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IFU-2475 Rev: H 11/2019
0197
INSTRUCTIONS FOR USE PRODUCT CODE: CVV VERSION 3.5.1, INTERNATIONAL EDITION
This document can be obtained at www.capsovision.com/capsoview-ifu
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Device Description CapsoView® is CapsoVision’s proprietary software program used to download and view CapsoCam Plus® images, and to generate capsule endoscopy reports.
Indication for Use CapsoView is intended for the download of images from CapsoCam Plus capsules, generation of video files, review of videos, annotation of images, and generation of reports. Contraindications CapsoView has no known contraindications. Warnings To prevent incorrect endoscopy reports as result of improper use of the program, please read these operating instructions carefully before using CapsoView. These instructions are furnished electronically. Printed instructions are available upon request. To request printed instructions, please contact your CapsoVision representative or CapsoVision, Inc. via the contact information at the end of this document. Intended User Profile Physicians and other trained medical personnel. Intended Conditions of Use Hospitals, outpatient clinics, and physician’s offices. Operating Principle Displaying images and video for review and diagnosis on a personal computer. Risk Although each risk has been addressed and mitigated as much as possible, there is a possibility that the CapsoView software may fail to produce expected results due to software bugs, user interface design or user error which may delay diagnosis.
Table of Symbols Symbol Meaning Symbol Meaning
Manufacturer’s catalog designation or number
Item lot number (with accompanying number)
Instructions are included and must be followed
Contact/European Representative
Symbol designating that product meets European standards for safety and quality
Manufacturer
Quantity
Date of Manufacture
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Table of Contents 1. What is CapsoView? .................................................................................................................................. 4
1.1. System Overview ................................................................................................................................ 4
1.2. CapsoView Intended Use .................................................................................................................... 4
2. System Requirements ................................................................................................................................ 5
3. Security Recommendations ........................................................................................................................ 6
4. How to Install CapsoView? ......................................................................................................................... 7
4.1. Windows OS ....................................................................................................................................... 7
4.2. Mac OS ............................................................................................................................................... 9
5. How to Uninstall CapsoView? ................................................................................................................... 11
5.1. Windows OS ...................................................................................................................................... 11
5.2. Mac OS ............................................................................................................................................. 12
6. Setting Up CapsoView .............................................................................................................................. 13
6.1. Basic Configuration ........................................................................................................................... 13
6.2. Advanced Configuration (Administrative Privileges Required) ........................................................... 13
6.3. Exporting Configurations (Administrative Privileges Required) .......................................................... 15
7. How to Download Capsules? .................................................................................................................... 16
7.1. Connecting the CapsoAccess ............................................................................................................ 16
7.2. Initiating the Download ...................................................................................................................... 16
7.3. Batch Video Creation ......................................................................................................................... 18
8. Main Screen ............................................................................................................................................. 19
8.1. Main Menu ........................................................................................................................................ 19
8.2. Procedure Information ....................................................................................................................... 19
8.3. Display Area ...................................................................................................................................... 21
8.4. Image Comments .............................................................................................................................. 22
8.5. Time Bar ............................................................................................................................................ 22
8.6. Toolbar .............................................................................................................................................. 24
8.6.1. Viewing Modes ........................................................................................................................... 24
8.6.2. Review Speed ............................................................................................................................ 25
8.6.3. Playback Options ....................................................................................................................... 25
8.6.4. Contrast & Saturation ................................................................................................................. 25
8.6.5. ACE & Red Detection ................................................................................................................. 25
8.6.6. Reference Library ....................................................................................................................... 25
8.6.7. Capturing Images ....................................................................................................................... 26
8.6.8. Setting Landmarks ..................................................................................................................... 26
8.6.9. Image Annotation ....................................................................................................................... 27
8.6.10. Zoom ...................................................................................................................................... 28
8.7. Image List .......................................................................................................................................... 28
9. How to Create a Report? .......................................................................................................................... 30
9.1. Including Images ............................................................................................................................... 30
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9.2. Adding Text ....................................................................................................................................... 30
9.3. Editing Procedure Information ........................................................................................................... 30
9.4. Adjusting Report Layout .................................................................................................................... 31
9.5. Saving Your Report ........................................................................................................................... 31
10. Exporting and Sharing Data .................................................................................................................. 33
10.1. Image Frames ................................................................................................................................ 33
10.2. Cropping Images before Exporting ................................................................................................. 33
10.3. Videos and Video Clips .................................................................................................................. 34
11. Training ................................................................................................................................................. 36
12. Getting Help and Troubleshooting ......................................................................................................... 37
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1. What is CapsoView? 1.1. System Overview
CapsoView is one of four components of the CapsoCam Plus® Capsule Endoscopy System:
CapsoCam Plus®: A single-use ingestible video capsule that acquires and stores capsule endoscopy examination images in on-board memory while moving through the patient’s gastrointestinal tract propelled by natural peristalsis.
CapsoRetrieve®: A single-use retrieval kit provided to the capsule endoscopy patient to retrieve the CapsoCam Plus capsule.
CapsoAccess®: A docking station provided to trained medical personnel to download examination images from the retrieved CapsoCam Plus capsule. CapsoAccess transfers the data to a computer running the CapsoView software.
CapsoView®: The stand-alone software application used to download and review images from the CapsoCam Plus capsule and to generate capsule endoscopy reports.
1.2. CapsoView Intended Use
After the patient has retrieved and returned the CapsoCam Plus capsule, CapsoView should be used in conjunction with CapsoAccess to download the data from the capsule. Clinicians can then use CapsoView to review the examination images and generate a report.
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2. System Requirements
CPU
Minimum Required Recommended Intel Core i3, 4th generation (for image review) Intel Core i5, 4th generation, 4+ threads (for data download)
Intel Core Quad-Core, 6th generation, 8+ threads
Memory Minimum Required Recommended
4GB 8GB
Operating System
Minimum Required Recommended
Windows 7 (Service Pack 1) (64-bit)
macOS X El Capitan
Windows 10 (64-bit)
macOS Sierra
Display
Minimum Required Recommended Display Resolution: 1366x768 (Windows) 1280x800 (Mac)
Display Resolution: 1920x1080
Panel Type: IPS (In-Plane Switching) Color Gamut: 100% sRGB with Delta-E <2
For low-resolution monitors, Scaling should be set to 100%.
Additional Software PDF Reader Adobe Reader
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3. Security Recommendations Since CapsoView is a standalone software application, it is the responsibility of the user to protect the confidentiality, integrity, and availability of your patient data. We recommend the following security practices: • Before installing CapsoView, use the MD5 file checksum to verify the integrity of the Application Installer. • Use the operating system’s authentication and access control to limit access to CapsoView to
authorized personnel only. • Ensure all patient data is stored in a location that is accessible only to authorized personnel. • Always keep the firewall and antivirus software up-to-date on the computer where CapsoView is installed. • Use encryption to protect your stored patient data. • Backup and archive patient data according to applicable regulations.
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Step 3
Right-click the installer (*.exe). Select Run as administrator. If you do not have administrative privileges, contact your IT Help
Desk.
Step 4
Select Yes to run the installation.
Step 5
Click Next.
Step 6
Click Next.
Step 1
Confirm that you have all necessary files. The CapsoView installation package contains an
Application Installer (*.exe), MD5 File Checksum and Installation Code.
Step 2
Confirm that the CapsoAccess device is NOT connected to your computer.
4. How to Install CapsoView?
4.1. Windows OS
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Step 7
Enter the Installation Code. Click Next.
Step 8
The installation will begin automatically.
Step 9
A codec pack will be installed automatically.
Step 10
The CapsoAccess USB Driver Installer will launch in a separate window.
Click Next to install it.
Step 11
Click Finish when the CapsoAccess USB Driver installation is complete.
Step 12
Return to CapsoView installation window. Click Finish when the installation is complete.
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Step 13
Select Yes to enable email notifications (recommended).
You can change your selection later.
Step 14
CapsoView will launch automatically.
Step 1
Confirm that you have all necessary files. The CapsoView installation package contains an
Application Installer (*.dmg), MD5 File Checksum and Installation Code.
4.2. Mac OS
Step 3
Double-click the installer. Click Next.
Step 4
Step 2
Confirm that the CapsoAccess device is NOT connected to your computer.
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Step 9
Select Yes to enable email notifications (recommended).
You can change your selection later.
Step 10
CapsoView will launch automatically.
Enter username and password. Click OK. If you do not have administrative privileges, contact your IT Help Desk.
Step 6
Enter the Installation Code. Click Next.
Step 5
The installation will begin automatically.
Step 7
Click Finish.
Step 8
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5. How to Uninstall CapsoView? If you are installing a new version of the CapsoView software, the old version will be uninstalled automatically. You may also uninstall the old CapsoView software manually by following the instructions below. 5.1. Windows OS
Step 1: Run the ‘Uninstaller.exe’ program under ‘C:\Program Files (x86)\CapsoVision Inc\CapsoView 3’.
Step 6: Search your computer for “Uninstall K-Lite”. Run the Uninstall K-Lite Codec Pack program.
Step 3
Launch Device Manager.
Step 4
Right-click CapsoVision Capsule Data Access System 2 under Universal Serial Bus controllers
Click Uninstall.
Step 5
Check the box. Click OK.
Step 2
Connect the CapsoAccess to your computer and turn it on.
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5.2. Mac OS
Step 1
Locate the Uninstall application in Go > Applications.
Step 2
Left-click the folder CapsoView3.
Step 3
Scroll down to locate the Uninstaller Application.
Step 4
Double-click the Uninstaller and the software will be automatically
removed.
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6. Setting Up CapsoView 6.1. Basic Configuration
For basic configuration, click the Settings icon in the top menu and navigate to the desired tab.
Language Tab: CapsoView is available in over 20 languages. Select your preferred language from the dropdown. The new language setting will not take effect until you restart CapsoView.
Font Tab: Select your preferred font size. Note that this will change the font size of text in the user interface, but it will not change the font size of your reports (see Report Font Size).
Preference Tab – Mouse Wheel Scrolling: When reviewing a video, your mouse wheel can be used to scroll to a subsequent or previous frame. Adjust these settings if you prefer a scroll-down motion of the mouse wheel to rewind the video (i.e. step backward) instead of playing it forward (i.e. step forward).
Preference Tab – Download Options: If you frequently review videos right after the data from the capsule has been downloaded, check the boxes for Automatically open video after download and Automatically generate video when capsule is downloaded. If you need to generate DICOM files, check the box for Automatically generate a separate DICOM file.
Note: The location where your videos will be stored is displayed at the bottom of the Preference Tab. If you would like to change the location, see Advanced Configuration.
6.2. Advanced Configuration (Administrative Privileges Required)
To access the options listed below, right-click the CapsoView icon and select Run as Administrator (contact your IT Help Desk if you do not have administrative privileges). Click the Settings icon in the Main Menu. System Tab: This tab allows you to select your preferred file paths (i.e. folder on your computer) for data download, video clip export and for storing your report templates. The default path for open will bring you to the specified location when you click the Open Video icon. The link button will sync the open and export file paths to the selected path for download.
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Facility Tab: This tab allows you to set up the header for your capsule endoscopy reports. Enter your facility’s information (Facility Name, Address, Website and Phone Number) and upload your facility’s logo. To see a preview of your report header, click inside the Preview box. You can adjust the position of your logo and contact information by using the arrows located above that box.
User Tab – Adding Users: In this tab, you can add all users who will be using the CapsoView software. At a minimum, it is recommended that you add any user who will be downloading CapsoCam Plus capsules or who would like to sign reports electronically. Only MD/DO users added to this list will be able to use the electronic signature function. However, users who are not on the list can still download capsules as a Guest User. To add a user, select the role, enter the user’s name and email address and click the Add User button.
To modify a user’s information, click the Pencil icon next to the user’s email. To delete a user from the list, click the Trash Can icon next to the Pencil icon.
Note: The default file path is C:/capso_video. This folder is automatically created when CapsoView is installed. If desired, you can delete, move, rename or keep the folder as is.
Note: The fields for Facility Name and Address allow multi-line text entries. The remaining fields can only accommodate one line of text.
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To reset a user’s PIN, click the Reset PIN icon next to the Trash Can icon. Note: Only users with MD or DO Role can use the electronic signature functionality. User Tab – PINs: After a user is added to the list, CapsoView will generate and display a 4-digit PIN number for this user. The user will have to enter this PIN number when signing a report electronically or when downloading a capsule.
Note: The PIN number will be displayed only once. Please save this information in a safe place for future reference. User Tab – Email Notifications: You can enable or disable email notifications by checking the box on the top right corner. If you have enabled email notifications, the PIN number in the above step will be emailed to the user. You can also use the email notifications to inform a user when a report has been signed electronically (see Electronically Signed Reports). If desired, this step can be skipped even when email notifications are enabled. Thus, it is recommended to enable email notifications. 6.3. Exporting Configurations (Administrative Privileges Required)
CapsoView allows users to export the settings from the User Tab, Facility Tab and System Tab into a single file to copy these settings onto another computer. This can be done by using the Import/Export Config File function. Administrative privileges are required.
On the computer with configured CapsoView settings, hover over the Settings icon and select Export Configure File. Select a destination and click Export. To use these settings with a different computer, copy the newly generated file to the other computer and import it using the Import Configure File option.
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7. How to Download Capsules? 7.1. Connecting the CapsoAccess
To connect the CapsoAccess to your computer and download a capsule, follow the steps below. Refer to the illustration when needed.
Step 1: Connect the power cable (3) to the AC adapter (2). Step 2: Connect the AC adapter (2) to the 12V DC input of the CapsoAccess (1). Step 3: Connect the power cable (3) to an outlet rated for a voltage between 110 and 240V AC. Step 4: Attach the USB cable (4) to the USB input of the CapsoAccess (1). Step 5: Connect the other end of the USB cable (4) to the computer intended to run CapsoView.
For more information about your CapsoAccess System, please refer to the CapsoAccess Instructions for Use which were provided to you with the system. 7.2. Initiating the Download
Before initiating the download, make sure you close other non-essential programs that are running in the background, such as web browser, media player, etc. Click the Download icon in the Main Menu and follow the steps below.
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Step 2
Check the box for Generate Video. Otherwise, only the raw data will be downloaded (see Batch
Video Creation). Click Next.
Step 3
Confirm the information, choose your name and type in your PIN. Click Yes. If user accounts have not been set up, you can use a Guest account without entering a PIN.
Step 4
Once download is confirmed, the device will calibrate images.
Step 5
Download automatically proceeds. The download may be terminated by clicking the Cancel button
below the progress bar.
Step 6
Click Finish to complete the download process. If you want CapsoView to open the video, check the
Open Video box.
Step 1
Enter the information and click Next. Physician Name and Facility can be entered manually or selected from the drop-down menu if they already exist (see User Tab).
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7.3. Batch Video Creation You can download the raw data from multiple capsules and create the videos later. Downloading the raw data will take less time than downloading and creating the videos. The Batch Video Creation process is ideal for users who would like to initialize multiple capsule downloads overnight or during an extended period when the user is away from their workstation. Step 1: Click the Open Video icon. Step 2: Change Files of type to binary files to open one or more downloaded examination files. Step 3: Select the folders that contain the raw data (*.bin files) of the videos you would like to create. Hold CTRL to select multiple folders. Click Choose. CapsoView will display the progress as video files are being created.
Warning: CapsoView will download all examination files into a new folder. Please do not add contents to or delete contents from this folder. Otherwise, CapsoView may not operate correctly. You may rename the video file or the BIN file directly inside the folder. You may also rename the folder itself. To share or make a copy of the examination, see Exporting and Sharing Data.
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8. Main Screen 8.1. Main Menu
The Main Menu is located at the top-left of the Main Screen.
The Main Menu provides access to the following functionalities: Open Video - Click this icon to open a video for review (*xam or *avi). You can also click inside the Video Display Area located in the center of your screen. Download - Click this icon to initialize download of a CapsoCam Plus capsule (See Initiating Download). Save - Click this icon to save your findings. Note that your findings will also be saved automatically. Export - Click this icon to export an image or video clip (see Exporting and Sharing Data). Settings - Click this icon to configure CapsoView (see Basic Configuration and Advanced Configuration). Help - Click this icon to access the CapsoView End User License Agreement or the About section of CapsoView. The About section will display a link to these Instructions for Use and the software version. 8.2. Procedure Information
The Procedure Information box is located under the Main Menu.
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The Procedure Information displays the following information entered at time of download. This information can be edited in the report section (see How to Create a Report).
• Facility • Patient ID • Patient Name • Patient Date of Birth • Procedure Date • Physician • Referring Physician
The Procedure Information also contains the following information which is automatically generated.
• Capsule SN - The capsule serial number is unique and is programed inside the capsule. • Capsule Run Time - The capsule run time displays the amount of time the capsule was recording
images. The Procedure Information can be hidden during video review. Click on the Procedure Information icon located at the top right corner to hide or show the Procedure Information.
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8.3. Display Area
Images from the video will be displayed in the center of the screen. The Display Area will change its size depending on the selected View. The Display Area will also change if Full Screen mode is enabled. Display Area – Panoramic View
Display Area – Duo View
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8.4. Image Comments
The Image Comments box is located under the Display Area.
8.5. Time Bar
The Time Bar is located under the Image Comments box.
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The Current Frame will be marked with a light-blue line.
On top of the Time Bar, you will see the Frame Information, such as frame number, frame location (percentage in respect to the entire video) and frame timestamp. You can move to a specific frame by typing the frame number in the textbox and pressing Enter.
If the landmarks have been set (see Setting Landmarks), each segment of the digestive tract will be marked in a different color.
Orange - Esophagus Blue - Stomach Yellow - Small Bowel Green - Colon
When the displayed image is inside the yellow small bowel segment, additional information about the frame location will be displayed (percentage and timestamp in respect to the small bowel only).
Below the colored lines, you will find the Tissue Bar. The Tissue Bar displays the color profile of the corresponding part of the video and may help you identify areas of interest, such as parts of the video that have a red color profile.
If images have been captured (see Capturing Images), the location of the captured images will be marked with white vertical lines.
If Red Detection has been triggered (see ACE & Red Detection), the location of the red frames will be displayed with red vertical lines.
On the right-top side of the Time Bar, you may find information about the CapsoView software version which was used to download the capsule. Note that this version may be different from the software you are using to view the video.
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8.6. Toolbar
The Toolbar contains the main controls used during video review.
Clicking a button in the Toolbar will activate a function and/or display a popup menu with further options. Clicking the button once again will de-activate that same function and/or hide the popup menu. 8.6.1. Viewing Modes
To toggle between Viewing Modes, hover over the Viewing Mode icon and select Duo or Panoramic. Panoramic Mode (Displays one 360◦ Frame)
Duo Mode (Displays two consecutive 360◦ Frames)
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8.6.2. Review Speed
To set the speed at which you would like to review the video, hover over the Review Speed icon and select a speed. Speeds range from 1X (for 5 frames per second) to 5X (for 25 frames per second). 8.6.3. Playback Options
The Playback Options are as follows:
8.6.4. Contrast & Saturation
To adjust the Contrast or Saturation , click the corresponding button and slide the bar up/down. Click the button again and the settings will reset to 0%. 8.6.5. ACE & Red Detection
The ACE (Advanced Color Enhancement) button allows you to toggle between three ACE modes for an advanced view of the mucosa. Click the ACE button again to go back to the original mode. The Red Detection button will identify red video frames where bleeding may be present. Click the button and review the identified images carefully. To go to a specific frame, double-click the image.
Click the Red Detection icon again to close the Red Detection popup menu. Warning: Red detection is to be used as an aid to the reader. This feature should not be relied upon for diagnostic purposes. 8.6.6. Reference Library
The Reference Library button allows you to compare reference images with the images in your videos. Using the top Reference Library menu, you can filter the images by location (CEST) or type of finding (Diagnosis).
Single Frame Backward
Pause
Single Frame Forward
Play Backward
Play Forward
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8.6.7. Capturing Images
You can capture any image by double-clicking the Display Area of the frame, hitting Enter or clicking the Capture Image icon. It is recommended that the video be paused prior to capturing an image. Captured images will be placed in your Image List. Images with comments and/or annotations will be captured automatically. 8.6.8. Setting Landmarks
Setting a landmark can be done in one of three ways:
(1) Hover over the landmark image and right-click the Display Area. Select the desired landmark.
(2) Hover over the Capture Image button. Select the desired landmark.
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(3) Capture the image (see Capturing Images) and locate it in the Image List. Hover over the image
thumbnail and select the letter corresponding to the landmark you would like to set.
The only restrictions for setting a landmark is to follow the correct anatomical sequence. For example, if a gastric landmark was already set, the duodenal landmark must be located after the gastric landmark. Depending on the exam information, CapsoView may provide Landmark Suggestions. If such suggestions are available, they will appear on top of the Image List. The user may accept or reject Landmark Suggestions.
To accept a Landmark Suggestion, double click the image thumbnail to navigate to the image and mark the landmark using one of the three methods described above. The landmark suggestion will disappear, and a new image thumbnail will become available in your Image List. To reject a Landmark Suggestion, simply pick another image for the corresponding landmark. The suggested landmark will disappear, and the new image frame will be saved in your Image List. Suggested Landmarks may not be available in which case you can set the landmarks manually using one of the three methods described above. 8.6.9. Image Annotation
The Draw Annotation icon located in the Toolbar allows for graphical annotation of an image.
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You can draw directly on the frame of interest. The frame will be added to the Image List if not there already. Hover over the Draw Annotations icon and select an annotation tool.
Arrow - Draw an arrow pointing to an area of interest. Ellipse - Draw an ellipse.
Free Draw - Free-draw within an area of interest.
Erase - Undo a drawing (hover over the region that you wish to erase). 8.6.10. Zoom
CapsoView provides users the ability to magnify images to get a closer look. Click the Zoom icon and the cursor will turn into a magnifying glass. Click the button again and the cursor will return to the default setting. 8.7. Image List
All captured images are saved in the Image List which is displayed at the right-hand side of the screen.
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To open the Image List, click the Exit Fullscreen Mode button in the bottom-right of the Main Screen. To close the Image List, click the Enter Fullscreen Mode button in the bottom-right of the Main Screen. In the Image List, the frame number, time stamp and any text annotations are displayed beneath each thumbnail. To mark landmarks, remove an image from the Image List or include an image in your report, hover over a frame in the Image List and the thumbnail options will be displayed.
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9. How to Create a Report? To access the Report section of CapsoView, click the Report icon in the bottom-right of your screen. 9.1. Including Images
To include an image in your report, click on the image in the Image List and a light blue border will appear around the image. Meanwhile, a blue folder icon will appear indicating the image is included in the report.
To exclude an image from your report, click the image thumbnail again. The blue border will disappear. To include all captured images in your report, check the Select All box in the bottom of the Image List. Note that this option is only visible from the Main Screen, not from the Report Section.
Image List: Turn the Image List on and off with in the report interface. Image List icon: You can access the Image List to include/exclude images from the report. can also type comments directly underneath each image in the Image List. 9.2. Adding Text
The main text fields in the report are: Clinical History, Description of Procedure, Findings Summary and Recommendations. You can type directly into each field and the text will appear in your report. If the Clinical History is already populated, this text was entered at the time of capsule download. For ease of use, the Description of Procedure field has pre-loaded text. Please review and edit the text as needed. The text you type into each field can be saved as a template for future use. To save as a template, click the Save as New Template button located at the top-right of the corresponding text field. The template will be saved in the default template location (see Advanced Configuration). Clinical History templates are not available. To add an existing template, click the Import an Existing Template button which is also located at the top-right of each text field. The text from the template will automatically appear in the corresponding text field. In addition to the above-mentioned text fields, each image that is included in the report may be accompanied by a comment (see Image Comments). You can edit previously entered comments by typing directly into the comment section under the image thumbnail, without the need to return to the Main Screen. 9.3. Editing Procedure Information
To edit the procedure information, click the Edit button. You can also select the rating of the bowel preparation using the dropdown menu. Once you finish editing, click on the Save button.
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To mask the procedure information, click the Deidentify button. Clicking the Un-Deidentify button again will unmask the procedure information. 9.4. Adjusting Report Layout
Report Font Size: Increase or decrease the font size of the report by clicking the Font dropdown menu and selecting a font size. The change in font size will affect the following text fields: Clinical History, Description of Procedure, Findings Summary, Recommendations, and Image Comments. Letter Head: If you would like to add a letterhead that is different from the default report header (see Facility Tab), click the Edit Letterhead button. Changes will only be applied to the current report. The default letterhead will remain unchanged. 9.5. Saving Your Report
CapsoView allows users to sign capsule endoscopy reports electronically or save the report with a blank signature field. Note that before signing reports electronically, a user account with a system generated 4-digit PIN should be created (see User Tab). Electronically Signed Reports: To sign the report electronically, click the E-Sign button. Select your username and enter your PIN, then click Sign. The report will be saved in the folder where the video is located. If you forgot you PIN, you can click the Forgot PIN button. The new PIN will be sent to the email address associated with your account. If you have chosen not to receive email notifications, the PIN will not be sent to you. Please contact your system administrator to reset your PIN.
After e-signing, you can notify others of the completion of the report. CapsoView will send an Email Notification to the specified users. For security reasons, the report file will not be provided with the email notification.
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Hand-Signed Reports: To save a report without an electronic signature, click the Save Report button. CapsoView will generate the report in PDF format and will automatically save it in the same location as the corresponding video. At this time you may print the report and hand-sign it. Note that DICOM files are automatically created with final report PDF.
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10. Exporting and Sharing Data CapsoView allows users to export images and video clips. The export functions may also be used to export the entire video into a single file to facilitate data transfer and/or data sharing. If you would like to export the CapsoView configurations, please see Exporting Configurations. 10.1. Image Frames
To export and save an image as a *.JPG file, click the Export button in the Main Menu. In the Image List, click on the image(s) you would like to export. Once clicked, the image border should turn blue.
Once you have made your selection, click the Export Image button at the bottom right of the Image List and select a location (typically default path is C:\capso_video) to save the exported images. The exported image will be with the Time Stamp and Procedure Date of the patient displayed under it.
10.2. Cropping Images before Exporting CapsoView allows users to crop and export sections of the image instead of exporting the entire image. This feature may be used to import the cropped images into an EMR/EHR system if such system does not support images with panoramic aspect ratio.
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To crop and export an image into a standard square format, click the Crop button next to the Export Image button.
When cropping is enabled, a crop window will be displayed over each image in the Image List. The crop window can be moved left or right to capture a specific section of the image as shown below.
10.3. Videos and Video Clips To export a short clip or the entire video, click the Export button in the Main Menu. Enter the frame you would like to start the export from, i.e. Start Frame, as well as the last frame of the clip, i.e. End Frame (for more information, see Frame Information). If you would like to export the entire video, the frame numbers will already be available for you in the corresponding boxes.
If you would like the exported video to be compatible with standard media players, check the box for Create video for use without CapsoView and the exported video will be in *.avi format.
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If you would like to share the video AND the corresponding annotations, check the box for Include annotations. The exported video will be in an *.xam format and the annotations will be contained in the exported file. Note that this file can only be opened with the CapsoView software. Upon opening this file in CapsoView, it might take a few minutes to un-pack the files. Once unpacked, a new folder which contains all the examination files will be created and the original *.xam file will be automatically deleted.
Note: To protect your patient’s confidentiality, you can export a video or video clip and hide the Procedure Information. To do this, simply click the De-identify button before you begin your export.
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11. Training Users can contact CapsoVision or its Authorized Representatives for training on how to use the CapsoView software application. Contact information is listed at the end of this document.
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12. Getting Help and Troubleshooting Please refer to the CapsoVision website for additional help and troubleshooting. Please include the following information if you are reporting a problem or requesting assistance from CapsoVision or its Authorized Representatives: • Computer hardware specification • Version of the operating system on the computer • CapsoView software version • Description of error situation, including screen shots when appropriate • Steps taken leading up to the error
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Storage The CapsoView software is stored on a CD/DVD. The CD/DVD should be kept in a cool dry location under normal environment conditions.
Warranty Refer to the Warranty section in the End User License Agreement, which is available under the Help menu in the CapsoView program.
Contact Information
European Authorized Representative Dr. Hans-Joachim Lau Airport Center (Building C) Flughafenstraße 52a 22335 Hamburg, Germany Fax: +49 40 53299-100
Manufacturer CapsoVision® 18805 Cox Avenue, Suite 250 Saratoga, CA 95070, U.S.A. Telephone: 1-(408) 624-1488 Email: [email protected]
Conformity Assessment Body TÜV Rheinland LGA Products GmbH Tillystrasse 2 90431 Nuremberg Germany
