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 16 of 90
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* Printed revisions are for Reference Only*
C-Scan
®
View
The C-Scan
®
View software is a client/server-based application that enables test's data
analysis, and report generation.
The C-Scan
®
View main functions are:
• Load and display test information and data
• Images review - enables to view structural information of the colon wall
• Generate test report
• Store test information, data and results on server
5.2 The C-Scan
®
System Procedure- General overview
The C-Scan
®
System procedure consists of the following steps:
At the clinic-
Preparing the subject for the ingestion of the C-Scan
®
Cap and testing the system.
Attaching the C-Scan
®
Track to the subject’s back, performing the Cap ingestion and
discharging the subject.
At the subject’s home-
The subject continues with his daily routine while ingesting the contrast agent and
fiber supplement. Once the procedure has been completed (after Cap excretion), the
subject informs the clinic and coordinate the C-Scan
®
Track collection.
Analysis process-
Data download from the C-Scan
®
Track to the C-Scan
®
View software.
Pre-Analysis of the data by a dedicated analysis team, including below steps:
o Procedure data review- data sanity assessment.
o Procedure data analysis- identify suspects and determine procedure data quality
level.
o Pre-analysis summary- log comments for the analyzing GI physician.
Pre-analysis process output: detailed summary including procedure data
evaluation and a list of potential suspects.
A certified GI physician performs final analysis, including the below steps:
o Pre-analysis summary review including
• Procedure’s quality level
• Potential suspects (pending GI physician’s discretion, reanalysis and/or
adding/replacing suspects is applicable).
o Final interpretation and decision – determine patient’s risk level, average or high
risk.
o Decision summary - comments and recommendations.
o Final report and signoff.