Huvitz HOCT-1, User Manual

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HOCT-1/1F
INTRODUCTION
3.1.
System Outline
The Huvitz Optical Coherence Tomography HOCT-1, HOCT-1F is a non-contact, high-resolution
tomographic and bio-microscopic imaging device. It is indicated for in-vivo viewing, axial cross-
sectional and three dimensional imaging, color fundus imaging (HOCT-1F only) and measurement of
posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell plus inner
plexiform layer, ganglion cell complex, macula, optic nerve head, and imaging the microvasculature of
the retina and choroid(Optional). It is also indicated for in-vivo viewing, axial cross-sectional and
three dimensional imaging of anterior ocular structures, including the cornea.
3.2.
Intended Use
The HOCT-1, HOCT-1F is intended for use to aid in the diagnosis and management of ocular diseases
such as macular holes, cystoid macular edema, diabetic retinopathy and aged related macular
degeneration which are occurred at a macular, an optic disk, an inner structure of retina, and a cornea.
3.3.
Classification
•
Classification of product : Class II according to Annex IX (Rule 10) of the Medical Device Directive 93/42/EEC as
amended by 2007/47/EC
•
Resistance against electric shock : Class I (earthed)
•
Protection class against electric : Type B(Head rest, chinrest paper)
•
Classification of Laser Product : Class 1 (laser based on IEC 60825-1:2014 Standard)
3.4.
Contraindications
•
Patients who are hypersensitive to light.
•
Patients who recently underwent photodynamic therapy
•
Patients taking medication that causes photosensitivity
3.5.
Patient requirements
The patient who undergoes and examination by this instrument must maintain concentration for a few minutes and
adhere to the following instructions;
-
After his/her face to the chinrest, forehead rest.
- Keep the eye open
- Understand and follow instructions when undergoing an examination.
If the patient does not conform to these conditions, it is not possible to take a picture correctly
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