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The iEEG device is intended to acquire and store electrical activity of the brain and patient data for review by a medical professional using a digital EEG system to monitor the brain. The device is intended for use in a healthcare facility, clinical research environment, or in the home under the supervision of a qualified healthcare professional. The device is intended for use on all patient populations including pediatric.

The Intelligent Electroencephalogram (iEEG) device acquires and stores electrical activity of the brain and patient data. The iEEG can be used with other FDA cleared devices such as the BraiNet Kit (K043009) and Ives EEG electrode (K062880). The BraiNet Kit consists of the BraiNet Template (electrode cap), and Sub-dermal EEG Needle Electrodes and Cutaneous EEG Electrodes. The iEEG consists of an iEEG transmitter module, a medical grade AC charging adapter/charging cable and an iEEG viewer/recorder software. The wireless iEEG transmitter module provides an EEG electrode connection, electrode impedance (connection) status indicator(s), a single-user multi-function push button switch that provides power on/off, electrode impedance check. The wireless module is powered by an internal rechargeable energy source. The AC charger module provides a convenient means to recharge the wireless module's internal energy source when not in use. The device is not intended to be charged when attached to the patient. The iEEG viewer/recorder software provides, with the aid of host computer hardware and operating system, the ability to collect EEG electrode data from the wireless iEEG transmitter module, view EEG data, and record data to digital file. The iEEG viewer/recorder provides eight signal graphic display of selectable EEG montages (lead/electrode combinations). It also enables subject data entry (Name, DOB, ID number etc.) and control of EEG data recording to digital file. The Intelligent Electroencephalogram (iEEG) is designed to be capable of usage and storage in hospital, clinic, and emergency room environments. The iEEG transmitter modules communicate with the computer by using Bluetooth wireless technology.

The BraiNet® Kit contents are placed on the scalp to support electroencephalograph (EEG) electrode placement.

The BraiNet® Kit components are used by medical professionals and paraprofessionals to simplify placement of electroencephalograph (EEG) electrodes on the scalp. The electrodes connect to medical equipment in support of brain electrophysiology recording. The BraiNet® Kit is provided to the user non-sterile, with the exception of the subdermal EEG needle electrodes which are provided sterile and prepackaged. The BraiNet® Kit & individual components is a single patient use, disposable device.