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1. The cell spot is imaged Slide review by the Cytotechnologist 0001234 0000030 01 25 01 12 00 Normal slide ThinPrep 0001234 0000030 01 25 01 12 00 ThinPrep 2 Ae lt Slide INTRODUCTION 1 Prepared ThinPrep slides are loaded into a slide cassette which is loaded into the Imaging Station The slide imaging system scans the entire cell spot The system identifies objects of interest found on the slide The coordinates of 22 objects of interest with the highest integrated optical density will be stored in the computer s database During Autolocate the system presents the 22 selected fields of view in geographic order to the Cytotechnologist Suspect cells may be electronically marked by the CT and a review of the entire cell spot is enforced The slide is physically marked At completion the slide data is updated with the location of any marked areas as well as infor mation on the review session Abnormal slides are reviewed by a cytopathologist for interpretation and diagnosis Figure 1 3 ThinPrep Imaging Process Imager Duo Operator s Manual 1 5 1 6 INTRODUCTION SECTION SPECIMEN PREPARATION AND PROCESSING Specimens for the ThinPrep Pap Test cytology slide are collected by a clinician then immersed and rinsed in a PreservCyt Solution sample vial The sample is then capped labeled and sent to a laboratory equippe
2. 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 148 204 320 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
3. 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 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 w
4. Data Managemert Data Managemert Description gt Database Maintain and backup the database Dx Accourts Add change and retire Review Scope users B Report Generate reports Q System Printer time date and alarm settings N N Data Management Database Backup Archive Restore Archive bias Import EF Export Lock Slides ws Maintenance d User Accounts EB Reports R Logs and History R RS Users Click on this button to R Slide Data Records close the window and R Workload return to the main R Rate Report interface R Run Report asa A l The About button f Lab Settings displays the soft E Page Setup ware version we Printers 8 Security Server Figure 4 11 Data Management Window Database Backup The Backup function enables the operator to make back ups of the database onto a CD DVD a USB drive or the NAS drive local area storage if your sys tem is configured with Hnet The backup media must be on the Server for Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 backup to perform even if you use the IPC Data Management interface to acti vate this function Click on the Backup selection The Backup window will appear Figure 4 12 Data Management Select Media como Ous Backup Type immedste Scheduled Backup Schedule Not Set Target Media CD DVD Status Ready Recent Backups Date Time Meda Type Status
5. 0001234 000030 A ThinPrep processed slide contains the patient accession thinpree D and cell samples gt The sample is processed on a ThinPrep processor using ThinPrep slides for use with the Imager The accession ID is placed The slide is then stained with ThinPrep Stain and cover slipped on the slide ko oee z 1 J ee Tiy f l e 2 Os Y amp O Prepared slides are loaded into The Imaging Station scans The Image Processor The Server stores cassettes which are placed in the the cell spot and sends the Controller analyzes the the slide data records ThinPrep Imaging Station images to the Image Processor images and identifies for later review at the Controller IPC coordinates of Objects Review Scope Of Interest OOls These are sent to the Server At the conclusion of review FR 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 the slide is physically marked 0000030 Case Report saai nite Patient Name to indicate it has been screened ID 0001234 Slides with marked target zo
6. IMAGER DUO MAINTENANCE 5 SECTION CLEANING THE CASSETTE MAPPING SENSOR The cassette mapping sensor is the optical 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 Cassette Mapping Sensor Clean this end Robot Arm 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 Imager Duo Operator s Manual 5 7 5 IMAGER DUO MAINTENANCE This page intentionally left blank 5 8 Imager Duo Operator s Manual Huljooysajqnoly 9 6 Troubleshooting TROUBLESHOOTING 6 Chapter Six Troubleshooting The Image Processor errors sort into two groups Slide Events an
7. Shutdown System Field Service SAM 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 sys tem to warm up and enter idle mode 6 8 Imager Duo Operator s Manual TROUBLESHOOTING 6 SECTION ems 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 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 a Label Area Coverslip Area 7706024 4000253 ThinPrep 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 malfunc tion Mounting media should not over
8. 7 DEFINITIONS AND ABBREVIATIONS This page intentionally left blank 7 4 Imager Duo Operator s Manual UOIEWIOJU 3911S g 8 Service Information SERVICE INFORMATION 8 Chapter Eight 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 and other terms and conditions of sale may be obtained by contacting Customer Service at the numbers listed above Technical Support For questions about ThinPrep Imager Duo 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 Imager Duo supplies and consum able items contact Technical Support Imager Duo Operator s Manual 8 1 8 SERVICE INFORMATION This page intentionally left blank 8 2 Imager Duo Operator s Manual UOI EWOJU H
9. Date Management Connected Review Scopes Database Device Id Connection Time User Accounts 10058103A0 Sep 20 2012 03 02 13 PM E Reports 10250C04A0 Sep 20 2012 03 10 23 PM QA System TO114K03A1 Sep 20 2012 01 33 14 PM amp Lab Settings E Page Setup am Printers amp Security We Service Connected Imagers Device Id Connection Time IP190ZKM1 Sep 20 2012 08 0249AM IPC202xP1 Sep 20 2012 08 12454M Figure 4 90 Server Window System Service The SAM service feature is for use by Hologic Service personnel It is password protected Gather Diagnostics Gather Diagnostics is a function intended for instrument troubleshooting by Hologic Technical Support It gathers and zips the error history logs and other instrument operating information The zip file contents are password protected Put a USB device into one of the USB ports and click the Gather Diagnostics button The system gathers the files and zips them placing the zip folder on a USB drive the user has placed in the USB port Imager Duo Operator s Manual 4 69 4 OPERATION OF THE SOFTWARE MENU Gather Diagnostics Gather Diagnostics Gather Diagnostics Gather Diagnostics Figure 4 91 Gather Diagnostics The instrument information will be gathered into a folder on the USB device titled ImagerDiagnostics zip The files in the folder are password protected The zip file can be e mailed to Hologic Technical Support for diagnostic troubl
10. Figure 4 12 Backup Database Select Media Select what kind of backup media the system will write to by clicking the radio button for that choice In this example it shows that if the system detects more than one USB drive is present a drop down box prompts the operator to select which drive to write to If CD or USB is not present a message will prompt for a device to be loaded If a NAS is not configured in your system the selection will be grayed out as shown here Select Media Ocpipvo Nas usB D STORN GO D STOR N GO E Hologic USB Figure 4 13 Backup Media Selection Backup Type Immediate Immediate backup is an operator initiated backup A backup can be performed while the system is idle or during batch processing It will not run if a scheduled backup is in progress A backup is to store media Imager Duo Operator s Manual 4 9 4 10 OPERATION OF THE SOFTWARE MENU separately from the Server Contact Hologic Technical Support if the internal Server database must be restored as service support will be required Select the type of media to write see above and place it on the Server Click on the Backup button to begin the backup See Figure 4 14 Immediate Backup Type Backup is Immediate Scheduled selected ee es The type of Target Media CD DYD media has been selected Click on Backup button to begin Figure 4 14 Immediate Backup Backup Type Scheduled Scheduled backups are se
11. Note If a large number of data records are selected for Archive Purge this could take a long time Plan to do this when you are not running batches Consider breaking a very large database into batches such as a year at a time Note If some slide data records are to be retained and not purged please refer to Lock Slides on page 4 31 prior to running the Archive function Imager Duo Operator s Manual 4 11 4 OPERATION OF THE SOFTWARE MENU Archive function available on Server Data Management menu Security feature is enabled ata Management Data Management Database B are archive E Export B Lock Slides 4 Maintenance ap User Accounts E Reports System amp Lab Settings E Page Setup mm Printers 3 EA Server we Service Figure 4 16 Archive Function on Server Data Management Menu Click on the Archive icon to launch the dialog window The user Archive slide records before deleting nee whether Select Media to backup rw before archiving cpjovo Omas Ouse Date range is Archive Options chosen 4rchive Delete slide records before date 900 Progress and Status resulting status Ready is shown S Y Figure 4 17 Archive Selection Screen 4 12 Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Use the checkbox to backup the database the selected date range before the purge function begins Select the desired storage media by clicking it
12. OPERATION OF THE SOFTWARE MENU 4 Report Results Detailed Import Preview Export Date Sep 20 2012 10 56 AM Export Lab Hologic PEG Summary Total slides 182 Slides imaged successfully 172 Slides with imaging errors 10 Minimum slide id 00000000009 Maximum slide id 00000009588 Slides 00000000223 00000000585 00000000714 00000000782 00000000969 00000001054 00000001056 00000001060 00000001173 00000001196 00000001319 00000001329 00000001452 00000001515 00000001522 00000001527 00000001602 00000001750 Figure 4 44 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 prepares 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 45 Imager Duo Operator s Manual 4 29 4 4 30 OPERATION OF THE SOFTWARE MENU Select Media C covo C nas isei os EvkeL2 Import Contents Import date E Importing lab Summary Total slides Slides imaged successfully Slides with imaging errors Minimum slide ID Maximum slide ID Import Import CD Contents Export Date Oct 09 2013 10 29 AM Exporting Lab Hologic Total Slides 182 Slides imaged successfully 181 Slides with imaging
13. The Reports menu contains the functions for generating reports from the data base It includes Logs and History RS Users Slide Data Records Workload Rate Report and the Run Report Report Logs and History The Logs and History reports gives the operator access to information pertain ing to system performance The reports may be viewed on screen or printed out Click on the Logs and History selection to open the window Figure 4 50 Data Management Data Management Database d User Accounts E Reports R Logs and History R RS Users R Slide Data Records R workload R Rate Report R Run Report J A System Log Selection Server error log Image Processor error log O Review Scope error log O System usage history Image Processor slide event log Figure 4 50 Logs and History Window 4 36 Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Report Server Error Log The Server Error log lists any error events that the server encountered display ing the most recent at the top of the list and older events following See Figure 4 51 Select the Server Error Log by clicking on the correct radio button and then click on the View button 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 56 Click on the Print button to print out a copy of the report Click on the Save to USB button to save
14. ThinPrep Imager Duo Imaging Station Operator s Manual Thi nPrep HOLOGIC MAN 03133 001 Rev 003 ThinPrep Imager Duo Imaging System Operator s Manual HOLOGIC The Women s Health Company ad 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 03133 001 The ThinPrep Imager Duo Imaging System is a PC based and automated review system for use with ThinPrep cervical cytology sample slides The ThinPrep Imager Duo 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 caused harm to a patient Hologic shall indemnify Customer for the compensatory damages paid by Customer to discharge the personal injury
15. 2012 03 04 PM IP190ZKM1 Sep 17 2012 02 08 PM IP190ZKM1 Sep 17 2012 01 55PM_IP1902KM1 Incomplete IP1902KM1 Sep 16 2012 03 11 PM IP1902KM1 Auto print batch reports Imager name Auto save to NAS Figure 4 4 IP190ZKM1 v C Show reports From all Imagers Run Report Display Select the report to view or print by clicking on it to highlight it and then click ing the View button or by double clicking on the report date A report in the list that reads incomplete for End Time indicates that the batch is either still in progress or failed to complete due to a system error as shown in Figure 4 5 Imager Duo Operator s Manual 4 3 4 OPERATION OF THE SOFTWARE MENU The start and com pletion times of the batch are recorded as is the lab name if enabled The Imag ing Station that the batch was run on is identified by its serial number and Imager name A Batch Summary lists number of slides any errors and num ber of slides ready for review Any System Errors that occurred are listed if no errors this table does not appear ThinPrep Imaging System Run Report Started Sep 20 2012 03 14 56 PM Completed Sep 20 2012 03 51 49 PM Lab Name Hologic TIS S N 20185J04AP Imager IP190ZKM1 Batch Summary Totals Slides System Errors Slide Events Slides Ready for Review 125 1 2 121 System Errors Error Num
16. 5 6 5 7 6 1 6 5 6 9 6 11 6 16 7 1 Chapter Eight SERVICE INFORMATION Chapter Nine ORDERING INFORMATION Chapter Ten REMOTE SITE SERVER USER S GUIDE Index 8 1 9 1 10 1 Imager Duo Operator s Manual iii iv This page intentionally left blank Imager Duo Operator s Manual uononpo u 1 Introduction Aa N INTRODUCTION 1 g Chapter One Introduction SECTION OVERVIEW AND FUNCTION OF THE IMAGER DUO The ThinPrep Imager Duo is a system for imaging and analyzing ThinPrep cervical cytology sample slides Slides that have been processed on a ThinPrep Processor are then stained with ThinPrep Stain and coverslipped The slides are loaded into slide cassettes and placed into the Imaging 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 Controller contains the processors 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 Review Scope The User Inter face is a menu driven graphical display used by the operator for operating the equipment The Imager Duo includes e Imaging Station images the slides Figure 1 1 e Image Processor Controller captures the images and controls the elec tromechanical components of the system e Server stores the slide
17. A maximum of 10 000 records may be exported at one time Refer to Figure 4 30 as an example A range of accession numbers 1 through 500 has been selected Slide Id Filter Enter just the Accession Number Range range 1 500 Slide Id Fi Accession Nurser Range 00123014001 00123014500 Or enter the entire Slide IDs Figure 4 30 Accession Number Range When the range has been entered next use the Slide ID Filter fields to add filter criteria to the range or even to filter just on variables Slide ID Filter Fields The filter fields allow you to select variables that may precede or follow the range of numbers you want Slide Id Filter Accession Number Range Selected range 1 500 field for entering any 8 500 preceding characters field for entering any following characters Figure 4 31 Fields For Entering any Filter Variables For example if a date code YYYY always precedes the accession number and you only want those slide ids in the range corresponding to year 2012 enter 2012 in the preceding box When anything is entered into the filter fields the buttons for single or multiple wild cards become active Imager Duo Operator s Manual 4 21 4 OPERATION OF THE SOFTWARE MENU Slide Id Filter Accession Number Range 1 500 Filter for a date code of 2012 that pre 2012 500 eo aiid _ wid card single 5 _ _Wid card
18. One set connects to the Image Processor Con troller the other set to the Server and they should be located close to each com puter 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 neces sary for slide imaging The Verification Slide is loaded at the time of equipment installation and is not accessible to the operator during batch processing The Image Processor Controller contains the frame imaging processor and con trols the electromechanical functions of the instrument It analyses the imaged slide data and then sends the data to be stored on the Server and to the optional Hnet if your system has one 3 6 Imager Duo Operator s Manual OPERATION OF THE IMAGER DUO 3 The Server stores the slide related data and controls communication of all sys tem services to the other devices on the network It is the master controller when more than one Image Processor is connected to the Server SECTION B SLIDE LABELING The camera that scans the slide label accession ID recognizes 1 dimensional or 2 dimensional barcode format 1 D or 2 D or OCR optical character recogni tion format It cannot
19. 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 Fields on page 4 21 Aborting previously cancelled task Try again The previous import export backup is still in progress Wait a few minutes before attempting an import export backup An error occurred The task may not be complete 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 writable media in the drive on the server There is no media in drive on the server Check that writable media is in a drive of the Server Check that the intended type of media was selected in the Data Management Backup Import Export window Cannot access export directory Unable to access t
20. or click Cancel to cancel the process and return to the Security window Enter password e 1 16 characters Password e alphanumeric e case sensitive New password evees Re enter password to confir Confirm new password OK to accept password Cancel to terminate the process Figure 4 80 Set Security Password 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 62 Imager Duo Operator s Manual If you lose or forget the security password contact Hologic Technical Support OPERATION OF THE SOFTWARE MENU 4 Note The password may be set changed or disabled at the server or any workstation on the network however the server must be turned on to ensure the necessary network communication is active 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 Data Management Database Backup Restore Archives E Import EY Export Ei Lock Slides X Maintenance a Reports R Logs and History R RS Users R Sl
21. persists contact Technical Sup port 4756 Slide has been rejected e See Section C Slide Preparation and Quality 4151 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 Insufficient fine focus operation and Quality 4759 Three 4758 errors within a cas sette generates a 4759 error 5050 Three consecutive 4450 4451 See errors 4450 through 4475 for 4452 errors in any combination details 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 Sys tem e Check that the doors are closed e At User Interface select CON TINUE in the User Assisted Recovery dialog If the problem is resolved continue processing e f the problem is not resolved power cycle the Imaging Sys tem NOTE that the IS and IPC should always be power cycled together See page 3 27 Shut ting Down the System Imager Duo Operator s Manual 6 13 6 TROUBLESHOOTING J 6 14 Table 6 2 Imaging Station and IPC Errors Error Error Text Corrective Action 5096 Fail connection to server e Check switch connections and data bus harness connections e Power Cycle the Imaging Sys tem
22. 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 IMAGER DUO 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 9 SECTION F Load Slide Cassettes into the Imaging Station 3 11 SECTION G Slide Processing 3 15 SECTION H Completing Slide Processing 3 26 SECTION I Shutting Down the Imager Duo 3 27 SECTION J Rebooting the System 3 29 Imager Duo Operator s Manual i So NI Chapter Four OPERATION OF THE SOFTWARE MENU SECTION A SECTION B SECTION C SECTION D SECTION E SECTION F Chapter Five Slide Processing Menu Reports Menu System Menu Data Management Menu Maintenance Menu About Menu IMAGER DUO MAINTENANCE SECTION A SECTION B SECTION C SECTION D Chapter Six Clean Verification Slide Replacing the User Accessible Fuses Replacing the Imaging Station Air Filter Clean the Cassette Mapping Sensor TROUBLESHOOTING SECTION A SECTION B SECTION C SECTION D SECTION E Chapter Seven Slide Events System Errors Slide Preparation and Quality Imaging Station and IPC Errors Data Export Import and Backup Errors DEFINITIONS AND ABBREVIATIONS ii Imager Duo Operator s Manual 4 1 4 2 4 6 4 8 4 71 4 71 5 1 5 3
23. 2 Use the System pull down menu and select Shut Down Follow shut down instructions described in Section I Shutting Down the Image Processor Stat Slide Processing A batch may be interrupted to run a single cassette of Stat slides The operator may resume or terminate the batch after running the stat slides the same way as interrupting a batch The stat slides are placed in a cassette at position 10 One to 25 slides can be run To run a stat slide either click the yellow Stat button or select Run Stat Cassette from the pull down menu Refer to Figure 3 26 3 22 Imager Duo Operator s Manual OPERATION OF THE IMAGER DUO 3 Hologic Inc ThinPrep Imager Duo Slide Processing Reports System Maintenance About Dw Hologic Inc ThinPrep Imager Duo Sea Reports System Maintenance About Start Slide Processing Run Stat Cassette Figure 3 26 Run Stat Cassette Menu Selection The system will prompt for confirmation that the batch is to be interrupted for a stat slide Figure 3 27 ThinPrep Imaging System P Interrupt current batch in progress to run Stat Batch we Note Progress within current cassette will be verified and saved Figure 3 27 Stat Interruption Confirmation Message Click OK to proceed with a stat slide or click Cancel to continue with the batch in progress A message is displayed that the batch is being interrupted The system will always interrupt by saving the cas
24. 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 specificity is a percent of true Non HSIL combined Negative ASCUS AGUS LSIL slides classified in either study arm as Non HSIL
25. 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 interest 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
26. 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 additional 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
27. 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 review 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 work
28. Database import errors 0 Import conflicts 3 Slides Ids With Conflicts gooooo000009 ooo00000203 ooooooooo223 OOOO foo Figure 4 46 Import Results Window To print out the report click the Print button To close the window click the Close button Lock Slides Specific slides and their slide data records can be selected and locked so that they are never purged from the database if the database is archived They can be deselected at a later time if desired The Lock Slides function is a secure function and Security must be enabled From the Data Management window click on the Lock slides icon Figure 4 47 Imager Duo Operator s Manual 4 31 4 OPERATION OF THE SOFTWARE MENU Data Management Data Management Database Backup a Import B Export 8 Locked Slides X Maintenance Slide Id gt User Accounts EA Reports H A System Lock Slide Enter slide ID to lock selec Figure 4 47 Lock Slides Screen Slide IDs must be entered one at a time Click on the Lock button to exempt the slide and its associated data record from being deleted 4 32 Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Lock Slide Enter Slide ID and click Lock button to Enter slide TD to lock prevent slides from being purged 79000002340 peere Locked Slides List of slide IDs that have been locked Slide Id 67210112827 To view the imaging and review status of 67210110823 one o
29. 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 Imager Duo throughout this manual Note Throughout this manual illustrations of the Image Process Controller and the Server are representative The appearance of the actual equip ment may differ from the illustrations Note For sites that perform ThinPrep slide reviews at a location separate from the imaging facility refer to Chapter 10 Remote Site Server User s Guide Imager Duo Operator s Manual 1 1 1 INTRODUCTION BSSSHEEEEHEE 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 Imager Duo Operator s Manual INTRODUCTION 1 ThinPrep Imager Duo System Laboratory Flow Patient Name Patient Name ID 0001234 0001234 A request form and a ThinPrep Vial containing cervical specimen collected from the patient arrive at the laboratory A unique accession number is assigned and attached to each item ThinPrep Processor
30. Management R Logs and History R RS Users R Slide Data Records BETWEEN Figure 4 69 Rate Report Window 4 54 Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Report Results Error Rate Report Report Date Aug 30 2012 11 38 AM Imager name IPHKY KM1 Total Slides Image Errors Error Rate 1086 5 2 17 Figure 4 70 Rate Report To print the report click on the Print button Click on the Save to USB button to save the report to a USB key or the report may be saved to the NAS drive if your system is configured with Hnet To close the report click on the Close button to return to the Workload display 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 MENU on page 4 2 Imager Duo Operator s Manual 4 55 4 OPERATION OF THE SOFTWARE MENU System The System has options for configuring your lab settings page setup for send ing 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 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 a
31. NOTE that the IS and IPC should always be power cycled together See page 3 27 Shut ting Down the System 6615 Slide has been rejected This is a biological event where the sample may contain abundant 6616 Three consecutive 6615 errors clumpy inflammation or bacteria within a cassette generate a 6616 error e See Section C Slide Preparation and Quality 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 imaging station e Be aware of other things slam ming doors high traffic area that may also cause the vibra tions 6628 Slide has been rejected This is a biological event where the sample may be too dense 6629 Three consecutive 6628 errors e See Section C Slide Preparation within a cassette generate a 6629 and Quality error e Manually review the slide 6630 Slide has been rejected If the error persists contact Tech nical Support 6631 Three consecutive 6630 errors within a cassette generate a 6631 error Imager Duo Operator s Manual TROUBLESHOOTING 6 J N I Table 6 2 Imaging Station and IPC Errors Error Error Text Corrective Action 6716 Failed to get a valid batch ID from Power cycle the system If the
32. 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 CA 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 p
33. Technical Support 2 1 8 1 Template export 4 24 Time setting 4 57 Troubleshooting 6 1 U UPS uninterruptable power supply 2 4 3 3 User Accounts 4 34 User Assessment 6 6 User Assisted Recovery 6 7 User Correctable Errors 6 6 UserID 4 35 User Notification 6 5 V Verification Slide 3 6 3 16 5 1 7 3 W Workload Report 4 49 Index 6 Imager Duo Operator s Manual BREAST IMAGING SOLUTIONS e INTERVENTIONAL BREAST SOLUTIONS e BONE HEALTH PRENATAL HEALTH e GYNECOLOGIC HEALTH e MOLECULAR DIAGNOSTICS e LABORATORY SOLUTIONS HOLOGIC Hologic Inc Hologic UK Ltd 250 Campus Drive Link 10 Napier Way Marlborough MA 01752 USA Crawley West Sussex RH10 9 RA UK 1 800 442 9892 44 0 1293 522 080 1 508 263 2900 www hologic com ThinPrep Imager Duo Imaging Station Operator s Manual
34. 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 collection 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 the ThinPrep Stain User s Manual Specimen Handling The ThinPrep slides are stored transported and handled the same as conven tional cytology slides Please refer to your laboratory guidelines for specimen handling SECTION IMAGER DUO TECHNICAL SPECIFICATIONS Overview of Components Refer to figures 1 4 to 1 12 for information regarding components and specifica tions Imager Duo Operator s Manual 1 7 1 INTRODUCTION Imaging Station Housing Sliding Doors Left Door Open Robot Shield Slide Cassette In Position 1 of 10 Positions Cassette Platform Divider Power On Indicator Imaging Station Figure 1 4 Front View Imaging Station 1 8 Imager Duo Operator s Manual Air Filter INTRODUCTION 1 Serial Number 0000000000 0000000000 00000000000 0000000 0000000000
35. 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 Can cel button to continue processing without interruption Imager Duo Operator s Manual OPERATION OF THE IMAGER DUO 3 _ 5 On the display notice that the status of the batch changes to Processing Inter rupted and the GO and STOP buttons in the menu bar are inactive not high lighted Refer to Figure 3 23 Hologic Inc ThinPrep Imager Duo Slide Processing Reports System Maintenance About sia Figure 3 23 Slide Processing Interrupted Note The duration of the interruption cycle is dependent on where in the pro cessing operation components are It may take several minutes or up to 100 minutes to complete an entire cassette for example 6 The Interruption process is complete when the GO button is available again The doors will unlock Refer to Figure 3 24 Hologic Corp ThinPrep Imaging System Slide Processing Reports System Maintenance About Dw Figure 3 24 Slide Interruption Complete 7 When the doors unlock the Imaging Station doors may be safely opened a Complete
36. error the server persists contact Technical Sup port 6901 through Verification slide and focus errors e See Section C Slide Preparation 6936 and Quality e Clean verification slide e f more than one Imaging Station is in the lab insure that the veri fication slides are not switched among Imaging Stations Power Cycle the Imaging Sys tem NOTE that the IS and IPC should always be power cycled together See page 3 27 Shut ting Down the System 6962 Accelerometer fail The imaging station is sensitive to vibrations Look for vibrating equipment such as a vortexer near the imaging station Be aware of other things slam ming doors high traffic area that may also cause the vibra tions 6963 Fiducial Mark failure Clean verification slide Power Cycle the Imaging Sys tem NOTE that the IS and IPC should always be power cycled together See page 3 27 Shut ting Down the System 7001 Light Level Drift Outside of Toler ance Clean verification slide May be temperature related Verify that the instrument is not near a heating or A C duct Power Cycle the Imaging Sys tem NOTE that the IS and IPC should always be power cycled together See page 3 27 Shut ting Down the System Imager Duo Operator s Manual 6 15 TROUBLESHOOTING SECTION DATA EXPORT IMPORT AND BACKUP ERRORS During data export import or backup procedures text messages appear if an
37. is alerted to any malfunction via a message on the user interface If the system does not function or there are persistent errors contact Hologic Techni cal Support refer to Service Information Chapter 8 Imager Duo Operator s Manual INTRODUCTION 1 f SECTION F IMAGER DUO HAZARDS The ThinPrep Imaging System is intended to be operated in the manner speci fied 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 provided 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
38. keyboard mouse printer and a multiport Ethernet hub must be located in the same area so that interconnection cables easily reach To avoid tripping each component within 1 8 meters 6 feet of each other Refer to Figure 10 1 overor Review Scopes connected to the Server may be located up to 100 meters disconnecting 328 feet away or extended another 100 meters using a second hub cabling do not place cabling near foot traffic Up to 328 ft 100 meters SS pA EA E N E Review Scope seo n Switch cae besssseeseesss di Additional Scopes depending on site configuration Server Uninterruptable Battery Backup Monitor Power Supply and 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 10 1 Local Network Interconnection Schematic Example 10 2 Imager Duo Operator s Manual CAUTION Route all connectors carefully to avoid pinching the cables To avoid tripping over or disconnecting cabling do not place cabling near foot traffic ee ene SD a Network Interconnections Printer seve oh fa REMOTE SITE SERVER USER S GUIDE 1 0 NI Extended Network Configuration 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
39. menu and click on System to expand the list of options Clicking on Server will bring up the same window Data Management E Data Management Connected Review Scopes Database Device Id Connection Time User Accounts 1005810340 Sep 20 2012 03 02 13 PM E Reports 10250C04A0 Sep 20 2012 03 10 23 PM Q System 10114K03A1 Sep 20 2012 01 33 14 PM Led Settings Conmacted Imagers Device Id Connection Time IPISOZKM1 Sep 20 2012 08 0249AM IPC202xP1 Sep 20 2012 08 12454M The Refresh button updates the list of connected RSs and IPCs mre Figure 4 10 Server Shut Down Window To continue with shut down click on Shutdown and click Yes when prompted if you are sure Imager Duo Operator s Manual 4 7 4 4 8 SECTION B OPERATION OF THE SOFTWARE MENU DATA MANAGEMENT MENU The Data Management menu contains functions for backing up and maintain ing 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 Management window Figure 4 11 The window appears with all submenu options collapsed Items with a symbol indi cates there is more than one item as a submenu Expanded Data Manage ment Menus NOTE Certain utilities are only available on the Server version Data Management window User Accounts Workload Lock Slides Data Management
40. or placed into storage be sure they are appropriately packaged and labeled Import The Import function enables imaged data to be imported at a remote site from media that was sent from the Imaging site 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 Figure 4 42 Data Management A Side Date Records R Rate Report R Run Report 2 A Sytem Preview button shows Details button displays Import button begins Results button shows the to be imported the range of slide IDs a window with import the Import function results of a completed information and a table Import with slide IDs Figure 4 42 Import Window Place the media containing imaged data into the correct drive of the Server Click on the Preview button to see a brief status of the date date of export name of lab number of slides Refer to Figure 4 43 Imager Duo Operator s Manual 4 27 4 OPERATION OF THE SOFTWARE MENU G EYKEL 2 F Figure 4 43 Import Dialogue 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 44 Click on Print to print a hard copy of this report Click Close to close the win dow and return to the Import screen 4 28 Imager Duo Operator s Manual
41. 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 uniformly 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 averag
42. read both at the same time Prior to running a batch select the label format via the User Interface see Lab settings page 4 56 Note Slide cassettes must not have mixed label formats Refer to Figure 3 8 OCR Imager format must be 14 digits long in two rows 7 digits over 7 digits with the patient ID being 11 digits and a 3 digit CRC at the end The font must be 12 point OCR A Numbers only no alpha characters Note For OCR Imager format 9999 as the last 4 digits before the CRC are reserved for field service use Slide IDs with those reserved numbers are removed from the patient database during a service visit so do not use that sequence Slide Barcode labels may be 1 or 2 dimensional see the table below for any restrictions required Refer to Figure 3 8 Slide labels may be printed and applied or directly printed or etched onto the slide but make sure the contrast is sufficient for the scanner to read the label Table 3 1 Slide Restrictions Based on Barcode Symbology Used 1 D Code 128 All printable ASCII 128 characters are supported The barcode width varies with content Minimum of 5 characters is required and maximum of 8 alphas or 14 digits will fit on a slide Mixing will shorten the max length 1 D Interleaved 2 of 5 Only digits are supported 5 7 9 or 11 characters 1 optional check digit is the format 1 D Code 39 Supported characters are A Z 0 9 space Minimum of 5 characters is
43. 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 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
44. 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 ThinPrep 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
45. 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 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 sit
46. switch Low level industry standard interconnection devices such as bridges repeat ers media converters copper and fiber wiring may be used Refer to Figure 10 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 net work 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 exclusively 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 Review Scope Additional Scopes depending on site configuration Uninterruptable Power Supply and Monitor Battery Backup Keyboard Power Cord Requires an Outlet Ta ea canes at Ean May go on the floor provided there is no dust Table Desk or Lab Bench accumulation on or around it Figure 10 2 Extended Network Interconnection Schematic Example Imager Duo Operator s Manual 10 3 1 0 REMOTE SITE SERVER USER S GUIDE WARNING Grounded Outlet WARNING Grounded Outlet 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
47. that was selected Then the slide data records for the date range are purged Figure 4 23 Status Creating backup Figure 4 23 Archive Delete Function in Process If a large number of data records have been selected for backup purge this function could take a long time If the system encounters an error condition during this process it will attempt to recover and restore data When the archive delete is complete a message box informs the user Data Management A Archived and deleted 1 290 870 slide records in 53 minutes Backup saved to EVTIS_Archive20041009 bak Figure 4 24 Archive Complete Restore Archive Restore Archive allows the user to restore one or more of the archived slide data records to the Imaging System database Imager Duo Operator s Manual 4 15 4 OPERATION OF THE SOFTWARE MENU From a Server Data Management menu enable Security if it is not already acti vated Click on the Restore Archive icon in the menu aa Management Data Management Security Database Current password Backup _ Archive Restore Archive mer Validate Export Lock Slides Maintenance lt P User Accounts E Reports System Lab Settings E Page Setup mm Printers WE Server ve Service Security is enabled Figure 4 25 Restore Archive on Server Data Management Menu 4 16 Imager Duo Operator s Manual Select which storage media the backup located on Select Slide s
48. 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 require 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
49. 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 ref erence the same slide data at a Review Scope Frosted Region of the Sapta OCR accession ID shown in Slide a000253 this example Cell Spot Contains ThinPrep Patient Cells ao N Fiducial Mark Fiducial Mark i cial Mark Slide Figure 3 9 ThinPrep Microscope Slide for Use With the Imager 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 Imager Duo Operator s Manual 3 9 3 OPERATION OF THE IMAGER DUO CAUTION Mounting media must be completely dry before loading slides into the Imaging Station 3 10 CORRECT SLIDE POSITION Empty Slots are OK S __ NES DE A Peer H INCORRECT SLIDE LOADING A PIA fF Multiple Slides d mem fa Cocked Slide Slide Overhangs Retaining Features Y A Slide In Backward Label Toward the Rear Ta Figure 3 10 Loading Slides into the Cassette When loading slides confirm that ThinPrep microscope slides with fiducial marks are being used The fiducial marks should not be scratched or marred The coverslip media is dry wet media could cause equipme
50. 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 Manual 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 w
51. 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 Fig ure 3 35 Hologic Corp ThinPrep Imaging System Slide Processing Reports PAGD Maintenance About EEE Shut Down System Shut Down Server Data Management Figure 3 32 Shut Down System Menu Selection 2 The Data Management Server window displays Figure 3 33 Click the Shutdown button at the bottom Imager Duo Operator s Manual 3 27 3 OPERATION OF THE IMAGER DUO Data Management Connected Review Scopes Device Id Connection Time Figure 3 33 Server Shut Down Button 3 Select Yes to continue with shut down Figure 3 36 ThinPrep Imaging System 4re you sure you want to shut down the system Figure 3 34 Confirm Shut Down Image Processor 1 To power off the Image Processor at the user interface use the mouse to ull down the menu under System and click once on Shut Down System Refer to Figure 3 35 Hologic Corp ThinPrep Imaging System Slide Processing Reports AGD Maintenance About Shut Down System Shut Down Server Data Management Figure 3 35 Shut Down System Menu Selection 3 28 Imager Duo Operator s Manual CAUTION Be sure to shut down the Imager Duo before the UPS backup power runs out OPERATION OF THE IMAGER
52. which indicates its presence and position to the Imaging System During batch processing the sys tem 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 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 pro cess is interrupted 1 Interrupt 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 red STOP button and click once Figure 3 36 Hologic Inc ThinPrep Imager Duo Slide Processing Reports System Maintenance About ow CET Figure 3 20 Slide Processing Stop Button OR b At the top of the menu bar select Slide Processing and then in the drop down menu click once on Interrupt Slide Processing Figure 3 21 Hologic Corp ThinPrep Imaging System SeA Reports System Maintenance About Interrupt Slide Processing Run Stat Cassette 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 Imager Duo Operator s Manual 3 19 3 3 20 OPERATION OF THE IMAGER DUO I
53. 00 0000000000 0000000000 00000000000 000000000000 09900000090 oy ie 02090 999 G G B G 9 9 00 o 000 o o o0 Fuses inside ee B On Off Switch mean 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 Imager Duo Operator s Manual 1 9 1 INTRODUCTION OCR Station Hold Station Verification Slide Station Slide Transfer Robot at the Park Station with a Slide Robot Shield Removed Imaging Stage Figure 1 7 Park Station and Imaging Stage 0123456 770b024 7890049 Frosted region of 8000253 Slide Accession ID the slide L_ OCR format shown 03249 003 ThinPrep ThinPrep Z o Cell Spot con y Cas tains patient cells Fiducial Mark Fiducial Mark o a k A Fiducial Mark Slide Slide Verification Slide ThinPrep Microscope Slide Figure 1 8 Slides Used in the System 1 10 Imager Duo Operator s Manual INTRODUCTION 1 Imaging Station Dimensions 25 63 5 cm Approximate Weight 170 Ibs 77 kg Figure 1 9 Imaging Station shown wi
54. 087 08392879902569 76536223678 587563873 83668809234556 79000151115002 78234766393214 76823451545675 76754688909000 3303 3 98745239678698 12454608665446 69856432679965 08386787390938 4 83805969999060 00425856784356 01974353065673 2407 5 10019939999083 10013245684322 17685463235667 94355668345214 entry ncdioates E p TOPPA SISA Serera SSR LLL 958575786762 74594612235 a slide failed 7 83668729999235 54894208423084 76784563345346 3478 3310 4450 8 74007569999002 65743566788989 78546231000566 67546657881114 96467345767677 9 79000351135022 00496865785877 74567980867656 45667879434567 Figure 4 5 Figure 4 6 Run Report continued Auto Print Run Report This function if selected will automatically print the Run Report at the conclu sion of a batch See Figure 4 4 Imager Duo Operator s Manual 4 5 4 4 6 OPERATION OF THE SOFTWARE MENU SYSTEM MENU Cc The System Menu contains options for shutting down the Image Processor sys tem and Server Data Management submenu contains the database backup function reporting function and system setup and shut down capabilities Refer to Figure 4 7 Hologic Corp ThinPrep Imaging System Slide Processing Reports AGD Maintenance About TOP starr Shut Down System Shut Down Server Data Management Figure 4 7 System Menu Shut Down Sy
55. 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 Associated 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 m
56. 3457721000 67210112827 67210116623 67210113045 70520746931 09459746345 69743673469 30494657046 97452235466 69425123456 12565768326 12456795346 95645313556 23470231577 94656255765 23457432706 23504688621 34567533000 76543567674 34586985322 24656773886 24359431111 al noe Cancel Figure 4 28 Slide ID List Select Slide to be Restored Export The Export function enables the operator to filter the database and export the selected data onto media located on the Server The data may be saved to a DVD CD USB drive or to the NAS drive if your system is configured with Hnet The media 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 com puter but the writable media must be in the Server in order to perform the command Imager Duo Operator s Manual 4 19 4 Accession Number Range Field Slide ID Filter to Sort for Specific Charac ters Lab ID Codes Date etc Checkbox to Expor all data since the last export Checkbox to view data before export Checkbox to auto print export log Checkbox to have the Slide IDs included on the export log 4 20 OPERATION OF THE SOFTWARE MENU Click on the Export icon to display the window Figure 4 29 Data Management Select
57. 4 19 exportlog 4 25 Export template 4 24 extended network 2 3 10 3 F fiducial marks 3 9 7 1 Fuses 5 3 G Gather Diagnostics 4 69 GO button 3 15 3 21 3 22 41 67 Index 2 Imager Duo Operator s Manual l Image Processor 7 2 Image Processor Controller 3 6 7 2 Imager Name setting 4 58 Imaging Station 3 6 Imaging Station and IPC Errors 6 11 Imaging System Usage History 4 41 Import data 4 27 Install Printers 4 60 Installation 2 1 Interrupt Slide Processing 3 18 3 19 Items Required For Slide Image Processing L Lab Settings 4 56 Loading Slide Cassettes 3 9 local network 2 2 10 2 lock slides 4 31 Logs and History Reports 4 36 M MAINTENANCE MENU 4 71 Maintenance Data Management menu 4 33 menu bar 4 1 Monitor Keyboard and Mouse 3 6 O OCR 7 2 OCR read failed 6 3 Ordering Information 9 1 3 6 INDEX Imager Duo Operator s Manual Index 3 INDEX 4 Page Setup 4 58 Password 4 61 change 4 67 disable 4 68 enable 4 62 validate 4 65 Power on equipment 3 3 Power Specifications 1 13 Printers 4 59 Processing Completed 3 26 Processing Interrupted 3 21 Protective Temperature Coefficient Devices 1 14 R Rate report 4 53 Rebooting the System 3 29 Remote site 10 1 Replace Clean Verification Slide 5 1 Replacing Fuses 5 3 Report Limit 4 58 Reports Data Management menu 4 36 REPORTS MENU 4 2 restore archive 4 15 Resume Slide Processing After Interruption 3 22 R
58. 5000 refer to System Lab Settings on page 4 56 Imager Duo Operator s Manual 4 45 4 OPERATION OF THE SOFTWARE MENU 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 60 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 specify or for all dates Slide Image Slide Image Slide Image Image status Image status Image status ALL v ALL v ALL v ALL ERROR SUCCESS Imager name Imager name IP1902KM1 v IP1902KM1 v Image date Image date Image date ALL v ALL v ALL vi 4 46 Pull down menu to select Image status as a parameter All lists all slide data records Error lists slides not imaged due to error Success lists slides imaged successfully Imager Duo Operator s Manual Pull down menu to select Imager name Pull down menu to select dat
59. 82 Slides imaged successfully 172 Slides imaging errors 10 Minimum slide id 00000000009 Maximum slide id 00000009588 Slides 00000000009 00000000203 00000000223 00000000282 00000000349 00000000498 00000000585 00000000714 00000000782 00000000801 00000000935 00000000968 00000000969 00000000970 00000000973 00000001071 00000001142 00000001148 00000001176 00000001185 00000001208 00000001503 Figure 4 41 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 The operator selects the type of media to write to CD DVD USB drive or a NAS drive if your system is configured with Hnet If media is not already inserted in the Server computer you will be prompted for it As listed on the Export window the system checks the media prepares the data writes the data to the media verifies it and shows a completed progress bar when finished There will be a check mark next to each action as it successfully completes Other Data Export Considerations Labeling of writable media to easily identify the contents of a CD DVD or USB key follow your facility s naming and labeling conventions for the storage of data Imager Duo Operator s Manual Select the type of media Import function icon OPERATION OF THE SOFTWARE MENU 4 Transport of patient slides if slides are to be transported
60. Change the export filter parameters to result in less than 10 000 records being exported The media is not blank The DVD CD or USB in the writ able drive on the server is not blank Place a blank writable storage media in the Server drive The media is not ready Be sure there is a DVD CD or USB in the drive on the server The storage media drive is not ready The writable media is not ready to be read yet Try the function again The disk drive may be open 6 18 Imager Duo Operator s Manual TROUBLESHOOTING 6 Table 6 3 Data Export Import and Backup Errors Error Text Possible Cause Corrective Action The media is not writable The DVD CD or USB in the drive on the server is not writable and it must be writable The storage media must be writable Try using a different DVD CD or USB 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 function again Unable to preview the import data The storage media could not be read Make sure the import media is readable Try the function again Imager Duo Operator s Manual 6 19 6 TROUBLESHOOTING This page intentionally left blank 6 20 Imager Duo Operator s Manual SUOIEIADIQGY pue suoluyeg 2 7 Definitions and Abbreviations DEFINITIONS AND ABBREVIA
61. DUO 3 2 Select Yes to continue with shut down Figure 3 36 ThinPrep Imaging System 2 j Are you sure you want to shut down the system Figure 3 36 Confirm Shut Down 3 The application quits and then Windows shuts down and the Image Pro cess Controller and monitor turn off Imaging Station 4 At the rear of the Imaging Station position the Power rocker switch to OFF Shut Down Due to Power Outage If a power outage condition occurs the Uninterruptable Power Supply UPS issues an audible alarm when providing backup power There will be approxi mately 30 minutes of power provided Follow the instructions for shutting down the Imager Duo in the previous section Turn off the UPS when the instru ment has been safely turned off Taking the Instrument Out of Service Extended Shut Down If the Imager Duo is to be shut down for an extended time follow the shut down instructions for Shutting Down the Image Processor page 3 27 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 Proces sor Controller and the Server SECTION J REBOOTING THE SYSTEM If the Imager Duo is being rebooted for any reason 1 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 Imager Duo O
62. Data Records R Workload R Rate Report R Run Report a A System The pull down list has the same modifier options Figure 4 57 Report Operators Window Select which parameter you would like to have the database query lab name 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 2 e Contains means a list that has a particular string of characters that is typed in for instance all entries with mar in them Imager Duo Operator s Manual 4 43 4 4 44 OPERATION OF THE SOFTWARE MENU 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 Click on the View button to view the report see Figure 4 58 Report Results Review Scope Users Report Date Aug 30 2012 11 36 AM Matches found 10 Sort order User Id Lab name Hologic PEG Lab name Hologic PEG Hologic PEG Hologic PEG Hologic PEG Hologic PEG Hologic PEG Hologic PEG Hologic PEG Hologic PEG Hologic PEG User Id 101 103 129 333 336 401 406 412 424 465 Last Name Smith Jones Brown Green Hill Swan Cook James Bradley West First Name Anne Mary John Paula Lawrence Carol Bill Ted Beth Eve Status Active Active Active
63. Date opopooo0o00 11 1 2004 9 29 39 AM Last p 27870118357 10 8 2007 11 59 41 PM Figure 4 20 Archive Summary Report The report tallies how many slide data records were found in the date range The report may be saved or printed Click Close to return to the Archive win dow To proceed with the Archive function click on the Go button If the backup checkbox was not selected a message prompts the user to confirm that no backup was desired Click Yes to proceed or No to go back to the Archive menu Data Management A Warning Proceeding will result in slide data being deleted Be sure you have collected all statistics that you will need For this data Would you like to continue with the archive delete operation Figure 4 21 Confirm Database Records Deletion Message If the date range that was selected includes data records that are less than five years old a message will prompt the user to confirm that Archive Delete is OK Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Data Management A Warning The date range you specified is less than 5 years before today Would you like to proceed with the archive delete anyway Figure 4 22 Confirm Database Records Deletion Message 2 The system proceeds to create a temporary backup of the purge database in case the archive function fails it attempts to recover and restore data At the same time a backup is created to the desired storage media if
64. EMOTE SITE SERVER USER S GUIDE 1 0 SNA Chapter Ten WARNING Service Installation Only Remote Site Server User s Guide Some facilities screen ThinPrep slides on Review Scopes in a location that is remote from or independent 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 Uninterruptable Power Supply interconnection hub s and a Review Scope Refer to the ThinPrep Imaging System Review Scope Operator s Manual for opera tion maintenance and troubleshooting of Review Scopes This chapter provides a getting started overview for remote sites using a Server INSTRUMENT DESCRIPTION Refer to Chapter 1 Introduction for a complete description of the ThinPrep Imaging System technical specifications and warnings INSTALLATION Refer to Chapter 2 Imager Duo System Installation for information regarding delivery unpacking storage and handling Imager Duo Operator s Manual 10 1 1 0 REMOTE SITE SERVER USER S GUIDE NA CAUTION Network Configuration Route all connectors carefully to avoid pinching the cables The Server monitor
65. Fuse Waste Electrical and Electronic Equipment contact Hologic for disposal of the instrument bl Oe Figure 1 14 Symbols Used on This Instrument Imager Duo Operator s Manual 1 17 J a A INTRODUCTION Location of Labels Used on the Instrument IPC Rear Server Rear Imaging Station Rear Grounded Outlet Grounded Outlet Grounded Outlet Serial Number Model Rating External Connections Fusing Figure 1 15 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 Imager Duo Maintenance chapter for instructions on replacing user accessible fuses Refer to Ordering Information for fuse specification and ordering 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 grounded outlet WARNING Glass The instrument uses microscope slide
66. HE SOFTWARE MENU When a password has been validated access to restricted data is restored and a lock icon appears in the lower right to indicate administra tive access is applied Data Management Data Management Data Management Description Database Database Maintain and backup the database Backup d User Accounts Add change and retire Review Scope users E Import E Reports Generate reports E Export System Printer time date and alarm settings Lock Slides Maintenance gt User Accounts amp a Reports R Logs and History R Workload R Rate Report R Run Report System amp Lab Settings E Page Setup wm Printers amp Security SK Server X Service Figure 4 85 Administrative Access Mode Administrative work can be done in any area of the Data Management pro gram 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 66 Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Change The Change button is used to change the password Once the current pass word has been validated click on the Change button to enter a new password Figure 4 86 Click on the Change button to change the password Figure 4 86 Change Password The password box will appear Enter a new password and click OK when done Password New password Confirm new pa
67. Jul 06 2012 09 46AM 20188J04A4P 7 0 10 Figure 4 54 Review Scope 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 56 Click on the Print button to print the report Click on the Save to USB button to save the report to a USB key or the report may be saved the NAS drive if your system is configured with Hnet Click on the Close button to return to the Logs Selection menu 4 40 Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Report ThinPrep Imaging System Usage History This report displays the usage history of the Review Scopes and Image Proces sors connected to a network The Review Scopes are listed by their serial num bers the Image Processors are listed by their System IDs The report is a tally of all slides processed to date See Figure 4 55 Report Results ThinPrep Imaging System Usage History Report Date Aug 30 2012 09 53 AM Matches found Review Scope 5 Image Processor 3 Review Scope System Id Total Count 10033A403C2 54314 10067 103C2 77759 10077J03C1 73017 10152L03A0 9814 10153L03A0 14685 Image Processor System Id Success Count Total Count 20185J04A4P 143 160 20692K12A1 654 680 21285 J04A1 9494 9464 v Figure 4 55 System Usage History Report Click on the Print butto
68. 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 Imager Duo Operator s Manual TROUBLESHOOTING 6 J 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 Log Error Message Possible Cause Corrective Action OCR read failed Wrong kind of slide or slide label Wrong accession ID format Slide ID misprint Slide not loaded in cassette correctly e Confirm that a ThinPrep micro scope slide is being used e Check the condition of the label and that the correct 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 45 Confirm if the ID is unique lf there is a duplicate reconcile both patient records relabel one and reproces
69. Media gt cowo Side Id Fiter Accession Number Range Expert Options Z Export only sides not already exported E Confirm export before writing data _ Auko print export log Use deta ed export log Export begins the data export function Log displays the results of the completed export Save to create tem plates for frequently used Slide ID Filters Figure 4 29 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 combina tion of these methods A Note on Slide IDs Refer to slide labeling types and restrictions on page 3 7 Depending on how your laboratory generates accession numbers how long they are and the symbology format used OCR 1 D 2 D the accession num ber is often preceded or followed by fixed characters for example a date or a Lab ID code or by zeros These fixed and sequential numbers can be used for filtering the database for exporting data OCR format only supports numeric characters but the barcodes support alpha numeric as well as special characters Imager Duo Operator s Manual N OPERATION OF THE SOFTWARE MENU 4 Accession Number Range To export a range of accession numbers enter the beginning and ending acces sion numbers into the Accession Number Range field The entire Slide ID num ber of the first slide and the last slide may also be entered
70. Replace the verification slide into slot 1 of the cassette and install the cassette onto the loading platform 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 display screen Wait while the slide is returned to the verification slide station Figure 5 4 Working 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 REPLACING THE USER ACCESSIBLE FUSES There are two user accessible fuses located in the Imaging Station refer to Fig ure 1 5 If the fuses must be replaced follow these steps 1 Turn off the instrument 2 Remove the power cord from the uninterruptable 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 Imager Duo Operator s Manual 5 3 5 IMAGER DUO 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 lt Fuse Holder Figure 5 6 Remove the Fuse Holder 7 Remove the existing fuses and discard them 8 Insert two new
71. Retired Retired Active Active Retired Active Active vv Figure 4 58 Operators Report Click on Print to print the report Click on the Save to USB button to save the report to a USB key or the report may be saved the NAS drive if your system is configured with Hnet Click on Close to close the report and return to the main menu Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 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 Management menu to open the window Figure 4 59 Data Management Data Management Slide Id i Database Qualifier Slide Id q User Accounts ALL v B A 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 Rate Report Imager name Review Scope serial number R Run Report IP190ZKM1 H A System Image date Review date ALL Review Scope User Lab name User Id s Figure 4 59 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 qualifi ers The report will display as many lines of data as selected in the report limit set ting 500 to
72. Smith Anne 101 Full Review Hologic PEG Lab 67210116623 Sep 21 2012 8 39 AM Smith Anne 101 Full Review Hologic PEG Lab 67210113045 Sep 21 2012 9 00 AM Smith Anne 101 Full Review Hologic PEG Lab 67210112243 Sep 21 2012 10 34 AM Smith Anne 101 Full Review Hologic PEG Lab 67210115525 Sep 21 2012 10 40 AM Smith Anne 101 Full Review Hologic PEG Lab 67210113759 Sep 21 2012 10 44 AM Smith Anne 101 Full Review Hologic PEG Lab 67210113758 Sep 21 2012 10 51 AM Smith Anne 101 Full Review Hologic PEG Lab 67210113761 Sep 21 2012 10 58 AM Smith Anne 101 Full Review Hologic PEG Lab 67210115590 Sep 21 2012 11 05 AM Smith Anne 101 Full Review Hologic PEG Lab 67210115589 Sep 21 2012 11 11 AM Smith Anne 101 Full Review Hologic PEG Lab 67210113757 Sep 21 2012 11 20 AM Smith Anne 101 Full Review Hologic PEG Lab 67210113756 Sep 21 2012 11 49 AM Smith Anne 101 Full Review Hologic PEG Lab i 67210115222 Sep 21 2012 11 59 AM Smith Anne 101 Full Review Hologic PEG Lat Rate Report v Save to USB Print l Close Figure 4 68 CT Reviews Report The rate report takes the total number of errors imaging and system against the total number of slides imaged and calculates the percentage of errors The operator selects which Imager and then a date range and clicks on the View but ton to see the report See Figure 4 69 Imager Duo Operator s Manual 4 53 4 OPERATION OF THE SOFTWARE MENU Data Management lt b Data
73. Stat Cassette Figure 4 2 Slide Processing Menu Imager Duo Operator s Manual 4 1 4 4 2 OPERATION OF THE SOFTWARE MENU SECTION B REPORTS MENU The Reports menu contains functions that generate reports for specific compo nents of the ThinPrep Imaging System Hologic Inc ThinPrep Imager Duo Slide Processing Wee System Maintenance About y Run Report D wee Figure 4 3 Reports Menu Run Report The Run Report generates the results from a processed batch Up to 250 reports may be viewed from the report window in Data Management They are 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 printing 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 Imager Duo Operator s Manual Data Management Data Management H Database User Accounts a Reports R Logs and History R RS Users R Slide Data Records R workload R Rate Report R EE H A System OPERATION OF THE SOFTWARE MENU 4 Reports Start Time Sep 20 2012 03 14 PM Sep 20 2012 03 08 PM Sep 20 2012 02 59 PM Sep 17 2012 02 04 PM Sep 17 2012 01 50 PM Sep 16 2012 04 20 PM Sep 16 2012 08 13 AM End Time Imager Sep 20 2012 03 31 PM IP190ZKM1 Sep 20 2012 03 11 PM IP190ZKM1 Sep 20
74. TIONS 7 J Chapter Seven Batch Cassette Cassette Status Cell Spot Fiducial Marks Definitions and Abbreviations 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 The container that holds slides for batch processing Each cassette may hold up to 25 slides The cassettes have a footprint designed to hold them securely in the Image Processor during slide processing There are locations for 10 cassettes to be loaded into the Image Processor Not Present No cassette present in the slot on the loading platform Unknown Unknown with respect to their completion status may occur as the result of an unexpected 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 The area within the pre printed arcs on a ThinPrep microscope slide that con tains the patient sample cells Permanently printed features on the ThinPrep microscope slide and the Verifi cation slide used as a reference axis to establish the X Y coordinates of Objects Of Interest and Fields Of Interest The f
75. a verification slide is damaged please contact Hologic Technical Support Imager Duo Maintenance SECTION a CLEAN VERIFICATION SLIDE The verification slide should be cleaned and inspected yearly or if 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 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 Processor 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 Hologic Corp ThinPrep Imaging System Slide Processing Reports System MRTG About amp TOP STAY Clean Yerification Slide Service Figure 5 1 Maintenance Menu The following screen is displayed prompting for an empty slide cassette to be placed in an unoccupied 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 Imager Duo Oper
76. age Processor Controller 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 Imager Duo Operator s Manual 3 3 3 OPERATION OF THE IMAGER DUO 3 At the Server push on the power button See Figure 3 3 Power On Button Note depending on which model computer you have it may look different than this graphic 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 I 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 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 3 4 Imager Duo Operator s Manual OPERATION OF THE IMAGER DUO 3 5 At the Image Processor Controller push the power on button Figure 3 5 Power On Button O Note depe
77. already imaged Sep 20 2012 3 17PM 7 0 11 3303 Slide ID Read Failed Sep 20 2012 3 16PM 7 0 11 3303 Slide ID Read Failed Sep 20 2012 3 11PM 7 0 11 3303 Slide ID Read Failed Sep 20 2012 3 09PM 7 0 11 3303 Slide ID Read Failed Sep 20 2012 3 04PM 7 0 11 3303 Slide ID Read Failed Sep 20 2012 3 03PM 7 0 11 3303 Slide ID Read Failed Sep 20 2012 3 02PM 7 0 11 3303 Slide ID Read Failed Sep 20 2012 3 01PM 7 0 11 3303 Slide ID Read Failed Slide ID DateTime SW Version Error Number Description cid FE Oo 2 3 4 5 6 7 8 3 e a N 0 NM wlol em oy ole uw a Figure 4 56 Slide Processing Events Window Click on the Print button to print the report Click on the Save to USB button to save the report to a USB key or the report may be saved the NAS drive if your system is configured with Hnet Click on the Close button to return to the Logs Selection menu 4 42 Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 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 57 Data Management Data Management a Database User Accounts GB Reports R Logs and History n R Side
78. anel 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 ASCUS 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
79. as required The report does not include manual reviews See Figure 4 66 The sort parameters are for which laboratory if more than one are in the data base date range and time interval 4 50 Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Report Results CT Workload Summary Report Date Sep 21 2012 09 04 AM This report does not include manual reviews FOV Only Full Review Smith Anne 101 50 40 Hologic PEG Lab Jones Mary 103 70 19 Hologic PEG Lab Brown John 129 18 12 Hologic PE Lab Green Paula 333 70 25 Hologic PEG Lab Hill Lawrence 336 Hologic PEG Lab Swan Carol 401 Hologic PEG Lab Cook Bill 406 Hologic PEG Lab James Ted 412 Hologic PEG Lab Figure 4 66 CT Workload Summary Report To print the report click on the Print button Click on the Save to USB button to save the report to a USB key or the report may be saved to the NAS drive if your system is configured with Hnet 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 Oper ator 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 67 Imager Duo Operator s Manual 4 51 4 OPERATION OF THE SOFTWARE MENU Report Results CT Workload History Report Date Aug 30 2012 09 52 AM This report does n
80. at 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 Slide Imaging Complete In Process Not Started 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 avail able 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 The Event Log lists unprocessed slides in sequence as they occur Each listing contains the Imager Duo Operator s Manual OPERATION OF THE IMAGER DUO 3 event description event number cassette number slot number date time and Slide ID if known 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 a
81. ator s Manual 5 1 5 IMAGER DUO MAINTENANCE CAUTION Do not place the empty cassette into an empty slot until directed to do so by the system Please place an empty cassette in an available slot then press Retrieve The verification slide will Clean Verification Slide be placed in slot 1 of the empty cassette Retrieve Cancel Working 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 5 2 Imager Duo Operator s Manual CAUTION The verification slide is very delicate Only hancle it by the edges Keep it clean and dust free at all times WARNING Instrument Fusing Only replace with fuses of the specified type and current rating Refer to the Ordering Information for ordering fuses IMAGER DUO MAINTENANCE 5 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 dam aged in any way
82. ber Description Date Time 3106 SlideNotFound Sep 20 2012 03 20 20 PM Slide Events CAssette Slot Slide ID Event Number Description of Event Date Time 5 2 N A 3303 Slide ID Read Failed Sep 20 2012 03 39 20 PI 5 4 83668809999025 2407 Slide Cannot Be Imaged Sep 20 2012 03 42 14 PN 5 7 74046379982 3310 Info Slide reimaged Imaging error slide _ Sep 20 2012 03 43 20 PD replaced in database previous error archived 5 7 eTA 4450 Slide cannot be imaged Sep 20 2012 03 43 50 PI Example of a slide that failed imaging once and that data was archived The slide was rerun in this batch and failed again Any Slide Processing Events encountered in the batch are listed with a brief description If no errors this table does not appear Figure 4 5 Run Report 4 4 Imager Duo Operator s Manual Slides that are ready for review are listed by slot position and cassette num ber Any slide events show the error number in bold at the slide position it occurred A blank space indicates a slide was not present in the cassette Double error imaging in two batches see OPERATION OF THE SOFTWARE MENU 4 ThinPrepo Imaging System Run Report Started Sep 20 2012 03 14 56 PM Completed Sep 20 2012 03 51 49 PM Lab Name Hologic TIS S N 20185J04AP Imager IP190ZKM1 Slides Ready for Review Scope Cassettes 1 5 Slide ID Slot Cassette 1 Casse Cassette 3 Cassette 4 Cassette 5 1 83668809999
83. chive Imaging Error slide in the data base Power cycle the system If the error persists contact Technical Sup port 3471 Slide Found in Slide Path e System will instruct the user to place 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 cassette e f there is no slide in the cas sette it means the verification slide was on the stage 3476 System Error Error during Slide Reader Camera initialization Power cycle the system If the error persists contact Technical Sup port 3477 System Error Timeout during Slide Reader Camera initialization Power cycle the system If the error persists contact Technical Sup port 4450 through 4475 Slide has been rejected Fiducial Mark error See Section C Slide Preparation and Quality 4618 Slide Error The camera malfunc tioned when capturing a frame on this slide Power cycle the system If the error persists contact Technical Sup port 6 12 Imager Duo Operator s Manual TROUBLESHOOTING Table 6 2 Imaging Station and IPC Errors Error Error Text Corrective Action 4619 System Error Consecutive black Power cycle the system If the error frames detected multiple slides
84. 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 demonstrate 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 Imagi
85. creen is dis played Refer to Figure 10 4 The printer and Review Scopes may be powered on before or after the Server No network communication can be made until the Server is fully booted up HOLOGIC The Women s Health Company Fle F Tar e Jan lal med cole LE LLA Copyright 1999 2012 Hologic Inc All rights reserved ThinPrep Imager Duo 3 4 0 Figure 10 4 Server Data Management Program Display Imager Duo Operator s Manual 10 5 1 0 REMOTE SITE SERVER USER S GUIDE Click on the Data Management Program link to access the Data Management menu options Data Management va Data Management Data Management Description Database Database Maintain and backup the database Backup A Reports Generate reports E Import System Printer time date and alarm settings E Export X Maintenance o H Reports R Logs and History R RS Users R Slide Data Records R Rate Report R Run Report system amp Lab Settings E Page Setup a Printers amp Security XE Server Figure 10 5 Data Management Window Refer to Chapter 4 Section D DATA MANAGEMENT MENU 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 system via th
86. d System Errors SECTION Maa SLIDE EVENTS During batch processing slide events are logged in a file and displayed on the user interface in the Slide Processing Event Log window See Slide Processing Event Log page 3 16 The event text message is in red followed by the event number cassette number slot number date time and slide ID if known Fig ure 6 1 Imager Duo Operator s Manual 6 1 6 6 2 TROUBLESHOOTING Event Number 3 Cassette Number 2 Slot Number 4 September 20 2012 03 03 13 PM Slide ID Event Number 2 Cassette Number 1 Slot Number 2 September 20 2012 03 02 01 PM Slide ID Event Number 1 Cassette Number 1 Slot Number 1 September 20 2012 03 01 16 PM Slide ID Figure 6 1 Event Log Display Slide events indicate some condition of the slide that makes the imaging pro cess 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 Ifa 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 Processing Event Log visible during instrument idle mode is that of the last batch run Beginning a new batch will start a new Event
87. d at that location to import data from an imaging site The Cytotechnologist CT reviews slides at the Review Scope RS The RS con sists of elements of a standard microscope augmented with automated capabil ities for viewing and marking the microscope slides The RS contains a 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 deter mined 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 com pletion 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 pre sented Before completing the review the CT may revisit any locations and electronically mark or unmark target zones as desired At the conclusion of electronically marking the slide physical marks are applied at those locations with semi per manent translucent marker Imager Duo Operator s Manual
88. d away from the Image Processor is determined by the requirements of the specific apparatus used to foot traffic 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 exclusively for the Imaging System network No other company networks sub networks or devices may be connected to the network Up to 328 ft l 100 meters l Network Interconnections _ Scope i Review f Scope Printer k LEL ta ok Additional Scopes l depending on site configuration Uninterruptable 4 Power Supply Keyboard and Battery Backup l Monitor i Power Cord Requires an Outlet oe May go on the floor provided there Table Desk or Lab Bench is no dust accumulation on or around it 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 Imager Duo Operator s Manual 2 3 2 IMAGER DUO SYSTEM INSTALLATION 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 ot
89. d cassettes may be removed and replaced with unprocessed slide cassettes or the slots may be left empty CAUTION b If uncompleted slide cassettes are removed they must be reimaged at Do not remove another time to be considered complete The system will start with the next partially processed unprocessed cassette it comes to when operation is resumed cassettes If they are removed all the slides in the cassette must be rerun c If the system is to be shut down remove the slide cassettes Run unprocessed cassettes in a later batch Imager Duo Operator s Manual 3 21 NA OPERATION OF THE IMAGER DUO 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 pro cessing menu and click on Start Slide Processing 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 Hologic Corp ThinPrep Imaging System Slide Processing Reports System Maintenance About Dw 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 unpro cessed cassettes in a later batch Partially processed cassettes are considered unprocessed and must be run in a later batch
90. d 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 JqLL Table of Contents Table of Contents Chapter One INTRODUCTION SECTION A Overview and Function of the Imager Duo 1 1 SECTION B The ThinPrep Imaging System Process 1 4 SECTION C Specimen Preparation and Processing 1 6 SECTION D Imager Duo Technical Specifications 1 7 SECTION E Internal Quality Control 1 16 SECTION F Imager Duo Hazards 1 17 SECTION G Disposal 1 19 Chapter Two IMAGER DUO INSTALLATION SECTION A General 2
91. d with a ThinPrep Pro cessor After being processed the slides are stained with ThinPrep Stain and coverslipped Please refer to the Operator s Manuals of these instruments for more informa tion regarding preparation and processing of ThinPrep slides Please refer to the ThinPrep Stain User s Manual for information regarding use of the stain and recommendations for coverslipping 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 malfunc tion 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 causing broken slides or instrument malfunction e The slide is appropriately labeled for use with the ThinPrep Imaging System refer to Chapter 3 Slide Labeling page 3 7 Imager Duo Operator s Manual INTRODUCTION 1 Specimen Integrity PreservCyt Solution with cytologic sample intended for ThinPrep Pap testing must be stored between 15 C 59 F and 30 C 86 F and tested within 6 weeks of collection Slides processed by
92. dded to the Export menu Try to add a template again Be sure it has a unique name Failed to write to the media The media type failed to write properly Try again with a different DVD CD or USB depending on what type of media was used Make sure the storage media is in the Server drive Failed to delete the template The template could not be deleted It may have already been deleted by another user Failed to modify the template A template could not be modi fied The template has been deleted It must be rec reated 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 Slidelmage table An error occurred during data import Contact Technical Support Import cannot be performed from the media The storage media in the server s drive does not have export data on it The storage media 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 storage media is readable Imager Duo Operator s Manual 6 17 TROUBLESHOOTING Table 6 3 Data Export Import and Backup Errors Error Text Possible Cause Corrective Action Incorrect FO Count An erro
93. de was prop erly loaded in the cassette with 3107 Three consecutive 3106 errors label facing outward and only within a cassette generate a one slide per slot 3107 e If slide was loaded correctly see 3111 Slot has multiple slides Section C Slide Preparation and Quality 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 Sys tem NOTE that the IS and IPC should always be power cycled together See page 3 27 Shut ting Down the System 3303 OCR Read Failed e See Section C Slide Preparation and Quality 3304 e If label was printed on a T3 replace ribbon 3305 Invalid Slide ID e See Section C Slide Preparation and Quality 3306 e Call Tech Support to verify the Slide ID has the proper CRC Imager Duo Operator s Manual 6 11 TROUBLESHOOTING 6 J Table 6 2 Imaging Station and IPC Errors Error Error Text Corrective Action 3307 Slide Already Imaged Use the Slide Data Record Query to determine if the Slide ID is unique See page 4 45 of the Image Pro cessor Operators Manual for details If there is a duplicate reconcile both patient records according to standard procedures 3310 Slide Error Slide ID in database due to imaging error The slide was not imaged success fully Rerun in another batch 3313 System Error Failure to ar
94. ded into the slide assette correctly ide with a lifted label edge Q icp Confirm that the slide is loaded with the label up and toward the front opening of the cassette Check that the slide is not cocked or overhanging the retaining fea ture Correct label issue Imager Duo Operator s Manual TROUBLESHOOTING 6 SECTION 2 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 Inter face see Report Image Processor Error Log on page 4 38 System Auto Recovery Errors These automatically recoverable errors are system errors that do not require user or service personnel 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 run ning 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 Mon Oct 01 08 14 18 2012 Too many SlideNotFound events Automatic System Error Recovery is complete Number of Automatic System Err
95. 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 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
96. dow If Yes is chosen the Data Management application closes the computer Win dows 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 IMAGER DUO for information on shut down due to power outage or for extended shut down 10 8 Imager Duo Operator s Manual x pul Index INDEX Index A About Menu 4 71 Accession Number Range 4 21 Accessories 9 2 Air Filter Imaging Station 5 6 Alarm 4 58 Applying power to the equipment 3 3 archive 4 11 Auto print batch reports 4 5 B barcode format 3 7 Batch 7 1 Batch process diagram 3 2 C Cancel The Batch After Interrupting Slide Processing 3 22 Cassette 7 1 cassette locations 3 13 cassette status 3 16 6 7 7 1 Clean Verification Slide 4 71 Completing Slide Processing 3 26 conflict 4 30 CT Reviews report 4 52 CT Workload History 4 51 CT Workload Summary 4 50 Customer Service 8 1 9 1 Imager Duo Operator s Manual Index 1 INDEX D Data Management menu 4 8 Data how many lines in a report 4 58 Database backup 4 8 database conflict 4 30 Date setting 4 57 Date Time format 4 58 Dimensions 1 14 Disposal consumables 1 19 device 1 19 electrical and electronic equipment 1 19 During Slide Processing 3 16 L Environmental specifications 1 13 Errors 6 11 Event Log 3 16 Event Log Display 3 17 Event Log window 6 1 Export data
97. e shooting 4 70 Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 SECTION E MAINTENANCE MENU There are maintenance items that the operator should do on a routine basis refer to Chapter Five Imager Duo 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 92 Refer to the Clean Verification Slide procedure in Chapter Five for instructions on cleaning the slide Hologic Corp ThinPrep Imaging System Slide Processing Reports System PARM G a About Clean Verification Slide Service Figure 4 92 Maintenance Menu SECTION F ABOUT MENU The ThinPrep Imaging System version and the Image Processor software ver sion can be viewed by clicking on the About ThinPrep Imaging System button Figure 4 93 Data Management ThinPrep Imager Duo 3 4 0 Copyright 1999 2012 Hologic Inc All rights reserved Figure 4 93 About ThinPrep Imaging System Imager Duo Operator s Manual 4 71 4 OPERATION OF THE SOFTWARE MENU This page intentionally left blank 4 72 Imager Duo Operator s Manual aoueUd UIeW S 5 Maintenance IMAGER DUO MAINTENANCE 5 Chapter Five WARNING Glass Sharp Edges CAUTION Verification slides are NOT interchangeable Each slide is unique to the system it is run on If
98. e 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 78 101 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
99. e qualifier for the report All lists all dates Equals lists a date you type in Before amp After are exclusive of the date you type in Between is inclusive of the date you type in Figure 4 61 Slide Image Sort Parameters OPERATION OF THE SOFTWARE MENU 4 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 v ALL v ALL REVIEWED Review Scope serial number NOT REVIEWED v i 10501G04AP Review date 1005240341 ALL F7 10132L03A1 Paai 10108K0341 sm 14 J 1005240340 n 1005810340 gt 1025000440 WTE 10114K0341 10253C0440 1005740340 Pull down list to select slide Pull down list to view all Review review status Scope serial numbers Figure 4 62 Slide Review Sort Parameters Imager Duo Operator s Manual 4 47 4 OPERATION OF THE SOFTWARE MENU Slide Review Date the report may be modified to show slide records for a par ticular 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 accord
100. e User Interface 10 6 Imager Duo Operator s Manual 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 10 REMOTE SITE SERVER USER S GUIDE 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 Jropes Database lt gt User Accounts FE Reports A System amp Lab Settings E Page Setup mm Printers Security Connection Time Nov 11 2005 09 10 AM Nov 11 2005 09 20 AM Nov 11 2005 09 21 AM 10253C04C0 1025000400 Connected Imagers The Shutdown button initiates Server shutdown The Refresh button updates the list of connected Review Scopes Server icon Figure 10 6 Server Status and Shut Down Window Click on the Shutdown button A dialog box appears prompting confirma tion of shut down Are you sure that you want to shut down the server ServerApp LY 4re you sure that you want to shut down the server Figure 10 7 Confirm Server Shut Down Imager Duo Operator s Manual 10 7 1 0 REMOTE SITE SERVER USER S GUIDE Click on Yes to shut down the Server Click on No to cancel the action and return to the Data Management win
101. e available when generat ing reports or other print activities See Figure 4 77 Imager Duo Operator s Manual 4 59 4 OPERATION OF THE SOFTWARE MENU Data Management Data Management Discovered Printers H Database Model IP Address Device Name Printer Name Description d User Accounts HP Las 10 10 51 2 NPIE2D53D HP LaserJet Server Printer Canon 10 10 51 18 NAQH5522 Canon Color Network Prin amp Lab Settings E Page Setup m Printers 8 Security pA Server X Service Install Installed Printers Printer Name Device Name Description HP LaserJet 2300 Series PCL 6 1 NPIBDC73F IPC 2 Printer 3 Properties Delete Figure 4 77 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 60 Imager Duo 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 Enabling Securi
102. ecificity 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 may 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 an
103. ed 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 Cytopathologist 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
104. equipment shut down should be planned to occur during off hours Imager Duo Operator s Manual 3 1 3 OPERATION OF THE IMAGER DUO Doors lock while warming up Doors unlock Load Slide Cassettes Close Doors Press GO Doors Lock y View Print Reports or Interrupt or Interrupt Resume Cancel i i Batch Complete Ended Doors Unlock Power Off Figure 3 1 Typical Batch Process 3 2 Imager Duo Operator s Manual WARNING Grounded Outlet Instrument Fusing Do not power on or operate if equipment has been damaged OPERATION OF THE IMAGER DUO 3 SECTION APPLYING POWER TO THE EQUIPMENT Apply power to the Server the Imaging Station and the Image Processor Con troller according to the following procedure Note All power cords must be plugged into a grounded outlet Disconnection from the power supply source is by removal of the power cord Make sure the uninterruptable 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 remaining system elements i e the Moni tor Keyboard Mouse Imaging Station and Review Scopes In addition do NOT touch any buttons on the Keyboard when turning on the Im
105. eration OPERATION OF THE IMAGER DUO N 3 g Chapter Three Operation of the Imager Duo SECTION CHAPTER OVERVIEW For Operators using a Server at a non imaging site see also Chapter 10 Remote Site Server User s Guide for an operation overview Routine operation of the Imager Duo System consists of powering on the moni tor the Image Processor Controller and the Imaging Station loading prepared cassettes 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 process ing 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 27 Refer to Figure 3 1 for a diagram of a typical batch process Note Review Scopes are connected to the Server during slide screening ses sions 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 los ing the communication connection Preferably any
106. errors 1 Minimum slide id 79450923754 Maximum slide id 79450963240 Activity and status Checking media Details Cancel Preparing data Updating database Status Preparing data PET TTT TTT TTT Ty Complete F To see a report of the 46 igure 4 45 Import Results Summary import results click the Results button Refer to Figure 4 A new slide is new to the database A duplicate is a slide being imported is identical The slide data being imported is not written to the database record that is already in the database and the slide data 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 the database and has differing values from imported and the Error ID is reported as a Conflict This might be a case of Lab the slide record being imported The slide data is not 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 Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Report Results Import Details Import date Sep 20 2012 10 56 AM Importing Lab Hologic PEG Import CD Contents Total slides 182 Minimum slide id 00000000009 Maximum slide id 00000009588 Summary New slides 0 Duplicate slide records 179
107. ers that were selected IDs will list by slide ID from lowest to highest To print the report click on the Print button Click on the Save to USB button to save the report to a USB key or the report may be saved the NAS drive if your system is config ured with Hnet To close the window and return to the main menu click the Close button Report Workload The workload report displays a tally of slides reviewed Click on Workload to open the Workload report window Figure 4 65 Note If Security is enabled this module will not appear in the Data Manage ment menu A password is required to view and print from these dialog windows Refer to System Security on page 4 61 Imager Duo Operator s Manual 4 49 4 OPERATION OF THE SOFTWARE MENU Data Management Data Management Workload Reports Database CT workload summary q gt User Accounts 3 H Reports O CT workload history R Logs and History R RS Users R Slide Data Records Lab name User Id R T R Rate Report R Run Report Date range Interval System ALL i MONTH OCT reviews Figure 4 65 Workload Window The CT Workload Summary displays a tally of all the auto reviews a CT has performed over a specified period of time The review count is split into FOV field of view only screenings in which no cells were marked during Autolo cate and Full Review screenings in which cells were marked and a full scan Autoscan of the cell spot w
108. es 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 annually 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 dia
109. etrieve verification slide 5 1 Review Scope Error Log 4 39 RS Users Data Management menu 4 43 Run Report 4 55 re Security 4 61 Server Data Management menu 4 69 Index 4 Imager Duo Operator s Manual Server Error Log 4 37 Service Data Management Menu 4 69 Service Information 8 1 Set Date 4 57 Set Imager Name 4 58 Set Time 4 57 Shut Down IP 3 22 3 27 3 28 Shut down server 4 7 4 69 10 6 Shut down system 4 6 Shutdown System 6 8 Shutting Down the Image Processor 3 27 Slide already imaged 6 3 Slide Cassette 9 2 Slide Cassette Imaging Status 3 16 Slide Data Record 7 2 Slide Data Record Report 4 49 Slide Data Records Data Management menu 4 45 SLIDE EVENTS 6 1 Slide has been rejected 6 3 Slide ID conflict 4 30 Slide ID not valid 64 Slide ID report 4 46 Slide IDs 4 20 slide label mode 4 57 Slide labeling 3 7 Slide not found 6 4 slide preparation and quality 6 9 SLIDE PROCESSING 3 15 Slide Processing Event Log 3 16 4 42 SLIDE PROCESSING MENU 4 1 Slot below has slide out of position or multiple slides Slot has multiple slides 6 4 Slot has slide out of position 6 4 Start Slide Processing 3 15 3 22 stat slides 3 22 STOP button 3 19 4 1 INDEX 6 4 Imager Duo Operator s Manual Index 5 INDEX Store verification slide 5 3 System Data Management menu 4 56 System Auto Recovery Errors 6 5 System Error Log 4 38 SYSTEM ERRORS 6 5 System Printers 4 59 System warmup 3 5 T
110. firm export before writing CD Figure 4 34 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 35 Report Results Export Confirmation Total slides 182 00000002289 00000002290 00000002291 00000002292 00000002294 Figure 4 35 Confirm Export Window If the export list is acceptable click on the Accept button and the export func tion will begin If the export list is not acceptable or changes are desired click on the Cancel button and the export function will cancel Imager Duo Operator s Manual 4 23 4 OPERATION OF THE SOFTWARE MENU 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 36 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 print out Use detailed export log Figure 4 37 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 Templa
111. fuses into the fuse holder as shown 5 4 Imager Duo Operator s Manual IMAGER DUO 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 uninterruptable power supply 13 Turn on the instrument 14 If the instrument still fails to operate contact Hologic Technical Support Imager Duo Operator s Manual 5 5 5 IMAGER DUO MAINTENANCE SECTION ome REPLACING THE IMAGING STATION AIR FILTER The Imaging Station air filter should be replaced yearly Refer to Ordering Information for replacement air filters Air Filter Cover Panel Thumb Screws Figure 5 9 Air Filter Location 1 Turn off power to the Imaging Station refer to Shutting Down the Image Processor on page 3 27 2 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 4 Remove the air filter cartridge Figure 5 10 w vi lh Hi Hi Figure 5 10 Air Filter Cartridge 5 Install the replacement cartridge replace the cover panel and tighten the retaining screws 5 6 Imager Duo Operator s Manual
112. gnosis 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 each 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
113. gure 3 14 Imager Duo Operator s Manual 3 13 3 OPERATION OF THE IMAGER DUO Side Processing Event Log Figure 3 14 Partial and Fully Loaded Cassette Locations 5 Fully close the Imaging Station sliding doors 3 14 Imager Duo Operator s Manual OPERATION OF THE IMAGER DUO 3 SECTION fem 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 Hologic Corp ThinPrep Imaging System Slide Processing Reports System Maintenance About err 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 Hologic Inc ThinPrep Imager Duo Sinister Reports System Maintenance About Start Slide Processing Run Stat Cassette Figure 3 16 Begin Slide Processing Menu Selection 2 The doors will lock The message Currently Processing is displayed on the monitor Hologic Inc ThinPrep Imager Duo Slide Processing Reports System Maintenance About ao Figure 3 17 Slide Processing in Progress Imager Duo Operator s Manual 3 15 3 3 16 OPERATION OF THE IMAGER DUO At the start of every batch and at the completion of each slide cassette the sys tem s internal Verification slide is processed This checks th
114. h 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 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 7 2 Imager Duo Operator s Manual SV ThinPrep Microscope Slide UPS Verification Slide TN DEFINITIONS AND ABBREVIATIONS 7 I Server The computer that controls communication between the Imager Duo components It is where all data such as user preferences slide data records system history logs are maintained A specific brand of glass microscope slide that must be used with the ThinPrep system of instruments The slide has features on it that enable automated regis tration of the slide with the Image Processor and the Review Scope Uninterruptable Power Supply This is a special slide stored inside of the Imaging Station that has custom fea tures that allow for periodic slide imaging subsystem adjustment and verifica tion required for imaging slides Imager Duo Operator s Manual 7 3
115. hang 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 Refer to the ThinPrep Stain User s Guide for recommended coverslipping and mounting media The coverslip must be placed so that it does not overhang any part of the slide Ensure that the coverslip is present and undamaged Imager Duo Operator s Manual 6 9 6 TROUBLESHOOTING 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 suc cessfully scan and read the ID Refer to SLIDE LABELING on page 3 7 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 10 Imager Duo Operator s Manual TROUBLESHOOTING N 6 SECTION B 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 2409 ya a e f more than one Imaging Station 2409 is in the lab insure that the veri i fication slides are not switched among Imaging Stations 3106 Slide not found e Ensure that the sli
116. has already been imaged accession ID already in the Server data base Note Always check Slide Already Imaged against the patient record to con firm that it is not a duplicate accession ID Other slide related errors but not necessarily user correctable may include Sample too dense Sample is sparse Other biological artifacts Occlusions or holes in the cell spot The slide is not a ThinPrep microscope slide for use with the Imager Duo Note Ifa slide is not successfully processed by the Image Processor the same slide cannot be automatically reviewed at the Review Scope A manual review must be performed Slides may be rerun on the Imager Duo 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 Do not remove a partially processed slide cassette Data may be lost e To run a Stat slide refer to Stat Slide Processing on page 3 22 To remove completed cassettes from a large batch in order for a Cyto technologist to start the screening process To shut the system down prior to a known power outage event To shut the system down in order to do maintenance or repair To address observable slide loading errors Imager Duo Operator s Manual OPERATION OF THE IMAGER DUO 3 Note When the slide cassette is properly loaded onto the platform it engages a cassette present sensor
117. he 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 2292 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
118. he directory containing export data Make sure writable export media is in the Server Cannot access import directory Unable to access the directory containing import data Make sure readable import media is in the Server Cannot find source directory The backup data couldn t be found to write onto the storage media Try the function again If the error persists con tact Technical Support 6 16 Imager Duo Operator s Manual TROUBLESHOOTING 6 Table 6 3 Data Export Import and Backup Errors Error Text Possible Cause Corrective Action Writable media verification failed After the media was written to the data didn t match what was exported Try the function again Database image too large for media Too much data to fit on selected media type 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 con tact Technical Support Export failed The export failed Try again with a different DVD CD or USB depending on what type of media was used Make sure the storage media is in the Server drive Export failed due to database error A database error prevented the export from succeeding Try the function again Failed to add the template A new template could not be a
119. her interference It should be accessible for routine maintenance The network printer will be installed and set up at the time of instrument instal lation Please refer to the manufacturer s guide for operation and maintenance Note The uninterruptable 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 stored and the robotic arm is safely parked The operator may then shut down the Imaging System refer to page 3 27 WARNING The uninterruptable power supply will be installed and setup at the time of Grounded Outlet instrument installation Please refer to the manufacturer s guide for proper operation maintenance and disposal SECTION 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 win dows 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 vibrations Keep away from other envi ronmental activity such as constant foot traffic proximity to elevators or doors that are frequently open and shut 24 Imager Duo Operator s Manual uoneado e 3 Op
120. ide Data Records LE Workload R Rate Report R Run Report SQ System E Lab Settings E Page Setup wm Printers 8 Security WE Server we Service Data Management Menu Data Management Database Backup E Import EX Export X Maintenance a Reports R Logs and History R RS Users R Slide Data Records R Run Report System amp Lab Settings E Page Setup mm Printers B Security WE Server a Data Management with Security Enabled Figure 4 81 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 82 Imager Duo Operator s Manual 4 63 4 OPERATION OF THE SOFTWARE MENU Slide Id Qualifier Slide Id ALL Slide Image Slide Review Image status Review status ALL ALL v Imager name Review Scope serial number IP1902KM1 Image date Review date ALL ALL v Review Scope User Lab name Slide Data Record Window 4 64 Imager Duo Operator s Manual Slide Id Qualifier Slide Id ALL Slide Image Slide Review Image status Review status ALL ALL v Imager name IP190ZKM1 Image date Review date ALL ALL v Slide Data Record Window with Security Enabled Figure 4 82 Slide Data Reco
121. iducial marks are also used to register the slide position on the imaging stage at the beginning and end of slide imag ing Imager Duo Operator s Manual 7 1 ZN Z TTI FOV IPC OCR ool Power Cycle RS Slide Data Record Slide Processing Event Log DEFINITIONS AND ABBREVIATIONS Field of View A circular area of the slide as viewed through the microscope The CT is responsible for looking at the entire field while reviewing slides Image Processor Controller The computer that interacts with the Imaging Sta tion in order to image the slides 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 successfully occurred Optical Character Recognition The Image Processor and the Review Scope each contain an Optical Character Recognition camera that reads a slide label ID and matches it against patient ID s already stored in the Server database Object of Interest An object of interest is a blob that has passed filtering which removes normal cells and recognized artifacts and undergone algorithmic rat ing An object of interest may be a single cell or a cluster Turning the Imager Duo off and then on again usually to clear an error condi tion Refer to Shutting Down the System in Chapter 3 before turning off power to any of the components Review Scope The data associated wit
122. ing to which operator reviewed slides Select the operator ID number from the pull down list Slide Review Review status ALL v Review Scope serial number Review date Pull down menu to select date qualifier for the report Review Scope User Lab name HOLOGIC PEG v Pull down list to select which lab name Slide Review Review status ALL v Review Scope serial number Review date ALL v Pull down list to select operator ID The user IDs that display depend on which lab name was selected Figure 4 63 Slide Review Sort Parameters continued 4 48 Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 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 Sep 21 2012 09 03 AM Matches found 7 Slide Id Slide Image Imager name IP190ZKM1 Slide Review Imaging Status 08392879999 IP190ZKM1 Sep 20 2012 3 23PM 08392899999 IP190ZKM1 Sep 20 2012 3 21PM Slide Id Imager Id Imaging Date 09163529999 IP190ZKM1 Sep 20 2012 3 25PM OK OK OK OK 09163549999 IP190ZKM1 Sep 20 2012 3 30PM 10043279999 IP190ZKM1 Sep 20 2012 3 25PM OK 79000911191 IP190ZKM1 Sep 17 2012 2 07PM OK gt Figure 4 64 Slide Data Record Report The report will list all slide data records within the paramet
123. ith 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 15 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
124. ith 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 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
125. 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 www hologic com en about us patent information Hologic ThinPrep and PreservCyt are registered trademarks in the United States and other countries Hnet is a trademark of Hologic 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 08342 001 Rev 003 IVD waj sks Bbuilbew od dulyL Oy tL The ThinPrep Imaging System ThinPrep IMAGING SYSTEM Operation Summary and Clinical Information The ThinPrep Imaging System HOLOGIC A INTENDED USE The Hologic ThinPrep Imaging System Imager is a
126. lected to occur at a future date and time and can be scheduled to recur daily weekly monthly or on a one time basis The schedule will remain even if the system is turned off and on The selected media must be placed in the Server ahead of time See Figure 4 15 Note If monthly backup is selected do not pick a date at the end of the month that may not occur in other months the 29th 30th 31st Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Select the start Backup Type date and time for a O Immediate Scheduled scheduled backup and whether it Backup Schedule Current recurs daily Target Media CD DVD weekly or monthly Start Date Start Time Schedule Type A Siaeaapnaite gj 912 m 02 01AM Weekly v enable the sched ule or Delete to inactivate the Status schedule Ready Status indicates Ready or backup Recent Backups in progress Date Time Media Type Status a EEES 9 2 12 2 14 08 AM CD weekly Fail 8 29 12 2 12 43 4M USB Daily Success backups and their 8 27 12 2 12 42 AM USB Daily Success status are listed 8 26 12 2 12 31 AM USB Daily Success Figure 4 15 Scheduled Backup Archive Archive will purge a database of old slide data records based on a user selected date range cut off This function is only accessed on a Server and is password protected The Archive function icon is not present on the Data Management menu unless Security is activated See Figure 4 16
127. led 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 Support Refer to Service Information Chapter 8 SECTION ACTION UPON DELIVERY Remove 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 Informa tion Chapter 8 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 PREPARATION PRIOR TO INSTALLATION Pre Installation Site Assessment A pre installation site assessment is performed by Hologic Service Personnel Be sure to have prepared any and all site configuration requirements as instructed by the Service personnel Imager Duo Operator s Manual 2 1 IMAGER DUO SYSTEM INSTALLATION Location And Configuration CAUTION Local Network Configuration Route allconnectors The Image Processor Controller the Imaging Station the monitor keyboard carefully to avoid mouse the printer and a multiport Ethernet switch must be located in the same pinching the cables area so that interconnection cables easil
128. ll events If a long message is displayed 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 Slide Event Log Report and Run Report to view previous slide processing event logs Slide Processing Event Log Event Number 3 Cassette Number 2 Slot Number 4 September 20 2012 03 03 13 PM Slide ID Event Number 2 Cassette Number 1 Slot Number 2 September 20 2012 03 02 01 PM Slide ID Event Number 1 Cassette Number 1 Slot Number 1 September 20 2012 03 01 16 PM Slide ID Figure 3 19 Typical Event Log Display Imager Duo Operator s Manual 3 17 3 NA 3 18 OPERATION OF THE IMAGER DUO If a slide caused an event during processing the operator should check it at the conclusion of the batch to determine if there is any corrective action that would allow it to be successfully processed in another batch This may include Slide incorrectly loaded into the slide cassette Slide was not completely dry when loaded into the cassette Mounting media was on the frosted portion of the slide Slide contains bubbles Slide coverslip protrudes over the edge amp causes interference Slide not labeled for use with the Imager Duo Slide is dirty dust fingerprints Slide label not legible for scanning of the accession ID Slide
129. load 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 sensitivity 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 sp
130. lue _3H 22 10 PM ad using the arrows Figure 4 74 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 update 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 click ing on it To save that setting click the Apply button See Figure 4 75 Local Settings Imager name Alarm i jon v Report date time format Report limit mon dd yyyy hhimm M or PM v 500 dd mon yyyy hh mm 24 hour dd mon yyyy hhimm M for PM mon dd hh mm 24 hour mon dd yyyy hh imm M for PM Figure 4 75 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 setti
131. multiple number Wild card single Wild card multiple If no other characters are between the date code of 2012 and the accession id nothing else is needed If a single character always separates the date code from the accession number and you want the system to ignore it press the wild card single button to insert a holder for that character during the search Slide Id Filter Accession Number Range Single character wild card 2012 500 Wild card single Wild card multiple If several characters always separate the date code from the accession number and they are to be ignored during the search press the wild card multiple but ton to insert a holder for those characters Slide Id Filter Accession Number Range Multiple character 1 500 wild card E 2012 500 Wild card single 5 Wild card multiple Figure 4 32 Filter Using Specific Characters Export Window Checkboxes Export only slides not already exported Figure 4 33 Export Only Slides Not Already Exported 4 22 Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 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 Con
132. n to print the report Click on the Save to USB button to save the report to a USB key or the report may be saved the NAS drive if your system is configured with Hnet Click on the Close button to return to the Logs Selection menu Imager Duo Operator s Manual 4 41 4 OPERATION OF THE SOFTWARE MENU Report Image Processor Slide Event Log The Slide Event Log displays all slide event occurrences from IPs on the net work 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 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 set ting 500 to 5000 refer to System Lab Settings on page 4 56 Report Results Slide Processing Events Report Date Sep 21 2012 09 02 AM Matches found 13 Imager name IP190ZKM1 Event Cassette Slot Number Number Number 1 1 13 Sep 20 2012 3 55PM 7 0 11 3303 Slide ID Read Failed 1 1 Sep 20 2012 3 54PM 7 0 11 3303 Slide ID Read Failed 11 09163549999 Sep 20 2012 3 43PM 7 0 11 3307 Slide already imaged 4 09163529999 Sep 20 2012 3 41PM 7 0 11 3307 Slide already imaged 11 09163549999 Sep 20 2012 3 39PM 7 0 11 3307 Slide
133. nd choose how many lines of data a report will display Data Management Data Management Lab Settings Database Lab name Slide label mode P User Accounts Hologic OCR i a Reports i System System date System time amp EEE Sep 21 2012 Y 09 06 38 AM E Page Setup wm Printers r Security W Server We Service ON Report date time format Report limit mon dd yyyy bhimmaAM for PM 500 E Local Settings Imager name Alarm Figure 4 71 Lab Settings Window Lab name to enter a name click the cursor in the lab name field then type the name of the lab If a name is already present or you wish to change it back space through the characters or highlight and delete Alphanumeric characters may be used up to 49 characters Click the Apply button to save this setting 4 56 Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 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 See Figure 4 72 To change the month click on the left or right arrows on the top of the calendar September 2012 fon Tue Wed Thu Fri Sat 1 Click on the forward or back arrows to change the month gt 3 4 5 6 7 8 Or click on the month in 9 10 11 12 13 14 15 this case September 16 17 18 19 20 BU z to see a drop down list of 23 24 25 26 27 28 29 months 30 S
134. nding on which i SS model computer you have it gt may look different than this m graphic 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 doors are unlocked To power the Imaging System off refer to SHUTTING DOWN THE IMAGER DUO on page 3 27 The IS IPC and Server should be shut off in the sequence described there Imager Duo Operator s Manual 3 5 3 OPERATION OF THE IMAGER DUO Slide cassettes are provided at installation see Ordering Information for ordering more SECTION fem MATERIALS REQUIRED PRIOR TO OPERATION Monitor Keyboard amp Mouse Imaging Station Image Processor Controller user Interface and Server 0 NG TT 3 o E l 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 Imager Duo System equipment at the time of installation They provide the User Interface with the system
135. nes re are reviewed by a Cytopathologist for interpretation and diagnosis All slides and patient data are yready to be filed Figure 1 2 Lab Flow Imager Duo Operator s Manual 1 3 14 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 instrument via a graphic menu driven interface A slide ID reader scans 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 coordinates of 22 of those objects are recorded and the slide is returned to its cassette Following processing of each cassette of slides the slide ID and associated data record are sent to the Server and to the ThinPrep Hnet laboratory network if your system is configured with it The Server acts as the central data manager for the ThinPrep Imaging System As slides are imaged by the Imager Duo and reviewed at the Review Scope the Server stores retrieves and transmits information based on the slide ID For installations with multiple controllers the server also controls the communica tion between all devices on the network Some facilities only perform slide screening and a Server is use
136. ng 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 ons 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 t
137. ngs 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 Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Select the desired options that are available and then click the Apply button The Reset button will reset all settings to the default Data Management Data Management Page Settings Database Printer User Accounts IPC 2 Printer Under Delta 2 Offline EA Reports System Page size amp Lab Settings Letter Os wm Printers Paper source B Security Automatically Select Server We Service Figure 4 76 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 b
138. nt malfunc tion 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 causing broken slides or instrument malfunction The slide is appropriately labeled for use with the ThinPrep Imaging System refer to Slide Labeling page 3 7 Mixed slide ID formats are not allowed in a cassette or a batch Select the slide label format via the User Interface Data Management Lab Settings to match the format of the slides in the slide cassette Each cassette holds up to 25 slides It is not necessary for the slides to be in any particular order slots may be skipped Imager Duo Operator s Manual OPERATION OF THE IMAGER DUO 3 LOAD SLIDE CASSETTES INTO THE IMAGING STATION 1 At the Imaging Station open the left or right sliding door to access the desired platform location Figure 3 11 Left Door Right Door Shown with doors fully closed Slide Cassette Position 10 Slide Cassette Position 1 Dividers Shown with doors removed for clarity Figure 3 11 Imaging Station and Slide Casset
139. nterrupt Slide Processing Please select one of the following options Interrupt the current slide immediately lose cassette progress O Interrupt the current slide immediately save cassette progress O Interrupt at the conclusion of the current cassette Retum to Slide Processing Figure 3 22 Interrupt Slide Processing Option Use the mouse to select the option for when the batch is interrupted Interrupt the current slide immediately lose cassette progress 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 Ima a Station mechanisms will come to an orderly halt The doors will unlock The batch is terminated and the slide data is not recorded Interrupt the current slide immediately save cassette progress Use this option to stop batch processing at the current slide The slide will not be completed The slide will be put away and 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 processing at the slide that was in progress during the interrupt 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
140. or Recoveries on this batch run 1 This dialog is for informational purposes only thse You may now close this dialog Chose Figure 6 2 User Notification Recoverable Error Display Imager Duo Operator s Manual 6 5 CAUTION Do not remove any slides or cassettes TROUBLESHOOTING 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 inter rupted 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 User Assessment Error Number System Error Information Error 3469 10 01 12 10 15 51 Date and Time Brief Description Failure on CheckSlides checking slide path Query Image Processor error log Begin User Assisted Recover Recovery Action Button eel ton always Silence Alarm available button 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 6 6 Imager Duo Operator s Manual TROUBLESHOOTING 6 User Assisted Recovery Option Click on the Begin Use
141. ore 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 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 identifi
142. otinclude manual reviews Smith Anne 101 Hologic PEG Lab FOV Only Full Review Dec 2011 31 2 Jan 2012 Feb 2012 11 Mar 2012 13 Apr2012 34 Ma y 2012 36 Jun 2012 45 Jul 2012 10 Total 152 Save to USB Print Figure 4 67 CT Workload History Report The tally of slides screened in the time frame selected is broken into FOV field of view Only and Full Review These distinguish between slides that have been physically marked or not marked Note Neither CT Workload Summary nor CT Workload History has a count of manual slide reviews CT Reviews The CT Review Report generates a list of selected RS User IDs or all User IDs plus a date range and scan type all full or FOV The report then displays the selected query information plus the lab name See Figure 4 68 To print the report click on the Print button Click on the Save to USB button to save the report to a USB key or the report may be saved to the NAS drive if your system is configured with Hnet To close the report click on the Close button to return to the Workload display 4 52 Imager Duo Operator s Manual Report Results CT Reviews Report Date Sep 21 2012 09 02 AM Matches found 13 User Id 101 Date Range BETWEEN SEP 20 2012 AND SEP 21 2012 Scan type Full Review This report does not include manual reviews OPERATION OF THE SOFTWARE MENU 4 Slide Id Review Date User Id Scan Type Lab 67210112827 Sep 21 2012 7 53 AM
143. perator s Manual 3 29 3 OPERATION OF THE IMAGER DUO This page intentionally left blank 3 30 Imager Duo Operator s Manual nua VAemyos vy 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 Hologic Corp ThinPrep Imaging System Menu Bar Sjide 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 Xa 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 func tions respectively Refer to Figure 4 2 Slide Processing Press the Go Button Sie Siege Reports System Mainten eae or select from the id A A r si drop down menu Start Slide Processing Run
144. provided it has adequate air circulation to prevent dust accumu lation 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 instal lation Please refer to the manufacturer s guide for operation and maintenance The uninterruptable power supply will be installed and setup at the time of instrument installation Please refer to the manufacturer s guide for proper operation maintenance and disposal Note The uninterruptable 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 10 6 POWER ON THE EQUIPMENT 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 button The keyboard and mouse will be active when the com puter boots up Note Do not touch the keyboard during power up 10 4 Imager Duo Operator s Manual REMOTE SITE SERVER USER S GUIDE 1 0 l Power On Button Figure 10 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 s
145. r Assisted Recovery button The system will return slides to their original locations and enter idle mode This process will take a couple 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 cassettes colored blue or gray as they were at the time of the error condition At this point the operator 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 unpro cessed 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 com pleted batch Note If the recovery is not successful a User Assessment window with a Shutdown System button will appear Imager Duo Operator s Manual 6 7 6 TROUBLESHOOTING Shutdown System Option If the system encounters an error condition that it cannot recover from the User Assessment dialog box will display and only the Shutdown System button is available Figure 6 4 The system must be restarted User Assessment System Error Information Error 3160 08 30 12 10 10 38 4 cassette changed status during processing Query Server error log Recovery Action
146. r multiple slides highlight them in 08000000016 the list and click the View button 08000000017 To unlock one or multiple slides high light them in the list and click the Unlock button Select all checkbox will highlight all slides listed 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 lon ger installed in your network Click on the Maintenance option of the Data Management menu and the Main tenance window appears Figure 4 48 Imager Duo Operator s Manual 4 33 4 OPERATION OF THE SOFTWARE MENU Data Management Data Management Clear Error And Usage Logs amp Database Review Scope serial number ea 100580340 xl E Import 10108K0341 EY Export 1025000440 8 Lock Slides 3251 7F04B1 5 33824F04B1 X 34003D12M1 q gt User Accounts E A Reports H A System Figure 4 48 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 screening 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 Note If Security is enabled this mod
147. r occurred during data import Contact Technical Support Initialization error A server error occurred while trying to initialize data for the operation Try the function again Invalid version of data on import media The version of data on the stor age media can not be imported into the current database ver sion Check that the versions match look at the Help button Media is locked The Server drive has the storage media locked for another import export Wait for any processes to finish Try again later No import data There is no data on the storage media to import The storage media may be blank or have data other than export data on it Use a DVD CD or USB 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 The user tried to modify a tem plate that is no longer in the database A user on a different system deleted it Recreate the template Template name must be unique within the view A template has been created or changed with a non unique name Rename the template with a unique name The export exceed the maximum allowed records Narrow the search criteria and try again Exports are limited to 10 000 records
148. rd Report Selection Criteria 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 pass word to access restricted data without entirely disabling the security feature To access the Workload Reports User Account management or entire Slide Data Record window open the security window There is an empty field titled Cur rent Password Type in the security password and click on the Validate button See Figure 4 83 To access restricted data type inthe correct Security security password and Current password click the Validate but Mi ton validate Figure 4 83 Validate Password Window If the password entered was not correct an Invalid password entry box is dis played Figure 4 84 ThinPrep Imager Duo X Invalid password entry Figure 4 84 Invalid Password Entry Click OK to clear the box Re enter the correct password in the field and click Validate If the password 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 85 Note Administrative access is only applied at the workstation or server that is being accessed Imager Duo Operator s Manual 4 65 4 OPERATION OF T
149. required and maximum of 6 characters will fit on a slide A single character check digit is optional 1 D Code 93 All printable ASCII 128 characters are supported A minimum of 5 charac ters is required and a maximum of 8 characters will fit on a slide 2 D datamatrix All printable ASCII 128 characters are supported A maximum of 16 charac ters is supported Imager Duo Operator s Manual 3 7 3 OPERATION OF THE IMAGER DUO N A 01234557890 Code 128 ULE G Oooo ode Code Interleaved 2 of 5 39 ThinPrep ThinPrep ThinPrep 1 Dimensional barcode examples HologicLab 4055853 92391590 ThinPrep MAM Code 93 ThinPrep OCR format HologicLab ThinPrep 2 D barcode example Figure 3 8 Examples of How Barcodes Fit Onto a ThinPrep Slide 3 8 Imager Duo Operator s Manual WARNING Glass Sharp Edges CAUTION The slides must have been processed on a ThinPrep Processor CAUTION To prevent unnecessary slide events during batch processing slides must be placed properly into the cassette OPERATION OF THE IMAGER DUO 3 SECTION LOADING SLIDE CASSETTES Only stained coverslipped ThinPrep Pap Test microscope slides for use with the Imaging System may be used Refer to the ThinPrep Stain User s Guide for recommendations for coverslipping media Refer to Figure 3 9 The fiducial marks are permanently printed features on the slide used
150. roduct is in vitro diagnostic IVD medical equipment This product contains a device classified 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 electromagnetic envi ronment should be evaluated prior to operation of the equipment Imager Duo Operator s Manual 1 15 1 16 INTRODUCTION SECTION E INTERNAL QUALITY CONTROL Verification Slide The verification slide Figure 1 13 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 oper ated 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 13 Verification Slide Power On Self Test POST At the time the Image Processor Controller and the Imaging Station are pow ered on refer to Applying Power to the Instrument on page 3 3 the system goes through a self diagnostic test All the electrical mechanical and software communication systems are tested to confirm each performs properly The operator
151. s which have sharp edges In addition the slides may be broken in their storage packaging or on the instrument Use caution when handling glass slides and when cleaning the instrument 1 18 Imager Duo Operator s Manual INTRODUCTION 1 SECTION e 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 dis posed of in your laboratory refuse Disposal of the device Please contact Hologic Service refer to Service Information Chapter 8 Do not dispose in municipal waste Please contact Hologic Technical Support Ee asd are Hologic Inc Hologic UK Ltd 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 Imager Duo Operator s Manual 1 19 1 INTRODUCTION This page intentionally left blank 1 20 Imager Duo Operator s Manual UONE ESU g 2 Installation IMAGER DUO SYSTEM INSTALLATION 2 Chapter Two WARNING Service Installation Only Imager Duo System Installation SECTION Na GENERAL The ThinPrep Imager Duo System and peripherals must be instal
152. s radio button If a media type is not available a message will prompt for a device to be loaded If your system is not configured with NAS that option will be grayed out and cannot be selected To purge records without backing them up deselect the checkbox Archive slide records before deleting Select Media cp DvD Onas Ouse lt _ Archive slide records before deleting Select Media CD DYC NAS USB KEL Figure 4 18 Backup Records Before Purge Option Select a date from which slide data records will be archived deleted Type a date directly into the field or click on it to bring up a calendar Archive Options 4rchive Delete slide records before date 10 9 2007 Type in a date or click on the calendar arrows to _ifers means change g ia z kia months Mon xed Thu lick on th Glice onthe 6 E o 11 12 calendar year to change the 15 16 17 18 19 22 23 24 25 2 27 year 3 29 30 31 Today 10 9 2012 View button to view a Go button to proceed summary report of the with the Archive function slide data records Figure 4 19 Select Archive Date Range Imager Duo Operator s Manual 4 13 4 4 14 OPERATION OF THE SOFTWARE MENU To view a report of the slides that have been selected click on the View button Report Results Archive Summary Report Date Oct 09 2012 09 46 AM Archive Before 10 9 2007 Slide Count 1904595 SlideiD_ Imaging
153. s the slide Slide has been rejected The slide was not successfully imaged Inspect the slide and confirm that e ThinPrep microscope slide with fiducial marks is being used e The slide is clean no fingerprints debris bubbles etc e The coverslip media is completely dry e The coverslip does not extend beyond the edge of the slide e The label is applied smoothly no wrinkles or lifted edges Rerun the slide The slide must be manually reviewed if it cannot be successfully imaged Imager Duo Operator s Manual 6 3 9 f 6 4 TROUBLESHOOTING Table 6 1 Event Log Error Messages Event Log Error Message Possible Cause Corrective Action Slide ID not valid Wrong accession ID format Label the slide with the correct ID format Slide not found Slide 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 Slides not loaded into the slide Confirm that the slide is loaded with position or multiple slides cassette correctly the label up and toward the front opening of the cassette Load one slide per slot Slot has multiple slides Slides not loaded into the slide Load one slide per slot Q assette correctly ide with a lifted label edge Correct label issue Slot has slide out of posi tion vJ Ww ide not loa
154. sette progress so that the batch may be resumed upon completion of the stat slide When interruption of the batch is complete the doors unlock and a dialog box prompts the operator to place a cassette with the stat slide s loaded into posi tion 10 on the cassette platform Figure 3 28 Imager Duo Operator s Manual 3 23 3 OPERATION OF THE IMAGER DUO Pinse erplace Canontte in ot 1D mth the Rak Castre Cone De bem doors erent Contre Run Stat Cassette Please replace cassette in Slot 10 with the Stat Cassette close the Imager doors and press Continue Cancel Figure 3 28 Run Stat Cassette Instructions Place the cassette in position 10 replacing the cassette already present at posi tion 10 if there is one close the doors and click the Continue button The sys tem processes the stat slide s 3 24 Imager Duo Operator s Manual OPERATION OF THE IMAGER DUO 3 Figure 3 29 Stat Cassette in Process The cassette displayed on the screen turns blue upon completion of processing the stat slides Figure 3 29 The doors unlock when the system is ready A dialog box prompts the operator to remove the stat cassette and replace it with the original slide cassette if one was present ThinPrep Imager Duo 9 Remove Stat Cassette and replace original cassette in Slot 10 YY Press OK to resume original batch Pressing Cancel willleave system in interrupted state Figure 3 30 Remove and Replace Stat Casse
155. ssword Figure 4 87 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 Imager Duo Operator s Manual 4 67 4 OPERATION OF THE SOFTWARE MENU Disable Once a security password has been activated a Disable button is displayed as an option on the security window See Figure 4 88 Click on the Disable button to disable pass word security and allow Security open access to all Current password reports and windows ne Figure 4 88 Security Disable Window To disable the password security click on the Disable button A dialogue box will appear with the question Disable Security Click OK to disable the pass word protection Click Cancel to keep the password protection enabled Figure 4 89 ThinPrep Imager Duo Disable security Figure 4 89 Disable Security 4 68 Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 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
156. stem This selection will shut down the Image Processor Controller IPC and power off the monitor keyboard 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 re 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 Imager Duo 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 con nected to it Communication will be lost data may be lost This function will power off the Server From the System Menu select Shut Down Server Hologic Corp ThinPrep Imaging System Slide Processing Reports EVE Maintenance About ap Stay Shut Down System Shut Down Server Data Management Figure 4 9 Select Shut Down Server The Data Management Server window will appear Figure 4 10 Note You can navigate to the Data Management
157. te When a filter parameter has been entered into the Export screen the Save but ton is available Figure 4 38 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 39 Template Name Template name Figure 4 39 Template Name 4 24 Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 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 Manage ment menu window Figure 4 40 Data Management Database Backup BEM Campus Path Lab S Lab ABC E Import X Maintenance d User Accounts A Reports System Export Templates Figure 4 40 Export Templates To use a template that has already been created click on the name of the tem plate in the Data Management menu The Export Parameters window will dis play with the filter profile parameters already present To change a template name or to delete it right click on the name of the tem plate 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 41 Imager Duo Operator s Manual 4 25 4 4 26 OPERATION OF THE SOFTWARE MENU Report Results Export Report Export date Sep 20 2012 10 56 AM Export lab Hologic PEG Summary Total slides 1
158. te Loading Platform Imager Duo Operator s Manual 3 11 3 OPERATION OF THE IMAGER DUO 2 Holding a loaded slide cassette upright slide it between two dividers onto the Imaging Station platform Note The base of the slide cassette has a tab on both sides that must fit into the guide on the undersides of each divider Refer to Figure 3 12 A Q A 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 3 12 Imager Duo Operator s Manual OPERATION OF THE IMAGER DUO 3 Urtochert Figure 3 13 Cassette Loaded View on the User Interface 4 Continue to load slide cassettes into available positions on the Imaging Sta tion 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 cassette containing at least one slide must be present to begin slide imaging Fi
159. the report to a USB key or the report may be saved to the NAS drive if your system is configured with Hnet Click on the Close button to return to the Log Selection menu Report Results Server Error Log Report Date Oct 01 201203 10 PM Matches found 5 Time Stamp Error Version Sep 27 2012 09 02 AM 8010 7 0 11 Sep 30 201203 16 PM 8024 7 0 11 Sep 30 2012 03 09 PM 8017 7 0 11 Oct 01 2012 09 10 AM 8006 7 0 11 Oct 01 2012 02 45 PM 8024 Figure 4 51 Server Error Log Report Imager Duo Operator s Manual 4 37 4 4 38 OPERATION OF THE SOFTWARE MENU 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 52 Report Results System Error Log Report Date Aug 30 2012 09 52 AM Matches found 3 Image Processor IPHKYY KM1 Error Number Date Time Imager Name IS System Id pict ersion 3469 Aug 30 2012 9 22AM IPHKYYKM1 20188J04AP 7 0 10 9100 Aug 30 2012 9 22AM IPHKYYKM1 20188J04AP 7 0 10 3000 Aug 30 2012 9 22AM IPHKYYKM1 20188J04AP 7 0 10 Save to USB Print Figure 4 52 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 set
160. thout doors Recommended clearances 3 76 2 mm on all sides Slide Cassette Dimensions Figure 1 10 Slide Cassette Loaded with Slides Imager Duo Operator s Manual 1 11 1 INTRODUCTION BEBERBREBEB 0 o anoj ma fe Cc o Image Processor Controller Server Figure 1 11 Image Processor Controller PC and Server PC 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 manufac turers products 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 3000 onOne a eGo EES RS Uninterruptable Monitor Keyboard and Network Device Postscript Network Printer Power Supply Mouse shown with battery backup Figure 1 12 Other System Components 1 12 Imager Duo Operator s Manual INTRODUCTION N 1 Environmental 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
161. ting 500 to 5000 refer to System Lab Settings on page 4 56 Click on the Print button to print the report Click on the Save to USB button to save the report to a USB key or the report may be saved the NAS drive if your system is configured with Hnet Click on the Close button to return to the Logs Selection menu Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 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 the network Select one by clicking on the RS serial number listed Figure 4 53 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 10501G044P v 10501G044P O J1os03G04aP Image Processor slide event log Figure 4 53 Select Review Scope for Error Log Report Then click on the View button to see the report See Figure 4 54 Imager Duo Operator s Manual 4 39 4 OPERATION OF THE SOFTWARE MENU Report Results Review Scope Error Log Report Date Aug 30 2012 09 52 AM Matches found 4 Review Scope 20188J04AP Error Number Date Time Review Scope id aa aare ersion 7108 Aug 30 2012 09 22 AM 20188J04AP 7 0 11 7182 Aug 29 2012 08 24 AM 20188J04AP 7 0 11 7416 Jul 27 2012 03 43PM 20188J04AP 7 0 10 7100
162. tions and functions are as follows System Hardware Electromechanical Processor 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 22 55 8 cm H x 25 63 5 cm W x 32 5 82 5 cm D 170 lbs 77kg uncrated Image Processor Controller Server and other components Refer to the documents that come with the equipment 1 14 Imager Duo Operator s Manual INTRODUCTION so 1 NA 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 stan dards 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 p
163. to 95 relative humidity non condensing Pollution Degree II in accordance with IEC 61010 1 Category II 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 4A maximum Image Processor Controller Refer to the documents that come with the equipment Server Refer to the documents that come with the equipment Heat Generated Imaging Station approximately 1600 BTU HR 470 W Image Processor Controller Refer to the documents that come with the equipment Server Refer to the documents that come with the equipment Fusing Imaging Station Two 5 x 20mm 6 3A time delay glass fuses Image Processor Controller Refer to the documents that come with the equipment Server Refer to the documents that come with the equipment Imager Duo Operator s Manual 1 13 INTRODUCTION Protective Temperature Coefficient Devices The Imaging Station contains protective temperature coefficient PTC devices intended for protection against occasional overcurrent or overtemperature fault conditions These devices automatically reset after the overcurrent or overtem perature condition has been removed The PTCs loca
164. to be system database Load Archive wamo Cas Cus y Selected File Select Load M Select Slides restored to the zal View Progress and status of the restore process OPERATION OF THE SOFTWARE MENU 4 Status Ready Restore Figure 4 26 Restore Archive Selection Screen From the Load Archive field select which media the archived material is stored on A window with all bak files found will appear Select the archive file that is to be loaded by clicking on it Figure 4 27 Imager Duo Operator s Manual 4 17 4 OPERATION OF THE SOFTWARE MENU Load Archive Selectrile xaj Media USB AdminCurrent bak CustomerBackup bak TIS_AllCharacters bak _Archive20041009 bak zip View cmi Figure 4 27 Select Archive file to be Restored Click on the Load button to begin restoration of the file When it has been decompressed and loaded it is available for browsing Note If this is a large file this step could take a long time A window listing the slide IDs appears Type the ID or part of the ID into the Search field of the browse window to search for it in the list Only one slide ID can be selected for restoration at a time Click on the slide ID to select it and click the Restore button to copy the ID into the Imaging System database 4 18 Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Slide ID list 1 290 870 Search
165. tte Close the doors and click the OK button to resume the batch Clicking Cancel will leave the system in the interrupted state Imager Duo Operator s Manual 3 25 3 3 26 OPERATION OF THE IMAGER DUO SECTION ie 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 but ton on the menu bar is highlighted as available Refer to Figure 3 31 lologic Inc ThinPrep Imager Duo Slide Processing Reports System Maintenance About ow Figure 3 31 Slide Processing Complete The doors will unlock It is safe to open the Imaging Station and remove the cas settes 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 Processor Section I Imager Duo Operator s Manual CAUTION If Review Scopes are also connected to the Imager Duo work schedules must be coordinated so that all operation is concluded prior to equipment shut down OPERATION OF THE IMAGER DUO 3 SECTION l SHUTTING DOWN THE IMAGER DUO WARNING Never turn off power to the equipment without shutting down the system via the User Interface 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
166. ty will reveal access to Slide Data Record Archiving The security feature provides the user the following options e Enable a password e Validate administrative access to restricted areas without entirely dis abling the password e Change a password e Disable a password Click on Security to open the Security window Refer to Figure 4 78 Data Management Data Management Security Database User Accounts Reports system amp Lab Settings E Page Setup mm Printers 8 Server We Service Figure 4 78 Security Window Imager Duo Operator s Manual 4 61 4 OPERATION OF THE SOFTWARE MENU 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 Imager Duo 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 79 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 substi tuted with dots on the display as they are typed Figure 4 80 Confirm the pass word by entering it again in the second field Click OK when finished
167. ule will not appear in the Data Manage ment menu A password is required to view and print from these dialog windows Refer to System Security on page 4 61 4 34 Imager Duo Operator s Manual OPERATION OF THE SOFTWARE MENU 4 Data Management Figure 4 49 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 bot tom of the display The User Id and Name fields will clear Type in a 3 digit number must be unique an ID number cannot be reused Type in the opera tor 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 clicking 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 database 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 reissued Only unique IDs may be assigned To return to the main user interface click on the Close button Imager Duo Operator s Manual 4 35 4 OPERATION OF THE SOFTWARE MENU Reports
168. ullapio 6 9 Ordering Information ORDERING INFORMATION a i 2 g 3 Chapter Nine 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 may be obtained by contacting Customer Service at the numbers listed above Imager Duo Operator s Manual 9 1 ORDERING INFORMATION S N a N P Reordering Supplies for the Imaging Station and Image Processor Controller PEPE Part Item Description Quantity Number Slide Cassette 10 pack Additional slide cassettes 1 pkg 70773 001 Operator s Manual Additional Operator s Manual ea MAN 03133 001 Fuse 5x20 mm Time Delay Replacement fuses ea 50077 021 Glass 6 3A for Imaging Station Air Filter for Imaging Station Replacement air filter ea 51056 001 9 2 Imager Duo Operator s Manual BPIND S 49Sf 1 M S SUS SJOWDSY Ol 10 Remote Site Server User s Guide Joa R
169. un Click the date to choose a new date setting Figure 4 72 Set System Date To save the setting click on the Apply button at the bottom of the window Slide label mode use this setting before running a batch to match the format of the slide labels in the cassettes The pull down menu lists the types the Imager Duo can accept No mixed label types are allowed in a cassette and no mixed cassettes are allowed in a batch If the wrong slide label type is selected and a batch begins after rejecting 3 slides an error will occur and the next cas sette is attempted The instrument will attempt to read all cassettes present and then end the batch if each of the first three slides in each cassette is rejected Lab Settings Lab name Slide label mode Hologic OCR v System date System time OCR 1D Barcode Sep 20 2012 03 52 23 PM 2D Barcode Figure 4 73 Slide Label Mode System time click on the hours minutes or seconds to highlight it as a selec tion 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 Imager Duo Operator s Manual 4 57 4 4 58 OPERATION OF THE SOFTWARE MENU Change the highlighted System time Scroll forward or backward va
170. y reach each component within 1 8 ites tripping meters 6 feet of each other Refer to Figure 2 1 Review Scopes connected to disconnecting the Image Processor Controller may be located up to 100 meters 328 feet away cabling do not or extended another 100 meters using a second switch place cabling near foot traffic Up to 328 ft 100 meters i Review E E E Scope i aan Review Switch i Scope Additional Scopes depending on site configuration Uninterruptable Power Supply Keyboard and Battery Backup Monitor Power Cord Requires an Outlet ee S a May go on the floor provided there Table Desk or Lab Bench is no dust accumulation on or around it Figure 2 1 Local Network Interconnection Schematic Example 2 2 Imager Duo Operator s Manual CAUTION Route all connectors carefully to avoid pinching the cables To avoid tripping over or disconnecting cabling do not place cabling near TN IMAGER DUO SYSTEM INSTALLATION 2 I Extended Network Configuration The Review Scopes may be located at a greater distance from the Image Proces sor 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 fig ure 2 2 The distance that Review Scopes may be locate

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