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 8 of 90
Before using this document, check that you use latest revision (see Arena)
* Printed revisions are for Reference Only*
1 Using this guide
1.1 Purpose
This guide includes instructions for: the clinic team, the subject and the analysis team.
The sections that apply to the clinic team in this UM will be given to the clinic team
as a separate instructions document - DOC001591 C-Scan System Clinic Team
IFU.
The sections that apply to the subject in this UM will be given to the subject as a
separate instructions document - DOC001592 C-Scan System-Patient Instruction
for Use.
Instructions for the C-Scan
®
View system is described in section 8-11 on this
manual.
Detailed instructions for the C-Scan
®
View analysis process is described in a
separate instructions document - DOC001212 C-Scan view user guide and
training.
1.2 List of Acronyms
Acronym Description
CRC Colorectal Cancer
IBD Inflammatory Bowel Disease
BIT Built-In Test
BMI Body Mass Index
CMT Compton Scattering
FIT Fecal Immunochemical Test
IFU Instructions For Use
mSv Milli Sievert (X-ray dose units)
RF Radio Frequency
SCA Scan Control Algorithm
USB Universal Serial Bus
XRF X-Ray Fluorescence
WGTT Whole Gut Transit Time
SF Suspicious Finding
Colon model Estimated capsule path in colon
1.3 Conventions
Note - A note provides clarification, extra information, or refers to related material.
Caution- A Caution warns about a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury to the user or damage to the
equipment or other property.