The OpenEEG WARNING.txt file

We include the following warning file to help make clear to everyone what the risks might be from using home-built EEG gear, and to help you make your own safety assessments:

EEG DEVICE DISCLAIMER
---------------------
 
IEC601 is a standard that specifies tests and requirements that medical
devices must pass before they can be used on humans.
 
However, none of the devices built from these designs have been tested
according to these guidelines because of the costs involved.
 
Therefore, a device based on any of these designs may not be used for
medical purposes as no medical claims are made.  Note that CONNECTING A
DEVICE VIA ELECTRODES TO HUMANS OR ANIMALS IS POTENTIALLY HAZARDOUS AND
MAY RESULT IN ELECTRIC SHOCK AND/OR SEIZURE.

Finally, the authors do not guarantee that the information provided in
the design files is complete or appropriate for any particular
application.



IMPORTANT WARNING
-----------------

If you choose to use the OpenEEG project hardware and/or software to
do neurofeedback training or experimentation on yourself or others,
you do so ENTIRELY AT YOUR OWN RISK.

The software and hardware designs are distributed in the hope that
they will be useful, but WITHOUT ANY WARRANTY; without even the
implied warranty of MERCHANTABILITY or FITNESS FOR A PARTICULAR
PURPOSE.

Whilst our aim is to create a genuinely useful and safe set of tools
for neurofeedback training and experimentation, it is quite possible
that our software, hardware or its accompanying documentation contain
bugs or mistakes which its authors cannot be held responsible for.

Please bear in mind that we are a loosely knit group of experimenters
and enthusiasts from all over the world, and many of us have no formal
training or qualifications in the field of neurofeedback.  It is up to
you to assess the risks you are taking by using our work.


EEG DEVICE RISKS
----------------

The most important aspect of device safety is to maintain an electrical
isolation barrier between a user connected to an EEG device, and the
device (typically a computer) to which the EEG device is connected.

All of the openEEG devices have been designed with the intention of
providing this electrical isolation barrier.

However, if there is an isolation failure in the EEG unit due to an
accident, or faulty design, or faulty parts, or faulty construction, and
the EEG subject touches a live mains voltage in their environment, the
mains voltage will take the shortest route to earth, which is through the
subject's body.  This electric shock passing through the head is likely
to have severe consequences.

There are a number of objects in the environment which may carry a mains
voltage if faulty.  If the isolation in your EEG device has failed, these
objects will deliver an incredibly dangerous shock through your brain if
they are carrying a mains voltage at the time they are touched.  So, as a
precaution for your own safety, it is best to avoid touching these objects
even if you are sure that the isolation in your EEG device is good.

Potentially dangerous objects to touch while connected to an EEG device
include, but are not limited to:
 
- Your PC
- Appliances such as refrigerators or electric tea kettles.
- Other electronic devices such as TVs (TV antenna outlets included)
- Light switches, mains power points and adaptors, etc
- Objects connected to earth, such as radiators or kitchen sinks.
 
In short, consider anything connected to mains power and/or earth off
limits when you are wearing electrodes.

Electric shock can also be caused by the EEG device itself, if the
electrode connections somehow become connected to the internal power
rails. The voltages are low, but that is no guarantee for safety.
 
It is important to take care when building the EEG unit to make sure that
the isolation is not compromised, in order to protect from these
eventualities, however unlikely they may seem.

Finally, you should never use an EEG device during a lightning storm or
whenever the electrical power grid is unstable.


NEUROFEEDBACK RISKS
-------------------
  
Neurofeedback training in itself can also cause unpleasant side-effects for
a small number of people, or in certain unusual circumstances.  In an attempt
to provide information to allow you to better judge the risks to yourself, we
are listing here the ones we are aware of.

As we are not experts, and you should research the subject yourself if
you want to be sure.

- Increased anxiety leading to tics, insomnia or even panic attacks.
- Stimulation of latent seizure activity to full (epileptic) seizure activity.
- Mood changes, such as depression or anger outbursts.

If you have any mental health problem, you must check with a clinician before
attempting neurofeedback on yourself. Neurofeedback can make your problems
worse.

Do not use it without the direction of someone qualified to give this
information. 
  
If you are aware of any other unpleasant side-effects of using EEG
equipment or doing neurofeedback training, please let us know through
our mailing list, and we will update this WARNING file.  See
http://openeeg.sf.net/ for details of our mailing list.

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A list member also provided the following warning that might be useful
to people in the USA who plan to use the OpenEEG hardware and/or
software with other people.  This is not legal advice.

  Working on one's self is one thing, but when a person uses it for
  others, there may be state laws that you can run afoul of.  For
  example, in some states there are title laws, meaning one can
  clinically practice anything one wants, but cannot call oneself a
  title which is protected by law, e.g. psychologist.

  Some states have practice laws which prohibit individuals from
  actually doing the activity.  Thus to the extent that NFB training
  can change personality (and it can) one is practicing psychotherapy.

  In the state I live in, that is statutory controlled activity,
  irrespective of what one calls oneself.  Probably if you and your
  friends do it to each other, no one will bother you as long as no one
  gets harmed and there is no basis for a lawsuit.

  If however, you accept money for it, then it could be construed as
  practice or even if no money is taken and you do things to structure
  it so that there is a patient-doctor relationship, there could be
  liability.

  Again, someone would have to claim a harm.  Or, even a practitioner
  in the community, if he or she knows you are doing it for free, can
  complain to the licensing board and have you shut down as engaging
  in unauthorized practice.

  In short, if you accept money for it and/or do it to or with someone
  other than yourself, it is a thin line requiring the lens of an
  expert.

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