User's Manual

Document Title
C-Scan System User Reference Manual
Document No. DOC0001667 Revision 14 Date 22 May 2022
Page 11 of 90
Before using this document, check that you use latest revision (see Arena)
* Printed revisions are for Reference Only*
 Nausea
4.4 Warnings
Alerts about a situation which, if not avoided, could result in death or serious injury.
 If the subject has had prior abdominal or pelvic surgery, the physician should consider
the compatibility of the subject for the C-Scan
®
procedure.
 When swallowing the C-Scan
®
Cap there is a rare possibility of choking. If the subject
exhibits any symptoms and/or clinical signs of choking (laboured breathing, wheezing,
involuntary coughing, etc.), the recommended first-aid procedure should be followed.
 In subjects with unsuspected strictures of the GI tract, C-Scan
®
Cap can potentially
cause intestinal obstruction resulting in the need for hospitalization and surgery.
 Instruct the subject to seek immediate medical attention if, after ingesting C-Scan
®
Cap, there is any abdominal pain, nausea, or vomiting.
4.5 Cautions
Caution is used for a potentially hazardous situation which, if not avoided, may result in
minor or moderate injury to the user or damage to the equipment or other property.
Procedure related:
 Read the manual before using the system for the first time.
 Make sure the subject received the IFU and thoroughly understands the procedure.
 Make sure that trained personnel, familiar with all the C-Scan
®
System operating
procedures, use the system.
 Only one C-Scan
®
Cap should be ingested at a time.
 Subject shall contact the clinic in case of swallowing more than one C-Scan
®
Cap.
 If excretion of the C-Scan
®
Cap from the subject has not been positively verified,
and the subject develops unexplained post-procedure abdominal pain, vomiting, or
other symptoms of obstruction, contact the physician for evaluation and possible
abdominal X-ray examination.
 Final diagnosis of the C-Scan
®
data should be made only by physicians who are
trained in the interpretation of C-Scan
®
images.
 A “No” result of C-Scan
®
examination does not exclude the possibility of colon
pathology, polyps or colon cancer.
 Women at child-bearing age shall use contraceptives during the procedure.
 Subject with any known condition that precludes compliance with device instructions
shall not go through the C-Scan
®
procedure.
Environment compatibility related:
 During the procedure the subject should not be near any source of powerful
electromagnetic fields such as one created near an MRI or CT device.