Certificate of Exclusivity – HRA+OCT

Unique selling points of the SPECTRALIS® HRA+OCT imaging platform

for the posterior segment of the eye
Heidelberg Engineering GmbH
Dear Sir or Madam, Max-Jarecki-Str. 8
69115 Heidelberg · Germany
We hereby confirm that the SPECTRALIS imaging platform delivers a
combination of features, which is unique and cannot be found in any other Phone +49/62 21/64 63-0
spectral domain OCT- and angiography device. Fax +49/62 21/64 63 62
www.HeidelbergEngineering.com
The SPECTRALIS HRA+OCT comprises the following features and
technologies:
• The SPECTRALIS is an upgradeable imaging platform which combines a
confocal Scanning Laser Ophthalmoscope (cSLO) with high-resolution
OCT. Since cSLO imaging minimizes the effects of light scatter, it can be
used effectively even in patients with cataracts. SPECTRALIS is the only
imaging platform with the patented TruTrack Active Eye Tracking
technology.
• Multimodal imaging in one device enables simultaneous acquisition of both
fundus and OCT images by using dual beam active eye tracking.
• By using laser light with longer central wavelengths of up to 880 nm,
SPECTRALIS enables capturing OCT images of great detail, even without
pupil dilation. The higher depth penetration of the laser light in combination
with the confocal scanning enables visualization of distinct details of
intraretinal lesions, e.g. cystoid macular oedema or central serous
chorioretinopathy. The lower intensity of the light is better accepted by
elderly patients, especially if they have problems with flash photography.
• Image capture is possible with a minimum pupil size of 1.5 to 2 mm.
• Spectral-domain OCT delivers high spatial resolution in cross-sectional
scans of the retina and the anterior segment of the eye.
• The A-scan rates of 40, 42.5 or 85 kHz allow capturing three-dimensional
OCT images of the retina, providing increasing signal in vitreous and
choroid as well as faster acquisition time in correlation to increased scan
speed.
• The patented TruTrack Active Eye Tracking…
o Recognizes anatomical structures within the cSLO image in real-
time and uses the information to continuously check the position of
the scan during acquisition.
o Mitigates motion artefacts in the OCT image and the volume.
o Controls the quality of the scan in real-time and only saves images
taken with sufficient quality and at the right location of the retina.
This feature even allows patients to blink or move during image
acquisition, making the examination less stressful for both the
patient and the photographer without sacrificing image quality.
o Enables visualization of minuscule changes within the central retinal
thickness of up to 1 µm. This cannot be achieved by any other
spectral-domain OCT device [1].
• In combination with the AutoRescan function, TruTrack Active Eye Tracking
enables automated capture of follow-up examinations at the exact same
position as in the initial examination. Furthermore, it allows precise and Managing Directors
confident measurements of the retinal nerve fiber layer thickness for early Arianna Schoess Vargas
detection and observation of progression of glaucoma. Christoph Schoess
• NoiseReduction is a proprietary technology that reduces noise inherent in
OCT and scanning laser imaging. By capturing multiple images in the exact Mannheim HRB 334163
 same location this technology is able to differentiate structural information
from noise and then effectively reduce noise. Several images taken at the
exact same spot are being averaged to one single image in real-time and
optic noise is suppressed. The so-called Automatic Real-Time technology
(ART) can average up to 100 scans, even within a volume scan.
• The HEYEX and HEYEX 2 software platforms allow to integrate all
Heidelberg Engineering devices within a clinic or practice network. Patient
data can be viewed at viewing stations, enabling more efficient workflow.

Furthermore, the device can be upgraded with several modules:

• SPECTRALIS dye-based Scanning Laser Angiography with fluorescein

(FA) and indocyanine green (ICGA) enables visualization of the capillary
network. Both modalities deliver detailed, high-resolution images and
videos, that show flow within vessels and support in detecting leakage for
example. FA and ICGA images can be captured simultaneously and can
even be used simultaneously with OCT imaging. This provides clinicians
with three images and thus increases diagnostic precision and efficiency in
the practice workflow.
• With a lateral resolution of 5.7 µm per pixel, the OCT Angiography Module
(OCTA) offers a non-invasive imaging method for three-dimensional
visualization of blood flow in the capillary network of the retina. The axial
resolution of 3.9 µm allows distinct segmentation of each individual plexus.
Image size, scan speed and resolution can flexibly be chosen based on the
individual needs. The Scan Planning Tool allows to define the location for
an OCT or OCTA scan to be acquired, based on existing OCTA or cSLO
fundus images. The follow-up scan is automatically acquired at the same
location as the initial examination.
• Red-free imaging: Blue light is used for the acquisition of red-free imaging
which highlights specific structures such as the nerve fiber layer, epiretinal
membranes, puckering of the retina or cysts.
• The BluePeak Module provides non-invasive blue fundus autofluorescence
and portrays the distribution of lipofuscin, a metabolic indicator. BluePeak
images can capture pathologic changes within the photoreceptors and the
retinal pigment epithelium and thus deliver insights into various retinal
diseases such as age-related macular degeneration (AMD) or genetic
diseases. In combination with the RegionFinder software, diseased areas
seen in BluePeak images can be quantified and followed over time.
• The MultiColor Module simultaneously uses three laser wavelengths to
provide diagnostic images that show distinct structural information at
different depths within the retina. The high-resolution, detailed MultiColor
images can highlight structures and pathologies not visible in
ophthalmoscopy and fundus photography.
• The Glaucoma Module Premium Edition delivers a comprehensive and
personalized analysis of the optic nerve head (ONH), retinal nerve fiber
layer (RNFL), and macular ganglion cell layer (GCL). The proprietary
Anatomic Positioning System (APS) precisely matches unique scan
patterns to the fine anatomic structures relevant in glaucoma diagnostics.
o The minimum distance between Bruch’s membrane opening and the
internal limiting membrane around the optic nerve head – referred to
as Bruch’s Membrane Opening – Minimum Rim Width (BMO-MRW)
– provides you with the true anatomic ONH boundary and the most
geometrically accurate measurement of the neuroretinal rim.
 o In the posterior pole asymmetry analysis (derived from the same
OCT volume scan as the deviation maps), the total thickness of the
retina is calculated and displayed in a color-coded map.
o High-quality, high-resolution B-scans are provided for reference.
o The thickness deviation maps of the total retina, RNFL, GCL and
inner plexiform layer reveal regions and patterns within these retinal
layers that have significantly thinner or thicker measurement values
when compared to eyes included in the reference data base and
highlight areas that are not within normal limits.
• The Widefield Imaging Module provides the standard field of view (55°) of a
mydriatic fundus camera for all SPECTRALIS fundus and OCT imaging
modalities, simplifying diagnostic protocols, and facilitating the detection of
peripheral pathology. Furthermore, the camera head can be panned and
tilted to capture the far periphery of the retina.
• The Ultra-Widefield Imaging Module (UWF) captures an extremely wide
field of view (102°) in one shot. It offers evenly illuminated, high-contrast
images even in the periphery. The module is compatible with SPECTRALIS
scanning laser angiography, including FA and ICGA, that can be acquired
both individually and simultaneously, as well as Infrared imaging. Using the
combination of the UWF and the 30° lens during acquisition of angiography
images provides both the wide field of view and the high-resolution detail
where required.
• The Anterior Segment Module enables high-resolution OCT imaging of
cornea, sclera, and anterior chamber angles. It even provides a 16 mm
widefield view from angle to angle, visualizing the entire anterior chamber.
• The High Magnification Module allows non-invasive cSLO imaging with high
resolution to resolve ocular microstructures on a microscopic level to
highlight critical diagnostic details that are often not visible in standard
fundoscopy or fundus photography.
• The Nsite Analytics Module measures both neuronal and axonal projection
within the retina from the central nervous system. It provides a
comprehensive analysis of the peripapillary retinal nerve fiber layer as well
as macular retinal thickness and posterior pole asymmetry analysis.

All modalities can be used in one single device by changing the lens and
software modules.

Please find further technical specifications below.

Kind regards,

Arianna Schoess Vargas

Managing Director
Heidelberg Engineering GmbH

1 Wolf-Schnurrbusch UE et al. Macular Thickness Measurements in Healthy Eyes Using Six

Different Optical Coherence Tomography Instruments. Invest Ophthalmol & Vis Sci 2009;
50:3432-3437.
o

200591-001 GL.AE20 © Heidelberg Engineering GmbH