ResMed Mirage Activa™ LT User Guide

ResMed Mirage Activa™ LT

Mask components

60193 (S)

2| Dial| 61289
3| Forehead support| 16393
4| Forehead support pad| 60123 (1)

60124 (10)

5| Activa LT Cushion & clip /| 60198 (S)

60177 (M)

60178 (L)

60179 (LW)

6| Cushion clip| 60176 (St)

60197 (S)

7| Headgear clip| 16569 (2)

16734 (10)

8| Headgear| 16118 (S)

16117 (M)

16119 (L)

9| Ports cap| 16570 (2)

16571 (10)

10| Swivel| 16565
11| Elbow| 16387
12| Vent| ****

—

A| Complete system| EUR1| APAC
60186 (S)

60151 (M)

60152 (L)

60153 (LW)

| 60212 (S)

60213 (M)

60214 (L)

60215 (LW)

B| Elbow assembly

| 16399
---|---|---
Also available
C| SoftGel Cushion & clip| 61631 (S)

61632 (M)

61633 (L)

61634 (LW)

SIZES

• S Small
• M Medium
• L Large
• LW Large Wide
• St Standard

Fitting

Removal

Disassembly

Reassembly

Thank you for choosing the Mirage ActivaTM LT. The Mirage Activa LT is the first of ResMed’s masks 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 Mirage SoftGel User Information section in this User Guide.

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 (>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.
• 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 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 optimise 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.

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

This mask should be reprocessed when used between patients. Cleaning, disinfection and sterilisation instructions are available from the ResMed website, www.resmed.com/masks/sterilization. If you do not have Internet access, please contact your ResMed representative.

Troubleshooting

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.

• Dead Space Information
  The dead space of the mask varies according to cushion size. It is 185 mL for the Medium size.

• Therapy Pressure 4 to 20 cm H2O

• Environmental Conditions

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

• Resistance
  Drop in pressure measured (nominal)

  • at 50 L/min: 0.1 cm H2O
  • at 100 L/min: 0.7 cm H2O

• Sound
  DECLARED DUAL-NUMBER NOISE EMISSION VALUES in accordance with ISO 4871. The A-weighted sound power level of the mask is 30 dBA, with uncertainty 3 dBA. The A-weighted sound pressure level of the mask at a distance of 1m is 22 dBA, with uncertainty 3 dBA.

• Gross dimensions

  • S: 141 mm (H) x 91 mm (W) x 107 mm (D)
  • M, L, LW: 154 mm (H) x 95 mm (W) x 117 mm (D)
  • Mask fully assembled – no headgear.

• Mask setting options
  Select ‘Activa’ (if available) otherwise select ‘Standard’ as the mask option.
  Notes:

  • The mask system does not contain PVC or DEHP materials.
  • This product does not contain natural rubber latex.
  • The manufacturer reserves the right to change these specifications without notice.

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

Symbols

Caution, consult accompanying documents; Batch Code; 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.

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.

User information

Please read this information in conjunction with your Mirage ActivaTM 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 (> 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

Fitting and assembly

Manufacturer:

• ResMed Pty Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia
• For patent information, see www.resmed.com/ip
• Mirage and Activa are trademarks of ResMed Pty Ltd and are registered in U.S. Patent and Trademark Office.

USING INSTRUCTION

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

References

• Sleep apnea and COPD - learn about symptoms and treatment | ResMed
• Legal disclaimers and intellectual property - ResMed

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