ResMed AirFit F30i Manual

Parts and Features

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.

1. Elbow
2. Frame
3. Cushion
4. Headgear
5. Soft Wrap

1. Vent holes (cushion)
2. Vent holes (elbow)
3. Side button
4. Elbow ring
5. Anti-Asphyxia valve (inside the left and right of frame connector)
6. Frame connector
7. Frame magnet
8. Magnetic clip
9. Lower headgear strap
10. Upper headgear strap

Intended Use

The AirFit F30i mask is intended to be used by patients weighing more than 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

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).

Safety Warnings

Keep the mask magnets at a safe distance of at least 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 contains safety features, the 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.
• 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.
• 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 replace 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 nebuliser 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.
• The mask is Magnetic Resonance (MR) unsafe and must be kept outside of MRI scanner rooms.
• The mask is not suitable for patients requiring life support ventilation or who would experience serious deterioration of health or death with a loss or degradation of therapy.
• 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.
• 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.
• For any serious incidents that occur in relation to this device, these should be reported to ResMed and the competent authority in your country.

• 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.

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).

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 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 into the top of the frame.

Using soft wraps

1. Unfasten the soft wrap.
   
2. Position the soft wrap around the frame
   
3. Fold the fastening tab over the frame.
   
4. The soft wrap should sit flat against the frame with the fastening tab facing outwards.
   

To disassemble the soft wrap, gently peel the fastening tab back and pull away from the frame.

Cleaning the soft wraps

The soft wraps should be cleaned weekly.

1. Soak the soft wrap in warm water with a mild liquid detergent.
2. Hand wash the soft wrap with a soft bristle brush.
3. Thoroughly rinse the soft wrap under running water.
4. Squeeze with a clean towel to remove excess water. Leave the soft wrap to air dry out of direct sunlight.

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 cmH₂O

Resistance with Anti-Asphyxia Valve closed to atmosphere
Drop in pressure measured (nominal) at 50 L/min: 0.2 cmH₂O
Drop in pressure measured (nominal) at 100 L/min: 1.0 cmH₂O Resistance may vary due to the flexible mask frame design.

Resistance with Anti-Asphyxia Valve open to atmosphere
Inspiration at 50 L/min: 0.2 cmH₂O
Expiration at 50 L/min: 0.4 cmH₂O

Anti-Asphyxia Valve open-to-atmosphere pressure: <4 cmH₂O

Anti-Asphyxia Valve closed-to-atmosphere pressure: <4 cmH₂O

Sound: Declared dual-number noise emission values in accordance with ISO4871:1996 and ISO3744:2010. A-weighted sound power level is 25 dBA, with uncertainty of 3 dBA. A-weighted pressure level at a distance of 1 m is 18 dBA, with uncertainly of 3 dBA.

Environmental conditions
Operating temperature: 5°C to 40°C

Operating humidity: 15% to 95% RH non-condensing

Storage and transport temperature: -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 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.

Reprocessing the mask between patients

When using between patients, the mask must be reprocessed according to the cleaning and disinfection instructions available on ResMed.com/downloads/masks.

Symbols

The following symbols may appear on your product or packaging:

See symbols glossary at ResMed.com/symbols.

References

• http://resmed.com/downloads/masks
• http://resmed.com/symbols

Download manual

Here you can download full pdf version of manual, it may contain additional safety instructions, warranty information, FCC rules, etc.

Download ResMed AirFit F30i Manual

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