Use Instructions

Page 6 of 46
iSyncWave uses dry electrode technology, which doesn’t require a preparation process(e.g.,
applying conductive gel), to obtain high quality EEG signal. This device measures overall EEG data
using 19 EEG electrodes, 1 reference electrode and 1 ground electrode.
With iSyncWave, you can measure both EEG and synchronized PPG data.
EEG is measured from 19 channels using the reference electrode. The measured data can be
digitally converted to common average, longitudinal and transverse montage.
Before measuring the EEG, you can check the impedance of each electrode under the impedance
check screen in the iSyncWave app. EEG amplifier, analog-to-digital converter and Bluetooth are
built in the device. All EEG and PPG signal is sampled at 250Hz and then converted to digital data
at 24-bit resolution.
The user can organize and control iSyncWave during the measurement process with iSyncWave
app. The measured data is automatically saved and can be seen on iSyncWave app.
iSyncWave can be only used by professional and/or medical personnel with product training and
experience in EEG measurement. The professional and/or medical personnel can check the signal
quality in real time and refer to the measured data in clinical practice.
2.2 Intended Use
iSyncWave is intended to be used to acquire EEG, the electrical activity signals of the brain, from
normal individuals and patients(children to adults) with a head circumference between 50cm to
62cm.
2.3 Indication of Use
iSyncWave is to be used to measure electroencephalogram from the scalp of children and
adults. It is not suitable for electro-cerebral inactivity (ECI) determination.
2.4 Patient-Contacting Components
19 EEG electrodes, 1 reference electrode, 1 base electrode and 1 PPG sensor
2.5 Intended Environment of Use
iSyncWave is intended for use in clinical environment.
2.6 Intended user profile and environment in usability test
2.6.1 Intended user environment
1) Conventional environment in hospital