Huvitz HOCT-1, Руководство пользователя

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3.6.
Operating Principles
3.6.1.
Fundus image
The anterior of an eye is illuminated by IR light, the posterior of an eye is illuminated by an infrared light and a white
LED, of which lightings are emitted by the fundus illumination optical system. The fundus observation/photography
optical system forms and makes an image with image sensors, which images are observed and manipulated with the
display panel.
3.6.2.
The anterior segment/fundus tomogram
Formation of anterior chamber cross-sectional image, retinal cross-sectional image, and fundus image
To form retinal cross-sectional images (OCT images) and fundus images (OCT Phase Fundus images), the system
main body scans light over the eye to obtain interference light. The obtained interference light is dispersed into
individual wavelengths and detected by the line image sensor. The detected light is converted to signals, and then
computed to form images. With the anterior segment adapter (optional), a fundus tomogram can be formed.
3.6.3.
The angiography of a retina (Optional)
To form retinal vessel maps, the system main body scans several times at the same position, and gets the same
number of tomography images. And then the system calculates the variance among those tomography, finally
projects those variances into 2D image. This projection is done at different layers which user choose.
3.7.
Applied Standard List
• IEC/EN 60601-1: MEDICAL ELECTRICAL EQUIPMENT
- Part 1: General requirements for safety
•
IEC/EN 60601-1-2: Medical electrical equipment Part1: General requirements for safety
- Collateral Standard: Electromagnetic Compatibility-Requirements and tests
• ISO15004-1: Ophthalmic instruments
- Fundamental requirements and test methods
General Requirements applicable to all Ophthalmic instrument
• ISO15004-2: Ophthalmic instruments-Fundamental requirements and test methods
- Part 2: Light hazard protection
•
ISO 10940: Ophthalmic instruments - Fundus Cameras
•
ISO 16971: Ophthalmic instruments - Optical Coherence Tomography for the posterior segment of the human eye
•
IEC 60825-1: 2014: Safety of laser products – Part1: Equipment classification and requirements