PesMed F20 AirFit Full Face Mask Premium Bundle User Guide

PesMed F20 AirFit Full Face Mask Premium Bundle

Thank you for choosing the AirFit™ F30i full face mask. This mask uses a cushion that seals under the nose and around the mouth, and a frame with a tube connection above the head. To breathe fresh air, this mask features vent holes in the cushion and elbow, and valves in the frame.

• A Elbow
• B Frame
• C Cushion
• D Headgear
  • Vent holes (cushion)
  • Vent holes (elbow)
  • Side button
  • Elbow ring
  • Anti-Asphyxia valve (inside the left and right of frame connector)
  • Frame connector
  • Magnetic clip
  • Lower headgear strap
  • Upper headgear strap

Intended Use

The AirFit F30i mask is intended to be used by patients weighing more than 66 lb (30 kg) who have been prescribed non-invasive positive airway pressure (PAP) therapy such as CPAP or bi-level therapy. The mask is intended for single-patient re-use in the home and multi-patient re-use in the hospital/institutional environment

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.

Before using your mask
Remove all packaging and inspect each mask component for visible deterioration.

Fitting your mask

1. Connect the air tubing from your device to the elbow.
2. Squeeze the side buttons on the elbow and pull from the frame. Put the elbow and air tubing aside for now.
3. Twist and pull both magnetic clips away from the frame connectors.
4. Place the cushion under your nose and ensure it sits comfortably against your face. With the ResMed logo on the headgear facing up, pull the headgear and frame over your head.
5. Bring the lower headgear straps under your ears and attach the magnetic clips to the frame connectors.
6. Undo the fastening tabs on the upper headgear straps and pull evenly. Repeat with the lower headgear straps.
7. Attach the elbow to the top of the frame. Your mask should now be positioned as shown.

Adjusting your mask

• With the device turned on and blowing air, adjust the position of the cushion for the most comfortable seal under your nose. Ensure that the cushion is not creased and the headgear is not twisted.
• To fix any mask leaks, adjust the upper or lower headgear straps. Adjust only enough for a comfortable seal and do not overtighten.

Sizing the mask
Use the fitting template to assist in selecting the right size cushion.
If the mask frame falls back over your head or sits too close to your ears, try a smaller frame size. If the mask falls forward on your head or sits too close to your eyes, try a bigger frame size.

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

1. Undo the fastening tabs on the upper headgear straps and pull from the frame. Keep the magnetic clips attached to the lower headgear straps.
2. Squeeze the side buttons on the elbow and detach from the frame.
3. Grip the frame connector and lift to unclip from the cushion. Repeat on the other side.

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

Weekly: Headgear, frame, and elbow

1. Soak the components in warm water with a mild liquid detergent.
2. Hand wash the components with a soft bristle brush. Pay particular attention to the vent holes in both the cushion and elbow.
3. Thoroughly rinse the components under running water.
4. 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 vent holes and anti-asphyxia valves are clean and clear.

Reassembling your mask

1. Align and insert the frame connector tab (a) into the cushion slot (b) and press down until it clicks. Repeat on the other side.
2. Attach the elbow to the top of the frame until it clicks.
3. With the ResMed logo facing outwards and up, insert the upper headgear straps into the frame from the inside and fold the fastening tabs over to secure.
   Note: If the elbow ring detaches, re-insert it into the top of the frame.

WARNING

• Magnets are used in the lower headgear straps and the frame of the mask. 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.
• The mask contains safety features, exhaust vent holes, and anti-asphyxia valves, to enable normal breathing and exhaust exhaled breath. Occlusion of the exhaust vent holes or anti-asphyxia valves 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 valves 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 determine compatible devices. Use in combination with incompatible medical devices can decrease the safety or alter the performance of the mask.
• The mask is not suitable for patients requiring life support ventilation.
• 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.

WARNING

• 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.
• 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.
• Discontinue using or replacing this mask if the patient has ANY adverse reaction to the use of the mask. Consult your physician or sleep therapist.
• The mask is not intended to be used simultaneously with nebulizer medications that are in the air path of the mask/tube.
• If there is any visible deterioration of a mask component (cracking, crazing, tears etc.) the component should be discarded and replaced.

CAUTION

• Always follow cleaning instructions and only use a mild liquid detergent. Some cleaning products may damage the mask, its parts and its function, or leave harmful residual vapors. Do not use a dishwasher or washing machine to clean the mask.
• When fitting the mask, do not overtighten the headgear as this may lead to skin redness or sores around the mask cushion.
• As with all masks, some rebreathing may occur at low pressures.
• Using a mask may cause tooth, gum, or jaw soreness or aggravate an existing dental condition. If symptoms occur, consult your physician or dentist.
• Do not iron the headgear as the material is heat-sensitive and will be damaged.

Technical specifications

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

Pressure-flow curve

• Therapy pressure: 4 to 30 cm H20
  Resistance with Anti Asphyxia Valve closed to the atmosphere

• Drop in pressure measured (nominal) at 50 L/min: 0.2 cm H2O

• Drop in pressure measured (nominal) at 100 L/min: 1.0 cm H2O
  Resistance with Anti Asphyxia Valve open to the atmosphere

• Inspiration at 50 L/min: 0.2 cm H2O

• Expiration at 50 L/min: 0.4 cm H2O

• Anti-Asphyxia Valve open-to-atmosphere pressure: <4 cm H2O

• Anti-Asphyxia Valve closed-to-atmosphere pressure: <4 cm H2O

• Sound: Declared dual-number noise emission values under ISO4871:1996 and ISO3744:2010. The a-weighted sound power level is 25 dBA, with an uncertainty of 3 dBA. A-weighted pressure level at a distance of 1 m is 18 dBA, with uncertainty of 3 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: u p 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.

• 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 regularly, 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.
• Accessories: Soft sleeves are available as an accessory,

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.
• Reprocessing the mask between patients
• Only Sleep Lab Mask (SLM) variants of the mask system are intended for multi-patient re-use. When used between patients, these masks must be reprocessed according to instructions available on ResMed.com/downloads/masks.

Symbols
The following symbols may appear on your product or packaging:

Caution, consult accompanying documents.

• Prescription-only (In the US, Federal law restricts these devices to sale by or on the order of a physician.)
• See the symbols glossary at ResMed.com/symbols.

Limited warranty

• ResMed Ltd (hereafter ’ResMed’) warrants that your ResMed mask system (including mask frame, cushion, headgear, and tubing) shall be free from defects in material and workmanship from the date of purchase for 90 days or in the case of disposable masks the maximum use period. 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 products 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 that vary from region to region. For further information on your warranty rights, contact your local ResMed dealer or  ResMed office.

Dear Patient,

ResMed is providing you with important information regarding our masks with magnets, which may interact with some implants or certain medical devices. You must understand the information contained in this letter, take action if necessary, and keep it for future reference.

In response to new information from the latest industry practices and global safety data, ResMed is updating the Contraindications and Warnings in our User Guides to instruct patients on the safe use of ResMed masks with magnets.

• Contraindications: conditions under which the mask is not to be used.
• Warnings: identify a possible hazard and provide information on how to safely use the mask.

General Product Description

• These masks are used to deliver air to a patient from a positive airway pressure (PAP) device.
• Magnets are used in some ResMed masks to provide a simple and easy way for patients to attach and detach the headgear to the mask frame when regularly fitting the mask for use.
• This can be notably beneficial to patients with disabilities, including those facing dexterity or vision impairment.

Which masks are affected?
The following ResMed masks contain magnets, please note that mask availability may differ in each country. If you do not use one of the masks identified below, this letter does not apply to you.

See Appendix A for more information on identifying your ResMed mask and the specific location of the magnets

What has changed?
ResMed is updating the Contraindications and Warning relating to magnetic interference, in its User Guides for all masks with magnets.

Updated 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 (i.e., pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, insulin/infusion pumps)
• Metallic implants/objects containing ferromagnetic material (i.e., 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)

Updated Warning

Keep the mask magnets at a safe distance of at least 6 inches (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. 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, e.g., 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.

Patient Safety Information
ResMed’s masks with magnets are safe when used under the updated Instructions for Use including the Contraindications and Warnings. When a magnet comes close to certain medical implants/devices (less than 6 inches / 150mm) there is potential for magnetic interference to change:

• the function of an implant/medical device
• the position of implants made of ferromagnetic material

In rare circumstances, this can lead to serious injury or death.
Contraindicated patients can avoid the potential harm from magnetic interference by using an alternative mask without magnets. All other patients using ResMed masks with magnets can continue to use the mask following the updated Instructions for Use.

From 2014 to November 2023, ResMed has sold tens of millions of masks with magnets
globally. In this time, ResMed has submitted five (5) reports of serious harm (medical intervention /hospitalization) that were potentially related to magnetic interference with implanted devices (including implantable cardioverter defibrillators (ICD) and cerebrospinal fluid (CSF) shunts) to relevant Regulatory Authorities. No permanent injuries or deaths have been reported.

Actions to be taken by you

Contraindicated patients using a ResMed mask with magnets

If you, or anyone in close physical contact while using the mask (e.g. bed partner), have an active medical implant or metallic implanted object that is identified within the Contraindications above:

• Replace your mask containing magnets with an alternative mask without magnets promptly. Contact your mask provider for alternative mask options.
  Note, that ResMed is making our masks without magnets available to your mask provider for replacement.

• If an alternative mask is not available, consult your physician/doctor for appropriate next steps regarding your therapy.

• Dispose of the mask with magnets after you receive an alternative mask.

Note, that not all models or variants of medical devices listed in the contraindications are affected by external magnetic fields. If you are not sure whether a medical device/implant falls under the Contraindications, or you require additional information on the potential adverse effects of magnetic fields for your particular device, please contact your physician/doctor.

All other patients using a ResMed mask with magnets
If you are NOT contraindicated from using a ResMed mask with magnets, you may continue to use the mask, ensuring you follow all user instructions, including the updates described in this letter
Importantly, ResMed masks with magnets are to be kept at least 6 inches (150mm) away from implants or medical devices that may be adversely affected by magnetic interference, as described in the updated Warning

For more information regarding these changes please visit www.resmed.com/magnetupdate.

Reporting an Adverse Event
If you have experienced an adverse event related to the use of ResMed masks with magnets, please visit www.resmed.com/contact or contact your mask provider. Alternatively, adverse events experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. 1- 800-332-1088 to request a form

Manufacturer

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

We appreciate your support and consider this action necessary to ensure that all patients are aware of these updates. If you have any questions or concerns or would like more information, please contact your mask provider or physician/doctor.

• Sincerely,
• Dawn Y. Haake
• Chief Quality Officer

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

References

• MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA
• Updated Information on Masks with Magnets for Mask Users - CPAP - Magnet Guidelines
• ResMed AirFit F30i Full Face Mask : 30-NIGHT Risk Free Trial : Ships Free

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