User's Manual

Document Title
C-Scan System User Reference Manual
Document No. DOC0001667 Revision 14 Date 22 May 2022
Page 9 of 90
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 Warning- A Warning warns about a situation which, if not avoided, could result in
death or serious injury.
 Contraindications- Specific situations in which the device and procedure should not
be used because it may be harmful to the person.
2 Applicable Documents
1. C-Scan System- Clinical team IFU DOC001591
2. C-Scan System- Patient IFU DOC001592
3. C-Scan view user guide and training DOC001212
3 About C-Scan
®
The C-Scan
®
System enables a subject-friendly, preparation free and painless
evaluation of colorectal abnormalities. Using the C-Scan
®
System, suspicious findings
such as colorectal polyps can be identified. Polyps in the colon may become cancerous
and may develop to colorectal cancer thus, it is important to identify it at an early stage
before they are becoming cancerous. Identification of polyps by the C-Scan
®
help define
subject as elevate risk for Colorectal Cancer (CRC) and refer the subject to colonoscopy
procedure for removing the polyps. The C-Scan
®
system is designed to evaluate the
presence of polyps without the need for fasting and prior bowel cleansing.
The Procedure: The subject swallows the C-Scan
®
Cap and can continue with his daily
routine. He is required to swallow contrast agent (15ml 3 times a day) and to intake
dietary fiber pills (1500 mg, 3 times a day) starting 48 hours prior to C-Scan
®
Cap
ingestion, and while the C-Scan
®
Cap travels painlessly through the gastrointestinal
tract. After the C-Scan
®
Cap is excreted the data collected by the C-Scan
®
system is
analyzed and the GI physician reviews the analysis in the C-Scan
®
view and generates
the final report as to whether the subject is assessed to be at average or at elevated-
risk.
4 Indications, Contraindications, Adverse Events, Warnings, Cautions
4.1 Indication for Use
C-Scan
®
is intended to identify adult subjects 50 years or older, within the average risk
population, who are at elevated risk for polyps. It is intended for subjects who are poor
candidates for colonoscopy or decline colonoscopy, or who had an incomplete
colonoscopy. Polyps have been shown to be associated with the development of
colorectal cancer. C-Scan
®
is not intended to replace colonoscopy. A positive C-
Scan
®
result should be followed by colonoscopy.
4.2 Contraindications
 Any condition believed to have an increased risk for capsule retention, known
strictures, known bowel adhesion or 'obstacles' to free passage of the capsule