Ultra Mirage Full Face Mask - User Guide English
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Ultra Mirage™ Full Face Mask
User Guide
English
A Pressure–Flow Curve / Courbe Pression-Débit /
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. /
Note: For complete instructions, read the text section in conjunction with the illustrations on this sheet. / Remarque : pour les instructions complètes, veuillez
Curva de Presión-Flujo / Curva de Pressão-Fluxo
70
Caudal de flujo por la ventilación / Taxa de fluxo de
60
Vent flow rate / Débit à l’orfice de ventilation /
50
Nota: Para obter informações completas, leia a secção de texto juntamente com as ilustrações que se encontram neste folheto. 40
ILLUSTRATIONS SHEET / FICHE D’ILLUSTRATIONS / HOJA DE FIGURAS / FOL-
30
20
ventilação (L/min)
10
0
4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
Mask Pressure / Pression dans le masque / Presión en la mascarilla / Pressão na máscara (cm
H2O)
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.
Pressure / Pression / Flow / Débit /
Presión / Pressão Flujo / Fluxo
(cm H2O) (L/min)
4 22
HETO DE ILUSTRAÇÕES
8 32
Component of 608337/1 2012-06
12 41
16 48
©2012 ResMed Ltd.
20 54B Mask Parts / Composants du masque / Piezas de la
mascarilla / Componentes da máscara
C Fitting the Mask / Mise en place du masque / Colocación de
la mascarilla / Colocação da máscara
Forehead support pad / Tampon du support frontal /
Almohadilla del apoyo para la frente / Almofada do Forehead support tab / languette du
Forehead support / Support frontal /
Apoyo para la frente / Suporte da testa suporte da testa C-1 support frontal / Lengüeta del apoyo para
la frente / Dispositivo de fixação do
C-2
suporte da testa
Mask cushion / Bulle du masque /
Almohadilla de la mascarilla /
Exhaust vent / Orifice de Almofada da máscara
ventilation / Ventilación /
Orifício de ventilação
4
1
Luer lock port cap/s / Bouchon(s) Cushion clip / Clip de la bulle /
d'entrée de raccord Luer / Tapas de Traba de la almohadilla / Dispositivo
puerto Luer lock / Tampas das de fixação da almofada
portas com fecho do tipo Luer
Valve / Valve / Mask frame / Entourage rigide / Armazón de la
Válvula / Válvula mascarilla / Armação da máscara
C-3 C-4
Valve membrane / Membrane de la valve / Membrana de
Valve elbow / Coude de la valve / Codo la válvula / Membrana da válvula
de la válvula / Cotovelo da válvula
Elbow retainer / Anneau de
Swivel clip / Clip de la pièce retenue du coude / Retenedor del
pivotante / Clip de la pieza giratoria / codo / Retentor do cotovelo
Dispositivo de fixação da peça
giratória
Valve frame / Corps de la valve / Armazón de la
Swivel / Pièce pivotante / Pieza válvula / Armação da válvula
giratoria / Peça giratória C-5 C-6
Upper Velcro straps / Bandes Velcro
supérieures / Correas laterales
superiores (Velcro) / Correias Velcro Headgear clip / Clip du harnais /
laterais superiores Broche del arnés / Dispositivo de
fixação do arnês para a cabeça
© 2012 ResMed Ltd.
© 2012 ResMed Ltd.
Lower Velcro straps / Bandes Velcro
inférieures / Correas laterales inferiores
(Velcro) / Correias Velcro laterais inferioresDisassembling for Cleaning / Démontage pour le nettoyage / Desmontaje para la limpieza /
D Desmontagem para limpeza
L-shaped ridge / Bord en L / Borde en
D-1 forma de L / Saliência em forma de L D-2 D-3
LIFT / SOULEVER / PUSH / POUSSER /
LEVANTE / LEVANTE EMPUJE / EMPURRE
D-4 D-5
Elbow retainer / Anneau de retenue
du coude / Retenedor del codo /
Retentor do cotovelo
Swivel clip / Clip de la pièce pivotante /
Clip de la pieza giratoria / Dispositivo de
fixação da peça giratória
a b
Swivel / Pièce pivotante /
Pieza giratoria / Peça giratória
D-6 D-7 D-8
Valve frame / Corps de la valve /
Armazón de la válvula / Armação da
válvula b
Valve elbow / Coude de la valve /
Codo de la válvula / Cotovelo da
válvula
a
© 2012 ResMed Ltd.
Tab / Patte d'attache /
Lengüeta / Lingueta Valve membrane / Membrane de la
valve / Membrana de la válvula /
Membrana da válvulaReassembling the Mask / Remontage du masque / Montaje de la mascarilla / Montagem da máscara
E Valve Reassembly / Réassemblage de la valve / Montaje de la válvula / Montagem da válvula
E-1 E-2 E-3 E-4
© 2012 ResMed Ltd.
F Mask Reassembly / Remontage du masque / Montaje de la mascarilla / Montagem da máscara
F-1 Bump on the exhaust vent /
Bosse de l'orifice de ventilation /
F-2 F-3 F-4
Luer lock port cap/s / Bouchon(s)
Protuberancia de la ventilación / d'entrée de raccord Luer / Tapas de
Protuberância no orifício de puerto Luer lock / Tampas das portas Assembled valve inserted into mask
ventilação com fecho do tipo Luer 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
a
Mask port/s / Port(s) du masque /
Puerto(s) de la mascarilla / Orifício b
da máscara
F-5 F-6 F-7 F-8 Pivot / Pivot /
Pivote / Pino
Elbow retainer / Anneau de
© 2012 ResMed Ltd.
retenue du coude / Retenedor del
codo / Retentor do cotoveloENGLISH
Ultra Mirage™ Full Face Mask
Thank you for choosing ResMed’s CONTRAINDICATION
ULTRA MIRAGE™ FULL FACE MASK. The ULTRA MIRAGE FULL FACE MASK, must
This is a full face mask which covers both be used under qualified supervision for
the nose and the mouth. Thus, you can patients who are unable to remove the
receive effective therapy even in the mask by themselves.
presence of mouth breathing and leak.
This user’s guide provides you with the WARNINGS AND CAUTIONS
information you need for the correct use
• This mask should be used only with
of your mask.
flow generators (CPAP or bilevel)
recommended by your physician or
INTENDED USE respiratory therapist. A mask should
The ULTRA MIRAGE FULL FACE MASK is not be used unless the flow generator
intended for multipatient use for adult is turned on and operating properly.
patients (>30 kg) prescribed continuous The exhaust vent should never be
positive airway pressure (CPAP) or bilevel blocked.
therapy in hospital, clinic and/or home Explanation of the Warning: Flow
environments. generators are intended to be used
with special masks with connectors
CAUTION which have vent holes or separate
In the USA, federal law restricts this exhaust vents to allow continuous flow
device to sale by, or on the order of, a of air out of the mask. When the flow
physician. generator is turned on and functioning
properly, new air from the flow
MEDICAL INFORMATION generator flushes the exhaled air out
Note: The mask system does not contain through the attached mask exhaust
latex materials. If you have ANY reaction to vent. However, when the flow
any part of the mask system, discontinue use generator is not operating, enough
and consult your sleep therapist. 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 inENGLISH
some circumstances lead to suffocation. • Always turn the oxygen supply off
This warning applies to most models of before stopping the airflow from the
flow generators. device.
• The exhaust vent flow is lower at lower • Please refrain from smoking while
mask pressures (see Pressure/Flow oxygen is in use.
Curve— section A). If the mask • Using a mask may cause tooth, gum or
pressure during expiration is too low, jaw soreness or aggravate an existing
there may not be enough exhaust vent dental condition. If symptoms occur,
flow to completely flush the air delivery consult your physician or dentist.
hose of exhaled air before the start of
Note: At a fixed flow rate of supplemental
the next inspiration.
oxygen flow, the inhaled oxygen concentration
• The mask should not be worn if the anti-
will vary, depending on the pressure settings,
asphyxia valve membrane is damaged or
patient breathing pattern, mask selection, and
missing. If the valve membrane is
the leak rate.
damaged, distorted or torn, it should be
replaced with a new valve membrane.
• The mask may not be suitable for those
PARTS OF THE MASK
at increased risk of gastric regurgitation. See section B on the illustrations sheet.
• The mask must be cleaned and
disinfected/sterilized if it is used FITTING THE MASK
between patients. Refer to the section See section C on the illustrations sheet.
“Cleaning the Mask between Patients” Note: Before fitting the mask, refer to the
for details. section on “Cleaning the Mask in the Home”.
• If oxygen is used with the flow The ULTRA MIRAGE FULL FACE MASK is
generator, the oxygen flow must be supplied fully assembled.
turned off when the flow generator is 1 Move the forehead support tab to
not operating. Position 4 (Fig. C-1). Position 4 is the
Explanation of the Warning: When the uppermost tab position.
flow generator is not in operation and
2 Disconnect one lower headgear clip.
the oxygen flow is left on, oxygen
Place the mask on the face and pull the
delivered into the air delivery tubing
headgear over your head (Fig. C-2).
may accumulate within the flow
Ensure that the upper straps pass across
generator enclosure and create a risk of
your forehead and the lower straps
fire. This applies to most types of flow
below your ears.
generators.
3 Reattach the headgear clip to the mask
• Oxygen supports combustion.
frame.
Oxygen should not be used while
you are smoking or in the presence 4 Gently tighten the upper headgear
of an open flame. straps (Fig. C-3).
• Always ensure airflow is being 5 Gently tighten the lower headgear
generated by the device before the straps (Fig. C-4).
oxygen supply is turned on. The pads of the forehead support
should lightly touch your forehead when
the mask is in place. If the pads do notENGLISH
touch your forehead, you may need to REMOVING THE MASK
change the position of the forehead To remove the ULTRA MIRAGE FULL FACE
support tab as described in step 8. MASK, disconnect one of the lower
6 The fitted mask should look like this headgear clips and pull the mask and
(Fig. C-5). headgear up over your head.
7 Connect the main air tubing to the Note: The headgear clips are easy to locate
swivel (Fig. C-6). Then connect the free and disconnect. They allow you to quickly
end of the air tubing to your flow remove the mask from your face in the event
generator and turn the flow generator of an emergency.
on. If you feel air leaks around the
cushion, you may need to gently tighten DISASSEMBLING FOR
the headgear straps.
CLEANING
Note: Do not overtighten the headgear See section D on the illustrations sheet.
straps as this may cause discomfort,
1 Detach the mask from the air tubing.
cushion creases, and mask leak.
2 Disconnect the headgear clips to release
8 If you are unable to get a proper seal
them from the mask frame. It is not
through gently tightening the headgear,
necessary to remove the headgear clips
you will need to change the position of
from the headgear.
the forehead support tab.
Loosen the headgear straps and move 3 Remove the exhaust vent and port caps
the forehead support tab to the next from the mask frame.
position (e.g., from Position 4 move it 4 Detach the cushion assembly from the
downwards to Position 3). Gently mask frame by depressing the cushion
tighten the upper headgear straps and clip at the base of the mask frame and
then the lower headgear straps. gently pulling it off. This releases the
cushion and cushion clip.
Take time to test all four positions of the
forehead support tab and to adjust the Then, separate the cushion from the
headgear straps so that you can achieve cushion clip.
a secure and comfortable fit. 5 To detach the elbow from the frame, lift
Notes: (Fig. D-1) and push (Fig. D-2) the right
wing of the elbow retainer over the right
• If you are unable to resolve any leaks you
L-shaped ridge on the mask frame.
may require another mask frame and/or
another cushion size. 6 Rotate the elbow retainer to the
position shown in Figure D-3. The
• Select “Mir Full” as the mask option when
elbow retainer is now in the correct
using the ULTRA MIRAGE FULL FACE
position for removal.
MASK with ResMed flow generators that
have mask setting options. 7 To 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.ENGLISH
8 To remove the swivel, lift the swivel clip WEEKLY
and slide it out (Fig. D-5). Handwash the headgear in warm, soapy
9 Squeeze the tabs of the valve elbow to water. Use pure soap. Rinse well and allow
remove the valve frame from the valve it to air dry out of direct sunlight.
elbow. Then, carefully remove the valve
membrane from the valve frame CAUTION
(Fig. D-6). • Do not use bleach, chlorine, alcohol,
10 To remove the forehead support from or aromatic-based solutions,
the mask, press the tab (Fig. D-7a) and moisturizing or antibacterial soaps, or
move it upwards until you can slide it off scented oils to clean any of the mask
the mask frame (Fig. D-7b). components. These solutions may
11 Pull firmly at the base of the forehead cause damage and reduce the life of
support pad plugs to release the pads the product.
from the forehead support (Fig D-8). • Do not expose any part of the mask
system or tubing to direct sunlight as
CLEANING THE MASK IN THE it may cause the product to
HOME deteriorate.
• If any visible deterioration of a mask
Notes:
component is apparent (cracking,
• Wash the headgear before first time use, crazing, tears, etc), the mask
as the dye may run. It is important to component should be discarded and
always handwash the headgear. replaced.
• The headgear may be washed without
being disassembled. REPROCESSING THE MASK
DAILY/AFTER EACH USE BETWEEN PATIENTS
The mask should be reprocessed when
Handwash the mask components in
used between patients. Cleaning,
lukewarm, soapy water. Use pure soap
disinfection and sterilization instructions are
(an example of pure soap is Dove®soap,
unscented; made by Unilever). Rinse the available from the ResMed website,
www.resmed.com/masks/sterilization/
components well and allow them to air dry
americas.
out of direct sunlight.
If you do not have Internet access, please
To clean the valve membrane, immerse it in
contact your ResMed representative.
soapy water and gently rub the membrane
to remove any foreign matter. Rinse the
CAUTION
membrane and allow it to air dry out of
direct sunlight. The valve membrane must be replaced
with a new valve membrane when the
Inspect the valve membrane for wear and
mask is reused on another patient. This
deterioration. If the valve membrane is
part cannot be disinfected or sterilized.
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.ENGLISH
REASSEMBLING THE MASK MASK REASSEMBLY
ATTENTION See section F on the illustrations sheet.
It is important to follow the instructions 1 Check that the holes in the exhaust vent
detailed in this section. Any deviation are not obstructed. If they are
from the specified order of assembly obstructed, replace the exhaust vent.
could affect the functioning of your mask. Push the exhaust vent onto the mask
frame so the small round bump on the
Reassembling the entire mask involves two
exhaust vent is on the outside of the
stages:
mask frame (Fig. F-1).
1. Valve Reassembly
2. Mask Reassembly CAUTION
The exhaust vent must be correctly
VALVE REASSEMBLY inserted into the mask frame to
See section E on the illustrations sheet. prevent leakage. Poor sealing may
Note: This stage must be completed before reduce pressure and affect therapy.
Mask Reassembly. 2 Twist the luer lock port caps onto the
Make sure all parts of the mask system, mask ports (Fig. F-2).
especially the valve membrane, are clean 3 Insert the assembled valve into the mask
and dry before reassembling. If the valve frame (Fig. F-3).
membrane is damaged, distorted or torn, Note: The valve must be assembled
replace it with a new valve membrane.
(as depicted in Figure E-4), before it is
1 Insert the valve membrane into the inserted into the mask frame.
valve frame and gently push it into place
4 Hold the mask frame and the inserted
(Fig. E-1). Make sure it is seated evenly
valve firmly together.
and flatly around the rim of the valve
frame, as the membrane may produce a 5 To attach the elbow retainer, fit one
noise while you are breathing out, if it is side of the elbow retainer against the
fitted incorrectly. groove of the valve. While holding one
wing of the elbow retainer down
2 Push the valve frame over the tabs of
(Fig. F-4a), press the other wing down
the valve elbow until they lock together
until the elbow retainer clicks into place
(Fig. E-2). Make sure the valve frame and
(Fig. F-4b).
valve elbow are securely connected to
each other. 6 Rotate the elbow retainer to its original
position (Fig. F-5).
3 Insert the swivel into the end of the
valve elbow and secure it with the swivel 7 Check that you have fitted the valve and
clip (Fig. E-3). elbow retainer correctly by firmly pulling
the valve away from the frame. If the
4 Set the assembled valve (Fig. E-4) aside
valve is fitted correctly, it should not
for use in the following stage.
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 valveENGLISH
still comes away from the frame when REPLACEMENT PARTS
you pull on it, you may need to replace
Part No. Item
the elbow retainer with a new one.
16613 Anti-asphyxia valve (1 pk.)
8 Fit the grooved edge of the mask
cushion to the mask frame. Fit the top 16604 Cushion, Small, Standard (1 pk.)
section first, then work your way around 16671 Cushion, Small, Shallow (1 pk.)
the mask, pushing the cushion onto the 16605 Cushion, Medium, Standard
frame, ensuring a good seal has been (1 pk.)
achieved. 16672 Cushion, Medium, Shallow
Then push the cushion clip over the (1 pk.)
cushion onto the mask frame, ensuring it 16606 Cushion, Large, Standard (1 pk.)
clicks into place in all locations (Fig. F-6). 16673 Cushion, Large, Shallow (1 pk.)
9 Attach the forehead pads to the 16674 Cushion clip, Small (1 pk.)
forehead support by inserting the pad 16675 Cushion clip, Medium (1 pk.)
plugs into the two holes on the back of
16676 Cushion clip, Large (1 pk.)
the forehead support (Fig F-7). Push the
pads firmly against the forehead support 60683 Elbow retainer (1 pk.)
to ensure that the pads fit securely into 16509 Exhaust vent (1 pk.)
the forehead support. 16510 Exhaust vent (10 pk.)
10 Connect the forehead support to the 60681 Luer lock port caps (2 pk.)
mask frame. Slide the pivots into the
60682 Luer lock port caps (10 pk.)
pivot slot on the mask frame (Fig. F-8).
Depress the forehead support tab and 16689 Swivel (1 pk.)
move it into any of the tab positions. 60680 Swivel clip (1 pk.)
11 Insert the headgear clips into the slots 16637 Swivel clip (5 pk.) and Elbow
on the mask frame. The headgear label clip (5 pk.)
should face outwards and be near your 16624 Valve elbow (1 pk.)
neck when fitted. 16617 Valve membrane (1 pk.)
16618 Valve membrane (10 pk.)
TECHNICAL SPECIFICATIONS 60115 Headgear clip (2 pk.)
PRESSURE–FLOW CURVE 60116 Headgear clip (10 pk.)
See section A on the illustrations sheet. 60123 Forehead pad (1 pk.)
60124 Forehead pad (10 pk.)
DEAD SPACE INFORMATION
60670 Mask Frame, Small (1 pk.)
Dead space is the empty volume of the
60671 Mask Frame, Medium (1 pk.)
mask up to the swivel.
60672 Mask Frame, Large (1 pk.)
The dead space of the mask varies
according to cushion sizes but is less than 60673 Forehead Support (1 pk.)
258 mL. 60674 Headgear (1 pk.)
60620 Frame System with cushion,
Note: The manufacturer reserves the right (excluding headgear) Small,
to change these specifications without notice. StandardENGLISH
Part No. Item LIMITED WARRANTY
60621 Frame System with cushion, ResMed warrants that your ResMed mask
(excluding headgear) Small, system, including its components: mask
Shallow frame, cushion, headgear, tubing and other
60622 Frame System with cushion, accessories (“Product”) shall be free from
(excluding headgear) Medium,
Standard defects in material and workmanship for a
period of ninety (90) days from the date of
60623 Frame System with cushion,
(excluding headgear) Medium, purchase by the initial consumer.
Shallow For further details refer to the Warranty.
60624 Frame System with cushion,
(excluding headgear) Large,
Standard
60625 Frame System with cushion,
(excluding headgear) Large,
ShallowManufacturer: 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. For patent information, see www.resmed com/ip. Ultra Mirage is a trademark of ResMed Ltd and Mirage is registered in U.S. Patent and Trademark Office. Velcro is a registered trademark of Velcro Industries B.V. © 2012 ResMed Ltd.
608337/1 2012-06
ULTRA MIRAGE FULL FACE MASK
User
AMER - ENG
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