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IASIS i2 Relaxation Neurofeedback System is a neurofeedback device intended for relaxation and stress reduction through the use of EEG biofeedback.

IASIS i2 Relaxation Neurofeedback System is a medical device system prescribed for providing relaxation and stress reduction biofeedback treatment. It consists of a multi‐channel EEG recording device and the software running on a Windows laptop.

The IASIS i2 Relaxation Neurofeedback System includes an EEG recording device encased in a plastic enclosure. It is connected to the laptop with a standard USB‐A to USB‐C cable capable of drawing at least 3 Amps of power. The device is powered by the laptop through the USB cable. The device has 9 standard, electrically safe DIN 42802 single‐pin input connectors. Pre‐existing EEG lead wires with integrated Ag/AgCl EEG electrodes made by Rhythmlink International, LLC (K061148), and Elefix V Paste for EEG & EMG made by Nihon Kohden Corporation (K191975) are connected to the input connectors of the device. The device does not have any user controls; it is turned on and off by the IASIS i2 Relaxation Neurofeedback System software through the USB connection. The device has a single indicator of operation – a cyclic pattern illumination is applied to the translucent plastic logo and a plastic rim around the bottom of the device when it is turned on.

The device has at least 2 input raw EEG channels with 24‐bit A/D resolution. This enables it to deliver more than 12 significant bits of EEG signals without the need for heavy analog filters, which significantly distort the raw EEG signals. It samples all input channels at least at a 250 Hz sampling rate.

The device provides an industry‐standard level of electrical safety against up to 5000V of electric shock from the power line. It also provides ESD protection of input channels for up to 15,000V.

The IASIS i2 Relaxation Neurofeedback System software is a desktop application installed and run on a laptop under Windows 10 or newer. The software operates in two modes: Cloud or Local. When it operates in Cloud mode, clinicians utilize the IASIS Cloud Portal – a web application running on the cloud server providing comprehensive patient management functions. To run a new biofeedback session, the clinician logs into the portal, selects a patient from the patient directory, and launches a new session. The web application launches the IASIS i2 Relaxation Neurofeedback System software on the laptop to start a new session.

The IASIS i2 Relaxation Neurofeedback System is designed to be Internet‐independent in the case of absence or poor Internet connection by operating in the local mode. If the clinician switches to the local mode, the software uses the local data storage, which automatically synchronizes with the Cloud storage when an Internet connection becomes available.

When a new biofeedback session is started, the clinician uses an intuitive graphical user interface to set all parameters needed for the session: selecting EEG topical sites where the EEG electrodes will be placed and selecting the type of biofeedback protocol. It also prompts the clinician to measure the impedance of all assigned EEG electrodes, checks raw EEG signals, and begins a new biofeedback session.

The electrode impedance is measured every time the electrode placement is conducted or changed. The duration of standard neurofeedback protocols is short, which does not lead to noticeable deterioration of the electric contact between electrodes and skin after proper placement and impedance measurement. Therefore, continuous real‐time electrode impedance measurement is not required.

During the session, the IASIS i2 Relaxation Neurofeedback System software displays raw EEG signals to control the quality of input data, their real‐time spectral images, and all standard brainwave amplitudes. It also displays the current threshold of the target EEG band according to the selected training protocol. When the selected EEG band hits the threshold level, the system may provide visual or auditory feedback.

Once the training session is completed, the software shows a session preview with the target EEG brainwaves recorded during the session. The clinician saves the results of the session in the local data storage, and the system automatically synchronizes the data to the cloud storage when an Internet connection is available.

The IASIS i2 Relaxation Neurofeedback System provides maximum security for the recorded information, including available patient health information, by storing all data in the local or cloud storage in an encrypted format and transmitting the information over the Internet using a secure data transmission protocol.

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