36C26118Q9531-001.pdf

Brand Name or Equal Worksheet (“Salient Characteristics”)

8/16/2018

Brand Name Item: ZEISS FORUM

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

• Must be FDA 510k approved and listed as a Medical Device.

• Must provide “Post Processing Analysis, Dynamic Review/Manipulation of RAW data” functionality for ZEISS Cirrus HD- OCT.

• Must be able to store and access raw instrument data from ZEISS Field Analyzer, ZEISS Cirrus HD-OCT, ZEISS Visucam Fundus Camera and ZEISS FF450/Visupac Fundus Camera systems.

• Must have functionality to enable real- time and dynamic editing/manipulation of all prior Visual Field Test data for all Glaucoma patients and allow for Baseline changes, real-time report generation for any VFI date, display RealEye images and data from the new ZEISS HFA 3 instruments.

• Must support DICOM standards and Work-List functionality in order to create and send patient demographics to a specific or all instrument’s via a DICOM work-list within the eye clinic’s network.

• Must support Combined Report for Structure Function analyses in Single Display with OD-OS on one (1) page print out from data of Cirrus HD OCT and a Humphrey Visual Field.

• Must have Bi-directional DICOM capabilities to send both DICOM Modality Work-lists containing Consult/Order details to instrument’s within the eye-clinics network and receive back the diagnostic test results and RAW data for storage within the Image and Data Management System for access.

• Must connect to any brand of non-DICOM diagnostic instrument with export capabilities, and convert the diagnostic test results into a DICOM compatible file containing all patient demographical information, UID’s, Accession number, Device name and type, laterality and other key pieces of data with the least amount of user interaction.

• Must not require the use of an external PC or import computer for a DICOM compatible modality.

• Must be able to download all past RAW data from one or more ZEISS Field Analyzers, ZEISS Cirrus HD-OCT’s, ZEISS Visucam Fundus Camera and ZEISS FF450/Visupac Fundus Cameras acquired within the main clinic and all satellite clinics upon installation of the Image and Data Management System.

• Must be able to display ZEISS Field Analyzer Glaucoma Progression Analysis (GPA) and enable the clinician to manipulate data and store baseline changes at the workstation within the Image and Data Management System.

• Must be able to display and allow the clinician to scroll through the various ZEISS Cirrus Macula Cube B-scan slices, within the Image and Data Management System viewer.

• Operating system must be Windows 7 or newer

• Server infrastructure system must run Windows Server 2012 or newer

Attachment 1

Brand Name or Equal Worksheet (“Salient Characteristics”)

• Must be compatible with any existing eye PACS system at NCHCS

• HL7 Interface to facilitate communication with Electronic Patient Information System.

2) Complete generic identification – Image and Data Management System for Ophthalmology

3) Applicable model/make/catalog number – ZEISS FORUM

4) Manufacturer name – ZEISS

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.

5/30/2017 Uriel Gomez, Biomedical Engineer

5/22/2018 Madison Pallante, Biomedical Engineer