IceCure ProSense FAS3100000 User manual

1
Cryoablation System
User Manual
DMS-7064 rev. C
Please read this document carefully before using the ProSense™
Cryoablation System. Do not attempt to perform any procedure before
carefully reading all instructions. Always follow product labeling and
manufacturer’s recommendations. If in doubt as to how to proceed in any
situation, contact your IceCure Medical representative.
IceCure Medical, Inc.
[email protected]
US/Canada Toll Free 1-888-902-5716
IceCure™ Medical Ltd.
7 Haeshel St., 2nd floor, P.O.B 3163
Caesarea 3079504, Israel
[email protected]
Tel: [phone]
Fax: [phone]
The information in this document is confidential and is intended only for use of the recipient. Unauthorized
use, duplication, publication or disclosure is strictly prohibited. If you have received this document in error,
please notify IceCure™ Medical immediately.

IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™
Confidential User Manual
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European User Manual
Table of Contents
OVERVIEW .........................................................................................................8
Introduction ...............................................................................................................8
Intended use ..............................................................................................................8
Indications for use......................................................................................................8
ProSense™ Qualified users.......................................................................................10
Clinical decisions ......................................................................................................10
Contraindications.....................................................................................................10
Qualified technician .................................................................................................10
Advanced Operator..................................................................................................11
SAFETY NOTES..................................................................................................12
Warnings and cautions.............................................................................................12
Basic safety principles..............................................................................................12
Ownership................................................................................................................12
Qualification.............................................................................................................12
Training ....................................................................................................................13
Clarity .......................................................................................................................13
Clinical Assessment ..................................................................................................13
Voltage and power ratings.......................................................................................15
Installation and Setup ..............................................................................................15
Proper use................................................................................................................15
Cyber security ..........................................................................................................18
Operating warnings..................................................................................................19
Liquid nitrogen .........................................................................................................20
Danger - explosion and fire hazard..........................................................................21
Opening the Dewar compartment...........................................................................21
Liquid nitrogen Safety ..............................................................................................21
Burn hazards ............................................................................................................24
Grounding ................................................................................................................24
Sterility .....................................................................................................................24
Mechanical handling of hose and cryohandle .........................................................25
Emergencies and errors ...........................................................................................25
Emergency Stop button ...........................................................................................25
Emergencies causing procedure halt.......................................................................25
Predictable Adverse Events .....................................................................................26
General surgery/ Minimal Invasive Procedures.......................................................26
Anesthesia................................................................................................................27
Cryoablation procedure in general ..........................................................................27
Percutaneous ablation procedure ...........................................................................27
Laparoscopic procedure...........................................................................................28
Breast - Fibroadenoma and breast cancer:..............................................................28
Urology - Renal and Prostate:..................................................................................28
Thoracic surgery - Lung and cardiac arrhythmia: ....................................................28
Liver..........................................................................................................................29
Musculoskeletal: ......................................................................................................29
Gynecology:..............................................................................................................29

IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™
Confidential User Manual
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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

IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™
Confidential User Manual
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European User Manual
Safe Operation in Percutaneous Procedures...........................................................86
Preliminaries ............................................................................................................86
Freeze Step...............................................................................................................89
Thaw.........................................................................................................................94
Extraction .................................................................................................................94
Show Last Treatment ...............................................................................................99
Replace (refill) the Dewar during a cryoablation procedure .................................100
Post-operational stages .........................................................................................104
Removing the temperature sensor from tissue.....................................................104
Removing the cryoprobe from the cryohandle .....................................................105
Disassembling the support device - Hose-Holder..................................................105
Disassembling the temperature sensor.................................................................105
Exiting the ProSense™ cryoablation system treatment mode ..............................106
General advice for patients....................................................................................107
System failures.......................................................................................................107
ProSense™ cryoablation system failure.................................................................107
ProSense™ cryoablation system touch screen failure...........................................108
COMPUTER INTERFACE ..................................................................................110
The technician menu..............................................................................................110
Reading the screen.................................................................................................110
System messages ...................................................................................................110
Status messages.....................................................................................................110
Warning messages .................................................................................................111
Error messages.......................................................................................................111
ACCESSORIES .................................................................................................113
Cryoprobe ..............................................................................................................113
Introducer ..............................................................................................................114
Foot pedal (Not available in some regions, e.g. China) .........................................115
Temperature sensor (Not available in some regions, e.g. China)..........................115
Holder (Not available in some regions, e.g. China)................................................115
SYSTEM MAINTENANCE ................................................................................. 116
General cleaning ....................................................................................................116
Sterility ...................................................................................................................117
Periodic servicing ...................................................................................................117
TROUBLESHOOTING.......................................................................................118
General...................................................................................................................118
Troubleshooting guide...........................................................................................118
ProSense™ cryoablation system - Step-by-Step procedure.............................. 123
SYSTEM SPECIFICATIONS................................................................................124
LIMITED WARRANTY CERTIFICATE ..................................................................125
CUSTOMER COMPLAINT FORM ......................................................................126
REPORT CUSTOMER COMPLAINT.................................................................... 127
Cryoablation Clinical References..................................................................... 128
Manufacturer’s Declaration of the EUT........................................................... 131

IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™
Confidential User Manual
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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