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 87 of 90
Before using this document, check that you use latest revision (see Arena)
* Printed revisions are for Reference Only*
Table 13: Guidance and Manufacturer’s Declaration- C-Scan
®
Cap and C-Scan
®
Track Immunity
The C-Scan
®
Cap and C-Scan
®
Track are intended for use in the electromagnetic environment specified
below. The customer or the user of the C-Scan
®
Cap and C-Scan
®
Track should assure that it is used in such
an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment
Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
For use in a typical domestic, commercial, or
hospital environment.
RATED Power
frequency (50 Hz)
magnetic field
IEC 61000-4-8
30 A/m, 50 Hz 30 A/m, 50 Hz
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Radiated RF EM
fields 61000-4-3
10 V/m
80 MHz - 2,7
GHz
10 V/m
80 MHz - 2,7
GHz
Portable and mobile RF communications
equipment should be used no closer to any part
of the C-Scan
®
Cap and C-Scan
®
Track,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.
Recommended separation distance
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
deter-mined by an electromagnetic site survey,
should be less than the compliance level in
each frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbol:
Proximity fields
from RF
wireless
communications
equipment
IEC 61000-4-3
27 V/m
385 MHz
28 V/m
450 MHz
9 V/m
710 MHz,
745 MHz,
780 MHz
28 V/m
810 MHz,
870 MHz,
930 MHz,
1720 MHz,
1845 MHz,
1970 MHz,
2450 MHz
9 V/m
5240 MHz,
5500 MHz,
5785 MHz
27 V/m
385 MHz
28 V/m
450 MHz
9 V/m
710 MHz,
745 MHz,
780 MHz
28 V/m
810 MHz,
870 MHz,
930 MHz,
1720 MHz,
1845 MHz,
1970 MHz,
2450 MHz
9 V/m
5240 MHz,
5500 MHz,
5785 MHz