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 85 of 90
Before using this document, check that you use latest revision (see Arena)
* Printed revisions are for Reference Only*
Table 11: Technical Specifications
C-Scan
®
Cap
Mechanical Dimensions (Length x Diameter) 35mm x 12mm (1.4” x 0.5”) +/- 5%
Weight 13 gram (0.5 oz.)
Material Biocompatible
X-ray source W-181 (Tungsten)
The C-Scan
®
Cap radiation source is assembled within a 3mm-thick Tungsten concealment.
RADIATION QUALITY is constant, guaranteed, and verified, thanks to isotope-based source. Hence no
ADDED FILTER required.
In normal use, dose levels might increase mainly due to abnormal motility, i.e. the capsule remaining static.
Procedure duration then limits the dose level to two orders-of-magnitude lower than the acceptable threshold
for deterministic effects.
The RADIATION DETECTORS integrated into the C-Scan
®
Cap are based on CdTe/CZT crystals,
demonstrating nearly perfect Quantum Efficiency within the imaging energies range.
The C-Scan
®
Cap radiation source housing ensures negligible exposure to any OPERATOR or STAFF.
Shelf life Up to 2 weeks
Operating Temperature +5ºC (41ºF) to 45ºC (113ºF)
Operating Humidity 100% Relative Humidity
Operating Pressure 520 mmHg to 940 mmHg
Storage and Transportation Temperature -10ºC (-4ºF) to 45ºC (113ºF)
Storage and Transportation Humidity 10% to 80% Relative Humidity
Storage and Transportation Pressure 520 mmHg to 1200 mmHg
Operating Frequency RF Band 433.5 MHz ±127 KHz
RF Modulation Type 2 FSK , 100 Kbit/sec
Effective Radiated Power (Avg @ 3[m] in
Air)
-52 [dBm]
Battery Type Lithium Ion – 3.8[V]
Battery Life maximum 150 hours
C-Scan® Track
Mechanical Dimensions Sensor Unit (Length
x Width x Depth)
< 70mm X 75mm X 15mm
Mechanical Dimensions Main Unit (Length x
Width x Depth)
< 86 mm x 76 mm x 22 mm
C-Scan
®
Track Weight 210 grams
Material
Withstands common detergents and perfumes, isopropyl
alcohol (IPA), Methylated spirit and water swiping
Operating Temperature +5°C to +45°C
Operating Humidity 10% to 80% Relative Humidity
Mechanical Shock 300 m/s
2
(30g) duration 6 ms
Water Drops IP26
Storage and Transportation Temperature -10ºC (-4ºF) to 45ºC (113ºF)
Storage and Transportation Humidity 10% to 80% Relative Humidity
Storage and Transportation Pressure 520 mmHg to 1200 mmHg