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The Mitsar-EEG is intended to acquire, display and store the electrical activity of a patient's brain obtained by placing two or more electrodes on the head to aid in diagnosis.

The device Mitsar-EEG is intended to acquire, display and store the electrical activity of a patient's brain obtained by placing two or more electrodes on the head to aid in diagnosis. The medical device "Mitsar EEG" consists of biosignal amplifier, USB cable, USB dongle and software. The USB cable is part of the device. It is a standard USB-cable, substantially equivalent to the legally marketed predicates. The USB dongle is also part of the device. It is a standard security token to authenticate software. The software is supplied by means of information media and intended for device functioning. The medical system includes "Mitsar EEG" device and computer (stationary PC with uninterruptible power supply (UPS) or laptop with internal battery). The system may include a medical cart and isolation transformer. The device does not come in direct contact with patients. Accessories that contact patients, such as electrodes and cap-type electrodes, are the same as used with the legally marketed devices or are comprised of the same components materials as legally marketed accessories. Electrodes and cap-type electrodes are not supplied together with the Mitsar-EEG. The device is intended for use in functional diagnostics wards and departments at out-patient clinics, hospitals, health research institutes, health centers and other medical institutions. Also, investigations can be performed outside of healthcare facilities, as long as they are led by qualified medical personnel. The device does not draw any diagnostic conclusion. Recorded data is intended for use as an aid to diagnosis only. No medication or treatment is applied based on this data only. The results have to be considered only in conjunction with other clinical findings. The device is not sterile. The device is intended for use by qualified medical personnel only and qualifies for exemption per 21 CFR 801 Subpart D «Prescription devices». Required Components - EEG amplifier - USB-cable - USB dongle - EEG Studio software - User manuals