AirFit N30 - Respiratory medical device ResMed - Free user manual and instructions

Product type	Nasal mask with intentional leak
Brand	ResMed
Model	AirFit N30
Category	Respiratory medical device
Intended use	Non-invasive positive pressure therapy (CPAP) for obstructive sleep apnea syndrome (OSAS)
Treatment pressure	4 to 20 cm H₂O
Operating temperature	5 °C to 40 °C
Operating humidity	15 to 95% RH without condensation
Storage temperature	-20 °C to +60 °C
Storage humidity	95% RH max without condensation
Sound level (acoustic power)	22 dBA (±3 dBA)
Sound level (pressure at 1 m)	15 dBA (±3 dBA)
Service life	Variable depending on use; replace damaged components (see instructions)
Main components	Cushion, rigid frame, split-band headgear, ventilation module, AirMini tubing, HumidX/HumidX Plus (optional)
Maintenance	Clean the cushion after each use; headgear and frame weekly; use mild detergent; do not machine wash
Safety	Do not obstruct ventilation holes; use only with the device powered on; do not use with supplemental oxygen
Compatibility	ResMed AirMini devices (list on ResMed.com/downloads/masks)
Patients	Adults over 30 kg
Material	Natural rubber latex-free
Warranty	Consumer rights according to European Directive 1999/44/EC

Frequently Asked Questions - AirFit N30 ResMed

How to adjust the AirFit N30 mask?

Place the cushion under your nose, pull the headgear straps over your head starting with the bottom strap. Adjust the straps by spreading or bringing them closer for a comfortable fit. To eliminate leaks, pull on the headgear at the buckle without overtightening. Check that the ventilation holes are not obstructed.

How often to clean the mask?

The cushion must be cleaned after each use. The headgear and rigid frame should be cleaned weekly. The ventilation module should be cleaned daily. Use warm water with a mild liquid detergent and a soft-bristle brush. Rinse thoroughly and let dry away from direct sunlight.

Is the mask compatible with oxygen?

No, the mask is not compatible with supplemental oxygen. Using oxygen with this mask could pose a risk of fire or burns.

What to do in case of mask leak?

Adjust the headgear by pulling on it via the buckle. Do not overtighten. Check that the cushion is correctly positioned under the nose and that the straps are not twisted. If leaks persist, inspect the components for any damage.

How to replace the HumidX or HumidX Plus humidifier?

HumidX and HumidX Plus must be replaced 30 days after opening their packaging. To replace them, remove the old one from the ventilation module and insert the new one. These devices cannot be washed.

Is the mask machine or dishwasher washable?

No, never clean the mask or its components in a washing machine or dishwasher. This could damage them and leave harmful residues. Hand wash them with a mild detergent and rinse thoroughly.

What are the signs of wear to look for?

Regularly inspect components: cracks, discoloration, tears, obstructions of ventilation holes, or any sign of deterioration. If damaged, replace the component immediately to ensure treatment safety and effectiveness.

Can I use this mask with a device other than the ResMed AirMini?

This mask is designed specifically for the ResMed AirMini system. It should only be used with compatible devices listed on ResMed.com/downloads/masks. Use with other devices could compromise treatment and safety.

How to disassemble the mask for cleaning?

Disconnect the mask tubing from the ventilation module by turning gently. Remove the HumidX if applicable. Disconnect the ventilation module from the AirMini tubing. Pinch one side of the cushion to detach it from the rigid frame. Unhook the headgear from the stabilizer by pulling on the cap to release the buttonhole. Follow the reverse steps for reassembly.

What is the service life of the AirFit N30 mask?

Service life depends on use, maintenance, and ambient conditions. There is no fixed duration, but it is recommended to replace any component showing signs of wear. The HumidX/HumidX Plus must be replaced every 30 days after opening. Refer to the manual for visual inspection criteria.

USER MANUAL AirFit N30 ResMed

A curved dotted line with black dots, resembling a stylized wave or curve (no text or symbols)

ResMed

AirFit™ N30 for AirMini™

Nasal cradle system

Device Setting

Pillows

User guide

The AirFit N30 for AirMini Mask System is an accessory that is used for channeling airflow to a patient non-invasively. It has custom connecting ports to ensure that it can only be connected to compatible ResMed CPAP devices.

The AirFit N30 for AirMini mask is intended to be used by patients weighing more than 66 lb (30 kg) who have been prescribed non-invasive positive airway pressure (PAP) therapy such as CPAP therapy. It 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 sleep apnoea (OSA).

GENERAL WARNINGS

• 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.
• The mask is not suitable for patients requiring life support ventilation.
• 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 this mask if you have ANY adverse reaction to the use of the mask, and consult your physician or sleep therapist.
• The mask is not compatible with supplemental oxygen.
• 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.
• The mask must only be used with listed compatible therapy device(s) and only as recommended by a physician or respiratory therapist. The AirFit N30 for AirMini requires connection to the listed compatible systems to provide therapy.
  • Refer to your therapy device manual for details on settings and

GENERAL WARNINGS

operational information.

- The AirMini system comes with a vent system to prevent carbon dioxide build-up in the mask. The vent system must be kept clean and clear of contamination in order to function correctly. Blocking or modifying the vent system may result in excessive carbon dioxide rebreathing.

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 your mask

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

HumidX and HumidX Plus

The HumidX and HumidX Plus are waterless humidifiers. These are designed to provide more comfort by improving the moisture level in the air you breathe and offering relief from possible dryness.

The HumidX is a good starting point for finding the right level of humidification. The HumidX Plus will improve the humidity level further and is useful when the ambient humidity level is very low (eg. high altitudes, on an aircraft).

The HumidX and HumidX Plus must be replaced within 30 days of opening the HumidX/HumidX Plus pack. For any issues with the HumidX or HumidX Plus, refer to the AirMini user guide.

Fitting your mask

To set up your AirMini machine, refer to the AirMini user guide. Once you have set up your AirMini, follow these steps to fit 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

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• 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

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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

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1. Disconnect the mask tubing from the vent module by gently twisting it and pulling apart. If you are using the HumidX or HumidX Plus, remove it from the vent module.
2. Disconnect the vent module from the AirMini tubing by gently twisting it and pulling apart.
3. Firmly pinch one side of the cushion and pull away from the frame.
4. Unhook the headgear from the stabilizer by pulling on the end cap to reveal the buttonhole.
5. Slide the headgear off the end of the stabilizer.

Reassembling your mask

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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.
5. Connect the AirMini tubing to the vent module by pushing the ends together and twisting until it locks in place.
6. To add optional humidification, insert the HumidX/HumidX Plus into the vent module. Connect the mask tubing to the vent module by pushing the ends together and twisting until it locks in place.

Cleaning your mask

Follow the cleaning instructions in this guide to maintain performance and safety of the mask.

WARNING

• Regularly clean your mask and components to receive optimal therapy and to prevent the growth of germs that can adversely affect your health.
• Regularly inspect the HumidX/HumidX Plus and follow the cleaning and maintenance instructions to prevent the growth of germs that can adversely affect your health.
• 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 vapors that could be inhaled if not rinsed thoroughly. Do not use a dish washer or washing machine to clean your mask.

Inspect the HumidX/HumidX Plus

1. Check daily for any signs of damage or blockages caused by dirt or dust.

Notes:

• HumidX/HumidX Plus cannot be washed.
- When HumidX/HumidX Plus is not being used, store it in a clean, dry location.
• HumidX/HumidX Plus must be replaced 30 days after opening.

Cleaning the AirMini tube

Refer to your AirMini user guide for cleaning instructions.

Cleaning the vent module

1. Clean and check the vent module daily.
2. Wash in warm water using a mild liquid detergent.
3. Clean with a soft bristle brush paying particular attention to the vent holes
4. Rinse well under running water. Shake to remove excess water and allow to air dry out of direct sunlight.
5. Check that there is no dirt or dust in the vent holes.

Note: Do not wash in a dishwasher or washing machine.

Technical illustration of a mechanical component with cross-sectional view and magnified detail (no text or symbols)

Cleaning the mask cushion, headgear and frame

After each use: Cushion

Weekly: Headgear and frame

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.

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.

CAUTION

• Visual 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.
• When fitting the mask, do not overtighten the headgear as this may lead to skin redness or sores around the mask cushion.
• Do not iron the headgear as the material is heat sensitive and will be damaged.

Troubleshooting

For troubleshooting issues with HumidX/HumidX Plus, refer to the AirMini user guide.

Technical specifications

Notes:

• The AirFit N30 for AirMini, when connected to the AirMini system, contains a vent system to prevent CO_2 build-up in the mask.
• For technical specifications related to venting, refer to the AirMini user guide.
• The manufacturer reserves the right to change these specifications without notice.

Therapy pressure: 4 to 20 cm H _2 O

Environmental conditions

Operating temperature: 41^ F to 104^ F ( 5^ C to 40^ C)

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

Storage and transport temperature: -4°F to 140°F (-20°C to +60°C)

Storage and transport humidity: up to 95% RH non-condensing

Sound: Declared dual-number noise emission values in accordance with ISO4871:1996 and ISO3744:2010. A-weighted sound power level is 22 dBA, with uncertainty of 3 dBA. A-weighted pressure level at a distance of 1 m is 15 dBA, with uncertainty of 3 dBA.

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. For the service life of the AirMini tube, vent module and HumidX/HumidX Plus refer to the AirMini device user 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.

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:

RxOnly Prescription only (In the US, Federal law restricts these devices to sale by or on the order of a physician.)

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.

Three-panel illustration showing a person receiving neck pain pressure using a medical tube, with arrows indicating direction of movement (no text or symbols)

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Taille - Petit large

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Decision Setting Pillows

⚠️ ALGEMENE WAARSCHUWINGEN

ALGEMENE WAARSCHUWINGEN

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Storlek – Small, Wide (bred)

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Apparatinnstilling – puter

Størrelse – medium

Størrelse – small wide (liten bred)

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清洗面罩护垫、头带和框架

每次使用后：护垫

每周清洗：头带和框架

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倘要取下面罩系統，將面罩和頭帶的對開束帶向上拉過頭頂即可。

拆卸面罩進行清潔

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Technical illustration of a mechanical component with cross-sectional view and magnified detail (no text or symbols)

清潔面罩軟墊、頭帶和框架

每次使用後：軟墊

每週清潔：頭帶與面罩框

Bella Vista NSW 2153 Australia

See ResMed.com for other ResMed locations worldwide. AirFit, AirMini and HumidX 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. 638213/3 2020-08

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