Resmed Airfit F20 User Manual

Full face mask

User guide

English

Fitting / 配戴 / 配戴 / Pemasangan

1

3 4

2

5

76

i

Adjustment / 调整 / 調整 / Penyesuaian

Removal /

取下面罩 / 取下面罩 / Penanggalan

1 2

ii

Disassembly /

拆卸 / 拆卸 / Menyahpasang

1 2

3

iii

Reassembly / 重新组装 / 重新組裝 / Pemasangan semula

1 2

iv

Cleaning the vent / 清洗通气孔 / 清洗通氣孔 /
Membersihkan bolong

v

ENGLISH

Full face mask

Thank you for choosing the AirFit F20. This document provides the user
instructions for the AirFit F20 and AirFit F20 for Her masks referred to
collectively as AirFit F20 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 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 AirFit F20 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.

WARNING

Magnets are used in the lower headgear straps and the frame of the
AirFit 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 localized magnetic fields.
The magnetic field strength is less than 400 mT.

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 1

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.

2

• 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.

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.

Use a standard conical connector if pressure readings and/or
supplemental oxygen are required.

English 3

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.

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.

4

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.

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.

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

Handwash your mask and headgear by gently rubbing in warm
(approximately 30°C) water using mild liquid detergent. Rinse all
components well under running water and allow to air dry out of direct
sunlight.

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.

English 5

CAUTION

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 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 magnets can remain attached to the
headgear during cleaning.

2. Handwash the headgear in warm water 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.

Reprocessing the mask between patients

Reprocess this mask when using between patients. Cleaning, disinfection
and sterilization instructions are available on
www.resmed.com/downloads/masks. If you do not have internet access,
please contact your ResMed representative.

6

Troubleshooting

Problem/possible cause

Solution

Mask is uncomfortable.

creased.

Mask is too noisy.

Mask leaks around the face.

creasing of the cushion.

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

Mask could be the wrong size. Talk to your clinician to have your face size

checked against AirFit F20 fitting template.
Note that sizing across different masks is not
always the same.

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.

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

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.

English 7

Technical specifications

Pressure-flow curve

The mask contains passive venting to protect

variations, the vent flow rate may vary.

Pressure
(cm H2O)

Flow

(L/min)

3

19 8 32

10

37

12

41

16

48

20

54

24

60

28

66

30

69

32

72

36

77

40

82

Dead space
information

Physical dead space is the empty volume of the mask to the end of

Therapy
pressure

Resistance with

atmosphere

Drop in pressure measured (nominal)

Inspiratory and

atmosphere

Inspiration at 50 L/min:

0.6 cm H2O

Expiration at 50 L/min:

0.7 cm H2O

against rebreathing. As a result of manufacturing

the swivel. Using the large cushions it is 240 mL.
3 to 40 cm H2O

Anti Asphyxia
Valve (AAV)

at 50 L/min: 0.2 cm H2O
at 100 L/min: 0.6 cm H

O

2

closed to

expiratory
resistance with
Anti Asphyxia
Valve (AAV)
open to

8

Anti Asphyxia

pressure

Anti Asphyxia

pressure

≤3 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

Mask fully assembled with elbow assembly (no headgear)
154 mm (H) x 159 mm (W) x 147 mm (D)

International

(ICNIRP)

Magnets used in this mask are within ICNIRP guidelines for general

Service life

The service life of the AirFit F20 mask system is dependent on the

of this guide for information of how to order replacement parts.

Valve (AAV)
open-to­atmosphere

Valve (AAV)
closed-to­atmosphere

≤3 cm H2O

conditions

Commission on
Non-Ionizing
Radiation
Protection

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
30 dBA, with uncertainty of 3 dBA. The A-weighted sound pressure
level of the mask at a distance of 1 m is 23 dBA, with uncertainty of

public use.

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

English 9

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.

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.

10

Symbols

The following symbols may appear on your product or packaging:

Catalog number

Humidity limitation

Fragile, handle with care

Manufacturer

Keep away from rain

Full face mask

Size - small

Size - large

Batch code

Temperature limitation

Not made with natural rubber
latex

European Authorized
Representative

This way up

Device setting - Full Face

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 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.

12

Mask Components / 面罩组件 / 面罩組件 / Komponen
topeng

AirFit F20 AirFit F20

A Elbow /

1 Valve (AAV) / 阀门(AAV) / 閥門(AAV) /

2 Vent / 通气孔 / 通氣孔 / Bolong

3 Side buttons / 侧按钮 / 側按鈕 /

4 Swivel / 万向轴 / 萬向軸 / Pemutar

B Frame / 框架 / 框架 / Bingkai 63465 63466

C Cushion / 护垫 / 護墊 / Kusyen 63467 (S)

D Headgear / 头带 / 頭帶 / Alat de

5 Magnetic clips (2 pack) / 磁性夹

6 Lower headgear straps / 下部头带 /

7 Upper headgear straps / 上部头带 /

A+B+C

弯头 / 彎頭 / Siku 63476 63476

Injap (AAV)

Butang sisi

ayun

63468 (M)
63469 (L)

kepala

(2包) / 磁性夾 (2包) / Kilp magnet (2)

下部頭帶 / Tali alat di kepala bahagian

bawah

上部頭帶 / Tali alat di kepala bahagian
atas

Frame system /
統 / Sistem bingkai

框架系统 / 框架系

63470 (S)
63471 (Std)
63472 (L)

63475 63475

63460 (S)
63461 (M)
63462 (L)

for Her

63467 (S)
63468 (M)
63469 (L)

63473

63463 (S)
63464 (M)

A+B+C+D

Complete system / 完整系统 /
完整系統 / Sistem lengkap

S: Small / 小号 / 小號 / Kecil
M: Medium / 中号 / 中號 / Sederhana
L: Large / 大号 / 大號 / Besar
Std: Standard / 标准 / 標準 / Standard

AirFit F20 AirFit F20

APAC:
63420 (S)
63421 (M)
63422 (L)

ANZ:
63430 (S)
63431 (M)
63432 (L)

CHINA:
63435 (S)
63436 (M)
63437 (L)

for Her

APAC:
63423 (S)
63424 (M)

ANZ:
63433 (S)
63434 (M)

CHINA:
63438 (S)
63439 (M)

638152

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ResMed Ltd

1 Elizab eth Macar thur Drive B ella Vista N SW 2153 Aust ralia

See Re sMed.com fo r other ResM ed locatio ns worldwid e. AirFit , AirSense an d AirCur ve are trade marks
and/o r registere d trademar ks of the Res Med family of co mpanies. F or patent an d other intell ectual pro perty
infor mation, see R esMed.co m/ip. © 2 018 ResMed Ltd . 638152 /1 2018-10

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