ResMed Mirage Activa LT User Manual

Mirage Activa™ LT
nasal mask
User Guide
English
Mirage Activa LT
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Mask components/ Composants du masque/ Piezas de la mascarilla/ Componentes da máscara
Item/
Description/ Description/ Descripción/ Descrição Article/ Artículo/ Item
1 Mask frame/ Entourage rigide/ Armazón de la mascarilla/
2 Dial/ Molette de réglage/ Disco/ Botão giratório
3 Forehead support/ Support frontal/ Apoyo para la frente/
4 Forehead support pad/ Tampon frontal/
5 Activa LT Cushion & clip/ Bulle et clip/ Almohadilla y broche/
6 Cushion clip/ Clip de la bulle/ Broche de la almohadilla/
7 Headgear clip/ Clip d’attache du harnais/ Broche del arnés/
8 Headgear/ Harnais/ Arnés/ Arnês
9 Ports cap/ Bouchon d’entrées/ Tapón de los puertos/
10 Swivel/ Pièce pivotante/ Pieza giratoria/ Peça giratória
11 Elbow/ Coude/ Codo/ Cotovelo
12 Vent/ Orifice de ventilation/ Ventilación/ Respiradouro
13 SoftGel Cushion & clip/ Bulle et clip/ Almohadilla y broche/
Armação da máscara
Suporte para a testa
Almohadilla del apoyo para la frente/
Almofada do suporte para a testa
Almofada e presilha
Presilha da almofada
Presilha do arnês
Tampa das portas
Almofada e presilha
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Item/
Description/ Description/ Descripción/ Descrição Article/ Artículo/ Item
A Complete system/ Système complet/ Sistema completo/
B Frame system/ Entourage complet/ Sistema de armazón/
C Frame assembly/ Ensemble entourage/ Conjunto del armazón/
D Elbow assembly/ Ensemble coude/ Conjunto del codo/
E SoftGel Cushion & clip/ Bulle et clip/ Almohadilla y broche/
Also available/ Également disponible/ También está disponible/ Também disponível
A + E ConvertAble Pack
Sistema completo
Sistema da armação
Conjunto da armação
Conjunto do cotovelo
Almofada e presilha
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Fitting/ Mise en place/ Colocación/ Colocação
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Removal / Enlèvement du masque / Para quitarse la mascarilla / Remoção
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Disassembly/ Démontage/ Desmontaje/ Desmontagem
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Reassembly/ Remontage/ Montaje/ Remontagem
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Mirage Activa™ LT
nasal mask
Thank you for choosing the Mirage Activa™ LT. The Mirage Activa LT is the first in ResMed’s ConvertAble™ Series—offering a choice of two high performance cushions (Mirage Activa LT and Mirage SoftGel) on the one durable frame. For further information, refer to the ConvertAble Series section in this User Guide.
Rx Only
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:
to be used by adult patients (>66 lb/30 kg) for whom positive airway pressure has been prescribed
intended for single-patient re-use in the home 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/Device Compatibility List on www.resmed.com on the Products page under Service & Support. If you do not have internet access, please contact your ResMed representative.
WARNING
The vent holes must be kept clear.
Follow all precautions when using supplemental oxygen.
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 varies, depending on the pressure settings, patient breathing pattern, mask, point of application and leak rate.
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The technical specifications of the mask are provided for your clinician to check that they are compatible with the flow generator. 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 mask if you have ANY adverse reaction to the use of the mask, and consult your physician or sleep therapist.
Using a mask may cause tooth, gum or jaw soreness or aggravate an existing dental condition. If symptoms occur, consult your physician or dentist.
As with all masks, some rebreathing may occur at low CPAP pressures.
Refer to your CPAP or bilevel device manual for details on settings and operational information.
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:
To optimize the mask seal, facial oils should be removed from the cushion after use.
Handwash the separated mask components (excluding headgear).
If the vent requires cleaning use a soft bristle brush.
Weekly:
Handwash the headgear. It may be washed without being disassembled.
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 vapors from these solutions can be inhaled if not rinsed thoroughly. They may also damage the mask, causing cracks.
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CAUTION
If any visible deterioration of a mask component is apparent (cracking, crazing, tears etc.), the mask component should be discarded and replaced.
Avoid connecting flexible PVC products (eg, PVC tubing) directly to any part of this 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
Only Sleep Lab Mask (SLM) variants of the mask are intended for multi-patient re-use. When using between patients, these masks must be reprocessed according to cleaning and disinfection instructions available on ResMed.com/downloads/masks.
Troubleshooting
Possible reason Solution
Mask is uncomfortable
Headgear straps are too tight. Adjust the straps evenly. The forehead support
Cushion incorrectly inflated. With the air turned off, adjust the straps so that
Mask is too noisy
Cushion clip is not inserted correctly.
Ports cap or elbow incorrectly inserted.
Vents are blocked or partially blocked.
Air leaking around the face
Mask not positioned correctly. Reposition the mask upon the face.
Air leaking around the bridge of the nose.
Air leaking around the top of the lip. Wind the dial out.
“anchors” your mask and should sit firmly on your forehead.
you can insert two fingers between your cheek and the lower headgear strap.
Check that the cushion clip is correctly inserted into the cushion, and that the cushion is correctly clipped to the frame.
Check the the ports cap and elbow are correctly inserted.
Clean vents according to instructions in “Cleaning the Mask at Home”.
Wind the dial in.
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The mask does not fit properly
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Cushion could be the wrong size. Talk to your clinician.
Mask is incorrectly assembled. Reassemble the mask according to the
instructions in “Reassembly”.
Cushion may be dirty. Clean cushion according to instructions in
“Cleaning the Mask at Home”.
Cannot insert forehead support into mask frame
When assembling the mask, you have inserted the dial into the frame
Push dial base onto a hard surface until the dial comes out of the frame.
before the forehead support.
Technical Specifications
The mask system does not contain latex, PVC or DEHP materials.
Pressure–Flow Curve
Dead Space Information
Therapy Pressure 4 to 20 cm H
Environmental Conditions
Resistance Drop in pressure measured (nominal)
Gross dimensions
Mask setting options
The manufacturer reserves the right to change these specifications without notice.
The mask contains passive venting to protect against rebreathing. As a result of manufacturing variations, the vent flow rate may vary.
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Vent Flow Rate (L/min)
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Mask Pressure (cm H2O)
Pressure (cm H
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20 45
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Flow
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(L/min)
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The dead space of the mask varies according to cushion size. It is 185 mL for the Medium size.
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Operating temperature: +41°F to 104°F (+5°C to +40°C) Operating humidity: up to 95% non-condensing Storage and transport temperature: -4°F to 140°F (-20°C to +60°C) Storage and transport humidity: up to 95% non-condensing
at 50 L/min: 0.1 cm H at 100 L/min: 0.7 cm H
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S: 5.55”/141mm (H) x 3.58”/91mm (W) x 4.21”/107mm (D) M, L, LW: 6.06”/154 mm (H) x 3.74”/95mm (W) x 4.6”/117 mm (D) Mask fully assembled – no headgear.
Select ‘Activa’ (if available) otherwise select ‘Standard’ as the mask option.
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Storage
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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 mask does not contain any hazardous substances and may be disposed of with your normal household refuse.
Symbols
English
Caution, consult accompanying documents;
Catalogue Number; European Authorised Representative;
Temperature limitation; Humidity limitation; Does not contain natural rubber latex; Manufacturer; 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. Keep away from rain; This way up;
Fragile, handle with care.
Batch Code;
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 above limitation may not apply to you.
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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.
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Mirage™ SoftGel
NASAL MASK / MASQUE NASAL / MASCARILLA NASAL / MÁSCARA NASAL
User information
English • Français • Español • Português
Rx Only
Cushion clip/ Clip de la bulle/ Broche de la almohadilla/ Presilha da almofada
Cushion & clip / Bulle et clip / Almohadilla y broche / Almofada e presilha
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English
Please read this information in conjunction with your Mirage Activa
TM
LT User Guide when changing your Mirage Activa LT cushion to the Mirage SoftGel cushion.
Intended use
The Mirage SoftGel 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 SoftGel is:
to be used by adult patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed
intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.
Troubleshooting
Problem/possible cause
Mask is uncomfortable
Headgear straps are too tight.
Fit is too tight. Wind out dial.
Solution
Adjust straps evenly. The forehead support ‘anchors’ your mask and should sit firmly on your forehead.
Technical specifications
Dead space information Physical dead space is the empty volume of the mask to
Resistance Drop in pressure measured (nominal)
Gross dimensions
Mask setting options Select ‘ACTIVA ’ (if available), otherwise select
the end of the swivel. Using the large cushions it is 145 mL.
at 50 L/min: 0.3 cm H at 100 L/min: 0.9 cm H
Mask fully assembled - no headgear
Large:
6.10“ (H) x 3.58“ (W) x 4.65“ (D) (155 mm (H) x 91 mm (W) x 118 mm (D))
‘STANDARD’ as the mask option.
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Fitting and assembly / Ajustement et montage / Colocación y montaje / Encaixe e montagem
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Manufacturer:
ResMed 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 Activa are trademarks of ResMed Ltd and are registered in U.S. Patent and Trademark Office.
© 2018 ResMed Ltd.
Global leaders in sleep and respiratory medicine www.resmed.com
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MIRAGE ACTIVA LT
USER
AMER
- ENG
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