EyeBrain NEO, a Class I medical device, is CE marked in Europe for the intended use indicated below:

• Claimed use of software: EyeBrain®NEO is a software-based medical device designed to help practitioners assist patients in characterising oculomotor dysfunctions. The EyeBrain®NEO software – with its accessories – will present different paradigms on a screen, while monitoring and analysing the patient’s ocular responses.
• Clinical benefits : The software and its accessories provide a measure of oculomotor performance, which can help to assess oculomotor and neurovisual functions that may be characteristic of brain disorders. Such an assessment does not provide a diagnosis.

Eye angles are the angles of the eyeballs in relation to the skull. Measurement range is between ±22° of visual angle in the horizontal axis and ±14° of visual angle in the vertical axis for a 22’ screen at a distance of 60cm.

The expected spatial accuracy for a healthy subject is around 0.5°, but this is recalculated for each patient.

Any serious incident occurring in connection with the device must be reported to the manufacturer and to the competent authority of the Member State in which the user is established.

• The device is installed and configured by SURICOG. Any modification to the software configuration of the device may affect its performance. If you have any questions about the configuration of the device after installation, maintenance or modification, contact SURICOG.
• We recommend using only CE-marked equipment with the EyeBrain®NEO solution that complies with safety standards (e.g. EC 62368-1 or IEC 60601-1).
• Patients are required to wear suitable personal protective equipment (such as a mobcap, mask, etc.) to prevent any contact between their skin and the accessories used. The aim of this provision is to ensure protection against the biological risks caused by such contact.
• Ensure that the oculometer and the patient’s head are in a stable position during the session. A chin rest should be used to stabilize the patient’s head. Any movement of the oculometer in relation to the patient’s eyes may cause measurement errors.
• In the case of an epileptic patient, it is the user’s responsibility to assess whether the type of epilepsy is compatible with the tests displayed on the screen.
• Pupil detection failures can occur with glasses, mascara or false eyelashes.
• Users must set a strong password for their email account to prevent the software’s data from being hacked.

The device has no contraindications