Operator Manual - Carbon Clinicals VA31A SAPEDM P02-001-CC.621.05.01.02 OM SyngoCarbonClinicals VA31
Operator Manual - Carbon Clinicals VA31A SAPEDM P02-001-CC.621.05.01.02 OM SyngoCarbonClinicals VA31
Clinicals
Operator Manual
VA31
siemens-healthineers.com
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ation
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keys, for example, the Save button
Is used for on-screen output of the system including code-related elements
or commands
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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
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
9 Glossary 44
Index 45
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.
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.
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”.
If required, you can narrow down the search results by choosing the
appropriate filter criteria in the navigation area.
For example, if you are looking for a specific software version, select
Products > Syngo > Syngo Carbon Clinicals and navigate to the required
software version.
1 Enter the following URL into a web browser with Internet access:
https://fleet.siemens-healthineers.com/
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.
Steps to order
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.
• 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.
To use Syngo Carbon Clinicals, you must be fluent in the language used in the
user interface and in the Instructions for Use.
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.
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.
• 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.
The following user roles and profiles have been identified for Syngo
Carbon Clinicals:
Technologist (Radiographer)
• Role
– Work experience
Radiologist
– Verifying reports
– Work experience
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.
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.
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.
We do not provide any technical support for the product if it has been modified.
2 Safety advisory
The following cautions are valid for Syngo Carbon Clinicals. Consider also the
safety advisories of the hosting products.
• 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.
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.
CAUTION
Syngo Carbon Clinicals has not been approved for diagnostic reading of
mammography images in the United States.
CAUTION
◆ When making a therapy decision, do not just rely on the image reading
supported by Syngo Carbon Clinicals, but also consider other evidence.
CAUTION
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.
CAUTION
2.3 Calibration
CAUTION
CAUTION
CAUTION
Malicious software can damage the system and cause all patient
data to be lost.
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.
CAUTION
The measurement results may not reflect the exact situation because the
evaluation results are inaccurate.
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.
Evaluation of an object The evaluation of the created object is performed with the utmost accuracy.
• Accuracy of evaluation
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.
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.
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.
• 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.
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.
All image pixels that are touched by the segmented structure, are taken into
account for this measurement.
The relative error increases with the amount of pixels, by which the segmented
object exceeds the anatomical structure in number of image pixels.
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.
• 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.
These tools are available in the Tool Gallery of your reading application, for
example, MM Reading.
Rendering tools
Calibration tools
Oncological evaluation
CAUTION
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.
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
You can edit the measurement object after you have drawn it.
• 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)
You can also deactivate orthogonal drawing by pressing the Shift key while
you draw the distance lines.
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
CAUTION
Lesion size and volume estimation by the algorithm may not be accurate
due to non-negligible error in segmentation.
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.
✓ One of the following display types is applied: MPR, MPR Thick, MIP Thin,
MinIP Thin
– or –
The evaluation results of the measured diameter and the size of the
volume are displayed next to the measurement. ( Page 30 Lesion
properties window)
When you right-click the measurement, you can choose the segmentation
object to edit it. ( Page 31 Editing lesions)
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.
2 Select the check boxes that correspond to the evaluation result that you
want displayed:
Mean/SD: The mean value and the standard deviation of the HU values in
the measured lesion
3 Click OK to confirm.
◆ 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 inside the volume, it will be removed from the
segmented lesion.
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.
✓ One of the following display types is applied to all segments: MPR, MPR
Thick, MIP Thin, MinIP Thin
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.
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.
When you right-click the measurement, you can choose the segmentation
object to edit it. ( Page 31 Editing lesions)
• 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.
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.
CAUTION
The LungCAD mini toolbar is displayed at the bottom of the segment and
the LungCAD algorithm starts processing.
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.
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.
– 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 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)
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.
2 Select the check boxes that correspond to the evaluation result that you
want displayed:
Mean/SD: The mean value and the standard deviation of the HU values in
the measured lesion
3 Click OK to confirm.
✓ 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.
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.
If required, you can modify the settings of the LungCAD mini toolbar.
( Page 39 Configuring the LungCAD tool)
◆ 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 inside the volume, it will be removed from the
segmented lesion.
The correction is applied to all slices within the volume of the lesion.
• Zoom Factor of Lens: You can modify the size of the region of interest
displayed within the lens
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.
• 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.
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:
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
✓ 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.
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.
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.
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.
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
Made in Germany
All product designations and company names are
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companies.
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