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 26 of 90
Before using this document, check that you use latest revision (see Arena)
* Printed revisions are for Reference Only*
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.
You will be asked to ingest the C-Scan
®
Cap, in the presence of a physician.
After swallowing, you will be sent home with a subject instructions packet which will
include instructions on following daily routine, the required materials and the package
for sending the C-Scan
®
Track for analysis following the C-Scan
®
Cap excretion.
7.4 Daily routine during the procedure
Keep the C-Scan
®
Track attached to the back during the procedure until C-Scan
®
Cap excretion.
Note: If the C-Scan
®
system is active and working properly, an indication of a flashing
green LED is visible every 2 sec on the C-Scan
®
Track.
Note: If the excretion indication not heard 100 hours (4 days) from ingestion contact
the clinic.
Note: If the excretion indication not heard 150 hours (7 days) from ingestion remove
the C-Scan
®
Track and contact the clinic.
Ingestion of contrast agent:
Contrast agent should be taken 3 time a day until C-Scan
®
Cap excretion, up to full
4 days (100 hours).
The contrast agent used in this procedure is water soluble Iodine (Omnipaque).
Detailed instructions:
o Take the measuring cup and pour 15 ml of contrast agent into the cup (see
measuring strip).
o Pour the contrast agent into a glass of water/juice, mix well and drink it fully. You
may also intake the contrast agent without dissolving it in any liquid, per your
preference.
o Repeat these steps 3 times a day: morning, noon and evening (with or without
food).
Important notice: The contrast agent is extremely critical for the success
of the procedure. Without it the imaging of your colon will not be performed
properly, and no data will be obtained!
Ingestion of dietary fibers:
Fibers should be taken 3 times a day until C-Scan
®
Cap excretion, up to full 4 days
(100 hours).
Detailed instructions: