User's Manual

Document Title
C-Scan System User Reference Manual
Document No. DOC0001667 Revision 14 Date 22 May 2022
Page 4 of 90
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1 USING THIS GUIDE ................................................................................................................ 8
1.1 PURPOSE .......................................................................................................................... 8
1.2 LIST OF ACRONYMS ........................................................................................................... 8
1.3 CONVENTIONS .................................................................................................................. 8
2 APPLICABLE DOCUMENTS .................................................................................................. 9
3 ABOUT C-SCAN
®
.................................................................................................................... 9
4 INDICATIONS, CONTRAINDICATIONS, ADVERSE EVENTS, WARNINGS, CAUTIONS ... 9
4.1 INDICATION FOR USE ......................................................................................................... 9
4.2 CONTRAINDICATIONS ......................................................................................................... 9
4.3 ADVERSE EVENTS ........................................................................................................... 10
4.4 WARNINGS ...................................................................................................................... 11
4.5 CAUTIONS ....................................................................................................................... 11
4.6 BENEFIT AND RISKS OF THE C-SCAN® PROCEDURE .......................................................... 14
5 C-SCAN
®
SYSTEM ................................................................................................................ 15
5.1 C-SCAN
®
SYSTEM COMPONENTS ..................................................................................... 15
5.2 THE C-SCAN
®
SYSTEM PROCEDURE- GENERAL OVERVIEW ............................................... 16
6 INSTRUCTION FOR USE FOR THE CLINIC TEAM ............................................................ 17
6.1 PREPARATIONS BEFORE PROCEDURE ............................................................................... 17
6.2 C-SCAN
®
CAP INGESTION PROCEDURE ............................................................................. 21
6.3 DURING THE PROCEDURE DAYS (FROM C-SCAN
®
CAP INGESTION TO EXCRETION) .............. 22
6.4 RADIOACTIVE SOURCE NOT PROPERLY CONCEALED – MALFUNCTION NOTIFICATION
INSTRUCTION
23
6.5 POST PROCEDURE- AFTER C-SCAN
®
CAP EXCRETION ....................................................... 23
6.6 ANALYSIS & REPORT RECEPTION ...................................................................................... 24
6.7 C-SCAN® USER INTERFACE NOTIFICATIONS ...................................................................... 24
7 INSTRUCTION FOR USE TO THE SUBJECT ..................................................................... 25
7.1 PERMITTED ACTIVITIES DURING THE PROCEDURE: ............................................................. 25
7.2 PROHIBITED ACTIVITIES DURING THE PROCEDURE: ............................................................ 25
7.3 C-SCAN
®
PROCEDURE ..................................................................................................... 25
7.4 DAILY ROUTINE DURING THE PROCEDURE ......................................................................... 26
7.5 POST PROCEDURE- AFTER C-SCAN
®
CAP EXCRETION: ...................................................... 27
7.6 WHEN TO CONTACT THE CLINIC ........................................................................................ 28
7.7 ANALYSIS & REPORT RECEPTION ...................................................................................... 28
7.8 C-SCAN® USER INTERFACE NOTIFICATIONS ...................................................................... 28
8 C-SCAN
®
VIEW INSTALLATION GUIDE ............................................................................. 29
9 USING C-SCAN
®
VIEW APPLICATION ............................................................................... 35
9.1 C-SCAN
®
VIEW APPLICATION LOGIN SCREEN ................................................................... 36
9.2 C-SCAN VIEW UPDATES .................................................................................................. 40
9.3 C-SCAN® TRACK DATA DOWNLOAD AND UPLOAD TO SERVER .......................................... 40
9.4 ADD A FAILED PROCEDURE TO DATABASE ........................................................................ 46
9.5 MANAGING YOUR LOCAL FILES ......................................................................................... 47
9.6 C-SCAN® VIEW EDITOR .................................................................................................. 55
10 TECHNICAL DESCRIPTION ................................................................................................. 79
10.1 SYSTEM LABELING .......................................................................................................... 79
10.2 C-SCAN
®
KIT LABELS ...................................................................................................... 80
10.3 C-SCAN
®
CAP LABEL ....................................................................................................... 81
10.4 C-SCAN
®
TRACK LABEL ................................................................................................... 81
10.5 C-SCAN
®
VIEW LABELS ................................................................................................... 81
10.6 C-SCAN
®
MODES OF OPERATION ..................................................................................... 82