Summary
1 INTRODUCTION TO THIS MANUAL......................................................................1-1
1.1 Contents.......................................................................................................... 1-1
1.2 Structure......................................................................................................... 1-1
1.3 Graphic conventions............................................................................................1-3
1.3.1 Text conventions.........................................................................................1-3
2 ABOUT SAFETY............................................................................................2-1
2.1 Local law......................................................................................................... 2-1
2.2 Symbols overview...............................................................................................2-2
2.3 Switching ON and OFF the device.............................................................................2-3
2.4 Emergency stop..................................................................................................2-3
2.5 Patient's and user's safety guidelines.........................................................................2-4
2.5.1 Patient's positioning.....................................................................................2-4
2.5.2 During the scan........................................................................................... 2-4
2.5.3 Patient's exit from the scanning area................................................................2-5
2.5.4 Patient's exit during fault / malfunctioning of the patient's table..............................2-5
2.6 Artifacts and repetition of a scan.............................................................................2-6
2.7 Protection from ionizing radiation............................................................................2-7
2.8 Protection from laser exposure...............................................................................2-9
2.9 Devices connected to the NewTom 5G console ...........................................................2-10
2.10 Maintenance time lag........................................................................................2-11
3 SAFETY AND MAINTENANCE OF THE DEVICE.........................................................3-1
3.1 Installation requirements......................................................................................3-1
3.2 Guidelines for safety...........................................................................................3-2
3.3 Device modifications...........................................................................................3-3
3.3.1 Responsibility limits.....................................................................................3-3
3.4 Device maintenance............................................................................................ 3-3
3.5 Cleaning and disinfection...................................................................................... 3-6
3.5.1 Hygiene procedures for patient protection..........................................................3-7
3.5.2 Sterilization.............................................................................................. 3-8
3.6 Transport and storage..........................................................................................3-8
3.7 Device disposal.................................................................................................. 3-9
3.7.1 Information for the device owner.....................................................................3-9
3.7.2 Information for the Disposing/Recycle centers.....................................................3-9
4 GETTING STARTED........................................................................................4-1
4.1 Introduction to the system....................................................................................4-1
4.1.1 Intended use.............................................................................................. 4-1
4.1.2 Indications for use.......................................................................................4-1
4.1.3 Improper Use............................................................................................. 4-2
4.1.4 Device Operation........................................................................................4-3