ResMed AirFit F40 Full Face Mask User Guide

ResMed AirFit F40 Full Face Mask

Specifications

• Product: AirFit F40 Full Face Mask
• Intended Use: Non-invasive CPAP or bi-level PAP therapy for patients weighing more than 66 lb (30 kg)
• Components: Elbow, short tube, frame, cushion, headgear
• Additional Features: Anti-asphyxia valve, magnetic clips, vent rings

Intended Use
The AirFit F40 mask is designed for patients who have been prescribed non- invasive CPAP or bi-level positive airway pressure therapy and weigh more than 66 lb (30 kg).

Fitting Your Mask

1. Remove all packaging before using the mask.
2. Twist and pull magnetic clips away from the frame magnets.
3. Place the cushion under your nose and adjust for a comfortable fit.
4. Pull the headgear over your head ensuring proper positioning.
5. Attach the magnetic clips to the frame.
6. Adjust headgear straps as needed for a secure fit.

Mask Setting Options
Ensure that “Pillows” is selected in the mask setting options of your ResMed device. Refer to the Mask/Device Compatibility List on ResMed.com for compatible devices.

Adjusting Your Mask
If necessary, adjust the mask by undoing fastening tabs on the headgear straps and pulling evenly to readjust the fit.

Removing Your Mask

1. Twist and pull magnetic clips away from the frame magnets.
2. Pull the mask away from your face and back over your head for removal.

User guide

1. Elbow and short tube
2. QuietAir™ vent ring
3. Frame
4. Multi-hole vent ring
5. Cushion  Cushion stud
6. Headgear Magnetic clip
7. Anti-asphyxia valve (AAV)
8. Lower headgear strapSide button
9. Upper headgear strap
10. Top headgear strap
11. Frame magnet

Intended use

The AirFit F40 mask has two product variants:

• The AirFit F40 variant is intended for single-patient reuse in the home environment.
• The AirFit F40 SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.

This mask is intended for patients weighing more than 66 lb (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients.

Contraindications
Masks with magnetic components are contraindicated for use by patients where they, or anyone in close physical contact while using the mask, have the following:

• Active medical implants that interact with magnets (ie, pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, insulin/infusion pumps)
• Metallic implants/objects containing ferromagnetic material (ie, aneurysm clips/flow disruption devices, embolic coils, stents, valves, electrodes, implants to restore hearing or balance with implanted magnets, ocular implants, metallic splinters in the eye).

WARNING
Keep the mask magnets at a safe distance of at least 6″ (150 mm) away from implants or medical devices that may be adversely affected by magnetic interference. This warning applies to you or anyone in close physical contact with your mask. The magnets are in the frame and lower headgear clips, with a magnetic field strength of up to 400 mT. When worn, they connect to secure the mask but may inadvertently detach while asleep.

Implants/medical devices, including those listed within contraindications, may be adversely affected if they change function under external magnetic fields or contain ferromagnetic materials that attract/repel to magnetic fields (some metallic implants, eg, contact lenses with metal, dental implants, metallic cranial plates, screws, burr hole covers, and bone substitute devices). Consult your physician and manufacturer of your implant/other medical device for information on the potential adverse effects of magnetic fields.

WARNING

• The mask contains safety features, the exhaust vent holes and anti-asphyxia valve, to enable normal breathing and exhaust exhaled breath. Occlusion of the exhaust vent holes or anti-asphyxia valve needs to be prevented to avoid having an adverse effect on the safety and quality of the therapy. Regularly inspect the vent holes and anti-asphyxia valve to ensure they are kept clean, clear of blockages and are not damaged.
• Only use compatible CPAP or bi-level therapy devices or accessories. The technical specifications of the mask are provided for healthcare professionals to identify compatible devices. Use in combination with incompatible medical devices can decrease the safety or alter the performance of the mask.
• 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.
• The mask must be used under qualified supervision for patients who are unable to remove the mask by themselves. The mask may not be suitable for those prone to aspiration.
• Discontinue using or replace this mask if the patient has ANY adverse reaction to the use of the mask. Consult your physician or sleep therapist.
• 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.
• If there is any visible deterioration of a mask component (cracking, crazing, tears etc.) the component should be discarded and replaced.
• The mask is Magnetic Resonance (MR) unsafe and must be kept outside of MRI scanner rooms.
• Always follow cleaning instructions and only use a mild liquid detergent. Some cleaning products may damage the mask, its parts and their function, or leave harmful residual vapours. Do not use a dishwasher or washing machine to clean the mask. Ozone or UV light products have not been validated for use with the mask and may lead to discoloration or damage.
• The mask is not intended to be used simultaneously with nebulizer medications that are in the air path of the mask/tube.

CAUTION

• When fitting the mask, do not overtighten the headgear as this may lead to skin redness or sores around the mask cushion.
• 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 mask should not be used unless the device is turned on. Once the mask is fitted, ensure the device is blowing air to reduce risk of rebreathing exhaled air.
• As with all masks, some rebreathing may occur at low pressures.
• Do not iron the headgear as the material is heat sensitive and will be damaged.

Fitting your mask

Remove all packaging before using the mask.

1. Twist and pull both magnetic clips away from the frame magnets.
2. Place the cushion under your nose and ensure it sits comfortably against your face. With the ResMed logo on the headgear facing out, pull the headgear over your head. The top headgear strap should sit on top of your head and not too far forward or back.
3. Bring the lower headgear straps under your ears and attach the magnetic clips to the frame.
4.  If the mask needs adjusting, undo the fastening tabs on the upper headgear straps and pull evenly. Repeat with the lower headgear straps.

Mask setting options

Ensure that Pillows is selected in the mask setting options of your ResMed device. For a full list of compatible devices for this mask, see the Mask/Device Compatibility List at ResMed.com/downloads/masks

Adjusting your mask

• With the device turned on and blowing air, adjust the position of the cushion for the most comfortable fit under your nose. Ensure that the cushion is not creased and the headgear is not twisted.
• The top headgear strap should sit on top of your head and not too far forward or back. Reposition the strap if needed to ensure the cushion has a good seal under the nose.
• To fix any leaks around the nose, pull the cushion slightly away from the face and reposition the cushion so that it sits comfortably under the nose. Adjust the upper headgear straps, if required.
• To fix any leaks around the mouth, adjust lower headgear straps. Adjust only enough for a comfortable seal and do not overtighten.
  If you continue to have leaks around the face, you may have the wrong mask size. Talk to your clinician to have your mask size checked. Note that sizing across different masks is not always the same.

Scan this QR code with your mobile device or visit ResMed.com/downloads/masks for helpful documents and support videos for your mask.

Removing your mask

1. Twist and pull both magnetic clips away from the frame magnets.
2. Pull the mask away from your face and back over your head.

Disassembling your mask for cleaning
If your mask is connected to a device, disconnect the device air tubing from the short tube.

1. Undo the fastening tabs on the upper headgear straps and pull from the frame.
   Tip: Keep the magnetic clips attached to the lower headgear straps to easily distinguish the upper and lower straps when reassembling.

2. Squeeze the side buttons on the elbow and detach from the vent ring.

3. Pull the cushion stud out of the frame stud hole, repeat on the other side.

4. Pull the vent ring from the cushion.

Cleaning your mask
If there is any visible deterioration of a mask component (cracking, crazing, tears etc.) the component should be discarded and replaced. Daily/After each use: Cushion, elbow and short tube, vent ring Weekly: Headgear, frame

1. Soak the components in warm water with a mild liquid detergent. Ensure that there are no air bubbles while soaking.
2. Shake the components vigorously in the water and hand wash with a soft bristle brush. Pay particular attention to the vent holes in the QuietAir/Multi-hole vent ring.
3. Thoroughly rinse the components under running water.
4. Squeeze the fabric components to remove excess water.
5. Leave the components to air dry out of direct sunlight.

If the mask components are not visibly clean, repeat the cleaning steps. Make sure that the vents and anti-asphyxia valves are clean and clear.

Reassembling your mask

1. Insert the cushion stud into the frame stud hole. Repeat on the other side.
2. Align the vent ring groove against the cushion opening. Press firmly to secure in place and ensure that the cushion opening sits into the vent ring groove.
3. Connect the elbow to the vent ring.
4. With dark grey fabric side facing inwards, insert both upper headgear straps into the frame from the inside and fold the fastening tabs over to secure.

Reprocessing the mask between patients
Only Sleep Lab Mask variants of the mask system are intended for multi-patient re-use. This variant is identified by the “SLM” acronym on the packaging label and a Unique Device Identifier labeling on the mask.
When using between patients, these masks must be reprocessed according to instructions available on ResMed.com/downloads/masks

Technical specifications

Mask setting options: For AirSense™, AirCurve™, and S9™ devices, select ‘Pillows’. Compatible devices: For a full list of compatible devices for this mask, see the
Mask/Device Compatibility List at ResMed.com/downloads/masks
SmartStart may not operate effectively when using this mask with some CPAP or bi-level devices.

Pressure-flow curve

• Therapy pressure: 4 to 30 cmH2O
• Resistance with Anti-Asphyxia Valve closed to atmosphere Drop in pressure measured (nominal)
• at 50 L/min: 0.4 cmH2O
• at 100 L/min: 1.7 cmH2O

Resistance with Anti-Asphyxia Valve open to atmosphere Inspiration at 50 L/min: 1.1 cmH2O

• Expiration at 50 L/min: 1.1 cmH2O

Anti-Asphyxia Valve pressure

• open-to-atmosphere (activation): <4 cmH2O
• closed-to-atmosphere (deactivation): <4 cmH2O

Sound: Declared dual-number noise emission values in accordance with ISO4871:1996 and ISO3744:2010. A-weighted sound power level with uncertainty of 3dBA and A-weighted pressure level at a distance of 1 m with uncertainty of 3 dBA are shown: Sound power level (with QuietAir vent ring): 20 dBA

• Pressure level (with QuietAir vent ring): 13 dBA
• Sound power level (with Multi-hole vent ring): 34 dBA
• Pressure level (with Multi-hole vent ring): 26 dBA

Environmental conditions

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

International Commission on Non-Ionizing Radiation Protection (ICNIRP) Magnets used in this mask are within ICNIRP guidelines for general public use. The static magnetic field strength is less than 400 mT at component surface and less than 0.5 mT at 2” (50 mm) distance.
Service life: The service life of the 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 instructions in the ‘Cleaning your mask’ section of this guide.

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 and packaging do 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:

Limited warranty

ResMed Pty Ltd (hereafter ’ResMed’) warrants that your ResMed mask system (including mask frame, cushion, headgear and elbow) 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. During the warranty period, 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 shall 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 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.
Visit ResMed.com for the latest information on ResMed’s Limited Warranty.

ResMed Pty Ltd
1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia

See ResMed.com for other ResMed locations worldwide. AirFit, AirCurve, AirSense, QuietAir and S9 are trademarks and/or registered trademarks of the ResMed family of companies. For patent and other intellectual property information, see ResMed.com/ip. © 2023 ResMed. 638415/1 2023-10

References

• Sleep apnea and COPD - learn about symptoms and treatment | ResMed
• ResMed.com/downloads/masks
• Legal disclaimers and intellectual property - ResMed
• ResMed.com/symbols
• ResMed.com/downloads/masks

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