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Related Manuals for Hologic Genius
Summary of Contents for Hologic Genius
- Page 1 Genius™ Image Management Server Dashboard Operator’s Manual...
- Page 2 Genius™ Image Management Server Dashboard User’s Manual Hologic, Inc. Australian Sponsor: Hologic BV 250 Campus Drive Hologic (Australia and Da Vincilaan 5 Marlborough, MA 01752 USA New Zealand) Pty Ltd 1930 Zaventem Tel: 1-800-442-9892 Suite 302, Level 3 Belgium 1-508-263-2900...
- Page 3 Hologic to evaluate ThinPrep-prepared slides. © Hologic, Inc., 2021 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...
- Page 5 Genius™ Digital Diagnostics System Instructions for Use Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 1/13...
- Page 6 The Genius Digital Diagnostics System includes the Genius™ Digital Imager, the Genius™ Image Management Server (IMS), 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 7 Only personnel who have been appropriately trained should operate the Genius Digital Imager or Review Station. • The Genius Cervical AI algorithm is only indicated for use with the ThinPrep Pap test. • The laboratory Technical Supervisor should establish individual workload limits for personnel using the Genius Digital Diagnostics System.
- Page 8 Slides were reviewed by CTs using the ThinPrep Imaging System (TIS-assisted review), and, after a washout period, the same CT reviewed the nine runs of that same case on the Genius Digital Diagnostics System. In each review on the Genius Digital Diagnostics System, the CT recorded what the CT observed in every tile in the gallery for the case on the Review Station.
- Page 9 CANCER Study Results: Cervical Cytology Diagnostic Categories The highest OOI category for any case across the nine runs of the case on the Genius Digital Diagnostics System was compared to the diagnostic category for the same slide in the TIS- assisted review.
- Page 10 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 11 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. For each table, the positive and negative agreement rates with reference to the TIS-assisted result are provided.
- Page 12 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. Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 8/13...
- Page 13 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 14 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 15 %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 16 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 17 TECHNICAL SERVICE AND PRODUCT INFORMATION For technical service and assistance related to use of the Genius Digital Diagnostics System, contact Hologic: Telephone: 1-800-442-9892 Fax: 1-508-229-2795 For international or toll-free blocked calls, please contact 1-508-263-2900. Email: info@hologic.com Hologic, Inc. Hologic BV...
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Page 19: Table Of Contents
T a b l e o f C o n t e n t s Contents Chapter One Introduction Overview ..................1.1 The Genius Digital Diagnostics System ........1.2 Image Management Server Technical Specifications....1.5 Internal Quality Control ..............1.7 Genius Image Management Server Hazards......1.8 Disposal..................1.11... - Page 20 Time Server..................3.12 Imager Service................3.13 ThinPrep DB ................3.14 Settings ..................3.18 Chapter Four Maintenance....................4.1 Chapter Five Troubleshooting ..................5.1 Red Status Indicator on System Dashboard ......5.1 Chapter Six Service Information..................6.1 Chapter Seven Ordering Information ................7.1 Index Genius™ Image Management Server User’s Manual...
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Page 22: Chapter One
The Image Management Server facilitates the display of the images in the Genius Digital Diagnostics System for cytotechnologists for primary review and QC reviews, as well as pathologists review as needed. -
Page 23: The Genius Digital Diagnostics System
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 24 Note: Throughout this manual, illustrations of the Image Management Server, an archive storage system and other components are representative. The appearance of the actual equipment may differ from the illustrations. Figure 1-2 Genius Digital Diagnostics System Network Genius™ Image Management Server User’s Manual...
- Page 25 Archive storage system A network connection between the Image Management Server and the other components of the Genius Digital Diagnostics System is required, using a minimum of cat 6 cabling. Additionally, another network connection to the site’s archive storage system is required.
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Page 26: Image Management Server Technical Specifications
Overview of Components Figure 1-3 Image Management Server Components Key to Figure 1-3 Server Monitor, keyboard, and mouse Network switch Connections to the Digital Imager and Review Station Connection to the archive storage system Genius™ Image Management Server User’s Manual... - Page 27 Depending on the configuration in your laboratory, the Image Management Server hardware may be supplied by Hologic. The hardware configuration will vary, depending on the quantity and type of slides imaged in your facility. The minimum specifications for the hardware are: Server Hardware: •...
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Page 28: Internal Quality Control
Image Management Server dashboard. The Review Station cannot be used until connection with the Image Management Server is reestablished. The Digital Imager cannot image slides or generate reports until connection with the Image Management Server is reestablished. Genius™ Image Management Server User’s Manual... -
Page 29: Genius Image Management Server Hazards
The installation and configuration of the Image Management Server must not be altered after installation by qualified Hologic service personnel and your facility’s IT staff. Proper installation and configuration are required for proper performance of the system and cannot be substituted. - Page 30 Symbols Used on the Instrument Refer to the documentation provided with the server and computer for a description of any symbols used on the hardware. The following symbols may appear on the labels supplied by Hologic. Consult the instructions for use...
- Page 31 Note: The appearance of the server in this illustration may differ from the server installed at your site, depending on the model of Hologic-supplied hardware you have. Note: If the server hardware is not supplied by Hologic, the serial number may be in a different location and the server part number label will not be present.
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Page 32: Disposal
The server must meet the specifications in this manual. The Image Management Server is designed specifically for the Genius Digital Diagnostics System. The Image Management Server must be running the Hologic-supplied software for proper performance of the system and the software cannot be substituted. - Page 33 NTRODUCTION This page intentionally left blank. 1.12 Genius™ Image Management Server User’s Manual...
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Page 35: Chapter Two
WARNING: Service Installation Only SECTION GENERAL The Genius Image Management Server must be installed and configured by qualified Hologic service personnel. The duration of the installation is dependent on the complexity of integration with the laboratory information technology (IT) infrastructure and connected systems. When installation and configuration are complete, Hologic personnel trains the laboratory’s information system staff, using... -
Page 36: Preparation Prior To Installation
PREPARATION PRIOR TO INSTALLATION Pre-Installation Site Assessment A pre-installation site assessment is performed by qualified Hologic service personnel. The site assessment requires networking considerations with your laboratory’s IT (Information Technologies) personnel. Be sure to have prepared any and all site configuration requirements as instructed by the qualified Hologic service personnel. -
Page 37: Moving The Image Management Server
Unit Shipped to New Location If the Image Management Server is to be shipped to a new location, please contact Hologic Technical Support or your local Hologic distributor. Refer to Chapter 8, Service Information. -
Page 38: Power On The Server
Figure 2-1 Power Switch Launch the application The Image Management Server dashboard application can be left running. If the dashboard application is closed, to launch the application, click on the desktop shortcut. Genius™ Image Management Server User’s Manual... -
Page 39: Storage And Handling - Post Installation
Because the Image Management Server hosts services and applications necessary to the operation of the Digital Imager and the Review Station, shutting down the Image Management Server shuts down the operation of the Genius Digital Diagnostics System. Notify the staff using the Digital Imagers and Review Stations before shutting down the server. - Page 40 NSTALLATION This page intentionally left blank. Genius™ Image Management Server User’s Manual...
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Page 42: Chapter Three
SECTION OVERVIEW The user interfaces with the Genius Image Management Server through the Image Management Server dashboard. The dashboard presents a quick confirmation or error notification for the services and applications necessary to store and retrieve data for the Digital Imager and the Review Station. -
Page 43: System
A green circle indicates that the services and applications are running. In normal operating conditions, all circles are green. A red circle indicates that a service or application is not running. Hover over the status to see more information. Figure 3-1 System dashboard Genius™ Image Management Server User’s Manual... - Page 44 Adequate storage capacity is necessary to continue to image slides at the Digital Imager. The amount of storage capacity varies with Imager usage. The Slides Root Folder is only changed by qualified Hologic service personnel. Hologic Technical Support may ask for the Slides Root Folder file path to assist with support.
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Page 45: Archiver And Retriever
Image Management Server. In the Genius Digital Diagnostics System, images and case data records are stored on the Image Management Server from the time a slide is imaged until the time a case is archived. Each day, the Image Management Server checks for cases whose images are eligible to be archived. - Page 46 Check queue button is clicked. Total scanned slides This is the quantity of slides whose data has been saved to the server, from all of the Digital Imagers connected to the server, since installation of the Genius Digital Diagnostics System. Total archived slides This is the quantity of slides whose images have been archived from the server, since installation of the Genius Digital Diagnostics System.
- Page 47 Retrieve History Refer to “Retrieve history” on page 3.9. Test Retriever The Test Retriever is used by qualified Hologic service personnel to confirm that the current settings are properly set up for retrieving slides from the archive storage system. Archiver Status Under normal operating conditions, when the Archiver Status is Ready, there are no actions required to archive data from the Image Management Server.
- Page 48 If the volume of slides imaged or reviewed at your lab increases significantly, the Archive History list can be helpful in considering if the current archive criteria at your lab should change so that cases are archived more frequently. Genius™ Image Management Server User’s Manual...
- Page 49 MAGE ANAGEMENT ERVER ASHBOARD Figure 3-4 Archive History, example Retriever Status Under normal operating conditions, when the Retriever Status is Ready, there are no actions required to archive data from the Image Management Server. Genius™ Image Management Server User’s Manual...
- Page 50 MAGE ANAGEMENT ERVER ASHBOARD Retrieve history The Retrieve History button generates a list of the quantity of slides whose images were retrieved from the archive storage system each month. Figure 3-5 Retrieve History, example Genius™ Image Management Server User’s Manual...
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Page 51: Review Station
The Review Station dashboard displays the current status of the service that allows any Review Station on the network to launch and run the Review Station application. The status must be “Running” to use a Review Station in the Genius Digital Diagnostics System network. Figure 3-6 Review Station dashboard The Http port is the name of the port through which the Image Management Server runs the Review Station service. -
Page 52: Network
The dashboard displays the name of the network on which the Image Management Server runs, along with the current network connections. The network information may be helpful in troubleshooting connection issues with Hologic Technical Support. The Network dashboard has an Open Network Connections button, to be used only by qualified Hologic service personnel. -
Page 53: Time Server
Image Management Server governs the time set not only on the server, but also on the Digital Imagers and Review Stations in the network. The time server status must be “Running” in order for the Genius Digital Diagnostic System to operate. Figure 3-8 Time Server dashboard The Time Server dashboard has a Start/Stop Time Service button, to be used only by qualified Hologic service personnel. -
Page 54: Imager Service
The Imager Service dashboard displays the current status of the service that allows any Digital Imager on the network to image slides and run reports. The status must be “Running” for normal operation of a Digital Imager in the Genius Digital Diagnostics System network. Figure 3-9 Imager Service dashboard The Http port is the name of the port through which the Image Management Server runs the Imager service. -
Page 55: Thinprep
Figure 3-10 ThinPrep DB dashboard Key to Figure 3-10 SQL Server Status Displays the current status of the SQL server. The status must be “running” in order for the Genius Digital Diagnostics System to function. 3.14 Genius™ Image Management Server User’s Manual... - Page 56 Use the Gather Diagnostics feature to create a zip file of system data for troubleshooting. The system data in the Gather Diagnostics file is intended for instrument troubleshooting by Hologic Technical Support. It gathers and zips the error history log and other instrument operating information.
- Page 57 Choose Folder... button. 4. Follow the instructions provided by Hologic Technical Support. Typically, the Gather Diagnostics file is small enough to send to Hologic Technical Support by e-mail. Daily slide report The Daily Slide Report is a .csv file showing the quantity of slides imaged each day for each sample type.
- Page 58 2. Click the Run Report button to generate the report. The .csv file is named “TotalSlidesByType.csv” and lists the date, the sample type for the slide, and the number of slides. Figure 3-12 Daily Slide Report, example Genius™ Image Management Server User’s Manual 3.17...
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Page 59: Settings
SECTION SETTINGS After the Image Management Server is installed by Hologic service personnel, there may be no need to change the language displayed on the dashboard. The Settings dashboard provides the option to change the language setting to a user with System Administrator rights on the server. -
Page 61: Chapter Four
AINTENANCE C h a p t e r F o u r Maintenance SECTION SECTION GENERAL MAINTENANCE Refer to the documentation provided by the server manufacturer. Genius™ Image Management Server User’s Manual... - Page 62 AINTENANCE This page intentionally left blank. Genius™ Image Management Server User’s Manual...
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Page 64: Chapter Five
Because the Image Management Server runs on a network at your site, troubleshooting some issues may require collaboration between your laboratory’s network IT staff and Hologic service personnel. The troubleshooting steps described in this manual are intended to resolve issues that arise from the Hologic-controlled components in the network. - Page 65 ROUBLESHOOTING Hologic Technical Support is usually required to resolve a “red status” and a Hologic service visit may be required. Hologic Technical support will typically request information available on the dashboard to assist with troubleshooting. Figure 5-1 Hover mouse for more information, Imager service installed but not running in this example Genius™...
- Page 66 Hologic Technical Support may ask you to check the archive queue, test the archiver, or access Archive History to assist with troubleshooting. Refer to “Archive History” on page 3.7.
- Page 67 If the Test Archiver fails, contact Hologic Technical Support. Username or password is incorrect To change the start or duration of the daily archive, a user with System Administrator rights in Windows enters a username and password.
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Page 69: Chapter Six
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. Europe, UK, Middle East Technical Solutions Cytology can be reached: Mon-Fri : 08.00 – 18.00 CET TScytology@hologic.com... - Page 70 ERVICE NFORMATION This page intentionally left blank. Genius™ Image Management Server User’s Manual...
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Page 72: Chapter Seven
EMEA 00800 8002 9892 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 Digital Diagnostics System items, contact Technical Support. - Page 73 RDERING NFORMATION Table 7.1 Orderable Items, Image Management Server Dashboard Item Description Quantity Part Number Image Management Additional user’s manual MAN-08020-001 Server Dashboard User’s Manual Genius™ Image Management Server User’s Manual...
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Page 75: Index
3.4 imager 3.13 network 3.11 Review Station 3.10 settings 3.18 system 3.2 ThinPrep DB 3.14 time server 3.12 Dashboard, launch 2.4 Digital Imager 1.3 3.13 Gather diagnostics 3.16 Genius Digital Diagnostics System 1.3 Genius™ Image Management Server User’s Manual Index.1... - Page 76 1.10 Launch the application 2.4 normal shutdown 2.5 Operating System 1.6 ordering information 7.1 Required but not provided 1.4 Required Materials 1.4 Retrieve history 3.9 Review Station 1.3 3.10 Index.2 Genius™ Image Management Server User’s Manual...
- Page 77 3.14 Slides Root Folder 3.3 Slides Root Folder, approaching capacity 5.3 Specifications 1.6 Status Indicators 3.2 System Network 1.3 Technical Solutions Cytology 6.1 temperature range 1.6 ThinPrep database 3.14 Troubleshooting 5.1 Warnings 1.8 Genius™ Image Management Server User’s Manual Index.3...
- Page 78 NDEX This page intentionally left blank. Index.4 Genius™ Image Management Server User’s Manual...
- Page 80 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-08020-001 Rev. 001...
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