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In Vitro Diagnostic Medical Device

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Содержание FocalPoint GS

Страница 1: ...bd com e labeling FocalPoint GS Imaging System Instrument User s Manual Becton Dickinson and Company 7 Loveton Circle Sparks Maryland 21152 USA 500040403 04 2022 03 490189 491490 443876 English...

Страница 2: ...ly packaged and shipped in accordance with BD s instructions This limited warranty does not apply to the use of the BD FocalPoint GS Imaging System other than as described herein This limited warranty...

Страница 3: ...17 2 3 2 BD FocalPoint GS Review Station 19 3 Guided Screening 21 3 1 Starting the Application 21 3 2 Calibrating the Stage 22 3 3 Selecting a Slide 25 3 3 1 Scan using the Barcode Reader 26 3 3 2 Ty...

Страница 4: ...ion 52 5 3 2 Multiple Slides Found Window 53 5 3 3 Slide Results Data Color Codes 53 6 BD FocalPoint GS Review Station MD and QC Modes 55 6 1 Enhanced QC Review option 55 6 1 1 Enabling Enhanced QC 56...

Страница 5: ...nformation 97 10 4 2 Specimen Adequacy Information 97 10 4 3 Processing Status Information 98 11 The BD FocalPoint Slide Profiler Main Window 99 11 1 Main Window 100 11 1 1 Help Icon 100 11 1 2 Instru...

Страница 6: ...t 132 14 2 Selecting QC Review Report Options 133 15 Operating the BD FocalPoint Slide Profiler 135 15 1 General Warnings and Cautions 137 15 2 Preparing Slides for Processing 138 15 2 1 Applying Barc...

Страница 7: ...e BD FocalPoint Slide Profiler 165 18 1 Introduction 165 18 2 Types of Slide Preparations Allowed 165 18 2 1 Conventionally Prepared Pap Smears 165 18 2 2 Slide and Coverslip Standards 165 18 2 3 Adhe...

Страница 8: ...193 20 3 Electronic Cables 193 20 4 Additional Items Supplied at Startup 193 20 5 Items to be Supplied by the Customer 194 21 BD FocalPoint Slide Profiler Processing Messages 195 21 1 Slide Not Scanne...

Страница 9: ...bbreviations 223 30 BD FocalPoint GS Review Station Maintenance Troubleshooting 225 30 1 Maintenance procedures 225 30 1 1 Controller Stage 225 30 1 2 Microscope 225 30 1 3 Monitor 227 30 1 4 Computer...

Страница 10: ...BD FocalPoint GS Imaging System Instrument User s Manual 10...

Страница 11: ...essfully processed slides as requiring no further review The BD FocalPoint Slide Profiler also identifies at least 15 of all successfully processed slides for a second manual review The device is inte...

Страница 12: ...uamous carcinoma and adenocarcinoma and their usual precursor conditions 1 3 2 BD FocalPoint GS Review Station The BD FocalPoint GS Review Station receives slide processing results data from the BD Fo...

Страница 13: ...RE NOT FOLLOWED WARNING INDICATES THE POSSIBILITY OF SHOCK AND FIRE POTENTIAL IF INSTRUCTIONS ARE NOT FOLLOWED WARNING INDICATES THE POSSIBILITY OF POTENTIAL EXPOSURE TO BLOOD AND OTHER POTENTIALLY IN...

Страница 14: ...cells and all other cytologic categories was defined by The Bethesda System for Reporting Cervical Vaginal Cytologic Diagnoses 1 6 How to Contact BD 1 6 1 In the United States BD Technical Service and...

Страница 15: ...ithin each print set are statistically ranked based on their individual slide scores the scores represent the probability of abnormality See Section 12 for details on creating a print set In addition...

Страница 16: ...he automated re location capability of the BD FocalPoint GS Review Station to evaluate the pre selected FOVs 2 2 1 BD FocalPoint Slide Profiler Slide Information The BD FocalPoint Slide Profiler proce...

Страница 17: ...designated for directed QC Review 5 Slide information and FOV coordinates are sent to the central server database 6 All slides that are not successfully processed on the BD FocalPoint Slide Profiler r...

Страница 18: ...lide Profiler NOTE Determined by normal laboratory QC Cytotechnologist QC Review Yes Process Review No FOVs or Rerun No Full slide review required Full slide review Yes No NILM slides Abnormal slides...

Страница 19: ...e slides at the BD FocalPoint GS Review Station using the BD FocalPoint GS review application Two additional optional applications are available QC Mode and MD Mode These applications electronically q...

Страница 20: ...and adding electronic dots Section 3 details the tasks performed in this mode FocalPoint GS QC Review of QC review slides The task performed in this mode is discussed in Section 3 FocalPoint GS MD Sc...

Страница 21: ...Application Section 3 1 Calibrating the Stage Section 3 2 Selecting a Slide Section 3 3 Screening FOVs Section 3 4 Navigating Through FOVs Section 3 5 Screening and Triaging Slides Section 3 6 Finish...

Страница 22: ...alibrate top edge Menu Option Tasks That Can Be Performed FocalPoint GS Tools Access the report utility and other administrative tasks These tasks are discussed in Section 8 Section 9 and Section 27 F...

Страница 23: ...RNING MAKE SURE THAT THE CLIP GRIPS THE SLIDE EDGE SECURELY AN UNSECURED SLIDE COULD FALL INTO A SLOTTED STAGE OPENING AND BE DAMAGED DAMAGED OR BROKEN SLIDES CAN CAUSE INJURIES BE CAREFUL NOT TO ALLO...

Страница 24: ...o continue The following dialog box opens Figure 3 4 Calibrate right edge 4 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...

Страница 25: ...t 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 clip con...

Страница 26: ...ch the corresponding barcode and displays the processing results in the slide results data area 3 3 2 Typing in the Slide Accession Number Use the following steps to identify the slide by typing in th...

Страница 27: ...ce the slide is selected notice that the slide information is now displayed in the slide selection window Figure 3 7 Slide Selection window controls Place the slide on the microscope stage with the la...

Страница 28: ...Select this button to perform full slide manual screening and to use annotations Refer to Section 4 3 for additional detail Sign Out This button is an alternative method to batch sign out batch sign...

Страница 29: ...d for diagnostic purposes and are provided for location verification only Slide map The slide map portion of the display is located just beneath the primary image area The slide map shows the current...

Страница 30: ...FOV and is to be used for Location Confirmation The image in the primary display should match the view as seen through the microscope at 10x magnification Figure 3 9 Location Confirmation image in the...

Страница 31: ...e foot pedal or Navigation buttons to navigate to each FOV as described below 3 5 1 Using the Mouse to Navigate Table 3 3 Mouse action functions 3 5 2 Using the Foot Pedal to Navigate Clicking the foo...

Страница 32: ...mouse wheel and it will advance to the next FOV 3 6 Screening and Triaging Slides The cytotechnologist is responsible for evaluating the entire area displayed in the FOV at 10x magnification as abnorm...

Страница 33: ...may include FOV only ECC uncertain due to atrophy or FOV with partial full slide review until ECC confirmed Any age cervix intact Limited Cellularity ECC NILM ECC Scant cellularity FOV followed by ce...

Страница 34: ...o buttons that initiate the process of finishing a slide are called Eval or No Eval These buttons are found in the control panel Figure 3 12 Evaluation dialog box NOTE Samples of low or inadequate squ...

Страница 35: ...on dialog box 2 From the Interpretation Result box select the primary evaluation 3 To add adequacy or other non neoplastic descriptive findings select one or more of each from their respective list bo...

Страница 36: ...the Name User ID box 6 Click OK to close the Evaluation dialog box 7 The Slide Status window appears 3 7 2 Using the No Evaluation Function After finishing FOV or FSR screening skip filling out the in...

Страница 37: ...rmines the slide is Negative and is ready to assign it a result Figure 3 18 QC Review message 8 Click the appropriate status button and then click OK The Slide Selection window is displayed NOTE Direc...

Страница 38: ...nual 38 9 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 i...

Страница 39: ...using traditional methods such as a dotting pen The BD FocalPoint GS Review Station can accommodate any type of slide for full manual review These can include Slides not processed on the BD FocalPoint...

Страница 40: ...displays the slide identification number For further information on how and when to use the slide map refer to Section 5 3 In screen mode the bottom of the display does not indicate location in the s...

Страница 41: ...ht side of the control panel 4 3 Screening Slides 4 3 1 BD FocalPoint Slide Profiler Processed Slides To begin a full slide review in Screen mode for slides processed by the BD FocalPoint Slide Profil...

Страница 42: ...to screen slides not processed on the BD FocalPoint Slide Profiler Manual screening with manual dotting Manual screening with electronic dotting and annotation 1 Enter the slide accession number in th...

Страница 43: ...dialog box as shown in Figure 4 6 Figure 4 6 New Slide dialog box 3 Select the preparation type for the slide to screen and then click OK to manually screen the slide 4 When finished manually screeni...

Страница 44: ...BD FocalPoint GS Imaging System Instrument User s Manual 44...

Страница 45: ...as a toggle switch that brings up the Laboratory Information System LIS application on the BD FocalPoint GS Review Station window Toggle back and forth from LIS to GS anytime during the screening proc...

Страница 46: ...ffset Function in Section 3 for details on how to perform the offset 5 1 3 Track Button Figure 5 3 Toolbar Track button The Track feature works only in Screen mode When activated the area screened is...

Страница 47: ...e 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 The currently viewed Most Significant...

Страница 48: ...lide Button Figure 5 8 illustrates the use of the Slide function Figure 5 8 Slide Button Click Slide to stop review of the current slide and bring up the Slide Selection window refer to Section 3 3 5...

Страница 49: ...tton Click No Eval to finish slide review without entering evaluation information See Section 3 7 2 5 1 11 Navigation Buttons Use the Navigation buttons across the bottom of the primary image area to...

Страница 50: ...dot locations that mark each FOV The accession number of the slide being reviewed displays along the left side The bottom of the display indicates which LOI is currently being reviewed in the sequence...

Страница 51: ...ted based on distinctive visual features it may contain cells useful for slide evaluation Blue A blue border indicates a LOI added by a user during full slide screening Black A black border indicates...

Страница 52: ...tatus icons that are used in the slide list Table 5 3 Slide Status Icons The slide list automatically sorts according to slide status however the barcode accession numbers displayed in the slide list...

Страница 53: ...review click the left mouse button over the desired selection Click OK to continue 2 Another dialog box will now appear asking to sign out the other slide runs as duplicates Clicking the Yes button wi...

Страница 54: ...BD FocalPoint GS Imaging System Instrument User s Manual 54...

Страница 55: ...in a mode specific color and evaluations made in each mode create tabs with icons indicative of that mode refer to Table 6 1 Table 6 1 Operating modes 6 1 Enhanced QC Review option The enhanced QC opt...

Страница 56: ...istration see Figure 6 2 Figure 6 2 Opening the Administration Tool 2 The BD FocalPoint GS Administration Tool main screen is displayed see Figure 6 3 From the main screen select Sign Out Figure 6 3 E...

Страница 57: ...cted for QC review will remain on the Ready for signout list To keep the list at a manageable size on the database server archive data at regular intervals Details on how to manage the database are in...

Страница 58: ...BD FocalPoint GS Imaging System Instrument User s Manual 58...

Страница 59: ...rmation in this section is addressed to the lab administrator For the cytotechnologist screening slides on the BD FocalPoint GS Review Station data transfer should be a transparent process 7 1 1 Opera...

Страница 60: ...D FocalPoint Slide Profiler to the BD FocalPoint GS Server Manual data transfer A second option is to disable automatic data transfer and run the copy service manually To run the copy service applicat...

Страница 61: ...D Technical Service and Support and a representative can walk the system administrator through the steps To restart the copy service application 1 Go to the BD FocalPoint GS Server and right click the...

Страница 62: ...calPoint GS Review Station Purpose of Archiving All cases need to be moved out of the database once the case is completed Ultimately the data should be removed from the server and the laboratory shoul...

Страница 63: ...Signing out a case refers to removing it from the slide list at the BD FocalPoint GS Review Station To sign out a batch of slides 1 Click on the FocalPoint GS Administration icon on the desktop Figur...

Страница 64: ...S FocalPoint GS Tools FocalPoint GS Administration Figure 7 7 Pathway to BD FocalPoint GS Administration 2 Click Sign Out in the BD FocalPoint GS Administration Tool window Figure 7 8 BD FocalPoint GS...

Страница 65: ...des prior to signing them out No Further Review These slides might be triaged this way from the BD FocalPoint Slide Profiler In the US the BD FocalPoint GS Imaging System will not designate BD SurePat...

Страница 66: ...Sign Out details 6 When the date and slide s have been selected click Sign Out 7 4 Archive 1 After clicking Sign Out on the Slide Sign Out window the Archive button turns green and the Archive Signed...

Страница 67: ...Enable Archive Reminder Message This box should be checked to generate archive reminders The default is 30 days after last archive It is recommended to change this value to 3 in order to generate rem...

Страница 68: ...o 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...

Страница 69: ...ct Generate Report 5 The number of slides in the database is noted at the top of the report Figure 7 15 BD FocalPoint GS Reports To locate archived files 1 From the Windows desktop right click the My...

Страница 70: ...hat archive appear Figure 7 17 My Computer menu archived slide folders 6 Click on the desired slide folder The data for that slide appear on the right side of the window Here verify that all the infor...

Страница 71: ...ation BD Service personnel will complete these steps 1 From the Windows desktop right click the My Network Places icon 2 Select Explore 3 Select Tools 4 Select Map Network Drive Figure 7 19 My Network...

Страница 72: ...rchive icon 7 In the BD FocalPoint GS Archive menu click Browse button to Select Archive Directory Figure 7 22 BD FocalPoint GS Archive Select archive directory 8 In the window that appears select the...

Страница 73: ...ther as in the BD FocalPoint GS review application Figure 7 25 BD FocalPoint GS Archive view archived slide FOV Slide Use this button to return to the main screen and select another slide Archive Dire...

Страница 74: ...move the data directly from the server to the external hard drive through its pathway Additionally the external drive can manually be backed up to another external drive for extra data safety 7 4 3 S...

Страница 75: ...location of the folder Figure 7 29 Search menu located file NOTE When searching for a slide the drive being searched can be changed For example with an external drive change the Look in to the extern...

Страница 76: ...BD FocalPoint GS Imaging System Instrument User s Manual 76...

Страница 77: ...y somewhat depending on the report type but the basic steps are the same in each case 8 1 1 Opening the BD FocalPoint GS report utility 1 To open the report utility From the Start menu select Programs...

Страница 78: ...1 3 Selecting the report style From the report work flow panel click the Select Report Style button The next set of choices depends on the report type selected For a summary report choose monthly week...

Страница 79: ...report should be sent click Printer Setup The standard Windows Printer Setup dialog box is displayed To generate a different report click Return to Report Type Selection To print the report click Prin...

Страница 80: ...from the slide barcode label Date Time This column displays the date and time that the slide started processing on the BD FocalPoint Slide Profiler User This column displays the name of the initial sc...

Страница 81: ...lides in this archive that were designated as ASC US atypical squamous cells of undetermined significance by a BD FocalPoint GS Review Station user ASC H This column displays the number of slides in t...

Страница 82: ...r cells favor neoplastic by a BD FocalPoint GS Review Station user AIS This column displays the number of slides in this archive that were designated as AIS endocervical adenocarcinoma in situ by a BD...

Страница 83: ...4 defines the columns in this report Evaluation This column displays the Interpretation Result category for the slide as designated by the BD FocalPoint GS Review Station reviewer Notes This column di...

Страница 84: ...anked slides in a print set as QC Review Slides evaluated as awaiting further review AFR by a BD FocalPoint GS Review Station reviewer are not eligible for QC review If due to the number of AFR slides...

Страница 85: ...Generating BD FocalPoint GS Review Station Reports 85 Figure 8 4 illustrates the first page of a typical final QC report Figure 8 4 Final QC Report detail FocalPointR GS QC Review slides Review slides...

Страница 86: ...BD FocalPoint GS Imaging System Instrument User s Manual 86...

Страница 87: ...o conform to the 2001 Bethesda System However to configure the selections to better suit your needs the Administration Tool can be used to change them The three following lists Organisms Other Non Neo...

Страница 88: ...to display summary instructions for use Sign Out Click to display the controls needed for signing out slide data used to select the slides to be archived Also contains some Administrative level option...

Страница 89: ...r click the Windows exit icon in the top right corner List type buttons Annotation Categories This functionality has been disabled Organisms other Non neoplastic Findings Entries in this list are avai...

Страница 90: ...Figure 9 3 Adding a row to a list 5 Type in a label and optional description for the new type 6 To close the window either click Finish on the control panel or click the Windows exit icon in the top...

Страница 91: ...ts categories 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 as...

Страница 92: ...router depending on configuration allows BD to communicate remotely to the device Printer The laser printer is used to print a variety of reports The printer is connected to the workstation computer...

Страница 93: ...also contains a calibration plate mounted on the microscope stage This calibration plate is moved under the microscope during system calibration and system integrity verification A target on the calib...

Страница 94: ...re checked for physical integrity are scanned and evaluated and are further qualified by system integrity checks As slides are successfully processed on the BD FocalPoint instrument they are said to b...

Страница 95: ...by the laboratory as being NILM No Further Review slides must meet the following criteria The slide and the specimen must be adequately prepared for automated scanning and pass a set of suitability te...

Страница 96: ...circumstances during processing the system falls outside specified operating limits during processing a tray is manually ejected slide processing is interrupted for example power failure Rerun slides...

Страница 97: ...tion obscuration expressed as a percentage of the coverslip area This information appears on all appropriate reports for slides that were successfully processed See Section 12 for details on the vario...

Страница 98: ...nstrument did not complete scanning or rejected the slide for the reason indicated In some cases the problem can be corrected and the slide can be rerun For problems that cannot be corrected and rerun...

Страница 99: ...he various components of the Main Window are described in the following sections Main Window Section 11 1 describes the BD FocalPoint Slide Profiler home screen which is used as the starting point for...

Страница 100: ...uments In this example instr67 is selected indicating that the user can print reports eject trays and so forth for that instrument Only one instrument can be selected at a time Each component of the M...

Страница 101: ...n 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 11 1 3 Instrument...

Страница 102: ...ing Status designation of each slide A series of dashes indicates that either the slide has not finished processing the tray has not gone through System Integrity SI or the slide barcode could not be...

Страница 103: ...ide result reports and information on print sets Printing Reports in Section 15 contains a description of the report generation process and a detailed discussion of printing operations Reprint Button...

Страница 104: ...stics System Integrity System Messages Figure 11 8 Statistics Window 11 2 1 Usage Statistics The Usage Statistics command opens a window see Figure 11 9 which is used to create a report containing tot...

Страница 105: ...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 Year Displays accumulated statistics for the current yea...

Страница 106: ...onitor the system s performance see Tracking SI Results in Section 19 To display the system integrity statistics 1 Choose Statistics System Integrity to display the window shown in Figure 11 11 Figure...

Страница 107: ...e FocalPoint database for SI results which are displayed as shown in Figure 11 12 4 To print the report choose the Print command to return to the Statistic Integrity Reports window choose Back 5 Choos...

Страница 108: ...ystem Messages menu 11 3 Automatic Printing Creating Print Sets To automatically generate print sets change the automatic printing capability 1 Choose Utilities Automatic Printing see Figure 11 7 2 Se...

Страница 109: ...er several seconds the tray will be ejected into the output hopper To not eject the tray click on the Back button 11 6 Shut Down Choose Utilities Shut Down to display this command see Figure 11 7 Use...

Страница 110: ...BD FocalPoint GS Imaging System Instrument User s Manual 110...

Страница 111: ...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...

Страница 112: ...fully processed slides posted in the Slides Processed Field see Figure 11 5 are printed to pre selected reports and stored in the database as a print set Do not create a print set containing less than...

Страница 113: ...s needs Thus we ve provided several types of reports with sorting and layout options that allow the user to print slide result reports that best suit the workflow in your laboratory 12 2 1 Report Typ...

Страница 114: ...out Options The term layout refers to how the slide results are presented on a report One of two layouts can be selected slide or tray Each type of layout has its uses and most laboratories will print...

Страница 115: ...rint set the 1st quintile contains the 20 of slides most likely to contain abnormalities the 2nd quintile contains the 20 of slides next most likely to contain abnormalities and so on with the 5th qui...

Страница 116: ...g System Instrument User s Manual 116 f 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 conta...

Страница 117: ...6 and Understanding Report Printing Operations Section 12 1 If reprinting reports When reprinting reports entire print sets can be reprinted sorted by rank barcode or date as appropriate or results f...

Страница 118: ...slides next most likely to contain abnormalities and so on with the 5th quintile containing the 20 of the slides least likely to contain abnormalities Each slide receives an individual rank from 1 to...

Страница 119: ...Additional information is printed as appropriate in the message column Refer to Section 21 for a description of these messages 12 3 Sample Reports Because the information on each type of report is si...

Страница 120: ...printing results slide results can be obtained for a specific print set or for slides selected by date or slide barcode range Keep in mind that ranking information is available only if a specific prin...

Страница 121: ...print set and ranking see Section 15 6 1 and Section 10 4 1 If the Review report is for previously unprinted results the report contains results for all Review slides processed since the last print s...

Страница 122: ...an action of QC Review must be rescreened as part of your QC program This report is used as a worksheet to aid in the selection of slides for QC re screening Refer to Section 19 2 for detailed inform...

Страница 123: ...ies For more information on creating a print set and ranking see Section 15 6 1 and Section 10 4 1 Use the QC Review report as a worksheet when doing QC rescreening of slides called within normal limi...

Страница 124: ...t be successfully rerun it must be rescreened by a cytotechnologist Note that no ranking information or specimen adequacy information is available for Process Review slides Figure 12 8 Example of a Pr...

Страница 125: ...or Date These slides must be rerun when the instrument is functioning properly If a slide cannot be successfully rerun it must be screened by a cytotechnologist Note that no ranking or slide adequacy...

Страница 126: ...BD FocalPoint GS Imaging System Instrument User s Manual 126...

Страница 127: ...Slide Preparations Allowed BD SurePath slides and Conventional Pap smears can be processed on the BD FocalPoint Slide Profiler See Slide and Coverslip Standards Section 13 2 for information on require...

Страница 128: ...13 2 see also Figure 13 2 The thickness dimensions in the following tables do not include mounting adhesive Table 13 1 Conventional Slides Table 13 2 BD SurePath Slides Figure 13 2 Slide and coverslip...

Страница 129: ...adhesive and mounting coverslips The combined thickness of the slide coverslip and adhesives must be between 0 98 and 1 90 mm in the scanning area The combined thickness of adhesive plus glass covers...

Страница 130: ...be durable so that they remain both human and machine readable under normal laboratory handling and application to microscope slides Slides may be exposed to and immersed in the following solvents Wat...

Страница 131: ...ir established workflow Each feature of the Report Type drop down menu is explained in the following sections Step by step instructions for defining reports and QC Review reports follow these descript...

Страница 132: ...in one of three ways rank barcode or date As much as practicable each type of report contains this information use these options to sort the reports as needed Whichever sort order is selected depends...

Страница 133: ...ions see Section 12 2 2 4 Tab to the Layout area and select a layout option For additional information on choosing the appropriate options see Section 12 2 3 5 When finished click on the OK button to...

Страница 134: ...centage greater than the normal QC review percentage ensures that this report contains enough slides to supplement the 15 QC Review population if necessary For example some of the slides listed for QC...

Страница 135: ...o perform that task 1 Prepare slides for automated screening Section 15 2 2 Load slides into the trays Section 15 3 3 Load and unload trays into the instrument Section 15 4 4 Monitor the status of sli...

Страница 136: ...ocalPoint Slide Profiler NOTE Determined by normal laboratory process QC Cytotechnologist QC Review Yes Process Review No FOVs or Rerun No Full slide review required Full slide review Yes No NILM slid...

Страница 137: ...HIS EQUIPMENT MAY BE IMPAIRED IF IT IS USED IN A MANNER NOT CONSISTENT WITH THE INSTRUCTIONS IN THIS MANUAL WARNING THE BD FOCALPOINT SLIDE PROFILER MUST BE GROUNDED AT ALL TIMES TO ENSURE THAT THE PO...

Страница 138: ...ise start with Step 2 1 To preserve an underlying label such as the accession or specimen number place cellophane tape over the label before applying the barcode label to the slide Do not allow the ta...

Страница 139: ...to indicate a change in the type of slide preparation and how to remove the slides from a tray when processing is finished Pay particular attention to these instructions because improperly loaded sli...

Страница 140: ...5 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 separ...

Страница 141: ...ence If necessary a tray of slides can also be ejected during the processing sequence Up to 36 trays can be loaded in the input hopper To load trays in the input hopper when the instrument is idle Thi...

Страница 142: ...lide the trays upward and out 3 Close the hopper door The system automatically resumes processing Note that the system will not resume processing until the output hopper door is securely closed 15 4 3...

Страница 143: ...5 3 The Main Window also displays a scrollable list of slide processing information see Figure 15 3 The slides on this list have been processed but have not yet had results printed The list displays t...

Страница 144: ...s or is calibrating To begin processing add trays to the input hopper If this condition occurs while Hopper Empty is displayed the message is Paused Hopper Full yellow The output hopper is full and th...

Страница 145: ...ble ranking information BD recommends that reports are printed create print sets at consistent intervals so that the number of qualified slides ranked remains consistent If a print set containing less...

Страница 146: ...factorily When slides are rejected or the scanning process is incomplete a reason is printed on the report Refer to Section 21 for a description of these reasons In some cases the problem may be corre...

Страница 147: ...ction 12 3 For a detailed discussion of slide results see Section 10 4 15 9 When to Manually Screen Slides All slides categorized as Review must be reviewed at the BD FocalPoint GS workstation The rem...

Страница 148: ...it button in the Slide Selection field to view options as shown in Figure 15 6 Figure 15 6 Slide Selection Options 3 Select the appropriate button to choose a reprint option Choices are Slide Barcode...

Страница 149: ...available with this option Figure 15 8 Reprint by Barcode Screen Figure 15 9 Reprint Reports by Date Time Range Date Time Range The system defaults to the current date No action is required to reprin...

Страница 150: ...ed to select reports that have never been printed for the selected print set barcode or time and date range To define additional reports follow the instructions in Slide Report Types in Section 14 4 W...

Страница 151: ...ete backup protection in the unlikely event of equipment failure When the backup procedure is complete the system displays a message in the information field of the Main Window indicating the success...

Страница 152: ...orage space is consumed the system discontinues processing Figure 15 13 Archive Backup Media message 15 11 3 Alternate Backup Media Daily BD recommends using at least two backup media which should be...

Страница 153: ...r the backup If unable to correct the problem Contact BD Technical Service and Support 15 12 Shutting Down the System The Shutdown command closes down all functions of the BD FocalPoint Slide Profiler...

Страница 154: ...Cancel button At this point the system components may be powered down as described in the following steps 1 Shut off the BD FocalPoint instrument by turning the switch at the bottom right of the instr...

Страница 155: ...ched on 2 Turn on the display monitor by pressing the push button at the lower right corner of the monitor case 3 Turn on the modem or router by pressing the switch on the rear panel of the modem or r...

Страница 156: ...BD FocalPoint GS Imaging System Instrument User s Manual 156...

Страница 157: ...leaned on a regular basis A Maintenance Schedule is provided in Section 24 Use this schedule as a master copy Each month make a photocopy of the schedule and perform the maintenance tasks as required...

Страница 158: ...both ridges corresponding to the grooves on the top side with a lint free cloth to remove dirt and debris Figure 16 1 Cleaning the slide trays 16 3 Cleaning the Calibration Plate When an instrument is...

Страница 159: ...intenance Schedule see Section 24 that the calibration plate was cleaned 16 4 Inspecting the Air Filter Inspect the air filter assembly weekly to ensure that the instrument is protected from excessive...

Страница 160: ...of the monitor Remove the power plug from the power outlet 2 Spray the cloth with the glass cleaner 3 Wipe the face of the monitor clean 4 Plug the monitor s power cord into the power outlet Apply po...

Страница 161: ...g slides WARNING SHOCK AND FIRE POTENTIAL WHEN POWER APPLIED IMPROPERLY THE SYMBOL NEXT TO THE POWER CONNECTOR INDICATES POTENTIAL SHOCK HAZARD ENSURE THAT THE SYSTEM IS CONNECTED TO A POWER RECEPTACL...

Страница 162: ...dust is present within the trackball enclosure carefully wipe the sides of the enclosure 5 Replace the trackball 6 Replace the cover 7 Wipe the mouse pad To clean an optical mouse If using an optical...

Страница 163: ...es are encountered while operating the BD FocalPoint Slide Profiler Refer to the following sections Troubleshooting Guide Section 17 3 System Time Section 17 4 If a system problem cannot be resolved c...

Страница 164: ...stem message for Cal Plate Dirt If the calibration plate is dirty refer to Section 16 3 Otherwise Contact BD for further instructions The automatic backup procedure fails No USB flash drive connected...

Страница 165: ...ars that meet the physical requirements described in this section can be successfully processed on the BD FocalPoint instrument Figure 18 1 Slide and coverslip dimensions 18 2 2 Slide and Coverslip St...

Страница 166: ...previous sections see list below This section lays out the task sequence and provides detailed instructions when appropriate A typical daily operation includes the task sequence listed below Figure 1...

Страница 167: ...each type of preparation insert the appropriate switch slide in the first position of the first tray for that group of slides Figure 18 3 shows examples of switch slides Use the first switch slide for...

Страница 168: ...slide was processed Date Barcode number of the slide Slide ID Mode of processing If necessary use the scroll bar to view the entire list Status designation of each slide A series of dashes indicates t...

Страница 169: ...plays a warning dialog box and the paper report includes a printed warning at the bottom of the report As shown in Figure 18 4 the number of qualified slides accumulated at any given time awaiting inc...

Страница 170: ...likelihood of being normal and can be archived by the laboratory as being NILM Process Review These slides were rejected or not scanned satisfactorily When slides are rejected or the scanning process...

Страница 171: ...hem by tray See Figure 12 4 for an example of this report For details on using both types of reports see Section 12 3 For a detailed discussion of slide results see Section 10 4 18 6 When to Manually...

Страница 172: ...n Section 14 2 and in Section 12 The QC Review report contains a ranked list of all slides selected for QC Review by the System followed by a set of the next highest ranking Review slides Note that th...

Страница 173: ...ection Rate This section describes the procedures necessary to ensure that your laboratory is properly monitoring the performance and results data of the BD FocalPoint Slide Profiler To do this monito...

Страница 174: ...y the Statistics Reports window as shown in Figure 18 6 Figure 18 6 Usage Statistics options 2 Click on the Month button Click on the Edit buttons and select the appropriate month and year 3 Click Pre...

Страница 175: ...view See Figure 12 5 for an example of this report QC Review Report Lists all slides selected for QC Review plus a limited number of Review slides When this report type is selected the same options ar...

Страница 176: ...the tray This type of report might be useful if slide trays are distributed without first sorting the slides into results categories If the laboratory sorts processed slides according to their results...

Страница 177: ...ities the 2nd quintile contains the 20 of slides next most likely to contain abnormalities and so on with the 5th quintile containing the 20 of the slides least likely to contain abnormalities Each sl...

Страница 178: ...aboratory are used Contents of the reports using the slide layout can vary depending on whether printing reports for the first time or if reprinting reports Consider the following If printing reports...

Страница 179: ...ple of a report using the slide layout option The callout numbers in the figure correspond to the following items in the report 1 The report header information This includes the time and date the repo...

Страница 180: ...ber of Review slides in a print set minus the scant cellularity slides For example the first slide listed on this sample report received an individual rank of 27 41 or 27 out of 41 For more informatio...

Страница 181: ...procedures for the BD FocalPoint Slide Profiler Comprehensive Quality Assurance Program Refer to the following sections The Quality Assurance Program Section 19 1 gives an overview of the BD FocalPoin...

Страница 182: ...s and procedures for analysis and reference Figure 19 2 illustrates the activities that take place during the pre installation phase Figure 19 2 Pre installation phase activities Laboratory Installati...

Страница 183: ...erforms the Laboratory Process Compatibility Assessment LPCA procedure which assesses the compatibility between your slide preparation process and the BD FocalPoint Slide Profiler This procedure is pe...

Страница 184: ...ults of all the previous tests are evaluated BD may recommend adjustments to your slide preparation and or staining processes 3 Process Acceptable Once compatible procedures are in place BD will set t...

Страница 185: ...information about SI and how to document SI performance daily Process Integrity Monitoring To ensure that the system and your laboratory process are performing within the parameters defined in the Pr...

Страница 186: ...istics report Calculate 15 of this number to determine the number of slides required for QC rescreening Compare the number of slides required for QC rescreening with the number of QC Review slides eli...

Страница 187: ...One means of evaluating your process is to analyze the mean stain scores on your Usage Statistics report 19 3 1 Mean Stain Score With BD FocalPoint Slide Profiler software version APPS 1 2 1 and later...

Страница 188: ...can do to correct the problem 6 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 th...

Страница 189: ...s automatically invoked SI is repeated up to four times after recalibration Continued failure of one or more of the System Integrity tests causes the instrument to stop processing SI also monitors any...

Страница 190: ...wn in Figure 19 7 Figure 19 7 Statistic Reports System Integrity 2 You can collect statistics for a specified date range or month Click on either the Date Range or the Month button To view the statist...

Страница 191: ...rposes you may be asked by BD Technical Service and Support to view the current system messages To view system messages 1 Choose Utilities Statistics to display the window illustrated in Figure 19 9 F...

Страница 192: ...BD FocalPoint GS Imaging System Instrument User s Manual 192...

Страница 193: ...oard Mouse and Mouse pad Cart Ethernet hub optional Modem or Router Printer 20 3 Electronic Cables Ethernet Printer to CPU BD FocalPoint system to CPU Monitor to CPU Modem or Router to CPU Keyboard to...

Страница 194: ...iler 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 Dustproof bins to store empty sli...

Страница 195: ...mit Ensure that the slide is clean properly seated and has the correct coverslip type for the instrument configuration Rerun the slide If the slide cannot be rerun it must be screened by a cytotechnol...

Страница 196: ...ide cannot be successfully rerun it must be screened by a cytotechnologist or The low power scan did not complete properly If the slide cannot be successfully rerun it must be screened by a cytotechno...

Страница 197: ...the processing of a tray Rerun the slide If the slide cannot be successfully rerun it must be screened by a cytotechnologist Switch to SurePath Glass A switch slide has changed the operating mode of...

Страница 198: ...able BD FocalPoint analysis Review this slide manually These slides must be screened by a cytotechnologist Nuc Stain chromatin blurring The average chromatin detail visible in nuclei on this slide is...

Страница 199: ...e reported Slide not detected The system did not locate a slide in this position on the tray Inspect the tray position and rerun the slide if necessary If the slide cannot be successfully rerun it mus...

Страница 200: ...BD FocalPoint GS Imaging System Instrument User s Manual 200...

Страница 201: ...es with obscuring matter such as dust fingerprints cytotechnologist marks and other optically significant debris may be rejected by the instrument Warning Do not install trays until all motion has cea...

Страница 202: ...l components have been exposed to fluid Warning Page 138 BD FocalPoint Slide Profiler Be careful not to drop or break slides during slide preparation and when loading and unloading slides into trays B...

Страница 203: ...ng a potential shock hazard Always connect the system power cord directly to an appropriate receptacle with a functional ground Warning Page 137 BD FocalPoint Slide Profile The BD FocalPoint Slide Pro...

Страница 204: ...BD FocalPoint GS Imaging System Instrument User s Manual 204...

Страница 205: ...rvice can be anticipated rapid and effective SI tests are performed automatically after each tray of slides is processed If any subsystem fails a system integrity check the slide results for the previ...

Страница 206: ...BD FocalPoint GS Imaging System Instrument User s Manual 206...

Страница 207: ...aintenance 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...

Страница 208: ...filter weekly Inspecting the Air Filter in Section 16 4 Clean monitor as needed Cleaning the Monitor in Section 16 5 Clean instrument device as needed Cleaning the Outer Surfaces of the Instrument in...

Страница 209: ...ty SI Results Log Record SI results data on a daily basis Refer to System Performance Verification in Section 19 for instructions on how to use this log Date Total SI Runs Pass Pass Recalibrate Reject...

Страница 210: ...BD FocalPoint GS Imaging System Instrument User s Manual 210...

Страница 211: ...he appropriate monthly statistics report Refer to Section 19 2 for instructions on using this log Write the percentage value displayed for Process Review slides in the log provided If the value is gre...

Страница 212: ...BD FocalPoint GS Imaging System Instrument User s Manual 212...

Страница 213: ...ialog 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 a...

Страница 214: ...tially opens with a right handed Main Window Each user can configure this setting it does not require administrative rights to change them Figure 27 2 Settings Orientation tab 27 1 3 Using the Default...

Страница 215: ...tings Scaling tab 27 1 5 Specifying the slide type The option selected here determines the appearance of the slide map on the main BD FocalPoint GS Review Station display Four types of slides can be s...

Страница 216: ...Access the report utility From the Windows desktop double click on the Report tool shortcut contact your system administrator to have the shortcut added to your desktop or From the Start menu select...

Страница 217: ...tation Custom Settings 217 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...

Страница 218: ...BD FocalPoint GS Imaging System Instrument User s Manual 218...

Страница 219: ...s are compatible with the BD FocalPoint GS Review Station Autostage Consult the microscope manufacturer s manual for electrical specifications Common applicable microscopes include Microscope Operatin...

Страница 220: ...Operating Voltage 110 volts 230 volts Operating Frequency 50 60 Hz 50 60 Hz Current 1 5 Amps 0 75 Amps Computer Power Supply Operating Voltage 100 120 VAC 220 240 VAC Operating Frequency 50 60 Hz 50 6...

Страница 221: ...ide Slide throughput will vary according to hardware software configurations Specification ARK1120 DFI M90 515 Monitor 17 inch LCD color display 17 inch LCD color display Dimensions Processor W x H x...

Страница 222: ...printer Operating Temperature 0 40 C 32 104 F Processor and Monitor Processor 0 42 C 32 107 6 F Monitor 0 40 C 32 104 F Operating Humidity Range Processor 95 40 C Monitor 10 90 non condensed Processo...

Страница 223: ...ncer Not Otherwise Specified FOV Field of View GS Guided Screening HSIL High grade squamous intraepithelial lesion encompassing moderate and severe dysplasia CI5 CIN2 CIN3 LIS Laboratory Information S...

Страница 224: ...BD FocalPoint GS Imaging System Instrument User s Manual 224...

Страница 225: ...replace or reposition the stage slide holder it is important to maintain the correct mounting position This component is often removed as part of annual or semi annual microscope cleaning Precise alig...

Страница 226: ...er left edge of the slide should now be roughly centered beneath the 10x objective see Figure 30 2 Figure 30 2 Slide holder alignment upper left slide corner 9 Manually adjust the slide holder until t...

Страница 227: ...ocessed on the BD FocalPoint GS Review Station and copy service was not run Reprocess the slides and create a print set within 10 days Has Service Mode been turned on BD Service Department will need t...

Страница 228: ...out the batch ___________ Are you looking for the slide in the correct folder or drive Review all of the folders and drives to be sure you are looking in the correct location ___________ Go to Windows...

Страница 229: ...l Lomas de Chapultepec 11000 Mexico D F Voice 52 5 237 1200 Fax 52 5 237 1287 11 Rue Aristide Berg s BP4 38800 Le Pont de Claix France Voice 33 476 68 36 36 Fax 33 476 68 34 95 Akasaka DS Building 5 2...

Страница 230: ...FocalPoint GS Imaging System Instrument User s Manual 230 bd com e labeling Key code 500040403 Non EU 31 20 794 7071 US 1 855 236 0910 CA 1 855 805 8539 AR CO UY AU NZ RU 800 135 79 135 BR 0800 5911 0...

Страница 231: ...ure 1 Remove all trays from the input hopper If the system is currently idle go to Step 6 If the system is currently processing go to Step 2 2 From the Main Window choose the Utilities button and then...

Страница 232: ...h from I to 0 8 Turn off the monitor by pressing the push button at the lower right corner of the monitor case 32 5 Start up Procedure 1 Apply power to each of the following components in the order gi...

Страница 233: ...ized Representative in the European Community In Vitro Diagnostic Medical Device Temperature limitation Batch Code Lot Contains sufficient for n tests Consult Instructions for Use Do not reuse Serial...

Страница 234: ...Upper limit of temperature Keep dry Collection time Peel Perforation Do not use if package damaged Keep away from heat Cut Collection date L test Keep away from light Hydrogen gas generated Patient ID...

Страница 235: ...p tapes replacing 152 Barcode tab Settings dialog box 213 barcode labels applying 138 requirements 138 BD FocalPoint GS Imaging System component maintenance 157 BD FocalPoint Slide Profiler descriptio...

Страница 236: ...e results report 132 delete list type 89 diagnostic terminology 14 E edit existing types 90 ejecting a tray during a power outage 142 electromagnetic fields 202 Empty position slide result rerunning s...

Страница 237: ...f 144 viewing 144 L layouts slide description 117 178 ranking information 118 180 tray description of 114 176 ranking information 115 177 types of 132 lists 87 90 administration tool controls 88 LPCA...

Страница 238: ...rinter cleaning 161 periodic maintenance 161 printing discussion of 112 printing operations 117 178 printing reports 117 178 discussion of 111 restrictions 112 Process Review report description of 124...

Страница 239: ...rinting 145 slide processing actions 95 Quality Assurance QA Program description of 181 phases of 181 quality control testing 189 quit 38 R ranking information 97 Report icon 131 133 Report Options wi...

Страница 240: ...ides manually 147 171 Section 27 22 select archive criteria 66 multiple slides 53 new slide 43 report type 78 slide 26 Service command 109 Shutdown command 153 shutting down the BD FocalPoint Slide Pr...

Страница 241: ...142 slides changing prep type when loading trays 140 changing preparations 140 inserting into trays 139 140 optical properties 129 preparing for automatic processing 138 removing from trays removing s...

Страница 242: ...tray handling system description of 93 tray layouts See layouts trays See slide trays trend analysis 189 types of 114 176 U usage statistics monitoring 173 187 USB flash drives changing 152 V view arc...

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