Chapter 1: Introduction; Purpose Statement; Intended Use; Bd Focalpoint Slide Profiler - Becton Dickinson BD FocalPoint GS Imaging User Manual

Chapter 1: Introduction

Chapter 1
Introduction

Purpose Statement

Intended Use

BD FocalPoint
Slide Profiler
Operator's Manual—BD FocalPoint
This chapter provides introductory information about the
BD FocalPoint™ GS Imaging System. This system includes the
BD FocalPoint™ Slide Profiler and the BD FocalPoint™ GS Review
Station.
The purpose of this manual is to describe the operations and functions
of the BD FocalPoint GS Imaging System as a complete cervical
cancer screening system. There are references in this manual to
individual components of the system such as the BD FocalPoint Slide
Profiler that, when used without the BD FocalPoint GS (Guided
Screener) enhancement, will have different limitations.
The BD FocalPoint GS Imaging System is comprised of the BD
FocalPoint Slide Profiler and the BD FocalPoint GS Review Station.
The Intended use statements below are for the BD FocalPoint Slide
Profiler configured as a stand-alone product and the BD FocalPoint
Slide Profiler configured with the BD FocalPoint GS Review Station,
respectively.
The FocalPoint (formerly the AutoPap System) is an automated
cervical cytology screening device intended for use in initial screening
of cervical cytology slides. The FocalPoint identifies up to 25% of
successfully processed slides as requiring no further review. The
FocalPoint also identifies at least 15% of all successfully processed
slides for a second manual review. The device is intended to be used
on both conventionally-prepared and SurePath cervical cytology
slides. For both preparation methods, the device is intended to detect
slides with evidence of squamous carcinoma and adenocarcinoma and
their usual precursor conditions; it is not intended to be used on slides
designated by the laboratory as high risk. Intended users are trained
cytology laboratory personnel operating operating under the direct
supervision of a qualified cytology supervisor or laboratory manager/
director.
TM GS Imaging System
Purpose Statement
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