ResMed Mirage SoftGel User manual

Mirage™ SoftGel
nasal mask
User Guide
English

i
Fitting / Anlegen / Mise en place / Applicazione
1 2 3
4 5 6
Removal / Abnehmen der Maske / Retrait / Rimozione
della maschera
1 2
MirageTM SoftGel

ii
Mirage SoftGel
A
1
2
3
4
5
6
7
9
10
11
12
8
B C

iii
Mask components / Maskenkomponenten / Composants
du masque / Componenti della maschera
Item /
Artikel /
Article /
Articolo /
Artikel
Description / Beschreibung /
Description / Descrizione / Beschrijving Part number / Artikelnummer /
Code produit /
Numero parte /
Onderdeelnummer
1Mask frame / Maskenrahmen / Entourage
rigide / Telaio della maschera / Maskerframe 60180 (St)
60193 (S)
2Dial / Drehregler / Molette de réglage /
Selettore di regolazione / Draaiknop 61289
3Forehead support / Stirnstütze / Support
frontal / Supporto frontale / Voorhoofdsteun 16393
4Forehead support pad / Stirnpolster /
Tampon frontal / Imbottitura del supporto
frontale / Kussentje van voorhoofdsteun
60123 (1)
60124 (10)
5 SoftGel Cushion & clip / Maskenkissen und
Clip / Bulle et clip / Cuscinetto e fermaglio /
Kussentje en klem
61631 (S)
61632 (M)
61633 (L)
61634 (LW)
6Cushion clip / Maskenkissen-Clip / Clip de la
bulle / Fermaglio del cuscinetto / Klem voor
kussentje
60176 (St)
60197 (S)
7Headgear clip / Kopfband-Clip / Clip
d’attache du harnais / Fermaglio del
copricapo / Hoofdbandklem
16569 (2)
16734 (10)
8 Headgear / Kopfband / Harnais / Copricapo /
Hoofdband 16118 (S) 16117 (M)
16119 (L)
9Ports cap / Anschlusskappe / Bouchon
d’entrées / Coperchio delle prese / Poortkap 16570 (2)
16571 (10)
10 Swivel / Drehadapter / Pièce pivotante /
Giunto rotante / Draaibare kop 16565
11 Elbow / Kniestück / Coude / Gomito / Bocht 16387
12 Vent / Luftauslassöffnung / Orifice
de ventilation / Foro per l’esalazione /
Ventilatieopening
-

iv
A Complete system / Komplettes System /
Masque complet / Maschera con tutti i
componenti / Volledig systeem
61605 (S)
61606 (M)
61607 (L)
61608 (LW)
BElbow assembly / Kniestück mit
Drehadapter / Coude / Complesso del
gomito / Complete bocht
16399
Also available / Außerdem erhältlich / Également disponible / Altri prodotti
C Acriva LT Cushion & clip / Maskenkissen
und Clip / Bulle et clip / Cuscinetto e
fermaglio / Kussentje en klem
60198 (S)
60177 (M)
60178 (L)
60179 (LW)
S Small / Small / Petit / Small / Small
M Medium / Medium / Médium / Medium / Medium
L Large / Large / Grand / Large / Large
LW Large Wide / Large Wide / Large Wide / Grande larga / Large Wide
St Standard / Standard / Standard / Standard / Standaard

v
Disassembly / Auseinanderbau / Démontage / Smontaggio
4
123
5 6
789

vi
4
1 2 3
56
7 8 9
10 11 12
Reassembly / Zusammenbau / Remontage /
Riassemblaggio

1
English
English
MirageTM SoftGel
nasal mask
Thank you for choosing the Mirage SoftGel.
The Mirage SoftGel is the first of ResMed’s masks offering a choice of two
high performance cushions (Mirage SoftGel and Mirage Activa LT) on the one
durable frame. For further information, refer to the Activa LT User Information
section in this User Guide.
Intended use
The Mirage SoftGel channels airflow noninvasively to a patient from a positive
airway pressure (PAP) device such as a continuous positive airway pressure
(CPAP) or bilevel system.
The Mirage SoftGel is:
to be used by adult 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.
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 selection 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, use of a humidifier is•
recommended.
WARNING
The vent holes must be kept clear.•
The mask should not be used unless the CPAP or bilevel device is
•
turned on and operating properly.
Follow all precautions when using supplemental oxygen.
•

2
Oxygen flow must be turned off when the CPAP or bilevel device•
is not operating, so that unused oxygen does not accumulate
within the CPAP or bilevel device enclosure and create a risk of
fire.
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.
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.
•
Cleaning your mask in the home
Your mask and headgear should only be handwashed by gently rubbing in
warm (approximately 30°C) water using mild soap. All components should
be rinsed well with drinking quality water and allowed to air dry out of direct
sunlight.
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).•
If the vent requires cleaning use a soft bristle brush.•
Weekly:
Handwash the headgear. It may be washed without being disassembled.•

3
English
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, causing cracks.
CAUTION
If any visible deterioration of a system component is apparent•
(cracking, crazing, tears or cushion damage resulting in gel
exposure, etc), the component should be discarded and replaced.
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.
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.

4
Troubleshooting
Problem/possible cause Solution
Mask is uncomfortable
Headgear straps are too tight. Adjust straps evenly. The forehead
support ‘anchors’ your mask and
should sit firmly on your forehead.
Fit is too tight. Wind out dial.
Mask is too noisy
Cushion clip is not inserted correctly. Remove cushion from frame and
reinsert starting at the top.
Check that the cushion clip is correctly
inserted into the cushion and that
the cushion is correctly clipped to the
frame. If the problem persists, talk to
your clinician.
Ports cap or elbow incorrectly inserted. Remove the ports cap or elbow from
the mask, then reassemble according
to the instructions.
Vent is blocked or partially blocked. If the vent requires cleaning, use a soft
bristle brush.
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. Wind the dial in.
Air leaking around the top of the lip. Wind the dial out and or tighten the
bottom straps.
The mask does not fit properly
Cushion could be the wrong size. Talk to your clinician.
Mask is incorrectly assembled. Disassemble the mask, then
reassemble according to the
instructions.
Cushion may be dirty. Clean cushion according to the
instructions.
Cannot insert forehead support into mask frame
The dial has been inserted into the
frame before the forehead support. Push the end of the dial onto a hard surface until the dial comes out of the
frame. Reassemble according to the
instructions.

5
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.
Dead space
information
Physical dead space is the empty volume of the mask to the end
of the swivel. Using the large cushions it is 145 mL.
Therapy pressure 4 to 20 cm H2O
Resistance Drop in pressure measured (nominal)
at 50 L/min: 0.3 cm H2O
at 100 L/min: 0.9 cm H2O
Sound DECLARED DUAL NUMBERED NOISE EMISSION VALUES IN
ACCORDANCE WITH ISO 4871
The A weighted sound power level of the mask is 29 dBA, with
uncertainty 3 dBA.
The A-weighted sound pressure level of the mask at a distance
of 1m is 22 dBA, with uncertainty 3 dBA.
Environmental
conditions
Operating temperature: +5°C to +40°C
Operating humidity: 15% to 95% relative humidity
non-condensing
Storage and transport: -20°C to +60°C
Storage and transport humidity: up to 95% relative humidity
non-condensing
Gross dimensions
Large:
Mask fully assembled – no headgear
155 mm (H) x 91 mm (W) x 118 mm (D)
Mask setting
options
Select ‘ACTIVA’ (if available), otherwise select ‘STANDARD’ as
the mask option.
Notes:
The mask system does not contain latex, PVC or DEHP materials.•
The manufacturer reserves the right to change these specifications•
without notice.
0
10
20
30
40
50
60
4 6 8 10 12 14 16 18 20
Mask pressure (cm H20)
Vent flow rate (L/min)
Pressure
(cm H2O) Flow
(L/min)
419
8 28
12 34
16 40
20 45

6
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
Caution, consult accompanying documents;
L O T
Lot number;
REF
Part
number; Temperature limitation; Humidity limitation; Does not
contain 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.
Consumer warranty
ResMed acknowledges all consumer rights granted under the EU Directive
1999/44/EG and the respective national laws within the EU for products sold
within the European Union.

1
Mirage Activa™ LT
nasal mask / nasEnmaskE / masQUE nasal /
masCHERa nasalE
User information
English•Deutsch•Français•Italiano
English
Please read this information in conjunction with your MirageTM SoftGel User
Guide when changing your Mirage SoftGel cushion to the Mirage Activa LT
cushion.
Intended use
The Mirage Activa LT channels airflow noninvasively to a patient from a positive
airway pressure device such as a continuous positive airway pressure (CPAP)
or bilevel system.
The Mirage Activa LT is:
to be used by adult 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.
Cushion & clip /
Maskenkissen und Clip /
Bulle et clip /
Cuscinetto e fermaglio
60198 (S)
60177 (M)
60178 (L)
60179 (LW)
Cushion clip /
Maskenkissen-Clip /
Clip de la bulle /
Fermaglio del
cuscinetto
60176 (St)
60197 (S)

2
Troubleshooting
Problem/possible cause Solution
Mask is uncomfortable
Cushion incorrectly inflated. With the air turned off, adjust the straps so that you can
insert two fingers between your cheek and the lower
headgear strap.
Technical specifications
Dead space information The dead space of the mask varies according to
cushion size. It is 185 mL for the Medium size.
Resistance Drop in pressure measured (nominal)
at 50 L/min: 0.1 cm H2O
at 100 L/min: 0.7 cm H2O
Sound DECLARED DUAL-NUMBER NOISE EMISSION
VALUES in accordance with ISO 4871. The
A-weighted sound power level of the mask is 30
dBA, with uncertainty 3 dBA. The A-weighted sound
pressure level of the mask at a distance of 1 m is
22 dBA, with uncertainty 3 dBA.
Gross dimensions S
M, L, LW:
Mask fully assembled – no headgear.
141 mm (H) x 91 mm (W) x 107 mm (D)
154 mm (H) x 95 mm (W) x 117 mm (D)
Mask setting options Select ‘Activa’ (if available) or ‘Standard’ as the mask
option when using the Mirage Activa LT with ResMed
devices that have mask setting options.
Deutsch
Lesen Sie diese Informationen bitte als Ergänzung zu Ihrer MirageTM SoftGel
Gebrauchsanweisung, wenn Sie vom Mirage SoftGel Maskenkissen zum
Mirage Activa LT Maskenkissen wechseln.
Verwendungszweck
Die Mirage Activa LT führt dem Patienten auf nicht-invasive Weise einen
Luftfluss von einem PAP-Atemtherapiegerät wie z. B. einem CPAP- oder
Bilevel-Gerät zu.
Die Mirage Activa LT ist:
für erwachsene Patienten (>30 kg) vorgesehen, denen positiver•
Atemwegsdruck verschrieben wurde
für den wiederholten Gebrauch durch einen einzelnen Patienten zu Hause•
sowie durch mehrere Patienten in der Klinik oder Schlafklinik geeignet.

3
Fehlersuche
Problem/Mögliche
Ursache Lösung
Maske ist unbequem
Maskenkissen ist nicht richtig
aufgeblasen.
Stellen Sie die Bänder bei abgeschaltetem Luftfluss so
ein, dass Sie zwei Finger zwischen Ihre Wange und das
untere Kopfband schieben können.
Technische Daten
Informationen zum
Totraum
Der Totraum der Maske ist je nach Maskenkissengröße
unterschiedlich. Bei Maskenkissengröße Medium
beträgt er 185 ml.
Widerstand Gemessene Drucksenkung (Sollwert)
bei 50 l/min: 0,1 cm H2O
bei 100 l/min: 0,7 cm H2O
Geräuschpegel ANGEGEBENER ZWEIZAHL-
GERÄUSCHEMISSIONSWERT nach ISO 4871. Der
A-gewichtete Schalldruckpegel der Maske liegt bei
30 dBA (mit einem Unsicherheitsfaktor von 3 dBA).
Der A-gewichtete Schalldruckpegel der Maske
bei 1 m Entfernung liegt bei 22 dBA (mit einem
Unsicherheitsfaktor von 3 dBA).
Abmessungen
S
M, L, LW:
Die Maske wird vollständig zusammengebaut und ohne
Kopfband geliefert.
141 mm (H) x 91 mm (B) x 107 mm (T)
154 mm (H) x 95 mm x (B) x 117 mm (T)
Maskeneinstelloptionen Wählen Sie (falls vorhanden) „Activa“ und ansonsten
„Standard“ als Maskenoption aus, wenn Sie die Mirage
Activa LT zusammen mit ResMed-Geräten benutzen,
die über Maskeneinstelloptionen verfügen.
Français
Veuillez lire ces informations en conjonction avec le guide utilisateur
MirageTM SoftGel lors du remplacement de la bulle Mirage SoftGel par la bulle
Mirage Activa LT.
Usage prévu
Le Mirage Activa LT achemine au patient de façon non-invasive le débit d'air
produit par un appareil à pression positive tel un appareil de PPC ou de VNDP.
Le Mirage Activa LT est prévu :

4
pour une utilisation par des patients adultes (> 30 kg) à qui une pression•
positive a été prescrite ;
pour un usage multiple par un seul patient à domicile ou pour un usage•
multiple par plusieurs patients en milieu médical.
Stratégie de dépannage
Problème/cause possible Solution
Le masque n'est pas confortable
La bulle n'est pas
correctement gonflée.
Lorsque le débit d'air est fermé, ajustez les sangles de
manière à pouvoir insérer deux doigts entre votre joue
et la sangle inférieure du harnais.
Caractéristiques
Informations concernant
l’espace mort
L'espace mort du masque varie en fonction de la taille
de la bulle. Pour la taille Medium, il est de 185 ml.
Résistance Chute de pression mesurée (nominale)
à 50 l/min : 0,1 cm H2O
à 100 l/min : 0,7 cm H2O
Niveau acoustique VALEURS D’ÉMISSION SONORE À DEUX
CHIFFRES DÉCLARÉES conformes à la norme ISO
4871. Le niveau acoustique pondéré A du masque
est de 30dBA avec une incertitude de 3 dBA.
Le niveau de pression acoustique pondéré A du
masque à une distance d’1 m est de 22 dBA, avec
une incertitude de 3 dBA.
Dimensions brutes S
M, L, LW :
Masque entièrement assemblé – sans harnais.
141 mm (H) x 91 mm (W) x 107 mm (D)
154 mm (H) x 95 mm (W) x 117 mm (D)
Fonction de sélection du
masque
Sélectionnez « Activa » (si disponible), sinon
sélectionnez « Standard » comme réglage lors de
l'utilisation de Mirage Activa LT avec les appareils
ResMed ayant des options de réglage du masque.
Italiano
Leggere questo libretto informativo insieme alla Guida per l'utente di
MirageTM SoftGel nel passaggio dal cuscinetto Mirage SoftGel al cuscinetto
Mirage Activa LT.
Indicazioni per l'uso
La maschera Mirage Activa LT eroga in modo non invasivo al paziente il flusso
d'aria proveniente da un dispositivo a pressione positiva alle vie respiratorie, ad
esempio un sistema CPAP (a pressione positiva continua alle vie respiratorie)
o bilevel.

5
La Mirage Activa LT:
va utilizzata da pazienti adulti (>30 kg) cui sia stata prescritta una terapia a•
base di pressione positiva alle vie respiratorie;
è di tipo monopaziente nell'uso a domicilio e multipaziente in contesto•
ospedaliero.
Risoluzione dei problemi
Problema/Possibile causa Soluzione
La maschera è scomoda
Il cuscinetto è stato gonfiato
in modo non corretto.
Ad aria spenta, regolare le cinghie in modo da poter
inserire due dita tra la guancia e la cinghia inferiore del
copricapo.
Specifiche tecniche
Informazioni sullo spazio
morto
Lo spazio morto della maschera varia secondo la misura
del cuscinetto. Per la misura Medium esso è pari a
185 mL.
Resistenza Caduta di pressione misurata (nominale)
a 50 L/min: 0,1 cm H2O
a 100 L/min: 0,7 cm H2O
Potenza acustica NUMERO BINARIO EMISSIONI ACUSTICHE
DICHIARATE come da norma ISO 4871. La potenza
acustica della maschera secondo la ponderazione A è
di 30 dBA, con un margine di errore di 3 dBA. Il livello
di pressione acustica della maschera secondo la
ponderazione A alla distanza di 1 m è di 22 dBA, con
un margine di errore di 3 dBA.
Dimensioni lorde S
M, L, LW:
Maschera completamente assemblata – senza copricapo.
141 mm (H) x 91 mm (W) x 107 mm (D)
154 mm (H) x 95 mm (W) x 117 mm (D)
Opzioni di impostazione
della maschera
Selezionare l'opzione di maschera ‘Activa’ (se
disponibile) o ‘Standard’ quando si utilizza la Mirage
Activa LT con apparecchi ResMed dotati di opzioni
d’impostazione della maschera.

6
Fitting and assembly / Anpassung und Zusammenbau /
Ajustement et montage / Applicazione e assemblaggio
4
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10
6
8
11
5
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2

Manufacturer:
ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia
Distributed by:
ResMedCorp9001SpectrumCenterBoulevardSanDiegoCA92123USA
ResMed(UK)Ltd96MiltonParkAbingdonOxfordshireOX144RYUK
Seewww.resmed.comforotherResMedlocationsworldwide.
MirageSoftGelNasalMask
Protectedbypatents:AU741003,AU766623,AU775051,AU777033,AU785376,DE
20122844.0,EP1187647,EP1187649,EP1187650,EP1314445,EP1582230,EP1621225,EP
1640034,HK1057714,JP3686609,NZ513052,NZ526165,NZ526166,NZ526167,NZ526168,
NZ542849,NZ543939,US6119693,US6374826,US6439230,US6463931,US6532961,US
6557556,US6581594,US6691708,US6823865,US6860269,US6997188,US7011090,US
7159587,US7216647,US7234466,US7316230.Otherpatentspending.
Protectedbydesignregistrations:AU156663,AU156665,AU321676,DE40301991.5,FR
031425,FR031430,JP1192859,JP1197930,NZ411222,USD486227,USD487510,US
D493521,USD493522,USD545960,USD567935.Otherspending.
MirageisatrademarkofResMedLtdandisregisteredinU.S.PatentandTrademarkOfce.
©2009ResMedLtd.
MirageActivaLT
Protectedbypatents:AU2001267133,AU2002301370,AU710733,AU741003,AU766623,
AU775051,AU777033,AU785376,CA2261790,CA2470671,DE20122844.0,EP0956069,
EP1187647,EP1187649,EP1187650,EP1314445,EP1334742,EP1479406,EP1582230,EP
1621225,EP1640034,HK1057714,HK1071083,JP3686609,JP3802872,JP4031422,NZ
513052,NZ526165,NZ526166,NZ526167,NZ526168,NZ542849,NZ543939,US6112746,
US6119693,US6357441,US6374826,US6412487,US6439230,US6463931,US6532961,
US6557556,US6581594,US6581602,US6634358,US6691708,US6772760,US6796308,
US6823865,US6823869,US6860269,US6871649,US6986352,US6997188,US7021311,
US7107989,US7159587,US7178527,US7216647,US7234466,US7243651,US7318439,US
7487777.Otherpatentspending.
Protectedbydesignregistrations:AU156663,AU156665,AU321676,DE40301991.5,EU
985601,FR031425,FR031430,JP1192859,JP1197930,JP1367396,NZ411222,USD486227,
USD487510,USD493521,USD493522,USD545960,USD567935,USD597661.Others
pending.
MirageandActivaaretrademarksofResMedLtdandareregisteredinU.S.Patentand
TrademarkOfce.
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