User's Manual
Table Of Contents
- 1 Using this guide
- 2 Applicable Documents
- 3 About C-Scan®
- 4 Indications, Contraindications, Adverse Events, Warnings, Cautions
- 5 C-Scan® system
- 6 Instruction for use for the clinic team
- 6.1 Preparations before procedure
- 6.2 C-Scan® Cap ingestion procedure
- 6.3 During the procedure days (from C-Scan® Cap ingestion to excretion)
- 6.4 Radioactive source not properly concealed – malfunction notification instruction
- 6.5 Post procedure- after C-Scan® Cap excretion
- 6.6 Analysis & report reception
- 6.7 C-Scan® user interface notifications
- 7 Instruction for use to the subject
- 7.1 Permitted activities during the procedure:
- 7.2 Prohibited activities during the procedure:
- 7.3 C-Scan® procedure
- 7.4 Daily routine during the procedure
- 7.5 Post procedure- after C-Scan® Cap excretion:
- 7.6 When to contact the Clinic
- 7.7 Analysis & report reception
- 7.8 C-Scan® user interface notifications
- 8 C-Scan® View Installation Guide
- 9 Using C-Scan® View Application
- 9.1 C-Scan® View Application Login Screen
- 9.2 C-Scan View Updates
- 9.3 C-Scan® Track Data Download and Upload to Server
- 9.4 Add a Failed Procedure to Database
- 9.5 Managing your local files
- 9.6 C-Scan® View Editor
- 9.6.1 Editor introduction
- 9.6.2 Slice Profile
- 9.6.3 2D XRF/CMT Map
- 9.6.4 Structural Model
- 9.6.5 2D Map Timeline
- 9.6.6 Play Bar
- 9.6.7 General Buttons
- 9.6.8 Report on Case Failure
- 9.6.9 Estimated Colon Path
- 9.6.10 Bookmarks
- 9.6.11 Suspect Metrics
- 9.6.12 Suspect Wizard
- 9.6.13 Pre-analysis Summary
- 9.6.14 Report Preview
- 10 Technical Description
- 11 Troubleshooting- C-Scan® View
Document Title
C-Scan System User Reference Manual
Document No. DOC0001667 Revision 14 Date 22 May 2022
Page 2 of 90
Before using this document, check that you use latest revision (see Arena)
* Printed revisions are for Reference Only*
CHANGE HISTORY
Rev. number
Change Owner
Change description
o Added instruction to keep the Kit package
(containing the Cap) in close proximity to the Track
when preparing for capsule ingestion
o Added instruction to follow the contour of the C-
Scan Track units when tightening the liners
• Section 6.2
o Added instruction – contrast agent may be ingested
without dissolving it in a glass of water, per the
patient’s preference. Same instruction added also to
7.3
o Added instruction to give the patient dietary fiber
pills equivalent to 1500 mg (e.g., Psyllium Husk
Caps 500 mg) to intake after capsule ingestion
• Section 4.5 “Cautions” – removed ‘’can be flushed in the
toilet’’
• Added new section 6.7 & 7.8 C-Scan® user interface
notifications C-Scan® user interface notifications to list the
notifications generated by the C-Scan® Track
• Added new section 6.4
Radioactive source not properly
concealed – malfunction notification instruction, to provide
clear instructions if the rare malfunction of radioactive source
within the C-Scan® Cap is not properly concealed occurs
• Adding “Being near powerful electromagnetic fields such as
those created by MRI or CT devices” to the list of prohibited
activities during the procedure in section 7.2, to align with
device cautions
• Adding relevant notes to emphasize device cautions that
appear in section 4.5 also in section 7
Instruction for use to
the subject
13
Daniella Bleistein
Updated section 4.2 Contraindications to align fully with CIP
exclusion criteria: know motility disorders of chronic constipation
and ongoing diarrhea, as well as any condition believed to have
an increased risk for capsule retention including diverticulosis.
14
Sivan Peleg-Cohen
Update C-Scan View related chapters (8,9,10) according to C-
Scan modified View version for the IDE May 2022 5-days notice
submission.
AUTHORIZATION
NAME
TITLE
DATE
SIGNATURE
Reviewer
Boaz Shpigelman
VP R&D
See Arena
See Arena
Reviewer
Yaara Tirosh
RA Engineer
See Arena
See Arena
Reviewer
Hanit Brenner
Lavie
VP Clinical
See Arena
See Arena
Approver
Israel Hershko
VP Q&R
See Arena
See Arena
PROPRIETARY INFORMATION