ResMed AirFit F20, AirTouch F20 Manual

Intended use

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.

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 multipatient 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.

QuietAir

The QuietAir elbow is intended for single-patient reuse in both home and hospital/institutional environments.

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.

Clinical benefits

The clinical benefit of vented masks is the provision of effective therapy delivery from a therapy device to the patient.

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.

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.
• 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.

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.

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

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

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.
• 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.

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. 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

AirFit F20

It is important to follow the steps below to get the best performance out of your mask.

• 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.

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.

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.

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.

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.

• 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.

• 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.

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.

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.

Cleaning the vent

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

AirFit F20

AirTouch F20

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.

	AirFit F20	AirTouch F20
Dead space: Empty volume of the mask to the end of the swivel. The mask dead space varies according to cushion size.	240 mL (Large)	281 mL (Large)
Therapy pressure	3 to 40 cm H 2 O	3 to 40 cm H
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
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	For AirSense, AirCurve or S9: Select 'Full Face'. options For other devices: Select 'MIR FULL' (if available), otherwise select 'FULL FACE' as the mask option.

Note: 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.

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
ize - 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
Clean with alcohol-free wipes only	Do not use alcohol wipes
Keep dry and away from liquids	Do not submerge in liquids

See symbols glossary at ResMed.com/symbols.