36C24818Q9435-001.docx

Salient Characteristics of the OCT machine:

· Ability to integrate the Cirrus Model HD OCT 4000 Or Model Cirrus 5000 HD OCT data into and with the current Cirrus HD-OCT 5000 data.

· Raw Data must be interchangeable between the Cirrus 4000 and Cirrus 5000. This can only be done using a Zeiss Cirrus 5000.

· Units must have exact Macular Scan Pattern of 512x128 for Retina Scan

· Must be able to scan at both scanning speeds: Scan at exactly 27,000 A-Scans/second, as well as the ability to scan at 68,000 A-Scans/second.

· Must have the ability to scan the Retinal Nerve Fiber, and Optic Nerve Head Analysis information using a 200-line x 200-line scan. Each line has 1024 data points. Meaning the 200 slices vertically acquired and the 200 slices horizontally acquired provide a cumulative value of over 40 million data points for RNFL and ONH Analysis.

· Must have the ability to scan Retina Nerve Fiber Layer and the Optic Nerve Disc, and Neuro Retina Rim Thickness at the same time in one Scan that takes 1.5 seconds.

· Must deliver an image that is over sampled 100 times.

· Must provide a 12 radial line scan for the Macula/Retina region.

· Must provide an automated Glaucoma Scan report on the same page with the HFA 750lii Visual Field Instrument Called a “Combined Report” via Forum.

· Must have ability to scan and acquire the Ganglion Cell Analysis (comprised of a 6mmx6mm cube scan with a minimum of 200x200 line scan pattern) that does NOT include the Inner Limiting Membrane or Retinal Nerve Fiber.

· Minimum Pupil requirements must be 2.0mm or less.

· Must have a line scanning laser ophthalmoscope fundus camera.

· Must provide global pachymetry report comprised of 24 radical scans and must be a minimum of 9mm in length.

· Must have the ability to provide a report called “Advanced RPE Analysis”. This report maps out the area of Geographic Atrophy as well as automatically provides a mathematical assessment that measures closest distance of the geographic Atrophy to the fovea. Report must show volume of drusen area and provide automatic mathematical evaluation and that provides serial analysis with percentage of change auto listed in a 3mm circle and 5mm circle.

· Must have the ability to produce a report that is called “Guided Progression Analysis” (GPA). This is different than a Trend Analysis report. The GPA report provides a comprehensive view analysis of both the short term and long-term RNFL and Optic Nerve Head Analysis including Neuro Retina Rim Tissue. GPA Furthermore provides a plotted graph that forecasts what the patient measurements of each of these areas will be in the future. This is done on a linear graph and displayed on the print out.

· Must have the ability to default to a print out of the Glaucoma Scan to display where the “Circle” was placed around the Optic Disc. The circle provides the quantitative analysis of the patient compared to the FDA cleared Normative Database.

· Must have “Auto-Center” trade Marked software for the Glaucoma scan.

· Must have the ability to provide a “PanoMap” wide analysis: The 1 page printout must include all of the following info related to the Posterior Pole: Optic Nerve Head Analysis, Ganglion Cell Analysis, and Macular Thickness Analysis.

· Must have the ability to use Magnetic Anterior Segment Lens that provides a 15.5 mm by 5.8mm view of the entire anterior chamber.

· Must have the ability to select pre-determined “En Face” views of the retina. The list of the predetermined views would include:

· En Face VRI View

· En Face Mid Retina View

· En Face IS/OS Ellipsoid View

· En Face Mid Retina View

· En Face Choroid View

· Must allow tech to sit at side of machine at a 90-degree angle.

· Must allow ability to measure corneal thickness.

· Must Capture OCT with a single scan.

· Must include a printer that supports printing available reports.

· TECHNICAL SPECIFICATIONS:

· 2048 Pixel OCT Camera

· Windows 7 Operating System

· Deviation Map demonstrating outside normative of Ganglion Cell Layer and Retinal Nerve Fiber Layer

· Fast Track Retinal Tracking

· Automatic Fovea Finder

· Instrument Dimensions: 26L x 18W x 21H (in)

· Table Dimensions: 39L x 22W (in)

· Internal Fixation Focus Adjustment: 20D to +20D (diopters)

· Electrical Rating (115V) – Single Phase, 100-120V systems: 50/60Hz, 2.5A

· Memory – Hard Drive/Internal storage: > 750GB, > 80,000 scans.

· Display – Integrated 19” color flat panel display at minimum.

· USB Ports = 6 ports