User Manual. Document number TEC0002EN Rev. 2.1, June 30th, Copyright Quipu srl

Transcription

1 User Manual Document number TEC0002EN Rev. 2.1, June 30th, 2015 Copyright Quipu srl

2 WARNING: This manual describes the instructions for proper use of the device software Cardiovascular Suite. Please read carefully the advice in this document. Cardiovascular Suite is a software for the estimation of early markers of cardiovascular risk. In particular, the software is composed of two main modules of measurement: 1) the FMD-Studio for the measurement of Flow- Mediated Dilatation (FMD) of the brachial artery 2) the Carotid-Studio for measuring the Intima-Media Thickness (IMT) and the diameter of the carotid artery that, when combined with an estimate of pressure, provides parameters of arterial elasticity. The device is based on an algorithm that identifies the edges of the arterial vessel by analyzing sequences of ultrasound images of the longitudinal section of the vessel itself. The system is able to process video files previously recorded or directly in real-time the video output of an ultrasound system. The software must be used by trained and qualified personnel, such as laboratory technicians, nurses, physicians and / or sonographers. The analysis performed by the device can be applied to any person over the age of 36 months. It is not recommended to use the system for analysis of people with a distorted anatomy of the examined arterial segment. It is recommended that the device is used according to the international guidelines for estimating carotid intima-media thickness (IMT), arterial elasticity and flow-mediated dilation (FMD). According to the description and the intended use, which are showed in the subsequent chapters, and in accordance with the rules of application of chapter 1.4 of Annex IX of the Directive 93/42/EEC and subsequent amended and the provisions of Chapter III of Annex IX of Directive 93/42/EEC and subsequent amendments, Cardiovascular Suite software is within the medical devices of Class IIa according to rule The product is in compliance with the legal requirements of 93/42/EEC and subsequent amendments and supplements (Directive 2007/47/EC) for medical devices. For USA only: Cardiovascular Suite is not FDA approved

3 Index 1. Installation Hardware Requirements 7 Minimum Requirements 7 Video converter (optional) Software installation 8 Installation License 10 MOBILE_PERPETUAL license 10 MOBILE_TIME license 10 NODE-LOCKED license 10 Updating a license based on a Dongle Key 11 Activation of a NODE-LOCKED license 12 Get your license 12 Enter the license key How to connect Cardiovascular Suite to the ultrasound system. 13 Connecting to S-Video or Composite Video with Grass Valley Canopus ADVC Connecting to VGA, DVI or HDMI with Epiphan DVI2USB Connecting to VGA with Epiphan VGA2USB LR 16 Connecting to DVI or HDMI with Epiphan DVI2USB Solo Using video clips for off-line analysis How to set up the ultrasound system How to set up the ultrasound system in Duplex Mode (FMD Studio) Backup Recommendations Extraordinary maintenance Home Screen 24 Authenticate as a user 24 Disconnect a user User Management 26 Add a new user: 26 Delete a user: 26 Modify a user: 26 Change the user password: Settings 28 Restoring factory setting Settings - General 29 Edit the information of the Institute: 29 Change the Archive Folder Settings - FMD Studio 31 Change the timing of Flow Mediated Dilation / GTN Induced Dilation: 31 Change the colors of plots in Flow Mediated Dilation / GTN Induced Dilation: 31 Change the colors of the contours in Flow Mediated Dilation / GTN Induced Dilation: 32 Set acoustic alerts: 32 Enable / disable the calculation of the shear rate: 32 Set the instrument for calculating the shear rate through doppler flow analysis: 32 Copyright Quipu srl 3

4 4.3. Settings - Carotid Studio 34 Change the time of analysis: 34 Change the colors of the contours Settings - Security 35 Set the backup options for the database index 35 Enable / disable automatic login as administrator 35 Lock / unlock the changes of the studies Settings - License Key 36 License based on a Dongle-Key 36 NODE-LOCKED License 36 Set a new license Settings - Advanced 38 Change the maximum recording time Archive Displaying grouped studies 40 Group studies 40 Choose the view mode 40 Set the default view Managing Studies 40 Importing a study 40 Import multiple studies 41 Exporting a study 41 Using the Add and Remove buttons 41 Optimizing the study size 41 Removing a study Export Aggregate Results 41 Exporting Aggregate Results Managing Documents and re-analyzing video clips 42 Re-analyzing a video clip 42 Duplicating a document 42 Deleting a document New Study 43 Create a new study Flow Mediated Dilation Video window Diameter ROI 46 Draw a new ROI: 46 Change the ROI: 46 Move the ROI: 46 Re-initialize the edge detection algorithm: Doppler Flow ROI 47 Change the ROI: 47 Move the ROI: Video controls bar 48 Adjust the image 48 Control the playback of a movie Control Panel 49 Description of the controls: 49 Warning about duration of the video source 49 Copyright Quipu srl 4

5 7.6. Calibration of the images. 50 Calibrate 50 Save a default calibration value Data Display 51 Description of the display data: Instantaneous diameter chart Mean diameter chart Time averaged positive shear rate chart FMD Document 53 Export the document. 53 Export data. 53 Export instantaneous diameter data. 53 Print the document Mean diameter chart Time averaged positive shear rate chart 56 Move the cursors Results display Video window 58 Synchronize video and data Instrument for Doppler flow analysis GTN Induced Dilation Mean diameter chart GTN Document 62 Export the document. 62 Export data. 62 Print the document Mean diameter chart 63 Remove the outliers 63 Move the cursors Results Display Carotid Analysis Video window Region of Interest (ROI) 67 Draw a new ROI: 67 Change the ROI: 67 Move the ROI: Controls panel 68 Description of the controls: 68 Warning about duration of the video source Calibration of the images 69 Calibrate 69 Save a default calibration value Data display 70 Description of the display data: Pressures panel Diameter chart IMT chart Processing a carotid scan. 72 Copyright Quipu srl 5

6 Acquisition of a sequence of data Carotid Analysis Document 73 Export the document. 73 Export data. 73 Print the document Diameter chart 74 Remove the outliers IMT chart 75 Remove the outliers Results display References Papers Contacts Notes Warnings Appendix A - Evaluation Software Evaluation license 80 MOBILE_EVALUATION license 80 WEB_EVALUATION license Activating a WEB_EVALUATION license 80 Copyright Quipu srl 6

7 1. Installation CAUTION: It is recommended to perform regular backups of the system as indicated in paragraph 1.8 Backup. The non-operation of the backup could result in permanent data loss Hardware Requirements Cardiovascular Suite can be installed on Apple computer (1). Minimum Requirements Apple Mac Computer with: Intel Core 2 Duo 2,53 GHz, 4GB RAM, 250GB Hard Disk, 1280x800 monitor resolution. Mac OS X 10.9 or later. Video converter (optional) Grass Valley - Canopus ADVC55 hardware video converter (to capture S-Video and Composite video sources) (2). or Epiphan - DVI2USB 3.0 hardware video converter (to capture VGA, DVI and HDMI video sources) (3). (1) Products shall bear CE Marking indicating compliance with the 89/366/EEC. (2) Firewire port (or Thunderbolt port with Firewire adapter) is required. (3) Also compatible with the following models: Epiphan - VGA2USB LR (to capture VGA video sources) ed Epiphan - DVI2USB Solo (to capture DVI and HDMI video sources). Copyright Quipu srl 7

8 1.2. Software installation The software installation follows the usual procedure of installing software on Mac OS X. In Mac OS X 10.9 and later, make sure that the Security and Privacy options allow you to open any app, regardless of their origin. This option is available in System Preferences - Security & Privacy - General - Allow applications downloaded from -> Anywhere. For information or support please contact Quipu Installation Insert the Cardiovascular Suite CD-ROM / Pen-Drive, or mount the Cardiovascular Suite CD-ROM image file (*.dmg file) on your desktop. Step 1: Double-click on the Fonts icon (1) and follow the given instructions to complete the Fonts installation. Step2: Double-click on the Perian icon (2) and follow the given instructions to complete the Perian installation. When asked, choose Install for all users of this computer. Step 3 (optional): If you are to use an Epiphan video converter, double-click on the Epiphan icon (3) and follow the given instructions to complete the Epiphan s driver installation. Step 4: Copy Cardiovascular Suite (4) into the Application Folder (4). Eject the Cardiovascular Suite CD-ROM / Pen-drive, or unmount the Cardiovascular Suite CD-ROM image file. Copyright Quipu srl 8

9 In the Mac OS X System Preferences, open the Epiphan panel. Set the following values: Video Resolution: Fixed 800x600 Default Frame Rate: 25 Run Cardiovascular Suite from your Application Folder. WARNING: Failure / Incomplete / incorrect installation makes it not possible to use the software. Copyright Quipu srl 9

10 1.3. License Cardiovascular Suite comes with three types of licenses (for Evaluation Version, please see Appendix A): MOBILE_PERPETUAL license It 'a perpetual license contained within a Dongle-Key. The Dongle-Key must be inserted into the computer where it is executed Cardiovascular Suite. The same license can be used on different computers but NOT at the same time. The MOBILE_PERPETUAL license comes with an upgrades expiration date. By that date, you are entitled to receive and run any new versions of the software (Upgrades). After that date, you can run (no time limit) versions of the software already in your possession. WARNING: The Dongle-Key contains your license. Store it in a safe place in order to avoid loss and / or theft. MOBILE_TIME license It 'a temporary license contained within a Dongle-Key. The Dongle-Key must be inserted into the computer where it is executed Cardiovascular Suite. The same license can be used on different computers but NOT at the same time. The MOBILE_TIME license comes with an expiration date: after the expiration date, it is no longer possible to run the program or access the data. WARNING: The Dongle-Key contains your license. Store it in a safe place in order to avoid loss and / or theft. NODE-LOCKED license It 'a perpetual license contained within the computer where it is executed Cardiovascular Suite. The license does not require any external device. WARNING: the license is permanently connected to a computer and you can not transfer this license to a new computer. For more information about evaluation license, please read the document QP105EN: END-USER LICENSE AGREEMENT FOR CARDIOVASCULAR SUITE ULTRASOUND EDITION contained on the installation CD. At startup, Cardiovascular Suite checks if a Dongle Key is inserted and, if present, use the license contained in it. If there is no Dongle Key, Cardiovascular Suite searches for a Node-Locked license. If there is no Node-Locked license, the program asks you to activate a license. For information on your license see Settings - License Key. Copyright Quipu srl 10

11 Updating a license based on a Dongle Key The licenses based on a Dongle Key can be updated via an update code given by Quipu. Insert the Dongle-Key in your computer. Run the Dinkey Change software that is in the Extras folder in the installation CD. Enter the update code in the update window (1). Click on the Make changes to dongle button. After a few seconds, the program will warn you that the update was successful and will returns a confirmation code (2). 1 2 Copyright Quipu srl 11

12 Activation of a NODE-LOCKED license At startup, Cardiovascular Suite checks if a license is preset. If a license is not found, Cardiovascular Suite requires registration of the product. The Cardiovascular Suite Registration Assistant window shows the Activation Key (1) to be sent to Quipu via , support@quipu.eu, to obtain the License Key. This code must be entered to register the software. Get your license Start Cardiovascular Suite. If the software is not registered, the Cardiovascular Suite Registration Assistant is shown. Press the Copy and Send Activation Key button. The default program will open with an addressed to support@quipu.eu and contains the activation key. Within 24 hours you will receive an containing the license key. Enter the license key Start Cardiovascular Suite. If the software is not registered, the Cardiovascular Suite Registration Assistant is shown. Press the Enter License Key... button. In Cardiovascular Suite Registration window, enter the name of the person/institution that is registering the product and enter the license key. Confirm with Register. Copyright Quipu srl 12

13 1.4. How to connect Cardiovascular Suite to the ultrasound system. To connect the computer with the ultrasound apparatus requires a video converter. Quipu recommends two different solutions depending on the type of video output that is available on the system. For information on the availability and standard of the video, please contact the manufacturer of the ultrasound apparatus. Video Standard S-Video / Composite Video Suggested Video Converter Grass Valley s Canopus ADVC-55 VGA/ DVI / HDMI Epiphan's DVI2USB 3.0 Cardiovascular Suite is also compatible with the following video converters: Epiphan - VGA2USB LR to capture VGA video sources. Epiphan - DVI2USB Solo to capture DVI and HDMI video sources. Additional technical information on how to connect the computer to the ultrasound apparatus and on the compatible video standards can be found on the website CAUTION: The scanner must be in accordance with the European Medical Device Directive 93/42/EEC. Copyright Quipu srl 13

14 Connecting to S-Video or Composite Video with Grass Valley Canopus ADVC-55 S-Video Output / Composite Video Output FireWire / Thunderbolt Connect your computer to the video converter via the FireWire cable. If your computer has a Thunderbolt port, you must use a Thunderbolt-FireWire adapter. The lighting of the red LED indicates proper connection between computers and video converter. Connect the video converter to the ultrasound device via the S-Video cable or the composite video cable. The lighting of the green LED indicates proper connection between the ultrasound device and the video converter. LED Color OFF Red Status Video converter not connected to the computer. Video converter connected to the computer. - video signal not present Green Video converter connected to the computer. - video signal OK The video converter ADVC-55 has the DIP switches to set the video format: for PAL video format: set to ON the DIP Switch 1, set to OFF the DIP switch 2-6. for NTSC video format: set all DIP switches to OFF. ADVC-55 DIP Switch For more information about video converter Grass Valley Canopus ADVC-55, please see the manufacturer's instruction. Copyright Quipu srl 14

15 Connecting to VGA, DVI or HDMI with Epiphan DVI2USB 3.0 VGA/DVI/HDMI Output USB Connect your computer to the video converter via the USB cable. The lighting of the red LED indicates proper connection between computers and video converter. After a few seconds, the LED turns blue or green flashing to indicate proper connection between computers and video converter. Connect the video converter to the ultrasound device via the VGA, DVI or HDMI cable. The blue or green LED will continue to flash until you start capturing a video signal. During the acquisition of a video signal, the LED must be green. LED color OFF Red Flashing blue or green Green Status Video converter not connected to the computer. Video converter connected to the computer - driver not working Video converter connected to the computer - driver OK Acquisition of video signal. WARNING: the video converter must be connected directly to a USB port on your computer: Do not use hubs or the USB socket on the external keyboard. For more information about video converter Epiphan's DVI2USB 3.0, please see the manufacturer's instruction. Copyright Quipu srl 15

16 Connecting to VGA with Epiphan VGA2USB LR VGA Output USB Connect your computer to the video converter via the USB cable. The lighting of the red LED indicates proper connection between computers and video converter. After a few seconds, the LED turns green flashing to indicate proper connection between computers and video converter. Connect the video converter to the ultrasound device via the VGA cable. The green LED will continue to flash until you start capturing a video signal. During the acquisition of a video signal, the LED must be flashing red/green. If the LED is green and flashes rapidly, this indicates the lack of a VGA video signal. LED color OFF Red Flashing green Flashing red/green Fast flashing green Status Video converter not connected to the computer. Video converter connected to the computer - driver not working Video converter connected to the computer - driver OK Acquisition of video signal. Acquisition of video signal failed - VGA signal absent WARNING: the video converter must be connected directly to a USB port on your computer: Do not use hubs or the USB socket on the external keyboard. For more information about video converter Epiphan's VGA2USB LR, please see the manufacturer's instruction. Copyright Quipu srl 16

17 Connecting to DVI or HDMI with Epiphan DVI2USB Solo DVI Output / HDMI Output USB Connect your computer to the video converter via the USB cable. After a few seconds, the LED turns green flashing to indicate proper connection between computers and video converter. Connect the video converter to the ultrasound device via the DVI cable or the HDMI cable. The green LED will continue to flash until you start capturing a video signal. During the acquisition of a video signal, the LED must be flashing red/green. If the LED is blue, this indicates the lack of a DVI/HDMI video signal. LED color Status OFF Flashing green Flashing red/green Blue Video converter not connected to the computer or driver not installed Video converter connected to the computer - driver OK Acquisition of video signal. Acquisition of video signal failed - DVI/HDMI signal absent WARNING: the video converter must be connected directly to a USB port on your computer: Do not use hubs or the USB socket on the external keyboard. For more information about video converter Epiphan DVI2USB Solo, please see the manufacturer's instruction. Copyright Quipu srl 17

18 1.5. Using video clips for off-line analysis Video clips recorded on the ultrasound imaging device can be moved on the computer using a digital medium (flash pen drive, hard disk, CD ROM). Video files can be in video formats supported by QuickTime or DICOM 3 AVI MOV DICOM Copyright Quipu srl 18

19 1.6. How to set up the ultrasound system Cardiovascular Suite is based on image processing of a B-mode ultrasound scans. The quality of the results can depend on the quality of the ultrasound image supplied to the system. We recommend the use of a vascular probe with a frequency between 7MHz and 15MHz. The general settings of the ultrasound system must be those suggested by the manufacturer of the apparatus. It is important, however, exclude any noise reduction filters that could degrade the performance of the edge detection algorithm. In particular, it is important to exclude any time filters that cause a smoothing effect on the images in motion. These filters may have different designations (the most common name is persistence) depending on the model of ultrasound equipment. Please contact the manufacturer of ultrasound apparatus for information on how to exclude this type of filter. WARNING: Exclude any noise reduction filter (especially temporal filters). The artery should be viewed in longitudinal section and should be as horizontal as possible to the image. For Carotid Study we recommend an image depth of 3-4 cm. For FMD Studio we recommend an image depth of 2-3 cm. It is suggested also to choose a projection so that the vein is not visible (this normally appears immediately above the brachial artery). The algorithm for automatic tracking of the edges of the vessel could recognize the edge of the vein instead of the artery. Copyright Quipu srl 19

20 1.7. How to set up the ultrasound system in Duplex Mode (FMD Studio) The ultrasound system must be in Duplex mode (simultaneous acquisition of B-mode and Doppler) for the determination of both vessel diameter and shear rate. The angle between the Doppler beam and the vessel orientation should be 60 degrees. The sample volume should be as wide as possible but without encompassing the vessel walls and allowing for a slight margin for error in case of movement. Pay attention that the cursor of the doppler sample volume (1) is not into the ROI where the diameter is computed. It is recommended that the sample volume is 5-15 mm apart from the ROI. 1 WARNING: pay attention that nothing but the ultrasound image is into the ROI. Please note that the processing can be affected by annotations or any other graphical object that is superimposed to the image. In particular, pay attention that the cursor of the doppler sample volume is not into the ROI. The scale of the Doppler flow profile should be set correctly on the ultrasound system. The vertical scale must be large enough to include the velocity profile during all the examination (in FMD measurements, greater velocity values are in reactive iperemia). For the horizontal scale, we suggest a value of 3-4 seconds. Please note that the time average is computed over all the extend of the horizontal scale. The Doppler Flow ROI must cover all the extent of the Doppler flow profile. The zero flow axis (2) must be included in the ROI: it will be automatically recognized and plotted in green. The vertical axis (3) must be external to the ROI. Please also ensure that any annotation (4) is outside the ROI since it could affect the flow analysis. Copyright Quipu srl 20

21 3 2 4 WARNING: the processing can be affected by annotations or any other graphical object that is superimposed to the image into the Doppler Flow ROI. Please remember that the tool for the calculation of the shear rate must be re-calibrated every time you change the size or scale of the Doppler flow profile. This calibration is present in Settings - FMD Studio. It is recommended that the size or scale of the Doppler trace will be no longer changed once you have decided how to set up the ultrasound system. Copyright Quipu srl 21

22 1.8. Backup Cardiovascular Suite automatically backs up only of the archive index, as set in Settings - Security. For a complete backup of the archive you must use an external backup program. We recommend using Time Machine, Apple's backup system that works with your Mac and an external drive. For information about Time Machine, please consult the Mac OS X user guide or the website CAUTION: It is recommended that you back up your entire system after each use of Cardiovascular Suite Recommendations WARNING: The software may be distributed via CD-ROM or through write-protected USB Pen Drive. Use the CD-ROM in an environment with the following conditions of temperature and humidity: Operating temperature: C ( F). Humidity: % Use the USB Pen Drive in an environment with the following conditions of temperature and humidity: Operating temperature: C, ( F). Humidity: % We recommend that you do not expose the media to sunlight, UV, solvents and flammable media. It is recommended to protect the media by physically damages. The software is installed on a computer and it can be used in conjunction with an ultrasound device and a video converter. For the correct operation it is advisable to pay attention to environmental influences that may alter the operation of these accessories. For details, refer to the instructions provided by individual producers. The software must be used by trained and qualified personnel, such as laboratory technicians, nurses, physicians and / or sonographers, who have experience in acquisition and analysis of vascular ultrasound images. It is recommended that the user be aware of the meaning of the parameters measured and returned as a result from the device. It is recommended that the operator has not serious problems with vision and hearing. It is required knowledge of the mother tongue or, for those countries that allow it, of the English language. A visual impaired due to particular weather conditions, a visually impaired user, a not optimized brightness and/or not optimized resolution of the monitor may affect the correct interpretation of the results provided. Copyright Quipu srl 22

23 1.10.Extraordinary maintenance There are no updates of parts of the software. In case of correction of "bugs", the user is alerted via and the software must be re-installed in the usual manner described above. WARNING: Failure / incomplete / incorrect installation makes it not possible to use the software. Copyright Quipu srl 23

24 2. Home Screen To access Cardiovascular Suite you must log in with a username and password (1). You can add or edit the users through the Users button, which is the only button (2) active before the user is authenticated. NOTE: The default user present at the first start is: Username = root, Password = Description of main controls:: Users: manages users. Settings: sets the options of the program. Archive: manages the archives. New Study: add a new study. Manuals: open to the user manual. Quit: exit the program. Authenticate as a user Enter the username and password (1). If you forgot your password, press the Forgot Password? to get the password hint. Click Authenticate. The user icon appears in the status bar at the top right (3). Copyright Quipu srl 24

25 Disconnect a user Click on the user icon, located in the status bar at the top right (3). Select Disconnect. With the About Cardiovascular Suite button in the home screen, top left (4), you get information about the version of the software. Copyright Quipu srl 25

26 3. User Management Allows you to manage user accounts The user list is given in frame (1). Selecting one of active users, general information are shown in frame (2), account in frame (3) and permissions in frame(4). Add a new user: Click on the Add button, located below the user list (1). In the new user window (5), enter the user name and password and confirm the password. You can add a password hint (optional) and notes (optional). At the bottom of the window (5), grant permissions for the user. You can associate a picture to the user by the button Associate picture, choosing between a file ( Browse) or acquiring a new image from the webcam ( Capture). Click on the New button. Delete a user: Select the user to delete. Click on the Delete button below the list of users (1). Click on the Confirm button in the window (6) to confirm the deletion. Modify a user: Select the user to modify. Click on the Edit button below the list of users (1). Modify the user data in the window (5). Click on the Update button to confirm the changes. Copyright Quipu srl 26

27 Change the user password: Type your user name and password in (3). Click on the Change Password button. Enter and confirm the new password in the window (7). Click on the Update button Copyright Quipu srl 27

28 4. Settings This manages the Cardiovascular Suite settings. The buttons at the top of the window provide access to the various setting windows: Settings - General Settings - FMD Studio Settings - Carotid Studio Settings - Security Settings - License Key Settings - Advanced Restoring factory setting. The button Factory Setting restores the default setting of CardioVascular Suite. To restore the default settings: Click on the Factory Setting button. Confirm the action by clicking on the Proceed button. Copyright Quipu srl 28

29 4.1. Settings - General 1 2 The information of the Institute is displayed in frame(1). The folder where the Cardiovascular Suite archive is stored (archive folder) is in frame (2). Edit the information of the Institute: Click on the Edit button, next to the Institute information (1). Change the Institute information in the Institute window. You can associate a picture to the Institute by the button Associate picture, choosing between a file ( Browse) or acquiring a new image from the webcam ( Capture). Click on the Update button to confirm the changes. Change the Archive Folder Click on the Edit button, next to the Archive Folder (2). Choose the new Archive Folder location. WARNING: changing the folder location data, the archive may no longer be accessible. Copyright Quipu srl 29

30 Copyright Quipu srl 30

31 4.2. Settings - FMD Studio Frame (1) contains the settings for an examination of Flow Mediated Dilation: baseline, ischemia, and vasodilation times, the colors of the plots, the colors of the contours, activation and settings of the flow analysis instrument. Frame (2) contains the settings for an examination of GTN Induced Dilation: baseline and vasodilation times, the colors of the plots, the colors of the contours. In the frame (3) you can set the Acoustic Alert. In Flow Mediated Dilation, the system provides an audible alert at the end of the baseline (at the time when the cuff must be inflated to create ischemia) and at the end of ischemia (the time when the cuff must be deflated ). In GTN Induced Dilation, the system provides an audible alert at the end of the baseline (at the time the vasodilator drug should be administered). Change the timing of Flow Mediated Dilation / GTN Induced Dilation: Change baseline, ischemia, and vasodilation times using the buttons or by typing the values in text boxes. Click on the Apply button to confirm the changes. NOTE: The range of possible values are: baseline [ sec], ischemia [ sec], vasodilation [ sec]. Change the colors of plots in Flow Mediated Dilation / GTN Induced Dilation: Click on the Modify Color button of the section of the plot you want to change. Choose the new color. Copyright Quipu srl 31

32 Click on the Apply button to confirm the changes. Change the colors of the contours in Flow Mediated Dilation / GTN Induced Dilation: Click on the Modify Color button of the contour to be modified. Choose the new color. Click on the Apply button to confirm the changes. Set acoustic alerts: Select the Acoustic Alert tick box. Select the sound in the drop down menu. Click on the Apply button to confirm the changes. Enable / disable the calculation of the shear rate: Select / deselect the Shear Rate Detection tick box. Set the instrument for calculating the shear rate through doppler flow analysis: Click on the Edit Video device... or button and choose the video source that you want to use: select Data file... X-axis calibration Locate, on the x axis of the doppler flow profile, a known time period, which is 4 sec in the example in Figure (17). Click on the CAL X button (6). Select from the drop-down menu (8), the time period specified above. Plot on the x axis of the doppler flow profile, a line corresponding to the time period specified above: click on one point end and drag the mouse to the other extreme (press the Shift key on your keyboard to force the tracing of a horizontal line). Y-axis calibration Locate, on the y axis of the doppler flow profile, a known flow amount, which is 200cm/sec in the example in Figure (18). Click on the CAL Y button (7). Select from the drop-down menu (9), the flow amount specified above. Plot on the y axis of the doppler flow profile, a line corresponding to the flow amount specified above: click on one point end and drag the mouse to the other extreme (press the Shift key on your keyboard to force the tracing of a vertical line). Drawing the Doppler Flow ROI Click on the ROI button(5). Click on a corner of the doppler flow profile and drag until the Doppler Flow ROI is complete. As you draw the Doppler Flow ROI, the system automatically draw also the trace of the doppler flow profile (in cyan) and the zero line (in green). Changing the Doppler Flow ROI Click on one of the corners of the Doppler Flow ROI: the scaling handles (white circles) appear. Drag the scaling handles to change the size of the the Doppler Flow ROI. Copyright Quipu srl 32

33 Upon completion, the values of the average positive and negative velocities (cm/sec) are displayed by the displays (14) and (15) and the calibration values are displayed by the displays (10) and (11). Sensitivity adjustment Use the slider (12) to adjust the sensitivity of the Doppler flow analysis tool. The sensitivity value is shown on the display (13). Enable / disable the calculation of the negative velocity. Select / deselect the Compute negative value of Velocity tick box. Once all changes have been made : Close the window with the red button in the upper right. Click on the Apply button to confirm the changes cm/sec 17 4 sec Copyright Quipu srl 33

34 4.3. Settings - Carotid Studio Contains software settings for Carotid Studio: the time used for analysis. the colors of the contours for both the Lumen-Intima and the Media-Adventitia interfaces. Change the time of analysis: Change the time of analysis using the button or by typing the value in the text box. Click on the Apply button to confirm the changes. NOTE: The range of possible values is: [5...30sec]. Change the colors of the contours Click on the Modify Color button of the contour to be modified (Lumen-Intima or Media-Adventitia). Choose the new color. Click on the Apply button to confirm the changes. Copyright Quipu srl 34

35 4.4. Settings - Security 1 2 Contains the security settings of the suite. Frame (1) contains the backup options for the database index. In frame (2), set Automatic Login as Administrator to automatically enable the administrator login when the program starts (you no longer need to enter your login and password in the home screen). The option Lock Study Changes after... prevents to make changes to a study after a given number of days since its creation. Set the backup options for the database index Select close. When closing application to backup the database index every time the application is Select Every and type a value N in the text boxes to backup the database index every N days. Select pressed. On Demand to backup the database index every time the Backup Now button is Enable / disable automatic login as administrator Select / deselect the Automatic Login as Administrator tick box. Click on the Apply button to confirm the changes. Lock / unlock the changes of the studies Select / deselect the Lock Study Changes after... tick box. Change the number of days after which the study can not be modified using the button or by typing the value in the text boxes. Click on the Apply button to confirm the changes. Copyright Quipu srl 35

36 4.5. Settings - License Key Contains information about the software license. The window has a different content depending on whether you possess a license based on Dongle-Key or a NODE-LOCKED license. License based on a Dongle-Key The window contains: the type of license (MOBILE_PERPETUAL or MOBILE_TIME). the license number. the expiry date of the license (for licenses MOBILE_PERPETUAL the date refers to the date of expiry of upgrades. available modules (FMD Studio and / or Carotid Studio). NODE-LOCKED License The window contains: the name of the owner of the license. the Activation Key. available modules (FMD Studio and / or Carotid Studio). Copyright Quipu srl 36

37 From this window, you can change a NODE-LOCKED license. WARNING: changing the NODE-LOCKED license will cancel the original license. Make sure to have a valid license. Set a new license Click on the Change License Key... button. Click on the Proceed button to confirm the removal of the old license. In Cardiovascular Suite Registration window, enter the name of the person/institution that is registering the product and enter the license key. Confirm with Register. Click on the Apply button to confirm the changes. Copyright Quipu srl 37

38 4.6. Settings - Advanced WARNING: an incorrect setting of these parameters could affect the proper functioning of the system. 1 2 Frame (1) shows the setting of the video files recorded by Cardiovascular Suite when using the live video source. You can choose the codec and the quality of the video files. Frame (2) contains the recording time of temporary video files used by Carotid Studio. This time corresponds to the maximum time available to perform a single measure of Carodid Analysis. Change the maximum recording time Change the recording time by using the button. Click on the Apply button to confirm the changes. NOTE: The range of possible values is: [ sec]. Copyright Quipu srl 38

39 5. Archive The left frame of the window contains the list of studies. The studies can be shown in list or icons view. Each study is identified by a folder icon or, the latter when the study size has been optimized. Next to the icon (in the list view) or below the icon (the icon view) are some of the data from the study: patient name, sex, modality of the examination (FMD, GTN, CAR), date of creation of the examination, examination time. When you select a one of the studies, the right frame of the window shows the contents of the study. The upper part shows the name of the patient, the performing physician, the institute, the modality and the duration of the study. You can to click on the fields Patient, Performing physician and Institute to modify the data. Clicking on more info... you can change the study code, keywords, notes, and description of the study. The upper part of the frame contains the list of documents of the study. Each document is identified by an ultrasound image icon. Next to the icon are some of the data in the document. These data vary depending on the examination modality. Copyright Quipu srl 39

40 5.1. Displaying grouped studies The studies can be grouped according to five criteria: 1. by patient. 2. by performing Physician. 3. by Institute. 4. by examination modality. 5. by study code. When studies are grouped, the left frame of the window contains the list of groups. Each group can be expanded to display the list of studies contained within it. You can choose a default view that will be used each time you access the archive. Group studies Click on the Menu button. Select Group studies by... Select the grouping criteria Choose the view mode Click on the Menu button. Select View as... Select the list view or the icons view. Set the default view Choose the preferred grouping mode and view mode. Click on the Menu button. Select Save default view Managing Studies This section describes how export and import the studies from Cardiovascular Suite, how to optimize the size of a study and how to delete a study. Importing a study Click on the Menu button. Select Import study. Select the folder containing the study to be imported. Click on the Choose button. Copyright Quipu srl 40

41 Import multiple studies Click on the Menu button. Hold down the ALT key on your keyboard and select Import study. Select the folder containing the studies to be imported. Click on the Choose button. Select the studies to be imported. Click on the Import button. Exporting a study Select the study to be exported. Click on the Menu button. Select Export study. Select the folder where to export the study. Click on the Choose button. Using the Add and Remove buttons The buttons Add and Remove have different meanings depending on how the studies are grouped and depending on what is selected in the left frame of the Archive window. Hint: Use the pop up message of the button to check the meaning. Optimizing the study size Select the study to be optimized. Right click and select Removing a study Select the study to be removed. Right click and select Confirm with Delete. Optimize Study Size Remove Study Export Aggregate Results Results from a group of studies can be aggregated and exported in a single data file. This feature is active only when the studies are not grouped (see section 5.1). Exporting Aggregate Results Select the studies whose data is to be exported. Click on the Menu button. Select Export Aggregate Results. Choose the folder where to export the file and press the Save button. Copyright Quipu srl 41

42 5.4. Managing Documents and re-analyzing video clips This section describes how manage a document and how to create a new document in order to re-analyze a video clip. Re-analyzing a video clip Select the document whose data is to be re-analyzed. Click on the Document Actions button at the top of the documents list. Select Add document. A new analysis will start and a new document will be created at the end of the analysis. Duplicating a document Select the document to be duplicated. Click on the Document Actions button Select Duplicate document. at the top of the documents list. Deleting a document Select the document to be delated. Click on the Document Actions button Select Remove document. Confirm with Delete. at the top of the documents list. Copyright Quipu srl 42

43 6. New Study Create a new study. Required fields are in red. The New Study button is disabled until you have entered all the required data Create a new study Enter the patient personal data into the frame (1). In frame (2), enter the study information and choose the modality of: Flow Mediated Dilation; GTN Induced Dilation; Carotid Studio. Enter the name of the performing physician into the frame (3). If the name is already present in the archive, it will be in the drop-down menu. Otherwise you can type name (middle name) and last name, separated by a space. Enter the name of the Institute into the frame (4). If the Institute is already present in the archive, it will be in the drop-down menu. Otherwise you can type the name of the Institute. In frame (5), choose the video source between Video Device (for external source, such as ultrasound equipment) or Video File (in the case of data recorded on a digital medium, eg. Flash pen drive, hard disk, CD ROM ). Video files can be in video formats supported by QuickTime or DICOM 3. The maximum allowable size for video images is 1200x800 pixels. Click on the New Study button on the bottom right of the window (6). Copyright Quipu srl 43

44 7. Flow Mediated Dilation Make an examination of Flow Mediated Dilation Components description: 1. Video window 2. Controls panel 3. Data display 4. Instantaneous diameter chart 5. Mean diameter chart 6. Positive shear rate chart (Note: the chart is present only if you selected Shear Rate Detection in Settings FMD Studio) Copyright Quipu srl 44

45 7.1. Video window The video window shows the video signal from your ultrasound system. Two ROIs (1) (2) are present in the window: the diameter ROI and the doppler flow ROI (*). The video controls bar is at the bottom of the window (3). (*) The doppler flow ROI is present in Flow Mediated Dilation exams only if the Shear rate detection options is selected in Settings - FMD Studio. Copyright Quipu srl 45

46 7.2. Diameter ROI The Diameter Region of Interest (ROI) is the portion of the image where the diameter is calculated. Two edges of the vessel obtained by the algorithm of edge detection are displayed within the ROI. The ROI can be moved and/or resized. Each time you change the position and/or size of the ROI, the contours of the vessel are re-initialized. Draw a new ROI: Click on the ROI button in the Control panel (button remains active). Click inside the video window and drag until the ROI is complete (the size of ROI is shown into the Data display). When you release the mouse, the contours are initialized, the ROI button in the Control Panel is disabled, the PROCESS button in the Control Panel becomes active and processing starts. Change the ROI: Click on one of the corners of the Diameter ROI: the scaling handles (white circles) appear. Drag the scaling handles to change the size of the the Diameter ROI (the size of ROI is shown into the Data display). Move the ROI: Click and hold inside the ROI. Drag the ROI to the location of interest. Re-initialize the edge detection algorithm: Click into the ROI. Copyright Quipu srl 46

47 7.3. Doppler Flow ROI The Doppler Flow Region of Interest is present in the video window if the PROCESS button of the Control Panel is pressed and the Shear rate detection options is selected in Settings - FMD Studio. The perimeter of the ROI-flow is drawn in red, the zero line is drawn in green, the doppler flow envelope is drawn in cyan. The Doppler Flow ROI can be moved or resized in order to allow little adjustment during the analysis. Please remember that the instrument for calculating the shear rate through doppler flow analysis must be calibrated before starting the examination. This calibration is present in Settings - FMD Studio. It is recommended that the size or scale of the Doppler trace will be no longer changed once you have decided how to set up the ultrasound system. WARNING: The tool for the calculation of the shear rate must be re-calibrated every time you change the size or scale of the Doppler flow profile. The lack of calibration can generate a software malfunction. Change the ROI: Click on one of the corners of the Doppler Flow ROI: the scaling handles (white circles) appear. Drag the scaling handles to change the size of the the Doppler Flow ROI. Move the ROI: Click and hold inside the ROI. Drag the ROI to the location of interest. Copyright Quipu srl 47

48 7.4. Video controls bar The video control bar is at the bottom of the video window and contains controls to manage the playback of a movie and the brightness and contrast adjustment. Adjust the image Drag the brightness slider Drag the contrast slider to adjust the brightness of the image. to adjust the contrast of the image. Control the playback of a movie Click on the Play/Pause buttons to play/pause the movie; Click on the Step forward button to advance an image; Click on the Step backward button to move back one image; Click on the End button to move forward until the end of the movie; Click on the Start button to return to the beginning of the movie; Drag the time slider to move to any part of the movie. Copyright Quipu srl 48

49 7.5. Control Panel The control panel allows you to perform the operations necessary to carry out an examination of Flow Mediated Dilation. Description of the controls: 1. CALIB: enters in calibration mode. 2. ROI: draw a new diameter ROI. 3. PROC: enable/disable the image processing. 4. REC: enable/disable recording. 5. RESET: remove the current registration. Warning about duration of the video source A warning message will be shown under the Control panel in the case where the source used is a video file and its duration is shorter than the Recording time set in the Settings - FMD Studio. Copyright Quipu srl 49

50 7.6. Calibration of the images. The calibration of the images must be done before starting a new examination because it is necessary to provide information about the size of the image generated by ultrasound system. The calibration factor changes depending on the settings of your ultrasound machine. You can save a default calibration value that will be used when you start a new examination. However, you should redo the calibration at each new examination. WARNING: the lack of calibration can generate a software malfunction. Calibrate Locate, in ultrasound image, a range of known distance (10 mm. in the example of figure). Click on the CALIB button (1) in the Controls panel (button remains active). Select from the drop-down menu (7), the distance specified above. Draw a line on the image corresponding to the known distance: click on one end and drag the mouse to the other extreme (press the Shift key on your keyboard to force the tracking of a vertical or horizontal line). 10mm Save a default calibration value Perform the calibration. Click on the Save as default button (6) Copyright Quipu srl 50

51 7.7. Data Display The data display shows the results of the examination Description of the display data: 1. CAL: calibration factor [pixel/mm]. If you have not already calibrated, the display shows the value of default calibration in red. 2. ROI: size (width, height) of the Diameter Region of Interest [mm]. 3. SRTAP: time averaged positive shear rate [s -1 ]. (*) 4. SRTAN: time averaged negative shear rate [s -1 ]. (*) 5. DIAM: mean diameter [mm]. 6. TIME: exam time [minutes: seconds] (*) The shear rate is present only if the Shear rate detection options is selected in Settings - FMD Studio Instantaneous diameter chart This chart shows the diameter changes within the cardiac cycle. The correct form of this chart is an index of measurement quality. The chart will automatically scale and the values shown are the extremes of the scale. Copyright Quipu srl 51

52 7.9. Mean diameter chart The chart shows the trend of the mean diameter during the examination. The chart is divided into three parts: basal (1), ischemia (2) and vasodilation (3). The timing and the colors of the three parts can be customized in Settings - FMD Studio. Using the buttons at the bottom right (4) you can move up or down the chart, enlarge or reduce the vertical scale Time averaged positive shear rate chart The graph shows the trend of the time averaged positive shear rate during the examination. The chart is divided into three parts in a similar manner to the graph of the mean diameter. Copyright Quipu srl 52

53 8. FMD Document The document produced by an examination of Flow Mediated Dilation consists of the following parts: 1. Mean diameter chart. 2. Time averaged positive shear rate chart. 3. Video window. 4. Results display. Export the document. Click on the Study Actions button at the bottom right corner of the document. Select Export document as... Choose the format in which you want to export. Choose the folder where to export the file and press the Save button. Export data. Click on the Study Actions button at the bottom right corner of the document. Select Export data as... Choose the format in which you want to export. Choose the folder where to export the file and press the Save button. Export instantaneous diameter data. Right click on the video window (3). Select Export Instant Diameters. Choose the folder where to export the file and press the Save button. Copyright Quipu srl 53

54 Print the document. Click on the Study Actions button Select Print. at the bottom right corner of the document. Copyright Quipu srl 54

55 8.1. Mean diameter chart The graph shows the trend of the mean diameter during the examination. The chart is divided into three parts: basal, ischemia, and vasodilation. On the chart there are three horizontal cursors that represent: the value of the baseline diameter (1), the maximum diameter during vasodilation (2), the value of the baseline diameter after vasodilation (3). The cursors can be moved vertically by clicking and dragging with the mouse. Pressing the ALT key on the keyboard and moving the mouse along the curve of the diameter, you will see the value of the diameter at the point. Simultaneously pressing ALT and CMD, will show both the value of the diameter and the value of time. Using the buttons at the top right (4) you can move up or down the chart, enlarge or reduce the vertical scale. The chart can be moved up and down also by using the scroll bar located on the right of the graph (5). Top Left (6) are: the Cut button to remove diameter values that are considered outliers; the Undo button to cancel previous operation and the Sync button to display the movie video clip synchronize with the data. Copyright Quipu srl 55

56 8.2. Time averaged positive shear rate chart The chart shows the the trend of the shear rate during the examination. The chart is divided into three parts: basal, ischemia, and vasodilation. On the chart there are three cursors that represent: the value of the baseline shear shearrate (1), this slider is also represented in vasodilation that delimits the area under the curve; the maximum shear rate during vasodilation (2); the time corresponding to the maximum value of the diameter (3), this cursor defines the area under the curve up to the maximum diameter. The cursors can be moved vertically or horizontally by clicking and dragging with the mouse. Pressing the ALT key on the keyboard and moving the mouse along the curve of the shear rate, you will see the value of the shear rate at the point. Simultaneously pressing ALT and CMD, will show both the value of the shear rate and the value of time. Move the cursors The cursors of both the mean diameter chart and the shear rate chart can be shifted manually. The shift is affects the results shown in the results display. Click with left mouse button to move the cursor. Hold down the mouse button and drag the mouse to the new location. Release the left mouse button. Copyright Quipu srl 56

57 8.3. Results display The display shows the results of the examination Description of the results display: 1. D Baseline [mm]: value of the baseline diameter. 2. D Maximum [mm]: value of the maximum diameter during vasodilation. 3. D Recovery [mm]: diameter value in the recovery phase after vasodilation. 4. FMD [%]: Flow Mediated Dilation. FMD = D massimo D basale D basale 5. FMDr [%]: Flow Mediated Dilation calculated in relation to the diameter in the recovery phase after vasodilation. FMDr = D massimo D recupero D recupero 6. SR Baseline [s -1 ]: baseline value of the shear rate. 7. SR Maximum [s -1 ]:maximum value of the shear rate. 8. SR Area [dimensionless]: area under the curve of the shear rate, calculated for the range of vasodilation and with reference to the baseline value of the shear rate. 9. SR Area to max [dimensionless]: area under the curve of the shear rate, calculated from the end of ischemia at maximum vasodilation, and with reference to the baseline value of the shear rate. SR Area SR Area to max 10.CAL [pixel/mm]: calibration factor. Copyright Quipu srl 57

58 8.4. Video window The video window shows the video signal from the ultrasound system and the computed contours. Using the video controls bar, which is located at the bottom of the window, you can control playback of your movie and adjust the brightness and contrast. You can expand the video window by right clicking and choosing Detach Video Window. The movie will be expanded in a floating window that overlays the FMD document. Moving the mouse outside the video window, this will become translucent allowing you to see the underlying FMD document. Synchronize video and data 1. Press the Sync button, located on the upper left of the mean diameter chart. The mean diameter charts and the shear rate charts will show a yellow marker current time on the video window. 2. Click the mouse and drag the yellow marker to navigate using the chart. 3. Use the video control bar to navigate using the video window. that identifies the Copyright Quipu srl 58

59 9. Instrument for Doppler flow analysis The instrument computes the envelope of the Doppler flow velocity waveform over the time interval defined by the Doppler Flow ROI. The result is used to compute the Time Average Wall Shear Rate. We assume the velocity profile to be parabolic and we assume that the Doppler flow analysis provides the maximum value (V) of the velocity profile (i.e. the maximum spatial velocity). In fact, the analysis is based only on the Doppler flow envelope because the video image data does not give information on the velocity profile of the vessel. With this assumptions, the Shear Rate (SR) can be computed as: SR = 4 V d where d is the diameter of the vessel. The doppler flow analysis instrument computes two values for velocity: V TAP : time averaged of the positive values of V. V TAN : time averaged of the negative values of V. Both the averages are computed over the Doppler Flow ROI. V TAP V TAN These two values are used to compute the Shear Rate as: SR TAP : Time Average Positive wall Shear Rate. SR TAN : Time Average Negative wall Shear Rate. You can choose the instrument will compute only the positive value or both the positive and the negative values (please see Settings - FMD Studio ). Note: the possibility of computing both the positive and the negative flow velocity may depend on the settings of the ultrasound system. Copyright Quipu srl 59

60 10.GTN Induced Dilation Make an examination of GTN Induced Dilation Components description: 1. Video Window (*) 2. Controls panel (*) 3. Data display (*) 4. Instantaneous diameter chart (*) 5. Mean diameter chart (*) For a description of these parts, see sections 7.1, 7.5, 7.7 and 7.8 of this manual. Copyright Quipu srl 60

61 10.1.Mean diameter chart The chart shows the trend of the mean diameter during the examination. The chart is divided into two parts: basal (1) and vasodilation (2). The timing and the colors of the three parts can be customized in Settings - FMD Studio. Using the buttons at the bottom right (3) you can move up or down the chart, enlarge or reduce the vertical scale. Copyright Quipu srl 61

62 11.GTN Document The document produced by an examination of GTN Induced Dilation consists of the following parts: 1. Video window. (*) 2. Mean diameter chart. 3. Results display. (*) For a description of this part, see section 8.4 of this manual. Export the document. Click on the Study Actions button at the bottom right corner of the document. Select Export document as... Choose the format in which you want to export. Choose the folder where to export the file and press the Save button. Export data. Click on the Study Actions button at the bottom right corner of the document. Select Export data as... Choose the format in which you want to export. Choose the folder where to export the file and press the Save button. Print the document. Click on the Study Actions button Select Print. at the bottom right corner of the document. Copyright Quipu srl 62

63 11.1.Mean diameter chart The graph shows the trend of the mean diameter of the diameter during the examination. The chart is divided into two parts: basal and vasodilation. On the chart there are two horizontal cursors that represent: the value of the baseline diameter (1) and the maximum diameter during vasodilation (2). The cursors can be moved vertically by clicking and dragging with the mouse. Pressing the ALT key on the keyboard and moving the mouse along the curve of the diameter, you will see the value of the diameter at the point. Simultaneously pressing ALT and CMD, will show both the value of the diameter and the value of time. Using the buttons at the top right (3) you can move up or down the chart, enlarge or reduce the vertical scale. The chart can be moved up and down also by using the scroll bar located on the right of the graph (4). Top right (3) are also: the Cut button to remove diameter values that are considered outliers; the Undo button to cancel previous operation and the Synch button to display the movie video clip synchronize with the data. Remove the outliers The procedure allows you to manually delete the values that are considered ouliers. Click on the Cut button located on upper right of the graph of the mean diameter. Click on one of the two extremes of the range to delete. Drag the mouse horizontally to the other extreme of the range to delete. Note: If you wish to cancel, press the Undo button. Note: To save changes to the document, press the Save document button. Move the cursors The cursors of the mean diameter chart can be shifted manually. The shift is affects the results shown in the results display. Click with left mouse button to move the cursor. Hold down the mouse button and drag the mouse to the new location. Release the left mouse button. Copyright Quipu srl 63

64 11.2.Results Display The display shows the results of the examination Description of the results display: 1. D Baseline [mm]: value of the baseline diameter. 2. D Maximum [mm]: value of the maximum diameter during vasodilation. 3. GTN [%]: GTN Induced Dilation. 4. CAL [pixel/mm]: calibration factor. GTN = D maximum D baseline D baseline Copyright Quipu srl 64

65 12.Carotid Analysis Make an examination of carotid Analisys Components description: 1. Video window 2. Controls panel 3. Data display 4. Pressures panel 5. Diameter chart 6. IMT chart Copyright Quipu srl 65

66 12.1.Video window 1 2 The video window shows the video signal from your ultrasound system and the ROI (1) where both the IMT and the diameter are computed. The video controls bar is at the bottom of the window (2). Copyright Quipu srl 66

67 12.2.Region of Interest (ROI) The Region of Interest (ROI) is the portion of the image where both the diameter and the IMT are calculated. Within the ROI, the Lumen-Intima interface and the Media-Adventitia interface are shown in the colors set in Settings - Carotid Studio. The ROI can be moved and/or resized. Draw a new ROI: Click on the ROI button in the Controls Panel (button remains active). Click inside the video window and drag until the ROI is complete (the size of ROI is shown into the Data display). When you release the mouse, the contours are initialized, the ROI button in the Control Panel is disabled, the PROCESS button in the Controls Panel becomes active and processing starts. Change the ROI: Click on one of the corners of the Diameter ROI: the scaling handles (white circles) appear. Drag the scaling handles to change the size of the the Diameter ROI (the size of ROI is shown into the Data display). Move the ROI: Click and hold inside the ROI. Drag the ROI to the location of interest. Copyright Quipu srl 67

68 12.3.Controls panel The control panel allows you to perform the operations necessary to carry out an examination of Carotid Analysis. Description of the controls: 1. CALIB: enters in calibration mode. 2. ROI: draw a new ROI. 3. SAVE: save data. 4. RESET: remove the current registration. Warning about duration of the video source A warning message will be shown under the Controls panel in the case where the source used is a video file and its duration is shorter than the Time of analysis set in the Settings - Carotid Studio. Copyright Quipu srl 68

69 12.4.Calibration of the images The calibration of the images must be done before starting a new examination because it is necessary to provide information about the size of the image generated by ultrasound system. The calibration factor changes depending on the settings of your ultrasound machine. You can save a default calibration value that will be used when you start a new examination. However, you should redo the calibration at each new examination. WARNING: the lack of calibration can generate a software malfunction. Calibrate Locate, in ultrasound image, a range of known distance (10 mm. in the example of figure). Click on the CALIB button (1) in the Controls panel (button remains active). Select from the drop-down menu (6), the distance specified above. Draw a line on the image corresponding to the known distance: click on one end and drag the mouse to the other extreme (press the Shift key on your keyboard to force the tracking of a vertical or horizontal line). 10mm Save a default calibration value Perform the calibration. Click on the Save as default button (5) Copyright Quipu srl 69

70 12.5.Data display The data display shows the results of the examination Description of the display data: 1. CAL: calibration factor [pixel/mm]. If you have not already calibrated, the display shows the value of default calibration in red. 2. ROI: size (width, height) of the Diameter Region of Interest [mm]. 3. DIAM: mean diameter [mm]. 4. IMT: intima media thickness [mm]. 5. TIME: exam time [minutes: seconds] 12.6.Pressures panel In this panel you can enter the values of diastolic and systolic pressure [mmhg]. Copyright Quipu srl 70

71 12.7.Diameter chart This chart shows the diameter changes within the cardiac cycle. The extension of the time scale is equal to the Time of analysis, set in Settings - Carotid Studio IMT chart This chart shows the IMT small changes within the cardiac cycle. The extension of the time scale is equal to the Time of analysis, set in Settings - Carotid Studio. Copyright Quipu srl 71

72 12.9.Processing a carotid scan. Once you place an ROI, the system begins to process the images automatically updating the Data display, the Diameter chart and the IMT chart. When the quality of the results is satisfactory, the user can press the Save button on the Controls panel to save the last seconds of processed data. The duration of the time of analysis can be set from Settings - Carotid Studio. You can save different sequences of data within the same study. Each sequence of data will be saved in a document of the study. Acquisition of a sequence of data 1. Make sure you have previously calibrated. 2. Place the ROI. 3. Wait until the analysis is satisfactory. 4. Click on the Save button in the Controls panel. 5. Check the diameter chart and the IMT chart are satisfactory.. 6. If so, enter a description of the sequence data and press Save. Otherwise press the Delete button. Copyright Quipu srl 72

73 13.Carotid Analysis Document The document produced by an examination of Carotid Analysis consists of the following parts: 1. Diameter chart. 2. IMT chart. 3. Video window. 4. Results display. Export the document. Click on the Study Actions button at the bottom right corner of the document. Select Export document as... Choose the format in which you want to export. Choose the folder where to export the file and press the Save button. Export data. Click on the Study Actions button at the bottom right corner of the document. Select Export data as... Choose the format in which you want to export. Choose the folder where to export the file and press the Save button. Print the document. Click on the Study Actions button Select Print. at the bottom right corner of the document. Copyright Quipu srl 73

74 13.1.Diameter chart The graph shows the trend of the diameter during the examination. Pressing the ALT key on the keyboard and moving the mouse along the curve of the diameter, you will see the value of the diameter at the point. Simultaneously pressing ALT and CMD, will show both the value of the diameter and the value of time. Top Left (6) are: the Cut button to remove diameter values that are considered outliers; the Undo button to cancel previous operation and the Sync button to display the movie video clip synchronize with the data. Remove the outliers The procedure allows you to manually delete the values that are considered ouliers. Click on the Cut button located on upper left of the graph of the diameter. Click on one cardiac cycle to delete. Note: If you wish to cancel, press the Undo button. Note: To save changes to the document, press the Save document button. Copyright Quipu srl 74

75 13.2.IMT chart The graph shows the trend of the IMT during the examination. Pressing the ALT key on the keyboard and moving the mouse along the curve of the IMT, you will see the value of the IMT at the point. Simultaneously pressing ALT and CMD, will show both the value of the IMT and the value of time. Remove the outliers The procedure allows you to manually delete the values that are considered ouliers. Click on the Cut button located on upper left of the graph of the diameter. Click on one of the two extremes of the range to delete. Drag the mouse horizontally to the other extreme of the range to delete. Note: If you wish to cancel, press the Undo button. Note: To save changes to the document, press the Save document button. Copyright Quipu srl 75

76 13.3.Results display Description of the contents of the results display: 1. Mean diameter [mm]: value of the average diameter. 2. Diastolic diameter [mm]: value of the diameter in diastole. 3. IMT [mm]: Intima media Thickness. 4. Distension [mm]: stroke change in diameter. Distension = ΔD = D s D d 5. Blood pressure [mmhg]: Dia = diastolic pressure; Sys = systolic pressure. 6. Compliance [10-6 m 2 kpa -1 ]: absolute change in lumen area during systole for a given pressure change. Compliance = ΔA ΔP = π 4 D 2 2 s D d P s P d 7. Distensibility [10-3 kpa -1 ]: relative change in lumen area during systole for a given pressure change. Distensibility = 1 ΔA A d ΔP = 1 D D 2 2 s D d 2 d P s P d 8. Carotid Stiffness [m s -1 ]: Stiffness value computed by Bramwell-Hill equation. Stiffness = 1 ρ Distesibility = 9. Young s elastic module [kpa]: ModuloYoung = 10.CAL [pixel/mm]: calibration factor. A d ΔP ρ ΔA = 3 Distensibility 1 + A d WCSA D 2 d (P s P d ) ρ (D 2 s D 2 d ) Note: D e = External Diameter (between the media-adventitia interfaces) measured in diastole. D i = Internal Diameter (between the lumen-intima interfaces) measured in diastole. Copyright Quipu srl 76

77 D s = Systolic Diameter (external). D d = Diastolic Diameter (external), D d = D e. WCSA = π 4 (D 2 e D 2 i ) = Wall Cross Section Area. ΔD = D s D d = Stroke change in diameter. ΔA = π 4 (D 2 s D 2 d ) A d = π 4 D 2 d P s = Systolic Pressure. = Diastolic Area. = Stroke change in lumen area. P d = Diastolic Pressure. ρ = Blood density: is assumed to be constant and equal to 1.06 g/cm3. Copyright Quipu srl 77

78 14.References 14.1.Papers Gemignani V, Faita F, Ghiadoni L, Poggianti E, Demi M. A system for real-time measurement of the brachial artery diameter in B-mode ultrasound images. IEEE Trans Med Imaging Mar; 26(3): Gemignani V, Bianchini E, Faita F, Giannarelli C, Plantinga Y, Ghiadoni L, Demi M. Ultrasound measurement of the brachial artery flow-mediated dilation without ECG gating Ultrasound Med Biol Mar;34(3): Epub 2007 Oct 26. Faita F, Gemignani V, Bianchini E, Giannarelli C, Ghiadoni L, Demi M. Real-time measurement system for evaluation of the carotid intima-media thickness with a robust edge operator. J Ultrasound Med Sep;27(9): Bianchini E, Bozec E, Gemignani V, Faita F, Giannarelli C, Ghiadoni L, Demi M, Boutouyrie P, Laurent S. Assessment of carotid stiffness and intima-media thickness from ultrasound data: comparison between two methods. J Ultrasound Med Aug;29(8): Faita F, Masi S, Loukogeorgakis S, Gemignani V, Okorie M, Bianchini E, Charakida M, Demi M, Ghiadoni L, Deanfield JE. Comparison of two automatic methods for the assessment of brachial artery flow-mediated dilation. J Hypertens Jan;29(1): Ghiadoni L, Faita F, Salvetti M, Cordiano C, Biggi A, Puato M, Di Monaco A, De Siati L, Volpe M, Ambrosio G, Gemignani V, Muiesan M, Taddei S, Lanza GA, Cosentino F. Assessment of Flow- Mediated Dilation Reproducibility: a Nationwide Multicenter Study". J Hypertens Charakida M, Masi S, Lüscher TF, Kastelein JJ, Deanfield JE. Assessment of atherosclerosis: the role of flow-mediated dilatation. Eur Heart J Dec;31(23): Epub 2010 Sep 23. Yeboah J, Crouse JR, Hsu FC, Burke GL, Herrington DM. Brachial flow-mediated dilation predicts incident cardiovascular events in older adults: the Cardiovascular Health Study. Circulation May 8;115(18): Epub 2007 Apr 23. O'Leary DH, Bots ML. Imaging of atherosclerosis: carotid intima-media thickness. Eur Heart J Jul;31(14): Epub 2010 Jun 11. Mattace-Raso FU, van der Cammen TJ, Hofman A, van Popele NM, Bos ML, Schalekamp MA, Asmar R, Reneman RS, Hoeks AP, Breteler MM, Witteman JC. Arterial stiffness and risk of coronary heart disease and stroke: the Rotterdam Study. Circulation Feb 7;113(5): Contacts Address Telephone Web Quipu srl (+39) via Moruzzi 1 support@quipu.eu I Pisa Italy Skype: quipu_team Copyright Quipu srl 78

79 14.3.Notes Cardiovascular Suite, FMD Studio e Carotid Studio are trademarks of Quipu srl. Canopus, ADVC are registered trademarks and Grass Valley is a trademark of GVBB Holdings S.a.r.l. MacBook, Firewire, Mac OS, QuickTime, Time Machine are registered trademarks of Apple Inc. DVI2USB 3.0, VGA2USB LR and DVI2USB Solo are trademarks of Epiphan Systems Inc. 15.Warnings WARNING: This software may provide incorrect results in the following cases: 1. if the images acquired by the operator are not of sufficient quality, they have been acquired through a machine or a probe not adequate or by an operator who is not sufficiently experienced. 2. if the user does not perform the basic operations required such as calibration and proper tracking of initial contours. Essential requirement for a correct analysis is the operation of the device. In case of a fault i) close and reopen the application software, or ii) restart the computer where the software is installed and open the application again iii) contact your dealer for assistance. Any malfunction of the device, however, does not affect the state of health of the patient. The user has the responsibility to check the accuracy of the external images to avoid the possibility of generating an incorrect diagnosis. The software device must be used in an environment that allows optimal visibility of the screen. The ambient noise level must be below the 35 db. The software device has a limited life span estimated at 5 years. Copyright Quipu srl 79

80 16. Appendix A - Evaluation Software The copy of Cardiovascular Suite given for evaluation has the same features of the full version and differs only in the type of license. For more information about evaluation license, please read the document QP106EN: EVALUATION LICENSE AGREEMENT FOR CARDIOVASCULAR SUITE ULTRASOUND EDITION contained on the installation CD Evaluation license Cardiovascular Suite comes with two types of evaluation licenses: MOBILE_EVALUATION license It 'a temporary license contained within a Dongle-Key. The Dongle-Key must be inserted into the computer where it is executed Cardiovascular Suite. The same license can be used on different computers but NOT at the same time. After the expiration date, it is no longer possible to run the program or access the data. WEB_EVALUATION license It 'a time license for the computer where it is executed Cardiovascular Suite. T The license resides on the web server of Quipu and it requires an active web link every time the program is run. At startup, Cardiovascular Suite checks if a Dongle Key is inserted and, if present, uses the MOBILE_EVALUATION license. If there is no Dongle Key, Cardiovascular Suite searches for a WEB_EVALUATION license on the Quipu web site. If there is no WEB_EVALUATION license, the program asks you to activate a license Activating a WEB_EVALUATION license If there is no license, Cardiovascular Suite requires the activation of a WEB_EVALUATION license. 1. Copy the activation code and send it to the address support@quipu.eu together with your data and the starting date of evaluation. 2. Within one business day your license will be activated on the Quipu web server and you can start using Cardiovascular Suite. Copyright Quipu srl 80