IceCure ProSense User manual

1
User Manual
DSR3210000 rev. D
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.
41-18 Christine Ct
Fair Lawn
NJ, 07410
[email protected]
Tel: [phone]
Toll-free : 888-516-7389
IceCure Medical Ltd.
HaEshel 7, 2nd floor
Southern Industrial Park,
Caesarea 3088900, 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.

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Contents
1OVERVIEW..................................................................................................................8
1.1 Introduction.............................................................................................................8
1.2 Intended use ............................................................................................................8
1.3 Indications for use...................................................................................................8
1.4 ProSense™ Qualified users...................................................................................10
1.5 Clinical decisions..................................................................................................10
1.6 Qualified technician ..............................................................................................11
1.7 Advanced Operator ...............................................................................................11
2SAFETY NOTES ........................................................................................................12
2.1 Warnings and cautions..........................................................................................12
2.2 Basic safety principles...........................................................................................12
2.2.1 Ownership......................................................................................................12
2.2.2 Qualification ..................................................................................................12
2.2.3 Training..........................................................................................................13
2.2.4 Clarity ............................................................................................................13
2.2.5 Clinical Assessment.......................................................................................14
2.2.6 Installation and Setup.....................................................................................16
2.2.7 Proper use ......................................................................................................17
2.3 Operating warnings...............................................................................................19
2.4 Liquid nitrogen......................................................................................................21
2.4.1 Danger - explosion and fire hazard................................................................21
2.4.2 Opening the Dewar compartment..................................................................21
2.4.3 Voltage and power ratings.............................................................................22
2.4.4 Liquid nitrogen Safety...................................................................................22
2.4.5 Burn hazards ..................................................................................................24
2.4.6 Grounding......................................................................................................24
2.4.7 Sterility...........................................................................................................25
2.4.8 Mechanical handling of hose and cryohandle................................................25
2.5 Emergencies and errors.........................................................................................26
2.5.1 Emergency Stop button..................................................................................26
2.5.2 Emergencies causing procedure halt..............................................................26
2.6 Adverse events ......................................................................................................27
2.7 Disposal.................................................................................................................27
2.8 Compliance ...........................................................................................................27
2.8.1 Compliance with international safety standards............................................27
2.9 Equipment classification.......................................................................................28
2.10 Accompanying labels ........................................................................................28
2.10.1 Important Symbols and Labels......................................................................34
3SYSTEM DESCRIPTION...........................................................................................38
3.1 Introduction...........................................................................................................38
3.2 Concept of operation.............................................................................................38
3.3 Major components.................................................................................................39
3.3.1 Main chassis...................................................................................................40

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3.3.2 Emergency Stop button..................................................................................40
3.3.3 Flexible hose..................................................................................................41
3.3.4 Touch screen and User Manual activation.....................................................41
3.3.5 Cryohandle and cryoprobe.............................................................................43
3.3.6 Holder –Optional (Not available in some regions, e.g. China).....................45
3.3.7 Foot pedal (Not available in some regions, e.g. China).................................46
3.3.8 Temperature sensor (TS) ...............................................................................46
3.3.9 Dewar storage cases.......................................................................................48
3.4 Operational details ................................................................................................49
3.4.1 Starting the system.........................................................................................49
3.4.2 System pre-tests.............................................................................................50
3.4.3 Cryoablation procedure..................................................................................51
3.4.4 EXTRACTION step ......................................................................................51
4INSTALLATION AND SETUP .................................................................................52
4.1 Space and positioning requirements......................................................................52
4.2 Setup warnings and cautions.................................................................................52
4.3 Electrical requirements..........................................................................................53
4.3.1 For countries in which local line voltage is 100-127 VAC ...........................53
4.3.2 For countries in which local line voltage is 220-240 VAC ...........................53
4.4 Shipment components...........................................................................................53
4.5 Installation.............................................................................................................54
5OPERATING THE SYSTEM .....................................................................................55
5.1 Procedure Overview..............................................................................................55
5.2 Pre-operational stages ...........................................................................................55
5.2.1 Preparing the system for procedure ...............................................................55
5.2.2 Preparing the patient for procedure ...............................................................56
5.2.3 Switching on the ProSense™ cryoablation system .......................................57
5.2.4 Cryohandle.....................................................................................................58
5.2.5 General settings..............................................................................................58
5.2.6 Preparing the system for treatment................................................................62
5.2.7 Treatment Selection.......................................................................................79
5.3 Operational stages.................................................................................................84
5.3.1 Safe Operation in Percutaneous Procedures..................................................84
5.3.2 Preliminaries..................................................................................................84
5.3.3 Freeze Cycle ..................................................................................................87
5.3.4 Pause Option:.................................................................................................87
5.3.5 THAW ...........................................................................................................92
5.3.6 EXTRACTION process.................................................................................92
5.3.7 Show Last Treatment.....................................................................................97
5.3.8 Replace (refill) the Dewar during a cryoprocedure .......................................99
5.4 Post-operational stages........................................................................................104
5.4.1 Removing the temperature sensor from tissue.............................................104
5.4.2 Removing the cryoprobe from the cryohandle ............................................104
5.4.3 Disassembling the support device - Hose-Holder........................................105
5.4.4 Disassembling the temperature sensor.........................................................105
5.4.5 Exiting the ProSense™ cryoablation system treatment mode.....................105
5.5 Instruct patients:..................................................................................................106
5.6 System failures....................................................................................................107

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5.6.1 ProSense™ cryoablation system failure......................................................107
5.6.2 ProSense™ cryoablation system touch screen failure .................................108
6COMPUTER INTERFACE.......................................................................................110
6.1 The technician menu ...........................................................................................110
6.2 Reading the screen ..............................................................................................110
6.3 System messages.................................................................................................111
6.3.1 Status messages............................................................................................111
6.3.2 Warning messages .......................................................................................111
6.3.3 Error messages.............................................................................................112
7ACCESSORIES.........................................................................................................113
7.1 Cryoprobe............................................................................................................113
7.1.1 Single use sterile cryoprobe.........................................................................113
7.2 The foot pedal (Not available in some regions, e.g. China)................................114
7.3 The temperature sensor (Not available in some regions, e.g. China) .................114
7.4 The Holder (Not available in some regions, e.g. China).....................................115
7.5 Shelf life..............................................................................................................115
8SYSTEM MAINTENANCE .....................................................................................116
8.1 General cleaning..................................................................................................116
8.2 Sterility................................................................................................................117
8.3 Periodic servicing................................................................................................117
9TROUBLESHOOTING.............................................................................................119
9.1 General................................................................................................................119
9.2 Troubleshooting guide ........................................................................................120
10 ProSense™ cryoablation system - Step-by-Step procedure ......................................124
11 SYSTEM SPECIFICATIONS...................................................................................125
12 LIMITED WARRANTY CERTIFICATE ................................................................126
13 CUSTOMER COMPLAINT FORM.........................................................................127
14 REPORT CUSTOMER COMPLAINT.....................................................................128
15 Manufacturer’s Declaration of the EUT ....................................................................129
Figures
Figure 1: Label 1 ON/OFF mechanical button - MLS1000002 Rev. B ..............................29
Figure 2: Label 2 - Emergency Stop - MLS1000003 Rev. B..............................................29
Figure 3: Label 3 - Identification - MLS3180001 Rev. E (220-240 VAC)
MLS3080003 Rev. D (110 –127 VAC)..............................................................................29
Figure 4: Label 4 - Follow instructions for use MLS 1000005 Rev D................................29
Figure 5: Label 5 - High voltage caution - MLS1000006 Rev. B.......................................30
Figure 6: Label 6 - Line voltage danger - MLS1000007 Rev. B.........................................30
Figure 7: Label 7 - Foot pedal - MLS1000008 Rev. B........................................................30
Figure 8: Label 8 - Risk of Explosion - MLS1000009 Rev. B............................................30
Figure 9: Label 9 - Single use probe (various options of shapes, tip, length and sizes) -
MLP7000001 Rev. J............................................................................................................31
Figure 10: Label 10 - Single use temperature sensor MLT8000001 Rev. H.......................31
Figure 11: Label 11 - Liquid nitrogen Dewar - MLS1000001 Rev. E ...............................31
Figure 12: Label 12 - Black Dewar - MLS1000015 Rev. B................................................32
Figure 13: Label 13 –Cold area - MLS1000010 Rev. B.....................................................32

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Figure 14: Label 14- Empty LN2 Dewars - MLS1000012 Rev. A .....................................32
Figure 15: Label 15- Applied parts - MLS1000014 Rev. A................................................32
Figure 16: Label 16- Holder –MLG1000006 Rev. B .........................................................33
Figure 17: Label 17- Shipping Art Work MLS3080002 Rev. A.........................................33
Figure 18: Label 18- Shipping Art Work UCG1000025.....................................................33
Figure 19: Label 19- Only IceCure technician is authorized to open the crate MLS1000013
Rev. A..................................................................................................................................34
Figure 20: Front and back view of the ProSense™ cryoablation system with numbered
components..........................................................................................................................39
Figure 21: The ProSense™ transportation rollers & brakes................................................40
Figure 22: The Emergency Stop button...............................................................................40
Figure 23: The touch screen display before a cryoablation procedure...............................41
Figure 24: The User Manual screen.....................................................................................42
Figure 25: The User Manual Table of contents...................................................................42
Figure 26: The User Manual screen....................................................................................43
Figure 27: The hose, cryohandle and connected Cryoprobe ...............................................43
Figure 28: The 90 degrees cryohandle (No 1) and connected Cryoprobe (No 2) ...............44
Figure 29: Handle plug holder and handle plug. .................................................................44
Figure 30: The Cryohandle on the Handle plug holder.......................................................45
Figure 31: The Holder and the holder position within the CT machine..............................45
Figure 32: The Action button as displayed on screen (several of the options)....................46
Figure 33: The foot pedal.....................................................................................................46
Figure 34: The temperature sensor and its components ......................................................47
Figure 35: Temperature display of sensor in the procedure screen (see no 1) ....................48
Figure 36: Dewar storage cases –the correct way to put the Dewars inside the storage
shelf......................................................................................................................................49
Figure 37: The system is loading screen..............................................................................50
Figure 38: The Main Menu screen.......................................................................................50
Figure 39 : Schematic illustration of placement of the system and patient.........................56
Figure 40: The system is loading screen..............................................................................57
Figure 41: The Main Menu screen.......................................................................................57
Figure 42: The Action button as displayed on screen (several of the options)....................58
Figure 43: The EXTRACTION button as displayed on screen...........................................58
Figure 44: Activating the Settings option from the Main Menu screen ..............................58
Figure 45: The Settings screen.............................................................................................59
Figure 46: Language Selection screen.................................................................................59
Figure 47:Technician Mode screen......................................................................................60
Figure 48: Export Log screen ..............................................................................................61
Figure 49: The Windows™ Date and Time Properties screen ............................................61
Figure 50: Preparing the system for treatment by pressing Prepare for Treatment (no. 1) on
Main Menu screen ...............................................................................................................62
Figure 51: The Dewar preparation screen............................................................................62
Figure 52: Frost on the Dewar border..................................................................................63
Figure 53: Correct insertion and positioning of the Dewar –bottom first –Make sure it’s
positioned freely in the base ................................................................................................65
Figure 54: Insertion of the Dewar –Head First –might cause wrong positioning of Dewar
leaning forward....................................................................................................................65
Figure 55: Insertion of the Dewar.......................................................................................65

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Figure 56: Dewar door open warning..................................................................................66
Figure 57: Ice ball isotherms of ProSense™ cryoprobe from experiments in gel at room
temperature. .........................................................................................................................69
Figure 58: Pre-Planning trajectory needle insertion ............................................................71
Figure 59: The cryoprobe (the figure is for illustration only)..............................................71
Figure 60: Cryoprobe registration screen ............................................................................72
Figure 61: Invalid serial number warning............................................................................72
Figure 62: Cryoprobe connection screen.............................................................................73
Figure 63: Cryoprobe reading failed....................................................................................73
Figure 64: Cryoprobe already used......................................................................................74
Figure 65: Cryoprobe expired..............................................................................................74
Figure 66: Wait for Functional test screen...........................................................................76
Figure 67: Functional test screen.........................................................................................76
Figure 68: Functional test - visual inspection screens.........................................................77
Figure 69: Treatment Selection screen ................................................................................79
Figure 70: Define a treatment protocol by choosing Setup Presets on the Treatment
Selection screen (see no 1)...................................................................................................80
Figure 71: Edit Presets in the Main Menu screen (see no 2)...............................................80
Figure 72: Editing an existing protocol (see no 1) or adding a new one (see no 2) ............81
Figure 73: Steps for adding a protocol................................................................................82
Figure 74: Edit Preset screen...............................................................................................83
Figure 75: Choosing the Manual Mode option (see no 1)...................................................83
Figure 76: Introducer shaft length .......................................................................................86
Figure 77: illustration of FAP7200000 probe Markings on the probe. ...............................86
Figure 78: Pause (No 1) and Play (No 2) buttons during the freeze cycle. .........................88
Figure 79: Manual Mode screen: press on Freeze to start the freeze cycle.........................88
Figure 80: Freeze screen in Manual Mode ..........................................................................89
Figure 81: THAW screen in Manual Mode.........................................................................89
Figure 82: Extraction screen in Manual Mode ....................................................................90
Figure 83: Automatic Mode screen: press on Start to begin the freeze cycle. ....................91
Figure 84: Freeze screen in Automatic mode......................................................................92
Figure 85: The EXTRACTION screen during procedure ...................................................93
Figure 86: The Extraction screen.........................................................................................94
Figure 87: Completed screen with 3 options: Extraction, Relocate and Finish.................94
Figure 88: The Passive THAW screen ................................................................................95
Figure 89: Completed screen without Extraction option.....................................................96
Figure 90: Treatment selection screen during relocate........................................................96
Figure 91: Dewar Replacement screen................................................................................97
Figure 92: Dewar Replacement finished screen..................................................................97
Figure 93: Last Treatment screen after relocation...............................................................98
Figure 94: Last Treatment screen after more than 3 freeze cycles without relocation........98
Figure 95: Last Treatment screen after up to 3 freeze cycles..............................................98
Figure 96: Replace Dewar option question..........................................................................99
Figure 97: Lowering the Dewar during THAW screen.....................................................100
Figure 98: The replace Dewar screen and press ok to continue ........................................100
Figure 99: The replacement done follow up screen...........................................................101
Figure 100: Replacement was completed before the THAW ended .................................101
Figure 101: Replacement was completed after the THAW ended ....................................102

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Figure 102: Replacement during Freeze, in case of empty Dewar....................................102
Figure 103: Procedure stopped due to Low Nitrogen.......................................................103
Figure 104: EXTRACTION Completed screen.................................................................103
Figure 105: Safe to Remove probe....................................................................................104
Figure 106: Protocol Completed screen. Pressing on the “Main Menu” icon (see no. 1)
will load the Main Menu screen. .......................................................................................105
Figure 107: The Main Menu screen. To shut down the system, press on the Shutdown icon
(see no 1)............................................................................................................................106
Figure 108: The System Shutdown screen. Press “OK” to proceed (see no 2). ................106
Figure 109: System Fail example screen...........................................................................107
Figure 110: The Emergency Stop button located ON the main chassis (see no. 1)...........108
Figure 111: A sample touch screen....................................................................................110
Figure 112: Status message example.................................................................................111
Figure 113: Warning message format example.................................................................111
Figure 114: Error message format example.......................................................................112
Figure 115: The cryoprobe components (the figure is for illustration only).....................113
Figure 116: Counter of the remaining procedure before maintenance (see no 1) at the....117

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1OVERVIEW
1.1 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.
1.2 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 , dermatology, thoracic surgery , gynecology, oncology , proctology, and urology .
The ProSense™ cryoablation system may be used with an ultrasound device to provide
real-time visualization of the cryosurgical procedure.
The system is suitable for use in a number of cryotherapy applications. However, it is
ONLY indicated for use in patients whom the practitioner has deemed eligible for
cryotherapy.
1.3 Indications for use
ProSense™ cryoablation system is indicated for use as a cryosurgical tool in the fields of
general surgery, dermatology, thoracic surgery, gynecology, oncology, proctology, and
urology as detailed below. 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.

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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
•The system may be used for ablation of benign and malignant lung tumors
•The system may be used for ablation of benign and malignant bone 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.

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The ProSense™ cryoablation system is indicated for patients whom the surgeon has
designated as eligible for cryotherapy.
1.4 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.
1.5 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.