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™
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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

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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

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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

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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

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Figure 41 : Schematic illustration of placement of the system and patient. ......................57
Figure 42: System is loading screen.....................................................................................58
Figure 43: Main Menu screen..............................................................................................59
Figure 44: Action button as displayed on screen (several of the options)..........................59
Figure 45: Extraction button as displayed on screen ..........................................................59
Figure 46: Activating the Settings option from the Main Menu screen..............................60
Figure 47: Settings screen....................................................................................................60
Figure 48: Language Selection screen .................................................................................61
Figure 49:Technician Mode screen......................................................................................61
Figure 50: Export Log screen................................................................................................62
Figure 51: Windows® Date and Time Properties screen .....................................................63
Figure 52: Preparing the system for treatment by pressing Prepare for Treatment on Main
Menu screen ........................................................................................................................64
Figure 53: Dewar preparation screen..................................................................................64
Figure 54: Frost on the Dewar opening ...............................................................................65
Figure 55: Freezing Has Stopped Pop-up Message .............................................................65
Figure 56: Correct insertion and positioning of the Dewar –bottom first..........................67
Figure 57: Insertion of the Dewar –head first, leaning forward.........................................67
Figure 58: Insertion of the Dewar - bottom first, leaning backwards ................................67
Figure 59: Dewar door open warning..................................................................................68
Figure 60: Ice ball measurement ranges .............................................................................69
Figure 61: Cryoprobe (the figure is for illustration only).....................................................71
Figure 62: Cryoprobe registration screen............................................................................72
Figure 63: Invalid serial number warning ............................................................................72
Figure 64 : “PEEL HERE” label ..............................................................................................73
Figure 65: Cryoprobe connection screen.............................................................................74
Figure 66: Wait for Functional test screen ..........................................................................77
Figure 67: Functional test screen.........................................................................................77
Figure 68: Functional test - visual inspection screens.........................................................78
Figure 69: Pre-Planning trajectory needle insertion in breast applications........................80
Figure 70: Select Organ........................................................................................................80
Figure 71: Lesion size value .................................................................................................81
Figure 72: Planned Margin...................................................................................................81
Figure 73: Calculated Result N/A .........................................................................................82
Figure 74: Treatment Selection screen................................................................................82
Figure 75: Edit Presets in the Main Menu screen................................................................83
Figure 76: Define a treatment protocol by choosing Setup Presets on the Treatment
Selection screen...................................................................................................................83
Figure 77: Steps for adding a protocol ...............................................................................85
Figure 78: Edit Preset screen ...............................................................................................85
Figure 79: Choosing the Manual Mode option....................................................................86
Figure 80: Introducer shaft length.......................................................................................88
Figure 81: Illustration of FAP7200000 cryoprobe Markings on the cryoprobe...................88
Figure 82: Left: Pause button available; Right: Pause in progress, Play button available ..90
Figure 83: Manual Mode screen: press on Freeze to start the Freeze step........................90
Figure 84: Freeze screen in Manual Mode ..........................................................................91

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Figure 85: Thaw screen in Manual Mode ............................................................................91
Figure 86: Extraction screen in Manual Mode.....................................................................92
Figure 87: Automatic Mode screen: press on Start to begin the Freeze step.....................93
Figure 88: Freeze screen in Automatic mode......................................................................93
Figure 89: Extraction screen during procedure...................................................................95
Figure 90: Extraction screen ................................................................................................95
Figure 91: Completed screen with 3 options: Extraction, Relocate and Finish. ................96
Figure 92: Passive Thaw screen ...........................................................................................97
Figure 93: Completed screen without Extraction option ....................................................97
Figure 94: Cryoprobe Placement Calculation screen during relocate.................................98
Figure 95: Dewar Replacement screen................................................................................98
Figure 96: Dewar Replacement finished screen ..................................................................98
Figure 97: Last Treatment screen after relocation..............................................................99
Figure 98: Last Treatment screen after more than 3 Freeze steps without relocation. .....99
Figure 99: Last Treatment screen after up to 3 Freeze steps............................................100
Figure 100: Replace Dewar option question .....................................................................100
Figure 101: Lowering the Dewar during Thaw screen.......................................................101
Figure 102: Replace Dewar screen ....................................................................................101
Figure 103: Replacement done follow up screen..............................................................102
Figure 104: Replacement was completed before the Thaw ended ..................................102
Figure 105: Replacement was completed after the Thaw ended .....................................103
Figure 106: Replacement during Freeze, in case of empty Dewar....................................103
Figure 107: Procedure stopped due to Low Liquid Nitrogen. ..........................................104
Figure 108: Extraction Completed screen. ........................................................................104
Figure 109: Safe to Remove cryoprobe .............................................................................105
Figure 110: Protocol Completed screen. ...........................................................................106
Figure 111: Main Menu screen..........................................................................................106
Figure 112: System Shutdown screen. ..............................................................................107
Figure 113: System Fail example screen............................................................................108
Figure 114: Emergency Stop button located on the main chassis ....................................109
Figure 115: A sample touch screen....................................................................................110
Figure 116: Status message example ................................................................................110
Figure 117: Warning message format example.................................................................111
Figure 118: Error message format example ......................................................................111
Figure 119: Cryoprobe components (the figure is for illustration only)............................113
Figure 120: Illustration of Mandrel (a) the Cannula with the Mandrel inserted (b) .........114
Figure 121: Counter of the remaining procedures before maintenance at the bottom of
the main menu screen. ......................................................................................................117

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OVERVIEW
Introduction
ProSense™ Cryoablation System is a comprehensive system for cryotherapy of human
tissue based on IceCure™ Medical’s technology. All established cryotherapy techniques
utilize a low temperature cryogen under pressure. The ProSense™ Cryoablation System
utilizes liquid nitrogen that causes the cryoprobe to reach very low temperatures thereby
freezing tissue with which it comes in contact.
Intended use
ProSense™ cryoablation system is intended for cryogenic destruction of tissue during
surgical procedures by the application of extreme cold temperatures. The ProSense™
cryoablation system is indicated for use as a cryosurgical tool in the fields of general
surgery (including breast and liver tissue), dermatology, thoracic surgery (including lung
tissue), gynecology, oncology (including Musculoskeletal tissue), proctology, and urology
(including kidney tissue). The ProSense™ cryoablation system may be used with an
ultrasound device to provide real-time visualization of the cryosurgical procedure.
This cryotherapy should only be executed if the operative standard therapy and established
therapies cannot be applied.
Indications for use
ProSense™ cryoablation system is intended for cryogenic destruction of tissue during
surgical procedures by the application of extreme cold temperatures. The ProSense™
cryoablation system is indicated for use as a cryosurgical tool in the fields of general
surgery (including breast and liver tissue), dermatology, thoracic surgery (including lung
tissue), gynecology, oncology (including Musculoskeletal tissue), proctology, and urology
(including kidney tissue). The ProSense™ cryoablation system may be used with an
ultrasound device to provide real-time visualization of the cryosurgical procedure.
Urology
•The system may be used to ablate prostatic tissue.
•The system may be used to ablate kidney tissue including renal cell carcinoma.
•The system may be used for the ablation of prostate tissue in cases of prostate
cancer and benign prostatic hyperplasia.
Oncology
•The system may be used for ablation of cancerous or malignant tissue.
•The system may be used for ablation of benign and malignant breast tumors

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•The system may be used for ablation of benign and malignant lung tumors
•The system may be used for ablation of benign and malignant musculoskeletal
tumors
•The system may be used for ablation of benign and malignant liver tumors
•The system may be used for ablation of benign tumors.
•The system may be used for palliative intervention.
Dermatology
•The system may be used for the ablation or freezing of skin cancers and other
cutaneous disorders.
Gynecology
•The system may be used for the ablation of malignant neoplasia or benign
dysplasia of the female genitalia.
General Surgery
•The system may be used for the ablation of leukoplakia of mouth, angiomas,
sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated
basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple
warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal
cysts actinic and seborrheic keratoses, cavernous hemangiomas, recurrent
cancerous lesions.
•The system may be used for the destruction of warts or lesions.
•The system may be used for the palliation of tumors of the oral cavity, rectum,
and skin.
•The system may be used for ablation of breast fibroadenomas and breast tumors.
Thoracic Surgery
•The system may be used for the ablation of arrhythmic cardiac tissue.
•The system may be used for the ablation of cancerous lesions, including lung
tissue.
Proctology
•The system may be used for the ablation of benign or malignant growths of the
anus and rectum
•The system may be used for the ablation of hemorrhoids.
This cryotherapy should only be executed if the operative standard therapy and
established therapies cannot be applied.

IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™
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ProSense™ Qualified users
You are a qualified ProSense™ cryoablation system user only if you meet all of the
following criteria:
You are a board-certified medical practitioner licensed in your country.
You have taken a certified ProSense™ cryoablation system training course.
You have read and understood all relevant material accompanying the ProSense™
cryoablation system.
Warning
If you do not meet the above criteria, do not use the ProSense™ cryoablation system.
Practitioners electing to be ProSense™ cryoablation system users must attend a training
course prior to using the system. The course is taught by IceCure™ Medical certified
personnel.
Warning
Do not use this system if you have not been adequately trained in its use.
Clinical decisions
The practitioner is solely responsible for all clinical use of the ProSense™ cryoablation
system and for any results obtained with the device.
Cryotherapy is beneficial in a variety of applications. However, sole responsibility for
determining when and how to use the system with a given patient and for a particular
medical condition lies with the practitioner.
Use of ProSense™ cryoablation system in special populations, such as pregnant women,
has not been established.
For further details, refer to Section 1.3 –Indications for use.
Contraindications
Severe infection, uncorrectable coagulopathy, hemodynamic or respiratory instability.
Qualified technician
Only a technician trained by IceCure™ Medical is qualified to service the ProSense™
cryoablation system.