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 28 of 90
Before using this document, check that you use latest revision (see Arena)
* Printed revisions are for Reference Only*
- 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.
7.6 When to contact the Clinic
If any of the following occurs, contact the clinic for further directions:
Any sensation of pain or discomfort.
Detachment of the C-Scan
®
Track stickers from the back.
Changes in bowel habits. Consult the clinic in case of major changes (constipation or
diarrhea).
C-Scan
®
Cap excretion.
In case the C-Scan
®
Cap has still not been excreted 4 days post ingestion.
In case of malfunction indication from the C-Scan
®
Track - vibration, repeated beeps,
and red LED light.
Note: If you feel something is not right, at any time during the procedure or
immediately after, and if there are any questions or doubts contact the clinic.
7.7 Analysis & report reception
The data from the C-Scan
®
track is downloaded and processed to create a structural
colon wall reconstructed model displayed in the C-Scan
®
View and analyzed by an
expert team.
A certified physician performs final analysis, reviews the data and the analysis
summary and generates the final report as to whether you are at average or at elevated
risk for colon polyps.
7.8 C-Scan® user interface notifications
The C-Scan
®
Track may generate the below listed notifications.
Table 2. C-Scan® user interface notifications
Notification
Implication
Error during procedure
Red LED + Buzzer + Vibration
Please contact the clinic team immediately
Rapid blue LED blinking
Track battery exhausted
Capsule excretion – end of procedure
Slow blue LED blinking (1 sec on, 1 sec off) +
Buzzer intermittent during 1 min
Capsule excretion
Slow blue LED blinking (1 sec on, 1 sec off)
Capsule is no longer in the subject’s body