Intended Use; Compatibility - Heidelberg Engineering SPECTRALIS User Manual

1.2

Intended Use

1.3

Compatibility

© Heidelberg Engineering GmbH, Article No. 230134-002 INT
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The SPECTRALIS is a non-contact ophthalmic diagnostic imaging
device. It is intended for:
viewing the posterior segment of the eye, including two- and three-
▪
dimensional imaging
▪ cross-sectional imaging (SPECTRALIS HRA+OCT and
SPECTRALIS OCT)
▪ fundus imaging
▪ fluorescence imaging (fluorescein angiography, indocyanine green
angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA)
▪ autofluorescence imaging (SPECTRALIS HRA+OCT,
SPECTRALIS HRA and SPECTRALIS OCT with BluePeak)
▪ performing measurements of ocular anatomy and ocular lesions.
The device is indicated as an aid in the detection and management
of various ocular diseases, including:
▪ age-related macular degeneration
▪ macular edema
▪ diabetic retinopathy
retinal and choroidal vascular diseases
▪
▪ glaucoma
The device is indicated for viewing geographic atrophy as well as
changes in the eye that result from neurodegenerative diseases.
The SPECTRALIS OCT Angiography Module is indicated as an aid
in the visualization of vascular structures of the retina and choroid.
The SPECTRALIS HRA+OCT and SPECTRALIS OCT include
reference databases for measurements of retinal layer and optic
nerve head anatomy, which are used to quantitatively compare
measurements in the human retina and optic nerve head to values
found in normal subjects.
The following software versions are required to run the Ultra-
Widefield Imaging Module with all of the features described in this
manual:
▪ Heidelberg Eye Explorer (HEYEX) software version 1.10
▪ Heidelberg Eye Explorer (HEYEX 2) software version 2.5.1 or
higher
Preface 1
Compatibility
7