36A77620Q0140-001.docx

Department of Veterans Affairs, Program Contracting Activity Central is procuring a Spectralis OCT System on behalf of VISN 22 – Chula Vista Outpatient Clinic Activation.

The Optometry/Ophthalmology Department at the San Diego VAMC has a Server infrastructure called HEYEX (purchased and installed at Main Hospital). OCT images require comparative analysis across time and across clinics (LJ,OS,MV,CV). The HEYEX server is specific to Heidelberg instruments and allows the view of all the raw data obtained from any OCT imaging study performed. The HEYEX will also provide comparative analysis across all images performed.

This requirement is for the purchase of the Heidelberg Engineering Spectralis Tracking OCT System consisting of the following items:

The Spectralis is an ophthalmic imaging platform with an upgradable, modular design allowing clinicians to configure the system to the specific diagnostic workflow in the clinic. OCT images require comparative analysis across time and across clinics (VA San Diego Medical Center, Oceanside Community Based Outpatient Clinic (CBOC), Mission Valley CBOC, and the Chula Vista CBOC. The Optometry/Ophthalmology Department at the San Diego VA Medical Center has already purchased and installed HEYEX server infrastructure. The HEYEX server is specific to Heidelberg Engineering instruments and allows clinicians to view all the raw data obtained from any OCT imaging study performed. The HEYEX also provides comparative analysis across all images performed.

Imaging Modes Single Imaging Modes Infrared reflectance imaging (IR) Blue reflectance imaging (BR) Fluorescein angiography (FA) Indocyanine green angiography (ICGA) BluePeak blue laser autofluorescence imaging (BAF) MultiColor (Option) Simultaneous Imaging Modes Simultaneous FA and ICGA Simultaneous FA and IR Simultaneous ICGA and IR Simultaneous BAF and IR Simultaneous OCT and IR Simultaneous OCT and BR Simultaneous OCT and FA Simultaneous OCT and ICGA Simultaneous OCT and BAF Simultaneous OCT and MultiColor (Option) Light Sources IR Laser, wavelength 815 nm, Class 1 laser product SD-OCT Super luminescence diode (SLD), average wavelength 870 nm, Class 1 laser product FA, FAF, BR Laser, wavelength 488 nm, Class 1 laser product ICGA Laser, wavelength 786 nm, Class 1 laser product GR Laser, wavelength 518 nm, Class 1 laser product Laser product classification according to IEC 60825-1:2007. The product complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No.50, dated June 24, 2007.

OCT Imaging Specifications General Specifications Optical Resolution [μm] 7 axially x 14 laterally Axial digital image size [pixels] 496 Maximum A-scan rate [kHz] 40 Scan depth in tissue [mm] 1.9 Section scan size [°] 30 / 20 / 15 (approx. 4.5 - 9 mm) Circle scan diameter [°] 12 High Speed (HS) mode Digital resolution [μm] 3.9 axially x 11 laterally Section scan [pixels] 768 x 496 / 512 x 496 / 384 x 496 Circle scan [pixels] 768 x 496 High Resolution (HR) mode Digital resolution [μm] 3.9 axially x 6 laterally Section scan [pixels] 1,536 x 496 / 1,024 x 496 / 768 x 496 Circle scan [pixels] 1,536 x 496

Scanning Laser Imaging Specifications Maximum scan depth 8 mm Transversal field of view Scan angle [°] 30 x 30 / 20 x 20 / 15 x 15 Scan angle wide field lens [°] 55 Wide field composite image up to 165° High Speed (HS) mode Digital image size [pixels] 768 x 768 / 512 x 512 / 384 x 384 Scan time per image [ms] 96 / 64 / 48 Lateral resolution (digital) 11 μm/pixel Image rate [Hz] 9 / 12.5 / 16 High Resolution (HR) mode Digital image size [pixels] 1,536 x 1,536 / 1,024 x 1,024 / 768 x Scan time per image [ms] 192 / 128 / 96 Lateral resolution (digital) 6 μm/pixel Image rate [Hz] 5 / 7 / 9

OCT Scan Patterns Volume Horizontal size [°] 30 / 20 / 15 Vertical size [°] 25 / 20 / 15 / 10 / 5 Vertical density [sections/°] 1.2 / 2.4 / 4.8 / 9.6 / 26 Sections per volume 7 – 599 Technical Specifications 19 Star Diameter [°] 30 / 20 / 15 Number of sections 48 / 24 / 12 / 6 / 4 / 2

Electrical Data Input Voltage 100 – 240 V Frequency 50/60 Hz Power consumption 140 VA Fuses For 240 V:

2 x 1.6 AT, 250 V, time delay, UL-CCN: JDYX2, UR, e.g. Littelfuse Typ 218 For 120 V:

2 x 3.15 AT, 250 V, time delay, UL-CCN: JDYX2, UR, e.g. Littelfuse Typ 218 Power Connection 1. Type SVT, 3 x 18AWG, Hospital Grade-marked plug, UL-CCN: ZJCZ or RTRT or AXUT, UR for US

2. Type H05VV-F 3G 0.75 mm2, IEC-320 standard power inlet connector, VDE Power outlets 1 IEEE 1394a (Fire Wire / i.Link) port: 12 V, 1.25 A Ingress protection rating IPX0 19 Technical Specifications Protection against electric shock Class 1 Mains Isolation Switch Rocker switch at power supply front side

Operating Environmental Conditions Temperature 10 – 35°C / 50 - 95°F Relative Humidity 10 – 90% non condensing Air Pressure 700 – 1,060 hPa Mode of Operation Suited for continuous operation

Non Operating Environmental Conditions Temperature -30 – 60°C / -22 – 140°F Relative Humidity 10 – 95% Air Pressure 500 – 1,060 hPa

PC Requirements General Requirements Operating System Windows XP (32bit) professional (SP2 or higher) or Windows 7 (32bit) RAM min. 2 GB 2 PC3-10600 modules or faster Permanent storage Internal hard disc, 40 GB capacity DVD/ CD drive User interface devices Keyboard, mouse

Acquisition PC Motherboard Processor Minimum: Intel Core2Quad Q6700 Recommended: Intel Xeon W3550 Chip set Minimum: Intel 975X Recommended: Intel x58; 2 x PCIExpress X16 slots (PEG) Further Requirements Graphic card NVIDIA® GeForce Chipset or AMD® Chipset, min. 768 MB Memory FireWire cards 1 PCI or PCI Express Card IEEE-1394a 1 PCI Express Card IEEE-1394b (Fire- Wire 800) Patient data storage External hard disc drive; eSata, min. 1 TB recommended Technical Specifications 19 Archive data storage Second external hard disk drive; USB, same size as patient data storage Monitor High quality TFT or CRT, minimum resolution 1600 x 1200 pixels

Viewing PC Processor Minimum: Intel Pentium 4, 2.4 GHz Recommended: Intel Xeon W3550 Monitor High quality TFT or CRT Minimum resolution:

1024 x 768 pixels, normal font size or 1280 x 960 pixels, large font size

Data Storage File Size High Speed (HS) mode 0.6 – 1.4 MB High Resolution (HR) mode 1.4 – 3.9 MB Volume Scan 3.3 – 182 MB Environment Guidance