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would like to do a open source mask
#1
thought I had posted this idea on this forum as well, guess I did not so here it goes.


with there being just 3 sizes of mask from most companies and a small selection of models of masks to choose from and the infinite variety of face shapes and sizes it would seem that there are lots of faces just making do with what is out there.

it would be cool to have 3D models of face masks on the net that can be downloaded and modded and then printed to fit ones face just perfect, that would work for the hard frame part of the mask, add to that say 6 different size soft parts one could buy in say 8 different styles. that is 48 different soft seals for each of any number of masks that could be designed and uploaded to the net, then add all the tweaks to mask designs that are uploaded and you have as many mask options as there are faces on gods green earth.

the idea is to standardize the lengths of the sealing ridge or channel of the hard printed unit so the length there of matches what the soft section is for that size so it will go in perfectly and seal the soft section to the hard section

again open to ideas and comments

also seeing as this is open source and all standardized it should bring the price down to real cheap for a much better fitting mask with real cheap replacement parts so the cost of ownership drops big time

buy cheap soft parts and down load and print the hard parts and your good to go, better product cheaper price

also one can download mods to mask one owns all ready to relocate arms or change quick connects or what ever up grades one can think of... one could even add a cup holder to their mask....lol

just a thought, open to input

there maybe a good solution to this problem that has come up in another forum but am looking for legal help in protecting it for public domain

will post more when I have it protected, if possible
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#2
Try something simple: Custom headgear for the Airfit P10.

Smile

There are a lot of people who would support you on this, and maybe even pay for it.
Sweet Dreams,

HerbM
Sleep study AHI: 49 RDI: 60 -- APAP 10-11 w/AHI: 1.5 avg for 7-days (up due likely to hip replacement recovery)

"We can all breathe together or we will all suffocate alone."
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#3
The problem is, it would have to meet FDA approval since it is a prescription only item. Good luck with that.
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.




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#4
I live in Canada and I do not need a prescription to get a CPAP unit, just walk in and buy one, same with the masks.
the FDA rules do not apply where I live. I can make masks and machines and sell them with no problems. just problems of being sued is the only worry.

(04-04-2014, 06:43 PM)PaulaO2 Wrote: The problem is, it would have to meet FDA approval since it is a prescription only item. Good luck with that.

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#5
(04-04-2014, 06:58 PM)space45 Wrote: I live in Canada and I do not need a prescription to get a CPAP unit, just walk in and buy one, same with the masks.

Stan, I really like your enthusiasm. I want to see you succeed and want to read about any breakthrough you make in this area. My story is similar to yours so I too know the medical establishment gets a failing grade in educating themselves and the public about this condition. I know you can make a difference. I'm cheering from the sideline.

To market into the U.S. or purchase from the U.S. you need FDA approval. Also, I know you have posted more than once that Canadians do not require a prescription for CPAP devices or masks. Because Canadians search these forums for accurate information I do not wish them to be misled. You need to verify your statement as fact.

I needed a prescription to purchase a mask from Supplier #1.

I don't consider this to be a great source but simply as more evidence that experts in this field believe a prescription is necessary in your province. From "Vancouver Coastal Health" in BC:

Quote:How Do I Get One?
[commercial link removed per Apnea Board rules]




-----
Moderator Action: Link Removed
To maintain our status as an educational organization, the only commercial links allowed in this forum are to CPAP-related manufacturer websites. This is stated in the Apnea Board Rules with details given in the Commercial Links Policy section.
-----
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#6
the 2 local shops here where I live said nothing about needing a script when shopping for a unit and masks. they were willing to sell me machine and masks and what ever I needed, no mention of any permission needed so if there is some sort of law in B.C. about needing one it is not enforced or well known or something, as one of the shops willing to sell it to me is a very large chain store for sleep products, you would think they would for sure know and follow the law. the local mom and pop guy he may not know about some obscure law but the chain store guy would.

that was what I was basing my opinion on, first hand experience. BTW the chain store guy did do a one night test and did apparently run it by a doc and paid him $50 for his trouble but there was no script or anything I got. that maybe how the chain guys are getting around it. my own doc did not say anything about me needing a script or anything at all really.

so I could be wrong on this needing permission on a official base but on the ground where I live it looks like the mom and pop guys would have sold me one, I ended up going on line and saving a ton buying one and again no script.



(04-05-2014, 06:49 AM)SleepWrangler Wrote:
(04-04-2014, 06:58 PM)space45 Wrote: I live in Canada and I do not need a prescription to get a CPAP unit, just walk in and buy one, same with the masks.

Stan, I really like your enthusiasm. I want to see you succeed and want to read about any breakthrough you make in this area. My story is similar to yours so I too know the medical establishment gets a failing grade in educating themselves and the public about this condition. I know you can make a difference. I'm cheering from the sideline.

To market into the U.S. or purchase from the U.S. you need FDA approval. Also, I know you have posted more than once that Canadians do not require a prescription for CPAP devices or masks. Because Canadians search these forums for accurate information I do not wish them to be misled. You need to verify your statement as fact.

I needed a prescription to purchase a mask from Supplier #1.

I don't consider this to be a great source but simply as more evidence that experts in this field believe a prescription is necessary in your province. From "Vancouver Coastal Health" in BC:

Quote:How Do I Get One?
[commercial link removed per Apnea Board rules]

Post Reply Post Reply


#7
I think you better do your homework. I believe you may find that you would need Health Canada approval for any type of device which would fall under medical devices which I think masks would. As for buying without prescriptions, not in Manitoba as far as I know. According to the Canadian Lung Assoc. you need a prescription to buy CPAP equipment (this may only be for the actual CPAP machine)

From their website:
To buy a CPAP unit, you need a doctor's prescription. Your doctor’s prescription will say what pressure your CPAP machine needs to be set at. For insurance purposes, the prescription should also mention your CPAP mask and humidifier.

Did more searching and found this on another Canadian suppliers website:
Do I require a prescription for a CPAP mask?

In Canada you do not require a prescription to purchase a CPAP mask. To purchase a CPAP machine will require a prescription. This may vary depending on your Extended Health Insurance provider.
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#8
(04-05-2014, 12:39 PM)TonyJ Wrote: In Canada you do not require a prescription to purchase a CPAP mask. To purchase a CPAP machine will require a prescription. This may vary depending on your Extended Health Insurance provider.

I tried to find a source to help clarify. B.C. government on-line information talks about needing a prescription but only in the context of social assistance (i.e., funding) and not solely in terms of access. Same for Ontario. Your evidence is similar because you mention Health Insurance.

Overall these devices are regulated by the Canadian Food and Drug Act, Canadian Medical Devices Regulations. CPAP is listed as class 2 device which means there are special licensing requirements for the manufacturer but I don't see anything related to the distribution.

The Canadian government publishes the guide "Buying Medical Devices from the Internet" and it says nothing about needing a prescription. A prescription may be best practices code-of-conduct and needed for liability but I don't see any specific criminal laws. I dunno and IANAL.
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#9
(04-04-2014, 06:58 PM)space45 Wrote: I live in Canada and I do not need a prescription to get a CPAP unit, just walk in and buy one, same with the masks.
the FDA rules do not apply where I live. I can make masks and machines and sell them with no problems. just problems of being sued is the only worry.

<sarcasm>Oh, well, then if that all you have to worry about, go for it. Rolleyes </sarcasm>

You need to not be so casual about this. If you are serious, then be serious. Like others have said, Canada and its provinces don't allow just anyone to make and sell a medical device.
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.




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#10
(04-05-2014, 03:09 PM)PaulaO2 Wrote:
(04-04-2014, 06:58 PM)space45 Wrote: I live in Canada and I do not need a prescription to get a CPAP unit, just walk in and buy one, same with the masks.
the FDA rules do not apply where I live. I can make masks and machines and sell them with no problems. just problems of being sued is the only worry.

<sarcasm>Oh, well, then if that all you have to worry about, go for it. Rolleyes </sarcasm>

You need to not be so casual about this. If you are serious, then be serious. Like others have said, Canada and its provinces don't allow just anyone to make and sell a medical device.
ResMed sues APEX Medical over device patents
http://www.apneaboard.com/forums/Thread-...ce-patents
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