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.
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.
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 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.
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.
(Thanks modular eeg designers for this warning document.)
Made 2008/09/07