ResMed Full Face Mask Mirage Quattro User Manual

Mirage Quattro™

61856

FULL FACE MASK

User Guide

English

61856/3

07 03

MIRAGE QUATTRO

USER

ENG ROW

Global leaders in sleep and respiratory medicine www.resmed.com

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New Zealand, Norway, Singapore, Spain, Sweden, Switzerland, UK, USA
(see www.resmed.com for contact details).

Mirage Quattro Full Face Mask
Protected by patents: AU 777033, EP 1187649, EP 1314445, HK 1057714, US 6412487, US 6439230, US 6513526,

US 6581594, US 6701927, US 6796308, US 6823865, US 6823869, US 6860269, US 7021311, US 7069933.
Other patents pending.

Protected by design registrations: AU 309495, AU 309789, AU 309800, AU 310242, AU 311114, AU 311132, AU
311133, AU 311134, AU 311135, AU 311136, AU 311137, AU 311186, AU 311187, EU 499173, EU 559208, NZ

407770. Others pending.

Mirage and Mirage Quattro are trademarks of ResMed Ltd and Mirage is registered in U.S. Patent and Trademark
Office.

CIDEX and STERRAD are trademarks of Johnson & Johnson. Alconox is a trademark of Alconox Inc.
Velcro is a registered trademark of Velcro Industries B.V.

© 2007 ResMed Ltd.

(Manufacturer) 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia

(US Designated Agent) 14040 Danielson Street Poway CA 92064-6857 USA

(EU Authorized Representative) 65 Milton Park Abingdon Oxfordshire OX14 4RX UK

Australia, Austria, Brazil, Finland, France, Germany, Hong Kong, Japan, Malaysia, Netherlands,

A

3
6
9
12
15
18
21
24

1

2

Mask parts

B

Fitting the mask

© 2007 ResMed Ltd.

Elbow
assembly

Dial

Vent

Ports cap

Elbow assembly

Valve

Elbow

Forehead support

Mask frame

Valve clip

Forehead support pad

Cushion clip

Mask cushion

Valve hinge

Valve membrane

C

1

1

Disassembling for cleaning

2

3

4

5

6

7

8

2 3 4 5 6

Lower straps

Headgear clip

Swivel

7

Upper straps

© 2007 ResMed Ltd.

8 9 10 11

© 2007 ResMed Ltd.

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2

1

2

3
6
9
12
15
18
21
24

Mirage Quattro

FULL FACE MASK

Illustrations Sheet

Note: For complete instructions, please read the text section

in conjunction with the illustrations on this sheet.

D

Reassembling the mask

Elbow Reassembly

1 2 3 4 5

Mask Reassembly

6 7 8 9

Component of: 61856/3

10 11 12 13

© 2007 ResMed Ltd.

Mirage Quattro™

FULL FACE MASK

Thank you for choosing ResMed’s Mirage Quattro Full Face Mask.
The Mirage Quattro is a full face mask that covers your nose and mouth. This

means that you can receive effective therapy even if you breathe through your
mouth.

The mask incorporates vent holes and a built-in valve so that you can continue
to breathe fresh air if the airflow to your mask is impeded for any reason.

Intended Use

The Mirage Quattro 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 Quattro is to be used by adult patients (>30 kg) for whom positive
airway pressure has been prescribed.

The Mirage Quattro is intended for single-patient re-use in the home

environment and multipatient re-use in the hospital/institutional environment.

English

Before Using the Mask

WARNINGS

• The Mirage Quattro must be used under qualified supervision with

patients who are unable to remove the mask by themselves. The mask
may not be suitable for those predisposed to aspiration.

• The elbow and valve assembly are intended to be used with the

Mirage Quattro and have specific safety functions. The mask should
not be worn if the valve is damaged as it will not be able to perform its
safety function. The valve should be replaced if it is damaged,
distorted or torn.

• The vent holes must be kept clear.

• Follow all precautions when using supplemental oxygen.

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•

Any oxygen flow must be turned off when the flow generator is not
operating, so that unused oxygen does not accumulate within the flow
generator enclosure and create a risk of fire.

• At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen

concentration will vary, depending on the pressure settings, patient
breathing pattern, mask, point of application and leak rate.

• The technical specifications of the mask and flow generator are

provided for your clinician to check that they are compatible. 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
flow generator function.

• Discontinue using the Mirage Quattro if you have ANY adverse

reaction to any part of the mask system, and consult your physician or
sleep therapist.

• Refer to your flow generator manual for details on settings and

operational information.

Using the Mask

Select ‘Mir Full’ or ‘Full Face’ as the mask option when using the Mirage
Quattro with ResMed flow generators that have mask setting options.

Fitting the Mask

The diagrams in section A on the illustrations sheet show how the parts of the
mask fit together.

The diagrams in section B show the sequence for obtaining the best fit and
comfort in using your mask. Please follow these instructions carefully.

1 Twist the forehead support dial to Position 24, where the forehead support

is fully extended (Fig. B-1).

2 Hold the mask steadily on your face (Fig. B-2) and pull the headgear over

your head.

3 Bringing the lower straps below your ears, clip the headgear to the lower

part of the mask frame (Fig. B-3).

®

4 Unfasten the Velcro

comfortable and firm, and reattach the Velcro (Fig. B-4).

5 Repeat step 4 with the lower headgear straps (Fig. B-5).
6 Test the functioning of the valve by sealing the swivel with your hand and

ensuring that you can still breathe freely.

7 Connect the main air tubing to the swivel (Fig. B-6). Then connect the free

end of the air tubing to your flow generator and turn the flow generator on.

, pull the upper headgear straps evenly until they are

2

8 Lie down in your sleeping position. Twist the forehead support dial

(Fig. B-7) until you feel that the mask is evenly positioned on your face. It

should be comfortable, with a satisfactory seal. Gently tighten the lower
headgear straps if necessary.

9 The fitted mask is shown in Fig. B-8.

Optimising Mask Seal and Comfort

To receive effective therapy it is important to have the best seal possible
between your mask and your face. If you are experiencing leaks, please ensure
that you have followed the fitting instructions carefully. Carry out a quick check
after fitting your mask:

• Is the mask cushion creased? Creases can allow air to leak out of the mask.

• Have you cleaned your mask cushion recently? Oils on the cushion can

affect the seal.

• Are your headgear straps overtightened? Try not to alter the upper headgear

straps once they have been tightened by your clinician.

• You may need to slightly adjust the dial. Note the dial setting when

comfortable.

• Does the mask seem too close to your eyes? You may need a smaller mask.

If you cannot resolve any problems, look at the Troubleshooting section, or talk
to your clinician. You may require another mask size.

Removing the Mask

To remove the Mirage Quattro, disconnect one of the lower headgear clips and
pull the mask and headgear up over your head.

English

Disassembling the Mask

See section C on the illustrations sheet.
1 Detach the air tubing.
2 Unclip the lower headgear clips (Fig. C-1) and unhook the upper headgear

straps (Fig. C-2). It is not necessary to remove the headgear clips from the
headgear.

3 Remove the elbow assembly from the mask frame (Fig. C-3). It’s easier to

pivot the bottom of the elbow away from the mask frame than to pull the
elbow straight off.

4 Remove the valve clip from the elbow (Fig. C-4).
5 Peel the valve away from the valve clip (Fig. C-5). Do not pull on the

membrane to remove the valve.

6 Detach the swivel from the elbow (Fig. C-6).
7 Note the position on the dial for the next time you use the mask.

3

8 Fully unscrew and remove the dial then pull the forehead support out of the

mask frame (Fig. C-7).

9 Remove the forehead support pads from the forehead support (Fig. C-8).
10 Squeeze and push the upper side tabs on the cushion clip out of the mask

frame. Pivot away from the mask, and gently pull out (Fig. C-9).
11 Separate the cushion from the cushion clip (Fig. C-10).
12 Remove the ports cap from the mask frame (Fig. C-11).

Cleaning the Mask in the Home

Notes:

• The mask and headgear can only be cleaned by handwashing.

• The headgear may be washed without removing the headgear clips.

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.

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

damaged.

Daily/After Each Use

To optimise the mask seal, facial oils should be removed from the cushion
before use.

Handwash the mask by gently rubbing in warm (30°C) water using mild soap
or diluted dishwashing detergent.

Do not twist the valve during cleaning as this may damage or tear the valve
membrane or hinge. Take care when handling the valve.

If the vent requires cleaning use a soft bristle brush.
Rinse all components well with drinking quality water and allow them to air dry

out of direct sunlight. Do not soak the mask.

Weekly

Handwash the headgear in warm (30°C) water using mild soap or diluted
dishwashing detergent. Rinse well and allow it to air dry out of direct sunlight.

4

Cleaning the Mask between Patients

The Mirage Quattro should be disinfected or sterilised when used between
patients.

Detailed disinfection and sterilisation instructions are available from the
ResMed website, www.resmed.com/masks/sterilization, and must be
consulted before multipatient use.

Reassembling the Mask

See section D on the illustrations sheet.
Before reassembling the mask, check that all components are clean and dry.

Check that the valve is not damaged, distorted or torn, and that none of the
other components are broken or cracked. Replace any parts that are damaged.

Flexible PVC contains elements that can be detrimental to the materials of the
mask. If flexible PVC tubing is used continuously, the attachment port should
be inspected for cracking. Replace any parts that are damaged.

Elbow Reassembly

1 Insert the valve into the valve clip (Fig. D-1).
2 Push the valve clip onto the elbow (Fig. D-2). Make sure both sides click into

place (Fig. D-3).
3 Insert the swivel into the end of the elbow (Fig. D-4).
4 Insert the assembled elbow (Fig. D-5) into the mask frame.

Mask Reassembly

1 Fit the cushion clip into the grooved edge of the mask cushion. Fit the top

section first, then work your way around, pushing the clip into the cushion

(Fig. D-6). Ensure that the cushion is not twisted or distorted around the

clip.
2 Align the cushion clip with the mask frame. Push the cushion clip into the

mask frame, ensuring that all three clips click into place (Fig. D-7).

3 Push the forehead pads firmly into the forehead support (Fig. D-8).
4 Insert the forehead support into the mask frame and screw the dial

clockwise onto the pole (Fig. D-9). Turn the dial until it clicks (Fig. D-10).

Ensure the dial sits flush against the frame.

5 Insert the ports cap (Fig. D-11).
6 Reattach the top headgear by threading it through the loop (Fig. D-12).
7 Turn the dial until you reach the setting that gives you good comfort and seal

(Fig. D-13).

English

5

Storage

Ensure that the mask is thoroughly clean and dry before storing it for any
length of time. Store the mask in a cool dry place out of direct sunlight.

Disposal

The Mirage Quattro does not contain any hazardous substances and may be
disposed of with your normal household refuse.

Troubleshooting

Problem Possible reason Possible solution

Mask won’t seal properly
or is uncomfortable

Mask is too noisy Vents are blocked or partially

Dial inserted into mask
frame before forehead support

Mask cushion may be dirty. Clean cushion according to

Mask may have been fitted
incorrectly or is incorrectly
adjusted.

Mask cushion is skewed in
cushion clip.

Mask cushion is misaligned or
creased on face.

Mask is wrong size. Talk to your clinician.

blocked.

Valve is misassembled. Reassemble valve.
Cushion is not fully clipped in. Check insertion of cushion.
Mask is assembled incorrectly. Reassemble mask.
Valve is torn or distorted and is

not sealing.
Misassembly. Push dial base onto a hard

instructions in “Cleaning the
Mask in the Home”.

Carefully follow instructions in
“Fitting the Mask”. Check
headgear and dial are not over­tightened. Extend dial to apply
more force to chin. Contract dial
to increase force at nose bridge.

Check insertion of cushion and
reinsert correctly.

Ensure cushion is properly
aligned and that there are no
creases in it: undo headgear clip,
check cushion and reposition the
mask on your face.

Clean vents according to
instructions in “Cleaning the
Mask in the Home”.

Replace valve.

surface until the dial comes out
of the frame.

6

Technical Specifications

Note: The mask system does not contain latex, PVC or DEHP materials.

Pressure–Flow Curve

70.0

60.0

50.0

40.0

30.0

20.0

10.0

Vent Flow Rate (L/min)

0.0
2 4 6 8 10 12 14 16 18 20 22 24 26 28 30

Mask Pressure (cm H2O)

Note: As a result of manufacturing variations, the vent flow rate may vary.

Dead Space Information

Dead space: the empty volume of the mask up to the swivel.
The dead space of the mask varies according to cushion size. It is 242 mL for the large

size.

Standards

CE designation in accordance with EC directive 93/42/EEC, class IIa.
ISO 14971, ISO 13485, ISO 10993-1 and ISO 17510-2.

Therapy Pressure

4 to 20 cm H2O

Resistance

Drop in pressure measured (nominal)
at 50 L/min: 0.5 cm H
at 100 L/min: 1.6 cm H

O

2

O

2

Sound

The A-weighted sound power of the mask is 28 dBA.

Environmental Conditions

Operating temperature: +5°C to +40°C
Operating humidity: 10%–95% relative humidity non-condensing
Storage and transport: -20°C to +60°C
Storage and transport humidity: 10%–95% relative humidity non-condensing

Pressure
(cm H2O)

422
832
12 41
16 48
20 54

Flow
(± 6.0 L/min)

English

7

Mask sizes

(Mask fully assembled with elbow assembly - no headgear)

size height (mm) width (mm) depth (mm)

extra smal l 176 109 108
small 186 109 108
medium 196 109 108
large 206 109 108

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

Symbols

System and Packaging

Caution, consult accompanying documents.

Lot number

LOT

Part number/Product code

REF

No latex

Humidity limitation

Temperature limitation

User Guide

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.

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Ordering Information

Ref. Item

Complete System

61204
61205
61206
61207
61224
61225
61226
61227

Replacement Parts

61270 Mask frame, Extra Small (1 pk)
61271 Mask frame, Small (1 pk)
61272 Mask frame, Medium (1 pk)
61273 Mask frame, Large (1 pk)
61274 Cushion clip, Extra Small (1 pk)
61275 Cushion clip, Small (1 pk)
61276 Cushion clip, Medium (1 pk)
61277 Cushion clip, Large (1 pk)
61282 Elbow (1 pk)
61286 Valve (AAV) + clip (1 pk)
61287 Valve (AAV) + clip (10 pk)
61288 Forehead support (1 pk)
61289 Dial (1 pk)
61290 Cushion + clip, Extra Small (1 pk)
61291 Cushion + clip, Small (1 pk)
61292 Cushion + clip, Medium (1 pk)
61293 Cushion + clip, Large (1 pk)
61294 Elbow assembly (elbow, valve, clip and swivel) (1 pk)
61295 Ports cap (2 pk)
61296 Ports cap (10 pk)
16565 Swivel (1 pk)
16118 Headgear, Small (1 pk)
16117 Headgear, Standard (1 pk)
16119 Headgear, Large (1 pk)
60115 Headgear clip (2 pk)

Mirage Quattro Full Face Mask,
Mirage Quattro Full Face Mask,
Mirage Quattro Full Face Mask,
Mirage Quattro Full Face Mask,
Mirage Quattro Full Face Mask,
Mirage Quattro Full Face Mask,
Mirage Quattro Full Face Mask,
Mirage Quattro Full Face Mask,

Extra Small

Small - Europe 1
Medium - Europe 1
Large - Europe 1
Extra Small - UK
Small - UK
Medium - UK
Large - UK

- Europe 1

English

9

Ref. Item

60116 Headgear clip, (10 pk)
60123 Forehead support pad (1 pk)
60124 Forehead support pad (10 pk)

Europe 1 – English, German, French, Italian, Spanish, Portuguese, Dutch.

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.

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