Brand_Name_Only_Justification.pdf

Brand Name Only Justification: Heidelberg Engineering

The Spectralis Tracking OCT System - HRA+OCT w/OCT2 – MultiColor and Widefield Imaging Module is the only system that properly performs multicolor scanning line ophthalmoscopy with high resolution indocyanine green, fluorescein, visible autofluorescence, near-infrared autofluorescence, OCT2 with eye tracking, and longitudinal visit-to-visit progression tracking OCT, including the following specs listed below. The Spectralis is a unique diagnostic imaging device and is the only spectral domain optical coherence tomography instrument to incorporate all of the features below.

The system must have ALL the following specifications:

1. Line scanning laser ophthalmoscope.

2. Multiple imaging modes including infrared, red-free, blue autofluorescence, fluorescein angiography, indocyanine green angiography, spectral domain optical coherence tomography, infrared autofluorescence.

3. Simultaneous imaging options including ICGA+IR, RF+IR, FA+IR, FA+ICGA, IR+OCT, RF+OCT, visible autofluorescence + OCT, FA + OCT, ICGA + OCT.

4. 486 nm light source for fluorescein angiography.

5. 500 nm barrier filter for fluorescein angiography.

6. 786 nm light source for indocyanine green angiography.

7. 830 nm barrier filter for indocyanine green angiography.

8. 815 nm light source for infrared reflectance SLO imaging.

9. 518 nm light source for multicolor SLO imaging.

10. 870 nm light source for spectral domain optical coherence tomography.

11. Multicolor imaging capabilities using 815 nm, 518 nm, and 486 nm light sources.

12. 55 degree widefield lens for widefield infrared SLO imaging and for widefield OCT imaging.

13. 85 kHz scanning rate for spectral domain optical coherence tomography.

14. Optical coherence tomography angiography upgradability.

15. High speed mode with scan width 768 a-scans, 19 ms acquisition time per b-scan, 11 micron/pixel lateral resolution, 48 bscans per second, or better.

16. High resolution mode with scan width 1536 a scans, acquisition time 38 ms per b scan, lateral resolution 6 microns per pixel, scan rate 25 bscans per second, or better.

17. Real-time eye tracking to accurately and actively follow the patient’s eye during the scan to minimize motion artifact and allow for targeted OCT scan placement.

18. Tracking for progressive visits to scan the same exact location on the retina from one visit to the other such that a baseline image can be selected and a follow up scan automatically placed in the same location.