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 21 of 90
Before using this document, check that you use latest revision (see Arena)
* Printed revisions are for Reference Only*
2. Use the liners attached to the top of the stickers to lock and tighten the C-Scan
®
Track in each of the three pockets. Be sure to follow the contour of the units
when tightening the liners.
Figure 5: Attaching the C-Scan
®
Track to the back
6.2 C-Scan
®
Cap ingestion procedure
Once the C-Scan
®
Track is attached to the subject back follow the steps below:
1. Take the C-Scan
®
Cap box out of the C-Scan
®
Kit and verify that it is intact and close.
Note: If the box has been opened, discontinue the procedure and contact Check-Cap
for further directions.
2. Hand the C-Scan
®
Cap sealed box to the subject. The subject opens the C-Scan
®
Cap box by removing the “Remove before ingestion” label on the side of the box and
releasing the blue clasp downward (preferably above a table).
Note: Be sure to keep the box above a table or similar work top to prevent
accidentally dropping the Cap on the floor. If it falls – it must not be ingested.
3. Ask the subject to stand.
Note: Ingestion should be performed while subject is standing.
4. Instruct the subject to take the C-Scan
®
Cap from the box just before swallowing and
put it in his mouth.
Note: Instruct the subject to avoid biting the Cap or hold it between the teeth.
5. Give the subject glass of water and instruct him to ingest the C-Scan
®
Cap with water.
6. Following the capsule ingestion give the subject a glass of water with 15ml of contrast
agent (Omnipaque 350mg Iodine /ml) and instruct him to drink the whole glass. The
patient may also intake the contrast agent without dissolving it in a glass of water, per
the patient’s preference.
7. Thereafter, give the patient dietary fiber pills equivalent to 1500 mg (e.g., Psyllium
Husk Caps 500 mg).
8. Document the date and time of the C-Scan
®
Cap ingestion.