IceCure ProSense FAS3100000, User Manual

Page: 5 / 133

IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™
Confidential User Manual
5
European User Manual
List of Figures
Figure 1: ON/OFF Switch label ............................................................................................. 32
Figure 2: Emergency Stop button label ............................................................................... 32
Figure 3: System Identification labels .................................................................................. 32
Figure 4: ProSense™ straight handle Identification labels .................................................. 33
Figure 5: Follow Instructions for Use ................................................................................... 33
Figure 6: High Voltage Caution ............................................................................................ 33
Figure 7: Label 6 - Line Voltage Danger ............................................................................... 33
Figure 8: Foot Pedal ............................................................................................................. 33
Figure 9: Risk of Explosion label ........................................................................................... 34
Figure 10: Single use cryoprobe label .................................................................................. 34
Figure 11: Color Tag Labels for Cryoprobes (A) and Introducers (B), and their location on
the external box. .................................................................................................................. 34
Figure 12: Single use temperature sensor label .................................................................. 35
Figure 13: Liquid Nitrogen Dewar label ............................................................................... 35
Figure 14: Black Dewar label ................................................................................................ 35
Figure 15: Cold area sticker ................................................................................................. 35
Figure 16: Empty LN2 Dewars sticker .................................................................................. 35
Figure 17: BF Applied Parts symbol ..................................................................................... 36
Figure 18: Holder label ......................................................................................................... 36
Figure 19: Shipping and storage conditions sticker ............................................................. 36
Figure 20: Shipping label ...................................................................................................... 37
Figure 21: Crate Opening Restriction sticker ....................................................................... 37
Figure 22: Single use Introducer labels ................................................................................ 37
Figure 23: Front and back view of the ProSense™ cryoablation system with numbered
components ......................................................................................................................... 42
Figure 24: ProSense™ transportation rollers & brakes ....................................................... 43
Figure 25: Emergency Stop button ...................................................................................... 44
Figure 26: Touch screen display before a cryoablation procedure .................................... 45
Figure 27: User Manual navigation panel ............................................................................ 45
Figure 28: Hose, Cryohandle and connected Cryoprobe ..................................................... 46
Figure 29: 90 degrees Cryohandle (No 1) and connected Cryoprobe (No 2) ...................... 46
Figure 30: Straight cryohandle and connected Cryoprobe.................................................. 46
Figure 31: Handle plug holder and handle plug. ................................................................. 47
Figure 32: Cryohandle closed with the plug on the Handle holder ..................................... 47
Figure 33: Holder and its position within the CT machine (not available in some regions,
e.g. China) ............................................................................................................................ 48
Figure 34: Action button as displayed on screen (several of the options) .......................... 48
Figure 35: Foot pedal ........................................................................................................... 48
Figure 36: Temperature sensor and its components .......................................................... 49
Figure 37: Temperature display of sensor in the bottom-right corner of the screen ......... 50
Figure 38: Dewar storage cases – the correct way to put the Dewars inside the storage
shelf. ..................................................................................................................................... 50
Figure 39: System is loading screen ..................................................................................... 51
Figure 40: Main Menu screen .............................................................................................. 52