Mirage Softgel User Guide
Contents
1. Cushion may be dirty Solution Remove the ports cap or elbow from the mask then reassemble according to the instructions If the vent requires cleaning use a soft bristle brush Gently pull the cushion away from the face to reinflate Reposition your mask according to the instructions 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 Wind the dial in Wind the dial out and or tighten the bottom straps Talk to your clinician Disassemble the mask then reassemble according to the instructions 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 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 Pressure Flow E a cm H O L min Ea 4 19 2 S 8 28 S lt 2 12 34 Z 16 40 Mask pressure cm H 0 20 45 Dead space Physical dead space is the empty volume of the mask to the end of information the swive2. Moyen Mediana M dio a St Standard Standard Est ndar Standard L Large Grand Grande Grande LW Large Wide Grand et large Grande Largo GL Grande Ancho GA Disassembly D montage Desmontaje Desmontagem 3 Reassembly Remontage Montaje Remontagem EXT Mirage SoftGel NASAL MASK Thank you for choosing the Mirage SoftGel The Mirage SoftGel is the first in ResMed s ConvertAble Series 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 ConvertAble Series 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 e to be used by adult patients gt 66 lb 30 kg for whom positive airway pressure has been prescribed e 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 Dev
3. 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 americas If you do not have internet access please contact your ResMed representative Troubleshooting Problem possible cause Mask is uncomfortable Headgear straps are too tight Fit is too tight Mask is too noisy Cushion clip is not inserted correctly Solution Adjust straps evenly The forehead support anchors your mask and should sit firmly on your forehead Wind out dial 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 English Problem possible cause Ports cap or elbow incorrectly inserted Vent is blocked or partially blocked Mask leaks around the face Mask not positioned correctly Cushion clip is not inserted correctly Air leaking around the bridge of the nose Air leaking around the top of the lip The mask does not fit properly Cushion could be the wrong size Mask is incorrectly assembled
4. Vent Orifice de ventilation Ventilaci n Respiradouro Activa LT Cushion amp clip Bulle et clip Almohadilla y broche Almofada e presilha Part number Code produit N mero de parte C digo do produto 60180 St 60193 S 61289 16393 60123 1 60124 10 61631 S 61632 M 61633 L 61634 LW 60176 St 60197 S 6569 2 16734 10 6118 S 6117 M 16119 L 6570 2 6571 10 6565 6387 60198 S 60177 M 60178 L 60179 LW Item Description Description Part number Code Article Descripci n Descri o produit N mero Art culo de parte C digo do Item produto A Complete system Syst me complet 61600 S 61602 L Sistema completo Sistema completo 61601 M 61603 LW B Frame system Entourage complet 61626 S 61628 L Sistema de armaz n Sistema da 61627 M 61629 LW arma o G Frame assembly Ensemble entourage 60175 St Conjunto del armaz n Conjunto da 60196 S arma o D Elbow assembly Ensemble coude 16399 Conjunto del codo Conjunto do cotovelo E Activa LT Cushion amp clip Bulle et clip 60198 S 60178 L Almohadilla y broche Almofada e 60177 M 60179 LW presilha Also available galement disponible Tambi n est disponible Tamb m dispon vel A E ConvertAble Pack 61604 S 61615 L 61609 M 61620 LW S Small Petit Peque a Pequeno a M Medium
5. above limitation may not apply to you ResMed shall not be responsible for any incidental or consequential damages claimed to have resulted from the sale installation or use of any ResMed product Some regions or states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation may not apply to you This warranty gives you specific legal rights and you may also have other rights which vary from region to region For further information on your warranty rights contact your local ResMed dealer or ResMed office English RESMED Mirage Activa LT Rx Only NASAL MASK MASQUE NASAL MASCARILLA NASAL M SCARA NASAL ConvertAble Series User information English e Fran ais e Espa ol e Portugu s Cushion amp clip Bulle et clip Almohadilla y broche Almofada e presilha de la bulle Broche de la almohadilla Presilha da almofada 60198 S 60177 M 60176 St 60178 L 60197 S 60179 LW Please read this information in conjunction with your Mirage 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 e to be used by adult patients gt 66 lb 30 kg for whom positive airway pressure
6. 23869 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 Office 2009 ResMed Ltd 618149 1 0910 MIRAGE SOFTGEL USER LUNN ONU 618149 AMER ENG Global leaders in sleep and respiratory medicine www resmed com
7. RESMED SoftGel Mirage NASAL MASK User Guide English e Francais e Espa ol e Portugu s Mirage SoftGel Re Only Fitting Mise en place Colocaci n Coloca o Removal Enlevement du masque Para quitarse la mascarilla Remo o Mirage SoftGel Mask components Composants du masque Piezas de la mascarilla Componentes da m scara Item Article Art culo Item 1 Description Description Descripci n Descri o Mask frame Entourage rigide Armaz n de la mascarilla Arma o da m scara Dial Molette de r glage Disco Bot o girat rio Forehead support Support frontal Apoyo para la frente Suporte para a testa Forehead support pad Tampon frontal Almohadilla del apoyo para la frente Almofada do suporte para a testa SoftGel Cushion amp clip Bulle et clip Almohadilla y broche Almofada e presilha Cushion clip Clip de la bulle Broche de la almohadilla Presilha da almofada Headgear clip Clip d attache du harnais Broche del arn s Presilha do arn s Headgear Harnais Arn s Arn s Ports cap Bouchon d entr es Tap n de los puertos Tampa das portas Swivel Pi ce pivotante Pieza giratoria Pe a girat ria Elbow Coude Codo Cotovelo
8. al measures for the safe and effective use of the device ka Keep away from rain tt This way up y Fragile handle with care Limited warranty ResMed Ltd hereafter ResMed warrants that your ResMed mask system including mask frame cushion headgear and tubing shall be free from defects in material and workmanship from the date of purchase for the period of 90 days or in the case of disposable masks the maximum use period This warranty is only available to the initial consumer It is not transferable If the product fails under conditions of normal use ResMed will repair or replace at its option the defective product or any of its components This limited warranty does not cover a any damage caused as a result of improper use abuse modification or alteration of the product b repairs carried out by any service organization that has not been expressly authorized by ResMed to perform such repairs and c any damage or contamination due to cigarette pipe cigar or other smoke Warranty is void on product sold or resold outside the region of original purchase Warranty claims on defective product must be made by the initial consumer at the point of purchase This warranty replaces all other expressed or implied warranties including any implied warranty of merchantability or fitness for a particular purpose Some regions or states do not allow limitations on how long an implied warranty lasts so the
9. existing dental condition If symptoms occur consult your physician or dentist e As with all masks some rebreathing may occur at low CPAP pressures e Refer to your CPAP or bilevel device manual for details on settings and operational information e 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 86 F 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 e To optimize the mask seal facial oils should be removed from the cushion after use e Handwash the separated mask components excluding headgear e If the vent requires cleaning use a soft bristle brush Weekly e Handwash the headgear It may be washed without being disassembled WARNING e 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 Ad CAUTION e 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 e Avoid connecting flexible PVC products eg
10. has been prescribed e intended for single patient re use in the home environment and multipatient re use in the hospital institutional environment 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 Resistance Gross dimensions S M L LW Mask setting options The dead space of the mask varies according to cushion size Itis 185 mL for the Medium size Drop in pressure measured nominal at 50 L min 0 1 cm H O at 100 L min 0 7 cm H O Mask fully assembled no headgear 5 55 141 mm H x 3 58 91 mm W x 4 21 107 mm D 6 06 154 mm H x 3 74 95 mm W x 4 6 117 mm D Select Activa if available or Standard as the mask option when using the Mirage Activa LT with ResMed devices that have mask setting options Fitting and assembly Ajustement et montage Colocaci n y montaje Encaixe e montagem 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 0X14 4RY UK See www resmed com for other ResMed locat
11. ice Compatibility List on www resmed com on the Products page under Service amp 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 e The vent holes must be kept clear e The mask should not be used unless the CPAP or bilevel device is turned on and operating properly e Follow all precautions when using supplemental oxygen e 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 English e Ata 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 e 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 e Discontinue using this mask if you have ANY adverse reaction to the use of the mask and consult your physician or sleep therapist e Using a mask may cause tooth gum or jaw soreness or aggravate an
12. ions worldwide Mirage SoftGel 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 7159587 US 7216647 US 7234466 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 Office 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 68
13. l Using the large cushions it is 145 mL Therapy 4 to 20 cm H O pressure Resistance Drop in pressure measured nominal Environmental conditions Gross dimensions Large Mask setting options Notes at 50 L min 0 3 cm H O at 100 L min 0 9 cm H O Operating temperature 41 F to 104 F 5 C to 40 C Operating humidity 15 to 95 relative humidity non condensing Storage and transport temperature 4 F to 140 F 20 C to 60 C Storage and transport humidity up to 95 relative humidity non condensing Mask fully assembled no headgear 6 10 H x 3 58 W x 4 65 D 155 mm H x 91 mm W x 118 mm D Select ACTIVA if available otherwise select STANDARD as the mask option e The mask system does not contain latex PVC or DEHP materials e The manufacturer reserves the right to change these specifications without notice English 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 AN Caution consult accompanying documents tor Lot number rer Part number a Temperature limitation S Humidity limitation amp Does not contain latex mal Manufacturer A Indicates a Warning or Caution and alerts you to a possible i injury or explains speci
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