ResMed AirFit N30i and P30i User Guide

Product Overview

The AirFit N30i and AirFit P30i masks are designed for patients weighing over 66 lb (30 kg) who have been prescribed non-invasive positive airway pressure (PAP) therapy, such as CPAP or bi-level therapy. These masks are intended for single-patient re-use at home and multi-patient re-use in a hospital or institutional environment.

Components:

• A: Elbow
• B: Elbow ring
• C: Headgear
• D: Frame
• E: N30i nasal cushion
• F: P30i pillows cushion
• 1: Vent
• 2: QuietAir vent (removable)
• 3: Side buttons
• 4: Sleeve

Before Using Your Mask

Remove all packaging and inspect each mask component for visible deterioration. Use the fitting template to assist in selecting the right size cushion and frame.

Fitting Your Mask

1. Pull the frame and headgear over your head until the elbow is positioned on top and the headgear is behind your head.
2. Place the cushion under your nose. For the AirFit P30i mask, align the pillows into your nostrils.
3. Tighten or loosen the headgear until the cushion fits comfortably under your nose.
4. Squeeze the side buttons on the elbow and detach from the frame. Connect the air tubing from your device to the elbow, then reattach to the frame.

Adjusting Your Mask

• When using the mask, air will flow out of the vents in the cushion and elbow. If air leaks from the side or top of the cushion, adjust the mask fitting to improve the seal.
• You can position the top of the frame forward or backwards over your head until the mask feels comfortable.

Sizing the Mask Frame

If the mask frame falls back over your head or sits too close to your ears, try a small frame size. If the mask falls forward on your head or sits too close to your eyes, try a standard frame size.

Disassembling Your Mask for Cleaning

1. Pull the cushion from the frame.
2. Undo the fastening tabs on the headgear strap and pull it from the frame.
3. Squeeze the side buttons on the elbow and detach from the frame. Note: For the AirFit P30i mask, the QuietAir vent can be removed to allow inspection of the vent holes.

Cleaning Your Mask

After each use: Cushion

Weekly: Headgear, frame and elbow

1. Soak the components in warm water with a mild liquid detergent. Ensure that there are no air bubbles while soaking.
2. Hand wash the components with a soft bristle brush. Pay particular attention to the vent holes.
3. Thoroughly rinse the components under running water.
4. For the frame sleeves, squeeze with a clean towel to remove excess water. For the AirFit P30i mask, shake the QuietAir vent to remove any excess water. Leave the components to air dry out of direct sunlight.

If the mask components are not visibly clean, repeat the cleaning steps.

Reassembling Your Mask

1. Connect the elbow into the top of the frame until it clicks.
2. Insert the headgear strap into the frame and fold the fastening tabs backwards.
3. Insert the ends of the frame into the cushion, ensuring that the arrows on the cushion and frame are aligned.

Note:

• If the elbow ring detaches, re-insert into the top of the frame.
• If the QuietAir vent is removed from the AirFit P30i mask, reinsert it into the cushion.

Warnings and Cautions

WARNING

• The mask is not suitable for patients requiring life support ventilation.
• 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 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.
• Regularly clean your mask to maintain the quality of your mask and to prevent the growth of germs that can adversely affect your health.
• 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.
• 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 with incompatible devices may affect the performance or safety of the mask.
• In case of adverse reaction, discontinue use and consult your physician or sleep therapist.
• This mask is not intended to be used simultaneously with nebulizer medications that are in the air path of the mask/tube.

CAUTION

• Remove all packaging before using 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.
• When fitting the mask, do not overtighten the headgear as this may lead to skin redness or sores around the mask cushion.
• 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.
• As with all masks, some rebreathing may occur at low pressures.
• 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 vapours. Do not use a dish washer or washing machine to clean the mask.
• Do not iron the headgear as the material is heat sensitive and will be damaged.

Technical Specifications

Compatible devices: For a full list of compatible devices for this mask, see the Mask/Device Compatibility List at ResMed.com/downloads/masks.

Pressure-flow curve:

Mask setting options: For AirSense, AirCurve or S9

Therapy Pressure: 4 to 25 cm H₂O

Resistance: Drop in pressure measured (nominal)

• at 50 L/min: 0.4 cm H₂O
• at 100 L/min: 1.7 cm H₂O (N30i) / 1.5 cm H₂O (P30i)

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

• Sound power level: 24 dBA (N30i) / 21 dBA (P30i)
• Sound pressure level: 17 dBA (N30i) / 14 dBA (P30i)

Environmental conditions:

• Operating temperature: 41°F to 104°F (5°C to 40°C)
• Operating humidity: 15% to 95% non-condensing
• Storage and transport temperature: -4°F to 140°F (-20°C to +60°C)
• Storage and transport humidity: up to 95% non-condensing

Service life: The service life of the mask system is dependent on the intensity of usage, maintenance, and environmental conditions. Regular maintenance and inspection are recommended.

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 does not contain any hazardous substances and may be disposed of with your normal household refuse.

Reprocessing the Mask Between Patients

Only Sleep Lab Mask (SLM) variants are intended for multi-patient re-use. When using between patients, these masks must be reprocessed according to cleaning and disinfection instructions available on ResMed.com/downloads/masks.

Symbols

The following symbols may appear on your product or packaging:

• Nasal cradle mask
• Nasal pillows mask
• QuietAir vent
• Device setting - Pillows
• Cushion size - small (S)
• Cushion size - medium (M)
• Cushion size - large (L)
• Cushion size - wide (W)
• Cushion size - small wide (SW)
• Standard frame
• Small frame
• This product is not made with natural rubber latex.
• Caution, consult accompanying documents.

See symbols glossary at ResMed.com/symbols.

Limited Warranty

ResMed Ltd warrants that your ResMed mask system will be free from defects in material and workmanship for 90 days from the date of purchase, or 7 days for disposable masks and components. This warranty is for the initial consumer only and is non-transferable. If the product fails under normal use, ResMed will repair or replace it at its option. This limited warranty does not cover: a) damage from improper use, abuse, modification, or alteration; b) repairs by unauthorized service organizations; or c) damage or contamination from smoke. The warranty is void if the product is sold or resold outside the original region of purchase.

Warranty claims must be made by the initial consumer at the point of purchase. This warranty replaces all other express or implied warranties. Some regions or states may not allow limitations on implied warranty duration. ResMed is not responsible for incidental or consequential damages. Some regions or states may not allow the exclusion or limitation of incidental or consequential damages. This warranty gives you specific legal rights, and you may have other rights that vary by region.