Hologic ThinPrep Imager Duo Operator's Manual page 6

A. INTENDED USE
The Hologic ThinPrep
technology to assist in primary 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 cytologic criteria as defined by 2001 Bethesda System: Terminology for Reporting Results of
Cervical Cytology
B. SUMMARY AND EXPLANATION OF THE SYSTEM
The ThinPrep Imaging System is an automated imaging and review system for use with ThinPrep
Pap Test slides. It combines imaging technology to identify microscopic fields of diagnostic interest
with automated stage movement of a microscope in order to locate these fields. In routine use, the
ThinPrep Imaging System selects 22 fields of view for a Cytotechnologist to review. Following
review of these fields, the Cytotechnologist will either complete the diagnosis if no abnormalities
are identified or review the entire slide if any abnormalities are identified. The ThinPrep Imaging
System also allows the physical marking of locations of interest for the Cytopathologist.
C. PRINCIPLES OF OPERATION
The ThinPrep Imaging System consists of an Image Processor and one, or more, Review Scopes.
The system makes use of computer imaging to select fields of view for presentation to a
Cytotechnologist on a Review Scope. Slides used with this system must first be prepared on a
ThinPrep 2000 System, ThinPrep 5000 Processor or ThinPrep Genesis Processor, and stained with
ThinPrep Stain.
The Imaging Processor acquires and processes image data from the slides to identify diagnostically
relevant cells or cell groups based on an imaging algorithm that considers cellular features and
nuclear darkness. During slide imaging, the alphanumeric slide accession identifier is recorded and
the x and y coordinates of 22 fields of interest are stored in the computer database. This computer
also coordinates the communication of information between the Image Processor and the Review
Scopes.
After image processing, slides are distributed to Cytotechnologists for review utilizing the Review
Scopes. The Review Scope is a microscope with an automated stage to facilitate the locating of the
22 fields containing the cells of interest. Additionally, the Review Scope provides a method for
automated marking of objects for further review. Slides are individually loaded onto the Review
Scope stage, the alphanumeric slide accession identifier is automatically scanned and the stored x
and y coordinates representing fields of interest for that slide are electronically downloaded from
the computer to the Review Scope. The Cytotechnologist then uses a keypad to step through each
of the fields of interest (Autolocate). If the Cytotechnologist identifies any of these fields as
containing abnormal objects, that field may be marked electronically. The Review Scope will guide
the Cytotechnologist to conduct a review of the entire cell spot for any slide that has had fields
electronically marked (Autoscan). The Cytotechnologist determines specimen adequacy and the
presence of infections during the review of the 22 fields of view presented by the ThinPrep Imaging
System. Either of two methods can be used to determine specimen adequacy. The first method is to
count cells and determine the average number of cells in the 22 fields of view presented by the
Imager. The second method is to count and determine the average number of cells in 10 fields of
view across the diameter of the cell spot. Either method will enable the Cytotechnologist to
determine if the minimum cells, as recommended by Bethesda System 2001 criteria, are present on
the slide. At the conclusion of the slide review electronically marked objects are automatically ink
marked. Any x and y coordinates representing marked locations along with a slide completion status
are then electronically transmitted back to the computer for storage.
® Imaging System (Imager) is a device that uses computer imaging
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MAN-08723-001 Rev. 001 page 2 of 28