Quick Start Manual
46 Pages
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QIvus® 3.0 Quick Start Manual
February 4, 2015
9.08.250.30.2
v3.0
Legal Notices Copyright Notice © 2010-2015 Medis medical imaging systems bv. All rights reserved. This manual is copyrighted and is protected by worldwide copyright laws and treaty provisions. No part of this manual may be copied, reproduced, modified, published or distributed in any form or by any means, for any purpose, without prior written permission of Medis medical imaging systems bv. Permission is granted to freely print unmodified copies of this document as a whole, provided that copies are not made or distributed for profit or commercial advantage.
Trademark Acknowledgments QIvus is a registered trademark of Medis Associated BV in the United States and in other countries. iMap is a trademark of Boston Scientific Corporation. VH and Volcano are registered trademarks of Volcano Corporation in the United States and in other countries. Infraredx is a registered trademark of InfraReDx, Inc. TVC Insight Catheter, TVC Imaging System, and Chemogram are trademarks of InfraReDx, Inc. ST. JUDE MEDICAL, ILUMIEN, OPTIS and the color gold are trademarks of St. Jude Medical or its affiliates. Terumo is a registered trademark of Terumo Medical Corporation. Microsoft and Excel are registered trademarks of Microsoft Corporation in the United States and/or other countries. All other brands, product, and company names mentioned in this document are trademarks or registered trademarks of their respective owners.
Regulatory Information Intended Use QIvus has been developed for the objective and reproducible analysis of intravascular ultrasound images. Its intended purposes are:
supporting clinical diagnoses concerning stenoses and/or placement of interventional devices
supporting subsequent clinical decision-making
supporting clinical research trials that study changes in vessel condition over time as a result of interventions and/or medication
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WARNINGS QIvus must be used by cardiologists, radiologists, or trained technicians who are qualified to perform IVUS and OCT analyses. If the analysis results are used to reach a diagnosis, the results must be interpreted by a qualified medical professional. QIvus should not be used for purposes other than those indicated in the section Intended Use. Users must make sure to read this manual to become familiar with the software and be able to obtain reliable analysis results.
Indications for Use QIvus has been developed for the objective and reproducible analysis of tomographic images of both lumen and arterial wall of a coronary or vascular segment, in particular the assessment of a stenosis or artherosclerotic plaque. This information supports the possible placement of intervention devices in these vessels. QIvus enables an advanced assessment of vessel, lumen, and stent morphology. It also avoids the very time-consuming conventional manual tracing of boundaries, which suffers from high intra- and inter observer variability. QIvus can be used to control stent placement and to assess in-stent restenosis. QIvus software package enables the automatic calculation and the display of various parameters such as: areas and diameters in individual slices; volumes over the segment of interest (Simpson’s Rule) for the vessel, lumen and stent contours; plaque and in-stent restenosis parameters. QIvus analytical software is intended to support all clinicians, i.e. cardiologists, radiologists, and referring physicians involved in the assessment of ultrasound images. When interpreted by a trained physician these parameters may be useful in supporting the determination of a diagnosis.
European Regulations QIvus is qualified as a class IIa medical device. It complies with the requirements of the Dutch Medical Devices Decree (Besluit Medische Hulpmiddelen, Stb. 243/1995) and the European Medical Device Directive 93/42/EEC.
0120
North American Regulations QIvus has been cleared for market in the United States by the FDA (Food and Drug Administration) under the provisions of Section 510(k) of the Food, Drug, and Cosmetic Act. QIvus complies with the requirements of the Canadian Medical Devices Regulations and has been licensed as a Class II medical device.
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Limitations iMap™ Module The iMap module of QIvus is intended for research use only in and is not to be used for diagnostic purposes in the United States.
VH® IVUS Module The VH IVUS module of QIvus is intended for research use only and is not to be used for diagnostic purposes. The VH IVUS module of QIvus is based on a library that is verified for Intel processors only.
TVC Chemogram™ Module The TVC Chemogram module of QIvus is intended for research use only and is not to be used for diagnostic purposes.
OCT Module The OCT module of QIvus is intended for research use only and is not to be used for diagnostic purposes.
Medis medical imaging systems bv Schuttersveld 9, 2316 XG Leiden, the Netherlands
http://www.medis.nl
Medis medical imaging systems bv Schuttersveld 9 2316 XG Leiden P.O. Box 384 2300 AJ Leiden the Netherlands
Medis medical imaging systems, Inc. 9360 Falls of Neuse Road, Suite 103 Raleigh, NC 27615-2484 USA
Telephone: +31 71 522 32 44 Fax: +31 71 521 56 17 E-mail: [email protected] Web: www.medis.nl
Telephone: +1 919 278 7888 Fax: +1 919 847 8817 E-mail: [email protected] Web: www.medis.nl
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Conventions Used The following conventions are used throughout this manual to indicate mouse and keyboard actions and to refer to elements in the user interface.
Mouse Click
Press and release the left mouse button. If you are left-handed, you may have set the right mouse button as your primary mouse button.
Right-click
Press and release the right mouse button. If you are left-handed, you may have set the left mouse button as your secondary mouse button.
Middle-click
Press and release the wheel button or the middle mouse button. If you have a two-button mouse, press and release the left and the right mouse button simultaneously.
Double-click
Press and release the left mouse button twice. If you are lefthanded, the right mouse button can be used.
Keyboard CTRL+click
Press and hold down the CTRL key on your keyboard while you click an object.
CTRL+O
Press and hold down the CTRL key on your keyboard while you press O, then release both keys. This example opens the dialog window for opening a study.
Typographical Conventions On the Segment tab, click Apply.
Names of buttons, fields, menus, menu options, and tab names are capitalized and in bold.
File > Browse for DICOM…
A sequence of menu options that you select to perform a specific task, is indicated by angular brackets.
Double-click New analysis.
Text that you type or that appears on the screen, such as file names and file locations, is displayed in Courier New.
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Symbols Used Reference. Points to related documentation or to related sections in the document that may be relevant in your situation. Tip. Provides helpful information or an alternative working method. Note. Brings additional information to your attention. Caution. Tells you to be careful when performing a task. Warning. Warns you for a potentially dangerous situation in the image representation or analysis, which may lead to incorrect results. You are advised to follow the instructions to avoid this.
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Table of Contents INTRODUCTION ... 1 1
About QIvus ... 1
2
Support ... 2
3
Starting QIvus and Opening Studies ... 3
4
3.1
Starting QIvus ... 3
3.2
Opening Image Runs ... 3
3.3
Closing Image Runs ... 5
The QIvus Workspace and Toolbars ... 6
WORKING WITH QIVUS ... 11 5
6
Reviewing ... 11 5.1
Reviewing Image Runs ... 11
5.2
Adjusting Contrast and Brightness ... 14
Performing Analyses in IVUS Images ... 15 6.1
Pre-Analysis Actions ... 15
6.2
Performing Segment Analyses ... 17
6.3
Editing Contours ... 20
7
Viewing Tissue Characterization ... 23
8
Performing Analyses in OCT Images ... 26 8.1
OCT Analysis Settings ... 27
8.2
Pre-Analysis Actions OCT ... 28
8.3
Performing OCT Analyses ... 29
9
Creating Reports ... 34
10
Exporting Results ... 35
TROUBLESHOOTING ... 36 REFERENCE ... 38
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Introduction
Introduction 1
About QIvus
QIvus® is the Medis software solution for reviewing and analyzing IVUS and OCT studies of the coronary arteries. QIvus enables you to view and analyze both IVUS and OCT studies, including tissue characterization as performed by the data provider. QIvus currently supports Boston Scientific Corporation’s iMap™, Volcano® VH® (Virtual Histology) IVUS and Infraredx TVC™ (True Vessel Characterization) tissue characterization. The tissue characterization and OCT features are only active in QIvus if you have the appropriate license(s). For IVUS studies, QIvus features rapid automatic detection of lumen, stent and vessel borders over the entire pull-back run, as well as powerful and intuitive editing, which saves you valuable time. Analysis results not only include 2D measurements, but also provide 3D data-lumen, stent, and vessel volumes. You can print the results in a one-page report or export them for further analysis. For OCT studies, QIvus features fast automatic detection of lumen contours, semi-automatic detection of stent contours and manual detection of stent struts. You can export stent strut data for further analysis.
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Introduction
2
Support
For quick and easy QIvus support, you can go to the menu bar (on top of the program), click Help and choose one of the three options: 1) UserManual for a simple explanation on all available QIvus functions. 2) Instruction Movies for a visual explanation on 1) Getting Started, 2) Gui & Buttons, 3) Contour Detection, 4) Results, and 5) More Information. 3) About… for general package information, like the QIvus version number, License Information, Legal Notices, and Contact Information (see also below). Medis is committed to offering high-quality products and services. If you have questions about the software or if you would like to make suggestions for improvements in the software or in the documentation, please contact the Medis helpdesk. If you contact the Medis helpdesk by e-mail, mention the name of the software and the version number in the subject field. The QIvus version number is displayed in the title bar. North and South America Medis medical imaging systems, Inc. E-mail: [email protected] Telephone: +1 919 278 7888 (working days 9.00-17.00 EST) Europe, Africa, Asia, and Australia Medis medical imaging systems bv E-mail: [email protected] Telephone: +31 71 522 32 44 (working days 9.00-17.00 CET)
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Introduction
3
Starting QIvus and Opening Studies
3.1 Starting QIvus QIvus must be installed and the licensing mechanism must be enabled before you can start. For instructions on installing QIvus and on enabling the license mechanism, we refer to the QIvus Installation Manual.
To start QIvus
Double-click
Select Start > (All) Programs > Medis QIvus > QIvus 3.0.
on your desktop.
Or,
3.2 Opening Image Runs After starting QIvus, you open the image run that you want to analyze in the two-step File Browser as follows: To open an image run
1. Click
or select File > Browse for DICOM…
2. In the Image Browser, browse the directory structure on the left and select the directory in which the image run is located. In the right-hand pane, select the image run and click Next, or double-click the image run. When you click on a folder in the directory structure, the Image Browser is immediately going to search for all files which QIvus can open. Therefore, clicking on a folder high in the directory structure can make the Image Browser slow. You can prevent this by clicking the [+] and [-] signs in the directory structure, in order to go down through the folder structure. When the directory structure is not displayed, click Folders to display it. To assist in the search for a specific image run, you can: o
Click Preview, to display an image of the selected image run at the right.
o
Click Screenshots, to display available screenshots of the selected image run at the bottom.
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Introduction
o
Check the Only tissue box, to display the image runs with tissue characterization only. (So, not the gray scale only image runs).
o
You can add or remove the headings (searchable items) of the right-hand pane. Right-click on the headings and select or deselect the headings in the displayed menu.
o
You can change the order of the headings in the right-hand pane. Click a heading, slide it to the left or right and release it at its new position.
QIvus supports DICOM and AVI image runs. You are recommended to use only DICOM image runs for analyses, as they contain necessary calibration, catheter and patient-study information. If you use an AVI image run, you must make sure to enter this necessary data in the General information dialog window. 3. In the next step, in the lower pane, select New analysis and click OK, or double-click New analysis. To resume the last analysis, select Last analysis in the lower pane and click OK, or double-click Last analysis. To review or continue an older analysis, select the analysis in the lower pane based on the date, time and analyst name and click OK, or double-click the analysis of your choice. As location of the new analyses, you can select the Image Folder or the Analysis Storage Folder from the drop down menu. To save new analyses to a different Analysis Storage Folder, click Change Analysis Storage Folder…. This opens a new dialog window. Browse the directory structure and select the directory where you want to store the analyses. Click OK. The Analysis Storage Folder functionality is not available for raw OCT image data. 4. If you are loading grayscale images, you can limit the number of frames that are loaded into QIvus in the Image Subset Selection dialog window. With large image runs, limiting the number of frames ensures that the image run is loaded quickly and that analyses are performed efficiently. You can do this in two ways: under Enter Frame Number, select a range of frames to be loaded, or specify a subset selection number, which loads just one frame out of the specified number of frames (also known as subsampling). In case of long pullbacks, it is recommended to load sufficient frames to maintain a slice thickness of 0.1 mm or less. If you are loading images with tissue characterization data, the data set is limited by default to the frames that show tissue characterization. Click OK. 5. QIvus now starts to load the image run and creates the longitudinal images. 6. In the General Information dialog window, check the DICOM properties. Make sure to check the catheter type, the pull-back speed, and the frame rate. The correctness of this information is very important, because it is used to accurately calculate the volume measurements and all other measurements in the longitudinal view. QIvus 3.0 Quick Start Manual
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Introduction
The changes you make to the DICOM properties are only stored with the QIvus analysis results, not in the original DICOM file. Your changes are stored with the current analysis and shown in reports. Click OK to close the General Information dialog window. For easy comparison, it is possible to open multiple pullback at the same time. Repeat step 1 to 6 to add additional image runs.
3.3 Closing Image Runs
Click
During the closure procedure, all analysis settings and results are automatically saved.
, when you are done reviewing and/or analyzing the Image file.
In both cases, whether it was opened for reviewing or analysis, an additional analysis will be added to the existing list of analyses.
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Introduction
4
The QIvus Workspace and Toolbars
The QIvus main workspace consists of a menu bar, a set of toolbars and a canvas that presents the transversal and the longitudinal views.
The version number of QIvus is displayed in the title bar. The name of the user currently logged on to Windows is displayed in the status bar. Tool Icon
Description
File Toolbar Browse for all types of image data that can be read in by QIvus and start analysis.
Close the currently active image file.
Save the current image run or part of the current image run as an AVI file, or save the currently selected frame or multiple frames as a BMP or JPG file.
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Introduction
Tool Icon
Description Hide or show the DICOM info.
Print a one-page report with analysis results.
General Toolbar Perform manual calibration and check the catheter and artifact circles.
Semi-automatically remove calibration markers.
Automatically remove artifacts.
Correct for cardiac motion.
(Re-)creates longitudinal images.
Specify the segment(s) and/or subsegments of interest for contour detection and reporting.
Hide or show the area graph in the longitudinal view.
Jump to the frame with the minimum lumen area in the selected segment. Click the arrow next to this icon to select other types of frames. For example, you can select the frame with the smallest or largest lumen area in the current segment, the largest calcium area in the current segment, or the largest area of malapposition in the current segment. Export the results of the selected analysis to Microsoft® Excel®.
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Introduction
Tool Icon
Description Open the General Information dialog window, in which you can view and edit basic details about the patient, intervention, catheter and stent. The changes you make to the properties are only stored with the QIvus analysis results, not in the original DICOM file. Your changes are stored with the current analysis and shown in reports. Open the Settings dialog window. In this dialog window, you can specify the scroll step and the loop interval. The other settings in this dialog window show the characteristics of the image run as detected by QIvus. The contour detection is optimized for each specific catheter type. Open the guidewire detection dialog window for iMap or VH-Revolution IVUS images.
Hide or show iMap, VH or TVC IVUS tissue characterization.
or
One of these icons is active if you have the appropriate license, if an image run set of the corresponding IVUS manufacturer is loaded, and if tissue characterization data and contours are available.
or
Display iMap, VH or TVC IVUS tissue characterization data or re-perform tissue characterization. or
One of these icons is active if you have the appropriate license, if an image run set of the corresponding IVUS manufacturer is loaded, and if tissue characterization data is available for the image run.
or
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Introduction
Tool Icon
Description Open the tissue characterization options of the iMap Analysis, VH IVUS Analysis or TVC Chemogram Analysis dialog window, respectively.
or
or
Using the options in this dialog window for iMap or VH, you can add a pie chart and a legend to the transversal view, you can change the transparency of the tissue characterization overlay, and you can select the tissues that must be shown in the overlay. If you are reviewing iMap or VH-Revolution images, you can also filter out black pixels using this dialog window, you can display the level of confidence with which the pixels are characterized as belonging to a tissue type, and you can mask specific areas. If you are reviewing TVC data, you can view the chemogram map and crosshair information, and you can detect the mxLCBI. One of these icons is active if you have the appropriate license, if an image run set of the corresponding IVUS manufacturer is loaded, and if tissue characterization data is displayed. Open the OCT analysis dialog window. This icon is only active if you have the appropriate license. Open the Loop Viewer window.
Open the OCT Raw Loop Viewer window.
Analysis Toolbar Indicate that you want to create or edit vessel contours.
Indicate that you want to create or edit stent contours.
Indicate that you want to create or edit lumen contours.
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Introduction
Tool Icon
Description Detect longitudinal contours in the segment(s) of interest.
Detect transversal contours in the segment(s) of interest.
Detect a transversal contour in a single frame.
Place a correction point and correct the currently active contour in only the current transversal image.
Undo your changes to the positions of the attraction points.
Open a dialog window with analysis results. Depending on the analyses performed, area, volume, diameter and tissue results may be presented. Hide or show the transversal contour of the selected contour type.
Exclude or re-include the current frame in the analysis.
Undo only the last manual transversal contour edit. After use, the icon it becomes inactive until an additional manual edit is applied. Open the Delete Contour dialog window, in which you can choose to delete either the selected contour in the current frame or in all frames.
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Working With QIvus
Working With QIvus 5
Reviewing
The large canvas gives you space to review the transversal and longitudinal views, which you can tile horizontally or vertically. You can also maximize the transversal view or the longitudinal view. The following illustration shows a QIvus window with maximized canvas and vertically tiled views.
To tile the transversal and longitudinal views
Select Window > Tile Horizontally or Window > Tile Vertically.
To maximize the transversal or longitudinal view
Double-click the title bar of the view. To return to the standard view, click
in the upper right corner of the menu bar.
5.1 Reviewing Image Runs When you review image runs, you use the movie controls and sliders at the top of the transversal view and the longitudinal view. The sliders are used respectively to select frames, to change the speed with which the image run is played, and to zoom in or out.
Frame Slider
Speed Slider
Zoom Slider
To play an image run QIvus 3.0 Quick Start Manual
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Working With QIvus
Click
to start playing the image run.
This plays the image run until the end of the pull-back run and then restarts at the beginning.
Click
to play the image run backward.
This plays the image run from the end of the pull-back run to the beginning, and then restarts at the end. To play the loop viewer
Click
in the toolbar to open the Loop Viewer window.
In the Loop Viewer window, click . This starts playing the image run forward and backward around the current frame shown in the transversal view, over a number of frames specified in the settings.
To close the Loop Viewer window, click
again.
The loop view mode may be useful to get a clearer view of the lumen edge and of stent malapposition. The loop view mode shows all frames of the original image run in the transversal plane. So, this is the non-skipped and non-filtered image run.
For the loop view mode of the raw OCT image runs click . The raw loop view shows all frames of the original image run in a stack of image lines. For comparison with the transversal view, the first image line starts at 3 o’clock and is followed by the adjacent image line in a counterclockwise order.
The “raw” OCT loop view
The transversal view
To adjust the loop view interval, click , and after Loop interval in the top right corner, specify the number of frames forward and backward that you want to view in the Loop Viewer.
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Working With QIvus
To change the movie speed
Drag the Speed slider to the right to increase movie speed, drag it to the left to decrease movie speed.
To change image selection
Drag the Frame slider in one of the views.
Use
In the longitudinal View, drag the red line to scroll through the images of the transversal image run.
Use the left and right arrow keys or the Z and X keys to step through the images of the transversal image run at a specified interval, known as the scroll step. By default, the scroll step is 1 (image by image).
Or,
and
to scroll the image run image for image in one of the views.
Or,
Or,
You can modify the scroll step. For instructions, we refer to the following section. Or,
Use the arrow up and arrow down keys to step through the images of the transversal image run five images at a time.
To modify the scroll step To change the number of frames skipped in the scroll step:
1. Click
.
This opens the Settings dialog window. 2. Fill in the scroll step in the Scroll step field in the top right corner. The scroll step value can be based upon the pull-back speed, the number of frames per second and your protocol or standard operating procedure. 3. Click OK. This closes the Settings dialog window. 4. When you next use the Z and X keys or the left and right arrows on your keyboard, the specified scroll step is applied. To zoom in
Drag the Zoom slider in the transversal, longitudinal or loop view to the right.
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