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Genius™ Digital Diagnostics System  

Instructions for Use 

English  AW-22963-001 Rev. 001  3-2021  10/13

 

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. 

 

Figure 1: Deming Regression  

Cell Count: Digital Imager vs. Manual  

 

 

 

 

Manual cell count 

Digital Ima

g

er cell count

 

Cell counts 

Содержание Genius

Страница 1: ...Operator s Manual Genius Image Management Server Dashboard ...

Страница 2: ... Inc 250 Campus Drive Marlborough MA 01752 USA Tel 1 800 442 9892 1 508 263 2900 Fax 1 508 229 2795 Web www hologic com Hologic BV Da Vincilaan 5 1930 Zaventem Belgium Australian Sponsor Hologic Australia and New Zealand Pty Ltd Suite 302 Level 3 2 Lyon Park Road Macquarie Park NSW 2113 Australia Tel 02 9888 8000 ...

Страница 3: ...gnetic optical chemical manual or otherwise without the prior written permission of Hologic 250 Campus Drive Marlborough Massachusetts 01752 United States of America Although this guide has been prepared with every precaution to ensure accuracy Hologic assumes no liability for any errors or omissions nor for any damages resulting from the application or use of this information This product may be ...

Страница 4: ...Genius Digital Diagnostics System Genius Digital Diagnostics System ...

Страница 5: ...Genius Digital Diagnostics System Instructions for Use English AW 22963 001 Rev 001 3 2021 1 13 Genius Digital Diagnostics System Instructions for Use ...

Страница 6: ...pared 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 A slide ID reader scans the slide s accession ID and locates the position of the cell spot Then the Digital Imager scans the entire ThinPrep cell spot creating an in focus whole slide i...

Страница 7: ...e coverslip should be dry and located correctly Slides that are broken or poorly coverslipped should not be used Slides used with the Genius Digital Imager must contain properly formatted accession number identification information as described in the operator s manual The performance of the Genius Digital Diagnostics System using slides prepared from reprocessed sample vials has not been evaluate...

Страница 8: ...oducibility of the Genius Digital Diagnostics System In the study 260 ThinPrep slides were enrolled made from individual residual ThinPrep Pap test specimens covering the full range of abnormal diagnostic categories as defined in The Bethesda System for Reporting Cervical Cytology The slides were imaged once on the ThinPrep Imaging System and the same slides were imaged three times on three differ...

Страница 9: ...ws the relationship between the Genius Digital Diagnostic System results and the TIS assisted results Table 2 TIS assisted Results vs Genius Digital Diagnostic System OOIs TIS UNSAT NILM ASCUS LSIL ASC H AGUS HSIL CANCER Total OOI NILM 2 83 4 0 0 2 0 0 91 ASCUS 0 10 6 3 1 0 0 0 20 LSIL 0 0 5 27 0 0 1 0 33 ASC H 0 1 5 11 2 0 7 0 26 AGUS 0 2 0 0 0 5 1 1 9 HSIL 0 0 2 2 2 1 49 5 61 CANCER 0 0 0 0 1 1 ...

Страница 10: ... in each category is shown in the table Table 3 ECC Detection on Normal Cases Agreement between TIS assisted Review and OOI Study Results ECC TIS OOI 4 2 31 59 Agreement Rates PPA 97 89 99 NPA 11 5 26 Detection Rates TIS 64 54 72 OOI 94 89 99 Diff 30 40 20 The positive and negative percent agreement PPA and NPA were calculated with reference to the TIS assisted result In addition the detection rat...

Страница 11: ...view 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 The overall detection rate for each organism and the difference in detection rates TIS OOI are also included Table 4 Trichomonas Detection Agreement between TIS assisted Review and OOI Study Results TRICH TIS OOI 2...

Страница 12: ...tion Agreement between TIS assisted Review and OOI Study Results CAND TIS OOI 232 5 3 17 Agreement Rates PPA 77 57 90 NPA 99 96 100 Detection Rates TIS 8 6 5 7 12 6 OOI 7 8 5 1 11 7 Diff 0 8 1 8 3 4 The detection rate for Candida for the Genius Digital Diagnostics System was 7 8 compared to 8 6 for TIS assisted review ...

Страница 13: ... of infected cells The difference in detection rates in the study is due to this difference in counting methodology and would not necessarily be reflected in clinical practice Overall the presentation of infectious organisms by the algorithm is equivalent or higher than with TIS assisted review CELL COUNT STUDY A study was conducted to evaluate the performance of the cell count metric produced by ...

Страница 14: ...y 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 Figure 1 Deming Regression Cell Count Digital Imager vs Manual Manual cell count Digital Imager cell count Cell counts ...

Страница 15: ...sult for abnormal slides The standard deviation of number of matching OOIs is 1 3 for abnormal slides Endocervical component ECC is detected in the OOI gallery at an equal or higher rate than in TIS assisted reviews Trichomonas is detected in the OOI gallery at an equal or higher rate than in TIS assisted reviews Candida is detected in the OOI gallery at an equal or higher rate than in TIS assiste...

Страница 16: ... a Hologic supplied graphics card In some configurations of the system a laboratory may supply the server hardware MATERIALS REQUIRED BUT NOT PROVIDED Slide staining racks Monitor keyboard mouse for the Image Management Server Keyboard and mouse for each Review Station STORAGE Refer to the Technical Specifications included in the Digital Imager operator s manual Additional storage requirements may...

Страница 17: ...elated 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 250 Campus Drive Marlborough MA 01752 1 800 442 9892 www hologic com Hologic BV Da Vincilaan 5 1930 Zaventem Belgium 2021 Hologic Inc All rights reserved ...

Страница 18: ...Table of Contents Table of Contents ...

Страница 19: ...Image Management Server Hazards 1 8 Disposal 1 11 Chapter Two Installation General 2 1 Action upon Delivery 2 1 Preparation prior to Installation 2 2 Moving the Image Management Server 2 3 Connecting Image Management Server Components 2 3 Power on the Server 2 4 Storage and Handling Post Installation 2 5 System Shutdown 2 5 Chapter Three Image Management Server Dashboard Overview 3 1 System 3 2 Ar...

Страница 20: ...e 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 ...

Страница 21: ...1 Introduction 1 Introduction ...

Страница 22: ...anagement Server can act as either a short or long term cache The Image Management Server is connected to a network switch which connects the Genius Digital Imager to the Image Management Server and connects the Review Station to the Image Management Server The Image Management Server stores the slide data imaging and review information in a SQL database and stores the image files as a repository ...

Страница 23: ...ise be appropriate for manual visualization by conventional light microscopy It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using this system For professional use THE GENIUS DIGITAL DIAGNOSTICS SYSTEM Slides that have been prepared for screening are loaded into slide carriers which ...

Страница 24: ...hologist has the option to electronically mark objects of interest and include the marks in the slide review The reviewer always has the option to move and zoom through a view of the whole slide image which provides complete freedom to move any portion of the cell spot into the field of view for examination SECTIONB Figure 1 2 Genius Digital Diagnostics System Network Genius Digital Imagers Genius...

Страница 25: ...nents 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 A user must have System Administrator rights in Windows to access the Image Management Server dashboard And to change any archive settings a user must have the proper credentials to access both the archive storage syste...

Страница 26: ...ER 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 SECTION D 1 2 5 4 3 1 2 3 4 5 ...

Страница 27: ...interface of type VGA HDMI or display port Dual hot plug redundant power supply 1 1 750 W or greater Operating System A minimum of Windows 64 Bit is required Windows Server 2016 is recommended Note To properly display the dashboard the minimum recommended display resolution for the monitor connected to server is 1366 by 768 ppi Operating temperature range Refer to the documentation provided with t...

Страница 28: ...MI and EMC Standards Refer to the documentation provided with the server and computer for safety EMI and EMC standard information INTERNAL QUALITY CONTROL The Image Management Server hosts the Review Station application hosts applications and services and provides data storage for the Review Station and Digital Imager The Image Management Server continuously checks for a proper connection with Rev...

Страница 29: ...age 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 Warnings Cautions and Notes The terms WARNING CAUTION and Note have specific meanings in this manual A WARNING advises against certain actions or situations ...

Страница 30: ...r 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 Serial number Manufacturer Authorized representative in the European Community Catalogue number Date of manufacture In vitro diagnostic medical device On Power switch Off Power switch On Off Standby mode ...

Страница 31: ...y Hologic are shown in Figure 1 5 Figure 1 5 Location of Labels on the Server USB port icon computer Ethernet port icon computer 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 Note The appearance of the server in this illustration may differ from the server installed at your site depending...

Страница 32: ...ifications 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 DISPOSAL Disposal of the device Please contact Hologic Service Refer to Chapter 6 Service Information Do not dispose in municipal...

Страница 33: ...INTRODUCTION 1 12 Genius Image Management Server User s Manual 1 This page intentionally left blank ...

Страница 34: ...2 Installation 2 Installation ...

Страница 35: ...lation and configuration of the archive storage system An archive storage system is mandatory Hologic service personnel collaborate with a laboratory s IT staff to connect the Image Management Server to the archive storage system The Image Management Server dashboard should only be used by personnel who have been trained by Hologic or by organizations or individuals designated by Hologic ACTION UP...

Страница 36: ...le conditioned power supply as well as environmental conditioning are recommended with proper regard for physical dimensions power requirements and BTU output The power requirements and environmental conditioning vary with the model of server for your facility Network requirements for the server The Image Management Server requires a minimum of 10 Gbps unimpeded network connectivity to the Digital...

Страница 37: ...d to a new location please contact Hologic Technical Support or your local Hologic distributor Refer to Chapter 8 Service Information 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 Di...

Страница 38: ...ed into a grounded outlet Disconnection from the power supply source is by removal of the power cord 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 SECTION F Note The appearance of the server in this illustration may differ from the se...

Страница 39: ...ement 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 Caution If the Image Management Server needs to be shut down shut down the Digital Imager first If the Digital Imager is transmitting data to the Image Management Server when the Image Management Server is being shut down the ...

Страница 40: ...INSTALLATION 2 6 Genius Image Management Server User s Manual 2 This page intentionally left blank ...

Страница 41: ...3 Image Management Server Dashboard 3 Image Management Server Dashboard ...

Страница 42: ... error notification for the services and applications necessary to store and retrieve data for the Digital Imager and the Review Station It is recommended that the IT support staff for a laboratory acquaint themselves with the material in this chapter using the Image Management Server dashboard This chapter describes each of the dashboard s tabs System 3 2 Archiver and Retriever 3 4 Review Station...

Страница 43: ...mary 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 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 mor...

Страница 44: ... storage capacity remains Refer to Unable to Archive or Approaching Full Capacity on page 5 3 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 wi...

Страница 45: ...criteria for archiving cases is set up at the Review Station When a case is archived its slide images are moved from the Image Management Server to a laboratory s archive storage system Note Case data records continue to reside on the Image Management Server after the images for the case are archived To view images from an archived case a reviewer at a Review Station must retrieve the images from ...

Страница 46: ...nstalled and configured by qualified Hologic service personnel Archive History button Refer to Archive History on page 3 7 Archive queue To display the quantity of slides that are eligible to be archived at the current point in time click the Check queue button The number in the In queue to archive field updates each time the Check queue button is clicked Total scanned slides This is the quantity ...

Страница 47: ...ntime needs to change 1 To change the starting time for the daily archive click the down arrow next to the current Start On time and select a new time 2 To change the duration of the daily archive click the down arrow next to the Max Runtime and select a new time 3 Enter your username The user must have System Admin rights 4 Enter your password 5 Click the Update Archiver button This applies the c...

Страница 48: ...em If the quantity of cases planned for the daily archive is lower than the quantity actually archived something prevented all of the cases from transferring to the archive storage system The difference could be caused by a max runtime that is too short or it could be one of the indicators of a failure to archive Refer to Unable to Archive or Approaching Full Capacity on page 5 3 If all of the cas...

Страница 49: ...ius Image Management Server User s Manual 3 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 ...

Страница 50: ...anual 3 9 3 IMAGE MANAGEMENT SERVER DASHBOARD 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 ...

Страница 51: ...n 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 The communication between the Review Station and the Image Management Server is set up by Hologic service personnel as ...

Страница 52: ...igure 3 7 Network dashboard 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 SECTION E ...

Страница 53: ...the 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 SECTION F ...

Страница 54: ...des 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 The communication between the Digital Imager and the Image Management Server is set up by Hologic service personnel as part...

Страница 55: ...case was reviewed as well as other data The slide image data is always available on the Image Management Server even after a slide s images have been archived This allows reports run from the Digital Imager or from the Review Station to include information about all slides if the person running the report so chooses Figure 3 10 ThinPrep DB dashboard Key to Figure 3 10 SQL Server Status Displays th...

Страница 56: ...gather that data click the Choose Folder button to navigate to the folder to which the zip file will be written or type in a file path By default the box is checked for Include Slide Event Data The slide accession IDs are included in the slide event data To exclude slide event data click to un check the box Note To save the Gather Diagnostics file to a thumb drive put a thumb drive into a USB port...

Страница 57: ...gate to a different path using the 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 To generate a Daily Slide Report 1 Click the Choose Fol...

Страница 58: ...17 3 IMAGE MANAGEMENT SERVER DASHBOARD 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 ...

Страница 59: ...ologic 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 Figure 3 13 Settings dashboard To change the language use the down arrow to select one of the available options SECTION I ...

Страница 60: ...4 Maintenance 4 Maintenance ...

Страница 61: ...Genius Image Management Server User s Manual 4 1 4 MAINTENANCE C h a p t e r F o u r Maintenance GENERAL MAINTENANCE Refer to the documentation provided by the server manufacturer SECTION A SECTION A ...

Страница 62: ...MAINTENANCE 4 2 Genius Image Management Server User s Manual 4 This page intentionally left blank ...

Страница 63: ...5 Troubleshooting 5 Troubleshooting ...

Страница 64: ...s 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 Additional troubleshooting by a laboratory s network IT staff may be necessary For example if a la...

Страница 65: ...ally 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 ...

Страница 66: ...em the Review Station users with a manager role receive an alert at the Review Station The alert instructs the manager to contact the site network administrator If the slides root folder approaches capacity and some of the eligible images are successfully archived each night the Review Station users with a manager role do not receive an alert The issue may be in the Image Management Server s side ...

Страница 67: ...ither the server or the archive storage system the test will fail without revealing any other cause of the failure to archive images If the test is not successful there is an issue with the Image Management Server s communication with the archive storage system If the Test Archiver fails the Image Management Server will not be able to do the daily transfer of slide image files from the server to t...

Страница 68: ...6 Service Information 6 Service Information ...

Страница 69: ...day through Friday excluding holidays Europe UK Middle East Technical Solutions Cytology can be reached Mon Fri 08 00 18 00 CET TScytology hologic com And via the toll free numbers below Finland 0800 114829 Sweden 020 797943 Ireland 1 800 554 144 United Kingdom 0800 0323318 France 0800 913659 Luxembourg 8002 7708 Spain 900 994197 Portugal 800 841034 Italy 800 786308 Netherlands 800 0226782 Belgium...

Страница 70: ...SERVICE INFORMATION 6 2 Genius Image Management Server User s Manual 6 This page intentionally left blank ...

Страница 71: ...7 Ordering Information 7 Ordering Information ...

Страница 72: ...y 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 Finland 0800 114829 Sweden 020 797943 Ireland 1 800 554 144 United Kingdom 0800 0323318 France 0800 913659 Luxembourg 8002 7708 Spain 900 994197 Portugal 800 ...

Страница 73: ...us Image Management Server User s Manual 7 Table 7 1 Orderable Items Image Management Server Dashboard Item Description Quantity Part Number Image Management Server Dashboard User s Manual Additional user s manual ea MAN 08020 001 ...

Страница 74: ...Index Index ...

Страница 75: ...t settings 3 6 Archiver Status 3 6 Archiver Test Failed 5 4 C component overview 1 5 D Daily slide report 3 16 Dashboard archiver and retriever 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 G Gather diagnostics 3 16 Genius Digital Diagnostics System 1 3 ...

Страница 76: ...rver Specifications 1 6 Indication for use 1 2 Installation 2 1 Intended use 1 2 L labels location on instrument 1 10 Launch the application 2 4 N normal shutdown 2 5 O Operating System 1 6 ordering information 7 1 R Required but not provided 1 4 Required Materials 1 4 Retrieve history 3 9 Review Station 1 3 3 10 ...

Страница 77: ...Shipped to new location 2 3 shutdown 2 5 slide image data 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 T Technical Solutions Cytology 6 1 temperature range 1 6 ThinPrep database 3 14 Troubleshooting 5 1 W Warnings 1 8 ...

Страница 78: ...INDEX Index 4 Genius Image Management Server User s Manual This page intentionally left blank ...

Страница 79: ...Operator s Manual Genius Image Management Server Dashboard ...

Страница 80: ...MAN 08020 001 Rev 001 Hologic Inc 250 Campus Drive Marlborough MA 01752 USA 1 508 263 2900 www hologic com Hologic BV Da Vincilaan 5 1930 Zaventem Belgium ...

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