Certificate of Exclusivity – HRA

Unique selling points of the SPECTRALIS® HRA 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
angiography device. Fax +49/62 21/64 63 62
www.HeidelbergEngineering.com
The SPECTRALIS HRA comprises the following features and technologies:
• The SPECTRALIS is an upgradeable imaging platform which uses a
confocal Scanning Laser Ophthalmoscope (cSLO). 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.
• Image capture is possible with a minimum pupil size of 1.5 to 2 mm.
• 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 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.
• 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.
• NoiseReduction is a proprietary technology that reduces noise inherent in
scanning laser imaging. By capturing multiple images in the exact 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.
• 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.
• 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 Managing Directors
membranes, puckering of the retina or cysts. Arianna Schoess Vargas
• The BluePeak Module provides non-invasive blue fundus autofluorescence Christoph Schoess
and portrays the distribution of lipofuscin, a metabolic indicator. BluePeak
images can capture pathologic changes within the photoreceptors and the Mannheim HRB 334163
 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 Widefield Imaging Module provides the standard field of view (55°) of a
mydriatic fundus camera for all SPECTRALIS fundus 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.

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
200589-001 GL.AE20 © Heidelberg Engineering GmbH