ResMed AirFit F20 & AirTouch F20 CPAP Full Face Mask User Guide – Footit Medical, CPAP, & Stairlift Service
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ResMed AirFit F20 & AirTouch F20 CPAP Full Face Mask User Guide

Posted by Richard Spafford on

 

ResMed Airfit F20 & AirTouch F20 User Guide

ENGLISH

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:

  • AirFitTM F20/AirFitTM F20 for Her

  • AirTouchTM F20/AirTouchTM F20 for Her

    These masks are referred to collectively as F20 throughout this manual. These masks may not be available in all countries.

    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 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.

      AirTouch F20 cushion

      The cushion is intended for single-patient reuse in both home and hospital/institutional environments and recommended to be replaced monthly.

English 1

WARNING

Magnets are used in the lower headgear straps and the frame of the F20. Ensure the headgear and frame is kept at least 2" (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.

    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

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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.

  • 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.

English 3

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.

Fitting

  1. Twistandpullbothmagneticclipsawayfromtheframe.

  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 (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.

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.

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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.

  •   Adjust only enough for a comfortable seal. Do not overtighten as this may cause discomfort.

    Adjustment (AirTouch F20)

    If necessary, slightly adjust the position of the mask for the most comfortable fit. Ensure that 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 enough for a comfortable seal. Removal

    1. Twistandpullbothmagneticclipsawayfromtheframe.

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.

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2. WiththeResMedlogoontheheadgearfacingoutsideandupright, thread the upper headgear straps into the frame slots from the inside. Fold them over to secure.

Cleaning your mask at home (AirFit F20)

Handwash your mask and headgear by gently rubbing in warm (approximately 86°F/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.

    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. Disassemblethemaskaccordingtothedisassemblyinstructions.

  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.

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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 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.

Cleaning your mask at home (AirTouch F20)

Handwash the elbow, frame and headgear (not the cushion) by gently rubbing in warm (approximately 86°F/30°C) water using mild liquid detergent. Rinse them well under running water and allow to air dry out of direct sunlight.

If required, it is recommended to wipe the cushion using CPAP wipes or equivalent and allow to dry. It is recommended to replace your cushion every month.

WARNING

  • As part of good hygiene, always follow cleaning instructions (using mild liquid detergent for recommended components and if required, wiping the cushion with CPAP wipes or equivalent). 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.

  • 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, discoloration, 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. English 7

Daily/After each use:

  1. Disassemblethemaskaccordingtothedisassemblyinstructions.

  2. Ifrequired,wipeyourcushionwithaCPAPwipeorequivalentand

    then allow to dry. Important – do not get cushion wet.

  3. Rinse the frame and elbow under running water. Clean with a soft

    brush until dirt is removed.

  4. Soak the components in warm water with a mild liquid detergent for

    up to ten minutes.

  5. Shake the components in the water.

  6. Brush the moving parts 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 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.

Monthly:

Replace the cushion by following relevant steps of the disassembly / reassembly instructions.

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.

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Troubleshooting (AirFit F20)

Problem/possible cause Mask is uncomfortable. Headgear straps are too tight.

Mask could be the wrong size.

Mask is too noisy.

Elbow incorrectly installed or incorrect assembly of the mask system.

Vent is dirty.

Mask leaks around the face.

Cushion membrane is creased. Mask is incorrectly positioned or adjusted.

Mask could be the wrong size.

Solution

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.

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.

Remove the elbow from your mask, then reassemble according to the instructions. Check that the mask is correctly assembled according to the instructions.

Use a soft bristle brush to clean the vent.

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.

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 9

Troubleshooting (AirTouch F20)

Problem/possible cause Mask is uncomfortable. Headgear straps are too tight.

Mask could be the wrong size.

Mask is too noisy.

Elbow incorrectly installed.

Vent is dirty.

Mask leaks around the face.

Headgear straps are too loose. Cushioned is not positioned correctly.

Cushion is nearing the end of its life.

Mask could be the wrong size.

Solution

Adjust straps evenly. Ensure that the headgear straps are not too tight.

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.

Remove the elbow from your mask, then reassemble according to the instructions.

Use a soft bristle brush to clean the vent.

Tighten the straps evenly until you have a comfortable seal.

Repostion mask on your face. If leak continues, turn off device, resettle your cushion and then turn device back on.

The cushion is designed to be replaced on a monthly basis. Cushion performance may deteriorate as it nears the end of its life.

Adjust your headgear and if the problem persists, replace the cushion.

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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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 Flow (cm H2O) (L/min)

3 19 10 37 16 48 24 60 30 69 40 82

AirTouch F20

281 mL (Large)

3to40cmH2O

0.2 cm H2O 0.6 cm H2O

Dead space: Empty volume of the mask to the end of the swivel. The mask deadspace varies according to cushion size.
Therapy pressure

Resistance with Anti Asphyxia Valve (AAV) closed to atmosphere: Drop in pressure measured (nominal)
at 50 L/min

at 100 L/min

Resistance with Anti Asphyxia Valve (AAV) open to atmosphere

AirFit F20

240 mL (Large) 3to40cmH2O

0.2 cm H2O 0.6 cm H2O

Inspiration at 50 L/min:
Expiration at 50 L/min:
Anti Asphyxia Valve (AAV)
open-to-atmosphere pressure
Anti Asphyxia Valve (AAV)
closed-to-atmosphere pressure
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 30 dBA 30 dBA
Pressure level 23 dBA 23 dBA

0.6 cm H2O 0.7 cm H2O ≤3 cm H2O

0.6 cm H2O 0.7 cm H2O

≤3 cm H2O

≤3 cm H2O

≤3 cm H2O

English 11

Environmental conditions

Gross dimensions

International Commission on Non-Ionizing Radiation Protection (ICNIRP) Service life

Operating temperature: 41°F to 104°F (5°C to 40°C)
Operating humidity: 15% to 95% non-condensing
Storage and transport temperature: -4°F to 140°F (-20°C to +60°C) Storage and transport humidity: up to 95% non-condensing

Mask fully assembled with elbow assembly (no headgear)
6.1" (H) x 6.3" (W) x 5.8" (D) (154mm(H)x159mm(W)x147mm(D))
Magnets used in this mask are within ICNIRP guidelines for general public use.

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.

For AirSense, AirCurve or S9: Select 'Full Face'.
For other devices: Select 'MIR FULL' (if available), otherwise select 'FULL FACE' as the mask option.

Mask setting options

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.

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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.

Disposal

This mask does not contain any hazardous substances and may be disposed of with your normal household refuse.

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

Batch code

Temperature limitation

Not made with natural rubber latex

European Authorized Representative

This way up

Device setting - Full Face Size - medium

English 13

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

Prescription only (In the US, Federal law restricts these devices to sale by or on the order of a physician)

Limited warranty

ResMed Ltd (ResMed) warrants that your ResMed mask system (including mask frame, cushion, headgear and tubing) will be free from defects in material and workmanship from the date of purchase for 90 days, or in the case of disposable masks and disposable mask components for 7 days. This warranty is only available to the initial consumer. It is not transferable. If the product fails under conditions of normal use, ResMed will repair or replace, at its option, the defective product or any of its components. This limited warranty does not cover: a) any damage caused as a result of improper use, abuse, modification or alteration of the product; b) repairs carried out by any service organization that has not been expressly authorized by ResMed to perform such repairs; and c) any damage or contamination due to cigarette, pipe, cigar or other smoke. Warranty is void on product sold, or resold, outside the region of original purchase.

Warranty claims on defective product must be made by the initial consumer at the point of purchase.

This warranty replaces all other expressed or implied warranties, including any implied warranty of merchantability or fitness for a particular purpose. Some regions or states do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you.

ResMed will not be responsible for any incidental or consequential damages claimed to have resulted from the sale, installation or use of any ResMed product. Some regions or states do not allow the exclusion or

14

limitation of incidental or consequential damages, so the above limitation may not apply to you. This warranty gives you specific legal rights, and you may also have other rights which vary from region to region. For further information on your warranty rights, contact your local ResMed dealer or ResMed office.

English 15

Mask components / Composants du masque / Piezas de la mascarilla / Componentes da máscara

A Elbow / Coude / Codo / Cotovelo

  1. 1  Valve (AAV) / Valve (VAA) / Válvula (AAV) / Válvula (VAA)

  2. 2  Vent / Ori ce de ventilation / Ventilación / Respiradouro

  3. 3  Side buttons / Boutons latéraux / Botones laterales / Botões laterais

  4. 4  Swivel / Pièce pivotante / Pieza giratoria / Peça giratória

  1. B  Frame / Entourage rigide / Armazón / Armação

  2. C  AirFit F20 – Cushion / Bulle / Almohadilla / Almofada

    AirTouch F20 – Cushion / Bulle / Almohadilla / Almofada

  3. D  Headgear / Harnais / Arnés / Arnês

  1. 5  Magnetic clips / Clips magnétiques / Broches magnéticos / Presilhas magnéticas

  2. 6  Lower headgear straps
    Sangles inférieures du harnais / Correas inferiores del arnés / Correias inferiores do arnês

AirFit F20 / AirTouch F20

AirFit F20
for Her / AirTouch F20 for Her

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

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

63028 (S) 63029 (M) 63030 (L)

63028 (S) 63029 (M) 63030 (L)

63470 (S) 63471 (M) 63472 (L)

63473 (Std)

AirFit F20 / AirTouch F20

AirFit F20
for Her / AirTouch F20 for Her

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

63463 (S) 63464 (M)

63021 (S) 63022 (M) 63023 (L)

63024 (S) 63025 (M)

63400 (S) 63401 (M) 63402 (L)

63403 (S) 63404 (M)

63000 (S) 63001 (M) 63002 (L)

63003 (S) 63004 (M)

7 Upper headgear straps / Sangles supérieures du harnais / Correas superiores del arnés / Correias superiores do arnês

A+B+C

AirFit F20 – Frame system / Entourage complet / Sistema de armazón / Sistema de armação

AirTouch F20 – Frame system / Entourage complet / Sistema de armazón / Sistema de armação

A+B+C+D

AirFit F20 – Complete system / Masque complet / Sistema

completo / Sistema completo

AirTouch F20 – Complete system / Masque complet / Sistema completo / Sistema completo

S: Small / Small / Pequeña / Pequeno
M: Medium / Medium / Mediana / Médio
L: Large / Large / Grande / Grande
Std: Standard / Standard / Estándar / Padrão

D

ABC

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2

3
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ResMed Ltd

1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia

Distributed by

ResMed Corp 9001 Spectrum Center Boulevard San Diego
CA 92123 USA ResMed (UK) Ltd 96 Jubilee Ave Milton Park Abingdon Oxfordshire OX14 4RW UK

See ResMed.com for other ResMed locations worldwide. AirFit, AirTouch, AirSense and AirCurve are trademarks and/or registered trademarks of the ResMed family of companies. For patent and other intellectual property information, see ResMed.com/ip. © 2016 ResMed Ltd. 638091/1 2016-11

ResMed.com

638091


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