RESMED 60648 Ultra Mirage Non-Vented Full Face Mask User Guide

Ultra Mirage™
NON-VENTED FULL FACE MASK
Clinical Guide

 608681/2 2021-11

Ultra Mirage NVFFM
CLINICAL
EUR 1

A Mask Parts

B Fitting the Mask

C Disassembling for Cleaning

Ultra MirageTM
NON-VENTED FULL FACE MASK

Illustrations Sheet

Note: For complete instructions, read the text section in conjunction with the illustrations on this sheet.

Ultra Mirage ™
NON-VENTED FULL FACE MASK
The Ultra Mirage NV (non-vented) Full Face Mask is a non-invasive device used for channeling air flow with or without supplemental oxygen.

Intended Use

The Ultra Mirage NV Full Face Mask is intended to be used with active-exhaust valve ventilator systems, to provide ventilatory assistance to patients with respiratory insufficiency and respiratory failure. The Ultra Mirage NV Full Face Mask is to be used on adult patients (>30 kg), who require non-life- support ventilatory assistance. The Ultra Mirage NV Full Face Mask is intended for single-patient re-use in the home or multi-patient re-use in the hospital/institutional environment.

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WARNINGS AND CAUTIONS

• The Ultra Mirage NV Full Face Mask, must not be used without qualified supervision for patients who are unable to remove the mask by themselves.

• This mask is not for use on patients with impaired laryngeal reflexes or other conditions predisposing to aspiration in the event of regurgitation or vomiting.

• The mask should not be worn unless the ventilator system is turned on and operating properly.

• At a fixed rate of supplemental oxygen flow (if used), the inhaled oxygen concentration will vary depending on the pressure settings, patient breathing pattern, mask size selection, and the mask leak.

• If oxygen is used with the ventilator, the oxygen flow must be turned off when the ventilator is not operating.
  Explanation: When the ventilator is not in operation, and the oxygen flow is left on, oxygen delivered into the ventilator tubing may accumulate within the ventilator enclosure. Oxygen accumulated in the ventilator enclosure will create a risk of fire. This warning applies to most types of ventilators.

• Please refrain from smoking while oxygen is in use.

• Using a mask may cause tooth, gum, or jaw soreness or aggravate an existing dental condition. If symptoms occur, consult your physician or dentist.

About the Mask

• The mask system does not contain latex, PVC, or DEHP materials. If the patient has ANY reaction to any part of the mask system, discontinue use and investigate the possible causes.
• ResMed has tinted the Ultra Mirage NV Full Face Mask elbow blue to identify it as a non-vented mask for use with active exhaust non-invasive ventilator systems only.
• The mask has a standard female 22 mm tapered fitting (ISO5356-1) for external connection to the ventilator.
• Refer to the section “Technical Specifications” of this guide for information about mask leak, dead space, and resistance.

CAUTION
The mask must be cleaned and disinfected/sterilized if it is used between patients. Refer to the section “Cleaning the Mask between Patients” for details.

Parts of the Mask

See section A on the illustrations sheet.

Fitting the Mask

Note: Refer to the relevant ventilator system operating instructions for detailed information about connecting the mask.
See section B on the illustrations sheet.
The Ultra Mirage NV Full Face Mask is supplied fully assembled.

1. Move the forehead support tab to Position 3. (Refer to illustration B-1 for the location of Positon 3.)

2. Disconnect one lower headgear clip. Place the mask on the face and pull the headgear over the patient’s head (B-2). Ensure that the upper straps pass across the forehead and the lower straps below the ears.

3. Reattach the headgear clip to the mask frame.

4. Gently tighten the upper headgear straps (B-3).

5. Gently tighten the lower headgear straps (B-4).
   The pads of the forehead support should sit comfortably on the forehead when the mask is in place. If the pads are at an angle and not completely seated on the forehead,  change the position of the forehead support tab.
   Note: Do not overtighten the headgear straps as this may cause discomfort, cushion creases, and mask leak. The Ultra Mirage NV Full Face Mask has been designed to provide a comfortable seal without the need to overtighten the headgear.

6. The fitted mask should look like this (B-5).

7. Connect the main air tubing to the elbow (B-6). Then connect the free end of the air tubing to the ventilator and turn the ventilator on. If the patient experiences air leaks around the cushion, it may be necessary to gently tighten the headgear straps.

8. If the patient is unable to get a proper seal:
   • reposition the mask by lifting it and placing the cushion comfortably on the face.
   • adjust the position of the forehead support tab by testing all four positions and finding the one that best prevents leaks.
   • gently tighten the headgear straps.
   Notes:
   • If it is not possible to resolve any leaks, your patient may require another mask frame and/or another cushion size.
   • As with all mask ventilation systems, a significant leak may occur between the mask and the patient’s face. The leak may vary depending on such factors as the patient’s position and sleep stage. Variation in leak may significantly affect patient ventilation, potentially producing profound hypoventilation or hyperventilation. The magnitude of this effect depends on the ventilator’s ability to compensate for leaks.
   • Leak or variation in the leak may cause mistriggering of the ventilator.

Removing the Mask

Normal Release
To remove the Ultra Mirage NV Full Face Mask, squeeze one of the lower headgear clips and pull the mask and headgear up over the patient’s head.
Emergency Release Cord
The Emergency Release Cord (Figure 1) allows the mask to come away from the face quickly in the event of an emergency.
Simply pull the Emergency Release Cord and the two-part clip separates, allowing you to remove the mask from the face.

Figure 1: Emergency Release Cord.

Note: The Emergency Release Cord should only be used to remove the mask in the event of an emergency. Overuse of the Emergency Release Cord may result in the deterioration of the two-part clip mechanism.

Disassembling for Cleaning

See section C on the illustrations sheet.

1. Detach the mask from the air tubing.

2. Disconnect the headgear clips to release them from the mask frame. It is not necessary to remove the headgear clips from the headgear.

3. Remove the port caps from the mask frame.

4. Detach the cushion assembly from the mask frame by depressing the cushion clip at the base of the mask frame and gently pulling it off. This releases the cushion and cushion clip.
   Then, separate the cushion from the cushion clip.

5. To detach the elbow from the frame, lift (C-1) and push (C-2) the right-wing of the elbow retainer over the right L-shaped ridge on the mask frame.

6. Rotate the elbow retainer to the position shown in C-3. The elbow retainer is now in the correct position for removal.

7. To remove the elbow retainer, hold one wing of the elbow retainer down, and firmly pull the other wing out (C-4a) and then up (C-4b) over the top of the elbow. Remove the elbow retainer and elbow from the mask frame.

8. To remove the forehead support from the mask, press the tab (C-5a) and move it upwards until it is possible to slide it off the mask frame (C-5b).

9. Pull firmly at the base of the forehead support pad plugs to release the pads from the forehead support (C-6).

Cleaning the Mask in the Home

Notes:

• Wash your hands before cleaning the mask.
• It is important to always handwash the headgear.
• The headgear may be washed without being disassembled from the headgear clips.

Daily/After each use
Handwash the mask components in warm (approximately 30ºC) water for one minute using mild soap or detergent. Rinse the components well with drinking quality water and allow them to air dry out of direct sunlight.
Weekly
Handwash the headgear in warm (approximately 30ºC) water using mild soap or detergent. Rinse well and allow them to air dry out of direct sunlight.

CAUTION

• Do not use bleach, chlorine, alcohol, aromatic-based solutions, moisturizing or antibacterial soaps, or scented oils to clean any of the mask components. These solutions may cause damage and reduce the life of the product.
• Do not expose any part of the mask system or tubing to direct sunlight as it may cause the product to deteriorate.
• The headgear is sensitive to heat and must not be ironed.
• If any visible deterioration of a mask component is apparent (cracking, crazing, tears, etc), the mask component should be discarded and replaced.

Reprocessing the Mask between Patients

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

Reassembling the Mask

See section D on the illustrations sheet.

1. Twist the Luer lock port caps onto the mask ports (D-1).

2.  Hold the mask frame and the elbow firmly together (D-2).

3. To attach the elbow retainer, fit one side of the elbow retainer against the groove of the elbow. While holding one wing of the elbow retainer down (D-3a), press the other wing down until it clicks into place (D-3b).

4.  Rotate the elbow retainer to its original position (D-4).

5. Check that you have fitted the elbow and elbow retainer correctly by firmly pulling the elbow away from the frame. If the elbow is fitted correctly, it should not separate from the frame.
   If the elbow comes away from the frame, try refitting the elbow retainer as described in Steps 3 and 4. If the elbow still comes away from the frame when you pull on it, you may need to replace the elbow retainer.

6. Fit the grooved edge of the mask cushion to the mask frame. Fit the top section first, then work your way around the mask, pushing the cushion onto the frame, ensuring a  good seal has been achieved. Then push the cushion clip over the cushion and onto the mask frame, ensuring it clicks into place in all locations (D-5).

7. Attach the forehead pads to the forehead support by inserting the pad plugs into the two holes on the back of the forehead support (D-6). Push the pads firmly against the forehead support to ensure that the pads fit securely into the forehead support.

8.  Connect the forehead support to the mask frame. Slide the pivots into the pivot slot on the mask frame (D-7). Depress the forehead support tab and move it into any of the tab positions.

9. Insert the headgear clips into the slots on the mask frame. The headgear label should face outward and be near the patient’s neck when fitted.

Note: The Emergency Release Cord must be attached to one of the bottoms headgear straps in order to function correctly.
Disposal

The Ultra Mirage NV Full Face Mask does not contain any hazardous substances and may be disposed of with your normal household refuse.

Technical Specifications

When determining ventilator settings and in particular the tidal volume for volume cycled ventilators, make appropriate allowances for mask dead space and leak.

Unintentional Mask Leak

The Unintentional Mask Leak comprises a leak between the cushion-frame and elbow-frame interfaces.

Dead Space
Dead space is the empty volume of the mask up to the elbow.
The dead space of the mask varies according to cushion sizes but is less than 260 mL.

Standards
CE designation in accordance with EC directive 93/42/EEC, class IIa.
EN ISO 14971, ISO 5356-1, ISO 594-1, ISO 10993-1, and ISO 13485.

Operating Pressure
0 to 40 cm H2O

Resistance
Drop-in pressure measured
at 50 L/min: 0.5 cm H2O
at 100 L/min: 1.5 cm H2O

Dimensions
The dimensions of the mask (Medium) are:
H = 200 mm, W = 100 mm and D = 100 mm
Symbols
System and Packaging

| Caution, consult accompanying documents
---|---
| Batch Code
| Catalog Number
| European Authorised Representative
| Humidity limitation
| Temperature limitation
| Does not contain natural rubber latex
****| Manufacturer

Clinical 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

Part No.
System
60643
60642
60645
60644
60647
60646| Item
UM NVFFM System Small, Standard – Europe 1
UM NVFFM System Small, Shallow – Europe 1
UM NVFFM System Medium, Standard – Europe 1
UM NVFFM System Medium, Shallow – Europe 1
UM NVFFM System Large, Standard – Europe 1
UM NVFFM System Large, Shallow – Europe 1
---|---

Replacement Parts

16604
16671
16605
16672
16606
16673
16674
16675
16676
60678
60683
60681
60682
60115
60116
60123| Cushion, Small, Standard (1 pk.)
Cushion, Small, Shallow (1 pk.)
Cushion, Medium, Standard (1 pk.)
Cushion, Medium, Shallow (1 pk.)
Cushion, Large, Standard (1 pk.)
Cushion, Large, Shallow (1 pk.)
Cushion clip, Small (1 pk.)
Cushion clip, Medium (1 pk.)
Cushion clip, Large (1 pk.)
Elbow (1 pk.)
Elbow retainer (1 pk.)
Luer lock ports caps (2 pk.)
Luer lock ports caps (10 pk.)
Headgear clip (2 pk.)
Headgear clip (10 pk.)
Forehead pad (1 pk.)
---|---
Part No.
60124
60675
60676
60677
60673
60917
60618
60619| Item
Forehead pad (10 pk.)
Mask Frame, Small (1 pk.)
Mask Frame, Medium (1 pk.)
Mask Frame, Large (1 pk.)
Forehead Support (1 pk.)
Headgear (1 pk.)
Emergency Release Cord assembly (1 pk.)
Emergency Release Cord assembly (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.

Note: Translations are based on the English version in this guide. However, there may be minor variations based on the disinfection/sterilization procedures applicable in some countries. ResMed has reviewed these changes and all procedures included here have been validated.

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

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
Ultra Mirage and Mirage are trademarks of ResMed and Mirage is registered in the U.S.
Patent and Trademark Office.
CIDEX and STERRAD are trademarks of Johnson & Johnson. Alconox is a trademark of Alconox Inc. Neodisher Medizyme is a trademark of Chemische Fabrik Dr Weigert. Aniosyme and Anioxyde are trademarks of Laboratoires Anios.
© 2021 ResMed.

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Documents / Resources

| RESMED 60648 Ultra Mirage Non-Vented Full Face Mask [pdf] User Guide
60648 Ultra Mirage Non-Vented Full Face Mask, 60648, Ultra Mirage Non-Vented Full Face Mask
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References

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

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