ResMed AirFit N20 User manual

Nasal mask
User guide
User guide
English | Español
Português | Ελληνικά
Türkçe | Polski
Magyar | Română
Български | Česky
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1
34
5
76
2
Fitting / Colocación / Colocação / Τοποθέτηση της μάσκας
/ MaskeninTakılması / Zakładanie / Felhelyezés / Fixarea
măştii / Поставяне / Nasazení masky
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11 22
Adjustment / Ajuste / Ajuste / Προσαρμογή / Ayarlama
/ Regulacja / Beállítás / Ajustare / Регулиране / Úprava
masky
Removal / Retirada / Remoção / Αφαίρεση / Çıkarma /
Zdejmowanie / Eltávolítás / Îndepărtare / Сваляне /
Sejmutí masky
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1 2
3
Disassembly / Desmontaje / Desmontagem /
Αποσυναρμολόγηση / Sökme / Demontaż / Szétszerelés /
Dezasamblare / Разглобяване / Demontáž
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1 2
Reassembly / Nuevo montaje / Nova montagem /
Επανασυναρμολόγηση / Yeniden montaj / Składanie
/ Ismételt összeszerelés / Reasamblare / Повторно
сглобяване / Opětovné sestavení
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30°C
1 2
Cleaning your mask at home / Limpieza de la mascarilla en el
domicilio / Limpeza da máscara em casa / Καθαρισμός της μάσκας
στο σπίτι / Maskenin evde temizlenmesi / Czyszczenie maski
w domu / A maszk otthoni tisztítása / Curăţirea măştii acasă /
Почистване на маската в домашни условия / Čištění masky doma
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English 1
ENGLISH
Nasal Mask
Thank you for choosing the AirFit N20. This document provides the user
instructions for the AirFit N20 and AirFit N20 for Her masks referred to
collectively as AirFit N20 throughout this manual.
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 N20 channels airflow non-invasively to a patient from a positive
airway pressure (PAP) device such as a continuous positive airway
pressure (CPAP) or bilevel device.
The AirFit 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.
WARNING
Magnets are used in the lower headgear straps and the frame of the
AirFit N20. Ensure the headgear and frame is kept at least 50 mm
away from any active medical implant (eg, pacemaker or
defibrillator) to avoid possible effects from localised magnetic fields.
The magnetic field strength is less than 400 mT.

2
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 following a penetrating eye
injury.
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

English 3
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.
•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 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.
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.
Fitting
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.

4
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.
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:
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.
Removal
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
Disassembly
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. Pull the straps
out of the frame.
Tip: Keep the magnetic 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 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.
Reassembly
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
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.
CAUTION
If any visible deterioration of a system component is apparent
(cracking, crazing, tears etc), the component should be discarded and
replaced.

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Daily/After each use:
Before cleaning, take the mask components apart according to the
disassembly instructions.
1. Soak and agitate the cushion, multi-hole 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 multi-hole 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.
Weekly:
The magnetic clips 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.
Reprocessing the mask between patients
Reprocess this mask when using between patients. Cleaning, disinfection
and sterilisation 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 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.

English 7
Problem/possible cause
Solution
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.
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.
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.
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.
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.

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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
Dead space
information
Physical dead space is the empty volume of the mask to the end of
the swivel. Using the large cushions it is 90.0 mL.
Therapy
pressure
4 to 30 cm H
2
O
Resistance
Drop in pressure measured (nominal)
at 50 L/min: 0.4 cm H2O
at 100 L/min: 1.3 cm H2O
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
Sound
DECLARED DUAL-NUMBER NOISE EMISSION VALUES in accordance
with ISO 4871. The A-weighted sound power level of the mask is
26 dBA, with uncertainty of 3 dBA. The A-weighted sound pressure
level of the mask at a distance of 1 m is 18 dBA, with uncertainty of
3 dBA.
Gross
dimensions
339 mm (H) x 291 mm (W) x 162 mm (D)
Mask fully assembled with the short tube assembly and swivel,
excluding the headgear

English 9
International
Commission on
Non-Ionising
Radiation
Protection
(ICNIRP)
Magnets used in this mask are within ICNIRP guidelines for general
public use.
Service life
The service life of the AirFit N20 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 and S9: Select 'Pillows'.
For other devices: Select 'SWIFT' (if available), otherwise select
'MIRAGE' as the mask option.
Notes:
•This product is not made with PVC, DEHP, DBP or BBP.
•This product is not made with natural rubber latex.
•The manufacturer reserves the right to change these specifications
without notice.
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 does not contain any hazardous substances and may be
disposed of with your normal household refuse.

10
Symbols
The following symbols may appear on your product or packaging:
Catalogue number Batch code
Humidity limitation Temperature limitation
Fragile, handle with care
Not made with natural rubber
latex
Manufacturer European Authorised
Representative
Keep away from rain This way up
Nasal mask Device setting - Pillows
Size - small Size - medium
Size - large
Indicates a Warning or Caution and alerts you to a possible injury or explains
special measures for the safe and effective use of the device
Caution, consult accompanying documents

English 11
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.

Español 1
ESPAÑOL
Mascarilla nasal
Le agradecemos que haya elegido AirFit N20. Este documento
proporciona al usuario instrucciones para las mascarillas AirFit N20 y AirFit
N20 for Her, denominadas conjuntamente AirFit N20 en este manual.
Uso de este manual
Lea por completo el manual antes de usar el producto. Al seguir las
instrucciones, consulte las imágenes que figuran al principio del manual.
Uso indicado
La AirFit N20 dirige el flujo de aire de forma no invasiva al paciente a partir
de un dispositivo de presión positiva en las vías respiratorias (PAP), por
ejemplo, un dispositivo de presión positiva continua en las vías
respiratorias (CPAP) o un dispositivo binivel.
La AirFit N20:
•está indicada para pacientes que pesen más de 30 kg a los que se les
ha prescrito presión positiva en las vías respiratorias.
•está indicada para el uso en repetidas ocasiones por un único paciente
en su domicilio o el uso en repetidas ocasiones por varios pacientes
en hospitales o instituciones.
ADVERTENCIA
Se utilizan imanes en las correas inferiores del arnés y en el armazón
de la AirFit N20. Asegúrese de mantener el arnés y el armazón como
mínimo a 50 mm de distancia de cualquier implante médico activo
(p. ej. marcapasos o desfibrilador) para evitar los posibles efectos de
los campos magnéticos localizados. La fuerza del campo magnético
es inferior a 400 mT.

2
Contraindicaciones
El uso de mascarillas con piezas magnéticas está contraindicado en
pacientes con las siguientes afecciones preexistentes:
•un clip hemostático metálico implantado en la cabeza con el fin de
tratar un aneurisma
•fragmentos metálicos en un ojo o en ambos tras haber sufrido una
lesión por penetración ocular.
ADVERTENCIAS GENERALES
•Los orificios de ventilación deben mantenerse despejados.
•La mascarilla solo se debe utilizar con los dispositivos CPAP o
binivel que recomiende un médico o un terapeuta respiratorio.
•La mascarilla no debe usarse si el dispositivo no está encendido.
Una vez puesta la mascarilla, asegúrese de que el dispositivo esté
emitiendo aire. Explicación: los dispositivos CPAP y binivel están
indicados para ser usados con mascarillas (o conectores)
especiales cuyos orificios de ventilación permiten un flujo
continuo de aire hacia fuera de la mascarilla. Mientras el
dispositivo esté encendido y funcionando correctamente, el aire
fresco del dispositivo desplaza el aire espirado hacia fuera a
través de los orificios de ventilación de la mascarilla. No obstante,
cuando el equipo no está funcionando, no se suministrará
suficiente aire fresco a través de la mascarilla y es posible que se
vuelva a respirar aire espirado. El volver a respirar el aire espirado
durante más de unos minutos puede provocar en algunas
circunstancias asfixia. Esto es válido para la mayoría de los
modelos de dispositivos CPAP o binivel.
•Si se utiliza oxígeno suplementario, tome todas las precauciones
necesarias.
•Cuando el dispositivo CPAP o binivel no esté funcionando, el flujo
de oxígeno debe desconectarse para que el oxígeno no utilizado
no se acumule dentro del dispositivo, lo que constituiría un riesgo
de incendio.
•El oxígeno favorece la combustión. Por lo tanto, no debe utilizarse
mientras se está fumando o en presencia de una llama expuesta.
Utilice oxígeno únicamente en salas bien ventiladas.

Español 3
•A un caudal fijo de oxígeno suplementario, la concentración de
oxígeno inhalado variará según la presión que se haya
configurado, el ritmo respiratorio del paciente, la mascarilla, el
punto de aplicación y el caudal de fuga. Esta advertencia se aplica
a la mayoría de los tipos de equipo CPAP o binivel.
•Se proporcionan las especificaciones técnicas de la mascarilla
para que su médico compruebe que son compatibles con las del
dispositivo CPAP o binivel. Si no se siguen las especificaciones, o
si la mascarilla se utiliza con dispositivos incompatibles: puede
que el sellado y la comodidad de la mascarilla no sean eficaces;
puede que no se logre el tratamiento deseado; y puede que haya
fugas o variaciones en el caudal de fuga que afecten el
funcionamiento del dispositivo CPAP o binivel.
•Deje de usar la mascarilla si presenta CUALQUIER reacción
adversa que se derive del uso de la mascarilla, y consulte a su
médico o a su terapeuta del sueño.
•El uso de una mascarilla puede causar dolores en los dientes, las
encías o la mandíbula, o agravar una afección dental ya existente.
Si experimenta síntomas, consulte al médico o al dentista.
•Como ocurre con todas las mascarillas, a bajas presiones de
CPAP puede darse cierto grado de reinspiración.
•Consulte el manual de su dispositivo CPAP o binivel para más
información sobre los parámetros de configuración y el
funcionamiento.
•Retire todos los materiales de embalaje antes de usar la
mascarilla.
•La mascarilla debe utilizarse bajo supervisión cualificada en el
caso de los usuarios que no puedan quitarse la mascarilla por sí
mismos.
•No se debe utilizar la mascarilla en pacientes con reflejos
laríngeos reducidos u otras afecciones que lo predispongan a la
aspiración en caso de regurgitar o vomitar.
•Evite la conexión directa de productos de PVC flexible (p. ej.,
tubos de PVC) con cualquier pieza de la mascarilla. El PVC flexible
contiene elementos que pueden estropear los materiales de la
mascarilla, y pueden hacer que las piezas se agrieten o rompan.
•La mascarilla está dotada de una función de seguridad
consistente en un puerto de salida del aire que permite que la
respiración sea normal. No se debe utilizar la mascarilla si falta
dicho puerto o si está dañado.