OCT device salient charasteristics.docx

Salient Characteristics List

Essential characteristics unique to the system:

· Combined UWF (200°) fundus imaging and image-guided, Swept Source OCT

· Single image captures 82% of the retina (927 mm2)

· Single capture covers 200° of the internal surface of the retina

· Single capture image reaches beyond the equator showing vortex vessels and ampullae

· Ultra-widefield (200°) image capture in less than ½ second

· Montage image shows up to 97% of the retina (1166 mm2)

· Ellipsoidal mirror with virtual point technology enables maximum imaging field of view

· Clinically validated color imaging – proven equivalent to color fundus photography for pathology detection(1)

· Multiple wavelength color imaging provides: color, red-free, choroidal, and true-color views with a single capture

· Ease of use validated in multi-site clinical studies(2)

· Proven to enhance clinic flow(3)

· Proprietary software presents images in a consistent geometry that accurately represents anatomical features across the retina and allows for accurate measurements across the retina

Essential characteristics which might be found in other systems:

· Auto-capture capability

· Non-mydriatic, cSLO technology images through 2 mm pupil

· cSLO technology images through most cataracts

· Light source wavelengths: red 635 nm, green 532 nm, blue 488 nm, IR 802 nm

· DICOM compliant as per the DICOM Conformance Statement

· System is listed on the VA’s “VistA Imaging Approved DICOM Modality Interfaces” list found at: https://www.va.gov/HEALTH/imaging/docs/VistA_Imaging_DICOM_Modality_Interfaces.pdf

· Able to perform fundus autofluorescence (AF) with green laser

· Able to perform fluorescein angiography (FA)

· Able to perform indocyanine green angiography (ICGA)

· All functions (color photo, red-free photo, choroidal imaging, AF imaging, FA, and ICGA) are included in a single compact system

· Includes alignment software to ensure that pictures are taken in the same place each time and that images in the same place taken with different modalities and/or on different dates can be accurately overlaid for clinical comparison

· Includes image overlay software for accurate comparison of images from different days and in different modes

· Includes HIPAA compliant, browser-based image review software

· Includes image measurement tools

· Capable of stereo disc imaging

· Capable of combined FA and ICGA capture

· Connects with OptosAdvance™ image management software and allows access to raw data via OptosAdvance software

· Connects to 3rd party image management systems and allows review of images via the 3rd party software

· System includes an automatic, wheelchair accessible table

· Powered via connection to standard AC outlet (100 to 240 V)

· System requires minimum maintenance

· System is field serviceable and can be routinely maintained by VAHCS engineering personnel

(1) Nonmydriatic Ultrawide Field Retinal Imaging Compared with Dilated Standard 7-Field 35- mm Photography and Retinal Specialist Examination for Evaluation of Diabetic Retinopathy; Silva, et al; AJO, 2012.

(2) Potential Efficiency Benefits of Nonmydriatic Ultrawide Field Retinal Imaging in an Ocular Telehealth Diabetic Retinopathy Program; Silva, et al; Diabetes Care, Volume 37, January 2014.

(3) The Impact of Ultra-widefield Retinal Imaging on Practice Efficiency; Paul E Tornambe MD; US Ophthalmic Review, March 2017.

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