ResMed Mirage FX For Her Nasal CPAP Mask Manual do usuário

Mirage™ FX for Her

NASAL MASK

User Guide

English • Français • Español • Português

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Did you know?

Replacing your mask and supplies is

one of the most important steps in

maintaining effective therapy.

Replace when...

• The cushion is no longer clear and

transparent.

• The cushion is cracked, torn or

damaged in any way.

• The headgear is stretched and

needs to be tightened more than

when it was new.

What to do...

Consult your equipment provider to learn

what replacement schedule may be

available through your insurance policy.

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Fitting/Ajustement/Colocación/Colocação e ajuste

3

1

4

5

6

Mirage FX

for Her

Mirage FX

for Her

2

Mirage™ FX for Her

nasal mask

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Removal/Retrait/Remoción/Remoção

Disassembly/Démontage/Desmontaje/Desmontagem

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2

1

2

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Reassembly/Remontage/Montaje/Remontagem

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Mirage FX for Her

A

B

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Mask components/Composants du masque/

Piezas de la mascarilla/Componentes da máscara

Item/

Article/

Artículo/

Item

Description/Description/Descripción/Descrição

1 Mask frame/Entourage rigide/Armazón de la mascarilla/

Armação da máscara

2 Forehead support/Support frontal/Apoyo para la frente/

Suporte para a testa

3 Cushion/Bulle/Almohadilla/Almofada

4 Vent/Oriﬁce de ventilation/Ventilación/Respiradouro

5 Headgear/Harnais/Arnés/Arnês

6 Elbow assembly/Ensemble coude/Conjunto del codo/

Conjunto do cotovelo

7 Elbow side tabs/Pattes d’attache latérales coude/

Lengüetas laterales del codo/Abas laterais do cotovelo

A Complete system/Système complet/Sistema completo/

Sistema completo

B Frame system/Entourage complet/Sistema de armazón/

Sistema da armação

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English

Mirage™ FX for Her

Nasal MasK

Thank you for choosing the Mirage FX for Her. Please read the entire

manual before use.

Intended use

The Mirage FX for Her channels airﬂow non-invasively to a patient

from a continuous positive airway pressure (CPAP) or bilevel device.

The Mirage FX for Her is:

• to be used by patients (> 66 lb/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

• The vent holes must be kept clear.

• This 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.

Explanation: CPAP and bilevel devices are intended to be

used with special masks (or connectors which have vent holes

to allow continuous ﬂow of air out of the mask. When the

device is turned on and functioning properly, new air from

the device ﬂushes the exhaled air out through the mask vent

holes. However, when the device is not operating, insufﬁcient

fresh air will be provided through the mask, and the exhaled

air may be rebreathed. Rebreathing of exhaled air for longer

than several minutes can, in some circumstances, lead to

suffocation. This applies to most models of CPAP or bilevel

devices.

• 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.

• Remove all packaging before using the mask.

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2

• 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.

Using your mask

When using your mask with ResMed CPAP or bilevel devices that

have mask setting options, refer to the Technical speciﬁcations section

in this user guide for mask setting options.

For a full list of compatible devices for this mask, see the

Mask/Device Compatibility List on www.resmed.com on the

Products page under Service & Support. If you do not have internet

access, please contact your ResMed representative.

Note: If you experience nasal dryness or irritation, using a humidiﬁer

is recommended.

Fitting

The ﬁtting illustrations section in this user guide show the sequence

for obtaining the best ﬁt and comfort when using your mask.

Fitting steps

Prior to ﬁtting your mask, remove the elbow from the mask by

pressing the side tabs. Connect the elbow to your device air tubing.

1. With both lower headgear straps released, hold the mask

against your face and pull the headgear over your head.

2. Bringing the lower straps below your ears, loop the headgear

into the lower hooks on the mask frame.

3. Unfasten the Velcro

®

, pull the upper headgear straps evenly

until they are comfortable and reattach the Velcro. Do not

overtighten.

4. Repeat step 3 with the lower headgear straps.

5. Attach the combined elbow assembly and air tubing to the

mask by pressing the side-tabs and pushing into mask frame.

6. Your mask and headgear should be positioned as shown.

Ensure the headgear label is facing outwards.

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English

Removing the mask

Refer to the removal illustrations section in this user guide. To remove

your mask, disconnect one of the lower headgear hooks and pull the

mask and headgear up over your head.

Disassembly

Refer to the disassembly illustrations in this user guide.

Disassembly steps

1. Unhook the upper headgear straps from the mask frame, there

is no need to undo the Velcro.

2. Remove the combined elbow assembly and air tubing from the

mask by pressing the side-tabs and pulling away from the mask

frame. Remove the elbow assembly from the air tubing.

3. Gently separate the cushion from the mask frame.

Reassembly

Refer to the reassembly illustrations in this user guide.

Reassembly steps

1. Ensure the cushion is oriented correctly by aligning the top

cushion tab with the recess in the top of the mask.

2. Gently pull the cushion through the front of the mask frame

until the cushion locks securely into the mask frame. The tabs

on either side of the cushion should be sitting against the mask

frame. Ensure the cushion is not twisted or distorted.

3. Attach the top headgear straps to the mask frame by looping

onto each of the upper headgear hooks.

4. Replace the elbow assembly into the air tubing and attach

the combined elbow assembly and air tubing to the mask by

pressing the side-tabs and pushing into the mask.

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Cleaning your mask in the home

Your mask and headgear should only be gently handwashed.

Daily/After each use:

• Disassemble the mask components according to the disassembly

instructions.

• Thoroughly clean the separated mask components (excluding

headgear), by gently rubbing in warm (approximately 86°F/30°C)

water using mild soap.

• To optimize the mask seal, facial oils should be removed from the

cushion after use.

• Use a soft bristle brush to clean the vent.

• Inspect each component and if required, repeat washing until

visually clean.

• Rinse all components well with drinking quality water and allow to

air dry out of direct sunlight.

• When all components are dry, reassemble according to the

reassembly instructions.

Weekly:

• Handwash the headgear.

WARNING

Do not use aromatic-based solutions or scented oils (eg,

eucalyptus or essential oils), bleach, alcohol or products that

smell strongly (eg, citrus) to clean any of the mask components.

Residual vapours from these solutions can be inhaled if not

rinsed thoroughly. They may also damage the mask.

CAUTION

If any visible deterioration of a system component is apparent

(cracking, crazing, tears etc), or, if after cleaning, any component

remains unclean, the component should be discarded and

replaced.

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English

Reprocessing the mask between patients

Only Sleep Lab Mask (SLM) variants of the mask 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.

Troubleshooting

Problem/possible cause Solution

Mask is too noisy

Vent is blocked or partially blocked. If the vent requires cleaning, use a

soft bristle brush.

Elbow incorrectly inserted. Remove the elbow from the mask

and then reassemble according to

the instructions.

Mask leaks around the face

Mask not positioned correctly. Gently pull the cushion away from

the face to reinﬂate. Reposition

your mask according to the

instructions.

Air leaking around the bridge of the nose

Mask is not tightened correctly. Tighten top headgear straps. Do

not overtighten.

Air leaking around the sides of the nose

Mask is not tightened correctly. Tighten both upper and lower

headgear straps. Do not

overtighten.

Turn off the CPAP or bilevel device

and remove mask. Reﬁt the mask

according to the instructions.

Ensure you position the cushion

correctly on the face before pulling

headgear over the head.

Do not slide mask down the face

during ﬁtting as this may lead to

folding or curling of the cushion.

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The mask does not ﬁt properly

Mask is incorrectly assembled. Disassemble the mask, then

reassemble according to the

instructions.

Cushion may be dirty. Clean cushion according to the

instructions.

WARNING

• 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.

• 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 devices.

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English

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.

Vent ﬂow rate (L/min)

0

10

20

30

40

50

60

4 6 8 10 12 14 16 18 20

Mask pressure (cm H

2

O)

Pressure

(cm H

2

O)

Flow

(L/min)

4 19

8 28

12 34

16 40

20 45

Dead space

information

Physical dead space is the empty volume of the mask

to the end of the swivel.

FX: 93 mL

FX Small: 71 mL

Therapy

pressure

4 to 20 cm H

2

O

Resistance Drop in pressure measured (nominal)

at 50 L/min: 0.2 cm H

2

O

at 100 L/min: 1.0 cm H

2

O

Environmental

conditions

Operating temperature: +41°F to +104°F

(+5°C to +40°C)

Operating humidity: 15% to 95% non-condensing.

Storage and transport: -4°F to +140°F

(-20°C to +60°C)

Storage and transport humidity: up to 95% non-

condensing.

Gross

dimensions

Mask fully assembled with elbow assembly – no

headgear.

FX: 5.43“ (H) x 3.38“ (W) x 3.46 “ (D)

138 mm (H) x 86 mm (W) x 88 mm (D)

FX Small: 4.88“ (H) x 3.23“ (W) x 3.46 “ (D)

124 mm (H) x 82 mm (W) x 88 mm (D)

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Mask setting

options

For S9: Select ‘NASAL’

For other devices: Select ‘STANDARD’, otherwise

select ‘VISTA’ as the mask option.

Notes:

• The mask system does not contain PVC, DEHP or phthalates.

• This product does not contain natural rubber latex.

• 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.

Symbols

The following symbols may appear on your product or packaging.

Caution, consult accompanying documents;

LOT

Batch Code;

REF

Catalogue number; Temperature limitation; Humidity

limitation;

Does not contain natural rubber latex; Manufacturer;

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;

Keep away from rain; This way up; Fragile,

handle with care;

European Authorized Representative;

Prescription only (In the US, Federal law restricts these devices to

sale by or on the order of a physician.)

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English

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.

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Le saviez-vous?

Il est essentiel de remplacer votre

masque et les fournitures aﬁn de garantir

l'efﬁcacité du traitement.

Remplacez...

• si la bulle n'est plus claire et

transparente;

• si la bulle est ﬁssurée, déchirée ou

endommagée d'une quelconque

manière;

• si le harnais est étiré et qu'il faut le

serrer davantage qu'à l'état neuf.

Procédure...

Contactez votre consultant en soins

à domicile pour en savoir plus sur la

fréquence de remplacement prise en

charge par votre police d'assurance.

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Français

Mirage™ FX for Her

MASQUE nASAl

Merci d'avoir choisi le Mirage FX for Her. Veuillez lire le guide dans

son intégralité avant d’utiliser ce masque.

Usage prévu

Le Mirage FX for Her achemine au patient de façon non invasive le

débit d'air produit par un appareil à pression positive continue (PPC)

ou une VNDP.

Le Mirage FX for Her est prévu pour:

• une utilisation par des patients adultes (>66lb/30kg) à qui une

pression positive a été prescrite;

• un usage multiple par un seul patient à domicile ou pour un usage

multiple par plusieurs patients en milieu médical.

AVERTISSEMENT

• Les orifices de ventilation ne doivent jamais être obstrués.

• Ce masque ne doit être utilisé qu'avec des appareils de PPC

oude VNDP recommandés par un médecin ou un spécialiste

de la respiration.

• Le masque ne peut être porté que si l’appareil est sous

tension. Une fois le masque en place, s’assurer que l’appareil

produit un débit d’air.

Explication : les appareils de PPC et de VNDP sont utilisés

avec des masques (ou des connecteurs) spéciaux possédant

des orifices de ventilation permettant l'expulsion continue de

l'air en dehors du masque. Lorsque l'appareil est mis sous

tension et fonctionne correctement, il produit de l'air frais

qui expulse l'air expiré, à travers les orifices de ventilation

du masque. Toutefois, lorsque l'appareil ne fonctionne pas,

une quantité insuffisante d'air frais est produite et l'air expiré

risque d'être de nouveau inhalé. La réinspiration d'air inspiré,

pendant une période supérieure à plusieurs minutes peut,

dans certaines circonstances, provoquer une suffocation. La

plupart des appareils de PPC et de VNDP sont concernés par

ce problème.

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• Prendre toutes les précautions applicables lors de l’adjonction

d’oxygène.

• L’oxygène est inflammable. Il ne faut pas fumer et utiliser de

l'oxygène en même temps ni utiliser de l'oxygène en présence

d'une flamme nue. L'oxygène ne doit être utilisé que dans des

salles bien ventilées.

• L’arrivée d’oxygène doit être fermée lorsque l’appareil de PPC

ou la VNDP n’est pas en marche afin d’empêcher l’oxygène

inutilisé de s’accumuler dans le boîtier de l’appareil et de créer

un risque d’incendie.

• Retirer tout l’emballage avant d’utiliser le masque.

Utiliser votre masque

Si vous utilisez le masque avec un appareil de PPC ou une VNDP

ResMed disposant d’une fonction de sélection du masque, veuillez

consulter la partie Caractéristiques de ce guide utilisateur pour

davantage d’informations sur cette fonction.

Pour une liste complète des appareils compatibles avec ce masque,

veuillez consulter la liste de compatibilité entre les masques et les

appareils sur le site www.resmed.com à la page Produits, sous la

rubrique SAV et assistance. Si vous n'avez pas accès à Internet,

veuillez contacter votre revendeur ResMed.

Remarque: En cas de sécheresse ou d’irritation nasale, il est

recommandé d’utiliser un humidificateur.

Mettre le masque en place

Les illustrations de ce guide utilisateur indiquent comment mettre en

place le masque afin d’obtenir un ajustement et un confort optimaux

lors de son utilisation.

Procédure d’ajustement

Avant de mettre votre masque, retirez le coude du masque en

appuyant sur les pattes d'attache latérales. Raccordez le coude au

circuit respiratoire de votre appareil.

1. Avec les deux sangles inférieures du harnais détachées,

maintenez fermement le masque sur votre visage et faites

passer le harnais par-dessus votre tête.

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3

Français

2. En faisant passer les sangles inférieures sous vos oreilles,

attachez le harnais en formant une boucle dans les crochets

inférieurs de l'entourage rigide du masque.

3. Défaites les bandes Velcro

®

, tirez sur les sangles supérieures

du harnais de façon égale jusqu'à ce qu'elles soient

confortables et rattachez les bandes Velcro. Ne serrez pas trop

fort.

4. Veuillez répéter l'étape3 pour les sangles inférieures du

harnais.

5. Branchez l'ensemble coude et circuit respiratoire au masque en

appuyant sur les pattes d'attache latérales et en poussant sur

l'entourage rigide du masque.

6. Le masque et le harnais doivent être positionnés comme

indiqué sur l'illustration. Assurez-vous que l'étiquette du harnais

est bien dirigée vers l'extérieur.

Retirer le masque

Veuillez consulter les illustrations de retrait que vous trouverez dans

ce guide utilisateur. Pour retirer votre masque, détachez l'un des

crochets inférieurs du harnais et faites passer le masque et le harnais

par-dessus votre tête.

Démonter le masque

Veuillez consulter les illustrations de démontage que vous trouverez

dans ce guide utilisateur.

Procédure de démontage

1. Décrochez les sangles supérieures du harnais de l'entourage

rigide du masque (il n'est pas nécessaire de défaire les bandes

Velcro).

2. Retirez l'ensemble coude et circuit respiratoire du masque en

appuyant sur les pattes d'attache latérales et en tirant pour le

retirer de l'entourage rigide. Retirez l'ensemble coude du circuit

respiratoire.

3. Retirez la bulle de l’entourage avec précaution.

628024r2 Mirage FX for Her AMER Multi.indb 3 2/11/2012 2:26:35 PM

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