IceCure DSR3200000, Руководство пользователя

Страница: 3 / 137

IceCure
™
Medical Ltd. DSR3200000 rev. G ProSense
™
Confidential User Manual
3
Return to first page U.S User Manual
3.3.3 Flexible hose .................................................................................................. 43
3.3.4 Touch screen and User Manual activation ..................................................... 43
3.3.5 Cryohandle and cryoprobe ............................................................................. 45
3.3.6 Holder – Optional (Not available in some regions, e.g. China) ..................... 47
3.3.7 Foot pedal (Not available in some regions, e.g. China) ................................. 48
3.3.8 Temperature sensor (TS) ............................................................................... 48
3.3.9 Dewar storage cases ....................................................................................... 50
3.4 Operational details ................................................................................................ 50
3.4.1 Starting the system ......................................................................................... 51
3.4.2 System pre-tests ............................................................................................. 52
3.4.3 Cryoablation procedure .................................................................................. 52
3.4.4 EXTRACTION step ...................................................................................... 52
4 INSTALLATION AND SETUP ................................................................................. 53
4.1 Space and positioning requirements ...................................................................... 53
4.2 Setup warnings and cautions ................................................................................. 53
4.3 Electrical requirements .......................................................................................... 54
4.3.1 For countries in which local line voltage is 100-127 VAC ........................... 54
4.3.2 For countries in which local line voltage is 220-240 VAC ........................... 54
4.4 Shipment components ........................................................................................... 54
4.5 Installation ............................................................................................................. 55
5 OPERATING THE SYSTEM ..................................................................................... 56
5.1 Procedure Overview .............................................................................................. 56
5.2 Pre-operational stages ........................................................................................... 56
5.2.1 Preparing the system for procedure ............................................................... 56
5.2.2 Preparing the patient for procedure ............................................................... 57
5.2.3
Switching on the ProSense™ cryoablation system ....................................... 58
5.2.4 Cryohandle ..................................................................................................... 59
5.2.5 General settings .............................................................................................. 59
5.2.6 Preparing the system for treatment ................................................................ 63
5.2.7 Treatment Selection ....................................................................................... 81
5.3 Operational stages ................................................................................................. 87
5.3.1 Safe Operation in Percutaneous Procedures .................................................. 87
5.3.2 Preliminaries .................................................................................................. 87
5.3.3 Freeze Cycle .................................................................................................. 89
5.3.4 Pause Option: ................................................................................................. 90
5.3.5 THAW ........................................................................................................... 95
5.3.6 EXTRACTION process ................................................................................. 95
5.3.7 Show Last Treatment ................................................................................... 101
5.3.8 Replace (refill) the Dewar during a cryoprocedure ..................................... 102
5.4 Post-operational stages ........................................................................................ 107
5.4.1 Removing the temperature sensor from tissue ............................................. 107
5.4.2 Removing the cryoprobe from the cryohandle ............................................ 107
5.4.3 Disassembling the support device - Hose-Holder ........................................ 108
5.4.4 Disassembling the temperature sensor ......................................................... 108
5.4.5
Exiting the ProSense™ cryoablation system treatment mode ..................... 108
5.5 Instruct patients: .................................................................................................. 109
5.6 System failures .................................................................................................... 110
5.6.1 ProSense™ cryoablation system failure ...................................................... 110