ResMed Ultra Mirage User manual

Global leaders in sleep and respiratory medicine www.resmed.com
Ultra Mirage™ Full Face Mask
User Guide
English •Français •Español •Português
608677/1 2020-06
ULTRA MIRAGE FULL FACE MASK
User
AMER ML
Log on now to www.resmed.com
to find useful tips on managing your treatment
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Manufacturer:
ResMed Pty Ltd 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.
Ultra Mirage is a trademark of ResMed Pty Ltd and Mirage is registered in U.S. Patent and Trademark
Ofce.
Velcro is a registered trademark of Velcro Industries B.V.
© 2020 ResMed.
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C
B
©2012 ResMed Ltd.
4
1
D-1 D-2 D-3
D-4
D-6
D-5
D-7 D-8
b
a
D
Mask Parts / Composants du masque / Piezas de la
mascarilla / Componentes da máscara
Forehead support / Support frontal /
Apoyo para la frente / Suporte da testa
Exhaust vent / Orifice de
ventilation / Ventilación /
Orifício de ventilação
Luer lock port cap/s / Bouchon(s)
d'entrée de raccord Luer / Tapas de
puerto Luer lock / Tampas das
portas com fecho do tipo Luer
Forehead support pad / Tampon du support frontal /
Almohadilla del apoyo para la frente / Almofada do
suporte da testa
Valve / Valve /
Válvula / Válvula
Mask frame / Entourage rigide / Armazón de la
mascarilla / Armação da máscara
Cushion clip / Clip de la bulle /
Traba de la almohadilla / Dispositivo
de fixação da almofada
Mask cushion / Bulle du masque /
Almohadilla de la mascarilla /
Almofada da máscara
Valve membrane / Membrane de la valve / Membrana de
la válvula / Membrana da válvula
Elbow retainer / Anneau de
retenue du coude / Retenedor del
codo / Retentor do cotovelo
Valve frame / Corps de la valve / Armazón de la
válvula / Armação da válvula
Swivel / Pièce pivotante / Pieza
giratoria / Peça giratória
Swivel clip / Clip de la pièce
pivotante / Clip de la pieza giratoria /
Dispositivo de fixação da peça
giratória
Valve elbow / Coude de la valve / Codo
de la válvula / Cotovelo da válvula
Upper Velcro straps / Bandes Velcro
supérieures / Correas laterales
superiores (Velcro) / Correias Velcro
laterais superiores Headgear clip / Clip du harnais /
Broche del arnés / Dispositivo de
fixação do arnês para a cabeça
Forehead support tab / languette du
support frontal / Lengüeta del apoyo para
la frente / Dispositivo de fixação do
suporte da testa
L-shaped ridge / Bord en L / Borde en
forma de L / Saliência em forma de L
LIFT / SOULEVER /
LEVANTE / LEVANTE
Elbow retainer / Anneau de retenue
du coude / Retenedor del codo /
Retentor do cotovelo
Valve elbow / Coude de la valve /
Codo de la válvula / Cotovelo da
válvula
Tab / Patte d'attache /
Lengüeta / Lingueta Valve membrane / Membrane de la
valve / Membrana de la válvula /
Membrana da válvula
Valve frame / Corps de la valve /
Armazón de la válvula / Armação da
válvula
Swivel clip / Clip de la pièce pivotante /
Clip de la pieza giratoria / Dispositivo de
fixação da peça giratória
Swivel / Pièce pivotante /
Pieza giratoria / Peça giratória
PUSH / POUSSER /
EMPUJE / EMPURRE
C-1 C-2
C-3 C-4
C-5 C-6
Lower Velcro straps / Bandes Velcro
inférieures / Correas laterales inferiores
(Velcro) / Correias Velcro laterais inferiores
a
b
Fitting the Mask / Mise en place du masque / Colocación de
la mascarilla / Colocação da máscara
Disassembling for Cleaning / Démontage pour le nettoyage / Desmontaje para la limpieza /
Desmontagem para limpeza
©2012 ResMed Ltd.
©2012 ResMed Ltd.
2020 ResMed.
2020 ResMed.
2020 ResMed.
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©2020 ResMed.
A
Vent flow rate / Débit à l’orfice de ventilation / Caudal de flujo por la ventilación / Taxa de fluxo de ventilação (L/min)
Mask Pressure / Pression dans le masque / Presión en la mascarilla / Pressão na máscara (cm
H2O)
Pressure–Flow Curve / Courbe Pression-Débit /
Curva de Presión-Flujo / Curva de Pressão-Fluxo
Note: As a result of manufacturing variations, the vent flow may vary from the values listed in the
following table. / Remarque : en raison des variations de fabrication, le débit aux orifices de ventilation
peut différer des valeurs indiquées dans le tableau suivant. / Nota: Como resultado de variaciones en
la fabricación, el flujo de ventilación podrá variar en relación con los valores listados en la siguiente
tabla. / Nota: Como resultado de variações de fabrico, o fluxo de ventilação poderá variar em
relação aos valores listados no quadro seguinte.
4
8
12
16
20
22
32
41
48
54
Flow / Débit /
Flujo / Fluxo
(L/min)
Pressure / Pression /
Presión / Pressão
(cm H2O)
Note: For complete instructions, read the text section in conjunction with the illustrations on this sheet. / Remarque : pour les instructions complètes, veuillez vous référer au texte et aux illustrations de cette fiche. / Nota: Para instrucciones detalladas, sírvase leer el texto en conjunto con las ilustraciones de esta hoja. / Nota: Para obter informações completas, leia a secção de texto juntamente com as ilustrações que se encontram neste folheto. ILLUSTRATIONS SHEET / FICHE D’ILLUSTRATIONS / HOJA DE FIGURAS / FOL- HETO DE ILUSTRAÇÕES
Component of 608677/1 2020-06
E
E-1 E-2 E-3
F-1 F-2 F-4
F-6 F-7
a
b
F-3
F-8
F-5
F
Bump on the exhaust vent /
Bosse de l'orifice de ventilation /
Protuberancia de la ventilación /
Protuberância no orifício de
ventilação
Elbow retainer / Anneau de
retenue du coude / Retenedor del
codo / Retentor do cotovelo
Luer lock port cap/s / Bouchon(s)
d'entrée de raccord Luer / Tapas de
puerto Luer lock / Tampas das portas
com fecho do tipo Luer
Pivot / Pivot /
Pivote / Pino
Mask Reassembly / Remontage du masque / Montaje de la mascarilla / Montagem da máscara
Reassembling the Mask / Remontage du masque / Montaje de la mascarilla / Montagem da máscara
Valve Reassembly / Réassemblage de la valve / Montaje de la válvula / Montagem da válvula
Assembled valve inserted into mask
frame / Valve assemblée insérée dans
l'entourage rigide / Válvula montada y
colocada en el armazón de la mascarilla /
Válvula montada e inserida na armação da
mascara
Mask port/s / Port(s) du masque /
Puerto(s) de la mascarilla / Orifício
da máscara
©2012 ResMed Ltd. ©2012 ResMed Ltd.
E-4
0
10
20
30
40
50
60
70
4567 8 9 10 11 12 13 14 15 16 17 18 19 20
2020 ResMed.
2020 ResMed.
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ENGLISH
Ultra Mirage™Full Face Mask
Thank you for choosing ResMed’s
ULTRA MIRAGE
™FULL FACE MASK.
This is a full face mask which covers both
the nose and the mouth. Thus, you can
receive effective therapy even in the
presence of mouth breathing and leak.
This user’s guide provides you with the
information you need for the correct use
of your mask.
INTENDED USE
The ULTRA MIRAGE FULL FACE MASK is
intended for multipatient use for adult
patients (>30 kg) prescribed continuous
positive airway pressure (CPAP) or bilevel
therapy in hospital, clinic and/or home
environments.
CAUTION
In the USA, federal law restricts this
device to sale by, or on the order of, a
physician.
MEDICAL INFORMATION
Note: The mask system does not contain
latex materials. If you have ANY reaction to
any part of the mask system, discontinue use
and consult your sleep therapist.
CONTRAINDICATION
The ULTRA MIRAGE FULL FACE MASK, must
be used under qualified supervision for
patients who are unable to remove the
mask by themselves.
WARNINGS AND CAUTIONS
•This mask should be used only with
flow generators (CPAP or bilevel)
recommended by your physician or
respiratory therapist. A mask should
not be used unless the flow generator
is turned on and operating properly.
The exhaust vent should never be
blocked.
Explanation of the Warning: Flow
generators are intended to be used
with special masks with connectors
which have vent holes or separate
exhaust vents to allow continuous flow
of air out of the mask. When the flow
generator is turned on and functioning
properly, new air from the flow
generator flushes the exhaled air out
through the attached mask exhaust
vent. However, when the flow
generator is not operating, enough
fresh air will not be provided through
the mask, and exhaled air may be
rebreathed. Rebreathing of exhaled air
for longer than several minutes can in
608337 Book.book Page 1 Tuesday, May 29, 2012 1:55 PM

ENGLISH
some circumstances lead to suffocation.
This warning applies to most models of
flow generators.
•The exhaust vent flow is lower at lower
mask pressures (see Pressure/Flow
Curve— section A). If the mask
pressure during expiration is too low,
there may not be enough exhaust vent
flow to completely flush the air delivery
hose of exhaled air before the start of
the next inspiration.
•The mask should not be worn if the anti-
asphyxia valve membrane is damaged or
missing. If the valve membrane is
damaged, distorted or torn, it should be
replaced with a new valve membrane.
•The mask may not be suitable for those
at increased risk of gastric regurgitation.
•The mask must be cleaned and
disinfected/sterilized if it is used
between patients. Refer to the section
“Cleaning the Mask between Patients”
for details.
•If oxygen is used with the flow
generator, the oxygen flow must be
turned off when the flow generator is
not operating.
Explanation of the Warning: When the
flow generator is not in operation and
the oxygen flow is left on, oxygen
delivered into the air delivery tubing
may accumulate within the flow
generator enclosure and create a risk of
fire. This applies to most types of flow
generators.
•Oxygen supports combustion.
Oxygen should not be used while
you are smoking or in the presence
of an open flame.
•Always ensure airflow is being
generated by the device before the
oxygen supply is turned on.
•Always turn the oxygen supply off
before stopping the airflow from the
device.
•Please refrain from smoking while
oxygen is in use.
•Using a mask may cause tooth, gum or
jaw soreness or aggravate an existing
dental condition. If symptoms occur,
consult your physician or dentist.
Note: At a fixed flow rate of supplemental
oxygen flow, the inhaled oxygen concentration
will vary, depending on the pressure settings,
patient breathing pattern, mask selection, and
the leak rate.
PARTS OF THE MASK
See section Bon the illustrations sheet.
FITTING THE MASK
See section Con the illustrations sheet.
Note: Before fitting the mask, refer to the
section on “Cleaning the Mask in the Home”.
The ULTRA MIRAGE FULL FACE MASK is
supplied fully assembled.
1Move the forehead support tab to
Position 4 (Fig. C-1). Position 4 is the
uppermost tab position.
2Disconnect one lower headgear clip.
Place the mask on the face and pull the
headgear over your head (Fig. C-2).
Ensure that the upper straps pass across
your forehead and the lower straps
below your ears.
3Reattach the headgear clip to the mask
frame.
4Gently tighten the upper headgear
straps (Fig. C-3).
5Gently tighten the lower headgear
straps (Fig. C-4).
The pads of the forehead support
should lightly touch your forehead when
the mask is in place. If the pads do not
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ENGLISH
touch your forehead, you may need to
change the position of the forehead
support tab as described in step 8.
6The fitted mask should look like this
(Fig. C-5).
7Connect the main air tubing to the
swivel (Fig. C-6). Then connect the free
end of the air tubing to your flow
generator and turn the flow generator
on. If you feel air leaks around the
cushion, you may need to gently tighten
the headgear straps.
Note: Do not overtighten the headgear
straps as this may cause discomfort,
cushion creases, and mask leak.
8If you are unable to get a proper seal
through gently tightening the headgear,
you will need to change the position of
the forehead support tab.
Loosen the headgear straps and move
the forehead support tab to the next
position (e.g., from Position 4 move it
downwards to Position 3). Gently
tighten the upper headgear straps and
then the lower headgear straps.
Take time to test all four positions of the
forehead support tab and to adjust the
headgear straps so that you can achieve
a secure and comfortable fit.
Notes:
•If you are unable to resolve any leaks you
may require another mask frame and/or
another cushion size.
•Select “Mir Full” as the mask option when
using the ULTRA MIRAGE FULL FACE
MASK with ResMed flow generators that
have mask setting options.
REMOVING THE MASK
To remove the ULTRA MIRAGE FULL FACE
MASK, disconnect one of the lower
headgear clips and pull the mask and
headgear up over your head.
Note: The headgear clips are easy to locate
and disconnect. They allow you to quickly
remove the mask from your face in the event
of an emergency.
DISASSEMBLING FOR
CLEANING
See section Don the illustrations sheet.
1Detach the mask from the air tubing.
2Disconnect the headgear clips to release
them from the mask frame. It is not
necessary to remove the headgear clips
from the headgear.
3Remove the exhaust vent and port caps
from the mask frame.
4Detach the cushion assembly from the
mask frame by depressing the cushion
clip at the base of the mask frame and
gently pulling it off. This releases the
cushion and cushion clip.
Then, separate the cushion from the
cushion clip.
5To detach the elbow from the frame, lift
(Fig. D-1) and push (Fig. D-2) the right
wing of the elbow retainer over the right
L-shaped ridge on the mask frame.
6Rotate the elbow retainer to the
position shown in Figure D-3. The
elbow retainer is now in the correct
position for removal.
7To remove the elbow retainer, hold one
wing of the elbow retainer down, and
firmly pull the other wing out (Fig. D-4a)
and then up (Fig. D-4b) over the top of
the valve. Remove the elbow retainer
and valve from the mask frame.
8To remove the swivel, lift the swivel clip
and slide it out (Fig. D-5).
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ENGLISH
9Squeeze the tabs of the valve elbow to
remove the valve frame from the valve
elbow. Then, carefully remove the valve
membrane from the valve frame
(Fig. D-6).
10 To remove the forehead support from
the mask, press the tab (Fig. D-7a) and
move it upwards until you can slide it off
the mask frame (Fig. D-7b).
11 Pull firmly at the base of the forehead
support pad plugs to release the pads
from the forehead support (Fig D-8).
CLEANING THE MASK IN THE
HOME
Notes:
•Wash the headgear before first time use,
as the dye may run. It is important to
always handwash the headgear.
•The headgear may be washed without
being disassembled.
DAILY/AFTER EACH USE
Handwash the mask components in
lukewarm, soapy water. Use pure soap
(an example of pure soap is Dove®soap,
unscented; made by Unilever). Rinse the
components well and allow them to air dry
out of direct sunlight.
To clean the valve membrane, immerse it in
soapy water and gently rub the membrane
to remove any foreign matter. Rinse the
membrane and allow it to air dry out of
direct sunlight.
Inspect the valve membrane for wear and
deterioration. If the valve membrane is
damaged, distorted, or torn, replace it with
a new valve membrane. Ensure that the
membrane is clean and dry before re-
inserting it into the valve.
WEEKLY
Handwash the headgear in warm, soapy
water. Use pure soap. Rinse well and allow
it to air dry out of direct sunlight.
CAUTION
•Do not use bleach, chlorine, alcohol,
or aromatic-based solutions,
moisturizing or antibacterial soaps, or
scented oils to clean any of the mask
components. These solutions may
cause damage and reduce the life of
the product.
•Do not expose any part of the mask
system or tubing to direct sunlight as
it may cause the product to
deteriorate.
•If any visible deterioration of a mask
component is apparent (cracking,
crazing, tears, etc), the mask
component should be discarded and
replaced.
REPROCESSING THE MASK
BETWEEN PATIENTS
The mask should be reprocessed when
used between patients. Cleaning,
disinfection and sterilization instructions are
available from the ResMed website,
www.resmed.com/masks/sterilization/
americas.
If you do not have Internet access, please
contact your ResMed representative.
CAUTION
The valve membrane must be replaced
with a new valve membrane when the
mask is reused on another patient. This
part cannot be disinfected or sterilized.
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ENGLISH
REASSEMBLING THE MASK
ATTENTION
It is important to follow the instructions
detailed in this section. Any deviation
from the specified order of assembly
could affect the functioning of your mask.
Reassembling the entire mask involves two
stages:
1. Valve Reassembly
2. Mask Reassembly
VALVE REASSEMBLY
See section Eon the illustrations sheet.
Note: This stage must be completed before
Mask Reassembly.
Make sure all parts of the mask system,
especially the valve membrane, are clean
and dry before reassembling. If the valve
membrane is damaged, distorted or torn,
replace it with a new valve membrane.
1Insert the valve membrane into the
valve frame and gently push it into place
(Fig. E-1). Make sure it is seated evenly
and flatly around the rim of the valve
frame, as the membrane may produce a
noise while you are breathing out, if it is
fitted incorrectly.
2Push the valve frame over the tabs of
the valve elbow until they lock together
(Fig. E-2). Make sure the valve frame and
valve elbow are securely connected to
each other.
3Insert the swivel into the end of the
valve elbow and secure it with the swivel
clip (Fig. E-3).
4Set the assembled valve (Fig. E-4) aside
for use in the following stage.
MASK REASSEMBLY
See section Fon the illustrations sheet.
1Check that the holes in the exhaust vent
are not obstructed. If they are
obstructed, replace the exhaust vent.
Push the exhaust vent onto the mask
frame so the small round bump on the
exhaust vent is on the outside of the
mask frame (Fig. F-1).
CAUTION
The exhaust vent must be correctly
inserted into the mask frame to
prevent leakage. Poor sealing may
reduce pressure and affect therapy.
2Twist the luer lock port caps onto the
mask ports (Fig. F-2).
3Insert the assembled valve into the mask
frame (Fig. F-3).
Note: The valve must be assembled
(as depicted in Figure E-4), before it is
inserted into the mask frame.
4Hold the mask frame and the inserted
valve firmly together.
5To attach the elbow retainer, fit one
side of the elbow retainer against the
groove of the valve. While holding one
wing of the elbow retainer down
(Fig. F-4a), press the other wing down
until the elbow retainer clicks into place
(Fig. F-4b).
6Rotate the elbow retainer to its original
position (Fig. F-5).
7Check that you have fitted the valve and
elbow retainer correctly by firmly pulling
the valve away from the frame. If the
valve is fitted correctly, it should not
separate from the frame.
If the valve comes away from the frame,
try refitting the elbow retainer as
described in Steps 4 and 5. If the valve
still comes away from the frame when
you pull on it, you may need to replace
the elbow retainer with a new one.
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ENGLISH
8Fit the grooved edge of the mask
cushion to the mask frame. Fit the top
section first, then work your way around
the mask, pushing the cushion onto the
frame, ensuring a good seal has been
achieved.
Then push the cushion clip over the
cushion onto the mask frame, ensuring it
clicks into place in all locations (Fig. F-6).
9Attach the forehead pads to the
forehead support by inserting the pad
plugs into the two holes on the back of
the forehead support (Fig F-7). Push the
pads firmly against the forehead support
to ensure that the pads fit securely into
the forehead support.
10 Connect the forehead support to the
mask frame. Slide the pivots into the
pivot slot on the mask frame (Fig. F-8).
Depress the forehead support tab and
move it into any of the tab positions.
11 Insert the headgear clips into the slots
on the mask frame. The headgear label
should face outwards and be near your
neck when fitted.
TECHNICAL SPECIFICATIONS
PRESSURE–FLOW CURVE
See section Aon the illustrations sheet.
DEAD SPACE INFORMATION
Dead space is the empty volume of the
mask up to the swivel.
The dead space of the mask varies
according to cushion sizes but is less than
258 mL.
Note: The manufacturer reserves the right
to change these specifications without notice.
REPLACEMENT PARTS
Part No. Item
16613 Anti-asphyxia valve (1 pk.)
16604 Cushion, Small, Standard (1 pk.)
16671 Cushion, Small, Shallow (1 pk.)
16605 Cushion, Medium, Standard
(1 pk.)
16672 Cushion, Medium, Shallow
(1 pk.)
16606 Cushion, Large, Standard (1 pk.)
16673 Cushion, Large, Shallow (1 pk.)
16674 Cushion clip, Small (1 pk.)
16675 Cushion clip, Medium (1 pk.)
16676 Cushion clip, Large (1 pk.)
60683 Elbow retainer (1 pk.)
16509 Exhaust vent (1 pk.)
16510 Exhaust vent (10 pk.)
60681 Luer lock port caps (2 pk.)
60682 Luer lock port caps (10 pk.)
16689 Swivel (1 pk.)
60680 Swivel clip (1 pk.)
16637 Swivel clip (5 pk.) and Elbow
clip (5 pk.)
16624 Valve elbow (1 pk.)
16617 Valve membrane (1 pk.)
16618 Valve membrane (10 pk.)
60115 Headgear clip (2 pk.)
60116 Headgear clip (10 pk.)
60123 Forehead pad (1 pk.)
60124 Forehead pad (10 pk.)
60670 Mask Frame, Small (1 pk.)
60671 Mask Frame, Medium (1 pk.)
60672 Mask Frame, Large (1 pk.)
60673 Forehead Support (1 pk.)
60674 Headgear (1 pk.)
60620 Frame System with cushion,
(excluding headgear) Small,
Standard
608337 Book.book Page 6 Tuesday, May 29, 2012 1:55 PM