HP filter glass - tanTALK

Chaemie · 05-04-2002, 10:22 PM

Don,
If a HP bed is certified with a certain kind of filter glass and then years later is retrofited with diferent filter glass, would the bed still be in fda compliance?
How would a manufacturer get the new filter glass certified and what documents would be required for proof? what documents from the manufacturers Insurance company would be required as proof of insurance?
If none of the above is done, would the owners that put the filter glass in be liable?
This is a very important issue?

Don Smith · 05-04-2002, 10:37 PM

Chaemie:

You have asked a very important question and one that is at the heart of FDA "Amendment 3 - Definition of a Manufacturer" that we are currently discussing.

Let's break apart your questions:

1. If a HP bed is certified with a certain kind of filter glass and then years later is retrofited with diferent filter glass, would the bed still be in fda compliance?

Only if the manufacturer of the HP system filled the necessary papers with FDA to have the new filter glass added to the original certification.

2. How would a manufacturer get the new filter glass certified and what documents would be required for proof?

By filing test data with FDA showing that the new filter glass didn't change the performance of the sunbed more than +(-) 10% of the original filter glass.

3. What documents from the manufacturers Insurance company would be required as proof of insurance?

Documents showing that both the old and the new filter glass was covered.

4. If none of the above is done, would the owners that put the filter glass in be liable?

Yes. I know that is not the answer you are looking for but that is the truth of the matter. You may have relied upon the statements of the person who sold you the new filter glass that it was "compatible" with the original but YOU are the responsible party. In FDA's language, you became the "manufacturer of record" for that product when you installed the filters if you don't have the proper documentation. And, you will find if you ask, that your salon liability insurance is "null and void" too.

Please let me know if you have other questions after you read this.

Don

Chaemie · 05-05-2002, 06:34 AM

Thank You Don,

that was exactly what I was looking for.

Chippp · 05-05-2002, 09:55 AM

This is a problem that anyone with facial lamps or high pressure beds all face over time.
The filter glass is totally resposable for client safty, high pressure lamps emit high levels of uvb and uvc.

If you cannot get original replacement glass filters, you are in trouble.

solarmeter · 05-05-2002, 06:02 PM

Here is a link where you can see UV percent transmission for the various Schott glasses commonly found in HP beds:

http://www.schott.com/desag/english/products/filter-glass/product_range.html

There is a new type called VIT available (very hi transmission), but not sure who makes it, or what the %T values are. It is single layer I am told, blocking some visible light, some UVB, and all UVC.

fungirlz · 05-05-2002, 06:23 PM

Sorry folks private talk now..
Hi Solar.. I miss you.. ..
Please pm me soon.. Glad to see you here..
Love and waiting to hear from you.. Chris

OK.. back to your busy work..
Sorry Don.. think of it as a commercial break..

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05-04-2002, 10:22 PM	#1 (permalink)
Chaemie Join Date: Jul 21 2001 Posts: 43 Rep Power: 0	Don, If a HP bed is certified with a certain kind of filter glass and then years later is retrofited with diferent filter glass, would the bed still be in fda compliance? How would a manufacturer get the new filter glass certified and what documents would be required for proof? what documents from the manufacturers Insurance company would be required as proof of insurance? If none of the above is done, would the owners that put the filter glass in be liable? This is a very important issue?

05-04-2002, 10:37 PM	#2 (permalink)
Don Smith Join Date: Feb 25 2000 Location: Tucson, AZ Posts: 1,643 Rep Power: 26	Chaemie: You have asked a very important question and one that is at the heart of FDA "Amendment 3 - Definition of a Manufacturer" that we are currently discussing. Let's break apart your questions: 1. If a HP bed is certified with a certain kind of filter glass and then years later is retrofited with diferent filter glass, would the bed still be in fda compliance? Only if the manufacturer of the HP system filled the necessary papers with FDA to have the new filter glass added to the original certification. 2. How would a manufacturer get the new filter glass certified and what documents would be required for proof? By filing test data with FDA showing that the new filter glass didn't change the performance of the sunbed more than +(-) 10% of the original filter glass. 3. What documents from the manufacturers Insurance company would be required as proof of insurance? Documents showing that both the old and the new filter glass was covered. 4. If none of the above is done, would the owners that put the filter glass in be liable? Yes. I know that is not the answer you are looking for but that is the truth of the matter. You may have relied upon the statements of the person who sold you the new filter glass that it was "compatible" with the original but YOU are the responsible party. In FDA's language, you became the "manufacturer of record" for that product when you installed the filters if you don't have the proper documentation. And, you will find if you ask, that your salon liability insurance is "null and void" too. Please let me know if you have other questions after you read this. Don

05-05-2002, 06:34 AM	#3 (permalink)
Chaemie Join Date: Jul 21 2001 Posts: 43 Rep Power: 0	Thank You Don, that was exactly what I was looking for.

05-05-2002, 09:55 AM	#4 (permalink)
Chippp Join Date: Apr 19 2001 Posts: 2,262 Rep Power: 24	This is a problem that anyone with facial lamps or high pressure beds all face over time. The filter glass is totally resposable for client safty, high pressure lamps emit high levels of uvb and uvc. If you cannot get original replacement glass filters, you are in trouble.

05-05-2002, 06:02 PM	#5 (permalink)
solarmeter Join Date: Nov 13 2001 Location: MI Posts: 861 Rep Power: 23	Here is a link where you can see UV percent transmission for the various Schott glasses commonly found in HP beds: http://www.schott.com/desag/english/products/filter-glass/product_range.html There is a new type called VIT available (very hi transmission), but not sure who makes it, or what the %T values are. It is single layer I am told, blocking some visible light, some UVB, and all UVC.

05-05-2002, 06:23 PM	#6 (permalink)
fungirlz Join Date: Jan 17 2002 Posts: 4,339 Rep Power: 24	Sorry folks private talk now.. Hi Solar.. I miss you.. .. Please pm me soon.. Glad to see you here.. Love and waiting to hear from you.. Chris OK.. back to your busy work.. Sorry Don.. think of it as a commercial break..

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