ResMed AirFit F30 Manual

Overview

1. QuietAir / standard elbow
2. Frame
3. Cushion
4. Headgear

1. Vent
2. Anti-Asphyxia Valve
3. Side buttons
4. Frame magnet
5. Magnetic clips
6. Upper headgear strap
7. Lower headgear strap
8. Top headgear strap

Intended use

The AirFit F30 mask has two product variants:

• The AirFit F30 variant is intended for single-patient reuse in the home environment
• The AirFit F30 SLM (Sleep Lab Mask) variant is intended for multipatient 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.

QuietAir elbow
The QuietAir elbow is intended for single patient re-use in the home and hospital/institutional environment.

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).

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.

• The mask must be used under qualified supervision for patients who are unable to remove the mask by themselves. This mask is not for use on patients with impaired laryngeal reflexes or other conditions predisposing to aspiration in the event of regurgitation or vomiting.
• To avoid affecting the safety and quality of therapy, the mask vents must be kept clear to protect against rebreathing. Regularly inspect the vents to ensure they are kept clean, undamaged and clear of blockages.
• The mask contains specific safety features with the supplied elbow (containing the valve and vent assembly) to ensure safe and functional usage. Do not use the mask if these features are damaged or missing.
• 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.
• Visual criteria for product inspection: If any visible deterioration of a mask component is apparent (cracking, crazing, tears, etc), the component should be discarded and replaced.
• 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 mask is Magnetic Resonance (MR) unsafe and must be kept outside of MRI scanner rooms.
• The technical specifications of the mask are provided for your clinician or respiratory therapist to check that they are compatible with the CPAP or bi-level 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 bi-level device function.
• Discontinue using the mask if you have ANY adverse reaction 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 mask is not intended to be used simultaneously with nebulizer medications that are in the air path of the mask/tube.
• Avoid connecting flexible PVC products (eg, PVC tubing) directly to any part of the mask. Flexible PVC contains elements that can be detrimental to the materials of the mask, and may cause the components to crack or break.
• Regularly clean your mask to maintain the quality of your mask and to prevent the growth of germs that can adversely affect your health.
• 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.

• Remove all packaging before using 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.

Before using your mask

Remove all packaging and inspect each mask component for visible deterioration.
Use the fitting template to assist in selecting the right size cushion and frame.

Fitting your mask

1. Twist and pull both magnetic clips away from the frame.
   
2. 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 over your head.
   
3. Bring the lower headgear straps under your ears and attach the magnetic clips to the frame.
   
4. Undo the fastening tabs on the upper headgear straps and pull evenly. Repeat with the lower headgear straps.
   
5. If the headgear is too close to the ear, adjust the top headgear strap
   
6. Connect the device air tubing to the elbow and attach the elbow to the mask, ensuring that it clicks in place.
   

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.
• To fix any leaks at the upper or lower part of the mask, adjust the top, upper or lower headgear straps. Adjust only enough for a comfortable seal and do not overtighten.

Removing your mask

1. Twist and pull both magnetic clips away from the frame.
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 mask elbow.

1. Undo the fastening tabs on the upper headgear straps and pull them 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. Hold the top and bottom of the cushion and separate from the frame.
   

Cleaning your mask

After each use: Elbow, frame, cushion
Weekly: Headgear

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 for at least one minute and hand wash with a soft bristle brush. Pay particular attention to all connection areas, elbow vent holes and valves.
3. Thoroughly rinse the components under running water.
4. Squeeze the headgear to remove excess water. Leave the components to air dry out of direct sunlight.

If the mask components are not visibly clean, repeat the cleaning steps.

Reassembling your mask

1. 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.
2. Hold the top and bottom of the cushion and attach to the frame.
3. Attach the elbow to the frame.

Technical specifications

Mask setting options
For AirSense or AirCurve: 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.
Pressure-flow curve:

Therapy pressure: 3 to 30 cm H₂O
Resistance with Anti- Asphyxia Valve closed to atmosphere
Drop in pressure measured (nominal) at 50 L/min: 0.3 cm H₂O
Drop in pressure measured (nominal) at 100 L/min: 0.7 cm H₂O
Inspiratory and expiratory resistance with Anti Asphyxia Valve open to atmosphere
Inspiration at 50 L/min: 0.6 cm H₂O
Expiration at 50 L/min: 0.8 cm H₂O
Anti Asphyxia Valve open-to-atmosphere pressure: ≤3 cm H₂O
Anti Asphyxia Valve closed-to-atmosphere pressure: ≤3 cm H₂O
Sound: Declared dual-number noise emission values in accordance with ISO4871 and ISO3744. The A-weighted sound power level and A-weighted sound pressure level of the mask at a distance of 1 m, with uncertainty of 3 dBA, are shown.
Power level (with QuietAir elbow): 21 dBA
Pressure level (with QuietAir elbow): 14 dBA
Power level (with standard elbow): 31 dBA
Pressure level (with standard elbow): 23 dBA
Environmental conditions
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
Gross dimensions
Mask fully assembled (H x W x D)
4.33" x 4.57" x 4.02" (110 mm x 116 mm x 102 mm)
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 50 mm distance.
Service life
The service life of the AirFit F30 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 'Warning' section of this guide.
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.

	Full face mask
	Device setting - Full face
	Cushion size - small
	Cushion size - medium
	Not made with natural rubber latex
	Magnetic resonance (MR) environment unsafe
	Prescription only (In the US, Federal law restricts these devices to sale by or on the order of a physician.)