IceCure ProSense DMS-7063, User Manual

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IceCure™ Medical Ltd. DMS-7063 rev. C ProSense™
Confidential User Manual
3
US User Manual
Thoracic surgery: Lung and cardiac arrhythmia....................................................... 28
General predictable adverse events for using the introducer ................................. 28
Disposal .................................................................................................................... 28
Compliance ............................................................................................................... 28
Compliance with international safety standards ..................................................... 28
Equipment classification .......................................................................................... 29
Accompanying labels ............................................................................................... 29
Important Symbols and Labels ................................................................................. 36
SYSTEM DESCRIPTION ...................................................................................... 41
Introduction ............................................................................................................. 41
Concept of operation ............................................................................................... 41
Major components ................................................................................................... 41
Main chassis ............................................................................................................. 42
Emergency Stop button ........................................................................................... 42
Flexible hose ............................................................................................................. 43
Touch screen and User Manual activation .............................................................. 43
Cryohandle and cryoprobe ...................................................................................... 45
Holder – Optional (Not available in some regions, e.g. China) ................................ 46
Foot pedal (Not available in some regions, e.g. China) ........................................... 47
Temperature sensor (TS).......................................................................................... 47
Dewar storage cases ................................................................................................ 49
Operational details ................................................................................................... 49
Starting the system .................................................................................................. 50
System functional tests ............................................................................................ 51
Cryoablation procedure ........................................................................................... 51
Extraction step ......................................................................................................... 51
INSTALLATION AND SETUP ............................................................................... 52
Space and positioning requirements ....................................................................... 52
Setup warnings and cautions ................................................................................... 52
Electrical requirements ............................................................................................ 53
For countries in which local line voltage is 100-127 VAC ........................................ 53
For countries in which local line voltage is 220-240 VAC ........................................ 53
Shipment components ............................................................................................. 53
Installation ............................................................................................................... 54
OPERATING THE SYSTEM .................................................................................. 55
Procedure Overview ................................................................................................ 55
Pre-operational stages ............................................................................................. 55
Preparing the system for procedure ........................................................................ 55
Preparing the patient for procedure ....................................................................... 56
Switching on the ProSense™ cryoablation system .................................................. 57
Cryohandle ............................................................................................................... 58
General settings ....................................................................................................... 59
Preparing the system for treatment ........................................................................ 62
Cryoprobe Positioning .............................................................................................. 78
Treatment Selection ................................................................................................. 81
Operational stages ................................................................................................... 85