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Operator Manual - Carbon Clinicals VA31A SAPEDM P02-001-CC.621.05.01.02 OM SyngoCarbonClinicals VA31

The Syngo Carbon Clinicals Operator Manual provides comprehensive guidance on using the software for medical data processing and clinical management. It includes sections on documentation access, intended use, safety advisories, and user profiles, as well as troubleshooting and operational instructions. The manual emphasizes the importance of IT security and provides integration scenarios with compatible products.

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kaladdino
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0% found this document useful (0 votes)
47 views46 pages

Operator Manual - Carbon Clinicals VA31A SAPEDM P02-001-CC.621.05.01.02 OM SyngoCarbonClinicals VA31

The Syngo Carbon Clinicals Operator Manual provides comprehensive guidance on using the software for medical data processing and clinical management. It includes sections on documentation access, intended use, safety advisories, and user profiles, as well as troubleshooting and operational instructions. The manual emphasizes the importance of IT security and provides integration scenarios with compatible products.

Uploaded by

kaladdino
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 46

Syngo Carbon

Clinicals
Operator Manual
VA31

siemens-healthineers.com
Legend

Legend
Indicates a hint
Is used to provide information on how to avoid operating errors or informa‐
tion emphasizing important details

Indicates the solution of a problem


Is used to provide troubleshooting information or answers to frequently
asked questions

Indicates a list item

Indicates a prerequisite
Is used for a condition that has to be fulfilled before starting a particular oper‐
ation

Indicates a one-step operation

Indicates steps within operating sequences

Italic Is used for references and for table or figure titles

Is used to identify a link to related information as well as previous or


next steps

Bold Is used to identify window titles, menu items, function names, buttons, and
keys, for example, the Save button
Is used for on-screen output of the system including code-related elements
or commands

Orange Is used to emphasize particularly important sections of the text

Courier Is used to identify inputs you need to provide

Menu > Menu Item Is used for the navigation to a certain submenu entry

<variable> Is used to identify variables or parameters, for example, within a string

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Legend

CAUTION
&$87,21
Used with the safety alert symbol, indicates a hazardous situation which, if
not avoided, could result in minor or moderate injury or material damage.
CAUTION consists of the following elements:
• Information about the nature of a hazardous situation
• Consequences of not avoiding a hazardous situation
• Methods of avoiding a hazardous situation

WARNING
:$51,1*
Indicates a hazardous situation which, if not avoided, could result in death or
serious injury.
WARNING consists of the following elements:
• Information about the nature of a hazardous situation
• Consequences of not avoiding a hazardous situation
• Methods of avoiding a hazardous situation

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Table of contents

1 Introduction 6
1.1 Documentation overview 6
1.1.1 Accessing the user documentation 6
1.1.2 Requesting printed user documentation 7
1.1.3 Supported user interface languages 8
1.2 Intended purpose / Intended use 9
1.2.1 Intended purpose 9
1.2.2 Intended use 9
1.2.3 Indications for use 9
1.2.4 Contraindications 9
1.2.5 Patient target group 10
1.3 IT security information 10
1.4 Clinical benefits and claims 10
1.5 Integration scenarios and interoperability 11
1.6 Incident reporting 11
1.7 User profiles 11
1.8 Legal notes 12
1.9 Hardware and software requirements 13
1.10 Open-source software 13
1.11 Comments and suggestions 14

2 Safety advisory 15
2.1 Image evaluation 15
2.2 Oncological evaluation tools 16
2.3 Calibration 17
2.4 Display types 17
2.5 Antivirus software 18
2.6 Measurement accuracy 18
2.6.1 Two-step approach 19
2.6.2 Measurement tools with subpixel accuracy 21
2.6.3 Measurement tools with original image pixel accuracy 21

3 Functional scope of Syngo Carbon Clinicals 23

4 Using Cinematic Insight templates 25

5 Using the Assisted Perpendicular tool to measure diameters 26

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Table of contents

6 Performing lesion quantification 28


6.1 Lesion properties window 30
6.2 Editing lesions 31
6.3 Performing follow-up evaluations with lesion quantification 32

7 Displaying lung nodule markers 34


7.1 Lesion properties window 36
7.2 Comparing lung nodule markers of multiple time points 38
7.3 Editing lesions 39
7.4 Configuring the LungCAD tool 39
7.5 Information about the lens view 41

8 Performing manual calibration 42

9 Glossary 44

Index 45

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1 Introduction

1 Introduction
The Syngo Carbon Clinicals provides a set of postprocessing and evaluation
tools, which covers different kinds of clinical questions and requirements.

You can use the Syngo Carbon Clinicals with compatible hosting products.

At Siemens Healthineers, we want to address all genders equally in our


Instructions for Use. It is not our intention to exclude anyone. We continue to
update our documentation with this in mind.

1.1 Documentation overview


The Syngo Carbon Clinicals software is accompanied by the Syngo Carbon
Clinicals Operator Manual.

You can access the Operator Manual directly in the software by clicking
the Help icon in the access bar and choosing Help from the menu of the
hosting application.

At Siemens Healthineers, we want to address all genders equally in our


Instructions for Use. It is not our intention to exclude anyone. We continue to
update our documentation with this in mind.

1.1.1 Accessing the user documentation


All operator manuals are available in electronic form on the Internet.

You will find them here:

https://doclib.siemens-healthineers.com/home

1 Before you start searching for the required operator manual, you can select
your Country and your preferred Language.

2 In the search bar of the document library, you can, for example, simply
enter “Syngo Carbon Clinicals”.

The available documentation is listed.

If required, you can narrow down the search results by choosing the
appropriate filter criteria in the navigation area.

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1 Introduction

For example, if you are looking for a specific software version, select
Products > Syngo > Syngo Carbon Clinicals and navigate to the required
software version.

The available documentation is displayed according to your selection.

1.1.2 Requesting printed user documentation


You can request printed documentation for your medical device in teamplay
Fleet. One printed copy may be free of charge, depending on the law in your
country. For example, if you are a customer inside the European Union.

✓ You are registered on the teamplay Fleet platform.

1 Enter the following URL into a web browser with Internet access:
https://fleet.siemens-healthineers.com/

2 Enter your login data.


teamplay Fleet opens.

For further information about your teamplay Fleet account, contact your
Siemens Healthineers representative.

3 Click Equipment and select your medical device from the list.

The contents area shows information about your device, and adds a new
navigation bar on top.

4 At this navigation bar, click Documents.

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1 Introduction

Steps to order

5 Click syngo Information.

6 In case, a version tree is presented, select the software version, and then
click the Request for Printed User Documents button.
7 Enter the delivery address and click Submit.

You will receive a confirmation email.

1.1.3 Supported user interface languages


Syngo Carbon Clinicals supports the following user interface languages:

• English

• German

• French

• Spanish

• Japanese

• Chinese (simplified)

If the Online Help is not available in your language, the Online Help as well as
the tooltips are displayed in English.

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1 Introduction

To use Syngo Carbon Clinicals, you must be fluent in the language used in the
user interface and in the Instructions for Use.

1.2 Intended purpose / Intended use

1.2.1 Intended purpose


Intended Purpose Statement under the European Medical Device
Regulation 2017/745:

Software solutions intended to process, communicate, display, read, and


archive medical data for informing and driving clinical management.

1.2.2 Intended use


Syngo Carbon Clinicals is intended to provide advanced visualization tools
to prepare and process the medical image for evaluation, manipulation and
communication of clinical data that was acquired by the medical imaging
modalities (for example, CT, MR, etc.).

1.2.3 Indications for use


The software package is designed to support technicians and physicians in
qualitative and quantative measurements and in the analysis of clinical data
that was acquired by medical imaging modalities.

An interface shall enable the connection between the Syngo Carbon Clinicals
software package and the interconnected software solution for viewing,
manipulation, communication, and storage of medical images.

1.2.4 Contraindications
Syngo Carbon Clinicals is not indicated for mammography images for diagnosis
in the U.S.

Syngo Carbon Clinicals is not to be used as a sole basis for clinical decisions.

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1 Introduction

1.2.5 Patient target group


Syngo Carbon Clinicals has neither limitations concerning the patient
population (e.g. age, weight, health, condition) nor limitations concerning
region of body or tissue type.

1.3 IT security information


To learn more about the security of your Syngo Carbon Clinicals medical
device and to obtain the Manufacturer Disclosure Statement for Medical Device
Security (MDS), contact your Siemens Healthineers representative and ask for
the document entitled Security Whitepaper and MDS2.

Consider that for the Syngo Carbon Clinicals medical device, the security
measures described in the Security Whitepaper of the hosting product (such as
syngo.via) are applicable.

1.4 Clinical benefits and claims


Syngo Carbon Clinicals provides the clinical benefits to facilitate performing
diagnosis with a wide range of tools from the major clinical fields supporting
multi-modality imaging with state-of-the art to innovative clinical tools for
routine to advanced cases.

Typical user scenarios are:

• Preparing the radiologist's reading workflow on a dedicated workplace or


workstation by generating additional results or renderings according to
his/her needs (e.g. cinematic rendering).

The following clinical claims are made:

• Syngo Carbon Clinicals offers a wide range of tools from the major clinical
fields, i.e. general radiology, oncology.

• Syngo Carbon Clinicals offers state-of-the art to innovative clinical tools for
advanced cases.

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1 Introduction

1.5 Integration scenarios and interoperability


The Syngo Carbon Clinicals are able to run on compatible software solutions,
for example, syngo.via, syngo.via View&GO.

1.6 Incident reporting


Any serious incident that has occurred in relation to the device must be
reported to the manufacturer and the competent authority of the member
state in which the user and/or patient is established.

1.7 User profiles


The following profiles may vary in practice depending on the (hospital)
organization, qualification, and personal responsibilities, and can only be
considered as a general guide.

The following user roles and profiles have been identified for Syngo
Carbon Clinicals:

Technologist (Radiographer)

• Role

– Quality assurance of the images

– Preparation of images for reading, such as manipulation of size, position,


or windowing values

– Creation of preliminary markers or measurements

– Generation of additional result series, for example, parallel ranges

– Sending data for archiving

• Knowledge and experience

– Vocational high school

– Radiation technologist training

– Work experience

– Product training certificate or comparable product experience

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1 Introduction

Radiologist

• Role 1 (for example, residents)

– Performing the imaging examination

– Exporting of patient images

– Completing but not verifying reports

– Intervention, responsible for the safety of patients and employees

– Sending data for archiving

• Role 2 (for example, attending physicians)

– Tasks of Role 1 listed above

– Justifying indication (medical check)

– Verifying reports

• Knowledge and experience

– Doctor of Medicine (MD)

– Specialist for radiology

– Work experience

– Product training certificate or comparable product experience

1.8 Legal notes


This document is confidential, proprietary to Siemens Healthineers, protected
by copyright laws in the U.S. and abroad, and licensed for use by customers only
in strict accordance with the license agreement governing its use.

Any reports or other figures that appear in this document are merely illustrative
and do not contain names or data of real people.
Any similarity with names of people, living or dead, or in data is strictly
coincidental and is expressly disclaimed.

Siemens Healthineers does not warrant that the material contained in its
documentation is error-free.

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1 Introduction

Documentation supplied to Siemens Healthineers by third parties and included


with this documentation is not warranted for accuracy or completeness.
The information contained in this document is subject to change. Revisions
and updates will be issued from time to time to document changes
and/or additions.

1.9 Hardware and software requirements


Syngo Carbon Clinicals is a set of plug-ins that can be interfaced with
compatible products (for example, syngo.via). Therefore, you may have to refer
to the data sheet of the respective product to find the minimum requirements
concerning the hardware and IT network characteristics that are necessary to
run the software as intended.

Protect your system against unauthorized access and malware attacks.

1.10 Open-source software


The product contains, among other things, open-source software developed by
third parties.

The open-source software used in the product and the license agreements
concerning this software can be found in the ReadMeOSS. These open-source
software files are protected by copyright. Your compliance with those license
conditions will entitle you to use the open-source software as foreseen in the
relevant license.

In the event of conflicts between Siemens Healthineers license conditions


and the open-source software license conditions, the open-source software
conditions shall prevail with respect to the open-source software portions of
the software. The open-source software is licensed royalty-free.

Insofar as the applicable open-source software license conditions provided for


this, you can order the source code of the open-source software from your
Siemens Healthineers sales contact – against payment of the shipping and
handling charges – for a period of at least 3 years after purchase of the product.

We are liable for the product including the open-source software contained in
it pursuant to the license conditions applicable to the product. Any liability for
the open-source software beyond the program flow intended for the product
is explicitly excluded.

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1 Introduction

Furthermore, any liability for defects resulting from modifications to the


open-source software by you or third parties is excluded.

We do not provide any technical support for the product if it has been modified.

1.11 Comments and suggestions


We hope that this documentation gives you the support you need. The
documentation is regularly updated along with the software development, and
your comments will be taken into account to improve the documentation.

Please address your comments or suggestions to your local Siemens


Healthineers representative.

We look forward to receiving your feedback.

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2 Safety advisory

2 Safety advisory
The following cautions are valid for Syngo Carbon Clinicals. Consider also the
safety advisories of the hosting products.

General advice for the USA.

For the USA, please note the following:

• Monitors should not be used for diagnosis unless the used monitor
(printer) has specifically received 510(k) clearance for this purpose.

• Paper printouts should not be used for diagnosis unless the used Post
Script printer has specifically received 510(k) clearance for this purpose

Please inform us if you encounter any serious problems during your work
with Syngo Carbon Clinicals.

To do this, go to the following web page and choose your region/country:

https://www.siemens-healthineers.com/services/customer-services

There, you will find the relevant options for contacting us.

The competent authority for your country must also be informed about any
serious problems.

2.1 Image evaluation

CAUTION

Syngo Carbon Clinicals has not been approved for diagnostic reading of
mammography images in the United States.

Diagnosis may be wrong.

◆ Use a device that is intended for diagnostic reading of mammography


images in the United States.

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2 Safety advisory

CAUTION

Diagnostic reading of medical images may not be correct in


all circumstances.

The diagnosis, made by just reading images, may not be sufficient.

◆ When making a therapy decision, do not just rely on the image reading
supported by Syngo Carbon Clinicals, but also consider other evidence.

2.2 Oncological evaluation tools

CAUTION

RECIST or WHO measurements are performed on CT images with a


non-axial orientation and therefore do not comply with the RECIST or
WHO standards.

Wrong basis for diagnosis.


◆ Only perform RECIST or WHO measurements on CT images with
axial orientation.

CAUTION

Lesion size and volume estimation by the algorithm may not be accurate
due to non-negligible error in segmentation.
Wrong diagnosis basis.
◆ Verify that the automatically generated lesion segmentation matches
the anatomic area of interest before using the results as a reference for
clinical decision.
◆ Make use of the Correction Pen option to manually adapt the
segmentation when needed.

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2 Safety advisory

CAUTION

If the filter for Solid nodules only is applied in the LungCAD


Configuration window, not all identified CAD markers may be displayed.

Wrong diagnosis since not all identified CAD markers will


be reviewed.
◆ By default, all identified CAD markers are displayed.
◆ A filtered view is indicated by a filter icon in the upper-left corner of the
LungCAD mini toolbar.

2.3 Calibration

CAUTION

In order to use evaluation tools on DICOM images without pixel spacing


information, you might have to perform manual calibration on the
available projection images.

Incorrect diagnosis due to incorrect manual calibration.


◆ Always perform manual calibration with great care using objects of
known size as reference.
◆ Consider that even after the images have been calibrated, the obtained
measurement results might not correspond to the real values.

2.4 Display types

CAUTION

Incorrect or incomplete segmentation objects due to


algorithm inaccuracy.

Incorrect basis for diagnosis.

◆ Use 2D/MPR CT image slices as basis for diagnosis.

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2 Safety advisory

2.5 Antivirus software

CAUTION

Antivirus software has not been installed or updated.

Malicious software can damage the system and cause all patient
data to be lost.

◆ The administrator is responsible for configuring the anti-virus


software. Configure and update your anti-virus software regularly.

It is recommended that you install anti-virus software tested by


Siemens Healthineers.

2.6 Measurement accuracy


The following chapter describes what users should know in order to correctly
interpret the results of measurement tools and what they have to do in order
to achieve high measurement accuracy.

Consider that this medical reading software does not measure in the
conventional sense. The actual measurement was already performed during
image acquisition at the scanner.

The provided measurement tools actually count the number (and fractions in
the case of subpixel accuracy) of original image pixels and with the help of
attributes such as pixel size and pixel spacing convert them to the resulting
physical quantity.

Please note that some of the described tools and measurement methods
might not apply to the product in question.

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2 Safety advisory

CAUTION

The measurement results may not reflect the exact situation because the
evaluation results are inaccurate.

Wrong interpretation of the patient situation, wrong diagnosis due


to inaccurate measurement results.
◆ Correct geometric measurement depends on the windowing setting
that you have applied and the geometric object that you have drawn.
◆ Correct volumetric measurement and density values greatly depend
on the segmentation performed by you or by an automatic algorithm.
◆ If one of these inputs is not correct, the measurement result will be
incorrect, and diagnosis will be wrong.

For more information on accuracy limitations for measurements, see


the “Measurement accuracy” chapter in this Operator Manual.

2.6.1 Two-step approach


All measurements performed with tools provided with this software follow a
two‐step approach:

• Creation of an object: First the user (or an algorithm) marks specific


anatomy by drawing a geometric object or by segmenting an area in the pixel
data to identify the anatomic structure that the user is interested in.

• Evaluation of an object: Then the physical quantities of this geometric


object or the segmented area are evaluated and shown to the user.

Creation of an object During the creation of an object, different levels of measurement accuracy
are considered:

• Subpixel accuracy

The geometric object is defined with an accuracy higher than the original
image pixel size.

Distance Line, Angle and ROI circle provide this accuracy.

If a geometric object is drawn with these tools, points of the geometric


object may be located in fractions of original image pixels, providing a higher
accuracy than one may expect with original image pixel size.

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2 Safety advisory

• Original image pixel accuracy

The measurements based on segmentations and/or thresholds have the


accuracy of the original image pixel size.

Tools like VOI‐Sphere, VOI Freehand, VOI‐Isocontour, Region Growing or


algorithm-based segmentations provide this accuracy.

If an object is drawn with one of these tools, the contour of the


segmentation object snaps to the grid provided by the DICOM image data.
It is not possible to achieve a higher accuracy than the size of the original
image pixel.

Evaluation of an object The evaluation of the created object is performed with the utmost accuracy.

The properties of the geometric object or the segmentation object are


evaluated without any error. They are merely calculated from their position
in the array of original image pixels with attributes such as pixel size and
pixel spacing.

This leads to the following consequences:

• Accuracy of evaluation

The evaluated physical quantities of each physical object are exactly


compared with the geometric object or segmentation object that the user
(or an algorithm) has drawn.

• Accuracy of geometric object or segmentation object


The alignment of the geometric object or the segmentation object with
the anatomic structure and the quality with which it matches the anatomic
structure of interest, are the only parameters that define the accuracy of the
measurement (except process of image scanning itself).

Because of the second consequence mentioned above, the only question


that has to be considered in determining the accuracy of a measurement is
the following:

How well does the geometric object or the segmentation object drawn
by the user (or an algorithm) match the anatomic structure of interest?

For all measurement tools that provide subpixel accuracy, the user is usually
able to create a geometric object or segmentation object that is suitable for
subsequent evaluations.

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2 Safety advisory

But it may be more difficult to segment the object that best matches the
anatomic structure of interest with measurement tools that are limited to
original image pixel accuracy. And even then, some limitation in accuracy may
still need to be taken into account.

In the following, we provide hints for assessing the original image


pixel accuracy, detecting misalignments and arriving at the optimum
measurement result.

2.6.2 Measurement tools with subpixel accuracy


The quantities length, angle, area etc. obtained from 2D measurement
tools (like Distance Line, Angle, ROI circle, etc.) are calculated with
subpixel accuracy.

Therefore, it makes sense to zoom the image so that the start- and end points
of the object to be measured are reasonably visible in the segment.

Even so, an error of the size of two screen pixels may be tolerated. This is
expected due to limitations when drawing the start- and end point.

Detecting and resolving measurement errors

• Compare the start- and end point of the distance line with the structure to
be measured.

Check that the distance line and the underlying structure are aligned.

• A reasonable zoom will increase the accuracy of measurement because it


will help the user to align the anatomy perfectly.

Switch to a layout with fewer segments or even just one segment to achieve
at least acquisition size zoom level or even further increase the zoom level
to reduce possible errors.

Adapt windowing as necessary to make the tissue of interest visible.

2.6.3 Measurement tools with original image pixel accuracy


Quantity volume and density values obtained from 3D measurement tools
(such as VOI tools, Region Growing, etc.) are calculated based on image pixels.

All image pixels that are touched by the segmented structure, are taken into
account for this measurement.

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2 Safety advisory

The relative error increases with the amount of pixels, by which the segmented
object exceeds the anatomical structure in number of image pixels.

Therefore, a tight approximation of the segmented object to the anatomical


structure is extremely important.

The relative error rapidly decreases with the true size of the anatomical
structure to be measured, which needs to be taken into account for subsequent
therapy decisions.

Detecting and resolving measurement errors

• Zoom the image up to acquisition size. It is not necessary to zoom the image
further as the VOI tool bases its calculation on original image pixels.

Compare the highlighted area of the segmentation object with the actual
anatomical structure to be measured that both are sufficiently aligned.

If you selected the VOI tool from the Anatomy Visualizer, you can use
additional tools such as Nudge or Region Growing to better align the
segmentation object with the anatomical structure.

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3 Functional scope of Syngo Carbon Clinicals

3 Functional scope of Syngo


Carbon Clinicals
The Syngo Carbon Clinicals provide the tools listed below.

These tools are available in the Tool Gallery of your reading application, for
example, MM Reading.

Rendering tools

Displays a fully rendered volume


When you apply Cinematic Insight, the recom‐
mended cinematic VRT preset for the currently dis‐
Cinematic Insight
played anatomy is automatically applied during the
rendering process.
( Page 25 Using Cinematic Insight templates)

Calibration tools

Used to calibrate X-ray images that do not contain


the required pixel spacing information.
X-ray images without pixel spacing information
Manual Calibration
must be calibrated before automatic measurements
can be performed. The manual distance and area
measurements that show "???" will update the val‐
ues after the calibration.
( Page 42 Performing manual calibration)

Oncological evaluation

Allows you to draw perpendicular distance lines to


perform diameter measurements and to support in
evaluating lesions.
Assisted Perpendic‐
( Page 26 Using the Assisted Perpendicular tool to
ular
measure diameters)

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3 Functional scope of Syngo Carbon Clinicals

Allows you to perform diameter measurements


(longest diameter, perpendicular diameter) and to
create segmentation objects of suspect lesions in
Lesion Quantifica‐ lung parenchyma with one click.
tion
With this tool you can also measure and compare
lesion diameters of two different time points.
If more than one prior time point is available, the
tool also allows you to select the time point that you
will use as the basis for comparison.
( Page 28 Performing lesion quantification)

Marks suspect lung tissue


Allows you to review lung nodule markers proposed
by the system. In the Lung CAD mini toolbar, you
Lung CAD can navigate through these markers, create findings
from the markers, or reject markers
The tool also allows you to select a prior time point
(if available) to perform change quantification.
( Displaying lung nodule markers)

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4 Using Cinematic Insight templates

4 Using Cinematic Insight


templates
With Cinematic Insight, the optimum VRT template can be applied to a
selected body region or tissue in CT images.

The templates contain the respective organ segmentation settings as well as


the optimum preset and view direction.

CAUTION

Incorrect or incomplete segmentation objects due to


algorithm inaccuracy.

Incorrect basis for diagnosis.


◆ Use 2D/MPR CT image slices as basis for diagnosis.

✓ The display type VRT or cVRT is applied.

1 In a VRT segment, choose Cinematic Insight from the bottom-right


corner menu.

The Cinematic Insight template dialog box opens.

2 Select a template for the required body region or tissue.

Once you have applied the template, a segmentation object of the selected
anatomy is created. In addition, the optimum preset and view direction is
applied to the segmentation object.

You can repeat this step and create further segmentation objects for
different kinds of body regions or tissue.

When you select the Objects tab in the Cinematic Insight presets dialog
box, you can show or hide particular objects within the previously created
segmentation objects and thus create a scenery according to your wishes.

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5 Using the Assisted Perpendicular tool to measure diameters

5 Using the Assisted


Perpendicular tool to
measure diameters
The Assisted Perpendicular tool allows you to perform diameter
measurements, for example, to determine changes in the anatomical structure
in follow-up evaluations.

With this multimodality tool, you can draw two orthogonal lines and calculate
the average diameter and the area. The Assisted Perpendicular tool ensures
that the drawn lines are positioned orthogonally to each other.

✓ One of the following display types is applied: 2D, MPR, MPR Thick, MIP Thin,
MinIP Thin, or MPR/MPR

1 In the Tool Gallery, click the Assisted Perpendicular icon.

The mouse pointer changes shape.

2 To create a diameter measurement, draw two orthogonal lines.


After you have drawn the first line, the second line can only be drawn
orthogonally to the first line.

The evaluation result is displayed next to the measurement.

A finding is automatically created.

You can edit the measurement object after you have drawn it.

• To rotate the measurement object, drag one of the handles on the


outside. (1)

The rotation axis is on the opposite side.

• To move the measurement object to another position, click the


measurement object (but not the handle) and drag it to the
required position.

• To move an individual line, drag the handle at the center of the line and
move it to the required position. (2)

• To change the length of a line, drag the handles on the outside. (3)

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5 Using the Assisted Perpendicular tool to measure diameters

You can also deactivate orthogonal drawing by pressing the Shift key while
you draw the distance lines.

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6 Performing lesion quantification

6 Performing lesion
quantification
The Lesion Quantification tool allows you to measure and quantify lesions in
lung parenchyma semiautomatically.

With this tool, you can create volume and diameter measurements with just
one click. As a result, a 3D segmentation object is created.
The tool also allows you to perform follow-up evaluation and so
determine changes in the anatomical structure across different time points.
( Page 32 Performing follow-up evaluations with lesion quantification)

CAUTION

RECIST or WHO measurements are performed on CT images with a


non-axial orientation and therefore do not comply with the RECIST or
WHO standards.

Wrong basis for diagnosis.


◆ Only perform RECIST or WHO measurements on CT images with
axial orientation.

CAUTION

Lesion size and volume estimation by the algorithm may not be accurate
due to non-negligible error in segmentation.

Wrong diagnosis basis.


◆ Verify that the automatically generated lesion segmentation matches
the anatomic area of interest before using the results as a reference for
clinical decision.
◆ Make use of the Correction Pen option to manually adapt the
segmentation when needed.

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6 Performing lesion quantification

The lesion segmentation algorithm carries non-negligible error and may


potentially cause some deviations in diagnosis. To reduce the impact of the
error on diagnosis, we recommend using the reader expertise in clinical
decision-making process. If needed, we suggest using the Correction Pen
option to adjust the lesion segmentation results. The 95% confidence
interval of the algorithm output for volumetric calculations is determined to
be +/- 37% in the Phantoms.

Calculations that are based on the lung lesion segmentation do not include
voxels with partial volume effects. This may result in HU statistics not being
calculated for certain lung lesions. In this case, NaN is displayed in the
evaluation results.

✓ You have loaded a CT data set into the image area.

✓ One of the following display types is applied: MPR, MPR Thick, MIP Thin,
MinIP Thin

1 In the Tool Gallery, click the Lesion Quantification icon.

The mouse pointer changes shape.

2 To perform a lesion quantification, click the lesion in question.

– or –

In case of lesions larger than 40 mm or ground-glass nodules, you can also


draw a line across the lesion.

A 3D segmentation object is created, and the diameter and the volume of


the lesion are calculated. The diameter measurement indicates the longest
diameter in axial orientation within the segmented volume.

The evaluation results of the measured diameter and the size of the
volume are displayed next to the measurement. ( Page 30 Lesion
properties window)

A finding is automatically created.

When you right-click the measurement, you can choose the segmentation
object to edit it. ( Page 31 Editing lesions)

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6 Performing lesion quantification

6.1 Lesion properties window


In the Lesion Properties dialog box, you can specify the values that will be
displayed next to the segmented lesion.

The Lesion Properties dialog box is available for the Lesion Quantification
tool and the LungCAD tool.

1 Right-click the Lesion Quantification icon in the Tool Gallery and choose
Lesion Properties from the context menu.

– or –

Right-click the LungCAD icon in the Tool Gallery and choose Lesion
Properties from the context menu.

The Lesion Properties dialog box opens.

2 Select the check boxes that correspond to the evaluation result that you
want displayed:

Diameter: Maximum diameter of the lesion measured in the axial plane

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6 Performing lesion quantification

Max. Orth.Diam: Maximum diameter measured orthogonal to


the diameter

Max. 3D Diam.: Maximum (3D) diameter of the lesion quantification

Mean Diameter: Mean value of the diameter and the maximum


orthogonal diameter

WHO Area: WHO area of the measured lesion

Volume: Volume of the lesion

Min/Max HU: The minimum and maximum HU value in the


measured lesion

Mean/SD: The mean value and the standard deviation of the HU values in
the measured lesion

VDT: Volume doubling time (only relevant for follow-up evaluations)

3 Click OK to confirm.

The settings are applied to subsequently segmented lesions.

6.2 Editing lesions


If required, you can subsequently edit the automatically segmented lesion.

◆ To edit part of the segmented lesion, right-click the contour and choose
Correction Pen from the context menu and redraw the part of the volume
that you want to add or remove.

If you mark tissue outside the volume, it will be added to the


segmented lesion.

If you mark tissue inside the volume, it will be removed from the
segmented lesion.

The correction is applied to all slices of the volume.

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6 Performing lesion quantification

6.3 Performing follow-up evaluations with lesion


quantification
The Lesion Quantification tool allows you to perform diameter measurements
in studies of different time points, which means that you compare the current
study with a selected prior study.

Once you have measured a lesion in the current study, the algorithm searches
for the corresponding matching lesion in the prior study. The longitudinal
assessment of both lesions is automatically computed and displayed next to
the measurement so that you can compare the anatomical structure of both
time points.
✓ You have loaded two or more CT data sets (of different time points) into the
image area.

✓ A follow-up layout has been selected.

✓ One of the following display types is applied to all segments: MPR, MPR
Thick, MIP Thin, MinIP Thin

1 In the Tool Gallery, click the Lesion Quantification icon.

The mouse pointer changes shape.

A mini toolbar is displayed in the image segment.

2 Click the required lesion in the current study.


A segmentation object is created and the matching lesion is displayed in the
prior study.

The evaluation results of the measured diameter, the size of the volume,
and the volume doubling time are displayed next to the measurement.
( Page 30 Lesion properties window)

Furthermore, the time point of the prior study with which the study was
compared is indicated.

Findings for both the current and the prior measurement are automatically
created. If required, you can merge both findings into one follow-up finding.

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6 Performing lesion quantification

If several prior time points are displayed in the image segments, you can
choose the time point from which you want to start the comparison.
3 In the mini toolbar, click the Select Prior icon and choose the required prior
time point from the list.

The displayed results are updated accordingly.

When you right-click the measurement, you can choose the segmentation
object to edit it. ( Page 31 Editing lesions)

Additional hints for Lesion Quantification for follow-up evaluation:

• If you load a prior study that already has findings and you start measuring
the lesions in the current study, the algorithm first searches in the findings
of the prior study for matching lesions.

• If you measure the same lesion twice, for example, because of subsolid
nodules, a warning message is displayed asking you if you want to replace
the existing measurement or if you want to add the new measurement as
a new finding.

• For subsolid or part-solid nodules, you can perform the diameter


measurement as follows:

Draw a line across the ground-glass nodule part.

Then click the solid part of the lesion to segment the solid portions of
the nodule.

As a result, two findings are created, which you can then merge into
one finding.

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7 Displaying lung nodule markers

7 Displaying lung nodule


markers
You use the LungCAD tool to evaluate lung parenchyma for suspect
lesions (nodules).

An underlying algorithm detects potential nodules and makes them available


in the LungCAD mini toolbar for clinical review.
You can also perform an evaluation with the LungCAD tool across different
time points. ( Page 38 Comparing lung nodule markers of multiple
time points)

In addition to this description, also consider the information given in the


syngo.CT Lung CAD Operator Manual.

CAUTION

If the filter for Solid nodules only is applied in the LungCAD


Configuration window, not all identified CAD markers may be displayed.

Wrong diagnosis since not all identified CAD markers will


be reviewed.

◆ By default, all identified CAD markers are displayed.


◆ A filtered view is indicated by a filter icon in the upper-left corner of the
LungCAD mini toolbar.

1 In the image area, select a segment.

2 In the Tool Gallery, click the LungCAD icon.

The LungCAD mini toolbar is displayed at the bottom of the segment and
the LungCAD algorithm starts processing.

Once processing is complete and the algorithm has detected potential


nodules, the corresponding CAD marks are available in the mini toolbar
for review.

A segmentation object is created for each detected nodule, and the


diameter and the volume of the lesion are calculated automatically.

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7 Displaying lung nodule markers

These evaluation results are displayed next to the segmentation object.


If required, you can specify the values that should be displayed.
( Page 36 Lesion properties window)

If results from diameter measurements with the Lesion Quantification


tool are already available on your system, these results can also be shown
in the LungCAD mini toolbar for clinical review.

By default, these results are not shown but you can adapt the respective
settings in the Configuration dialog box. ( Page 39 Configuring the
LungCAD tool)

You may find that the images have been marked for preprocessing at the
acquisition workplace. In this case, the CAD marks will be available for review
as soon as you activate the LungCAD tool in the Viewer.

The mini toolbar shows thumbnail images in coronal view for each
potential nodule. Each thumbnail image shows the location of the CAD
mark within the lung parenchyma.

A pair of numbers (1/2) is displayed at the bottom of the thumbnail preview.


The first number (1) represents the currently displayed CAD mark and the
second number (2) identifies the total number of detected CAD marks.

3 To navigate through the CAD marks, click the arrow icons next to the
thumbnail images.

The image segments are updated accordingly to visualize the CAD mark. A
lens display in the image segment provides a magnified view of the CAD
mark. The measured diameter and the size of the volume are displayed next
to each segmented nodule. ( Page 41 Information about the lens view)

4 To accept the currently displayed marker, click the Accept CAD Mark icon.

A finding is created and displayed in the Findings panel and the CAD mark
is removed from the collection.

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7 Displaying lung nodule markers

– or –

If you disagree with the algorithm, you can ignore the CAD mark and
continue the review or you click the Reject CAD Mark icon.

When you click this icon, the marker is removed from the collection.

If necessary, you can edit the segmentation object.


( Page 31 Editing lesions)

If the message LungCAD did not find any results is displayed, this means
that processing was successful but the algorithm did not find any results.

If required, you can modify the settings of the LungCAD mini toolbar.
( Page 39 Configuring the LungCAD tool)

7.1 Lesion properties window


In the Lesion Properties dialog box, you can specify the values that will be
displayed next to the segmented lesion.

The Lesion Properties dialog box is available for the Lesion Quantification
tool and the LungCAD tool.

1 Right-click the Lesion Quantification icon in the Tool Gallery and choose
Lesion Properties from the context menu.

– or –

Right-click the LungCAD icon in the Tool Gallery and choose Lesion
Properties from the context menu.

The Lesion Properties dialog box opens.

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7 Displaying lung nodule markers

2 Select the check boxes that correspond to the evaluation result that you
want displayed:

Diameter: Maximum diameter of the lesion measured in the axial plane

Max. Orth.Diam: Maximum diameter measured orthogonal to


the diameter

Max. 3D Diam.: Maximum (3D) diameter of the lesion quantification

Mean Diameter: Mean value of the diameter and the maximum


orthogonal diameter

WHO Area: WHO area of the measured lesion

Volume: Volume of the lesion

Min/Max HU: The minimum and maximum HU value in the


measured lesion

Mean/SD: The mean value and the standard deviation of the HU values in
the measured lesion

VDT: Volume doubling time (only relevant for follow-up evaluations)

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7 Displaying lung nodule markers

3 Click OK to confirm.

The settings are applied to subsequently segmented lesions.

7.2 Comparing lung nodule markers of multiple time


points
The LungCAD tool provides follow-up evaluation for comparing the CAD marks
of the current study with the CAD marks in available prior studies.
Once you start the tool, the algorithm detects potential nodules in the current
study. In addition, you can select the required time point and the algorithm
searches for the matching CAD marks in the prior study.

✓ Series of the current and the required prior study/studies are displayed in
the image segments.

✓ The displayed images have the same orientation and display type.

1 In the image area, select a segment.

2 In the Tool Gallery, click the LungCAD icon.

The LungCAD mini toolbar is displayed at the bottom of the segment and
the LungCAD algorithm starts processing.

If more than one prior time point is displayed in the image segments, you
can select the time point for comparison.

3 In the LungCAD mini toolbar, click the Select Prior icon and select the date
of the required prior study from the list.
The algorithm also searches for matching CAD marks in the selected
prior study.

When you start navigating through the CAD marks, the respective current
and matching prior CAD mark are displayed in the image segments.

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7 Displaying lung nodule markers

If required, you can modify the settings of the LungCAD mini toolbar.
( Page 39 Configuring the LungCAD tool)

7.3 Editing lesions


After you have accepted the CAD marks, you can edit the automatically
segmented lesions, if required.

◆ To edit part of the segmented lesion, right-click and choose Correction Pen
from the context menu and redraw the part of the volume that you want to
add or remove.

If you mark tissue outside the volume, it will be added to the


segmented lesion.

If you mark tissue inside the volume, it will be removed from the
segmented lesion.

The correction is applied to all slices within the volume of the lesion.

As soon as you navigate to another CAD mark or accept/reject a CAD


mark, the Correction Pen mode is disabled. Thus, if you want to continue
correcting CAD marks, you have to enable the tool again.

7.4 Configuring the LungCAD tool


You can modify the default settings of the CAD marks.

◆ In the LungCAD mini toolbar, click the Settings icon.


The Configuration window opens.

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7 Displaying lung nodule markers

Here, you can modify the following settings:

• Zoom Factor of Lens: You can modify the size of the region of interest
displayed within the lens

• Filtering of LungCAD Markers: Display only solid nodules or display all


nodules that the algorithm detects

If you filter for solid nodules only, a filter icon is displayed in the mini
toolbar. This icon indicates that only a subset of the detected CAD marks
is displayed.

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7 Displaying lung nodule markers

• Sorting of LungCAD Markers: Change the order of the markers by


sorting them according to their size, starting with the largest nodule, or
by sorting the markers along the anatomy from lung apex to lung bottom

• Exclude calcified nodules: You can exclude specific nodules so that they
are not shown in the LungCAD mini toolbar

• Show incremental findings: If you select this option, markers that have
already been reported will not be shown in the LungCAD mini toolbar
list. For example, if results from diameter measurements with the Lesion
Quantification tool are already available on your system, these results
will not be available in the LungCAD mini toolbar.

• Number of CAD markers displayed: You can specify a maximum


number of CAD markers that can be shown in the LungCAD mini toolbar.

7.5 Information about the lens view


In the LungCAD mini toolbar, each CAD mark also shows an associated lens.

The lens displays a magnified view of the CAD mark.


You can move the mouse pointer over the lens to zoom the CAD mark or scroll
through the slices.

The zoom factor of the lens can also be configured. ( Page 39 Configuring the
LungCAD tool)

The lens shows the CAD mark with the thinnest slice thickness that is available
in the study.

For example, if you review a study that contains series of 1.0 mm, 3.0 mm,
or 5.0 mm slice thickness, then the CAD mark is shown in the lens with the
thinnest slice thickness, in this case, 1.0 mm.

Furthermore, you can adapt the windowing values within the magnifying lens
by selecting one of the following settings:

• Bone Window (B)

• Lung Window (L)

• Soft Tissue Window (S)

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8 Performing manual calibration

8 Performing manual
calibration
Some of the images available to you for evaluation might not contain any pixel
spacing information which is required to perform geometric measurements,
for example, Distance Line. Instead of measurement result values, the
measurement result box will only show “???”.

To obtain the required pixel spacing information, you can use the Manual
Calibration tool.

CAUTION

In order to use evaluation tools on DICOM images without pixel spacing


information, you might have to perform manual calibration on the
available projection images.

Incorrect diagnosis due to incorrect manual calibration.


◆ Always perform manual calibration with great care using objects of
known size as reference.
◆ Consider that even after the images have been calibrated, the obtained
measurement results might not correspond to the real values.

✓ X-ray images without pixel spacing information have been loaded into the
image area.

✓ You know the size of the displayed image or an object of known size is
displayed in the image.

1 In a segment, choose Manual Calibration from the upper-right


corner menu.

The mouse pointer changes shape.

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8 Performing manual calibration

2 Draw a calibration distance line in the image.

If an object of known size is depicted in the image, you can draw the
calibration distance line along this object.

As soon as you stop drawing, you are asked to enter the length of the
calibration line.

If required, you can adjust the drawn line afterwards and then confirm the
entered value.

This value is taken as a reference to determine the size of the depicted


anatomical structures that you measure during the evaluation.

Consider that when you use the Manual Calibration tool, it does not have
any effect on already archived images. The manual calibration results remain
effective until you close the study.

Images may have to be calibrated again to obtain further measurements, for


example, in case you close the study and reopen it to continue reading at a
later point in time.

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9 Glossary

9 Glossary
Cinematic VRT Special volume rendering technique that gives an even more realistic
impression of the anatomy.

VDT Volume doubling time. The time a growing nodule would need to double its
volume. This value is shown in follow-up evaluations.

VRT Volume rendering technique. Aligns colors to the tissues according to their
density. Based on a black-and-white radiology image in a 3D-reconstruction,
the organs can be shown in different colors.

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Index

A Q
Assisted perpendicular 26 Quantification 30, 36
lesions 28, 31, 32, 39
C
Cinematic Insight S
display types 25 Safety advisory 15
Clinical extensions 6 Software requirements 13
comments and suggestions 14 syngo.via
user profiles 11
D
diameter measurement 26 U
Diameter measurements 30, 36 user profiles 11

display types
Cinematic Insight 25
V
documentation overview 6 Volume segmentation 30, 36

E W
Extensions 6 WHO measurement 26

H
Hardware requirements 13

L
legal notes 12
Lesion quantification 28, 30, 31, 32,
36, 39
LungCAD 31, 39

M
Measuring lesions 30, 36

O
Orthogonal line drawing 26
overview
documentation 6

P
performing
lesion quantification 28, 31, 32,
39

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This document is maintained in electronic form through Siemens Healthineers distribution channels. Printed versions not
provided by Siemens Healthineers and/or downloaded copies are considered uncontrolled.

notice. Some of the specifications described herein may


not be currently available in all countries. Please contact
your local Siemens Healthineers Sales representative for
the most current information.

Caution: US federal law restricts the herein described


devices to sale by or on the order of a physician.

The original language of this document is English.

Made in Germany
All product designations and company names are
trademarks or registered trademarks of the corresponding
companies.

Siemens Healthineers reserves the right to modify the


design and specifications contained herein without prior

Manufacturer Siemens Healthineers


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Published by Siemens Healthineers AG / Print No. P02-001-CC.621.05.01.02 / © Siemens Healthineers AG, 2022 - 2024
Date of first issue: 2024-03

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