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Release 6.2
English
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Philips Healthcare
Published by Philips Medical Systems Nederland B.V.
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Issue Number 4522 203 03151
Philips Healthcare
Published in The Netherlands.
1 Introduction.............................................................................................. 1-1
2 Safety......................................................................................................... 2-1
4 Maintenance.............................................................................................. 4-1
5 Glossary..................................................................................................... 5-1
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Index.......................................................................................................... I-1
CD. The product itself can be identified using the About box of the related
software tool. Both the label and the About box of the installed software
tool indicate the following:
• Name of the software tool
• Release number of the software tool
All Instructions for Use supplied with the software tool are identified using
the name and release number (first two digits) of the software tool, as
indicated in the footer of each document. Before using these Instructions for
Use with your system, ensure that it corresponds with the software tool
installed.
The English language version of the Instructions for Use was originally
drafted, approved, and supplied by Philips Healthcare.
The following table provides details of the documentation that has been
supplied with the software tool:
Documents forming the instruction set
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Allura 3D-RA - Extended Operation
Interventional Workspot - Basic Operation
Interventional Workspot - Extended Operation
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Before attempting to operate the software tool, you must read these
Instructions for Use, noting and strictly observing all WARNINGS and
CAUTION notices.
Pay special attention to all the information given and procedures described
in the Safety section.
WARNING A WARNING alerts you to a potential serious outcome, adverse event or safety
hazard. Failure to observe a warning may result in death or serious injury to the user
or patient.
CAUTION A CAUTION alerts you to where special care is necessary for the safe and effective
use of the product. Failure to observe a caution may result in minor or moderate
personal injury or damage to the product or other property, and possibly in a remote
risk of more serious injury, and/or cause environmental pollution.
supplied with the software. Please contact your hospital administrator for
details.
If the media containing the Instructions for Use are not available, please
contact your local Philips Healthcare representative or the manufacturer.
Information about the acquisition of images with the correct protocol is
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WARNING Images created by the viewing application are artificially reconstructed images.
Although the greatest care has been taken in the design and development of the
product, and its operation has been tested and confirmed in extensive clinical tests,
the very nature of the type of image does not fully exclude the possibility of artifacts.
Diagnosis or treatment cannot be based on these images. All findings and decisions/
CAUTION In the United States, Federal law restricts this device to sale, distribution, and use by,
or on the order of, a physician.
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Device description
Allura 3D-RA is a software product (Interventional Tool) intended to
provide high-speed and high resolution 3D visualization of vessels and
bones anatomy. Allura 3D-RA is intended to be used in combination with
an Allura X-ray system.
Allura 3D-RA generates a 3D reconstruction to visualize vascular anatomy,
and helps to identify vascular pathologies from a single contrast-enhanced
rotational angiogram. It can be used during any angiography procedure and
can cover any anatomical area including cerebral, abdominal, and
peripheral. It also allows for 3D visualization of the spine.
Medical Purpose
Allura 3D-RA is intended to assist physicians in analyzing two dimensional
X-ray images by creating three dimensional views from sets of two
dimensional images created during rotational angiographic runs.
Allura 3D-RA is intended to assist in the diagnosis and treatment of
endovascular diseases, for example, stenosis, aneurysms, and arteriovenous
malformations.
Allura 3D-RA also supports measurement of lesion dimensions and
anatomical distances.
Patient Population
Allura 3D-RA is suitable for use with the entire human population.
Intended Operator Profile
The Operator is a physician who is fully skilled and responsible for sound
clinical judgment and for applying the best clinical procedure, for example:
• Interventional radiologist
• Interventional neuro-radiologist
• Vascular or Cardiac surgeon
• Interventional Cardiologist
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1.4 Compatibility
Allura 3D-RA is compatible with Allura X-ray systems.
To make use of the software, the X-ray system must be equipped with the
following options (depending on the X-ray system in use):
• Rotational Scan (Allura Xper FD10 series)
• FD Rotational Angio (Allura Xper FD20 series)
• Rotational Angio (Allura CV20 series)
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Changes or additions to the product should only be carried out by Philips
Healthcare or by third parties expressly authorized by Philips Healthcare to
do so. Such changes or additions must comply with all applicable laws and
regulations that have the force of law within the jurisdictions concerned,
and with best engineering practice.
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1.4.1 Options
3D on Xper
3D on Xper is an optional package for the X-ray system that can be used
with the Interventional Tool. 3D on Xper comprises:
• 3D APC (Automatic Stand Positioning) allows the frontal stand to be
moved to a working position without using X-ray. Instead, previously
stored projections are used
• Follow C-arc allows movements of the frontal stand (without X-ray) to
automatically update the view displayed in the main display area.
1.5 Contra-indications
The images made with the product use X-ray imaging as the source data,
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1.6 Training
Users of this product must have received adequate training on its safe and
effective use before attempting to operate the product described in this
Instructions for Use. Training requirements for this type of device will vary
from country to country. Users must make sure they receive adequate
training in accordance with local laws or regulations. As a minimum level of
training, users should read and understand these Instructions for Use (Basic
Operation and Extended Operation).
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2.2 Warnings
Task-specific safety warnings are provided with the procedures in these
Instructions for Use.
General warnings, and warnings contained in the “Extended” Instructions
for Use, are provided here.
Intended use and compatibility
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WARNING Do not use the product for any purpose other than those for which it is intended. Do
not use the product with products other than that which Philips Medical Systems
recognizes as compatible. Operation of the product for unintended purposes, or with
incompatible products, could lead to fatal or other serious injury. It could also lead to
clinical misdiagnosis.
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Making measurements
WARNINGS • All measurements made using the software are prone to ‘vessel thickening effect’.
This effect is based on the subjective nature of the vessel segmentation level
definition. This means that slight changes in the window width and window level
can result in different vessel segment diameter. In order to compensate for this
effect and assure accuracy of the performed segmentation, the following technique
should be followed: by manually sliding the window width (from left to right) a
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that this measurement method does not take into account any vessel tortuosity
and possible cross section anomalies. To achieve maximum measurement accuracy
you must position the 3D image in such a way that the measurement has minimal
2D distortion (foreshortening).
Performing analysis
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3.1 Configuration
3.1.1 Image acquisition
Image acquisition is performed with the rotational scan / rotational angio
feature of the X-ray equipment. During acquisition, the C-arm may be
positioned as follows:
• Head position for Allura Xper FD10 and FD10/10
• Head or Side position for Allura Xper FD20, FD20/10 and FD20/20
(only one Side position - Nurse or Doctor - can be calibrated for
acquisition)
• Nurse position for Allura CV20.
Be aware that metal objects such as cables, coils or tooth repairs may cause
streaked artifacts in the image. Objects with high X-ray absorption may also
cause artifacts to appear.
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WARNINGS • For optimal image quality, ensure that the patient does not move during the
rotation scan, using appropriate supports and straps if necessary.
• For optimal image quality, be sure to use the correct injection protocol so that
vessels are properly filled with contrast agent for the entire duration of the
rotation scan.
• The reliability of vessel reconstruction might be affected when anatomical
structures with high X-ray absorption qualities are in the field of view (for
example, when viewing arteries in the base of the skull or vessels between dense
ear bone structures).
NOTES •
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When using biplane X-ray systems, only the frontal stand is supported.
• The table must not be tilted when acquiring a rotation scan.
• Wedge shutters must not be used when acquiring a rotation scan.
• When acquiring a rotation scan, the pivot angle must be 0 degrees.
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Workspot, and the initial 3D reconstruction is displayed. Additional
reconstructions can be created of zoomed areas of interest within the initial
reconstruction.
NOTE The Real Time Image Link option allows the software to receive images as soon as
they are acquired.
Legend
The reconstruction is displayed in the main display area of the screen and is
manipulated directly with the mouse and using function buttons in the
control panel and the toolbar.
Snapshots, movies and VRML files can be created at any time during
processing. These are saved with the run and are available for viewing,
storing or printing.
NOTE The Xper module option can be used to control the application from the examination
room, without leaving the patient.
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3.3.1 Reconstruction tabs
Reconstruction 1 is by default the original reconstruction. Click the tab to
display the reconstruction. Reconstruction 2 and Reconstruction 3 are
derived from further processing of the original reconstruction. Their tabs are
only enabled if a second and third reconstruction are available.
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The Orientation indicator can be displayed by selecting it from the View
settings menu. It indicates the orientation of the patient in relation to the
user, according to the way the reconstruction is displayed in the main
display area. The orientation indicator rotates with the reconstruction.
WARNING Fast Imaging Mode uses fewer images or a lower resolution during acquisition
(depending on selected Xper setting). This results in decreased reliability of displayed
anatomy and any measurements performed on it.
Orthogonal view
Orthogonal view divides the main display area into four viewports. The top
left viewport displays rotatable view of the reconstruction, while the other
three viewports display fixed orthogonal views: Coronal (Frontal), Sagittal
(Lateral left) and Axial:
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3.3.6 Configuring view settings
The View settings menu provides controls for configuring the interface:
Menu item Description
Patient Info The Patient info submenu allows one of three levels of
detail to be selected. The levels available are: None,
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Essential or All. The default setting is Essential.
Axes Turns the display of axes on or off. The following axes are
displayed: L-R (Left and Right), H-F (Head and Feet) and A-
P (Anterior and Posterior).
Cubebox Turns the display of the cubebox on or off. The cubebox
depicts the outer boundaries of the reconstructed volume.
Orientation Indicator Turns the display of the human anatomy model on or off.
The anatomy model displays the orientation of the patient
in relation to the view shown in the main display area.
Histogram Value Turns the display of WW and WL settings in the histogram
on or off.
Patient Orientation Opens the Patient orientation dialog. This dialog ensures
the vessels are displayed in the correct orientation in the
If the Patient Orientation
main display area:
dialog is not available, patient
orientation has been managed Head first: patient’s head at the head of the table
automatically.
Feet first: patient’s feet at the head of the table
Supine: patient lying face up
Prone: patient lying face down
Decubitus Right: patient lying on the right side
Decubitus Left: patient lying on the left side.
Configure Tool Buttons Opens the Configure Buttons dialog, allowing you to select
which function buttons are visible in the function panel.
The Histogram function button is always visible. Tools for
which the appropriate license is not installed are
unavailable.
All available functions can be selected from the Tools
menu, irrespective of whether they are displayed in the
function panel.
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3.4 Toolbar
The toolbar provides quick access to several tools for making direct
modifications to the image in the main display area. Tools are selected by
clicking on the appropriate button.
Select
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The Select tool is used for basic functions such as moving objects within the
view, making measurements, or making a freeform cut.
Rotate volume
Use this tool to rotate the volume in any direction in the main display area.
Rotation is performed on any axis around the center of the display.
NOTE In orthogonal view, only the variable view (top left) can be rotated.
NOTE In orthogonal view, only the variable view (top left) can be rotated.
Rotate in a plane
Use this tool to rotate the volume around the fixed ‘z’ axis (perpendicular to
the viewing plane). Rotation is performed around the center of the display.
NOTE In orthogonal view, only the variable view (top left) can be rotated.
Pan
Use this tool to move the reconstruction in the main display area.
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Zoom
Use this tool to zoom in or zoom out of the view in the main display area.
NOTE The zoom tool enlarges the view in the main display area, but does not increase the
level of detail in the volume. To increase the level of detail, create a new
reconstruction of the area of interest; this is known as ‘reconstructive zooming’.
Render mode
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Use this tool to set the render mode.
Available render modes
Volume Rendered
Gradient Rendered
Shaded Surface
Sum
MIP
Normal
Orthogonal
Default views
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AP
PA
Lateral Left
Default views
Lateral Right
Caudo Cranial
Cranio Caudal
NOTE Actual rotation and angulation values depend on the X- ray equipment in use.
Snapshot
Use this tool to take a snapshot of the main display area. You can export the
snapshot in DICOM- or PC-compatible format using the Export activity.
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NOTE Use the View settings menu to ensure that the main display area contains the desired
display settings for the snapshot.
WARNING If patient information is displayed in the main display area, this is also captured in the
snapshot. You must handle personal data in accordance with any privacy laws in
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This tool is used when viewing a volume as a slab. It allows you to select a
suitable slab for viewing. Drag with the mouse to move through the volume.
Movie interactor
This tool is not used in the software.
Hide primary volume (contrast)
When available, this tool turns the visibility of the primary volume
(contrast) on and off. It is available in Overlay mode when the overlay
volume is visible.
Not all available functions are displayed by default in the Function button
panel. You can configure which function buttons are visible using the
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‘Configure tool buttons’ option in the View settings menu. This allows you
to customize the panel to display the functions you use most often.
Clicking a function button opens the control panel for that function; the
control panel appears below the function button panel.
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WARNINGS • The angle information displayed is for the frontal stand only.
• If you apply these values to the stand, it results in a projection in the X-ray
equipment that is (apparently) identical to the one displayed in the software.
However, even though the projections are identical, the images may still differ in a
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rotation around an axis perpendicular to the screen and could lead an
inexperienced viewer to make a misinterpretation of the images. You can
synchronize the orientations by pressing Follow C-arc on the Xper module.
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5.1 Abbreviations
Abbreviation Explanation
2D 2-Dimensional
3D 3-Dimensional
APC Automatic Position Control
CAU Caudal
CRA Cranial
DICOM Digital Imaging and Communications in Medicine
LAO Left Anterior Oblique
PC Personal Computer
RAO Right Anterior Oblique
VRML Virtual Reality Mark-up Language (not used in StentBoost)
WL Window Level
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WW Window Width
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R
H
Real Time Image Link (option) 1-7
Hide overlay volume tool 3-11
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V
T
View settings 3-6
Toolbar 3-7–3-11 Viewing mode tool 3-9
– 3D Overlay 3-11 Views 3-5, 3-6, 3-9
– Annotation 3-8 – default views 3-9
– Contrast and Brightness 3-10 – normal view 3-5
– Default views 3-9 – orthogonal view 3-6
– Hide overlay volume 3-11
– Hide primary volume 3-10
– Movie interactor 3-10 W
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– Pan 3-8 Warnings (safety) 2-1
– Position interactor 3-10
– Render mode 3-8
– Rotate around an axis 3-8 X
– Rotate in a plane 3-8 Xper module (option) 1-7
– Rotate volume 3-7
– Select 3-7
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www.philips.com/healthcare
[email protected]
Manufacturing address
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
5684 PC Best
The Netherlands
0344