Resmed Airtouch N20 Nasal Cpap Mask With Headgear User Guide

ResMed AirTouch N20 Nasal CPAP Mask with Headgear User Guide

Product Overview

• A Elbow and short tube
• B Frame
• C Cushion
• D Headgear

1. Elbow
2. Side buttons
3. Vent
4. Short tube
5. Swivel
6. Magnetic clip
7. Lower headgear straps
8. Upper headgear straps

Thank you for choosing the AirFit™ N20/AirTouch™ N20. These masks are identical – except for the interchangeable AirFit N20 silicone cushion and AirTouch N20 foam cushion. This offers two choices for your mask, depending on your preferred comfort, stability and seal. These masks may not be available in all countries.

Intended use

The AirFit N20 and AirTouch N20 nasal masks channel airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device.

The N20 is:

• to be used by patients weighing more than 30 kg for whom positive airway pressure has been prescribed
• intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.

AirTouch N20 cushion

The AirTouch N20 cushion is intended for single patient re-use in both the
home and hospital/institutional environment and recommended to be replaced monthly.

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 medical implant (eg, pacemaker, 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.

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).

Clinical benefits

The clinical benefit of vented masks is the provision of effective therapy delivery from a therapy device to the patient.

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.

Fitting your mask

1. Twist and pull both magnetic clips away from the frame.
   
2. With both lower headgear straps released, hold the mask against your face and pull the headgear over your head.
   Headgear check: Ensure that the ResMed logo on the headgear is facing outwards and is upright when the headgear is put on.
   
3. Bring the lower straps below your ears, and attach the magnetic clip to the frame.
   
4. Undo the fastening tabs on the upper headgear straps. Adjust the straps evenly until the mask sits comfortably just over the nose.
   Reattach the fastening tabs.
5. Undo the fastening tabs on the lower headgear straps. Adjust the straps evenly until the mask is stable. Reattach the fastening tabs.
   
6. Connect the device air tubing to the short tube. Attach the elbow to the mask by pressing the side buttons and pushing the elbow into the mask, ensuring it clicks in on both sides.
   
7. Your mask and headgear should be positioned as shown in the illustration.
   

Adjusting your mask

If necessary, slightly adjust the position of the mask for the most comfortable fit. Ensure that the headgear is not twisted and for the AirFit N20 the cushion is not creased.

1. Turn on your device so that it is blowing air.

Adjustment tips:

• 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.
• The upper strap adjustment is the key to seal and comfort.
• Do not overtighten the lower straps because they mainly serve to keep the cushion in position.

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 the mask is connected to your device, disconnect the device air tubing from the short tube.

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. Remove the elbow from the mask by pressing the side button and pulling the elbow away.
   
3. Hold the frame by placing your thumb over the side slot. Pull the cushion away from the frame.
   

Reassembling your mask

1. Push the cushion into the frame. The frame has a shape that allows you to insert the cushion only one way.
2. 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 your mask at home

It is important to follow the steps below to get the best performance out of your 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.
• 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.

CAUTION

Visible criteria for product inspection: If any visible deterioration of a system component is apparent (cracking, crazing, tears etc), the component should be discarded and replaced.
Once you have disassembled the mask, clean the components as follows.

AirFit N20 cushion, elbow and short tube (Daily/After each use)

1. Soak and agitate the AirFit N20 cushion, elbow and short tube in warm water (approximately 30°C) using a mild liquid detergent for up to 10 minutes.
2. Clean the components with a soft bristle brush, paying particular attention to the small vent holes on the elbow.
3. Thoroughly rinse the components under warm flowing drinking quality water.
4. Inspect each component to ensure that they are visually clean and free of detergent residue. If required, repeat washing.
5. Allow the components to dry out of direct sunlight before assembling.

Headgear, frame (Weekly)

The magnetic clips on the frame can be left on for washing.

1. Soak and agitate the separated headgear and frame in warm water (approximately 30°C) using a mild liquid detergent for up to 10 minutes.
2. To rinse the components, repeatedly squeeze them under warm flowing drinking quality water until it is free of detergent residue.
3. Squeeze the components to remove excess water.
4. Allow the components to dry out of direct sunlight before assembling.

AirTouch N20 cushion (as required)

CAUTION

• The cushion must not be submerged in liquid as this may damage the cushion and affect mask performance.
• Discard the cushion if it is submerged in liquid or heavily soiled.
• Do not expose the cushion to domestic cleaning products or cleaning devices.

You do not need to clean the AirTouch N20 cushion every day. It is recommended to replace your cushion every month. If any visible deterioration of the cushion is apparent, the cushion should be discarded and replaced. If required, wipe the outside of the foam cushion with CPAP wipes or similar alcohol-free wipes and allow to dry. Do not store or place the cushion in direct sunlight.

Troubleshooting

GENERAL WARNINGS

• The vent holes must be kept clear.
• The mask should only be used with CPAP or bilevel devices recommended by a physician or respiratory therapist.
• The mask should not be used unless the device is turned on. Oncethe mask  is fitted, ensure the device is blowing air. Explanation: CPAP and bilevel devices are intended to be used with special masks (or connectors) which have vent holes to allow continuous flow of air out of the mask. When the device is turned on and functioning properly, new air from the device flushes the exhaled air out through the mask vent holes. However, when the device is not operating, insufficient fresh air will be provided through the mask, and the exhaled air may be rebreathed. Rebreathing of exhaled air for longer than several minutes can, in some circumstances, lead to suffocation. This applies to most models of CPAP or bilevel devices.
• 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 technical specifications of the mask are provided for your clinician to check that they are compatible with the CPAP or bilevel 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 bilevel device function.
• Discontinue using this mask if you have ANY adverse reaction to the use of the mask, 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.
• As with all masks, some rebreathing may occur at low CPAP pressures.
• Refer to your CPAP or bilevel device manual for details on settingsand  operational information.
• Remove all packaging before using the mask.
• The mask must be used under qualified supervision for users 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.
• Avoid connecting flexible PVC products (eg, PVC tubing) directly to any part of the mask. Flexible PVC contains elements that can be damaging to the materials of the mask, and may cause the components to crack or break.
• The N20 line of nasal CPAP masks are not intended to be used simultaneously with nebulizer medications that are in the air path of the mask/tube.
• The mask contains an exhaust port safety feature to enable normal breathing. The mask should not be worn if this safety feature is damaged or missing.

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.

Technical specifications

Pressure-flow curve

The mask contains passive venting to protect against rebreathing.
As a result of manufacturing variations, the vent flow rate may vary.

Note: The manufacturer reserves the right to change these specifications without notice.

Reprocessing the mask between patients

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

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 does 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:

Importer
Nasal mask
Not made with natural rubber latex
Do not submerge in liquids
Size – medium
Medical device
Device setting – Pillows
Clean with alcohol-free wipes only
Size – small
Size – large

See 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.