ResMed AirFit F20 NV Non-Vented Full Face Mask User Guide

ResMed AirFit F20 NV Non-Vented Full Face Mask

OVERVIEW

• Non-vented elbow
• Frame
• Cushion
• Headgear

1. Side buttons
2. Magnetic clips
3. Lower headgear straps
4. Upper headgear straps

Using this guide

Please read the entire guide before use. When following instructions, refer to the images at the front of the guide

Intended use

The AirFit F20 Non-Vented full-face mask is a patient interface to deliver non-invasive positive pressure ventilation. It is intended to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, to administer continuous or intermittent ventilatory support. The AirFit F20 Non-Vented full-face mask is:

• to be used by patients weighing more than 30 kg
•  intended for single-patient re-use in the home environment and/or multi-patient re-use in the hospital/institutional environment.

Clinical benefits

The clinical benefit of non-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, and obesity hypoventilation syndrome (OHS).

Compatible devices

This mask is compatible with the following devices:

WARNING: Magnets are used in the lower headgear straps and the frame of the mask. Ensure the headgear and frame is kept at least 50 mm away from any active medical implant (eg, defibrillator, magnetic cerebrospinal fluid (CSF) shunt valve, cochlear implants, etc) to avoid possible effects from localized magnetic fields. The magnetic field strength is less than 400 mT.
Contraindications: The 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.

GENERAL WARNINGS

• This mask is to be used with patients requiring non-life support ventilatory assistance.
• This mask must be used with an external exhalation device. This mask must be fitted, and therapy maintained by trained medical staff. Failure to monitor the patient may result in loss of therapy, serious injury or death.
• This mask must be used under qualified supervision for users who are unable to remove the mask by themselves or are at risk of not responding to an issue. This mask is not suitable for individuals predisposed to aspiration. Failure to use under supervision in these circumstances may result in serious injury or death.
• This mask does not contain an exhaust feature or anti-asphyxia valve (AAV). This mask must be used with non-invasive ventilation (NIV) circuit with an exhaust system or a Positive Pressure Ventilator with an exhalation valve. When the ventilator is functioning properly, the exhalation valve allows exhaled air to escape to the ambient. When the ventilator is not operating, exhaled air may be re-breathed. Re-breathing exhaled air can in some circumstances, lead to suffocation and/or injury.
• The mask should not be used unless the ventilator device is turned on.
• 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.
• Follow all precautions when using supplemental oxygen.
• Oxygen flow must be turned off when the ventilator device is not operating (if used) 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.
•  The technical specifications of the mask are provided to check that the mask is compatible with the ventilator device. If used outside specification or if used with incompatible devices optimum therapy may not be achieved.
• Discontinue using this mask if the patient has ANY adverse reaction to the use of the mask, and consult their physician or sleep therapist.
• Using a mask may cause tooth, gum or jaw soreness or aggravate an existing dental condition. If symptoms occur, consult their 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.
• As with all masks, some rebreathing may occur at low pressures.
• Refer to the appropriate ventilator 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 the mask

When using the mask with ResMed devices that have mask setting options, refer to the Technical specifications section in this user guide for the correct setting.

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 the patient’s face and pull the headgear over the their head.
3.  Bring the lower straps below the patient’s 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 pushing the elbow into the frame, ensuring it clicks in and is firmly secured.
7.  The mask and headgear should be positioned as shown in the illustration.

Adjustment

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.

Turn on the patient’s device so that it is blowing air.
Adjustment tips

• With air pressure applied, pull the mask away from the patient’s face to allow the cushion to inflate and reposition onto their 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.

Removal

•  Twist and pull both magnetic clips away from the frame for quick release.
•  Pull the mask away from the patient’s face and back over their head.

Disassembly

If the mask is connected to the device, disconnect the device air tubing from the elbow.

•  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.

•  Remove the elbow from the mask by squeezing the top and bottom side buttons and pulling away from the frame.

•  Hold the side of the frame between the upper and lower arms. Gently pull the cushion away from the frame.

Reassembly

•  Attach the cushion to the frame by aligning the circular openings and pushing them together until retained.
•  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 the mask at home

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

• 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 vapors that could be inhaled if not rinsed thoroughly. Do not use a dishwasher or washing machine to clean the mask.
• Regularly clean the mask and its components to maintain the quality of the mask and to prevent the growth of germs that can adversely affect the patient’s health.
  CAUTION: Visible criteria for product inspection: If any visible deterioration of a system component is apparent (cracking, discoloration, tears, etc.), the component should be discarded and replaced.

Daily/After each use

•  Disassemble the mask according to the disassembly instructions.
•  Rinse the frame, elbow, and cushion under running water. Clean with a soft brush until the dirt is removed.
•  Soak the components in warm water with a mild liquid detergent for up to ten minutes.
•  Shake the components in the water.
•  Brush the areas of the frame where the arms connect, and inside and outside the frame where the elbow connects.
•  Rinse the components under running water.
•  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

•  Disassemble the mask. The magnets can remain attached to the headgear during cleaning.
•  Handwash the headgear in warm water with mild liquid detergent.
•  Rinse the headgear under running water. Inspect to ensure the headgear is clean and detergent free. Wash and rinse again, if necessary.
•  Squeeze the headgear to remove excess water.
•  Leave the headgear to air dry out of direct sunlight.

Reprocessing the mask between patients

Reprocess this mask when used between patients. Reprocessing instructions are available on ResMed.com/downloads/masks.

Troubleshooting

Problem/possible cause

• Mask is uncomfortable. Headgear straps are too tight.
  The cushion membrane is designed to inflate against the patient’s face to provide a comfortable seal with low headgear tension. Adjust straps evenly. Ensure that the headgear straps are not too tight and that the cushion is not creased.

• Mask could be the wrong size.
  Check the patient’s face size against the mask fitting template. Note that sizing across different masks is not always the same.

• Mask is too noisy. Elbow incorrectly installed or incorrect assembly of the mask system.
  Remove the elbow from the mask, then reassemble according to the instructions. Check that the mask is correctly assembled according to the instructions.

• Mask leaks around the face. The cushion membrane is creased. Mask is incorrectly positioned or adjusted.
  Refit the mask according to the instructions. Ensure that the cushion is positioned correctly on the patient’s face before pulling headgear over their head. Do not slide the mask down the patient’s face during fitting as this may lead to creasing of the cushion.

• Mask could be the wrong size.
  Check the patient’s face size against the mask fitting template. Note that sizing across different masks is not always the same.

Technical specifications

Compatible devices Astral

1. Deadspace
   Empty volume of the mask up to the end of the elbow. The mask deadspace varies according to cushion size.
   Cushion – small: 206 mL
   Cushion – medium: 226 mL
   Cushion – large: 247 mL

2. Therapy pressure
   3 to 40 cm H2O

3. Pressure-flow
   3 – 20 cm H2O: < 3 L/min 20 – 40 cm H2O: < 6 L/min

4. Resistance
   Drop in pressure measured (nominal) at 50 L/min: 0.2 cm H2O
   at 100 L/min: 0.6 cm H2O

5. 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

6. Gross dimensions
   Mask fully assembled with elbow (no headgear) 138 mm (H) x 159 mm (W) x 158 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 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 the mask at home’ 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.
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.

Size – large 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
See the symbols glossary at ResMed.com/symbols.
Consumer Warranty
ResMed acknowledges all consumer rights granted under the EU Directive 1999/44/EC and the respective national laws within the EU for products sold within the European Union.

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

See ResMed.com for other ResMed locations worldwide. AirFit and Astral are trademarks and/or registered trademarks of the ResMed family of companies. For patent and other intellectual property information, see ResMed.com/ip. © 2021 ResMed. 638300/1 2021-11

References

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

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