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Leica BIOSYSTEMS APERIO GT 450 DX Administrator's Manual

Digital pathology slide scanner
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APERIO GT 450 DX
DIGITAL PATHOLOGY SLIDE SCANNER
IT MANAGER AND LAB ADMINISTRATOR GUIDE

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Summary of Contents for Leica BIOSYSTEMS APERIO GT 450 DX

  • Page 1 APERIO GT 450 DX DIGITAL PATHOLOGY SLIDE SCANNER IT MANAGER AND LAB ADMINISTRATOR GUIDE...
  • Page 2 Copyright © Leica Biosystems Imaging, Inc. 2024. All Rights Reserved. LEICA and the Leica logo are registered trademarks of Leica Microsystems IR GmbH. Aperio, GT, and GT 450 are trademarks of Leica Biosystems Imaging, Inc. in the USA and optionally in other countries.
  • Page 3 Barcode management PIN management Configuring a PIN and timeout Enabling DICOM image output Viewing system information Displaying scanner information and settings Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 4 Scanner Administration Manager DX (SAM DX) server troubleshooting Restart the DataServer Verify Mirth is running IIS configuration error Scanner network troubleshooting Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 5 Binding an SSL certificate to Aperio SAM DX Assign the SSL certificate to your website Bind the SSL certificate Index Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 6 Cautions and Notes Serious Incidents Reporting — Any serious incident that has occurred in relation to the Aperio GT 450 DX shall be reported to the manufacturer and the competent authority of the member state in which the user and/or the patient is established.
  • Page 7 As a system security measure, Leica Biosystems products capture and log external attempts to access system data. For more information, contact your Leica Biosystems representative. Training — This manual is not a substitute for the detailed operator training provided by Leica Biosystems or for other advanced instruction.
  • Page 8 Intended Use The Aperio GT 450 DX is an automated digital slide creation and viewing system. The Aperio GT 450 DX is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue.
  • Page 9 On. To indicate connection to the mains, at least for mains switches or their positions, and those cases where safety is involved. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 10 California to cause Cancer and Reproductive Harm. For more information go to https://www.P65Warnings.ca.gov. Device is made in the USA of U.S. and foreign components. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 11 Introduction In this section: About this guide Related documents Log into SAM DX The SAM DX user interface Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 12 15 racks, priority rack scanning, automated image quality check and a scan speed of ~32 seconds at 40x scanning magnification for a 15 mm x 15 mm area. The Aperio GT 450 DX was designed to fit into your network environment and offer the best in security and performance.
  • Page 13 This guide is intended for laboratory administrators, IT managers, and anyone else responsible for managing the Aperio GT 450 DX on their facility network. For general information on how to use the scanner, see the Aperio GT 450 DX User's Guide.
  • Page 14 Aperio GT 450 DX Specifications — Detailed specifications on the Aperio GT 450 DX. Log into SAM DX After the Aperio GT 450 DX is installed and configured, the next step is to use the SAM DX to manage the Aperio GT 450 DX scanners and users.
  • Page 15 This displays the user name for the current SAM DX user. Select your login name to display links for changing the password and logging out. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 16 The icons used to display System Information, Event Log, and Configuration pages are included in this area. Note that the Configuration icons are only available to users with the Lab Admin role. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 17 Network bandwidth requirements How the Aperio GT 450 DX fits into your network Secure access Aperio GT 450 DX recommended network configuration Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 18 IT network failure may lead to delay in diagnosis/prognosis until the network is restored. Aperio GT 450 DX architecture The Aperio GT 450 DX was designed with IT ease of use and security in mind. It is integration-ready for your image and data management system (IDMS), an LIS, and other networked systems.
  • Page 19 These are the major components of the Aperio GT 450 DX and SAM DX system: Aperio GT 450 DX — One or more Aperio GT 450 DX scanners can be connected to a SAM DX server through the network. Each SAM DX server can support multiple scanners.
  • Page 20 2 Aperio GT 450 DX network architecture Aperio GT 450 DX recommended network configuration This section describes the recommended way to connect your Aperio GT 450 DX in your IT environment for optimal performance. Figure 2-1: Recommended network configuration Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A...
  • Page 21 SAM DX Server. The SAM DX DataServer displays the configuration data through the SAM DX HTTP(S) web page. 80/443 Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 22 Scanner configuration settings (on page 28) provides information on how to configure the various connections between the components and services through the SAM DX interface. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 23 Configuring the Aperio GT 450 In this section: General instructions Scanner configuration settings Images page Enabling DICOM image output Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 24 Scanner Configuration settings, such as communication settings for the DICOM Image converter and the DSR server, event management, time zone, and PIN management Each set of parameters is discussed in this chapter. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 25 For additional information on each option, see Summary of scanner setting and configuration options (on page 61). Click Save to save your changes. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 26 Use the System Information Info page to review the scanner settings. (You cannot make changes on this page.)  The Firmware and Hardware versions are automatically updated once SAM DX establishes communication with the scanner. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 27 (The illustration above displays only some of the available settings.) Most or all of the settings on this page will be configured for you by a Leica Biosystems representative when the scanner is installed. However, you may be asked to check the settings during a troubleshooting procedure.
  • Page 28 Scanner configuration settings The settings on these pages will be configured for you by a Leica Biosystems representative when the scanner is installed. However, you may be asked to check the settings during a troubleshooting procedure. You may also need to change settings if there are changes to your network that impact one or more of the communication settings.
  • Page 29 If you made changes, click Save to save the changes and return to viewing mode. For more details on each option, see Summary of scanner setting and configuration options (on page 61). Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 30 DICOM image settings (see below) The Lab Admin can click the Edit button to modify the settings on this page. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 31 Modifier field value of [\x00-\x1f\x7f] replaces all non-printable characters with a question mark “?”. Leave this value empty to remove characters matched by characters in the Barcode Value Modifier field. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 32 The features discussed in this section allow for more advanced modifications to the barcode. If you require additional control over the barcode string returned by the Aperio GT 450 DX, contact Leica Biosystems Technical Services. PIN management PINs control access to the scanner.
  • Page 33 Click Save to return to the list of PINs. Enabling DICOM image output The Aperio GT 450 DX has the ability to output image files in either SVS or DICOM format. (The default is .SVS image file format.) The optional DICOM feature is purchased and installed separately for each Aperio GT 450 DX scanner. You must use SAM DX to configure the final storage location for the DICOM images (PACS, IMS, or file share).
  • Page 34 Hover over the name of the scanner you want to configure for DICOM until the Edit symbol appears, then click the scanner name. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 35 If you are not familiar with regular expressions, contact Leica Biosystems Technical Support for assistance. In the Case ID Format box, type the Case ID format as a regular expression. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 36 When using a scanner that has been configured to output DICOM images, the Console will show “(DICOM)” at the top of the Console page: Aperio GT 450 DX (DICOM) Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 37 Viewing system information In this section: Displaying scanner information and settings Displaying scanner statistics Working with the Event Log Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 38 Refer to the table below for instructions on how to display scanner and system settings. In many cases you cannot modify these settings, but Leica Biosystems Technical Support may ask you for the information during troubleshooting or maintenance procedures. Some settings can only be seen by users with the Lab Admin role.
  • Page 39 We recommend backing up the scanner log files downloaded to the SAM DX server and storing the backups offsite. We also recommend backing up Windows Event logs on the SAM DX server and storing those backups offsite. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 40 SSH. Note that automated analysis software such as Intrusion Detection System, IDS, can be used to analyze the log files. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 41 User management In this section: Understanding roles Managing users Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 42 Administrator role can do the following: Add, modify, and delete other user accounts Change user passwords View System Information and edit some of the settings Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 43 At least one special character: ! @ # $ % ^ * or _ Different from the previous 5 passwords Select a Role: Lab Admin or Operator. Click Save. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 44 Select Users from the top ribbon on the main page. Click Unlock next to the name of the user account you want to unlock. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 45 At least one special character: ! @ # $ % ^ * or _ Different from the previous 5 passwords Confirm the password, and then click OK. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 46 Physical safeguards for Aperio GT 450 DX Protecting the Aperio SAM DX server Use of off-the-shelf software Support and cybersecurity patches Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 47 DX software are hardened with CIS (Center for Internet Security) benchmarks. The Aperio GT 450 DX scanner and SAM DX are not intended to store sensitive data, only to export/upload data to connected applications on separate network servers. The connection between the Aperio GT 450 DX scanner and the SAM DX server is secured through an encrypted, secure SSL/TLS connection.
  • Page 48 DataServer database which can be a part of your overall backup plan. The Aperio GT 450 DX database is maintained by Microsoft SQL Server and the automatic backup is created as a SQL Server backup file under the direction of the DataServer.
  • Page 49 Allow listing, an administrative tool that allows only authorized programs to run, should be implemented on the SAM DX server. Leica Biosystems recommends you use SQL Standard (2019 or later) or Enterprise SQL server which comes with database encryption. Use normal care in maintaining and using servers. Interrupting network connections or turning off the servers while they are processing data (such as when they are analyzing digital slides or generating an audit report) can result in data loss.
  • Page 50 Require SMB encryption with Windows Admin Center To further protect your SAM DX server, Leica Biosystems recommends requiring SMB encryption for shared files. Follow the steps below to enable SMB encryption using Windows Admin Center.
  • Page 51 By default, Windows servers enable weak encryption protocols and ciphers to preserve compatibility with older systems. Leica Biosystems recommends disabling these encryption protocols and ciphers by adding the registry entries specified Recommended registry settings to secure Windows Server 2019 and Windows Server 2022 (on page 52) to your registry.
  • Page 52 "ServerMinKeyBitLength"=dword:00000800 [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\KeyExchangeAlgorithms\ECDH] "Enabled"=dword:ffffffff [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\KeyExchangeAlgorithms\PKCS] "Enabled"=dword:ffffffff [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\Protocols] [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\Protocols\Multi-Protocol Unified Hello] [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\Protocols\Multi-Protocol Unified Hello\Server] "Enabled"=dword:00000000 "DisabledByDefault"=dword:00000001 [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\Protocols\PCT 1.0] [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\Protocols\PCT 1.0\Server] "Enabled"=dword:00000000 "DisabledByDefault"=dword:00000001 Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 53 [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\Protocols\TLS 1.2] [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\Protocols\TLS 1.2\Server] "Enabled"=dword:ffffffff "DisabledByDefault"=dword:00000000 [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\Ciphers] [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\Ciphers\AES 128/128] "Enabled"=dword:ffffffff [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\Ciphers\AES 256/256] "Enabled"=dword:ffffffff [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\Ciphers\DES 56/56] "Enabled"=dword:00000000 [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\Ciphers\NULL] "Enabled"=dword:00000000 [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\Ciphers\RC2 128/128] "Enabled"=dword:00000000 Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 54 "Enabled"=dword:00000000 [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\Ciphers\RC2 56/128] "Enabled"=dword:00000000 [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\Ciphers\RC4 128/128] "Enabled"=dword:00000000 [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\Ciphers\RC4 40/128] "Enabled"=dword:00000000 [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\Ciphers\RC4 56/128] "Enabled"=dword:00000000 [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\Ciphers\RC4 64/128] "Enabled"=dword:00000000 [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Control\SecurityProviders\SCHANNEL\Ciphers\Triple DES 168] "Enabled"=dword:00000000 Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 55 While conducting cybersecurity assessments, you may wish to consider which third party software components are used by Leica Biosystems software. Lists of all off-the-shelf software (OTS) used by Aperio GT 450 DX and SAM DX are maintained by Leica Biosystems. If you would like information on OTS used, contact your Leica Biosystems Sales or Customer Support representative and ask for the Software Bills of Materials for Aperio GT 450 DX and SAM DX.
  • Page 56 Troubleshooting In this section: Scanner Administration Manager DX (SAM DX) server troubleshooting Scanner network troubleshooting Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 57 This appendix provides causes and solutions for problems related to the SAM DX server and related components. It also provides common troubleshooting procedures that may need to be performed by the Aperio GT 450 DX lab administrator. For general troubleshooting information for the scanner operator, see the Aperio GT 450 DX User's Guide.
  • Page 58 Authentication item and ensure the Specific user is set to “IUSR” (no password). If the site is running and all settings are correct, please see the IIS logs for more details. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 59 Check if your site’s image storage location is full. Check if there is a permissions or account problem with the account running the DICOM server. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 60 IP address again. If the issue persists, consult with your organization’s IT professionals prior to calling Leica Biosystems Technical Services. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 61 Summary of scanner setting and configuration options In this section: Basic scanner information Scanner configuration Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 62 For internal use. Do not change unless instructed to do so by Leica View/Edit None Factor Biosystems Technical Support. Hostname Name of the server where the DICOM Image converter resides. View/Edit None Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 63 Timeout interval (minutes); the scanner locks the display and control View/Edit None pad when there is no operator interaction for this period of time. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 64 This is a general description field, and can contain numbers, letters, and punctuation characters. Time Zone Scanner time Set by SAM DX administrator View/Edit None zone Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 65 Binding an SSL certificate to Aperio SAM DX In this section: Assign the SSL certificate to your website Bind the SSL certificate Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 66 Assign the SSL certificate to your website by expanding the Sites subsection in the Connections menu on the left and selecting your website: Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 67 In the Actions panel on the right side, locate the Edit Site menu and select the Bindings option. On the right side of the Site Bindings window, click Add: Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 68 The Require Server Name Indication box needs to be checked if there are multiple SSL certificates on the server. Click OK for the new https entry to appear in the Site Bindings window: Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 69 C Binding an SSL certificate to Aperio SAM DX The certificate is now installed and the SAM DX user interface should be accessible via HTTPS. Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 70 18, 21 log files configuring DICOM output downloading Digital Slide Repository (DSR) server login timeout 32, 63 documents best practices Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 71 29, 64 PIN, view current timeout 32, 63 troubleshooting related documents roles unlocking user accounts user interface user roles definitions Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...
  • Page 72 Index Lab Admin role Operator role users adding deleting editing unlocking accounts Aperio GT 450 DX IT Manager and Lab Administrator Guide, MAN-0507 Revision A Copyright © Leica Biosystems Imaging, Inc. 2024...