Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 C-Scan System User Reference Manual Rev. number 01 02 03 04 05 Change Owner Michal Nachmanovich Michal Nachmanovich Michal Nachmanovich Michal Nachmanovich Linur Yeter & Hadas Shahar 06 Linur Yeter & Hadas Shahar 07 Linur Yeter 08 Linur Yeter 09 10 Linur Yeter Linur Yeter 11 Yaara Tirosh 12 Daniella Bleistein CHANGE HISTORY Change description Initial release ECO 228.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 CHANGE HISTORY Rev. number Change Owner 13 Daniella Bleistein 14 Sivan Peleg-Cohen Change description o Added instruction to keep the Kit package (containing the Cap) in close proximity to the Track when preparing for capsule ingestion o Added instruction to follow the contour of the CScan Track units when tightening the liners • Section 6.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 © Copyright Check-Cap, Ltd. All rights reserved. Proprietary. CONFIDENTIAL. C-Scan® System User Reference Manual Revision 14 Rx Only "CAUTION Investigational device. Limited by Federal (or United States) law to investigational use." Check-Cap LTD 29 Abba Hushi Ave. P.O. Box 1271 Isfiya, 3009000 Israel INFORMATION IN THIS DOCUMENT IS PROVIDED IN CONNECTION WITH CHECK CAP PRODUCTS.
1 Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 USING THIS GUIDE ................................................................................................................ 8 1.1 1.2 1.3 PURPOSE.......................................................................................................................... 8 LIST OF ACRONYMS .......................................................................................................
10.7 11 Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 SYSTEM SPECIFICATIONS ................................................................................................ 84 TROUBLESHOOTING- C-SCAN® VIEW .............................................................................. 89 Figures Figure 1: C-Scan® system parts ....................................................................................................................
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Figure 52: Filter details ..................................................................................................................................... 48 Figure 53: Data ................................................................................................................................................. 48 Figure 54: Procedure for Download ......................................
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Table 6: Play Bar Control.................................................................................................................................. 67 Table 7: General Buttons Functions ................................................................................................................. 68 Table 8: Bookmarks Table Display and Buttons ............................................
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 1 Using this guide 1.1 Purpose This guide includes instructions for: the clinic team, the subject and the analysis team. The sections that apply to the clinic team in this UM will be given to the clinic team as a separate instructions document - DOC001591 C-Scan System Clinic Team IFU.
2 Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Warning- A Warning warns about a situation which, if not avoided, could result in death or serious injury. Contraindications- Specific situations in which the device and procedure should not be used because it may be harmful to the person. Applicable Documents 1. C-Scan System- Clinical team IFU DOC001591 2. C-Scan System- Patient IFU DOC001592 3.
4.3 Document Title C-Scan System User Reference Manual Document No.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Nausea 4.4 Warnings Alerts about a situation which, if not avoided, could result in death or serious injury. 4.5 If the subject has had prior abdominal or pelvic surgery, the physician should consider the compatibility of the subject for the C-Scan® procedure. When swallowing the C-Scan® Cap there is a rare possibility of choking.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 During and after the procedure the subject should not immerse the C-Scan® Track in any liquid (no- bath, pool, Jacuzzi and swimming). During the procedure the subject should not travel by airplane. During the procedure the subject should not perform any active or contact sport (such as running, Jogging, physical training in the gym, ball games, Skiing, contact sports).
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Use the C-Scan® system only with components\ accessories purchased from or approved by Check-Cap. Changes or modifications not expressly approved by Check-Cap could void the user’s authority to operate the C-Scan® equipment.
4.6 Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Benefit and Risks of the C-Scan® procedure Benefits: C-Scan® system is subject-friendly tool for structural analysis of the colon. C-Scan® system provides an alternative for those subjects who refuse or cannot undergo colonoscopy procedure. No cleansing of the intestine is required prior the use of the C-Scan® system.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 5 C-Scan® system 5.1 C-Scan® System Components The C-Scan® system includes three main parts: C-Scan® Cap, C-Scan® Track and C-Scan® View (illustrated in Figure 1) Figure 1: C-Scan® system parts C-Scan® Cap An ingestible capsule enabling intra-colon visualization, based on an X-Ray source and an array of detectors. During C-Scan® procedure the subject can continue with his daily routine.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 C-Scan® View The C-Scan® View software is a client/server-based application that enables test's data analysis, and report generation. The C-Scan® View main functions are: • Load and display test information and data • Images review - enables to view structural information of the colon wall • Generate test report • Store test information, data and results on server 5.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 6 Instruction for use for the clinic team This section is for the clinic team use. It describes the steps for completing a C-Scan® procedure. It includes the following information: 6.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Inform the subject to contact the clinic if the following occurs: Pain or discomfort, detachment of the stickers on the back, beeping of the Track, Capsule excretion. Explain how to remove and send the C-Scan® Track. Write the subject identification details and C-Scan® details on the designated C-Scan® package.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Figure 2A Date 22 May 2022 Figure 2B Figure 2: Activation of the C-Scan® Track 4. Attach the Track to the subject's back: Note: This step shall be performed only after activation of the C-Scan® Track. Equipment needed: C-Scan® Track, C-Scan® Track position stencil, stickers, body marker, razor and medical grade alcohol. Note: The C-Scan® Track stickers must be applied directly to smooth skin for proper adhesion.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 The lower frame of the stencil shall be placed around 2 cm above the groove of the buttock along the spine. Once the stencil is located, the places for the three stickers shall be marked. Remove the stencil. 1. Take the C-Scan® Track and stickers from the C-Scan® Kit package. Be sure to keep the Kit package (containing the Cap) in close proximity to the Track at all times during this step.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 2. Use the liners attached to the top of the stickers to lock and tighten the C-Scan® Track in each of the three pockets. Be sure to follow the contour of the units when tightening the liners. Figure 5: Attaching the C-Scan® Track to the back 6.2 C-Scan® Cap ingestion procedure 1. 2. 3. 4. 5. 6. 7. 8.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 9. Give the subject the required materials (contrast material and fiber pills) for the procedure. 10. Verify that the subject has the Subject IFU and understands the requirements. 11. Release the subject home. 6.3 During the procedure days (from C-Scan® Cap ingestion to excretion) Subject continues normal life routine during the procedure days.
6.4 Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 At 150 hours (7 days) from ingestion, instruct the subject to remove the C-Scan® Track and coordinate its collection.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 The subject should store the excreted capsule in the dedicated biohazard package, coordinate the package collection and notify the clinic about the excretion. After the indication of excretion, the subject shall take the C-Scan® Track out of the sticker’s pockets, place it in the C-Scan® package that includes the subject identification details and C-Scan® details and coordinate its collection.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 7 Instruction for use to the subject This section is for the subject use. It describes the steps for completing a C-Scan® procedure and includes the following information: Permitted activities during the procedure Prohibited activities during the procedure C-Scan® procedure Daily routine during the procedure Post procedure- After C-Scan® Cap excretion When to contact the Clinic 7.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Note: If you are a woman of child-bearing age, you must use contraceptives during the C-Scan® procedure Note: Do not bite the C-Scan® Cap prior to swallowing it Note: Do not connect any devices to the C-Scan® Track USB port. Note: Do not attempt to open, puncture or damage the Track. Note: Do not expose the C-Scan® Track to intense sunlight or high temperature.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 o Dietary fiber pills equivalent to 1500 mg (e.g., Psyllium Husk Caps 500 mg, as directed by the clinic team) should be taken with a glass of water, 3 times a day - morning, noon, and evening. 7.5 Post procedure- after C-Scan® Cap excretion: Note: Do not throw the C-Scan® Cap into the trash or flush it in the toilet. The procedure concludes upon excretion of the C-Scan® Cap.
- 7.6 Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 If the capsule return box is not with you, be sure to warp the capsule bag with any soft material (product protection) and place the bag in an alternative container with a similar size to the capsule return box. Do not put the capsule in your pockets, keep it away from the body.
8 Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 C-Scan® View Installation Guide C-Scan® View is a proprietary application that reconstructs the raw data from the C-Scan® Track to a viewable format for review and analysis. It is installed by Check-Cap on a PC supplied by Check-Cap. Note: The C-Scan® View workstation is designed to be used only with the C-Scan® System.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Remove the PC from the package. Remove the power cable from the Accessory Package and connect it to the PC. See Figure 8 Figure 8: Accessory Package Connect the other end of the power cable to the power outlet. Figure 9: PC Connection to Power Remove the mouse from the Accessory Package. Figure 10: Mouse Connect the mouse to any of the USB ports on the rear of the PC, as shown in Figure 11.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Remove the keyboard from the Accessory Package. Connect the keyboard to any of the USB ports on the rear of the PC, as shown in Figure 11 Connect the network cable, as shown in Figure 12. Figure 12: Network Connection Prepare the monitor for operation, according to the monitor user manual provided in the monitor package.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 6. Attach the stand assembly to the monitor, as shown in Figure 15. a. Fit the 2 tabs on the upper part of the stand to the groove on the back of the monitor. b. Press the stand down till it snaps into place. Figure 15: Attaching the stand 7. Place the monitor upright.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Figure 18: DisplayPort cable connection Turn on the PC by pressing the power button (see Figure 19). Make sure screen is on. Note: Check the completeness of the power cord before booting the C-Scan® View. Figure 19: Power-on Button The workstation is intended to be operated in an office setting like standard PC operation, see Figure 20.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Figure 20: Fully Installed System Upon system boot, the Login screen is displayed (see Figure 21). Figure 21: Login Screen Click User Settings on the Welcome screen to open the User Settings window. The User Settings dialog opens, as seen in Figure 22. Figure 22: User Settings Edit the Facility Name and click Save. Change the time zone to your local time zone and click Save time zone.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 9 Using C-Scan® View Application C-Scan® View is a proprietary application that reconstructs the raw data from the C-Scan® Track to a viewable format for review and analysis by the application users. It is installed by Check-Cap on a PC supplied by Check-Cap. Note: The C-Scan® View workstation is designed to be used only with the C-Scan® System.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date C-Scan View Case Life Cycle Figure 23- C-Scan View Case Life Cycle 9.1 C-Scan® View Application Login Screen The C-Scan® View application requires user’s login. Upon system boot, the Login screen is displayed, as shown in Figure 24. Figure 24: C-Scan® View Login Screen Actions available in login screen are specified in Figure 25.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Figure 25: Login Screen 1. Username field 2. Password field 3. Login button 4. Change password button 5. Forgot password? button 6. Switch to Technician user button 7. User settings button 8. Shutdown PC button 9. Facility name display 10. Application info button 11. Date and time display 12. Network connection 9.1.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 9.1.3 Forgotten Password If you forgot your password, click Forgot password and follow instructions to reset your password, see Figure 27. 1. Enter Username 2. Click “Reset Password” Figure 27: Password Reset 3. A temporary password will be sent to your email account (entered upon user creation), see application message in Figure 28 Figure 28: Password Successfully Reset Message 4. Click OK. 5.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 To login as technician, go to Login window: 1. Click Switch to Technician. 2. Choose Technician user. 3. Enter the Technician password to log in. 9.1.5 User Settings In the login screen, Clicking User Settings button (see Figure 30). opens the User Settings window Figure 30: User Settings To change the Facility Name, edit and click Save.
9.2 Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 C-Scan View Updates Whenever a new application update is ready, the application will suggest updating (see Figure 32). Figure 32: Application Update Whenever a new system update is ready a System update available button appears at the top of the screen (See Figure 33), click it to initiate the update. Figure 33: System Update 9.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Figure 34: Connecting the C-Scan® Track to the C-Scan® View Click the Connect C-Scan® Track button (see Figure 35). Figure 35: Connect C-Scan® Track Button If C-Scan® Track connection fails, the C-Scan® View displays the following notification: “Connect to C-Scan® Track failed. Please connect C-Scan® Track cable” (see Figure 36). Go to troubleshooting section 11 for more instructions.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Figure 37: Procedure Details Window Verify that the C-Scan® Cap Serial Number and the C-Scan® Track Serial Number match those used in procedure. (If the information on the screen is incorrect, click Cancel to close the window. Connect the C-Scan® Track with the correct serial number to the CScan® View and continue the download). Choose Subject’s gender, Male/Female. Click Load data.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Once loaded successfully, the procedure can be seen in My Local Files (see Figure 40): Figure 40: Procedure In My Local Files To add a comment on a specific case, click the plus button in the left side up, click on , a menu pops Comments, a window pops up (see Figure 41) : Figure 41: Add your comment Add your comment, press ok to save and close the window.
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Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Locally: On server: Figure 48: Procedure Processing Failure Indication 9.4 Add a Failed Procedure to Database If C-Scan Track connection is not possible, or any reason that procedure data cannot be loaded to C-Scan® View, click the Add manually button (see Figure 49). Figure 49: Report Failed Case Button Failed case Procedure Details window opens (see Figure 50).
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Figure 50: Procedure Details Window 9.5 Enter C-Scan® Cap Serial Number and C-Scan® Track Serial Number (Case ID automatically updated according to Cap SN). Choose Start time (UTC). Choose Subject gender Male/Female. Choose issue cause from list. Add comments, such as additional information about failure cause. Choose Excretion time. Click Load data. Managing your local files 9.5.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Figure 51: Data Base Filter The filter (see #1 Figure 51) can be used to see a subset of the cases in the data base.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Cases table The Cases table includes the procedures ID, Day of ingestion (Start time), a colored circle is shown in the relevant field according to case status (see case state legend for further explanation 9.1.6). Hovering over the circle also displays verbal explanation of case status.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Figure 55: Procedure Download Progress Indication To cancel download press . A Download canceled massage appears confirming your action. Once case is downloaded, it is visible in My local files (see Figure 56). Figure 56: Procedure Downloaded To analyze procedure, click the Analyze button . C-Scan® View editor opens. Editor startup takes time.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Once Editor starts loading, a progress bar is displayed while loading the procedure data (see Figure 58). See Chapter 9.6 for instructions for use of C-Scan® View editor. Figure 58: Procedure Data Loading Progress Bar 9.5.3 Deleting Records from Your Local Files Your local files display all procedures uploaded/downloaded.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Figure 61: Deleting Local Procedure Only Confirmation Message The C-Scan® View application does not delete local files automatically. In case local disk is full, C-Scan® Track upload or Procedure download from database is no longer possible. The application will notify and ask to delete local files (see Figure 62). Figure 62: Local Disk Is Full Message 9.5.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 9.5.5 Uploading/Releasing Your Local Files to The Database Loader user- to upload C-Scan® Track data to the server database, click the Release button on the specific procedure in your local files. Analyst/supervisor user- to upload procedure pre-analysis to the server database, click the Release button on the specific procedure in your local files. 9.5.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Figure 66: Physician Sign & Release Progress Bar Once action completed, the signed report is displayed. 9.5.7 Physician Share Report To share the report via Email, click the Share button on the specific procedure in your local files. The share report dialog opens, see Figure 67.
9.6 Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 C-Scan® View Editor 9.6.1 Editor introduction C-Scan® View Editor is used to analyze procedure data. Users able to perform analysis are Analyst, Supervisor and Physician. Analysts - use the Editor to perform pre-analysis, review entire data, identify suspects, analyze suspects, and mark suspicious findings.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 • Bookmarks table (#5 in Figure 70) • Suspect wizard (#6 in Figure 70) • Buttons control (#7 in Figure 70) See following chapters for detailed information on editor functionalities. Figure 70: C-Scan® View Editor Main Functionalities 9.6.2 Slice Profile The 2D slice (#1 in Figure 70) is the basic reconstructed unit, representing the distances from capsule center to colon wall.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Figure 72: Slice Profile Bump Highlighted and ROI Marking In case a bookmark is marked, the ROI is highlighted in white, and the rest of the slice is gray (see Figure 72). For details on bookmarks, see 9.6.10.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 -The second click on the toggle, when already on, will open a menu with editing optionsallowing to edit or remove the CMT limits and save or cancel the changes per slice. When pressing the editing option, the red dots of the CMT bump limits become blue and it is possible to move them. Grid view, added along with slice convex marking: Off CMT/XRF line visibility toggle.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 9.6.3 2D XRF/CMT Map The 2D XRF/CMT map (#2 in Figure 70) displays a constant number of slices, connected to create a 2D map of the reconstructed colon. The XRF/CMT headline enables toggle between the two signals. For additional information and background on reconstruction process and XRF/CMT signals see DOC001212 C-Scan® View User Guide and Training.
• • Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Double clicking anywhere on the map, the current slice mark will jump to that location Right click on slice number enables jumping to selected slice. First a Go to option opens (Figure 75).
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Button/Action Description Filter on: Default Filter off: Air overlay – air presence marking on top of terrain markings (for air indication outside terrain, use Air Net) The less transparent the marking the greater the air presence detected.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Button/Action Description Default Air Net off: Terrain on/off – inwards bumps in slices are highlighted in 2D map. On Terrain on: Terrain off: Bookmark visibility – bookmarks are marked in all displays.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date Button/Action Description On: 22 May 2022 Default Off: Lock current slice positioning when scrolling. Off Current slice visibility. On On: Off: Segment lines visibility.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Button/Action Description Zoom in – allows to zoom in inside XRF/CMT map by marking a rectangle area. Windowing - Use the Windowing button to select a window in the 2D map. The map display changes to adjust the map dynamic range according to the range of the selected window only. Automatic ROI - Use the ROI button to mark a region of interest around a suspect in the 2D map.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Button/Action Description Default If the pixel is highlighted with terrain, additional info is displayedXRF Bump and CMT Bump metrics (Depths). 9.6.4 Structural Model The Structural model (#3 in Figure 70) shows the slices connected to form a structural view of the reconstructed model. There are arranges in the order of acquisition, not considering time differences and positioning in space.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Structural model: outside view Off The controller enables rotation the tube around a fixed axis. The tube can also be rotated freely using the mouse. Structural model: inside from back view Off The upper right controller enables forward and backwards movement inside the tube. The middle lower controller enables 360 sideways movement inside the tube around a fixed point.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date Tissue like / wire wallpaper toggle 22 May 2022 Off 9.6.5 2D Map Timeline The 2D map timeline in the control panel (#7 in Figure 70) displays the position of the currently selected slice (in red) relative to other slices in 2D map, see Figure 78. Figure 78: Editor Map Timeline 9.6.6 Play Bar The play bar in the control panel (#7 in Figure 70) enables XRF/CMT maps control, see Figure 79.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date Next window – moves a window forward Off Go to the end – moves to last slice Off + increase continuous scrolling speed - decrease continuous scrolling speed Home- moves all display to default configuration 22 May 2022 X1.00 On 9.6.7 General Buttons The general buttons in the control panel (#7 in Figure 70) can be seen in Figure 80.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Reporting failure detected during pre-analysis/analysis by an analyst/supervisor/physician, is done from the editor, using the Report issue button 82: Report Case Failure). , opening a pop up (see Figure Figure 82: Report Case Failure Choose the cause and any additional comments and click Ok. The Report issue button turns red , indicating an issue to next users in workflow.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Figure 83: Estimated Colon Path The colon model is divided into four anatomical sections: Cecum-Ascending, Transverse (containing both flexures), Descending-Sigmoid and Rectum (see Figure 84). Figure 84: Estimated Colon Path Additional information in this display includes: • Current slice distance from rectum • Coverage%, meaning Percentage of colon model covered by scans.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Figure 85: Segments Marking for Examination Quality Level 9.6.10 Bookmarks Analyst/Supervisor/Physician can add a suspect bookmark to the bookmarks table (see Figure 86, #5 in Figure 70). Figure 86: Bookmarks Table To add a bookmark, mark an ROI around region of interest of a suspect using the Automatic ROI button .
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date Bookmark visibility – bookmarks are marked in all displays. On: On: 22 May 2022 On Off: Off: On: Off: Bookmark filled in structural model. On in left picture, off in right picture Take snapshot for report.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 “Are you sure you wish to delete the bookmark? Yes/No”. Click Yes to delete bookmark or No to cancel. Mark a specific bookmark. 9.6.11 Suspect Metrics The metric section displays seven metrics (Figure 87, #6 in Figure 70), evaluating the suspect based on a database of known SFs. Suspect metrics are used during the analysis process.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 9.6.12 Suspect Wizard As part of analysis process, the suspect wizard (see Figure 89, #6 in Figure 70) is used. To start the analysis process, click the Start/restart the wizard button A classification of a suspect can be changed manually by clicking on the Classification (see Figure 89) which will enable button, click it and override your answer.
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Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Figure 92: Procedure Quality Findings table (#3 in Figure 91) If suspicious findings were reported during pre-analysis, their information and pictures appear at the top of the Findings table (see #1 Figure 93). Figure 93:Findings Table A suspicious finding is automatically marked to appear in procedure report.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Figure 94: Procedure Summary, Comments and Recommendations Summary field includes suspicious findings if there are any, total quality level and an indication when WGTT exceeds threshold. Comments field is free text. Recommendations field shows subject risk level: Average/elevated risk (chosen automatically according to findings in analysis and WGTT).
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Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 10 Technical Description 10.1 System Labeling Table 10: Labeling Explanations Labeling Explanation Single use only - Do not re-use. Consult accompanying documents (required to consult for Safety) Serial number Manufacturer Date of Manufacture [YYYY-MM-DD] Use-by date [YYYY-MM-DD] “Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
Labeling Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Explanation Keep dry Fragile, handle with care Humidity limitation Product contains natural rubber latex Temperature limit LOT number Not for general waste Caution Radioactive Material Non-Sterile MR Unsafe 10.2 C-Scan® Kit Labels Each C-Scan® Kit box has a label on the cover as shown in Figure 96.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 10.3 C-Scan® Cap Label Each capsule box has a label at the bottom as shown in Figure 97. Each capsule is marked with the expiration date, lot number, and a unique capsule serial number. Figure 97: C-Scan® Cap Label 10.4 C-Scan® Track Label The C-Scan® Track has two labels on the sensor units as shown in Figure 98. Each C-Scan® Track is marked with a unique serial number.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Figure 99: C-Scan® View Production Label Figure 100: C-Scan® View Packaging Labels 10.6 C-Scan® Modes of Operation 10.6.1 C-Scan® Cap The C-Scan® Cap has 3 modes of operation: Standby, BIT and Active. The C-Scan® Cap stays in Standby mode as long as it does not receive a valid wakeup request to switch to BIT mode, from the C-Scan® Track via the communication channel.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Active Mode: Active mode is C-Scan® Cap main mode of operation. Only in Active mode the C-Scan® Cap can perform scans and transmit acquired data. X-ray transmission occurs only while the C-Scan® Cap is in motion inside the colon, limiting radiation exposure.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 USB Interface Unit – USB interface that enables data transfer from the C-Scan® Track to the C-Scan® View, as well as production and service needs. 10.6.3 C-Scan® View The C-Scan® View is a client/server-based application that processes and displays the data acquired by the C-Scan® System.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Table 11: Technical Specifications C-Scan® Cap Mechanical Dimensions (Length x Diameter) 35mm x 12mm (1.4” x 0.5”) +/- 5% Weight 13 gram (0.5 oz.) Material Biocompatible X-ray source W-181 (Tungsten) C-Scan® The Cap radiation source is assembled within a 3mm-thick Tungsten concealment. RADIATION QUALITY is constant, guaranteed, and verified, thanks to isotope-based source.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision Operating Frequency RF Band 433.5 MHz ±127 KHz RF Modulation Type GFSK Effective Radiated Power (Avg @ 3[m] in Air) -20 [dBm] Battery Type Lithium-Ion 3.8[V] Battery Life Max. 150 hours 14 Date 22 May 2022 10.7.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Table 13: Guidance and Manufacturer’s Declaration- C-Scan® Cap and C-Scan® Track Immunity The C-Scan® Cap and C-Scan® Track are intended for use in the electromagnetic environment specified below. The customer or the user of the C-Scan® Cap and C-Scan® Track should assure that it is used in such an environment.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 Revision 14 Date 22 May 2022 Connect the equipment to an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. 11 Troubleshooting- C-Scan® View Problem Action The PC fails to start. 1. Make sure that your computer is switched ON and all the components receive power. 2.
Document Title C-Scan System User Reference Manual Document No. DOC0001667 C-Scan® Track connection failed. C-Scan® Track loading failed. Monitor problem. Network connection problem C-Scan® View Processing Data Failed C-Scan® View report share failure C-Scan® View data upload/download failure C-Scan® View login failure C-Scan Track connection cable is damaged Revision 14 Date 22 May 2022 1.
