Resmed Airfit N20 User Manual

Nasal mask

User guide

English

Fitting / Anlegen / Ajustement / Applicazione / Opzetten /

ءاﺪﺗرﻻا

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3 4

5 6

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i

AdjustmentAdjustment / Anpassen / Ajustement / Regolazione /
Afstellen / ﻂﺒﻀﻟا

Removal / Abnehmen / Retrait / Rimozione / Afnemen /
عﺰﻨﻟا

1 2

ii

Disassembly / Auseinanderbau / Démontage /
Smontaggio / Demonteren / ﻚﯿﻜﻔﺘﻟا

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Reassembly / Zusammenbau / Remontage /
Riassemblaggio / Opnieuw monteren / ﻊﯿﻤﺠﺘﻟا ةدﺎﻋإ

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M

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ENGLISH

Nasal Mask

Thank you for choosing the AirFit N20 Classic. This document provides
the user instructions for the AirFit N20 Classic.

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 Classic 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 Classic 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.

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

English 1

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.

• 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. The mask may not
be suitable for those predisposed to aspiration.

• 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 nebuliser medications that are in the air path
of the mask/tube.

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• 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. With both lower headgear straps released, hold the mask against your
face and pull the headgear over your head.

2. Bringing the lower straps below your ears, loop the headgear into the
lower hooks on the mask frame.

3. Undo the Velcro

®

tabs on the upper headgear straps. Adjust the straps
evenly until the mask sits comfortably just over the nose. Reattach the
Velcro tabs.

4. Undo the Velcro tabs on the lower headgear straps. Adjust the straps
evenly until the mask is stable. Reattach the Velcro tabs.

5. 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.

6. 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.

English 3

 Ensure the headgear straps are not overtightened or too loose.

Removal

1. Unloop the lower headgear straps from the lower hooks of the frame.

2. With both lower straps released, pull the headgear back over your
head.

Disassembly

If the mask is connected to your device, disconnect the device air tubing
from the elbow.

1. Pull the straps out of the frame.

2. Remove the elbow from the mask by pressing the side button and
pulling the elbow away.

3. Pull the cushion away from the frame.

Reassembly

1. Push the cushion into the frame.
Note: Ensure the cushion mask size indicator is facing downwards.

2. Attach the top headgear straps to the mask frame by looping onto
each of the upper headgear hooks.

3. Attach the elbow by pressing the side buttons and pushing into the
mask.

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.

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CAUTION

Problem/possible cause

Solution

Mask is too noisy.

If any visible deterioration of a system component is apparent
(cracking, crazing, tears etc), the component should be discarded and
replaced.

Daily/After each use:

Before cleaning, take the mask components apart according to the
disassembly instructions.

1. Soak and agitate the cushion and elbow 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. 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:

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. Rinse the components under warm flowing drinking quality water until
they are free of detergent residue.

3. Squeeze the headgear 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

Vent is dirty. Clean the vent according to the instructions.

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Problem/possible cause

Solution

Mask is incorrectly assembled. Disassemble the mask, then reassemble

Mask leaks around face.

keep the mask in the right place.

Check that the headgear is not twisted.

Mask does not fit properly.

according to the instructions.

Mask may be the wrong size.

Talk to your clinician.

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 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

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.

Mask may be the wrong size. Talk to your clinician.

Mask is not positioned correctly. Check that the mask size indicator on the

bottom of the cushion is facing downward.

Mask is incorrectly assembled.

Disassemble the mask, then reassemble

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Technical specifications

Pressure-flow

The mask contains passive venting to protect against rebreathing.

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 55.8 mL.

Therapy
pressure

Resistance

Drop in pressure measured (nominal)

at 100 L/min: 1.5 cm H2O

Environmental

Operating temperature: 5°C to 40°C

Storage and transport humidity: up to 95% non-condensing

Sound

DECLARED DUAL-NUMBER NOISE EMISSION VALUES in accordance

3 dBA.

Gross
dimensions

141 mm (H) x 73 mm (W) x 90 mm (D)

curve

conditions

As a result of manufacturing variations, the vent flow rate may vary.

4 to 30 cm H2O

at 50 L/min: 0.4 cm H2O

Operating humidity: 15% to 95% non-condensing
Storage and transport temperature: -20°C to +60°C

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

Mask fully assembled with elbow assembly (no headgear)

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Service life

The service life of the AirFit N20 Classic 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

parts.

Mask setting

For AirSense, AirCurve and S9: Select 'Pillows'.

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

options

For other devices: Select 'SWIFT' (if available), otherwise select
'MIRAGE' as the mask option.

Notes:

• This product is not made with PVC or phthalates such as 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.

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Symbols

The following symbols may appear on your product or packaging:

Catalogue number

Humidity limitation

Fragile, handle with care

Manufacturer

Keep away from rain

Classic nasal mask

Size - small

Size - large

Batch code

Temperature limitation

Not made with natural rubber
latex

European Authorised
Representative

This way up

Device setting - Pillows

Size - medium

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 9

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.

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Mask Components / Maskenkomponenten /
Composants du masque / Componenti della maschera /
Maskeronderdelen / عﺎﻨﻘﻟا تﺎﻧﻮﻜﻣ

AirFit N20
Classic

A

Elbow / Kniestück / Coude / Gomito / Bocht /

1 Vent / Luftauslassöffnung / Orifice de ventilation / Foro

per l'esalazione / Ventilatieopening /

2 Side buttons / Seitlich angebrachte Laschen / Boutons

latéraux / Pulsanti laterali / Zijknoppen / نﺎﯿﺒﻧﺎﺟ نارز

3 Swivel / Drehadapter / Pièce pivotante / Giunto

rotante / Draaibare kop / ةراود ﺔﻠﺻو

B Frame / Maskenrahmen / Entourage rigide /

Telaio / Frame / رﺎطإ

C Cushion / Maskenkissen / Bulle / Cuscinetto /

Kussentje /

D Headgear / Kopfband / Harnais / Copricapo /

Hoofdband /

4 Lower headgear straps / Untere Kopfbänder / Sangles

inférieures du harnais / Cinghie inferiori del
copricapo / Onderste banden van de hoofdband /

ةدﺎﺳو

سأر ءﺎﻄﻏ

ﺔﯾﻮﮭﺗ بﻮﻘﺛ

ﻖﻓﺮﻣ

63765

63766

63550 (S)
63551 (M)
63552 (L)

63760 (S)
63761 (Std)

نﺎﯿﻠﻔﺴﻟا سأﺮﻟا ءﺎﻄﻏ ﺎﻄﯾﺮﺷ

5 Upper headgear straps / Obere Kopfbänder / Sangles

supérieures du harnais / Cinghie superiori del
copricapo / Bovenste banden van de hoofdband /

نﺎﯾﻮﻠﻌﻟا سأﺮﻟا ءﺎﻄﻏ ﺎﻄﯾﺮﺷ

A+B+C+D

Complete system / Komplettes System / Système
complet / Sistema completo / Volledig systeem /

ﻞﻣﺎﻜﻟا مﺎﻈﻨﻟا

63710 (S)
63711 (M)
63712 (L)

S: Small / Small / Small / Piccolo / Small / ﺮﯿﻐﺻ
M: Medium / Medium / Medium / Medio / Medium / ﻂﺳو
L: Large / Large / Large / Grande / Large / ﺮﯿﺒﻛ
Std: Standard / Standard / Standard / Standard / Standaard / ﻲﺳﺎﯿﻗ

638123

BA C

D

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