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1. Data Management Connected Review Scopes 6 on Device Id Connection Time Backup 1006810340 Jan 18 200505 33 PM Et Export 10106KO3A1 Jan 18 200604 06 PM E Import 10114K03A1 Jan 18 200505 10 PM 10152L03A1 Jan 18 200505 50 PM 10250 C04A0 Jan 18 2005 06 50 PM 10253C04A0 Jan 18 2005 05 50 PM X Maintenance d Operator Accounts EB Reports system amp Lab Settings E Page Setup mm Printers amp Security Connected Imagers Device Id Connection Time T6XN661 Jan 18 200605 33 PM DSXN551 Jan 18 2005 04 06 PM H amp XN651 Jan 18 2005 05 10 PM IPGo002 Jan 18 2005 06 50 PM IPC0003 Jan 18 2005 05 50 PM IPGO004 Jan 18 2005 06 50 PM IPCO0005 Jan 18 2005 05 50 PM IPCOO06 Jan 18 2005 05 50 PM IPCO007 Jan 18 2005 05 50 PM The Refresh button updates the list of connected RSs and IPCs Cretan f rsm Figure 4 9 Server Shut Down Window To continue with shut down click on Shutdown ThinPrep Imaging System 2 j amp re you sure you want to shut down the system Figure 4 10 Confirm Server Shutdown Image Processor Operator s Manual 4 7 OPERATION OF THE SOFTWARE MENU SECTION BE DATA MANAGEMENT MENU The Data Management menu contains functions for backing up and maintaining the database maintaining Operator accounts generating reports and setting system printer time date and alarm options Clicking on System Data Management will bring up the Data Manage
2. 6 2 Image Processor Operator s Manual TROUBLESHOOTING 6 Table 6 1 Event Log Error Messages Event Log Error Message Possible Cause Corrective Action Slide has been rejected The slide was not successfully imaged Inspect the slide and confirm that ThinPrep microscope slide with fiducial marks is being used The slide is clean no fingerprints debris bub bles etc The coverslip media is completely dry e The coverslip does not extend beyond the edge of the slide The label is applied smoothly no wrinkles or ifted edges The slide must be manually reviewed Slide ID not valid Wrong accession ID format Label the slide with the correct ID format Slide not found S lide not loaded into the slide cassette correctly Confirm that the slide is loaded with the label up and toward the front opening of the cassette Slot below has slide out of SI lides not loaded into the slide cassette Confirm that the slide is loaded with the label up position or multiple slides correctly and toward the front opening of the cassette Load one slide per slot Slot has multiple slides Slides not loaded into the slide cassette Load one slide per slot correctly Correct label issue Slide with a lifted label edge Slot has slide out of posi Slide not loaded into the slide cassette Confirm that the slide is loaded with the label up tion correctly and tow
3. System OPERATION OF THE SOFTWARE MENU 4 Clear Error And Usage Logs Review Scope serial number 3 1005240340 1005240341 1005740340 10132L0341 1025000440 10253C0440 Figure 4 33 RS Logs Maintenance Window Select the serial number of the Review Scope that is to be cleared Click on the Delete button to clear that number Click on the Close button to close the window and return to the main interface User Accounts The User Accounts window is used to assign and retire User IDs needed for users to login to screen ing sessions at a review Scope Click on the User Accounts selection of the Data Management menu and the User Accounts window will open Figure 4 12 Image Processor Operator s Manual 4 21 OPERATION OF THE SOFTWARE MENU ull A Data Management Data Management User Id 1 6 nee 101 Anne Smith Active H E Reports 104 Mary Jones Active H 108 Tony Bowen Retired H System 112 dane Miller Retired 120 Ed OConnell Active First Name LastName Status Profile User Id C Retired First name Last name Figure 4 34 User Accounts Window A list of all user IDs is displayed in the information area It will show the ID number the operator first and last name and the ID status active or retired To add a new user ID in the User ID field click on the New button at the bottom of the display The User Id and Name fields will clear Type in a 3 digit number must be unique an
4. 3 12 Image Processor Operator s Manual OPERATION OF THE IMAGE PROCESSOR ie Cytyc Corp ThinPrep Imaging System Slide Processing Reports System Maintenance About e Slide Processing Event Log Keme gt ThinPrep Imaging System Unlocked AUTO ERROR RECOVERY OFF Cytyc Corp ThinPrep Imaging System Slide Processing Reports System Maintenance About le Slide Processing Event Log 4 p6 7 ie ThinPrep Imaging System Unlocked AUTO ERROR RECOVERY OFF CAP Figure 3 14 Partial and Fully Loaded Cassette Locations 5 Fully close the Imaging Station sliding doors Image Processor Operator s Manual 3 13 OPERATION OF THE IMAGE PROCESSOR il SLIDE PROCESSING 1 Start the slide processing operation by using the mouse to perform either of the following a At the top of the display position the cursor on the green GO button and click once Cytyc Corp ThinPrep Imaging System Slide Processing Reports System Maintenance About Figure 3 15 Begin Slide Processing Go Button OR b At the top of the menu bar select Slide Processing and then in the drop down menu click once on Start Slide Processing Slide Processing Reports System Maintenance About Start Slide Processing Figure 3 16 Begin Slide Processing Menu Selection 2 The doors will lock The message Currently Processing is displayed on the monitor yty brp ThinPiep keaging System Sie Procese
5. Try again with a different CD Make sure the CD is a blank writable CD and it is in the Server CD drive Failed to delete the tem plate The template could not be deleted It may have already been deleted by another user Image Processor Operator s Manual 6 13 6 TROUBLESHOOTING Table 6 3 Data Export Import and Backup Errors Error Text Possible Cause Corrective Action Failed to modify the tem plate A template could not be modified The template has been deleted It must be recreated Failed to start the task The server was unable to begin the requested import export backup Try the function again Failed to update FO table An error occurred during data import Contact Technical Support Failed to update Slidelm age table An error occurred during data import Contact Technical Support Import cannot be per formed from the media The CD in the server s CD drive does not have export data on it The CD may have other data on it Only data exported from a ThinPrep Server will be imported Import failed The import failed Try the import again Make sure the CD is a blank CD R format Incorrect FO Count An error occurred during data import Contact Technical Support Initialization error A server error occurred while try ing to initialize data for the opera tion Try the function again Invali
6. s Manual OPERATION OF THE SOFTWARE MENU 4 Data Management E Data Management Progress Database Checking media Preparing data Help 7 E Export Writing data to CD E Import Benne X Maintenance NEE lt gt User Accounts a E Reports System Figure 4 12 Backup Database A blank writable CD ROM is required for this If a CD is not already in the CD drive of the com puter you will be prompted for one As listed on the Backup window the system checks the media prepares the data writes the data to the CD and shows a completed progress bar when finished There will be a check mark next to each action as it successfully completes Export The Export function enables the operator to filter the database and export the selected data onto a CD ROM located on the Server The CD containing exported data would accompany imaged slides to a remote site for slide review Only imaged data is exported no slide review data is exported Up to 10 000 records may be exported at one time Note The Export window can be accessed from either a Server or an IPC computer but the CD must be in the Server in order to perform the command Click on the Export icon to display the window Figure 4 13 Image Processor Operator s Manual 4 9 OPERATION OF THE SOFTWARE MENU Data Management BER Accession Number Data Management Export Parameters Close Range Field Database Accession Number Ran
7. sively for the Imaging System network No other company networks sub networks or devices may be connected to the network Up to 328 ft 100 meters Network Interconnections Review Scope Review Scope Server Additional Scopes depending on site configuration Uninterruptible Power Supply pO leet and Battery Backup Monitor Power Cord Requires an Outlet May go on the floor provided there is no dust accumulation on or around it Table Desk or Lab Bench Figure 2 2 Extended Network Interconnection Schematic example Component Configuration The components may be arranged on the bench top as desired providing the connection cables can reach easily The Image Processor Controller may be placed on the floor near the work area provided it has adequate air circulation to prevent dust accumulation and it is safely removed from foot traffic or other interference It should be accessible for routine maintenance The network printer will be installed and set up at the time of instrument installation Please refer to the manufacturer s guide for operation and maintenance Note The uninterruptible power supply UPS provides battery backup power for a period of time up to 30 minutes for a fully charged battery in the event of a power outage Slides will be Image Processor Operator s Manual 2 3 2 IMAGE PROCESSOR INSTALLATION stored and th
8. CellFyx Solution in the instrument No further fixation is required SECTION oZ STAINING REQUIREMENTS gt Refer to the ThinPrep Stain User s Manual and follow all the staining instructions for the applicable staining protocol being used CAUTION Follow the staining instructions and applicable protocols exactly as stated in the ThinPrep Stain User s Manual Altering these instructions and protocols may compromise the performance of the ThinPrep Imaging System CAUTION Do not substitute any solutions or stain reagents required in the proto cols as that may compromise the performance of the ThinPrep Imaging System Recycled Alcohol Alcohols recycled via the following systems are acceptable for use with the ThinPrep Imaging System Filtration Systems Creative Waste Solutions Inc Bench Top Alcohol Recycling System www cwsincorp com SunCycle Technologies Inc Gravity Recycling Alcohol Cartridge GRAC www suncycletech com Distillation Systems CBG Biotech Solvent Recyler model SLV 99U L Recycled Alcohol Guidelines General Guidelines applies to all alcohol recycling e Laboratories must follow manufacturers recommendations for alcohol recycling e Only Hologic recommended alcohols should be used Reagent or Ethyl alcohol e Laboratories are responsible for ensuring that the recycled alcohol concentration used in the ThinPrep staining protocol meets Hologic s recommendation 7 2 Image Processor Operato
9. Do not remove a partially processed slide cassette Data may be lost e To remove completed cassettes from a large batch in order for a Cytotechnologist to start the screening process e To shut the system down prior to a known power outage event e To shut the system down in order to do maintenance or repair e To address observable slide loading errors Note When the slide cassette is properly loaded onto the platform it engages a cassette present sensor which indicates its presence and position to the Imaging System During batch pro cessing the system uses this information as a landmark in determining cassette status in progress not been processed completely processed Pulling a cassette part way out or removing it renders the cassette unknown to the system For a partially completed cassette Image Processor Operator s Manual 3 17 OPERATION OF THE IMAGE PROCESSOR il slide data is lost and the slides must be reprocessed Therefore be very careful not to disturb the cassette being processed if a batch in process is interrupted 1 Interrupt the slide processing operation by using the mouse to perform EITHER of the fol lowing a At the top of the display position the cursor on the red STOP button and click once Figure 3 20 Cytyc Corp ThinPrep Imaging System Slide Processing Reports System Maintenance About Figure 3 20 Slide Processing Stop Button OR b At the top of the menu bar selec
10. EJ Page Setup mat Printers By Security SE Server Figure 11 5 Data Management Description 5 Database Maintain and backup the database lt P User Accounts Add change and retire Review Scope users E Reports Generate reports System Printer time date and alarm settings Data Management Window Image Processor Operator s Manual 11 5 REMOTE SITE SERVER USER S GUIDE Refer to Chapter 4 Section D Data Management Window for instructions on operating the Data Management functions Note The Server user interface only has the Data Management portion of the Imaging System application The other menus described in Chapter 4 are used by the IPC at Imaging sites SHUT DOWN THE SERVER WARNING Never turn off power to the equipment without shutting down the sys tem via the User Interface CAUTION If Review Scopes are also connected to the Imaging System work schedules must be coordinated so that all operation is concluded prior to equipment shut down Normal Shut Down To shut down the Server expand the System menu and click on Server If Review Scopes are still connected via the network they will be listed here Review sessions should be concluded before shutting off the Server Data Management Data Management Connected Review Scopes b Database Device Id f Connection Time JE R 1005810340 Nov 11 2005 09 10 AM P 10253C04C0 Nov 11 2005 09 20 AM tga 10250C04C0 Nov 11 2005 09 21
11. SECTION am DATA EXPORT IMPORT AND BACKUP ERRORS During data export import or backup procedures text messages appear if an error condition has occurred Many conditions can be corrected by the operator for example by checking for a blank CD in the CD drive Some errors may not be corrected by the operator for example if a database error caused a backup to fail Table 6 3 Data Export Import and Backup Errors Error Text Possible Cause Corrective Action A slide ID filter must be specified when using an accession number range When exporting a range of num bers a Slide ID filter is required Enter a slide ID filter See Slide ID Filter on page 4 11 Aborting previously can celled task Try again The previous import export backup is still in progress 6 12 Image Processor Operator s Manual Wait a few minutes before attempting an import export backup TROUBLESHOOTING 6 Table 6 3 Data Export Import and Backup Errors Error Text Possible Cause Corrective Action An error occurred The task may not be com plete An error occurred during the import export or backup Try the function again An unexpected error occurred An error occurred during import export or backup Try the function again Backup failed due to database error There was a database related error during the backup Try the function again Be sure there is
12. Server error log O Image Processor error log O Review Scope error log ThinPrep Imaging System usage history ALL Image Processor slide event log Figure 4 35 Logs and History Window Image Processor Operator s Manual 4 23 OPERATION OF THE SOFTWARE MENU oll At Report Server Error Log The Server Error log lists any error events that the server encountered displaying the most recent at the top of the list and older events following See Figure 4 36 Select the Server Error Log by clicking on the correct radio button and then click on the View but ton The report will display as many lines of data as selected in the report limit setting 500 to 5000 refer to System Lab Settings on page 4 40 Click on the Print button to print out a copy of the report Click on the Close button to return to the Log Selection menu Report Results Server Error Log Report Date Dec 03 2004 02 10 PM Matches found 15 Time Stamp Error Version Nov 30 2004 02 40 PM 8202 5 0 14 Nov 23 2004 01 46 PM 8006 5 0 14 Nov 23 2004 01 46 PM 6006 5 0 14 Nov 23 2004 01 46 PM 8006 5 0 14 Nov 23 2004 01 46 PM 8006 5 0 14 Nov 23 2004 01 46 PM 8006 5 0 14 Nov 23 2004 01 46 PM 3006 5 0 14 Nov 23 2004 01 45 PM 3006 5 0 14 Nov 23 2004 01 45 PM 8006 5 0 14 Nov 23 2004 01 45 PM 6006 5 0 14 Nov 23 2004 01 45 PM 8006 5 0 14 Nov 23 2004 01 45 PM 8006 5 0 14 Nov 23 2004 01 45 PM 8006 5 0 14 Nov 23 2004 01 45 PM 8006 5 0 14 Nov 2
13. The following information provides specifications for slide labels used with the ThinPrep Imaging System Slide Accession IDs Cyclical Redundancy Check CRC Of the 14 numeric characters of the Accession ID the last three numerals are the CRC These are automatically generated when the label software creates the series of Accession IDs The Imaging System uses these numerals to confirm that it read the ID correctly Refer to Figure 1 Reserved Numbers A range of numbers has been reserved for use by Hologic personnel Do not use slide IDs within this reserved range at risk of losing patient data during a service visit Any slide ID with the four digits before the CRC as 9999 is a reserved number These will be removed from your patient database at the time of a service call Refer to Figure 1 Starting with an even numbered accession ID and incrementing the IDs by two 2 is one way to avoid conflict with the reserved numbers 9999 indicates a reserved number Do not use this as part of a patient slide ID xxx are the CRC they will appear as numerals Figure 1 Accession ID Required Format Xylene resistant 52 lb label stock on backing Label Contents up to an 11 digit number roll or sheet with clear laminate and rubber asediadhesive o back Print quality to meet ANSI X3 182 requirements Black characters on white stock The required format is a row of seven numerals over seven numerals no
14. tem will return slides to their original locations and enter idle mode This process will take a cou ple of minutes from the time the Recovery button is clicked When the system has recovered the doors will unlock and the display will show the slide cas settes colored blue or gray as they were at the time of the error condition At this point the oper ator may do one of the following e Begin processing by clicking on the green GO button The system will start processing at the point where it left off e Remove completed slide cassettes all blue and replace with unprocessed cassettes Do NOT remove partially completed cassettes Leave them in place to be processed to completion Note The batch was terminated at the time of the error The Run Report refer to Run Report in Chapter 4 will list any completed cassettes as a completed batch Note If the recovery is not successful a User Assessment window with a Shutdown System button will appear Shutdown System Option If the system encounters an error condition that it cannot recover from the User Assessment dia log box will display and only the Shutdown System button is available Figure 6 4 The system must be restarted 6 6 Image Processor Operator s Manual TROUBLESHOOTING 6 User Assessment System Error Information Error 6502 12 1 404 8 07 07 AM Could not initialize the serial communication port in ShempProxy Query Server error log Recovery Action Shu
15. 101 Imager 1266 4 7 148 178 212 Site 4 Manual 2612 7 6 42 69 94 Imager 2524 5 1 86 138 198 4 1 Manual 1305 8 2 59 75 84 Imager 1252 5 1 86 150 190 4 2 Manual 1307 6 9 42 63 94 Imager 1272 5 0 109 126 198 Table 15 summarizes the Manual Review versus the Imager Review for ASCUS and HSIL sensitivity and specificity by site The table also presents the prevalence of ASCUS LSIL and HSIL among the reviewed slides and the respective screening daily rates of each review method The daily screening rates are extrapolated to an 8 hour workday and are presented as the low average and high daily screening rates by site Table 15 Screening Rates Prevalence of ASCUS LSIL HSIL and Respective Performance for ASCUS and HSIL Site of of of Review Extrapolated Daily Rates Performance for Performance for ASCUS LSIL HSIL Methods 8 hour workday ASCUS HSIL Low Average High Sensitivity Specificity Sensitivity Specificity Day Day Day Sia Fai aso peg EmA 49 69 94 77 2 98 7 89 5 98 8 ite a acs Fl Imager 107 153 206 78 3 1 1 99 2 0 4 92 1 2 6 99 5 0 7 ae o2 a0 Ley E 40 68 80 63 1 95 8 72 5 99 8 m P y Imager 69 109 131 777 14 4 96 1 0 3 70 0 2 5 99 6 0 1 Site 3 Manual 20 80 101 80 6 98 5 64 3 99 7 4 4 27 1 0 7 e e wae Imager 148
16. 10114K03A1 p 10253C0440 1005740340 Pull down list to select slide Pull down list to view all Review review status Scope serial numbers Figure 4 47 Slide Review Sort Parameters 4 34 Image Processor Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Slide Review Date the report may be modified to show slide records for a particular date or for a data range that you specify or for all dates Lab Name this is to select which lab the data is associated with Operator ID the slide data report may be sorted according to which operator reviewed slides Select the operator ID number from the pull down list Slide Review Slide Review Review status Review status ALL v ALL v Review Scope serial number Review Scope serial number v v Review date Review date ALL v ALL vi Pull down menu to select date qualifier for the report User Id E v Review Scope User ar Lab name a v 103 Pull down list to select operator ID The user IDs that display depend Pull down list to select which lab on which lab name was selected name Figure 4 48 Slide Review Sort Parameters continued Image Processor Operator s Manual 4 35 OPERATION OF THE SOFTWARE MENU oll At Slide Data Record Report When all sort parameters have been selected for the slide data report click the View button to see the report Report Results Slide Data Records Report Date Jan 19 2005 09 02 A
17. 204 320 94 2 13 6 98 8 0 4 78 6 13 6 99 7 0 Nie A 32 asy Ley Ema 42 69 94 87 2 97 3 61 5 99 5 Ai ee ee Oe Imager 86 138 198 84 4 2 8 97 0 0 3 74 4 12 8 99 8 0 3 The clinical study data show that the screening rates achieved with the ThinPrep Imaging System resulted in sensitivity or specificity values that fall within acceptable limits MAN 03938 001 Rev 001 page 13 of 15 Laboratorians should use the following method when calculating workload e All slides with Fields of View FOV only review count as 0 5 or 1 2 slide e All slides with full manual review FMR using the Autoscan feature count as 1 slide as mandated by CLIA 88 for manual screening e Then slides with both FOV and FMR count as 1 5 or 1 slides e Use these values to count workload not exceeding the CLIA maximum limit of 100 slides in no less than an 8 hour day FMR 1 slide FOV 0 5 slide FMR FOV 1 5 slides Upper Limit 100 slides The ThinPrep Imaging System limit of 100 slides in an 8 hour workday includes the following Screening 22 Fields of View Full manual slide review using the Autoscan feature Review clinical history Record results and triage appropriately An example of workload scenario for ThinPrep Pap slides using the ThinPrep Imaging System 100 FOV review only 50 slides 100 x 0 5 50 30 FOV revie
18. AM ab Settings E Page Setup wm Printers Security Connected Imagers Device Id Connection Time Refresh Server icon The Refresh button updates The Shutdown button the list of connected Review initiates Server shutdown Scopes Figure 11 6 Server Status and Shut Down Window 11 6 Image Processor Operator s Manual REMOTE SITE SERVER USER S GUIDE 1 1 Click on the Shutdown button A dialog box appears prompting confirmation of shut down Are you sure that you want to shut down the server ServerApp 2 re you sure that you want to shut down the server Figure 11 7 Confirm Server Shut Down Click on Yes to shut down the Server Click on No to cancel the action and return to the Data Man agement window If Yes is chosen the Data Management application closes the computer Windows XP application closes and then the power to the Server is shut off The monitor keyboard and mouse are turned off Refer to Chapter 3 Section I SHUTTING DOWN THE IMAGE PROCESSOR for information on shut down due to power outage or for extended shut down Image Processor Operator s Manual 11 7 REMOTE SITE SERVER USER S GUIDE This page intentionally left blank 11 8 Image Processor Operator s Manual x pul Index Index A About Menu 4 54 Accession Number Range 4 10 Accessories 10 2 Air Filter Imaging Station 5 6 Alarm 4 41 Applying power to the equipment 3 3 Auto print ba
19. Cose Figure 6 2 User Notification Recoverable Error Display 6 4 Image Processor Operator s Manual TROUBLESHOOTING 6 User Correctable Errors User correctable errors are system errors that the Image Processor is capable of recovering from with user assistance by either allowing the system to recover or allowing the system to shutdown When a user correctable error condition is encountered slide processing is interrupted and a User Assessment dialog box is displayed Figure 6 3 If the audible alarm is enabled the instrument will beep intermittently until a recovery action is chosen CAUTION Do not remove any slides or cassettes User Assessment Error Number System Error Information Error 5073 4 26 04 6 11 25 AM Date and Time Brief Description Door s Opened While Batch In Progress Query Image Processor error log Recovery Action Begin User raceme Recovery Begin User Assisted Recovery Shutdown System Shutdown But es ton always utton Silence Alarm available Figure 6 3 User Assessment Window User Correctable System Error The window displays the error number the date and time a brief description of the error and one or two options e Begin User Assisted Recovery e Shutdown always available Image Processor Operator s Manual 6 5 6 TROUBLESHOOTING User Assisted Recovery Option Click on the Begin User Assisted Recovery button The beeping will stop at this point The sys
20. Cov 5 minutes slipping Film erslipper 4770 Tissue Tek FILM 5 minutes Coverslipper see Table 7 2 Richard Allan Toluene Richard Allan Scien Shandon Xylene DO NOT USE Tissue 1 hour Mountng Medium tific Substitute Histo Tek Glas Coverslip solve per Xylene Check coverslipper Pro Par Clearant Mfg recommenda Anatech Ltd Suie CoverSafe D Limonene American Mas Shandon Xylene Check coverslipper 1 hour Mounting Medium ter tech Scientific Substitute Histo Mfg recommenda solve tions Pro Par Clearant Anatech Ltd Pertex Xylene Medite Xylene Check coverslipper 1 hour l Mfg recommenda Histo Clear tions National Diagnos tics Permount Toluene Fisher Scientific Xylene DO NOT USE Tissue 3 hours Tek Glas Coverslip per Check coverslipper Mfg recommenda tions Image Processor Operator s Manual 7 5 7 THINPREP STAIN Coverslip Review If any of the following are noted prior to imaging of the slide the slide should be re coverslipped e Air bubbles CAUTION Large or numerous air bubbles can obscure cellular material e Retraction of mounting medium e Coverslip is not straight or overhangs the edge of the slide Reagents Follow manufacturer s recommendations for handling and cleaning up spills Refer to manufac turer s MSDS for further information Table 7 2 Sakura Tissue Tek FILM Coverslipper Settings for Use with the ThinPrep Imaging System Setting Tissue Tek
21. Drying Time After coverslipping slides must be allowed to adequately dry before being placed in the Thin Prep Imaging System A slide can be considered dry when the medium has cured sufficiently so there is no movement of the coverslip in response to normal laboratory handling Table 7 1 illustrates drying times for slides placed in an oven set at 37 C after automatic covers lipping Note Drying times will differ depending upon variables such as the type of mounting medium quantity of medium used mounting method temperature and humidity Manually coverslipped slides may have drying times longer than those indicated in Table 7 1 It is the responsibility of the laboratory to monitor and ensure that adequate but not excessive medium is applied to the slides and that they dry sufficiently prior to being placed on the ThinPrep Imaging System CAUTION Failure to allow slides to dry sufficiently may compromise the perfor mance of the Imager 7 4 Image Processor Operator s Manual THINPREP STAIN 7 Table 7 1 ThinPrep Imaging System Microscope Slide Coverslip Processes Mountin Mounting Media Clearin Automatic Minimum Media g Media Distributor or A ae Coverslip Dry Time Solvent Manufacturer g System 37 C 3 Tissue Tek Glas Xylene Sakura Finetek Xylene Tissue Tek Glas Cov 1 hour 6419 erslipper Tissue Tek Cover Xylene Activated Sakura Finetek Xylene Tissue Tek SCA
22. ID number cannot be reused Type in the operator first and last names in the appropriate fields and click on the Apply button To retire a user ID for instance if an employee no longer works in the lab select the ID by click ing on the name in list It will become highlighted Click on the Retired checkbox and then Apply This changes the status from Active to Retired but does not delete the ID from the data base A user may be deleted if they have not done any reviews Select the User ID or Name and click on the Delete button Note To maintain the integrity of the previous slide data records User IDs are not to be reis sued Only unique IDs may be assigned To return to the main user interface click on the Close button Reports The Reports menu contains the functions for generating reports from the database It includes Logs and History RS Users Slide Data Records Workload and the Run Report 4 22 Image Processor Operator s Manual OPERATION OF THE SOFTWARE MENU p Report Logs and History The Logs and History reports gives the operator access to information pertaining to system perfor mance The reports may be viewed on screen or printed out Click on the Logs and History selection to open the window Figure 4 35 Data Management Data Management Database q User Accounts FA Reports R R RS Users R Slide Data Records R Workload R Run Report System EEk Log Selection
23. Off Figure 3 1 Typical Batch Process 3 2 Image Processor Operator s Manual OPERATION OF THE IMAGE PROCESSOR 3 SECTION 3 APPLYING POWER TO THE EQUIPMENT WARNING Grounded Outlet Instrument Fusing Do not power on or operate if equipment has been damaged Apply power to the Server the Imaging Station and the Image Processor Controller according to the following procedure Note All power cords must be plugged into a grounded outlet Disconnection from the power sup ply source is by removal of the power cord Make sure the uninterruptible power supply UPS is plugged in to a grounded outlet and all devices are plugged into the UPS backup outlets Do not operate any devices if the UPS is not plugged in Application of power to the equipment must be performed in the sequence described in order to establish proper communication between the Server the Image Processor Controller and the remain ing system elements i e the Monitor Keyboard Mouse Imaging Station and Review Scopes In addition do NOT touch any buttons on the Keyboard when turning on the Image Processor Control ler 1 Make sure the doors of the Imaging Station are fully shut 2 At the monitor turn on the power Figure 3 2 Power On Indicator amp Power Switch Figure 3 2 Power On the Monitor Image Processor Operator s Manual 3 3 OPERATION OF THE IMAGE PROCESSOR 3 At the Server push on the power button See Figur
24. Server Data Management Figure 4 7 System Menu Shut Down System This selection will shut down the Image Processor Controller IPC and power off the monitor key board and mouse connected to it Click on the Shut Down System option A confirmation window will appear Figure 4 8 ThinPrep Imaging System 2 j Sre you sure you want to shut down the system Figure 4 8 Confirm Shut Down Click Yes to shut down the system The application will quit and then Windows will shut down The power to the IPC monitor keyboard and mouse will shut off Click No to return to the User Interface Once the IPC is shut down the Imaging Station may be turned off by turning the rocker switch on the rear of the unit to Off Note The Server continues running independently if it has not already been shut down This would be used in configurations with multiple Image Processors 4 6 Image Processor Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Shut Down Server Note Do not shut down the Server if IPCs and Review Scopes are actively connected to it Commu nication will be lost data may be lost This function will power off the Server From the System Menu select Shut Down Server The Data Management Server window will appear Figure 4 9 Note You can navigate to the Data Management menu and click on System to expand the list of options Clicking on Server will bring up the same window Data Management
25. The errors are displayed with the most recent events at the top and older events following Each event entry shows which cassette number and which slot the slide was in what the Slide ID was time and date stamp and a brief error code description The report will display as many lines of data as selected in the report limit setting 500 to 5000 refer to System Lab Settings on page 4 40 Report Results Slide Processing Events Report Date 26 Apr 2004 06 07 Matches found 500 Event Cassette Slot Number Number Number 1 4 22 46050000000 22 Apr 2004 19 33 5 0 14 4564 Slide has been rejected 15 46049900000 22 Apr 2004 19 32 6 0 14 2407 Slide has been rejected 4 46049800000 22 Apr 2004 19 30 5 0 14 4564 Slide has been rejected 16 46049700000 22 Apr 2004 19 29 6 0 14 2407 Slide has been rejected 13 46049600000 22 Apr 2004 19 26 6 0 14 4564 Slide has been rejected 19 46049500000 22 Apr 2004 19 27 5 0 14 2407 Slide has been rejected 21 46049400000 22 Apr 2004 19 25 6 0 14 4564 Slide has been rejected 23 46049300000 22 Apr 2004 19 24 6 0 14 2407 Slide has been rejected 13 46049200000 22 Apr 2004 19 23 5 0 14 4564 Slide has been rejected 17 46049100000 22 Apr 2004 19 22 5 0 14 2407 Slide has been rejected 21 46049000000 22 Apr 2004 19 20 6 0 14 4564 Slide has been rejected 7 46048900000 22 Apr 2004 19 19 6 0 14 2407 Slide has been rejected 19 46048800000 22 Apr 2004 19 18 6 0 14 4564 Slide has been rejected 10 460487000
26. The patient slide will be printed in the correct format Reserved Numbers Accession ID numbers with 9999 in the position just before the CRC are reserved for Hologic personnel and will be removed from the patient database at the time of a service visit Starting with an even numbered accession ID and incrementing the IDs by two 2 is one way to avoid conflict with the reserved numbers Refer to the ThinPrep 3000 Processor Operator s Manual for specifications for printing vial barcode labels Ordering Information Consumable Accessory Items 2014 Hologic Inc 2 MAN 03907 001 Rev 001 Hologic Inc 250 Campus Drive Marlborough MA 01752 USA 1 508 263 2900 hologic com ThinPrep LMA GUNG SYSTEM Image Processor Operator s Manual HOLOGIC tat Hologic Inc e 250 Campus Drive Marlborough MA 01752 US e 1 800 442 9892 1 508 263 2900 www hologic com Hologic UK Ltd e Link 10 Napier Way Crawley West Sussex RH10 9 RA UK e 44 0 1293 522 080
27. alpha characters The first seven numerals are placed on the top row of the label and the second seven numerals are placed on the bottom row The font must be 12 point OCR A The dimensions of the placement of the characters are shown in Figure 2 Please note that a no text zone of exactly one 1 character dimension 1 6 mm or 063 should surround the print area 2014 Hologic Inc 1 MAN 03907 001 Rev 001 Hologic Inc 250 Campus Drive Marlborough MA 01752 USA 1 508 263 2900 hologic com Label Specifications for Use with the ThinPrep Imaging System Dimensions 0 93 in 0 03 in max 23 62 mm 0 76 mm max r 063 073 in 0 93 in 23 62 mm 1 60 1 85 mm ThinPrep 0 22 0 32 in 5 59 8 13 mm Figure 2 Dimensions of the Slide Label Vial Barcode Labels for the ThinPrep 3000 Processor 0123456789 Figure 3 Vial Barcode Label ThinPrep 3000 Because the ThinPrep 3000 Processor prints the Accession ID directly onto the patient slide slide labels are not required However the CRC and reserved number conditions described previously should be followed Cyclical Redundancy Check CRC This is required for vial barcodes which will be used to prepare slides for use with the ThinPrep Imaging System The ThinPrep 3000 system setup configuration must be in Imaging System Mode Printing The system software will automatically append the CRC numerals to the Accession ID when the vial barcode is scanned
28. j U o O 3 Q Q p U O U V enuen S JoyesodoQ LABORATORY SOLUTIONS ThinPey a Thi nPrep IMAGING SYSTEM ae Image Processor Operator s Manual HOLOGIC MAN 001 Po 08 ThinPrep Imaging System Image Processor Operator s Manual HOLOGIC The Women s Health Company pal EC REP HOLoGIc INC Ho tocic UK LIMITED 250 CAMPUS DRIVE UNIT 2 LINK 10 NAPIER WAY MARLBOROUGH MA 01752 USA CRAWLEY WEST SUSSEX RH10 9 RA TEL 1 800 442 9892 UNITED KINGDOM 1 508 263 2900 TEL 44 0 1293 522 080 FAX 1 508 229 2795 Fax 44 0 1293 528 010 WEB WWW HOLOGIC COM For Use With Version 3 x y Software MAN 01445 001 Rev 002 The ThinPrep Imaging System is a PC based and automated review system for use with ThinPrep cervical cytology sample slides The ThinPrep Imaging System is intended to help a cytotechnologist or pathologist highlight areas of a slide for further manual review The Product is not a replacement for manual review Determination of slide adequacy and patient diagnosis is at the sole discretion of the cytotechnologists and pathologists trained by Hologic to evaluate ThinPrep prepared slides If and only if it is finally determined by a court of competent jurisdiction that the Product sold to Customer hereunder was defective in design or contained a manufacturing defect and that such defect was solely responsible for an error in diagnosis that c
29. one or more Review Scopes The system makes use of computer imaging to select fields of view for presentation to a Cytotechnologist on a Review Scope Slides used with this system must first be prepared on a ThinPrep 2000 or 3000 Processor and stained with ThinPrep Stain The Imaging Processor acquires and processes image data from the slides to identify diagnostically relevant cells or cell groups based on an imaging algorithm that considers cellular features and nuclear darkness During slide imaging the alphanumeric slide accession identifier is recorded and the x and y coordinates of 22 fields of interest are stored in the computer database This computer also coordinates the communication of information between the Image Processor and the Review Scopes After image processing slides are distributed to Cytotechnologists for review utilizing the Review Scopes The Review Scope is a microscope with an automated stage to facilitate the locating of the 22 fields containing the cells of interest Additionally the Review Scope provides a method for automated marking of objects for further review Slides are individually loaded onto the Review Scope stage the alphanumeric slide accession identifier is automatically scanned and the stored x and y coordinates representing fields of interest for that slide are electronically downloaded from the computer to the Review Scope The Cytotechnologist then uses a keypad to step through each of the fields of in
30. power cycled together See page 3 22 Shutting Down the System 6 10 Image Processor Operator s Manual TROUBLESHOOTING 6 Table 6 2 Imaging Station and IPC Errors Error Error Text Corrective Action 5096 Fail connection to server e Check hub connections and data bus harness connec tions e Power Cycle the Imaging System NOTE that the IS and IPC should always be power cycled together See page 3 22 Shutting Down the System 6615 Slide has been rejected This is a biological event where the sample may contain abundant clumpy inflammation or bacteria 6616 Three consecutive 6615 errors within a cassette generate a6616 See Section C Slide Preparation and Quality aah e Manually review the slide 6617 Slide has been rejected See Section C Slide Preparation and Quality 6618 Three consecutive 6617 errors within a cassette generate a 6618 error 6619 Vibration Error e The imaging station is sensitive to vibrations Look for vibrating equipment such as a vortexer near the imag ing station e Be aware of other things slamming doors that may also cause the vibrations 6628 Slide has been rejected This is a biological event where the sample may be too dense 6629 Three consecutive 6628 errors l within a cassette generate a 6629 e See Section C Slide Preparation and Quality error e Manually review the slide 6630 Slide has been rejected Contact Tech
31. right click on the name of the template and select Rename or Delete View the Export Log The Log button will display the export log of the last export Refer to Figure 4 27 Report Results Export Report Export date Nov 22 2005 10 56 AM Export lab D3A7CB5A B2BE 4664 B71E F68EB9FBBDAD Summary Total slides 162 Slides imaged successfully 172 Slides with imaging errors 10 Minimum slide id 00000000009 Maximum slide id 00000009588 Slides Figure 4 27 Export Log To print the export log click on the Print button To close the window click on the Close button Export Command The Export button begins the export function A blank writable CD ROM is required for this DVDs cannot be used If a CD is not already in the CD drive of the Server computer you will be prompted for one As listed on the Export window the Image Processor Operator s Manual 4 15 OPERATION OF THE SOFTWARE MENU system checks the media prepares the data writes the data to the CD verifies it and shows a completed progress bar when finished There will be a check mark next to each action as it suc cessfully completes Other Data Export Considerations Labeling of CD ROMs to easily identify the contents of a CD ROM follow your facility s nam ing and labeling conventions for the storage of data Transport of patient slides if slides are to be transported or placed into storage be sure they are appropriately packaged and lab
32. slide and correctly identify objects of interest found on the slide based on integrated optical density while maintaining an appearance consistent with a traditional Papanicolaou stain SECTION s5 FIXATION REQUIREMENTS Slides Prepared on the ThinPrep 2000 Processor The ThinPrep 2000 Processor deposits completed slides into a fixative vial that contains 95 reagent alcohol or 95 ethyl alcohol 1 Remove each slide after it is deposited into the fixative vial in the ThinPrep 2000 System Note The alcohol in the ThinPrep 2000 fixative vial should be changed every 100 slides or daily 2 Place the slide into a multi slide holder e g staining rack immersed in a bath of 95 reagent alcohol or 95 ethyl alcohol Notes Do this step quickly to minimize exposure of the ThinPrep slide to air Change the fixative bath every two weeks maximum 3 The slides must remain in 95 reagent alcohol or 95 ethyl alcohol for at least 10 minutes prior to staining Notes e Solutions should be kept covered when not in use to minimize evaporation e Do not allow the slides to air dry at any time prior to staining e For slides which must be shipped prior to staining CellFyx Solution fixative must be applied Contact Hologic Customer Service for ordering Image Processor Operator s Manual 7 1 7 THINPREP STAIN Slides Prepared on the ThinPrep 3000 Processor Slides prepared on the ThinPrep 3000 Processor are automatically treated with fixative
33. slide is physically marked to indicate it has been screened Slides with marked target zones are reviewed by a Cytopathologist a interpretation and diagnosis All slides and patient data are ready to be filed s000030 Case Report manoll Patient Name ID 0001234 ThinPrep i wna gt MN Figure 1 2 Lab Flow Image Processor Operator s Manual 1 3 INTRODUCTION THE THINPREP IMAGING SYSTEM PROCESS Slides that have been prepared for screening are loaded into cassettes which are placed into the Imaging Station The operator uses a PC keyboard mouse and monitor to interact with the instru ment via a graphic menu driven interface An optical character recognition OCR camera reads the slide accession ID and then the Imaging Station scans the entire ThinPrep cell spot The system identifies objects of interest found on the slide based on integrated optical density Refer to Figure 1 3 ThinPrep Imaging Process The coor dinates of 22 of those objects are recorded and the slide is returned to its cassette Following process ing of each cassette of slides the slide ID and associated data record are sent to the Server The Server acts as the central data manager for the ThinPrep Imaging System As slides are imaged by the Image Processor and reviewed at the Review Scope the Server stores retrieves and transmits information based on the slide ID For installations with multiple contro
34. specify or for all dates Slide Image Slide Image Slide Image Image status Image status i Image status ALL v ALL v ALL v ALL ERROR Imager name _ Imager name SUCCESS 6XN5S v vi Image date Image date Image date ALL E ALL vi ALL vi Pull down menu to select Pull down menu to select Pull down menu to select date Image status as a parameter Imager name qualifier for the report All lists all slide data records All lists all dates Error lists slides not imaged Equals lists a date you type in due to error Before amp After are exclusive of Success lists slides imaged the date you type in successfully Between is inclusive of the date you type in Figure 4 46 Slide Image Sort Parameters Image Processor Operator s Manual 4 33 OPERATION OF THE SOFTWARE MENU wll Slide Review Parameters Review Status data may be queried by the review status those slides that have been reviewed those that have not been reviewed or all slides regardless of whether they have been reviewed Review Scope Serial Number slide data reports may be sorted according to which Review Scope they were screened on Select the serial number from the drop down list Slide Review Slide Review Review status Review status ALL vi ALL v ALL REVIEWED Review Scope serial number E NOT REVIEWED 7 10501G044P Review date 1005240341 10132L0341 10108K0341 1005240340 1005810340 102500440 i
35. to determine if there is any corrective action that would allow it to be successfully processed in another batch This may include e Slide incorrectly loaded into the slide cassette 3 16 Image Processor Operator s Manual OPERATION OF THE IMAGE PROCESSOR 3 e Slide was not completely dry when loaded into the cassette e Mounting media was on the frosted portion of the slide e Slide contains bubbles e Slide coverslip protrudes over the edge amp causes interference e Slide not labeled for use with the ThinPrep Imaging System e Slide is dirty dust fingerprints e Slide label not legible for scanning of the accession ID e Slide has already been imaged accession ID already in the Server database Note Always check Slide Already Imaged against the patient record to confirm that it is not a duplicate accession ID Other slide related errors but not necessarily user correctable may include e Sample too dense e Sample is sparse e Other biological artifacts e Occlusions or holes in the cell spot e The slide is not a ThinPrep microscope slide for use with the Imaging System Note Ifa slide is not successfully processed by the Image Processor the same slide cannot be auto matically reviewed at the Review Scope A manual review must be performed Interrupt Slide Processing The batch may be interrupted and resumed or interrupted and canceled via the user interface A batch might be interrupted for reasons below CAUTION
36. used to image and analyze the slide data The slide data is sent to the system Server for storage The Server maintains the database and communicates to the Reviews Scope The User Interface is a menu driven graphical display used by the operator for operating the equipment The Image Processor includes e Imaging Station images the slides Figure 1 1 e Image Processor Controller captures the images and controls the electromechanical compo nents of the system e Server stores the slide ID and pertinent image data e User Interface consists of a monitor keyboard and mouse The operator uses these to operate the instrument Note The Imaging Station and Image Processor Controller together are referred to as the Image Processor throughout this manual Note For sites that perform ThinPrep slide reviews at a location separate from the imaging facility refer to Chapter 11 Remote Site Server User s Guide Image Processor Operator s Manual 1 1 INTRODUCTION bebil HEH j 4 E e aa l gt O p Ez et pee LN User Interface Imaging Station Image Processor Server Monitor Keyboard Controller IPC and Mouse Figure 1 1 The ThinPrep Imaging Station Image Processor Controller Server and User Interface 1 2 Image Processor Operator s Manual INTRODUCTION ThinPrep Imaging System Laborato
37. 00 22 Apr 2004 19 17 6 0 14 2407 Slide has been rejected 12 46048600000 22 Apr 2004 19 15 6 0 14 4564 Slide has been rejected 14 4AnaRannnnn Anr INNA 19 14 AN1A 2407 Slide has heen rriected Slide ID DateTime SW Version Event Number Description 2 3 4 5 6 7 8 g A ae os al Mm el oo o WlH 1 HOO alwl AI Ny H wol o almim D gt Figure 4 41 Slide Processing Events Window Click on the Print button to print the report Click on the Close button to return to the Logs Selection menu Image Processor Operator s Manual 4 29 OPERATION OF THE SOFTWARE MENU ull A Report RS Users This report lists all the operators that have been entered into the database It may be sorted by all operators or by first name last name or lab name Note This is for reporting only to add or change the status of an RS User see User Accounts in the Data Management menu Click on the RS Users submenu to open the window see Figure 4 42 Data Management Data Management Parameters Database Sort Lab name gt User Accounts o EB Reports R Logs and History User Id Status R GEES R Slide Data Records R Workload Last name qualifier Last name R Run Report O fa 4 System First name qualifier First name O jaw The pull down list has the same modifier options Figure 4 42 Report Operators Window Select which parameter you would like to have the database query lab na
38. 2 5 with a 95 confidence interval of 15 4 10 4 to 13 6 with a 95 confidence interval of 0 7 28 0 The increase in specificity of the Imager Review over the Manual Review was statistically significant with a 95 confidence interval of 0 06 to 0 4 The observed differences between specificities varied among the sites from 0 1 to 0 7 Tables 5 9 show the performance of the Imager Review and Manual Review compared to the final consensus diagnosis made by the adjudication panel truth for the following major descriptive diagnosis classifications of the Bethesda System Negative ASCUS AGUS LSIL HSIL Cancer CA Includes SQ CA and GL CA Abbreviations for Diagnoses NEG Normal or negative ASCUS Atypical Squamous Cells of Undetermined Significance AGUS Atypical Glandular Cells of Undetermined Significance LSIL Low grade Squamous Intraepithelial Lesion HSIL High grade Squamous Intraepithelial Lesion SQ CA Squamous Cell Carcinoma GL CA Glandular Cell Adenocarcinoma Table 5 6x6 True Negative Contingency Table For All Sites Combined All 786 Cases Determined To Be Negative By Adjudication Unadjudicated Manual Review Arm Diagnosis bats NEG ASCUS AGUS LSIL HSIL CA TOTAL Sp NEG 425 138 6 10 6 2 587 amp ASCUS 130 39 1 3 173 E S AGUS 5 5 SE ESL 9 5 i 2 3 16 ot gt HSIL 1 1 3 5 F S 3 CA z 3 0 gt a TOTAL 570 183 7 1
39. 292 0 2292 KEA 100 16 7 83 3 site 98 9 99 6 0 6 6 6 6 1 6 5 6 2476 2449 2476 2465 2476 16 2476 ae 80 0 60 0 20 0 sites 99 2 99 7 0 5 5 4 5 3 5 1 5 2323 2304 2323 2315 2323 11 2323 STA 30 8 19 2 11 5 Site4 99 9 99 9 0 04 26 8 26 5 26 3 26 2478 2475 2478 2476 2478 1 2478 All 29 3 13 8 15 5 All 99 5 99 8 0 3 58 17 58 8 58 9 58 9569 9520 9569 9548 9569 28 9569 cl 18 1 42 7 6 1 25 4 25 9 5 0 CI 99 3 99 6 99 7 99 9 0 2 0 4 95 Confidence Interval MAN 03938 001 Rev 001 page 11 of 15 All ThinPrep slides that produced discordant unsatisfactory determinations Manual Review arm vs Imager Review arm during the clinical study were assessed in an additional clinical support study to compare the method used for specimen adequacy in the clinical study with a control cell count of the slides and 3 different methods as follows 1 Manual assessment of specimen adequacy on the entire microscope slide based on ThinPrep Bethesda System 1991 criteria 2 Using the diameter method of Bethesda System 2001 which requires that the Cytotechnologist counts cells in 10 fields of view along the diameter of the cell spot and calculate the number of cells on the slide 3 Having the Cytotechnologist count the cells in the 22 fields of view presented by the system and calculate the number of cells on the slide This additi
40. 3 2004 01 45 PM 8006 5 0 14 Mw Figure 4 36 Server Error Log Report 4 24 Image Processor Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Report Image Processor Error Log This report displays errors encountered by the Imaging System If multiple Imagers are at a site a drop down list displays the Imagers available Select one by clicking on the Imager name Then click on the View button to see the report See Figure 4 37 Report Results System Error Log Report Date Jan 13 2005 01 45 PM Matches found 5 Image Processor Deltal Software Version 6713 Jan 09 2005 5 05PM Deltat 201 80J04AP 5 0 14 6502 Jan 09 2005 5 03PM Deltat 201 B0J04AP 5 0 14 2193 Jan 09 2005 5 02PM Deltat 201 80J04AP 5 0 14 2193 Jan 09 2005 5 00PM Deltat 201 B0J04AP 5 0 14 Error Number Date Time Imager Name I System ld v Figure 4 37 System Error Log The errors are displayed with the most recent events at the top and older events following The report will display as many lines of data as selected in the report limit setting 500 to 5000 refer to System Lab Settings on page 4 40 Click on the Print button to print the report Click on the Close button to return to the Logs Selection menu Image Processor Operator s Manual 4 25 OPERATION OF THE SOFTWARE MENU Report Review Scope Error Log This report displays errors encountered by Review Scopes A drop down list displays the Review Scopes that are connected to
41. 3 7 1 6 Image Processor Operator s Manual INTRODUCTION Specimen Integrity Specimen sample once PreservCyt Solution vials contain samples cells are preserved for 6 weeks at 4 37 C 39 98 6 F Slides processed by a ThinPrep Processor should be stained within 5 days Stained slides should be imaged by the Imager in a timely manner according to normal laboratory practises Imaging performance has not been assessed beyond 4 months Interfering Substances Specimen sample the use of lubricants e g KY Jelly should be minimized prior to specimen col lection Lubricants can adhere to the filter membrane and may cause poor cell transfer to the slide Stain do not substitute solutions for the ThinPrep Stain solutions Follow the stain protocols exactly as they are written Refer to Chapter 7 ThinPrep Stain and to the ThinPrep Stain User s Manual Specimen Handling The ThinPrep slides are stored transported and handled the same as conventional cytology slides Please refer to your laboratory guidelines for specimen handling IMAGE PROCESSOR TECHNICAL SPECIFICATIONS Overview of Components Refer to Figures 1 4 to 1 13 for information regarding components and specifications Image Processor Operator s Manual 1 7 INTRODUCTION vill Hi Imaging Station Housing Vanity Panel Robot Shield Slide Cassette In Position 1 of 10 Positions Sliding Doors Left Door Open Cassette P
42. 5 8 1 Site3 99 2 99 5 0 3 62 65 0 87 1 74 2 93 1 4 0 20 1 2237 98 7 99 5 99 1 99 8 0 1 0 6 REA 84 7 78 4 6 3 sitea 98 7 98 7 0 08 111 98 1 99 1 76 6 90 8 14 7 2 1 2381 98 2 99 2 98 1 99 1 0 6 0 4 Ai 79 7 79 2 0 5 an 99 0 99 1 0 09 375 15 3 83 7 14 7 83 2 5 0 4 0 9168 98 8 99 2 98 9 99 3 0 1 0 3 Numbers in parentheses represent 95 confidence intervals The results presented in Table 3 show that the difference between sensitivities of the Imager Review and Manual Review arms for LSIL for all sites combined was not statistically significant with a 95 confidence interval of 5 0 to 4 0 The observed difference between sensitivities for LSIL varied among the sites from 6 3 with a 95 confidence interval of 14 7 2 1 to 8 1 with a 95 confidence interval of 4 0 20 1 The difference in specificity results between the Imager Review and the Manual Review was not statistically significant with a 95 confidence interval of 0 1 to 0 3 The observed differences between specificities varied among the sites from 0 4 to 0 6 Table 4 Adjudicated Review Versus Imager Review HSIL Descriptive Diagnosis Summary for Each Site and All Sites Combined Sensitivity is a percent of true HSIL combined HSIL SQ CA and GL CA slides classified in either study arm as HSIL and specific
43. 5 05 50 PM IPCOO07 Jan 18 2005 05 50 PM Connection Time Figure 4 70 Server Window Image Processor Operator s Manual 4 53 OPERATION OF THE SOFTWARE MENU SECTION MAINTENANCE MENU There are maintenance items that the operator should do on a routine basis refer to Chapter Five Image Processor Maintenance The Clean Verification Slide task is located under Maintenance on the system menu bar because the system software is required in order to retrieve and return the verification slide for the operator Refer to Figure 4 71 Refer to the CLEAN VERIFICATION SLIDE procedure in Chapter Five for instructions on clean ing the slide Slide Processing Reports System About Clean Verification Slide Figure 4 71 Maintenance Menu SECTION ABOUT MENU The ThinPrep Imaging System version and the Image Processor software version can be viewed by clicking on the About ThinPrep Imaging System button Figure 4 72 About ThinPrep Imaging System Fa ThinPrep Imaging System 3 1 0 Copyright 1999 2006 CYTYC Corporation all rights reserved Figure 4 72 About ThinPrep Imaging System 4 54 Image Processor Operator s Manual aoueuDlUleW S 5 Maintenance IMAGE PROCESSOR MAINTENANCE 5 Chapter Five Image Processor Maintenance SECTION fae CLEAN VERIFICATION SLIDE WARNING Glass Sharp Edges The verification slide should be cleaned and inspected yearly or if
44. 5 9 2 786 Among the 786 cases determined by the adjudication panel to be Negative 587 74 7 cases in the Imager Review arm and 570 72 5 cases in the Manual Review arm were diagnosed as Negative and 21 2 7 cases in the Imager Review arm and 26 3 3 cases in the Manual Review arm were diagnosed as LSIL Table 6 6x6 True ASCUS Contingency Table For All Sites Combined All 251 Cases Determined To Be ASCUS By Adjudication Unadjudicated Manual Review Arm Diagnosis 8 NEG ASCUS AGUS LSIL HSIL CA TOTAL p 2 NEG 3 32 z 7 3 A 45 amp amp ASCUS 70 47 1 20 4 5 142 E a AGUS 1 1 SE ESE 6 21 z 16 7 A 50 aot Z HSIL 2 3 z 5 1 1 12 T E gt CA 1 g 3 z g 1 TOTAL 83 103 1 48 15 1 251 Among the 251 cases determined by the adjudication panel to be ASCUS 142 56 6 cases in the Imager Review arm and 103 41 0 cases in the Manual Review arm were diagnosed as ASCUS and 45 17 9 cases in the Imager Review arm and 83 33 1 cases in the Manual Review arm were diagnosed as Negative MAN 03938 001 Rev 001 page 7 of 15 Table 7 6x6 True AGUS Contingency Table For All Sites Combined All 10 Cases Determined To Be AGUS By Adjudication Unadjudicated Manual Review Arm Diagnosis NEG ASCUS AGUS LSIL HSIL CA TOTAL NEG 3 2 z 1 z 4 ASCUS z z z AGUS 2 i LSIL z 3 z z 3 HSIL 3 3 C
45. 68522005 error number in 4 10067532005 10067732005 10068032005 10068282005 10068532005 E si Fy T imee e 2407 10068042005 10068292005 10068542005 occurred 10067802005 10068052005 10068302005 10068552005 E3 10067812005 10068062005 10068312005 10068562005 8 10067822005 10068072005 10068322005 10068572005 9 10067832005 10068082005 10068332005 10068582005 10 10067842005 10063092005 10084832005 10068592005 ES 10067852005 10063102005 10068352005 10068602005 12 10067862005 10068112005 10068362005 10068612005 13 10067872005 10068122005 10068372005 10068622005 14 10067882005 10068132005 10068382005 10068632005 15 10067892005 10068142005 10068392005 10068642005 16 10067902005 10068152005 10068402005 10063652005 17 10067912005 10068162005 10068412005 10068662005 Auto Print Run Report Figure 4 6 Run Report continued This function if selected will automatically print the Run Report at the conclusion of a batch See Figure 4 4 Image Processor Operator s Manual 4 5 OPERATION OF THE SOFTWARE MENU o SYSTEM MENU The System Menu contains options for shutting down the Image Processor system and Server Data Management submenu contains the database backup function reporting function and system setup and shut down capabilities Refer to Figure 4 7 Slide Processing Reports System Maintenance About Gol Shut Down System Shut Down
46. A 3 3 1 TOTAL 2 2 3 0 1 2 10 p p pa Unadjudicated Imager Review Arm Diagnosis ml ol co a Among the 10 cases determined by the adjudication panel to be AGUS 4 40 0 cases in the Imager Review arm and 3 30 0 cases in the Manual Review arm were diagnosed as AGUS and 4 40 0 cases in the Imager Review arm and 2 20 0 cases in the Manual Review arm were diagnosed as Negative Table 8 6x6 True LSIL Contingency Table For All Sites Combined All 236 Cases Determined To Be LSIL By Adjudication Unadjudicated Manual Review Arm Diagnosis ee NEG ASCUS AGUS LSIL HSIL CA TOTAL 8 A NEG 4 12 1 gt 17 ASCUS 13 16 20 1 50 E S AGUS 3 B a o Oe S LSIL 8 20 3 1s 12 155 ot amp gt HSIL 5 9 14 Cn an E a a a an ae Se CA 5 g z 0 gt TOTAL 21 40 0 152 23 0 236 Among the 236 cases determined by the adjudication panel to be LSIL 155 65 6 cases in the Imager Review arm and 152 64 4 cases in the Manual Review arm were diagnosed as LSIL and 17 7 2 cases in the Imager Review arm and 21 8 9 cases in the Manual Review arm were diagnosed as Negative Table 9 6x6 True HSIL Contingency Table For All Sites Combined All 138 Cases Determined To Be HSIL By Adjudication Unadjudicated Manual Review Arm Diagnosis ats NEG A
47. CESSOR MAINTENANCE 5 Figure 5 7 Install New Fuses 9 Insert the fuse holder back into the power entry module The module can only be installed in one orientation 10 Close the access cover Figure 5 8 Install the Fuse Holder 11 Plug the power cord into the socket on the instrument 12 Reattach the power cord to the uninterruptible power supply 13 Turn on the instrument 14 If the instrument still fails to operate contact Hologic Technical Support Image Processor Operator s Manual 5 5 5 IMAGE PROCESSOR MAINTENANCE SECTION femme REPLACING THE IMAGING STATION AIR FILTER The Imaging Station air filter should be replaced yearly Refer to Ordering Information for replacement air filters ONS Air Filter Cover Panel Thumb Screws Figure 5 9 Air Filter Location Turn off power to the Imaging Station refer to Shutting Down the Image Processor on page 3 22 Loosen the four thumb screws at each corner of the air filter cover panel Figure 5 9 Lift off the cover panel and set it aside Remove the air filter cartridge Figure 5 10 itt p M UN duenn m Figure 5 10 Air Filter Cartridge 5 Install the replacement cartridge replace the cover panel and tighten the retaining screws 5 6 Image Processor Operator s Manual IMAGE PROCESSOR MAINTENANCE 5 SECTION pie CLEANING THE CASSETTE MAPPING SENSOR The cassette mapping sensor is the opti
48. ECTION D Imaging Station and IPC Errors SECTION E Data Export Import and Backup Errors Chapter Seven THINPREP STAIN SECTION A Introduction SECTION B Fixation Requirements SECTION C Staining Requirements SECTION D Coverslipping Requirements Chapter Eight DEFINITIONS AND ABBREVIATIONS Chapter Nine SERVICE INFORMATION ii Image Processor Operator s Manual 4 1 4 2 4 6 4 8 4 54 4 54 5 1 5 3 5 6 5 7 6 1 6 4 6 7 6 9 6 12 7 1 7 1 7 2 7 3 8 1 9 1 CONTENTS Chapter Ten ORDERING INFORMATION 10 1 Chapter Eleven REMOTE SITE SERVER USER S GUIDE 11 1 INDEX Label Specifications for Use with the ThinPrep Imaging System Image Processor Operator s Manual iii CONTENTS This page intentionally left blank iv Image Processor Operator s Manual uononpowyy 4 1 Introduction INTRODUCTION Chapter One Introduction SECTION ame OVERVIEW AND FUNCTION OF THE IMAGE PROCESSOR The Image Processor is a system for imaging and analyzing ThinPrep cervical cytology sample slides Slides that have been processed on a ThinPrep 2000 or 3000 Processor are then stained with ThinPrep Stain and coverslipped The slides are loaded into slide cassettes and placed into the Imag ing Station The slides are processed in a batch one slide at a time by the Imaging Station which reads the slide accession ID number and images the cell spot of the slide The Image Processor Con troller contains the processors
49. FILM Automated Coverslipper Coverslip Length 45 mm Xylene Dispensing Range 1 5 Setting 1 Xylene Holding Bath Full Bath Spring Tension Setting Full Tension Slide Drying e Remove staining racks from instrument immediately after coverslipping is complete Do not let them sit in the output carousel e Remove excess xylene dab base of stain rack on kim wipe or paper towel and stand the rack up so the slides are vertical e Immediately remove slides from rack and wipe excess xylene from back if slide with kim wipe Slides are now ready to label if needed 7 6 Image Processor Operator s Manual sSuO eIAaiqqy pue suouljaq 8 8 Definitions and Abbreviations DEFINITIONS AND ABBREVIATIONS 8 Chapter Eight Definitions and Abbreviations Batch A group of slides or cassettes containing slides that are being processed by the Image Processor Each cassette holds up to 25 slides 10 cassettes may be loaded into the Image Processor therefore a batch may have up to 250 slides in it Cassette The container that holds slides for batch processing Each cassette may hold up to 25 slides The cas settes have a footprint designed to hold them securely in the Image Processor during slide process ing There are locations for 10 cassettes to be loaded into the Image Processor Cassette Status Not Present No cassette present in the slot on the loading platform Unknown Unknown with respe
50. G SYSTEM Operation Summary and Clinical Information The ThinPrep Imaging System HOLOGIC A INTENDED USE The Hologic ThinPrep Imaging System Imager is a device that uses computer imaging technology to assist in primary cervical cancer screening of ThinPrep Pap Test slides for the presence of atypical cells cervical neoplasia including its precursor lesions Low Grade Squamous Intraepithelial Lesions High Grade Squamous Intraepithelial Lesions and carcinoma as well as all other cytologic criteria as defined by 2001 Bethesda System Terminology for Reporting Results of Cervical Cytology B SUMMARY AND EXPLANATION OF THE SYSTEM The ThinPrep Imaging System is an automated imaging and review system for use with ThinPrep Pap Test slides It combines imaging technology to identify microscopic fields of diagnostic interest with automated stage movement of a microscope in order to locate these fields In routine use the ThinPrep Imaging System selects 22 fields of view for a Cytotechnologist to review Following review of these fields the Cytotechnologist will either complete the diagnosis if no abnormalities are identified or review the entire slide if any abnormalities are identified The ThinPrep Imaging System also allows the physical marking of locations of interest for the Cytopathologist C PRINCIPLES OF OPERATION The ThinPrep Imaging System consists of an Image Processor and
51. HE SOFTWARE MENU The start and com pletion times of the ThinPrep Imaging System Run Report batch are recorded Started Jun 13 2006 06 30 04 PM as is the lab name if Completed Jun 14 2006 07 55 45 AM enabled The Imag Lab Name ing Station that the TIS S N 20151104C2 batch was run on is Imager identified by its serial number and Imager name Batch Summary Totals ma Slides System Errors Slide Events Slides Ready for Review 200 0 1 199 A Batch Summary lists number of slides any errors and num Slide Events sh aes ready for Cassette Slot SlideID EventNumber DescriptionofEvent Date Time 2 5 10067962005 2407 Slide cannot be imaged Jun 13 2006 09 18 30 PM Any Slide Process ing Events encoun tered in the batch are listed with a brief description Figure 4 5 Run Report 4 4 Image Processor Operator s Manual OPERATION OF THE SOFTWARE MENU A ThinPrep Imaging System Run Report Started Jun 13 2006 06 30 04 PM Completed Jun 14 2006 07 55 45 AM Lab Name TIS S N 2015110402 Imager Slides Ready for Review Scope Cassettes 1 5 Slides that are ready for review ears are listed by slot Slot Cassetiel Cassetie2 Cassetie3 Cassetied Cassette5 position and 1 10067752005 10068002005 10063252005 10068502005 cassette num 2 10067512005 10067762005 10068012005 10068262005 10084822005 ae es heim 3 10067772005 10068022005 10068272005 100
52. M Number indicates a slide event occurred slide not Matches found 14 Slide Id imaged Refer to Chapter 6 Troubleshooting Slide Image OK indicates the slide was successfully imaged Slide Review Review status REVIEWED Slide Id Imager Id Imaging Date ys hy Review Scope Id Review Date User Id Lab 752A3D1F 0507 4F2A 79000021102 PEGIPC Jul 08 2002 1 06PM 4757 10501 GO04AP Nov 02 2004 3 15PM 111 ADD5 40624068BADD 752A3D1F 05D7 4F2A 79000181118 PEGIPC Jul 08 2002 11 14AM OK 10501G04AP Jun 03 2003 4 24PM 111 ADD5 40624068BADD 752A3D1F 05D7 4F2A ADD5 40624068BADD 79000351135 PEGIPC Jul 08 2002 12 15PM OK 10501G04AP Dec 21 2004 3 20PM 101 PAA etn al 752A3D1F 05D7 4F2A ADDS5 40624068BA0D 752A3D1F 05D7 4F2A ADDS 40624068BADD 752A3D1F 05D7 4F2A ADDS 40624068BADD v Print Close 79000211121 PEGIPC Jul 08 2002 1 21PM OK 10501 GO4AP Oct 11 2004 4 13PM 101 79000411141 PEGIPC Jul 08 2002 11 37AM OK 10507G04AP Jul 27 2004 4 06PM 111 79000531153 PEGIPC Jul 08 2002 11 45AM OK 10501G04AP Mar 09 2004 2 56PM 101 79000541154 PEGIPC Jul 08 2002 12 47PM OK 10501G04AP May 13 2004 3 59PM 101 The report will list all slide data records within the parameters that were selected IDs will list by slide ID from lowest to highest To print the report click on the Print button To close the win dow and return to the main menu click the Close button Report Workload The workload rep
53. N THE EQUIPMENT WARNING Grounded Outlet Note All power cords must be plugged into a grounded outlet Disconnection from the power supply source is by removal of the power cord At the Server push on the power button If the monitor is not already on push on the power but ton The keyboard and mouse will be active when the computer boots up Note Do not touch the keyboard during power up Power On Button Figure 11 3 Power On the Server and Monitor models may look different from the illustration shown here The system is ready for use when the Data Management Program screen is displayed Refer to Figure 11 4 The printer and Review Scopes may be powered on before or after the Server No network com munication can be made until the Server is fully booted up 11 4 Image Processor Operator s Manual REMOTE SITE SERVER USER S GUIDE i ThinPrep Pia aN G SYSTEM Data Management Program Copyright 1999 2005 CYTYC is a registered trademark of the Cytye Corporation and its subsidiaries Figure 11 4 Server Data Management Program Display Click on the Data Management Program link to access the Data Management menu options Dat Management Sua Data Management a Database amp Backup E Import E Export J Maintenance User Accounts E Reports R Logs and History RRS Users gt R Slide Data Records R Workload R Run Report System amp B Lab Settings
54. OCESSOR Section I aa SHUTTING DOWN THE IMAGE PROCESSOR WARNING Never turn off power to the equipment without shutting down the system via the User Interface CAUTION If Review Scopes are also connected to the Imaging System work sched ules must be coordinated so that all operation is concluded prior to equipment shut down Normal Shut Down Server Before shutting off the Server make sure that all other IPCs and Review Scopes that are networked to it are either turned off or not actively communicating with it 1 To power off the server at the user interface use the mouse to pull down the menu under System and click once on Shut Down Server Refer to Figure 3 29 3 22 Image Processor Operator s Manual OPERATION OF THE IMAGE PROCESSOR 3 Slide Processing Reports System Maintenance About inn Shut Down System Shut Down Server Data Management Figure 3 27 Shut Down System Menu Selection 2 Select Yes to continue with shut down Figure 3 30 ThinPrep Imaging System 2 j re you sure you want to shut down the system Figure 3 28 Confirm Shut Down Image Processor 1 To power off the Image Processor at the user interface use the mouse to pull down the menu under System and click once on Shut Down System Refer to Figure 3 29 Slide Processing Reports System Maintenance About m a Shut Down System Shut Down Server Data Management Figure 3 29 Shut Down Sys
55. Path Lab Howard Breezie 113 Gam pus Path Lab Betz Charles 115 4637 Gam pus Path Lab Greeno Eleanor 117 Gam pus Path Lab Tufts Mason 118 3 Gam pus Path Lab Figure 4 50 CT Workload Summary Report To print the report click on the Print button To close the report click on the Close button to return to the Workload display The CT workload history generates a report of activity by operator In the Operator ID drop down menu select which ID to display Also the date range and time interval may be specified Click on the View button to see the report See Figure 4 51 4 38 Image Processor Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Report Results CT Workload History Report Date Dec 10 2004 02 47 PM This report does not include manual reviews Howard Breezie 113 Campus Path Lab FOV Only Full Review Noy 2003 31 2 ec 2003 8 2 eb 2004 77 13 ar 2004 248 197 Figure 4 51 CT Workload History Report The tally slides screened in the time frame selected is broken into FOV field of view only and Full Review These distinguish between unmarked and marked slides Note Neither CT Workload Summary nor CT Workload History has a count of manual slide reviews Report Run Report The Run Report displays the results of a processed batch Information from the 100 most recent batches is available This is the same report that is accessed from the main menu under Reports Refer to REPORTS MEN
56. Printers 4 44 Installation 2 1 Interrupt Slide Processing 3 17 3 18 Items Required For Slide Image Processing 3 6 L Lab Settings 4 40 Loading Slide Cassettes 3 8 local network 2 1 11 1 Logs and History Reports 4 23 M MAINTENANCE MENU 4 54 Maintenance Data Management menu 4 20 menu bar 4 1 Monitor Keyboard and Mouse 3 6 Review Scope Operator s Manual Index 3 INDEX O OCR 8 2 OCR read failed 6 2 optical character recognition 1 4 Ordering Information 10 1 P Page Setup 4 42 Password 4 45 change 4 51 disable 4 52 enable 4 46 validate 4 49 Power on equipment 3 3 Power Specifications 1 13 Printers 4 43 Processing Completed 3 22 Processing Interrupted 3 19 Protective Temperature Coefficient Devices 1 14 R Rebooting the System 3 24 Recycled alcohol 7 2 Remote site 11 1 Replace Clean Verification Slide 5 1 Replacing Fuses 5 3 Report Limit 4 42 Reports Data Management menu 4 22 REPORTS MENU 4 2 Resume Slide Processing After Interruption 3 21 Retrieve verification slide 5 1 Review Scope Error Log 4 26 RS Users Data Management menu 4 30 Index 4 Review Scope Operator s Manual Run Report 4 39 S Security 4 45 Server Data Management menu 4 24 9 1 4 53 Server Error Log Service Information Set Date 4 40 Set Imager Name Set Time 4 41 Shut Down IP Shut down server 4 41 3 21 4 7 4 6 6 6 Shutting Down the Image Processor 6 2 3 22 4 53 3 23 11 6
57. Recommended clearances 3 76 2 mm on all sides Slide Cassette Dimensions 10 254 mm 139 7 mm Figure 1 10 Slide Cassette loaded with slides Image Processor Operator s Manual 1 11 INTRODUCTION Image Processor Controller PC and Server PC Image Processor Controller Server Refer to the documents which come with the equipment for technical specifications Other Components The other components that complete the Imaging System network are other manufacturers prod ucts They will be unpacked and installed by Hologic personnel Please refer to the documents that came with them for specifications operation safety and maintenance Note If maintenance is required contact Hologic Technical Support 777193 Seer ae 24388 a 433 Jit ee ee V Uninterruptible Monitor Keyboard and Network Device Postscript Network Printer Power Supply Mouse shown with battery backup Figure 1 11 Other System Components 1 12 Image Processor Operator s Manual Environmental INTRODUCTION Operating Temperature Range 16 C to 32 C Non Operating Temperature Range 28 C to 50 C Operating Humidity Range 20 to 80 relative humidity non condensing Non Operating Humidity Range 15 to 95 relative humidity non condensing Pollution Degree II in accordance with IEC 61010 1 Cate
58. SCUS AGUS LSIL HSIL CA TOTAL Bp NEG 1 3 E 1 3 2 ASCUS 2 4 z 2 1 E 9 E AGUS 0 S E TSL 1 7 3 10 6 3 17 oa Zg HSIL 3 3 1 9 91 1 108 25 CA z 1 1 2 a TOTAL 6 8 1 21 100 2 138 MAN 03938 001 Rev 001 page 8 of 15 Among the 138 cases determined by the adjudication panel to be HSIL 108 78 3 cases in the Imager Review arm and 100 72 5 cases in the Manual Review arm were diagnosed as HSIL and 2 1 4 cases in the Imager Review arm and 6 4 3 cases in the Manual Review arm were diagnosed as Negative There was one 1 squamous cell carcinoma SQ CA case resulting from adjudication It was diagnosed as HSIL in the Imager Review arm and SQ CA in the Manual Review arm Table 10 shows the study subjects unadjudicated descriptive diagnosis marginal frequencies for benign cellular changes for all sites combined Table 10 Unadjudicated Marginal Frequencies Summary of Descriptive Diagnosis for Benign Cellular Changes All Sites Combined Manual Review Imager Review 9550 9550 Descriptive Diagnosis Benign Cellular Changes ee ee ee ee Infection Trichomonas Vaginalis Eat 8 o Predominance of coccobacilli _ 7n 07 6o o6 Bacteria consistent with Actinomyces spp 1 00o f 00 Cellular Changes associated with Herpes virus 1 00 1 f 00 Other Infection _ _ 1 00o o f oo Reactive Cellular Changes Asso
59. SHEMP F1 1A PTC 5V sensor power to sensor ports J4 and J5 F2 1A PTC 5V sensor power to sensor ports J2 and J3 F3 1A PTC Isolated 5V for the CAN BUS F4 500ma PTC 24V line to protect against motor or drive failure Servo Interface Module SERVIM R21 1 85A PTC 24V line to protect FETS and motors Stepper Interface Module STEPIM R22 R28 1 85A PTC Digital I O Module F1 300ma PTC 12V sensor power to connector J1 F2 1A PTC 5V sensor power to connector J2 Dimensions and Weight Approximate Imaging Station 23 584 2 mm H x 32 812 8 mm W x 25 635 mm D 139 Ibs 59 kg uncrated Image Processor Controller Server and other components Refer to the documents that come with the equipment 1 14 Image Processor Operator s Manual INTRODUCTION ThinPrep Imaging System Standards The ThinPrep Imaging System has been tested and certified by a U S nationally recognized testing Laboratory NRTL to comply with current Safety Electro Magnetic Interference EMI and Electro Magnetic Compatibility EMC standards Refer to the product label located on the rear of the instrument to see the safety certification markings Do not use this device in close proximity to sources of strong electromagnetic radiation e g unshielded intentional RF sources as these may interfere with the proper operation This product is in vitro diagnostic IVD medical equipment This product contains a device classi
60. See Figure 4 53 To change the month click on the left or right arrows on the top of the calendar 4 40 Image Processor Operator s Manual OPERATION OF THE SOFTWARE MENU 4 June 2006 fon Tue Wed Thu Click on the forward or back arrows to change the month Or click on the month Fri Sat Aoao a0 A ed NFO 11 EEJ 4 15 16 17 Click the date to choose l a Aa 18 19 20 21 22 23 24 anew date setting see a drop down list of 25 26 27 28 months Figure 4 53 Set System Date To save the setting click on the Apply button at the bottom of the window System time click on the hours minutes or seconds to highlight it as a selection Then type in the new setting Or scroll forward and backward by using the arrows to the right of the time field Note This sets the time on the Server and affects all IPCs which will be updated with this date time It may take up to ten minutes for it to take effect after clicking on the Apply button Change the highlighted System time Scroll forward or backward 22 10 PM A using the arrows value Figure 4 54 Set System Time Imager name to type in a name click on the empty Imager name field then type the name of the Imager Alphanumeric characters may be used up to 49 characters Click the Apply button to save this setting Note This takes effect immediately on the IPC and Server but any other IPCs on the network must visit the Lab Settings page to up
61. Settings El Page Setup am Printers 8 Security 3B Server Data Management Menu Data Management with Security Enabled Figure 4 61 Data Management Menu When Data Management has security enabled the Slide Data Record window will not display the Review Scope serial number field or the Review Scope User field including Lab Name and User ID See Figure 4 62 Image Processor Operator s Manual 4 47 OPERATION OF THE SOFTWARE MENU will At Slide Id Slide Id Qualifier Slide Id Qualifier Slide Id au a _ au JL Slide Image Slide Review Slide Image Slide Review Image status Review status Image status Review status ALL v fau v ALL lau v Imager name Review Scope serial number Imager name f 46XN551 v vi IPBPSKZ81 v Image date E Review date Er Image date Review date ALL jau v pau Jes i Review Scope User Lab name Slide Data Record Window Slide Data Record Window with Security Enabled Figure 4 62 Slide Data Record Report Selection Criteria 4 48 Image Processor Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Validate The Validate button is available on the security window only when password protection is in effect This allows a user who knows the administrative password to access restricted data without entirely disabling the security feature To access the Workload Reports User Account management or entire Slide Data Record wind
62. Shut down components as described in Section I 2 Allow 15 seconds to pass before powering on the monitor Server Imaging Station and Image Processor Controller 3 24 Image Processor Operator s Manual nus aeMmyos r 4 Software Menu OPERATION OF THE SOFTWARE MENU 4 Chapter Four Operation of the Software Menu The menu bar is located at the top left of the User Interface just above the Go and Stop buttons The software has five main menu items Slide Processing Reports System Maintenance and About Refer to Figure 4 1 Cytyc Corp ThinPrep Imaging System Menu Bar Slide Processing Reports System Maintenance About Menu Items Figure 4 1 Main Menu To view the options within a menu place the cursor over the menu item and click once The menu box expands to display the functions Note If a function is unavailable some functions cannot be performed during slide processing for instance the function will be visible but grayed out Clicking on the grayed out item will have no effect SECTION fw SLIDE PROCESSING MENU This menu presents user selectable commands for starting or interrupting slide processing Note The green Go button and the red Stop button seen directly below the Slide processing pull down menu box will execute the same functions respectively Refer to Figure 4 2 Sea Reports System Maintenance About Start Slide Processing Figure 4 2 Slide Processing Menu Image Proc
63. Shut down system Shutdown System 3 22 Slide already imaged Slide Cassette 10 2 Slide Cassette Imaging Status Slide Data Record 8 3 Slide Data Record Report 4 36 Slide Data Records Data Management menu SLIDE EVENTS 6 1 Slide has been rejected Slide ID conflict 4 19 Slide ID not valid 6 3 Slide ID report 4 33 Slide IDs 4 10 Slide labeling 3 7 Slide not found 6 3 slide preparation and quality SLIDE PROCESSING 3 14 Slide Processing Event Log 3 15 SLIDE PROCESSING MENU 4 1 Slot below has slide out of position or multiple slides 6 3 3 15 4 32 6 3 6 7 4 29 Slot has multiple slides INDEX 6 3 Review Scope Operator s Manual Index 5 INDEX Slot has slide out of position 6 3 Staining requirements 7 2 Start Slide Processing 3 14 3 21 STOP button 3 18 4 1 Store verification slide 5 3 System Data Management menu 4 39 System Auto Recovery Errors 6 4 System Error Log 4 25 SYSTEM ERRORS 6 4 System Printers 4 43 System warmup 3 5 T Technical Support 2 1 9 1 Template export 4 14 Time setting 4 41 Troubleshooting 6 1 U UPS uninterruptible power supply 2 3 3 3 User Accounts 4 21 User Assessment 6 5 User Assisted Recovery 6 6 User Correctable Errors 6 5 User ID 4 22 User Notification 6 4 V Verification Slide 3 6 3 15 51 8 3 W Workload Report 4 36 Index 6 Review Scope Operator s Manual HOLOGIC Label Specifications for Use with the ThinPrep Imaging System
64. U on page 4 2 System The System has options for configuring your lab settings page setup for sending reports to print printers for selecting a printer if more than one is on the network and an interface with the Server for shut down purposes Image Processor Operator s Manual 4 39 OPERATION OF THE SOFTWARE MENU wll At System Lab Settings The Lab Settings display allows the operator to enter the Lab name which will appear on reports that use it set the date and time and the preferred date time format enter the Imager name turn the audible alarm on or off and choose how many lines of data a report will display Data Management A BR Data Management Lab Settings H Database Lab name lt P User Accounts Campus Path Lab a EA Reports 3 System System date System time amp Lab Settings Jan 14 2005 11 58 58 AM E Page Setup ma Printers 8 Security ME Server Local Settings Imager name Alarm ON Report date time format Report limit mon dd yyyy hhimmAM for PM w 500 Figure 4 52 Lab Settings Window Lab name to enter a name click the cursor on the empty lab name field then type the name of the lab Alphanumeric characters may be used up to 49 characters Click the Apply button to save this setting System date Use the pull down menu to access a pop up calendar The date may be changed by clicking on a date on the calendar That day will become highlighted
65. a CD in the drive on the server There is no CD in the CD drive on the server Check that a CD is in the CD drive of the Server The backup export and import commands only work when the CD is in the Server Cannot access export directory Unable to access the directory containing export data Try the function again Cannot access import directory Unable to access the directory containing import data Try the function again Cannot find source directory The backup data couldn t be found to write onto the CD Try the function again CD verification failed After the CD was written the data didn t match what was exported Try the function again Database image too large for media Too much data to fit on a CD If this message appears during database backup consult Hologic Technical Support Database query failed when viewing Import Results A database query failed Try the function again If the error persists contact Tech nical Support Export failed The export failed Try the function again Export failed due to database error A database error prevented the export from succeeding Try the function again Failed to add the tem plate A new template could not be added to the Export menu Try to add a template again Be sure it has a unique name Failed to write to the media The CD failed to write properly
66. ace an empty cassette into the IS e Place an empty cassette into any available position on the IS e Close the doors and click the CONTINUE button e The system will place the slide in the cassette e When finished open the doors and remove the cas sette e f there is no slide in the cassette it means the verifica tion slide was on the stage 4450 through Slide has been rejected See Section C Slide Preparation and Quality 4475 Fiducial Mark error 4756 Slide has been rejected e See Section C Slide Preparation and Quality 4757 e Check whether the cell spot is thick or uneven e Check whether the slide is uneven 4758 Slide has been rejected See Section C Slide Preparation and Quality Insufficient fine focus operation 4759 Three 4758 errors within a cas sette generates a 4759 error 5050 Three consecutive 4450 4451 See errors 4450 through 4475 for details 4452 errors in any combination within a cassette generates a 5050 error 5051 Three consecutive 4453 4454 4455 errors in any combination within a cassette generates a 5051 error 5073 Door s Open e Follow the instructions on the System monitor This may require power cycling the System e Check that the doors are closed e At User Interface select CONTINUE in the User Assisted Recovery dialog If the problem is resolved continue processing e f the problem is not resolved power cycle the Imaging System NOTE that the IS and IPC should always be
67. ach of the four sites and all sites combined for true ASCUS LSIL and HSIL Table 2 Adjudicated Review Versus Imager And Manual Reviews ASCUS Descriptive Diagnosis Summary Sensitivity is a percent of true ASCUS combined ASCUS AGUS LSIL HSIL SQ CA and GL CA slides classified in either study arm as ASCUS and specificity is a percent of true Negative slides classified in either study arm as Negative Sensitivity Specificity Site Site Number Manual Imager Difference Number Manual Imager Difference Cases Cases Fen 77 2 78 3 1 1 Site1 98 7 99 2 0 4 180 70 4 83 1 71 6 84 1 5 8 8 0 2132 98 1 99 1 98 7 99 5 0 1 1 0 ae 63 1 77 5 14 4 site gt 95 8 96 1 0 3 230 56 5 69 3 71 4 82 6 8 2 20 5 2210 94 9 96 6 95 2 96 9 0 7 1 3 Sioa 80 6 94 2 13 6 Site3 98 5 98 8 0 4 103 71 6 87 7 87 8 97 8 4 3 22 9 2196 97 9 99 0 98 3 99 2 0 3 1 0 Spa 87 2 84 4 28 e 97 3 97 0 0 3 179 81 4 91 7 78 2 89 4 10 6 5 0 2313 96 6 97 9 96 2 97 7 1 1 0 5 i 75 6 82 0 6 4 an 97 6 97 8 0 2 692 72 2 78 8 78 8 84 8 2 6 10 0 8851 97 2 97 9 97 4 98 1 0 2 0 6 Numbers in parentheses represent 95 confidence intervals The results presented in Table 2 show that for ASCUS the increase in sensitivity of the Imager Review over the Manua
68. aded slide cassette upright slide it between two dividers onto the Imaging Sta tion platform Note The base of the slide cassette has a tab on both sides that must fit into the guide on the under sides of each divider Refer to Figure 3 12 Ul A A O Figure 3 12 Loading a Slide Cassette into the Imaging Station 3 Push the cassette forward to seat the base firmly against the divider stops When it is fully inserted the cassette engages an optical sensor that detects it is present An image of the slide cassette appears in the corresponding location on the User Interface Refer to Figure 3 13 Note Do not slam the cassettes into position This can cause the slides to pop out and potentially break Note Visually check to confirm that slides are not overhanging the retaining features Image Processor Operator s Manual 3 11 OPERATION OF THE IMAGE PROCESSOR il Cytyc Corp ThinPrep Imaging System Slide Processing Reports System Maintenance About 4 6 7 Figure 3 13 Cassette Loaded View on the User Interface 4 Continue to load slide cassettes into available positions on the Imaging Station platform Note There are ten slide cassette positions Depending on the batch size load as many cassettes as necessary Each cassette can hold 25 slides for a total batch size of 250 slides At least one cas sette containing at least one slide must be present to begin slide imaging Figure 3 14
69. ard the front opening of the cassette Slide with a lifted label edge Check that the slide is not cocked or overhanging the retaining feature Correct label issue Image Processor Operator s Manual 6 3 TROUBLESHOOTING ER SYSTEM ERRORS There are two types of system errors system self recoverable errors and user correctable errors All system errors are logged to a file which may be accessed via the User Interface see Report Image Processor Error Log on page 4 25 System Auto Recovery Errors These automatically recoverable errors are system errors that do not require user or service per sonnel intervention During operation the system encounters an error condition for which it has a sequence of steps to perform to recover from the condition The system restarts the application and the IPC hard drive and processors The Server remains running and is not interrupted The system returns to processing slides A User Notification box containing the error number and brief description time and date will be left on screen until the operator acknowledges this by clicking on the Close button Figure 6 2 User Notification System Error Information Error 3107 Wed Dec 01 08 14 18 2004 Too many SlideNotFound events Automatic System Error Recovery is complete Number of Automatic System Error Recoveries on this batch run 1 This dialog is for informational purposes only haac You may now close this dialog
70. atched or marred CAUTION Mounting media must be completely dry before loading slides into the Imag ing Station The coverslip media is dry wet media could cause equipment malfunction The slides are clean no fingerprints dust debris bubbles Handle the slides by the edges Chipped or damaged slides might not be imaged The coverslip does not extend beyond the surface of the slide The label is applied smoothly without overhang Lifted edges may stick during handling caus ing broken slides or instrument malfunction The slide is appropriately labeled for use with the ThinPrep Imaging System refer to Section D Slide Labeling page 3 7 Each cassette holds up to 25 slides It is not necessary for the slides to be in any particular order slots may be skipped Image Processor Operator s Manual 3 9 OPERATION OF THE IMAGE PROCESSOR il LOAD SLIDE CASSETTES INTO THE IMAGING STATION 1 At the Imaging Station open the left or right sliding door to access the desired platform loca tion Figure 3 11 Left Door Right Door Shown with doors fully closed Tuntre ee Slide Cassette Slide Cassette Position 10 Position 1 D od oo Loading Platform Dividers S Shown with doors removed for clarity Figure 3 11 Imaging Station and Slide Cassette Loading Platform 3 10 Image Processor Operator s Manual OPERATION OF THE IMAGE PROCESSOR 3 2 Holding a lo
71. athologist was blinded from the original manual review results For each of the 22 fields of view selected by the ThinPrep Imaging System the Cytopathologist verified and recorded the number of individual cancer cells clusters of cancer cells and any other abnormalities present Table 11 summarizes the results from this study Table 11 Summary of Results From Restricted Analytical Cancer Study Cytopathologist Full Manual Cytotechnologist Review of Imager Cytopathologist Review of Review Identified 22 Fields of View Imager Identified 22 Fields of View 5 Glandular Carcinoma 7 Glandular Carcinoma 1 Squamous Cell Carcinoma 1 Squamous Cell Carcinoma 1 Adenocarcinoma In situ 1 AGUS 10 Glandular Cancer 2 HSIL AGUS 1 HSIL 1 ASC H ASC US 1 Adenocarcinoma In situ 1 Adenocarcinoma In Situ 1 Adenocarcinoma In Situ 3 Glandular Carcinoma 21 Squamous Cell Carcinoma 12 Squamous Cell Carcinoma 1 Adenocarcinoma In situ 1 Squamous Glandular Carcinoma 2 Adenocarcinoma In situ 4 HSIL 22 Squamous Cell Carcinoma Total 33 Total 33 Total 33 In the intended use of the ThinPrep Imaging System Imager the Cytotechnologist would perform a full manual slide review of each of these cases and pass them on to a Cytopathologist for further review In the intended use of the ThinPrep Imaging System Imager the Cytopathologist would perform a full manual slide review of each of these cases The results in Table 1 de
72. aused harm to a patient Hologic shall indemnify Customer for the compensatory damages paid by Customer to discharge the personal injury judgment with respect to Product Hologic Inc 2014 All rights reserved No part of this publication may be reproduced transmitted transcribed stored in a retrieval system or translated into any language or computer language in any form or by any means electronic mechanical magnetic optical chemical manual or otherwise without the prior written permission of Hologic 250 Campus Drive Marlborough Massachusetts 01752 United States of America Although this guide has been prepared with every precaution to ensure accuracy Hologic assumes no liability for any errors or omissions nor for any damages resulting from the application or use of this information This product may be covered by one or more U S patents identified at http hologic com patentinformation Hologic ThinPrep and PreservCyt are registered trademarks of Hologic Inc and or its subsidiaries in the United States and other countries All other trademarks registered trademarks and product names are the property of their respective owners Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment Document Number AW 03608 001 Rev 002 wa sAS Bulbew daiquiy oul The ThinPrep Imaging System ThinPrep IMAGIN
73. ay be obtained by contacting Customer Service at the numbers listed above Image Processor Operator s Manual 10 1 1 0 ORDERING INFORMATION Reordering Supplies for the Imaging Station and Image Processor Controller Item Description Quantity Part Number Slide Cassette 10 pack Additional slide cassettes 1 pkg 70773 001 Operator s Manual Additional Operator s Manual ea MAN 01445 001 Fuse 5x20 mm Time Delay Glass Replacement fuses ea 50077 021 6 3A for Imaging Station Air Filter for Imaging Station Replacement air filter ea 51056 001 10 2 Image Processor Operator s Manual apiny s 19sp JOAIOS OS s OWSY LL 11 Remote Site Server User s Guide REMOTE SITE SERVER USER S GUIDE 1 1 Chapter Eleven Remote Site Server User s Guide Some facilities screen ThinPrep slides on Review Scopes in a location that is remote from or indepen dent of the site where the slide imaging is done These sites do not require the equipment needed for imaging slides only that needed for reviewing slides The slide data is exported onto CD ROM from the imaging site and is shipped with the patient slides to the remote review site There the data is imported into a Server PC and slide review is performed A remote site is equipped with a Server PC with monitor keyboard and mouse printer Uninter ruptible Power Supply interconnection hub s and a Review Scope Refer to the ThinPrep Imaging System Rev
74. ay vary from site to site as a result of differences in patient populations and reading practices As a result each laboratory using this device should employ quality assurance and control systems to ensure proper use and selection of appropriate workload limits Bibliography Solomon D Davey D Kurman R Moriarty A O Connor D Prey M Raab S Sherman M Wilbur D Wright T Young N for the Forum Group Members and the 2001 Bethesda Workshop The 2001 Bethesda System Terminology for Reporting Results of Cervical Cancer JAMA 2002 287 2114 2119 Kurman RJ Solomon D The Bethesda System for Reporting Cervical Vaginal Cytologic Diagnoses Springer Verlag 1994 Schafer J L Multiple imputation a primer Statistical Methods in Medical Research 1999 8 3 15 National Cancer Institute SEER Cancer Statistics Review 1973 1998 Available at http www seer cancer gov Accessed February 2002 Hologic Inc Hologic UK AW 03498 001 Rev 002 250 Campus Drive Unit 2 Link 10 Napier Way 2014 Hologic Inc All rights reserved Marlborough MA 01752 USA Ec REP Crawley West Sussex RH10 9RA 1 800 442 9892 United Kingdom www hologic com 44 1293 522 080 MAN 03938 001 Rev 001 page 15 of 15 U9 U09 Jo a1qeL Table of Contents CONTENTS Table of Contents Chapter One INTRODUCTION SECTION A Overview and Function of the Image Processor 1 1 SECTION B The ThinPrep Imaging System Process 1 4 SECTION C Specimen Preparation an
75. cal sensor on the robotic arm that senses the presence of slides in the slide cassettes The lens of it should be wiped clean on a monthly basis or if cassette mapping errors occur 31 Note Clean the sensor when there are no cassettes in the Imaging Station Removing a partially processed cassette of slides could result in data loss The sensor is located behind the robot shield It is attached to the side of the slide transfer arm Refer to Figure 5 11 Open the right hand door of the Imaging Station Gently rotate the robot shield to the left Robot Arm Cassette Mapping Sensor Clean this end Figure 5 11 Cassette Mapping Sensor top view Locate the cassette mapping sensor It is a round black object with a lens in the center If the Imaging Station power is on a red light shines out of the sensor Clean the end of the sensor with a lens paper The robot shield may be returned to its original position or just left as is At the start of the new batch it will automatically return to the correct position Image Processor Operator s Manual 5 7 5 IMAGE PROCESSOR MAINTENANCE This page intentionally left blank 5 8 Image Processor Operator s Manual Buljooysajqnoly 9 6 Troubleshooting TROUBLESHOOTING a Chapter Six Troubleshooting The Image Processor errors sort into two groups Slide Events and System Errors ae SLIDE EVENTS During batch processing slide events are logged in a file an
76. cessing 3 The doors will lock The display on the monitor indicates that processing has begun The STOP button on the menu bar is highlighted as available Refer to Figure 3 25 Cytyc Corp ThinPrep Imaging System Slide Processing Reports System Maintenance About Figure 3 25 Slide Processing Resumed Cancel the Batch after Interrupting Slide Processing 1 If the system is to be shut down remove the slide cassettes Run unprocessed cassettes in a later batch Partially processed cassettes are considered unprocessed and must be run ina later batch 2 Use the System pull down menu and select Shut Down Follow shut down instructions described in Section I SHUTTING DOWN THE IMAGE PROCESSOR Image Processor Operator s Manual 3 21 3 OPERATION OF THE IMAGE PROCESSOR H COMPLETING SLIDE PROCESSING After all the slides have been processed and returned to their slide cassettes the status on the display changes to Processing Completed The green GO button on the menu bar is highlighted as avail able Refer to Figure 3 26 Cytyc Corp ThinPrep Imaging System Slide Processing Reports System Maintenance About Figure 3 26 Slide Processing Complete The doors will unlock It is safe to open the Imaging Station and remove the cassettes If more slides are to be processed reload slide cassettes and place them in the Imaging Station If the system is to be shut down see instructions on SHUTTING DOWN THE IMAGE PR
77. ciated with J Atrophic with inflammation atrophic vaginitis 68 07 46 05 Radiation CT 0 oo f o f o Intrauterine contraceptive device QUD 0 00o o f oo Note Some patients had more than one diagnostic subcategory Number of Patients The Manual Review showed a higher rate of Benign Cellular Changes 405 than the Imager Review cases 293 G 3 ANALYTICAL PERFORMANCE OF THINPREP IMAGING SYSTEM FOR DETECTION OF CERVICAL CANCER USING THINPREP PAP TEST SLIDES FRESHLY PREPARED FROM ARCHIVAL SAMPLES This analytical study was conducted to compare the Bethesda System 2001 results obtained by a Cytotechnologist and a Cytopathologist when their review was limited to 22 fields that were selected by the ThinPrep Imaging System to their diagnostic results obtained from their independent blinded review of the entire cell spot on the ThinPrep Pap Test slides All of the reviews were performed in an independent and blinded manner The test materials consisted of 33 archival PreservCyt preserved cervical samples that had been previously diagnosed as AGUS or cancer One ThinPrep Pap Test slide was freshly prepared from each of the 33 original PreservCyt vials All of the ThinPrep slides used in the study were made on the TP 2000 processor and stained with ThinPrep Stain Based on the current cervical cancer prevalence rate in the United States 33 cases of cervical cancer would represent the
78. clusion of the current slide on the stage Use this option to let the current slide complete imaging and analysis and then be put away The Imaging Station mechanisms will come to an orderly halt The doors will unlock If the batch is resumed without a power cycle the verification slide is run then the data for any previous slides in the cassette are written to the Server and then the system continues pro cessing with the next slide Interrupt at the conclusion of the current cassette Use this option to let the current cassette complete run the verification slide and write the slide data record information to the Server The slides are put away and the Imaging Station mechanisms will come to an orderly halt The doors will unlock If the batch is resumed the system begins processing at the next unprocessed cassette Return to Slide Processing Use this option to continue slide processing without interruption Click once on the OK button when a choice is selected Or click on the Cancel button to con tinue processing without interruption On the display notice that the status of the batch changes to Processing Interrupted and the GO and STOP buttons in the menu bar are inactive not highlighted Refer to Figure 3 23 Image Processor Operator s Manual 3 19 OPERATION OF THE IMAGE PROCESSOR il Cytyc Corp ThinPrep Imaging System Slide Processing Reports System Maintenance About Figure 3 23 Slide Pr
79. ct to their completion status may occur as the result of an unex pected loss of power This status applies to any cassettes depicted as gray on the User Interface Processed All slides in the cassette have been processed Cassettes are depicted as entirely blue In Process Currently processing slides within a cassette Depicted as partially blue on the User Interface Cell Spot The area within the pre printed arcs on a ThinPrep microscope slide that contains the patient sam ple cells Fiducial Marks Permanently printed features on the ThinPrep microscope slide and the Verification slide used as a reference axis to establish the X Y coordinates of Objects Of Interest and Fields Of Interest The fidu cial marks are also used to register the slide position on the imaging stage at the beginning and end of slide imaging Image Processor Operator s Manual 8 1 8 DEFINITIONS AND ABBREVIATIONS FOV Field of View A circular area of the slide as viewed through the microscope The CT is responsi ble for looking at the entire field while reviewing slides IPC Image Processor Controller The computer that interacts with the Imaging Station in order to image the slides IS Imaging Station Stores and monitors slide cassettes and slide processing The slides are imaged at the IS Slide data is communicated to and retrieved from the Server once imaging has success fully occurred OCR Optical Character Recognit
80. d If the Export only slides not already exported checkbox is checked only slides imaged since the last export will be included If the box is not checked all records for that selected range will be included even if it was previously exported No slide review data is exported only image data Confirm export before writing CD Figure 4 20 Confirm Export before Writing If the Confirm export before writing checkbox is checked upon clicking on the Export button a window will display a list of the selected Slide ID numbers for export See Figure 4 21 4 12 Image Processor Operator s Manual OPERATION OF THE SOFTWARE MENU ENLITE I Report Results Export Confirmation Total slides 182 00000002289 00000002290 00000002291 00000002292 00000002294 Figure 4 21 Confirm Export Window If the export list is acceptable click on the Accept button and the export function will begin If the export list is not acceptable or changes are desired click on the Cancel button and the export function will cancel If the Confirm export before writing checkbox is not checked clicking on the Export button will immediately begin the export function C Auto print export log Figure 4 22 Auto print Export Log If the Auto print Export Log checkbox is checked the report of the summary for the current export will automatically be printed at the time of the export Note The printer must be installed and turned on for the report to pri
81. d Processing 1 6 SECTION D Image Processor Technical Specifications 1 7 SECTION E Internal Quality Control 1 16 SECTION F Image Processor Hazards 1 17 SECTION G Disposal 1 19 Chapter Two IMAGE PROCESSOR INSTALLATION SECTION A General 2 1 SECTION B Action Upon Delivery 2 1 SECTION C Preparation Prior to Installation 2 1 SECTION D Post Installation Storage and Handling 2 4 Chapter Three OPERATION OF THE IMAGE PROCESSOR SECTION A Chapter Overview 3 1 SECTION B Applying Power to the Equipment 3 3 SECTION C Materials Required Prior to Operation 3 6 SECTION D Slide Labeling 3 7 SECTION E Loading Slide Cassettes 3 8 SECTION F Load Slide Cassettes into the Imaging Station 3 10 SECTION G Slide Processing 3 14 SECTION H Completing Slide Processing 3 22 SECTION I Shutting Down the Image Processor 3 22 SECTION J Rebooting the System 3 24 Image Processor Operator s Manual i CONTENTS Chapter Four OPERATION OF THE SOFTWARE MENU SECTION A Slide Processing Menu SECTION B Reports Menu SECTION C System Menu SECTION D Data Management Menu SECTION E Maintenance Menu SECTION F About Menu Chapter Five IMAGE PROCESSOR MAINTENANCE SECTION A Clean Verification Slide SECTION B Replacing the User Accessible Fuses SECTION C Replacing the Imaging Station Air Filter SECTION D Clean the Cassette Mapping Sensor Chapter Six TROUBLESHOOTING SECTION A Slide Events SECTION B System Errors SECTION C Slide Preparation and Quality S
82. d User Accounts B A Reports R Logs and History R RS Users R Slide Data Records R Workload R Run Report system amp Lab Settings E Page Setup mmm Printers pa Server Figure 4 58 Security Window Image Processor Operator s Manual 4 45 OPERATION OF THE SOFTWARE MENU oll At Enable To create an administrative password for the security feature click on the Enable button The following dialog box will appear explaining that security is system wide and that a password will be required to access restricted data ThinPrep Imaging System Enabling security will provide system wide restriction of some Data Management Features The specified password will need to be entered by any user wanting access to restricted features re you sure you want to enable security Figure 4 59 Security Yes No Dialog Box Click Yes to set the password or No to cancel the process To set a password type the characters into the top field They will be substituted with dots on the display as they are typed Figure 4 60 Confirm the password by entering it again in the sec ond field Click OK when finished or click Cancel to cancel the process and return to the Secu rity window Enter password e 1 16 characters Password e alphanumeric e case sensitive New password Re enter password to confir Confirm new password OK to accept password Cancel to terminate the process Figure 4 60 Set Security Pas
83. d displayed on the user interface in the Slide Processing Event Log window See Slide Processing Event Log page 3 15 The event text mes sage is in red followed by the event number cassette number slot number date time and slide ID if known Figure 6 1 Slide Processing Event Log Event Number 4 Cassette Number 2 Slot Number 9 Date 5 15 04 Time 10 14 33 AM Slide 1D 41003671000 Event Number 3 Cassette Number 2 Slot Number 6 Date 5 15 04 Time 10 02 44 AM Slide ID 41003668000 Event Number 2 Cassette Number 1 Slot Number 2 Date 5 15 04 Time 9 32 31 AM Slide 1D 41003707000 Event Number 1 Cassette Number 1 Slot Number 1 Date 5 15 04 Time 9 32 13 AM Slide ID 41003706000 NO rT ked P NT l Figure 6 1 Event Log Display Image Processor Operator s Manual 6 1 6 TROUBLESHOOTING Slide events indicate some condition of the slide that makes the imaging process not possible with the exception of the slide already imaged When the batch ends inspect the specific slides listed in the error log to see if the slide problem can be corrected and the slide imaged in another batch Note If a slide was not successfully processed by the Image Processor the same slide cannot undergo Autoreview at the Review Scope The slide must be manually reviewed The Slide Processing Event Log displays slide events of the batch in progress Any Slide Process ing Event Log visible dur
84. d other terms and conditions of sale may be obtained by contacting Customer Service at the numbers listed above Technical Support For questions about ThinPrep Imaging System issues and related application issues representatives from Technical Support are available by phone 7 00 a m to 7 00 p m EST Monday through Friday at 1 800 442 9892 Option 6 or 508 263 2900 Service contracts can also be ordered through Technical Support Protocol for Returned Goods For returns on warranty covered ThinPrep Imaging System supplies and consumable items contact Technical Support Image Processor Operator s Manual 9 1 9 SERVICE INFORMATION This page intentionally left blank 9 2 Image Processor Operator s Manual UOI EWOJU Hulsapso OL 10 Ordering Information ORDERING INFORMATION 0 Chapter Ten Ordering Information Mailing Address Hologic Inc 250 Campus Drive Marlborough MA 01752 Remittance Address Hologic Inc PO Box 3009 Boston MA 02241 3009 Business Hours Hologic s business hours are 8 30 a m to 5 30 p m EST Monday through Friday excluding holidays Customer Service Product orders which include standing orders are placed through Customer Service by phone during business hours at 1 800 442 9892 Option 5 or 508 263 2900 Orders can also be faxed to the attention of Customer Service at 508 229 2795 Warranty A copy of Hologic s limited warranty and other terms and conditions of sale m
85. d version of data on import CD The version of data on the CD can not be imported into the current database version Check that the versions match look at the Help button Media is locked The CD drive has the CD locked for another import export Wait for any processes to finish Try again later No import data There is no data on the CD to import The CD may be blank or have data other than export data on it Use a CD that has export data on it No slides match export criteria The user specified export criteria that doesn t match any data in the database Refine the export parameters to match slide IDs that are in the database Template has been deleted since last refresh Recreate the template Template name must be unique within the view The user tried to modify a tem plate that is no longer in the data base A user on a different system deleted it A template has been created or changed with a non unique name Recreate the template Rename the template with a unique name 6 14 Image Processor Operator s Manual TROUBLESHOOTING 6 Table 6 3 Data Export Import and Backup Errors Error Text Possible Cause Corrective Action The export exceed the maximum allowed records Narrow the search criteria and try again The media is not blank Exports are limited to 10 000 records The CD in the CD drive on the server is not blank C
86. date the name Restarting the remote IPC s will also update the setting Alarm this turns the audible alarm on or off This is the alarm that sounds when an error condition has occurred Select ON or OFF To save the setting click the Apply button Report date time format to select the preferred format for the date and time click on the pull down list to see the options Select the desired format by clicking on it To save that setting click the Apply button See Figure 4 55 Image Processor Operator s Manual 4 41 tT OPERATION OF THE SOFTWARE MENU EEH Report date time Format mon dd yyyy hhimmAM for PM v dd mon hh mm 24 hour vy hhimm M for PM mon dd yyyy hh mm 24 hour Figure 4 55 Set Date and Time Format Report limit this sets the maximum number of lines of data that are retrieved from the database for a report from 500 to 5000 If there is less data than the number chosen all the available data will report The Reset button is to reset all settings to the last saved settings System Page Setup The Page Setup window allows you to choose which printer to print to if more than one is on the network choose what size paper to print on limited by the printer s paper size capability and the paper source which tray from the printer to use Select the desired options that are available and then click the Apply button The Reset button will reset all settings to the default 4 42 I
87. ded outlet WARNING Glass The instrument uses microscope slides which have sharp edges In addition the slides may be bro ken in their storage packaging or on the instrument Use caution when handling glass slides and when cleaning the instrument SECTION Cm DISPOSAL Disposal of consumables Printer toner cartridge Please refer to the manufacturer s guide for disposal instruction Imaging Station air filter No special instructions used filter may be disposed of in your laboratory refuse Disposal of instrument fuses No special instructions used fuses may be disposed of in your labora tory refuse Disposal of the device Please contact Hologic Service refer to Service Information Chapter 9 Image Processor Operator s Manual 1 19 INTRODUCTION This page intentionally left blank 1 20 Image Processor Operator s Manual uonejjesul z 2 Installation IMAGE PROCESSOR INSTALLATION 2 Chapter Two Image Processor Installation WARNING Service Installation Only SECTION ee GENERAL The ThinPrep Image Processor and peripherals must be installed by Hologic Service Personnel When installation is complete the Service personnel trains the operator s using the Operator s Manual as the training guide In the event the equipment must be moved after installation please contact Hologic Technical Sup port Refer to Service Information Chapter 9 SECTION s ACTION UPON DELIVERY Remov
88. doors are unlocked To power the Imaging System off refer to SHUTTING DOWN THE IMAGE PROCESSOR on page 3 22 The IS IPC and Server should be shut off in the sequence described there Image Processor Operator s Manual 3 5 3 OPERATION OF THE IMAGE PROCESSOR ri MATERIALS REQUIRED PRIOR TO OPERATION Monitor Keyboard amp Mouse Imaging Station Image Processor Controller user Interface and Server Slide Cassettes ThinPrep Pap Test Microscope Slides Figure 3 7 Items Required for Slide Image Processing The Monitor Keyboard and Mouse are provided and configured with the ThinPrep Imaging System equipment at the time of installation They provide the User Interface with the system They connect to the Image Processor Controller and should be located close to it Slide cassettes are provided at installation see Ordering Information for ordering more The Imaging Station holds the slide cassettes during slide processing The operator ensures that the Imaging Station is powered on the slide cassettes are loaded properly and the doors are securely closed prior to slide processing The Imaging Station images each slide and sends the data to the Image Processor Controller Note A Verification Slide is a component within the Imaging Station necessary for slide imaging The Verification Slide is loaded at the time of equipment installatio
89. e 3 3 Power On Button Figure 3 3 Power On the Server 4 At the rear of the Imaging Station Figure 3 4 position the Power rocker switch to ON 1 Note The Imaging Station should be turned on before turning on the Image Processor Controller Turning on power to the Imaging Station initiates a 2 minute warm up cycle During this time the sliding doors are locked to prohibit loading and unloading of Slide Cassettes Power Switch 9000000000 Seen BESS RS eSa 3308088380 N 0000000000 SSSR 0808080 D 090909090 080809089099 000900090 99909090909 80899990999 09090290909 30899989999 a 090909090 D I esesego Power On Indicator Firewire conn USB conn Serial conn Service to IPC to IPC to IPC Port Rear Front Figure 3 4 Imaging Station Power Switch 5 At the Image Processor Controller push the power on button Figure 3 5 3 4 Image Processor Operator s Manual OPERATION OF THE IMAGE PROCESSOR 3 Power On Button Figure 3 5 Image Processor Controller Power Switch 6 At the Monitor observe that the message System warmup will be complete in 2 minutes please wait is displayed on the user interface Figure 3 6 Please wait System warmup will be complete in 2 minutes please wait Figure 3 6 Warmup in Progress Note When the warmup cycle ends the message disappears and the
90. e and read the Operating Instructions Prior to Installation sheet attached to the packing carton Inspect the packing cartons for damage Report any damage immediately to the shipper and or Hologic Service as soon as possible Refer to Service Information Chapter 9 Leave the equipment in the packing cartons for Hologic Service installation Store the equipment in a suitable environment until installation cool dry vibration free area SECTION oZ PREPARATION PRIOR TO INSTALLATION Pre Installation Site Assessment A pre installation site assessment is performed by Hologic Service Personnel Be sure to have pre pared any and all site configuration requirements as instructed by the Service personnel Location And Configuration Local Network Configuration CAUTION Route all connectors carefully to avoid pinching the cables To avoid tripping over or disconnecting cabling do not place cabling near foot traffic The Image Processor Controller the Imaging Station the monitor keyboard mouse the printer and a multiport Ethernet hub must be located in the same area so that interconnection cables easily reach each component within 1 8 meters 6 feet of each other Refer to Figure 2 1 Review Scopes con Image Processor Operator s Manual 2 1 2 IMAGE PROCESSOR INSTALLATION nected to the Image Processor Controller may be located up to 100 meters 328 feet away or extended another 100 meters using a second hub Prin
91. e applied at those locations with semi permanent translucent marker A physical slide reviewed mark is placed on the slide at the end of the review whether or not any physical marks were placed 1 4 Image Processor Operator s Manual INTRODUCTION e white blood cell i Cluster Artifact The coordinates of 22 objects of interest with the highest integrated optical density will be i stored on the Server These 22 selected fields of i view are presented in geographic order to the Cytotechnologist during slide screening at the Review Scope Object Of Interest Blob normal cell O The slide imaging system scans the entire cell spot The system identifies objects of interest found on the slide Field of View as seen through the microscope 0001234 0000030 01 25 01 12 00 Electronic Mark Indicator White Unselected Green Selected ThinPrep j By using the joystick position abnormal or suspect cells to be marked in this area Dotted line is not really visible At the end of slide review marking dye will be applied inside this area if the area has been selected Figure 1 3 ThinPrep Imaging Process Image Processor Operator s Manual 1 5 INTRODUCTION SECTION Oe SPECIMEN PREPARATION AND PROCESSING Specimens for the ThinPrep Pap Test cytology slide are collected by a clinician then immersed and rinsed in a PreservCyt Solu
92. e database and has differing values from the slide record being imported The slide data is not imported and the Error ID is reported as a Conflict This might be a case of Lab ID or Imager ID conflicts but it is most often two different slides having the same ID number The patient information must be checked and reconciled for both slides Image Processor Operator s Manual 4 19 OPERATION OF THE SOFTWARE MENU wll At Report Results Import Details Import date Nov 22 2005 10 56 AM Importing lab DBA7CB5A B2BE 4664 B7 1E F68EB9FBBDAD Import CD Contents Total slides 182 Minimum slide id 00000000009 Maximum slide id 00000009588 Summary New slides 0 Duplicate slide records 179 Database import errors 0 Import conflicts 3 Slide Ids With Conflicts ooo00000009 o0000000203 ooooooooz23 6f f O O Figure 4 32 Import Results Window To print out the report click the Print button To close the window click the Close button Maintenance The Maintenance window is used to delete old Review Scope Error and Usage Logs This would be used if Review Scopes have been replaced and are no longer installed in your network Click on the Maintenance option of the Data Management menu and the Maintenance window appears Figure 4 33 4 20 Image Processor Operator s Manual Data Management E Data Management Database Backup E Export p Import X Maintenance User Accounts a E Reports
93. e robotic arm is safely parked The operator may then shut down the Imag ing System refer to page 3 22 WARNING Grounded Outlet The uninterruptible power supply will be installed and setup at the time of instrument installa tion Please refer to the manufacturer s guide for proper operation maintenance and disposal BES STORAGE AND HANDLING POST INSTALLATION Environmental Considerations e The Imaging Station and the Image Processor Controller are sensitive to sudden thermal or humidity changes Do not locate them next to windows heaters air conditioners HVAC vents or doors that are frequently opened and shut e During operation the Imaging Station is sensitive to vibrations It should be placed on a sturdy flat surface away from centrifuges vortexors or any equipment that may cause vibra tions Keep away from other environmental activity such as constant foot traffic proximity to elevators or doors that are frequently open and shut 24 Image Processor Operator s Manual uoneado g 3 Operation OPERATION OF THE IMAGE PROCESSOR 3 Chapter Three Operation of the Image Processor SECTION aS CHAPTER OVERVIEW For Operators using a Server at a non imaging site see also Chapter 11 Remote Site Server User s Guide for an operation overview Routine operation of the ThinPrep Image Processor consists of powering on the monitor the Image Processor Controller and the Imaging Station loading prepared casset
94. ed on this Instrument Image Processor Operator s Manual 1 17 INTRODUCTION Location of Labels Used on the Instrument 0000000000 0000000000 0000000000 Cc 0808080 D 885968580 98080908080 89998089809 99000000090 990099909 80009099996 89990099099 88899992988 ry 090909090 D y 82000000 IPC Rear Server Rear l Imaging Station Rear Grounded Outlet Grounded Outlet Grounded Outlet Serial Number Model Rating External Connections Fusing Figure 1 14 Label Locations Warnings Used in this Manual WARNING Service Installation Only This instrument is to be installed by trained Hologic personnel only WARNING Instrument Fusing For continued protection against fire replace only with fuses of the specified type and current rating Refer to the Maintenance chapter for instructions on replacing user accessible fuses Refer to Order ing Information for fuse specification and ordering 1 18 Image Processor Operator s Manual INTRODUCTION WARNING Moving Parts The instrument contains moving parts Keep hands loose clothing jewelry etc clear WARNING Grounded Outlet To ensure safe operation of the instruments use a three wire groun
95. eled Import The Import function enables slide data from other Imaging Systems to be added to the database on the Server The data is on CD ROM and can only be added via the Server s CD drive Note Only slide image data is imported Slide review data is not exported so it will not be imported To access the Import window click on the Import icon in the Data Management menu See Fig ure 4 28 Data Management Data Management Import Database Backup F Import function Epa icon X Maintenance q gt User Accounts Reports system Import Progress Preview button Details button displays Import button begins Results button shows the shows the range of a window with import the Import function results of a completed slide IDs to be information and a table Import imported with slide IDs Figure 4 28 Import Window 4 16 Image Processor Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Place a CD with slide data into the CD drive of the Server Click on the Preview button to see a brief status of the CD date of export name of lab number of slides Refer to Figure 4 29 Import Import CD Contents Import CD Contents Export date ExportDate Nov 22 2005 10 56 AM Exporting lab Exporting Lab D8A7CB5A 82BE 4664 87 1E F6SEBSFBEDAD T Isli Total Slides 182 f otal slides Slides imaged successfully 172 Slides imaged successfully Slides with imaging errors 10 Slides with imag
96. ending on site configuration _ Mouse Uninterruptible j Power Supply and Monitor Battery Backup Keyboard Power Cord Requires an Outlet Diesel el de al May go on the floor provided there is no dust Table Desk or Lab Bench accumulation on or around it Figure 11 2 Extended Network Interconnection Schematic example Component Configuration The components may be arranged on the bench top as desired providing the connection cables can reach easily The Server may be placed on the floor near the work area provided it has adequate air circulation to prevent dust accumulation and it is safely removed from foot traffic or other interfer ence It should be accessible for routine maintenance The network printer will be installed and set up at the time of instrument installation Please refer to the manufacturer s guide for operation and maintenance WARNING Grounded Outlet Image Processor Operator s Manual 11 3 i REMOTE SITE SERVER USER S GUIDE The uninterruptible power supply will be installed and setup at the time of instrument installa tion Please refer to the manufacturer s guide for proper operation maintenance and disposal Note The uninterruptible power supply provides battery backup power for a period of time up to 30 minutes for a fully charged battery in the event of a power outage The operator may shut down the Server and other equipment refer to page 11 6 POWER O
97. energy and may cause interference to radio communications A Hologic authorized service representative must install the ThinPrep Imaging System PRECAUTIONS Caution should be used when loading and unloading glass slides on the ThinPrep Imaging System to prevent slide breakage and or injury Care should be taken to assure that slides are correctly oriented in the ThinPrep Imaging System cassettes to prevent rejection by the system Partially processed slide cassettes should not be removed from the Image Processor as data may be lost The Image Processor should be placed on a flat sturdy surface away from any vibrating machinery to assure proper operation MAN 03938 001 Rev 001 page 3 of 15 G PERFORMANCE CHARACTERISTICS A multi center two armed clinical study was performed over an eleven 11 month period at four 4 cytology laboratory sites within the United States The objective of the study entitled Multi Center Trial Evaluating the Primary Screening Capability of the ThinPrep Imaging System was to show that routine screening of ThinPrep Pap Test slides using the ThinPrep Imaging System is equivalent to a manual review of ThinPrep slides for all categories used for cytologic diagnosis specimen adequacy and descriptive diagnosis as defined by the Bethesda System criteria The two arm study approach allowed a comparison of the cytologic interpretation descriptive diagnosis and specimen adequacy from a single ThinPr
98. ents at the top and older events following The report will display as many lines of data as selected in the report limit setting 500 to 5000 refer to System Lab Settings on page 4 40 Click on the Print button to print the report Click on the Close button to return to the Logs Selection menu Image Processor Operator s Manual 4 27 OPERATION OF THE SOFTWARE MENU oll At Report ThinPrep Imaging System Usage History This report displays the usage history of the Review Scopes and Image Processors connected to a network The Review Scopes are listed by their serial numbers the Image Processors are listed by their System IDs The report is a tally of all slides processed to date See Figure 4 40 Report Results ThinPrep Imaging System Usage History Report Date Dec 03 2004 02 15 PM Matches found Review Scope 2 Image Processor 7 Review Scope System Id Total Count 10501 GO4A4P 542 10503G044P 468 Image Processor 20198J044P 9464 9464 Figure 4 40 System Usage History Report e Click on the Print button to print the report Click on the Close button to return to the Logs Selection menu 4 28 Image Processor Operator s Manual Report Image Processor Slide Event Log The Slide Event Log displays all slide event occurrences from IPs on the network system These are the same slide events that are displayed on the batch report for each batch run on an IP but they are also captured in this report
99. ep prepared slide screened first using standard laboratory cervical cytology practices Manual Review and then after a 48 day time lag were screened with the assistance of the ThinPrep Imaging System Imager Review A subset of slides from the study were reviewed and adjudicated by a panel of three 3 independent Cytopathologists to determine a consensus diagnosis The consensus diagnosis was used as a gold standard for truth to evaluate the results of the study G 1 LABORATORY AND PATIENT CHARACTERISTICS Of the 10 359 subjects in the study 9 550 met the requirements for inclusion in the descriptive diagnosis analysis During the study 7 1 732 10 359 slides could not be read on the Imager and required a manual review during the Imager Review arm Excessive number of air bubbles on the slides was the leading contributor Additional factors included focus problems slide density slide identification read failures slides detected out of position multiple slides seated within a cassette slot and slides that had already been imaged The cytology laboratories participating in the study were comprised of four centers All sites selected had extensive experience in the processing and evaluation of gynecologic ThinPrep slides and were trained in the use of the ThinPrep Imaging System The study population represented diverse geographic regions and subject populations of women who would undergo cervical screening with the ThinPrep Imaging System
100. es an Outlet May go on the floor provided there is no dust accumulation on or Table Desk or Lab Bench around it Figure 11 1 Local Network Interconnection Schematic example Extended Network Configuration CAUTION Route all connectors carefully to avoid pinching the cables To avoid trip ping over or disconnecting cabling do not place cabling near foot traffic The Review Scopes may be located at a greater distance from the Server by using an extended network interconnection between the Server hub switch and the Review Scope hub switch Low level industry standard interconnection devices such as bridges repeaters media convert ers copper and fiber wiring may be used Refer to Figure 11 2 The distance that Review Scopes may be located away from the Server is determined by the requirements of the specific apparatus used to create the network The throughput of the extended network must be capable of 10Mbps or greater 11 2 Image Processor Operator s Manual REMOTE SITE SERVER USER S GUIDE 1 1 Note High level interconnecting devices routers and gateways and wireless devices must not be used The devices used for the extended network must form an isolated network used exclu sively for the Imaging System network No other company networks sub networks or devices may be connected to the network Up to 328 ft Network Interconnections 100 meters oo Review i i Scope Printer swe oh dep
101. essor Operator s Manual 4 1 OPERATION OF THE SOFTWARE MENU SECTION 2 REPORTS MENU The Reports menu contains functions that generate reports for specific components of the ThinPrep Imaging System Cytyc Corp ThinPrep Imaging System Slide Processing PSSS System Maintenance About co Run Report Figure 4 3 Reports Menu Run Report The Run Report generates the results from a processed batch Information from the 100 most recent batches is retained and listed in chronological order starting with the most recent Refer to Figure 4 4 The Run Report should be printed and retained at the conclusion of each batch For automatic print ing of the report see the next section Auto Print Run Report Click on Reports gt Run Report The Run Report list window is displayed Refer to Figure 4 5 4 2 Image Processor Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Reports Aor 2004 04 26 24 Apr 2004 17 08 22 Apr 2004 10 46 22 Apr 2004 07 05 21 Apr 2004 14 13 21 Apr 2004 10 57 21 Apr 2004 10 50 21 Apr 2004 10 31 20 Apr 2004 14 23 Auto print batch reports Select this checkbox to automatically print the run report at the conclusion of a batch Figure 4 4 Run Report List Select the report to view or print by clicking on it to highlight it and then clicking the View button or by double clicking on the report date Image Processor Operator s Manual 4 3 7 AE OPERATION OF T
102. fied per EN 60825 1 1994 Issue 2 June 1997 as a Class 1 LED Product This equipment meets the emission and immunity requirements of IEC 61326 2 6 This equipment has been designed and tested to CISPR 11 Class A In a domestic environment it may cause radio interference in which case you may need to take measures to mitigate the interference The electro magnetic environment should be evaluated prior to operation of the equipment Image Processor Operator s Manual 1 15 4 INTRODUCTION INTERNAL QUALITY CONTROL Verification Slide The verification slide Figure 1 12 is a microscope slide that has permanent custom features that allow for periodic slide imaging subsystem verification It is handled by the instrument robotic arm to retrieve it and store it and it is operated by the system software The verification slide is stored inside the Imaging Station Other than to clean it periodically the operator does not use it 0123456 7890049 03249 003 Figure 1 12 Verification Slide Power On Self Test POST At the time the Image Processor Controller and the Imaging Station are powered on refer to Apply ing Power to the Instrument on page 3 3 the system goes through a self diagnostic test All the elec trical mechanical and software communication systems are tested to confirm each performs properly The operator is alerted to any malfunction via a message on the user interface If the system does not function or there are
103. ge Backup f t jean Side Id Fiter Slide ID Filter to Sort X Maintenance 0 9 Match specific number A lt gt User Accounts SS SSSI E Accession numbers for Specific Charac Senate it Wet i ters Lab ID Codes System Date etc f7 Export only slides not already exported b4 Confirm export before writing CD P Auto print export log Checkbox to Export all data since the 5 Use detailed export log last export Progress Checking meg Checkbox to view Prepating ata Slides data before export ee aes frifying data Checkbox to auto Complete print export log l Checkbox to have Save to create tem Log displays the results Export begins the data the Slide IDs plates for frequently of the completed export export function included on the used Slide ID Filters export log Figure 4 13 Export Window Data can be filtered for export in several ways by Accession Number Range by Slide ID Filter by Exporting Only Slides Not Already Exported or any combination of these methods A Note on Slide IDs A Slide ID is 11 digits long plus three more digits for the CRC which cannot be altered by the operator An accession number is a subset of the 11 digit Slide ID It is often five or fewer characters long and it is a series that increments for example 001 002 003 004 and so on The accession number is often preceded or followed by fixed numbers for example a date or a Lab ID code or by zer
104. gory Il the ThinPrep Imaging System is for indoor use only in an office or a clean laboratory environment Altitude 0 meters sea level to 2000 meters Atmospheric Pressure 1100 millibar to 500 millibar Power Voltage 100 240 Volts Alternating Current no selection required Mains supply voltage not to exceed 10 of the nominal voltage Frequency 50 to 60 Hz Power Imaging Station Image Processor Controller Server Heat Generated Imaging Station Image Processor Controller Server Fusing Imaging Station Image Processor Controller Server 4A maximum Refer to the documents that come with the equipment Refer to the documents that come with the equipment approximately 1600 BTU HR 470 W Refer to the documents that come with the equipment Refer to the documents that come with the equipment Two 5 x 20mm 6 3A time delay glass fuses Refer to the documents that come with the equipment Refer to the documents that come with the equipment Image Processor Operator s Manual 1 13 INTRODUCTION Protective Temperature Coefficient Devices The Imaging Station contains protective temperature coefficient PTC devices intended for protec tion against occasional overcurrent or overtemperature fault conditions These devices automatically reset after the overcurrent or overtemperature condition has been removed The PTCs locations and functions are as follows System Hardware Electromechanical Processor
105. hange the export filter parameters to result in less than 10 000 records being exported Place a blank writable CD in the Server CD drive Note only one export per CD is allowed Any data on the CD renders the CD unusable for further export The media is not ready Be sure there is a CD in the drive on the server The CD drive is not ready The CD is not ready to be read yet Try the function again The media is not writ able The CD in the CD drive on the server is not writable and it must be writable The CD must be a blank writable CD Try using a different CD Note some Read Write CDs will not work if they already had data on them even if it has been erased Unable to get import results The Results button was pressed while the server was still updating the database tables The server was still cleaning up processes Try the func tion again Unable to preview the import data The CD could not be read Make sure the correct type of CD was used for export Try the function again Image Processor Operator s Manual 6 15 6 TROUBLESHOOTING This page intentionally left blank 6 16 Image Processor Operator s Manual UIEIS gdoiquiyt Z 7 ThinPrep Stain THINPREP STAIN 7 Chapter Seven ThinPrep Stain INTRODUCTION ThinPrep Stain must be used with the ThinPrep Imaging System The stain s unique properties enable the Imager to scan the ThinPrep Pap
106. he Event Log lists unprocessed slides in sequence as they occur Fach listing contains the event description event number cassette number slot number date time and Slide ID if known Image Processor Operator s Manual 3 15 OPERATION OF THE IMAGE PROCESSOR il If more than four events have occurred a scroll bar appears at the right of the Slide Processing Event Log graphic Use the mouse to scroll through the list to view all events If a long message is dis played a scroll bar on the bottom of the frame will appear Note The event log is only accumulated and displayed with the batch that is in progress When a new batch is started the Slide Processing Event Log is cleared Refer to Chapter 4 Sections Report Image Processor Slide Event Log and Report Run Report to view previous slide processing event logs Slide Processing Event Log Event Number 4 Cassette Number 2 Slot Number 9 Date 5 15 04 Time 10 14 33 AM Slide ID 41003671000 Event Number 3 Cassette Number 2 Slot Number 6 Date 5 15 04 Time 10 02 44 AM Slide ID 41003668000 Event Number 2 Cassette Number 1 Slot Number 2 Date 5 15 04 Time 9 32 31 AM Slide ID 41003707000 Event Number 1 Cassette Number 1 Slot Number 1 Date 5 15 04 Time 9 32 13 AM Slide ID 41003706000 Figure 3 19 Typical Event Log Display If a slide caused an event during processing the operator should check it at the conclusion of the batch
107. he computer that controls communication between the Imaging System components It is where all data such as user preferences slide data records system history logs are maintained ThinPrep Microscope Slide A specific brand of glass microscope slide that must be used with the ThinPrep system of instru ments The slide has features on it that enable automated registration of the slide with the Image Pro cessor and the Review Scope UPS Uninterruptible Power Supply Verification Slide This is a special slide stored inside of the Imaging Station that has custom features that allow for periodic slide imaging subsystem adjustment and verification required for imaging slides Image Processor Operator s Manual 8 3 8 DEFINITIONS AND ABBREVIATIONS This page intentionally left blank 8 4 Image Processor Operator s Manual UOI EULOJU 3913S 6 9 Service Information SERVICE INFORMATION 9 Chapter Nine Service Information Corporate Address Hologic Inc 250 Campus Drive Marlborough MA 01752 USA Business Hours Hologic s business hours are 8 30 a m to 5 30 p m EST Monday through Friday excluding holidays Customer Service Product orders which include standing orders are placed through Customer Service by phone during business hours at 1 800 442 9892 Option 5 or 508 263 2900 Orders can also be faxed to the attention of Customer Service at 508 229 2795 Warranty A copy of Hologic s limited warranty an
108. iew Scope Operator s Manual for operation maintenance and troubleshooting of Review Scopes This chapter provides a getting started overview for remote sites using a Server PC INSTRUMENT DESCRIPTION Refer to Chapter 1 Introduction for a complete description of the ThinPrep Imaging System techni cal specifications and warnings INSTALLATION WARNING Service Installation Only Refer to Chapter 2 Image Processor Installation for information regarding delivery unpacking stor age and handling Network Configuration CAUTION Route all connectors carefully to avoid pinching the cables To avoid tripping over or disconnecting cabling do not place cabling near foot traffic The Server monitor keyboard mouse printer and a multiport Ethernet hub must be located in the same area so that interconnection cables easily reach each component within 1 8 meters 6 feet of each other Refer to Figure 11 1 Review Scopes connected to the Server may be located up to 100 meters 328 feet away or extended another 100 meters using a second hub Image Processor Operator s Manual 11 1 i REMOTE SITE SERVER USER S GUIDE Up to 328 ft 100 meters TEER Review Scope l t Lueeekeed Review Scope Additional Scopes depending on site configuration erver 4 S Mouse Uninterruptible Power Supply and Battery Backup Keyboard Monitor i Power Cord Requir
109. in normal clinical use These sites included both women being routinely screened screening population and patients with a recent previous cervical abnormality referral population The characteristics of the study sites are summarized in Table 1 Table 1 Site Characteristics Site 1 2 3 4 Low Risk Population 88 82 90 94 High Risk Population 12 18 10 6 HSIL prevalence 1 1 0 7 0 4 0 6 ThinPrep Pap Tests Per Year 120 000 70 200 280 000 105 000 Number of Cytotechnologists 14 9 32 11 Number of Cytotechnologists in Study 2 2 2 2 Number of Cytopathologists 6 D 6 14 Number of Cytopathologists in Study 1 2 1 2 MAN 03938 001 Rev 001 page 4 of 15 G 2 DESCRIPTIVE DIAGNOSIS SENSITIVITY AND SPECIFICITY ESTIMATES A panel of three independent Cytopathologists adjudicated slides from all discordant one grade or higher cytologic difference descriptive diagnosis cases 639 all concordant positive cases 355 and a random 5 subset of the 8550 negative concordant cases 428 The Cytopathologists on the adjudication panel were board certified all of whom had a subspecialty certification in Cytopathology Their experience levels in Cytopathology ranged from 6 to 12 years Two of the adjudicators were from university practices and one adjudicator was from a private medical center The volumes for the adjudicator s institutions ranged from 12 000 to 30 000 ThinPrep Pap Tests an
110. ing errors Minimum slide id 00000000009 Minimum slide ID A Maximum slide id 00000009588 Maximum slide ID Progress Checking media Preparing data Updating database Complete C Figure 4 29 Import Preview Window To see the import data details click on the Details button A window will open to show the import data information and a table of slide IDs that will be imported Refer to Figure 4 30 Click on Print to print a hard copy of this report Click Close to close the window and return to the Import screen Image Processor Operator s Manual 4 17 OPERATION OF THE SOFTWARE MENU wll At Report Results Detailed Import Preview Export date Nov 22 2005 10 56 AM Export lab DBA7CB5A B2BE 4664 B71E F68EB9FBBDAD Summary Total slides 162 Slides imaged successfully 172 Slides with imaging errors 10 Minimum slide id 00000000009 Maximum slide id 00000009588 Sli des 00000000009 00000000203 00000000223 00000000282 00000000349 00000000498 00000000585 00000000714 00000000782 00000000801 00000000935 00000000968 00000000969 00000000970 00000000973 00000001046 00000001056 00000001142 00000001148 00000001173 00000001176 00000001191 00000001196 00000001255 00000001329 00000001505 00000001515 00000001521 00000001527 00000001691 00000001750 Figure 4 30 Detailed Import Preview To begin Import of the data click on the Import button As listed on the Import window the system checks the media prepare
111. ing instrument idle mode is that of the last batch run Beginning a new batch will start a new Event Log display The last 100 batch reports are available via the Run Report function Refer to Run Report on page 4 2 With each subsequent batch the oldest batch report will be deleted and replaced with the newest report Batches with no slide events will have a report with no Slide Event section in it The following is a list of Slide Processing Event Log text messages The slide is not imaged Three consecutive occurrences of a slide event will cause a system error Refer to Section B System Errors Table 6 1 Event Log Error Messages Event OG ENOr Possible Cause Corrective Action Message OCR read failed Wrong kind of slide or slide label e Confirm that a ThinPrep microscope slide is being Wrong accession ID format used Slide ID misprint e Check the condition of the label and that the cor Slide not loaded in cassette correctly rect ID format is used refer to Slide Labeling page 3 7 e Load the slide into the cassette with the label face up and toward the opening OCR malfunction Contact Hologic Technical Support Slide already imaged The slide has been imaged The slide may undergo review at the Review Scope Duplicate slide accession ID Use the Slide Data Record query page 4 36 Con firm if the ID is unique If there is a duplicate reconcile both patient records relabel one and reprocess the slide
112. ion The Image Processor and the Review Scope each contain an Opti cal Character Recognition camera that reads a slide label ID and matches it against patient ID s already stored in the Server database ool Object of Interest An object of interest is a blob that has passed filtering which removes normal cells and recognized artifacts and undergone algorithmic rating An object of interest may be a single cell or a cluster Power Cycle Turning the Imaging System off and then on again usually to clear an error condition Refer to SHUTTING DOWN THE IMAGE PROCESSOR in Chapter 3 before turning off power to any of the components RS Review Scope 8 2 Image Processor Operator s Manual DEFINITIONS AND ABBREVIATIONS 8 Slide Data Record The data associated with a specific accession ID slide The data is stored on the Server database It is generated at the time a slide ID is successfully scanned in the Imaging Station prior to imaging The data record is updated when the slide has been imaged and image analysis completed and again when the slide has completed automated review at the RS Slide Processing Event Log Slide events during processing are displayed on the right hand side of the user interface There is a brief description of the kind of error in red text followed by the event number cassette number slot number date time and slide ID if known Only events pertaining to the current batch are listed SV Server T
113. ire manual rescreening of the selected fields of view by a Cytotechnologist using a Review Scope The ThinPrep Imaging System is only indicated for use with the ThinPrep Pap Test The laboratory Technical Supervisor should establish individual workload limits for personnel using the ThinPrep Imaging System The maximum daily limit specified is only an upper limit and should never be used as an expectation for daily productivity or as a performance target The ThinPrep Imaging System has not been proven to be safe or effective at workload levels which exceed product labeling ThinPrep slides with fiducial marks must be used Slides must be stained using the ThinPrep Stain according to the applicable ThinPrep Imaging System slide staining protocol Slides should be clean and free of debris before being placed on the system The slide coverslip should be dry and located correctly Slides that are broken or poorly coverslipped should not be used Slides used with the ThinPrep Imaging System must contain properly formatted accession number identification information as described in the operator s manual Slides once successfully imaged on the Image Processor cannot be imaged again The performance of the ThinPrep Imaging System using slides prepared from reprocessed sample vials has not been evaluated therefore it is recommended that these slides be manually reviewed WARNINGS The Imager generates uses and can radiate radio frequency
114. ity is a percent of true Non HSIL combined Negative ASCUS AGUS LSIL slides classified in either study arm as Non HSIL Sensitivity Specificity Site Site Number Manual Imager Difference Number Manual Imager Difference Cases Cases eel 89 5 92 1 2 6 siter 98 8 99 5 40 7 38 75 2 97 1 78 6 98 3 8 9 14 1 2274 98 3 99 2 99 1 99 8 0 2 1 2 oa 72 5 70 0 2 5 Site2 99 8 99 6 0 1 40 56 1 85 4 53 4 83 4 15 4 10 4 2400 99 5 99 9 99 2 99 8 0 3 09 SBa 72 7 86 4 13 6 sites 99 7 99 7 0 22 49 8 89 3 65 1 97 1 0 7 28 0 2277 99 4 99 9 99 4 99 9 0 2 0 2 RA 61 5 74 4 12 8 siteg 99 5 99 8 0 3 39 44 6 76 6 57 9 87 0 1 7 27 4 2453 99 2 99 8 99 5 99 9 0 003 0 6 All 74 1 79 9 5 8 an 99 4 99 6 0 2 139 66 0 81 2 72 2 86 2 1 1 12 6 9404 _ 9 2 99 6 99 5 99 7 0 06 0 4 Numbers in parentheses represent 95 confidence intervals MAN 03938 001 Rev 001 page 6 of 15 The results presented in Table 4 show that the difference between sensitivities of the Imager Review and Manual Review arms for HSIL for all sites combined was not statistically significant with a 95 confidence interval of 1 1 to 12 6 The observed difference between sensitivities for HSIL varied among the sites from
115. ks are permanently printed features on the slide used to register the slide position on the imaging stage and to provide a coordinate system for location of fields of view The same marks are used to reference the same slide data at a Review Scope Frosted Region of the___ smn ie 14 digit numeric accession ID Slide a000253 Cell Spot Contains ThinPrep Patient Cells ia A Fiducial Mark a a Slide Fiducial Mark Fiducial Mark Figure 3 9 ThinPrep Microscope Slide for Use With the Imager CAUTION To prevent unnecessary slide events during batch processing slides must be placed properly into the cassette Carefully load the microscope slides into the slide cassette s one slide per slot Orient the slide so that the label side is up and facing out Refer to Figure 3 10 for correct and incorrect slide loading 3 8 Image Processor Operator s Manual OPERATION OF THE IMAGE PROCESSOR 3 A YT P CORRECT SLIDE POSITION M Empty Slots are OK INCORRECT SLIDE LOADING mr Multiple Slides d mem m Cocked Slide perra Slide Overhangs Retaining Features Z Slide In Backward Label Toward the Rear Figure 3 10 Loading Slides into the Cassette WARNING Glass Sharp Edges When loading slides confirm that ThinPrep microscope slides with fiducial marks are being used The fiducial marks should not be scr
116. l Review was statistically significant with the lower limit of the 95 confidence interval being 2 6 for all sites combined The observed difference between sensitivities for ASCUS varied among the sites from 2 8 with a 95 confidence interval of 10 6 5 0 to 14 4 with a 95 confidence interval of 8 2 20 5 The difference in specificity results between the Imager Review and the Manual Review was not statistically significant with a 95 confidence interval of 0 2 to 0 6 The observed differences between specificities varied among the sites from 0 3 to 0 4 MAN 03938 001 Rev 001 page 5 of 15 Table 3 Adjudicated Review Versus Imager Review LSIL Descriptive Diagnosis Summary for Each Site and All Sites Combined Sensitivity is a percent of true LSIL combined LSIL HSIL SQ CA and GL CA slides classified in either study arm as LSIL and specificity is a percent of true Non LSIL combined Negative ASCUS AGUS slides classified in either study arm as Non LSIL Sensitivity Specificity Site Site Number Manual Imager Difference Number Manual Imager Difference Cases Cases e 84 6 82 7 1 9 Site1 98 7 99 3 0 6 104 76 2 90 9 74 0 89 4 9 5 5 6 2208 98 1 99 1 98 9 99 6 0 1 1 0 ae 70 4 72 4 2 0 Site2 99 3 98 9 0 4 98 60 3 79 2 62 5 81 0 6 9 11 0 2342 98 8 99 6 98 4 99 3 0 8 001 eae 77 4 85
117. latform Divider Power On Indicator Imaging Station Figure 1 4 Front View Imaging Station 1 8 Image Processor Operator s Manual INTRODUCTION Serial Number Air Filter Fuses inside On Off 080908089090 j i 089090990 A Sw itc h Power Cord Firewire USB Serial Model Rating Labels Interconnection Cables to Image Processor Controller Figure 1 5 Rear View Imaging Station Slide Cassettes in Slots 1 and 2 Robot Shield Removed Slide Transfer Arm Robot Figure 1 6 Internal Components covers removed Image Processor Operator s Manual 1 9 INTRODUCTION Slide Transfer Robot at the OCR Station Park Stati ith a Slid Hold Station Sears spine Verification Slide Station Robot Shield Removed Imaging Stage O Figure 1 7 Park Station and Imaging Stage 0123496 770b024 the slide _ 03249 003 ThinPrep ThinPrep zo Cell Spot con ZA Oo Fiducial Mark tains patient cells Fiducial Mark Fiducial Mark Q a ne _ Slide Slide Verification Slide ThinPrep Microscope Slide Figure 1 8 Slides Used in the System 1 10 Image Processor Operator s Manual INTRODUCTION Imaging Station Dimensions er 23 584 2 mm i 25 o 635 mm 812 3 mm Approximate Weight 130 Ibs 59 kg Figure 1 9 Imaging Station shown without doors
118. llers the server also controls the communication between all devices on the network Some facilities only perform slide screening and a Server is used at that location to import data via CD from an imaging site The Cytotechnologist CT reviews slides at the Review Scope RS The RS consists of elements of a standard microscope augmented with automated capabilities for viewing and marking the micro scope slides The RS contains an OCR camera which reads the slide ID when a slide is loaded on the stage When a valid slide accession ID has been identified at the RS the Server sends the object of interest coordinates for that ID and the CT is presented with the 22 fields of view determined for that slide It is required that the CT review each of these fields of view before completing a slide review As each field of view is being reviewed the CT has the option to electronically mark the contents of the target zone for subsequent physical marking at completion of the slide review The CT always has the option to control the position of the stage slide manually which provides complete freedom to move any portion of the cell spot into the field of view for examination Note The CT must screen the entire field of each of the 22 fields of view presented Before completing the review the CT may revisit any locations and electronically mark or unmark tar get zones as desired At the conclusion of electronically marking the slide physical marks ar
119. mage Processor Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Data Management Data Management Page Settings Database Printer s User Accounts HP LaserJet 2300 Series PS J F Reports 7 j Seems System Page size amp Lab Settings Letter Page Setup i wm Printers Paper source amp Security Automatically Select WE Server i Figure 4 56 Page Setup Window Printer the drop down list will display all printers that are available to you Select which printer to use by clicking on it to highlight it Any printed material will output on that printer Page size the drop down list will display the page sizes the selected printer can accommodate Select the desired page size by clicking on it to highlight it Paper source the drop down list will display the paper trays the printer has Usually the default is autoselect System Printers The printers window allows the operator to locate what printers are on the network and then install them so that they will be available when generating reports or other print activities Gee Figure 4 57 Image Processor Operator s Manual 4 43 OPERATION OF THE SOFTWARE MENU wll At Data Management SEE Data Management Discovered Printers H Database Model IP Address Device Name Printer Name Description User Accounts HP Les 10 10 51 2 NPIE2D53D HPLeserJet Server Printe a E Reports Canon 10 10 51 18 NAQH5522 CanonColor Netwo
120. me ID names and which option for that parameter For the modifier option pull down e All means a list of all names available e Equals means a list that matches a typed in value for instance a name Jones e Contains means a list that has a particular string of characters that is typed in for instance all entries with mar in them e Begins With means a list of all entries that begin with a particular string of characters e Ends With means a list of all entries that end with a particular string of characters 4 30 Image Processor Operator s Manual OPERATION OF THE SOFTWARE MENU b Click on the View button to view the report see Figure 4 43 Report Results Operators Report Date Dec 03 2004 02 17 PM Matches found 2 Sort order User Id Lab Name User Id First Name Status ReallyGreat Lab 100 Anne Active ReallyGreat Lab 101 Mary Active Figure 4 43 Operators Report Click on Print to print the report Click on Close to close the report and return to the main menu Image Processor Operator s Manual 4 31 OPERATION OF THE SOFTWARE MENU oll At Report Slide Data Records Slide data records may be sorted in a wide variety of ways depending on how specifically you care to define your database query Select the Slide Data Records option from the Data Manage ment menu to open the window Figure 4 44 Data Management A 5 x Data Management Slide Id Database Qualifier gp User Accou
121. ment window Figure 4 11 The window appears with all Dat Management submenu options collapsed Data Management anA a XK Bese Jata Management gement Description xX Close Database Database Maintain and backup the database Kee i i Backup qb User Accounts Add change and retire Review Scope users Items with a symbol indi E Import B Repor Generate reports cates there is more than E Export System Sii time date and alarm settings Jg Maintenance one item asa submenu lt gt User Accounts XN aa E v Data Management a ie Database ide Expanded Data Manage R Work Backup ment Menus re soy E Import Lab 4 E Export ass X Maintenance amp secur a gt User Accounts seve E Reports R Logs and History R RS Users R Slide Data Records R Workload R Run Report x Click on this button to System close the window and Lab Settings return to the main EE Page Setup interface mm Printers Securit N eee The Help button displays the soft Note Run Report function is not available on the Server User Interface ware version Run reports must be accessed from IPCs Figure 4 11 Data Management Window Database Backup The Backup function enables the operator to make back ups of the database onto CD ROM located on the Server Click on the Backup selection The Backup window will appear Figure 4 12 4 8 Image Processor Operator
122. monstrate the ability of the ThinPrep Imaging System to successfully identify abnormalities in the 22 fields of view presented during the Autolocate mode of slide review In all 33 cases in this study the ThinPrep Imaging System identified and presented cells among the 22 fields of view that were categorized as Cancer HSIL AGUS or ASCUS In addition the Cytopathologists confirming review of the identical 22 fields of view showed consistent but slightly improved results with all cases being categorized as Cancer HSIL or AGUS Consistent with the intended use of the ThinPrep Imaging System the Cytotechnologists diagnoses in every one of these 33 cases would have invoked the full slide Autoscan mode that would require a Cytotechnologist to screen the entire slide before making a final diagnosis The results of this study indicate that ThinPrep Imaging System will accurately lead to a full manual slide review for the detection of cervical cancer or its precursor lesions G 4 SPECIMEN ADEQUACY STUDY Of the 10 359 subjects in the study 9627 met the requirements for inclusion in the specimen adequacy analysis MAN 03938 001 Rev 001 page 10 of 15 Table 12 Unadjudicated Marginal Frequencies Summary of Specimen Adequacy Results All Sites Combined Manual Review 3627 3627 Obseuring hammation fof fT n i a Com ooo e o y a A 66 07 2 E Endovervical Component Absent 6 or o 00 _ e 02 Obseuringlammaion f s o
123. n and is not accessible to the operator during batch processing The Image Processor Controller contains the frame imaging processor and controls the electrome chanical functions of the instrument It analyses the imaged slide data and then sends the data to be stored on the Server The Server stores the slide related data and controls communication of all system services to the other devices on the network It is the master controller when more than one Image Processor is con nected to the Server 3 6 Image Processor Operator s Manual OPERATION OF THE IMAGE PROCESSOR 3 D SLIDE LABELING ThinPrep 3000 Processor Microscope slides prepared on a ThinPrep 3000 Processor have the accession ID automatically printed onto the slide by the instrument and do not require any further labeling before or after stain ing and coverslipping Refer to the Label Specification Sheet P N MAN 03907 001 at the rear of the manual for specifica tions when ordering or creating vial bar code labels for use with the Imaging System Note Inspect the printing on the slides to ensure that the printing is not too light If the printing is light the slide printer ribbon on the TP3000 Processor should be replaced Always replace the printer ribbon when prompted by the TP3000 Processor ThinPrep 2000 Processor Microscope slides prepared on a ThinPrep 2000 Processor should be labeled with a white high con trast label with the appropriate accession ID on i
124. ng Reports System Merfererce Abat Figure 3 17 Slide Processing in Progress 3 14 Image Processor Operator s Manual OPERATION OF THE IMAGE PROCESSOR 3 How Long it Takes to Process Slides Slide processing takes approximately 4 5 to 5 5 minutes per slide At the start of every batch and at the completion of each slide cassette the system s internal Verification slide is processed This checks that the slide imaging system is functioning properly During Slide Processing As slides are processed the color of the cassette graphic on the monitor changes from gray to blue to represent how much progress has been made cassette by cassette within the batch Refer to Figure 3 18 Slide Imaging Slide Imaging Complete In Process Slide Imaging Not Started 4 5 6 7 Figure 3 18 Slide Cassette Imaging Status example The partial blue coloring of a slide cassette is used only to indicate that imaging of the slides is still in process the percentage of area that is colored blue is a graduated measure of the slides completed As an example if a cassette only had five slides in it the whole cassette would turn blue when the fifth slide completed processing indicating that all available slides and the verification slide had been processed Slide Processing Event Log If a slide is not processed it will be listed in the Slide Processing Event Log located on the right side of the user interface Refer to Figure 3 19 T
125. nical Support 6631 Three consecutive 6630 errors within a cassette generate a 6631 error 6901 through 6936 Verification slide and focus errors e See Section C Slide Preparation and Quality e Clean verification slide e If more than one Imaging Station is in the lab insure that the verification slides are not switched among Imaging Stations e Power Cycle the Imaging System NOTE that the IS and IPC should always be power cycled together See page 3 22 Shutting Down the System Image Processor Operator s Manual 6 11 6 TROUBLESHOOTING Table 6 2 Imaging Station and IPC Errors Error Error Text Corrective Action 6962 Accelerometer fail e The imaging station is sensitive to vibrations Look for vibrating equipment such as a vortexer near the imag ing station e Be aware of other things slamming doors that may also cause the vibrations 6963 7001 Fiducial Mark failure Light Level Drift Outside of Toler ance e Clean verification slide e Power Cycle the Imaging System NOTE that the IS and IPC should always be power cycled together See page 3 22 Shutting Down the System e Clean verification slide e May be temperature related Verify that the instrument is not near a heating or A C duct e Power Cycle the Imaging System NOTE that the IS and IPC should always be power cycled together See page 3 22 Shutting Down the System
126. ns No Cine iso Si P08 Gross A A A L Cow ooo oa 08 Note Some patients had more than one diagnostic subcategory For SAT cases there was agreement between the Manual Review cases 7375 and the Imager Review cases 7346 For SBLB cases there is agreement between the Manual Review cases 2186 and the Imager Review cases 2252 Unsatisfactory cases were greater in the Manual Review cases 66 versus the Imager Review cases 29 The adjudicated results were used as a gold standard to define true specimen adequacy classifications of the Bethesda System SAT SBLB and UNSAT There were 58 true UNSAT cases and 9569 true SAT SBLB cases Table 13 below summarizes specimen adequacy performance for the Imager Review and Manual Review arms for all four sites and all sites combined using the Bethesda System 1991 criteria Table 13 Adjudicated Review Versus Imager Review Specimen Adequacy Summary for All Sites and All Sites Combined Sensitivity is a percent of true UNSAT slides classified in either study arm as UNSAT and specificity is a percent of true SAT SBLB slides classified in either study arm as SAT SBLB Sensitivity Specificity Site Site Number Manual Imager Difference Number Manual Imager Difference Cases Cases cn 0 0 0 0 sitet 100 100 0 0 21 0 21 0 21 0 21 2292 2292 2292 2292 2
127. nt out Image Processor Operator s Manual 4 13 OPERATION OF THE SOFTWARE MENU ull A Use detailed export log Figure 4 23 Use Detailed Export Log The Use Detailed Export Log checkbox ensures that a list of all slide IDs exported will be printed in the report Note It is useful to print this report to accompany slides that are transported to another location Save an Export Filter Template When a filter parameter has been entered into the Export screen the Save button is available Figure 4 24 Save Log and Export Buttons To save a particular filter profile that may be used often click the Save button and a template name box appears Figure 4 25 Template Name Template name Figure 4 25 Template Name Type in a name for the filter template and click OK A list of templates will be visible under the Export icon on the Data Management menu window Fig ure 4 26 Data Management Database Backup BEE 5 Campus Path Lab 5 Lab ABC fa Import X Maintenance d User Accounts A Reports System Export Templates Figure 4 26 Export Templates 4 14 Image Processor Operator s Manual OPERATION OF THE SOFTWARE MENU _ To use a template that has already been created click on the name of the template in the Data Man agement menu The Export Parameters window will display with the filter profile parameters already present To change a template name or to delete it
128. nts ALL E Reports R Logs and History Slide Image Slide Review R RS Users Image status Review status R Slide Data Records ALL ALL R Workload R Run Report Imager name Review Scope serial number System 46XN551 Image date Review date Lime Review Scope User Lab name Figure 4 44 Slide Data Record Window The slide data record report may be sorted by slide ID information by slide image parameters by slide review parameters or a combination of these qualifiers The report will display as many lines of data as selected in the report limit setting 500 to 5000 refer to System Lab Settings on page 4 40 4 32 Image Processor Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Slide ID A slide data report may be sorted by slide ID a range of IDs or IDs containing a particular character string When the slide ID qualifier menu is pulled down you may choose an option and type in the condition or select All Figure 4 45 Slide ID Sort Parameters Image Parameters Data may be queried by the image status those slide records that were imaged successfully not imaged due to error or all slide data records Name Slide data reports may be sorted according to which Imager they were imaged on Select the Imager name from the drop down list Image date the report may be modified to show slide records for a particular date or for a date range that you
129. nually A consensus diagnosis was defined as agreement by at least 2 of 3 Cytopathologists All slides sent to the panel of Cytopathologists were not identified by site nor ordered in any fashion When a consensus diagnosis could not be obtained by at least 2 of 3 Cytopathologists the full panel of Cytopathologists reviewed each case simultaneously using a multi headed microscope to determine a consensus diagnosis The adjudicated results were used as a gold standard to define the following major true descriptive diagnosis classifications of the Bethesda System Negative ASCUS AGUS LSIL HSIL Squamous Cell Carcinoma SQ CA and Glandular Cell Carcinoma GL CA Estimates of sensitivity and specificity together with 95 confidence intervals were calculated for the Manual Review and Imager Review arms of the study The differences in sensitivity and specificity between the two arms together with their 95 confidence intervals were also calculated Among the random 5 subset of 8 550 cases 428 slides that were found to be negative by both arms and adjudicated there were 425 true negative and 3 true ASCUS slides A multiple imputation technique was used to adjust the numbers of true positives and true negatives for the 8 550 negative concordant cases based on the 5 of cases that were adjudicated Tables 2 4 below summarize the descriptive diagnosis sensitivity and specificity estimates with 95 confidence intervals for e
130. number of invasive cervical cancer cases in a population of approximately 275 000 women Initially a board certified Cytopathologist manually reviewed all of the fields on the ThinPrep Pap Test slides and identified and recorded the number of individual cancer cells and clusters of cancer cells that were present For this part of the study the Cytopathologist was not required to record any other cells with other Bethesda System 2001 diagnoses The 33 cases included slides that represented both rare numbers of cancer cells 5 20 per slide and numerous cancer cells gt 20 slide Cancer cells were categorized according to Bethesda System 2001 criteria for Glandular Cancer Adenocarcinoma in situ and Squamous Cell Cancer Each slide was then processed on a ThinPrep Imaging System The Cytotechnologist then reviewed only the 22 fields of view presented by the Autolocate mode of the Review Scope No review outside of the selected 22 fields of view was permitted For each field of view the Cytotechnologist counted and recorded all abnormal cell types based on the following seven Bethesda System classifications ASCUS LSIL HSIL AGUS Glandular Cancer Squamous Cell Carcinoma and Adenocarcinoma In Situ MAN 03938 001 Rev 001 page 9 of 15 Finally the same Cytopathologist who had conducted the manual review of the entire ThinPrep Pap Test slide independently re reviewed the slides using the identical method used by the Cytotechnologists The Cytop
131. ocessing Interrupted Note The duration of the interruption cycle is dependent on where in the processing operation components are It may take several minutes or up to 100 minutes to complete an entire cas sette for example 6 The Interruption process is complete when the GO button is available again The doors will unlock Refer to Figure 3 24 Cytyc Corp ThinPrep seine System Slide Processing Reports System Maintenance About Figure 3 24 Slide Interruption Complete 7 When the doors unlock the Imaging Station doors may be safely opened a Completed cassettes may be removed and replaced with unprocessed slide cassettes or the slots may be left empty CAUTION Do not remove partially processed cassettes If they are removed all the slides in the cassette must be rerun b If uncompleted slide cassettes are removed they must be reimaged at another time to be con sidered complete The system will start with the next unprocessed cassette it comes to when operation is resumed c Ifthe system is to be shut down remove the slide cassettes Run unprocessed cassettes in a later batch 3 20 Image Processor Operator s Manual OPERATION OF THE IMAGE PROCESSOR 3 Resume Slide Processing after Interruption 1 Confirm that at least one cassette is loaded in the Imaging Station Firmly close the sliding doors 2 On the menu bar click on the green GO button or pull down the slide processing menu and click on Start Slide Pro
132. on slides are not switched among within a cassette generate a linauine Statins 2409 ging 3106 Slide not found e Ensure that the slide was properly loaded in the cas sette with label facing outward and only one slide per 3107 Three consecutive 3106 errors slot within a cassave generate a e f slide was loaded correctly see Section C Slide Prepa 3107 ration and Quality 3111 Slot has multiple slides 3113 Slot below has slide out of posi tion or multiple slides 3159 Map Cassette Timeout e Clean cassette mapping sensor refer to page 5 7 e Power Cycle the Imaging System NOTE that the IS and IPC should always be power cycled together See page 3 22 Shutting Down the System 3303 OCR Read Failed e See Section C Slide Preparation and Quality 3304 e f label was printed on a T3 replace ribbon 3305 Invalid Slide ID e See Section C Slide Preparation and Quality 3306 a Support to verify the Slide ID has the proper 3307 Slide Already Imaged Use the Slide Data Record Query to determine if the Slide ID is unique See page 4 32 of the Image Processor Oper ators Manual for details lf there is a duplicate reconcile both patient records according to standard procedures Image Processor Operator s Manual 6 9 6 TROUBLESHOOTING Table 6 2 Imaging Station and IPC Errors Error Error Text Corrective Action 3471 Slide Found in Slide Path e System will instruct the user to pl
133. onal support study demonstrated that the Bethesda System 1991 estimation methods including the method used in the clinical study do not generate similar specimen adequacy determinations when compared against each other or with the control method Therefore the recommended methods for determining specimen adequacy on the ThinPrep Imaging System are 1 the Bethesda System 2001 count of fields along a diagonal of the cell spot or 2 counting the cells in the 22 fields of view selected by the ThinPrep Imager System Refer to the ThinPrep Imaging System Review Scope Operator s Manual for instructions on the proper use of these methods G 5 CYTOTECHNOLOGIST SCREENING RATES Daily Cytotechnologist screening rates were recorded throughout the duration of the clinical study The study was conducted in a manner designed to reproduce actual clinical conditions Eight 8 Cytotechnologists participated in the study two 2 at each clinical site The experience levels of the Cytotechnologists ranged from 5 to 23 years During the study the Cytotechnologist s screening times for the Imager Review arm included automated screening of the 22 fields of view with subsequent full side review of abnormal slides A full slide review consists of approximately 120 fields of view The number of hours each Cytotechnologist screened slides per day varied due to logistical issues and scheduling With the ThinPrep Imaging System Cytotechnologist screening rates were uniforml
134. ort displays a tally of slides reviewed Click on Workload to open the Workload report window Figure 4 49 4 36 Image Processor Operator s Manual OPERATION OF THE SOFTWARE MENU Data Management E x Data Management Workload Reports H Database CT workload summary a User Accounts 3 H Reports O CT workload history R Logs and History Lab name arid R RS Users R Slide Data Records R Workload Date range R Run Report ALL 4 System Figure 4 49 Workload Window The CT Workload Summary displays a tally of all the auto reviews a CT has performed over a speci fied period of time The review count is split into FOV field of view only screenings in which no cells were marked during Autolocate and Full Review screenings in which cells were marked and a full scan Autoscan of the cell spot was required The report does not include manual reviews See Figure 4 50 The sort parameters are for which laboratory if more than one are in the database date range and time interval Image Processor Operator s Manual 4 37 OPERATION OF THE SOFTWARE MENU wll At Report Results CT Workload Summary Report Date Dec 10 2004 02 43 PM This report does not include manual reviews RS User 100 Gam pus Path Lab Cytyc Service 101 43 63 Gam pus Path Lab a Dave 102 Gam pus Path Lab Jacobson Natalie 105 3692 Gam pus Path Lab Karr Robert 110 4335 1659 Gam pus
135. os These fixed and sequential numbers can be used for filtering the database for exporting data Accession Number Range To export a range of accession numbers enter the beginning and ending accession numbers into the Accession Number Range field The entire Slide ID number of the first slide and the last slide may also be entered A maximum of 10 000 records may be exported at one time 4 10 Image Processor Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Refer to Figure 4 14 as an example A range of accession numbers 1 through 500 has been selected Export Parameters Enter just the Accession Number Range range 500 Export Parameters Accession Number Range Or enter the i entire Slide ID 0212301 4001 001 2301 4500 Figure 4 14 Accession Number Range When the range has been entered next use the Slide ID Filter to place the accession number location Slide ID Filter The Slide ID Filter is used to specify the format of the ID by indicating the meaning of specific char acters like a Lab ID code or date code if these are part of the Slide ID number It is used to select ranges of slide IDs such as accession numbers The character boxes represent the seven over seven character format required for the Imaging Sys tem Slide ID The last 3 numbers on the bottom row are reserved for the CRC code and may not be selected Refer to Figure 4 15 Slide Id Filter 0 9 Match specific n
136. ow open the security window There is an empty field titled Current Password Type in the security password and click on the Validate button See Figure 4 63 To access restricted data type in the cor Security rect security password Current password and click the Validate _ button Figure 4 63 Validate Password Window If the password entered was not correct an Invalid password entry box is displayed Figure 4 64 ThinPrep Imaging System X Invalid password entry Figure 4 64 Invalid Password Entry Click OK to clear the box Re enter the correct password in the field and click Validate If the pass word entry is correct a lock icon will appear on the bottom right of the window This indicates administrative access mode is applied The User Accounts management Workload Reports and Slide Data Record fields will be restored See Figure 4 65 Note Administrative access is only applied at the workstation or server that is being accessed Image Processor Operator s Manual 4 49 OPERATION OF THE SOFTWARE MENU ull A Data Management When a password has been validated access Data Management Security to restricted data is m Database NI amp User Accounts restored and a lock 2 E Reports icon appears in the R Logs and History lower right to indicate R RS Users side bd R Slide Data Records administrative acces is applied E Page Setup mm Printers B Security W Server To e
137. persistent errors contact Hologic Technical Support refer to Service Information Chapter 9 1 16 Image Processor Operator s Manual INTRODUCTION IMAGE PROCESSOR HAZARDS The ThinPrep Imaging System is intended to be operated in the manner specified in this manual Be sure to review and understand the information listed below in order to avoid harm to operators and or damage to the instrument If this equipment is used in a manner not specified by the manufacturer then the protection pro vided by the equipment may be impaired Warnings Cautions And Notes The terms WARNING CAUTION and Note have specific meanings in this manual e A WARNING advises against certain actions or situations that could result in personal injury or death e A CAUTION advises against actions or situations that could damage equipment produce inaccurate data or invalidate a procedure although personal injury is unlikely e A Note provides useful information within the context of the instructions being provided Symbols Used on the Instrument The following symbols are used on this instrument Attention refer to accompanying documents Warning risk of electric shock internal use only not accessible to operators Protective Conductor Terminal internal use only not accessible to operators On Off Fuse Waste Electrical and Electronic Equipment contact Hologic for disposal of the instrument xl OFC Figure 1 13 Symbols Us
138. r s Manual THINPREP STAIN 7 Filtration Systems e Only the 95 and 100 alcohols from the ThinPrep Stain set up should be put through the filtra tion system e 95 and 100 alcohols combined on the filtration system will result in an output alcohol concen tration that will need to be adjusted to 95 prior to use in the ThinPrep Stain set up Distillation System e Only 70 and greater alcohols from the ThinPrep Stain set up should be combined and recycled through the recycler at one time e Laboratories who wish to recycle solvents other than alcohol xylene or xylene substitutes on the same recycler are responsible to ensure the resultant alcohol is not contaminated with residual solvent The CBG Biotech Solvent Recycler Installation and Operating Instructions Manual provides step by step instructions for recycling alcohols and solvents on the same recycler The laboratory should perform a xylene water test to ensure the recycled alcohols are not contaminated with residual solvent prior to being placed in the ThinPrep Stain set up Refer to the CBG Biotech Solvent Recycler Installation and Operating Instructions Manual Trouble shooting section for details e Recycling 70 or greater alcohols will result in an output alcohol concentration that will need to be readjusted to the appropriate concentration prior to being used in the ThinPrep Stain set up SECTION BES COVERSLIPPING REQUIREMENTS Required Materials Table 7 1 lists
139. r s Manual 5 1 IMAGE PROCESSOR MAINTENANCE oll Ht Clean Verification Slide Please place an empty cassette in an available slot then press Retrieve The verification slide will be placed in slot 1 of the empty cassette Retrieve Cancel Please wait Please wait while the Verification Slide is retrieved from the verification station Figure 5 2 Retrieve Verification Slide The cassette and slide may be removed when the Store screen is displayed Figure 5 3 Clean Verification Slide Please remove the Verification Slide from the cassette and clean the slide Insert the Verification Slide in slot 1 of the cassette when finished Replace the cassette in the system and press Store Figure 5 3 Store Verification Slide CAUTION The verification slide is very delicate Only handle it by the edges Keep it clean and dust free at all times Remove the verification slide from the cassette and gently clean it with a lint free tissue and alcohol Inspect the slide to make sure it is not cracked scratched or damaged in any way Contact Hologic Technical Support if the slide is damaged in any way 5 2 Image Processor Operator s Manual IMAGE PROCESSOR MAINTENANCE 5 Replace the verification slide into slot 1 of the cassette and install the cassette onto the loading plat form of the Image Processor Note The slide must be placed in slot 1 the bottom slot of the slide cassette Click the Store button on the di
140. rk Prin System amp Lab Settings E Page Setup mm Printers B Security Server Discover Installed Printers Printer Name Device Name Description Location a LaserJet 2300 NPIE2D53D Server Printer Next to Server Properties Figure 4 57 Setup Printers Window Click on the Discover button to see what printers are on the network To install a printer select the printer by clicking on it and then click the Install button To install several printers at once hold the Control key and click on the desired printers The printer will appear in the Installed Printers field 4 44 Image Processor Operator s Manual OPERATION OF THE SOFTWARE MENU 4 System Security Enabling Security will restrict access to e Workload History e User Account Management e Fields on the Slide Data Record report Lab name User ID RS serial number A password will be required to view or print this data The Security feature is system wide the Server and all workstations will have the same restrictions The security feature provides the user the following options e Enable a password e Validate administrative access to restricted areas without entirely disabling the password e Change a password e Disable a password Click on Security to open the Security window Refer to Figure 4 58 Data Management Data Management Security Database Backup E Import BE Export X Maintenance
141. ry Flow Patient Name A request form and a ThinPrep Vial containing cervical specimen collected from the patient arrive at the laboratory The sample is processed on either a ThinPrep 2000 or 3000 instrument using ThinPrep slides for use with the Imager The accession ID is placed on the slide Prepared slides are loaded into cassettes which are placed in the ThinPrep Imaging Station At the Review Scope the slide ID is scanned and the related data is retrieved from the Server 22 fields of view are presented to the CT via the review microscope Suspect cells may be electronically marked by the CT during review Patient Name ID 0001234 0001234 A unique accession number is assigned and attached to each item onza in J 030 A ThinPrep processed slide Il contains the patient accession ID and cell samples ThinPrept 4 The slide is then stained with ThinPrep Stain and cover slipped Slide The Server stores the slide data records for later review at the Review Scope The Image Processor Controller analyzes the images and identifies coordinates of Objects Of Interest OOls These are sent to the Server The Imaging Station scans the cell spot and sends the images to the Image Processor Controller IPC At the conclusion of review the
142. s the data updates the database and shows a completed progress bar when finished There will be a check mark next to each action as it successfully completes When the import of data concludes the summary on the Import window changes to an Import summary as shown in Figure 4 31 4 18 Image Processor Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Import Import Results Summary Import date j mort date Nov 22 2005 10 56 AM Importing lab Importing lab D3A7CB5A B2BE 4664 B71E F68EB9FBBDAD Im D nten Import CD Contents port E a a 7 Total Slides 182 a Colars Iges Minimum slide id 00000000009 Minimum slide ID Maximum slide id 00000009588 Maximum slide ID Summary New slides 0 Summary Duplicate slide records 182 N ew slides Database import errors 0 Duplicate slide records Import conflicts 0 Slides with imaging errors Import conflicts Progress 4 Checking media Y Preparing data Y Updating database Y Complete cee Figure 4 31 Import Results Summary To see a report of the import results click the Results button Refer to Figure 4 32 A new slide is new to the database A duplicate is a slide record that is already in the database and the slide data being imported is iden tical The slide data being imported is not written to the database An error is a slide that has an error within its data it will not have been imported into the database A conflict is a condition where a slide record is already in th
143. splay screen Wait while the slide is returned to the verification slide station Figure 5 4 Please wait Please wait while the Verification Slide is returned to the verification station Figure 5 4 Please Wait while Verification Slide Is Stored The system will return to the idle mode screen when complete SECTION 2 REPLACING THE USER ACCESSIBLE FUSES There are two user accessible fuses located in the Imaging Station refer to Figure 1 5 If the fuses must be replaced follow these steps WARNING Instrument Fusing Only replace with fuses of the specified type and current rating Refer to the Ordering Information for ordering fuses 1 Turn off the instrument 2 Remove the power cord from the uninterruptible power supply 3 Remove the power cord from the receptacle on the instrument 4 Using the small 1 slotted screwdriver provided with the system carefully pry open the cover of the power entry module Figure 5 5 Image Processor Operator s Manual 5 3 5 IMAGE PROCESSOR MAINTENANCE Figure 5 5 Remove Fuse Access Cover 5 Gently pull down the cover It is hinged at the bottom end 6 Insert the screwdriver under the fuse holder to pull it out Fuse Holder Figure 5 6 Remove the Fuse Holder 7 Remove the existing fuses and discard them 8 Insert two new fuses into the fuse holder as shown 5 4 Image Processor Operator s Manual IMAGE PRO
144. sword The password is stored in the database on the server Important Close and re open the Data Management window on the server and all workstations to apply the data restriction 4 46 Image Processor Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Note The password may be set changed or disabled at the server or any workstation on the net work however the server must be turned on to ensure the necessary network communica tion is active If you lose or forget the security password contact Hologic Technical Support This will require a Field Service visit The password may be any alpha numeric combination from 1 to 16 characters long a blank field is not allowed The password is case sensitive Note If your password is lost or forgotten a Hologic Service visit is required to disable the security Restricted Data When Data Management has security enabled the User Accounts menu and the Workload Report menu are not accessible without the administrative password v Data Management Database Backup E Import EY Export X Maintenance Ey Reports R Logs and History R RS Users R Slide Data Records R Run Report Q System amp Lab Settings E Page Setup a Printers Security pd Server wa Data Management Database Backup E Import EF Export X Maintenance EB Reports R Logs and History R RS Users R Slide Data Records R Run Report B System amp Lab
145. t Slide Processing and then in the drop down menu click once on Interrupt Slide Processing Figure 3 21 Cytyg Corp ThinPrep Imaging System Seea Reports System Maintenance About Interrupt Slide Processing Figure 3 21 Interrupt Slide Processing Menu Selection 2 An option selection menu will be displayed The slides will continue to be processed until an interrupt option is selected Figure 3 22 3 18 Image Processor Operator s Manual OPERATION OF THE IMAGE PROCESSOR 3 Interrupt Slide Processing Please select one of the following options Interrupt the current slide immediately _Cancel_ Interrupt at the conclusion of the current slide on the stage Interrupt at the conclusion of the current cassette Return to Slide Processing Figure 3 22 Interrupt Slide Processing Option Use the mouse to select the option for when the batch is interrupted a d Interrupt the current slide immediately Use this option to stop batch processing at the current slide The slide will not be completed The slide will be put away and then the Imaging Station mechanisms will come to an orderly halt The doors will unlock If the batch is resumed without a power cycle the verification slide is run then the data for any previous slides in the cassette are written to the Server and then the system continues pro cessing at the slide that was in progress during interrupt Interrupt at the con
146. t after completion of staining and coverslipping Note Labels that are not resistant to xylene should not be immersed in it for more than 10 minutes This can cause the label to lift peel off or otherwise make it difficult for the instrument ID reader to read Labels should be centered from side to side and positioned toward the top of the painted area with out overhanging the slide Refer to the Label Specification Sheet P N MAN 03907 001 at the rear of the manual for specifica tions when ordering or creating slide labels for use with the Imaging System 0 93 in 23 62 mm Label j 000123 KDA santa ThinPrep Figure 3 8 Slide Labeling for slides processed on a ThinPrep 2000 Processor Vendors Label Arts Inc will take international orders P O Box 727 Kemp TX 75143 Tel in US 1 800 634 99431 903 498 6041 Fax 1 903 498 8169 Image Processor Operator s Manual 3 7 3 OPERATION OF THE IMAGE PROCESSOR SECTION LOADING SLIDE CASSETTES WARNING Glass Sharp Edges Only stained coverslipped ThinPrep Pap Test microscope slides for use with the ThinPrep Imaging System may be used Only glass coverslips 1 thickness 24 mm wide 40 50 mm long or Sakura Tis sue Tek SCA coverslipping film Sakura part number 4770 may be used to coverslip the micro scope slide CAUTION The slides must have been processed on a ThinPrep 2000 or 3000 Proces sor Refer to Figure 3 9 The fiducial mar
147. tch reports 4 5 B Batch 8 1 Batch process diagram 3 2 C Cancel The Batch After Interrupting Slide Processing Cassette 8 1 cassette locations 3 12 cassette status 3 15 66 8 1 CellFyx Solution fixative 7 1 Clean Verification Slide 4 54 Clearing agents 7 5 Completing Slide Processing 3 22 conflict 4 19 coverslip drying time 7 4 7 5 Coverslip processes 7 5 coverslipping requirements 7 3 CT Workload History 4 38 CT Workload Summary 4 37 Customer Service 9 1 10 1 INDEX 3 21 Review Scope Operator s Manual Index 1 INDEX D Data Management menu 4 8 Data how many lines in a report 4 42 Database backup 4 8 database conflict 4 19 Date setting 4 40 Date Time format 4 41 Dimensions 1 14 Disposal consumables 1 19 device 1 19 electrical and electronic equipment 1 19 During Slide Processing 3 15 E Environmental specifications 1 13 Errors 6 9 Event Log 3 15 Event Log Display 3 16 Event Log window 6 1 Export data 4 9 Export template 4 14 extended network 2 2 11 2 F fiducial marks 3 8 8 1 Fixation requirements 7 1 fixative 7 1 Fuses 5 3 Index 2 Review Scope Operator s Manual INDEX G GO button 3 14 3 20 3 21 4 1 6 6 H How Long it Takes to Process Slides 3 15 I Image Processor 8 2 Image Processor Controller 3 6 8 2 Imager Name setting 4 41 Imaging Station 3 6 Imaging Station and IPC Errors 6 9 Imaging System Usage History 4 28 Import data 4 16 Install
148. tdown System Silence Alarm Figure 6 4 User Assisted Shutdown Click on the button and allow the system to shut down The system will shut down the application and then exit Windows and shut down the IPC Power off the Imaging Station using the power switch on the rear of the unit Wait at least 15 seconds before turning the components on again Allow the system to warm up and enter idle mode SECTION eZ SLIDE PREPARATION AND QUALITY Careful preparation of the microscope slides can prevent many types of slide events or system errors When a slide event or system error occurs inspect the slide that generated the event Correct Slide Always use a ThinPrep Imaging Microscope slide with fiducial marks see Figure 6 5 Image Processor Operator s Manual 6 7 6 TROUBLESHOOTING Make sure the slide is not damaged fiducial marks are present and unmarred the slide is not scratched or chipped the frosted area is unblemished Clean any dirt or stain using isopropyl alcohol and a lint free wipe Be sure to clean the edges of the slide Frosted Area Fiducial Marks LN ThinPrep Label Area 7706024 8000253 Coverslip Area Figure 6 5 ThinPrep Imaging Microscope Slide Dry Mounting Media The mounting media must be dry before loading slides into the cassettes and imaging them Wet or tacky mounting media could cause equipment malfunction Mounting media should not overhang
149. tem Menu Selection 2 Select Yes to continue with shut down Figure 3 30 ThinPrep Imaging System j re you sure you want to shut down the system Figure 3 30 Confirm Shut Down 3 The application quits and then Windows shuts down and the Image Process Controller and monitor turn off Image Processor Operator s Manual 3 23 3 OPERATION OF THE IMAGE PROCESSOR Imaging Station 4 At the rear of the Imaging Station position the Power rocker switch to OFF Shut Down Due to Power Outage CAUTION Be sure to shut down the Image Processor before the UPS backup power runs out If a power outage condition occurs the Uninterruptible Power Supply UPS issues an audible alarm when providing backup power There will be approximately 30 minutes of power provided Follow the instructions for shutting down the Image Processor in the previous section Turn off the UPS when the instrument has been safely turned off Taking the Instrument Out of Service Extended Shut Down If the Image Processor is to be shut down for an extended time follow the shut down instructions for Shutting Down the Image Processor page 3 22 Remove and safely store any patient slides that might be in the slide cassettes Close the Imaging Station doors Unplug the power cord to the Imaging Station the monitor the Image Processor Controller and the Server aa REBOOTING THE SYSTEM If the Image Processor is being rebooted for any reason 1
150. ter I Monitor Server Keyboard Table Desk or Lab Bench Up to 328 ft 100 meters pear geract Iii Scope depending on site configuration Uninterruptible Power Supply and Battery Backup Power Cord Requires an Outlet May go on the floor provided there is no dust accumulation on or around it Figure 2 1 Local Network Interconnection Schematic example Extended Network Configuration CAUTION Route all connectors carefully to avoid pinching the cables To avoid trip ping over or disconnecting cabling do not place cabling near foot traffic The Review Scopes may be located at a greater distance from the Image Processor by using an extended network interconnection between the Server hub and the Review Scope hub Low level industry standard interconnection devices such as switches bridges repeaters media converters copper and fiber wiring may be used Refer to Figure 2 2 The distance that Review Scopes may be located away from the Image Processor is determined by the requirements of the 2 2 Image Processor Operator s Manual IMAGE PROCESSOR INSTALLATION 2 specific apparatus used to create the network The throughput of the extended network must be capable of 10Mbps or greater Note High level interconnecting devices routers and gateways and wireless devices must not be used The devices used for the extended network must form an isolated network used exclu
151. terest Autolocate If the Cytotechnologist identifies any of these fields as containing abnormal objects that field may be marked electronically The Review Scope will guide the Cytotechnologist to conduct a review of the entire cell spot for any slide that has had fields electronically marked Autoscan The Cytotechnologist determines specimen adequacy and the presence of infections during the review of the 22 fields of view presented by the ThinPrep Imaging System Either of two methods can be used to determine specimen adequacy The first method is to count cells and determine the average number of cells in the 22 fields of view presented by the Imager The second method is to count and determine the average number of cells in 10 fields of view across the diameter of the cell spot Either method will enable the Cytotechnologist to determine if the minimum cells as recommended by Bethesda System 2001 criteria are present on the slide At the conclusion of the slide review electronically marked objects are automatically ink marked Any x and y coordinates representing marked locations along with a slide completion status are then electronically transmitted back to the computer for storage MAN 03938 001 Rev 001 page 2 of 15 LIMITATIONS Only personnel who have been appropriately trained should operate the ThinPrep Imaging System Image Processor or Review Scope All slides that undergo primary automated screening with the Image Processor requ
152. tes of slides and starting the slide processing function At the conclusion of slide processing slide cassettes are removed from the Imaging Station A Slide Processing Event Log visible on the user interface during slide processing indicates which slide s may require further operator attention At any time during slide processing the operator may interrupt and resume batch processing or interrupt and cancel processing System database queries may be viewed and printed while processing a batch Refer to Operation of the Software Menu on page 4 1 If necessary the equipment may be shut down following a prescribed sequence Refer to Shutting Down the Image Processor on page 3 22 Refer to Figure 3 1 for a diagram of a typical batch process Note Review Scopes are connected to the Server during slide screening sessions by the Cytotechnologists CTs If the Imaging System is to be shut down the CTs need to be notified in order to save slide data prior to losing the communication connection Preferably any equipment shut down should be planned to occur during off hours Image Processor Operator s Manual 3 1 OPERATION OF THE IMAGE PROCESSOR Doors lock while warming up Doors unlock Load Slide Cassettes Close Doors Press GO Doors Lock i View Print Reports or Interrupt or Interrupt Resume Cancel p Batch Complete Ended Doors Unlock Open Doors Unload Cassettes n Power
153. the edge of the slide Clean the edges of the slide with xylene and a lint free wipe There should not be any bubbles present over the fiducial marks or the cell spot Coverslip Material and Placement Coverslip material must be either glass 20mm x 40 50mm or Sakura Tissue Tek Coverslipping Film refer to Coverslipping Requirements on page 7 3 The coverslip must be placed so that it does not overhang any part of the slide Ensure that the coverslip is present and undamaged Note If Sakura Tissue Tek SCA coverslipping film is used slides must be cleared with xylene Slide Label Format and Placement The slide label must have the correct accession ID format for the Imager to successfully scan and read the ID Refer to SLIDE LABELING on page 3 7 and to Labeling Specifications for Use with the ThinPrep Imaging System P N MAN 03907 001 at the end of this manual The slide label must be positioned correctly on the slide so that the ID reader can locate it The slide label must be clean undamaged and not overhanging the edge of the slide 6 8 Image Processor Operator s Manual TROUBLESHOOTING 6 IMAGING STATION AND IPC ERRORS Table 6 2 Imaging Station and IPC Errors Error Error Text Corrective Action 2407 Slide has been rejected e See Section C Slide Preparation and Quality e If more than one Imaging Station is in the lab insure ane a OONA CeO that the verificati
154. the mounting media clearing agents coverslips and combinations of these items that have been evaluated and approved for use with the ThinPrep Imaging System CAUTION Use of other mounting media clearing agents coverslips or approved com binations of these items may compromise the performance of the Imager Use of lint free wipes is recommended Automated Coverslipping Refer to manufacturer s instructions for use of automated coverslipping instruments Note Refer to Table 7 2 at the end of this section for recommendations for setting up a Sakura Tis sue Tek FILM coverslipper for use with a ThinPrep Imaging System Image Processor Operator s Manual 7 3 7 THINPREP STAIN Manual Coverslipping 1 Quickly drain excess clearing agent from the slide 2 Immediately apply sufficient mounting medium to the slide to minimize cornflaking air bubbles or retraction Avoid excessive medium which may ooze out from under the covers lip and run down the edges of the slide 3 Apply the coverslip using standard laboratory practice 4 Using a lint free wipe moistened in clearing agent wipe the edges of the coverslip to clear any residual mounting medium 5 Allow slides to dry completely a minimum of 16 hours at room temperature or in a slide oven set at 37 C 1 C for 3 to 12 hours before placing in a slide folder or in Imager slide cas settes CAUTION Make sure the coverslips do not overhang any edges of the slide Coverslip
155. the network Select one by clicking on the RS serial number listed Figure 4 38 Note An RS that is on the network but has not written an error to the database yet will not appear on the drop down list Log Selection Server error log Image Processor error log Review Scope error log TE v 10501G04AP O Ji0503604AP O Image Processor slide event log Figure 4 38 Select Review Scope for Error Log Report Then click on the View button to see the report See Figure 4 39 4 26 Image Processor Operator s Manual Report Results OPERATION OF THE SOFTWARE MENU A N Review Scope Error Log Report Date 26 Apr 2004 06 06 Matches found 67 Review Scope 10501G04AP Error Number 7408 7182 7418 Software Version 11 Jan 2005 09 15 10501G04AP 5 0 13 10 Jan 2005 16 52 10501G04AP 5 0 13 10 Jan 2005 16 50 10501G04AP 5 0 13 Date Time Review Scope Id 7418 10 Jan 2005 16 50 10501G04AP 5 0 13 7408 09 Jan 2005 09 02 10501G04AP 5 0 13 7182 7418 7418 7186 7183 06 Jan 2005 15 42 10501G04AP 5 0 13 06 Jan 2005 15 40 10501G04AP 5 0 13 05 Jan 2005 12 56 10501G04AP 5 0 13 31 Dec 2004 14 05 10501G04AP 5 0 13 31 Dec 2004 11 00 10501G04AP 5 0 13 7183 31 Dec 2004 11 00 10501G04A4P 5 0 13 7183 31 Dec 2004 10 59 10501G04AP 5 0 13 7183 7303 31 Dec 2004 10 59 10501G04AP 5 0 13 31 Dec 2004 10 59 10501G04AP 5 0 13 Figure 4 39 Review Scope Error Log The errors are displayed with the most recent ev
156. there is a noted increase in system errors Because the slide cannot be accessed manually the software commands the slide transfer robot to retrieve and replace the slide Note If the verification slide must be removed follow this procedure to remove and return it CAUTION Verification slides are NOT interchangeable Each slide is unique to the sys tem it is run on If a verification slide is damaged please contact Hologic Technical Sup port e Verification slide cleaning must only be performed when the instrument is idle e An empty slide cassette and one unoccupied position on the cassette platform of the Image Pro cessor are needed to retrieve and replace the slide e Lint free tissues or lens paper and alcohol are needed to clean the slide To retrieve the verification slide from the Image Processor from the main menu select Maintenance and then Clean Verification Slide Figure 5 1 Slide Processing Reports System About Clean Verification Slide Figure 5 1 Maintenance Menu The following screen is displayed prompting for an empty slide cassette to be placed in an unoc cupied slot Any available slot may be used Click on the Retrieve button when ready It takes several seconds to retrieve the slide and place it in the slide cassette A please wait message is displayed Figure 5 2 CAUTION Do not place the empty cassette into an empty slot until directed to do so by the system Image Processor Operato
157. tion sample vial The sample is then capped labeled and sent to a labo ratory equipped with either a ThinPrep 2000 or 3000 Processor After being processed the slides are stained with ThinPrep Stain and coverslipped with either of the following e glass coverslips 1 thickness 24 mm wide 40 50 mm long e Sakura Tissue Tek SCA coverslipping film Sakura part number 4770 Please refer to the Operator s Manuals of these instruments for more information regarding prepara tion and processing of ThinPrep slides Please refer to Chapter 7 ThinPrep Stain and to the ThinPrep Stain User s Manual for information regarding use of the stain Special Precautions There are conditions that might result in a slide not being successfully imaged Some conditions may be prevented or corrected by following these guidelines e ThinPrep microscope slides with fiducial marks are being used The fiducial marks should not be scratched or marred e The coverslip media is dry wet media could cause equipment malfunction e The slides are clean no fingerprints dust debris bubbles Handle the slides by the edges e The coverslip does not extend beyond the surface of the slide e The label is applied smoothly without overhang Lifted edges may stick during handling caus ing broken slides or instrument malfunction e The slide is appropriately labeled for use with the ThinPrep Imaging System refer to Chapter 3 Section D Slide Labeling page
158. tivity varied among the sites from 2 8 to 14 4 For LSIL and HSIL the sensitivity of the Imager Review method is equivalent to the Manual Review method e For all sites combined for HSIL the improvement in specificity of the Imager Review method over the Manual Review method is statistically significant This increase is 0 2 with a 95 confidence interval of 0 06 to 0 4 for all sites combined The differences in specificity varied among the sites from 0 1 to 0 7 For ASCUS and LSIL the specificity of the Imager Review method is equivalent to the Manual Review method MAN 03938 001 Rev 001 page 14 of 15 e Specimen adequacy can be determined using the method described in Bethesda System 2001 or by having the Cytotechnologist count the cells in the 22 fields of view presented by the Imager e The workload limit for the ThinPrep Imaging System has been established at 200 slides in no less than an 8 hour workday This workload limit of 200 slides includes the time spent for manual review of slides that is not to exceed 100 slides in an 8 hour workday For these clinical sites and these study populations the data from the clinical trial and clinical support studies demonstrate that the use of the ThinPrep Imaging System to assist during primary screening of ThinPrep Pap Test slides for all cytologic interpretations as defined by the Bethesda System is safe and effective for the detection of cervical abnormalities Performance m
159. tton A dialogue box will appear with the question Disable Security Click OK to disable the password protection Click Cancel to keep the password protection enabled Figure 4 69 ThinPrep Imaging System 2 Disable security Figure 4 69 Disable Security 4 52 Image Processor Operator s Manual N OPERATION OF THE SOFTWARE MENU j System Server The server window displays all Imagers and Review Scopes that are actively communicating with the network The Refresh button is used to review active network connections Instruments that have been turned off and are no longer communicating will not appear on the list Instruments that have been turned on will appear on the list To shut down the server click on the Shutdown button Data Management Data Management Connected Review Scopes Database Dena Backup 1005810340 Jan 18 2005 05 33 PM E Export 10106K0341 Jan 18 2005 04 06 PM E emt IURAT Jen 1 200808 pa A an 18 X Maintenance 1020C04A0 Jan 18 2006 06 50 PM gt Operator Accounts 10253C04A0 Jan 18 2005 06 50 PM A Reports 3 System amp Lab Settings E Page Setup mm Printers Connected Imagers amp Security Device Id Connection Time x 6XN651 Jan 18 200506 33 PM D amp xN 551 Jan 18 2005 04 06 PM HSxXN 551 Jan 18 2005 05 10 PM IPCo002 Jan 18 2005 05 50 PM IPCO003 Jan 18 2005 05 50 PM IPGo004 Jan 18 2005 06 50 PM IPCO005 Jan 18 2005 06 50 PM IPCO006 Jan 18 200
160. umber l I Accession numbers Figure 4 15 Slide ID Filter Type in specific characters in the position they appear in the Slide ID to sort for all slides that match Figure 4 16 shows a sort filter for all Slide IDs with the date 2005 in them Slide Id Filter 0 9 Match specific number Accession numbers 2 loko ls i Figure 4 16 Filter Using Specific Characters The character is used to indicate the location of accession ID numbers on the slide ID format Figure 4 17 shows a sort filter that is for a 5 digit accession number located on the top row of the slide ID format Note The characters must be adjacent they cannot be separated Image Processor Operator s Manual 4 11 A OPERATION OF THE SOFTWARE MENU Use the in the Slide Id Filter position of the 0 9 Match specific number accession num X e Accession numbers ber characters l Figure 4 17 Filter by Accession Number Length or Placement Specific characters and accession numbers can be filtered Figure 4 18 shows a sort filter using a Lab ID code and a 5 digit accession number Slide Id Filter alla lg ae Match specific number Accession numbers Figure 4 18 Filter Using Characters and Accession Number Export Window Checkboxes Export only slides not already exported Figure 4 19 Export Only Slides Not Already Exporte
161. w FMR 45 slides 30 x 1 5 45 Total number of slides screened 95 50 FOV only and 45 FOV FMR e Note ALL laboratories should have a clear standard operation procedure for documentation of their method of workload counting and for establishing workload limits e It is the responsibility of the Technical Supervisor to evaluate and set workload limits for individual cytotechnologists based on laboratory clinical performance According to CLIA 88 these workload limits should be reassessed every six months For less than an 8 hour workday the following formula must be applied to determine the maximum number of slides to be reviewed during that workday Number of hours examining slides ge 100 The manual workload limit does not supercede the CLIA requirement of 100 slides in a 24 hour period in no less than an 8 hour day Manual review includes the following types of slides e Slides reviewed on the ThinPrep Imaging System using the Autoscan feature e Slides reviewed without the ThinPrep Imaging System e Non gynecologic slides When conducting manual review refer to the CLIA requirements for calculating workload limits H Clinical Investigation Conclusions e For all sites combined for ASCUS the improvement in sensitivity of the Imager Review method over the Manual Review method is statistically significant This increase is 6 4 with a 95 confidence interval of 2 6 to 10 0 for all sites combined The differences in sensi
162. xit administrative access mode click Close Figure 4 65 Administrative Access Mode Administrative work can be done in any area of the Data Management program To exit the access mode click on the Close button at the upper right of the data management window When Data Management is opened again security will be enabled 4 50 Image Processor Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Change The Change button is used to change the password Once the current password has been validated click on the Change button to enter a new password Figure 4 66 Click on the Change button to change the password Figure 4 66 Change Password The password box will appear Enter a new password and click OK when done Password New password Confirm new password Figure 4 67 Enter New Password Note Only one password can be used at a time Previous passwords are not retained The new password will be enabled the next time Data Management is opened Image Processor Operator s Manual 4 51 OPERATION OF THE SOFTWARE MENU oll At Disable Once a security password has been activated a Disable button is displayed as an option on the security window See Figure 4 68 Click on the Disable button to disable pass word security and allow open access to all reports and windows Security Figure 4 68 Security Disable Window To disable the password security click on the Disable bu
163. y faster than the Manual Review method Table 14 summarizes the Cytotechnologist screening rates for both the Imager Review and the Manual Review methods The total number of slides reviewed in the study and the average number of hours screened per day are presented for each Cytotechnologist and site Screening rates extrapolated to an 8 hour workday are presented as the low average and high daily screening rates achieved by each Cytotechnologist and site The low and high daily rates were selected from the lowest and highest daily hourly rates respectively and are extrapolated to 8 hours MAN 03938 001 Rev 001 page 12 of 15 Table 14 Cytotechnologist Screening Rates Total Average Extrapolated Daily Rates Site CT Review Number of Number of 8 hour workday Methods Slides Hours Low Average High Evaluated Screened Per Day Day Day Day Site 1 Manual 2568 7 4 49 69 94 Imager 2297 6 0 107 153 206 1 1 Manual 1284 T3 49 60 72 Imager 1168 6 1 117 153 182 1 2 Manual 1284 7 3 70 78 94 Imager 1129 5 9 107 154 206 Site 2 Manual 2686 TEN 40 68 80 Imager 2665 7 8 69 109 131 2 1 Manual 1348 7 6 40 71 80 Imager 1309 7 9 97 110 118 2 2 Manual 1338 7 8 55 66 75 Imager 1356 Td 69 109 131 Site 3 Manual 2738 79 20 80 101 Imager 2726 4 5 148 204 320 3 1 Manual 1368 7 9 63 82 91 Imager 1460 4 2 167 230 320 3 2 Manual 1370 7 8 20 78

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