Hologic Genius IMS User Manual
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Hologic Genius IMS User Manual

Image management server dashboard
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Genius™
Image Management Server
Dashboard
User's Manual

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Summary of Contents for Hologic Genius IMS

  • Page 1 Genius™ Image Management Server Dashboard User’s Manual...
  • Page 2 Image Management Server Dashboard User’s Manual Hologic, Inc. Hologic BV Australian Sponsor: 250 Campus Drive Da Vincilaan 5 Hologic (Australia and Marlborough, MA 1930 Zaventem New Zealand) Pty Ltd Belgium 01752 USA Suite 302, Level 3 Tel: 1-800-442-9892 2 Lyon Park Road...
  • Page 3 The Product is not a replacement for professional review. Determination of slide adequacy and patient diagnosis is at the sole discretion of the cytologists and pathologists trained by Hologic to evaluate ThinPrep-prepared slides.
  • Page 4 Revision History Revision Date Description AW-24822-001 Rev. 001 8-2021 Clarify instructions. Add instructions regarding reporting serious incidents. AW-24822-001 Rev. 002 3-2023 Clarify intended purpose. Administrative changes. AW-24822-001 Rev. 003 3-2024 Clarify the use of archiving. Describe the Slide Management feature and data clean-up measures. Clarify the cybersecurity measures.
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  • Page 7: 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 ........1.3 Image Management Server Technical Specifications....1.6 Internal Quality Control ..............1.8 Genius Image Management Server Hazards......1.10 Disposal..................1.14 Chapter Two Installation...
  • Page 8 Time Server..................3.16 Imager Service................3.17 ThinPrep DB ................3.18 Settings ..................3.22 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...

  • Page 10: Chapter One

    NTRODUCTION C h a p t e r O n e Introduction SECTION OVERVIEW The Genius™ Image Management Server (IMS) is one component of the Genius™ Digital Diagnostics System. The Image Management Server is a Windows-based server computer connected via wired Ethernet. The Image Management Server stores the image data set, maintains the image metadata database, and hosts web services for external Genius™...
  • Page 11 NTRODUCTION Note: The hardware shown in this operator’s manual may differ from the appearance of the hardware used at your site. It is the customer's responsibility to comply with all applicable record retention procedures. It is also the customer's responsibility to establish and implement policies and practices for maintaining storage capacity on the Genius Image Management Server.

  • Page 12: The Genius Digital Diagnostics System

    NTRODUCTION SECTION THE GENIUS DIGITAL DIAGNOSTICS SYSTEM 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 13 Genius Digital Imager • Genius Review Station • Network switch • Server – available from Hologic, or provided by customer Required but not provided • Computer monitor, keyboard, and mouse (for customers using a Hologic-supplied server) Genius™ Image Management Server User’s Manual...
  • Page 14 And, to change any archive settings, a user must have the proper credentials to access both the archive storage system and the Image Management Server. If Hologic has not supplied the server, a user must have access to the server. Hologic service personnel will install the Genius Image Management Server software on the server.

  • Page 15: Image Management Server Technical Specifications

    Key to Figure 1-3 Server The hardware shown may differ from the appearance of the hardware used at your site. Monitor, keyboard, and mouse (for customers using a Hologic-supplied server) Network switch Connections to the Digital Imager and Review Station Connection to the archive storage system Genius™...
  • Page 16 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: •...

  • Page 17: Internal Quality Control

    NTRODUCTION Pollution Degree Refer to the documentation provided with the server and computer. Altitude Refer to the documentation provided with the server and computer. Atmospheric pressure Refer to the documentation provided with the server and computer. Sound levels Refer to the documentation provided with the server and computer. Power Refer to the documentation provided with the server and computer.
  • Page 18 NTRODUCTION stored with the slide image data set. The Genius Image Management Server software verifies the hash each time that slide image data set is retrieved from the customer's archive. The Genius Digital Diagnostics System continuously checks for a proper connection between the Image Management Server and its clients: the Review Station and Digital Imager.

  • Page 19: Genius Image Management Server Hazards

    If any serious incident occurs related to this device or any components used with this device, report it to Hologic Technical Support and the competent authority local to the user and/or patient. Warnings, Cautions and Notes...
  • Page 20 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 hologic.com/ifu...
  • Page 21 NTRODUCTION USB port icon (computer) Made in USA Information is applicable only in the USA and Canada Information is applicable only in the USA Ethernet port icon (computer) 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 use or order the use of the device and are trained and experienced in the use of the product.
  • Page 22 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.

  • Page 23: Disposal

    NTRODUCTION SECTION DISPOSAL Disposal of the device Please contact Hologic Service. (Refer to Chapter 6, Service Information.) Do not dispose in municipal waste. Hologic, Inc. Hologic BV 250 Campus Drive Da Vincilaan 5 Marlborough, MA 01752 USA 1930 Zaventem 1-508-263-2900...

  • Page 25: 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 26: 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 27 (IT) infrastructure at your site. Limit access and back-up off-system As part of normal operation, data is saved to the Genius IMS in the following directories: • Hologic Main Application Folder C:\Program Files\Hologic Hologic application files for IMS dashboard, Archiver, etc., as well as SQL Server MDF/LDF...
  • Page 28 Always ensure the external USB flash drive or portable storage medium is virus-free and not used on public or home computers. • If the instrument is connected to a network, Hologic requires a firewall be placed between the system and the network to protect against malicious network threats. •...
  • Page 29 Location of main image repository. As this is a user-definable location, it may be different on an installed system. Hologic recommends the use of antivirus software on the computer that will run the IMS Server. Hologic has tested the following antivirus software on the computer that will run the IMS Server: •...
  • Page 30 “Hologic IMS Database Backup” – Powershell to execute database backup script. Cybersecurity assessment A cybersecurity assessment of the Genius IMS running Windows Server 2016 was performed. The results are presented in Table 2.1. Table 2.1 Cybersecurity Assessment, IMS Running Windows Server 2016...

  • Page 31: 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 32: Connecting Image Management Server Components

    CONNECTING IMAGE MANAGEMENT SERVER COMPONENTS If it becomes necessary to change the archive storage system connected to your Image Management Server, contact Hologic Technical Support or your local Hologic distributor. A service visit is required. The Genius Digital Diagnostics System components must be fully assembled before turning on the power and using the instrument.
  • Page 33 NSTALLATION Note: The appearance of the server in this illustration may differ from the server installed at your site, and the position of the power button may differ. 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.

  • Page 34: Storage And Handling - Post Installation

    NSTALLATION SECTION STORAGE AND HANDLING - POST INSTALLATION The Image Management Server must be stored in the location where it was installed. Typically, the server is left running. Follow your laboratory’s policy for handling computer equipment. SECTION SYSTEM SHUTDOWN Normal and Extended Shutdown Typically, the Image Management Server is left running.

  • Page 36: Chapter Three

    MAGE ANAGEMENT ERVER ASHBOARD C h a p t e r T h r e e Image Management Server Dashboard SECTION 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 37: System

    MAGE ANAGEMENT ERVER ASHBOARD SECTION SECTION SYSTEM The System dashboard shows an overview of the entire Image Management Server services, applications and connections. Status Indicators The System dashboard displays a summary of each of the other tabs in the dashboard. Each of the services and applications on the left of the System dashboard are described in more detail further in this chapter.
  • Page 38 MAGE ANAGEMENT ERVER ASHBOARD Slides Root Folder The Slides Root Folder is the storage location for the images sent by the Digital Imager and reviewed at the Review Station. The Slides Root Folder is set up during the system installation. When the amount of data saved to the Slides Root Folder approaches the limit of its storage capacity, and a notification message appear.
  • Page 39 Delete unused tags. Refer to the Genius Review Station Operator’s Manual for instructions. 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.
  • Page 40 Review Station. Storage capacity considerations Hologic recommends considering the archiving criteria and the local repository size (image cache) of the Genius Image Management Server in your lab when setting the storage capacity threshold for Slide Management to run.
  • Page 41 Instructions for Use for the performance characteristics of the Genius Digital Diagnostics System with the Genius Cervical AI algorithm. Hologic recommends that customers enable a solution for long-term storage and archiving of digital image files. It is a customer’s responsibility to determine the storage and archival strategy, which could be affected by rules or requirements affecting retention of such information.

  • Page 42: Archiver And Retriever

    MAGE ANAGEMENT ERVER ASHBOARD • Any comments or marks associated with a case are also deleted. • The CT workload reports (CT Workload Summary, CT Workload History and CT Reviews) and the Slide Data reports will only be accurate for the duration of the cached slides (before the case data record is deleted).
  • Page 43 MAGE ANAGEMENT ERVER ASHBOARD Figure 3-3 Archiver and Retriever dashboard Key to Figure 3-3 Archiver Status Refer to “Archiver Status” on page 3.10. Enable/Disable Archiver Refer to "Enable or Disable existing archiver" on page 3.10. Current time settings for the daily archive Refer to “Current time settings for the daily archive”...
  • Page 44 Refer to “Retrieve history” on page 3.13. Test Retriever The Test Retriever is used by qualified Hologic service personnel after an archiver is set up. The test confirms that the current settings are properly set up for retrieving slides from the archive storage system.
  • Page 45 To enable a disabled archiver, change the setting to Enable. Configure archiver The Archiver and Retriever dashboard has a Configure field, to be used only by qualified Hologic service personnel. The field has the network storage location for the archiver.
  • Page 46 MAGE ANAGEMENT ERVER ASHBOARD 7. Click OK when the “Archiver task updated successfully” message appears on the screen. Figure 3-4 Archiver task updated successfully Caution: If the archiver is not successfully updated and tested, images will not be archived from the server to the archive storage system.
  • Page 47 MAGE ANAGEMENT ERVER ASHBOARD Note: 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. Figure 3-5 Archive History, example Retriever Status Under normal operating conditions, when the Retriever Status is Ready, there are no actions...
  • Page 48 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 3-6 Retrieve History, example Genius™ Image Management Server User’s Manual 3.13...

  • Page 49: Review Station

    Station service. The communication between the Review Station and the Image Management Server is set up by Hologic service personnel as part of system installation. The Review Station dashboard has a Start/Stop button, to be used only by qualified Hologic service personnel.

  • Page 50: 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 51: Time Server

    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 3-9 Time Server dashboard The Time Server dashboard has a Start/Stop button, to be used only by qualified Hologic service personnel. 3.16...

  • Page 52: Imager Service

    The communication between the Digital Imager and the Image Management Server is set up by Hologic service personnel as part of system installation. The Imager Service dashboard has a Start/Stop button, to be used only by qualified Hologic service personnel.

  • Page 53: Thinprep

    MAGE ANAGEMENT ERVER ASHBOARD SECTION THINPREP DB The ThinPrep DB dashboard displays information about the database containing slide image data. The slide image data stored on the Image Management Server includes the accession ID, the date and time the slide was imaged, and the date and time a case was reviewed, as well as other data. The slide image data is available on the Image Management Server even after a slide’s images have been archived.
  • Page 54 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 55 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 56 MAGE ANAGEMENT ERVER ASHBOARD 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 3-13 Daily Slide Report, example Genius™...

  • Page 57: 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 59: 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 60 AINTENANCE This page intentionally left blank. Genius™ Image Management Server User’s Manual...

  • Page 62: 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 63 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 64 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 3.11.
  • Page 65 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.

  • Page 67: 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 68 ERVICE NFORMATION This page intentionally left blank. Genius™ Image Management Server User’s Manual...

  • Page 70: 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 71 RDERING NFORMATION Table 7.1 Orderable Items, Image Management Server Dashboard Item Description Quantity Part Number Image Management Additional user’s manual MAN-08800-001 Server Dashboard User’s Manual Genius™ Image Management Server User’s Manual...

  • Page 73: Index

    NDEX Index Antivirus 3.11 Archive history Archive, troubleshooting Archiver 3.10 change start or duration 3.10 current settings 3.10 Archiver Status Archiver Test Failed component overview Cybersecurity 3.20 Daily slide report Dashboard archiver and retriever 3.17 imager 3.15 network 3.14 Review Station 3.22 settings system...
  • Page 74 NDEX 3.20 Gather diagnostics Genius Digital Diagnostics System 1.10 hazards humidity range Image Management Server Specifications Indication for use Installation Intended purpose Intended use 1.13 labels, location on instrument Launch the application Manage delete slide images and case data records Network requirements 2.10...
  • Page 75 NDEX Operating System ordering information Required but not provided Required Materials 3.13 Retrieve history 3.14 Review Station safety standards Security Server Hardware Shipped to new location 2.10 shutdown 3.18 slide image data Slide Management Slides Root Folder Slides Root Folder, approaching capacity Specifications network Status Indicators...
  • Page 76 NDEX 1.10 Warnings Genius™ Image Management Server User’s Manual...
  • Page 78 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-08800-001 Rev. 003...

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