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BD FocalPoint GS User Manual

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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.com/e-labeling

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Summary of Contents for BD FocalPoint GS

  • Page 1 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.com/e-labeling...
  • Page 2 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.

  • Page 3: Table Of Contents

    1.6.1 In the United States ..................14 1.6.2 Outside of the United States ................14 BD FocalPoint™ GS Imaging System Introduction ............... 15 BD FocalPoint™ GS Imaging System ................ 15 BD FocalPoint™ GS Review Station ................16 2.2.1 BD FocalPoint™ Slide Profiler Slide Information ........... 16 BD FocalPoint™...
  • Page 4 5.3.2 Multiple Slides Found Window............... 53 5.3.3 Slide Results Data Color Codes ..............53 BD FocalPoint™ GS Review Station MD and QC Modes............. 55 Enhanced QC Review option..................55 6.1.1 Enabling Enhanced QC ................. 56 Managing the BD FocalPoint™ GS Review Station Server ..........59 Copy Service Basics ....................
  • Page 5 Table of Contents 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 Customizing BD FocalPoint™ GS Review Station Lists ............87 Editing BD FocalPoint™ GS Review Station Lists............87 9.1.1...
  • Page 6 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 ..................
  • Page 7 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............
  • Page 8 BD FocalPoint™ GS Imaging System Instrument User’s Manual 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................
  • Page 9 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....................
  • Page 10 BD FocalPoint™ GS Imaging System Instrument User’s Manual...

  • Page 11: Introduction

    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™...

  • Page 12: System Overview

    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...

  • Page 13: Document Conventions

    Introduction 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.

  • Page 14: Diagnostic Terminology

    The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses. 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...

  • Page 15: 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.

  • Page 16: Bd Focalpoint™ Gs Review Station

    BD FocalPoint™ GS Imaging System Instrument User’s Manual 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.

  • Page 17: Bd Focalpoint™ Gs Imaging System Workflow

    Table 2-1 – Physical Dimensions 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™...
  • Page 18 Cytology Reports 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™...

  • Page 19: Bd Focalpoint™ Gs Review Station

    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.
  • Page 20 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.

  • Page 21: Guided Screening

    Guided Screening This section reviews the process of reviewing FOVs on the BD FocalPoint™ GS Review Station. This process is used to evaluate a slide using guided screening. As previously discussed in Section 2, all BD SurePath™ Liquid-based Pap Test slides are initially processed on the BD FocalPoint™...

  • Page 22: Calibrating The Stage

    BD FocalPoint™ Slide Profiler data. This section details the tasks performed in this mode. Table 3-1 – Menu options and tasks When the BD FocalPoint™ GS Review application is first opened, the user is instructed to calibrate the stage. Calibrating the Stage In order to set the x and y coordinates of the microscope stage, a stage calibration must be performed to establish the reference point.
  • Page 23 Guided Screening Use the following steps to calibrate the stage. NOTE Perform the calibration process with the same magnification (for example 10x) that is used for screening slides. Put the slide securely on the stage with the label on the left. WARNING MAKE SURE THAT THE CLIP GRIPS THE SLIDE EDGE SECURELY.
  • Page 24 BD FocalPoint™ GS Imaging System Instrument User’s Manual Top edge Figure 3-3 – Top edge Focus the image again, and then recheck the alignment. When the stage location is correct, select OK to continue. The following dialog box opens. Figure 3-4 – Calibrate right edge Move the stage to position the right edge of the slide as demonstrated in Figure 3-5 and center the slide edge in the center of the field of view.

  • Page 25: Selecting A Slide

    Guided Screening NOTE To aid in locating the right side edge, bring the slide to the top right corner so that the top edge and right edge are in view. Then center the right edge. This aids in visualizing the actual edge of the slide as the clip may appear too dark to allow for slide vs.

  • Page 26: Scan Using The Barcode Reader

    Position the cursor in the Enter Slide ID box, and delete any numbers already displayed. Use the BD FocalPoint™ GS Review Station keyboard to type in the number from the slide label. The BD FocalPoint™ GS Review Station will recognize the number and access the information in the database.

  • Page 27: Select From The Slide List

    To identify the slide by selecting it from the slide list, use your mouse to select the slide accession number from the list. The BD FocalPoint™ GS Review Station will access the information in the database. Your slide is listed at the top of the slide list and the processing results are displayed in the slide results data area.

  • Page 28: Screening Fovs

    Table 3-2 – Slide Selection window buttons Screening FOVs If the BD SurePath™ slide was successfully processed by the BD FocalPoint™ Slide Profiler and FOVs are available for that slide then the Review button will be enabled. NOTE Some slides may not have FOVs available, i.e., Process Review,...

  • Page 29: Bd Focalpoint™ Gs Review Mode Basics

    Figure 3-8 – BD FocalPoint™ GS review mode main display Primary image area The primary image area is used to display the FOV images captured from the BD FocalPoint™ Slide Profiler. These black and white, 20x magnification images are not to be used for diagnostic purposes and are provided for location verification only.

  • Page 30: Verifying The Stage Position/Using The Offset Function

    BD FocalPoint™ GS Imaging System Instrument User’s Manual 3.4.2 Verifying the Stage Position/Using the Offset Function When reviewing FOVs, the stage moves according to the location coordinates recorded in the database for that slide. Before beginning reviewing, the stage position must be verified.

  • Page 31: Navigating Through Fovs

    Navigating Through FOVs Remember, the Review button enables FOV review. If the slide has been successfully processed on the BD FocalPoint™ Slide Profiler and FOV images are available, the system enables the review mode. Use the mouse, foot pedal or Navigation buttons to navigate to each FOV as described below.

  • Page 32: Using The Navigation Buttons

    BD FocalPoint™ GS Imaging System Instrument User’s Manual 3.5.3 Using the Navigation Buttons Use the mouse to select Navigation. See Figure 3-10. First FOV Back Last FOV Forward Navigation Buttons Figure 3-10 – Navigation Buttons When advancing from FOV to FOV, the color of the dot on the slide map changes from black to pink indicating the FOV has been reviewed.
  • Page 33 Guided Screening The following table indicates recommended screening action guidelines: (individual laboratory policies may differ) BD FocalPoint™ Situation Summary Action Slide Information findings Any age, all patients ABNORMAL FOV plus Full Slide Review Abnormal ECC+ / ECC– Cyclic Patient, ECC+...

  • Page 34: Full Slide Manual Review

    Samples of low or inadequate squamous cellularity must be considered at increased risk for harboring a significant lesion, and thus deserve additional attention during the screening process. (Refer to the BD FocalPoint™ GS Imaging System product insert.) 3.6.1 Full Slide Manual Review To perform a full slide review, use the manual stage controls on the microscope and perform a full slide manual review.

  • Page 35: Using The Eval Function

    Guided Screening 3.7.1 Using the Eval Function After finishing FOV or FSR screening, click the Eval control button from either the Screen or Review window to bring up the Evaluation form. Figure 3-13 – Eval button The Evaluation dialog box, illustrated in Figure 3-14 is displayed. Figure 3-14 –...

  • Page 36: Using The No Evaluation Function

    BD FocalPoint™ GS Imaging System Instrument User’s Manual To use one of the listed statements, scroll the list to display the desired statement, and then left-click on it to add the statement to the evaluation. Figure 3-15 – List of evaluation statements To add additional notes or comments, type them in the Notes box.

  • Page 37: Assigning A Slide Status

    Awaiting further review (AFR) is selected when the slide requires further review by a second individual such as a pathologist. Slides queued up as Awaiting further review can be retrieved using the BD FocalPoint™ GS Review Station in either GS review mode or by the second reviewer.
  • Page 38 BD FocalPoint™ GS Imaging System Instrument User’s Manual To continue with the next slide, scan in the next slide barcode to bring up all the appropriate slide information, and then click OK. 10 Continue reviewing slides. When finished, click the Exit icon to close the application.

  • Page 39: Screening Slides

    Manual full slide review (FSR) Manual Screening A full slide, manual review is performed at the BD FocalPoint™ GS Review Station using the microscope’s manual stage controls. Areas of interest on the slide can be marked using traditional methods such as a dotting pen.
  • Page 40 BD FocalPoint™ GS Imaging System Instrument User’s Manual Toolbar Buttons The toolbar buttons are used to turn BD FocalPoint™ GS Review Station features on and off, and to control various functions during the screening process. Information on how and when to use these features is described as it occurs in the workflow (refer to Section 5 for additional information).

  • Page 41: Screening Slides

    Screening Slides When adding an electronic dot, the BD FocalPoint™ GS Review Station adds a blue dot to the slide map and saves the location coordinates. Figure 4-3 illustrates the BD FocalPoint™ GS Review Station display as it appears when adding a new dot.

  • Page 42: Other Types Of Slides

    FOV. Refer to Annotating an FOV in Section 5. When slide evaluation is complete, proceed to Section 3.7. 4.3.2 Other Types of Slides There are two options to screen slides not processed on the BD FocalPoint™ Slide Profiler: • Manual screening with manual dotting •...
  • Page 43 Select the preparation type for the slide to screen and then click OK to manually screen the slide. When finished manually screening the slide, proceed to Section 3.7. NOTE Because this slide was not processed by the BD FocalPoint™ Slide Profiler, it is not a candidate for BD FocalPoint™ GS System-directed QC review.
  • Page 44 BD FocalPoint™ GS Imaging System Instrument User’s Manual...

  • Page 45: Bd Focalpoint™ Gs Review Station User Interface

    BD FocalPoint™ GS Review Station with this interface. The LIS button is turned off when the BD FocalPoint™ GS Review Station is first started. Before this button can be used, settings to identify your LIS application must be customized by the BD Service personnel.

  • Page 46: Track Button

    BD FocalPoint™ GS Imaging System Instrument User’s Manual The Offset button will re-align the x/y coordinates of the stage position as needed after calibrating the stage. Refer to Verifying the Stage Position/Using the Offset Function in Section 3 for details on how to perform the offset.

  • Page 47: Help Button

    The Help button provides a help file and an index of useful help topics. The Help window opens in a secondary window that can be re-sized and positioned as desired. Either keep it open for future reference, or close it to return to the BD FocalPoint™ GS software application. 5.1.5 Most Significant Dot Button Figure 5-6 illustrates the use of the Most Significant Dot function.

  • Page 48: Delete Field Button

    BD FocalPoint™ GS Imaging System Instrument User’s Manual 5.1.6 Delete Field Button Figure 5-7 illustrates the use of the Delete function. Removes a location recently added by the current user Figure 5-7 – Delete Button Click Delete Field to remove the image and location coordinates for the selected dot. Only electronically added dots from the current session can be deleted.

  • Page 49: Eval Button

    The Navigation buttons are: Beginning (back to the first dot), Rewind (back one dot), Forward (ahead one dot), and End (ahead to the last marked dot). LOIs marked by the BD FocalPoint™ Slide Profiler appear as black dots in the slide map area.

  • Page 50: Understanding The History Panel

    BD FocalPoint™ GS Imaging System Instrument User’s Manual Understanding the History Panel The History Panel (Figure 5-12) shows slide information or cytologic interpretations made by previous reviewers using the BD FocalPoint GS Review Station. Figure 5-12 – History Panel CAUTION This feature provides the history of BD FocalPoint™...
  • Page 51 BD FocalPoint™ GS Review Station User Interface Border Outline Color Indicates A red border indicates a Location Confirmation LOI. If available, this will be the first LOI for the slide and has been selected by the BD FocalPoint™ Slide Profiler to aid in confirming the position of the stage.

  • Page 52: Slide Status Information

    BD FocalPoint™ GS Imaging System Instrument User’s Manual 5.3.1 Slide Status Information Slides are assigned different icons with associated colors based on their processing and interpretation status. As illustrated in Figure 5-14, these icons are displayed just to the left of the slide list.

  • Page 53: Multiple Slides Found Window

    Profiler. Usually, this is because the slide was indicated as Rerun or Process Review the first time through the BD FocalPoint™ Slide Profiler and was put back into the system. If a slide with an M next to it is selected for review, a dialog window similar to the one in Figure 5-16 will appear.
  • Page 54 BD FocalPoint™ GS Imaging System Instrument User’s Manual...

  • Page 55: Bd Focalpoint™ Gs Review Station Md And Qc Modes

    Table 6-1 – Operating modes 6.1 Enhanced QC Review option The enhanced QC option notifies the user of slides that the BD FocalPoint™ Slide Profiler designated as QC Review. This option is enabled by default. This notification (see Figure 6-1) occurs when the slide is assigned the Ready for Signout status.

  • Page 56: 6.1.1 Enabling Enhanced Qc

    FocalPoint™ GS - Administration (see Figure 6-2). Figure 6-2 – Opening the Administration Tool The BD FocalPoint™ GS Administration Tool main screen is displayed (see Figure 6-3). From the main screen, select Sign Out. Figure 6-3 – Enabling Enhanced QC review...
  • Page 57 When Enable Enhanced QC review is selected, after a slide's initial review, information is provided whether or not it was selected by the BD FocalPoint™ Slide Profiler for QC review. Slides selected this way are assigned the status Awaiting QC Review.
  • Page 58 BD FocalPoint™ GS Imaging System Instrument User’s Manual...

  • Page 59: Managing The Bd Focalpoint™ Gs Review Station Server

    Managing the BD FocalPoint™ GS Review Station Server This section discusses the flow of data into and out of the BD FocalPoint™ GS Server. Two utilities manage this process: Copy Service and Archive. • The Copy Service transfers data to the BD FocalPoint™ GS Server.

  • Page 60: Transferring Data

    Double-click the FocalPoint™ GS Copy Service shortcut on the desktop of the BD FocalPoint™ GS Server. Slide data for all print sets run on the BD FocalPoint™ Slide Profiler, but not yet downloaded, is copied to the BD FocalPoint™ GS Server. Once copied, slide data is ready to review.

  • Page 61: Restarting Copy Service

    No slide information or images would have been sent to the workstations. Call BD Technical Service and Support, and a representative can walk the system administrator through the steps.

  • Page 62: Archive Utility Basics

    Under normal use the server accumulates significant amounts of slide data. For example, full capacity use of the BD FocalPoint™ GS Review Station could generate as much as 450 MB of data a week (7 business days) per each BD FocalPoint™ GS Review Station.

  • Page 63: Sign Out

    7.3.1 Signing Out a Batch of Slides The BD FocalPoint™ GS Review Station is a closed system (unless it has been interfaced with your LIS system). Signing out a case refers to removing it from the slide list at the BD FocalPoint™...
  • Page 64 BD FocalPoint™ GS Imaging System Instrument User’s Manual If there is no BD FocalPoint™ GS - Administration icon on your desktop, select: Programs†FocalPoint™ GS†FocalPoint™ GS -Tools†FocalPoint™ GS - Administration. Figure 7-7 – Pathway to BD FocalPoint™ GS - Administration Click Sign Out in the BD FocalPoint™ GS - Administration Tool window.
  • Page 65 In the Date Selection area, use the calendar to select the day for sign out. Slides processed on the BD FocalPoint™ Slide Profiler before the selected date will be signed out. For example, if May 17 is selected, slides processed through May 16 will be signed out.

  • Page 66: Archive

    Slides that meet your selected criteria will be unsigned out. NOTE Archived slides cannot be unsigned out. Figure 7-10 – BD FocalPoint™ GS - Administration Tool (Slide Sign Out details) When the date and slide(s) have been selected, click Sign Out. Archive After clicking Sign Out on the Slide Sign Out window, the Archive button turns green and the Archive Signed Out Slides window appears for archiving previously signed out slides.
  • Page 67 Click Archive Now. The slides that have met the selected criteria will be archived. These slides will be moved out of the database and will no longer be part of the slide list on the BD FocalPoint™ GS Review Station.
  • Page 68 A window appears to confirm closing the application. Click YES to continue. Figure 7-14 – BD FocalPoint™ GS - Administration Tool (Close Archive Signed Out Slides) The Finish button on the display turns red. This indicates that signing out and archiving the slide(s) is now complete.
  • Page 69 Managing the BD FocalPoint™ GS Review Station Server To determine how many slides/batches are in the database: From the Windows Start menu, select Programs†FocalPoint™ GS† FocalPoint™ GS -Tools†FocalPoint™ GS - Reports. Select Report Type†Summary Reports. Select Report Style†All Slides. Select Generate Report.
  • Page 70 BD FocalPoint™ GS Imaging System Instrument User’s Manual A different folder exists for each time slides were archived. NOTE The name of the folder starts with “SWArchive” and also contains the date and time that slides were archived. Click on the + for the desired archive folder. The slide folders for that archive appear.

  • Page 71: Viewing Archived Slide Data

    Viewing Archived Slide Data Once the slides have been archived (removed from the database on the server), they might need to viewed again. This can be done by opening the Archive Application at the BD FocalPoint™ GS Review Station. First, ensure that the BD FocalPoint™ GS Review Station has been properly mapped on the network to receive this information.
  • Page 72 FocalPoint™ GS - Archive icon on the desktop. Figure 7-21 – BD FocalPoint™ GS - Archive icon In the BD FocalPoint™ GS - Archive menu click Browse button to Select Archive Directory. Figure 7-22 – BD FocalPoint™ GS - Archive (Select archive directory) In the window that appears, select the Archives folder located in the Local Disk (C:) drive.
  • Page 73 12 The list of slides in the folder appears. Use the drop-down menu to select the slide to view. Figure 7-24 – BD FocalPoint™ GS - Archive (Select archived slides to view) 13 The FOVs that were archived can now be viewed. Use the same mechanisms to move from one FOV to another as in the BD FocalPoint™...

  • Page 74: Moving Data To An External Media

    BD FocalPoint™ GS Imaging System Instrument User’s Manual 7.4.2 Moving Data to an External Media After archiving data, back up the data by moving the folders that were created on the C: drive to an external hard drive. An alternative method to backing up files is to archive directly to an external hard drive. To do this, instead of using the default destination pathway to the C: drive, set up a new pathway.
  • Page 75 Figure 7-29 – Search menu (located file) NOTE If the search is performed at a BD FocalPoint™ GS Review Station, click over the located slide and click Send to My Documents on the Review Station. To review the FOV for that slide, browse My...
  • Page 76 BD FocalPoint™ GS Imaging System Instrument User’s Manual...

  • Page 77: Generating Bd Focalpoint™ Gs Review Station Reports

    Generating BD FocalPoint™ GS Review Station Reports This section discusses the reports available from the BD FocalPoint™ GS Review Station. To view, customize, or print slide data reports, use the BD FocalPoint™ GS Review Station Report utility. Generating Reports There are a number of different data management and statistical reports that can be generated at the BD FocalPoint™...

  • Page 78: Selecting The Report Type

    BD FocalPoint™ GS Imaging System Instrument User’s Manual 8.1.2 Selecting the report type Select the type of report to be created. From the Report utility work flow panel, click the Select Report Type button. The Select Report Type panel is displayed beneath the work flow panel.

  • Page 79: Overview Of Bd Focalpoint™ Gs Review Station Reports

    There are three types of reports that can be generated: summary, custom, and QC. 8.2.1 Summary Reports Summary reports can either display a summary of BD FocalPoint™ GS Review Station processing activity for the selected time period (month, week, or day), or all of the slides currently stored in the database.
  • Page 80 NOTE The meaning of the term “archive” on the BD FocalPoint™ GS Review Station is different than the meaning for the BD FocalPoint™ Slide Profiler. On the BD FocalPoint™ GS Review Station it means the slide data has been removed from the database and stored on external media.
  • Page 81 NFR (No Further Review) by the BD FocalPoint™ Slide Profiler. Note: This column displays 0 for BD SurePath™ slides in the United States because the BD FocalPoint™ GS Imaging System combined with No Further Review is not available.
  • Page 82 (i.e., the categories were modified using the BD FocalPoint™ GS Review Station Administration Tool), a warning message will appear at the bottom of the report and there will be no breakdown of archived slides by category.

  • Page 83: Qc Reports

    8.2.2 QC Reports The QC report details the progress of BD FocalPoint™ GS Review Station processing for each slide in the print set. Generating interim versions of this report and analyzing this progress determines when it is appropriate to generate the Final QC Report that details which slides are the most appropriate candidates for QC rescreening.

  • Page 84: Generating The Final Qc Report

    8.2.3 Generating the Final QC report As described previously in this section, the BD FocalPoint™ GS System Results - By Rank report details the progress of BD FocalPoint™ GS Review Station processing for each slide in the print set. When generating a QC report, if all slides in the print set have not yet been reviewed, the report is considered preliminary.
  • Page 85 Generating BD FocalPoint™ GS Review Station Reports Figure 8-4 illustrates the first page of a typical final QC report. FocalPoint QC Review slides Review slides Figure 8-4 – Final QC Report detail...
  • Page 86 BD FocalPoint™ GS Imaging System Instrument User’s Manual...

  • Page 87: Customizing Bd Focalpoint™ Gs Review Station Lists

    Archive and Lists functions. Managing the BD FocalPoint™ GS Review Station Server details how to use the archive portion of this utility. This section describes how to customize the lists that are used in the BD FocalPoint™ GS Review Station user interface. Editing BD FocalPoint™ GS Review Station Lists The BD FocalPoint™...
  • Page 88 Figure 9-2 illustrates the basic controls used to work with lists. Figure 9-2 – BD FocalPoint™ GS Administration Tool (list controls) List controls The following table details the functions of the controls available on the BD FocalPoint™ GS Administration Tool when working with lists. Group...

  • Page 89: Revising The Lists

    Delete Remove the current line. Table 9-1 – BD FocalPoint™ GS Administration Tool controls The controls discussed in Table 9-1 are common to all four lists. The steps performed to add, delete, or edit a list are essentially the same. All that differs is the name and type of list that is being worked on.
  • Page 90 BD FocalPoint™ GS Imaging System Instrument User’s Manual To add a new row to a list Open the BD FocalPoint™ GS Administration Tool. Click the list type button that corresponds to the list to be viewed or edited. Position the cursor over the desired row, and click the left mouse button.

  • Page 91: The Bd Focalpoint™ Slide Profiler

    Slide Result Report Options , provides an overview of the printed slide result reports. • 10.1 BD FocalPoint™ Slide Profiler Overview This section provides a brief overview of the following aspects of the BD FocalPoint™ Slide Profiler: • Description of the workstation and instrument components •...
  • Page 92 BD FocalPoint™ GS Imaging System Instrument User’s Manual Workstation Components The following table provides a detailed description of the workstation components. The number following each item corresponds to the numbered component locations illustrated in Figure 10-1. Workstation Components Keyboard and Mouse...
  • Page 93 The BD FocalPoint™ Slide Profiler Tray Handling System (not pictured) The tray handling system moves trays from the input hopper to the microscope stage, to various scanning positions on the stage, and to the output hopper. Trays are lowered with an input hopper elevator, pulled onto the stage with a transport chain, positioned on the stage, and when processing is complete, raised to the output hopper.

  • Page 94: Slide Processing

    Each prepared Pap test (BD SurePath™ or conventional Pap smear) slide is affixed with a slide barcode label and loaded into a BD FocalPoint™ slide tray, which holds up to eight slides. Up to 36 trays can be placed in the input hopper for automatic slide processing.

  • Page 95: Successfully Processed Slides

    QC Review (Rescreen) Slides During normal operation, up to 15% of the highest ranking slides interpreted as NILM by the cytotechnologist and classified as Review by the BD FocalPoint™ Slide Profiler are selected for directed QC rescreening. Refer to Section 19 for a detailed description of recommended QC procedures.

  • Page 96: Slides Not Successfully Processed

    Slides receiving an action of Process Review could not be analyzed because of slide physical characteristics or specimen limitations. Some Process Review slides with physical damage can be repaired and rerun on the BD FocalPoint™ Slide Profiler. If a slide cannot be rerun, it must be manually screened.

  • Page 97: Ranking Information

    10.4.1 Ranking Information Some of your Review slides may have been classified by the BD FocalPoint™ as scant cellularity. These slides do not have associated ranking information. The reason for the scant cellularity classification is that there are not an adequate number of reference cells on the slide to successfully qualify and rank the slide.

  • Page 98: Processing Status Information

    Processing Status Information Each slide result report confirms if the slide was completely and successfully imaged by the BD FocalPoint™ Slide Profiler. If a slide was not successfully processed, a message stating the reason for the unsuccessful scan accompanies the status.

  • Page 99: The Bd Focalpoint™ Slide Profiler Main Window

    The BD FocalPoint™ Slide Profiler Main Window The BD FocalPoint™ Slide Profiler consists of an instrument and a computer workstation. The instrument processes the slides and calculates the slide results. The workstation, consisting of a computer and a color monitor, runs the workstation software that displays the windows-based, graphical Main Window.

  • Page 100: Main Window

    11.1 Main Window The BD FocalPoint™ Slide Profiler Main Window is the highest level window. That is, it appears when the workstation software is started and it remains visible while performing various screening tasks. Figure 11-1 illustrates a typical BD FocalPoint™ Slide Profiler Main Window.

  • Page 101: Instrument Icons

    A Home button to the right of the instrument bar indicates which instrument screen is in use and can be used to return to the Main Window. See Section 15, Main Window Operating the BD FocalPoint™ Slide Profiler, for detailed information on the Main Window instrument icons.

  • Page 102: Processed Slides

    Figure 11-5 – Main Window Processed Slides field 11.1.5 Task Buttons There are three task buttons located in the lower portion of the BD FocalPoint™ Slide Profiler Main Window: Report, Reprint, and Utilities (see Figure 11-6). Figure 11-6 – Main Window Task Buttons...

  • Page 103: Utilities Button

    The BD FocalPoint™ Slide Profiler Main Window Each task button is described in the following subsections. Report Button • Select the Report button to display the Report window which is used to print reports. The following sections contain detailed information on subjects related to printing: •...

  • Page 104: Usage Statistics

    BD FocalPoint™ GS Imaging System Instrument User’s Manual Each of the Utilities commands is described below. Select the Statistics button to access the following types of reports (see Figure 11-8): Each window function is described below. • Usage Statistics •...
  • Page 105 The BD FocalPoint™ Slide Profiler Main Window To display and print usage statistics: Choose Statistics Usage Statistics to display the window illustrated in Figure 11-9. † Figure 11-9 – Statistics Report Window Select the appropriate button for the desired time.

  • Page 106: System Integrity

    BD FocalPoint™ GS Imaging System Instrument User’s Manual Choose Back again to return to the Statistic Reports window; click on the question mark to view the Help screen. Figure 11-10 – Example of daily usage statistics 11.2.2 System Integrity This command allows the user to monitor the system’s performance for quality assurance purposes.

  • Page 107: System Messages

    The BD FocalPoint™ Slide Profiler Main Window Month — Displays statistics for a current month and year. To specify a different date, select the Edit button in the appropriate field (month or year) and use the arrow buttons to select the desired date.

  • Page 108: Automatic Printing (Creating Print Sets)

    BD FocalPoint™ GS Imaging System Instrument User’s Manual To display system messages: Choose Statistics†System Message to display a window of system messages similar to the one shown in Figure 11-8. The system automatically scrolls to the most recent messages, at the bottom of the message list.

  • Page 109: Backup

    Occasionally, this may be requested by BD Technical Service and Support for troubleshooting purposes. This may also be done if the BD FocalPoint™ Slide Profiler has to be powered off or shut down for an extended period. For complete instructions on how to shut down the system, see Shutting Down the System in Section 15.
  • Page 110 BD FocalPoint™ GS Imaging System Instrument User’s Manual...

  • Page 111: Using Bd Focalpoint™ Slide Profiler Reports

    12.1 Understanding Report Printing Operations There are two types of printing operations on the BD FocalPoint™ Slide Profiler: printing and reprinting. Both operations use the concept of a print set. It is important to understand what a print set is and the differences between these two printing operations; the differences are subtle, but critical to producing the reports most useful in your laboratory.

  • Page 112: Printing

    BD FocalPoint™ GS Imaging System Instrument User’s Manual The slide results window is then cleared except for results for the slides in the tray currently being processed. A series of dashes in the status column indicates processing is not complete.

  • Page 113: Print Summary Statistics

    Using BD FocalPoint™ Slide Profiler Reports 12.1.4 Print Summary Statistics When the reports from the printer are collected, a Print Summary Statistics sheet accompanies each set of reports. An example of such a report is illustrated in Figure 12-1. Operating Mode...

  • Page 114: Report Sorting Options

    BD FocalPoint™ GS Imaging System Instrument User’s Manual • Process Review Report: Lists all slides that were designated Process Review. (See Section 12.3.5 for an example of this report.) • Rerun Report: Lists all slides that were designated Rerun . (See Section 12.3.6 for an example of this report.)
  • Page 115 Using BD FocalPoint™ Slide Profiler Reports The Review action indicators. A black box indicates that the corresponding slide has the action Review/Process Review/ review slide must be reviewed on the BD FocalPoint™ GS Review Station. Rerun/Empty Process Review and Rerun slides must be manually screened.
  • Page 116 BD FocalPoint™ GS Imaging System Instrument User’s Manual Figure 12-2 – Slide result report, tray layout NOTE This example shows GS Review in conjunction with NFR. This option is only available in some regions. Please contact a BD representative.
  • Page 117 Using BD FocalPoint™ Slide Profiler Reports Slide Layout A report using the slide layout option lists the slide results in a tabular format sorted by rank, barcode number, or date. Figure 12-3 shows an example of a report using the slide layout option sorted by date.
  • Page 118 BD FocalPoint™ GS Imaging System Instrument User’s Manual Figure 12-3 – Slide Result Report (slide layout, sorted by date) NOTE This example shows GS Review in conjunction with NFR. This option is only available in some regions. Please contact a BD representative.

  • Page 119: Sample Reports

    Using BD FocalPoint™ Slide Profiler Reports Action required: Review/Process Review/QC Review/Rerun/Empty. (See Section ). The specimen results for each slide: • Squamous cells: Detected/Insufficient • Endocervical cells: Detected/Insufficient • Inflammation/Obscuration: Less than 50% (Satisfactory), between 50–75% (SBLB), or greater than 75% (Unsatisfactory).

  • Page 120: Review Report

    Keep in mind that ranking information is available only if a specific print set is reprinted. For additional information, refer to: • Setting BD FocalPoint™ Slide Profiler Report Options (Section 14) • Operating the BD FocalPoint™ Slide Profiler (Section 15) 12.3.2...
  • Page 121 Keep in mind that ranking information is available only if a specific print set is reprinted. For additional information, refer to: • Setting BD FocalPoint™ Slide Profiler Report Options (Section 14) • Operating the BD FocalPoint™ Slide Profiler (Section 15)

  • Page 122: Qc Review Report

    Console or when using the GS application from the BD FocalPoint™ GS Review Station server. Refer to Section 14 for BD FocalPoint™ GS Review Station QC Review Reports. Figure 12-6 – Example of a QC Review Report (Sorted By Rank) generated from BD FocalPoint™ workstation...

  • Page 123: Archive Report

    Refer to Section 19 for recommendations about performing QC rescreening. For additional information, refer to: • Setting BD FocalPoint™ Slide Profiler Report Options (Section 14) • Operating the BD FocalPoint™ Slide Profiler (Section 15) 12.3.4 Archive Report The Archive report contains a list of all slides that were designated No Further Review for a selected print set (see Figure 12-7).

  • Page 124: Process Review Report

    If reprinting results, slide results can be obtained for a specific print set, or for slides selected by date or slide barcode range. For additional information, refer to: • Setting BD FocalPoint™ Slide Profiler Report Options (Section 14) • Operating the BD FocalPoint™ Slide Profiler (Section 15)

  • Page 125: Rerun Report

    If reprinting results, slide results can be obtained for a specific print set, or for slides sorted by date or slide barcode range. For additional information, refer to: • Setting BD FocalPoint™ Slide Profiler Report Options (Section 14) • Operating the BD FocalPoint™ Slide Profiler (Section 15)
  • Page 126 BD FocalPoint™ GS Imaging System Instrument User’s Manual...

  • Page 127: Slides, Coverslips, And Slide Preparations

    Slides, Coverslips, and Slide Preparations For a Pap test slide to be successfully processed on the BD FocalPoint™ Slide Profiler, it must meet certain physical requirements and standards. This section provides information on slide and coverslip specifications, adhesive specifications, and the types of Pap smear slides that can be processed on the BD FocalPoint™ Slide Profiler.

  • Page 128: Slide And Coverslip Standards

    BD FocalPoint™ GS Imaging System Instrument User’s Manual 13.2 Slide and Coverslip Standards The following subsections present various standards and specifications for slide and coverslip optical properties, slide and coverslip dimensions, barcode labels, and adhesives. All users should become familiar with these standards in order to quickly identify slides not suitable for machine processing.

  • Page 129: Slide Optical Properties

    • The adhesive must not protrude beyond the glass slide edge by more than 0.20 mm. • For BD SurePath™ slides, no more than 11% of the area containing cellular material can be covered with air bubbles. • For plastic coverslips, the adhesive must cure for a minimum of 30 minutes before processing on the BD FocalPoint™...

  • Page 130: Staining And Fixative Requirements

    13.2.5 Staining and Fixative Requirements The slides must be stained with the Papanicoloau method. 13.2.6 Barcode Formats The barcode types supported by the BD FocalPoint™ Slide Profiler are listed below. • Interleaved 2-of-5 • Code 128 A, B, and C •...

  • Page 131: Setting Bd Focalpoint™ Slide Profiler Report Options

    Setting BD FocalPoint™ Slide Profiler Report Options This section provides detailed instructions on how to select and define various slide result reports, which are automatically printed when the Print button is selected in the Instrument window. Before report types are set, users should be familiar with the information contained in Section 12.

  • Page 132: Sort Order And Layout Options

    BD FocalPoint™ GS Imaging System Instrument User’s Manual Six reports are available: • Slide Results — For a given print set, lists results for all slides. (See Section 12.2.1 for examples of these reports). • Review Report — For a given print set, lists all slides designated Review.

  • Page 133: Selecting Qc Review Report Options

    14.2 Selecting QC Review Report Options To ensure that the BD FocalPoint™ Slide Profiler and your laboratory process are performing within the parameters defined in the product labeling (see product insert), a manual QC rescreen of at least 15% of the slides interpreted as NILM should be performed. Section 19.2, describes the BD-recommended method for compliance with these requirements.
  • Page 134 BD FocalPoint™ GS Imaging System Instrument User’s Manual To define a QC Review Report: Follow steps 1 through 4 in Section 14.1.2 to define a QC Review report with the desired sort order and layout options. Tab to the QC Review Report area and in the Portion (%) of Review Slides area specify the percentage of Review slides to print on the QC Review reports (see Figure 14-2).

  • Page 135: Operating The Bd Focalpoint™ Slide Profiler

    Operating the BD FocalPoint™ Slide Profiler This section provides detailed instructions on how to operate the BD FocalPoint™ Slide Profiler. In general, the material in this section is organized in the order of use. A typical daily operation includes the following tasks Figure 15-1 illustrates a typical laboratory workflow.
  • Page 136 Cytology Reports Figure 15-1 – Example of a typical laboratory workflow using the BD FocalPoint™ Slide Profiler NOTE If appropriate corrections are made, some of the process review slides may also be processed again on the BD FocalPoint™ Slide Profiler.

  • Page 137: General Warnings And Cautions

    Operating the BD FocalPoint™ Slide Profiler 15.1 General Warnings and Cautions Observe the following general warnings and cautions while operating the BD FocalPoint™ Slide Profiler. Other, more specific warnings and cautions appear throughout this section and elsewhere in the manual.

  • Page 138: Preparing Slides For Processing

    15.2 Preparing Slides for Processing For slides to be successfully processed on the BD FocalPoint™ Slide Profiler, they must meet specific physical standards as described in Section 13. Additionally, each slide must also undergo certain cleaning procedures and have a properly applied BD-approved barcode label.

  • Page 139: Cleaning Slides

    To run both coverslip type slides on a BD FocalPoint™ instrument for the first time, requires a service call. Both coverslip types cannot be run on the same BD FocalPoint™ instrument until the instrument has been properly configured.

  • Page 140: Changing Preparation Types With Switch Slides

    15.3.2 Changing Preparation Types with Switch Slides If processing more than one type of slide preparation on a single BD FocalPoint™ Slide Profiler, a special slide must be inserted in the tray to separate each type of preparation. These special slides are called switch slides.

  • Page 141: Removing Slides From Trays

    A stack of trays can be placed in an idle BD FocalPoint™ Slide Profiler and processing initiated, or additional trays can be added to the input hopper during processing without interrupting the processing sequence.

  • Page 142: Unloading Trays

    BD FocalPoint™ GS Imaging System Instrument User’s Manual After the first tray is inserted properly, several slide trays can be stacked and added to the hopper as a unit (a total of 36 trays). Close the hopper door securely to begin processing. Note that the instrument will not start processing until the hopper door is properly closed.

  • Page 143: Monitoring The Instrument During Processing

    Operating the BD FocalPoint™ Slide Profiler 15.5 Monitoring the Instrument during Processing After loading trays in the input hopper and closing the door, the system automatically begins its calibration sequence, which takes about ten minutes. After the system completes the calibration, the first tray automatically advances under the microscope objective and slide processing begins.

  • Page 144: Instrument Status Indicator

    BD FocalPoint™ GS Imaging System Instrument User’s Manual 15.5.2 Instrument Status Indicator Another way to monitor the operating status of the instrument is through the instrument status indicator, which appears in the instrument icon in the Main Window. At any given time, this indicator displays the operating status of the instrument (see Section 11.1.2).

  • Page 145: Printing Reports

    It is important to remember that once reports are printed for a set of slides, the slide results for that print set are archived in the BD FocalPoint™ Slide Profiler database and the only way to get another set of printed reports or additional reports for that print set is to select the Reprint icon from the task icon bar in the Main Window.

  • Page 146: Analyzing Slide Result Reports

    BD FocalPoint™ GS Imaging System Instrument User’s Manual Review the contents of this report as it summarizes the data for the print set. Present on this report are: • the operating mode • the processing mode (Standard Processing Mode) •...

  • Page 147: Sorting Slides By Action Categories

    15.9 When to Manually Screen Slides All slides categorized as Review , must be reviewed at the BD FocalPoint™ GS workstation. The remaining slides must be manually screened by a cytotechnologist. Exceptions to this are any Process Review or Rerun slides that were successfully reprocessed on the BD FocalPoint™ Slide Profiler.
  • Page 148 BD FocalPoint™ GS Imaging System Instrument User’s Manual Select the Edit button in the Slide Selection field to view options as shown in Figure 15-6. Figure 15-6 – Slide Selection Options Select the appropriate button to choose a reprint option. Choices are: •...
  • Page 149 Operating the BD FocalPoint™ Slide Profiler Slide Barcode Range — Click the Edit button in the From: field and type the first barcode number in the range. Tab to the To: field and type the optional last barcode number in the range to access available slide barcodes (Figure 15-8).
  • Page 150 BD FocalPoint™ GS Imaging System Instrument User’s Manual Figure 15-10 – Reprint Reports—by print set Print Set — Select the print set option to reprint results (Figure 15-10). Only one print set can be selected at a time. Click on a print set to select or deselect it. If necessary scroll the list of print sets to view the entire list.

  • Page 151: 15.11 Backing Up Your Data

    To protect your data, BD recommends establishing a routine backup procedure. The slide processing data is stored on the hard disk of the BD FocalPoint™ Slide Profiler, and each day at approximately 1:00 AM the system automatically copies important system and slide results data from the hard disk to a removable storage device.

  • Page 152: Backup Media Archive Reminder

    15.11.2 Backup Media Archive Reminder Slide data is stored on the BD FocalPoint™ Slide Profiler for a maximum of 2 months. Billing and System Integrity information will be stored on the device for a minimum of 13 months, and a maximum of 14 months.

  • Page 153: 15.12 Shutting Down The System

    The Shutdown command closes down all functions of the BD FocalPoint™ Slide Profiler computer. Occasionally, a BD-authorized technical or field support employee may ask to do this for troubleshooting purposes. This may also be needed if the BD FocalPoint™ Slide Profiler needs to be shut down for an extended period.
  • Page 154 BD FocalPoint™ GS Imaging System Instrument User’s Manual From the BD FocalPoint™ Slide Profiler Main Window, choose Utilities†Shutdown. A window similar to the one shown in Figure 15-14 appears asking for a password. Type your password and click on OK.

  • Page 155: 15.13 Restarting The System

    When the system is completely booted, the Main Window will appear. Turn on the BD FocalPoint™ instrument by pressing the switch at the bottom right of the instrument from 0 to I. The instrument will begin the initialization routine, which takes...
  • Page 156 BD FocalPoint™ GS Imaging System Instrument User’s Manual...

  • Page 157: Bd Focalpoint™ Slide Profiler Maintenance

    • Cleaning the Mouse (Section 16.8) • Changing the Backup Media (Section 16.9) Once every 12 months, preventive maintenance is required to be performed by BD authorized service personnel. 16.1 Maintenance Schedule Certain components must be cleaned or serviced at regular intervals. Table 16-1 lists the service intervals for those components that must be cleaned on a regular basis.

  • Page 158: Cleaning The Calibration Plate

    BD FocalPoint™ GS Imaging System Instrument User’s Manual The following materials are required: • Lint free swabs • 70% Isopropyl alcohol or glass cleaning solution • Lint free cloth To clean the slide trays: Remove all slides from the tray.

  • Page 159: Inspecting The Air Filter

    Inspecting the Air Filter Inspect the air filter assembly weekly to ensure that the instrument is protected from excessive dust. If the filter assembly is dirty, contact BD Technical Service and Support for a replacement filter. The following materials are required: 1 sheet of paper, typing or copy grade, 8 1/2"...

  • Page 160: Cleaning The Monitor

    BD FocalPoint™ GS Imaging System Instrument User’s Manual Air Filter 8 1/2 X 11 Paper Figure 16-2 – Inspecting the air filter 16.5 Cleaning the Monitor Clean the monitor as necessary to remove fingerprints, dust, or any other debris. The following materials are required: •...

  • Page 161: Printer Maintenance

    BD FocalPoint™ Slide Profiler Maintenance CAUTION Do not clean the instrument while it is processing slides. To clean the outer surfaces of the instrument: Make sure that no slides are processing. Spray the cloth with the cleaner. Wipe the surfaces of the instrument clean.

  • Page 162: Cleaning The Mouse

    BD FocalPoint™ GS Imaging System Instrument User’s Manual 16.8 Cleaning the Mouse Over time, the track ball inside the mouse may need to be cleaned. Perform this procedure if it becomes difficult to direct the pointer when using the mouse.

  • Page 163: Bd Focalpoint™ Slide Profiler Troubleshooting

    BD FocalPoint™ Slide Profiler Troubleshooting This section contains a troubleshooting guide and procedures that may help solve problems if difficulties are encountered while operating the BD FocalPoint™ Slide Profiler. Refer to the following sections: Troubleshooting Guide (Section 17.3) • •...

  • Page 164: Troubleshooting Guide

    The workstation keeps time with its own internal clock. If the date and time shown on any report are incorrect, contact BD Technical Support. (Note that the system’s clock may vary from a watch or laboratory clock by a few minutes.)

  • Page 165: Processing Conventional Slides On The Bd Focalpoint™ Slide Profiler

    18.2 Types of Slide Preparations Allowed Both conventionally prepared Pap smears and BD SurePath™ slides can be processed on the BD FocalPoint™ Slide Profiler. General standards for conventional slides are given below. See Section 13 for information on required dimensional, mounting, and optical standards for BD SurePath™...

  • Page 166: Adhesive And Mounting Requirements

    Smears, all fixatives (a combination of alcohol with or without a wax-like substance called CarboWax) must be removed by immersing in 95% ethanol for a minimum of 10 minutes. For details about the barcode types supported by the BD FocalPoint™ Slide Profiler refer to Section 13.2.6.

  • Page 167: Changing Preparation Types With Switch Slides

    18.3.1 Changing Preparation Types with Switch Slides If processing more than one type of slide preparation on a single BD FocalPoint™ Slide Profiler, a special slide must be inserted in the tray to separate each type of preparation. These special slides are called switch slides.

  • Page 168: Processed Slides Field In Main Window

    BD FocalPoint™ GS Imaging System Instrument User’s Manual 18.3.3 Processed Slides Field in Main Window The Processed Slides field in the BD FocalPoint™ Slide Profiler Main Window is similar to the one shown in Figure 18-4. Instrument name Number of...

  • Page 169: Creating A Print Set (Establishing Rank)

    It is important to remember that once reports are printed for a set of slides, the slide results for that print set are archived in the BD FocalPoint™ Slide Profiler database and the only way to get another set of printed reports or additional reports for that print set is to select the Reprint icon from the task icon bar in the Main Window.

  • Page 170: Analyzing Slide Result Reports

    BD FocalPoint™ GS Imaging System Instrument User’s Manual Operating Mode Processing Mode Report title Print set number (assigned at time of printing) Number of qualified slides and a summary of the results for the selected slide set Figure 18-5 – Print Summary Statistics Review the contents of this report as it summarizes the data for the print set.

  • Page 171: Sorting Slides By Action Categories

    For a complete description of each type of report available and tips for use, see Section 12. Once familiar with all the reports produced by the BD FocalPoint™ Slide Profiler, there may be other ways to use these reports.

  • Page 172: Selecting Slides For Qc Rescreening

    To ensure that the system and your laboratory processes are performing within the specifications outlined in the Product Insert, BD recommends that a manual QC rescreen of at least 15% of all qualified slides be performed. The slides in this enriched group have the highest likelihood of being abnormal.

  • Page 173: Monitoring The Slide Rejection Rate

    If the slide rejection rate is above the acceptable limit, Contact BD Technical Support. BD service personnel will assist in evaluating and correcting the cause of the increased slide rejection rate. One means of process evaluation is to analyze the mean stain scores on the Usage Statistics report.
  • Page 174 BD FocalPoint™ GS Imaging System Instrument User’s Manual To check the slide reject rate: Choose Utilities†Statistics†Usage Statistics to display the Statistics Reports window as shown in Figure 18-6. Figure 18-6 – Usage Statistics options Click on the Month button. Click on the Edit buttons and select the appropriate month and year.

  • Page 175: Report Options

    If analysis of the Process Review report doesn’t suggest any corrective actions, Contact BD Technical Support. BD may examine the System Logs to determine the cause of the process failures and propose corrective action to reduce the frequency of slide rejections.

  • Page 176: Report Sorting Options

    The Review action indicators. A black box indicates that the corresponding slide has the action Review/Process Review/ Rerun/Empty. A review slide must be reviewed on the BD FocalPoint™ GS Review Station. Process Review and Rerun slides must be manually screened.
  • Page 177 Processing Conventional Slides on the BD FocalPoint™ Slide Profiler The results for each slide. This includes: • Action required—Review/Process Review/Rerun/Empty. (For additional information, see Section .) • Specimen Adequacy • Squamous cells—Detected/Insufficient • Endocervical cells—Detected/Insufficient • Inflammation/Obscuration—less than 50% (Satisfactory), between 50–75% (SBLB, Satisfactory But Limited By), or greater than 75% (Unsatisfactory).
  • Page 178 BD FocalPoint™ GS Imaging System Instrument User’s Manual Figure 18-8 – Slide result report, tray layout Slide Layout A report using the slide layout option lists the slide results in a tabular format sorted by rank, barcode number, or date. Figure 18-9 shows an example of a report using the slide layout option sorted by date.
  • Page 179 Processing Conventional Slides on the BD FocalPoint™ Slide Profiler If reprinting reports When reprinting reports, entire print sets (sorted by rank, barcode, or date, as appropriate) or results for a barcode range or a date range can be reprinted. Reports reprinted using either the barcode range or date/time range will not contain any ranking information because these options may include data that spans multiple print sets.
  • Page 180 BD FocalPoint™ GS Imaging System Instrument User’s Manual Ranking information: All successfully processed slides having an action of Review or QC Review receive a group (or quintile) ranking, an individual ranking based on their scoring position within the print set, and their individual rank expressed as a percentage.

  • Page 181: Quality Assurance On The Bd Focalpoint™ Slide Profiler

    Program enable you to comply with the requirements of 42 CFR 493, Subpart K insofar as they apply to the BD FocalPoint™ Slide Profiler. This Program is designed to be supplemental to all other requirements of Subpart K. Note that the BD FocalPoint™ Slide...

  • Page 182: Pre-Installation

    19.1.1 Pre-Installation Before installing a BD FocalPoint™ Slide Profiler, a BD-designated service representative performs an inspection of your facility during which any necessary modifications to the facilities, such as the installation of dedicated power and/or telephone lines, are identified. This representative will also obtain a copy of your staining protocol and general information about your cytology laboratory processes and procedures for analysis and reference.

  • Page 183: Installation

    19.1.2 Installation When the pre-installation phase is completed, BD ships your BD FocalPoint™ Slide Profiler. A BD-designated representative installs the system and performs all required calibration and performance verification tests. Figure 19-3 illustrates the activities that take place during the Installation phase.
  • Page 184 Algorithm Compatibility Test — This test determines if the slides are classified correctly when processed by the BD FocalPoint™ Slide Profiler. Test Results Integration — After the results of all the previous tests are evaluated, BD may recommend adjustments to your slide preparation and/or staining processes.

  • Page 185: Post Installation Phase

    To ensure that the system and your laboratory processes are performing within the specifications outlined in the Product Insert, BD recommends that you perform a manual QC rescreen of at least 15% of all qualified slides. The slides in this enriched group have the highest likelihood of being abnormal.
  • Page 186 BD FocalPoint™ GS Imaging System Instrument User’s Manual The following procedure describes how to select slides for a 15% QC rescreening. Obtain the QC Review report (sorted by rank) and Print Summary — This report should have been printed at the same time the other slide result reports were printed. If not, you can reprint a QC Review report (sorted by rank) for the desired print set.

  • Page 187: Monitoring The Slide Rejection Rate

    If the slide rejection rate is above the acceptable limit, Contact BD Technical Support. BD service personnel will assist you in evaluating and correcting the cause of the increased slide rejection rate. One means of evaluating your process is to analyze the mean stain scores on your Usage Statistics report.
  • Page 188 If analysis of the Process Review report doesn’t suggest any corrective actions, Contact BD Technical Support. BD may examine the System Logs to determine the cause of the process failures and advise you on corrective action to reduce the frequency of slide rejections.

  • Page 189: Training Records

    Quality Assurance on the BD FocalPoint™ Slide Profiler 19.4 Training Records Training will be conducted by BD. Copies of training documentation for all staff will be made available to the laboratory for their files. 19.5 System Performance Verification This section describes the BD FocalPoint™ Slide Profiler automated quality control monitoring system, System Integrity (SI), and the procedures necessary to print reports containing the results of the SI tests and any system messages.

  • Page 190: Tracking Si Results

    BD FocalPoint™ GS Imaging System Instrument User’s Manual 19.5.3 Tracking SI Results BD recommends that you document the SI results once per day to document the system’s performance. These results can be tracked using the log sheet provided in Section 25. To print the SI results: Choose Utilities†Statistics†System Integrity to display the window shown in Figure 19-7.

  • Page 191: System Messages

    Choose Close to close the Statistic Reports window; choose Help to view the Help screen. 19.5.4 System Messages Occasionally, for troubleshooting purposes, you may be asked by BD Technical Service and Support to view the current system messages. To view system messages: Choose Utilities†Statistics to display the window illustrated in Figure 19-9.
  • Page 192 BD FocalPoint™ GS Imaging System Instrument User’s Manual...

  • Page 193: Bd Focalpoint™ Slide Profiler Installation Checklist

    BD FocalPoint™ Slide Profiler Installation Checklist When the BD FocalPoint™ Slide Profiler is installed in your laboratory, ensure that all the necessary components are present.  The BD FocalPoint™ system consists of the following components: 20.1 BD FocalPoint™ Instrument or Device •...

  • Page 194: Items To Be Supplied By The Customer

    One dedicated 15-amp power line (for 100–120 VAC) or 10-amp power line (for 220–240 VAC) for each BD FocalPoint™ Slide Profiler • One dedicated 15-amp power line (for 100–120 VAC) or 10-amp power line (for 220–240 VAC) for each BD FocalPoint™ Slide Profiler Workstation • Voice grade telephone line •...

  • Page 195: Bd Focalpoint™ Slide Profiler Processing Messages

    BD FocalPoint™ Slide Profiler Processing Messages When slides are rejected because the scanning process did not complete, or because the slide or specimen was unsuitable, a reason is printed on the report. Refer to this section for a description of these reasons. In some cases the slide may be repaired and rerun. If the laboratory identifies a subset of slides that cannot be rerun through the device, these slides must be screened by a cytotechnologist.
  • Page 196 Occasionally, this error can occur when the current slide does in fact match the expected preparation type. For example, this situation might occur if a BD SurePath™ slide had an excessive number of cells outside the 12 mm specimen circle.

  • Page 197: Scant Cellularity

    21.2 Scant Cellularity The BD FocalPoint™ Slide Profiler evaluates each slide to verify that it contains enough cellular material to be processed. If any one of the cellularity limit checks fails, the Processing Result will be Scant cellularity with description of the failure given.

  • Page 198: Staining Not Within Limits

    21.3 Staining Not Within Limits The BD FocalPoint™ Slide Profiler evaluates each slide to verify that it is suitably stained. Stain characteristics of the slide are analyzed with respect to their influence on the scanning performance of the instrument. A slide determined by the system to be unsuitable for analysis is reported as Staining not within limits with the description of the failure given.

  • Page 199: Other Errors

    BD FocalPoint™ Slide Profiler Processing Messages Dust or dirt on coverslip The system detected images indicative of dust and scratches on the coverslip or possibly excessive mounting medium. Ensure that the coverslip is clean and within limits. Repair and rerun. If the slide cannot be successfully rerun, it must be screened by a cytotechnologist.
  • Page 200 BD FocalPoint™ GS Imaging System Instrument User’s Manual...

  • Page 201: Warnings And Cautions

    Warnings and Cautions The following table lists the warning and caution labels that appear on the BD FocalPoint™ GS Imaging System. The table includes the text of each label, the general location of the label on the instrument, and a description of the effect if the warning or caution is not adhered to.
  • Page 202 Station Caution Page 60 BD FocalPoint™ Your images are stored on the BD FocalPoint™ Slide Profiler for 10 GS Review days. Your copy service settings should be set to less than 10 day Station intervals.
  • Page 203 Warning Page 137 BD FocalPoint™ The BD FocalPoint™ Slide Profiler must be positioned in such a Slide Profile manner that both, the power switch and the AC input are easily accessible to the operator at all times.Unplug the supply cord from the main circuit to disconnect the device.
  • Page 204 BD FocalPoint™ GS Imaging System Instrument User’s Manual...

  • Page 205: Bd Focalpoint™ Slide Profiler System Integrity

    BD FocalPoint™ Slide Profiler System Integrity BD has built into its BD FocalPoint™ GS Imaging System a comprehensive, fully automated quality assurance technology called System Integrity (SI). SI validates slide results produced by the BD FocalPoint™ GS Imaging System by regular monitoring of the system operating parameters.
  • Page 206 BD FocalPoint™ GS Imaging System Instrument User’s Manual...

  • Page 207: Bd Focalpoint™ Slide Profiler Maintenance Schedule

    BD FocalPoint™ Slide Profiler Maintenance Schedule The following maintenance schedule is provided for your convenience. Make a photocopy of the schedule for each month and use it to keep a record of your scheduled maintenance tasks. Initial each task as it is completed.
  • Page 208 BD FocalPoint™ GS Imaging System Instrument User’s Manual...

  • Page 209: System Integrity (Si) Results Log

    System Integrity (SI) Results Log System Performance Verification in Record SI results data on a daily basis. Refer to Section 19 for instructions on how to use this log. Total SI Pass- Date Pass Reject Tray Error Initials Runs Recalibrate...
  • Page 210 BD FocalPoint™ GS Imaging System Instrument User’s Manual...

  • Page 211: Bd Focalpoint™ Slide Profiler Slide Rejection Rate Log

    Write the percentage value displayed for Process Review slides in the log provided. If the value is greater than ten percent, Contact BD Technical Service and Support for assistance in evaluating the cause of the increased rejection rate.
  • Page 212 BD FocalPoint™ GS Imaging System Instrument User’s Manual...

  • Page 213: Bd Focalpoint™ Gs Review Station Custom Settings

    FocalPoint™ Report Setup dialog box. This section discusses the controls in each of these dialog boxes. To access the controls that govern BD FocalPoint™ GS Review Station setup, the user must be logged into the workstation with administrative rights. See the network administrator for assistance with access rights.

  • Page 214: Using The Orientation Tab

    27.1.2 Using the Orientation tab The Orientation tab allows the BD FocalPoint™ GS Review Station display to be customized. The BD FocalPoint™ GS application initially opens with a right-handed Main Window. Each user can configure this setting; it does not require administrative rights to change them.

  • Page 215: Using The Scaling Tab

    BD FocalPoint™ GS Review Station Custom Settings 27.1.4 Using the Scaling tab The Scaling tab allows the BD FocalPoint™ GS Review Station display to be customized and the user to choose between an x1 and x2 scaling. Figure 27-4 – Settings, Scaling tab 27.1.5...

  • Page 216: Reports Settings

    In addition to the BD FocalPoint™ GS Review Station custom settings already discussed, there is one more control that governs the performance of the BD FocalPoint™ GS Review Station. This control is accessed via the FocalPoint™ GS - Reports utility.
  • Page 217 BD FocalPoint™ GS Review Station Custom Settings Figure 27-8 – Institution Name tab In the field provided, enter the name of your hospital or lab. This name will then be displayed in the upper-left corner on all BD FocalPoint™ GS Review Station reports.
  • Page 218 BD FocalPoint™ GS Imaging System Instrument User’s Manual...

  • Page 219: System Requirements

    System Requirements 28.1 BD FocalPoint™ GS Review Station The BD FocalPoint™ GS Review Station hardware requires a minimum 15 Amp, 50/60 Hz circuit with proper grounding, and must meet local requirements. 28.1.1 Electrical Specifications Operating Voltage 110 volts 230 volts...

  • Page 220: Environmental Operating Conditions

    BD FocalPoint™ GS Imaging System Instrument User’s Manual Operating Voltage 110 volts 230 volts Flat Panel Monitor Power Supply Operating Frequency 50–60 Hz 50–60 Hz Current 1.5 Amps 0.75 Amps Operating Voltage 100-120 VAC 220-240 VAC Computer Power Supply Operating Frequency 50–60 Hz...

  • Page 221: Bd Focalpoint™ Slide Profiler Workstation

    Tray Capacity Slide Capacity Estimated Slide Approximately 6 minutes per conventional slide Approximately 4 minutes per BD SurePath™ slide Throughput † †Slide throughput will vary according to hardware/software configurations. 28.2.1 BD FocalPoint™ Slide Profiler Workstation...
  • Page 222 BD FocalPoint™ GS Imaging System Instrument User’s Manual Specification ARK1120 DFI M90-515 Operating Power Processor: Processor: Consumption Typical: 9.12 W Typical: 7.3 W Max: 10.80 W Max: 8.64 W Monitor: Monitor: Typical: 19 W Typical: 19 W Max: 20.5 W Max: 20.5 W...

  • Page 223: Bd Focalpoint™ Gs Review Station Abbreviations

    BD FocalPoint™ GS Review Station Abbreviations Abbreviation Definition Awaiting Further Review Atypical squamous cells, cannot exclude HSIL ASC-H Atypical squamous cells, undetermined ASC-US significance Cancer, Not Otherwise Specified Cancer NOS Field of View Guided Screening High grade squamous intraepithelial lesion encompassing...
  • Page 224 BD FocalPoint™ GS Imaging System Instrument User’s Manual...

  • Page 225: Bd Focalpoint™ Gs Review Station Maintenance & Troubleshooting

    BD FocalPoint™ GS Review Station Maintenance & Troubleshooting 30.1 Maintenance procedures Once every 12 months, preventive maintenance is required to be performed by BD authorized service personnel. 30.1.1 Controller/Stage Clean the stage and controller with a clean, dry cloth. 30.1.2 Microscope Refer to the manufacturer’s manual for cleaning instructions.
  • Page 226 BD FocalPoint™ GS Imaging System Instrument User’s Manual Figure 30-1 – Slide holder alignment, upper-right slide corner Manually adjust the slide holder until the upper right corner of the slide is centered when looking through the microscope oculars. If your slide holder retaining screws are thumbscrews, skip to the next step. (If the screws require a screwdriver, continue with this step.) Hold the slide holder firmly in place while...

  • Page 227: Monitor

    BD FocalPoint™ GS Review Station Maintenance & Troubleshooting 30.1.3 Monitor Refer to the monitor manufacturer’s manual for cleaning instructions. 30.1.4 Computer Clean computer with a clean, dry cloth. 30.1.5 Manufacturing information Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152 USA 30.2...
  • Page 228 BD FocalPoint™ GS Imaging System Instrument User’s Manual Symptom Possible Cause Solution Slide information is Review the slide information, no available, but no images will be seen for: images are seen. 1.Process Review 2.Slide Edge not detected 3.“Scant cellularity” slides ___________ 4.ReRun...

  • Page 229: Contacts

    Contacts 7 Loveton Circle Sparks, Maryland 21152 USA Technical Service and Support: 1.800.638.8663 bd.com 2100 Derry Road West Suite 100 Mississauga, Ontario Canada L5N 0B3 Voice: 866-979-9408 • Fax: 800-565-0897 Monte Pelvoux 111 • 9th Floor Col. Lomas de Chapultepec 11000 Mexico D.F.
  • Page 230 BD FocalPoint™ GS Imaging System Instrument User’s Manual bd.com/e-labeling Key-code: 500040403 Non-EU: +31 20 794 7071 +1 855 236 0910 +1 855 805 8539 AR, CO, UY, AU, NZ, RU +800 135 79 135 0800 5911 055...

  • Page 231: Bd Focalpoint™ Slide Profiler Quick Reference Guide

    32.3 Manual Backup Procedure If necessary, insert a USB drive. Choose File†Backup. The BD FocalPoint™ GS Imaging System begins the backup. When complete, a message window appears indicating success or failure of the backup.

  • Page 232: Start-Up Procedure

    BD FocalPoint™ GS Imaging System Instrument User’s Manual At this point the system components can be powered down as described in the following steps: Shut off the instrument by turning the switch at the bottom right of the instrument from I to 0.

  • Page 233: Symbol Glossary

    Symbol Glossary Symbol Glossary US Customers only: For symbol glossary, refer to bd.com/symbols-glossary Manufacturer Use by YYYY-MM-DD / YYYY-MM (MM = end of month) Catalog number Authorized Representative in the European Community In Vitro Diagnostic Medical Device Temperature limitation Batch Code (Lot) Contains sufficient for <n>...
  • Page 234 BD FocalPoint™ GS Imaging System Instrument User’s Manual Method of sterilization: irradiation Biological Risks Caution, consult accompanying documents Upper limit of temperature Keep dry Collection time Peel Perforation Do not use if package damaged Keep away from heat Collection date µL/test...

  • Page 235: Index

    Barcode tab, Settings dialog box ..................213 barcode labels applying ......................138 requirements ....................... 138 BD FocalPoint GS Imaging System component maintenance ..................157 BD FocalPoint Slide Profiler description of components ..................91 instrument components ..................92 monitor illustrated ....................92 restarting ......................
  • Page 236 BD FocalPoint™ GS Imaging System Instrument User’s Manual slide trays ......................157 computer power supply ....................220 contact information ..................... 227, 229 controller, MCX-2 ECO ....................219 conventional slides ..................... 165 coverslips adhesives ......................129 requirements ....................... 129 create a report ......................77–79 defining options for a slide results report ..............
  • Page 237 Index icons slide status ......................52 image areas ........................29 inserting slides into trays .................... 139 inspecting the air filter ....................159 Installation ........................183 instrument cleaning outer surfaces of ................... 160 Instrument Interface window description of ...................... 143 illustration ......................103 instrument status messages, list of ....................
  • Page 238 BD FocalPoint™ GS Imaging System Instrument User’s Manual new slide ........................43 Nikon E400 microscope ....................219 opening report utility ......................77 operating conditions ....................220 options, defining for slide reports ................132 power outage ejecting trays during .................... 142 power switch .........................
  • Page 239 Index QC rescreening number of Process Review slides required ..........173, 186 number of slides required ................172, 186 number of supplemental QC Review slides required ........173, 186 QC Review report defining options for ..................... 133 discussion of ....................... 122 eliminating ineligible slides from ..............
  • Page 240 ......................78 slide ........................26 Service command ....................... 109 Shutdown command ....................153 shutting down the BD FocalPoint Slide Profiler ............109 shutting down the FocalPoint, how to ................. 153 SI monitoring ......................185 slide adequacy criteria used ......................97...
  • Page 241 Index reports ........................96 Slide Results report description of ...................... 119 discussion ......................119 example ......................120 printing for the first time ..................120 reprinting ......................120 slide review screen mode ......................41 slide specifications ...................... 128 slide status ......................37, 52 slide trays cleaning ......................
  • Page 242 BD FocalPoint™ GS Imaging System Instrument User’s Manual slide data ......................60 tray handling system, description of ................93 tray layouts See layouts trays See slide trays trend analysis ......................189 types of ....................... 114, 176 usage statistics monitoring ....................173, 187 USB flash drives changing ......................

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