User's Manual

Document Title
C-Scan System User Reference Manual
Document No. DOC0001667 Revision 14 Date 22 May 2022
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(such as diverticulosis, intestinal tumors, radiation enteritis) or incomplete
colonoscopies as determined by a physician
 Cardiac pacemakers or other implanted electromedical devices
 Dysphagia or other swallowing disorders
 Known allergy to Iodine
 Abdominal circumference larger than 125cm
 Paediatric population under the age of 22
 Known IBD (Crohn’s, ulcerative Colitis)
 Acute kidney failure
 Pregnant or nursing women
 Subjects who undergo nuclear imaging or therapy during the last 4 weeks from
using the C-Scan
®
System
 Subjects at high risk for CRC: adenomatous polyps; a personal history of CRC; a
family history of CRC or adenomatous polyps diagnosed in a relative before age 60
years; high risk due to a history of inflammatory bowel disease of significant duration
or the presence of one of two (2) hereditary syndromes
 A subject with known motility disorders:
o Chronic Constipation: less than three (3) bowel movements/week, without
the use of laxatives within the last 3 months.
o Ongoing diarrhea defined as passage of loose or watery stools at least three
times within 24-hour.
o Gastroparesis (delayed gastric emptying)
 Prior history of gastrointestinal tract surgery
 Significant changes in the frequency or diameter of stools within the last 3 months
 GI bleeding within the last 3 months i.e. rectal outlet bleeding, hematochezia or
melena
4.3 Adverse Events
The following adverse events may occur when undergoing the C-Scan
®
procedure:
 Change in bowel habits during the C-Scan
®
Cap passage- constipation, soft stool
or diarrhea
 Abdominal pain, cramps or discomfort during the passage of the C-Scan
®
Cap
 Discomfort in the oesophagus following the swallowing of the C-Scan
®
Cap
 Loss of appetite
 Irritation from the C-Scan
®
Track attached to the back of the subject
 Back pain due to the C-Scan
®
Track
 Aspiration of the C-Scan
®
Cap that may cause chocking
 Long retention of the C-Scan
®
Cap that may require intervention
 Obstruction, perforation, and mucosal injury or bleeding
 Allergic reaction to contrast medium
 Blood in the stool (small amount)