Leica APERIO GT 450 DX User Manual
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Leica APERIO GT 450 DX User Manual

Digital pathology slide scanner
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APERIO GT 450 DX
DIGITAL PATHOLOGY SLIDE SCANNER
USER'S GUIDE

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Summary of Contents for Leica APERIO GT 450 DX

  • Page 1 APERIO GT 450 DX DIGITAL PATHOLOGY SLIDE SCANNER USER'S GUIDE...
  • Page 2 Copyright © 2024 Leica Biosystems Imaging, Inc. 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: Table Of Contents

    Key features Continuous load workflow Scan magnification Automatic image quality check Image types supported Slide types supported Coverslips Slide racks supported Slide capacity Barcodes supported Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 4 Image quality control for histotechnicians and pathologists Check that the scanned image covers all slide tissue Scan statistics Maintenance Maintenance schedule Serial number and firmware version Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 5 9000: Scanner cover is open Rack warnings and solutions 1005: Cannot process rack 1006: Cannot process one or more slides in rack Slide errors and solutions Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 6 Slides are broken inside the scanner Network connection lost Performance characteristics Precision Intra-System Study Inter-System/Site Study Intra- and Inter-Pathologist Study Accuracy Technical performance assessment summary Index Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 7: Notices

    Notices Revision Record Rev. Issued Sections Affected Detail April 2024 New manual for Aperio GT 450 DX 1.2. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 8: Cautions And Notes

    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 9: Intended Use

    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 10: Symbols

    IEC 60417 - 5007 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 User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 11 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 User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 12: Introduction

    Introduction In this section: Resources Warnings Compliance specifications Installation Disposal of the Aperio GT 450 DX Scanner safety instructions Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 13 40x scanning magnification for a 15 mm x 15 mm area. The Aperio GT 450 DX is intended for use by trained clinical pathology histotechnicians, while the Aperio GT 450 DX Aperio GT 450 SAM DX software is intended for use by IT professionals and laboratory administrators.

  • Page 14: Resources

    Provides video instruction on performing various tasks. You can view the videos from the Help area on the scanner’s touchscreen interface. Customer Support If you have an issue with the scanner you cannot resolve, contact Leica Biosystems Technical Services. Training Leica Biosystems offers classroom and virtual training courses.

  • Page 15: Instrument Warnings

    Component and part replacement warnings There are no user-replaceable parts or components in the Aperio GT 450 DX. Replacement of parts or components within the Aperio GT 450 DX must be performed by qualified Leica Biosystems Technical Services personnel using Leica Biosystems specified parts.

  • Page 16: Compliance Specifications

    WARNING: Two people are required for lifting the scanner. Installation and setup of the scanner should only be performed by a trained Leica Biosystems Service representative. After installation, the Leica Biosystems Service representative will check the scanner for proper operation.

  • Page 17: Disposal Of The Aperio Gt 450 Dx

    1 Introduction When you first receive the Aperio GT 450 DX and accessories, inspect the pallet and attached boxes for any damage. If the package has visible damage from shipment, contact Leica Biosystems Customer Service for assistance. Disposal of the Aperio GT 450 DX Contact Leica Biosystems Imaging, Inc.
  • Page 18 Moving – Use care if you must slide the scanner around the workbench. If you need to pick up the scanner to move it off the workbench, contact Leica Biosystems Technical Services. Moving the scanner may void the applicable product warranty—contact Leica Biosystems for advice.
  • Page 19 Unauthorized substitutions may result in fire, electric shock, or other hazards and may affect product compliance. The objective in the Aperio GT 450 DX scanner has been specifically designed for this device. Do not replace it with another type of objective.

  • Page 20: Aperio Gt 450 Dx Overview

    Aperio GT 450 DX overview In this section: Theory of operation Scanner overview Touchscreen interface overview Help videos and guides Key features Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 21: Theory Of Operation

    This chapter provides an overview of the Aperio GT 450 DX Scanner. Theory of operation The Aperio GT 450 DX scanner contains an automated slide loader subsystem which is designed to process standard 1" × 3" (2.54 cm × 7.62 cm) microscope slides.

  • Page 22: Turn The Scanner On And Off

    Turn the scanner on and off The On/Off switch is located on the right side of the scanner near the back. On position = Off position = Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 23: Touchscreen Interface Overview

    The Home screen (Carousel view) is where you view rack and slide status. The buttons along the top enable you to access other areas, such as Help and Maintenance. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 24 (on page 49) Note: Rack settings appear when you The rack settings enable you to scan the entire select a rack. slide for the whole rack. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 25 (on page 46) Rack Order Tap Rack Order to view scan order and status of View rack scan order (on page 46) the racks. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 26: Help Videos And Guides

    2 Aperio GT 450 DX overview Help videos and guides You can access training videos and the Aperio GT 450 DX Quick Reference Guide directly from the touchscreen interface. We recommend that you watch the training videos before operating the scanner for the first time.

  • Page 27: Image Types Supported

    Image types supported The Aperio GT 450 DX creates SVS files or DICOM compatible images. The .svs image format is the default. For information on enabling the optional DICOM feature, see the Aperio GT 450 DX IT Manager and Lab Administrator’s Guide.

  • Page 28: Slide Preparation

    Slide preparation In this section: Tissue preparation Staining Slide preparation guidelines Coverslips Labels Barcodes Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 29: Tissue Preparation

    It is the responsibility of the lab to verify the quality of the tissue preparation, the physical characteristics of the slide, and the staining quality. CAUTION: Ensure that the slides and racks you use meet the Aperio GT 450 DX specifications. For details, see the Aperio GT 450 DX Specifications, MAN-0506. Do not modify racks or attach labels to them.

  • Page 30: Tissue Placement

    Leica Biosystems HistoCore SPECTRA Coverslipper. The Aperio GT 450 DX supports common industry glass or plastic coverslips used for 1-inch x 3-inch (2.54 cm x 7.62 cm) slides. See the Aperio GT 450 DX Specifications for coverslip specifications. (Glass coverslips are recommended).

  • Page 31: Labels

    Wipe the coverslip clean of dust and fingerprints before loading the slide in the scanner. Labels The Aperio GT 450 DX supports common industry labels used for 1 x 3 inch (2.54 cm x 7.62 cm) slides. Improperly applied slide labels can cause slides to jam.
  • Page 32 Apply only one barcode label per slide. Use only supported barcode labels. See Barcodes supported (on page 27). Use only high-quality printed barcode labels. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 33: Scan Slides

    Rotate a rack to the rack loading area Unload racks from the carousel Check scan status Scan entire slide for whole rack Image quality control for histotechnicians and pathologists Scan statistics Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 34: Scanning Concepts

    Scan workflow The Aperio GT 450 DX is a continuous load scanner. You can continually load new racks and unload completed racks, as shown below: Aperio GT 450 DX User's Guide, MAN-0505 Revision A...

  • Page 35: Carousel Rotation

    As a security measure, the scanner logs you out after a period of time and requires you to enter the passcode. From the touchscreen interface, tap Login. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 36 When the keypad screen appears, enter your 5-digit passcode. To log out: Logging out locks the touchscreen interface until a valid passcode is entered. From the touchscreen interface, tap Logout. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 37: Load Slides In The Rack

    For a successful scan, ensure you use the correct orientation of the slides and the rack. To load slides in the rack: Position the rack so the Leica logo and “SIDE UP” face Insert each slide as shown with the label facing out and...

  • Page 38: Load Racks In The Carousel

    When the rack is fully inserted, there is a “click” sound, and the rack position on the Home screen turns light blue. Continue loading racks as needed or until you fill the front six rack slots. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 39 If the completed rack is in the back of the carousel, you can rotate it to the rack loading area. See Rotate a rack to the rack loading area (on page 41). Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 40: Priority Scanning

    The Priority option appears when you select the rack position. Tap Priority. The priority icon and scan queue number appear on the rack position. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 41: Rotate A Rack To The Rack Loading Area

    After the rack is rotated to the front, you can remove the rack. (The status light in the loading area blinks to indicate the location of the rotated rack). Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 42: Unload Racks From The Carousel

    If the rack is in the loading area, carefully remove the rack from the rack slot. If the rack is not in the loading area, you can rotate it to the front: Tap the rack position. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 43: Check Scan Status

    CAUTION:  If you must remove a rack before all slides in the rack are scanned, note the rack and slide status. After removal, the rack’s scan status is no longer available. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 44: Check Rack Status

    If there is an error on at least one slide in the rack that is currently scanning, the rack position pulses blue and orange. Rack warnings (on page 47). Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 45: View Slide Status For A Rack

    The slide scanned successfully, passed image QC, and was transferred to the specific image location. The slide has a scan warning. See Rack warnings (on page 47). Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 46: View Macro Images Of Scanned Slides

    Racks in the list appear in the scan order. The scan status is indicated for each rack. In the example, rack 3 is set as priority. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 47: Rack Warnings

    Take note of the error code and message. For information and steps to resolve the rack error, go to Rack warnings and solutions (on page 91). Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 48 Take note of the error code and message. For information and steps to resolve the error, go to Slide errors and solutions (on page 93). Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 49: Scan Entire Slide For Whole Rack

    Tap Settings , and then tap Scan Entire Slide. The Scan Entire Slide option is selected, and the Settings icon appears on the rack position: Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 50: Image Quality Control For Histotechnicians And Pathologists

    (Tap to navigate through the slides in the rack. You can view slide images only after the scanner has completed scanning the slide.) Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 51 If any tissue is outside the scan area, you can tap Scan Entire Slide to rescan the whole slide. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 52: Scan Statistics

    Scan statistics The Aperio GT 450 DX provides scan statistics, such as the number of slides or racks scanned per day, per week, etc. Tap Stats to view statistics for the Last 7 Days, Last 12 Months, or Lifetime by Year.

  • Page 53: Maintenance

    Maintenance This chapter contains a maintenance schedule and procedures for maintaining your Aperio GT 450 DX scanner. Call Leica Biosystems Technical Services if you cannot perform a maintenance routine or if you discover a problem with your scanner. Before performing maintenance, we recommend you watch the maintenance videos available on the touchscreen. See Help videos and guides (on page 26).

  • Page 54: Maintenance Schedule

    5 Maintenance Maintenance schedule To keep your Aperio GT 450 DX scanner in optimal working condition, follow these maintenance routines. Frequency Maintenance Task Procedure Daily Restart the scanner. Restart the scanner (on page 57) (Recommended) Every Six Months 1.  Clean the objective and Koehler Clean the objective and Koehler (on page 58) 2.  Clean the stage slide tray...

  • Page 55: Shut Down The Scanner

    Complete these steps to access the inside of the scanner for maintenance or troubleshooting. If you are performing maintenance on the scanner, you should first remove any racks from the carousel. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 56 Grasp the cover using the handhold indentations: Slide the cover out until it reaches the point shown below. Rotate the VPU latch 180 degrees, as shown below. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 57: Recommended Daily Maintenance

    Before restarting the scanner, ensure the following: All racks are unloaded from the carousel. There are no slides scanning. The system does not have any errors displayed. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 58: Six Month Maintenance

    Do not drag anything (including lens paper) across the lens surface using a lot of pressure. This may damage the lens. Materials needed Texwipe TX404 Absorbond Synthetic Wipers (lens cleaning wipes made of lint-free microfiber) Laboratory gloves Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 59 Rotate the VPU latch. Pivot out the VPU. For detailed steps, see Open the scanner cover and access the interior components (on page 55). Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 60 Manually position the slide stage so that you have clear access to the objective, as shown below. CAUTION: The objective may move when you're cleaning it. Wear gloves when cleaning the objective. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 61 If you are ready to close the scanner cover and restart the scanner, follow the steps in Restart the scanner after interior maintenance (on page 67). Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 62: Clean The Stage Slide Tray

    Open the scanner cover and access the interior components (on page 55). CAUTION: The stage slide tray is not removable. Do not attempt to remove it. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 63: Clean The Carousel

    If the scanner is on, shut down the scanner by following the steps in Shut down the scanner (on page 55). Remove all slide racks from the carousel. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 64 If you are ready to close the scanner cover and restart the scanner, follow the steps in Restart the scanner after interior maintenance (on page 67). Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 65: Clean The Fan Filter

    Dry the filter thoroughly with a clean cloth or a dryer. CAUTION: Ensure the fan filter is completely dry before inserting it in the scanner. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 66: Clean The Slide Racks

    To clean the scanner cover: Wipe the outer cover of the scanner with a damp cloth. Immediately dry the cover using a dry cloth. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 67: Clean The Touchscreen

    Follow these steps to restart the scanner after you have accessed the scanner interior. Pivot the VPU into the closed position. Secure the VPU in place by rotating the VPU latch 180 degrees. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 68: Transporting Or Moving The Aperio Gt 450 Dx

    Slide the scanner cover back into position so that it is aligned with the rear latches and clicks closed. Turn on the scanner. Transporting or moving the Aperio GT 450 DX If you need to relocate the scanner, contact Leica Biosystems Technical Services. Be aware that moving the scanner yourself may void the hardware warranty. Long term storage If you are not going to use the scanner for a considerable amount of time, shut it down and unplug it.

  • Page 69: Troubleshooting

    This chapter contains information and instructions to help you resolve troubleshooting issues with your scanner. For issues with the Scanner Administration Manager, see the Aperio GT 450 DX IT Manager and Lab Administrator's Guide. WARNING: Do not attempt to perform troubleshooting procedures not shown in this chapter. For additional troubleshooting assistance, contact Leica Biosystems Technical Services.

  • Page 70: Personal Protective Equipment

    (on page 91) for steps to resolve slides in the rack. the specific error. The scanner can continue scanning other racks or slides. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 71: Perform A Safe Restart After An Error

    Follow these steps to safely restart the scanner after an error: Open the cover and access the interior: Open the scanner cover. Rotate the VPU latch. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 72 If there is a slide on the stage, carefully remove it from the stage without touching the surrounding components. If the pusher is extended, return the pusher to the safe (retracted) position. Align the pusher teeth with the slide stage grooves. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 73 Slide the pusher to the front of the scanner, as shown in the rightmost image below. Hold the pusher in one of the areas circled below. Avoid touching the LED and objective. Close the scanner cover. Pivot the VPU into place. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 74 Restart the scanner after interior maintenance (on page 67). Tap Maintenance on the touchscreen interface, then tap Restart Scanner. Wait for the scanner to complete the restart process. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 75: Error Codes And Solutions

    Cause: An unexpected event occurred in the system that prevents it from continuing operation. Follow these steps: Open the cover and access the interior: Open the scanner cover. Rotate the VPU latch. Pivot out the VPU. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 76 Open the scanner cover and access the interior components (on page 55). Take photos of any obstructions. Leica Biosystems Technical Services may request the photos if you need additional assistance after completing the steps below. Check if there is a slide on the stage or partially on the stage.
  • Page 77 Slide the pusher to the front of the scanner, as shown in the rightmost image below. Hold the pusher in one of the areas circled below. Avoid touching the LED and objective. Close the scanner cover: Pivot the VPU into place. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 78: 1001: Scanner Cannot Initialize

    1001: Scanner cannot initialize Cause: The scanner cannot complete the initialization process. Follow these steps: Open the cover and access the interior: Open the scanner cover. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 79 CAUTION:  Restarting the scanner with a slide on the stage may damage the slide. If there is a slide on the stage, carefully remove it from the stage without touching the surrounding components. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 80 Slide the pusher to the front of the scanner, as shown in the rightmost image below. Hold the pusher in one of the areas circled below. Avoid touching the LED and objective. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 81 Shut down the scanner (on page 55). Turn on the scanner and wait for the initialization process to complete. If the issue persists, call Leica Biosystems Technical Services. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 82: 1002: Carousel Cannot Rotate

    When you insert the rack, ensure the rack position and the rack status light turns light blue (waiting to scan): Figure 6-11: Empty rack slot Figure 6-12: Rack inserted and waiting to scan Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 83: 1003: Carousel Cannot Rotate. Carousel Pinch Point Obstructed

    If there are no obstructions and the carousel still does not rotate, restart the scanner by following the steps in Perform a safe restart after an error (on page 71). If the issue persists, contact Leica Biosystems Technical Services. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 84: 1007: Internal Storage Full. Cannot Send Images To Dicom Converter

    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. If the issue persists, consult with your organization’s IT professionals prior to calling Leica Biosystems Technical Services.
  • Page 85 Open the scanner cover and access the interior components (on page 55). Take photos of the obstruction. Leica Biosystems Technical Services may request the photos if you need additional assistance after completing the steps below. Check if there is a slide on the stage or partially on the stage.
  • Page 86 Check the slide stage, rack, and pusher area for an obstruction. If possible, carefully remove the slide that is causing the obstruction. WARNING:  Do not attempt to recover broken slides. Call Leica Biosystems Technical Services. Check the slide for preparation issues, such as over-hanging coverslips and label issues.
  • Page 87 Slide the pusher to the front of the scanner, as shown in the rightmost image below. Hold the pusher in one of the areas circled below. Avoid touching the LED and objective. Close the scanner cover: Pivot the VPU into place. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 88: 2001: Slide Handling Error At Rack Gripper, Lift, Or Carousel

    Cause: There is an obstruction near the rack gripper, lift, or carousel. Follow these steps until the issue is resolved: Open the cover and access the interior: Open the scanner cover. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 89 Open the scanner cover and access the interior components (on page 55). Take photos of the obstruction. WARNING:  Do not attempt to recover broken slides. Call Leica Biosystems Technical Services. Check if there is a slide on the stage or partially on the stage. Figure 6-17: Slide on the stage Figure 6-18: Slide partially on the stage CAUTION:  Restarting the scanner with a slide on the stage may damage the slide.
  • Page 90 Check the rack gripper, lift, and carousel area for an obstruction. Close the scanner cover: Pivot the VPU into place. Rotate the VPU latch. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 91: 9000: Scanner Cover Is Open

    CAUTION: If you need to remove a rack before all slides in the rack are scanned, first take note of the rack and slide status. After you remove a rack, the rack’s scan status is no longer available on the Home screen. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 92: 1005: Cannot Process Rack

    If the scanner still cannot process the rack, attempt to restart the scanner by following the steps in Perform a safe restart after an error (on page 71). If the issue persists, remove the rack and contact Leica Biosystems Technical Services. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 93: 1006: Cannot Process One Or More Slides In Rack

    If there is an issue scanning a slide, one of the following error messages appears in Slide View. Follow the steps in order until the issue is resolved. If you follow the steps and the issue persists, contact Leica Biosystems Technical Services.

  • Page 94: Tilted Slide(S)

    Barcodes supported (on page 27). Ensure barcodes meet minimum quality requirements. See Barcodes (on page 31). If the issue persists, call Leica Biosystems Technical Services. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 95: No Tissue

    There is only one label applied to the slide. Slide is clean. If every slide has the same error, or if the issue persists after following the previous steps, call Leica Biosystems Technical Services. Aperio GT 450 DX User's Guide, MAN-0505 Revision A...

  • Page 96: Image Quality

    If all slides are out of focus, clean the objective. See Clean the objective and Koehler (on page 58). If the issue persists after following the previous steps, call Leica Biosystems Technical Services. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 97: Image Transfer Error - Pending Retry

    There is only one label applied to the slide. There is only one coverslip applied to the slide. Slide is clean. Clean the slide. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 98: Aborted Message Appears On All Slides

    6 Troubleshooting Insert the slide into a different rack and scan it again. If the issue persists after following the previous steps, call Leica Biosystems Technical Services. Aborted message appears on all slides Follow these steps in order until the issue is resolved: Remove any completed slide racks from the carousel.
  • Page 99 If there is a slide on the stage, carefully remove it from the stage without touching the surrounding components. Close the scanner cover: Pivot the VPU into place. Rotate the VPU latch. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 100: Symptoms And Solutions

    Shut down the scanner by following the steps in Shut down the scanner (on page 55). Turn the scanner on. If the issue persists, contact Leica Biosystems Technical Services with details. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 101: Touchscreen Is Black

    Leica Biosystems Technical Services may request the photos when providing assistance. Network connection lost The Aperio GT 450 DX must be connected to the Scanner Administration Manager (Aperio GT 450 SAM DX) through your Local Area Network to function. If that connection is lost, you see: Contact your IT Administrator for assistance.
  • Page 102 6 Troubleshooting If the issue persists, consult with your organization’s IT professionals prior to calling Leica Biosystems Technical Services. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 103: A Performance Characteristics

    Performance characteristics This section discusses the clinical studies performed using the Aperio GT 450 DX: Precision Accuracy Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 104: Precision

    (see Table A-1: Intra-System Precision Study: Agreement Within Systems). The overall intra-system precision was based on the pooled data of all 3 systems. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 105: Inter-System/Site Study

    96.4 94.0% 98.5% System 3 Overall 96.3 94.9% 97.6% Note: 1. 95% CI was produced using the percentile bootstrapping approach on 5000 bootstrap samples. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 106: Intra- And Inter-Pathologist Study

    Table A-4 Intra- and Inter-Pathologist Precision Study: Agreement Between Pathologists). The overall inter-pathologist precision was based on the pooled data from each pathologist to pathologist comparison. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 107 Pathologist 1 vs 95.8 94.3% 97.2% Pathologist 3 Pathologist 2 vs 89.1 86.9% 91.2% Pathologist 3 Overall 2089 2277 91.7 90.6% 92.8% Note:  1. 95% CI was produced using the percentile bootstrapping approach on 5000 bootstrap samples. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 108: Accuracy

    Accuracy Study (510(k) no: K190332) and included a diverse mixture of pathologic diagnoses and tissue/organ types. At each site, technicians scanned slides from cases identified at their site using the Aperio GT 450 DX. Each reading pathologist at each site (3 or 4 pathologists per site) evaluated all study cases from their site using the Aperio GT 450 DX, as well as the case ancillary information to determine WSIR diagnosis.
  • Page 109 3.99% and 3.57% for the local and remote cohorts, respectively which was less than the predefined acceptance criteria of ≤4%. Thus, both secondary endpoints were met. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 110 95% CI 95% CI Rate (%) Rate (%) Local Observed 1806 6.59% 1844 3.85% Model 6.13% (4.99%, 3.52% (2.71%, 2.61% (1.23%, 7.51%) 4.57%) 3.99%) Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 111 Rate (%) Remote Observed 1743 5.68% 1787 3.47% Model 5.51% (4.40%, 3.34% (2.52%, 2.17% (0.78%, 6.88%) 4.40%) 3.57%) Note:  WSIRD: WSIR diagnosis, MSRD: MSR diagnosis. Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 112: B Technical Performance Assessment Summary

    Technical performance assessment summary This section provides a summary of the Aperio GT 450 DX Technical Performance Assessment (TPA). TPA Guidance Test Description Result Slide Feeder Slide dimensions meet ISO8037/1 Optics and Optical Instruments Pass Number of slides in queue...
  • Page 113 Magnification of imaging optics per ISO 8039:2014 Pass Relative irradiance per ISO 13653:1996 Pass Distortion per ISO 9039:2008 Pass Chromatic aberrations per ISO 15795:2002 Pass Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 114 Physical control for single slide, non-batch mode Pass Method for selecting area to be scanned Pass Failure modes and effects analysis Pass Positional repeatability and accuracy per ISO 230-2:2014 Pass Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 115 Exposure control Pass Software White balance Pass Color correction Pass Sub-sampling Pass Pixel-offset correction Pass Pixel-gain or flat-field correction Pass Pixel defect correction Pass Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 116 Pass Focus method (auto-focus) Pass Selection of manual focus points (if applicable) Pass Focus evaluation metrics Pass Constructing focus map from sample points Pass Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 117 Evaluate quality of the actual stitching boundaries with the perfect one that does not Pass have stitching artifacts Quality Control Frequency and test methods, responsibility and quantitative limits Pass Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

  • Page 118: Index

    See also scanner cover Intended Use open and close internal storage full coverslips 27, 30 Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 119 Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 120 (TPA) clean fan filter tissue preparation clean objective Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.
  • Page 121 See touchscreen unload racks unload slides user interface 23, See also touchscreen close open warnings rack 47, 91 whole slide scan See scan entire slide workflow, scan Aperio GT 450 DX User's Guide, MAN-0505 Revision A Copyright © 2024 Leica Biosystems Imaging, Inc.

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