91-Salient Characteristics.pdf

Specifications and Characteristics of the Cirrus Photo 600 The Fundus Photography Unit and Tomography Unit (1 each) shall provide and contain the following salient characteristics:

Unit must be a Combined 1 Unit with capability to do OCT scan, Fundus Photography, , Fundus Autofluorescence. SALIENT Specs below.

1.) The Unit must have the ability to import and integrate with the Cirrus Model HD OCT 4000 or 400 Models raw data through FORUM. The raw data must be interchangeable between the Cirrus 4000, 400 and Cirrus 5000 or 500 unit and CIRRUS Photo 600 and 800 Models Benefit-- The clinic can implement the patients’ data from the Cirrus Photo 600/800 Cirrus 4000/400 and incorporate it into the Cirrus 5000/500, which allows for continuity, continual, and precise progression data management. The RAW data needs be interchangeable/ compatible. If not, all data from the from other devices becomes only a static report of PDF that cannot be built on, meaning that the Doctor starts over with regards to historical data and new “Baselines”.

2). The unit must be able to offer exact Macular Scan Patterns of 512x128, and a 200x200 scans for retina scan with exact scanning speed at 27,000 A-scans a second.

Benefit- the clinic can include/ continue with the patients historical data from a Cirrus 4000/400 or Cirrus 5000/500 in the Macula Repot on the Cirrus Photo 600. In addition the Patients’ report/ raw from other Military Locations and or VA Medical Centers will have exact corresponding data from one clinic to the another clinic.

3). The unit must have exact scan pattern of 200x200 (Slices) for Glaucoma Scan with exact scanning speed at 27,000 A-scans a second.

Benefit- The clinic can include/ continue with the patients historical data from a Cirrus 4000/400 or Cirrus 5000/500 in the Glaucoma Report on the Cirrus Photo 600/800. In addition the Patients’ report/ raw data from other Military Locations and or VA Medical Centers will have exact corresponding data from one clinic to the another clinic.

4) The Unit must be able to the scan at Scanning speeds: Scan at exactly 27,000 A-scans/sec.

Benefit—Scanning at 27,000 A-scans/sec, the raw data scans from the Cirrus Photo/600/800 becomes interchangeable and can be implemented into the Model Cirrus 5000 raw data. Also, by scanning at the 27,000 A-scans/sec, the practice and the Clinician can utilize the new upgrades/analytics/analyses of the Cirrus Photo Mode lin FORUM. If not, all data from the Cirrus Photo becomes only a static report of PDF and cannot be built on; meaning that the Doctor starts over with new “Baselines” for evaluation.

5.) The units Motorized Focus Range (Focus Adjustment) must be able to handle patients from minus 35 diopeters to plus 35 diopters.

Benefit-The unit then can accommodate wide range of visual imparities for a complete scan.

6.) Minimum Pupil Requirements must be 3.3 mm in Small Pupil mode must be able to perform OCT on greater than or equal to 2mm.

Benefit: Covers ~73% of patients without dilation** JE Richman et al., Optometry, Vol.75, No.3, March 2004

7) Fundus Autofluoresence:

Benefit: Autofluorescence imaging has the potential to provide useful information in conditions where the health of the RPE plays a key role. FAF is effective because it can document metabolic change from the accumulation of toxic fluorophores in the retinal pigment epithelium. Hyper-autofluorescence is a sign of increased lipofuscin accumulation, which may indicate degenerative changes or oxidative injury. Areas of hypo-autofluorescence indicate missing or dead RPE cells.

8.) Telecentric Optics Benefit: neutralizes the effect of patient's emmetropia, eliminating the potential for image distortion and delivering repeatable and precise measurements of retinal physiology, True pathological size regardless of focus maximized precision, speed and outcome

9.) The unit must be able to take an OCT Scan AND a Fundus Photo with 1 click of the joystick capture button and have the ability to register and overlay the Fundus Photo and the OCT Data Cube.

Benefit: The data sets from the OCT and the Photo can be registered so that physicians can align treatment based off of the quantitative OCT data and the qualitative Fundus Photo

10) The unit must be a single optical device, so that the tech (operator) does not have to align/change the head of the system in order to take an OCT or a Photo.

Benefit: The tech (operator) can in one press of the capture button acquire both OCT & Fundus Photo. This ensures that the tech can capture the proper data and scan, with speed and accuracy.

11.) The unit must be able to store its RAW data within the FORUM Data Management Archive for use in FORUM Retina & Glaucoma Workplace.

Benefit: No patient identifiable data is stored on the device which is against regulations.

All patient data is stored off the device and at the FORUM server.

12.) The unit must have the ability to provide an automated Glaucoma Scan report that is on the same 1 page report with the HFA which is called “Combined Report”. Via

FORUM.

Benefit- The ability for the Clinician to evaluate Structural information provided by the Zeiss HD-OCT and the Functional information provided by the HFA 750i and or the HFA3 860.

This provides an efficient view of these corresponding reports on the same page.

13) The unit must have the ability to scan Retinal Nerve Fiber Layer, Optic Disc, and Neuro-Retinal Rim Thickness all in one scan at the same time in one scan, under 2 seconds.

Benefit- Acquiring the Retinal Nerve Fiber Layer and the Optic Disc measurement at the same time ensures all corresponding data points are correctly aligned, compared and analyzed.

Having this data acquired in one scan ensures that there is not an issue with the positioning of the eye from one scan to another.

14.) The unit must have the ability to scan and acquire the Ganglion layer that does NOT include the Inner Limiting Membrane or the Retinal Nerve Fiber Layer.

Benefit- If the Inner Limiting Membrane or Retinal Nerve Fiber Layer has pathology the data could be compromised. A scan that does not include these regions provides a focal assessment of the Ganglion Cells.

15.) The unit must have the ability to produce a Report that is called GPA (Guided Progression Analysis). This report must display the forecasted measurements in future years: Trend Analysis would not suffice.

Benefit- A comprehensive report is the best care for our patients. By having the GPA report from Cirrus HD OCT 600 the doctor can determine the rate of progression in the disease state that they are investigating.

16.) Advanced Positioning /Focusing Aid Benefit- Internal Focusing Aid can be moved freehand within the CIRRUS Photo Software so that the patient can be fixated. Fixation comes in multiple sizes for patients with decreased vision SMALL, MEDIUM, LARGE, CIRCULAR. CIRCULAR enables patients with drastic central vision loss to estimate the point of focus with high reliability.

17.) Auto FOCUS Benefit- Internal Auto Focusing system allows for ease of image acquisition and for technicians of all skill sets to capture images with high accuracy.

18.) Auto FLASH Benefit- Internal Flash Metering system allows for ease of image acquisition and for technicians of all skill sets to capture images with proper exposure for quality review by physicians. Acquire images with the correct exposure nearly 100% the first time, Opportunity to acquire more images non-mydriatically, by not over-exposing. Easy to train and easy to use Eliminates exposure guess work

19.) Auto MONTAGE Benefit- Internal Auto Fixation Positioning system allows for ease of ETDRS 7 Standard Field image acquisition and for technicians of all skill sets to capture images with high accuracy. After each image the Fixation Target will move to the appropriate position for the next field to be captured automatically. 3, 5, 7-field montage quickly and repeatable, Maximize outcomes wide anatomical composite of 3+ images to give positioning awareness and early peripheral diagnosis.

20) Field Angle 45 & 30 Degrees Benefit: Resolve high quality images optical magnification for optic nerve assessment.

21.) Built-In Medical Scientific Sensor Benefit: Calibrated for retinal images. True retina color versus images taken with a consumer-grade camera designed for landscape or family photographs. Tailored for ophthalmic applications. Not Substituted with LED capture based system.

22.) Integrated System all components in one single housing:

Benefit: All components in one single device, No additional external cables, • Compact, clean setup

23.) Network Ready and DICOM Conformance Benefit: Various image export formats Import Modality Worklist (MWL) and export DICOM files to a DICOM compatible system FORUM/VISTA Greater workflow efficiency

24.) Telecentric Optics Benefit: neutralizes the effect of patient's emmetropia, eliminating the potential for image distortion and delivering repeatable and precise measurements of retinal physiology, True pathological size regardless of focus maximized precision, speed and outcome

25.) Color Image Separation (R, G, B) Benefit: Besides Color, Red-free, Red and Blue acquisition modes this added benefit will allow the digital separation of the color photograph resulting in distinct red-free, red and blue image channels

26.) Customizable Workflow Capture Benefit: Preconfigure your commonly used imaging protocols with the customized capture workflow on the CIRRUS Photo 600. Increased flexibility, Optimized workflow, Fewer Mouse clicks and minimization of operator error, automate routine workflow.

27.) Multi-Mode Navigator with HD Line Raster Benefit: The HD Line Raster scans are also registered with the fundus image in MutiMode Navigator. Easily correlate the HD OCT Image data with brilliant fundus images.

28.) Enhanced Depth Imaging (EDI) MODE Benefit: EDI Imaging Mode for Chorodial Imaging. Better visualize the details of the chorodial structures.

29.) Accurate Centering Benefit: FoveaFinder & AutoCenter automatically ensure that measurements are made in the correct locations taking the pressure off the operator to perfectly center the scans.

Technical Features:

1) 5MP Medical Grade

2) Fundus Camera,

3) Windows 7 Embedded operating system,

4) FORUM RAW Data Storage ,

5) Monitor 23” TFT

6) Fixation Targets: 7 internal, plus free hand mouse control

7) Field of View 30 degree and 45 degree field of views

8) Ability to provide 5 different sets of Filters for viewing pathologies: Color, Red-Free, Blue, Red, Fundus Autofluorescence

9) 16 different Flash Levels (30Ws)

10) Dimensions: ( W 16.1x D 18.9 x H 26.8) all in one unit (complete with CPU)

11) Frequency 50/60 HZ

Brian Close Zeiss Meditec National Accounts Manager brian.close@zeiss.com Cell 913-660-6295