IceCure ProSense, Руководство пользователя

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IceCure Medical Ltd.
DSR3210000 rev. D ProSense™
Confidential User Manual
2
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Contents
1 OVERVIEW .................................................................................................................. 8
1.1 Introduction ............................................................................................................. 8
1.2 Intended use ............................................................................................................ 8
1.3 Indications for use ................................................................................................... 8
1.4 ProSense™ Qualified users ................................................................................... 10
1.5 Clinical decisions .................................................................................................. 10
1.6 Qualified technician .............................................................................................. 11
1.7 Advanced Operator ............................................................................................... 11
2 SAFETY NOTES ........................................................................................................ 12
2.1 Warnings and cautions .......................................................................................... 12
2.2 Basic safety principles ........................................................................................... 12
2.2.1 Ownership ...................................................................................................... 12
2.2.2 Qualification .................................................................................................. 12
2.2.3 Training .......................................................................................................... 13
2.2.4 Clarity ............................................................................................................ 13
2.2.5 Clinical Assessment ....................................................................................... 14
2.2.6 Installation and Setup ..................................................................................... 16
2.2.7
Proper use ...................................................................................................... 17
2.3 Operating warnings ............................................................................................... 19
2.4 Liquid nitrogen ...................................................................................................... 21
2.4.1 Danger - explosion and fire hazard ................................................................ 21
2.4.2 Opening the Dewar compartment .................................................................. 21
2.4.3 Voltage and power ratings ............................................................................. 22
2.4.4 Liquid nitrogen Safety ................................................................................... 22
2.4.5 Burn hazards .................................................................................................. 24
2.4.6 Grounding ...................................................................................................... 24
2.4.7 Sterility ........................................................................................................... 25
2.4.8 Mechanical handling of hose and cryohandle ................................................ 25
2.5 Emergencies and errors ......................................................................................... 26
2.5.1 Emergency Stop button .................................................................................. 26
2.5.2 Emergencies causing procedure halt .............................................................. 26
2.6 Adverse events ...................................................................................................... 27
2.7 Disposal ................................................................................................................. 27
2.8 Compliance ........................................................................................................... 27
2.8.1 Compliance with international safety standards ............................................ 27
2.9 Equipment classification ....................................................................................... 28
2.10 Accompanying labels ........................................................................................ 28
2.10.1 Important Symbols and Labels ...................................................................... 34
3 SYSTEM DESCRIPTION ........................................................................................... 38
3.1 Introduction ........................................................................................................... 38
3.2 Concept of operation ............................................................................................. 38
3.3 Major components ................................................................................................. 39
3.3.1 Main chassis ................................................................................................... 40