Sam James

If Bellaruum S is on the label, then you can use any lamp that is compatible to a Bellarium S. But if the only lamp listed is the Puretan lamp, then any replacement lamp MUST be compatible to a Puretan Lamp. Just because a Puretan lamp is compatible to a Bellarium S, and a Bellarium S is compatible Brand X, this does not mean that a Puretan is compatible to Brand X.

This is clearly a responsible requirement from the FDA and the states, but can be confusing at times.

It seems that a few years ago, OEM's changed thier thinking from selling beds with lots of flexiblilty in replacement lamp choices by listing the Wolff Bellarium S on the label, and they decided to focus more on selling the replacement lamps by limiting what lamps can be used, hopefully forcing bed owners to purchase replacement lamps from them or thier distributors. I think some bed purchasers prefer the flexibility and would rather buy equipment that allows more choices when it comes time buy new lamps. As you are now experiencing with your newer Puretans, owners of beds that have private label lamps on the label and nothing else, sometimes have very few choices available when purchasing replacement lamps.

In the next year, I expect we will see some changes in the lamp compatibility rules from the FDA which shoud filter right down to the states. It will be interesting to see if these new changes will give more or less flexibility to someone in your situation.

Don Smith

Viptanner:

There are two aspects of sunlamp compatibililty to keep in mind.

1. Spectral Compatibility. Currently, FDA regulations dictate that a replacement sunlamp must be +(-) 10% of the original sunlamp in order to be compatible.

2. Manufacturers Compatibility. Even if a sunlamp meets the FDA spectral compatibility requirements, it still might violate the requirements set forth by the sunbed manufacturer. Use of another sunlamp might cause the sunbed manufacturers' warranty and product liability insurance to become null and void. If this happens (which means that YOU would become the "manufacturer of record" for the sunbed, I think you will find that your salon liability insurance policy might also become null and void. That is why many regulated states rule that the label on the bed must be followed and not "replacement sheets" sent out by sunlamp vendors (and if you think about it, that makes sense).

Thus, the best thing to do is to call Roger Brown at puretan and let him know about your problem. If he sends you (1) a new sticker for your sunbed with the sunlamp you want to use listed, and, (2) a new page (or pages) for your product manual, you will be OK when the inspector comes to call.

As Sam James mentioned in an earlier post, the 2/7 & 2/8/2002 FDA meetings will (hopefully!) resolve some of these vexing issues.

Will it make the sunlamp compatibility issue easier to understand? Probably not!

Don