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 18 of 90
Before using this document, check that you use latest revision (see Arena)
* Printed revisions are for Reference Only*
Inform the subject to contact the clinic if the following occurs: Pain or discomfort,
detachment of the stickers on the back, beeping of the Track, Capsule excretion.
Explain how to remove and send the C-Scan
®
Track.
Write the subject identification details and C-Scan
®
details on the designated C-Scan
®
package. Give it to the subject and make sure he understands how to send the C-
Scan
®
Track and C-Scan
®
Cap at the end of the procedure.
Specify alarms and indications which require subject’s attention:
In case of malfunction, the C-Scan
®
Track vibrates, beeps and a red LED lights up. In
this case the subject should contact the clinic. See section 6.7 for a detailed overview
of the system’s notifications.
6.1.3 Equipment preparation before procedure
The following steps should be performed:
1. Verify that the C-Scan
®
Kit package is intact with no damages
Note: Do not use a C-Scan
®
Cap if the package is damaged.
2. Verify that the seal is intact. Remove the MEDICAL DEVICE label which seals the
package. If the box has been opened, discontinue the procedure and contact Check-
Cap for further directions.
3. Activation of the C-Scan
®
Track (illustrated in Figure 2)
Open the C-Scan
®
Kit package and activate the C-Scan
®
Track by pressing the “On”
button continuously (about 3 seconds) until you feel a vibration. A green LED will light
up and start to blink right next to the activation button.
This step turns the device on.
Note: Do not remove C-Scan
®
Track and C-Scan
®
Cap from their package before
activation is completed.
After turning the C-Scan
®
Track ON you will see several colorful blinks of the LED
and hear auditory indications. Activation will take up to 30 seconds, at the end, a
green LED will start blinking every 2 sec. (see figure 2A).
In case of failed activation, a red LED will appear for about a minute, (see figure 2B)
discontinue the procedure and contact Check-Cap for further instructions.