Becton Dickinson BD FocalPoint GS Imaging User manual

BFocalPoint™GS Imaging
Instrument User's Manual


Becton, Dickinson and Company
7 Loveton Circle
Sparks, MD 21152 USA
Benex Limited
Pottery Road, Dun Laoghaire
Co. Dublin, Ireland
Australian Sponsor:
Becton Dickinson Pty Ltd.
4 Research Park Drive
Macquarie University Research Park
North Ryde, NSW 2113 Australia
Document Number: 500011292
2016-03(01)
443875, 490189, 491085, 491086, 491087, 491089,491090, 491091
English



ii
Change History
Hewlett Packard is a trademark of the Hewlett Packard Development Company, LP.
© 2016 BD. BD, BD Logo and all other trademarks are property of Becton, Dickinson and Company.
U.S. Patent Numbers:
5,499,097, 5,528,703, 5,557,097, 5,566,249, 5,581,631, 5,619,428, 5,621,519, 5,625,706, 5,627,908, 5,638,459, 5,642,433, 5,642,441,
5,647,025, 5,654,535, 5,671,288, 5,677,762, 5,692,066, 5,710,842, 5,715,326, 5,715,327, 5,740,269, 5,745,601, 5,757,954, 5,760,387,
5,763,871, 5,781,667, 5,787,188, 5,787,189, 5,787,208, 5,797,130, 5,799,101, 5,812,692, 5,828,776, 5,841,124, 5,875,258, 5,877,489,
5,883,982, 5,892,218, 5,912,699, 5,933,519, 5,937,103, 5,978,497, 5,959,726, 5,978,498, 5,987,158, 5,991,432, 5,991,462, 5,995,680,
6,011,861, 6,067,370, 6,134,354, 6,137,899, 6,181,811, 6,198,839, 6,252,979
The following paragraphs contain BD Diagnostics' 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 war-
ranty will not apply if the device (a) has not been installed, operated, or maintained in accordance with applicable instructions and man-
uals; (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 warran-
ties 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 war-
ranty. Any device to be returned for repair or replacement must be properly packaged and shipped in accordance with BD's instruc-
tions. 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 instru-
ment. 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 www.bd.com/ds. Software license doc-
umentation for all open source software can be found at /usr/share/licenses on the BD FocalPoint Workstation.
Revision Pages Reason
01 All Initial release for Sparks, MD Manufacturing

Table of Contents
Operator’s Manual—BD FocalPointTM GS Imaging System i
Table of Contents
Table of Contents.................................................................................................................. i
List of Figures ..................................................................................................................... ix
Chapter 1: Introduction
Purpose Statement .......................................................................................................... 1-1
Intended Use.................................................................................................................... 1-1
System Overview ............................................................................................................. 1-2
BD FocalPoint Slide Profiler .......................................................................................... 1-2
BD FocalPoint GS Review Station ................................................................................ 1-3
LOI versus FOV ............................................................................................................ 1-3
Using This Manual ........................................................................................................... 1-3
How This Manual is Organized ..................................................................................... 1-3
Document Conventions ................................................................................................. 1-6
Diagnostic Terminology ................................................................................................ 1-6
How to Contact BD Diagnostics....................................................................................... 1-7
In the United States ...................................................................................................... 1-7
Outside of the United States ......................................................................................... 1-7
Chapter 2: BD FocalPoint GS Imaging
System Introduction
BD FocalPoint GS Imaging System................................................................................. 2-1
BD FocalPoint GS Review Station................................................................................... 2-2
BD FocalPoint Slide Profiler Slide Information .............................................................. 2-3
BD FocalPoint GS Imaging System Workflow ................................................................. 2-4
BD FocalPoint Slide Profiler .......................................................................................... 2-4
BD FocalPoint GS Review Station ................................................................................ 2-5
Chapter 3: Guided Screening
Starting the Application.................................................................................................... 3-1
Calibrating the Stage ....................................................................................................... 3-2
Selecting a Slide .............................................................................................................. 3-5
Scan using the Barcode Reader ................................................................................... 3-5
Typing in the Slide Accession Number ......................................................................... 3-5
Mouse Click from the Slide List ..................................................................................... 3-6

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ii Operator’s Manual—BD FocalPointTM GS Imaging System
Screening FOVs............................................................................................................... 3-7
BD FocalPoint GS Review Mode Basics ...................................................................... 3-8
Verifying the Stage Position/Using the OffSet Function ................................................ 3-9
Navigating Through FOVs ............................................................................................. 3-10
Using the Mouse to Navigate ...................................................................................... 3-10
Using the Foot Pedal to Navigate ............................................................................... 3-10
Using the VCR Buttons to Navigate ............................................................................ 3-10
Screening and Triaging Slides ....................................................................................... 3-11
Full Slide Manual Review ............................................................................................ 3-12
Finishing a Slide............................................................................................................. 3-13
Using the Eval Function .............................................................................................. 3-13
Using the No Evaluation Function ............................................................................... 3-15
Assigning a Slide Status ............................................................................................. 3-15
Chapter 4: Screening Slides
Manual Screening............................................................................................................ 4-1
Screen Mode Basics ........................................................................................................ 4-1
Screening Slides .............................................................................................................. 4-3
BD FocalPoint Slide Profiler Processed Slides ............................................................. 4-3
Other Types of Slides ................................................................................................... 4-4
Chapter 5: BD FocalPoint GS Review Station
User Interface
Understanding the Toolbar Buttons ................................................................................. 5-1
LIS Interface ..................................................................................................................5-1
History Button ............................................................................................................... 5-1
Offset Button ................................................................................................................. 5-3
Track Button .................................................................................................................. 5-3
HotDot Button ............................................................................................................... 5-4
Help Button ................................................................................................................... 5-4
Understanding the Control Panel..................................................................................... 5-5
Control Buttons ............................................................................................................. 5-6
Using the slide map ......................................................................................................... 5-7
Slide Status Information ................................................................................................ 5-8
Multiple Slides Found Window ...................................................................................... 5-9
Slide Results Data Color Codes ................................................................................... 5-9
Annotating an FOV ..................................................................................................... 5-10

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Operator’s Manual—BD FocalPointTM GS Imaging System iii
Chapter 6: BD FocalPoint GS Review Station MD and QC Modes
Enhanced QC Review option........................................................................................... 6-1
Enabling Enhanced QC ................................................................................................ 6-2
Chapter 7: Managing the BD FocalPoint GS Review Station Server
Copy Service Basics ........................................................................................................ 7-1
Operating Modes .......................................................................................................... 7-1
Transferring Data .......................................................................................................... 7-2
Restarting Copy Service ............................................................................................... 7-2
Archive Utility Basics........................................................................................................ 7-4
Sign Out........................................................................................................................... 7-5
Signing Out a Batch of Slides ....................................................................................... 7-5
Archive............................................................................................................................. 7-9
Viewing Archived Slide Data ....................................................................................... 7-13
Moving Data to an External Media .............................................................................. 7-17
Searching for a Slide ................................................................................................... 7-17
Chapter 8: Generating BD FocalPoint GS Review Station Reports
Generating Reports.......................................................................................................... 8-1
Opening the BD FocalPoint GS report utility ................................................................. 8-1
Selecting the report type ............................................................................................... 8-2
Selecting the report style .............................................................................................. 8-2
Previewing and printing the report ................................................................................ 8-3
Overview of BD FocalPoint GS Review Station Reports ................................................. 8-4
Summary Reports ......................................................................................................... 8-4
QC Reports ................................................................................................................... 8-7
Generating the Final QC report ..................................................................................... 8-7
Chapter 9: Customizing BD FocalPoint GS Review
Station Lists
Editing BD FocalPoint GS Review Station Lists .............................................................. 9-1
To access the list revision controls ............................................................................... 9-1
Revising the lists ........................................................................................................... 9-3
Chapter 10: The BD FocalPoint Slide Profiler
Slide Profiler Overview................................................................................................... 10-1
System Components ................................................................................................... 10-1
Slide Processing ............................................................................................................ 10-4
Slide Processing Results ............................................................................................... 10-5
Successfully Processed Slides ................................................................................... 10-5

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iv Operator’s Manual—BD FocalPointTM GS Imaging System
Slides Not Successfully Processed ............................................................................. 10-6
Slide Result Report Options........................................................................................... 10-7
Ranking Information .................................................................................................... 10-7
Specimen Adequacy Information ................................................................................ 10-8
Processing Status Information .................................................................................... 10-8
Chapter 11: The BD FocalPoint Slide Profiler Main Window
Main Window ................................................................................................................ 11-2
Help Icon ..................................................................................................................... 11-3
Instrument Icons ......................................................................................................... 11-3
Instrument Status ........................................................................................................ 11-4
Processed Slides ........................................................................................................ 11-4
Task Buttons ............................................................................................................... 11-5
Utilities Button................................................................................................................ 11-6
Usage Statistics .......................................................................................................... 11-8
System Integrity ........................................................................................................ 11-10
System Messages ..................................................................................................... 11-12
Automatic Printing........................................................................................................ 11-13
Backup......................................................................................................................... 11-14
Eject Tray..................................................................................................................... 11-14
Shut Down ................................................................................................................... 11-14
Service Mode Disabled................................................................................................ 11-15
Chapter 12: Using BD FocalPoint Slide Profiler Reports
Understanding Report Printing Operations.................................................................... 12-1
Print Sets .................................................................................................................... 12-1
Printing ........................................................................................................................ 12-2
Reprinting .................................................................................................................... 12-2
Print Summary Statistics ............................................................................................. 12-3
Report Options............................................................................................................... 12-3
Report Types .............................................................................................................. 12-4
Report Sorting Options ............................................................................................... 12-4
Report Layout Options ................................................................................................ 12-5
Sample Reports ........................................................................................................... 12-10
Slide Result Report ................................................................................................... 12-11
Review Report .......................................................................................................... 12-12
QC Review Report .................................................................................................... 12-13
Archive Report .......................................................................................................... 12-14
Process Review Report ............................................................................................ 12-15
Rerun Report ............................................................................................................ 12-16

Table of Contents
Operator’s Manual—BD FocalPointTM GS Imaging System v
Chapter 13: Slides, Coverslips, and Slide Preparations
Types of Slide Preparations Allowed ............................................................................. 13-1
BD SurePath Slides .................................................................................................... 13-1
Slide and Coverslip Standards....................................................................................... 13-2
Slide and Coverslip Dimensions ................................................................................. 13-2
Slide Optical Properties .............................................................................................. 13-3
Coverslip Requirements .............................................................................................. 13-3
Adhesive and Mounting Requirements ....................................................................... 13-3
Staining and Fixative Requirements ........................................................................... 13-4
Barcode Formats ........................................................................................................ 13-4
Chapter 14: Setting BD FocalPoint Slide Profiler Report Options
Slide Report Types ........................................................................................................ 14-1
Sort Order and Layout Options ................................................................................... 14-3
Defining a Report ........................................................................................................ 14-4
Selecting QC Review Report Options............................................................................ 14-5
Chapter 15: Operating the BD FocalPoint Slide Profiler
General Warnings and Cautions.................................................................................... 15-3
Preparing Slides for Processing..................................................................................... 15-3
Applying Barcode Labels ............................................................................................ 15-3
Cleaning Slides ........................................................................................................... 15-4
Loading Trays ................................................................................................................ 15-5
Inserting Slides Into Trays .......................................................................................... 15-5
Changing Preparation Types with Switch Slides ........................................................ 15-6
Removing Slides from Trays ....................................................................................... 15-7
Handling Slide Trays...................................................................................................... 15-7
Loading Trays ............................................................................................................. 15-7
Unloading Trays .......................................................................................................... 15-8
Ejecting Trays ............................................................................................................. 15-8
Monitoring the Instrument During Processing................................................................ 15-9
The Main Window ....................................................................................................... 15-9
Instrument Status Indicator ....................................................................................... 15-10
Printing Reports ........................................................................................................... 15-11
Creating a Print Set (Establishing Rank) .................................................................. 15-12
Analyzing Slide Result Reports.................................................................................... 15-13
Sorting Slides by Action Categories............................................................................. 15-14
When to Manually Screen Slides................................................................................. 15-15
Reprinting Reports....................................................................................................... 15-15
Backing Up Your Data ................................................................................................. 15-21

Table of Contents
vi Operator’s Manual—BD FocalPointTM GS Imaging System
Type of USB Flash Drive to Use (for USB backup systems) .................................... 15-22
Backup Media Archive Reminder .............................................................................. 15-22
Alternate Backup Media Daily ................................................................................... 15-23
Manual Daily Backup ................................................................................................ 15-23
Shutting Down the System........................................................................................... 15-24
Restarting the System.................................................................................................. 15-26
Chapter 16: BD FocalPoint Slide Profiler Maintenance
Maintenance Schedule .................................................................................................. 16-1
Checking the Isolation Table.......................................................................................... 16-2
Cleaning the Trays......................................................................................................... 16-3
Cleaning the Calibration Plate ....................................................................................... 16-3
Inspecting the Air Filter .................................................................................................. 16-5
Cleaning the Monitor...................................................................................................... 16-5
Cleaning the Outer Surfaces of the Instrument.............................................................. 16-6
Printer Maintenance....................................................................................................... 16-7
Cleaning the Mouse....................................................................................................... 16-7
Changing the Backup Media.......................................................................................... 16-8
Chapter 17: BD FocalPoint Slide Profiler
Troubleshooting
In the United States .................................................................................................... 17-1
Outside of the United States ....................................................................................... 17-1
Troubleshooting Guide................................................................................................... 17-2
System Time.................................................................................................................. 17-2
Chapter 18: Processing Conventional Slides on the BD FocalPoint Slide Profiler
Introduction .................................................................................................................... 18-1
Types of Slide Preparations Allowed ............................................................................. 18-1
Conventionally Prepared Pap Smears ........................................................................ 18-1
Slide and Coverslip Standards .................................................................................... 18-2
Adhesive and Mounting Requirements ....................................................................... 18-2
Staining and Fixative Requirements ........................................................................... 18-3
Operating the BD FocalPoint Slide Profiler.................................................................... 18-3
Changing Preparation Types with Switch Slides ........................................................ 18-4
Monitoring the Instrument During Processing ............................................................. 18-4
Processed Slides Field in Main Window ..................................................................... 18-5
Printing Reports .......................................................................................................... 18-6
Creating a Print Set (Establishing Rank) .................................................................... 18-6
Analyzing Slide Result Reports...................................................................................... 18-7

Table of Contents
Operator’s Manual—BD FocalPointTM GS Imaging System vii
Sorting Slides by Action Categories............................................................................... 18-8
When to Manually Screen Slides................................................................................... 18-9
Selecting Slides for QC Rescreening............................................................................. 18-9
Monitoring the Slide Rejection Rate............................................................................. 18-11
Mean Stain Score ..................................................................................................... 18-11
Report Options............................................................................................................. 18-13
Report Types ............................................................................................................ 18-13
Report Sorting Options ............................................................................................. 18-14
Report Layout Options .............................................................................................. 18-14
Chapter 19: Quality Assurance on the BD FocalPoint Slide Profiler
The Quality Assurance Program................................................................................... 19-2
Pre-Installation ............................................................................................................ 19-2
Installation ...................................................................................................................19-3
Post Installation Phase ............................................................................................... 19-6
Selecting Slides for QC Rescreening............................................................................. 19-6
Monitoring the Slide Rejection Rate............................................................................... 19-8
Mean Stain Score ....................................................................................................... 19-8
Training Records.......................................................................................................... 19-10
System Performance Verification................................................................................. 19-11
SI Overview ............................................................................................................... 19-11
Test Information Reporting ....................................................................................... 19-11
Tracking SI Results ................................................................................................... 19-12
System Messages ..................................................................................................... 19-13
Appendix A: BD FocalPoint Slide Profiler Installation Checklist
BD FocalPoint Instrument or Device .............................................................................A-1
Workstation ...................................................................................................................A-1
Electronic Cables ..........................................................................................................A-1
Additional Items Supplied at Startup .............................................................................A-2
Items to be Supplied by the Customer ..........................................................................A-2
Appendix B: BD FocalPoint Slide Profiler Processing
Messages
Slide Not Scanned ........................................................................................................... B-1
Scant Cellularity ............................................................................................................... B-4
Staining Not Within Limits................................................................................................ B-5
Image Quality Not Within Limits....................................................................................... B-6
Other Errors ..................................................................................................................... B-7

Table of Contents
viii Operator’s Manual—BD FocalPointTM GS Imaging System
Appendix C: Warnings and Cautions
Appendix D: BD FocalPoint Slide Profiler
System Integrity
Appendix E: BD FocalPoint Slide Profiler Maintenance Schedule
Appendix F: System Integrity (SI) Results Log
Appendix G: BD FocalPoint Slide Profiler
Slide Rejection Rate Log
Appendix H: BD FocalPoint GS Review Station
Custom Settings
BD FocalPoint GS Settings.............................................................................................. H-2
To access BD FocalPoint GS Review Station settings .................................................H-2
Using the General tab ...................................................................................................H-2
Using the Microscope tab .............................................................................................H-3
Using the Barcode tab ..................................................................................................H-5
Using the Screening tab ................................................................................................H-6
Reports settings ............................................................................................................... H-8
Appendix I: System Requirements
BD FocalPoint GS Review Station ................................................................................. I-1
Electrical Specifications ................................................................................................. I-1
Environmental Operating Conditions ............................................................................. I-1
Environmental Safety ..................................................................................................... I-1
BD FocalPoint Slide Profiler Specifications ...................................................................... I-2
BD FocalPoint Slide Profiler Workstation ....................................................................... I-3
Appendix J: BD FocalPoint GS Review Station
Abbreviations
Appendix K: BD FocalPoint GS Review Station
Maintenance & Troubleshooting
Maintenance procedures ................................................................................................. K-1
Controller/Stage ............................................................................................................K-1
Microscope ....................................................................................................................K-1
Monitor ..........................................................................................................................K-3
Computer ......................................................................................................................K-3
Manufacturing information ............................................................................................K-3
Troubleshooting Guide..................................................................................................... K-3

Table of Contents
Operator’s Manual—BD FocalPointTM GS Imaging System ix
Appendix L: International Contacts
BD FocalPoint Slide Profiler
Quick Reference Guide
Instrument/Device Status Alerts .................................................................................QR-1
Beginning Processing ................................................................................................QR-1
Manual Backup Procedure .........................................................................................QR-1
Shut Down Procedure ................................................................................................QR-1
Start-up Procedure .....................................................................................................QR-3
Symbol Glossary
Index

Table of Contents
x Operator’s Manual—BD FocalPointTM GS Imaging System

List of Figures
Operator’s Manual—BD FocalPointTM GS Imaging System ix
List of Figures
Figure 2-1 BD FocalPoint GS Imaging System.................................................... 2-2
Figure 2-2 Slide Information area......................................................................... 2-3
Figure 2-3 BD FocalPoint GS Imaging System workflow..................................... 2-5
Figure 2-4 BD FocalPoint GS Review Station workflow....................................... 2-6
Figure 3-1 Start, Program, and BD FocalPoint GS menus................................... 3-2
Figure 3-2 Calibrate top edge............................................................................... 3-3
Figure 3-3 Top edge............................................................................................. 3-3
Figure 3-4 Calibrate right edge............................................................................. 3-4
Figure 3-5 Right side edge................................................................................... 3-4
Figure 3-6 Slide Selection window ....................................................................... 3-5
Figure 3-7 Slide Selection window controls.......................................................... 3-6
Figure 3-8 BD FocalPoint GS review mode main display .................................... 3-8
Figure 3-9 Location Confirmation image in the slide map .................................... 3-9
Figure 3-10 VCR Buttons ..................................................................................... 3-11
Figure 3-11 Second FOV in the slide map ........................................................... 3-11
Figure 3-12 Evaluation dialog box........................................................................ 3-13
Figure 3-13 Eval button........................................................................................ 3-13
Figure 3-14 Evaluation dialog box........................................................................ 3-14
Figure 3-15 List of evaluation statements ............................................................ 3-15
Figure 3-16 Assigning a slide status .................................................................... 3-15
Figure 4-1 Main Display ....................................................................................... 4-2
Figure 4-2 Slide map detail .................................................................................. 4-3
Figure 4-3 Electronically added dot...................................................................... 4-3
Figure 4-4 Main screening display ....................................................................... 4-4
Figure 4-5 Slide Selection window ....................................................................... 4-5
Figure 4-6 New Slide dialog box .......................................................................... 4-5
Figure 5-1 LIS toolbar button................................................................................ 5-1
Figure 5-2 Toolbar History button......................................................................... 5-1
Figure 5-3 History dialog box ............................................................................... 5-2

List of Figures
x Operator’s Manual—BD FocalPointTM GS Imaging System
Figure 5-4 History dialog box ............................................................................... 5-3
Figure 5-5 Toolbar Offset button .......................................................................... 5-3
Figure 5-6 Toolbar Track button........................................................................... 5-3
Figure 5-7 Tracking function................................................................................. 5-4
Figure 5-8 Toolbar HotDot button......................................................................... 5-4
Figure 5-9 HotDot not close to target (left) and centered on target (right) ........... 5-4
Figure 5-10 Toolbar Help button ............................................................................ 5-4
Figure 5-11 Control Panel tools.............................................................................. 5-5
Figure 5-12 Selected MSD..................................................................................... 5-6
Figure 5-13 Slide Map detail .................................................................................. 5-7
Figure 5-14 Slide List (emphasized)....................................................................... 5-8
Figure 5-15 Slide Status window............................................................................ 5-8
Figure 5-16 Selection window for slides processed more than once ..................... 5-9
Figure 5-17 Annotated FOV ................................................................................. 5-10
Figure 6-1 QC Review message .......................................................................... 6-2
Figure 6-2 Opening the Administration Tool......................................................... 6-2
Figure 6-3 Enabling Enhanced QC review........................................................... 6-3
Figure 6-4 Enabling Enhanced QC review........................................................... 6-3
Figure 7-1 My Computer menu ............................................................................ 7-3
Figure 7-2 Service and Applications menu........................................................... 7-3
Figure 7-3 APSW61 Service selection ................................................................. 7-3
Figure 7-4 APSW61 Properties menu.................................................................. 7-4
Figure 7-5 Automatic copy service restarted........................................................ 7-4
Figure 7-6 BD FocalPoint GS - Administration icon ............................................. 7-5
Figure 7-7 Pathway to BD FocalPoint GS - Administration.................................. 7-5
Figure 7-8 BD FocalPoint GS - Administration Tool............................................. 7-6
Figure 7-9 BD FocalPoint GS - Administration Tool (Slide Sign Out) .................. 7-6
Figure 7-10 BD FocalPoint GS - Administration Tool (Slide Sign Out details)....... 7-8
Figure 7-11 BD FocalPoint GS - Administration Tool (Archive Signed Out Slides) 7-9
Figure 7-12 BD FocalPoint GS - Administration Tool (Archive Results) .............. 7-10
Figure 7-13 Archived slide report ......................................................................... 7-10
Figure 7-14 BD FocalPoint GS - Administration Tool
(Close Archive Signed Out Slides) .................................................... 7-11
Figure 7-15 BD FocalPoint GS - Reports............................................................. 7-12
Figure 7-16 My Computer menu .......................................................................... 7-12

List of Figures
Operator’s Manual—BD FocalPointTM GS Imaging System xi
Figure 7-17 My Computer menu (archived slide folders) ..................................... 7-13
Figure 7-18 My Computer menu (archived slide data)......................................... 7-13
Figure 7-19 My Network Places menu ................................................................. 7-14
Figure 7-20 Map Network Drive menu ................................................................. 7-14
Figure 7-21 BD FocalPoint GS - Archive icon...................................................... 7-14
Figure 7-22 BD FocalPoint GS - Archive (Select archive directory)..................... 7-15
Figure 7-23 BD FocalPoint GS - Archive (Select archived slides folder) ............. 7-15
Figure 7-24 BD FocalPoint GS - Archive (Select archived slides to view) ........... 7-16
Figure 7-25 BD FocalPoint GS - Archive (view archived slide FOV).................... 7-16
Figure 7-26 Search for Files or Folders................................................................ 7-17
Figure 7-27 Search menu..................................................................................... 7-17
Figure 7-28 Search menu (enter search criteria) ................................................. 7-18
Figure 7-29 Search menu (located file)................................................................ 7-18
Figure 8-1 BD FocalPoint GS Report utility.......................................................... 8-2
Figure 8-2 Select Report Type panel ................................................................... 8-2
Figure 8-3 QC report (sorted by rank).................................................................. 8-3
Figure 8-4 Final QC Report detail ........................................................................ 8-8
Figure 9-1 BD FocalPoint GS Administration Tool (instructions) ......................... 9-2
Figure 9-2 BD FocalPoint GS Administration Tool (list controls).......................... 9-2
Figure 9-3 Adding a row to a list........................................................................... 9-4
Figure 10-1 The BD FocalPoint Slide Profiler ...................................................... 10-2
Figure 11-1 BD FocalPoint™ Profiler Main Window ............................................ 11-2
Figure 11-2 Help Icon........................................................................................... 11-3
Figure 11-3 Instrument Icons ............................................................................... 11-3
Figure 11-4 Main Window Instrument Status field................................................ 11-4
Figure 11-5 Main Window Processed Slides field................................................ 11-5
Figure 11-6 Main Window Task Buttons .............................................................. 11-5
Figure 11-7 Utilities window ................................................................................. 11-6
Figure 11-8 Statistics Window.............................................................................. 11-7
Figure 11-9 Usage Statistics Report window ....................................................... 11-8
Figure 11-10 Example of daily usage statistics...................................................... 11-9
Figure 11-11 View SI Statistics window ............................................................... 11-10
Figure 11-12 Example of system integrity statistics (monthly) ............................. 11-11
Figure 11-13 System Messsages menu............................................................... 11-12
Figure 11-14 Automatic Printing window.............................................................. 11-13

List of Figures
xii Operator’s Manual—BD FocalPointTM GS Imaging System
Figure 11-15 Shutdown window........................................................................... 11-14
Figure 12-1 Print Summary Statistics................................................................... 12-3
Figure 12-2 Slide result report, tray layout ........................................................... 12-7
Figure 12-3 Slide Result Report (slide layout, sorted by date)............................. 12-9
Figure 12-4 Example of a Slide Result Report................................................... 12-11
Figure 12-5 Example of a Review Report (Sorted by Rank) .............................. 12-12
Figure 12-6 Example of a QC Review Report (Sorted By Rank) ....................... 12-13
Figure 12-7 Example of Archive Report ............................................................. 12-14
Figure 12-8 Example of a Process Review Report ............................................ 12-15
Figure 12-9 Example of a Rerun Report ............................................................ 12-16
Figure 13-1 Example of a BD SurePath slide....................................................... 13-2
Figure 13-2 Slide and coverslip dimensions......................................................... 13-3
Figure 13-3 Slide thickness, adhesive and coverslip mounting specifications..... 13-4
Figure 14-1 Example of Report Type drop down menu ...................................... 14-2
Figure 14-2 Defining a QC Report........................................................................ 14-6
Figure 15-1 Typical laboratory workflow using the BD FocalPoint Slide Profiler.. 15-2
Figure 15-2 Four example switch slides............................................................... 15-6
Figure 15-3 Main Window .................................................................................... 15-9
Figure 15-4 Print Summary Statistics................................................................. 15-13
Figure 15-5 Reprint window ............................................................................... 15-15
Figure 15-6 Slide Selection Options................................................................... 15-16
Figure 15-7 Reprint Reports - by Barcode Range............................................. 15-17
Figure 15-8 Reprint by Barcode Screen............................................................. 15-18
Figure 15-9 Reprint Reports - by Date/Time Range........................................... 15-19
Figure 15-10 Reprint Reports—by Print Set........................................................ 15-20
Figure 15-11 Print Summary for reprinted report ................................................. 15-21
Figure 15-12 Daily Backup Status message ........................................................ 15-22
Figure 15-13 Archive Backup Media message..................................................... 15-23
Figure 15-14 Password window ........................................................................... 15-25
Figure 16-1 Cleaning the slide trays..................................................................... 16-3
Figure 16-2 Inspecting the air filter....................................................................... 16-5
Figure 18-1 Slide and coverslip dimensions......................................................... 18-1
Figure 18-2 Slide thickness, adhesive and coverslip mounting specifications..... 18-2
Figure 18-3 Conventional switch slides................................................................ 18-4
Figure 18-4 Processed Slides field in Main Window ............................................ 18-5

List of Figures
Operator’s Manual—BD FocalPointTM GS Imaging System xiii
Figure 18-5 Print Summary Statistics................................................................... 18-7
Figure 18-6 Usage Statistics options.................................................................. 18-11
Figure 18-7 Usage statistics............................................................................... 18-12
Figure 18-8 Slide result report, tray layout ......................................................... 18-16
Figure 18-9 Slide Result Report (slide layout, sorted by barcode)..................... 18-18
Figure 19-1 BD FocalPoint Slide Profiler QA program......................................... 19-2
Figure 19-2 Pre-installation phase activities......................................................... 19-3
Figure 19-3 Installation phase activities ............................................................... 19-3
Figure 19-4 Laboratory Process Compatibility Assessment procedures.............. 19-5
Figure 19-5 Usage Statistics options.................................................................... 19-9
Figure 19-6 Usage Statistics .............................................................................. 19-10
Figure 19-7 Statistic Reports—System Integrity ................................................ 19-12
Figure 19-8 System Integrity Statistics............................................................... 19-13
Figure 19-9 Statistics window............................................................................. 19-14
Figure 19-10 System Messages........................................................................... 19-15
Figure H-1 Settings, General tab ..........................................................................H-2
Figure H-2 Settings, Microscope tab.....................................................................H-3
Figure H-3 Configure Objective dialog box...........................................................H-4
Figure H-4 Settings, Barcode tab..........................................................................H-5
Figure H-5 Settings, Screening tab.......................................................................H-6
Figure H-6 Slide Type options ..............................................................................H-6
Figure H-7 Left- and right-handed Main Window..................................................H-7
Figure H-8 Report Setup portion...........................................................................H-7
Figure H-9 Report Setup dialog box .....................................................................H-8
Figure H-10 Institution Name tab............................................................................H-8
Figure K-1 Slide holder alignment, upper-right slide corner .................................K-2
Figure K-2 Slide holder alignment, upper-left slide corner....................................K-2

List of Figures
xiv Operator’s Manual—BD FocalPointTM GS Imaging System

Chapter 1: Introduction Purpose Statement
Operator’s Manual—BD FocalPointTM GS Imaging System 1-1
Chapter 1
Introduction
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.
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.
Intended Use
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 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.

System Overview Chapter 1: Introduction
1-2 Operator’s Manual—BD FocalPointTM GS Imaging System
BD FocalPoint
GS Imaging
System
The FocalPoint GS Imaging System is intended to assist in cervical
cancer screening of both conventionally-prepared and BD SurePath
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 15 fields of view (FOVs) most
likely to contain abnormal cells. The BD FocalPoint GS Imaging
System identifies up to 25% of successfully processed slides as
requiring no further review. The BD FocalPoint GS Imaging System
also identifies at least 15% of all successfully processed slides with the
FocalPoint Slide Profiler “Directed QC Technology” for a directed QC
re-screen. Intended users are trained cytology laboratory personnel
operating under the direct supervision of a qualified cytology
supervisor or laboratory manager/director.
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.
BD FocalPoint
Slide Profiler The BD FocalPoint Slide Profiler is an automated cytology screening
device that classifies slides. The slides are classified 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.
BD FocalPoint
GS Review
Station
The BD FocalPoint GS Review Station reads 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.
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 is referred to as the field of view or a