36C26119Q0793-004.pdf

Brand Name or Equal Worksheet (“Salient Characteristics”) v 2.0

Brand Name Item: California P200DTXICG with color, AF, FA, ICGA OPTOS

1) Essential/significant physical, functional, or performance characteristics.

• Single image must be able to capture 82% of the retina

• Single capture must be able to cover 200 degrees of the internal surface of the retina

• Single capture image must be able to reach beyond the equator showing vortex vessels and ampullae

• Ultra-widefield (200 degree) image must be able to be captured in less than ½ second

• Montage image must be able to show up to 97% of the retina (1166 mm^2)

• Ellipsoidal mirror with virtual point technology must enable maximum imaging field of view

• Must have clinically validated color imaging – must be proven to be equivalent to color fundus photography for pathology detection

• Must provide multiple wavelength color imaging: color, red-free, choroidal, and true-color views with a single capture

• Must present the images in a consistent geometry that accurately represents anatomical features across the retina and that allows for accurate measurements across the retina

• Must have color imaging with red/green lasers to minimize exposure to blue light

• Must have auto capture capabilities

• Must be non-mydriatic, cSLO technology images through 2 mm pupil

• Must include the following light source wavelengths: red 635 nm, green 532 nm, blue 488 nm, IR 802 nm

• Must include DICOM and be DICOM compliant

• Must be on the VistA imaging approved DICOM list

• Must be able to perform fundus autofluorescence (AF) with green laser to minimize exposure to blue light

• Must be able to perform fluorescein angiography (FA)

• Must be able to perform indocyanine green angiography (ICGA)

• Must include the following functions in one system: color photo, red-free photo, choroidal imaging, AF imaging, FA, and ICGA

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

• Must include image overlay software for accurate comparison of images from different days and in different modes

• Must be HIPAA compliant

Brand Name or Equal Worksheet (“Salient Characteristics”) v 2.0

• Must include image measurement tools

• Must be capable of combined FA and ICGA capture

• Must be able to connect to 3rd party image management software

• Must include an automatic, wheelchair accessible table

• Must be powered via connection to a standard AC outlet (100 to 240V)

• Maximum weight 75 lbs

• At least two-year warranty

• Must include installation and training

2) Complete generic identification – Fundus Camera

3) Applicable model/make/catalog number – California P200DTXICG with color, AF, FA, ICGA OPTOS, see quote #Q804246

4) Manufacturer name –

OPTOS

Per VAAR 811.104 and 811.105, I certify the following regarding the above information:

• The salient characteristics listed above are essential to the Government’s requirements.

• To my knowledge, the restrictions listed above will not limit the acquisition to an item peculiar to one manufacture.