AirFit N10 - Medical device ResMed - Free user manual and instructions

USER MANUAL AirFit N10 ResMed

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ResMed

AirFit™ N10

Nasal Mask

User Guide

Slovenčina

AirFit™ N10

3D rendering of a medical device with blue and gray straps and a white connector (no text or symbols visible)

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AirFit™ N10

Fitting / Anlegen / Mise en place / Applicazione / Colocación / Colocação / Opzetten / Topoθέτηση της μάσκας / Zakładanie maski / A maszk felhelyezése / Установка маски / Nastavenie masky / Maskenin Takılması / Nasazení masky

AirFit™ N10

Removal / Abnehmen / Retrait / Rimozione / Para quitarla / Remoção / Afnemen / Aφαίρεση / Zdejmowanie / Levétel / Снятие маски / Snímanie / Çikarma / Sejmutí masky

Medical illustration showing a procedure on nasal and oral airway treatment with labeled step 1

Line drawing of a person applying nasal pressure with a medical device (no text or symbols)

Disassembly / Auseinanderbau / Démontage / Smontaggio / Desmontaje / Desmontagem / Demontage / Αποσυναρμολόγηση / Demontaż / Szétszerelés / Разборка / Rozobratie / Sökme / Demontáż

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Illustration of a mechanical tool interacting with a component, showing a handle and lever mechanism (no text or symbols)

Illustration of two hands holding a tool with an arrow indicating direction (no text or symbols)

AirFit™ N10

Reassembly / Zusammenbau / Remontage / Riassemblaggio / Montaje / Montagem / Opnieuw monteren / Επανασυναρμολόγηση / Składanie / Összeszerelés / Повторная сборка / Opätovné zloženie / Yeniden Montaj / Opětovné sestavení

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English

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 multipatient 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 localised 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 handwashed in warm (30°C) water using mild soap.

Daily/After each use:

• To optimise 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 sterilisation 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.

AirFit N10

Pressure (cm H2O)	Flow (L/min)
4 20
11 35
17 44
24 54
30 61
Deadspace: Empty volume of mask to swivel. The deadspace 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 uncertainty of 3 dBA, are shown.

Power level 31

Pressure level at 1 m 23

Gross Dimensions: Mask fully assembled – no headgear. Largest variant 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 -20°C to +60°C

temperature:

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

Catalog number

Batch code

Humidity limitation

Temperature limitation

Fragile, handle with care

Not made with natural rubber latex

Manufacturer

European Authorised Representative

Keep away from rain

This way up

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.

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 sterilised 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 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.

Deutsch

transport : condensation

Stockage

NOT MADE WITH NATURAL

RUGGER LATEX

Produttore

Rappresentante

autorizzato per

l'Europa

KEEP DRY

Tenere al riparo

dalla pioggia

THIS WAY UP

Alto

FRAGILE. HANDLE WITH CARE

Frágil, manusear com cuidado

NOT MADE WITH NATURAL RUBBER LATEX

ALGEMENE WAARSCHUWINGEN

1 Elizabeth Macarthur Drive, Bella Vista, NSW 2153. Australia

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

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