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Talk About Sleep was pleased to welcome Respironics as our special guest on Monday, April 26, 2004 , to answer your questions about the Comfort Series of Masks and the new ComfortLite™ Nasal Mask.
For more than 25 years, Respironics has been a global leader in the respiratory medical device industry. By providing innovative products and unique programs, Respironics serves as a resource to healthcare professionals to help improve business efficiency and to enhance patient quality of life.
Respironics recently introduced the ComfortLite™ Nasal Mask. The ComfortLite™ provides a smaller and lighter alternative to a traditional nasal mask. Through a unique mask and headgear that minimizes facial contact and pressure points, the ComfortLite™ is just right for patients seeking less bulk or weight on their face. It is also perfect for patients with skin sensitivities or who feel claustrophobic with a traditional mask.
The ComfortLite™ features two interchangeable cushions to deliver maximum patient comfort and choice in a minimal contact mask. The pillow-like Direct Seal cushion offers a comfortable seal without insertion into the nostrils while the Simple cushion provides a small, tip-of-the-nose interface. The ComfortLite™ also offers multiple adjustment points for a personal fit that enables patients to find the best seal.
Joining us today is Justin Crout, Assistant Product Manager in Patient Interface at Respironics. Justin has over 5 years experience in engineering, consulting and product management. As Assistant Product Manager for Laurie Scott (Global Product Manager, Patient Interface), Justin has been actively involved in the development and launch of ComfortFull, ComfortGel, ComfortLite™ and the Respironics Premium Chin Strap. Justin has a BS in Mechanical Engineering and an MBA from Carnegie Mellon University .
Special thanks to Respironics for donating 5 fabulous prizes. All those present will automatically be included in the drawing. Each winner will receive a mask of their choice from any within the Respironics Comfort Series, which includes the ComfortLite™ Nasal Mask.
1. What interface options are available with the ComfortLite™?
The ComfortLite™ mask system has two separate and distinctly different cushion choices. The Direct Seal T cushion is a single piece cushion with two bulbs. Each bulb is intended to block the end of your nostril while directing your PAP flow into it. The Direct Seal cushion is available in 6 sizes; most adults fit in sizes 4, 5 or 6. The Simple Cushion T is a small, tip of the nose, dual flap nasal cushion available in petite, small, medium and large sizes.
2. With two cushion options, how is the mask packaged?
The ComfortLite™ mask is sold in 'combo packs' which include the mask, headgear and two sizes of Direct Seal cushion and two sizes of the Simple Cushion in one package. You can purchase the ComfortLite™ with the Direct Seal cushion only; it comes packaged with the 3 most common adult sizes. ComfortLite™ with Simple Cushion-only is also packaged with the 3 most common adult sizes.
3. I have tried the Breeze and didn't like something up my nose. Isn't the Direct Seal cushion also worn up the nose?
The Direct Seal generally just blocks the nostril openings vs. being inserted into the nose.
4. How far in the nose does the Direct Seal go?
An analogy might help. Bend your index finger as far as possible. Hold the mid-finger knuckle up to the end of your nostril. Feel how little of the knuckle actually enters your nose? That is pretty much how the Direct Seal cushion should be worn, with the majority of the bulb on the outside of your nose.
5. Is the headgear one-size-fits all?
Yes it is. However, based on early feedback we are creating an optional accessory to accommodate larger heads. A long Rear Strap will be available in soon.
6. What are the key means to properly wear and fit this mask?
First, let's talk about proper headgear fitting. The headgear should be somewhat snug and is worn so that it sits just above the eyebrows and above the ears. You may need to detach and adjust the crown strap in order to get the main headgear to sit that low on your head.
7. Can your ComfortLite™ mask be used with any other CPAP units ?
Generally yes, our masks will work with other CPAP's. Please note: the ComfortLite™ in NOT suitable for AUTO CPAP devices.
8. Can I purchase ComfortLite™ directly from Respironics ?
Respironics does not sell directly to the public. You will need to contact your local medical equipment distributor or online providers to purchase your mask.
9. How do you adjust the mask to properly fit it to avoid leaks?
There are two key adjustments you can make regardless of the cushion option you choose. Once the headgear is properly fit, you have an Angle Adjuster and a Vertical Adjuster. The Angle Adjuster controls the tilt of the cushion to the face and the twist Vertical Adjuster helps position the cushions relative to the length of your face and nose. You can find a FITTING GUIDE for the ComfortLite™ on our Comfort Series mask website: www.ComfortSeries.Respironics.com
10. Can you explain the Angle Adjuster in more detail?
Sure. If you have seen a picture of the ComfortLite™ on the Talk About Sleep site, or the ComfortSeries.Respironics.com site, you will notice that the cushions connect to a tube. The tube is suspended from the center of the headgear where the Angle Adjuster is. By squeezing the black tabs on each side of the Angle Adjuster, you are able to change the angle of the tube and cushion either closer to or away from the face. You will have slightly different angular adjustments when using the Simple Cushion vs. the Direct Seal cushion.
11. Ok, now what does the Vertical Adjuster do?
As you look at the mask picture, you'll see a circular black knob at the top of the tube connected to the ComfortLite™ cushion. By twisting the knob, you either extend or retract the length of the tube. There are many varieties of faces in the population and we want to accommodate both short and longer faces by extending or shortening the length of the tube. Again, if you choose to wear both the Direct Seal cushion and the Simple Cushion, the vertical adjustment will be slightly different for each since the Direct Seal cushion is worn UNDER the nose vs. over it like the Simple Cushion.
12. Are there any 'fine tuning' adjustments available for the Simple cushion besides the Angle Adjuster and length or Vertical Adjustment?
Yes. The Simple Cushion sits on a ball joint fitting. The cushion rotates freely on the ball, allowing you to change the tilt of the nasal cushion to adjust for leaks or pressure points.
13. Any fine tuning options for the Direct Seal cushion?
The Direct Seal cushion has a small metal band on the underside of the cushion. You can squeeze the cushion and bend that wire to change the angle of the two bulbs of the cushion. This adjustment is primarily used to change the distance between the two bulbs - allowing better fit for nostrils that might be tightly spaced together or more widely spaced.
14. Tell me more about the Simple cushion interface option.
As I mentioned earlier, the Simple Cushion is a small, tip of the nose, dual flap nasal cushion. It rotates on a ball joint fitting of the exhalation port. The cushion sits below the bridge, eliminating pressure points at that sometimes sensitive area. Use the rotating Vertical Adjuster and the Angle Adjuster to get the proper position of the cushion. Since the mask is suspended from the headgear at the center of your forehead, no straps will touch your face at the cheeks or your neck. The most common size Simple Cushion is Medium.
15. I'd like to hear more about the Direct Seal cushion.
Again, the Direct Seal cushion is a single piece cushion with two bulbs. Each bulb is intended to block the end of your nostril to create a seal vs. being inserted into the nose to create a seal. The most common size Direct Seal cushion is size 5.
16. I'm confused with what you consider the mask, what is the headgear, etc.?
It might be easier to start with the headgear. Everything that is grey is part of the headgear. It also includes the black rear strap. All other parts are considered the 'mask' - including at least one interface or cushion. (When insurance payers reimburse for a 'mask', it must be capable of delivering your PAP therapy.) The Direct Seal and Simple Cushion are replaceable cushions of the mask.
17. Do I have to wear my tubing over my head? Is that the only option?
Yes, the tubing for the ComfortLite™ is directed up over the head. As you may have noticed, the mask tubing attaches to the headgear at two points. The standard PAP tubing connects to the 360 degree swivel at the headgear crown strap. In order to maintain seal, it is important to separate the movements of the PAP tubing from the cushion. The mask tubing and the structure of the headgear work to absorb movements while keeping cushion seal.
18. Why is the headgear made of both soft and hard pieces? My Adam Circuit only has straps and it works ok for me.
As mentioned above, we feel it is important to minimize the impact of tubing movement (as you sleep) on the cushion seal. We found the best alternative to be a combination of semi-rigid support with a cushioning, moisture-absorbing lining. Our goal was to eliminate excessive strapping around the head and simplify the headgear design.
19. You say that wearing the headgear low like a ball cap will help stability. How do I know if the headgear is in the right place on my head for best stability?
The front of the headgear should be just above the eyebrows. The sides should be just above your ears. If you can't get the headgear close to these points, it is because the crown strap needs to be readjusted. Unfasten the crown strap at both ends and reattach it so that more holes are exposed on each side. This will allow you to cinch the headgear lower around your head's circumference.
20. How does the ComfortLite™ compare to the Breeze or Nasal-Aire?
We'll only cover a few points of difference. First, the ComfortLite™ seals without any insertion of the cushion into the nose. Second, the headgear systems of the Breeze, Nasal-Aire and ComfortLite™ take completely difference approaches to mask stability. I will say that after using the ComfortLite™, 79% of the trial participants who normally used the leading pillows mask preferred the ComfortLite™ to their pre-trial mask.
21. Which of the two options is the better cushion for me?
You are the only one who can make that determination. Our goal in designing the ComfortLite™ with multiple cushion options was to give patients two chances to find at least one cushion that they will like and use. Compliance is the key.
22. From the picture, the Simple cushion looks like your Simplicity mask cushion. Am I right?
Yes, the Simple Cushion has roots that stem from the Simplicity nasal mask. We added a second flap to improve seal and additional sizes (petite, small, medium and large).
23. Do I have to get both of the cushions with the ComfortLite™?
No, the ComfortLite™ can be purchased with just the Direct Seal cushions or just the Simple Cushions in addition to the 'mask combo packs' that include both of the cushion options.
24. If I like one style of the cushions vs. the other, will I need to keep buying both cushions when I need a replacement?
No, if you are just replacing the cushion, you should be able to purchase the specific cushion and size you need from your provider. If you are replacing the entire mask, you can purchase the mask with just that cushion style. All masks come with multiple sizes to ensure you have the size you need with less guess work.
25. Can I still wear a chinstrap with this mask?
Yes. You will need to put the chin strap on first before putting on the mask. Some patients have had success using our standard chin strap and the ComfortLite™. The Velcro of the chinstrap traditionally attached to our Softcap headgear. Some patients have successfully hooked the chin strap straps through the ComfortLite™ headgear just in front of the ears.
26. Why can't this mask be used with Auto PAP devices?
You are correct; the ComfortLite™ is not suitable for Auto Pap devices. The key reason relates to the changes in tubing diameter, which can interfere with proper snore detection and impact the complex algorithms that are built into Auto devices.
27. Any 'key tips' we should all remember to ensure success with the ComfortLite™?
One: the headgear should be worn low to the brow and ears. Two: The headgear should be worn snuggly without discomfort. Third: Wear the Direct Seal cushion so it gently blocks the nostrils and is not inserted. Lastly: use the angle adjuster, vertical adjuster and fine tuning adjustments to find the proper seal and comfort settings.
28. What direction does the exhaled air of the ComfortLite™ mask go?
The exhalation feature of the ComfortLite™ has been placed on the elbows of the Direct Seal and Simple cushions and is a series of small holes. When using ComfortLite™, the exhaled air is diffused through these holes for a less-direct and quiet stream of air.
29. How can I pack the ComfortLite™ for traveling?
The mask and tubing assembly of the ComfortLite™ can be disassembled from the headgear. In addition, the ComfortLite™ headgear can be taken apart into a more convenient size for packing.
30. How do I order accessories for ComfortLite™?
Respironics does not sell directly to the public. You will need to contact your local DME or homecare provider or online providers to purchase accessories for your mask.
31. Does the ComfortLite™ work for people who sleep on their sides?
Yes, the ComfortLite™ is designed to accommodate side sleeping by providing an assembly and interface that is centered over the nose.
32. Where should the back strap of the ComfortLite™ headgear be placed?
The back strap of the headgear is intended to make the headgear more secure - providing a more stable foundation for the cushion. The strap should be placed below the bone on the back of the head and tightened snugly so that it will stay in place throughout the night.
33. I currently use an Ultra Mirage and would be interested in trying the ComfortLite™. Is the pillows style cushion on the ComfortLite™ mainly designed for people that use pillows masks like the Breeze?
No, actually in our preference trials (which included both traditional and pillows-based mask users) more users preferred the Direct Seal over the Simple cushion. Its unique design and placement beneath the nostrils makes it an excellent choice for Breeze users AND traditional nasal mask users such as yourself. Keep in mind, many users liked both style cushions.
34. I need to occasionally use oxygen. I don't see the little oxygen port on the new ComfortLite™ mask. Is this an option with ComfortLite™?
There is no way to bleed in oxygen at the mask itself, however, ask your homecare provider about an adapter that can be used to bleed in the oxygen down at the PAP device end of your tubing.
35. Is your new ComfortLite™ mask difficult to put back together after cleaning? I can never seem to get my nasal mask back together without having to retrace some steps?
There are just a few removable parts with the ComfortLite™. The Direct Seal and Simple cushions simply engage into and detach from the vertical tubing and the tubing assembly can be removed from the headgear. No other parts need to be removed for daily cleaning.
36. When was ComfortLite™ released?
The ComfortLite™ mask was released in March, 2004.
37. What are the features of ComfortLite™ ?
The ComfortLite™ is provided with interchangeable cushions - a Direct Seal cushion provides a secure seal by blocking the nostrils, a Simple cushion provides a seal around the tip-of-the-nose and functions as a more traditional nasal cushion. Both cushions can be adjusted for a better seal. Also, an adjustable ball-cap style headgear uses a familiar design to provide stability and comfort for the mask. In addition, an angular and vertical adjustment on the mask allow the cushions to be fine-tuned for a personalized fit.
38. Where can I get more information on ComfortLite™?
Visit our web site at www.comfortseries.respironics.com
39. What sizes does the ComfortLite™ mask come in?
Since the ComfortLite™ comes with 2 cushion styles, it is offered in multiple sizes of each. The Direct Seal cushion comes in six sizes labeled 1 through 6 (5 and 6 being the most commonly used). The Simple cushion comes in 4 sizes labeled P, S, M, L (M is the most common size). The headgear comes in 1 size.
40. Will there be more sizes introduced for the ComfortLite™?
The 6 sizes of the Direct Seal and 4 sizes of the Simple cushion for ComfortLite™ were designed to account for the majority of the patient population. There are no immediate plans to introduce additional sizes.
41. I live out of the US , how do I get a ComfortLite™ Mask?
Contact your homecare provider. If you do not have a homecare provider in your area, contact our customer service department at 1-800-345-6443 or 724-387-5200 and they will be able to give you a list of providers. You also can check the internet for providers who are able to sell masks via the internet.
42. How much does the ComfortLite™ mask cost?
Contact your homecare provider to discuss costs. Generally, depending on your insurance coverage, you can get a replacement mask every 3 months to 6 months. Please check with your insurance carrier for details.
43. Can I take apart the cushions for ComfortLite™?
The Simple cushion can be separated from the exhalation (ball-and-socket) elbow for cleaning. The Direct Seal cushion was not designed to be disassembled.
44. Can I use the Respironics ComfortLite™ with your C-Flex machine?
Yes, REMstar Pro and REMstar Plus with C-Flex can be used with all of our Comfort Series masks.
45. Does the new ComfortLite™ mask make a lot of noise?
In our user preference trials, participants using Respironics and non-Respironics masks stated our ComfortLite™ mask was quieter than other masks they were using.
46. Does the ComfortLite™ replace the Simplicity mask?
No, the Simplicity mask will not be discontinued in the near future however we DO consider ComfortLite™ a superior mask.
47. How do I know I have the right size mask?
Your homecare provider is able to size you correctly for the ComfortLite™ mask by using the sizing gauge provided on the mask bag. The headgear should fit comfortably and snug around your head - with placement just above your eyebrows for optimal stability. The Simple cushion should be slightly wider than your nose. The Direct Seal cushion should block your nostrils without inserting into the nares (we recommend choosing the larger of 2 sizes when questioning which size to select). To learn more about sizing and fitting the ComfortLite™ mask go to www.comfortseries.respironics.com
48. How does the ComfortLite™ compare to your other masks like ComfortGel and your full face mask?
The ComfortLite™ was designed as a tip-of-the-nose alternative to traditional nasal masks such as our ComfortGel. Unlike ComfortFull, ComfortLite™ is only a nasal mask and does not provide therapy through the nose and mouth.
49. Did you do patient trials with this mask?
Yes, we do patient trials throughout development to ensure that each new mask will work well with regard to seal, comfort, noise, pressure points, etc. Trial patients understand that the intent is to provide us with feedback - both good and bad, to improve the mask and their overall experience with PAP therapy.
50. What did you learn in the trials?
We asked patients to evaluate the new ComfortLite™ mask vs. their regular mask. We ask about a number of attributes and if the mask is better than, about the same or worse than their regular mask.. We are excited to say that the ComfortLite™ was rated BETTER THAN their regular masks on all the attributes within our survey. When asked overall preference, the ComfortLite™ was a clear winner.
51. I'd like to order a ComfortLite™ over the internet, how do I know what size I need?
As with all our Comfort Series masks, we will soon be providing our sizing gauges on the Comfort SeriesT website, www.comfortseries.respironics.com. All you will need to do is print one (be sure to verify that it prints in "actual size"), cut it out and size yourself.
52. There is air coming out of the elbow on the cushion - is this OK?
Yes, this is air coming from the exhalation valve. This leak is intentional and removes CO2 from the mask. Never cover or attempt to block these holes. Your Pap unit is designed to still provide your therapy pressure.
53. Is it easy to take the ComfortLite™ mask on and off?
Yes, this is as easy as putting on and removing a cap. To take the ComfortLite™ off, simply grasp the angular adjustment area and pull the mask forward then back. This way, the mask can be placed on and taken off without changing any of the adjustments.
54. How do I know what size ComfortLite™ I'd take?
Proper fit is important. Your homecare provider should use a sizing gauge; one is integrated into the mask bag. Choose the smallest Simple cushion that fits without pinching or obstructing the nostrils. The Direct Seal cushion should block your nostrils but not insert into them (we recommend choosing the larger of 2 sizes when in question). Refer to our website for more information on proper sizing/fitting.
55. Will your ComfortLite™ mask work with my Bi-level?
Yes.
56. Can I use my Simplicity with the ComfortLite™ Simple cushion?
No, the Simple cushion is designed solely for the ComfortLite™. Please also note that the Simplicity cushion is not designed to work with the ComfortLite™.
57. What is your headgear made of?
The Headgear used on the ComfortLite™ is made of different materials - the plastic parts are polyethylene and the liner is made of microban foam with Tricot on one side and Micromesh tricot with Akwadyne on the other. The rear strap is Velcro. If you need information on any other Respironics headgear, please contact your homecare provider.
58. Can I use the ComfortLite™ headgear with other products?
No, the unique headgear on the ComfortLite™ can only be used with this product.
59. How did the users of the Breeze Pillows rate the ComfortLite™ in your trials?
79% of the participants that used the leading competitor's mask preferred the ComfortLite™. In addition, 86% of these same users indicated that the ComfortLite™ provided more adjustability, was more comfortable, and was quieter than their current mask.
60. What pressures will the ComfortLite™ mask work with?
The ComfortGel has been approved for a minimum pressure of 3 cm H20, up to the maximum limits of your device.
61. Where can I get leak rate for ComfortLite™?
Please refer to the ComfortLite™ operating instructions for pressure vs. leak. This information is also available for our other Comfort Series mask at www.comfortseries.respironics.com. Operating instructions are also included in the bag for every mask.
62. I have a fairly large nose; will this mask work for me?
Most likely yes but it is best to contact your homecare provider and be properly sized. The large ComfortLite™ Simple cushion accommodates the majority of larger or wider noses. Remember, the Direct Seal cushion is measured based on nostril size so it will likely accommodate noses regardless of external sizes.
63. How do I clean the ComfortLite™ mask?
We recommend using mild soapy water on a daily basis for optimal results for any of our masks. Avoid soap with moisturizers. Cushions tend to interact to natural facial oils, so be sure to wash your face each night before use. Your seal and comfort can be compromised if cushions acquire build up on the cushion surface. For those with sensitive skin, it is a good idea to soak ANY new mask you use for 30-60 minutes in mild soapy water.
64. As a new user, I am starting with the ComfortLite™. What suggestions do you have to make this mask work well for me?
ComfortLite™ comes with a variety of comfort and adjustment options including the Simple and Direct Seal cushions, the ball-cap style headgear, and the angular and vertical adjustments. Please carefully read the Operating Instructions packaged with the mask and work with your provider. Instructions are also available on www.comfortseries.respironics.com .
65. When should someone pick a minimal contact mask like the ComfortLite™ vs. a more traditional nasal mask?
There are several reasons why someone might want to use a minimal contact mask like the ComfortLite™. Some patients have trouble being compliant because of feelings of claustrophobia when wearing a mask, or they have skin sensitivities that are irritated by using larger masks on their face. Some seek improved visibility or are dissatisfied with aspects of their traditional nasal mask. Others just have a personal preference for less bulk on their face. The ComfortLite™ helps meet all these patient needs.
66. My current mask causes the bridge of my nose to hurt - what should I do?
A big benefit of the ComfortLite™ is that it does not interact with the bridge of the nose with either cushion - you may consider the ComfortLite™ as your next nasal mask if appropriate. In the mean time, check with the instructions of your mask and work with your provider. Detailed instructions on proper fitting of the Comfort Series masks can be found on our website at www.comfortseries.respironics.com .
67. How often should I replace my mask?
With proper care, a mask should last several months... If a breakage occurs, contact your provider to see if it can be replaced. Remember, depending on your insurance coverage, you can generally get a replacement mask every 3 months to 6 months. Please check with your insurance carrier for details.
68. I frequently wake up with severe nasal dryness and nosebleeds while using my mask?
If you experience a runny nose, dryness, congestion, or a nosebleed when using CPAP therapy, contact your provider and ask about adding a humidifier to your therapy device.
69. When I wake up in the morning, my mouth, throat and nose are real dry. I don't feel like my CPAP is working right as I'm also still real tired. Any suggestions?
If you are only mildly dry, you may need to add heated humidification. However, you may be a mouth breather...as you are sleeping, your mouth may be opening. The air from your CPAP follows the path of least resistance into your nose and right out your mouth. This causes you to dry out and also reduces your CPAP therapy. Talk to your provider about getting a ComfortFull Face mask. A full mace mask covers and delivers the therapy through the mouth as well as the nose.
70. I have a new ComfortGel mask. Do I need to take it apart when I clean it?
No, there is no need to disassemble the mask. Wash the mask in warm water with a mild soap and air dry. You may need to shake the mask or unsnap the Comfort Flap to remove excess moisture. Avoid soap with moisturizers.
71. You mentioned your ComfortLite™ trials - how did the trials for ComfortGel go?
We asked patients to evaluate the new ComfortGel mask vs. their regular, pre-trial mask. We questioned them on a number of attributes and ask if the ComfortGel was better than, about the same or worse than their regular mask.. We are excited to say that the ComfortGel was rated BETTER THAN their regular masks on: overall comfort, seal and fit, adjustability, stability, minimal pressure points, noise level, ease of cleaning, headgear comfort and overall satisfaction. As you can guess, when asked their preference, the ComfortGel won hands down!
72. How often should I replace my headgear?
Your headgear should be replaced when you notice significant wear and tear. Check with your insurance provider regarding their policy on accessory replacement. The life of your headgear depends on your usage and care. Wash your headgear once a week or more in mild soapy water.
73. I noticed a website, www.comfortseries.respironics.com on my headgear - what is this on here for?
The Comfort Series website is a one-stop resource library for our masks. Look for detailed section on our key masks, brochures, fitting suggestions, operating instructions and much, much more!
74. When I wake up in the morning my mask is often off of my face, why is this happening?
This could happen for a number of reasons, nasal congestion, wrong size mask, need for humidification or even resistance to PAP therapy. It's best to discuss this matter with your physician.
75. I've been using my CPAP for a month and I don't feel any better than before I was on it, what should I do?
You should contact your physician and discuss how you are feeling. You may need an adjustment to your therapy or a change in your mask type eg: you may have a nasal mask but you are a mouth breather and need a full face mask to receive your full therapy.
76. Do any of your masks have any Latex parts?
No, we do not use Latex in any of our masks.
77. What type of masks does Respironics manufacture?
Respironics manufactures traditional nasal masks (ComfortClassic, ComfortSelect), nasal gel masks (ComfortGel, Profile Lite, Gold Seal), full face masks (ComfortFull) and total face masks (Total Face). The ComfortLite™ and Simplicity are 'tip of the nose' nasal masks. Our Comfort Series is a full family of masks designed to provide the highest degree of comfort and fit. Visit our web site at www.comfortseries.respironics.com to learn more.
78. Can I use my Breeze with Auto PAP devices?
I am not able to comment on other manufacturers mask capabilities. Contact your homecare provider for more information.
79. Can you buy the headgear separately or the mask without HG? Sometimes my insurance doesn't allow me to get replacements of the headgear when it is time for a new mask.
Yes, the headgear can be purchased separately. The ComfortLite™ mask also can be purchased without headgear.
80. We heard about a recall on one of your masks late last year. What happened?
Immediately after the release of the ComfortGel in early September, we discovered that some masks had been assembled without the proper exhalation elbow or port. We immediately stopped shipments. Less than 5000 masks had shipped and most had been sent to our sales force. We immediately compiled a team to follow up and account for every mask that that shipped. The FDA informed Respironics on December 3 that the recall had been classified as a Class I recall. As a result, we issued a press release on December 3 detailing the recall and corrective action that began on September 16. In March, FDA closed the recall.
81. What do I do if I can't get a mask to stop leaking?
If this is a traditional nasal mask, make sure you are not over-tightening the headgear - this usually makes the leak worse. If the mask has a forehead adjuster, try adjusting it to see if you can eliminate the leaks. If these suggestions do not solve your leak problem, it is possible that you might have the incorrect size. Contact you homecare provider to be refitted.
82. Whom do I call if I have a problem with my mask adjustment?
Your homecare provider or DME can help, however, detailed instructions on proper adjustment of ComfortLite™ (or other Comfort Series masks) can be found packaged with the mask and also on our website at www.comfortseries.respironics.com .
83. How does my provider get trained in fitting your masks?
We offer guides to help providers learn the best practices for sizing and fitting masks. Our sales reps also offer Mask Fitting workshops to keep providers skills up to date.
84. Do you test your masks using real patients?
We perform multiple patient preference trials and focus groups with actual xPAP users throughout our product development process.
85. Should I be standing or lying down when I am being fitted for a mask?
To start, we suggest a patient be fitted in a sitting position. Final adjustments should be made with the patient lying down. To learn more about sizing and fitting the ComfortLite™ mask go to www.comfortseries.respironics.com.
86. I was told to use vinegar and water on my mask but I don't see that on your instructions. Would this be ok?
While occasional use of vinegar will not harm the mask, we recommend mild, soapy water.
87. How often can I get a new mask?
Many insurers allow replacement every 3-6 months but it is important to work closely with your provider in order to understand options for receiving a new mask and replacing your old mask. Contact your provider to determine your mask replacement options.
88. It is time to think about replacing my mask. What mask is the best?
We recommend the mask that fits you the best and is the most comfortable. Faces, heads and noses vary greatly, so patient preference is frequently the deciding factor. It's best to become familiar with the masks available to you. We found the ComfortLite™ worked well for our trial participants - especially with the two cushion styles! View our Comfort Series of masks visit our web site at www.comfortseries.respironics.com.
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