BD FocalPoint GS User manual

bd.com/e-labeling
FocalPoint™ GS Imaging System
Instrument User's Manual
Becton, Dickinson and Company
7 Loveton Circle
Sparks, Maryland 21152 USA
500040403(04) 2022-03
490189, 491490, 443876
English

BD FocalPoint™ GS Imaging System Instrument User’s Manual
2
Change History
Hewlett Packard is a trademark of the Hewlett Packard Development Company, LP.
BD, the BD Logo, FocalPoint, and SurePath are trademarks of Becton, Dickinson and Company or its
affiliates. All other trademarks are the property of their respective owners. © 2022 BD. All rights reserved.
The following paragraphs contain BD’s standard warranty statements. In the event of a discrepancy,
contractual Terms found in Individual Customer Equipment User Agreements take precedence.
BD warrants that, at the time of shipment, the device provided to the customer is free from defects in
material and workmanship. This limited warranty is conditioned upon the customer giving BD notice of
any defect within one (1) year after shipment. This limited warranty will not apply if the device (a) has not
been installed, operated, or maintained in accordance with applicable instructions and manuals; (b) has
been repaired or altered by unauthorized persons or misused, abused, accidentally damaged or
subjected to operation for which it was not intended; or (c) has had its serial number altered or removed.
This limited warranty does not apply to expendable items such as fuses or lamps. Except as expressly
stated herein, BD makes no other warranties, express or implied, including warranties of merchantability
or fitness for a particular purpose.
Under this limited warranty, BD, at its option, will repair or replace any defective device. This is the sole
remedy for any breach of warranty. Any device to be returned for repair or replacement must be properly
packaged and shipped in accordance with BD's instructions. This limited warranty does not apply to the
use of the BD FocalPoint™ GS Imaging System other than as described herein.
This limited warranty contains BD's sole obligation and liability for defective devices. BD shall not be
liable to the customer for any other remedies for damages, including special, indirect, incidental, and
consequential damages, whether based upon warranty, strict liability, tort, contract or otherwise. This
limited warranty may not be changed in any way without the express written permission of BD.
This product uses open source software as well as BD FocalPoint™ proprietary software. The
BD FocalPoint™ software dynamically links to open source libraries that are governed by the GNU
Lesser General Public License (LGPL) software license. No open source software has been modified by
BD except for certain drivers used on the Emerson MVME7100 processor board in the FocalPoint™
instrument. Drivers for the Emerson MVME7100 processor board are modified versions of drivers
provided with the Linux kernel. For copies of the modified driver source code contact BD Technical
Service and Support at 800.638.8663 or bd.com. Software license documentation for all open source
software can be found at /usr/share/licenses on the BD FocalPoint™ Workstation.
Revision Date Change Summary
02 2020-02 Added new DFI computer specifications for Workstation to
Section 28.2.1
03 2021-05
Reformatted layout of user interface, updated icons, added resizing
option for certain user interface elements, and removed the slide
annotation functionality for Software update 2.5.0 release.
04 2022-03
Removed CE mark and EC Rep address. Removed discontinued
catalog number 491464 and added current 120V refurbished part
catalog number 491490.

3
Table of Contents
1. Introduction............................................................................................................................ 11
1.1 Purpose Statement ..................................................................................................... 11
1.2 Intended Purpose........................................................................................................ 11
1.3 System Overview ........................................................................................................ 12
1.3.1 BD FocalPoint™ Slide Profiler ....................................................................... 12
1.3.2 BD FocalPoint™ GS Review Station ............................................................. 12
1.3.3 LOI versus FOV ............................................................................................. 12
1.4 Document Conventions............................................................................................... 13
1.5 Diagnostic Terminology .............................................................................................. 14
1.6 How to Contact BD ..................................................................................................... 14
1.6.1 In the United States ....................................................................................... 14
1.6.2 Outside of the United States .......................................................................... 14
2. BD FocalPoint™ GS Imaging System Introduction ............................................................... 15
2.1 BD FocalPoint™ GS Imaging System ........................................................................ 15
2.2 BD FocalPoint™ GS Review Station .......................................................................... 16
2.2.1 BD FocalPoint™ Slide Profiler Slide Information ........................................... 16
2.3 BD FocalPoint™ GS Imaging System Workflow......................................................... 17
2.3.1 BD FocalPoint™ Slide Profiler ....................................................................... 17
2.3.2 BD FocalPoint™ GS Review Station ............................................................. 19
3. Guided Screening.................................................................................................................. 21
3.1 Starting the Application ............................................................................................... 21
3.2 Calibrating the Stage .................................................................................................. 22
3.3 Selecting a Slide ......................................................................................................... 25
3.3.1 Scan using the Barcode Reader .................................................................... 26
3.3.2 Typing in the Slide Accession Number .......................................................... 26
3.3.3 Select from the Slide List ............................................................................... 27
3.4 Screening FOVs.......................................................................................................... 28
3.4.1 BD FocalPoint™ GS Review Mode Basics.................................................... 29
3.4.2 Verifying the Stage Position/Using the Offset Function ................................. 30
3.5 Navigating Through FOVs .......................................................................................... 31
3.5.1 Using the Mouse to Navigate......................................................................... 31
3.5.2 Using the Foot Pedal to Navigate .................................................................. 31
3.5.3 Using the Navigation Buttons......................................................................... 32
3.6 Screening and Triaging Slides .................................................................................... 32
3.6.1 Full Slide Manual Review............................................................................... 34
3.7 Finishing a Slide.......................................................................................................... 34
3.7.1 Using the Eval Function ................................................................................. 35
3.7.2 Using the No Evaluation Function.................................................................. 36
3.7.3 Assigning a Slide Status ................................................................................ 37
4. Screening Slides ................................................................................................................... 39
4.1 Manual Screening ....................................................................................................... 39
4.2 Screen Mode Basics ................................................................................................... 39

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4.3 Screening Slides......................................................................................................... 41
4.3.1 BD FocalPoint™ Slide Profiler Processed Slides .......................................... 41
4.3.2 Other Types of Slides .................................................................................... 42
5. BD FocalPoint™ GS Review Station User Interface............................................................. 45
5.1 Understanding the Toolbar Buttons ............................................................................ 45
5.1.1 LIS Interface................................................................................................... 45
5.1.2 Offset Button .................................................................................................. 45
5.1.3 Track Button................................................................................................... 46
5.1.4 Help Button .................................................................................................... 47
5.1.5 Most Significant Dot Button............................................................................ 47
5.1.6 Delete Field Button ........................................................................................ 48
5.1.7 Slide Button.................................................................................................... 48
5.1.8 Screen Button ................................................................................................ 48
5.1.9 Eval Button..................................................................................................... 49
5.1.10 No Eval Button ............................................................................................... 49
5.1.11 "Navigation" Buttons ...................................................................................... 49
5.2 Understanding the History Panel ................................................................................ 50
5.3 Using the slide map .................................................................................................... 50
5.3.1 Slide Status Information................................................................................. 52
5.3.2 Multiple Slides Found Window....................................................................... 53
5.3.3 Slide Results Data Color Codes .................................................................... 53
6. BD FocalPoint™ GS Review Station MD and QC Modes..................................................... 55
6.1 Enhanced QC Review option...................................................................................... 55
6.1.1 Enabling Enhanced QC ................................................................................. 56
7. Managing the BD FocalPoint™ GS Review Station Server .................................................. 59
7.1 Copy Service Basics ................................................................................................... 59
7.1.1 Operating Modes ........................................................................................... 59
7.1.2 Transferring Data ........................................................................................... 60
7.1.3 Restarting Copy Service ................................................................................ 61
7.2 Archive Utility Basics................................................................................................... 62
7.3 Sign Out...................................................................................................................... 63
7.3.1 Signing Out a Batch of Slides ........................................................................ 63
7.4 Archive ........................................................................................................................ 66
7.4.1 Viewing Archived Slide Data.......................................................................... 71
7.4.2 Moving Data to an External Media................................................................. 74
7.4.3 Searching for a Slide...................................................................................... 74
8. Generating BD FocalPoint™ GS Review Station Reports .................................................... 77
8.1 Generating Reports..................................................................................................... 77
8.1.1 Opening the BD FocalPoint™ GS report utility .............................................. 77
8.1.2 Selecting the report type ................................................................................ 78
8.1.3 Selecting the report style ............................................................................... 78
8.1.4 Previewing and printing the report ................................................................. 78

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8.2 Overview of BD FocalPoint™ GS Review Station Reports......................................... 79
8.2.1 Summary Reports .......................................................................................... 79
8.2.2 QC Reports .................................................................................................... 83
8.2.3 Generating the Final QC report...................................................................... 84
9. Customizing BD FocalPoint™ GS Review Station Lists ....................................................... 87
9.1 Editing BD FocalPoint™ GS Review Station Lists...................................................... 87
9.1.1 To access the list revision controls ................................................................ 87
9.1.2 Revising the lists ............................................................................................ 89
10. The BD FocalPoint™ Slide Profiler ....................................................................................... 91
10.1 BD FocalPoint™ Slide Profiler Overview .................................................................... 91
10.1.1 System Components...................................................................................... 91
10.2 Slide Processing ......................................................................................................... 94
10.3 Slide Processing Results ............................................................................................ 94
10.3.1 Successfully Processed Slides ...................................................................... 95
10.3.2 Slides Not Successfully Processed................................................................ 96
10.4 Slide Result Report Options........................................................................................ 96
10.4.1 Ranking Information....................................................................................... 97
10.4.2 Specimen Adequacy Information ................................................................... 97
10.4.3 Processing Status Information ....................................................................... 98
11. The BD FocalPoint™ Slide Profiler Main Window................................................................. 99
11.1 Main Window ............................................................................................................ 100
11.1.1 Help Icon...................................................................................................... 100
11.1.2 Instrument Icons .......................................................................................... 101
11.1.3 Instrument Status......................................................................................... 101
11.1.4 Processed Slides ......................................................................................... 102
11.1.5 Task Buttons ................................................................................................ 102
11.2 Utilities Button ........................................................................................................... 103
11.2.1 Usage Statistics ........................................................................................... 104
11.2.2 System Integrity ........................................................................................... 106
11.2.3 System Messages........................................................................................ 107
11.3 Automatic Printing (Creating Print Sets) ................................................................... 108
11.4 Backup ...................................................................................................................... 109
11.5 Eject Tray.................................................................................................................. 109
11.6 Shut Down ................................................................................................................ 109
11.7 Service Mode Disabled ............................................................................................. 109
12. Using BD FocalPoint™ Slide Profiler Reports..................................................................... 111
12.1 Understanding Report Printing Operations ............................................................... 111
12.1.1 Print Sets ..................................................................................................... 111
12.1.2 Printing......................................................................................................... 112
12.1.3 Reprinting..................................................................................................... 112
12.1.4 Print Summary Statistics.............................................................................. 113
12.2 Report Options.......................................................................................................... 113
12.2.1 Report Types ............................................................................................... 113
12.2.2 Report Sorting Options ................................................................................ 114
12.2.3 Report Layout Options ................................................................................. 114

BD FocalPoint™ GS Imaging System Instrument User’s Manual
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12.3 Sample Reports ........................................................................................................ 119
12.3.1 Slide Result Report ...................................................................................... 119
12.3.2 Review Report ............................................................................................. 120
12.3.3 QC Review Report ....................................................................................... 122
12.3.4 Archive Report ............................................................................................. 123
12.3.5 Process Review Report ............................................................................... 124
12.3.6 Rerun Report ............................................................................................... 125
13. Slides, Coverslips, and Slide Preparations ......................................................................... 127
13.1 Types of Slide Preparations Allowed ........................................................................ 127
13.1.1 BD SurePath™ Slides.................................................................................. 127
13.2 Slide and Coverslip Standards.................................................................................. 128
13.2.1 Slide and Coverslip Dimensions .................................................................. 128
13.2.2 Slide Optical Properties ............................................................................... 129
13.2.3 Coverslip Requirements............................................................................... 129
13.2.4 Adhesive and Mounting Requirements ........................................................ 129
13.2.5 Staining and Fixative Requirements ............................................................ 130
13.2.6 Barcode Formats ......................................................................................... 130
14. Setting BD FocalPoint™ Slide Profiler Report Options....................................................... 131
14.1 Slide Report Types ................................................................................................... 131
14.1.1 Sort Order and Layout Options .................................................................... 132
14.1.2 Defining a Report ......................................................................................... 132
14.2 Selecting QC Review Report Options....................................................................... 133
15. Operating the BD FocalPoint™ Slide Profiler...................................................................... 135
15.1 General Warnings and Cautions............................................................................... 137
15.2 Preparing Slides for Processing................................................................................ 138
15.2.1 Applying Barcode Labels ............................................................................. 138
15.2.2 Cleaning Slides ............................................................................................ 139
15.3 Loading Trays ........................................................................................................... 139
15.3.1 Inserting Slides Into Trays ........................................................................... 139
15.3.2 Changing Preparation Types with Switch Slides ......................................... 140
15.3.3 Removing Slides from Trays........................................................................ 141
15.4 Handling Slide Trays................................................................................................. 141
15.4.1 Loading Trays .............................................................................................. 141
15.4.2 Unloading Trays........................................................................................... 142
15.4.3 Ejecting Trays .............................................................................................. 142
15.5 Monitoring the Instrument during Processing ........................................................... 143
15.5.1 The Main Window ........................................................................................ 143
15.5.2 Instrument Status Indicator .......................................................................... 144
15.6 Printing Reports ........................................................................................................ 145
15.6.1 Creating a Print Set (Establishing Rank) ..................................................... 145
15.7 Analyzing Slide Result Reports................................................................................. 146
15.8 Sorting Slides by Action Categories.......................................................................... 147
15.9 When to Manually Screen Slides.............................................................................. 147
15.10 Reprinting Reports .................................................................................................... 147
15.11 Backing Up Your Data .............................................................................................. 151
15.11.1 Type of USB Flash Drive to Use (for USB backup systems) ....................... 151
15.11.2 Backup Media Archive Reminder................................................................. 152

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15.11.3 Alternate Backup Media Daily...................................................................... 152
15.11.4 Manual Daily Backup ................................................................................... 152
15.12 Shutting Down the System........................................................................................ 153
15.13 Restarting the System............................................................................................... 155
16. BD FocalPoint™ Slide Profiler Maintenance....................................................................... 157
16.1 Maintenance Schedule ............................................................................................. 157
16.2 Cleaning the Trays.................................................................................................... 157
16.3 Cleaning the Calibration Plate .................................................................................. 158
16.4 Inspecting the Air Filter ............................................................................................. 159
16.5 Cleaning the Monitor................................................................................................. 160
16.6 Cleaning the Outer Surfaces of the Instrument......................................................... 160
16.7 Printer Maintenance.................................................................................................. 161
16.8 Cleaning the Mouse .................................................................................................. 162
16.9 Changing the Backup Media..................................................................................... 162
17. BD FocalPoint™ Slide Profiler Troubleshooting.................................................................. 163
17.1 In the United States .................................................................................................. 163
17.2 Outside of the United States ..................................................................................... 163
17.3 Troubleshooting Guide.............................................................................................. 164
17.4 System Time ............................................................................................................. 164
18. Processing Conventional Slides on the BD FocalPoint™ Slide Profiler.............................. 165
18.1 Introduction ............................................................................................................... 165
18.2 Types of Slide Preparations Allowed ........................................................................ 165
18.2.1 Conventionally Prepared Pap Smears......................................................... 165
18.2.2 Slide and Coverslip Standards..................................................................... 165
18.2.3 Adhesive and Mounting Requirements ........................................................ 166
18.2.4 Staining and Fixative Requirements ............................................................ 166
18.3 Operating the BD FocalPoint™ Slide Profiler ........................................................... 166
18.3.1 Changing Preparation Types with Switch Slides ......................................... 167
18.3.2 Monitoring the Instrument during Processing .............................................. 167
18.3.3 Processed Slides Field in Main Window ...................................................... 168
18.3.4 Printing Reports ........................................................................................... 168
18.3.5 Creating a Print Set (Establishing Rank) ..................................................... 169
18.4 Analyzing Slide Result Reports................................................................................. 170
18.5 Sorting Slides by Action Categories.......................................................................... 171
18.6 When to Manually Screen Slides .............................................................................. 171
18.7 Selecting Slides for QC Rescreening........................................................................ 172
18.8 Monitoring the Slide Rejection Rate.......................................................................... 173
18.8.1 Mean Stain Score ........................................................................................ 173
18.9 Report Options.......................................................................................................... 175
18.9.1 Report Types ............................................................................................... 175
18.9.2 Report Sorting Options ................................................................................ 176
18.9.3 Report Layout Options ................................................................................. 176

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19. Quality Assurance on the BD FocalPoint™ Slide Profiler ................................................... 181
19.1 The Quality Assurance Program............................................................................... 181
19.1.1 Pre-Installation ............................................................................................. 182
19.1.2 Installation.................................................................................................... 183
19.1.3 Post Installation Phase ................................................................................ 185
19.2 Selecting Slides for QC Rescreening........................................................................ 185
19.3 Monitoring the Slide Rejection Rate.......................................................................... 187
19.3.1 Mean Stain Score ........................................................................................ 187
19.4 Training Records....................................................................................................... 189
19.5 System Performance Verification.............................................................................. 189
19.5.1 SI Overview.................................................................................................. 189
19.5.2 Test Information Reporting .......................................................................... 189
19.5.3 Tracking SI Results...................................................................................... 190
19.5.4 System Messages........................................................................................ 191
20. BD FocalPoint™ Slide Profiler Installation Checklist........................................................... 193
20.1 BD FocalPoint™ Instrument or Device ..................................................................... 193
20.2 Workstation ............................................................................................................... 193
20.3 Electronic Cables ...................................................................................................... 193
20.4 Additional Items Supplied at Startup......................................................................... 193
20.5 Items to be Supplied by the Customer...................................................................... 194
21. BD FocalPoint™ Slide Profiler Processing Messages ........................................................ 195
21.1 Slide Not Scanned .................................................................................................... 195
21.2 Scant Cellularity ........................................................................................................ 197
21.3 Staining Not Within Limits ......................................................................................... 198
21.4 Image Quality Not Within Limits................................................................................ 198
21.5 Other Errors .............................................................................................................. 199
22. Warnings and Cautions....................................................................................................... 201
23. BD FocalPoint™ Slide Profiler System Integrity.................................................................. 205
24. BD FocalPoint™ Slide Profiler Maintenance Schedule....................................................... 207
25. System Integrity (SI) Results Log........................................................................................ 209
26. BD FocalPoint™ Slide Profiler Slide Rejection Rate Log.................................................... 211
27. BD FocalPoint™ GS Review Station Custom Settings ....................................................... 213
27.1 BD FocalPoint™ GS Settings ................................................................................... 213
27.1.1 Using the Barcode tab ................................................................................. 213
27.1.2 Using the Orientation tab ............................................................................. 214
27.1.3 Using the Default Evaluation tab.................................................................. 214
27.1.4 Using the Scaling tab ................................................................................... 215
27.1.5 Specifying the slide type .............................................................................. 215
27.2 Reports settings........................................................................................................ 216

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28. System Requirements ......................................................................................................... 219
28.1 BD FocalPoint™ GS Review Station ........................................................................ 219
28.1.1 Electrical Specifications ............................................................................... 219
28.1.2 Environmental Operating Conditions ........................................................... 220
28.1.3 Environmental Safety................................................................................... 220
28.2 BD FocalPoint™ Slide Profiler Specifications........................................................... 220
28.2.1 BD FocalPoint™ Slide Profiler Workstation ................................................. 221
29. BD FocalPoint™ GS Review Station Abbreviations............................................................ 223
30. BD FocalPoint™ GS Review Station Maintenance & Troubleshooting............................... 225
30.1 Maintenance procedures .......................................................................................... 225
30.1.1 Controller/Stage ........................................................................................... 225
30.1.2 Microscope................................................................................................... 225
30.1.3 Monitor ......................................................................................................... 227
30.1.4 Computer ..................................................................................................... 227
30.1.5 Manufacturing information ........................................................................... 227
30.2 Troubleshooting Guide.............................................................................................. 227
31. Contacts .............................................................................................................................. 229
32. BD FocalPoint™ Slide Profiler Quick Reference Guide ...................................................... 231
32.1 Instrument/Device Status Alerts................................................................................ 231
32.2 Beginning Processing ............................................................................................... 231
32.3 Manual Backup Procedure........................................................................................ 231
32.4 Shut Down Procedure............................................................................................... 231
32.5 Start-up Procedure.................................................................................................... 232
33. Symbol Glossary ................................................................................................................. 233
34. Index.................................................................................................................................... 235

BD FocalPoint™ GS Imaging System Instrument User’s Manual
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11
1 Introduction
This section 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.
1.1 Purpose Statement
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.
For more information about the performance and intended use of the BD FocalPoint™ GS
Imaging System, please see the Product Insert applicable to your region and/or contact your
BD representative
1.2 Intended Purpose
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.
BD FocalPoint™ Slide Profiler
The BD FocalPoint™ Slide Profiler (formerly the AutoPap System) is an automated cervical
cytology screening device intended for use in initial screening of cervical cytology slides. The
BD FocalPoint™ Slide Profiler identifies up to 25% of successfully processed slides as requiring
no further review. The BD FocalPoint™ Slide Profiler 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 BD SurePath™ (formerly
AutoCyte PREP) 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 under the direct supervision
of a qualified cytology supervisor or laboratory manager/director.
BD FocalPoint™ GS Imaging System
The BD FocalPoint™ GS Imaging System is intended to assist in cervical cancer screening of
BD SurePath™ Liquid-based Pap Test slides to detect evidence of squamous carcinoma,
adenocarcinoma and their usual precursor conditions. These slides will be ranked according to
the likelihood of abnormality, and provide relocation and visual review of up to 10 fields of view
(FOVs) most likely to contain abnormal cells. Additionally, the system identifies at least 15% of all
successfully processed slides with the BD FocalPoint™ Slide Profiler* Directed QC Technology
for a directed QC rescreen.
Intended users are trained cytology laboratory personnel operating under the direct supervision
of a qualified cytology supervisor or laboratory manager/director.
*For more information about the performance of the BD FocalPoint™ Slide Profiler, please see
the product insert document No. 500040543.

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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 LOI versus FOV
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.

Introduction
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1.4 Document Conventions
There are five notice types used in this manual: three warnings, a
caution, and a note. The appearance and usage of each type is detailed below:
WARNING
INDICATES THE POSSIBILITY OF SEVERE PERSONAL INJURY
OR LOSS OF LIFE IF INSTRUCTIONS ARE NOT FOLLOWED.
WARNING
INDICATES THE POSSIBILITY OF SHOCK AND FIRE
POTENTIAL IF INSTRUCTIONS ARE NOT FOLLOWED.
WARNING
INDICATES THE POSSIBILITY OF POTENTIAL EXPOSURE TO
BLOOD AND OTHER POTENTIALLY INFECTIOUS BODILY
FLUIDS IF INSTRUCTIONS ARE NOT FOLLOWED.
CAUTION
Indicates the possibility of severe equipment damage or invalid
results if instructions are not followed.
NOTE
Take care to pick up the slide by the edges, so that fingerprints do
not get on top of the coverslip.

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1.5 Diagnostic Terminology
The diagnostic terminology used in this manual for use in the screening and detection of cervical
cancer, pre-cancerous lesions, atypical cells and all other cytologic categories was defined by
The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses.
1.6 How to Contact BD
1.6.1 In the United States
BD Technical Service and Support at 1.800.638.8663 or bd.com
1.6.2 Outside of the United States
Contact your local BD representative.
For product availability, consult our product catalog (online) or contact your local distributor or
BD representative.

15
2 BD FocalPoint™ GS Imaging System Introduction
This section provides overview information on the basic operation of the BD FocalPoint™ GS
Imaging System and a brief review of the workflow process for orientation. Specific details on
how to operate the BD FocalPoint™ Slide Profiler and BD FocalPoint™ GS Review Station are
discussed in subsequent sections.
2.1 BD FocalPoint™ GS Imaging System
The BD FocalPoint™ GS Imaging System consists of the following:
• BD FocalPoint™ Slide Profiler
• BD FocalPoint™ GS Review Station
Slides are initially processed on the BD FocalPoint™ Slide Profiler, an automated screening
instrument. Each slide is scanned using 4x and 20x objectives. Digital images are captured and
processed by computers that use multiple algorithms to assess both squamous and glandular
changes as well as specimen adequacy. Each slide is given a score that corresponds to the
likelihood of abnormality. The slides are then grouped or batched into a unit called a print set.
The slides within each print set are statistically ranked based on their individual slide scores
(the scores represent the probability of abnormality). See Section 12 for details on creating a
print set.
In addition to ranking the slides, the BD FocalPoint™ Slide Profiler identifies specific fields of
view on each slide. These FOV represent the locations most likely to contain cells of interest.
The BD FocalPoint™ Slide Profiler also selects 15% of the highest scoring slides that were
initially reported as negative for quality control review. All BD FocalPoint™ Slide Profiler slide
information data, including the coordinates and cell images for the FOVs are transferred to a
central server or database. The slide information is retrieved by the cytotechnologist or
pathologist at the BD FocalPoint™ GS Review Station. Figure 2-1 demonstrates this relationship
between the BD FocalPoint™ Slide Profiler and the BD FocalPoint™ GS Review Station.
In summary, the BD FocalPoint™ GS Imaging System combines the automated primary
screening capability of the BD FocalPoint™ Slide Profiler with the precision field relocation
capability of the BD FocalPoint™ GS Review Station.
Figure 2-1 – BD FocalPoint™ GS Imaging System

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2.2 BD FocalPoint™ GS Review Station
The BD FocalPoint™ GS Review Station is designed for the desktop and allows the user to
perform a computer assisted slide review. It consists of a Main Window (monitor), specialized
guided screening software and an automated review microscope.
The BD FocalPoint™ GS Review Station components include the following:
• Monitor
• Keyboard and Mouse
• CPU
• Foot pedal (optional)
• Automated Microscope Stage
• Barcode Scanner
BD FocalPoint™ Slide Profiler produced slide information, FOV coordinates and cell images
from the central database are transferred to the BD FocalPoint™ GS Review Station. The
cytotechnologist uses the automated re-location capability of the BD FocalPoint™ GS Review
Station to evaluate the pre-selected FOVs.
2.2.1 BD FocalPoint™ Slide Profiler Slide Information
The BD FocalPoint™ Slide Profiler processes slides and transmits slide information data to a
central server that can be retrieved at the BD FocalPoint™ GS Review Station. When the
cytotechnologist reviews a slide at the BD FocalPoint™ GS Review Station the slide information
is presented. It is important to understand the significance of this information in the workflow
process.
Figure 2-2 illustrates the Slide information data as it appears at the BD FocalPoint™ GS Review
Station.
Figure 2-2 – Slide Information area
NOTE
The black and white, 20x magnification jpeg digital images that the
BD FocalPoint™ Slide Profiler provides are intended for relocation/
calibration purposes only and are not intended for the purpose of
interpretation.

BD FocalPoint™ GS Imaging System Introduction
17
Table 2-1 describes the data in the slide information area.
Table 2-1 – Physical Dimensions
2.3 BD FocalPoint™ GS Imaging System Workflow
There are two phases to the BD FocalPoint™ GS Imaging System workflow: Phase 1 is
performed on the BD FocalPoint™ Slide Profiler and Phase 2 is performed on the
BD FocalPoint™ GS Review Station.
2.3.1 BD FocalPoint™ Slide Profiler
The following sequence describes Phase 1 of the workflow. Refer to Figure 2-3 for an illustration.
1All slides are processed on BD FocalPoint™ Slide Profiler.
2Print sets are created.
3Slides are ranked based on the likelihood of abnormality.
4Slides are designated for directed QC Review.
5Slide information and FOV coordinates are sent to the central server database.
6All slides that are not successfully processed on the BD FocalPoint™ Slide Profiler require a
full manual screen (see Section 4).
Barcode Slide accession number or unique identifier.
FocalPoint Action Indicates whether the slide was successfully
processed.
Quintile ranking Each print set is divided into 5 groups based on slide
scores. Quintile 1 has the highest probability of
abnormality, followed by Quintile 2, Quintile 3, and so
on.
Report Message Displays the processing message if the
BD FocalPoint™ Slide Profiler produced one.
Slide status Tracks screening and reporting activities.
Endocervical
Component and
Squamous Cells
Provides adequacy information.
Percentile &
Numeric Ranking
Provide additional methods of indicating slide ranking
information.

BD FocalPoint™ GS Imaging System Instrument User’s Manual
18
Figure 2-3 – Example of BD FocalPoint™ GS Imaging System workflow
NOTE
If appropriate corrections are made, some of the process review
slides may also be processed again on the BD FocalPoint™ Slide
Profiler. Rerun slides can be processed again on the
BD FocalPoint™ Slide Profiler.
NOTE
Determined by normal laboratory.
QC Cytotechnologist
QC Review?
Yes
Process Review,
No FOVs,
or Rerun
No
Full slide
review
required? Full slide review
Yes
No NILM
slides Abnormal
slides
Slides classified as Review
BD SurePath
Slides
Review using
BD FocalPoint GS
Review Station
BD FocalPoint
Slide Profiler
Pathologist
Cytology
Reports
Abnormal
slides
Final
Interpretation/Result
NILM
slides
NILM
slides
Slides classified as
Process Review or
Rerun
(see Note 1)
(see Note 1)
(see Note 2)
Manual primary screening

BD FocalPoint™ GS Imaging System Introduction
19
2.3.2 BD FocalPoint™ GS Review Station
The following sequence describes Phase 2 of the workflow. Figure 2-3 illustrates this sequence
as well.
1All slides successfully processed on the BD FocalPoint™ Slide Profiler are initially evaluated
on the BD FocalPoint™ GS Review Station using the BD FocalPoint™ GS review
application.
2Slide evaluation includes any of the following:
• FOV only
• FOV Review triaged to full slide review (FSR)
• Full slide review because no FOVs are presented (for example, Process Review or
incomplete processing)
3Abnormal slides are triaged to a pathologist.
4Directed QC Review slides are triaged to a second manual full slide review.
5Slides are assigned a result and final reports are sent to provider.
The cytotechnologist performs initial evaluation of the slides at the BD FocalPoint™ GS Review
Station using the BD FocalPoint™ GS review application. Two additional optional applications
are available: QC Mode and MD Mode. These applications electronically queue slides for QC or
Pathologist review and enable electronic review of slides at the BD FocalPoint™ GS Review
Station. Both applications are optional and use the BD FocalPoint™ GS Review Station for
evaluation. Figure 2-4 demonstrates the workflow using these three applications; GS Review,
QC Mode and MD Mode.
Figure 2-4 illustrates the workflow with the BD FocalPoint™ GS Review Station and Table 2-2
details the operating modes and their associated tasks.
Figure 2-4 – BD FocalPoint™ GS Review Station workflow
NOTE
In the US and Canada, Conventional Pap smears are not eligible for
Field of View (FOV) screening. Refer to Section 18 for a discussion
of conventional slide processing.
Signed-Out - awaiting archive
BD FocalPoint GS
Review
RFS
MD Mode
RFS
QC Mode
RFS
A
ll slides
AFR
AFR = Awaiting Further Review
RFS = Ready For Signout

BD FocalPoint™ GS Imaging System Instrument User’s Manual
20
.
Table 2-2 – Menu options and tasks
Menu Option Functionality of each mode
FocalPoint™ GS - Review Reviewing BD FocalPoint™ Slide Profiler slide data, FOV only
Review, FOV Review with triage to full slide review, Full Slide Review
for slides classified as Process Review or Full Slide Review and
adding electronic dots. Section 3 details the tasks performed in this
mode.
FocalPoint™ GS - QC Review of QC review slides. The task performed in this mode is
discussed in Section 3.
FocalPoint™ GS - MD Screen and evaluate abnormal slides. The task performed in this
mode is discussed in Section 4.
FocalPoint™ GS - Tools Access the report utility and other administrative tasks. These tasks
are discussed in Section 8, Section 9 as well as in Section 27.
FocalPoint™ GS - Archive View archived slide data. Section 7 details the tasks performed in this
mode.