ResMed AirFit N10 CPAP Nasal Mask User Guide

ResMed AirFit N10 CPAP Nasal Mask

Product Information

The AirFit N10 is a nasal mask designed to channel airflow from a positive airway pressure (PAP) device, such as a CPAP or bilevel device, to the patient. It is available in two versions: AirFit N10 with blue headgear and AirFit N10 for Her with pink headgear. The mask is intended for use by patients who have been prescribed positive airway pressure and can be used by patients weighing more than 30 kg. It is designed for single-patient re-use in home environments and multi-patient re-use in hospital/institutional environments.

The mask contains magnets that are within ICNIRP guidelines for general public use. However, it should be kept at least 50 mm away from any active medical implant, such as a pacemaker or defibrillator, as these implants may be affected by localized magnetic fields. There are contraindications for using the AirFit N10 in patients with metallic hemostatic clips implanted in their head or metallic splinters in one or both eyes due to a penetrating eye injury.

Product Usage Instructions

1. Refer to the Technical specifications section in the user guide for mask setting options.
2. Follow the instructions provided by your physician or sleep therapist.
3. To fit, remove, disassemble, or reassemble your mask, follow the illustrations at the front of the user guide.
4. Do not overtighten the headgear straps. If you experience air leaks, you may need to have the mask refitted.
5. 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.
6. The mask system does not contain natural rubber latex, PVC, DEHP, or phthalates materials.

Cleaning Instructions:
Daily/After each use:

• To optimize the mask seal, remove facial oils 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 Instructions:
If the mask is used between patients, it should be reprocessed. Cleaning, disinfection, and sterilization instructions are available on the ResMed website at www.resmed.com/masks/sterilization. If you do not have internet access, please contact your ResMed representative.

Technical Specifications:

• Pressure (cm H2O): 4-30
• AirFit N10 Flow (L/min):

Deadspace: Empty volume of mask to swivel. The deadspace of the mask varies according to cushion size. For the Wide cushion size, the deadspace is 104 mL.

Resistance (cm H2O):

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 Parts

Fitting

Removal

Disassemble

Reassembly

This document provides the user instructions for:

• AirFit N10 (blue headgear) and AirFit N10 for Her (pink headgear) 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 multipotent 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.

Cleaning the mask at home
The mask and headgear can only be gently handwasher in warm (30°C) water using mild soap.

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

Weekly:
Handwasher 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.

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

• Catalog number
• Humidity limitation
• Fragile, handle with care
• Manufacturer
• Keep away from rain
• Indicates a Warning or Caution and alerts you to a possible injury or explains special measures for the safe and effective use of the device
• Caution, consult accompanying documents.
• Batch code
• Temperature limitation
• Not made with natural rubber latex
• European Authorized Representative
• This way up

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 their function, or leave harmful residual vapors 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.

Ordering Information

| AirFit N10| AirFit N10 for Her
---|---|---
1| Headgear| 63260 (Std)| 63261 (S)
2| Upper headgear strap| —| —
3| Lower headgear strap| —| —
4| Magnet clips| —| —
5| Cushion| 63240 (Std) 63242 (W)| 63241 (S)
| AirFit N10| AirFit N10 for Her
6| Frame| —| —
7| Vent| —| —
8| Mask tubing| —| —
9| Swivel| —| —
10| Soft sleeves| —| —
A| Complete system| 63215 (Std) 63217 (W)| 63216 (S)
B| Frame system| 63230 (Std) 63232 (W)| 63231 (S)

• S small
• Std standard
• W wide

See www.resmed.com for other ResMed locations worldwide. For patent information,
see www.resmed.com/ip. AirFit is a trademark of ResMed Pty Ltd. © 2017 ResMed. 628056/2 2017-10

ResMed.com

References

• Sleep apnea and COPD - learn about symptoms and treatment | ResMed
• Sleep apnea and COPD - learn about symptoms and treatment | ResMed
• Legal disclaimers and intellectual property - ResMed

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