DocuSign Envelope ID: C9E26C4D-6C1E-4419-897A-F86C07868EC4. Capsule Endoscope. Installation & Software User Guide



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Capsule Endoscope Installation & Software User Guide 1

2 MIROCAM, MIROVIEW are trademarks and registered trademarks of IntroMedic, Co., Ltd. 2014 Medivators Inc. 50098-695 Rev A All rights reserved. This publication is protected by copyright. Copying, disclosure to others, or the use of this publication is prohibited without the express written consent of Medivators Inc. MEDIVATORS reserves the right to make changes in the specifications shown herein without notice or obligation. Contact your MEDIVATORS representative or MEDIVATORS customer service for more information

Table of Contents Overview... 5 Purpose... 5 About MIROCAM Capsule Endoscope... 5 About MIROVIEW... 5 Installation... 7 User Account Control... 7 Standalone Installation... 9 Customized Installation (Multi-PC)... 15 Atlas Drive Patch... 20 MIROVIEW Operator... 23 Import / Export Case Files... 23 Backing up Case Files... 27 MIROVIEW Client... 29 Printing Reports... 29 Save Report as a PDF... 31 Review Mode... 33 Review Mode Features... 33 Report Mode... 37 Report Mode Features... 38 Export Mode... 41 Export Mode Features... 41 MIROVIEW Atlas... 43 Atlas... 43 My Atlas... 44 3

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Overview Purpose The purpose of this guide is to help the user to better understand the MIROVIEW software and to better utilize its functions. This guide is specifically made for the usage of MIROVIEW 2.0 including installation and procedural use. It does not contain troubleshooting information, please refer to the Troubleshooting Guide or call MEDIVATORS Technical Support for further assistance. About MIROCAM Capsule Endoscope MIROCAM Capsule Endoscope has the diameter and length of 11x24 mm and is intended for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule containing a light source, camera, transmitter, and battery. MIROCAM Capsule Endoscope has the longest operation time of more than 11hours. Longest operation time ensures images of entire small bowel and also able to capture colon images. The MIROCAM Capsule endoscope procedure is a safe and patient friendly procedure and the patient can go about a normal daily life. About MIROVIEW MIROVIEW is the software used with MIROCAM Capsule Endoscope to view the footage captured by the device postprocedure. The software has been significantly enhanced through new features and design, including interoperability with PACS system and network support. The software includes an enhanced interface which gives a more comfortable user experience, a reporting tool with enhanced design and new features simplifying the reporting process, express view which is a second generation quick view mode to streamline the review process, range view and map view to help assist with identifying GI landmarks more readily, and drag bag which enables the gathering of desired images in designated folders created by the user for faster diagnosis. The drag bag function also assists in faster landmark placement with a simple click and drag motion. 5

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Installation User Account Control It is compulsory to disable the User Account Setting to install MIROVIEW successfully. 1. Go to Control Panel and click User Accounts. 2. Click Change User Account Control Settings. 7

3. Put the lowest level to Never Notify to install MIROVIEW. 8

Standalone Installation Minimum server requirements: User Account Control (UAC) OFF Windows Vista or 7 (32 & 64 bit) CPU: Core 2 Duo E6300 4GB RAM and 1TB Hard Drive Video 1024x768 Must be logged in with local admin rights! 1. Execute the installation file by double clicking on the correct version of the.exe 9

2. Close the Cautions WordPad window. 3. Click Next. 4. Accept the Agreement and click Next. 10

5. Select Complete then click Next. 6. Click Install. 11

7. The receiver device drivers then get installed. NOTE: You will go through the following install wizard twice. 8. Clink Install. If you click the box to Trust IntroMedic Co. Ltd. you will not get prompted again. 9. Click Finish. 12

10. Click Finish. 11. REBOOT the system. 13

12. Run MIROVIEW Server. a. IP Address is localhost b. Port is 2000 c. Set password d. Set path to the drive with the greatest space for saving files e. Scroll down and fill out the remaining fields f. Click Save 13. Repeat the same process with Operator and Client. 14

Customized Installation (Multi-PC) Installation Prerequisites required for EACH computer: User Admin Rights (Shut off UAC, directions from Standalone Install) 32 or 64 bit operating system Static IP Address that will be assigned to the MIROVIEW Server MIROVIEW Server software must remaining to access data All installations must be logged into with an account that has User Admin Rights 1. MIROVIEW Server must be installed and configured first. Select Custom Install. 15

2. Select the MIROVIEW Server checkbox ONLY. 3. REBOOT after installation. 4. Run MIROVIEW Server a. IP Address is localhost b. Port is 2000 c. Set password d. Set path to the drive with the greatest space for saving files e. Scroll down and fill out the remaining fields f. Click Save 16

5. MIROVIEW Operator Install also requires a Custom Install. 6. Select the MIROVIEW Operator, Client, Atlas, and Viewer checkboxes 17

7. Complete the installation 8. Run MIROVIEW Operator a. IP Address is the Static IP Address assigned to the server b. Port is 2000 c. Set path to drive with the greatest space for saving files d. Click Save 9. MIROVIEW Client Install also requires a Custom Install. 18

10. Select the MIROVIEW Client, Atlas, and Viewer checkboxes 11. Complete the installation 12. Run MIROVIEW Client a. IP Address is the Static IP Address assigned to the server b. Port is 2000 c. Set path to drive with the greatest space for saving files d. Click Save 19

Atlas Drive Patch This is required for both 32 and 64 bit machines. 32 bit can use the Atlas Patch program, but 64 bit machines will need to be patched manually. Contact MEDIVATORS Customer Support if you need the patch file. 64 bit Manual Patch Directions: 1. Run regedit.exe. 2. Double-click HKEY_LOCAL_MACHINE 3. Double-click SOFTWARE 4. Double-click Wow6432Node 5. Double-click IntroMedic > MIROVIEW > 2.0 6. Select Atlas 20

7. Double-click ConfigExist and set to 0 8. Double-click HKEY_CURRENT_USER 9. Double-click Software 10. Double-click IntroMedic > MIROVIEW > 2.0 11. Select Atlas 12. Set Active Video Path and Local File Path from D:\ to C:\ 13. Run MIROVIEW Client 14. Select Help > Atlas 21

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MIROVIEW Operator This software is used to upload/ import/ export case files and utilize the MIROCAM Capsule Endoscope receivers. When a case file is uploaded to Operator with a Multi-PC set up, the case file can be viewed on other operator/ client machines on the network. NOTE: You can do all of these in MIROVIEW Client. The only difference between MIROVIEW Operator and MIROVIEW Client is that MIROVIEW Operator can initialize and set up receivers. Import/ Export Case Files This function allows the user to export/ import case files to / from a removable media device or other storage location. NOTE: Case files are approximately 3GB in size. Importing a Case File 1. Open MIROVIEW Operator. 2. Select List > Import Case/ Review File > Import Case. 3. Select the.mec file from the storage location. 4. Click Import. 23

5. A Task Manager window should open with the import status. 6. Once the file has been imported it should be visible on the List screen, and the Task Manager status should say Complete. 24

Exporting a Case File 1. Select the case file(s) you wish to export. 2. Select List > Export Selected Case(s). 3. Select the location you wish to export the case file(s) to. Click OK. 25

4. A Task Manager window should open with the export status. 5. Task Manager will show a status of Complete when the export is finished. 26

Backing up Case Files This tool is so the user can safely back up important case files to a different location to ensure that it does not get deleted on accident, or disappears if something happens with the MIROVIEW software. 1. Select the case file(s) you wish to backup. 2. Select List > Backup Selected Case(s) > (Select storage DVD or General). NOTE: General is for any external USB media or a location on the machine. 3. If DVD is selected a Task Manager screen with automatically pop up. If General is selected a Browse to Folder screen will open. 27

4. Select the backup location and click OK. 5. A Task Manager window should open with the backup status. NOTE: If exporting to DVD this window will open straight away. 28

MIROVIEW Client This is the viewing software for MIROCAM Capsule Endoscope. It allows the user to review the case file(s) in different ways. You can also create reports using this software and save them in PDF format. Printing Reports This selection allows the user to print out a report of the case file(s) selected in the MIROVIEW Client list screen. 1. Select the case file(s) you wish to create a report with. 2. Select List > Print Report for Selected Case(s). 29

3. Select the Print Options to include, and the Layout of the report. 4. Click OK. 30

Save Report as a PDF This selection allows the user to save the case file report(s) to a PDF format instead of printing. 1. Select the case file(s) you wish to save. 2. Select List > Save Report as PDF for Selected Case(s). 3. Select the Print Options to include, and the Layout of the report. 31

4. Select the location you wish to save the PDF. 5. A Task Manager window should open with the save status. 32

Review Mode This tab allows the user to review the selected case file. Review Mode Features These features make it easier for the user to view the case file(s) in a timely manner while also capturing images for reporting purposes. 33

View Mode: Single View Single image in the center Dual View Two images next to each other Quad View Four images in a square Range View Nine images before and after the center image Map View The entire reel of images in a line on the screen, the user can hover over the line to view the images Play Mode: Normal Play Shows all images captured by the MIROCAM Capsule Endoscope Express Play Hides similar images that have no change in them to shorten the viewing time SGIB Play Play Buttons: In order from left to right Play Reverse, Play, Play Capture: Allows the user to capture a specific image and add it to a list for later use in reporting. Landmark: Marks a specific slide so the user can separate the image strip into sections of the body. 34

Image Enhancement: Allows the user to change the image coloring to better see images and get a better idea if a slide contains a diagnosis or not using the ALICE feature. Findings Summery Box: Allows the user to see the captured images and sort them based on what was seen in the image. Also includes the location of the body that the image was found in. 35

Comparison Mode: Allows the user the ability to compare an image found to a known, diagnosed image in Atlas. Thumbnail Extension: Allows the user to view the images in thumbnail form. Also makes it easier for the user to mass select images to be captured. 36

Report Mode This tab allows the user to create reports from the case file they were viewing. 37

Report Mode Features These features make it easier for the user to write, enhance and edit captured images so they are easier to read when the report is created for the case file(s). Circumference Markers: Allows the user to add circumference lines to the main image to easily show where the issue is in the image by sectioning it off. (Purple lines in image below) 38

Drawing Tools: (In order from left to right) Draw Circle Draw Line Eraser Color Palette Undo Redo Image Enhancement: Same feature as described under Review Mode Features. Findings: Allows the user to add their findings to the image selected. 39

Image Comments: Allows the user to add comments to a specific image. Also give the ability to add a voice recording to the image. GI Dictionary: Allows the user to add commonly used words for reports into an easy dictionary, where the user can select a word and then click the Input Selected Word button to add that word to the Image Comments section. This tool also helps with repeat spelling errors on reports. 40

Export Mode This tab gives the user the ability to save, print and export the case file after it has been edited and viewed. Export Mode Features These features make it quick and easy for the user to print the report, save the report to a PDF file or even export the case file(s) elsewhere for use. Data to Include: Allows the user to choose if they wish to include the above options in the report or not. 41

Print and Save Options: Print Allows the user to print the report created Preview Allows the user to preview the report before printing Save to PDF Allows the user to save the report to a PDF file instead of printing Export Review Allows the user to review the report before exporting it Export Options: Export Captured Images with EXMIF Export Captured Images as Image/ Video/ MIROVIDEO Export Segments as Video/ MIROVIDEO Export Case as Video/ MIROVIDEO 42

MIROVIEW Atlas This software is used as a comparison tool for users so they can compare images from their MIROCAM Capsule Endoscope trials and determine a diagnosis. Atlas is used only as a comparison tool and should not be used to confirm a specific diagnosis, only a certified medical professional can. Atlas This tab shows the preloaded images of diagnosis made with MIROCAM Capsule Endoscope. 43

My Atlas This tab allows the user to create their own comparison guide based on their own trials and images found from them. Import Atlas Images from File: Allows the user to add their images to the My Atlas catalog. NOTE: For additional assistance using MIROVIEW Atlas got to Help > User Guide. If you have any questions or need further assistance please contact MEDIVATORS Customer Support at 1.800.444.4729. 44

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Manufactured in the USA by: Medivators Inc. 14605 28th Avenue North Minneapolis, MN 55447 USA Toll Free: +1.800.444.4729 www.medivators.com Medivators BV Sourethweg 11 6422PC Heerlen The Netherlands Tel: +31.45.5.471.471 Cantel Medical Asia/Pacific Pte. Ltd. 1A International Business Park #05-01 Singapore 609933 Tel: +65.6227.9698 Medivators Inc. Beijing Representative Office Room 1801, Floor 18th, Tower A, Beijing Marriott Hotel, Office Building No. 7, Jianguomen South Avenue, Dongcheng District, Beijing 100005 China Tel: +86 10 65204039 48