ResMed AirFit F20 User manual

User guide
Full face mask
User guide
English | Deutsch
Français | Italiano
Nederlands | ﺔﯿﺑﺮﻌﻟا
QuietAir

i
Fitting / Anlegen / Ajustement / Applicazione /
Opzetten / ءاﺪﺗرﻻا
12
3 4
5
76

ii
Removal / Abnehmen / Retrait / Rimozione / Afnemen /
عﺰﻨﻟا
Adjustment / Anpassen / Ajustement / Regolazione /
Afstellen / ﻂﺒﻀﻟا
1 2

iii
Disassembly / Auseinanderbau / Démontage /
Smontaggio / Demonteren / ﻚﯿﻜﻔﺘﻟا
1 2
3

iv
Reassembly / Zusammenbau / Remontage /
Riassemblaggio / Opnieuw monteren / ﻊﯿﻤﺠﺘﻟا ةدﺎﻋإ
1 2

v
Cleaning the vent / Luftauslassöffnung reinigen /
Nettoyage de l’orifice de ventilation / Pulizia del foro
per l’esalazione / De ventilatieopening schoonmaken /
ةيوھتلا بوقث فيظنت
~ 86°F / 30°C

English 1
ENGLISH
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Full face mask
Thank you for choosing the AirFit™ F20/AirTouch™ F20. These masks are
identical—except for the interchangeable AirFit F20 silicone cushion and
AirTouch F20 foam cushion. This offers two choices for your mask,
depending on your preferred comfort, stability and seal.
This document provides the user instructions for:
 AirFit™ F20/AirFit™ F20 for Her
 AirTouch™ F20/AirTouch™ F20 for Her
These masks are referred to collectively as F20 throughout this manual.
These masks may not be available in all countries.
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Using this guide
Please read the entire guide before use. When following instructions,
refer to the images at the front of the guide.
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Intended use
The F20 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 F20 is:
 to be used by patients weighing more than 66 lb (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.
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AirTouch F20 cushion
The cushion is intended for single-patient reuse in both home and
hospital/institutional environments and recommended to be replaced
monthly.
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2
QuietAir
The QuietAir elbow is intended for single-patient reuse in both home and
hospital/institutional environments.
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WARNING
Magnets are used in the lower headgear straps and the frame of the
F20. 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.
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Clinical benefits
The clinical benefit of vented masks is the provision of effective therapy
delivery from a therapy device to the patient.
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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).
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.

English 3
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 elbow, valve and vent assembly have specific safety
functions. 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.
 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.

4
GENERAL WARNINGS
 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 nebuliser 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.
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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.
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.

English 5
Use a standard conical connector if pressure readings and/or
supplemental oxygen are required.
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Fitting
1. Twist and pull both magnetic 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 magnetic 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.
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Adjustment (AirFit F20)
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.
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1. Turn on your device so that it is blowing air.
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Adjustment tips:
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 With air pressure applied, pull the mask away from your face to
allow the cushion to inflate and reposition onto your face.
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 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.
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 Adjust only enough for a comfortable seal. Do not overtighten as
this may cause discomfort.
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6
Adjustment (AirTouch F20)
If necessary, slightly adjust the position of the mask for the most
comfortable fit. Ensure that the headgear is not twisted.
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1. Turn on your device so that it is blowing air.
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Adjustment tips:
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 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.
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 Adjust enough for a comfortable seal.
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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.
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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 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 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.
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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.
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English 7
Cleaning your mask at home (AirFit F20)
It is important to follow the steps below to get the best performance out
of your mask.
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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
Visible criteria for product inspection: If any visible deterioration of a
system component is apparent (cracking, discolouration, tears etc.),
the component should be discarded and replaced.
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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 vigorously in the water for at least one minute.
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.
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Weekly:
1. Disassemble the mask. The magnets can remain attached to the
headgear during cleaning.
2. Handwash the headgear in warm water (approximately 30°C) with
mild liquid detergent.

8
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.
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Cleaning your mask at home (AirTouch F20)
It is important to follow the steps below to get the best performance out
of your mask. It is recommended to replace your cushion every month.
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WARNING
 As part of good hygiene, always follow cleaning instructions.
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
 Visible criteria for product inspection: If any visible deterioration
of a system component is apparent (cracking, discolouration,
tears, etc.), the component should be discarded and replaced.
 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.
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Cleaning the cushion
You do not need to clean the cushion every day. 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 rinse or submerge in liquid
 Do not expose to domestic cleaning products or cleaning devices
 Do not store or place in direct sunlight.
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English 9
Cleaning the frame and elbow
Daily:
1. Disassemble the mask components according to the disassembly
instructions.
2. Rinse the frame and elbow under running water.
3. Clean with a soft brush until dirt is removed.
4. Soak the components in warm water (approximately 30°C) with a mild
liquid detergent for up to ten minutes.
5. Shake the components vigorously in the water for at least one minute.
6. Brush the moving part of the elbow and around the vent holes.
7. Brush the areas of the frame where the arms connect, and inside and
outside the frame where the elbow connects.
8. Rinse the components under running water.
9. Leave the components to air dry out of direct sunlight. Make sure to
squeeze the arms of the frame to ensure excess water is removed.
Cleaning the headgear
Weekly:
1. Disassemble the mask. The magnets 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.
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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.
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10
Troubleshooting (AirFit F20)
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
against F20 fitting template. 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
against fitting template. Note that sizing across
different masks is not always the same.
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Troubleshooting (AirTouch F20)
Problem/possible cause Solution
Mask is uncomfortable.
Headgear straps are too tight. Adjust straps evenly. Ensure that the headgear
straps are not too tight.
Mask could be the wrong size. Talk to your clinician to have your face size checked
against F20 fitting template. Note that sizing across
different masks is not always the same.

English 11
Problem/possible cause Solution
Mask is too noisy.
Elbow incorrectly installed. Remove the elbow from your mask, then
reassemble according to the instructions.
Vent is dirty. Use a soft bristle brush to clean the vent.
Mask leaks around the face.
Headgear straps are too loose. Tighten the straps evenly until you have a
comfortable seal.
Cushioned is not positioned
correctly.
Repostion mask on your face. If leak continues, turn
off device, resettle your cushion and then turn
device back on.
Cushion is nearing the end of its
life.
Cushion performance may deteriorate as it nears
the end of its life.
Adjust your headgear and if the problem persists,
replace the cushion.
Mask could be the wrong size. Talk to your clinician to have your face size checked
against fitting template. Note that sizing across
different masks is not always the same.
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12
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
10 37
16 48
24 60
30 69
40 82
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AirFit F20 AirTouch F20
Dead space: Empty volume of the mask to the
end of the swivel. The mask deadspace varies
according to cushion size.
240 mL (Large) 281 mL (Large)
Therapy pressure 3 to 40 cm H2O 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 cm H2O 0.2 cm H2O
at 100 L/min 0.6 cm H2O 0.6 cm H2O
Resistance with Anti Asphyxia Valve (AAV)
open to atmosphere
Inspiration at 50 L/min: 0.6 cm H2O 0.6 cm H2O
Expiration at 50 L/min: 0.7 cm H2O 0.7 cm H2O
Anti Asphyxia Valve (AAV) open-to-
atmosphere pressure
≤3 cm H2O ≤3 cm H2O
Anti Asphyxia Valve (AAV) closed-to-
atmosphere pressure
≤3 cm H2O ≤3 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 (with Standard elbow) 30 dBA 30 dBA
Power level (with QuietAir elbow) 21 dBA 21 dBA
Pressure level (with Standard elbow) 22 dBA 22 dBA
Pressure level (with QuietAir elbow) 13 dBA 13 dBA

English 13
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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
Gross
dimensions
Mask fully assembled with elbow assembly (no headgear)
154 mm (H) x 159 mm (W) x 147 mm (D)
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 F20 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.
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Note: The manufacturer reserves the right to change these specifications
without notice.
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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.
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14
Disposal
This mask and packaging 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:
Importer Not made with natural rubber
latex
Full face mask Device setting - Full Face
Size - small Size - medium
Size - large Medical device
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
Do not use if package
damaged
Single patient reuse
Discard once signs of
deterioration forms Do not expose to direct sunlight
Replace once signs of
deterioration forms
Do not use domestic cleaner or
domestic cleaning devices