Chapter 2 - Introduction
2 Introduction
Welcome to your P200TxE User Guide.
2.1 Device description
The P200TxE is a re-usable desktop, non-contact, high resolution ophthalmic imaging device that supports
ultra-widefield confocal SLO and deep OCT imaging of the retina and its structures. SLO modalities include
fundus imaging using color, auto-fluorescence, Fluorescein Angiography (FA) and Indocyanine Green
Angiography (ICG) techniques. OCT imaging capabilities enable deep, high-resolution OCT imaging of
vitreous, retina, choroid and sclera. The system outputs calibrated and position-correlated SLO fundus
images, OCT line scans and OCT volume scans, which are encoded as DICOM for display on compatible
devices, where Optos
Advance
is provided as the viewing client. The device is offered in a number of
configurations depending on the needs of the end user.
Optos’ technology is designed to operate through a minimum pupil diameter of 2 mm. Although pupil
dilation is
NOT
required, the decision to dilate is a medical decision to be made by the eyecare professional.
Note
Depending on the features available on your device, you may have a subset of the features described in
this user guide.
2.2 Clinical benefits statement
The device offers the following benefits:
l
Capturing 82% or 200⁰ anatomically correct images helps clinicians evaluate eye disease earlier
when treatment is potentially the most effective.
1.
l
Capturing images in less than half a second improves clinic workflow and efficiency.
2.
l
Motorized head and chin rest to more easily assist those patients requiring additional assistance
during imaging.
l
UWF with integrated swept-source OCT, facilitates detailed examination of the retina-vitreous to
sclera
l
UWF guided, swept-source OCT, images pathology anywhere on the optomap
l
1050 nm OCT light source, provides deeper tissue penetration for clear, detailed choroidal imaging
l
3-in-1 Color Depth Imaging™ provides important clinical data from the retinal surface through the
choroid
2.3 Intended use
The P200TxE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer
intended for in-vivo digital imaging of posterior ocular structures, including the vitro-retinal interface, retina,
retinal layers, optic disc, choroid and choroido-scleral interface. It is indicated for producing high-resolution,
1.
Sagong, M., et al., Assessment of accuracy and precision of quantification of ultra-widefield images. Ophthalmology, 2015. 122(4): p. 864-866, and Silva, P.S., et
al., Peripheral Lesions Identified on Ultra-wide Field Imaging Predict Increased Risk of Diabetic Retinopathy Progression over 4 Years. Ophthalmology, 2015. 122
(5): p. 949-956.
2.
Tornambe, P.E., The Impact of Ultra-widefield Retinal Imaging on Practice Efficiency. US Ophthalmic Review, 2017. 10(01): p. 27-30.
Part Number: G110230-003-ENG
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