Use Instructions

Instructions for Use
QSL01-001-rev8.0-A
HS01-019
Page 5 of 42
Chapter 1: Introduction and Product Safety Information
About Nurochek
The NUROCHEK-I System is a medical device that evokes and records steady-state visual-evoked potentials
(SSVEP) via electroencephalography (EEG). It wirelessly communicates with an associated smartphone via
Bluetooth and is controlled via a dedicated smartphone application (App).
The NUROCHEK-I System records EEGs through 3 channels of the 10-20 system (O1, O2 and Oz). Saline-
soaked foam cylinders act as an electrical conduit to the scalp, allowing it to record brain activity non-invasively.
Intended Use
The NUROCHEK-I System is intended for prescription use in healthcare facilities or clinical research environments
for subjects ages 14 years and older. The NUROCHEK-I System is indicated for the generation of visual evoked
potentials (VEPs) and to acquire, transmit, display and store electroencephalograms (EEGs) during the generation
of VEPs. The NUROCHEK-I System only acquires and displays physiological signals: no claims are being made
for use as a diagnostic criterion or for the analysis of the acquired signals with respect to the accuracy, precision
and reliability.
1.2.1 Environment for Use
Use in healthcare facilities or research environments, including:
• Doctor’s room
• School “sick bay”/nurse’s office
1.2.2 Contraindications
Contraindications include, but are not limited to:
• History of epilepsy and/or seizures
• History of “fits, faints or funny turns”
• Existing structural and/or functional brain diseases
• Blindness
• Open head wounds/breached skin