System Overview; Bd Focalpoint™ Slide Profiler; Bd Focalpoint™ Gs Review Station; Loi Versus Fov - BD FocalPoint GS User Manual

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BD FocalPoint™ GS Imaging System Instrument User's Manual

1.3

System Overview

The BD FocalPoint™ GS Imaging System combines the automated screening capability of the

BD FocalPoint™ Slide Profiler with the precision field location capability of the BD FocalPoint™

GS Review Station.

1.3.1

BD FocalPoint™ Slide Profiler

The BD FocalPoint™ Slide Profiler is an automated cytology screening device that classifies

slides for review according to their likelihood of containing an abnormality. Cell images are

captured using a high speed video equipped microscope and image interpretation software. The

software analyzes the complex images on a cervical cytology slide using screening algorithms.

The screening algorithms are comprised of over 100 object analysis features, including both

squamous and glandular algorithms to determine potential abnormality. The device is intended to

detect slides with evidence of squamous carcinoma and adenocarcinoma and their usual

precursor conditions.

1.3.2

BD FocalPoint™ GS Review Station

The BD FocalPoint™ GS Review Station receives slide processing results data from the

BD FocalPoint™ Slide Profiler and presents the results data to a cytotechnologist to assist the

cytotechnologist in interpretation of the specimen on a slide. The slide results include slide

identification information, ranking and sorting information, specimen quality indicators,

associated cell pattern images, slide reference frame data, and processing status indications for

each slide via a network connection.

1.3.3

The BD FocalPoint™ GS Review Station provides rapid data retrieval and rapid navigation to

locations of interest (LOI) on the slide. When the microscope stage is focused on one of these

locations, the area visible to the cytotechnologist through the microscope is referred to as the

field of view or a FOV. These two terms are not interchangeable, but are often used to refer to the

same point on a slide. The correct term to describe a particular point on a slide depends on the

context.

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