Page 1 Genius™ Review Station Operator’s Manual...
Page 2 Genius™ Review Station Operator’s Manual Hologic, Inc. Hologic BV Australian Sponsor: 250 Campus Drive Da Vincilaan 5 Hologic (Australia and Marlborough, MA 01752 USA 1930 Zaventem New Zealand) Pty Ltd Tel: 1-800-442-9892 Belgium Suite 302, Level 3 1-508-263-2900 2 Lyon Park Road...
Page 3 Hologic to evaluate ThinPrep-prepared slides. © Hologic, Inc., 2022 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.
Page 4 Revision History Revision Date Description AW-24825-001 Rev. 001 Clarify instruction use. Add instructions regarding reporting serious 8-2021 incidents. AW-24825-001 Rev. 002 Administrative change 3-2022...
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Page 7 Genius™ Digital Diagnostics System Instructions for Use Genius™ Digital Diagnostics System Instructions for Use English AW-24823-001 Rev. 001 8-2021 1/32...
Page 8 INTENDED USE The Genius™ Digital Diagnostics System, when used with the Genius™ Cervical AI algorithm, is indicated for assisting in 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 cytological categories, including adenocarcinoma, as defined by The Bethesda System for Reporting Cervical Cytology...
Page 9 The summary of safety and performance for this device may be found within Hologic's website at hologic.com/package-inserts and in the EUDAMED database at ec.europa.eu/tools/eudamed.
Page 10 PRECAUTIONS • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Digital Imager, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Page 11 OOI Study: Specimen Enrollment Table 1 shows the nominal enrollment diagnoses (base on donor lab results) for the slides in the study. In this study there was no independent truth standard, so the study did not measure absolute accuracy; the study compared TIS-assisted review with the OOIs on the Genius Digital Diagnostics System.
Page 12 Study Results: ECC Detection on Normal Cases Endocervical component (ECC) presence is noted during slide review to confirm adequate cellular sampling. ECC consists of either endocervical or squamous metaplastic cells. Because the Genius Digital Diagnostics cervical cancer algorithm prioritizes the presentation of abnormal cells when they are present, ECC detection was assessed in this study on the subset of slides deemed normal (NILM) by TIS-assisted review.
Page 13 Infectious Organism Detection The presence of infectious organisms is noted as part of slide review to help in the clinical assessment of the case. In this study, slides were enrolled that included three classes of organism: Trichomonas, Candida, and Coccobacilli. The tables below compare the detection of each organism on TIS-assisted review and review of OOIs in the gallery of a Genius Digital Diagnostic Review Station.
Page 14 Table 5. Candida Detection: Agreement between TIS-assisted Review and OOI Study Results CAND (57%, 90%) Agreement (96%, 100%) Rates 8.6% (5.7%, 12.6%) Detection 7.8% (5.1%, 11.7%) Rates 0.8% (-1.8%, 3.4%) (Diff) The detection rate for Candida for the Genius Digital Diagnostics System was 7.8%, compared to 8.6% for TIS-assisted review.
Page 15 To obtain the manual cell count for the slides in the study, a CT viewed the whole slide image presented on the Genius Review Station, counted the cells presented in a portion of the cell spot image, and estimated the total number of cells based on the portion, similar to the normal process for counting cells on slides viewed on a microscope.
Page 16 A total of 50 specimens, including at least 8 slides with counts near the clinically critical threshold of 5000 cells, were enrolled in the study. The slides covered a range of cellularity typical of a clinical environment. Figure 1 compares the cell counts between the Genius Cervical AI algorithm and a manual cell count method for each specimen.
Page 17 The study calculated the average cell count generated by the Genius Cervical AI algorithm for each case across the three runs on each of the three Digital Imagers in the study. The intra-instrument %CV in the study was 0.6%. The inter-instrument %CV in the study was 2.7%. The study also estimated the systematic bias of the cell count generated by the Genius Cervical AI algorithm as compared to the manual count, at a count of 5000 cells, the clinical threshold for diagnosis.
Page 18 Laboratory and Patient Characteristics The cytology laboratories participating in the study were comprised of four (4) centers. All sites selected had extensive experience in the processing and evaluation of gynecologic ThinPrep slides, and were trained in the use of the Genius Digital Diagnostics System. A total of 2020 cases, with 1 slide from each patient (505 cases at each site), were evaluated in this study.
Page 19 Exclusion Criteria Slides that were broken or rendered unreadable for the purposes of this study were excluded from the study. Criteria for Evaluation The primary objective of this study was to estimate the sensitivity and specificity when diagnosing cases imaged and reviewed on the Genius Digital Diagnostics System compared with manual review at the ASCUS+ threshold.
Page 20 Table 8. Adjudicated Review vs. Manual Review and Genius Digital Diagnostics System Review, Descriptive Diagnosis Summary (All Cases) Sensitivity % Specificity % Diagnostic Manual Genius Difference Manual Genius Difference Threshold (95% CI) (95% CI) (95% CI) (95% CI) (95% CI) (95% CI) ASCUS+ 76.8...
Page 21 Table 9. Adjudicated Review vs. TIS Review and Genius Digital Diagnostics System Review (Genius), Descriptive Diagnosis Summary (All Cases) Sensitivity % Specificity % Diagnostic Genius Difference Genius Difference Threshold (95% CI) (95% CI) (95% CI) (95% CI) (95% CI) (95% CI) ASCUS+ 76.1 76.4...
Page 22 Table 10. “True Negative” (NILM) Contingency Table (for all Sites Combined) Overall Adjudicated NILM Genius Digital Diagnostics System vs. Manual Review Manual UNSAT NILM ASCUS AGUS LSIL ASC-H HSIL Cancer UNSAT 2881 NILM ASCUS AGUS Genius LSIL ASC-H HSIL Cancer Table 11.
Page 23 Table 12. “True AGUS” Contingency Table (for all Sites Combined) Overall Adjudicated AGUS Genius Digital Diagnostics System vs. Manual Review Manual UNSAT NILM ASCUS AGUS LSIL ASC-H HSIL Cancer UNSAT NILM ASCUS AGUS Genius LSIL ASC-H HSIL Cancer Table 13. “True LSIL” Contingency Table (for all Sites Combined) Overall Adjudicated LSIL Genius Digital Diagnostics System vs.
Page 24 Table 14. “True ASC-H” Contingency Table (for all Sites Combined) Overall Adjudicated ASC-H Genius Digital Diagnostics System vs. Manual Review Manual UNSAT NILM ASCUS AGUS LSIL ASC-H HSIL Cancer UNSAT NILM ASCUS AGUS Genius LSIL ASC-H HSIL Cancer Table 15. “True HSIL” Contingency Table (for all Sites Combined) Overall Adjudicated HSIL Genius Digital Diagnostics System vs.
Page 25 Table 16. “True Cancer” Contingency Table (for all Sites Combined) Overall Adjudicated Cancer Genius Digital Diagnostics System vs. Manual Review Manual UNSAT NILM ASCUS AGUS LSIL ASC-H HSIL Cancer UNSAT NILM ASCUS AGUS Genius LSIL ASC-H HSIL Cancer Table 17. “True UNSAT” Contingency Table (for all Sites Combined) Overall Adjudicated UNSAT Genius Digital Diagnostics System vs.
Page 26 Table 18 shows the performance of Genius Digital Diagnostics System review and manual review compared to adjudicated diagnostic threshold made by the adjudication panel for the following major descriptive diagnostic thresholds: ASCUS+, LSIL+, ASC-H+, and HSIL+. Table 18. Contingency Table (for all Sites Combined) Overall Adjudicated vs.
Page 27 Cellular changes consistent with Herpes virus 0.0% 0.1% Other infection 0.0% 0.0% Other Non-Neoplastic Findings 7.5% 8.7% Reactive cellular changes associated with 3.8% 4.7% inflammation Atrophy 3.3% 3.4% Reactive cellular changes associated with 0.0% 0.0% radiation Reactive cellular changes associated with IUD 0.0% 0.0% Glandular cells status post hysterectomy...
Page 28 Seventeen-hundred, forty-four (1744) slides produced from clinical specimens were available for review by CTs using the Genius Review Station in this study. Slides were imaged using two Genius Digital Imagers. Ten cytotechnologists each reviewed the resulting case images over the course of five days, working up to 8 hours per day.
Page 29 Table 21. CT Review Rates, Time Per Case Internal Study Median Minimum Maximum Reviewer Review Time per Case Review Time per Case Review Time per Case (minutes:seconds) (minutes:seconds) (minutes:seconds) CT-1 01:03 00:17 07:04 CT-2 01:03 00:16 06:44 CT-3 01:02 00:19 05:41 CT-4 00:56...
Page 30 Table 22. Sensitivity and Specificity Summary for all CTs vs. Clinical Thresholds (internal study) Median Review Sensitivity Specificity Time per Case ASCUS +/- LSIL +/- ASC-H +/- ASCUS +/- LSIL +/- ASC-H +/- (minutes:seconds) CT-1 01:03 77.0% 81.0% 80.1% 92.5% 92.6% 93.2% CT-2...
Page 31 Figure 2. CT Case Review Time vs. Sensitivity / Specificity (internal study) Figure 3 shows the diagnostic agreement with adjudicated truth at the ASCUS +/- threshold as a function of individual CT case review times across all CTs in this study. Figure 3.
Page 32 Table 23. Case Adequacy Contingency Table – Results from all 10 CTs Combined (internal study) Adjudicated Result Satisfactory Unsatisfactory Satisfactory 15772 Genius Digital Diagnostics System Result Unsatisfactory The results show a 98.6% agreement across all results between the Genius Digital Diagnostics System adequacy reviews versus adjudicated adequacy results, and unsatisfactory rates of 1.2% for both the Genius Digital Diagnostics System and adjudicated results.
Page 33 Figure 4. CT Case Review Time vs. Sensitivity (Clinical Study and Internal Study) Figure 5 compares the median CT review rates from both the clinical study and the internal study to the specificity of diagnostic agreement with adjudicated truth at the ASCUS+/- threshold. Genius™...
Page 34 Figure 5. CT Case Review Time vs. Specificity (Clinical Study and Internal Study) In both studies, the amount of time spent by the CT to review a case on the Genius Digital Diagnostics System did not change the rate of agreement with the adjudicated diagnostic result at the ASCUS +/- threshold.
Page 35 The slides were evaluated using a manual microscope as a control. The slides were imaged on a Genius Digital Imager. After a two-week washout period to minimize recognition bias, the case images were evaluated using the Genius Review Station. Non-gynecological Study Results Table 24 provides the overall results of the diagnostic screening of the specimens.
Page 36 Further analysis of the study data was performed to compare the diagnoses from the Genius case review versus the manual review of the glass slides for slides where a diagnosis was possible. The results are presented in Table 25. Table 25. Proportions of Diagnoses of Abnormal Cases, Non-Gynecological Specimens Proportion 95% confidence interval Manual Review...
Page 37 Network switch *In some configurations of the system, the laboratory may supply the Review Station computer into which Hologic installs a Hologic-supplied graphics card. In some configurations of the system, a laboratory may supply the server hardware. MATERIALS REQUIRED BUT NOT PROVIDED •...
Page 38 Hologic, Inc. Hologic BV 250 Campus Drive Da Vincilaan 5 Marlborough, MA 01752 1930 Zaventem 1-800-442-9892 Belgium www.hologic.com ©2021 Hologic, Inc. All rights reserved. Genius™ Digital Diagnostics System Instructions for Use English AW-24823-001 Rev. 001 8-2021 32/32...
Page 40: Table Of Contents
SECTION C: The Genius Digital Diagnostics System Process for Non-Gyn and UroCyte Specimens .....1.6 SECTION D: Specimen Preparation...........1.8 SECTION E: Review Station Technical Specifications ....1.9 SECTION F: Internal Quality Control........1.13 SECTION G: Genius Review Station Hazards .......1.14 SECTION H: Disposal ..............1.18 Chapter Two Installation SECTION A: General..............2.1 SECTION B: Action Upon Delivery ..........2.1...
Page 41 SECTION B: Log In ..............3.3 SECTION C: Display Overview ..........3.7 SECTION D: Settings..............3.12 SECTION E: Customize the view ..........3.26 SECTION F: Bookmarks ............3.42 SECTION G: Reports..............3.43 Chapter Four Operation SECTION A: Overview ..............4.1 SECTION B: Materials Required Prior to Operation ....4.4 SECTION C: Review a Case............4.5 Chapter Five Maintenance...
Page 43: Chapter One
The Review Station consists of: The Monitor, a specialized, high-resolution computer display screen provided by Hologic, with resolution sufficient to view the images at the images’ full captured resolution.
Page 44 The Computer that hosts the system application, a keyboard and a mouse. An optional barcode scanner can also be used with the computer. Figure 1-1 Genius Review Station Note: The computer shown in photos and illustrations in this operator’s manual may differ from the appearance of the computer used in your laboratory.
Page 45 The Genius Digital Diagnostics System includes the Genius Digital Imager, the Genius Image Management Server, and the Genius Review Station. The system is for the creation and viewing of digital images of scanned ThinPrep glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy.
Page 46: Section B: The Genius Digital Diagnostics System Process For
NTRODUCTION SECTION THE GENIUS DIGITAL DIAGNOSTICS SYSTEM PROCESS FOR CERVICAL CANCER SCREENING Slides that have been prepared for screening are loaded into slide carriers which are placed into the Digital Imager. The operator uses a touch screen on the Digital Imager to interact with the instrument via a graphic, menu-driven interface.
Page 47 NTRODUCTION Genius Digital Diagnostics System Process, Gyn Cases Prepared ThinPrep slides are loaded into a slide carrier, which is loaded into the Digital Imager. The cell spot is imaged. The Digital Imager scans the entire cell spot. The algorithm identifies objects of interest found on the slide.
Page 48: Section C: The Genius Digital Diagnostics System Process For
NTRODUCTION SECTION THE GENIUS DIGITAL DIAGNOSTICS SYSTEM PROCESS FOR NON-GYN AND UROCYTE SPECIMENS Slides that have been prepared for screening are loaded into slide carriers which are placed into the Digital Imager. The operator uses a touch screen on the Digital Imager to interact with the instrument via a graphic, menu-driven interface.
Page 49 NTRODUCTION Genius Digital Diagnostics System Process, Non-Gyn Cases or UroCyte Cases Prepared ThinPrep slides are loaded into a slide carrier, which is loaded into the Digital Imager. The Digital Imager scans the entire cell spot. Case data and images are stored on the The cell spot is Image Management Server.
Page 50: Section Dspecimen Preparation
NTRODUCTION SECTION SPECIMEN PREPARATION The Review Station is used to review images and slide data from specimens that have been processed on a Genius Digital Imager. Refer to the operator’s manual for the Digital Imager for information on using the Digital Imager. Genius™...
Page 51: Section Ereview Station Technical Specifications
NTRODUCTION SECTION REVIEW STATION TECHNICAL SPECIFICATIONS Overview of Components Monitor Computer Figure 1-4 Review Station Components Key to Figure 1-4 Monitor power button, under the connector compartment cover Connection to the Image Management Server (depicted in concept in Figure 1-4) Computer processor card, installed in the computer Genius™...
Page 52 NTRODUCTION Key to Figure 1-4 Computer power button, location varies by computer model Computer keyboard Computer mouse Barcode scanner (optional, not shown in Figure 1-4) 1.10 Genius™ Review Station Operator’s Manual...
Page 53 The Review Station monitor only weighs approximately 17.7 kg (39 lbs.). Review Station Computer Specifications Depending on the configuration in your laboratory, the computer may be supplied by Hologic with the graphics card already installed. The minimum specifications for the Review Station computer...
Page 54 NTRODUCTION • Keyboard and Mouse Operating System: • Window 10 – 64Bit Operating temperature range Refer to the documentation provided with the monitor and computer. Non-operating temperature range Refer to the documentation provided with the monitor and computer. Operating humidity range Refer to the documentation provided with the monitor and computer.
Page 55: Section Finternal Quality Control
NTRODUCTION Fuses Refer to the documentation provided with the monitor and computer for power specifications. Fuses are not user-accessible and are not intended to be changed by users. Contact Technical Support if the instrument does not operate. Do not remove any covers on the components other than the monitor’s connector compartment cover.
Page 56: Section Ggenius Review Station Hazards
If this equipment is used in a manner not specified by the manufacturer, then the protection provided by the equipment may be impaired. The monitor and graphics card for the Review Station are those supplied by Hologic specifically for the Genius Digital Diagnostics System. They are required for proper performance of the system and cannot be substituted.
Page 57 Consult the instructions for use In Vitro diagnostic medical device Fuse (Not user-accessible) Waste Electrical and Electronic Equipment Do not dispose in municipal waste Contact Hologic for disposal of the instrument Serial number Manufacturer Date of manufacturer Authorized representative in the European Community Genius™...
Page 58 NTRODUCTION Catalogue number On (Power switch) Off (Power switch) On/Off, Standby mode USB 3 port (computer) Ethernet port (computer) Made in USA Information is applicable only in the USA and Canada Product meets the requirements for CE marking in accordance with EU-IVD Regulation 2017/746 Caution: Federal (USA) law restricts this device to sale by or on the order of a physician, or any other practitioner licensed by the law of the State in which the practitioner practices to...
Page 59 Note: The number and exact location of ports, labels and buttons may be different, depending on the computer model you have. If the computer is not supplied by Hologic, the serial number may be in a different location. Figure 1-7 Location of Labels on the Instrument Genius™...
Page 60: Section H: Disposal
WARNING: Grounded Outlet. To ensure safe operation of the instruments, use a three-wire grounded outlet. Limitations The monitor and graphics card for the Review Station are those supplied by Hologic specifically for the Genius Digital Diagnostics System. They are required for proper performance of the system and cannot be substituted.
Page 62: Chapter Two
Hologic personnel trains the operator(s), using the operator’s manual as the training guide. The Review Station should only be used by personnel who have been trained by Hologic or by organizations or individuals designated by Hologic. SECTION ACTION UPON DELIVERY Inspect the packing cartons for damage.
Page 63 Do not position the instrument so that it is difficult to disconnect the power cords. Computer preparation Depending on the configuration in your laboratory, the computer may be supplied by Hologic with the required graphics card already installed, or Hologic Field Service may install the required graphics card in a computer which meets the required specifications.
Page 64 Hologic incorporates secure design principles into the product development life cycle to minimize cybersecurity risks. Genius Review Station software may come preinstalled on hardware provided by Hologic or hardware provided by the customer. Installation of third-party software beyond antivirus software is not officially supported by Hologic and may adversely affect system performance.
Page 65: Section Dmoving The Review Station
Hologic continually evaluates software updates, security patches, and the effectiveness of the implemented security safeguards to determine if updates are needed to mitigate emerging threats. Hologic will provide validated software updates and patches throughout the lifecycle of the medical device to assure its continued safety and effectiveness.
Page 66: Section Econnecting Review Station Components
NSTALLATION SECTION CONNECTING REVIEW STATION COMPONENTS The Genius Review Station components must be fully assembled before turning on the power and using the instrument. Hologic service personnel will assemble the instrument: • Monitor • Computer • Computer graphics processing unit (GPU, graphics card) •...
Page 67: Section Fpower On The Review Station
Figure 2-3 Power Switches 1. Press the power button on the computer. Allow the computer and monitor to initialize. 2. Double-click “Genius Review Station” icon on the computer desktop to launch the Review Station software. Genius™ Review Station Operator’s Manual...
Page 68 NSTALLATION Figure 2-4 Launch the application 3. The application launches. Figure 2-5 Launch the Review Station Software There are two specifications that need to be set or confirmed the first time the Review Station is set up. These do not need to be used every time the Review Station is launched. The IP address and network speed information are helpful in troubleshooting communication issues.
Page 69 NSTALLATION 2. If the IP address field is empty, enter the IP address for the Image Management Server. If the Review Station has previously connected with the Image Management Server, the IP address used the last time is shown. Figure 2-6 Enter Server IP Address Network Speed 1.
Page 70 NSTALLATION Figure 2-7 Review Station Startup Screen, Example Key to Figure 2-7 IP address Network speed When the Review Station is connected to a network, select Launch Review Station to launch the Review Station application. Next, log into the application with a username and password. (Refer to “Login Screen” on page 3.6.) Genius™...
Page 71 NSTALLATION Figure 2-8 Login Screen The Review Station is ready for use when the Dashboard is displayed (Figure 2-9). 2.10 Genius™ Review Station Operator’s Manual...
Page 72: Section Gstorage And Handling - Post Installation
NSTALLATION Figure 2-9 Review Station Dashboard SECTION STORAGE AND HANDLING - POST INSTALLATION The Review Station may be stored in the location where it was installed. When it is not in use, the Review Station can be left with the power on. Follow your laboratory’s policy for handling computer equipment.
Page 73: Section Hsystem Shutdown
NSTALLATION SECTION SYSTEM SHUTDOWN Normal Shutdown Figure 2-10 Exit the application Key to Figure 2-10 Exit Exit . Click the arrow next to your name to see the command. It is important to shut down the system in the correct order. To shut down the Review Station: 1.
Page 74 NSTALLATION Figure 2-11 Exit the launch application Key to Figure 2-11 Exit button 3. Shut down from Windows. The computer and monitor will shut down. 4. If necessary, to completely disconnect from the power supply source, unplug the power cords from the outlets.
Page 75 NSTALLATION This page intentionally left blank. 2.14 Genius™ Review Station Operator’s Manual...
Page 77: Chapter Three
OVERVIEW The Genius Review Station is used to review images from the Genius Digital Imager. The user can set some user preferences for Genius Review Station. The user interacts with the system via a keyboard, mouse, and optional barcode scanner.
Page 78 NTERFACE Launch application Log in Customize View Settings Review Cases Non-Gyn cases Customize Gyn cases UroCyte cases Reviewer widgets Language Date/time Review gallery of Review image Password images Filter the Case Add/remove marks Autoscan List Add/remove marks Add comments preferences Add comments Add/remove tags Add/remove tags...
Page 79: Section B: Log
Standard reports ......... 3.43 SECTION SECTION LOG IN Normal Login 1. From the Windows desktop, double-click on the icon for “Genius Review Station”, if it is not already running. Genius™ Review Station Operator’s Manual...
Page 80 NTERFACE Figure 3-2 Launch the application from the computer desktop 2. The application launches. Figure 3-3 Launch the Review Station Software • If the screen display is in another language, pick the name of your language from the list in the lower left.
Page 81: Log In
NTERFACE If more than one language is spoken in your lab, the language may need to be reset for the Login screen. Figure 3-4 Select language when launch application (optional) 3. Select Launch Review Station. 4. The Review Station application opens. Genius™...
Page 82: Forgotten Username Or Password
When the Login screen displays, enter your username and password. • As part of the Review Station installation, Hologic Field Service personnel will set up a manager username and password. The manager can then set up additional reviewers and managers for the Review Station. A user needs a username and password in order to log in.
Page 83: Section Cdisplay Overview
NTERFACE 3. Log in using the temporary password and then reset your password. The new password must meet the requirements for passwords. Refer to “Password” on page 3.14 for the requirements for the new password. SECTION DISPLAY OVERVIEW The Review Station has some elements that are always displayed and some that can be customized for each user.
Page 84: Menu Bar And Case Lists
NTERFACE Key to Figure 3-6 Center pane of the Review Station display Information section on the right. This section provides details on the content selected in the center section, for some of the menu items. The lighter color in the menu bar indicates that the Dashboard view is the current view. The Dashboard provides a quick view of case data, in a way that the user can customize.
Page 85 NTERFACE Figure 3-7 Typical Case List (All Cases selected in this example) Key to Figure 3-7 The lighter color in the menu bar indicates that the All Cases view is the current view. The name of Case List The total number of cases in the list A search box, to search for an Accession ID A search box, to search for all of the cases that have the same tag Genius™...
Page 86 NTERFACE Key to Figure 3-7 A check box to hide archived cases in the list of cases. When this box is checked, archived cases will not be displayed in the list. The number of cases that this reviewer has completed today Applied filters describe how the data shown in the center section has been filtered The filter icon (Refer to “Data Filters”...
Page 87 NTERFACE For any case in the list (any row in the list), each column in the list presents information: Figure 3-8 Typical Case List (All Cases selected in this example) Key to Figure 3-8 Bookmark icon (Refer to “Bookmarks” on page 3.42) Clear bookmark indicates a case is not bookmarked.
Page 88: Section Dsettings
NTERFACE Key to Figure 3-8 Accession ID for a case - clicking on the accession ID for a case displays the images for that case Sample type for the case: Gyn, Non-Gyn, or UroCyte Status - The status is New, In Progress, or Reviewed The date that the slide(s) for the case were imaged on the Genius Digital Imager The most recent date that the case was reviewed on the Review Station The name of the reviewer who completed the most recent review of the case on that...
Page 89 NTERFACE A change to the settings requires the user to click Save to apply the setting. If you make changes but do not save them, a message pops up to confirm if you want to discard the changes. Click on Discard to discard the changes and keep the current setting, or click Cancel to return to the settings screen.
Page 90 NTERFACE Key to Figure 3-9 Language Select a language. To change the language displayed on the display screen user interface, click on the arrow to the right of the current language name to see the full list of languages. Click on a language name to select it. Date format Select the date format.
Page 91 NTERFACE temporary password to a different password. The password can be changed at any time from the Settings screen by the user. Figure 3-10 Change Password Key to Figure 3-10 The lighter color in the menu bar indicates that Settings is selected. The blue color in the list of settings indicates that the Password settings are selected.
Page 92 NTERFACE Key to Figure 3-10 Confirm the new password by entering it again. If the new password does not meet the format requirements, or if the new and confirmed passwords do not match, an error message appears. Try to set the password again. And an error will also display if the current password is incorrect.
Page 93 NTERFACE Slide (Reviewer and Manager) The Slide setting sets the preferences for the Autoscan feature. Figure 3-11 Slide settings for Autoscan (automatic mode in this example) Genius™ Review Station Operator’s Manual 3.17...
Page 94 NTERFACE Key to Figure 3-11 The lighter color in the menu bar indicates that Settings is selected. The blue color in the list of settings indicates that the Slide settings are selected. Autoscan orientation The Autoscan orientation is the direction in which the scan pattern travels through the whole slide image.
Page 95 NTERFACE Key to Figure 3-11 To save the Autoscan settings, click the Save button. (Manager) A user with a manager role can establish settings that apply to all cases reviewed in Review Station network. Unlike the other settings, these lab settings are not customizable for each user account. Refer to Figure 3-12 on page 3.19.
Page 96 NTERFACE Key to Figure 3-12 The blue color in the list of settings indicates that the Lab settings are selected. Lab name (Manager only) To have a lab name appear on Reports, type in the name of your lab. Archive slides that have been inactive After a period of time, data for inactive cases is transferred to a long-term archive storage system from the Image Management Server.
Page 97 NTERFACE Key to Figure 3-12 Change tag To rename or remove an existing tag for all users in the Review Station network, click on the arrow to the right of the Select box to see the list of current tags. Select the tag from the list.
Page 98: User Management
NTERFACE Report (Manager only) A user with a manager role can set the maximum number of lines of data that are retrieved from the Image Management Server for a report. If there are fewer results than the limit, all of the available data will report. When a report is run, if the number of entries is greater than the report length limit, only the results highest in the sort order appear in the report and a message appears on the screen.
Page 99 NTERFACE Figure 3-13 User Management: List of Users Key to Figure 3-13 In the upper left, the number of users is shown. The number displayed in the upper left may change if the list is filtered by status or filtered by role. The Print button generates a PDF view on the screen, and opens the print dialog window from the web browser.
Page 100 NTERFACE Key to Figure 3-13 User details Click on any user in the list to display details describing the user whose name is highlighted in the list. The list of users has a column for first name, last name, status, role and username. The list can be sorted by each of these columns.
Page 101 NTERFACE 7. Select a role for the new user. A user with the reviewer role can search for and review cases. A reviewer can run reports, but a reviewer’s view is typically limited to the workload for that reviewer. A user with the manager role can also perform other activities: •...
Page 102: Section Ecustomize The View
NTERFACE • On the confirmation screen, click Yes to continue with the change, or click No to cancel the change. 4. To reset a user’s password, click the Reset password button at the bottom of the panel on the right. •...
Page 103 NTERFACE The default set up shows two widgets: Slides Imaged and Reviews Completed Figure 3-14 Review Station Dashboard, Default Widgets of Slides Imaged and Reviews Completed Key to Figure 3-14 The lighter color in the menu bar indicates that the Dashboard view is the current view. The name Dashboard also appears at the top of the center window.
Page 104 NTERFACE There are four options for widgets: • Slides Imaged: The Slides Imaged widget graphs the number of slides imaged over a period of time. The data to display can be filtered by sample type, by Digital Imager, and by time. The data can be segmented to show each Digital Imager.
Page 105 NTERFACE A user can remove a widget from the Dashboard, change the type of graph used in an existing widget, and change the range of data included in the graph. Dashboard widgets can be set up with a custom data filter and a custom name in many combinations to suit each user. Figure 3-15 Review Station Dashboard, widget options button Key to Figure 3-15 Use the +Add Section button on the Dashboard.
Page 106 NTERFACE If desired, select the “x” in the upper corner to remove the box surrounding the empty area. Figure 3-16 Review Station Dashboard, add widget section, remove or edit widget Key to Figure 3-16 The options button looks like three dots. Click here to see the Edit Widget and Remove Widget options.
Page 107 NTERFACE Edit a widget There are several options for editing a widget. Choose as many or few customizations as desired. To edit a widget, select “Edit Widget”. The Edit Widget window opens and shows the options for that widget. Figure 3-17 Review Station Dashboard, edit a widget Key to Figure 3-17 Widget Name Type in a name for the widget.
Page 108 NTERFACE Key to Figure 3-17 Filters Use the drop-down menus to set the criteria for a filter. In this example, the data displayed in the widget can be filtered by sample type, by Digital Imager, and/or by slide image time because this example is a Slides Imaged widget. The filter criteria differ for the different widgets.
Page 109: Case Lists
NTERFACE Case Lists Hide Archived Cases The reviewer can specify whether the list of cases should show or hide cases that have been archived or not. Data for archived cases is stored in the Genius Digital Diagnostics System database. The images for an archived cases are not immediately available for viewing on the Review Station.
Page 110 NTERFACE Select “All Cases” on the menu bar on the left and the main pane displays all of the slide data. The data in the list of cases can be filtered by different criteria. The lists of cases can include or exclude archived cases by un-checking or checking the “Hide Archived Cases”...
Page 111 NTERFACE Figure 3-18 Case Detail - Gyn example, manager role The Case Details section shows the case type, a photo of the entire slide including its label, a status indicator describing if the case has been reviewed or not, the date the slide was imaged, and the Imager where the slide was imaged.
Page 112 NTERFACE 2. A confirmation message appears to confirm that you want to reassign the case. • Click yes to confirm and reclaim the case. • Click no to keep the case in progress with the current reviewer. The status remains “In progress”, and that manager is now assigned as the reviewer for the case. The existing comments and marks are included with the case.
Page 113: Data Filters
NTERFACE Delete a Slide (Manager only, new cases only) A manager has a Delete Slide button available in the Case Details section of new cases. This feature may be helpful in cases where there is a need to re-image the slide. Cases that are in progress or already reviewed cannot be deleted.
Page 114 NTERFACE Accession ID Filter – the Accession ID Filter can be used to search for all cases that contain specific number or letters. Or, the Accession ID Filter can be used to search for all cases between a specific numeric range. Figure 3-21 Accession ID Filter Case Type Filter –...
Page 115 NTERFACE • Set the filter to “In Progress” to display cases where a review of the slide image has started but has not been completed. • Set the filter to “Reviewed” to display cases where the review of the slide image has been marked as reviewed in the Review Station.
Page 116 NTERFACE data for a case was saved from any Review Station connected to the Image Management Server, reviewed by any reviewer. • Click on the filter icon and select from the pre-set options or set a custom filter for the date. •...
Page 117: Log Out
NTERFACE Edit the name of a custom filter 1. To change the name of a custom filter or its filter criteria, select the custom filter in the menu bar on the left. 2. Select the Edit name button in the upper right. 3.
Page 118: Section Fbookmarks
NTERFACE • Click no to keep the alert visible on the Dashboard. SECTION BOOKMARKS Use the Bookmarks feature to save an individual case or groups of cases for future reference. The Bookmarks feature is intended to make individual cases and individual categories of cases readily available.
Page 119: Section Greports
NTERFACE SECTION REPORTS There are several standard reports available on the Review Station and variations of the standard reports can be saved as custom reports by the user. Standard reports Each of the standard reports requires the user to enter some criteria, such as a date range. Each report is displayed on the screen, can be printed as a PDF, and can be saved.
Page 120 NTERFACE Figure 3-26 List of Reports, CT Reviews selected Key to Figure 3-26 Click on Reports Select the name of an existing report. Select the criteria for filtering and sorting the data in the report. Select Run Report, or save the report as a custom report and then run the report. 5.
Page 121 NTERFACE Use the buttons on the upper right to print the report as a PDF or to export the report as a CSV file. Reports saved as CSV will open in Microsoft Excel or Notepad depending on what applications are installed on the Review Station computer. A PDF or CSV file can be saved on the Review Station computer.
Page 122 NTERFACE Note: Each review of a case, whether an initial review by a CT, a subsequent review for quality control or a review by a pathologist, is considered a review by the Review Station. 3. Choose the category that will be used to sort the data in the report. The CT Reviews report is preset to sort by the name of the reviewer, and it is the only available option.
Page 123 NTERFACE Key to Figure 3-27 Lab name Print to PDF Export the data as a CSV file The sorting criteria for the data in the report. For the CT Reviews Report, the “Sort by” criteria is by Reviewer. The sorting order for the data in the report. The name of this CT The date and time that the case review was completed The Accession ID for each case reviewed by this CT during this time period...
Page 124 NTERFACE Select a review time from the available options of: • All (up to one year of data on the server, starting at the current date) • Today • Yesterday • Last 7 Days • Last 30 Days • Custom 2.
Page 125 NTERFACE Figure 3-28 CT Workload History Report, example CT Workload Summary The CT Workload Summary lists how many reviews were done by each reviewer over a specific time period. When a manager runs the CT Workload Summary Report, the report includes all reviewers in the database.
Page 126 NTERFACE 3. Choose the order in which the data will appear: • Sort the results by the reviewers’ names • Sort the results by the number of completed reviews Figure 3-29 CT Workload Summary Report, example Review Station Reports for Errors There are several standard reports available on the Review Station that report data from the Digital Imager.
Page 127 NTERFACE For example, if the time period for the report is set as today and a Digital Imager processed 100 slides today, with one of those 100 slides generating a slide event, the Imager Error Rate is 1%. Note: The Imager Error Rate Report is similar to the Imager Slide Events Report. The Imager Error Rate Report expresses the result as a percentage, and the Imager Slide Events Report does not.
Page 128 NTERFACE Figure 3-30 Imager Error Rate Report, example Imager Slide Events The Imager Slide Events Report lists detailed information about errors from one or more Digital Imager over a specific time period. The Imager Slide Events Report lists the Accession ID, the date and time that the error occurred, the error number, the sample type, the name of the Digital Imager and the version of software running on the Digital Imager at the time.
Page 129 NTERFACE • UroCyte • Note: Reports on the Review Station list the entire Accession ID. In instances where a Non- Gyn cases consists of several slides, the Accession ID for each slide is reported, regardless of whether the Genius Digital Diagnostics System has been set up to group the slides from one case together in the Case Lists on the Review Station.
Page 130 NTERFACE Figure 3-31 Imager Slide Events Report, example Imager System Errors The Imager System Errors Report lists the system errors from one or more Digital Imager over a specific time period. 1. Choose the time period for the report data. The time in this report is the time the slide was processed on the Digital Imager.
Page 131 NTERFACE • The error number • The software version 4. Choose the order in which the data will appear. Sort the results in ascending or descending order. Note: In the report, click on an error number to see a brief description of that error. Figure 3-32 Imager System Errors Report, example Slide Data The Slide Data Report lists detailed information about slides reviewed over a specific time period.
Page 132 NTERFACE Select the imaging criteria for the Slide Data Report Figure 3-33 Select criteria for Slide Data Report 1. Choose the slide image time period for the report data. This is the time the slide was processed on the Digital Imager. 2.
Page 133 NTERFACE • Non-Gyn • UroCyte • Note: Review Station reports list the entire Accession ID. In instances where a Non-Gyn cases consists of several slides, the Accession ID for each slide is reported, regardless of whether the Genius Digital Diagnostics System has been set up to group the slides from one case together in the Case List on the Review Station.
Page 134 NTERFACE When a reviewer runs this report, that reviewer’s name is preselected and is the only available option. 4. Choose whether to include or exclude archived cases in the report. Select a “Slide Archived” status from the available options of: •...
Page 135 NTERFACE Figure 3-34 Slide Data Report, example System Usage History The System Usage History Report lists instrument activity over a specific time period. 1. Choose the time period for the report data. Select an imaged time from the available options of: •...
Page 136 NTERFACE • Total 4. Choose the order in which the data will appear. Sort the results in ascending or descending order. Figure 3-35 System Usage History Report, example 3.60 Genius™ Review Station Operator’s Manual...
Page 138: Chapter Four
SECTION SECTION OVERVIEW The Genius Review Station is used to review digital images created in the Genius Digital Diagnostics System for cytological specimens. The images are reviewed by a cytotechnologist (CT) or pathologist. The same images may be reviewed by additional cytotechnologists and pathologists. During review, the reviewer can mark objects of interest, and the marks are available to anyone reviewing the same case later.
Page 139 PERATION a valid slide ID is accepted into the Image Management Server’s database. Items that are associated with the case data record include: • Date/time stamp when imaging ended (even if imaging was unsuccessful) • Serial number of the Digital Imager that imaged the slide •...
Page 140 PERATION User Login Open a case Status: New* Non-Gyn Case Gyn Case UroCyte Case View whole slide View tiles in gallery Options available, all image case types Note: The whole slide Mark images image is also available on Gyn cases. Status: Add comments to case In Progress...
Page 141: Section Bmaterials Required Prior To Operation
SECTION MATERIALS REQUIRED PRIOR TO OPERATION • Slide data on the Genius Image Management Server from imaged ThinPrep slides • Genius Review Station Important Operational Notes: • For Gyn samples, examine the gallery of tiles • Marking images - the case images are digitally marked by the CT or pathologist. Follow your laboratory’s guidelines for marking objects of interest in case images.
Page 142: Section Creview A Case
PERATION SECTION REVIEW A CASE For Gyn cases, a gallery of images is presented to the reviewer. Additional images of the case are also available for viewing. A reviewer can mark the images and comment on the case. For Non-Gyn and UroCyte cases, one image of the whole slide cell spot is presented to the reviewer. A reviewer can add marks and comments.
Page 143 PERATION Figure 4-2 Case List - Click Accession ID to Open Case Note: For Non-Gyn cases comprised of multiple slides grouped together with a primary ID, the accession ID in the Case List represents the group of slides. Click the arrow to the left of the primary ID or click anywhere in the blue shaded line to see the accession ID for each of the slides in that case.
Page 144 PERATION Note: The magnification values displayed on the Review Station are intended as digital equivalents of the magnification when glass slides are viewed through a microscope objective. Each tile in the gallery on the left is an object of interest in the whole slide image shown on the right. The heading of the review screen shows: •...
Page 145 PERATION Figure 4-3 Gyn case - new case opened for review, example Key to Figure 4-3 Above the gallery, the approximate cell count, date the slide was imaged, and algorithm version display. Refer to “Cell count, date and algorithm version” on page 4.9 for more details.
Page 146 PERATION Key to Figure 4-3 “Shortlist” of marked cells. Refer to “About Shortlists of marked objects” on page 4.23 for more details. Arrow to show or hide additional rows in the Shortlist. Refer to “About Shortlists of marked objects” on page 4.23 for more details. Whole Slide Image and tools for navigating the whole slide image.
Page 147 PERATION To generate the approximate cell count, the system locates all potential cell nuclei in the whole slide image, classifies those objects, and counts the number which are deemed to be squamous cell types. The count includes the entire cell region. It is not based on a partial sampling. This count is rounded off to provide an estimate.
Page 148 PERATION Navigate the Gallery and Mark Objects with a Mouse When the gallery opens, the tile in the upper left is ready to be selected. The image in the whole slide image is shown at <2x. Click on a tile, and the image in the whole slide image changes to 40x, presenting the area of the whole slide image that corresponds to the tile.
Page 149 PERATION Informational Messages from the Genius Cervical AI Algorithm For some Gyn cases, the Genius cervical AI algorithm provides additional information, which may assist a reviewer. When additional information is available, the bar over the top row of the gallery is pink.
Page 150 PERATION review the case. A reviewer can review the gallery of images and may opt to also check the whole slide image. Follow your laboratory’s procedures or standard practices for interpreting cases with these notifications. Table 4.1Informational Messages Message for Gyn Case Possible Cause Suggested Next Steps Very few cells detected...
Page 151 PERATION The Whole Slide Image, all Sample Types For Gyn cases, the whole slide image is on the right of the display. For Non-Gyn and UroCyte cases, the whole slide image is centered on the display. Note: The magnification values displayed on the Review Station are intended as digital equivalents of the magnification when glass slides are viewed through a microscope objective.
Page 152 PERATION 3. Type in a comment, if any. Figure 4-5 Add comments, view existing comments, Gyn example 4. Click on the Close button beneath the comment. The comment is associated with the case, and visible to other users who view or review the case. 5.
Page 153 PERATION The toolbar under the whole slide image has several tools. Figure 4-6 Toolbar under the whole slide image, example Key to Figure 4-6 Expand to full screen (available only when a gallery is present) Select the icon to change the screen display so that the whole slide image fills the entire display area.
Page 154 PERATION Key to Figure 4-6 Zoom to 10x Click on the 10x button and the magnification zooms to the 10x view. Zoom to 40x Click on the 40x button and the magnification zooms to the 40x view. Object Information Click on the Object Information tool (the question mark) to select the tool. Then, click on a marked object in the Shortlist of tiles to see the name of the reviewer who made the mark.
Page 155 PERATION To move the view of the whole slide image up, down, left, or right, click anywhere in the whole slide image and drag the mouse. To move the view in the whole slide image, click in the macro image of the whole slide image. The view in the whole slide image moves to the area clicked in the macro image.
Page 156 PERATION 2. After the tag is set up, as a reviewer is reviewing a case, click the Tags... button to select a tag. Figure 4-7 Tags, manager role shown 3. In the box that appears on the screen, select the name of the tag from the available options in the drop-down list, or type in the first few characters of the name of the tag to navigate to and select the tag in the list.
Page 157 PERATION After a case is tagged the icon on the case list screen changes to the Tagged Case icon, and the name of the tag is on the case details section for that case. Figure 4-8 Case Details screen for a case with a tag Key to Figure 4-8 The tagged case icon shows in the Case List.
Page 158 PERATION Note: A tag can be added or removed from a case using the Tags... button in the Case Details section. The tag selection steps are the same as using the Tags... button in the Case Review screen. More than one tag can be applied to the same case. To remove a tag from this one case, in the Case Review screen, click the Tags...
Page 159 PERATION Figure 4-9 Autoscan toolbar Key to Figure 4-9 Autoscan Start button When Autoscan has started, the Start button changes to a Pause button. When Autoscan is paused, the button changes to a Resume button. Use the buttons to start, pause, and resume the movement of the whole slide image through the Autoscan.
Page 160 PERATION Key to Figure 4-9 Autoscan speed or dwell time. In Continuous mode, click the +/- buttons to increase or decrease the speed of the Autoscan movement. The speed ranges from 1 to 15, and the current speed is shown. In Automatic mode, click the +/- buttons to increase or decrease the amount of time that the view will dwell in one position.
Page 161 PERATION The Shortlist is a gallery of marked tiles. For Gyn cases, the Shortlist is below the gallery. When a mark is added to a tile in the gallery, a flag icon is added to the tile in the gallery. Refer to “The Gallery, Gyn Case”...
Page 162 PERATION Non-Gyn cases grouped with a primary ID For Non-Gyn cases that consist of multiple slides, the Digital Imager can be set up to group the individual slides together using the concept of a primary ID and a secondary ID. The primary ID is the portion of the accession ID that each of the slide IDs have in common, and the method for identifying a primary ID is configured on the Digital Imager.
Page 163 PERATION The steps for reviewing each slide within a Non-Gyn case grouped with a primary ID are the same as with other Non-Gyn reviews. In Reports, data for each individual slide is reported as a separate entry, rather than as a grouped case.
Page 164 PERATION Note: Consider filtering options and the Review Station status when working with Non-Gyn cases grouped with a primary ID. For example: A new case consists of three slides. Two are imaged on Monday, and one imaged on Tuesday. If a reviewer filters the new Case List with an “imaged on” date for Monday, the Case List will only yield two of the slides, grouped together by the primary ID.
Page 165 PERATION Figure 4-13 Save a case as In Progress, Gyn example Key to Figure 4-13 Click Cancel. Click Save. A dialog box appears with the option to save changes from the review session. To cancel the review, undo any new marks or comments, and keep the case in the “New Cases” status, select “Don’t Save”. To save changes from this review session and change the status for the case to “In Progress”, select Save.
Page 166 PERATION Complete a review of a case When a reviewer is ready to complete the review of the case, click the Complete Review button in the upper right of the review screen. Figure 4-14 Complete the review of a case 5.
Page 167 PERATION With the mouse On the keyboard Select the next tile in the gallery Click on the tile Left arrow - move left Right arrow - move right Up arrow - move up Down arrow - move down A - move left (Q on AZERTY keyboards) D - move right W - move up (Z on AZERTY...
Page 168 PERATION With the mouse On the keyboard Zoom to 10x magnification Click the 10x button: 1 - 10x magnification Zoom to 20x magnification Not available 2 - 20x magnification Zoom to 40x magnification Click the 40x button: 4 - 40x magnification Pan to the left Click and drag right Left arrow - move left...
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Page 171: Chapter Five
AINTENANCE C h a p t e r F i v e Maintenance SECTION SECTION GENERAL CLEANING CAUTION: Do not use strong solvents on painted or plastic surfaces. CAUTION: Do not scratch the monitor. Take care with rings and other jewelry when wiping the monitor surface.
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Page 174: Chapter Six
ROUBLESHOOTING C h a p t e r S i x Troubleshooting SECTION NO CONNECTION TO IMAGE MANAGEMENT SERVER The Review Station must have an active connection to the Image Management Server in order to work. If communication is disrupted before a user logs in, the application will not launch. Figure 6-1 Review Station, Not Connected Genius™...
Page 175: Review Station
Depending on the cause of the disruption, your laboratory’s computer network administrator may be able to reestablish the network connection, or Hologic Technical Support may be required. The Genius Digital Diagnostics System network design varies from lab to lab, depending on volume requirements, and infrastructure integration.
Page 176 ROUBLESHOOTING The following is a list of Slide Events. The slide is not imaged when there is a slide event. Slide events and Imager errors are corrected at the Digital Imager not the Review Station. Table 6.1: Slide Event Messages Event Corrective action for the Event description...
Page 177 ROUBLESHOOTING Table 6.1: Slide Event Messages Event Corrective action for the Event description Possible cause code Digital Imager Operator E0010 Slide imaging failed due The stage moved or was During operation, the Imager/Scanner is sensitive to an imaging stage disturbed during imaging. to vibrations.
Page 178 ROUBLESHOOTING Table 6.1: Slide Event Messages Event Corrective action for the Event description Possible cause code Digital Imager Operator E0016 Slide imaging failed due Sample collection or slide Possible sample collection or slide preparation to cell focus error preparation issue causing issue the cell spot to be blank or very faint.
Page 179 ROUBLESHOOTING Table 6.2: Imager Error Codes E1000, Error with one of the Power cycle the system. If the error persists, E1001, system components. contact Technical Support. E1002, Imager error E1004, E1005, E1006 E1003 The door or window was Door or window lock The Imager/Scanner cannot operate with the found open during start failed;...
Page 180 ROUBLESHOOTING Table 6.2: Imager Error Codes E2003 An error occurred while Camera failed to produce Power cycle the system. If the error persists, waiting for the ending frames. FocalMerger contact Technical Support. swath. timed out while merging. E2004 An error occurred while An image processing Power cycle the system.
Page 181 ROUBLESHOOTING Table 6.2: Imager Error Codes E4012 A pick from a carrier The slide was not present The system will move to the next slide to pick. failed. in the slot or was incorrectly inserted in the slot. E4013 A pick from the macro The slide on the macro A recovery dialog is displayed.
Page 182 ROUBLESHOOTING Table 6.2: Imager Error Codes E4515 Particle defect found Particles on the V-Chip or Power cycle the system. If the error persists, during auto-calibration. lens. Incorrectly contact Technical Support. configured V-Chip position. E4516 Imager error Error with one of the Power cycle the system.
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Page 185: Chapter Seven
NFORMATION C h a p t e r S e v e n Service Information Technical Support Corporate Address Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 USA Europe, UK, Middle East Technical Solutions Cytology can be reached: Mon-Fri : 08.00 – 18.00 CET TScytology@hologic.com...
Page 186 ERVICE NFORMATION This page intentionally left blank. Genius™ Review Station Operator’s Manual...
Page 188: Chapter Eight
8002 7708 Spain 900 994197 Portugal 800 841034 Italy 800 786308 Netherlands 800 0226782 Belgium 0800 77378 Switzerland 0800 298921 EMEA 00800 8002 9892 Mailing Address Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 USA Genius™ Review Station Operator’s Manual...
Page 189 PO Box 3009 Boston, MA 02241-3009 USA 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. Protocol for Returned Goods For returns on warranty-covered Genius Review Station accessory items, contact Technical Support.
Page 190 RDERING NFORMATION Table 8.1Reordering Supply Items for the Review Station Item Description Quantity Part Number Review Station Additional operator’s manual MAN-08802-001 Operator’s Manual Table 8.2 Optional Accessories Item Description Quantity Part Number Barcode scanner Barcode scanner with USB connection MEL-00970 Genius™...
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Page 193: Index
NDEX Index Accessories 3.24 Add new user 3.32 Add widget 3.41 Alerts 3.33 All Cases 3.21 Archive settings 3.42 Bookmarks Case 4.29 complete review open review Review Gyn case review process Case Data Record 3.34 Case Details 3.33 Case Lists Case Review Cleaning 4.29...
Page 194 NDEX 3.37 Data Filters 3.13 Date format 3.41 Delete custom filter 3.29 Delete widget 1.11 Dimensions 3.40 Edit custom filter 3.31 Edit widget 2.13 Extended shutdown Filter 3.37 data Forgotten username or password 1.13 Fuses Gallery 4.25 Grouped Non-Gyn slides Gyn Case, gallery 1.14 hazards...
Page 195 NDEX Imaging process 3.34 In Progress Cases Indication for Use Installation 3.19 Lab settings 1.17 Labels, location on instrument 3.13 Language Location 3.41 Log out Login Manager 3.21 archive settings 3.37 delete a slide 3.19 lab settings 3.35 reclaim case 3.22 reports, data limit 3.22...
Page 196 NDEX 4.25 Non-Gyn cases grouped with a primary ID 2.12 Normal shutdown Ordering information 3.14 Password 1.12 Power power switch computer microscope 3.35 Reclaim a case 3.29 Remove widget 3.22 Report settings 3.43 Reports 3.45 CT Reviews 3.47 CT Workload History 3.49 CT Workload Summary 3.50...
Page 197 NDEX 2.12 Shutdown Site assessment Specifications 1.11 Review Station computer technical specimen preparation 1.15 Symbols 3.22 Tags 1.12 Temperature range Tiles 3.13 Time format Troubleshooting User Interface 3.22 User Management (Manager only) 3.37 Using Data Filters 1.14 Warnings 1.11 Weight 4.14 Whole Slide Image 3.26...
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Page 200 Hologic, Inc. Hologic BV 250 Campus Drive Da Vincilaan 5 Marlborough, MA 01752 USA 1930 Zaventem +1-508-263-2900 Belgium www.hologic.com MAN-08802-001 Rev. 002...

Hologic Genius Review Station Operator's Manual

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