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 25 of 90
Before using this document, check that you use latest revision (see Arena)
* Printed revisions are for Reference Only*
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
7.1 Permitted activities during the procedure:
Eating and drinking as usual
Driving/ travelling (except for air travelling)
Showering with the C-Scan
®
Track on your back
Taking routine medications
Daily routine, except for the activities listed in section 7.2
7.2 Prohibited activities during the procedure:
MRI procedures, unless in case of emergency
Note: This device is MR unsafe. Be sure to notify the medical team about the C-
Scan
®
Cap and C-Scan
®
Track if the procedure is necessary
Active sports such as: running, jogging, physical training in the gym, ball games,
skiing, contact sports, etc.
Prolonged immersion in water: bathing, swimming, Jacuzzi and sauna
Travel by airplane
Being near powerful electromagnetic fields such as those created by MRI or CT
devices
7.3 C-Scan
®
procedure
Please read carefully the contraindications, warnings, cautions and possible adverse
events before going through the procedure.
Contrast agent and dietary fiber pills intake shall begin approximately 48 hours prior to
the scheduled C-Scan
®
Cap ingestion following the below schedule:
o Contrast agent: 15 ml every 8 hours
o Dietary fiber pills: 1500 mg, every 8 hours
The C-Scan
®
procedure performed at the clinic, includes attachment of the C-Scan
®
Track to your back and ingestion of the C-Scan
®
Cap.
The C-Scan
®
Track that records the data from the C-Scan
®
Cap will be attached to your
back.