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.

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1.6 Qualified technician
Only a technician trained by IceCure Medical is qualified to service the ProSense™
cryoablation system.
Servicing includes periodic maintenance and repair of the system according to
requirements.
Warning
Do not modify this equipment without authorization of the manufacturer
1.7 Advanced Operator
You are a qualified ProSense™ cryoablation system ‘Advanced Operator’only if you meet
all of the following criteria:
You have taken a certified ProSense™ cryoablation system technical operating training
course per this user manual.
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 for
presentation or other marketing use.

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2SAFETY NOTES
While this manual is designed to provide instructions in the use of the ProSense™
cryoablation system, it is not intended to take the place of the user training course which
must be completed before using the system.
This chapter defines the different types of safety notices that appear in the manual.
2.1 Warnings and cautions
Safety notices appear throughout the manual and take one of the following forms:
Warning - this notice is called a Warning: it deals with danger to people.
Warning
It is dangerous for people to do this.
Caution - this notice is called a Caution: it deals with danger to equipment and data.
Caution
It is dangerous for equipment and data to do this.
2.2 Basic safety principles
All the safety issues explained in this manual are grouped within the following areas of
responsibility:
2.2.1 Ownership
Warning
U.S. federal law restricts this device to sale by or on order of a physician.
2.2.2 Qualification
Warning
Any procedures using this system must be performed by licensed
practitioners or board-certified doctors who are trained and experienced
in the use of this system.
Warning
Do not attempt to perform any troubleshooting or corrective action
beyond those specified in the following guide. Any malfunction not listed
in the guide, or one that persists after the recommended action has been
taken, must be referred to IceCure Medical.

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Warning
Never allow untrained personnel to operate the ProSense™ cryoablation
system.
Warning
Never enter the Technician mode screen. Only an IceCure Medical
technician or authorized representative is allowed to use the technician
mode for maintenance or repair of the system.
Warning
Never open the console. Only an IceCure Medical technician or authorized
representative is allowed to open the console for maintenance or to repair
the system.
2.2.3 Training
Warning
Do not use this system if you have not been adequately trained in its use.
2.2.4 Clarity
Warning
Do not use this system until you have read the User Manual in its entirety
and fully understand its contents.
While every effort has been made to make this User Manual
comprehensive, certain sections may be unclear or difficult to understand
depending on the user's background and experience. Do not use this system
if there is any instruction, direction, precaution or note which you do not
understand or which is unclear. Never hesitate to contact an authorized
IceCure Medical representative for further information and clarification
before using the system.

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2.2.5 Clinical Assessment
2.2.6
Warning
Practitioners should be aware of the possibility of imaging findings at the site
of a cryoablated area. Practitioners should inquire if a patient has a history of
cryoablation.
Warning
Exercise caution when treating patients who have had previous difficulty
with surgical procedures or local anesthesia.
Warning
Safety and effectiveness of the ProSense™ cryoablation system in pregnant
women has not been established. Physicians should exercise caution when
using the cryoablation system in pregnant women.
Warning
The handle and hose portions of the ProSense™ cryoablation system may
become cold during the cryoablation procedure. Operators should consider
insulating these parts in order to prevent discomfort to the patient.
Warning
The supplier and manufacturer of the ProSense™ cryoablation system do not
claim that it will be useful for assisting with the treatment of any particular
condition or set of circumstances. Full responsibility for assessing the
potential benefit of the system for a given medical condition lies with the
practitioner.
While experience has shown that the system is useful for certain applications
in cryosurgery, no representation or warranty is made that the system is
useful for any specific person or condition.
Warning
For patients with breast implants, you must document that adequate
distance exists between the lesion and the implant to ensure that the ablated
lesion will not contact or jeopardize the implant, and there is enough space
to create the required margins.

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Warning
Do not rely solely on the temperature sensor measurement. Always monitor
the procedure using Ultrasound or other appropriate imaging systems.
Caution
Artifacts from the devices may appear in the Ultrasound or CT image.
Warning
Temperature sensor and probe insertion and navigation within tissue MUST
be done under guidance of an appropriate imaging device.
Warning
You must NOT allow the freeze process to start before the cryoprobe active
area is actually within the target tissue.

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2.2.6 Installation and Setup
Warning
The cryoablation system should be operated in an adequately ventilated
room. Failure to do so may result in risk of suffocation due to increased levels
of nitrogen in the room.
Caution
After positioning the main chassis, lock the front roller brakes. Failure to do
so may result in damage to the system or to other equipment in the clinic
room.
Caution
The ProSense™ cryoablation system must be unpacked, installed, and tested
by an IceCure Medical authorized technician only.
Caution
There are no user-serviceable parts in the system. Refer all service issues to
IceCure Medical’s Customer Service Department.
Caution
Make sure the time is set according to local time zone before executing a
cryotherapy procedure.

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2.2.7 Proper use
Caution
Do not disconnect the probe from the system during FREEZE, EXTRACTION,
or THAW unless you are required to do so.
Caution
Do not use the workstation or the liquid nitrogen Dewar for any purpose
other than operating the ProSense™ cryoablation system.
Caution
The liquid nitrogen Dewar supplied with the ProSense™ cryoablation system
is a dedicated system part and should not be used for any other purpose.
Make sure to use only IceCure approved and labeled Dewars for your
system.
Caution
Dewars should always be stored with their lids in place.
Caution
Only Dewars and lids supplied by IceCure Medical may be used with the
ProSense™ cryoablation system. Make sure to use only an approved IceCure
Dewar for your system.
Warning
Always turn OFF the cryoablation system and lock the wheels when not in
use.
Before you start a procedure, lock at least two of the four wheels.
Caution
The ProSense™ cryoablation system should be moved with care in order to
avoid damage to the system or other clinical equipment.
Warning
After extraction step, before removing the cryoprobe from the tissue, make
sure that the freeze effect has been deactivated so that the probe can easily
be removed from the tissue.

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Do not force removal of the cryoprobe from the tissue as it might increase
the risk of tissue damage. Continue the Extraction step or wait for passive
thaw until the cryoprobe can be withdrawn easily.
Warning
If one or more of the wheels is damaged, do not use the system.
Warning
Cryoprobes are fragile and can be damaged if mishandled. Do not use a
cryoprobe that has been bent, dropped, hit against a hard surface or
compromised in any manner, as internal damage to the cryoprobe may have
occurred.
Caution
Do not move the system when the Dewar contains liquid nitrogen.
Warning
Removing the Dewar, or placing it back within the system after refilling it
must ONLY be done according to system instructions and with the carriage in
the bottom position. If the carriage is not in the bottom position, liquid
nitrogen may spill out.
Caution
Follow the detailed instructions on opening the Dewar storage- when you
want to replace a Dewar.
Caution
The system will not allow additional treatment when zero procedures are
left to maintenance. Make sure to call IceCure Medical service
representatives in time.

IceCure Medical Ltd. DSR3210000 rev. D ProSense™
Confidential User Manual
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2.3 Operating warnings
Warning
Ensure that the cryoprobe is securely connected.
Warning
Ensure that the temperature sensor is securely connected.
Warning
Insertion of the cryoprobe into the target tissue is performed under the
guidance of an appropriate imaging device and by an authorized practitioner
trained by IceCure Medical.
Warning
The probe must be IN THE TARGET TISSUE BEFORE starting the freeze
treatment.
Warning
If the procedure is not yet underway after a cryoprobe is screwed onto the
cryohandle, hang the cryohandle in its cradle to prevent a stabbing injury
from the cryoprobe.
Be sure to maintain sterility of the cryohandle and cryoprobe.
Warning
Before removing the cryoprobe from the tissue, make sure that the freeze
effect has been deactivated so that the probe can easily be removed from the
tissue.
Do not force removal of the cryoprobe from the tissue as it might increase
the risk of tissue damage. Continue the EXTRACTION step or wait for passive
THAW until the cryoprobe can be withdrawn easily.
Warning
Before removing the temperature sensor from the tissue, make sure the
freeze effect has been deactivated and the sensor can be easily withdrawn.
Never use excessive force to extract the temperature sensor.

IceCure Medical Ltd. DSR3210000 rev. D ProSense™
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Warning
DO NOT push the EXTRACTION button when the cryoprobe is not within the
target tissue, as skin burns could occur, and not before the freezing protocol
is completed, unless you want to shorten the procedure due to clinical
judgment.
Warning
Never detach the cryoprobe from the cryohandle if you are not clearly
instructed to unscrew or disengage it.
Caution
Verify cryoprobe S/N registration by double checking the serial number ON
the package and on the cryoprobe itself. Entering an incorrect cryoprobe S/N
registration will result in probe nullification.
Warning
Do not allow any liquid or humidity to enter the cryohandle. Always keep the
cover ON the cryohandle.
Warning
In case of the EXTRACTION process isn't available, Wait for passive THAW.
Warning
In case of frost on shaft, if possible start EXTRACTION. If not, wait for passive
THAW. In both cases use skin protection techniques.
Warning
Pay attention to the probe during pre-test: bubbles, leak or frost on shaft
may signal internal problems that could be hazardous.
Warning
If you don’t press SKIP after replacing Dewar, the system will stay in THAW
mode.