ResMed AirFit N30 User Manual

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USER GUIDE

ENGLISH

A	Split-band headgear	3	End cap
B	Cushion	4	Stabilizer
C	QuietAir™ / standard frame	5	QuietAir vent
1	Buckle	6	Vent
2	Buttonhole	7	Mask tubing

Intended use

The AirFit N30 nasal cradle 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 or bi-level therapy. The mask is intended for single patient re-use in the home and multipatient re-use in the hospital/institutional environment.

QuietAir frame

The QuietAir frame is intended for single patient re-use in the home and hospital/institutional environment.

English 1

Fitting 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.

2

Adjusting your mask

•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

To take off your mask system, pull the mask and headgear by the split-band up and over your head.

English 3

Disassembling your mask for cleaning

1.Firmly pinch one side of the cushion and pull away from the frame.

2.Unhook the headgear from the stabilizer by pulling on the end cap to reveal the buttonhole.

3.Slide the headgear off the end of the stabilizer.

Cleaning your mask

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.

4

Reassembling your mask

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.

English 5

WARNING

•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

•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 in combination with incompatible medical devices can decrease the safety or alter the performance of the mask.

•The mask is not suitable for patients requiring life support ventilation.

•Regularly clean your mask and its components to maintain the quality of your mask and to prevent the growth of germs that can adversely affect your health.

•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 or replace this mask if the patient has ANY adverse reaction to the use of the mask. Consult your physician or sleep therapist.

•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.

•Refer to your CPAP or bilevel device manual for details on settings and operational information.

•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

•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.

6

CAUTION

•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.

•When fitting the mask, do not overtighten the headgear as this may lead to skin redness or sores around the mask cushion.

•Avoid connecting flexible PVC products (eg, PVC tubing) directly to any part of the mask. Flexible PVC contains elements that can be detrimental to the materials of the mask, and may cause the components to crack or break.

•Do not iron the headgear as the material is heat sensitive and will be damaged.

Technical specifications

Mask setting options: For AirSense: Select 'Pillows'.

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

Pressure	Flow
(cm H2O)	(L/min)
4	20
8	29
12	37
16	43
20	49

Therapy pressure: 4 to 20 cm H20

Resistance: Drop in pressure measured (nominal) at 50 L/min: 0.4 cm H2O

at 100 L/min: 1.7 cm H2O

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

Power level (with QuietAir Frame): 25 dBA Pressure level (with QuietAir frame): 18 dBA Power level (with standard frame): 28 dBA Pressure level (with standard frame): 21 dBA

Environmental conditions

Operating temperature: 41°F to 104°F (5°C to 40°C) Operating humidity: 15% to 95% RH non-condensing

English 7

Storage and transport temperature: -4°F to 140°F (-20°C to +60°C) Storage and transport humidity: up to 95% RH non-condensing

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.

Note: The manufacturer reserves the right to change these specifications without notice.

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 of the mask system are intended for multi-patient reuse. When using between patients, these masks must be reprocessed according to instructions available on ResMed.com/downloads/masks.

Symbols

The following symbols may appear on your product or packaging:

Nasal cradle mask	Device setting - Pillows
QuietAir vent	Size - small
Size - medium	Size - small wide

Caution, consult accompanying documents.

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.

8

Limited warranty

ResMed Pty Ltd (hereafter ’ResMed’) warrants that your ResMed mask system (including mask frame, cushion, headgear and tubing) shall be free from defects in material and workmanship from the date of purchase for the period of 90 days or in the case of disposable masks the maximum use period. This warranty is only available to the initial consumer. It is not transferable. If the product fails under conditions of normal use, ResMed will repair or replace, at its option, the defective product or any of its components. This limited warranty does not cover: a) any damage caused as a result of improper use, abuse, modification or alteration of the product; b) repairs carried out by any service organization that has not been expressly authorized by ResMed to perform such repairs; and c) any damage or contamination due to cigarette, pipe, cigar or other smoke. Warranty is void on product sold, or resold, outside the region of original purchase.

Warranty claims on defective product must be made by the initial consumer at the point of purchase.

This warranty replaces all other expressed or implied warranties, including any implied warranty of merchantability or fitness for a particular purpose. Some regions or states do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you.

ResMed shall not be responsible for any incidental or consequential damages claimed to have resulted from the sale, installation or use of any ResMed product. Some regions or states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation may not apply to you. This warranty gives you specific legal rights, and you may also have other rights which vary from region to region. For further information on your warranty rights, contact your local ResMed dealer or ResMed office.

English 9

FRANÇAIS

A	Harnais avec bande à lanière	3	Capuchon
	double
B	Bulle	4	Stabilisateur
C	Entourage rigide	5	Orifice de ventilation QuietAir
	QuietAir™/standard
1	Boucle	6	Orifice de ventilation
2	Boutonnière	7	Circuit du masque

Usage prévu

Le masque ultra-compact nasal AirFit N30 est destiné aux patients de plus de 30 kg (66 lb) à qui un traitement par pression positive non invasif, comme un traitement par PPC ou à deux niveaux de pression, a été prescrit. Le masque est prévu pour un usage multiple par un seul patient à domicile ou pour un usage multiple par plusieurs patients à l’hôpital ou en milieu médical.

Entourage rigide QuietAir

L'entourage rigide QuietAir est prévu pour une utilisation multiple par un seul patient à domicile ou en milieu médical.

Français 1

Ajustement de votre masque

1.Tout en tenant la bulle éloignée de votre visage, assurez-vous que la taille de la bulle et les indicateurs de gauche (L) et de droite (R) sont face à vous. Placez la bulle sous votre nez.

2.Tirez les bandes du harnais au-dessus de votre tête en tenant la bande inférieure et en la tirant vers l'arrière de votre crâne. La bande supérieure doit être installée de manière confortable sur le haut du crâne.

3.Éloignez brièvement le masque de votre visage et remettez-le en place pour vous assurer que la bulle repose confortablement.

2

Ajustement de votre masque

•Pour un positionnement confortable, ajustez les lanières de la bande en les séparant pour un ajustement plus lâche ou en les rapprochant pour un ajustement plus serré.

•Pour éliminer les fuites au niveau du masque, ajustez le harnais en tirant dessus à travers la boucle. Ne le serrez pas trop : ajustez-le uniquement pour obtenir une étanchéité confortable. Il est éventuellement nécessaire d'ajuster le harnais car il s'étire au fil du temps.

Votre masque est maintenant prêt à être utilisé. En position allongée ou pendant le fonctionnement de l'appareil, un mince filet d'air devrait s'échapper autour de la connexion du circuit respiratoire. Pour vérifier les orifices de ventilation, posez votre doigt à proximité de la zone de connexion pour détecter l'air. La zone des orifices de ventilation ne doit pas être bloquée.

Retrait de votre masque

Pour retirer votre masque, utilisez les lanières de la bande pour tirer le masque et le harnais par-dessus votre tête.

Français 3