From: Doug Sutherland (wearable_at_earthlink.net)
Date: 2002-01-14 20:46:51
Hi Jim,
> My reason for contributing to this list is not to get a
> cheap and dirty EEG machine.
Neither is my reason based on cost. I already spent $1300
on brainmaster plus accessories. I am interested in the
openness and modularity of the openeeg design. And I am
interested in the potential for smaller EEG designs for
mobility.
> Would compatibility with the BrainMaster be important?
I don't think so, given that the brainmaster software is
no longer freely available. If the ftp site was still up
with the version 1.8 brainmaster software, then I would
say yes. The choice of microcontroller should be
independent of the communications protocol anyways, so
compatibility does not mean 68HC11 is advantageous.
The same protocol could be easily done using Atmel.
> The laws in the USA are very severe, and if you build and
> sell a non-approved medical device you may end up in jail.
> The brain monitor would be classified as a medical device.
> The bio-feedback field is highly regulated and you have to
> be licensed to use a brain monitor.
I'm not a lawyer either (thankfully), but I have done some
investigation into this. It appears that a lot of the low
end EEGs are not FDA approved for medical use. And the ones
that are do NOT state anything more than "alpha training
for relaxation" as intended use. What seems to be the BIG
issue is CLAIMS that people make about medical usage. What
FDA jumps all over is something that claims appropriateness
for medical use without necessary FDA approval. I can't
find FDA records for WaveRider or Procomp. It appears that
only SOME of the low end EEGs have the FDA approval. For
example Lexicor has two low end EEGs priced at $1000 and
$1300, only the $1300 model seems to be FDA approved.
> The only possibility for the buildcheapeeg project that I
> see is that it could be published for free like the
> BrainMaster was or sold as a kit like the HAL-4.
That was basically the same conclusion that I arrived at.
One other option that might be worthwhile is to just sell
the blank PCB boards. This makes it a lot easier for
people to assemble these things.
> The law allows people to build things for their own
> experimentation, but they cannot sell it, or use it on
> others.
American laws and regulations are very bizarre. Why then
is Brainmaster only approved for "alpha relaxation
training"? There seems to be an art in finding the loop
holes and walking through them. I'd be happy to be able
to buy just PCB boards or a kit with board and parts.
-- Doug
This archive was generated by hypermail 2.1.4 : 2002-07-27 12:28:36 BST