Resmed Airfit N30 Mask Headgear User Guide

Intended Use

The AirFit N30 nasal cradle 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.

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

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).

Fitting your mask

1. While holding the cushion away from your nose, make sure that the cushion size, left (L), and right (R) indicators are facing towards you. Place the cushion under your nose.
2. Pull the headgear bands over your head by holding the bottom band and stretching it around the back of your head. The top band should sit comfortably on the crown of your head.
3. Briefly pull your mask away from your nose and place it back to ensure that the cushion fits comfortably.

Adjusting your mask

• To achieve a comfortable fit, adjust the split bands by spreading them apart to loosen or draw them closer together to tighten.
• To fix any mask leak, adjust the headgear by pulling the headgear through the buckle. Adjust only enough for a comfortable seal and do not overtighten. You may need to adjust the headgear as it stretches over time.
  Your mask is now fitted and ready to use. While lying down and the device is running, a light breeze should be felt near the venting area around the tube connection. To inspect the vent, place a finger close to the connection area and feel for air. Do not allow the venting area to become blocked.

Removing your mask

To take off your mask system, pull the mask and headgear by the split-band up and over your head.

Disassembling your mask for cleaning

1. Firmly pinch one side of the cushion and pull away from the frame.
2. Unhook the headgear from the stabilizer by pulling on the end cap to reveal the buttonhole.
3. Slide the headgear off the end of the stabilizer.

Cleaning your mask

After each use: Cushion
Weekly: Headgear and frame

1. Soak the components in warm water with a mild liquid detergent.
2. Hand washes the components with a soft bristle brush. Pay particular attention to the vent.
3. Thoroughly rinse the components under running water.
4. Shake the frame to remove any excess water from the vent. 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 is clean and clear.

Reassembling your mask

1. With the gray side of the headgear facing out, insert each end of the headgear band over the stabilizers through the buttonholes.
2. Secure the headgear by pulling the buttonholes over the ends of the stabilizers.
3. Holding the mask frame, stretch the headgear lightly to ensure it is securely attached. Ensure that the headgear band is not twisted.
4. Align the notch in the cushion to the tab on the mask frame. Firmly push one side of the cushion onto the frame, then repeat on the other side. Push down all the edges of the cushion onto the frame to ensure that the edges are completely flat.

WARNING

• Remove all packaging before using the mask
• 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
• Only use compatible CPAP or bi-level therapy devices. 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.
• The mask is not suitable for patients requiring life support ventilation.
• 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 replacing this mask if the patient has ANY adverse reaction to the use of the mask. Consult your physician or sleep therapist.
• 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.

WARNING

• Refer to your CPAP or bilevel device manual for details on settings and operational information.
• Always follow cleaning instructions and only use a mild liquid detergent. Some cleaning products may damage the mask, its parts, and its function, or leave harmful residual vapors. Do not use a dishwasher or washing machine to clean the mask
• 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 pressures.
• The mask is not intended to be used simultaneously with nebulizer medications that are in the air path of the mask/tube.

CAUTION

• Visual criteria for product inspection: If there is any visible deterioration of a mask component (cracking, crazing, tears, etc.), the component should be discarded and replaced.
• When fitting the mask, do not overtighten the headgear as this may lead to skin redness or sores around the mask cushion.
• 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.
• Do not iron the headgear as the material is heat sensitive and will be damaged.

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

Mask setting options: For AirSense: Select ‘Pillows’.
Compatible devices: For a full list of compatible devices for this mask, see the
Mask/Device Compatibility List at ResMed.com/downloads/masks.

Therapy pressure: 4 to 20 cm H20
Resistance: Drop-in pressure measured (nominal)
at 50 L/min: 0.4 cm H2O
at 100 L/min: 1.7 cm H2O
Sound: Declared dual-number noise emission values in accordance with ISO4871:1996
and ISO3744:2010. The A-weighted sound power level and the A-weighted pressure level
at a distance of 1 m, with an uncertainly of 3 dBA, are shown.
Power level (with QuietAir Frame): 25 dBA
Pressure level (with QuietAir frame): 18 dBA
Power level (with standard frame): 28 dBA
Pressure level (with standard frame): 21 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
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 ‘Caution’ 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 product and packaging do not contain any hazardous substances and may be disposed of with your normal household refuse.

Reprocessing the mask between patients

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

Symbols

The following symbols may appear on your product or packaging:

	Nasal cradle mask		Device setting – Pillows
	quieter vent		Size – small
	Size – medium		Size – small wide
	Medical device		Importer

LATEX? Not made with natural rubber latex 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.

ResMed Pty Ltd
1 Elizabeth Macarthur Drive
Bella Vista NSW 2153 Australia
See ResMed.com for other ResMed locations worldwide. AirFit, QuietAir, and AirSense 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. 638254/1 2020-09

ResMed.com