11.08.2025
VAIDLUSTUS
Riigihange: „Digipatoloogia (WSI) skanneri ostmine“
viitenumber: 292949
Vaidlustaja: Osaühing Balti Intermed
registrikood: 10170298
Esindaja: Erki Fels, vandeadvokaat
Gregor Saluveer, vandeadvokaadi abi
Advokaadibüroo TEGOS
e-post:
[email protected]
Hankija: Aktsiaselts Lääne-Tallinna Keskhaigla
registrikood: 10822269
e-post:
[email protected]
Kolmas isik: Quantum Eesti AS
registrikood: 10832463
e-post:
[email protected]
TAOTLUSED
1. Tunnistada kehtetuks Aktsiaseltsi Lääne-Tallinna Keskhaigla 30.07.2025 otsused:
1.1. tunnistada riigihanke osas 1 Osaühingu Balti Intermed pakkumus
mittevastavaks;
1.2. tunnistada riigihanke osas 1 Quantum Eesti AS pakkumus vastavaks;
1.3. tunnistada riigihanke osas 1 Quantum Eesti AS pakkumus edukaks.
2. Jätta Osaühingu Balti Intermed menetluskulud Aktsiaseltsi Lääne-Tallinna Keskhaigla
kanda.
1. ASJAOLUD
1.1. 14.05.2025 avaldas Aktsiaselts Lääne-Tallinna Keskhaigla (hankija) avatud
hankemenetlusena läbi viidava riigihanke „Digipatoloogia (WSI) skanneri ostmine“ (vr
292949) (riigihange) hanketeate ja tegi kättesaadavaks riigihanke alusdokumendid
(RHAD).
1.2. Riigihange on jagatud kolmeks osaks. Osas 1 on riigihanke esemeks tehnilise kirjelduse
(TK) järgi koepreparaatide mikroskoopiliseks skaneerimiseks vajaliku WSI (Whole Slide
Image) skanneri ost koos paigalduse, korralise hoolduse ja remondiga.
Advokaadibüroo TEGOS AS Liivalaia 36, 10132 Tallinn Kaluri 2, 51004 Tartu
[email protected] Telefon +372 626 4300 Telefon +372 730 1610
1.3. Riigihanke osas 1 esitasid pakkumuse Quantum Eesti AS (kolmas isik), Osaühing Balti
Intermed (vaidlustaja), Mediq Eesti OÜ ja AS Surgitech.
1.4. 30.07.2025 tegi hankija riigihanke osas 1 järgmised otsused:
a. tunnistada mittevastavaks vaidlustaja, Mediq Eesti OÜ ja AS Surgitech
pakkumused;
b. tunnistada vastavaks ja edukaks kolmanda isiku pakkumus.
1.5. 08.08.2025 edastas vaidlustaja hankijale riigihangete registri kaudu päringu, paludes
hankijal omaalgatuslikult eelviidatud otsused nende õigusvastasuse tõttu kehtetuks
tunnistada.
1.6. 11.08.2025 vastas hankija, et ei ole nõus otsuseid muutma.
1.7. Vaidlustaja on eelnevast tulenevalt sunnitud esitama hankija otsustele riigihangete
vaidlustuskomisjoni (VAKO) kaudu vaidlustuse. Vaidlustajal on kaebeõigus, kuna tema
pakkumus on majanduslikult soodsaim.
2. PÕHJENDUSED
2.1. Hankija on vaidlustaja pakkumuse ebaõigesti mittevastavaks tunnistanud (ptk A). Ebaõige
on ka kolmanda isiku pakkumuse vastavaks (ptk B) ja edukaks (ptk C) tunnistamine.
A. Vaidlustaja pakkumus on vastav
2.2. Hankija on tunnistanud pakkumuse RHS § 114 lg 2 alusel mittevastavaks järgmise
põhjendusega:
"Seadme komplektsuses ei sisaldu seadme juhtimiseks ja uuringute esmaseks
ülevaatamiseks vajalik riistvara (tehnilise kirjelduse p 2.12)." (nn juhtarvuti)
2.3. Hankija väide on faktiliselt ebaõige. Vaidlustaja pakub osas 1 skännerit Pannoramic 480
DX. 1 Juhtarvuti on üks osa pakutava skänneri komplektist. See tuleneb selgelt nii
pakkumusest kui teabevahetusest.
▪ Pakkumuse vastavus nähtub pakkumusest
2.4. Vaidlustaja esitas pakkumuses vormi 2 („Tehnilise kirjelduse vastavustabel“), mille kaks
parempoolset veergu pidi pakkuja ise täitma. Sellest nähtub:
2.5. Viidatud tootja infomaterjali („TDS-P480DX(GEN II)“) lehekülje 4 allosas on esitatud
juhtarvuti tehniline spetsifikatsioon:
1
Vt pakkumuse dokument „Komplektsus“.
2/7
2.6. Ka kasutusjuhendist („Manual-P480DX“) tuleneb selgelt, et juhtarvuti on üks osa skänneri
komplektist:
3/7
2.7. Juhtarvuti on elementaarne osa skänneri komplektist. Tootja ei tarni skännerit ilma
selleta. Selleks, et vaidlustaja saaks hankijale müüa skännerit ilma juhtarvutita, peaks ta
arvuti komplektist eemaldama ja lattu seisma jätma või ära viskama (ilma skännerita
puudub juhtarvutil teiste klientide jaoks väärtus).
▪ Hankija on teinud pakkumusest ebaõige järelduse
2.8. Järeldusele, et juhtarvuti ei sisaldu skänneri komplektis, on hankija jõudnud pakkumuse
ebaõige tõlgendamise teel. Hankija väitis teabevahetuses:
„Olete pakkumuses esitanud dokumendi „1_2_1_Vorm 2 - Tehnilise kirjelduse
vastavustabel_osa 1_0“, mille punkti 8 alla olete sisestanud järgmise info „AMD Ryzen
Threadripper 64 Cores / 128 threads, 128 GB DDR4, (256 GB, 256 GB, 4 TB, 8x 8 TB
NVME SSD)“. Samas olete pakkumuse koosseisus esitanud dokumendi
„1_2_3_Komplektsus.xlsx“, mille kohaselt on riigihanke osale 1 pakutud riistvara
„Pannoramic 480 DX“ ning osale 2 pakutud riistvara „Control Unit Workstation PC“.
Dokumendis mainitud „Pannoramic 480 DX“ on skanner, osa 1 riistvara real (asukoht
tabelis A2 ja A3) juhtarvutit mainitud ei ole.“
2.9. Hankija viitab sellele dokumendile vaidlustaja pakkumusest:
2.10. Hankija tõlgendus on meelevaldne. Vormil 2 on selgelt kirjutatud, et vaidlustaja pakub
juhtarvutit – eraldi on välja toodud ka juhtarvuti tehnilise spetsifikatsioon. Juhtarvuti
on osa pakutava skänneri komplektist ja seega ei pidanud vaidlustaja vajalikuks seda
Exceli dokumendis „Komplektsus“ eraldi välja tuua (selle dokumendi esitamine polnud
niigi kohustuslik).
2.11. Riigihanke osa 2 puhul on arvuti Exceli dokumendis eraldi välja toodud, kuna riigihanke
osas 2 hangitaksegi arvutit ja monitore („Arvuti koepreparaatide skaneerimisel saadud
andmete lühiajaliseks salvestamiseks ja esitamiseks ning erimonitorid töökohtadele“).
Riigihanke osas 1 hangitakse skännerit, mille puhul on juhtarvuti üks komplekti osa,
mistõttu vaidlustaja arvutit eraldiseisvalt ei nimetanud.
▪ Hankija on teinud teabevahetusest ebaõige järelduse
2.12. Hankija on teinud ebaõige järelduse ka teabevahetusest. 18.06.2025 esitas hankija
vaidlustajale järgmise küsimuse:
"Milline riistvara on pakutud hanke osas 1 seadme juhtimiseks (komplektsuse failis on
control unit pakutud ainult osas 2, vastavustabelis ka osas 1)? Kas osades 1 ja 2 on
pakutud ühesuguseid arvuteid või on arvutit pakutud ainult ühes nendest osadest?"
2.13. Vaidlustaja vastas järgmiselt:
4/7
"Pakutud on skänneri töökomplekt all-in-one lahendus, mille kirjeldus jaguneb osade 1
ja 2 vahel. Skänneri tehniline kirjeldus on toodud osas 1 ja control unit arvuti kirjeldus
on toodud osas 2. Füüsiliselt on tegemist ühe arvutiga, aga see on virtualiseeritud
Hyper-V platformil ja seal peal jookseb kaks virtuaalset arvutit eri
operatsioonisüsteemidega. Esimene on Windows 11 koos tarkvaradega klaaside
digitaliseerimiseks ja teine on Windows Server 2022, kus peal on serveri klaaside
hoiustamise ja halduse tarkvarad."
2.14. Hankija on teinud sellest teabevahetusest järgmise järelduse:
„Vastasite 02.07.2025, et skanneri töökomplekt jaguneb osade 1 ja 2 vahel, sh on
skanneri tehniline kirjeldus osas 1 ja control unit arvuti kirjeldus osas 2. 02.07.2025
vastusega andsite kinnituse, et pakkumus sisaldab ühte füüsilist arvutit. Teie selgituste
ning dokumendi „1_2_3_Komplektsus.xlsx“ koosmõjulisest tõlgendamisest lähtudest
järeldas hankija, et olete juhtarvutit pakkunud ainult osale 2 ning osale 1 füüsilist
juhtarvutit pakutud ei ole. Hankija on seisukohal, et eelpool mainitud dokumentide
grammatilisest tõlgendusest lähtudes on see ka ainuvõimalik tõlgendus („skänner [...]
osas 1 ja control unit arvuti [...] osas 2“, „[...] kirjeldus jaguneb osade 1 ja 2 vahel“,
„füüsiliselt on tegemist ühe arvutiga [...]).“
2.15. Teisisõnu kinnitas hankija arvates teabevahetuses antud vastus seda, et riigihanke osas 1
esitatud pakkumus ei sisalda juhtarvutit. Hankija hinnangul proovib vaidlustaja nüüd
pakkumust tagantjärele muuta.
2.16. Vaidlustaja vastusest ei ole võimalik järeldada, et pakkumus ei sisalda juhtarvutit. Nagu
esimeses lauses kirjutatud, pakub vaidlustaja skänneri töökomplekti all-in-one
lahendust. Selle "kõik ühes" lahenduse üks osa on seadme juhtimiseks vajalik riistvara,
nagu nähtub ka pakkumuses esitatud dokumentidest. Vaidlustaja selgitas, et kui osutub
edukaks nii osas 1 kui osas 2, on füüsiliselt tegemist ühe arvutiga, mis jookseb virtuaalselt
erinevate operatsioonisüsteemidega.
2.17. Vastupidiselt hankija arusaamaga vaidlustaja vastus ju kinnitabki seda, et arvuti sisaldub
nii osa 1 kui osa 2 pakkumuses. Vastupidisel juhul ei kirjutaks vaidlustaja kahest erinevast
virtuaalsest arvutist, millest üks on nähtud ette osas 1, teine osas 2. Vaidlustaja oleks
lihtsalt öelnud, et arvutit pakutakse osas 2. Kui vaidlustaja osutub edukaks vaid osas 1,
saab ta ilmselgelt pakkuda arvutit vaid osas 1. Vastusest pole kuidagi võimalik välja
lugeda, et vaidlustaja seda ei tee.
2.18. Vaidlustaja hinnangul puudus hankijal vajadus küsida vaidlustajalt selgitust, kuna
pakkumus (nii vorm II kui seda toetavad dokumendid) kinnitavad, et pakutava skänneri
komplekt sisaldab juhtarvutit. Just pakkumus on pakkuja tahteavaldus lepingu
sõlmimiseks, mis on siduv pakkumuste esitamise tähtpäeva saabumiseni (RHS § 110 lg
1). Seda tahteavaldust ei saa selgituste kaudu sisuliselt muuta (RHS § 46 lg 4). Vaidlustajal
ei olnud igal juhul võimalik pakkumust teabevahetuse kaudu muuta nii, et juhtarvuti siiski
pakkumuses ei sisaldu.
2.19. Kui hankijale jäi vaidlustaja tahteavalduse sisu ebaselgeks, pidanuks ta küsima
täiendavaid küsimusi. Hankija peab kasutama talle ette nähtud selgituste küsimise
5/7
võimalust maksimaalselt selliselt, et pakkujalt küsitaks kahtluse korral konkreetseid
küsimusi või tõendeid, mis võimaldaksid hinnata pakkumuse nõuetekohasust.2
B. Kolmanda isiku pakkumus on mittevastav
2.20. Kolmanda isiku pakkumus on mittevastav osa 1 TK p-le 1:
„Seade peab võimaldama nii histoloogiliste kui tsütoloogiliste preparaatide
skaneerimist.“
2.21. Vaidlustajal on kaebeõigus kolmanda isiku pakkumuse vastavaks tunnistamise otsuse
suhtes ka siis, kui vaidlustus jääb tema enda pakkumuse mittevastavaks tunnistamise
osas rahuldamata. Kolmanda isiku pakkumus on neljast pakkumusest ainsana
tunnistatud vastavaks. Euroopa Kohtu praktikast tuleneb, et hankevaidluses kaitstav
subjektiivne õigus hõlmab ka õigust osaleda võimalikus uues riigihanke menetluses. 3
2.22. Mittevastavus TK p-ga 1 on ilmne. Vaidlustajale teadaolevalt pakkus kolmas isik toodet
Aperio GT 450 DX ja RUO tarkvaraga. Toote kasutusjuhendi (lisa 1) leheküljel 8 on kirjas:
„The Aperio GT 450 DX is not intended for use with frozen section, cytology, or non-
FFPE hematopathology specimens.“
2.23. TK nõuab tsütoloogiliste preparaatide skänneerimise võimekust, milleks aga kolmanda
isiku pakutud seade ette nähtud ei ole. Hankija tõenäoliselt lihtsalt ei ole kasutusjuhendit
hoolikalt lugenud ning on tuginenud pimesi kolmanda isiku antud kinnitusele.
Kohtupraktikas on aga selgitatud, et kui hankija on nõudnud pakkumuse vastavuse
tõendamiseks tootja tehnilist dokumentatsiooni – nt kasutusjuhend, katseprotokollid,
tootejoonised – ning pakkuja kinnitust toote omaduste kohta, siis vastuolude korral peab
eelistama tootjapoolseid tehnilisi dokumente.4
2.24. Võrdluseks: vaidlustaja enda pakutud toote kasutusjuhendis („Manual-P480DX“) on
leheküljel 11 kirjas:
„The PANNORAMIC ® 480 DX Digital Scanner as a diagnostic scanner in the whole slide
imaging (WSI) system can be used as an aid to the pathologist to create, review and
interpret digital images of surgical pathology slides prepared from formalin - fixed
paraffin embedded (FFP E) tissue, cytology smear/specimen, peripheral blood smear,
HE (hematoxylin - eosin - stained) tissue, IHC labeled tissue, or frozen section.“
2.25. Kuna kolmanda isiku pakkumuses esitatud dokumendid kinnitavad mittevastavust TK p-
ga 1, pidi hankija tema pakkumuse RHS § 114 lg 2 alusel mittevastavana tagasi lükkama.
C. Kolmanda isiku pakkumuse edukaks tunnistamine on õigusvastane
2.26. Kolmanda isiku pakkumuse edukaks tunnistamine on õigusvastane kahel põhjusel.
Esiteks, kui hankija oleks vaidlustaja pakkumuse õigesti vastavaks tunnistanud, tuleks
edukaks tunnistada vaidlustaja pakkumus kui majanduslikult soodsaim pakkumus (RHS
§ 117 lg 1 ls 2). Teiseks, kolmanda isiku pakkumus on mittevastav; hindamisele kuuluvad
vaid vastavad pakkumused (RHS § 117 lg 1 ls 1).
2
TrtRnKo 3-22-607, p 13.
3
EKo C-100/12, p 33; EKo C-689/13, p-d 24—30; EKo C-355/15, p 29; EKo C-131/16, p 55; EKo C-771/19, p 31.
4
TlnHKo 3-16-211, p-d 28—33.
6/7
3. MENETLUSLIKUD KÜSIMUSED
3.1. Riigilõiv. Vaidlustaja on tasunud riigilõivu 1280 eurot (RLS § 258 lg 1 p 1) (lisa 2).
3.2. Esindusõigus. Vandeadvokaat Erki Fels ja vandeadvokaadi abi Gregor Saluveer
kinnitavad, et on vaidlustaja lepingulised esindajad (RHS § 190 lg 11).
3.3. Tähtaegsus. Hankija tegi vaidlusalused otsused 30.07.2025. Vaidlustus on tähtaegne
(RHS § 189 lg 1).
3.4. Läbivaatamine. Vaidlustaja on nõus kirjaliku menetlusega (RHS § 190 lg 1 p 7).
3.5. Esitamine. Vaidlustus on esitatud VAKO-le (
[email protected]) ja menetlusosalistele e-kirja
teel.
Lugupidamisega
(digitaalselt allkirjastatud)
Erki Fels, Gregor Saluveer,
vandeadvokaat vandeadvokaadi abi
LISAD
Lisa 1 Aperio GT 450 DX kasutusjuhend
Lisa 2 Riigilõivu tasumist tõendav maksekorraldus
7/7
Aperio GT 450 DX
User’s Guide
MAN-0475, Revision B | May 2022
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. Aperio, GT, and GT 450 are trademarks of Leica Biosystems Imaging, Inc. in the USA and optionally in other
countries. Other logos, products, and/or company names might be trademarks of their respective owners.
Ì This product is protected by registered patents. For a list of patents, contact Leica Biosystems.
Customer Resources
Ì For the latest information on Leica Biosystems Aperio products and services, please visit www.LeicaBiosystems.com/Aperio.
Contact Information – Leica Biosystems Imaging, Inc.
Headquarters Customer Support General Information
Leica Biosystems Imaging, Inc. Contact your local support US/Canada Tel: +1 (866) 478-4111 (toll free)
1360 Park Center Drive representative with any query and Direct International Tel: +1 (760) 539-1100
Vista, CA 92081 service request. Email:
[email protected]
USA
Tel: +1 (866) 478-4111 (toll free) https://www.leicabiosystems.com/
Direct International Tel: +1 (760) 539-1100 service-support/technical-support/
European Union Authorized Representative United Kingdom Responsible Person
CEpartner4U Leica Microsystems (UK) Limited
Esdoornlaan 13 Larch House, Woodlands Business Park
3951 DB Maarn Milton Keynes, England, United Kingdom, MK14 6FG
The Netherlands
Importers
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Heidelberger Straße 17-19 Larch House, Woodlands Business Park
69226 Nussloch, Germany Milton Keynes, England, United Kingdom, MK14 6FG
00815477020297, 00815477020389
23GT450DXIVD, 23SAMSWDXIVD
2 Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022
Contents
Notices...................................................................................................................................... 7
Revision Record..............................................................................................................................7
Cautions and Notes.........................................................................................................................7
Intended Purpose............................................................................................................................8
Symbols.........................................................................................................................................8
Customer Service Contacts.........................................................................................................11
1 Introduction......................................................................................................................... 13
Resources....................................................................................................................................14
Warnings......................................................................................................................................14
Electromagnetic Warnings..........................................................................................................14
Instrument Warnings..................................................................................................................15
Component and Part 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....................................................................................................................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 3
Contents
Coverslips.................................................................................................................................26
Slide Racks Supported...............................................................................................................26
Slide Capacity...........................................................................................................................26
Barcodes Supported...................................................................................................................26
3 Slide Preparation................................................................................................................. 27
Tissue Preparation........................................................................................................................27
Staining.......................................................................................................................................27
Slide Preparation Guidelines...........................................................................................................27
Tissue Placement...................................................................................................................28
Fixing Slide Preparation Errors.................................................................................................28
Coverslips....................................................................................................................................28
Labels..........................................................................................................................................29
Barcodes......................................................................................................................................29
4 Scan Slides......................................................................................................................... 30
Scanning Concepts........................................................................................................................30
Scan Workflow..........................................................................................................................30
Carousel Rotation......................................................................................................................31
Log In and Log Out 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 Quality Control for Histotechnicians and Pathologists..............................................................45
Scan Statistics..............................................................................................................................45
5 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
4 Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022
Contents
Recommended Daily Maintenance...................................................................................................50
Restart the Scanner...................................................................................................................50
Six Month Maintenance..................................................................................................................51
Clean the Objective and Koehler..................................................................................................51
Materials Needed...................................................................................................................51
Clean the Stage Slide Tray...........................................................................................................54
Clean the Carousel.....................................................................................................................55
Clean the Fan Filter....................................................................................................................55
Clean the Slide Racks.................................................................................................................57
Clean the Scanner Cover.............................................................................................................57
Clean the Touchscreen...............................................................................................................58
Restart the Scanner After Interior Maintenance.................................................................................58
Transporting or Moving the Aperio GT 450 DX...................................................................................59
Long Term Storage........................................................................................................................59
6 Troubleshooting................................................................................................................... 60
Personal Protective Equipment.......................................................................................................60
Red Blinking Lights on Carousel......................................................................................................60
How 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 handling error at rack gripper, lift, or carousel...............................................................72
9000: Scanner cover is open.......................................................................................................74
Rack Warnings and Solutions..........................................................................................................74
1005: Cannot process rack..........................................................................................................74
1006: Cannot process one or more slides in rack...........................................................................75
Slide Errors and Solutions...........................................................................................................76
Tilted Slide(s)........................................................................................................................76
No Barcode...........................................................................................................................77
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 5
Contents
Symptoms and Solutions................................................................................................................81
Scanner Does Not Power 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
6 Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022
Notices
Revision Record
Sections
Rev. Issued Detail
Affected
B May 2022 Page 75 Corrected a typographical error.
A April 2022 All New version for Aperio GT 450 DX product. Based on existing
Aperio GT 450 DX Scanner User’s Guide, MAN-0458, Revision A
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.
` Specifications and Performance - For device specifications and performance characteristics, refer to the document
Aperio GT 450 DX Specifications.
` Installation - Aperio GT 450 DX must be installed by a trained Leica Biosystems Technical Services representative.
` Repair - Repairs may be done only by a trained Leica Biosystems Technical Services representative. After repairs
are done, ask the Leica Biosystems technician to perform operation checks to determine the product is in good
operating condition.
` Accessories - For information on using Aperio GT 450 DX with third-party accessories such as a Laboratory
Information System (LIS) not provided by Leica Biosystems, 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.
` Cybersecurity - Be aware that workstations are susceptible to malware, viruses, data corruption, and privacy
breaches. Work with your IT administrators to protect workstations by following your institution’s password and
security policies.
To protect workstations from malware intrusion, use caution when inserting USB drives and other removable
devices. Consider disabling USB ports that are not in use. If you plug in a USB drive or other removable device, you
should scan the devices with an anti-malware utility. For Aperio recommendations on protecting your workstations
and servers, see the document Aperio GT 450 DX IT Manager and Lab Administrator Guide.
If a suspected Aperio GT 450 DX cybersecurity vulnerability or incident is detected, contact Leica Biosystems
Technical Services for assistance.
` Training - This manual is not a substitute for the detailed operator training provided by Leica Biosystems or for other
advanced instruction.
` Safety - Safety protection may be impaired if this device is used in a manner not specified by the manufacturer.
Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022 7
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.
The Aperio GT 450 DX is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is
the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the
interpretation of images obtained using the Aperio GT 450 DX.
Symbols
The following symbols appear on your product label or in this user guide.
Regulation/
Symbol Description
Standard
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 manufacture
ISO 15223-1 - 5.1.2 European Union Authorized Representative
ISO 15223-1 - 5.1.8 Importer
Device is in compliance with with the Australian Communications Media
AS/NZS 4417.1 Authority (ACMA) requirements (safety and EMC) for Australia and New
Zealand.
ISO 15223-1 - 5.1.7 Serial number
ISO 15223-1 – 5.5.1 In Vitro Diagnostic medical device.
ISO 15223-1 – 5.1.6 Catalog number
ISO 15223-1 – 5.7.10 Unique Device Identifier
EU 2017/746 Device carries the CE (Conformité Europëenne) Mark and fulfils the
Article 18 requirements of EU Regulation 2017/746.
8 Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022
Regulation/
Symbol Description
Standard
Medical Devices
Device is in compliance with UK Conformity Assessment requirements.
Regulations 2002
ISO 15223-1 - 5.4.4 Caution
SO 7010 – W001 General warning
TÜV Product Services have certified that the listed products comply with both
IEC 61010-1
U.S. and Canadian safety requirements.
IEC 60417 - 5031 This device is suitable for direct current only.
On. To indicate connection to the mains, at least for mains switches or their
IEC 60417 - 5007
positions, and those cases where safety is involved.
Off. To indicate disconnection from the mains, at least for mains switches, and
IEC 60417 - 5008
all those cases where safety is involved.
ISO 15523-1 5.7.3 Temperature limitation
ISO 15223-1 5.3.8 Humidity limitation
Device is regulated under 2012/19/EU (WEEE Directive) for Electrical and
2012/19/EU
Electronic Equipment Waste and must be discarded under special conditions.
People’s Republic Device contains certain toxic or hazardous elements and can be used safely
of China Electronic during its environmental protection use period. The number in the middle of
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 9
Regulation/
Symbol Description
Standard
Device is a Class 1 Laser Product that is in compliance with international
IEC 60825-1
standards and US requirements.
This product can expose you to chemicals known to the State of California to
CA Proposition 65 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.
10 Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022
Customer Service Contacts
Please contact the office for your country for technical assistance.
Australia: Deutschland:
96 Ricketts Road Leica Biosystems Nussloch GmbH
Mount Waverly, VIC 3149 Technical Assistance Center
AUSTRALIA Heidelberger Strasse 17
Tel: 1800 625 286 (toll free) Nussloch 69226
Between 8:30 AM-5 PM, Monday-Friday, AEST GERMANY
Email:
[email protected] Tel: 0080052700527 (toll free)
In-country Tel: +49 6441 29 4555
Austria: Email:
[email protected]
Leica Biosystems Nussloch GmbH
Technical Assistance Center Eire:
Heidelberger Strasse 17 Tel: 0080052700527 (toll free)
Nussloch 69226 In-country Tel: +44 1908 577 650
GERMANY Email:
[email protected]
Tel: 0080052700527 (toll free)
In-country Tel: +43 1 486 80 50 50 España:
Email:
[email protected] Tel: 0080052700527 (toll free)
In-country Tel: +34 902 119 094
België/Belgique: Email:
[email protected]
Tel: 0080052700527 (toll free)
In-country Tel: +32 2 790 98 50 France:
Email:
[email protected] Tel: 0080052700527 (toll free)
In-country Tel: +33 811 000 664
Canada: Email:
[email protected]
Tel: +1 844 534 2262 (toll free)
Direct International Tel: +1 760 539 1150 Italia:
Email:
[email protected] Tel: 0080052700527 (toll free)
In-country Tel: +39 0257 486 509
China: Email:
[email protected]
17F, SML Center No. 610 Xu Jia Hui Road, Huangpu
District Japan:
Shanghai, PRC PC:200025 1-29-9 Takadanobaba, Shinjuku-ku
CHINA Tokyo 169-0075
Tel: +86 4008208932 JAPAN
Fax: +86 21 6384 1389
Email:
[email protected] Nederland:
Remote Care email:
[email protected] Tel: 0080052700527 (toll free)
In-country Tel: +31 70 413 21 00
Danmark: Email:
[email protected]
Tel: 0080052700527 (toll free)
In-country Tel: +45 44 54 01 01
Email:
[email protected]
Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022 11
New Zealand:
96 Ricketts Road
Mount Waverly, VIC 3149
AUSTRALIA
Tel: 0800 400 589 (toll free)
Between 8:30 AM-5 PM, Monday-Friday, AEST
Email:
[email protected]
Portugal:
Tel: 0080052700527 (toll free)
In-country Tel: +35 1 21 388 9112
Email:
[email protected]
The Russian Federation
BioLine 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:
[email protected]
Sweden:
Tel: 0080052700527 (toll free)
In-country Tel: +46 8 625 45 45
Email:
[email protected]
Switzerland:
Tel: 0080052700527 (toll free)
In-country Tel: +41 71 726 3434
Email:
[email protected]
United Kingdom:
Tel: 0080052700527 (toll free)
In-country Tel: +44 1908 577 650
Email:
[email protected]
USA:
Tel: +1 844 534 2262 (toll free)
Direct International Tel: +1 760 539 1150
Email:
[email protected]
12 Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022
1 Introduction
The Aperio GT 450 DX is a high performance, brightfield whole slide scanner that includes continuous loading with 450-slide
capacity across 15 racks, priority rack scanning, automated image quality check and a scan speed of ~32 seconds at 40x
scanning magnification for a 15 mm x 15 mm area.
The Aperio GT 450 DX 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.
The Aperio GT 450 DX is intended for use in medium- to high-volume clinical pathology laboratories that support the
pathology services of a hospital, reference laboratory or other clinical facility.
It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the
interpretation of images obtained using the Aperio GT 450 DX. Pathologists should exercise professional judgment 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 The SAM DX server connects to multiple Aperio GT 450 DX scanners and runs
(SAM DX) Server the SAM DX Application Software.
Scanner Administration Manager DX The SAM DX client application software enables IT implementation, PIN
(SAM DX) Application Software configuration, and service access of multiple scanners from a single desktop
client location for IT professionals.
Workstation, monitor, and keyboard A workstation, monitor, and keyboard must be connected to your local
area network with access to the SAM DX server to administer the GT
450 DX scanners.
See the Aperio GT 450 DX Specifications for more information on these components.
Ensure you follow appropriate good laboratory practices and the policies and procedures required by your institution for slide
preparation, processing, storage, and disposal. Use this equipment only for this purpose and in the manner described in this
guide.
Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022 13
Chapter 1: Introduction
Resources
Resource Description
Aperio GT 450 DX User’s Guide Provides reference information and instructions for scanning, troubleshooting,
and maintenance.
Aperio GT 450 DX Quick Reference Contains quick instructions for scanning, basic troubleshooting, and
Guide maintenance. We recommend keeping this printed guide with your scanner.
An electronic version of the quick reference guide is available from the Help area
on the scanner’s touchscreen interface.
Aperio GT 450 DX IT Manager and Lab Contains information and instructions regarding IT administration of the scanner,
Administrator Guide including network administration and configuration.
Aperio GT 450 DX Specifications Provides detailed specifications for the scanner.
Instructional videos 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. See “Customer Service Contacts” on page 11
for contact information.
Training Leica Biosystems 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 be
impaired.
CAUTION: Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the scanner, including
cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could
result.
This device complies with the emissions and immunity requirements as specified in the EN/1EC 61326 series of Product
Family Standards for a “basic electromagnetic environment.” Such equipment is supplied directly at low voltage from public
mains network. This equipment is not intended for residential use.
This device generates, uses, and can radiate unintentional radio-frequency (RF) energy. If this device is not installed and
operated correctly, this 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.
14 Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022
Chapter 1: Introduction
This equipment is designed for use in a PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT. It is likely to perform
incorrectly if used in a HOME HEALTHCARE ENVIRONMENT. If it is suspected that performance is affected by electromagnetic
interference, correct operation may be restored by increasing the distance between the equipment and the source of the
interference.
In addition, other equipment can radiate RF energy to which this device is sensitive. If one suspects interference between this
device and other equipment, Leica Biosystems recommends the following actions to correct the interference:
` Evaluate the electromagnetic environment before installation and operation of this device.
` Do not operate this device close to sources of strong electromagnetic radiation (for example: unshielded intentional
RF sources), as these can interfere with proper operation. Examples of unshielded intentional radiators are handheld
radio transmitters, cordless phones, and cellular phones.
` Do not place this device near medical electrical equipment that can be susceptible to malfunctions caused by close
proximity 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 can cause electrocution, burns, fires, and other hazards
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.
CAUTION: Use of accessories, transducers and cables other than those 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.
Compliance Specifications
This device complies with Part 15 of the FCC rules. Operation is subject to the following two conditions: (1) This device may
not cause harmful interference and (2) this device must accept any interference received, including interference that may
cause undesired operation.
This device has been evaluated against and conforms to the following standards:
Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022 15
Chapter 1: Introduction
Feature Details
Safety
IEC 61010-1:2010
IEC 61010-1: 2010/AMD1:2016
IEC 61010-2-101: 2018
CAN/CSA C22.2 No. 61010-1:2012/A1:2018
CAN/CSA C22.2 No. 61010-2-101:2019
UL 61010-1:2012/R2019-07
UL 61010-2-101:2019
EN 61010-1:2010/A1:2019
EN 61010-2-101:2017
EMC EMC Directive (Directive 2014/30/EU)
EN 61326-1:2013
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 operation.
WARNING: Incorrect installation could result in serious injury to the operator or ergonomic strain. Refer to
Aperio GT 450 DX Specifications, MAN-0479 for work surface and operating specifications.
16 Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022
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. Contact Leica Biosystems, Inc. for assistance or questions regarding device disposal.
Device Lifetime
The lifetime of the Aperio GT 450 DX is ten years.
Scanner Safety Instructions
This section contains important safety information for the Aperio GT 450 DX.
When using your scanner, always take basic safety precautions, including all of those listed below.
` Read All Instructions – All safety and operating instructions must be read before operating the product.
` Retain All Instructions – All safety and operating instructions must be retained for future reference.
` Heed All Warnings – All warnings on the scanner and those listed in the operating instructions must be adhered to.
` Follow All Instructions – All operating and scanner usage instructions must be followed.
1. Heat – The scanner must be situated away from any heat sources such as radiators, heat registers, stoves, or other
products that produce heat.
2. 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 installation procedures.
3. Biosafety Procedures – Please refer to your institution’s biosafety policies and procedures regarding the proper
handling of tissue and other potentially hazardous materials in connection with the use of this device.
4. Water and Moisture – Do not use the scanner near water—for example, near a water bath, wash bowl, kitchen sink,
or laundry tub; in a wet basement; or near an open pool of water or the like. If the scanner becomes wet, unplug it
before touching it.
5. Environment - This device is intended for indoor use only.
6. Attachments – Do not use any attachments not recommended by the product manufacturer as they may cause
hazards.
7. Power Sources – The scanner must be operated from the type of power source indicated on the marking label and in
the installation instructions. If you are not sure of the type of power supplied to your facility, consult your local power
company. Check that the voltage setting matches the electrical supply voltage.
8. Grounding and Polarization – The scanner AC/DC adapter is equipped with a polarized AC plug with integral safety
ground pin. Do not defeat the safety ground in any manner.
9. Cable Protection – Secure all external cables to avoid operator injury.
Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022 17
Chapter 1: Introduction
10. Power Cord Protection – Power supply cords must be routed so that they are not likely to be walked on nor pinched
by items placed upon or against them. Pay particular attention to the cords at AC wall plugs and convenience
receptacles and at the point where the cord enters the AC/DC adapter. The appliance coupler on the external AC/DC
power supply is considered the mains disconnect device.
11. Lightning – For added protection for this scanner during a lightning storm, or when it is left unattended and unused
for long periods of time, unplug it from the AC wall outlet. This will prevent damage to the product due to lightning
and power line surges.
12. Power Overloading – Do not overload AC wall outlets, extension cords, or integral convenience outlets as this can
result in a fire or electric shock hazard.
13. Operating Environment – Observe these basic safety requirements. Do not operate the scanner out of doors.
` Do not use where aerosol sprays are being used or where oxygen is being administered.
` Do not let the scanner or its cables or accessories come into contact with surfaces which are too hot to touch.
` Do not place anything on top of the scanner.
14. Object and Liquid Entry – Never push objects of any kind into the scanner through openings as they may touch
dangerous 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 anything on top of the scanner.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation.
16. 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.
17. Servicing – Refer all servicing to qualified service personnel.
18. Damage Requiring Service – Unplug the scanner from the wall AC outlet and refer servicing to qualified service
personnel under the following conditions:
` When the AC cord or AC/DC adapter is damaged.
` If liquid has been spilled or objects have fallen into the scanner.
` If the scanner has been exposed to rain or water.
` If the scanner does not operate normally (when you are following operating instructions).
` If the scanner has been dropped or damaged in any way.
` When the scanner exhibits a distinct change in performance. This indicates a need for service.
19. Replacement Parts – When replacement parts are required, be sure the service technician has used replacement
18 Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022
Chapter 1: Introduction
parts specified by the manufacturer. Unauthorized substitutions may result in fire, electric shock, or other hazards
and may affect product compliance.
The objective in the GT 450 DX scanner has been specifically designed for this device. Do not replace it with another
type of objective.
WARNING: Use of accessories, transducers and cables other than those 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 technician to perform operation
checks to determine that the product is in proper operating condition.
21. 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 19
2 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.
The scanner automatically loads the slides from the slide racks that the technician loaded into the scanner carousel. The
slides are moved onto the scanning stage based on the automated processing and queueing of the racks.
Once the slide is on the stage, the imaging process begins with capturing the macro image, automatically detecting tissue,
automatic placement of initial focus points (and reference stripe location), capturing label image (including any barcode), and
the image acquisition is initiated.
The 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 Source through the specimen to the optical path (including the objective, tube
lens, apertures, and mirrors). At this point the light travels to the line scan camera where the imaging data is captured and
processed. The Aperio GT 450 DX scanner acquires images in stripes, as the motion subsystem moves the slide across
the Koehler and optical path. These stripes of data are processed in the control VPU and sent to a database for use in later
pathology workflow steps. Once the slide has finished scanning, it is automatically removed from the stage, returned to the
slide rack and the next slide is loaded.
20 Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022
Chapter 2: Aperio GT 450 DX Overview
Scanner Overview
This section describes the parts of your scanner used in daily operation.
Front Back
Fan filter
Touchscreen
interface
Carousel
Status lights (6)
On/off switch
Rack loading area (front-six) Power / network connections
The following section describes the main scanner elements:
Element: Use: More details:
Touchscreen Interface View rack statuses, set rack options, and view other See “Touchscreen Interface Overview”
information. on page 22.
Carousel The carousel contains 15 rack slots. After you load See “Carousel Rotation” on page
racks in the carousel, the carousel rotates the racks to 31.
the scanning area and the rack loading area.
Rack loading area Provides access to the carousel to load and unload See “Load Racks in the Carousel” on
slide racks. This area is also referred to as the “front- page 33.
six,” because the rack loading area gives you access
to six rack slots at a time.
Safety light curtain The infrared safety light curtain detects objects in the See “Carousel Rotation” on page
rack loading area. The carousel only rotates when the 31.
safety light curtain area is clear.
Status lights The status lights are located below the rack slots See “Check Scan Status” on page
in the rack loading area. They indicate the status of 39.
the front-six racks and the scanner. 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 21
Chapter 2: Aperio GT 450 DX Overview
Element: Use: More details:
Fan filter The fan filter is located on the back of the scanner. See “Clean the Fan Filter” on page
Clean the fan filter at least every six months. You can 55.
insert the fan filter from the left side, the right side, or
the top (requires a different fan filter holder).
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 Interface Overview
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.
22 Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022
Chapter 2: Aperio GT 450 DX Overview
Home Screen
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.
Help videos and guides Log in to the scanner
Maintenance area Rack view
Scanner statistics Slide view
Home screen Rack order
(carousel view)
Carousel and rack status
Selected rack
Rack status legend
Rack actions
Slide view, rack
Rack settings order, rack view
appear here
Home screen (carousel view), scanner statistics, help videos and guides appear here
The following section describes the Home screen elements.
Element: Use: More details see:
Rack status legend The Legend defines colors and icons that indicate “Check Scan Status” on page 39.
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.
Scanner statistics Tap Stats to view scan statistics, such “Scan Statistics” on page 45.
as the number of slides or racks scanned
within a certain time period.
Maintenance Tap Maintenance if you need to restart the “Serial Number and Firmware Version” on
scanner, or view the serial number and the page 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 23
Chapter 2: Aperio GT 450 DX Overview
Element: Use: More details see:
Help Tap Help to view training and maintenance “Help Videos and Guides” on page 25.
videos, or access an online version of the
quick reference guide.
Carousel and rack Use the carousel and rack position on the “Carousel Rotation” on page 31.
status touchscreen interface to: “Check Scan Status” on page 39.
y View the rack status, indicated by the
color of the rack position.
y Tap a rack position to select the rack.
y Apply an action to the selected rack,
such as Priority or Rotate (described
next).
Rack actions Select a rack and tap Priority to move the “Priority Scanning” on page 35.
Note: Rack actions rack to the top of the scan queue.
appear when you
Select a rack and tap Rotate to rotate the “Rotate a Rack to the Rack Loading Area”
select a rack.
rack to the rack loading area. on page 36.
Rack settings Select a rack and tap Settings to select and “Scan Entire Slide for Whole Rack” on page
Note: Rack settings apply a rack setting. 43.
appear when you
select a rack.
Login, Logout Tap Login to open a keypad and enter your “Log In and Log Out of the Scanner” on
pass code to access the scanner. page 31.
Tap Logout to lock access to the scanner
touchscreen interface.
Rack View Select a rack and tap Rack View to view the “View Slide Status for a Rack” on page
scan status for each slide in the rack. 40.
Slide View Select a rack and tap Slide View to view “View Macro Images of Scanned Slides” on
macro images for each slide. page 41.
Rack Order Tap Rack Order to view scan order and “View Rack Scan Order” on page 41.
status of the racks.
24 Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022
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.
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 scan status is green for “complete,” the scan and Image QC were
successful. If there is a problem with the scan quality on a slide, the system alerts you.
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Chapter 2: Aperio GT 450 DX Overview
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. For information on enabling DICOM format, see the Aperio GT 450 DX IT Manager and Lab
Administrator Guide.
Slide Types Supported
The scanner supports 1 x 3 inch (2.54 cm x 7.62 cm) glass 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 Coverslipper Rack
20-slide capacity racks are also accepted.
Slide Capacity
The maximum slide capacity depends on the racks used:
` 20-slide racks – load up to 300 glass slides.
` 30-slide racks – load up to 450 glass slides.
Barcodes Supported
The Aperio GT 450 DX supports the following barcodes:
y NW7 y Code 39
y QR Code y Code 128
y Data Matrix y PDF417
y Interleaved 2 of 5 y MicroPDF41
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3 Slide Preparation
When preparing slides for scanning, you must use the procedures required by the vendors of the stains and reagents you
i are using.
Well prepared slides are crucial to a successful scan. After reading this section, if you have questions about whether your
slide preparation techniques will provide good scan quality, contact Leica Biosystems Technical Services for advice.
Always consult the material safety data sheets for the stains and re-agents you are using, as well as your institution’s
biosafety policies and procedures regarding safely handling biological materials.
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.
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 morphological studies and controls as specified in the reagent manufacturer’s instructions.
` Avoid excessive stain residue, as this may affect scanner performance.
Slide Preparation Guidelines
Many scanning issues are avoided by checking slide quality. Ensure the following:
` Slides are very clean and in good condition. Wipe them with a clean cotton cloth (don’t use chemical cleaners).
Make sure the slides have no dirt, no fingerprints, no markings, no writing, no extra mounting media, no broken
slides, no chips, no scratches, etc.
` Slides are fully cured (not “wet”).
` All slides have coverslips. Coverslips are required when using the Aperio GT 450 DX scanner.
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Chapter 3: Slide Preparation
` There is no mounting adhesive around the edges of a slide. This can cause it to stick or catch in the scanner stage
area.
CAUTION: Do not attempt to scan damaged or broken slides, as doing so may damage the scanner.
Tissue Placement
Place the tissue in the middle of the slide, a distance from the edges of the slide, the label, and any other markings. Ensure
the following:
` The coverslip covers all the tissue.
` The label does not cover any tissue.
The example below shows minimum distances from the side and bottom edges of a 26mm x 76mm slide.
≥ 0.77 mm
≥ 0.31 mm
≥ 1.61 mm
For more details on slide specifications, see “Slide Types Supported” on page 26.
Fixing Slide Preparation Errors
Some physical problems of a slide can be resolved by cleaning the 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 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.
` Keep the mounting media that attaches the coverslip to the slide to a minimum. Excess mounting media makes it
hard for the tissue finder to distinguish between actual tissue and the mounting media.
` Make sure there are no air pockets under the coverslip.
` For best results, do not mark or write on the coverslip.
` The coverslip must not hang over the side of the slide.
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Chapter 3: Slide Preparation
` Make sure there is only one coverslip attached to the slide.
` 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.
Ensure the following:
` Do not apply multiple labels to the same slide—this can cause the slide to exceed the specification for slide
thickness. See the Aperio GT 450 DX Scanner Specifications for slide specifications.
` Labels do not extend past the edges of the slide and do not cover any tissue.
` Labels are not underneath coverslips.
` Labels are firmly 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” on page 26. For best performance, we recommend using
barcode labels that have a white background and black ink.
Improperly applied slide barcodes can cause slides to jam. Ensure the following:
` Barcode labels meet the same application requirements as slide labels. See “Labels” on page 29.
` Apply barcode labels to the slide label region.
` Ensure a minimum of 0.5 mm between each side of the barcode and the edge of the label.
` Apply only one barcode label per slide.
` Use only supported barcode labels. (See “Barcodes Supported” on page 26.)
` Use only high-quality printed barcode labels.
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4 Scan Slides
This chapter shows you how to scan slides.
Scanning Concepts
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:
Scanner on Slides loaded Rack loaded
Rack rotated Scanning starts Scan and image auto-QC complete
automatically
If manual image check
fails, re-scan slide
Perform manual image
check
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Chapter 4: Scan Slides
Carousel Rotation
Review the following information to understand the carousel rotation and safety features.
The carousel automatically rotates after you load racks: Safety light curtain
10-second timer before An infrared safety light
1. Racks rotated to scan
Racks loaded carousel rotates: curtain detects objects in
area in order loaded
the loading area:
If an object breaks the
2. Maximum empty rack slots light curtain:
rotated to front y the carousel does not
rotate
y the 10-second timer
starts again
WARNING: Keep hands away from the carousel and pinch point areas
when the carousel is rotating.
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 into the scanner to interact with the touchscreen interface. You do not need to log in to load and
unload racks for scanning.
As a security measure, the scanner logs you out after a period of time and requires you to enter the passcode.
1. From the touchscreen interface, tap Login.
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Chapter 4: Scan Slides
2. 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.
1. From the touchscreen interface, tap Logout.
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:
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 loading slides into a rack to prevent
improper slide orientation or damaged slides. Never use damaged
slides in the scanner.
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Chapter 4: Scan Slides
Load Racks in the Carousel
Slides are scanned in the order you load 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:
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Chapter 4: Scan Slides
` The first rack is rotated to the scan area.
` Any empty rack slots are rotated to the loading area.
WARNING: To prevent injury, keep hands away from the carousel and pinch point 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 the rack loading area. See “Rotate a Rack to
the Rack Loading Area” on page 36.
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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.
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Chapter 4: Scan Slides
The Priority icon and scan queue number appear on the rack position:
The rack with the first level priority is moved to the top of the scan queue, and begins processing when the active
rack is complete. 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 loading area:
1. Tap the rack position.
The Rotate option appears when you select the rack position.
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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.)
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Chapter 4: Scan Slides
Unload Racks from the Carousel
CAUTION: Use caution when unloading racks from the carousel and when unloading slides from a rack to
prevent damaged slides or operator injury. Never use damaged slides in the scanner.
To unload racks 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 currently being scanned, the system asks you for confirmation.
4. After the rack is rotated to the loading area, you can remove the rack.
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Chapter 4: Scan Slides
Check Scan Status
This section describes the different ways to 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.
Check Rack Status
To check the scan status of a rack:
1. Check the rack position status color against the Legend:
2. The rack 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 The rack is loaded successfully and is waiting to scan.
Scan
Warning There is an issue with the rack, or one or more slides in the rack. If you get a rack
warning, see page 42.
Priority The rack is set for priority scanning. (See “Priority Scanning” on page 35.)
Rack Error on Current Scan
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.
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Chapter 4: Scan Slides
View Slide Status for a Rack
To view the status for slides in a rack:
1. Tap the rack position on the touchscreen 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. (See page 42.)
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Chapter 4: Scan Slides
View Macro Images of Scanned Slides
To view a macro image of a scanned slide:
1. Tap the rack position on the touchscreen interface.
2. Tap the Slide View icon to view individual images for 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.
y The scan status is indicated for each rack.
y In the example, rack 3 is set as priority.
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Chapter 4: Scan Slides
Rack Warnings
A rack has a warning if the status color is orange or if the rack position is pulsating blue and orange.
To check the rack for errors:
1. Tap the rack position you want to check.
2. If there 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 the scanner from creating an image.
In the example below, slide 7 in the selected rack has a warning.
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Chapter 4: Scan Slides
5. Tap the Slide View icon to view the macro image for the slide that has a warning.
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.
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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:
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Chapter 4: Scan Slides
Image Quality Control for Histotechnicians and Pathologists
After scanning slides, it is important to review the digital slides to make sure the images are of
good quality. Ultimately, it is up to the pathologist to look at digital slides to verify they are of
sufficient quality to perform their task. In addition, scanner operators should verify digital slide
quality after scanning.
The quality criteria that are important for primary 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 image quality review.
For additional image quality assessment instructions, refer to the user guide for your viewer.
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.
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5 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 25.
CAUTION: It is important that you perform the maintenance procedures listed below on a regular schedule.
Not doing so could result in scanner misalignment which could impair image quality.
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 50.
(Recommended)
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 carousel “Clean the Carousel” on page 55
4. Clean the slide racks “Clean the Slide Racks” on page 57
5. Clean the fan filter “Clean the Fan Filter” on page 55
6. Clean the touchscreen “Clean the Touchscreen” on page 58
7. Clean the scanner cover “Clean the Scanner Cover” on page 57
Once a year Schedule annual maintenance visit by Call Leica Biosystems Technical Services.
Leica Biosystems Technical Services. Refer to “Customer Service Contacts” on page 11.
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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.
1. From the touchscreen interface, tap Maintenance.
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Chapter 5: Maintenance
2. Tap Shut Down Scanner.
3. After the touchscreen goes dark, turn the scanner off using the On/Off switch.
Open the Scanner 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 the point shown below.
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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.
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Chapter 5: Maintenance
Recommended Daily Maintenance
This section provides the recommended daily maintenance procedures.
Restart the Scanner
` Frequency: daily, and as needed to resolve a scanner issue.
Restarting the scanner initializes 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 Restart Scanner.
You can use the scanner again after initialization is complete and the Home screen appears.
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Chapter 5: Maintenance
Six Month Maintenance
This section provides the six-month maintenance procedures. The purpose of the six month maintenance is to clean the
scanner components.
Clean the Objective and Koehler
` Frequency: at least every six months.
CAUTION: When cleaning the scanner’s objective:
y Do not remove the objective.
y Only use the recommended cleaning cloth and solution 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 off. (For instructions, see “Turn the Scanner On and Off” on page 22.)
2. Open the cover and access the interior:
a. Open 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.
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Chapter 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.
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Chapter 5: Maintenance
6. Clean the objective using small circular motions with the recommended lint-free microfiber cloth.
7. With a clean 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 Maintenance” on page 58.
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Chapter 5: Maintenance
Clean the Stage Slide Tray
` Frequency: at least every six months.
To clean the stage slide tray:
1. If the scanner is on, shut down the scanner by following the steps in,“Shut Down the Scanner” on page 47.
2. Open the cover and access the interior.
a. Open 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 again from back to front using a microfiber cloth.
5. If necessary, use a gentle solvent such as denatured alcohol to remove any remaining residue.
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Chapter 5: Maintenance
6. If you are performing the entire six-month maintenance routine, continue to the next procedure.
7. 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.
Clean the Carousel
` Frequency: at least every six months.
To clean the carousel:
1. If the scanner is on, shut down the scanner by following the steps in,“Shut Down the Scanner” on page 47.
2. Remove all slide racks from the carousel.
3. Use a cotton swab soaked in a cleaning 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 you are performing the entire six-month maintenance routine, continue to the next procedure.
7. 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.
Clean the Fan Filter
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.
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Chapter 5: Maintenance
To clean the fan filter:
1. If the scanner is on, shut down the scanner by following the steps in,“Shut Down the Scanner” 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 it in the scanner.
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Chapter 5: Maintenance
6. When the filter is completely dry, slide it back into position.
7. If you are performing the entire six-month maintenance routine, continue to the next procedure.
8. 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.
Clean the Slide Racks
` Frequency: at least every six months.
To clean the slide racks:
1. Check 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 scanner cover and restart the scanner, follow the steps in “Restart the Scanner After
Interior Maintenance” on page 58.
Clean the Scanner Cover
` Frequency: at least every six months.
To clean the scanner cover:
1. Wipe the outer cover of the scanner with a damp cloth.
2. Immediately dry the cover using a dry cloth.
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Chapter 5: Maintenance
Clean the Touchscreen
` Frequency: at least every six months.
To clean the touchscreen:
1. Spray standard monitor cleaner directly on a clean non-scratch cloth. (Avoid spraying the touchscreen directly to
ensure that no liquid 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 position.
2. Secure the VPU in place by rotating the VPU latch forward or backward 180 degrees, depending on its current
position.
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Chapter 5: Maintenance
3. Slide the scanner cover back into position so that it is aligned with the rear latches and clicks closed.
4. 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. 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 for assistance.
For information on disposing of the scanner, see “Disposal of the Aperio GT 450 DX” on page 17.
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6 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.
Personal Protective Equipment
If you need to access the interior of the scanner while troubleshooting an issue, follow the policies and procedures of your
institution, including the use of personal protective 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 appropriate troubleshooting section:
Steps to resolve the
Type of issue: Scanner status:
issue:
An error message box similar to this example appears on the Until the error is 1. You can tap the to
touchscreen interface: resolved: minimize the message box.
y You cannot This enables you to view the
interact with the
rack status and access the
carousel
Help resources.
y The scanner 2. See “Error Codes and
cannot continue
Solutions” on page 63 for
scanning.
steps to resolve the specific
error.
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Chapter 6: Troubleshooting
Steps to resolve the
Type of issue: Scanner status:
issue:
A rack warning and error message similar to this example There is a problem See “Rack Warnings and
appears on the touchscreen interface: with the rack or one Solutions” on page 74 for steps
or more slides in the to resolve the specific error.
rack.
The scanner can
continue scanning
other racks or slides.
No message or warning appears on the touchscreen Varies with the See “Symptoms and Solutions” on
interface, but there is a problem with the scanner. For situation. page 81.
example, the scanner does not power up when you turn it on.
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 the scanner, you need to ensure there is no slide on the stage.
Follow these steps to safely restart the scanner after an error:
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 Scanner Cover and Access the Interior Components” on page 42.
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Chapter 6: Troubleshooting
2. Check if there is a slide on the stage or partially on the stage.
CAUTION: Restarting the scanner with a slide on the stage may damage the slide.
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 b. Slide the stage to the rear of the scanner, as shown:
grooves:
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 touching the LED and objective.
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5. Close the scanner cover:
a. Pivot the VPU into b. Rotate the VPU latch. c. Slide the cover until it clicks
place. closed.
For detailed steps, see “Restart the Scanner After Interior Maintenance” on page 52.
6. Tap Maintenance on the touchscreen interface, then tap Restart Scanner. Wait for the scanner to complete the
restart process.
Error Codes and Solutions
If an error 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. Pivot out VPU
For detailed steps, see “Open the Scanner Cover and Access the Interior Components” on page 42.
2. Take photos of any obstructions. Leica Biosystems Technical Services may request the photos if you need additional
assistance after completing the steps below.
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Chapter 6: Troubleshooting
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 may damage the slide.
4. If 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 b. Slide the stage to the rear of the scanner, as shown:
grooves:
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 touching the LED and objective.
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6. Close the scanner cover:
a. Pivot the VPU into b. Rotate the VPU latch. c. Slide the cover until it clicks
place. closed.
For detailed steps, see “Restart the Scanner After Interior Maintenance” on page 52.
7. Tap Restart Scanner 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 Scanner Cover and Access the Interior Components” on page 42.
2. Check if there is a slide on the stage or partially on the stage.
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Chapter 6: Troubleshooting
CAUTION: Restarting the scanner with a slide on the stage might damage the slide.
3. If there is a slide on the stage, carefully 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 b. Slide the stage to the rear of the scanner, as shown:
grooves:
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 touching the LED and objective.
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5. Close the scanner cover:
a. Pivot the VPU into b. Rotate the VPU latch. c. Slide the cover until it clicks
place. closed.
For detailed steps, see “Restart the Scanner After Interior Maintenance” on page 52.
6. Shut down the scanner 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 for any unexpected object.
Rack loading area with light curtain highlighted: Pinch points on either edge of rack loading area:
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2. Ensure the racks in the rack loading area are inserted correctly:
Leica logo facing out and up: Rack inserted fully into the rack slot:
3. When 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 persists, contact Leica Biosystems Technical Services.
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1003: Carousel cannot rotate. Carousel pinch point obstructed.
` Cause: There is an obstruction at a pinch point.
Follow these steps in order until the issue is resolved and the error message closes:
1. Check the rack loading area and pinch points for any unexpected object that may break the light curtain.
Rack loading area with light curtain highlighted: Pinch points on either edge of rack loading area:
2. 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 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 LAN cables are connected at the scanner LAN port and at the SAM server.
2. Run network diagnostics.
3. Ensure the DICOM server is running. Restart the DICOM server if necessary.
4. 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.
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Follow these steps in order 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 the Scanner Cover and Access 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 from the stage without touching the surrounding components.
5. Check the slide stage, rack, and pusher area for an obstruction.
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6. If possible, carefully remove the slide that is causing the obstruction.
WARNING: Do not attempt to recover broken slides. Call Leica Biosystems Technical Services.
7. Check the slide for preparation issues, such as over-hanging coverslips and label 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 b. Slide the stage to the rear of the scanner, as shown:
grooves:
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 touching the LED and objective.
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Chapter 6: Troubleshooting
9. Close the scanner cover:
a. Pivot the VPU into b. Rotate the VPU latch. c. Slide the cover until it clicks
place. closed.
For detailed steps, see “Restart the Scanner After Interior Maintenance” on page 52.
10. Tap Restart Scanner on the touchscreen interface, and wait for the scanner to complete 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 the Scanner Cover and Access the Interior Components” on page 42.
2. Take photos of the obstruction.
WARNING: Do not attempt to recover broken slides. Call Leica Biosystems Technical Services.
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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. 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. Contact Leica Biosystems Technical Services.
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Chapter 6: Troubleshooting
9000: Scanner cover is open
` The scanner cover is not closed completely.
Follow these steps until the issue is resolved:
1. Slide the cover to the closed position, making sure the cover aligns with rear 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 the Home screen.
1005: Cannot process rack.
` Cause: There is an issue with a rack that prevents scanning.
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Follow these steps in order until the issue is resolved:
1. Rotate the rack to the rack loading area. (See “Rotate a Rack to the Rack Loading Area” on page 31.)
2. Ensure the rack is inserted correctly:
Leica logo facing out and up: Rack inserted fully into the carousel:
3. Remove the rack and check the following:
y You are using a supported rack. (See “Slide Racks Supported” on page 21.)
y The rack is not damaged or modified.
4. Verify the error only occurs on one rack.
y If the error only occurs on one rack, go to step 5.
y If the error occurs on multiple racks, contact 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 process one or more slides in rack.
` Cause: There is an issue with one or more slides in the rack.
Follow these steps in order until the issue is resolved:
1. On the touchscreen, tap the rack position that has the error, and tap Rack View to identify which slides have the
error.
2. Tap Slide View to view the macro image of the slide, and check for an error message.
3. Go to the section that matches the slide error:
` “Tilted Slide(s)” on page 76
` “No Barcode” on page 77
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Chapter 6: Troubleshooting
` “No Tissue” on page 77
` “No Macro Focus” on page 77
` “Image Quality” on page 78
` “Image Transfer Error – Pending Retry” on page 79
` “Aborted” on page 79
4. 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. Follow the steps in order until
the issue is resolved. If you follow the steps and the issue persists, contact Leica Biosystems Technical Services.
You can temporarily hide some error messages by tapping the x in the top-right corner. This enables you to view the
i macro image.
Tilted Slide(s)
` Cause: The slide is tilted between two or more slots in the rack and cannot be scanned.
Follow these steps in order:
1. Remove the rack from the carousel, and locate the tilted slide:
2. Insert the slide in a new rack for scanning, ensuring it sits level horizontally in one slot.
3. Insert the rack into an empty rack slot for scanning.
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No Barcode
` Cause: The scanner does not detect a barcode on the slide.
Follow these steps in order until the issue is resolved:
1. Check the slides and rack are inserted correctly:
` Slide label facing out and up.
` Leica logo facing out and up.
` See also, “Load Slides in the Rack” on page 27.
2. Ensure barcodes meet specifications. See “Barcodes Supported” on page 21.
3. Ensure barcodes meet minimum quality requirements. See “Barcodes” on page 24.
4. If the issue persists, call Leica Biosystems Technical Services.
No Tissue
` Cause: The scanner does not detect tissue on the slide.
Follow these steps in order until the issue 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 a new rack and scan it again.
9. If the issue persists, check for slide preparation errors. See “Slide Preparation” on page 22.
10. If the issue persists after completing the previous steps, call Leica Biosystems Technical Services.
No Macro Focus
` Cause: The scanner’s camera cannot focus on the tissue.
Follow these steps in order until the issue is resolved:
1. 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.
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Chapter 6: Troubleshooting
2. Check the stain quality.
3. Check that the slide and coverslip thickness meet the requirements. See the Aperio GT 450 DX Scanner
Specifications.
4. Check for common slide preparation issues and verify:
` 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.
5. 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.
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. Review the newly scanned slide image in your viewing software.
5. If the issue persists, display the slide in Slide View, and tap Scan Entire Slide. (To scan the whole area for a rack of
slides, see “Scan Entire Slide for Whole Rack” on page 37.)
6. Check if other slides are in focus.
7. If all slides are out of focus, clean the objective. (See “Clean the Objective and Koehler” on page 44.)
8. If the issue persists after following the previous steps, call Leica Biosystems Technical Services.
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Image Transfer Error – Pending Retry
` Cause: The scanner cannot transfer the scanned image to the image storage location.
Follow the appropriate steps below:
Error appears on some slides: Error appears on all slides:
The system often resolves the issue without intervention. The Lab Administrator should:
1. If all slides in the rack are finished scanning, remove the 1. Check connectivity from the scanner to the DICOM
rack. server, and the DICOM server to your site’s image
storage location.
2. Check for the image in eSlide Manager.
2. Check if your site’s image storage location is full.
3. If necessary, rescan only the slides that are missing
from eSlide Manager. 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
message appears on one or some slides, continue to the next step.
2. Check for damage or common slide preparation issues and verify:
` Coverslip is not missing or overhanging.
` Labels are not overhanging or on wrong side.
` There is only one label applied to the slide.
` There is only one coverslip applied to the slide.
` Slide is clean.
3. Clean the slide.
4. Insert the slide into a different rack and scan it again.
5. If the issue persists after following the previous steps, call Leica Biosystems Technical Services.
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Chapter 6: Troubleshooting
Aborted Message Appears on All Slides
Follow these steps in order until the issue is resolved:
1. Remove any completed slide racks from the carousel.
2. 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 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 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.
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6. Shut down the scanner by tapping Maintenance, then tapping Shut Down Scanner.
7. When touchscreen is dark, turn the scanner off using the On/Off switch.
8. Turn the scanner back on using the On/Off switch.
9. Allow the scanner to scan any remaining racks.
10. If the issue persists, call Leica Biosystems Technical Services.
Symptoms and Solutions
This section contains troubleshooting information organized by symptom for scanner issues that do not have an error
message or code.
Scanner Does Not Power On
1. Ensure the scanner is turned on.
2. If you 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 Technical Services.
Touchscreen Does Not Respond to Touch
1. Shut down the scanner by following the steps in, “Shut Down the Scanner” on page 41.
2. Turn the scanner on.
3. If the issue persists, contact Leica Biosystems Technical Services with details.
Touchscreen is Black
1. Shut down the scanner by following the steps in, “Shut Down the Scanner” on page 41.
2. Turn the scanner on.
3. If the issue persists, contact Leica Biosystems Technical Services with details.
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Slides are Broken inside the Scanner
WARNING: Do not attempt to recover broken slides. Call Leica Biosystems Technical Services.
1. Take photos of the location of the damage. Leica Biosystems 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 information.) If this does not establish network connection, contact your IT staff for assistance.
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A 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 y 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 – 98% success rate image file.
y System encompasses all stained portions of
the tissue block at defined success rates for
FFPE IHC Stained slides – 90% success rate
y System scans ≤ 30% excessive area 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
Focus Error System has a focus error within the allowable Demonstrates that the focus quality of the
calculated limits for both auto-focusing and Aperio GT 450 DX scanner is acceptable
scanning methods: even in the presence of uneven tissue.
y Focus low : -1.83 microns
y Focus high : 1.21 microns
Color System provides color management using an ICC Measures the color differences between
profile per established industry guidelines. the input color stimuli and the output digital
image file.
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Appendix A: Performance Information
Test Acceptance Criteria Test Purpose
Stitching Error System has > 85% analysis stripes for all the slides Analyzes potential stitching error sources,
across all 3 Aperio GT 450 DX scanner devices and capture image/stripe data, executes the
has actual stitching errors less than stitching error stitching algorithm, and measures the
specification. alignment of the stitching algorithm to
the established ground truth image data
(perfect stitching). This comparison is
performed by comparing the stripe overlap
statistics with the actual data generated by
the stitching algorithm.
Precision (Repeatability and Reproducibility)
Test Acceptance Criteria Test Purpose
Image Repeatability Image repeatability is ≥ 90%. Assesses image quality repeatability, which
is a key component to ensuring first time
scan success rate.
Image Quality Inter-device reproducibility is ≥ 90% (90 of 100 Assesses image quality reproducibility,
Reproducibility slides must result in a “Pass”). which is the key component to ensuring
first time scan success rate.
Focus Reproducibility Systems have an overall intra-system agreement of Assesses that the intra-system focus
>85%. quality of the Aperio GT 450 DX scanner is
acceptable even in the presence of uneven
tissue.
Stitching Systems have an overall intra-system agreement > Analyzes potential stitching error sources,
Reproducibility 85%. capture image/stripe data, executes the
stitching algorithm, and measures the
alignment of the stitching algorithm to
the established ground truth image data
(perfect stitching) and compares intra-
system agreement.
Accuracy (Resulting from Trueness and Precision)
Test Acceptance Criteria 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.
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Appendix A: Performance Information
Clinical Performance
Clinical performance is based on the concordance between the Aperio GT 450 DX and traditional light microscopy.
Clinical performance of the Aperio GT 450 DX is based on available scientific literature as, to date, no clinical performance
studies, data from routine diagnostic testing or other clinical performance data is available for the Aperio GT 450 DX. A
systematic literature search was performed to identify relevant literature which supports the clinical performance of the
Aperio GT 450 DX.
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%.
Overall, based on the clinical performance evidence available, the Aperio GT 450 DX is able to perform as per its intended
purpose in a clinical setting.
Results from the clinical performance studies reported in the literature are shown below.
Performance
Comparator Results Reference
Outcome
Concordance Glass slide microscopy Major diagnostic concordance Hanna et al. 20201
100% (254/254)
Minor diagnostic concordance
98.8% (251/254)
1 Hanna MG, Parwani A, Sirintrapun SJ: Whole Slide Imaging: Technology and Applications. Adv Anat Pathol, 27: 251-259, 2020
10.1097/pap.0000000000000273
Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022 85
Index
Symbols DICOM 26
40x 25 DICOM converter error 69
disposal 17
A
add racks 33 E
add slides to rack 32 electromagnetic warnings 14
analytical performance 83 error codes, solutions for 63
Auto-Image QC 25 rack warnings 74
error message 60
B
barcodes 29 F
barcodes supported 26 fan filter
clean 55
blinking lights, red 60
remove 56
broken slides, recover 82
FCC compliance 15
C I
cannot process rack 74
image quality check, automatic 25
capacity, slide 26
image quality review 45
carousel 21
image types, supported 26
clean 55
lights 60 insert racks 33
carousel cannot rotate 67 insert slides 32
clean objective 51 installation 16
clinical performance 85 instrument warnings 15
compliance specifications 15 internal storage full 69
continuous load 25 internet connection lost 82
cover. See scanner cover
L
cover, open and close 48
labels, requirements 29
coverslips 26, 28
labels, slides 29
D legend 23
daily maintenance 50 light curtain 21
86 Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022
Index
load racks in scanner 33 R
load slides in rack 32 rack
check status 39
M load in scanner 33
magnification, scan 25 load slides in 32
unload 38
maintenance
warning 42
cleaning slide tray 54
daily 50 rack order 41
schedule 46 rack process error 74
six-month 51 racks
messages clean 57
rack issues 61 rack view, display 40
scanner error 60 rack warning 61
slide issues 61 current scan 39
move scanner 59 red blinking lights 60
regulatory compliance 15
N
remove rack 38
number of slides 26
reports, scan 45
O restart scanner
after an error 61
objective
daily maintenance 50
clean 51
location 52
S
on/off switch 22
safety instructions 17
open cover 48
safety light curtain 21
options
priority 35 scan entire slide
single slide 41
orange status 42
whole rack 43
overview, scanner 21
scan magnification 25
overview, touchscreen interface 22
scanner
close cover 58
P disposal 17
personal protective equipment 60 move 59
pinch point obstruction error 69 open cover 48
power on problem 81 restart 50
restart after maintenance 58
PPE 60 service life 17
preparing slides 27 storage 59
priority scan 35 Scanner Administration Manager 26
pusher, safe position 58 scanner cover
clean 57
Q scanner not powered on 81
quality check, image 25
Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022 87
Index
scanner safety instructions 17 clean 58
scan statistics 45 touchscreen interface overview 22
scan workflow 30 touchscreen problem 81
sensors, light 21 troubleshooting 60
service life 17 error codes 63
error messages 60, 61
shut down scanner 47
how to use steps 60
six-month maintenance rack warnings 74
clean carousel 55 symptoms 74
clean fan filter 55 touchscreen 81
clean objective 51
turn on scanner 22
clean scanner cover 57
clean slide racks 57
clean stage slide tray 54 U
clean touchscreen 58 UI. See touchscreen
slide capacity 26 unload racks 38
slide handling error 69, 72 unload slides 38
slide labels, requirements 29 user interface 22. See touchscreen
slide preparation 27
coverslips 28 V
fix errors 28 VPU
labels 29 close 58
slide racks open 49
clean 57
slides, broken 82 W
slides, load in rack 32 warnings
rack 42, 74
slide staining requirements 27
whole slide scan. See scan entire slide
slide view 41
workflow, scan 30
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
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Index
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