Hologic ThinPrep Imager Duo Operator's Manual
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Hologic ThinPrep Imager Duo Operator's Manual

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  • Page 1 ThinPrep Imager Duo Imaging Station ® Operator’s Manual...
  • Page 2 ThinPrep Imager Duo ® Imaging System Operator’s Manual OLOGIC 250 C AMPUS RIVE , MA 01752 USA ARLBOROUGH : 1-800-442-9892 1-508-263-2900 : 1-508-229-2795 HOLOGIC For Use With Version 3.x.y Software MAN-08735-001...
  • Page 3 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...
  • Page 5 Operation Summary and Clinical Information The ThinPrep ® Imaging System...
  • Page 6 INTENDED USE The Hologic ThinPrep ® Imaging System (Imager) is a device that uses computer imaging technology to assist in primary cervical cancer screening of ThinPrep Pap Test slides for the presence of atypical cells, cervical neoplasia, including its precursor lesions (Low Grade Squamous...
  • Page 7 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 slides on the ThinPrep Imaging System to prevent slide breakage and/or injury.
  • Page 8 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”...
  • Page 9 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.
  • Page 10 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+.
  • Page 11 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%;...
  • Page 12 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 ASCUS AGUS LSIL HSIL TOTAL ASCUS AGUS LSIL HSIL TOTAL Among the 10 cases determined by the adjudication panel to be AGUS, 4 (40.0%) cases in the Imager Review arm and 3 (30.0%) cases in the Manual Review arm were diagnosed as AGUS and 4 (40.0%) cases in the Imager Review arm and 2 (20.0%) cases in the Manual Review arm were diagnosed as Negative.
  • Page 13 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.
  • Page 14 seven Bethesda System classifications: ASCUS, LSIL, HSIL, AGUS, Glandular Cancer, Squamous Cell Carcinoma and Adenocarcinoma-In-Situ. ® Finally, the same Cytopathologist who had conducted the manual review of the entire ThinPrep Test slide, independently re-reviewed the slides using the identical method used by the Cytotechnologists.
  • Page 15 Table 12: Unadjudicated Marginal Frequencies Summary of Specimen Adequacy Results – All Sites Combined. Manual Review Imager Review Number of Patients: 9627 9627 Descriptive Diagnosis Satisfactory for Evaluation 7375 76.6 7346 76.3 Satisfactory but Limited by 2186 22.7 2252 23.4 Endocervical Component Absent 1196 12.4...
  • Page 16 ® 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;...
  • Page 17 Table 14: Cytotechnologist Screening Rates Total Average Extrapolated Daily Rates Site/CT Review Number of Number of (8-hour workday) Methods Slides Hours Average High Evaluated Screened Per Manual 2568 Site 1 Imager 2297 Manual 1284 Imager 1168 Manual 1284 Imager 1129 Manual 2686 Site 2...
  • Page 18 Laboratorians should use the following method when calculating workload • All slides with Fields of View (FOV) only review count as 0.5 or ½ slide • All slides with full manual review (FMR) using the Autoscan feature count as 1 slide (as mandated by CLIA’88 for manual screening) •...
  • Page 19 Bethesda System 2001 criteria for all slides . The study was conducted at Hologic, Inc., Marlborough, MA and at two external laboratories in the United States. Table 16: Laboratory Imager-Assisted Review Diagnosis vs. Laboratory Manual Review...
  • Page 20 Clinical Study Results Tables 17 through 20 present the comparison of Laboratory true positive and negative rates for ASC-US+, LSIL+, ASC-H+, and HSIL+. Table 17: Laboratory Imager-Assisted Review Results vs. Laboratory Manual Review Results for the Specimens with Reference Diagnosis of ASC-US+ In the study, there were 467 specimens with Reference Diagnosis of ASC-US+ (combined ASC-US, AGUS, LSIL, ASC-H, HSIL, and Cancer) and 770 specimens with Reference Diagnosis of NILM.
  • Page 21 Table 18: Laboratory Imager-Assisted Review Results vs. Laboratory Manual Review Results for the Specimens with Reference Diagnosis of LSIL+ In the study, there were 327 specimens with Reference Diagnosis of LSIL+ (combined LSIL, ASC-H, HSIL, and Cancer) and 910 specimens with Reference Diagnosis of (combined NILM, ASC-US, and AGUS). In this table, “Positive”...
  • Page 22 Table 19: Laboratory Imager-Assisted Review Results vs. Laboratory Manual Review Results for the Specimens with Reference Diagnosis of ASC-H+ In the study, there were 147 specimens with Reference Diagnosis of ASC-H+ (combined ASC-H, HSIL, and Cancer) and 1,090 specimens with Reference Diagnosis of (combined NILM, ASC-US/AGUS, and LSIL). In this table, “Positive”...
  • Page 23 Table 20: Laboratory Imager-Assisted Review Results vs. Laboratory Manual Review Results for the Specimens with Reference Diagnosis of HSIL+ In the study, there were 110 specimens with Reference Diagnosis of HSIL+ (combined HSIL and Cancer) and 1,127 specimens with Reference Diagnosis of (combined NILM, ASC-US/AGUS, LSIL, and ASC-H). In this table, “Positive”...
  • Page 24 Agreement among Laboratory Cytotechnologists/Pathologists The following tables indicate the extent to which the laboratory Cytotechnologists/Pathologists at a given site agreed amongst themselves on the diagnosis, comparing the Imager-assisted review to the manual review. Tables are provided for ASC-US+ and ASC-H+. Note that since one site had only two CT/Pathologist pairs, the three-way agreement analysis is available for just two sites, with 840 total specimens.
  • Page 25 The rate of agreement between the Imager-assisted review result and the manual review result from the previous table is presented below. PPA is the positive percent agreement, percent of specimens of ASC-H+ diagnosis with Imager-assisted review by a majority of laboratory CT/Pathologists among all specimens of ASC-H+ diagnosis with manual review by a majority of laboratory CT/Pathologists.
  • Page 26 The rate of agreement between the Imager-assisted review result and the manual review result from the previous table is presented below. PPA is the positive percent agreement, percent of specimens of ASCUS+ diagnosis with Imager-assisted review by a majority of laboratory CT/Pathologists among all specimens of ASCUS+ diagnosis with manual review by a majority of laboratory CT/Pathologists.
  • Page 27 Clinical Study Design This study was a multi–center, split-sample, blinded evaluation of ThinPrep slides generated from the ThinPrep Genesis processor from the residual cytological specimens. The study was conducted at three (3) laboratories in the United States. All study specimens were processed on ThinPrep Genesis processor using “Slide Only”...
  • Page 28 LSIL, 5 AGUS, 148 ASC-US, 691 NILM, and 5 UNSAT specimens. Clinical sensitivity and specificity (e.g., with reference to a histological diagnosis) cannot be measured in this study which relied on cytological examination alone. Instead, laboratory positive and negative diagnoses by both methods, Imager-assisted and manual review, for the specimens with Reference Diagnosis of ASC- US+ (combined ASC-US, AGUS, LSIL, ASC-H, HSIL, and Cancer), LSIL+ (combined LSIL, ASC-H, HSIL, and Cancer), ASC-H+ (combined ASC-H, HSIL, and Cancer), HSIL+ (combined...
  • Page 29 Table 27: Sensitivity and Specificity for Genesis TIS and Genesis Manual Review Results with Genesis Diagnostic Threshold LSIL+ In the study, there were 402 specimens with Reference Diagnosis of LSIL+ (combined LSIL, ASC-H, HSIL, and Cancer) and 844 specimens with Reference Diagnosis of (combined NILM, ASC-US, and AGUS). In this table, “Positive”...
  • Page 30 Table 29: Sensitivity and Specificity for Genesis TIS and Genesis Manual Review Results with Genesis Diagnostic Threshold HSIL+ In the study, there were 170 specimens with Reference Diagnosis of HSIL+ (combined HSIL and Cancer) and 1,076 specimens with Reference Diagnosis of (combined NILM, ASC-US/AGUS, LSIL, and ASC-H). In this table, “Positive”...
  • Page 31 Results of the clinical study for 22 slides with Reference Diagnosis of Cancer is also presented below where “Positive” means HSIL+ (combined Cancer and HSIL). Table 31: Performance of Laboratory Imager-Assisted Review Results vs. Laboratory Manual Review Results for the Specimens with Reference Diagnosis of Cancer where Positive Means HSIL+ ThinPrep Genesis Manual Total...
  • Page 32 4. National Cancer Institute. SEER Cancer Statistics Review 1973-1998. Available at: http://www.seer.cancer.gov. Accessed February 2002. Hologic, Inc. AW-24499-001 Rev. 001 250 Campus Drive © 2021 Hologic, Inc. All rights reserved. Marlborough, MA 01752 1-800- 442-9892 www. hologic.com MAN-08723-001 Rev. 001 page 28 of 28...

  • Page 34: Table Of Contents

    T a b l e o f C o n t e n t s Chapter One INTRODUCTION SECTION A: Overview and Function of the Imager Duo SECTION B: The ThinPrep ® Imaging System Process SECTION C: Specimen Preparation and Processing SECTION D: Imager Duo Technical Specifications SECTION E: Internal Quality Control 1.16...
  • Page 35 Chapter Four OPERATION OF THE SOFTWARE MENU SECTION A: Slide Processing Menu SECTION B: Reports Menu SECTION C: System Menu SECTION D: Data Management Menu SECTION E: Maintenance Menu 4.71 SECTION F: About Menu 4.71 Chapter Five IMAGER DUO MAINTENANCE SECTION A: Clean Verification Slide SECTION B: Replacing the User-Accessible Fuses SECTION C: Replacing the Imaging Station Air Filter...
  • Page 36 Chapter Eight SERVICE INFORMATION Chapter Nine ORDERING INFORMATION Chapter Ten REMOTE SITE SERVER USER’S GUIDE 10.1 Index Imager Duo Operator’s Manual...
  • Page 37 This page intentionally left blank. Imager Duo Operator’s Manual...

  • Page 39: Chapter One

    NTRODUCTION C h a p t e r O n e 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.
  • Page 40 NTRODUCTION User Interface Imaging Station Image Processor Monitor, Keyboard Server Controller (IPC) and Mouse Figure 1-1 The ThinPrep Imaging Station, Image Processor Controller, Server and User Interface Imager Duo Operator’s Manual...
  • Page 41 NTRODUCTION ThinPrep Imager Duo System: Laboratory Flow Figure 1-2 Lab Flow Imager Duo Operator’s Manual...

  • Page 42: Section B: The Thinprep ® Imaging System Process

    NTRODUCTION SECTION 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.
  • Page 43 NTRODUCTION 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 cell spot is imaged The coordinates of 22 objects of interest with the highest integrated optical density will be...

  • Page 44: Section C: Specimen Preparation And Processing

    NTRODUCTION 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 equipped with a ThinPrep Pro- cessor.

  • Page 45: Section D: Imager Duo Technical Specifications

    NTRODUCTION 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 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.
  • Page 46 NTRODUCTION Sliding Doors (Left Door Open) Imaging Station Housing Robot Shield Slide Cassette (In Position 1 of 10 Positions) Power On Indicator Cassette Platform Divider Imaging Station Figure 1-4 Front View, Imaging Station Imager Duo Operator’s Manual...
  • Page 47 NTRODUCTION Serial Number Air Filter Fuses (inside) On/Off Switch 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...
  • Page 48 NTRODUCTION OCR Station Slide Transfer Robot at the Hold Station Park Station with a Slide Verification Slide Station (Robot Shield Removed) Imaging Stage Figure 1-7 Park Station and Imaging Stage 0123456 7706024 7890049 Frosted region of 8000253 Slide Accession ID the slide (OCR format shown) ®...
  • Page 49 NTRODUCTION Imaging Station Dimensions 22” (55.8 cm) 32.5” (82.5 cm) 25” (63.5 cm) Approximate Weight: 170 lbs (77 kg) Figure 1-9 Imaging Station (shown without doors) Recommended clearances: 3” (76.2 mm) on all sides. Slide Cassette Dimensions 3” (76.2 mm) 10”...
  • Page 50 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.
  • Page 51 NTRODUCTION 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% 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.
  • Page 52 NTRODUCTION 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 Protective Temperature Coefficient Devices The Imaging Station contains protective temperature coefficient (PTC) devices...
  • Page 53 NTRODUCTION 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.

  • Page 54: Section E: Internal Quality Control

    The operator 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).

  • Page 55: Section F: Imager Duo Hazards

    NTRODUCTION SECTION 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.
  • Page 56 NTRODUCTION To identify any terminal which is intended for connection to an external conductor for pro- IEC 60417 Graphical symbols Protective Conductor tection against electric shock for use on equipment, symbol Terminal in case of a fault, or the termi- 5019 nal of a protective earth (ground) electrode...
  • Page 57 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. Imager Duo Operator’s Manual 1.19...
  • Page 58 NTRODUCTION 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.

  • Page 59: Section G: Disposal

    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.
  • Page 60 NTRODUCTION This page intentionally left blank. 1.22 Imager Duo Operator’s Manual...

  • Page 62: Chapter Two

    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.
  • Page 63 MAGER YSTEM NSTALLATION Location And Configuration CAUTION Local Network Configuration Route all connectors 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.
  • Page 64 MAGER YSTEM NSTALLATION CAUTION Extended Network Configuration Route all connectors The Review Scopes may be located at a greater distance from the Image Proces- carefully to avoid sor by using an extended network interconnection between the Server hub and pinching the cables. the Review Scope hub.
  • Page 65 MAGER YSTEM NSTALLATION placed on the floor near the work area, provided it has adequate air circulation to prevent dust accumulation and it is safely removed from foot traffic or other interference. It should be accessible for routine maintenance. The network printer will be installed and set up at the time of instrument instal- lation.

  • Page 67: Chapter Three

    PERATION OF THE MAGER C h a p t e r T h r e e 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.
  • Page 68 PERATION OF THE MAGER Power On (Doors lock while warming up) Doors unlock Load Slide Cassettes Close Doors, Press GO (Doors Lock) View / Print Reports Interrupt / Interrupt / Resume Cancel Batch Complete (Ended) (Doors Unlock) Open Doors, Unload Cassettes Power Off Figure 3-1 Typical Batch Process Imager Duo Operator’s Manual...

  • Page 69: Section B: Applying Power To The Equipment

    PERATION OF THE MAGER SECTION APPLYING POWER TO THE EQUIPMENT WARNING Apply power to the Server, the Imaging Station and the Image Processor Con- troller according to the following procedure. Grounded Outlet Note: All power cords must be plugged into a grounded outlet. Disconnection Instrument Fusing from the power supply source is by removal of the power cord.
  • Page 70 PERATION OF THE MAGER 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.
  • Page 71 PERATION OF THE MAGER 5. At the Image Processor Controller, push the power on button. (Figure 3-5.) Power On Button Note - depending on which model computer you have, it may look different than this graphic Figure 3-5 Image Processor Controller, Power Switch 6.

  • Page 72: Section C: Materials Required Prior To Operation

    PERATION OF THE MAGER SECTION MATERIALS REQUIRED PRIOR TO OPERATION Imaging Station Monitor, Keyboard & Mouse Image Processor Controller (user Interface) and Server Slide Cassettes ThinPrep Pap Test Microscope Slides Figure 3-7 Items Required For Slide Image Processing The Monitor, Keyboard and Mouse are provided and configured with the Imager Duo System equipment at the time of installation.

  • Page 73: Section D: Slide Labeling

    PERATION OF THE MAGER 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 SLIDE LABELING The camera that scans the slide label accession ID recognizes 1-dimensional or...
  • Page 74 PERATION OF THE MAGER 1-Dimensional barcode examples 2-D barcode example OCR format Figure 3-8 Examples of How Barcodes Fit Onto a ThinPrep Slide Imager Duo Operator’s Manual...

  • Page 75: Section E: Loading Slide Cassettes

    PERATION OF THE MAGER SECTION LOADING SLIDE CASSETTES WARNING ® Only stained, coverslipped ThinPrep Pap Test microscope slides for use with Glass the Imaging System may be used. Refer to the ThinPrep Stain User’s Guide for Sharp Edges recommendations for coverslipping media. CAUTION Refer to Figure 3-9.
  • Page 76 PERATION OF THE MAGER CORRECT SLIDE POSITION Empty Slots are OK INCORRECT SLIDE LOADING: Multiple Slides Cocked Slide Slide Overhangs Retaining Features Slide In Backward (Label Toward the Rear) Figure 3-10 Loading Slides into the Cassette When loading slides, confirm that: ®...

  • Page 77: Section F: Load Slide Cassettes Into The Imaging Station

    PERATION OF THE MAGER SECTION 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.) Right Door Left Door Shown with doors fully closed Slide Cassette Position 10 Slide Cassette...
  • Page 78 PERATION OF THE MAGER 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.) Figure 3-12 Loading a Slide Cassette Into the Imaging Station 3.
  • Page 79 PERATION OF THE MAGER 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.
  • Page 80 PERATION OF THE MAGER Figure 3-14 Partial and Fully Loaded Cassette Locations 5. Fully close the Imaging Station sliding doors. 3.14 Imager Duo Operator’s Manual...

  • Page 81: Section G: Slide Processing

    PERATION OF THE MAGER SECTION SLIDE PROCESSING 1. Start the slide processing operation by using the mouse to perform either of the following: At the top of the display, position the cursor on the green GO button and click once. Figure 3-15 Begin Slide Processing - Go Button At the top of the menu bar, select Slide Processing and then in the drop- down menu, click once on Start Slide Processing.
  • Page 82 PERATION OF THE MAGER Figure 3-17 Slide Processing in Progress 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 that the slide imaging system is functioning properly. During Slide Processing As slides are processed, the color of the cassette graphic on the monitor changes from gray to blue to represent how much progress has been made cassette by...
  • Page 83 PERATION OF THE MAGER 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.
  • Page 84 PERATION OF THE MAGER Figure 3-19 Typical Event Log Display If a slide caused an event during processing, the operator should check it at the conclusion of the batch to determine if there is any corrective action that would allow it to be successfully processed in another batch. This may include: •...
  • Page 85 PERATION OF THE MAGER • Slide is dirty (dust, fingerprints) • Slide label not legible for scanning of the accession ID • Slide has already been imaged (accession ID already in the Server database) Note: Always check Slide Already Imaged against the patient record, to confirm that it is not a duplicate accession ID.
  • Page 86 PERATION OF THE MAGER 1. Interrupt the slide processing operation by using the mouse to perform EITHER of the following: At the top of the display, position the cursor on the red STOP button and click once. (Figure 3-20.) Figure 3-20 Slide Processing - Stop Button At the top of the menu bar, select Slide Processing and then in the drop- down menu, click once on Interrupt Slide Processing.
  • Page 87 PERATION OF THE MAGER Figure 3-22 Interrupt Slide Processing Option 3. 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.
  • Page 88 PERATION OF THE MAGER “Return to Slide Processing” Use this option to continue slide processing without interruption. 4. Click once on the OK button when a choice is selected. Or, click on the Can- cel button to continue processing without interruption. 5.
  • Page 89 PERATION OF THE MAGER 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 partially processed next unprocessed cassette it comes to when operation is resumed. cassettes.
  • Page 90 PERATION OF THE MAGER 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.
  • Page 91 PERATION OF THE MAGER 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 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.
  • Page 92 PERATION OF THE MAGER 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). 3.26 Imager Duo Operator’s Manual...
  • Page 93 PERATION OF THE MAGER 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).

  • Page 94: Section H: Completing Slide Processing

    PERATION OF THE MAGER SECTION 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.) Figure 3-31 Slide Processing Complete The doors will unlock.

  • Page 95: Section I: Shutting Down The Imager Duo

    PERATION OF THE MAGER SECTION SHUTTING DOWN THE IMAGER DUO WARNING: Never turn off power to the equipment without shutting down the system via the User Interface! CAUTION Normal Shut Down If Review Scopes Server are also connected Before shutting off the Server, make sure that all other IPCs and Review Scopes to the Imager Duo, work schedules that are networked to it are either turned off, or not actively communicating...
  • Page 96 PERATION OF THE MAGER Figure 3-33 Server Shut Down Button 3. Select “Yes” to continue with shut down. (Figure 3-36). Figure 3-34 Confirm Shut Down Image Processor 1. To power off the Image Processor, at the user interface, use the mouse to pull down the menu under System and click once on Shut Down System.
  • Page 97 PERATION OF THE MAGER Figure 3-35 Shut Down System Menu Selection 2. Select “Yes” to continue with shut down. (Figure 3-36). 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.

  • Page 98: Section J: Rebooting The System

    PERATION OF THE MAGER SECTION 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.

  • Page 100: Chapter Four

    PERATION OF THE OFTWARE C h a p t e r F o u r 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.

  • Page 101: Section B: Reports Menu

    PERATION OF THE OFTWARE SECTION REPORTS MENU The Reports menu contains functions that generate reports for specific compo- ® nents of the ThinPrep Imaging System. 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.
  • Page 102 PERATION OF THE OFTWARE Figure 4-4 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).
  • Page 103 (if Sep 20, 2012, 03:14:56 PM Started: enabled). The Imag- Completed: Sep 20, 2012 03:51:49 PM Lab Name: Hologic ing Station that the 20185J04AP TIS S/N batch was run on is Imager: IP190ZKM1 identified by its serial...
  • Page 104 PERATION OF THE OFTWARE ThinPrep Imaging System Run Report ® Sep 20, 2012, 03:14:56 PM Started: Completed: Sep 20, 2012 03:51:49 PM Hologic Lab Name: Slides that are 20185J04AP TIS S/N ready for review Imager: IP190ZKM1 are listed by slot...

  • Page 105: Section C: System Menu

    PERATION OF THE OFTWARE SYSTEM MENU SECTION 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.) Figure 4-7 System Menu Shut Down System This selection will shut down the Image Processor Controller (IPC) and power...
  • Page 106 PERATION OF THE OFTWARE 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.

  • Page 107: Section D: Data Management Menu

    PERATION OF THE OFTWARE SECTION 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).
  • Page 108 PERATION OF THE OFTWARE 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.) 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.
  • Page 109 PERATION OF THE OFTWARE 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.
  • Page 110 PERATION OF THE OFTWARE Select the start date and time for a scheduled backup and whether it recurs daily, weekly or monthly Click Submit to enable the sched- ule or Delete to inactivate the schedule. Status indicates Ready or backup in progress.
  • Page 111 PERATION OF THE OFTWARE Archive function available on Server Data Management menu Security feature is enabled Figure 4-16 Archive Function on Server Data Management Menu Click on the Archive icon to launch the dialog window. The user selects whether to backup before archiving Date range is chosen...
  • Page 112 PERATION OF THE OFTWARE Use the checkbox to backup the database (the selected date range) before the purge function begins. Select the desired storage media by clicking its radio button. If a media type is not available a message will prompt for a device to be loaded.
  • Page 113 PERATION OF THE OFTWARE To view a report of the slides that have been selected, click on the View button. 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.
  • Page 114 PERATION OF THE OFTWARE 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 that was selected. Then the slide data records for the date range are purged.
  • Page 115 PERATION OF THE OFTWARE From a Server Data Management menu, enable Security if it is not already acti- vated. Click on the Restore Archive icon in the menu. Restore Archive Security is enabled Figure 4-25 Restore Archive on Server Data Management Menu 4.16 Imager Duo Operator’s Manual...
  • Page 116 PERATION OF THE OFTWARE Select which storage media the backup located on. Select Slide(s) to be restored to the system database Progress and status of the restore process Figure 4-26 Restore Archive Selection Screen From the Load Archive field, select which media the archived material is stored on.
  • Page 117 PERATION OF THE OFTWARE 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.
  • Page 118 PERATION OF THE OFTWARE 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).
  • Page 119 PERATION OF THE OFTWARE Click on the Export icon to display the window (Figure 4-29). Accession Number Range Field Slide ID Filter to Sort for Specific Charac- ters (Lab ID Codes, Date, etc.) Checkbox to Export all data since the last export Checkbox to view data before export...
  • Page 120 PERATION OF THE OFTWARE 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. A maximum of 10,000 records may be exported at one time.
  • Page 121 PERATION OF THE OFTWARE Filter for a date code of 2012 that pre- cedes the accession number 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 Single character...
  • Page 122 PERATION OF THE OFTWARE 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.
  • Page 123 PERATION OF THE OFTWARE If the Confirm export before writing checkbox is not checked, clicking on the Export button will immediately begin the export function. 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.
  • Page 124 PERATION OF THE OFTWARE 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. 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.
  • Page 125 PERATION OF THE OFTWARE 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).
  • Page 126 PERATION OF THE OFTWARE Transport of patient slides: if slides are to be transported 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.
  • Page 127 PERATION OF THE OFTWARE 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.
  • Page 128 PERATION OF THE OFTWARE 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.
  • Page 129 PERATION OF THE OFTWARE Import Contents Import date Importing lab Summary Total slides Slides imaged successfully Slides with imaging errors Minimum slide ID Maximum slide ID Activity and status: Checking media Preparing data Updating database Complete Figure 4-45 Import Results Summary To see a report of the import results, click the Results button.
  • Page 130 PERATION OF THE OFTWARE 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.
  • Page 131 PERATION OF THE OFTWARE 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...
  • Page 132 PERATION OF THE OFTWARE Enter Slide ID and click Lock button to prevent slides from being purged. List of slide IDs that have been locked. To view the imaging and review status of one or multiple slides, highlight them in the list and click the View button.
  • Page 133 PERATION OF THE OFTWARE 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).
  • Page 134 PERATION OF THE OFTWARE 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.
  • Page 135 PERATION OF THE OFTWARE Reports 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.
  • Page 136 PERATION OF THE OFTWARE 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.
  • Page 137 PERATION OF THE OFTWARE 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.) Figure 4-52 System Error Log The errors are displayed with the most recent events at the top and older events...
  • Page 138 PERATION OF THE OFTWARE 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.
  • Page 139 PERATION OF THE OFTWARE 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”...
  • Page 140 PERATION OF THE OFTWARE 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.
  • Page 141 PERATION OF THE OFTWARE 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.
  • Page 142 PERATION OF THE OFTWARE 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.
  • Page 143 PERATION OF THE OFTWARE • Begins With means a list of all entries that begin with a particular string of characters • 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). Figure 4-58 Operators Report Click on Print to print the report.
  • Page 144 PERATION OF THE OFTWARE 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.) Figure 4-59 Slide Data Record Window The slide data record report may be sorted by slide ID information, by slide...
  • Page 145 PERATION OF THE OFTWARE 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...
  • Page 146 PERATION OF THE OFTWARE 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.
  • Page 147 PERATION OF THE OFTWARE 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 according to which operator reviewed slides.
  • Page 148 PERATION OF THE OFTWARE Slide Data Record Report When all sort parameters have been selected for the slide data report, click the View button to see the report. Figure 4-64 Slide Data Record Report The report will list all slide data records within the parameters that were selected.
  • Page 149 PERATION OF THE OFTWARE 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 was required.
  • Page 150 PERATION OF THE OFTWARE 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).
  • Page 151 PERATION OF THE OFTWARE 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.
  • Page 152 PERATION OF THE OFTWARE Figure 4-68 CT Reviews Report Rate 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.
  • Page 153 PERATION OF THE OFTWARE Figure 4-69 Rate Report Window 4.54 Imager Duo Operator’s Manual...
  • Page 154 PERATION OF THE OFTWARE 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).
  • Page 155 PERATION OF THE OFTWARE 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...
  • Page 156 PERATION OF THE OFTWARE 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.
  • Page 157 PERATION OF THE OFTWARE Scroll forward or backward Change the highlighted using the arrows value 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.
  • Page 158 PERATION OF THE OFTWARE Select the desired options that are available and then click the Apply button. The Reset button will reset all settings to the default. 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.
  • Page 159 PERATION OF THE OFTWARE 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.
  • Page 160 PERATION OF THE OFTWARE System - Security Enabling Security will restrict access to: • Workload History • User Account Management • 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.
  • Page 161 PERATION OF THE OFTWARE 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. Figure 4-79 Security Yes/No Dialog Box Click Yes to set the password, or No to cancel the process.
  • Page 162 (a blank field is not allowed). The password is case sensitive. password, contact Note: If your password is lost or forgotten, a Hologic Service visit is required Hologic Technical to disable the security. Support. Restricted Data When Data Management has security enabled, the User Accounts menu and the Workload Report menu are not accessible without the administrative password.
  • Page 163 PERATION OF THE OFTWARE Slide Data Record Window Slide Data Record Window with Security Enabled Figure 4-82 Slide Data Record Report Selection Criteria 4.64 Imager Duo Operator’s Manual...
  • Page 164 PERATION OF THE OFTWARE 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.
  • Page 165 PERATION OF THE OFTWARE 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. Figure 4-85 Administrative Access Mode Administrative work can be done in any area of the Data Management pro- gram.
  • Page 166 PERATION OF THE OFTWARE 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.
  • Page 167 PERATION OF THE OFTWARE 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 open access to all reports and windows Figure 4-88 Security Disable Window To disable the password security, click on the Disable...
  • Page 168 To shut down the server, click on the Shutdown button. 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.
  • Page 169 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 trouble- shooting. 4.70...

  • Page 170: Section E: Maintenance Menu

    PERATION OF THE OFTWARE SECTION 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.
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  • Page 173: Chapter Five

    Imager Duo Maintenance The instrument must be maintained regularly in order to ensure reliable perfor- mance. Perform maintenance on the instrument as described in this section. The instrument requires supplemental preventive maintenance annually by Hologic service personnel. SECTION CLEAN VERIFICATION SLIDE...
  • Page 174 MAGER AINTENANCE Retrieve button when ready. It takes several seconds to retrieve the slide and place it in the slide cassette. A “please wait...” message is displayed. (Figure 5-2.) CAUTION Do not place the empty cassette into an empty slot until directed to do so by the system.

  • Page 175: Section B: Replacing The User-Accessible Fuses

    Inspect the slide to make sure it is not cracked, scratched is very delicate. Only or damaged in any way. Contact Hologic Technical Support if the slide is dam- handle it by the aged in any way.
  • Page 176 MAGER AINTENANCE WARNING 1. Turn off the instrument. Instrument Fusing 2. Remove the power cord from the uninterruptable power supply. 3. Remove the power cord from the receptacle on the instrument. Only replace with 4. Using the small #1 slotted screwdriver provided with the system, carefully fuses of the pry open the cover of the power entry module (Figure 5-5).
  • Page 177 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...

  • Page 178: Section C: Replacing The Imaging Station Air Filter

    MAGER AINTENANCE SECTION 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 3.29.) 2.
  • Page 179 MAGER AINTENANCE 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.
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  • Page 182: Chapter Six

    ROUBLESHOOTING C h a p t e r S i x Troubleshooting The Image Processor errors sort into two groups - Slide Events and System Errors. SECTION 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.
  • Page 183 ROUBLESHOOTING 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.
  • Page 184 3.7). • 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.
  • Page 185 ROUBLESHOOTING Table 6.1: Event Log Error Messages Event Log Error Possible Cause Corrective Action Message 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 Confirm that the slide is loaded with cassette correctly.

  • Page 186: Section B: System Errors

    ROUBLESHOOTING SECTION 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.
  • Page 187 ROUBLESHOOTING 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.
  • Page 188 ROUBLESHOOTING User Assisted Recovery Option Click on the Begin User 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.
  • Page 189 ROUBLESHOOTING 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. Figure 6-4 User Assisted Shutdown Click on the button and allow the system to shut down.

  • Page 190: Section C: Slide Preparation And Quality

    ROUBLESHOOTING SECTION 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.
  • Page 191 ROUBLESHOOTING 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.
  • Page 192 ROUBLESHOOTING SECTION IMAGING STATION AND IPC ERRORS Table 6.2: Imaging Station and IPC Errors Error # Error Text Corrective Action 2407 Slide has been rejected. • See Section C, Slide Preparation and Quality. 2409 Three consecutive 2407 errors • If more than one Imaging Station within a cassette generate a is in the lab, insure that the veri- 2409.

  • Page 193: Section D: Imaging Station And Ipc Errors

    ROUBLESHOOTING 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.
  • Page 194 ROUBLESHOOTING 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). persists, contact Technical Sup- port. 4756 Slide has been rejected. •...
  • Page 195 ROUBLESHOOTING Table 6.2: Imaging Station and IPC Errors Error # Error Text Corrective Action 5096 Fail connection to server. • Check switch connections and data bus harness connections • Power Cycle the Imaging Sys- tem. NOTE that the IS and IPC should always be power cycled together.
  • Page 196 ROUBLESHOOTING 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 error the server. persists, contact Technical Sup- port. 6901 through Verification slide and focus errors. •...
  • Page 197 ROUBLESHOOTING SECTION DATA EXPORT, IMPORT AND BACKUP ERRORS During data export, import or backup procedures, text messages appear if an error condition has occurred. Many conditions can be corrected by the operator, for example, by checking for a blank CD in the CD drive. Some errors may not be corrected by the operator, for example, if a database error caused a backup to fail.
  • Page 198 Database image too large for media. Too much data to fit on selected If this message appears during database media type. backup, consult Hologic Technical Support. Database query failed. A database query failed. Try the function again. If the error persists, con- (when viewing Import Results) tact Technical Support.
  • Page 199 ROUBLESHOOTING Table 6.3: Data Export, Import and Backup Errors Error Text Possible Cause Corrective Action Incorrect FOI Count. An error occurred during data Contact Technical Support. import. Initialization error. A server error occurred while Try the function again. trying to initialize data for the operation.
  • Page 200 ROUBLESHOOTING 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 The storage media must be writable. Try using a on the server is not writable and different DVD/CD or USB.
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  • Page 203: Chapter Seven

    EFINITIONS AND BBREVIATIONS C h a p t e r S e v e n Definitions and Abbreviations Batch A group of slides, or cassettes containing slides, that are being processed by the Image Processor. Each cassette holds up to 25 slides. 10 cassettes may be loaded into the Image Processor, therefore a batch may have up to 250 slides in it.
  • Page 204 EFINITIONS AND BBREVIATIONS 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.
  • Page 205 EFINITIONS AND BBREVIATIONS 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. ® ThinPrep A specific brand of glass microscope slide that must be used with the ThinPrep Microscope system of instruments.
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  • Page 208 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.
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  • Page 211 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.
  • Page 212 RDERING NFORMATION Reordering Supplies for the Imaging Station and Image Processor Controller Part Item Description Quantity Number Slide Cassette, 10-pack Additional slide cassettes 1 pkg 70773-001 Operator’s Manual Additional Operator’s Manual MAN-08735- Fuse, 5x20 mm Time Delay, Replacement fuses 50077-021 Glass, 6.3A for Imaging Station Air Filter for Imaging Station Replacement air filter...
  • Page 214 ’ EMOTE ERVER UIDE C h a p t e r T e n 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.
  • Page 215 ’ EMOTE ERVER UIDE CAUTION Network Configuration Route all connectors The Server monitor, keyboard, mouse, printer and a multiport Ethernet hub carefully to avoid must be located in the same area, so that interconnection cables easily reach pinching the cables. each component (within 1.8 meters [6 feet] of each other).
  • Page 216 ’ EMOTE ERVER UIDE CAUTION Extended Network Configuration Route all connectors The Review Scopes may be located at a greater distance from the Server by carefully to avoid using an extended network interconnection between the Server hub/switch pinching the cables. and the Review Scope hub/switch.
  • Page 217 ’ EMOTE ERVER UIDE Component Configuration The components may be arranged on the bench top as desired, providing the connection cables can reach easily. The Server may be placed on the floor near the work area, provided it has adequate air circulation to prevent dust accumu- lation and it is safely removed from foot traffic or other interference.
  • Page 218 ’ EMOTE ERVER UIDE 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 screen is dis- played. Refer to Figure 10-4. The printer and Review Scopes may be powered on before or after the Server.
  • Page 219 ’ EMOTE ERVER UIDE Click on the Data Management Program link to access the Data Management menu options. 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.
  • Page 220 ’ EMOTE ERVER UIDE CAUTION Normal Shut Down If Review Scopes To shut down the Server, expand the System menu and click on Server. are also connected to the Imaging If Review Scopes are still connected via System, work the network, they will be listed here. schedules must be Review sessions should be concluded coordinated so that...
  • Page 221 ’ EMOTE ERVER UIDE Click on Yes to shut down the Server. Click on No to cancel the action and return to the Data Management window. 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.
  • Page 223 NDEX Index 4.71 About Menu 4.21 Accession Number Range Accessories Air Filter, Imaging Station 4.58 Alarm Applying power to the equipment 4.11 archive Auto print batch reports barcode format Batch Batch process diagram 3.24 Cancel The Batch After Interrupting Slide Processing Cassette 3.13 cassette locations...
  • Page 224 NDEX Data Management menu 4.58 Data, how many lines in a report Database backup 4.30 database conflict 4.57 Date, setting 4.58 Date/Time format 1.14 Dimensions Disposal consumables 1.21 device 1.21 electrical and electronic equipment 1.21 3.16 During Slide Processing 1.13 Environmental specifications 6.11 Errors...
  • Page 225 NDEX 3.15, 3.22, 3.24, 4.1, GO button Image Processor 3.6, Image Processor Controller 4.58 Imager Name, setting Imaging Station 6.11 Imaging Station and IPC Errors 4.41 Imaging System Usage History 4.27 Import data 4.60 Install Printers Installation 3.19, 3.20 Interrupt Slide Processing Items Required For Slide Image Processing 4.56 Lab Settings...
  • Page 226 NDEX Ordering Information 4.58 Page Setup 4.61 Password change 4.67 disable 4.68 enable 4.62 validate 4.65 Power on equipment 1.13 Power Specifications 4.59 Printers 3.28 Processing Completed... 3.22 Processing Interrupted 1.14 Protective Temperature Coefficient Devices 4.53 Rate report 3.32 Rebooting the System 10.1 Remote site Replace/Clean Verification Slide...
  • Page 227 NDEX 4.61 Security 4.69 Server - Data Management menu 4.37 Server Error Log 4.69 Service - Data Management Menu Service Information 4.57 Set Date 4.58 Set Imager Name 4.57 Set Time 3.24, 3.29, 3.30 Shut Down IP 4.7, 4.69, 10.6 Shut down server Shut down system Shutdown System...
  • Page 228 NDEX Slot has slide out of position 3.15, 3.24 Start Slide Processing 3.24 stat slides 3.20, STOP button Store verification slide 4.56 System - Data Management menu System Auto-Recovery Errors 4.38 System Error Log SYSTEM ERRORS 4.59 System Printers System warmup 2.1, Technical Support 4.24...
  • Page 230 Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 USA 1-800-442-9892 1-508-263-2900 www.hologic.com MAN-08735-001 Rev. 001...

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