Aperio GT 450 Release 1.3
CUSTOMER NOTICE

1. Introduction
The purpose of a Customer Notice is to provide timely communication regarding updates to Leica Biosystems
product user manuals. This Customer Notice contains information about your Leica Biosystems product thatwill be included in a future release of one or more user manuals for your product. This information may include
new instructional content, updated specifications, or additional information about the use or care of yourproduct. Use this document as supplementary information until the revised user manuals are available.
This Customer Notice provides information and instructions for using the new features provided with theAperio GT 450 Release 1.3.
This document contains the following sections:
1. Introduction
2. Aperio GT 450 Release 1.3 overview
3. Configure default Scan Settings in SAM
4. 20x magnification scanning
5. Z-Stack scanning
6. Set up Auto Narrow Stripe scanning on SAM
7. Aperio GT 450 optional DICOM upgrade
8. Specifications updates

Products Affected
Aperio GT 450 Scanner, Aperio GT 450 Software, and Aperio GT 450 Controller Version 1.3.

User Manuals Affected
The information contained in this document will be incorporated into the following user manuals upon theirnext major scheduled release:
Document Title

Base Document Number

Aperio GT 450 User’s Guide

MAN-0391

Aperio GT 450 IT Manager and Lab Administrator’s Guide

MAN-0394

Aperio GT450 Scanner Specifications

MAN-0393

Aperio GT 450 Quick Reference Guide

MAN-0392

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2. Aperio GT 450 Release 1.3 overview
The Aperio GT 450 release 1.3 includes the following new features and updates:

20x magnification scanning
Prior to Aperio GT 450 release 1.3, the Aperio GT 450 scanner scanned all slides at 40x magnification. With
Aperio GT 450 release 1.3, you have the option to scan slides at 20x or 40x magnification, depending on theneeds of your organization or specific project.
The primary benefit to scanning at 20x is to reduce the image file size, which then increases your image
storage capacity. When you scan your slides at 20x magnification instead of 40x magnification, the image
size is approximately 71 percent smaller than a slide scanned at 40x magnification.
For more information on setting up and using 20x magnification, see 20x magnification scanning on page 4.

Z-Stack scanning
Z-Stack scanning enables you to scan a glass slide at different focal planes along the vertical z-axis, and stackthe images on top of each other to produce a 3D composite multiplane image.​ Pathologists can review slide
samples at varied “heights” using a software focus adjustment, comparable to the fine-focus knob of aconventional light microscope. To view z-stack images, use the Aperio ImageScope viewer.
For more information, see Z-Stack scanning on page 7.

Auto Narrow Stripe quality check and rescan
The Auto Narrow Stripe scanning feature helps mitigate potential image quality issues by enabling thescanner to automatically rescan a slide using an alternative scanning process, Auto Narrow Stripe scanning,when the system detects an excessive tilt of the slide tissue. Excessive slide tissue tilt can occur when the slide
does not sit level in the slide tray, or when tissue is not laid flat on the glass surface along the short axis (indexaxis) of the slide due to poor slide preparation. Auto Narrow Stripe scanning is not available when scanning zstack images.
For more information, see Set up Auto Narrow Stripe scanning on SAM on page 11.

Optional DICOM upgrade overview
Aperio GT 450 releases 1.3 and later support an optional DICOM feature pack that enables third-party
developers to obtain digital slide images (and metadata) created by the Aperio GT 450 scanner to use in theirown viewers or LIS (Laboratory Information System) products.
When the DICOM feature pack is enabled, the Aperio GT 450 scanner creates SVS and DICOM compatible
images. The .svs format is the default.
The optional DICOM feature pack is not supported with the 20x magnification scanning, Zstack scanning, or Auto Narrow Stripe scanning features.
For more information, see Aperio GT 450 optional DICOM upgrade on page 12.
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3. Configure default Scan Settings in SAM
The Configure Scan Settings page in SAM enables you to set the default scan magnification, to set z-stackscanning options, and to enable or disable the Auto Narrow Stripe feature.
Only a user who is assigned the Lab Admin role can make configuration changes.
To configure scan settings for a scanner, follow these steps:
1. Log in to the SAM software.
2. When the SAM Home screen appears, confirm that the Scanners icon in the banner is selected, and thepage shows the list of scanners. Click the Scanners icon to display the list, if necessary.

3. Click the Configuration icon to the right of the scanner you want to configure.

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4. In the left pane, click Scan Settings to open the Configure Scan Settings page.

5. To change the scan settings, click Edit .
6. To save your changes, click Save .
For more information and instructions for adjusting specific settings, see:l

20x magnification scanning on page 4l

Z-Stack scanning on page 7l

Set up Auto Narrow Stripe scanning on SAM on page 11

4. 20x magnification scanningThis section contains instructions for setting the scan magnification default in SAM, and performing rack-levelscans at 20x or 40x magnification.
Your Aperio GT 450 scanner is initially set to scan all racks using 40x magnification. If you want this scanner
to scan using 20x magnification by default, turn on the DEFAULT TO 20X SCANNING option in SAM.
When scanning slides, you can override the default scan magnification using the rack settings on the scannerconsole.

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Set the scan magnification default on SAM
Follow the steps below to set the default scan magnification for a specific Aperio GT 450 scanner:
1. Log on to SAM.
2. Confirm that the Scanners icon in the banner is selected, and the page shows the list of scanners. (Foran example, see Configure default Scan Settings in SAM on page 3.)
3. Click the Configuration icon to the right of the scanner.
4. Click Scan Settings in the side menu bar.
5. On the Configure Scan Settings page, click Edit.

6. To set the scan magnification default to 20x, click to turn on the DEFAULT TO 20X SCANNING option.
(If this setting is turned off, the scanner uses the default of 40x magnification.)

7. To save your settings, click Save .

Change the scan magnification for a rack of slides
For each Aperio GT 450 scanner, your Lab Administrator has the option of changing the default scanmagnification from 40x to 20x within the SAM software. This section shows how to override the default during
scanning, and manually change the scan magnification for a rack of slides.
This procedure describes how to scan a rack of slides at 40x magnification, when the default scanmagnification is set to 20x. (If the default scan magnification is set to 40x, use the same process to scan arack of slides at 20x magnification.)
To scan a rack of slides at 40x when the scan magnification is set to 20x, follow these steps:
1. Load the rack with only the slides that you want to scan at 40x.
2. Tap the rack position that contains the slides you just loaded.

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3. Tap Settings, and then tap Scan at 40X.

The Scan at 40x option is selected, and 40x appears on the rack position.

During scanning, the Rack View indicates the scanner is scanning this rack at 40x magnification.

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5. Z-Stack scanning
The scanner can create multiple digital images of slide tissue scanned at different focal depths, creating a 3D
composite multiplane image that you can visually navigate through much as a microscope user can navigate
through different tissue focal depths by using the microscope objective fine and coarse adjustments. Thisability to create a 3D image is called “z-stack" scanning.
Pathologists can review slide samples at varied “heights” using a software focus adjustment, comparable tothe fine-focus knob of a conventional light microscope. The Z-Stack scanning feature is specifically useful incytology and dermatopathology.
For all types of scanning, the scanner determines the layer within the tissue that provides the optimal focus—
this is called the best focus layer. For z-stack scanning, by default the best focus layer is placed in the middleof the z-stack, with an equal number of layers above and below it.
As described in the following section, you configure the default z-stack scan settings by indicating how manylayers you want to scan and the distance between the layers (layer separation) in microns. For example, if you
configure the z-stack to use 5 layers separated by .5 microns, there are two layers above the best focus layer
and two layers below it.

Set up Z-Stack parameters on SAM
Follow the steps below to set the default Z-Stack parameters:
1. Log on to SAM.
2. Confirm that the Scanners icon in the banner is selected, and the page shows the list of scanners. (Foran example, see Configure default Scan Settings in SAM on page 3.)
3. Click the Configuration icon to the right of the scanner.
4. Click Scan Settings in the side menu bar.

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5. On the Configure Scan Settings page, click Edit.

6. In the Number of Layers field, enter the default number of layers (focal planes) used for scanning zstack images. You can select from 3 and 25 layers. (The number of layers includes odd numbers only.)
Typically, the number of layers you choose depends on the type of tissue you are scanning. The
scanner operator can adjust this setting on the scanner console when scanning a rack of slides.
Note that scan time and file sizes increase based on number of focus planes you select.
7. In the Layer Separation field, enter the default distance between planes from 0.25 to 1.0 micron. Thissetting controls the focus offset between layers. The scanner operator can adjust this setting on thescanner console when scanning a rack of slides.
8. To save your changes, click Save.

Scan a rack of slides using z-stack scanningYour Lab Administrator sets the default number of layers and the distance between layers (in microns) for
each scanner.​ You can adjust these settings on the scanner console for each rack of slides you scan.

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Aperio GT 450 Release 1.3 Customer NoticeNote the following when using Z-Stack scanning:ll

The Auto Narrow Stripe feature is not used to scan z-stack images. If the Auto Narrow
Stripe scanning feature is turned on in SAM, the system disables this feature during zstack scanning.
When using Z-stack scanning, the scan time and file size can increase, based on
specified number of layers and the distance between layers.

To scan a rack of slides using z-stack scanning, follow these steps:
1. Load the rack with only slides that you want to scan as z-stack images. You should load slides of similar
tissue types in the same rack. This is because you choose the number of layers to use depending on thetype of tissue you are scanning.
2. Tap the rack position that contains the slides you just loaded.
3. Tap Settings, and then tap Z-Stack.

The Z-STACK OPTIONS screen appears with the default Number of layers and Layer separation(microns) that your Lab Administrator previously set in SAM.

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4. Follow these steps to adjust the z-stack scan settings for the rack you are scanning:a. To adjust the Number of layers, tap the Minus and Plus buttons until you reach the desired
number of layers. You can also use the number pad to enter the desired values directly. Tap
inside the Number of layers field to activate the keypad. (Note that the number of layers must be
an odd number.)b. To adjust the Layer separation, tap the Minus and Plus buttons until you reach the desired
number (in microns). As described in the step above, you can also use the number pad to enter
the desired values directly.
5. Tap Apply Z-Stack Settings to start scanning the specified rack of slides.
After you tap Apply Z-Stack Settings, the Z-Stack icon

During scanning, the Z-Stack icon

appears on the rack position.

appears in Rack View to indicate the scanner is scanning this rackas z-stack images.

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View z-stack images
To view the 3-dimensional z-stack images, you must use a digital slide viewer that supports z-stack viewing.
For information on viewing z-stack images, refer to the Aperio ImageScope User’s Guide, or the user manualfor your viewer.

6. Set up Auto Narrow Stripe scanning on SAM
The Auto Narrow Stripe scanning feature helps mitigate potential image quality issues by enabling thescanner to automatically rescan a slide using an alternative scanning process, Auto Narrow Stripe scanning,when the system detects an excessive tilt of the slide tissue. Excessive slide tissue tilt can occur when the slide
does not sit level in the slide tray, or when tissue is not laid flat on the glass surface along the short axis (indexaxis) of the slide due to poor slide preparation.
This feature works with a tilt threshold that is defined in SAM. When Auto Narrow Stripe scanning is enabled in
SAM, the system evaluates every slide during the scanning process according to the tilt threshold. If the slide
exceeds the tilt threshold, the scanner automatically rescans the slide using Auto Narrow Stripe scanning.
Your Leica Biosystems Technical Services representative can adjust the tilt threshold value according to theneeds of your organization.
The Auto Narrow Stripe scanning feature is not available when scanning z-stack images.
Note that the total scan time increases when the scanner rescans one or more slides using
Auto Narrow Stripe scanning.
Your Leica Biosystems Technical Services representative can adjust the defined tilt threshold according to theneeds of your organization.
Follow the steps below to enable Auto Narrow Stripe on SAM:
1. Log on to SAM.
2. Confirm that the Scanners icon in the banner is selected, and the page shows the list of scanners. (Foran example, see Configure default Scan Settings in SAM on page 3.)
3. Click the Configuration icon to the right of the scanner.
4. Click Scan Settings in the side menu bar.

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5. On the Configure Scan Settings page, click Edit.

6. Click the ENABLE AUTO NARROW STRIPE button to turn on the Auto Narrow Stripe work flow feature.

7. To save your changes, click SAVE.

7. Aperio GT 450 optional DICOM upgrade
The Aperio GT 450 has the ability to output image files in either SVS or DICOM format. (The default is .SVS
image file format.) The optional DICOM feature is purchased and installed separately for each Aperio GT 450
scanner. You must use SAM to configure the final storage location for the DICOM images (PACS, IMS, or fileshare).
Before you can enable DICOM image output, your IT environment must meet the requirements detailed in the
Aperio DICOM Conformance Statement. Also, a Leica Biosystems Technical Services representative will needto log into SAM as a Leica Admin and enable Optional Features for the scanner you want to configure for
DICOM.
For information specific to configuring the Aperio GT 450 DICOM upgrade, including how to configure theAperio SAM for DICOM, see the Aperio GT 450 DICOM Upgrade Guide.

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Aperio GT 450 Release 1.3 Customer NoticeThis section includes updates to your Aperio GT 450 user manuals to support the new optional DICOM
upgrade.

Recommended network configuration
This section describes the recommended way to connect your Aperio GT 450 in your IT environment for
optimal performance. It includes details for those customers who are using the optional DICOM upgrade.
Figure 1: Recommended network configuration

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Aperio GT 450 Release 1.3 Customer Notice

Legend1 Image Data, TCP 2762, TLS

7 Events, HTTPS 44386, TLS

2 Image metadata, Port 44386, HTTPS

8 Configuration data

3 Configuration data, Port 44386, HTTPS

9 WebApp, HTTPS 443

4 Time synchronization, Port 123

10 Image metadata, HTTPS 44386

5 Event logs; Ports 6662, 6663

11 Image data; SMB3 (uses UDP 137, 138; TCP 139,445)

6 Log Data

12 Image data; TCP 2762 (stunnel optional)
Data Type
Image Data

DescriptionPort

By default, the Scanner sends DICOM image data to the DICOM converter. TCP 2762
The data is sent using TLS encryption.
Configure the communication between the scanner and the DICOM
converter using the Hostname and Port settings on the Images
configuration page.
By default, the DICOM converter sends the image data (either as aconverted SVS file, or as raw DICOM data) to the image and data
management system (IDMS) on the DSR Server. The data is sent using
SMB3 Encryption.

UDP 137,
138
TCP 139,
445

Configure the communication between the DICOM converter and the DSR
using the File Location setting on the Images page.
Alternatively, the scanner may send image data to the Sectra module,
bypassing the DICOM Converter. This option is only available when using
the Sectra Digital Pathology Module.
This connection is not encrypted by default. To secure this connection,
you can configure stunnel to create a secure communication tunnel
between Sectra and the scanner.
DICOM C-Store communication between the scanner and Sectra isconfigured on SAM DX.
Images can be sent to viewing stations connected to the DSR.

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TCP
2762-SSL(default)

47823(stunneldefault)
HTTP(S)
80/44314

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Data Type
Scanner
Configuration
Data

Description

Port

The scanner sends a call to the SAM DataServer to request configuration HTTPS
data. The SAM DataServer returns the configuration data to the scanner. 44386
The data is sent using TLS Encryption. Communication between thescanner and the SAM DataServer is configured on the scanner.
The SAM software stores the configuration data on the SQL Server
Database on the SAM Server.

TCP 1433

The SAM DataServer displays the configuration data through the SAM
web page.

HTTP(S)
80/443Time
Synchronization

Timeclock synchronization between SAM and multiple scanners ismaintained using network time protocol.

UDP 123

Image Metadata

When using Aperio eSlide Manager: The Scanner sends Image Metadata
to the SAM DataServer using TLS encryption. Communication between
the scanner and the SAM DataServer is configured on SAM. The SAM
DataServer sends image metadata to the IDMS location on the DSR.
Configure the communication between SAM DataServer using the
Hostname and Port settings on the SAM DSR page.

HTTPS
44386

When using Sectra Digital Pathology Module: Image Metadata isembedded directly in the DICOM images that are sent to the Sectra
module.
Log and Event
Data

The scanner sends logs and event data to the Mirth Connect Server. No
sensitive data is transferred.
Configure the communication between the scanner and the Mirth
Connect Server on the Event Handling configuration page.
The Mirth Connect Server copies critical event and error data to the SAM
DataServer, and then the SAM DataServer sends this data to the SQL
database. This is the data reported out via the SAM Event Logs.

TCP 6662,
6663

The SAM DataServer displays the event data through the SAM web page.

HTTPS
44386

The Mirth Connect Server processes the Log data and appends the EventLog, which resides on the file system. The communication between Mirthand the Event Log is configured within the Mirth Application setup. It is
not accessible through SAM.

HTTP(S)
80/443

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8. Specifications updates
The following specifications are new or updated with Aperio GT 450 release 1.3.

Scanner specifications
FeatureDetails

Scan output

SVS and DICOM1

Focusing system

Real-time automatic focusing (U.S. Patent 9841590B2).
Z-Stack Scanning: Automatic point focusing.

Class 1 laser

Laser compliance. This symbol indicates that the product is a Class 1 Laser
Product and is in compliance with international standards and US requirements.

Performance specifications
FeatureScanning resolution

Details
0.26 µm/pixel at 40x.
0.52 µm/pixel at 20x.

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 was evacuated against and complies to the following standards.

1To use the DICOM file format, this feature must be enabled for your scanner. See Aperio GT 450 DICOM

Upgrade document for details. Also, your IT environment must meet the requirements detailed in the Aperio
DICOM Conformance Statement. Note that the DICOM feature is not compatible with 20x magnification
scanning, Z-stack scanning, or Auto Narrow Stripe scanning features.
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FeatureDetails

SafetyIEC 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
Electromagnetic
Compatibility (EMC)

EMC 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

Machinery andMaterials

IEC 60825-1:2014 (Class 1 Laser)
2011/65/EU - Restriction of the use of certain hazardous
substances in electrical and electronic equipment (RoHS 2)
2015/863 - Restriction of the use of certain hazardous
substances in electrical and electronic equipment (RoHS 3)
2006/42/EC - Machinery Directive
2014/35/EU – Low Voltage Directive

Safety noticeslThis device is intended for indoor use only.

l

Safety protection may be impaired if used in a manner not specified by the manufacturer.

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Notices
CN-0001, Revision A | October 2023
This manual applies to Aperio GT 450 Controller, Aperio GT 450 Console, and Aperio GT 450 SAM versions 1.3 and later.
Original Instructions.

Copyright Noticell

Copyright © 2023 Leica Biosystems Imaging, Inc. All Rights Reserved. LEICA and the Leica logo are registered trademarksof Leica Microsystems IR GmbH. , GT, and GT 450 are trademarks of Leica Biosystems Imaging, Inc. in the USA andoptionally in other countries. Other logos, products, and/or company names might be trademarks of their respective
owners.
This product is protected by registered patents. For a list of patents, contact Leica Biosystems.

Customer Resourcesl

For the latest information on Leica Biosystems products and services, please visit LeicaBiosystems.com/Aperio.

Contact Information – Leica Biosystems Imaging, Inc.
Headquarters
Leica Biosystems Imaging, Inc.
1360 Park Center Drive
Vista, CA 92081
USA
Tel: +1 (866) 478-4111 (toll free)Direct International Tel:
+1 (760) 539-1100

Customer Support
Contact your local support representative with any query andservice request.
https://www.leicabiosystems.com/contact-us/

For research use only. Not for use in diagnostic procedures.

815477020228, 815477020464, 815477020471, 815477020563
23GT450, 23GT450SAM, 23GT450SAMSW, 23GT450ZSTACKSW

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Symbols
The following symbols appear on your product label or in this user guide:
SymbolRegulation/Standard

Description

ISO 15223-1 - 5.4.3

Consult instructions for use

ISO 15223-1 - 5.1.1

Manufacturer

ISO 15223-1 - 5.1.3

Date of manufacture

ISO 15223-1 - 5.1.7

Serial number

ISO 15223-1 – 5.1.6

Catalog number

ISO 15223-1 – 5.7.10

Unique Device Identifier

Machinery Directive
2006/42/EC

Device carries the CE (Conformitè Europëenne) Markand fulfils the requirements of Machinery Directive
2006/42/EC and additional EU Directives, as shown on
page 17.

ISO 15223-1 - 5.4.4

CautionSO 7010 – W001

General warning

IEC 61010-1

TÜV Product Services have certified that the listed
products comply with both U.S. and Canadian safety
requirements.

IEC 60417 - 5031

This device is suitable for direct current only.

IEC 60417 - 5007

On. To indicate connection to the mains, at least formains switches or their positions, and those cases
where safety is involved.

IEC 60417 - 5008

Off. To indicate disconnection from the mains, at least
for mains switches, and all those cases where safety is
involved.

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Symbol

Regulation/Standard

Description

ISO 15523-1 5.7.3

Temperature limitation

ISO 15223-1 5.3.8

Humidity limitation

2012/19/EU

Device is regulated under 2012/19/EU (WEEE Directive)
for Electrical and Electronic Equipment Waste and must
be discarded under special conditions.

People’s Republic of China
Electronic Industry Standard
SJ/T11364

Device contains certain toxic or hazardous elements
and can be used safely during its environmental
protection use period. The number in the middle of thelogo indicates the environmental protection use period(in years) for the product. The outer circle indicates that
this product can be recycled.

National Standard of thePeople’s Republic of China
Requirements ofconcentration limits forcertain restricted substancesin electrical and electronic
products GB/T 26572-201

Device contains certain toxic or hazardous elements
and can be used safely during its environmental
protection use period. The "e" inside circle indicatesproduct is compliant with Requirements ofconcentration limits for certain substances in electricaland electronic products GB/T 26572-2011. The outercircle indicates that the product can be recycled.

IEC 60825-1

Device is a Class 1 Laser Product that is in compliancewith international standards and US requirements.

CA Proposition 65

This product can expose you to chemicals known to theState of California to cause Cancer and Reproductive
Harm. For more information go tohttps://www.P65Warnings.ca.gov.

N/A

Device is made in the USA of U.S. and foreigncomponents.

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