User's Manual

Document Title
C-Scan System User Reference Manual
Document No. DOC0001667 Revision 14 Date 22 May 2022
Page 17 of 90
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6 Instruction for use for the clinic team
This section is for the clinic team use. It describes the steps for completing a C-Scan
®
procedure. It includes the following information:
 Preparations before procedure
- Subject compliance verification
- Subject preparation
- Equipment preparation
 C-Scan
®
Cap Ingestion procedure
 During the procedure days (from C-Scan
®
Cap ingestion to excretion)
 Post procedure (after C-Scan
®
Cap excretion)
 Analysis & Report reception
6.1 Preparations before procedure
Before ingesting a C-Scan
®
Cap the following tasks must be performed:
6.1.1 Subject compliance Verification
 Verify that the subject does not have any of the contraindications described in section
4.2.
 Provide the subject with contrast agent and dietary fiber pills, and instruct the subject to
start intake following the below schedule:
o Contrast agent: 15 ml every 8 hours starting approximately 48 hours prior to C-Scan
®
Cap ingestion
o Dietary fiber pills: 1500 mg, every 8 hours starting approximately 48 hours prior to C-
Scan
®
Cap ingestion
 Before the procedure contact the subject, verify the ingestion hour and location and ask
him/her to skip the meal before the procedure. Water and coffee are allowed. Instruct the
subject to wear comfort clothes.
6.1.2 Subject preparation before procedure
Review the IFU with the subject and repeat the highlights:
Note: Introduce the C-Scan
®
system to single subject per room.
 Instruct the subject what to expect before, during, and after the procedure.
Inform the subject about the required materials that needs to be used during the
procedure and the pattern of usage: contrast agent, fibers, possible laxatives.
Note: Intake of contrast agent 3 times a day (morning, noon and evening)
is extremely critical for the success of the procedure. Without it the imaging
of the colon will not be performed properly, and no data will be obtained!
Note: Dietary fiber pills should be taken 3 times a day (morning, noon and evening).
 Subject shall continue routine medication intake.
 Instruct subject regarding permitted and prohibited activities during the procedure.
 Explain the possible risks involved with using the C-Scan
®
system.