) open to atmosphere:
Inspiration at 50 L/min:
0.6 cm H2O
Expiration at 50 L/min:
0.8 cm H2O
Anti Asphyxia Valve (AAV) open-to-atmosphere pressure:
≤3 cm H2O
Anti Asphyxia Valve (AAV) closed-to-atmosphere pressure:
≤3 cm H2O
Sound: DECLARED DUAL-NUMBER NOISE EMISSION VALUES in accordance with
ISO 4871:1996 and ISO 3744:2010. The A-weighted sound power level and the A-weighted
sound pressure level of the mask at a distance of 1 m, with uncertainty of 3 dBA, are
shown
Power level (with Standard elbow)
30 dBA
Power level (with QuietAir elbow)
21 dBA
Pressure level (with Standard elbow)
22 dBA
Pressure level (with QuietAir elbow)
13 dBA
Environmental
conditions
Operating temperature: 5°C to 40°C
Operating humidity: 15% to 95% non-condensing
Storage and transport temperature: -20°C to +60°C
Storage and transport humidity: up to 95% non-condensing

English 9
Service life
The service life of the AirFit F20 Non Magnetic mask system is
dependent on the intensity of usage, maintenance, and
environmental conditions to which the mask is used or stored. As
this mask system and its components are modular in nature, it is
recommended that the user maintain and inspect it on a regular
basis, and replace the mask system or any components if deemed
necessary or according to the ‘visual criteria for product inspection’
in the ‘Cleaning your mask at home’ section of this guide. Refer to
the ‘Mask components’ section of this guide for information of how
to order replacement parts.
Mask setting
options
For AirSense, AirCurve or S9: Select 'Full Face'.
For other devices: Select 'MIR FULL' (if available), otherwise select
'FULL FACE' as the mask option.
Storage
Ensure that the mask is thoroughly clean and dry before storing it for any
length of time. Store the mask in a dry place out of direct sunlight.
Disposal
This mask and packaging do not contain any hazardous substances and
may be disposed of with your normal household refuse.
Symbols
The following symbols may appear on your product or packaging.
Full face mask Device setting - Full Face
Size - small Size - medium
Size - large QuietAir vent

10
Not made with natural rubber latex
See symbols glossary at ResMed.com/symbols
Consumer Warranty
ResMed acknowledges all consumer rights granted under the EU
Directive 1999/44/EC and the respective national laws within the EU for
products sold within the European Union.

Deutsch 1
DEUTSCH
Vielen Dank, dass Sie sich für die AirFit™ F20 Non Magnetic Full Face
Maske entschieden haben.
Diese Gebrauchsanweisung
Lesen Sie sich bitte vor der Verwendung die gesamte
Gebrauchsanweisung durch. Schauen Sie sich beim Befolgen der
Anweisungen die Abbildungen vorne in der Gebrauchsanweisung an.
Verwendungszweck
Die AirFit F20 Non Magnetic ist ein Zubehörteil, das dem Patienten Luft
mit oder ohne zusätzliche Sauerstoffgabe auf nicht-invasive Weise von
einem PAP-Gerät (positiver Atemwegsdruck), wie z. B. einem CPAP- oder
BiLevel-Gerät, zuführt.
Die AirFit F20 Non Magnetic ist:
•für Patienten (>30 kg) vorgesehen, denen positiver Atemwegsdruck
verschrieben wurde.
•für den wiederholten Gebrauch durch einen einzelnen Patienten zu
Hause sowie durch mehrere Patienten im Krankenhaus oder in der
Schlafklinik geeignet.
QuietAir-Kniestück
Das QuietAir-Kniestück ist für den wiederholten Gebrauch durch einen
einzelnen Patienten zu Hause oder im Krankenhaus oder in der
Schlafklinik vorgesehen.
Hinweis für blinde und sehbehinderte Benutzer
Eine elektronische Version dieser Gebrauchsanweisung ist online auf den
Produktinformationsseiten von ResMed.de verfügbar.
Klinische Vorteile
Masken mit Luftauslassöffnungen ermöglichen die Bereitstellung einer
wirksamen Therapie von einem Therapiegerät an den Patienten.
Zielpatientenpopulation/Erkrankungen
Obstruktive Lungenerkrankungen (z. B. chronisch obstruktive
Lungenerkrankung), restriktive Lungenerkrankungen (z. B.

2
Lungenparenchymerkrankungen, Brustwanderkrankungen,
neuromuskuläre Erkrankungen), Erkrankungen der zentralen
Atemregulation, obstruktive Schlafapnoe (OSA) und Adipositas-
Hypoventilationssyndrom (OHS).
ALLGEMEINE WARNUNGEN
•Die Maske muss unter qualifizierter Aufsicht für Benutzer
verwendet werden, die die Maske nicht selbst abnehmen können.
Die Maske ist eventuell nicht für Patienten geeignet, bei denen
das Risiko der Aspiration besteht.
•Um eine sichere Funktionsweise zu gewährleisten, muss die
Maske, falls nicht anders angegeben, mit dem mitgelieferten
Kniestück angepasst werden, das Ventil und Ausatemöffnung
umfasst. Verwenden Sie die Maske nicht, wenn das Ventil bzw.
die Ausatemöffnung beschädigt ist oder fehlt.
•Die Maske enthält Sicherheitsmerkmale im Kniestück, nämlich das
Ventil und die Ausatemöffnung, um eine normale Atmung zu
ermöglichen und die ausgeatmete Luft auszustoßen. Um die
Sicherheit und Qualität der Therapie zu gewährleisten, dürfen das
Ventil und die Ausatemöffnung nicht verdeckt oder verstopft sein.
Kontrollieren Sie das Ventil und die Ausatemöffnung regelmäßig.
Sie müssen sauber sein und dürfen keine Schäden und
Verstopfungen aufweisen. Die Maske darf nicht benutzt werden,
wenn das Sicherheitsventil beschädigt ist, da es ansonsten diese
Sicherheitsfunktion nicht ausüben kann. Das Kniestück muss
ausgewechselt werden, wenn das Sicherheitsventil beschädigt,
verdreht oder gerissen ist. Die Ausatemöffnungen und das Ventil
dürfen nicht blockiert sein.
•Diese Maske darf nur mit dem von Ihrem Arzt oder
Atemtherapeuten empfohlenen CPAP- oder BiLevel-Gerät
verwendet werden.
•Flexible PVC-Produkte (z. B. PVC-Schlauch) dürfen nicht direkt an
dieser Maske angeschlossen werden. Flexible PVC-Produkte
enthalten Bestandteile, die das Material der Maske beschädigen
und zu Rissen oder Brüchen in den Komponenten führen können.
•Die Maske darf nur bei eingeschaltetem Therapiegerät verwendet
werden. Stellen Sie nach dem Anlegen der Maske sicher, dass das
Gerät Luft bereitstellt.
Erklärung: CPAP- und BiLevel-Geräte sind für die Verwendung mit
speziellen Masken (oder Verbindungsstücken) vorgesehen, die mit

Deutsch 3
Ausatemöffnungen ausgestattet sind, um einen kontinuierlichen
Luftstrom aus der Maske heraus zu gewährleisten. Wenn das
Gerät eingeschaltet ist und ordnungsgemäß funktioniert, wird die
ausgeatmete Luft durch frische Luft vom Gerät über die
Ausatemöffnungen aus der Maske heraustransportiert. Wenn das
Gerät ausgeschaltet ist, öffnet sich das Maskenventil und
ermöglicht das Einatmen frischer Luft aus der Umgebung.
Allerdings besteht bei ausgeschaltetem Gerät die Gefahr, dass
mehr ausgeatmete Luft wieder eingeatmet wird. Dies trifft für die
meisten Full Face Masken zu, die mit CPAP- und BiLevel-Geräten
verwendet werden.
•Bei zusätzlicher Sauerstoffgabe müssen alle
Vorsichtsmaßnahmen beachtet werden.
•Wenn das CPAP- bzw. BiLevel-Gerät nicht in Betrieb ist, muss die
Sauerstoffzufuhr abgeschaltet werden, damit sich nicht
verwendeter Sauerstoff nicht im Gehäuse des Gerätes
ansammelt, wo er eine Feuergefahr darstellen könnte.
•Sauerstoff fördert die Verbrennung. Rauchen und offenes Feuer
während der Verwendung von Sauerstoff müssen daher
unbedingt vermieden werden. Die Sauerstoffzufuhr darf nur in gut
belüfteten Räumen erfolgen.
•Wird eine konstante Menge an zusätzlichem Sauerstoff zugeführt,
variiert die Konzentration des eingeatmeten Sauerstoffs je nach
Druckeinstellung, Atemmuster des Patienten, Maskentyp,
Zufuhrstelle und Leckagerate. Diese Warnung bezieht sich auf die
meisten CPAP- bzw. BiLevel-Geräte.
•Ihr Arzt kann anhand der technischen Daten der Maske deren
Kompatibilität mit dem CPAP- bzw. BiLevel-Gerät überprüfen.
Werden die technischen Daten der Maske nicht beachtet bzw.
wird die Maske mit inkompatiblen Atemtherapiegeräten
verwendet, können Sitz, Komfort und Therapie beeinträchtigt
werden. Außerdem können sich Leckagen bzw.
Leckagevariationen negativ auf die Funktion des CPAP- bzw.
BiLevel-Gerätes auswirken.
•Sollten IRGENDWELCHE Nebenwirkungen im Zusammenhang mit
dem Gebrauch der Maske auftreten, stellen Sie den Gebrauch der
Maske ein und konsultieren Sie Ihren Arzt oder Schlaftherapeuten.
•Die Verwendung einer Maske kann Zahn-, Zahnfleisch- oder
Kieferschmerzen verursachen oder ein bestehendes Zahnleiden