User's Manual

Document Title
C-Scan System User Reference Manual
Document No. DOC0001667 Revision 14 Date 22 May 2022
Page 24 of 90
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The subject should store the excreted capsule in the dedicated biohazard package,
coordinate the package collection and notify the clinic about the excretion.
After the indication of excretion, the subject shall take the C-Scan
®
Track out of the
sticker’s pockets, place it in the C-Scan
®
package that includes the subject
identification details and C-Scan
®
details and coordinate its collection.
The stickers shall be removed from the back and discarded.
After the subject informs that the C-Scan
®
Cap is excreted verify the subject has sent
both the C-Scan® Cap and Track to analysis.
6.6 Analysis & report reception
The data from the C-Scan
®
Track is downloaded to the client, uploaded to the server
and processed to create a structural colon wall reconstructed model displayed in the
C-Scan
®
View, as well as the Whole Gut Transit Time (WGTT) data. Pre-analysis is
done by an experts' analysis team, who review the structural information to identify
suspicious findings which are protruding and/or bulging on the colon wall. All the
analysis data is uploaded to the server. A GI expert physician downloads the data,
examines pre-analysis results and performs final data analysis using the C-Scan
®
View. The physician determines the final decision as to whether the subject is
assessed to be at average or elevated-risk and generates the test report.
6.7 C-Scan® user interface notifications
The C-Scan® Track may generate the below listed notifications
Table 1. C-Scan® user interface notifications
Notification
Implication
Initial activation
Green LED + Vibration
Device power up (pressing ON button) - BIT process
initiated
Blue LED

red LED

Vibration

Buzzer
C-Scan Track initialization
Blue LED blinking
Initial self-test (BIT) in process

Red LED
BIT fail

Green LED
BIT pass (single blink – track alive / double blinking –
track and capsule communicated)
Error during procedure
Red LED + Buzzer + Vibration
Radioactive source not properly concealed
CAUTION see section 5.4 for instructions
Rapid blue LED blinking
Track battery exhausted
Capsule excretion – end of procedure
Slow blue LED blinking (1 sec on, 1 sec off) +
Buzzer intermittent during 1 min
Capsule excretion
Slow blue LED blinking (1 sec on, 1 sec off)
Capsule is no longer in the subject’s body