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SOCT User Manual Version 10.0 rev. A
1 DESCRIPTION OF THE DEVICE
This manual explains the details of the function and method of application to make a good use
of the SOCT system. Before using the device, read this manual carefully to ensure that you
operate it efficiently and safely. Always keep this manual at hand for reference.
SOCT uses Spectral Domain Optical Coherence Tomography method to obtain 3-dimensional
and cross-sectional images of the retina.
SOCT is an optical coherence tomography system indicated for the in vivo imaging and
measurement of the retina layers, retina nerve fiber layer, and optic nerve head as an aid in
the diagnosis and management of posterior segment diseases as well as imaging of anterior
segment structure. The device produces a light beam, which is focused on the human eye
tissue. The light that reflects from internal structures of an eye is then interferometrically
analyzed by the device. The raw data are processed by a PC to obtain images of eye tissue
cross-sections.
The SOCT contains features including: Retina Thickness, Optical Nerve Head, Retinal Nerve
Fiber Layer, Angle assessment, Cornea measurement, Blood vessels visualization, measuring
distances along the visual axis.
The SOCT software with optional OCT Angiography visualization functionality is indicated as
an aid in the visualization of vascular structures of the retina and choroid.
The SOCT software with optional Corneal Topography function is intended to measure and
visualize anterior and posterior corneal curvatures.
The SOCT software with optional OCT Biometry function is intended for biometric
measurements and visualization of ocular structures and performing IOL power calculations
based on the patient’s biometric data and a selection of recognized IOL calculation formulas.
REVO FC version allows non-contact biomicroscopic imaging that incorporates a high-
resolution digital camera for photographing, displaying and storing images of the retina and
surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions.
REVO FC version provides images which are display only and the device does not provide any
diagnostic, pathological analysis or classification of ocular health based on the acquired
images.
Intended use
The SOCT is intended for use as a diagnostic device to aid the detection and management of
ocular diseases, including but not limited to, age-related macular degeneration, macular holes,
diabetic retinopathy, macular edema and glaucoma.
With optional OCT Biometry software feature the device is intended to measure ocular
structure along the eye axis. It measures the following parameters: Axial Length (AL), Central
Corneal Thickness (CCT), Anterior Chamber Depth (ACD), Lens Thickness (LT), Pupil Diameter
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