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USER MANUAL Mirage Quattro ResMed
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Person wearing a medical headgear mask and respirator device, enclosed in a circular frame (no text or symbols visible)
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Transparent medical device with green and gray components, no visible text or symbols
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
Mirage and Mirage Quattro are trademarks of ResMed Pty Ltd and Mirage is registered in U.S. Patent and Trademark Office.
Velcro is a registered trademark of Velcro Industries B.V. STERRAD and CIDEX are trademarks of Johnson & Johnson. Alconox is a trademark of Alconox Ltd. Neodisher Medizyme is a trademark of Chemische Fabrik Dr. Weiger L. Aniosyme is a trademark of Laboratories Anios.
© 7020 ResMed
CE0123
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Mask parts / Maskparts / Components de meso. C / Ferti-cella maschona / Planar de a maschona / Aposa de maschona / brackera de delosi Dial / Diplar / D'orner - 100 mm x 100 mm - 200 mm x 200 mm - 300 mm x 300 mm - 400 mm x 400 mm - 500 mm x 500 mm - 600 mm x 600 mm - 700 mm x 700 mm - 800 mm x 800 mm - 900 mm x 900 mm - 1000 mm x 1000 mm - 1100 mm x 1100 mm - 1200 mm x 1200 mm - 1300 mm x 1300 mm - 1400 mm x 1400 mm - 1500 mm x 1500 mm - 1600 mm x 1600 mm - 1700 mm x 1700 mm - 1800 mm x 1800 mm - 1900 mm x 1900 mm - 2000 mm x 2000 mm - 2100 mm x 2100 mm - 2200 mm x 2200 mm - 2300 mm x 2300 mm - 2400 mm x 2400 mm - 2500 mm x 2500 mm - 2600 mm x 2600 mm - 2700 mm x 2700 mm - 2800 mm x 2800 mm - 2900 mm x 2900 mm - 3000 mm x 3000 mm - 3100 mm x 3100 mm - 3200 mm x 3200 mm - 3300 mm x 3300 mm - 3400 mm x 3400 mm - 3500 mm x 3500 mm - 3600 mm x 3600 mm - 3700 mm x 3700 mm - 3800 mm x 3800 mm - 3900 mm x 3900 mm - 4000 mm x 4000 mm - 4100 mm x 4100 mm - 4200 mm x 4200 mm - 4300 mm x 4300 mm - 4400 mm x 4400 mm - 4500 mm x 4500 mm - 4600 mm x 4600 mm - 4700 mm x 4700 mm - 4800 mm x 4800 mm - 4900 mm x 4900 mm - 5000 mm x 5000 mm - 5100 mm x 5100 mm - 5200 mm x 5200 mm - 5300 mm x 5300 mm - 5400 mm x 5400 mm - 5500 mm x 5500 mm - 5600 mm x 5600 mm - 5700 mm x 5700 mm - 5800 mm x 5800 mm - 5900 mm x 5900 mm - 6000 mm x 6111. (A) / (B) / (C) / (D) / (E) / (F) / (G) / (H) / (I) / (J) / (K) / (L) / (M) / (N) / (O) / (P) / (Q) / (R) / (S) / (T) / (U) / (V) / (W) / (X) / (Y) / (Z) / (A) / (B) / (C) / (D) / (E) / (F) / (G) / (H) / (I) / (J) / (K) / (L) / (M) / (N) / (O) / (P) / (Q) / (R) / (S) / (T) / (U) / (V) / (W) / (X) / (Y) .B Fitting the mask / iniegen den Mesko / Mise en place ou mesque / Corre indossare la maschera / Co coación de la mascarla / Co coagao da méscera / Masker opazellen an asperceson
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Illustration showing a medical procedure with numbered steps from initial device to final device, including hand positioning and insertion instructions.Disassembling for cleaning / Muscenderau zu Herpungsrechnen / Desmontage pour le nettovage / Desmontaggio per la puita a / Des montaje para le Impresa / Desmontagem para Impresa / Desmontage voor montagem
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1 2 3 4 5 6 7 8 9 10 11 2 3 4 5 6 7 8 9 10 11 2000-0000-0000ResMed
Mirage Quattro
Full Face Mask / Full Face Mask / Masque facial / Maschera oro-resele / Mascentia Facial / Mascara Facial / Vorgalaats masder
Illustrations Sheet / Illustrationsblatt /
Note: For complete instructions, please read the text section in conjunction with the illustrations on this sheet.
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.
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.
- 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 a mask may cause tooth, gum or jaw soreness or aggravate an existing dental condition. If symptoms occur, consult your physician or dentist.
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 ^® , pull the upper headgear straps evenly until they are 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.
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.
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.
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 optimize 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.
Cleaning the Mask between Patients
The Mirage Quattro should be disinfected or sterilised when used between patients. All components, except the headgear, are validated for up to 20 disinfection or sterilisation cycles using one of the following processes:
- Thermal disinfection at a maximum temperature–time combination of 93°C for 10 minutes
•Chemical disinfection (eg, Cidex™ OPA or Cidex Plus™)
•The STERRAD™ Sterilization System (eg, 100S or NX).
The headgear should be thoroughly washed between patients, as described in "Cleaning the Mask in the Home".
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).
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 cushion may be dirty. Clean cushion according to instructions in “Cleaning the Mask in the Home”. | |
| Mask may have been fitted incorrectly or is incorrectly adjusted. | Carefully follow instructions in “Fitting the Mask”. Check headgear and dial are not over-tightened. Extend dial to apply more force to chin. Contract dial to increase force at nose bridge. | |
| Mask cushion is skewed in cushion clip. | Check insertion of cushion and reinsert correctly. | |
| Mask cushion is misaligned or creased on face. | 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. | |
| Mask is wrong size. Talk to your clinician. | ||
| Mask is too noisy Vents are blocked or partially blocked. | Clean vents according to instructions in “Cleaning the Mask in the Home”. | |
| Dial inserted into mask frame before forehead support | Misassembly. Push dial base onto a hard surface until the dial comes out of the frame. | |
Technical Specifications
Note: The mask system does not contain latex, PVC or DEHP materials.
Pressure-Flow Curve
line
| Mask Pressure (cm H₂O) | Vent Flow Rate (L/min) | | ---------------------- | ---------------------- | | 4 | 20 | | 6 | 30 | | 8 | 40 | | 10 | 50 | | 12 | 60 | | 14 | 70 | | 16 | 80 | | 18 | 90 | | 20 | 100 | | 22 | 110 | | 24 | 120 | | 26 | 130 | | 28 | 140 | | 30 | 150 | | 32 | 160 | | 34 | 170 | | 36 | 180 | | 38 | 190 | | 40 | 200 | | 42 | 210 | | 44 | 220 |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 40 cm H_2O
Inspiratory and expiratory resistance
with Anti Asphyxia Valve (AAV) open to atmosphere.
Inspiration at 50 L/min 0.8 cm H_2O
Expiration at 50 L/min 0.8 cm H_2O
Resistance
Drop in pressure measured (nominal)
at 50 L/min: 0.5 cm H_2O
at 100 L/min: 1.6 cm H_2O
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^ to +60^
Storage and transport humidity: 10%–95% relative humidity non-condensing
Mask sizes
(Mask fully assembled with elbow assembly - no headgear)
size height (mm) width (mm) depth (mm)
extra small 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
Batch Code
REF
Catalogue Number
EC REP
European Authorised Representative
Does not contain natural rubber latex
Humidity limitation
Temperature limitation
Manufacturer
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.
Ordering Information
Ref. Item
Complete System
| 61204 | Mirage Quattro Full Face Mask,Extra Small - Europe 1 |
| 61205 | Mirage Quattro Full Face Mask,Small - Europe 1 |
| 61206 | Mirage Quattro Full Face Mask,Medium - Europe 1 |
| 61207 | Mirage Quattro Full Face Mask,Large - Europe 1 |
| 61220 | Mirage Quattro Full Face Mask,Extra Small - France |
| 61221 | Mirage Quattro Full Face Mask,Small - France |
| 61222 | Mirage Quattro Full Face Mask,Medium - France |
| 61223 | Mirage Quattro Full Face Mask,Large - France |
| 61224 | Mirage Quattro Full Face Mask,Extra Small - UK |
| 61225 | Mirage Quattro Full Face Mask,Small - UK |
| 61226 | Mirage Quattro Full Face Mask,Medium - UK |
| 61227 | Mirage Quattro Full Face Mask,Large - UK |
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) |
Ref. Item
16119 Headgear, Large (1 pk)
60115 Headgear clip (2 pk)
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.
Mirage Quattro™
FULL FACE MASKE
61277 Kussenklem, large (1 st.)
61282 Kniestuk (1 st.)
61286 (Anti-verstikkings)-klep + klem (1 st.)
61287 (Anti-verstikkings)-klep + klem (10 st.)
