User's Manual
Table Of Contents
- 1 Using this guide
- 2 Applicable Documents
- 3 About C-Scan®
- 4 Indications, Contraindications, Adverse Events, Warnings, Cautions
- 5 C-Scan® system
- 6 Instruction for use for the clinic team
- 6.1 Preparations before procedure
- 6.2 C-Scan® Cap ingestion procedure
- 6.3 During the procedure days (from C-Scan® Cap ingestion to excretion)
- 6.4 Radioactive source not properly concealed – malfunction notification instruction
- 6.5 Post procedure- after C-Scan® Cap excretion
- 6.6 Analysis & report reception
- 6.7 C-Scan® user interface notifications
- 7 Instruction for use to the subject
- 7.1 Permitted activities during the procedure:
- 7.2 Prohibited activities during the procedure:
- 7.3 C-Scan® procedure
- 7.4 Daily routine during the procedure
- 7.5 Post procedure- after C-Scan® Cap excretion:
- 7.6 When to contact the Clinic
- 7.7 Analysis & report reception
- 7.8 C-Scan® user interface notifications
- 8 C-Scan® View Installation Guide
- 9 Using C-Scan® View Application
- 9.1 C-Scan® View Application Login Screen
- 9.2 C-Scan View Updates
- 9.3 C-Scan® Track Data Download and Upload to Server
- 9.4 Add a Failed Procedure to Database
- 9.5 Managing your local files
- 9.6 C-Scan® View Editor
- 9.6.1 Editor introduction
- 9.6.2 Slice Profile
- 9.6.3 2D XRF/CMT Map
- 9.6.4 Structural Model
- 9.6.5 2D Map Timeline
- 9.6.6 Play Bar
- 9.6.7 General Buttons
- 9.6.8 Report on Case Failure
- 9.6.9 Estimated Colon Path
- 9.6.10 Bookmarks
- 9.6.11 Suspect Metrics
- 9.6.12 Suspect Wizard
- 9.6.13 Pre-analysis Summary
- 9.6.14 Report Preview
- 10 Technical Description
- 11 Troubleshooting- C-Scan® View
Document Title
C-Scan System User Reference Manual
Document No. DOC0001667 Revision 14 Date 22 May 2022
Page 75 of 90
Before using this document, check that you use latest revision (see Arena)
* Printed revisions are for Reference Only*
If a suspicious finding was found during pre-analysis, the subject risk level is updated to
elevated risk due to SF, Pre-analysis summary shows the procedure highlights and list of
suspects found:
Procedure general information (#1 in Figure 91)
Procedure quality information (#2 in Figure 91)
Suspicious and Non-suspicious findings table (#3 in Figure 91)
Procedure summary, comments and recommendations (#4 in Figure 91)
Action buttons (#5 in Figure 91)
Figure 91: Pre-Analysis Summary Highlights
Procedure Overview (#1 in Figure 91) includes:
Total colon examination quality level (for additional information, see chapter 9.6.9)
System indications
C-Scan
®
Test ID (procedure ID)
Gender
Procedure Start Time (UTC): (YYYY-MM-DD-HH:MM:timezone)
Whole Gut Transit Time (for additional information, see chapter 9.6.9)
Colon path length
Procedure quality information (#2 in Figure 91)
Procedure quality diagram shows the estimated quality throughout the capsule estimated
path (see Figure 92). Optional levels are Low/Medium/High according to the color bar shown
in the left side (NA option is relevant for non-selected sections).
Findings are marked according to their location on estimated capsule path.
SF (Suspicious Findings) is marked with red triangle, non-SF with white circle.