User's Manual

Document Title
C-Scan System User Reference Manual
Document No. DOC0001667 Revision 14 Date 22 May 2022
Page 23 of 90
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 At 150 hours (7 days) from ingestion, instruct the subject to remove the C-Scan
®
Track
and coordinate its collection.
6.4 Radioactive source not properly concealed – malfunction notification
instruction
 Instruct the patient to contact the clinic if he/she experiences the following notification
from the C-Scan® Track: Red LED + Buzzer + Vibration
 This indication implies the radioactive source within the C-Scan® Cap is not properly
concealed. This is a very rare malfunction. However, if it occurs the clinic team shall
act according to the instructions below:
1. Instruct the patient to:
a. Start colonoscopy preparation
b. NOT remove the C-Scan
®
Track from the back at this point
c. Stop taking fiber supplements and contrast agent
d. Continue to check the stool collector before disposal, as detailed in the
Subject IFU, but NOT to collect the capsule when it is excreted. The
capsule should be flushed down the toilet to reduce the radiation exposure
to the patient and the surroundings.
Note: This is the only scenario where capsule can be disposed in the
toilet. Otherwise, it is prohibited to flush the C-Scan
®
Cap down the toilet.
e. Inform the clinic if the excreted capsule has been identified or if the
excretion notification has been heard and seen (Green LED + Buzzer).
2. If the capsule is still in the colon after 48 hours from colonoscopy preparation start,
perform colonoscopy to extract the capsule.
3. If there is uncertainty about the capsule excretion after 48 hours, perform an
abdominal X-ray.
 Note: Following the acknowledgment of the event, the clinic can instruct the subject
how to disable the indication, in order to avoid a state of ongoing discomfort to the
subject and to ensure he stays with the C-Scan
®
Track attached to his back. This is
done by pressing the C-Scan
®
Track “ON button” for ~2[sec]. This action will be
considered as an acknowledgment by the user and disable the buzzer and vibration
indication (the red LED indication will remain flashing as long as the problem occurs).
6.5 Post procedure- after C-Scan
®
Cap excretion
The procedure concludes upon excretion of the C-Scan
®
Cap.
When the C-Scan
®
Cap is excreted, the C-Scan
®
Track indicates the end of the
procedure with an audible indication- a series of short beeps, repeated within 1
minute.
The excreted capsule should be located in the stool and collected by the subject using
the collection kit provided.