Hologic Genius, Operator'S Manual

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I
NTRODUCTION
1.2 Genius™ Image Management Server User’s Manual
1
Indication for Use
The Image Management Server is one component of the Genius Digital Diagnostics System.
The Genius Digital Diagnostics System, when used with the Genius™ Cervical AI algorithm, is
indicated for assisting in cervical cancer screening of ThinPrep
®
Pap test slides for the presence of
atypical cells, cervical neoplasia, including its precursor lesions (Low Grade Squamous
Intraepithelial Lesions, High Grade Squamous Intraepithelial Lesions), and carcinoma, as well as all
other cytological categories, including adenocarcinoma, as defined by
The Bethesda System for
Reporting Cervical Cytology
1
.
The Genius Digital Diagnostics System can also be used with ThinPrep® non-gynecological
microscope slides and ThinPrep
®
UroCyte
®
microscope slides to provide a digital image of the
whole cell spot for screening.
The Genius Digital Diagnostics System includes the Genius Digital Imager, the Genius Image
Management Server, and the Genius Review Station. The system is for the creation and viewing of
digital images of scanned ThinPrep glass slides that would otherwise be appropriate for manual
visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to
employ appropriate procedures and safeguards to assure the validity of the interpretation of images
obtained using this system.
For professional use.
THE GENIUS DIGITAL DIAGNOSTICS SYSTEM
Slides that have been prepared for screening are loaded into slide carriers which are placed into the
Digital Imager. The operator uses a touch screen on the Digital Imager to interact with the instrument
via a graphic, menu-driven interface.
A slide ID reader scans the slide’s accession ID and locates the position of the cell spot. Then the
Digital Imager scans the entire ThinPrep cell spot, creating images of the slides. The slide image data,
the slide ID and its associated data record are transmitted to the Image Management Server, and the
slide is returned to its slide carrier.
The Image Management Server acts as the central data manager for the Genius Digital Diagnostics
System. As slides are imaged by the Digital Imager and reviewed at the Review Station, the server
stores, retrieves and transmits information based on the case ID.
1. Nayar R, Wilbur DC. (eds), The Bethesda System for Reporting Cervical Cytology: Definitions, Criteria, and
Explanatory Notes. 3rd ed. Cham, Switzerland: Springer: 2015
SECTION
B