DeVilbiss FlexAire™ Nasal CPAP Mask September 22, 2003

Hello and thank you for joining in our Special Events Chat!. We will begin at the top of the hour. A reminder that this is a "hushed" room. Anything you type into the chat will be sent to the guest speaker as a question. Communication with others in the chat room is by private messaging only. Feel free to begin asking your questions at any time.

Talk About Sleep proudly welcomes DeVilbiss this evening to answer your questions about their new FlexAire mask that officially launches today! DeVilbiss didn't invent CPAP interfaces, but after 110 years of respiratory innovations, they may have just perfected it. You are among the first to see this innovative new mask that is available now through your local home health suppliers and in our Sleep eStore soon.

Joining us tonight as our guest speaker is Nick Macmillan - Global Sleep Product Manager from DeVilbiss. Nick is here to walk us through the innovative FlexAire Mask. As you will see, this new mask is a fusion of revolutionary ideas, materials and technology. No other mask can offer the superior comfort or ease-of-use of this breakthrough interface.

This is a hushed room and does not allow for chat amongst you. Think of it as a lecture hall. Anything typed into the chat room will be presented as a question to Nick. You can communicate with others in the room by sending private messages.

Please submit your questions now and at any time during the chat. To submit a question, simply type in your question in the chat screen and press the enter key on your keyboard! If duplicate or similar questions are submitted, only one will be answered.

A special thank you to DeVilbiss for donating 5 FlexAire masks. All those present will automatically be included in the drawing. 5 names will be announced during this chat and you must be present to win!. When the winning names are announced, you will receive a private message from TASchristie, asking for your email address so that we may contact you for mailing instructions.

Questions

1. What don't you have multiple sizes?
2. Does the Mask ratchet when you push on it?
3. Can the foam can get sweaty and oily?
4. Why are the Mask parts are stiff?
5. Why does the Velcro feel too aggressive?
6. Why don't you have a full-face mask?
7. What are the part numbers associated with the FlexAire™ Mask?
8. How do you explain the cushion?
9. What does dielectrically welded mean?
10. What is the "theory" behind the FlexAire cushion?
11. So how does this "theory" lead to a better mask cushion design?
12. So what role does the foam in the air bladder play?
13. Are there any other reasons why this cushion offers a superior design?
14. How many sizes are available?
15. Ok, but it still doesn't fit every face?
16. What shape is the standard cushion?
17. Will there be a sizing gauge?
18. Can the Serenity™ Mask cushion fit on this frame?
19. Does the FlexAire™ Mask seal on individuals with facial hair?
20. What is the purpose of the date code on the mask packaging?
21. I don't recall seeing this on the Serenity™ mask?
22. What is the maximum number of pumps?
23. Why is it limited to five?
24. Is there any other reason it's limited to five pumps?
25. What if I over-pump the cushion?
26. So how many pumps before the mask bursts?
27. Is bursting or creating a bulge in the mask cushion covered in the warranty?
28. Why not?
29. What does 5xMAX indicate?
30. What is the warranty on the FlexAire?
31. The pump looks like the Reebok® or Nike® pump?
32. This is so innovative, how long will it take for competitors to copy it?
33. Do you need to pump the mask each night?
34. Why is the relief valve recessed?
35. Why are there two large tusks instead of one large one?
36. Is the mask reimbursable?
37. Has the HCPCS verification documentation been submitted?
38. How many parts and with what materials is the mask made?
39. Is the mask latex free?
40. Where is the mask made?
41. Where are the parts for the mask made?
42. Where are the parts for the mask assembled?
43. How do you clean the mask?
44. Can the mask be washed in the dishwasher?
45. Why do you pump the mask prior to washing by hand?
46. Why do you have to deflate the cushion if being washed in the dishwasher?
47. Why do you pump the mask prior to washing by hand?
48. Why do you have to deflate the cushion if being washed in the dishwasher?
49. Will using the dishwasher harm the Velcro® on the forehead rest?
50. How do you clean the headgear and forehead pad?
51. Can you clean the headgear and the forehead pad in a washing machine?
52. Can you wash the headgear with the forehead rest attached?
53. Can you clean the mask using the cold sterilization or autoclaving?
54. Is the mask for single-patient use?
55. Can you wear glasses while wearing the mask?
56. Is the cushion removable/replaceable?
57. Can the patient easily remove /replace the cushion?
58. Can you pump the cushion when it is removed from the mask?
59. Why Not?
60. How was the durability of the mask tested?
61. How much does the mask weigh?
62. How does the mask weight compare to the Serenity?
63. How does the FlexAire™ Mask weight compare to the competition?
64. How quiet is the mask?
65. Can the mask be used with the bilevel and AutoAdjust?
66. Can the mask be used with other manufacturers CPAP devices?
67. How long with the mask last?
68. Is the mask FDA approved?
69. Is the mask approved for Canada or CE marked?
70. Was biocompatibility testing performed?
71. How was the mask tested for biocompatibility?
72. How do I know that the mask works?
73. What is the maximum CPAP pressure the mask can withstand?
74. Does the patented DeVilbiss auto on/off feature still work with this mask?
75. Does the mask have a chinstrap?
76. Can the pressure/oxygen port be used when the mask is in the "over the head" option?
77. Are there any special precautions when traveling?
78. Why?
79. How many languages are in the Instruction Guide?
80. Is there any other mask like it on the market?
81. Is the mask patented?
82. What will happen to the Serenity™ mask?
83. Why did we make a "mainstream" mask instead of a specialized mask?

Answers

1. What don't you have multiple sizes?
   Inflation/deflation of the mask cushion alters the size. We are expecting to release a shallow version later this calendar year.
2. Does the Mask ratchet when you push on it?
   Yes it does. As with the Ultra Mirage and Comfort Select, this allows the mask to "give" if necessary. The mask will not ratchet to increase pressure on the forehead, it can only ratchet in the direction for which it would decrease pressure on the forehead
3. Can the foam can get sweaty and oily?
   The soft foam is made of breath-o-prene and it allows for improved air circulation. Plus, the foam is superior in comfort and does not leave skin irritation. Additionally, this material is washable.
4. Why are the Mask parts are stiff?
   New mask parts are usually stiff. Once they are used a few times they become easier to work with. Additionally, once you adjust the mask, changes are rarely required with the exception of the pump cushion.
5. Why does the Velcro feel too aggressive?
   This is common with new headgear. Again, once the material is used a few times it becomes easier to work with. Additionally, once you adjust the headgear, changes are rarely required.
6. Why don't you have a full-face mask?
   Inquire as to what percent of patients use a full-face mask and then emphasize that the FlexAire will fully accommodate the remaining percentage.
7. What are the part numbers associated with the FlexAire™ Mask?
   -- 9353D DeVilbiss FlexAire™ Nasal CPAP Mask -- 9353D-601 DeVilbiss FlexAire™ Mask Cushion -- 9353D-619 DeVilbiss FlexAire™ Headgear -- 9353D-604 DeVilbiss FlexAire™ Pad/Vent
8. How do you explain the cushion?
   The cushion is a foam-filled air bladder that is dielectrically welded to a urethane interface.
9. What does dielectrically welded mean?
   It is a process whereby two pieces of material are welded between a radio frequency arc.
10. What is the "theory" behind the FlexAire cushion?
    Most masks require the user to turn on the CPAP device before putting the mask on. This allows the mask to "fill" with air and seal. When conducting mask interviews and demonstrations, virtually all of the CPAP users put the mask on first before turning on the CPAP device, which negates the sealing properties of the mask. The end result was over-tightening to get a good seal.
11. So how does this "theory" lead to a better mask cushion design?
    With the foam-filled air bladder, it doesn't matter if the CPAP machine is on or off prior to applying the mask. Airflow from the CPAP device is not necessary to form an effective seal: the foam-filled bladder forms the seal. ----- Also, airflow follows the path of least resistance. If pressure were to be applied to one side of the mask, the air from that side would move to the other side thus filling any void - maintaining the seal with the foam-filled bladder. Therefore, any movement or pressure on any part of the mask will result in natural compensation in the opposite direction.
12. So what role does the foam in the air bladder play?
    During patient demonstrations, patients often times pressed the mask on their face until they met resistance and this lead to applying the mask too tight. The foam creates resistance giving the patient the impression that they have applied enough pressure. This prevents patients from applying the mask too tight and leaves adequate space for the cushion to inflate and form a better, yet softer seal.
13. Are there any other reasons why this cushion offers a superior design?
    Yes, think of the benefits of a radial tire. The wide flat profile leads to improved traction while decreasing friction and wear. With the FlexAire™ Mask, the wide profile on the face leads to a better seal while decreasing pressure on any one particular point. The bottom line is a soft, comfortable and effective seal without leaving indentations on the face.
14. How many sizes are available?
    The mask cushion available today is the Standard Size. By virtue of having a cushion that can expand it is able to fit a wider range of facial profiles.
15. Ok, but it still doesn't fit every face?
    True, and no mask will fit every face. The Shallow Size cushion, designed for a wider nasal profile will be available later this year.
16. What shape is the standard cushion?
    The mask cushion is the same size as the Serenity™ mask cushion. The Shallow size will be roughly the same shape as our exiting Shallow cushion.
17. Will there be a sizing gauge?
    Yes, when the Shallow cushion becomes available.
18. Can the Serenity™ Mask cushion fit on this frame?
    Due to the unique features of the foam-filled air bladder, the shapes are different and thus the Serenity™ Cushion is not compatible with the FlexAire™ frame.
19. Does the FlexAire™ Mask seal on individuals with facial hair?
    Individuals with facial hair participated in the product validation and obtained a seal without difficulty.
20. What is the purpose of the date code on the mask packaging?
    This is for tracking purposes
21. I don't recall seeing this on the Serenity™ mask?
    The Serenity™ Mask uses a unique serial number for the same purpose.
22. What is the maximum number of pumps?
    Five
23. Why is it limited to five?
    Pumping the mask more than five times makes it hard, uncomfortable, and prone to a poor seal.
24. Is there any other reason it's limited to five pumps?
    Over-pumping can also lead to permanent cushion damage
25. What if I over-pump the cushion?
    With excessive pumping, well over the recommended five times, the mask cushions will herniate. Once this occurs, the bulge will remain permanently in the cushion leading to difficulty in maintaining an effective seal.
26. So how many pumps before the mask bursts?
    Twenty-five or more
27. Is bursting or creating a bulge in the mask cushion covered in the warranty?
    No
28. Why not?
    The instructions clearly state not to pump the cushion over five times.
29. What does "5xMAX: indicate?
    The maximum number of pumps is five.
30. What is the warranty on the FlexAire?
    6 months or 180 days, whichever comes first.
31. The pump looks like the Reebok® or Nike® pump?
    That is exactly what it is.
32. this is so innovative, how long will it take for competitors to copy it?
    There is an exclusive license agreement for the pump technology AND we have an exclusive agreement for using the pump in mask.
33. Do you need to pump the mask each night?
    he instructions indicate that prior to applying the mask each night, the cushion should be deflated. The benefit of this step is that you obtain an effective and unique seal each night.
34. Why is the relief valve recessed?
    To prevent accidental deflation of the cushion while rolling over or when adjusting the mask.
35. Why are there two large tusks instead of one large one?
    Having two tusks decreases the side-to-side friction, which allows for headgear movement with mask movement.
36. Is the mask reimbursable?
    PART / CODE / REPLACMENT SCHEDULE: : DeVilbiss FlexAire Nasal CPAP Mask / A7034 / 1 per 3 months; DeVilbiss FlexAire Cushion / A7032 / 2 per month; DeVilbiss FlexAire Mask Headgear / A7035 / 1 per 6 months; DeVilbiss FlexAire Mask Headgear w/vents / NONE / N/A; DeVilbiss Mask Chin Strap / A7036 / 1 per 6 months
37. Has the HCPCS verification documentation been submitted?
    It has been submitted. It is ok for providers to bill for this product as this decision is being made. This process normally takes 3-4 months.
38. How many parts and with what materials is the mask made?
    18 parts, all are Brethoprene, Polypropylene, Polycarbonate, Silicone, or Urethane
39. Is the mask latex free?
    Yes.
40. Where is the mask made?
    United States
41. Where are the parts for the mask made?
    United States
42. Where are the parts for the mask assembled?
    United States
43. How do you clean the mask?
    As with other masks, use a mild detergent and rinse thoroughly. FYI - the mask should be deflated and then pumped five times prior to cleaning to prevent water from entering the cushion.
44. Can the mask be washed in the dishwasher?
    Yes, on the top rack, cushion side up with the mask deflated.
45. Why do you pump the mask prior to washing by hand?
    The pump has a one-way valve and the pressure in the mask keeps this valve closed.
46. Why do you have to deflate the cushion if being washed in the dishwasher?
47. Why do you pump the mask prior to washing by hand?
    The pump has a one-way valve and the pressure in the mask keeps this valve closed.
48. Why do you have to deflate the cushion if being washed in the dishwasher?
    Any gas that is heated will automatically expand. If there is air in the mask while in the dishwasher, the heat from the dishwasher could cause the cushion to expand and overextend.
49. Will using the dishwasher harm the Velcro® on the forehead rest?
    No, provided that it is washed on the top rack. Furthermore, it is not necessary to wash this piece in a dishwasher.
50. How do you clean the headgear and forehead pad?
    As with all masks, wash by hand with a mild detergent.
51. Can you clean the headgear and the forehead pad in a washing machine?
    It is recommended that you wash these components by hand. Washers and dryers can potentially fray the materials.
52. Can you wash the headgear with the forehead rest attached?
    Yes and the Velcro® on the forehead rest will tolerate repeated washings.
53. Can you clean the mask using the cold sterilization or autoclaving?
    These tests have not yet been performed on the cushion. However, all of the other plastic parts have been tested and do indeed tolerate these cleaning techniques. Once testing is complete the results will be announced.
54. Is the mask for single-patient use?
    Yes.
55. Can you wear glasses while wearing the mask?
    We did not engineer the mask to worn with glasses because when we were conducting patient interviews, most indicated that this was not an important feature for a mask.
56. Is the cushion removable/replaceable?
    Yes.
57. Can the patient easily remove /replace the cushion?
    Yes. The instruction manual provides detailed instruction for changing the cushion.
58. Can you pump the cushion when it is removed from the mask?
    No.
59. Why Not?
    The cushion is equipped with a one-way valve. When you finger is on the backside of the pump, the one-way valve is compressed and blocks the air from filling the cushion.
60. How was the durability of the mask tested?
    Each of the mask parts went through extensive cycle testing. That is each piece was activated in its normal fashion for repeatedly. The number of test cycles was well beyond the estimated number of cycles that would occur over the life of the mask.
61. How much does the mask weigh?
    3.75 oz. With headgear and 2.35 z. without headgear
62. How does the mask weight compare to the Serenity?
    Serenity is 4.0 oz. With headgear and 2.60 oz. without.
63. How does the FlexAire™ Mask weight compare to the competition?
    Equal or lighter than
64. How quiet is the mask?
    Less than 2.0dBA
65. Can the mask be used with the bilevel and AutoAdjust?
    Yes.
66. Can the mask be used with other manufacturers CPAP devices?
    Yes.
67. How long with the mask last?
    The mask is warranted for six months. It is designed to last 6-12 months. Depending on care, the mask may last longer
68. Is the mask FDA approved?
    Yes.
69. Is the mask approved for Canada or CE marked?
    These applications are being completed.
70. Was biocompatibility testing performed?
    Yes.
71. How was the mask tested for biocompatibility?
    Generally, parts are ground up into minute particles and injected into laboratory animals. These animals are then observed and tested for adverse effects. In addition, when possible, parts pre- approved for medical applications are used.
72. How do I know that the mask works?
    Several CPAP users have tested the mask and responded positively with their feedback. The feedback that you heard today was part of that validation. The launch materials will include these comments.
73. What is the maximum CPAP pressure the mask can withstand?
    60 CMP H2O
74. Does the patented DeVilbiss auto on/off feature still work with this mask?
    Yes.
75. Does the mask have a chinstrap?
    The same chinstrap that we use today can be used with the FlexAire™ Mask.
76. Can the pressure/oxygen port be used when the mask is in the "over the head" option?
    Oxygen can be administered at the CPAP unit with an oxygen adapter (7353D-601), where there is more even mixing of the oxygen. This is also the best long-term option because it decreases the total weight pulling on the mask. Pressure can be monitored with the same adapter placed at the mask elbow. The tubing possibly will kink if attached while the elbow is in the upright position.
77. Are there any special precautions when traveling?
    Yes. The cushion should be fully deflated.
78. Why?
    When in a plane, the atmospheric pressure, that is the air pressure around you, goes down even though the plane is "pressurized". Therefore, air in the cushion can expand beyond the tolerance of the cushion.
79. How many languages are in the Instruction Guide?
    Six: Dutch, English, French, German, Italian, and Spanish
80. Is there any other mask like it on the market?
    No.
81. Is the mask patented?
    An application has been filed for the innovative features of the mask.
82. What will happen to the Serenity™ mask?
    We will keep this product indefinitely.
83. Why did we make a "mainstream" mask instead of a specialized mask?
    We needed a mask that fits and would have strong appeal to a great number is users. Building a niche mask would only work for about 5% of the CPAP population.

This concludes our FlexAire chat with DeVilbiss. Feel free to now enter the sleep apnea chat room and continue discussion. We thank Nick Macmillan for his participation, and thank you for joining in. Watch our chat calendar for upcoming Special Events Chats! Good night, and sleep well.