IceCure ProSense FAS3000000, Руководство пользователя

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IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™
Confidential User Manual
3
European User Manual
Dermatology: ........................................................................................................... 29
General predictable adverse events when using the introducers ........................... 30
Disposal .................................................................................................................... 30
Compliance ............................................................................................................... 30
Compliance with international safety standards ..................................................... 30
Equipment classification .......................................................................................... 30
Accompanying labels ............................................................................................... 30
Important Symbols and Labels ................................................................................. 37
SYSTEM DESCRIPTION ...................................................................................... 42
Introduction ............................................................................................................. 42
Concept of operation ............................................................................................... 42
Major components ................................................................................................... 42
Main chassis ............................................................................................................. 43
Emergency Stop button ........................................................................................... 43
Flexible hose ............................................................................................................. 44
Touch screen and User Manual activation .............................................................. 44
Cryohandle and cryoprobe ...................................................................................... 46
Holder – Optional (Not available in some regions, e.g. China) ................................ 47
Foot pedal (Not available in some regions, e.g. China) ........................................... 48
Temperature sensor (TS).......................................................................................... 48
Dewar storage cases ................................................................................................ 50
Operational details ................................................................................................... 50
Starting the system .................................................................................................. 51
System functional tests ............................................................................................ 52
Cryoablation procedure ........................................................................................... 52
Extraction step ......................................................................................................... 52
INSTALLATION AND SETUP ............................................................................... 53
Space and positioning requirements ....................................................................... 53
Setup warnings and cautions ................................................................................... 53
Electrical requirements ............................................................................................ 54
For countries in which local line voltage is 100-127 VAC ........................................ 54
For countries in which local line voltage is 220-240 VAC ........................................ 54
Shipment components ............................................................................................. 54
Installation ............................................................................................................... 55
OPERATING THE SYSTEM .................................................................................. 56
Procedure Overview ................................................................................................ 56
Pre-operational stages ............................................................................................. 56
Preparing the system for procedure ........................................................................ 56
Preparing the patient for procedure ....................................................................... 57
Switching on the ProSense™ cryoablation system .................................................. 58
Cryohandle ............................................................................................................... 59
General settings ....................................................................................................... 60
Preparing the system for treatment ........................................................................ 63
Cryoprobe Positioning .............................................................................................. 79
Treatment Selection ................................................................................................. 82
Operational stages ................................................................................................... 86