General Information and Cautions

Indications for Use

This device is to be used for general relaxation training when used with supported amplifier/encoders.

General Warnings

• US Federal Law restricts this device to sale by or on the order of health care practitioners.
• Operators of this device are expected to be health care practitioners trained in neurofeedback or technicians trained in neurofeedback supervised by health care practitioners.

Precautions to Observe

• When using an EEG sensor, the result of the sensor's slight susceptibility to strong Radio Frequency Interference (RFI) could be to artificially increase the microvolt reading and, in almost every case, to obviously corrupt the raw waveform. By paying regular attention to the display on the PC screen of the raw EEG waveform, it should be possible to readily identify whether or not obvious extraneous artifacts are present or to confirm that the signal is “clean”. If you observe random or increased signal readings unrelated to user activity, move the amplifier/encoder and client away from any radiating device.
• You can also test for susceptibility of the active sensors by clipping the three electrodes together and observing the display for non-zero readings or variations. If you are unable to resolve the conditions, contact Technical Support.
• Do not mix electrode types. Electrode connections using mixed combinations of metals can lead to incorrect reporting of EEG data.
• Do not forget to clean and sanitize electrodes between use. Follow the electrode manufacturer's recommendations.
• Ensure that proper connection of the electrodes to the client is made. This is most easily checked by measuring the impedance of the electrodes to the head using some measurement device.
• Follow all the instructions in the instruction manual for the amplifier/encoder to be used.

Other Warnings and Contraindications

Warnings

It has been noted that EEG biofeedback (neurofeedback) may engender a “rebound effect” in some clients, i.e., biofeedback training for relaxation may result, sometime later, in an elevated level of arousal, heightened sensory awareness and increased vigilance. This is usually transitory and fades after a short time.

Contraindications

EEGer is contraindicated in clients with the following conditions:
  • Individuals who are unwilling or unable to understand the general principles and goals of the feedback used. This includes individuals with excessive behavioral problems or low IQ.
  • Individuals who experience anxiety or other unpleasant experiences in connection with EEG biofeedback training.
  • Certain individuals may be unable to learn to control their EEG through biofeedback. Therapy should be discontinued if periodic monitoring of therapeutic progress indicates that the client is not learning despite adequate review of instructions for feedback.
  • Among those individuals who experience a “rebound effect”, some may find it mildly uncomfortable. In some of these cases it may be necessary to alter the level of relaxation being trained or discontinue biofeedback training altogether.

Possible Adverse Reactions

There have been some anecdotal reports of dizziness, drowsiness, fatigue, excitability and/or anxiety associated with an EEG biofeedback session.. These symptoms are usually mild and pass within a short time. If they persist, the supervising health care professional should change the training parameters or discontinue biofeedback training altogether.
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