6525--TopCon Maestro 2 OCT Brand name or Equal

Statement of Need (SON)

BRAND NAME OR EQUAL

TeleEye Equipment Retinal Camera with OCT to MAESTRO2

Background: VISN 4 TeleEye is expanding to include new Mydriatic/Nonmydriatic retinal imaging cameras with OCT scan capability.

The Department of Veterans Affairs and VISN 4 have an immediate need for Topcon Medical Maestros2 units. Maestro2 is the basis of design, item number 102449804KUS brand name or equal. The objective is to expand the Tele Eye care services to include higher level screening for diabetic retinopathy, glaucoma, and macular degeneration, allowing providers to be more definitive in their initial assessment, improving accuracy and appropriateness of referrals for patients with identified pathology, reduce the number of referrals to eye clinics to obtain this baseline OCT scan, thereby preserving face to face access in the clinics and reducing related community care costs. This instrument allows for combined imaging of the retina and anterior segment and an OCT scan of the macula and optic nerve in one compact device.

Purpose of Project:

TeleEye to include higher level screening for diabetic retinopathy, glaucoma, and macular degeneration within VISN4.

Statement of Work:

Description of Work: The Vendor will deliver and install 3D OCT-1 Optical Coherence Tomography equipment to VISN 4 Veterans Affairs Medical Centers as outlined in the quote/contract. After set-up, the contractor must demonstrate that the System works as designed. Once this is completed and accepted by the COR, or designee, the contractor will provide training for clinical staff upon delivery and installation for the following facility:

Units

Location

Address

Attention

5

Erie VAMC

135 East 38th Street, Erie, PA 16504

CCM Holly Mukina and Dr. Tyler Mautino

1

Wilmington VAMC

1601 Kirkwood Hwy

Wilmington, DE 19805

Thomas Urso

1

Cape May CBOC

In the care of Wilmington

3801 Route 9 South, Suite 2, Rio Grande, NJ 08242-1915

TBD

1

Vineland CBOC

In the care of Wilmington

79 West Landis Avenue, Vineland, NJ 08360-8122

TBD

2

Lebanon VAMC

1700 South Lincoln Avenue

Lebanon, PA 17042-7529

TBD

Schedule of Deliverables:

Description of Tasks and Associated Deliverables and Salient Characteristics meets or exceeds:

Combination color fundus and oct images.

12x9mm 3D wide OCT with true color retinal photography

Pinpoint Registration to match OCT scans to the fundus reference image.

Ability to view images directly from the camera to see all OCT fields.

Widefield OCT

Panoramic fundus imaging

Picture angle 45 degrees +/- 5%

Scan range of 3-12 mm +/-5%

Scan speed of at least 50,000 scans per second - This high speed enables the acquisition of data sets within a few seconds

Fundus Resolution of at least 60 lines/mm or more for the center, 40 lines/mm or more for the middle( r/2), 25 lines/mm or more for the middle (r), and 5 lines/mm or more for center IR photography.

Anterior segment scanning

Color and IR photography for the anterior segment and fundus

Photographable diameter of pupil for fundus: 4.0 or more; small pupil diameter of 3.3mm or more; fundus tomogram diameter of pupil: 2.5mm or more

Fixation target: internal, peripheral, and external

DICOM compliant and able to integrate and archive data to the existing VISTA/CPRS Hospital Information System/Electronic Medical Record.

Fully automated OCT system that can capture high-resolution non mydriatic, true color fundus photography, and OCT with the single press of a button.

360 rotating intuitive touchscreens, 5 x7 - 7 x9 .

No Cost training by clinical application Specialist

Associated Deliverables- Brand name or equal

Item#

Item Name

Qty

102449804KUS

Maestro 2 3D OCT-1- w/Camera

10

25042-11-001

AIT-250 Two Position Instrument Table 24X36 Tabletop, Low Height 38", 450 Pound Capacity

10

-

Installation, Calibration, and On-Site Training

10

-

Shipping & Handling Included in Total Cost

10

Reports: Hood Report 1 for the structure/function analysis of glaucoma. This report will display the retinal nerve fiber layer (RNFL) thickness in nasal-superior-temporal-inferior-nasal (NSTIN) orientation so that the most vulnerable to nerve damage, the temporal region, is in the center, thus keeping RNFL bundles together.

Delivery and Packing, Inspection/Acceptance requirements, Warranty: The Systems are to be delivered to VISN 4 facilities listed in the Delivery Schedule. The contractor will be notified of the date the equipment will arrive at our facility and will schedule a date with the COR, or designee, for on-site set-up and installation of the System. After arrival, the System will be received by our Logistics/Warehouse staff, received in the services Equipment Inventory (EIL), barcoded, and safety inspected by Biomedical Engineering.

End of Statement of Work