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Indiegogo campaign for a new CPAP hose
#11
OOOps.. Sorry. Stupid mistake. This is the correct link: w w w . accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=75
Just remove the extra spaces at the beginning.
I fully understand the concern, although I must confess that in 25 years of designing, manufacturing and exporting medical devices to the US, I never had problems with the FDA. Disagreements, yes, but no problems.
Oh, and Happy 4th Of July, everybody!
#12
Thanks for the link.
#13
My pleasure! Does this mean you'll order a Travelhose? or three?


#14
Thanks Noam. Your link and some other links from that page convinced me that CPAP tubing is Class 1, no prescription required in the U.S, no 510(k) needed either.

So only CPAP machines themselves, CPAP humidifiers and CPAP masks are now Class 2, prescription-required items in the U.S.

Thanks - hope you meet your funding goal - it will be interesting to see how these hoses work.

Just from watching the video, the only concern I would have is the durability of the flexible "membrane" that covers the tubing. It just "looks" thin and fragile on video and I'm wondering at what point the tubing would develop cracks and leak-points. On a product testing angle, it would be interesting (but time consuming) to see the product pressure-tested for leaks after compressing/decompressing the tubing onto the cylindrical holder x number of times. I'm sure there's some point at which the product will develop leaks, and given the fact that conventional CPAP tubing just "looks" more durable than this compact travel version, I'm sure customers might be interested in answering that question. If it takes 1,000 compression/decompression cycles before the product develops leaks, that's a pretty good lifespan, but if it develops leaks after 100 nightly cycles of use, that might be of concern.
SuperSleeper
Apnea Board Administrator
www.ApneaBoard.com


INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.



#15
I'm very interested! It would not be my every day hose but my travel hose.
PaulaO2
Apnea Board Moderator
www.ApneaBoard.com


Breathe deeply and count to zen.

INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.




#16
(07-03-2014, 01:42 PM)SuperSleeper Wrote: Just from watching the video, the only concern I would have is the durability of the flexible "membrane" that covers the tubing. It just "looks" thin and fragile on video and I'm wondering at what point the tubing would develop cracks and leak-points.

Hi Noam,
I watched the video - very interesting idea. A couple other concerns come to mind. I use a ResMed S9 Autoset, and it is pre-programmed to use either of 2 diameters of hose: 15mm (Slimline), and 22mm (standard). Someone will correct me if I'm wrong, but I believe the Climateline heated host is the 22mm diameter. It is necessary when setting up the machine to designate the type of tubing, which implies the diameter. Your video does not indicate the diameter of your product, except to say it has "a larger bore". The machine's programming expects and supports only 2 sizes of tubing. What will be the effect on the data collection and therapy functions of the machine from using a replacement tubing if it does not match one of the "standard" diameters?

Also, part of the programming of the S9 Autoset includes an (FOT) algorithm for detecting the difference between Obstructive and Central (or Clear Airway) apneas, and adjusting the machine's behavior accordingly. If the machine is operating as an Auto-PAP, it can respond to an Obstructive event by increasing the pressure. It does not increase pressure when it detects a Central event. So the correct performance of the FOT algorithm is critical to the S9's treatment. The FOT algorithm sends 4 hz pressure pulses down the tubing, and watches the pressure and flow sensors for indications that the airway is open or not. A traditional PAP tube will always have a (nearly) circular cross-section during use, regardless of the twists or turns in its path. The TravelHose will not - its cross-section will vary based on the flexible covering. I am concerned that the TravelHose might have quite different fluid dynamics than a traditional hose, and might influence or impair the FOT detection. This could be very detrimental for a patient who is susceptible to pressure-induced Central events. I am much less aware of the PR equipment, but I imagine they also have a means to differentiate between Central and Obstructive events, so a similar issue may exist for those machines.

Good luck with your project.
A.Becker
PAPing in NE Ohio, with a pack of Cairn terriers


#17
(07-03-2014, 07:26 PM)PaulaO2 Wrote: I'm very interested! It would not be my every day hose but my travel hose.

Thanks Paula, this is indeed the expected use of the hose. I guess some people would also like to have a spare hose in the house, just in case, and the Travelhose is much easier to keep around than a standard hose.
Anyway, we'll have the product only if we get enough people to pre-order... there's no risk because you get your money back if the target is not reached.
Thanks for your support, and if there's any way you can share this with others you think might enjoy it, go ahead!
Noam
#18
(07-03-2014, 01:42 PM)SuperSleeper Wrote: Thanks Noam. Your link and some other links from that page convinced me that CPAP tubing is Class 1, no prescription required in the U.S, no 510(k) needed either.

So only CPAP machines themselves, CPAP humidifiers and CPAP masks are now Class 2, prescription-required items in the U.S.

Thanks - hope you meet your funding goal - it will be interesting to see how these hoses work.

Just from watching the video, the only concern I would have is the durability of the flexible "membrane" that covers the tubing. It just "looks" thin and fragile on video and I'm wondering at what point the tubing would develop cracks and leak-points. On a product testing angle, it would be interesting (but time consuming) to see the product pressure-tested for leaks after compressing/decompressing the tubing onto the cylindrical holder x number of times. I'm sure there's some point at which the product will develop leaks, and given the fact that conventional CPAP tubing just "looks" more durable than this compact travel version, I'm sure customers might be interested in answering that question. If it takes 1,000 compression/decompression cycles before the product develops leaks, that's a pretty good lifespan, but if it develops leaks after 100 nightly cycles of use, that might be of concern.

SuperSleeper, Thanks for the encouragement.
To calm your durability concerns, let me tell you that this thin film is not PVC like all standard hoses, but a special polyurethane film the manufacturer declares as intended specifically for "medical applications that must not fail" !. I can talk about this all day, but it is unbelievingly strong. In fact, you simply can't break or tear it without a very sharp tool. I had samples that were used in testing that survived thousands of compressions with no sign of wear. On top of that, its very soft and smooth to touch.

Still, as I just wrote PaulaO2, if we don't reach the campaign target, there will be no product. If I share my belief that many people can be helped by this product, support the campaign, and help me get as many other CPAP users to support it too.

Thanks!
Noam
#19
(07-03-2014, 08:34 PM)becker44a Wrote:
(07-03-2014, 01:42 PM)SuperSleeper Wrote: Just from watching the video, the only concern I would have is the durability of the flexible "membrane" that covers the tubing. It just "looks" thin and fragile on video and I'm wondering at what point the tubing would develop cracks and leak-points.

Hi Noam,
I watched the video - very interesting idea. A couple other concerns come to mind. I use a ResMed S9 Autoset, and it is pre-programmed to use either of 2 diameters of hose: 15mm (Slimline), and 22mm (standard). Someone will correct me if I'm wrong, but I believe the Climateline heated host is the 22mm diameter. It is necessary when setting up the machine to designate the type of tubing, which implies the diameter. Your video does not indicate the diameter of your product, except to say it has "a larger bore". The machine's programming expects and supports only 2 sizes of tubing. What will be the effect on the data collection and therapy functions of the machine from using a replacement tubing if it does not match one of the "standard" diameters?

Also, part of the programming of the S9 Autoset includes an (FOT) algorithm for detecting the difference between Obstructive and Central (or Clear Airway) apneas, and adjusting the machine's behavior accordingly. If the machine is operating as an Auto-PAP, it can respond to an Obstructive event by increasing the pressure. It does not increase pressure when it detects a Central event. So the correct performance of the FOT algorithm is critical to the S9's treatment. The FOT algorithm sends 4 hz pressure pulses down the tubing, and watches the pressure and flow sensors for indications that the airway is open or not. A traditional PAP tube will always have a (nearly) circular cross-section during use, regardless of the twists or turns in its path. The TravelHose will not - its cross-section will vary based on the flexible covering. I am concerned that the TravelHose might have quite different fluid dynamics than a traditional hose, and might influence or impair the FOT detection. This could be very detrimental for a patient who is susceptible to pressure-induced Central events. I am much less aware of the PR equipment, but I imagine they also have a means to differentiate between Central and Obstructive events, so a similar issue may exist for those machines.

Good luck with your project.
Dear Becker,
Your concern is certainly in place, but I think it is not as significant as it may appear. I can list several reasons for that:
A. First , the Travelhose is only slightly larger in diameter than the standard hose (23-24 instead of 22 mm). So no huge difference there.
B. Thanks to the internal spring support, the bore (or lumen) through which the air flow is mostly circular. It is certainly smoother along much of the length of the hose than some of the lower cost hoses on the market.
C. I've tested the Travelhose resistance to flow, and validated that even under the worst situation of being folded 180 degrees (right back in itself) on a zero radius (something standard hoses simply can't do), pressure drop is only about 1cmH2O at 80l/s! This is comparable to the best hoses.
D. The Travelhose is not intended as a replacement for your everyday hose, but rather for use during travel. I think the extra comfort of having a collapsible hose outweighs the slightly compromised (if at all, this remains to be tested) performance for a few days.
I hope you find my answers reasonable, and will support me buy pre-ordering one or more Travelhoses for your next vacation, OK?

Noam
Hi everyone,
Can you help me find more CPAP users forums like this one?
Thanks!
Noam


#20
(07-01-2014, 02:10 PM)tcarmen Wrote: The newer "smart" machines require hoses of a particular diameter and length with known pressure characteristics, so they can determine what's going on.

It looks to me like once that hose is unpacked and connected to a CPAP machine it will have the standard 6 ft length and 22 mm diameter. I'm not sure how flexible it would be, though.

I wouldn't "invest" in this product for the following reason. There's always some risk involved in every investment, so it has to be weighed against the rewards, and I have no idea what those rewards would be. It looks like all I'll get are "free" hoses that will cost me a lot of money. To me, investing includes profit sharing, and I see no sign of that.

Kinda the same way I feel about Obama care -- free health care that costs a lot -- and I'm forced to "invest".
Sleepster
Apnea Board Moderator
www.ApneaBoard.com


INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.


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