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Leica Aperio GT 450 DX User Manual

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Aperio GT 450 DX
User's Guide
MAN-0475, Revision B | May 2022

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  • Page 1 Aperio GT 450 DX User’s Guide MAN-0475, Revision B | May 2022...
  • Page 2 Aperio GT 450 DX User’s Guide This manual applies to Aperio GT 450 DX Controller, Aperio GT 450 DX Console, and Aperio GT 450 DX SAM DX versions 1.1 and later Copyright Notice Ì Copyright © 2022 Leica Biosystems Imaging, Inc. All Rights Reserved. LEICA and the Leica logo are registered trademarks of Leica Microsystems IR GmbH.

  • Page 3: Table Of Contents

    Help Videos and Guides ........................25 Key Features ..........................25 Continuous Load Workflow ......................25 Scan Magnification ........................25 Automatic Image Quality Check ....................25 Image Types Supported ......................26 Slide Types Supported .......................26 Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 4 Maintenance ........................46 Maintenance Schedule ........................46 Serial Number and Firmware Version ....................47 Shut Down the Scanner .........................47 Open the Scanner Cover and Access the Interior Components............48 Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 5 No Tissue ..........................77 No Macro Focus ........................77 Image Quality ........................78 Image Transfer Error – Pending Retry ..................79 Aborted ..........................79 Aborted Message Appears on All Slides ...................80 Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 6 Performance Information ....................83 Analytical Performance .........................83 Trueness ..........................83 Precision (Repeatability and Reproducibility) ................84 Accuracy (Resulting from Trueness and Precision) ................84 Clinical Performance ........................85 Index ............................86 Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 7: Notices

    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 8: Intended Purpose

    Intended Purpose The Aperio GT 450 DX is a device for creation of digital images of scanned surgical pathology glass slides prepared from formalin-fixed paraffin embedded (FFPE) tissue that would otherwise be appropriate for manual visualization by conventional light microscopy. Aperio GT 450 DX is intended for in vitro diagnostic use with compatible viewing software and display that has been validated for use with this scanner as an aid to the pathologist in the qualitative review and interpretation of digital images.
  • Page 9 Industry Standard SJ/ the logo indicates the environmental protection use period (in years) for the T11364  product. The outer circle indicates that this product can be recycled. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 10 CA Proposition 65 cause Cancer and Reproductive Harm. For more information go to https://www. P65Warnings.ca.gov. Device is made in the USA of US and foreign components. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 11: Customer Service Contacts

    Remote Care email: tac.cn@leica-microsystems.com In-country Tel: +31 70 413 21 00 Email: support.nl@leicabiosystems.com Danmark: Tel: 0080052700527 (toll free) In-country Tel: +45 44 54 01 01 Email: support.dk@leicabiosystems.com Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 12 Tel: 0080052700527 (toll free) In-country Tel: +44 1908 577 650 Email: support.uk@leicabiosystems.com USA: Tel: +1 844 534 2262 (toll free) Direct International Tel: +1 760 539 1150 Email: TechServices@leicabiosystems.com Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 13: Introduction

    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 SAM DX software is intended for use by IT professionals and laboratory administrators.

  • Page 14: Resources

    RF energy can cause interference with other equipment. It is the responsibility of the end user to be sure that a compatible electromagnetic environment for the device can be maintained so that the device operates as intended. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • 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: Installation

    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

    Chapter 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 The Aperio GT 450 DX is regulated as Electrical and Electronic Equipment Waste (WEEE) under 2012/19/EU and must be discarded under special conditions.
  • 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 Cleaning – Apply the recommended cleaning solution to a clean cloth to clean the equipment. Do not apply cleaning solutions directly to the equipment. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 20: Aperio Gt 450 Dx Overview

    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” X 3” (2.54 cm x 7.62 cm) microscope slides.

  • Page 21: Scanner Overview

    The colors of See “Red Blinking Lights on Carousel” the status lights match the colors of the rack status on page 60. Legend on the touchscreen interface. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 22: Turn The Scanner On And Off

    The touchscreen interface is where you view the scan status and interact with the scanner. Tap an area on the touchscreen interface to view information or perform an action. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 23: Home Screen

    47. hardware and firmware versions of your “Shut Down the Scanner” on page 47. scanner. “Restart the Scanner” on page 50. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 24 41. Rack Order Tap Rack Order to view scan order and “View Rack Scan Order” on page 41. status of the racks. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 25: Help Videos And Guides

    Chapter 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 26: Image Types Supported

    Image Types Supported The Aperio GT 450 DX creates SVS files and DICOM compatible images. If you want your scanned images to be in DICOM format, this must be enabled on SAM DX and your IT environment must meet the requirements detailed in the Aperio DICOM Conformance Statement.

  • Page 27: Slide 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. Refer to Aperio GT 450 DX Specifications, MAN-0479.

  • Page 28: 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 Scanner Specifications for coverslip specifications. (Glass coverslips are recommended.) The quality of the scan is affected by the condition of the coverslip.

  • Page 29: 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 30: Scan Slides

    This section provides basic concepts on the scanning workflow and the carousel rotation features. We recommend reviewing this section before using the scanner. 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: Slides loaded...

  • Page 31: 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, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 32: Load Slides In The Rack

    CAUTION: Use caution when loading slides into a rack to prevent improper slide orientation or damaged slides. Never use damaged slides in the scanner. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 33: 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. When you’ve finished loading the first set of racks: Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 34 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 36. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 35: Priority Scanning

    Use Priority to move a rack to the front of the scan queue. You can apply the Priority option on up to three racks at a time. Tap the rack position. The Priority option appears when you select the rack position. Tap Priority. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 36: Rotate A Rack To The Rack Loading Area

    To rotate a rack to the rack loading area: Tap the rack position. The Rotate option appears when you select the rack position. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 37 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, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 38: Unload Racks From The Carousel

    If you try to rotate the rack that is currently being scanned, the system asks you for confirmation. After the rack is rotated to the loading area, you can remove the rack. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 39: Check Scan 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. See “Rack Warnings” on page 42. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 40: View Slide Status For A Rack

    No scanned image created. (See page 42.) The slide scanned successfully, passed image QC, and was transferred to the specific image location. The slide has a scan warning. (See page 42.) Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 41: 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, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 42: Rack Warnings

    The scanner created an image, but there is an error. An error prevented the scanner from creating an image. In the example below, slide 7 in the selected rack has a warning. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 43: Scan Entire Slide For Whole Rack

    Load only the slides that require a full slide area scan in the rack. Load the rack in the carousel. Tap to select the rack position. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 44 Chapter 4: Scan Slides 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, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 45: Image Quality Control For Histotechnicians And Pathologists

    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 46: 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”...

  • Page 47: Serial Number And Firmware Version

    Chapter 5: Maintenance Serial Number and Firmware Version You need the serial number and current software version if you call Leica Biosystems Technical Support. Tap Maintenance on the touchscreen interface to view the serial number, firmware version, and other system information. Shut Down the Scanner Use this procedure when you need to turn off the scanner.

  • Page 48: Open The Scanner Cover And Access The Interior Components

    Shut down the scanner using the steps in “Shut Down the Scanner” on page 47. Grasp the cover using the handhold indentations: Slide the cover out until it reaches the point shown below. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 49 Rotate the VPU latch 180 degrees to the open position, as shown below. Carefully pivot the VPU outward as shown: You can now access the interior components of the scanner for maintenance or troubleshooting purposes. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 50: Recommended Daily Maintenance

    The system does not have any errors displayed. From the touchscreen interface, tap Maintenance and tap Restart Scanner. You can use the scanner again after initialization is complete and the Home screen appears. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 51: Six Month Maintenance

    Open the cover and access the interior: Open scanner cover. Rotate VPU latch. Pivot out VPU For detailed steps, see “Open the Scanner Cover and Access the Interior Components” on page 48. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 52 Manually position the slide stage so that you have clear access to the objective, as shown below. CAUTION: The objective may move when you are cleaning it. Wear gloves when cleaning the objective. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 53 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 58. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 54: Clean The Stage Slide Tray

    Wipe the slide tray again from back to front using a microfiber cloth. If necessary, use a gentle solvent such as denatured alcohol to remove any remaining residue. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 55: Clean The Carousel

    The fan filter is located on the back of the scanner. You may need to pivot the scanner to access the fan filter. Frequency: at least every six months. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 56 Shake off any excess water. 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, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 57: Clean The Slide Racks

    Frequency: at least every six months. 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, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 58: Clean The Touchscreen

    Pivot the VPU into the closed position. Secure the VPU in place by rotating the VPU latch forward or backward 180 degrees, depending on its current position. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 59: 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 60: 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 Scanner IT Manager and Lab Administrator Guide. WARNING: Do not attempt to perform troubleshooting procedures not shown in this chapter. For additional troubleshooting assistance, contact Leica Biosystems Technical Services.

  • Page 61: Perform A Safe Restart After An Error

    Open scanner cover. Rotate the VPU latch. Pivot out VPU For detailed steps, see “Open the Scanner Cover and Access the Interior Components” on page 42. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 62 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, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 63: Error Codes And Solutions

    Pivot out VPU For detailed steps, see “Open the Scanner Cover and Access the Interior Components” on page 42. Take photos of any obstructions. Leica Biosystems Technical Services may request the photos if you need additional assistance after completing the steps below.
  • Page 64 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, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 65: 1001: Scanner Cannot Initialize

    For detailed steps, see “Open the Scanner Cover and Access the Interior Components” on page 42. Check if there is a slide on the stage or partially on the stage. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 66 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, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 67: 1002: Carousel Cannot Rotate

    Check the rack loading area and pinch points for any unexpected object. Rack loading area with light curtain highlighted: Pinch points on either edge of rack loading area: Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 68 If there are no obstructions and the carousel still does not rotate, restart the scanner. See “Perform a Safe Restart After an Error” on page 61. If the issue persists, contact Leica Biosystems Technical Services. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 69: 1003: Carousel Cannot Rotate. Carousel Pinch Point Obstructed

    If issue persists, contact Leica Biosystems Technical Services. 2000: Slide handling error at slide stage, rack, or pusher. Cause: There is an obstruction at the slide stage, rack, or pusher. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 70 Pivot out VPU For detailed steps, see “Open the Scanner Cover and Access the Interior Components” on page 42. Take photos of the obstruction. Leica Biosystems Technical Services may request the photos if you need additional assistance after completing the steps below.
  • Page 71 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, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 72: 2001: Slide Handling Error At Rack Gripper, Lift, Or Carousel

    For detailed steps, see “Open the Scanner Cover and Access the Interior Components” on page 42. Take photos of the obstruction. WARNING: Do not attempt to recover broken slides. Call Leica Biosystems Technical Services. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 73 Rotate the VPU latch. Slide the cover until it clicks closed. For detailed steps, see “Restart the Scanner After Interior Maintenance” on page 52. Contact Leica Biosystems Technical Services. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 74: 9000: Scanner Cover Is Open

    After you remove a rack, the rack’s scan status is no longer available on the Home screen. 1005: Cannot process rack. Cause: There is an issue with a rack that prevents scanning. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 75: 1006: Cannot Process One Or More Slides In Rack

    Tap Slide View to view the macro image of the slide, and check for an error message. Go to the section that matches the slide error: “Tilted Slide(s)” on page 76 “No Barcode” on page 77 Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 76: Slide Errors And Solutions

    “Image Quality” on page 78 “Image Transfer Error – Pending Retry” on page 79 “Aborted” on page 79 If the issue persists after following the relevant procedure, keep the slide available for inspection and contact Leica Biosystems Technical Services. Slide Errors and Solutions If there is an issue scanning a slide, one of the following error messages appears in Slide View.

  • Page 77: No Barcode

    Check for slide loading issues: Slide orientation is correct with the specimen-side facing up. (See “Load Slides in the Rack” on page 27.) Slide tray is clean. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 78: Image Quality

    Labels are not overhanging or on wrong side. 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. Image Quality Cause: The scanner’s Auto-Image QC feature detected an image quality issue.

  • Page 79: Image Transfer Error - Pending Retry

    Clean the slide. 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. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 80: Aborted Message Appears On All Slides

    Pivot the VPU into place. Rotate the VPU latch. Slide the cover until it clicks closed. For detailed steps, see “Restart the Scanner After Interior Maintenance” on page 52. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 81: Symptoms And Solutions

    Shut down the scanner by following the steps in, “Shut Down the Scanner” on page 41. Turn the scanner on. If the issue persists, contact Leica Biosystems Technical Services with details. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 82: Slides Are Broken Inside The Scanner

    Internet Connection Lost The Aperio GT 450 DX must be connected to the Scanner Administration Manager (SAM DX) through your Local Area Network to function. If that connection is lost, you see: You can attempt to re-establish network connection by typing the IP address of the SAM DX server. (Contact your IT staff for this information.) If this does not establish network connection, contact your IT staff for assistance.

  • Page 83: Performance Information

    Performance Information Analytical Performance This section gives a summary of the Aperio GT 450 DX analytical performance studies. Trueness Test Acceptance Criteria Test Purpose Tissue Finder System encompasses all stained portions of Demonstrates that all tissue specimen on the tissue block at defined success rates for the glass slide is included in the digital FFPE H&E-Stained slides –...

  • Page 84: Precision (Repeatability And Reproducibility)

    Test Purpose Spatial Resolution System has a Modulation Transfer function with Evaluates the composite optical MTF1/4 Nyquist >.70. performance of all components in the image acquisition phase. Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...

  • Page 85: Clinical Performance

    The clinical performance, measured in terms of concordance of pathology findings between the Aperio GT 450 DX and traditional light microscopy has been demonstrated by Hanna et al. 2020, who demonstrated that the Aperio GT 450 DX had a major diagnostic concordance of 100% and a minor diagnostic concordance of 98.8%.

  • Page 86: Index

    25 cover.  scanner cover cover, open and close 48 labels, requirements 29 coverslips 26, 28 labels, slides 29 legend 23 light curtain 21 daily maintenance 50 Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 87 59 priority scan 35 Scanner Administration Manager 26 pusher, safe position 58 scanner cover clean 57 scanner not powered on 81 quality check, image 25 Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 88 54 staining 27 staining requirements 27 statistics, scan 45 status legend 23 status, rack descriptions 39 status, slide 40 storage, scanner 59 tissue preparation 27 touchscreen Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 89 Index Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022...
  • Page 90 LeicaBiosystems.com/Aperio...

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