AirFit N20 - Respiratory ventilator ResMed - Free user manual and instructions

USER MANUAL AirFit N20 ResMed

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ResMed

AirFit™ N20

AirTouch™ N20

Nasal mask

Device Setting

Pillows

Medical device with blue and gray sections, labeled 'Recified' (no text or symbols on the device itself)

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User guide

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A B C D 1 2 3 4 5 7 AirFit™ N20 AirTouch™ N20 6 8

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 non-invasively 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 multi-patient 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

Illustration of a hand holding a mechanical component with a downward arrow indicating motion (no text or symbols present)

Medical illustration showing a hand applying a mask to a person's face, with an arrow indicating direction and a magnified inset showing the mask detail.

Illustration of a person using a face mask to apply a finger to the lower face (no text or symbols present)

Diagram illustrating two-step instructions for using a face mask to adjust the mask, labeled with numbers 4 and 5.

6

Line drawing of a person wearing a respirator device (no text or symbols present)

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.

1. Bring the lower straps below your ears, and attach the magnetic clip to the frame.

2. 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.

3. Undo the fastening tabs on the lower headgear straps. Adjust the straps evenly until the mask is stable. Reattach the fastening tabs.

4. 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.

5. Your mask and headgear should be positioned as shown in the illustration.

Adjusting your mask

Line drawing of a person adjusting a respirator mask (no text or symbols present)

Illustration of a person performing a nasal pressure technique with two different angles (no text or symbols)

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

Illustration of a person using a nasal mask to apply a nasal pressure technique (no text or symbols present)

Illustration of a person wearing a head-mounted visor with an arrow indicating direction (no text or symbols)

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.

Medical illustration showing a surgical procedure on a joint with an arrow indicating direction (no text or labels)

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Illustration of a mechanical component being held, showing a hand holding a cylindrical part with an arrow indicating motion (no text or symbols present)

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

Problem/possible cause	Solution
Mask is too noisy.
Vent is dirty.	Clean the vent according to the instructions.
Mask is incorrectly assembled.	Disassemble the mask, then reassemble according to the instructions.
Elbow and short tube incorrectly installed	Remove the elbow and short tube from your mask frame, then reassemble according to the instructions.
Mask is leaking.	Refit or reposition your mask. Readjust the headgear straps to bring the mask closer to the face and improve your seal. Check that your mask is assembled correctly.
Mask leaks around face.
Mask is not positioned correctly.	Check that the mask size indicator is facing downward on the bottom of the cushion along the bottom of your nose.
Mask may have been fitted incorrectly.	Pull the mask away from your face and reposition, ensuring that the lower corners of the mask fully enclose your nose. If necessary, readjust the headgear straps to keep the mask in the right place.
Cushion may be dirty. Clean the cushion according to the instructions.
(For AirFit N20 only) Cushion membrane is creased or folded.	Remove and refit your mask according to the fitting instructions. Ensure that you position the cushion correctly over your nose before pulling the headgear over your head. Do not slide the mask down your face during fitting as this may lead to folding or curling of the cushion.
Cushion is not positioned correctly.	Reposition the mask on your face. If leak continues, turn off device, resettle your cushion and then turn device back on.
(For AirTouch N20 only) Cushion is nearing the end of its life	Cushion performance may deteriorate as the foam nears the end of its lifespan. Adjust your headgear and if the problem persists, replace the cushion.
Mask is not tightened correctly.	Ensure that the headgear straps are not overtightened or too loose. You may find that this mask does not need to be tightened as much as other nasal masks. Check that the headgear is not twisted.
Mask may be the wrong size.	Talk to your clinician to have your face size checked against the fitting template. Note that sizing across different masks is not always the same.
Mask does not fit properly.
Mask is incorrectly assembled.	Disassemble the mask, then reassemble according to the instructions.
Mask may be the wrong size.	Talk to your clinician to have your face size checked against the fitting template, Note that sizing across different masks is not always the same..

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. Once the 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.

GENERAL WARNINGS

• 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 settings and 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.

Pressure (cm H2O)	Flow (L/min)
4	20
7	27
11	35
14	40
17	44
20	49
24	54
27	58
30	61

	AirFit N20	AirTouch N20
Therapy pressure	4 to 30 cm H_2O	4 to 30 cm H_2O
Dead space: Physical dead space is the empty volume of the mask to the end of the swivel. Using the large cushion it is
	103 mL (Large)	103 mL (Large)
Resistance: Drop in pressure measured (nominal)
at 50 L/min	0.3 cm H_2O	0.4 cm H_2O
at 100 L/min	1.3 cm H_2O	1.4 cm H_2O
Sound: DECLARED DUAL-NUMBER NOISE EMISSION VALUES in accordance with ISO 4871. The A-weighted sound power level and the A-weighted sound pressure level of the mask at a distance of 1 m, with uncertainty of 3 dBA, are shown
Power level	24 dBA	24 dBA
Pressure level	16 dBA	16 dBA
Gross dimensions: Mask fully assembled with the short tube assembly and swivel, excluding the headgear (H x W x D)
	339 mm x 291 mm x 162 mm	339 mm x 291 mm x 170 mm

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.

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 your mask at home’ section of this guide.

Mask Setting options

For AirSense, AirCurve or S9: Select "Pillows".

For other devices: Select 'SWIFT' (if available), otherwise select 'MIRAGE' as the mask option.

Device Setting

Pillows

Compatible devices: For a full list of compatible devices for this mask, see the Mask/Device Compatibility List at ResMed.com/downloads/masks. If you do not have internet access, please contact your ResMed representative.

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

Medical device

Nasal mask

Device setting - Pillows

LATEX?

Not made with natural rubber latex

Clean with alcohol-free wipes only

Do not submerge in liquids

Size - small

Size - medium

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.

A B C D 1 2 3 4 5 7 AirFit™ N20 AirTouch™ N20 6 8

Illustration of a hand holding a mechanical component with a downward arrow indicating motion (no text or symbols)

Medical illustration showing a person applying nasal pressure using a surgical mask, with an arrow indicating downward pressure and a magnified inset showing the same face.

Illustration of a person using a pair of eyeglasses to apply or adjust the face (no text or symbols present)

Diagram illustrating two-step instructions for using a face mask to adjust the nose area, labeled with numbers 4 and 5.

Medical illustration showing a person using a nasal pressure device with an inset diagram illustrating the procedure.

Line drawing of a person wearing a respirator mask and headband (no text or symbols)

Line drawing of a person adjusting a respirator (no text or symbols present)

Illustration of a person performing a nasal pressure technique with two different angles (top and bottom), no text or symbols present.

Illustration of a person applying a mask to their ear (no text or symbols present)

Illustration of a person applying eye care to the face with an arrow indicating direction (no text or symbols)

Medical illustration showing a surgical procedure on a joint with an arrow indicating direction (no text or symbols present)

Illustration of a hand holding a tool with arrows indicating motion or force (no text or symbols)

Illustration of a mechanical component being held, showing a handle and part with an arrow indicating direction (no text or symbols)

Diagram of a mechanical joint or connector being adjusted, showing a force arrow (no text or symbols present)

Medical illustration showing a hand holding a nasal mask with an arrow indicating force or pressure, and a magnified view of the head with a checkmark.

Illustration of a person using a mask to apply a finger to their face (no text or symbols present)

4

Medical illustration showing a person using a nasal mask to interact with a device, with instructional arrows and a numbered label '6' in the corner.

Line drawing of a person wearing a respirator and head cover (no text or symbols)

Illustration of a person adjusting a respirator mask, showing three sequential steps (no text or symbols present)

Illustration of a person applying nasal pressure using a surgical mask (no text or symbols present)

Illustration of a person applying eye care to the face with an arrow indicating direction (no text or symbols)

Medical illustration showing a surgical procedure on a joint, with arrows indicating direction (no text or symbols)

Illustration of a hand holding a tool with arrows indicating motion or force (no text or symbols)

Illustration of a mechanical component with an arrow indicating direction (no text or symbols)

Courbe pression/débit

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Medical illustration showing a hand using a nasal mask to address the nose and mouth, with an arrow indicating direction and a cross-sectional view.

Illustration of a person using a pair of eyeglasses to apply face-to-face movements (no text or symbols present)

4

Medical illustration showing a person using a nasal mask to interact with a device, with instructional arrows and labeled step 6.

Line drawing of a person wearing a respirator and head cover (no text or symbols)

Illustration of a person adjusting a respirator mask, showing three sequential steps (no text or symbols present)

Illustration showing two-step instructions for using a facial mask to adjust the face, labeled with arrows and numbered steps.

Medical illustration showing a surgical procedure on a joint with an arrow indicating direction (no text or symbols present)

Illustration of a hand holding a tool with arrows indicating motion or force (no text or symbols)

Illustration of a hand holding a mechanical component with an arrow indicating direction (no text or symbols)

Device Setting
Pillows

Diagram of a mechanical component with a hand holding a tool, showing a curved joint and directional arrow (no text or symbols)

Medical illustration showing a person applying a nasal mask to another person, with a directional arrow indicating motion or pressure.

Illustration of a person using a pair of eyeglasses to adjust the face (no text or symbols present)

Illustration showing two-step instructions for adjusting a face mask, labeled with numbers 4 and 5.

Medical illustration showing a person using a nasal mask to adjust air quality, with instructional arrows and a numbered label '6' in the corner.

Line drawing of a person wearing a respirator mask and headband, holding a tube (no text or symbols)

Medical illustration showing a person adjusting a gas mask with directional arrows indicating motion or pressure.

Illustration of a person applying face-to-face mask to another person (no text or symbols)

Illustration of a person applying facial care to the jaw (no text or symbols)

Diagram of a hand holding a curved object with an arrow indicating direction (no text or symbols present)

Illustration of a hand holding a tool with arrows indicating motion or force (no text or symbols)

Illustration of a mechanical component with a hand holding a cylindrical part, showing motion direction (no text or symbols)

ALGEMENE WAARSCHUWINGEN

ALGEMENE WAARSCHUWINGEN

ALGEMENE WAARSCHUWINGEN

International Commission on Non-Ionizing Radiation Protection (ICNIRP)

Diagram of a mechanical component with a downward arrow indicating motion (no text or symbols present)

Medical illustration showing a hand-drawn head with surgical instruments and a magnified view of the head with a checkmark.

Illustration of a person applying facial mask to another person's face (no text or symbols)

Diagram illustrating two-step instructions for using a face mask to adjust the nose area, labeled with numbers 4 and 5.

Medical illustration showing a person using a nasal mask with instructions and magnified view of the device being adjusted.

Line drawing of a person wearing a respirator mask and cap (no text or symbols)

عن الإطار. مع

مgrenطيسيل

Illustration of a person adjusting a nasal mask with three sequential steps showing the process (no text or symbols present)

Illustration showing two-step instructions for using a face mask to adjust the nose area, labeled with arrows and numbered steps.

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Illustration of a hand holding a tool with arrows indicating motion or force (no text or symbols)

Illustration of a hand holding a mechanical component with an arrow indicating direction (no text or symbols present)

.ResMed.com/downloads/masks

الاتخزين

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ResMed

MANUFACTURER

ResMed Pty Ltd

1 Elizabeth Macarthur Drive

Bella Vista NSW 2153 Australia

See ResMed.com for other ResMed locations worldwide. AirFit, AirTouch, AirSense, AirCurve and S9 are trademarks and/or registered trademarks of the ResMed family of companies. For patent and other intellectual property information, see ResMed.com/ip. © 2020 ResMed. 638230/1 2020-07