Leica Aperio GT 450 DX User Manual Download Page 10

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

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Regulation/

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Description

IEC 60825-1

Device is a Class 1 Laser Product that is in compliance with international

standards and US requirements.

CA Proposition 65

This product can expose you to chemicals known to the State of California to

cause Cancer and Reproductive Harm. For more information go to https://www.

P65Warnings.ca.gov.

N/A

Device is made in the USA of US and foreign components.

Summary of Contents for Aperio GT 450 DX

Page 1: ...Aperio GT 450 DX User s Guide MAN 0475 Revision B May 2022 ...

Page 2: ...osystems com Aperio Contact Information Leica Biosystems Imaging Inc Headquarters Customer Support General Information Leica Biosystems Imaging Inc 1360 Park Center Drive Vista CA 92081 USA Tel 1 866 478 4111 toll free Direct International Tel 1 760 539 1100 Contact your local support representative with any query and service request https www leicabiosystems com service support technical support ...

Page 3: ...rt Replacement Warnings 15 Compliance Specifications 15 Installation 16 Disposal of the Aperio GT 450 DX 17 Device Lifetime 17 Scanner Safety Instructions 17 2 Aperio GT 450 DX Overview 20 Theory of Operation 20 Scanner Overview 21 Turn the Scanner On and Off 22 Touchscreen Interface Overview 22 Home Screen 23 Help Videos and Guides 25 Key Features 25 Continuous Load Workflow 25 Scan Magnification...

Page 4: ...t of the Scanner 31 Load Slides in the Rack 32 Load Racks in the Carousel 33 Priority Scanning 35 Rotate a Rack to the Rack Loading Area 36 Unload Racks from the Carousel 38 Check Scan Status 39 Check Rack Status 39 Rack Error on Current Scan 39 View Slide Status for a Rack 40 View Macro Images of Scanned Slides 41 View Rack Scan Order 41 Rack Warnings 42 Scan Entire Slide for Whole Rack 43 Image ...

Page 5: ...w to Use the Troubleshooting Steps 60 Perform a Safe Restart After an Error 61 Error Codes and Solutions 63 1000 Internal error 63 1001 Scanner cannot initialize 65 1002 Carousel cannot rotate 67 1003 Carousel cannot rotate Carousel pinch point obstructed 69 1007 Internal storage full Cannot send images to DICOM converter 69 2000 Slide handling error at slide stage rack or pusher 69 2001 Slide han...

Page 6: ... On 81 Touchscreen Does Not Respond to Touch 81 Touchscreen is Black 81 Slides are Broken inside the Scanner 82 Internet Connection Lost 82 A 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 ...

Page 7: ...osystems contact your Leica Biosystems Technical Services representative Quality Control For information on image quality checks see Image Quality Control for Histotechnicians and Pathologists on page 45 Maintenance and Troubleshooting For information on maintenance see Chapter 5 Maintenance on page 46 For information on troubleshooting problems see Chapter 6 Troubleshooting on page 60 Cybersecuri...

Page 8: ...of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using the Aperio GT 450 DX Symbols The following symbols appear on your product label or in this user guide Symbol Regulation Standard Description ISO 15223 1 5 4 3 Consult the instructions for use ISO 15223 1 5 1 1 Manufacturer ISO 15223 1 5 1 3 Date of manufa...

Page 9: ... those cases where safety is involved IEC 60417 5008 Off To indicate disconnection from the mains at least for mains switches and all those cases where safety is involved ISO 15523 1 5 7 3 Temperature limitation ISO 15223 1 5 3 8 Humidity limitation 2012 19 EU Device is regulated under 2012 19 EU WEEE Directive for Electrical and Electronic Equipment Waste and must be discarded under special condi...

Page 10: ... a Class 1 Laser Product that is in compliance with international standards and US requirements CA Proposition 65 This product can expose you to chemicals known to the State of California to cause Cancer and Reproductive Harm For more information go to https www P65Warnings ca gov N A Device is made in the USA of US and foreign components ...

Page 11: ...ghai PRC PC 200025 CHINA Tel 86 4008208932 Fax 86 21 6384 1389 Email service cn leica microsystems com Remote Care email tac cn leica microsystems com Danmark Tel 0080052700527 toll free In country Tel 45 44 54 01 01 Email support dk leicabiosystems com Deutschland Leica Biosystems Nussloch GmbH Technical Assistance Center Heidelberger Strasse 17 Nussloch 69226 GERMANY Tel 0080052700527 toll free ...

Page 12: ...LLC Pinsky lane 3 letter A Saint Petersburg 197101 THE RUSSIAN FEDERATION Tel 8 800 555 49 40 toll free In country Tel 7 812 320 49 49 Email main bioline ru Sweden Tel 0080052700527 toll free In country Tel 46 8 625 45 45 Email support se leicabiosystems com Switzerland Tel 0080052700527 toll free In country Tel 41 71 726 3434 Email support ch leicabiosystems com United Kingdom Tel 0080052700527 t...

Page 13: ...nt in each clinical situation and examine the glass slides by conventional microscopy if there is doubt about the ability to accurately render an interpretation using this device alone Use of the Aperio GT 450 DX requires the following components Component Description Scanner Administration Manager DX SAM DX Server The SAM DX server connects to multiple Aperio GT 450 DX scanners and runs the SAM D...

Page 14: ...stems offers classroom and virtual training courses Contact Leica Biosystems Customer Support for information about training options Warnings This section contains important safety and operation warnings Also refer to Scanner Safety Instructions on page 17 Electromagnetic Warnings If the scanner is used in any manner not specified in this documentation the protection provided by the equipment may ...

Page 15: ...roximity to electromagnetic fields This device has been designed and tested to CISPR 11 Class A emission limits In a domestic environment this device can cause radio interference in which case you need to take measures to mitigate the interference Instrument Warnings WARNING To reduce the risk of fire or electric shock do not expose the scanner to rain or moisture Misuse of electrical equipment ca...

Page 16: ...326 1 2013 CISPR 11 2015 FCC Part 15 Subpart B ICES 003 Issue 6 2016 CNS13438 2006 KN 32 2015 12 KN 35 2015 12 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 operati...

Page 17: ...Ventilation Slots and openings in the scanner are provided for ventilation They ensure reliable operation of the product keeping it from overheating These openings must not be blocked nor covered during operation Keep air openings free of lint hair fluff etc This product should not be placed into a rack unless proper ventilation is provided through following the manufacturer s recommended installa...

Page 18: ...angerous voltage points or short out parts that could result in a fire or electric shock Never spill liquid of any kind on the scanner 15 Accessories Do not place the scanner on an unstable cart stand tripod bracket or table or the scanner may fall causing serious injury and damage to the product Any mounting of the scanner needs to follow manufacturer s installation instructions Do not place anyt...

Page 19: ...e specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation Unauthorized substitutions may result in fire electric shock or other hazards and may affect product compliance 20 Operational Check Upon completion of any repairs to this scanner ask the service t...

Page 20: ...tissue finding and scanning processes are automated without any need for the user to manipulate the slides being processed If there is a need based on the quality review of the scanned image or tissue finder results the device has the capability to reinitiate the scan with a different user selected mode entire slide scan The device images the slide using transmitted light from the Koehler Light So...

Page 21: ...cks to the scanning area and the rack loading area See Carousel Rotation on page 31 Rack loading area Provides access to the carousel to load and unload slide racks This area is also referred to as the front six because the rack loading area gives you access to six rack slots at a time See Load Racks in the Carousel on page 33 Safety light curtain The infrared safety light curtain detects objects ...

Page 22: ...lter on page 55 Turn the Scanner On and Off The On Off switch is located on the right side of the scanner near the back On position I Off position O When you are turning the scanner off and on follow these procedures according to the situation Shut Down the Scanner on page 47 Restart the Scanner After Interior Maintenance on page 58 Perform a Safe Restart After an Error on page 61 Touchscreen Inte...

Page 23: ... rack Rack settings The following section describes the Home screen elements Element Use More details see Rack status legend The Legend defines colors and icons that indicate rack status Status colors appear on the rack slot positions on the touchscreen interface and on the status lights in front of the carousel Note the Legend is for information only and is not interactive Check Scan Status on pa...

Page 24: ...move the rack to the top of the scan queue Priority Scanning on page 35 Select a rack and tap Rotate to rotate the rack to the rack loading area Rotate a Rack to the Rack Loading Area on page 36 Rack settings Note Rack settings appear when you select a rack Select a rack and tap Settings to select and apply a rack setting Scan Entire Slide for Whole Rack on page 43 Login Logout Tap Login to open a...

Page 25: ...ime 1 Tap Help and then tap a video or guide to view Key Features This section describes some key features of your Aperio GT 450 DX Continuous Load Workflow You can continuously load new racks and unload completed racks without interruption Scan Magnification Custom optics for native 40x scanning magnification Automatic Image Quality Check The Auto Image QC automatically checks scan quality If the...

Page 26: ...ass slides per ISO 8037 1 Coverslips Fully cured coverslips are required The Aperio GT 450 DX supports common industry coverslips used for 1 x 3 inch slides Slide Racks Supported Optimized and recommended for use with Leica HistoCore Spectra workstation racks stainer and coverslipper which include the Leica Universal Rack 30 slide capacity part number 23RACKGT450 Sakura Prisma Stainer and Coversli...

Page 27: ...he Aperio GT 450 DX specifications Refer to Aperio GT 450 DX Specifications MAN 0479 Tissue Preparation For optimal scanner performance slides must be well prepared Staining Reproducibility of the slide staining is important for consistent and accurate diagnosis Make sure that the variations of the staining process are controlled and eliminated to the greatest extent possible Use appropriate morph...

Page 28: ...e slide with a lint free cloth or trimming the sides with a razor blade Permanent problems with a slide may require the preparation of a new slide Coverslips Coverslips are required when using the Aperio GT 450 DX They must be fully cured or have completed the on board drying process for an automated coverslipper such as the Leica Biosystems HistoCore SPECTRA Coverslipper The Aperio GT 450 DX supp...

Page 29: ... attached Do not apply labels to the bottom surface of the slide Always load slides into the rack with the label facing out and up as shown in Load Slides in the Rack on page 32 The examples below show a slide with multiple labels that cause the slide to exceed the allowable maximum thickness and a slide with the label peeling away Barcodes For a list of supported barcodes see Barcodes Supported o...

Page 30: ...l 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 Rack rotated automatically Scanning starts Scan and image auto QC complete Scanner on Slides loaded Rack loaded If manual image check fails re scan slide Perform manual image che...

Page 31: ...e carousel does not rotate y the 10 second timer starts again An infrared safety light curtain detects objects in the loading area Racks loaded The carousel automatically rotates after you load racks Safety light curtain Log In and Log Out of the Scanner Your Lab Administrator sets up the scanner pass codes and timeout period for your lab using the SAM client application software You need to log i...

Page 32: ...ack For a successful scan ensure you use the correct orientation of the slides and the rack To load slides in the rack 1 Position the rack so the Leica logo and SIDE UP faces up 2 Insert each slide as shown with the label facing out and up 3 Push each slide into the rack until the slide touches the back of the rack ensuring each slide is fully inserted into the rack CAUTION Use caution when loadin...

Page 33: ... them 1 Place the loaded rack into an open slot in the carousel 2 Push the rack forward until it stops and you hear a click When the rack is fully inserted there is a click sound and the rack position on the Home screen turns light blue 3 Continue loading racks as needed or until you fill the front six rack slots 4 When you ve finished loading the first set of racks ...

Page 34: ...areas when the carousel is rotating Never manually rotate the carousel unless you are performing maintenance and power is off to the scanner as discussed in Chapter 5 Maintenance on page 46 5 When a rack is scanned successfully the rack status turns green 6 You can unload any completed racks and continue loading new racks If the completed rack is in the back of the carousel you can rotate it to th...

Page 35: ...2022 35 Chapter 4 Scan Slides 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 1 Tap the rack position The Priority option appears when you select the rack position 2 Tap Priority ...

Page 36: ...lete To view the rack scan order see View Rack Scan Order on page 41 i To cancel a priority you have to remove the rack Rotate a Rack to the Rack Loading Area The main reason for using the rotate feature is to rotate a completed rack to the loading area If you try to rotate the rack that is currently being scanned the system asks you for confirmation before continuing To rotate a rack to the rack ...

Page 37: ...stems Imaging Inc 2022 37 Chapter 4 Scan Slides 2 Tap Rotate to rotate the rack to the loading area 3 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 ...

Page 38: ... from the carousel 1 Make sure all the slides in the rack were successfully scanned the rack status is green If the rack status is orange see Rack Warnings on page 42 2 If the rack is in the loading area carefully remove the rack from the rack slot 3 If the rack is not in the loading area you can rotate it to the front a Tap the rack position b Tap Rotate i If you try to rotate the rack that is cu...

Page 39: ...ack statuses are Empty Rack is empty and available for use Complete All slides in the rack scanned successfully and passed image QC Scanned images are saved to the specific location Scanning The rack is currently being scanned Waiting to Scan The rack is loaded successfully and is waiting to scan Warning There is an issue with the rack or one or more slides in the rack If you get a rack warning se...

Page 40: ...en interface 2 Tap the Rack View icon Slide status colors correspond to the Legend The slide is scanning The slide is waiting to scan The slide slot is empty The scanned image was successfully transferred to the specific image location 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 ...

Page 41: ... the selected rack y Tap and to view other slides in the rack y If any tissue is outside the scan area you can tap Scan Entire Slide to rescan the whole slide y If there is an error scanning the slide a message appears in the box See Slide Errors and Solutions on page 76 View Rack Scan Order 1 Tap the Rack Order icon to show the scan order of the racks y Racks in the list appear in the scan order ...

Page 42: ...re is a problem with the rack a message appears similar to the example below 3 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 74 4 If there is a problem with one or more slides in the rack a warning icon appears next to the slide in Rack View The scanner created an image but there is an error An error prevented ...

Page 43: ...6 Take note of the error code and message For information and steps to resolve the error go to Slide Errors and Solutions on page 76 Scan Entire Slide for Whole Rack This feature enables you to scan the full slide area for an entire rack of slides 1 Load only the slides that require a full slide area scan in the rack 2 Load the rack in the carousel 3 Tap to select the rack position ...

Page 44: ...ser s Guide Revision B Leica Biosystems Imaging Inc 2022 44 Chapter 4 Scan Slides 4 Tap Settings and then tap Scan Entire Slide The Scan Entire Slide option is selected and the Settings icon appears on the rack position ...

Page 45: ...rimary diagnosis and that should be verified by scanner operators are 1 that the entire tissue sample has been scanned and 2 that the tissue is in focus Aperio scanners provide a macro image a low resolution image of the entire slide that also provides a green outline of the scanned image Check that image for the quality criteria mentioned above Re scan any slides that failed to scan or failed the...

Page 46: ...tenance Schedule To keep your Aperio GT 450 DX scanner in optimal working condition follow these maintenance routines Frequency Maintenance Task Procedure Daily Recommended Restart the scanner Restart the Scanner on page 50 Every Six Months 1 Clean the objective and Koehler Clean the Objective and Koehler on page 51 2 Clean the stage slide tray Clean the Stage Slide Tray on page 54 3 Clean the car...

Page 47: ...eed 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 1 From the touchscreen interface tap Maintenance ...

Page 48: ...Cover and Access the Interior Components Complete these steps to access the inside of the scanner for maintenance or troubleshooting i If you are performing maintenance on the scanner you should first remove any racks from the carousel 1 Shut down the scanner using the steps in Shut Down the Scanner on page 47 2 Grasp the cover using the handhold indentations 3 Slide the cover out until it reaches...

Page 49: ...Imaging Inc 2022 49 Chapter 5 Maintenance 4 Rotate the VPU latch 180 degrees to the open position as shown below 5 Carefully pivot the VPU outward as shown 6 You can now access the interior components of the scanner for maintenance or troubleshooting purposes ...

Page 50: ...itializes the controller and puts the camera stage and autoloader in their home positions CAUTION Restarting the scanner with a slide on the stage may damage the slide 1 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 2 From the touchscreen interface tap Maintenance and tap Restar...

Page 51: ...olution on the objective Otherwise this may damage the objective and impact image quality y 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 To clean the objective and Koehler 1 Ensure the scanner is turned of...

Page 52: ...apter 5 Maintenance 3 The objective and Koehler shown below in blue Objective Koehler 4 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 5 Wear gloves when cleaning the objective ...

Page 53: ...an lint free microfiber cloth use the same technique described in step 6 to clean the Koehler The Koehler is located below the objective as shown circled in white below 8 If you are performing the entire six month maintenance routine continue to the next procedure 9 If you are ready to close the scanner cover and restart the scanner follow the steps in Restart the Scanner After Interior Maintenanc...

Page 54: ...en scanner cover b Rotate VPU latch c Pivot out VPU For detailed steps see Open the Scanner Cover and Access the Interior Components on page 48 CAUTION The stage slide tray is not removable Do not attempt to remove it 3 Gently wipe the slide tray shown in blue from back to front with a lint free cloth CAUTION Be careful not to bump the LED or the objective highlighted in red 4 Wipe the slide tray ...

Page 55: ...ing solvent such as denatured alcohol to thoroughly clean the carousel Be sure to clean inside the slide rack slots CAUTION When manually rotating the carousel to access the rack slots grasp the area circled in green Do not grasp the area circled in red 4 Manually rotate the carousel to access the rear slide rack slots 5 Repeat the cleaning steps until you have cleaned every slide rack slot 6 If y...

Page 56: ... on page 47 2 Remove the fan filter by gripping the handle shown in blue and sliding it left right or up depending on your scanner s configuration 3 With the front of the filter up toward the faucet as shown below rinse the filter under warm water 4 Shake off any excess water 5 Dry the filter thoroughly with a clean cloth or a dryer CAUTION Ensure the fan filter is completely dry before inserting ...

Page 57: ...the racks for any damage or accumulated glass dust and mounting media 2 If a rack is damaged replace it immediately 3 Use compressed air or a cleaning solvent to clean all grooves in the rack ensuring the racks are clean and smooth We recommend Xylene cleaning solvent 4 If you are performing the entire six month maintenance routine continue to the next procedure 5 If you are ready to close the sca...

Page 58: ... gets inside the scanner 2 Thoroughly wipe down the touchscreen with the cloth 3 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 Restart the Scanner After Interior Maintenance Follow these steps to restart the scanner after you have accessed the scanner interior 1 Pivot the VPU into the closed positio...

Page 59: ...canner 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 To shut down the scanner follow the steps in Shut Down the Scanner on page 47 If you want to store the scanner contact Leica Biosystems Technical Services fo...

Page 60: ...ective equipment PPE Red Blinking Lights on Carousel If the lights in front of the carousel are blinking red the scanner needs attention If there is an issue with a rack in the rack loading area the light below that rack position blinks red See the next section for more details on resolving scanner issues How to Use the Troubleshooting Steps The following table describes how to find the appropriat...

Page 61: ...face but there is a problem with the scanner For example the scanner does not power up when you turn it on Varies with the situation See Symptoms and Solutions on page 81 Perform a Safe Restart After an Error Some procedures in this chapter ask you to restart the scanner Restarting the scanner initializes the controller and puts the stage and autoloader in their home positions Before restarting th...

Page 62: ...de 3 If there is a slide on the stage carefully remove it from the stage without touching the surrounding components 4 Return the pusher to the retracted safe position a Align the pusher teeth with the slide stage grooves b Slide the stage to the rear of the scanner as shown c Slide the pusher to the front of the scanner as shown in the rightmost image below Hold the pusher in one of the areas cir...

Page 63: ...rror box appears on the touchscreen you must resolve the issue before the scanner can continue scanning This section contains error codes and messages with troubleshooting steps 1000 Internal error Cause An unexpected event occurred in the system that prevents it from continuing operation Follow these steps 1 Open the cover and access the interior a Open scanner cover b Rotate the VPU latch c Pivo...

Page 64: ...there is a slide on the stage carefully remove it from the stage without touching the surrounding components 5 If the pusher is extended return the pusher to the safe position a Align the pusher teeth with the slide stage grooves b Slide the stage to the rear of the scanner as shown c Slide the pusher to the front of the scanner as shown in the rightmost image below Hold the pusher in one of the a...

Page 65: ...r on the touchscreen interface and wait for the scanner to complete the restart process 8 If the issue persists call Leica Biosystems Technical Services 1001 Scanner cannot initialize Cause The scanner cannot complete the initialization process Follow these steps 1 Open the cover and access the interior a Open scanner cover b Rotate the VPU latch c Pivot out VPU For detailed steps see Open the Sca...

Page 66: ...refully remove it from the stage without touching the surrounding components 4 If the pusher is extended return the pusher to the safe position a Align the pusher teeth with the slide stage grooves b Slide the stage to the rear of the scanner as shown c 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 touchin...

Page 67: ...ner using the steps in Shut Down the Scanner on page 41 7 Turn on the scanner and wait for the initialization process to complete 8 If the issue persists call Leica Biosystems Technical Services 1002 Carousel cannot rotate Cause Something is blocking the light curtain Follow these steps in order until the issue is resolved and the error message closes 1 Check the rack loading area and pinch points...

Page 68: ...you insert the rack ensure the rack position and the rack status light turns light blue waiting to scan Empty rack slot Rack inserted and waiting to scan 4 Ensure all the slides are fully inserted so that they touch the back of the rack 5 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 6 If the issue persi...

Page 69: ...does not rotate restart the scanner by following the steps in Perform a Safe Restart After an Error on page 61 3 If the issue persists contact Leica Biosystems Technical Services 1007 Internal storage full Cannot send images to DICOM converter Cause If the internal storage is full the system cannot send the images to the DICOM converter The Lab Administrator should perform these steps 1 Ensure the...

Page 70: ... the Interior Components on page 42 2 Take photos of the obstruction Leica Biosystems Technical Services may request the photos if you need additional assistance after completing the steps below 3 Check if there is a slide on the stage or partially on the stage CAUTION Restarting the scanner with a slide on the stage might damage the slide 4 If there is a slide on the stage carefully remove it fro...

Page 71: ... issues If there are no obvious preparation issues re insert the slide in an available rack after you restart the scanner If there are slide preparation issues correct the slide issues before rescanning 8 If the pusher is extended return the pusher to the safe position a Align the pusher teeth with the slide stage grooves b Slide the stage to the rear of the scanner as shown c Slide the pusher to ...

Page 72: ...mplete the restart process 11 If the issue persists contact Leica Biosystems Technical Services 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 1 Open the cover and access the interior a Open scanner cover b Rotate the VPU latch c Pivot out VPU For detailed steps see Open ...

Page 73: ...age the slide 4 If there is a slide on the stage carefully remove it from the stage without touching the surrounding components 5 Check the rack gripper lift and carousel area for an obstruction 6 Close the scanner cover a Pivot the VPU into place b Rotate the VPU latch c Slide the cover until it clicks closed For detailed steps see Restart the Scanner After Interior Maintenance on page 52 7 Conta...

Page 74: ...ear latches and clicks closed Rack Warnings and Solutions Rack warnings indicate a problem with the rack or one or more slides in the rack The scanner can continue scanning when there is a rack warning 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 t...

Page 75: ...ontact Leica Biosystems Technical Services 5 If you verified the rack is a supported and undamaged rack reinsert it into the carousel for scanning 6 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 61 7 If the issue persists remove the rack and contact Leica Biosystems Technical Services 1006 Cannot ...

Page 76: ...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 i You can temporarily hide some error messages by tapping the x in the top right corner This enables you to view the macro image Tilted Slide s Cause The slide is tilted between two or more slots in the r...

Page 77: ...ue is resolved 1 On the touchscreen interface tap the rack position that has the error 2 Tap the Slide View icon to view the macro image of the slide 3 Tap the error message to temporarily hide it 4 Verify there is tissue on the slide 5 Take note of the slide number 6 Rotate and remove the rack to access the slide 7 Remove the slide from the rack and then clean the slide 8 Re insert the slide into...

Page 78: ...sue Follow these steps in order until the issue is resolved 1 Review the scanned slide image in your viewing software 2 Check for common slide preparation issues Coverslip is not missing or overhanging Labels are not overhanging or on wrong side There is only one label applied to the slide Slide is clean 3 Scan the slide again When the scan is finished do not remove the rack from the scanner 4 Rev...

Page 79: ...on 2 Check if your site s image storage location is full 3 If the issue persists consult with your organization s IT professionals prior to calling Leica Biosystems Technical Services Aborted Cause The scanner cannot scan the slide Follow these steps in order until the issue is resolved 1 If the Aborted message appears on all slides go to Aborted Message Appears on All Slides on page 80 If the mes...

Page 80: ...U For detailed steps see Open the Scanner Cover and Access the Interior Components on page 42 3 Check if there is a slide on the stage or partially on the stage CAUTION Restarting the scanner with a slide on the stage might damage the slide 4 If there is a slide on the stage carefully remove it from the stage without touching the surrounding components 5 Close the scanner cover a Pivot the VPU int...

Page 81: ... are using an optional uninterruptible power supply UPS ensure it is turned on 3 Check the connections to wall outlet and the Ethernet cable that attaches to the back of the scanner 4 Ensure there is power available where the scanner is plugged in 5 Verify there is a network connection to the device 6 Ensure the main scanner cover is fully closed 7 If the issue persists call Leica Biosystems Techn...

Page 82: ...ystems Technical Services may request the photos when providing assistance 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 informati...

Page 83: ... at a success rate of 90 for FFPE H E stained slides y System scans 30 excessive area at a success rate of 90 for FFPE IHC stained slides Demonstrates that all tissue specimen on the glass slide is included in the digital image file Focus Error System has a focus error within the allowable calculated limits for both auto focusing and scanning methods y Focus low 1 83 microns y Focus high 1 21 micr...

Page 84: ...key component to ensuring first time scan success rate Image Quality Reproducibility Inter device reproducibility is 90 90 of 100 slides must result in a Pass Assesses image quality reproducibility which is the key component to ensuring first time scan success rate Focus Reproducibility Systems have an overall intra system agreement of 85 Assesses that the intra system focus quality of the Aperio ...

Page 85: ...easured 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 Overall based on the clinical performance evidence available the Aperio GT 450 DX is able to perform as per its in...

Page 86: ...pliance specifications 15 continuous load 25 cover See scanner cover cover open and close 48 coverslips 26 28 D daily maintenance 50 DICOM 26 DICOM converter error 69 disposal 17 E electromagnetic warnings 14 error codes solutions for 63 rack warnings 74 error message 60 F fan filter clean 55 remove 56 FCC compliance 15 I image quality check automatic 25 image quality review 45 image types support...

Page 87: ...osal 17 move 59 open cover 48 restart 50 restart after maintenance 58 service life 17 storage 59 Scanner Administration Manager 26 scanner cover clean 57 scanner not powered on 81 load racks in scanner 33 load slides in rack 32 M magnification scan 25 maintenance cleaning slide tray 54 daily 50 schedule 46 six month 51 messages rack issues 61 scanner error 60 slide issues 61 move scanner 59 N numb...

Page 88: ...lean 57 slides broken 82 slides load in rack 32 slide staining requirements 27 slide view 41 specifications regulatory compliance 15 stage slide tray clean 54 staining 27 staining requirements 27 statistics scan 45 status legend 23 status rack descriptions 39 status slide 40 storage scanner 59 T tissue preparation 27 touchscreen clean 58 touchscreen interface overview 22 touchscreen problem 81 tro...

Page 89: ...Aperio GT 450 DX User s Guide Revision B Leica Biosystems Imaging Inc 2022 89 Index ...

Page 90: ...LeicaBiosystems com Aperio ...

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