ResMed AirFit N20 User manual

Nasal mask
User guide
User guide
English | Dansk | Eesti
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English 1
ENGLISH
A
Elbow and short tube
3
Vent
B
Frame
4
Short tube
C
Cushion
5
Swivel
D
Headgear
6
Magnetic clip
1
Elbow
7
Lower headgear straps
2
Side buttons
8
Upper headgear straps
Thank you for choosing the AirFit™ N20/AirTouch™ N20. These masks
are identical - except for the interchangeable AirFit N20 silicone cushion
and AirTouch N20 foam cushion. This offers two choices for your mask,
depending on your preferred comfort, stability and seal. These masks
may not be available in all countries.
Intended use
The AirFit N20 and AirTouch N20 nasal masks channel airflow non-
invasively to a patient from a positive airway pressure (PAP) device such
as a continuous positive airway pressure (CPAP) or bilevel device.

2
The N20 is:
•to be used by patients weighing more than 30 kg for whom positive
airway pressure has been prescribed
•intended for single-patient re-use in the home environment and multi-
patient re-use in the hospital/institutional environment.
AirTouch N20 cushion
The AirTouch N20 cushion is intended for single patient re-use in both the
home and hospital/institutional environment and recommended to be
replaced monthly.
WARNING
Magnets are used in the lower headgear straps and the frame of the
mask. Ensure the headgear and frame is kept at least 50 mm away
from any medical implant (eg, pacemaker, defibrillator, magnetic
cerebrospinal fluid (CSF) shunt valve, cochlear implants etc) to avoid
possible effects from localized magnetic fields. The magnetic field
strength is less than 400 mT.
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).
Clinical benefits
The clinical benefit of vented masks is the provision of effective therapy
delivery from a therapy device to the patient.
Contraindications
Use of masks with magnetic components is contraindicated in patients
with the following pre-existing conditions:
•a metallic hemostatic clip implanted in your head to repair an
aneurysm
•metallic splinters in one or both eyes.

English 3
Fitting your mask
1. Twist and pull both magnetic clips away from the frame.
2. With both lower headgear straps released, hold the mask against your
face and pull the headgear over your head.
Headgear check:
Ensure that the ResMed logo on the headgear is facing outwards and
is upright when the headgear is put on.
3. Bring the lower straps below your ears, and attach the magnetic clip
to the frame.
4. Undo the fastening tabs on the upper headgear straps. Adjust the
straps evenly until the mask sits comfortably just over the nose.
Reattach the fastening tabs.
5. Undo the fastening tabs on the lower headgear straps. Adjust the
straps evenly until the mask is stable. Reattach the fastening tabs.
6. Connect the device air tubing to the short tube. 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.

4
Adjusting your mask
If necessary, slightly adjust the position of the mask for the most
comfortable fit. Ensure that the headgear is not twisted and for the AirFit
N20 the cushion is not creased.
1. Turn on your device so that it is blowing air.
Adjustment tips:
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.
The upper strap adjustment is the key to seal and comfort.
Do not overtighten the lower straps because they mainly serve to
keep the cushion in position.
Removing your mask
1. Twist and pull both magnetic clips away from the frame.
2. Pull the mask away from your face and back over your head.

English 5
Disassembling your mask for cleaning
If the mask is connected to your device, disconnect the device air tubing
from the short tube.
1. Undo the fastening tabs on the upper headgear straps and pull them
from the frame. Keep the magnetic clips attached to the lower
headgear straps.
2. Remove the elbow from the mask by pressing the side button and
pulling the elbow away.
3. Hold the frame by placing your thumb over the side slot. Pull the
cushion away from the frame.
Reassembling your mask
1. Push the cushion into the frame. The frame has a shape that allows
you to insert the cushion only one way.
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.
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
vapors that could be inhaled if not rinsed thoroughly.

6
•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.
CAUTION
Visible criteria for product inspection: If any visible deterioration of a
system component is apparent (cracking, crazing, tears etc), the
component should be discarded and replaced.
Once you have disassembled the mask, clean the components as
follows.
AirFit N20 cushion, elbow and short tube (Daily/After each use)
1. Soak and agitate the AirFit N20 cushion, elbow and short tube in
warm water (approximately 30°C) using a mild liquid detergent for up
to 10 minutes.
2. Clean the components with a soft bristle brush, paying particular
attention to the small vent holes on the elbow.
3. Thoroughly rinse the components under warm flowing drinking quality
water.
4. Inspect each component to ensure that they are visually clean and
free of detergent residue. If required, repeat washing.
5. Allow the components to dry out of direct sunlight before assembling.
Headgear, frame (Weekly)
The magnetic clips on the frame can be left on for washing.
1. Soak and agitate the separated headgear and frame in warm water
(approximately 30°C) using a mild liquid detergent for up to 10
minutes.
2. To rinse the components, repeatedly squeeze them under warm
flowing drinking quality water until it is free of detergent residue.
3. Squeeze the components to remove excess water.
4. Allow the components to dry out of direct sunlight before assembling.

English 7
AirTouch N20 cushion (as required)
CAUTION
•The cushion must not be submerged in liquid as this may damage
the cushion and affect mask performance.
•Discard the cushion if it is submerged in liquid or heavily soiled.
•Do not expose the cushion to domestic cleaning products or
cleaning devices.
You do not need to clean the AirTouch N20 cushion every day. It is
recommended to replace your cushion every month. If any visible
deterioration of the cushion is apparent, the cushion should be discarded
and replaced. If required, wipe the outside of the foam cushion with
CPAP wipes or similar alcohol-free wipes and allow to dry. Do not store or
place the cushion in direct sunlight.
Troubleshooting
Problem/possible cause
Solution
Mask is too noisy.
Vent is dirty.
Clean the vent according to the instructions.
Mask is incorrectly assembled. Disassemble the mask, then reassemble
according to the instructions.
Elbow and short tube incorrectly
installed Remove the elbow and short tube from your mask frame, then reassemble according to the
instructions.
Mask is leaking. Refit or reposition your mask.
Readjust the headgear straps to bring the
mask closer to the face and improve your
seal.
Check that your mask is assembled correctly.
Mask leaks around face.
Mask is not positioned correctly. Check that the mask size indicator is facing
downward on the bottom of the cushion along
the bottom of your nose.

8
Problem/possible cause
Solution
Mask may have been fitted incorrectly. Pull the mask away from your face and
reposition, ensuring that the lower corners of
the mask fully enclose your nose. If
necessary, readjust the headgear straps to
keep the mask in the right place.
Cushion may be dirty. Clean the cushion according to the
instructions.
(For AirFit N20 only) Cushion membrane
is creased or folded. Remove and refit your mask according to the fitting instructions. Ensure that you position
the cushion correctly over your nose before
pulling the headgear over your head. Do not
slide the mask down your face during fitting
as this may lead to folding or curling of the
cushion.
Cushion is not positioned correctly. Reposition the mask on your face. If leak
continues, turn off device, resettle your
cushion and then turn device back on.
(For AirTouch N20 only) Cushion is
nearing the end of its life Cushion performance may deteriorate as the foam nears the end of its lifespan. Adjust your
headgear and if the problem persists, replace
the cushion.
Mask is not tightened correctly. Ensure that the headgear straps are not
overtightened or too loose. You may find that
this mask does not need to be tightened as
much as other nasal masks.
Check that the headgear is not twisted.
Mask may be the wrong size. Talk to your clinician to have your face size
checked against the fitting template. Note
that sizing across different masks is not
always the same.
Mask does not fit properly.
Mask is incorrectly assembled. Disassemble the mask, then reassemble
according to the instructions.
Mask may be the wrong size. Talk to your clinician to have your face size
checked against the fitting template, Note
that sizing across different masks is not
always the same..

English 9
GENERAL WARNINGS
•
The vent holes must be kept clear.
•The mask should only be used with CPAP or bilevel devices
recommended by a physician or respiratory therapist.
•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 vent holes 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
vent holes. However, when the device is not operating, insufficient
fresh air will be provided through the mask, and the exhaled air may
be rebreathed. Rebreathing of exhaled air for longer than several
minutes can, in some circumstances, lead to suffocation. This applies
to most models of CPAP or 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.
•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.

10
GENERAL WARNINGS
•
Using a mask may cause tooth, gum or jaw soreness or aggravate an
existing dental condition. If symptoms occur, consult your physician or
dentist.
•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.
•The mask must be used under qualified supervision for users who are
unable to remove the mask by themselves.
•This mask is not for use on patients with impaired laryngeal reflexes
or other conditions predisposing to aspiration in the event of
regurgitation or vomiting.
•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 N20 line of nasal CPAP masks are not intended to be used
simultaneously with nebulizer medications that are in the air path of
the mask/tube.
•The mask contains an exhaust port safety feature to enable normal
breathing. The mask should not be worn if this safety feature is
damaged or missing.
Note: For any serious incidents that occur in relation to this device, these
should be reported to ResMed and the competent authority in your
country.

English 11
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)
4
20
7
27
11
35
14
40
17
44
20
49
24
54
27
58
30
61
AirFit N20
AirTouch N20
Therapy pressure
4 to 30 cm H2O
4 to 30 cm H2O
Dead space: Physical dead space is the empty volume of the mask to the end of the
swivel. Using the large cushion it is
103 mL (Large)
103 mL (Large)
Resistance: Drop in pressure measured (nominal)
at 50 L/min
0.3 cm H
2
O
0.4 cm H
2
O
at 100 L/min
1.3 cm H2O
1.4 cm H2O
Sound: DECLARED DUAL-NUMBER NOISE EMISSION VALUES in accordance with
ISO 4871. 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
24 dBA
24 dBA
Pressure level
16 dBA
16 dBA
Gross dimensions: Mask fully assembled with the short tube assembly and swivel,
excluding the headgear (H x W x D)
339 mm x 291 mm x
162 mm
339 mm x 291 mm x
170 mm
Environmental Conditions
Operating temperature: 5°C to 40°C
Operating humidity: 15% to 95% RH non-condensing
Storage and transport temperature: -20°C to +60°C
Storage and transport humidity: up to 95% RH non-condensing

12
International Commission on Non-Ionizing Radiation Protection (ICNIRP)
Magnets used in this mask are within ICNIRP guidelines for general public use.
Service Life
The service life of the 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.
Mask Setting options
For AirSense, AirCurve or S9: Select "Pillows'.
For other devices: Select 'SWIFT' (if available), otherwise select 'MIRAGE' as
the mask option.
Compatible devices:
For a full list of compatible devices for this mask, see the
Mask/Device Compatibility List at ResMed.com/downloads/masks. If you do not have
internet access, please contact your ResMed representative.
Note: The manufacturer reserves the right to change these specifications without notice.
Reprocessing the mask between patients
Reprocess this mask when using between patients. Reprocessing
instructions are available on ResMed.com/downloads/masks.
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 does not contain any hazardous substances and
may be disposed of with your normal household refuse.

English 13
Symbols
The following symbols may appear on your product or packaging:
Importer Medical device
Nasal mask Device setting - Pillows
Not made with natural rubber
latex
Clean with alcohol-free wipes
only
Do not submerge in liquids Size - small
Size - medium Size - large
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.

Dansk 1
DANSK
A
Vinkelstykke og kort slange
3
Lufthul
B
Ramme
4
Kort slange
C
Pude
5
Drejestuds
D
Hovedbånd
6
Magnetisk clips
1
Vinkelstykke
7
Nederste hovedbåndsstropper
2
Sideknapper
8
Øverste hovedbåndsstropper
Tak, fordi du har valgt AirFit™ N20/AirTouch™ N20. Disse masker er
identiske – bortset fra den udskiftelige AirFit N20-silikonepude og
AirTouch N20-skumpude. Dette giver to valgmuligheder for din maske
afhængigt af din foretrukne komfort, stabilitet og tæthed. Disse masker er
muligvis ikke tilgængelige i alle lande.
Tilsigtet anvendelse
AirFit N20- og AirTouch N20-næsemaskerne kanaliserer luftstrømmen til
en patient på en ikke-invasiv måde fra et apparat, der giver positivt
luftvejstryk (PAP), som f.eks. et CPAP-apparat (kontinuerligt positivt
luftvejstryk) eller et bilevel-apparat.

2
N20 er:
•beregnet til patienter der vejer over 30 kg, som har fået ordineret
positivt luftvejstryk.
•beregnet til genanvendelse til en enkelt patient i hjemmet og til
genanvendelse til flere patienter i et hospitals-/institutionsmiljø.
AirTouch N20-pude
AirTouch N20-puden er beregnet til genanvendelse til en enkelt patient
både i hjemmet og i et hospitals-/institutionsmiljø, og det anbefales, at
den udskiftes én gang om måneden.
ADVARSEL
Der bruges magneter på de nederste hovedbåndsstropper og på
rammen af masken. Sørg for, at hovedbåndet og rammen holdes
mindst 50 mm væk fra ethvert aktivt medicinsk implantat (f.eks.
pacemaker, defibrillator, magnetisk cerebrospinalvæske (CSF)-
shuntventil, øresneglsimplantater osv.) for at undgå mulige
påvirkninger fra lokale magnetiske felter. Magnetfeltets styrke er
mindre end 400 mT.
Tilsigtet patientgruppe/medicinske tilstande
Obstruktive lungesygdomme (f.eks. kronisk obstruktiv lungesygdom),
restriktive lungesygdomme (f.eks. sygdomme i lungeparenkymet,
sygdomme i thoraxvæggen, neuromuskulære sygdomme), sygdomme i
det centrale respiratoriske drev, obstruktiv søvnapnø (OSA) og Obesity
Hypoventilationsyndromet (OHS).
Kliniske fordele
De kliniske fordele ved ventilerede masker er den effektive behandling,
der sker mellem behandlingsenhed og patienten.
Kontraindikationer
Brug af masker med magnetiske dele er kontraindiceret hos patienter
med følgende præeksisterende tilstande:
•En metalclips til hæmostase implanteret i hovedet på grund af en
aneurisme
•Metalsplinter i et eller begge øjne.

Dansk 3
Tilpasning af masken
1. Vrid og træk begge magnetiske clips væk fra rammen.
2. Åbn begge de nederste hovedbåndsstropper; hold masken mod
ansigtet med fast hånd, og træk hovedbåndet over hovedet.
Kontrol af hovedbånd:
Sørg for, at ResMed-logoet på hovedbåndet vender udad og er lodret,
når du tager hovedbåndet på.
3. Anbring de nederste stropper under ørerne, og sæt de magnetiske
clips fast på rammen.
4. Frigør clipsene på de øverste hovedbåndsstropper. Indstil stropperne
ensartet, indtil masken sidder bekvemt lige over næsen. Sæt clipsene
fast igen.
5. Frigør clipsene på de nederste hovedbåndsstropper. Indstil stropperne
ensartet, indtil masken sidder stabilt. Sæt clipsene fast igen.
6. Forbind apparatets luftslange til den korte slange. Gør vinkelstykket
fast til masken ved at trykke på sideknapperne og skubbe
vinkelstykket ind i masken indtil det klikker på plads i begge sider.
7. Masken og hovedbåndet skal sidde som vist på illustrationen.

4
Justering af masken
Hvis det er nødvendigt kan maskens stilling justeres en smule, så den
sidder bedst muligt. Sørg for at hovedbåndet ikke er snoet, og ved AirFit
N20 at puden ikke er krøllet.
1. Tænd for apparatet så det blæser luft.
Tips til justering:
For at fjerne eventuelle utætheder i maskens øverste del skal de
øverste hovedbåndsstropper justeres. For den nederste del skal de
nederste hovedbåndsstropper justeres. Justér kun nok til at sikre
en komfortabel tæthed.
Tilpasningen af den øverste strop er afgørende for tæthed og
komfort.
Stram ikke den nederste strop for hårdt, da den fortrinsvis tjener til
at holde puden på plads.
Sådan tages masken af
1. Vrid og træk begge magnetiske clips væk fra rammen.
2. Træk masken væk fra ansigtet og tilbage over dit hovede.

Dansk 5
Demontering af masken ved rengøring
Hvis masken er tilsluttet dit apparat, skal enhedens luftslange frakobles
fra den korte slange.
1. Løsn clipsene på de øverste hovedbåndsstropper og træk dem fra
rammen. Hold de magnetiske clips fæstnet til de nederste
hovedbåndsstropper.
2. Tag vinkelstykket af masken ved at trykke på sideknappen og trække
vinkelstykket væk.
3. Hold rammen ved at anbringe din tommelfinger over åbningen i siden.
Træk puden væk fra rammen.
Genmontering af masken
1. Skub puden ind i rammen. Rammen har en form, som kun gør det
muligt at indsætte puden på én måde.
2. Med ResMed-logoet på hovedbåndet vendt udad og lodret stikkes de
øverste hovedbåndsstropper ind i rammens riller indefra. Fold dem
over for at fastgøre den.
Rengøring af masken i hjemmet
Det er vigtigt at følge trinene nedenfor for at få den bedste ydeevne ud af
masken.
ADVARSEL
•Som en del af en god hygiejne skal du altid følge
rengøringsvejledningen og bruge et mildt rengøringsmiddel.
Nogle rengøringsmidler kan beskadige masken, dens dele og
deres funktion, eller efterlade skadelige restdampe, der kan
inhaleres, hvis der ikke skylles grundigt.

6
•Rengør masken og dens dele regelmæssigt for at opretholde
kvaliteten af masken og for at forhindre bakterievækst, som kan
påvirke dit helbred negativt.
FORSIGTIG
Synlige kriterier for produktinspektion: Hvis der er nogen synlig form for
skade på en systemdel (revner, krakeleringer, rifter osv.), skal delen
kasseres og udskiftes med en ny.
Når du har adskilt masken, skal du rengøre delene som følger.
Pude, vinkelstykke og kort slange på AirFit N20 (dagligt/efter
hver brug)
1. Væd og ryst puden, vinkelstykket og den korte slange på AirFit N20 i
varmt vand (ca. 30 °C) med et mildt flydende rengøringsmiddel i op til
10 minutter.
2. Rengør delene med en blød børste; vær særligt omhyggelig med de
små ventilationshuller på vinkelstykket.
3. Skyl delene grundigt under varmt vand af drikkelig kvalitet.
4. Efterse alle delene for at sikre, at de er synligt rene og uden
rengøringsmiddel. Gentag om nødvendigt vaskningen.
5. Lad komponenterne tørre uden for direkte sollys, før de samles.
Hovedbånd, ramme (ugentligt)
Du kan lade de magnetiske clips på rammen sidde på under vasken.
1. Væd og ryst det adskilte hovedbånd og rammen i varmt vand (ca. 30
°C) med et mildt flydende rengøringsmiddel i op til 10 minutter.
2. For at rengøre komponenterne skal du flere gange klemme dem
sammen under rindende rent drikkevand, indtil de er fri for rester af
rengøringsmiddel.
3. Klem komponenterne sammen for at fjerne overskydende vand.
4. Lad komponenterne tørre uden for direkte sollys, før de samles.
AirTouch N20-pude (efter behov)
FORSIGTIG
•Puden må ikke nedsænkes i væske, da det kan beskadige puden
og påvirke maskens præstation.