Since using the Pur-sleep oils

WearyOne wrote:Snoredog, Okay, I really don't know the answer to this. What's the difference between "pressure" and "flow related"? Would "flow" be the machine being able to sense what my breathing is doing possibly being impaired so it might not be able to "read" apneas, snoring, etc., properly that it needs to respond to or keep a record of?

Pam

Stuff a sock in your mask and you get the idea behind what I am saying (make sure it is clean).

The machines we use for OSA are flow-based generators. Flow is the volume of air that flows back and forth as you breathe. While you may have a pressure associated with that flow, it is the flow that the machine uses to determine if you are having a FL, Hypopnea or apnea.

The air in the circuit essentially becomes like a solid under pressure and is moved back and forth in the hose as you breathe and measured by the transducer. The machine samples your normal breathing flow rate and determines what normal is. Then when it sees a different flow rate it compares the new to baseline and responds appropriately by increasing or decreasing pressure.

In the industrial environment using 4" ID tubing even installing a 90 degree elbow into the circuit can be equal (in resistance) to adding 10ft of smooth rigid tubing. This resistance the machine's blower and transducers all have to overcome in any kind of response. The Remstars use a MAS (mass airflow sensor) to measure the flow rate just like your fuel injected automobile has to measure how much incoming air there is when you step on the gas peddle. On most newer fuel injected cars you are opening a flapper valve to allow the air into the cyclinder as the gas is injected directly into the combustion chamber, the computer measures the incoming air flow from the MAS sensor and the computer determines how much fuel to spray out the nozzle when you step on the gas while maintaining the proper 16:1 air to fuel ratio. It can also be compared to a water hose, if someone stands on the water hose as you are watering the lawn pressure drops at the end of the hose. In an industrial environment the static pressure is measured, the velocity (speed of the moving air through the pipe/hose) is calculated and flow rate (CFM) is determined based upon the area of the duct and you can actually measure the difference in added resistance.

Our cpaps follow along the same concept as the industrial example only on a smaller scale but the effect is the same when you start adding resistance into the circuit. Add humidifiers, foam filters, swivel elbows, longer hoses all can impact the sensitivity of the machine to respond.

Here is what the website's FAQ's say:

Are Your Products Approved by the FDA?

Our products are not medications or medical devices but are regulated as "cosmetics" under the federal Food and Drug Act and related regulations. While there is evidence that certain essential oils may have therapeutic value (such as lavender oil improving deep sleep), the FDA regulates essential oils used for their aromatic qualities as cosmetics. Our products and business are in full compliance with FDA laws and regulations pertaining to cosmetics.

What About Pressure Loss?
Our In-Line Diffuser has been designed to allow more than enough space for the free flow of air and, unlike in-line HEPA filters, should not cause a loss in pressure and should not interfere with pressure-sensing devices installed on some xPAP machines.

Bold and underlining emphasis mine.


1. Under FDA approval FAQ they are only talking about the essential oils. The "diffuser" is also a "Product" they sell. I doubt very much it falls under the guidelines as "cosmetic".

2. Our cpap machines are flow-based generators, flow is different than pressure and that statement is meaningless as it relates to our machines ability to respond to SDB events based upon flow. Then the statements above "should not" and "should not" interfere are just another testimonial that says to me WE HAVE NOT actually TESTED THIS in a laboratory environment to confirm these findings or it would say "do not" instead of "should not".

3. Next they reference another sold product, the in-line "HEPA" filter in the FAQ, that means they already KNOW there can be a problem with restrictive properties of in-line devices like the diffuser.

If you are going to say the product does NOT interfere with your xpap machine ability to respond you package it up and send it off to an independent testing lab and have them confirm your findings. "Should not" implies some one's educated guess and not any actual testing.

SD, you raise a number of fair questions and I didn't try to avoid them earlier.

I'll post more on this later tonight but for now I would like to respond to your question about FDA approval for the in-line diffuser itself.

The federal Food, Drug and Cosmetic Act defines a "medical device" as a device that is:

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

FDCA § 201(h), 21 U.S.C. § 321(h).

While it is not always necessary to obtain FDA approval for medical devices (the agency maintains detailed regs governing the manufacture of many classes of common medical devices, like toothbrushes), it is necessary to obtain approval for "medical devices" that are not otherwise approved.

I've put quite a bit of time and research into this very question, both directly and through an attorney who practices intellectual property / FDA law, and am confident that the diffuser does not qualify as a "medical device" under the FDCA.

But like I said, I'll post more on this after I get my kids to bed.

SleepGuy wrote:SD, you raise a number of fair questions and I didn't try to avoid them earlier.

I'll post more on this later tonight but for now I would like to respond to your question about FDA approval for the in-line diffuser itself.

The federal Food, Drug and Cosmetic Act defines a "medical device" as a device that is:

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

FDCA § 201(h), 21 U.S.C. § 321(h).

While it is not always necessary to obtain FDA approval for medical devices (the agency maintains detailed regs governing the manufacture of many classes of common medical devices, like toothbrushes), it is necessary to obtain approval for "medical devices" that are not otherwise approved.

I've put quite a bit of time and research into this very question, both directly and through an attorney who practices intellectual property / FDA law, and am confident that the diffuser does not qualify as a "medical device" under the FDCA.

But like I said, I'll post more on this after I get my kids to bed.

Please note: The main question is:

Have you tested this device to determine if there is any effect on xpap machines ability to sense SDB more specifically is the sensitivity of the machine to respond to events changed in any way.

Saying it "should not" is not answering the question, you either did scientific testing or you didn't.

I have worked with many Patent attorneys and directly assisted in obtaining over 100 US and Foreign patents. I am familar what intellectual property law is and we all know your device doesn't treat anything that is not what is in question.

All I want to know is if I put this device on the tail end of my machine it will respond exactly as it did before installation (and hopefully smell much better).

I hope you win your patent claim and I hope you sell a gazillion of these little things. Once you get your patent keep that attorney, wait 5years make a small change and file a continuation in part and extend the life of said patent by making it broader.

SD, I understood that the "medical device" issue was part of your question.

In answer to your specific question, the diffuser has not yet been tested by an independent lab "to determine if there is any effect on xpap machines ability to sense SDB more specifically is the sensitivity of the machine to respond to events changed in any way." I think that is certainly a fair question and one that will take a bit of time and effort to answer definitively. I am presently working with an independent underwriting lab to develop a testing protocol to accomplish that but expect it to take several months to get to the end of that process.

In the meantime, I have tested the diffuser's performance in comparison to the in-line hepa filter presently on the market and can state that the diffuser's bi-directional airflow is better than the hepa filter.

Everything you have said here about demonstrating that the diffuser has any effect on xpap machines' ability to sense SDB can and should be said about the in-line hepa filter product. I have asked about and looked for independent testing of the in-line hepa filter (in order to assist in the development of testing protocols) but have found none.

I'd be appreciative of any feedback/comments you may be able to pass my way in that regard.

I do note that the internal volume of the diffuser is 80 cubic centimeters. My F&P water chamber holds 400 cc of water (to the fill line) and a 6 foot hose has an internal volume of 500 cc. A 10-foot hose has an internal volume of 800 cc. The average daily variabilty of the water level in any HH is more than the diffuser displacement.

SleepGuy wrote:SD, I understood that the "medical device" issue was part of your question.

In answer to your specific question, the diffuser has not yet been tested by an independent lab "to determine if there is any effect on xpap machines ability to sense SDB more specifically is the sensitivity of the machine to respond to events changed in any way." I think that is certainly a fair question and one that will take a bit of time and effort to answer definitively. I am presently working with an independent underwriting lab to develop a testing protocol to accomplish that but expect it to take several months to get to the end of that process.

In the meantime, I have tested the diffuser's performance in comparison to the in-line hepa filter presently on the market and can state that the diffuser's bi-directional airflow is better than the hepa filter.

Everything you have said here about demonstrating that the diffuser has any effect on xpap machines' ability to sense SDB can and should be said about the in-line hepa filter product. I have asked about and looked for independent testing of the in-line hepa filter (in order to assist in the development of testing protocols) but have found none.

I'd be appreciative of any feedback/comments you may be able to pass my way in that regard.

That is fair enough, if I don't ask the question someone else certainly will. You might want to touch base with the guys from Valley Inspired Products out of Mn.

These guys developed an iron lung used for autopap testing (no matter how controversial that discussion may have been). I'm sure if anyone can perform the test and do it in a cost effective manner it would be these guys. Should you ever need FDA approval, you have the testing done and only need to submit a copy along with the application.

Here is their website:
http://www.inspiredrc.com/

Should you ever decide to take that company of yours public, you will need that testing completed and under your belt for any underwriting. I would also expect your sales to increase once you have that testing completed and the patent in place. This question will only come up again at a later point. Don't know if you have shipped anything to Canada or not but if they ever require CSA approval, you will also need the same test data so it will save you money over the long haul.

OK

Lets back-off all the legalese, and devil's advocate rhetoric for a moment, and just look at this pragmatically:

What you have is an airtight "bulb" inline with your circuit. This bulb suspends a small cotton cylinder. The volume of the area around that suspended cylinder is greater than, or equal to, the volume of the same length of CPAP tubing.

Assuming this setup creates no weird vortex (a perfectly logical assumption) there's absolutely no reason to suspect that it, IN ANY WAY, disrupts the flow of the machine.

We're not dealing with super complex physics here.

Snoredog, you need to find a more worthy cause. This product is helping people cope with their therapy. You are trying to raise doubt for the sake of your own ego. Move on.

[quote="Rabid1"]OK

Lets back-off all the legalese, and devil's advocate rhetoric for a moment, and just look at this pragmatically:

What you have is an airtight "bulb" inline with your circuit. This bulb suspends a small cotton cylinder. The volume of the area around that suspended cylinder is greater than, or equal to, the volume of the same length of CPAP tubing.

Assuming this setup creates no weird vortex (a perfectly logical assumption) there's absolutely no reason to suspect that it, IN ANY WAY, disrupts the flow of the machine.

We're not dealing with super complex physics here.

Snoredog, you need to find a more worthy cause. This product is helping people cope with their therapy. You are trying to raise doubt for the sake of your own ego. Move on.

Snoredog wrote:and if the little suspended cotton ball becomes dislodged from the bulb and goes out the hose I assume it eventually comes out the butt?

all valid questions are relevant.

Exactly; so present one.

Snoredog wrote:and if the little suspended cotton ball becomes dislodged from the bulb and goes out the hose I assume it eventually comes out the butt?

I really think if you held one in your hand you would see why people think your questions aren't valid. If your pressure is 12 million and you think the jetstream of air is gonna dislodge, it, then spin the grid on the inside so the pressure pushes the bud in further instead of dislodging it.

blarg wrote:

Snoredog wrote:and if the little suspended cotton ball becomes dislodged from the bulb and goes out the hose I assume it eventually comes out the butt?

I really think if you held one in your hand you would see why people think your questions aren't valid. If your pressure is 12 million and you think the jetstream of air is gonna dislodge, it, then spin the grid on the inside so the pressure pushes the bud in further instead of dislodging it.

Snoredog wrote: I knew the peanut gallery would be along any time.

Please, Snoredog, let's keep the personal put downs out of this thread.

Snoredog,

I think Bret has gone to great length to answer your questions to the best of his knowledge. I'm not sure why you don't just leave it alone?!?! If you are so convinced this aparatus will harm, then don't buy or use one. (since it's obvious you haven't already, made obvious by your unsupported opinions) It's as simple as that. But believe me, this Pur-Sleep system is probably a whole lot safer to use than the car you drive!

I truly respect the right of opinion. Yours seems to differ from most. That's okay. That's what discussion is about. Your comments and statements are presented in a learned manner, and on the surface seem harmless enough. But to say my testimonial means nothing and that I don't know what the hell I'm talking about is neither learned nor harmless. You are just being rude. It's my opinion you are being argumentative just to argue. I won't play that game with you.

Well, I have little to say other than thank you to everyone responding to this thread. I think that it is interesting and that I should def. consider all sides before I alter my cpap usage at all...

I will bring it up to my Dr. and unless he tells me it may disrupt the machine or my results, then I will probably try these.

=)

Snoredog wrote: and if the little suspended cotton ball becomes dislodged from the bulb and goes out the hose I assume it eventually comes out the butt?

all valid questions are relevant.

SD, I agree that this is a valid question, particularly if people choose to use a light cotton ball or something like (despite warnings to the contrary) that instead of the diffusion pads, which are relatively heavy and dense and held firmly in place in the bracket. As others have noted, it would be extremely difficult for the diffusion pad to become dislodged (but I suppose anything could happen).

Fortunately, just before going into production this very issue occurred to me and the diffuser was re-designed with an integral plastic "grate" at the base of the top connection to prevent almost anything that may become dislodged from exiting the diffuser. It would have to be very small to get through the grate.

I have found the substance of this discussion to be helpful (personal barbs aside) and I do appreciate SD's critical thinking on this. These are the kinds of questions that are being raised by others and most certainly will be raised sooner or later as the product grows.