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 83 of 90
Before using this document, check that you use latest revision (see Arena)
* Printed revisions are for Reference Only*
Active Mode:
Active mode is C-Scan
®
Cap main mode of operation. Only in Active mode the C-Scan
®
Cap can perform scans and transmit acquired data.
X-ray transmission occurs only while the C-Scan
®
Cap is in motion inside the colon,
limiting radiation exposure. To detect C-Scan
®
Cap motion, the C-Scan
®
Cap generates a
positioning signal, which is interpreted by the C-Scan
®
Track Scan Control Algorithm which
then informs the C-Scan
®
Cap to open the concealment cover and begin the scan. When
the C-Scan
®
Track determines that the motion has ended, the C-Scan
®
Cap's X-ray source
is concealed.
The C-Scan
®
Cap verifies that the X-ray source is concealed. If there’s a suspect for the
X-ray source not being concealed, the C-Scan
®
Cap sends a message to the C-Scan
®
Track informing it that the X-ray source is exposed. If the issue is not resolved by the
system, the C-Scan
®
Track indicates a malfunction to the subject, who should contact the
clinic immediately.
10.6.2 C-Scan
®
Track
The C-Scan
®
Track is an external device attached to the subject back. The C-Scan
®
Track
tracks the C-Scan
®
Cap position, sends commands to the C-Scan
®
Cap, receives and
stores imaging data sent by the C-Scan
®
Cap, and interfaces at the end of the procedure
with the C-Scan
®
View.
The C-Scan
®
Track has several main modes of operation:
Idle mode- includes sleep mode
Calculation cycle mode- a single process of C-Scan
®
Cap position estimation and full
SCA calculation
C-Scan
®
Cap temperature/pressure data transfer mode- C-Scan
®
Cap sensor data is
received through RF
The C-Scan
®
Track consists of the following units:
Positioning System - a localization device that tracks and records the position and
orientation of the C-Scan
®
Cap, enabling intra-colon mapping for the purpose of colon
surface imaging.
Data Recorder - a recording device, which captures the C-Scan
®
Cap data (imaging,
etc.) to a non-volatile memory. Data transmission is through RF communication during
the C-Scan
®
Cap transition in the GI tract.
Processing Unit – an embedded device that controls localization and recording
functions, running an embedded Scan Control Algorithm through which the C-Scan
®
Cap’s scan mechanism is operated.
User Interface Unit –Provides status indicators to the subject and operator.