ResMed AirFit N10 Mask with Headgear User Guide

: June 10, 2024
: ResMed

Table of Contents

ResMed AirFit N10 Mask with Headgear
Product Information
Specifications
Product Usage Instructions
Fitting
Removal
Disassembly
Reassembly
Contraindications
Using the mask
Technical Specifications
Symbols
GENERAL WARNINGS
Consumer Warranty
Ordering Information
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

ResMed AirFit N10 Mask with Headgear

Product Information

The AirFit N10 Nasal Mask is a device that channels airflow noninvasively from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device to a patient. The mask is intended for single-patient re-use in the home environment and multi-patient re-use in the hospital/institutional environment. The mask is equipped with magnets that are within ICNIRP guidelines for general public use. However, patients with active medical implants, such as a pacemaker or defibrillator, should keep the magnetic clips at least 50 mm away from any active medical implant to avoid any interference.

The AirFit N10 Nasal Mask is contraindicated in patients with a metallic hemostatic clip implanted in their head to repair an aneurysm, and metallic splinters in one or both eyes following a penetrating eye injury.

The mask system does not contain natural rubber latex, PVC, DEHP, or phthalate materials. The mask setting options and compatible devices are provided in the Mask/Device Compatibility List on www.resmed.com on the Products page under Service & Support.

Specifications

Pressure (cm H2O): 4-30
AirFit N10 Flow (L/min): 20-61 (varies with pressure)
Deadspace: 104 mL (Wide) (Empty volume of the mask to swivel; varies with cushion size)
Resistance: Drop in pressure measured (nominal) (cm H2O) at 50 L/min: 0.4; at 100 L/min: 1.2
Sound: DECLARED DUAL-NUMBER NOISE EMISSION VALUES in accordance with ISO 4871. The A-weighted sound power level and variations, the vent flow rate may vary.

Product Usage Instructions

Refer to the Technical Specifications section in the user guide for mask setting options.
Follow the instructions provided by your physician or sleep therapist for using the mask.
To fit, remove, disassemble, or reassemble your mask, follow the illustrations at the front of the user guide.
Do not overtighten the headgear straps. If you feel air leaks, you may need to have your mask refitted.
To clean the mask at home:
- Daily/After each use: Handwash the separated mask components (excluding headgear and soft sleeves). To optimize the mask seal, facial oils should be removed from the cushion after use. If the vent or swivel requires cleaning, use a soft bristle brush.
- Weekly: Handwash the headgear and soft sleeves. The headgear may be washed without being disassembled.
If you use the mask between patients, the mask should be reprocessed. Cleaning, disinfection, and sterilization instructions are available from the ResMed website, www.resmed.com/masks/sterilization. If you do not have internet access, please contact your ResMed representative.

Fitting

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Removal

Disassembly

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Reassembly

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This document provides the user instructions for:

AirFit N10 (blue headgear) and AirFit N10 for Her (pink headgear) are collectively referred to as AirFit N10.

Intended Use
The AirFit N10 channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device.

The AirFit N10 is:

to be used by patients (>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.

WARNING
Magnets used in this mask are within ICNIRP guidelines for general public use. Some active medical implants—such as a pacemaker or defibrillator—may be affected by localized magnetic fields. The magnetic clips in this mask should be kept at least 50 mm away from any active medical implant.

Contraindications

Use of the AirFit N10 may be contraindicated in some 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 following a penetrating eye injury.

Using the mask

Refer to the Technical Specifications section in this user guide for mask setting options.
Follow the instructions provided by your physician or sleep therapist.
To fit, remove, disassemble, or reassemble your mask, follow the illustrations at the front of this guide.
Do not overtighten the headgear straps. If you feel air-leaks
you may need to:
- refit or reposition your mask
- adjust your headgear
- check that your mask is assembled correctly
- contact your physician or sleep therapist to have your mask refitted.
For a full list of compatible devices and mask setting options, see the “Mask/Device Compatibility List” on www.resmed.com on the Products page under Service & Support.
The mask system does not contain natural rubber latex, PVC, DEHP or phthalates materials.

Daily/After each use:

To optimize the mask seal, facial oils should be removed from the cushion after use.
Handwash the separated mask components (excluding headgear and soft sleeves).
If the vent or swivel requires cleaning, use a soft bristle brush.

Weekly:
Handwash the headgear and soft sleeves. The headgear may be washed without being disassembled.

Reprocessing the mask between patients
This mask should be reprocessed when used between patients. Cleaning, disinfection, and sterilization instructions are available from the ResMed website, www.resmed.com/masks/sterilization. If you do not have internet access, please contact your ResMed representative.

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. $ResMed-AirFit-N10-Mask-with-Headgear-fig- $6$$

	AirFit N10
Pressure (cm H2O)	Flow (L/min)
4	20
11	35
17	44
24	54
30	61

Deadspace: Empty the volume of the mask to swivel. The dead space of the mask varies according to cushion size.
104 mL (Wide)
Therapy pressure (cm H2O)
4-30

Resistance: Drop in pressure measured (nominal) (cm H2O)

at 50 L/min 0.4
at 100 L/min 1.2

AirFit N10

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 the uncertainty of 3 dBA, are shown.

Power level 31
Pressure level at 1 m 23

Gross Dimensions:
Mask fully assembled – no headgear. The largest variant is only shown.

Height 483 mm
Width 155 mm
Depth 110 mm

Environmental conditions

Operating temperature: +5°C to +40°C
Operating humidity: 15% to 95% non-condensing
Storage and transport temperature: -20°C to +60°C
Storage and transport humidity: up to 95% non-condensing

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.

Symbols

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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.
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 settings and operational information.
Remove all packaging before using the mask.
This mask must be disinfected and/or sterilized when used between users.
Do not combine components from different mask systems.
Always follow cleaning instructions and use mild soap. Some cleaning products may damage the mask, its parts, and its function, or leave harmful residual vapours that could be inhaled if not rinsed thoroughly.

CAUTION
If any visible deterioration of a mask component is apparent (cracking, tears, etc), the mask component should be discarded and replaced.

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.