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NX01 is intended for use in healthcare or home settings to acquire, record, and transmit electrical activity of the brain by placing non-invasive electrodes in the ears of patients. It acquires, records and transmits one channel of electroencephalogram (EEG) data. The medical use of data acquired by NX01 is to be performed under the direction and interpretation of a licensed medical professional. NX01 does not provide any diagnostic conclusions about the patient's condition.

The NX01 is intended for use with adult and pediatric patients (6+).

NX01 is a wearable device for continuous recording of non-invasive EEG signals in healthcare and home settings. NX01 is intended to be prescribed by a trained healthcare professional. It consists of a pair of earbuds (one per ear) integrating a pair of active, dry electrodes, connected by a cable to a command panel. This command panel houses the battery, the internal memory to store the data, the main acquisition unit with function buttons and LEDs which display the device's status.

The NX01 solution is composed of:

• Two earbuds (1) connected by 45 cm cables, to a command panel (5). This command panel houses the battery, the internal memory to store the data, the main acquisition unit with function buttons (2 - Left button and 3 - Right button) and LEDs (4) which display the device's status.
• A set of eartips, to be placed on the earbuds for the recording. Eartips are single use consumable that should be discarded and replaced for every recording that takes place.
• A medical grade PSU with the following specifications: Input AC 100-240V, 50/60Hz; Output USB-C DC 5.0V, min 1.0A; Compliance IEC 60601-1, IEC 62368-1 or IEC 60950-1.

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