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 15 of 90
Before using this document, check that you use latest revision (see Arena)
* Printed revisions are for Reference Only*
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. The C-Scan
®
Cap is ingested by the subject and propelled by peristalsis natural
motility, it passes through the gastrointestinal tract and excreted naturally.
The C-Scan
®
Cap is designed to start scanning when the capsule enters the colon.
While stationary (which is most of the time) the C-Scan
®
Cap is set at an idle mode and
the radiation X-ray source is blocked. During normal procedure, Large Intestine receives
dose up to 1 mGy (the same as single Abdomen x-ray), other organs doses are much
lower. The C-Scan
®
Cap is powered by onboard batteries and is designed to operate up
to 150 hours.
C-Scan
®
Track
The C-Scan
®
Track is an external device that wirelessly communicates with the C-Scan
®
Cap: tracks the Cap position, sends commands to the C-Scan
®
Cap, receives and stores
imaging data sent by the C-Scan
®
Cap. The C-Scan
®
Track also records the transit time
from capsule ingestion to excretion and enables data download for analysis in the C-
Scan
®
View software.
The C-Scan
®
Track contains several LEDs, which blink at a fixed rate, as well as a
vibration and a buzzer. These features provide an indication of proper functioning of the
system and alert in case of a system malfunction, see section 6.7 for a detailed overview
of the system’s notifications.
The C-Scan
®
Track is attached to the subject's back via adhesive skin pouches. The
subject can continue his routine behavior with the C-Scan
®
Track attached to his back.
C-Scan
®
Kit
The C-Scan
®
Kit contains the C-Scan
®
Cap and the C-Scan
®
Track.