Mirage Swift™ Nasal Pillows System Chat Transcript Summary

November 8, 2004

Talk About Sleep is pleased to welcome ResMed as our special guest this evening to answer your questions about their exciting new Mirage Swift nasal interface.

ResMed is a global leading developer, manufacturer, and marketer of medical equipment for the diagnosis and treatment of sleep-disordered breathing (SDB), selling a comprehensive range of products. They are dedicated to improving the awareness of the potentially serious health consequences of untreated SDB, and to developing innovative technology to improve the lives of those who suffer from this condition.

Tonight our special guest speaker is Allen Ehrlich, ResMed’s Senior Product Manager of Masks. Since joining ResMed he has launched the Ultra Mirage full face mask and the Mirage Activa nasal mask.

1. Why did you introduce this mask?
2. Is this mask really a revolutionary step for mask technology?
3. What is Mirage cushion technology?
4. Is the Mirage Swift really as lightweight as it claims?
5. How many tubing positions are there with the Swift?
6. What benefit does the choice of side for the tubing entry have if a patient rolls from side to side during the night?
7. Is the headgear material breathable like your other Mirage mask systems?
8. What makes Breathe-O-Prene better?
9. Do the Mirage Swift prongs fit right into the nostrils?
10. If they don't go inside the nostril, how can the system provide an adequate seal?
11. How many sizes of the Mirage Swift will my sleep lab need to stock?
12. Does the Mirage Swift include a pressure port to feed in oxygen or measure pressure?
13. Is it better to position the tubing over the head or downward?
14. I am a smaller female patient on CPAP. There are not many masks out there that will fit me. Is the Mirage Swift available in a small size?
15. Is the headgear available in different colors?
16. I am a patient that has been using a ResMed Ultra Mirage mask for a while now and will need to replace it soon. Is it worth replacing it with a Mirage Swift?
17. I've seen the Mirage Vista mask and felt that the side panels were rather hard. Does the Mirage Swift have these hard panels?
18. Most masks I've seen have headgear clips that really help when I take my mask off. Why doesn't the Mirage Swift have any headgear clips?
19. Is there a fitting template for Mirage Swift?
20. How easy is this system to set up on a patient?
21. Does it come in a travel bag?
22. Isn't it difficult to switch sleeping positions from side to side when the tube will stick out on one of the sides?
23. Does it come with a user guide to help me understand how to use it?
24. With the tubing being on one side or the other, doesn't this cause unequal distribution of weight and therefore air leaks?
25. I heard you have to develop calluses in order to use nasal pillows, is this true?
26. What mask setting do you use on the AutoSet ® flow generators?
27. Can you use the Mirage Swift with a ResMed AutoSet flow device?
28. Does the Mirage Swift work with other manufacturers' auto-titrating devices?
29. How much does the Mirage Swift cost?
30. Is the Mirage Swift approved for multi-patient, multi-use?
31. How do I clean the Mirage Swift?
32. What type of soap should the Mirage Swift be washed with?
33. Is the Mirage Swift latex-free?
34. Can I order spare parts for the Mirage Swift?
35. How was the Mirage Swift tested prior to market release?
36. What has been the general feedback about Mirage Swift so far?
37. Are you able to have two different sizes of pillows on? In other words, medium in one nostril and small in the other?
38. Are the straps on the side of the face of rigid plastic or neoprene?
39. In pictures, it appears that the nasal pillows put a lot of pressure on the nose. Is this just how it looks in the pictures or how it really is to the user?
40. Has ResMed considered making a third optional spot to attach the Mirage Swift's hose, for example, in the center?
41. What should I do if I hear air leaks?
42. What is the easiest way to remove the Mirage Swift?
43. When you place the headgear on the head and place the pillows at the entrance of the nostrils, which direction should the air vent holes face?
44. When adjusting the headgear straps, which one should be adjusted first?
45. What is the purpose of the rotating elbow and swivel?
46. What are the Medicare reimbursement codes for the Mirage Swift?
47. What is the difference between nasal prongs and nasal pillows?
48. At what setting can the Mirage Swift be used with your flow generators?
49. How do I know if I have a good fit?
50. What should I avoid in fitting?
51. How do I know if the pillow size is too small?
52. How do I know if the pillow size is too large?
53. What is the tube retainer used for?

1. Why did you introduce this mask?
   Many people are looking for a less obtrusive, lightweight and flexible alternative that also provides a clear field of vision.
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2. Is this mask really a revolutionary step for mask technology?
   Yes, we view the Mirage Swift as an amazing alternative to a nasal mask. This is the first pillows system that offers four interchangeable tube positions and the flexibility to position the tube upward or downward. Offers a clear field of vision, and is one of the most comfortable options available.
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3. What is Mirage cushion technology?
   Mirage cushion technology is ResMed's basis for all of our premium patient interfaces. It is the global standard for fit, seal, comfort, and convenience.
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4. Is the Mirage Swift really as lightweight as it claims?
   Yes, it weighs a mere 2.5 ounces (70 grams). It's as light on the scales as it is on your face.
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5. How many tubing positions are there with the Swift?
   There are four tubing positions with the Mirage Swift, up on the right, down on the right, up on the left, and down on the left.
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6. What benefit does the choice of side for the tubing entry have if a patient rolls from side to side during the night?
   The left or right side chosen for the inlet tube is most likely going to coincide with the side where your flow generator is located. This allows plenty of freedom for the main 2m (6.5 ft) tubing to move during sleep without pulling on the mask. When the short tubing is attached per instructions, the patient has freedom to roll side to side without lying on the tubing.
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7. Is the headgear material breathable like your other Mirage mask systems?
   Yes, the headgear uses our special "Breathe-O-Prene ® " fabric.
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8. What makes Breathe-O-Prene better?
   Breathe-O-Prene material actually wicks away moisture rather than collecting it. This keeps the material dry, making it more comfortable.
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9. Do the Mirage Swift prongs fit right into the nostrils?
   No. Unlike some prongs that are inserted inside the nostrils and may irritate delicate nasal passages or nasal hairs, the Mirage Swift pillows rest gently at the opening of the nostrils.
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10. If they don't go inside the nostril, how can the system provide an adequate seal?
    The nasal pillows were designed so that the fit at the entrance of the nostrils. In conjunction with the nasal pillow frame and headgear they provide excellent seal and stability.
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11. How many sizes of the Mirage Swift will my sleep lab need to stock?
    The Mirage Swift is available in three sizes. The mask system, however, comes packaged with ALL three sizes in a custom-designed carry bag. By including all sizes in one product code, there is less inventory to stock and the patient can take home the other sizes should a subsequent re-fitting be required (eg the patient finds another size more comfortable after a week of use).
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12. Does the Mirage Swift include a pressure port to feed in oxygen or measure pressure?
    A separate component called a distal pressure port is available for this purpose. It easily fits on to the swivel at the end of the short tube.
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13. Is it better to position the tubing over the head or downward?
    This is really a matter of personal preference. Our trials showed that patients appreciated the freedom of choice and our engineers have provided them with an ability to move the tubing up or down without any disconnection of components. (Left or right entry is also selectable).
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14. I am a smaller female patient on CPAP. There are not many masks out there that will fit me. Is the Mirage Swift available in a small size?
    Our patient trial included more petite females as well as larger males. Not only do the three nasal pillow sizes (S, M, L) have a wide fitting range (including smaller faces), but females also reported that the headgear does not disturb the hair as much as conventional designs.
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15. Is the headgear available in different colors?
    Not at this time. The blue and teal color combination appears to be a generally well-accepted color scheme by many patients and is also the visual identification of ResMed's premium Mirage family of masks.
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16. I am a patient that has been using a ResMed Ultra Mirage mask for a while now and will need to replace it soon. Is it worth replacing it with a Mirage Swift?
    This is a personal preference or one that a sleep clinician can guide you on. If you would appreciate a mask that is much less obtrusive and easier to use, the Mirage Swift is certainly worth a try. If you decide to stick with an Ultra Mirage, rest assured that you're one of millions of patients who have come to trust it.
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17. I've seen the Mirage Vista mask and felt that the side panels were rather hard. Does the Mirage Swift have these hard panels?
    The panel headgear design provides excellent stability despite the elimination of the traditional forehead support. The new Mirage Swift headgear is a new, improved design that has greater flexibility and excellent comfort on a broad range of facial shapes. The headgear provides stability for the system and is comfortable for the user.
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18. Most masks I've seen have headgear clips that really help when I take my mask off. Why doesn't the Mirage Swift have any headgear clips?
    The unique design of the mask and headgear allows the system to be removed and fitted to a patient as easy as a baseball cap (simply lift it off or slip it on). The headgear has two buckles. One buckle is on top of the head and one on the back of the head. These are similar to buckles used on backpacks. There's also no need to readjust any straps. This is the easiest-fitting mask ResMed has ever produced.
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19. Is there a fitting template for Mirage Swift?
    No, it does not require a fitting template because each system includes all three pillows sizes.
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20. How easy is this system to set up on a patient?
    It is extremely simple because you're actually using the pillows themselves to fit the patient. The patient takes home all three sizes so they can switch sizes if they find that after use, they prefer a different size.
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21. Does it come in a travel bag?
    Yes, It comes in a convenient carrying case that is reusable and can be easily placed inside a suitcase, backpack, or briefcase.
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22. Isn't it difficult to switch sleeping positions from side to side when the tube will stick out on one of the sides?
    The placement of the tubing is close enough to the front of the face that it does not interfere with sleeping on that side. We've had numerous patients tell us that it hasn't been a problem.
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23. Does it come with a user guide to help me understand how to use it?
    Yes, it comes complete with a quick-fit guide, detailed user instructions, and a CD with fitting and care information.
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24. With the tubing being on one side or the other, doesn't this cause unequal distribution of weight and therefore air leaks?
    The mask is designed so that the frame, headgear, and cushion provide an even distribution of weight regardless of which side the tube is located.
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25. I heard you have to develop callouses in order to use nasal pillows, is this true?
    Absolutely not. The Mirage Swift nasal pillows rest gently at the entrance of the nostrils and are not inserted inside, nor do they put pressure on your nares. Therefore, it is not necessary to develop callouses. Sometimes people find that using KY ® or Neosporin ® on the nares is helpful if there is a bit of discomfort.
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26. What mask setting do you use on the AutoSet ® flow generators?
    Mirage Swift uses the Mirage setting.
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27. Can you use the Mirage Swift with a ResMed AutoSet flow device?
    Yes.
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28. Does the Mirage Swift work with other manufacturers' auto-titrating devices?
    We do not validate any of our patient interfaces with other manufacturers' devices because the software is always changing, giving us no control over ensuring our claims are consistently validated.
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29. How much does the Mirage Swift cost?
    The Mirage Swift is priced competitively with other comparable nasal pillows and prongs in the market. Pricing for the system can be obtained from your local distributor.
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30. Is the Mirage Swift approved for multi-patient, multi-use?
    At this point, the mask is not approved for multi-patient, multi-use. We have submitted this information to the FDA for approval so the masks can be disinfected.
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31. How do I clean the Mirage Swift?
    The pillows and short tube assemblies should be washed every day by using mild soap and warm water then allowing to air dry. We also recommend that you first wash your face to remove excess oils. The pillows sleeve assembly, itself, only needs to be disassembled and cleaned once per week.
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32. What type of soap should the Mirage Swift be washed with?
    Wash the pillow sleeve assembly, short tube assembly, and cap with warm, soapy water. Use pure soap, such as unscented Dove. Rinse well and then allow to air dry out of direct sunlight.
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33. Is the Mirage Swift latex-free?
    Yes.
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34. Can I order spare parts for the Mirage Swift?
    Yes, a number of components can be ordered, including the headgear and pillows by contacting your local dealer.
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35. How was the Mirage Swift tested prior to market release?
    Exhaustive user trials were done on a global basis.
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36. What has been the general feedback about Mirage Swift so far?
    It has been extraordinarily positive. We've received numerous comments about how comfortable the system is and that, for the first time, people are sleeping through the entire night. Patients have made a lot of different comments, but the most notable ones have to do with Mirage Swift's comfort, stability, optimal seal, low obtrusiveness, and effectiveness.
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37. Are you able to have two different sizes of pillows on? In other words, medium in one nostril and small in the other?
    No, we don't recommend it. Our pillows sizes come packed with the two pillows on a sleeve that are attached. This design and the various sizes will fit variances between one nostril to the other. In other words, size medium, for example, will provide comfort, seal and stability even if one nostril size is slightly larger or smaller than the other. The rotating adjustment on the pillow frame allows for adjustments to give additional comfort and fit.
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38. Are the straps on the side of the face of rigid plastic or neoprene?
    There is no neoprene in any part of the headgear. It is made of Breathe-O-Prene material. The side strap has a very soft and flexible amount of plastic for added stability.
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39. In pictures, it appears that the nasal pillows put a lot of pressure on the nose. Is this just how it looks in the pictures or how it really is to the user?
    The Mirage Swift nasal pillows are designed so that the nostrils rest gently upon them. Nasal prongs are inserted inside the nostrils and can cause greater discomfort. As with any new product, there is often an adjustment period. However, the Mirage Swift pillows are uniquely designed to maximize comfort and minimize the need to overtighten the headgear or strap down the pillows too tightly.
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40. Has ResMed considered making a third optional spot to attach the Mirage Swift's hose, for example, in the center?
    No, we have no plans to change the design of the Mirage Swift. The side position of the hose (tubing) allows for greater flexibility to change the position of the tubing. Additionally, with the tubing at the side, it does not cover up the mouth.
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41. What should I do if I hear air leaks?
    If you hear air leaks, adjust the headgear straps and/or angle of the nasal pillows until the leaks are sealed.
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42. What is the easiest way to remove the Mirage Swift?
    Pull the pillow sleeve assembly away from the nose and lift the headgear over head.
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43. When you place the headgear on the head and place the pillows at the entrance of the nostrils, which direction should the air vent holes face?
    The air vent holes should face upward, away from your body. If air is blowing on your chest, the pillow sleeve is on the frame backwards.
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44. When adjusting the headgear straps, which one should be adjusted first?
    First adjust the back strap, then the top strap so that the panels at the front of the headgear rest on the cheekbone. The pillow sleeve should rest above the upper lip.
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45. What is the purpose of the rotating elbow and swivel?
    It allows for adjustment of the angle of the nasal pillows forward or backward so the nasal pillows sits comfortably at the entrance of the nostrils to establish a good seal and optimize comfort. The rotating elbow also offers more sleeping positions, decouples movement of the patient from the tube to reduce tube drag and adds more flexibility to the system.
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46. What are the Medicare reimbursement codes for the Mirage Swift?
    The codes are the same as other nasal pillows on the market. A7034 for nasal application device with positive airway pressure, one per three months, A7035, headgear used with positive airway pressure (PAP) device, one per six months and A7033, replacement pillows for nasal application device, one pillow sleeve per month. One pillow sleeve=one pair of pillows.
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47. What is the difference between nasal prongs and nasal pillows?
    The Mirage Swift is made with pillows that sit at the rim of the nostrils and seal without excessive pressure. Prongs insert directly into the nostrils and can create pressure areas inside the nostrils.
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48. At what setting can the Mirage Swift be used with your flow generators?
    The Mirage Swift is tested and can be used with pressures from 4-20 cm H20.
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49. How do I know if I have a good fit?
    Pillows should sit snugly at the entrance of the nostrils, the pillow sleeve should rest comfortably on the upper lip, the headgear panels should sit between the ear and eye, and the ear should be free from headgear contact.
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50. What should I avoid in fitting?
    Heads traps should not be over tightened causing panel distortion and marks on the face, the pillows should not cause nasal flaring or distortion of the nose and excessive air leaks.
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51. How do I know if the pillow size is too small?
    There will be visible gaps between the pillows and nostrils, as well as uncontrollable air leaks.
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52. How do I know if the pillow size is too large?
    There will be nasal flaring, pillows will protrude from the nostrils, and there will be pressure points in the nose.
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53. What is the tube retainer used for?
    The tube retainer is attached to the top of the headgear on either the left or right side to hold the tube if the tubing is positioned above the head.
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