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 27 of 90
Before using this document, check that you use latest revision (see Arena)
* Printed revisions are for Reference Only*
o Dietary fiber pills equivalent to 1500 mg (e.g., Psyllium Husk Caps 500 mg, as
directed by the clinic team) should be taken with a glass of water, 3 times a day
- morning, noon, and evening.
7.5 Post procedure- after C-Scan
®
Cap excretion:
Note: Do not throw the C-Scan® Cap into the trash or flush it in the toilet.
The procedure concludes upon excretion of the C-Scan
®
Cap.
Once the C-Scan
®
Track detects that the C-Scan
®
Cap is excreted from the body it
indicates the end of the procedure with audible indication- a series of short beeps,
repeated within 1 minute.
The excreted capsule should be located and collected using the collection kit
provided to you on the ingestion day, according to the instructions detailed below.
After the indication of C-Scan
®
Cap excretion, take the C-Scan
®
Track units out of the
pouches attached to your back. Place the units in the C-Scan
®
Track package you
received from the clinic, ship according to instructions given to you by the clinic.
Remove the stickers from your back and discard.
C-Scan
®
Cap Collection instructions:
1. Place the disposable stool collector on the toilet seat following the instructions for use
provided with it. Be sure to use it with every excretion.
2. Make sure the following accessories needed for collection are within reach:
disposable gloves, tongs/ tweezers/ wooden spatulas, waste bag, bio-hazard plastic
bag, capsule box).
3. During your bowel movement, pay attention to the system beep sound indicating
capsule excretion.
4. Use gloves, tweezers and spatulas to locate and collect the capsule.
5. Wash the capsule with soap and water and place it in the small box provided to you in
the collection kit.
6. Insert the box into the bio-hazard plastic bag, seal it and lay the bag in the C-Scan
®
Cap return package.
7. Coordinate the package collection and notify the clinic.
Important notes:
- Carry all the required equipment with you when you leave the house.
- Make sure you use the stool collector with every bowel movement.
- Pay attention, while sitting on the toilet for the audible indication.
- It is possible that the environment of the collection container will cause a delay in
identifying the excretion of the capsule from the body, which will lead to a delay in
the audible indication of the C-Scan
®
Cap excretion. Please check the stool
collector before disposal, even if you have not heard the audible indication.