IceCure IceSense3 User manual

1
User Manual
DSR3000000 rev. L
Please read this document carefully before using the IceSense3™
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
498 Halle Park Dr., Ste. 102
Collierville, TN 38017
[email protected]
Toll-free 888-516-7389
Tel [phone]
Fax [phone]
IceCure Medical Ltd.
HaEshel 7, 2nd floor
Southern Industrial Park,
Caesarea 38900, 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. DSR3000000 rev.L
Confidential User Manual
2
IceSense3™
Table of Contents
1OVERVIEW..................................................................................................................7
1.1 Introduction.............................................................................................................7
1.2 Intended use ............................................................................................................7
1.3 Indications for use...................................................................................................7
1.4 Qualified users ........................................................................................................8
1.5 Clinical decisions....................................................................................................9
1.6 Qualified technician ................................................................................................9
2SAFETY NOTES ........................................................................................................10
2.1 Warnings and cautions..........................................................................................10
2.2 Basic safety principles...........................................................................................10
2.2.1 Ownership......................................................................................................10
2.2.2 Qualification ..................................................................................................10
2.2.3 Training..........................................................................................................11
2.2.4 Clarity ............................................................................................................11
2.2.5 Clinical assessment........................................................................................12
2.2.6 Installation and setup.....................................................................................13
2.2.7 Proper use ......................................................................................................14
2.3 Operating warnings...............................................................................................15
2.4 Liquid nitrogen......................................................................................................18
2.4.1 Danger - explosion and fire hazard................................................................18
2.4.2 Opening the Dewar compartment..................................................................18
2.4.3 Voltage and power ratings.............................................................................19
2.4.4 Liquid nitrogen Safety...................................................................................19
2.4.5 Burn hazards ..................................................................................................20
2.4.6 Grounding......................................................................................................21
2.4.7 Sterility...........................................................................................................21
2.4.8 Mechanical handling of flexible hose and cryohandle ..................................21
2.5 Emergencies and errors.........................................................................................22
2.5.1 Emergency Stop button..................................................................................22
2.5.2 Emergencies causing procedure halt..............................................................22
2.6 Adverse events ......................................................................................................23
2.7 Compliance ...........................................................................................................23
2.7.1 Compliance with international safety standards............................................23
2.8 Equipment classification.......................................................................................23
2.9 Accompanying labels............................................................................................24
2.9.1 Important Symbols and Labels......................................................................29
3SYSTEM DESCRIPTION...........................................................................................32
3.1 Introduction...........................................................................................................32
3.2 Concept of operation.............................................................................................32
3.3 Major components.................................................................................................32
3.3.1 Main chassis...................................................................................................33
3.3.2 Emergency Stop button..................................................................................33
3.3.3 Flexible hose..................................................................................................34
3.3.4 Touch screen..................................................................................................34
3.3.5 Cryohandle and cryoprobe.............................................................................35
3.3.6 Handle plug holder.........................................................................................36
3.3.7 Foot pedal (Not available in some regions, e.g. China).................................37

IceCure Medical Ltd. DSR3000000 rev.L
Confidential User Manual
3
IceSense3™
3.3.8 Temperature sensor (TS) ...............................................................................37
3.3.9 Dewar storage cases.......................................................................................39
3.4 Operational details ................................................................................................40
3.4.1 Starting the system.........................................................................................40
3.4.2 System pre-tests.............................................................................................41
3.4.3 Cryoablation procedure..................................................................................42
3.4.4 Warm step......................................................................................................42
4INSTALLATION AND SETUP .................................................................................43
4.1 Space and positioning requirements......................................................................43
4.2 Setup warnings and cautions.................................................................................43
4.3 Electrical requirements..........................................................................................44
4.4 Shipment components...........................................................................................44
4.5 Installation.............................................................................................................44
5OPERATING THE SYSTEM.....................................................................................45
5.1 Procedure Overview..............................................................................................45
5.2 Pre-operational stages ...........................................................................................45
5.2.1 Preparing the system for procedure ...............................................................45
5.2.2 Preparing the patient for procedure ...............................................................45
5.2.3 Switching on the IceSense3™ cryoablation system ......................................46
5.2.4 Cryohandle.....................................................................................................48
5.2.5 Show Last Treatment.....................................................................................48
5.2.6 General settings..............................................................................................49
5.2.7 Preparing the system for treatment................................................................51
Treatment Selection.....................................................................................................60
5.3 Operational stages.................................................................................................63
5.3.1 Safe Operation in Percutaneous Procedures..................................................63
5.3.2 Preliminaries..................................................................................................63
Once you have verified the probe is located in its right place, you may begin freezing.
.....................................................................................................................................65
5.3.3 Freeze Cycle ..................................................................................................65
5.3.4 Pause Option:.................................................................................................66
5.3.5 Manual freeze mode.......................................................................................67
5.3.6 Thaw ..............................................................................................................70
5.3.7 Active warm process......................................................................................71
5.3.8 Replace the Dewar during a cryo-procedure .................................................72
5.4 Post-operational stages..........................................................................................78
5.4.1 Removing the temperature sensor from tissue...............................................78
5.4.2 Removing the cryoprobe from the cryohandle ..............................................79
5.4.3 Disassembling the temperature sensor...........................................................80
5.4.4 Exiting the IceSense3™ cryoablation system treatment mode......................80
5.5 System failures......................................................................................................81
5.5.1 IceSense3™ cryoablation system failure......................................................81
5.5.2 IceSense3™ cryoablation system touch screen failure..................................81
6COMPUTER INTERFACE.........................................................................................84
6.1 The technician menu .............................................................................................84
6.2 Reading the screen ................................................................................................84
6.2.1 Parts of the Screen .........................................................................................84
6.3 System messages...................................................................................................85
6.3.1 Status messages..............................................................................................85

IceCure Medical Ltd. DSR3000000 rev.L
Confidential User Manual
4
IceSense3™
6.3.2 Warning messages .........................................................................................85
6.3.3 Error messages...............................................................................................86
7ACCESSORIES...........................................................................................................88
7.1 Cryoprobe..............................................................................................................88
7.1.1 Single use sterile cryoprobe...........................................................................88
7.2 The Foot pedal (Not available in some regions, e.g. China).................................89
7.3 The temperature sensor .........................................................................................89
8SYSTEM MAINTENANCE .......................................................................................90
8.1 General cleaning....................................................................................................90
8.2 Sterility..................................................................................................................90
8.3 Periodic servicing..................................................................................................91
9TROUBLESHOOTING...............................................................................................92
9.1 General..................................................................................................................92
9.2 Troubleshooting guide ..........................................................................................92
10 IceSense3™ cryoablation system - Step-by-Step procedure.......................................95
11 SYSTEM SPECIFICATIONS.....................................................................................96
12 TEMPERATURE DISTRIBUTION ANALYSIS IN HOMOGENEOUS MEDIUM 97
13 LIMITED WARRANTY CERTIFICATE ..................................................................98
14 CUSTOMER COMPLAINT FORM...........................................................................99
15 REPORT CUSTOMER COMPLAINT.....................................................................100
16 Manufacturer’s Declaration of the EUT ....................................................................101
Figures
Figure 1: Label 1 - On/Off mechanical button - MLS1000002 Rev. B...............................25
Figure 2: Label 2 - Emergency Stop - MLS1000003 Rev. B..............................................25
Figure 3: Label 3 - Identification - MLS3080001 Rev. F....................................................25
Figure 4 Label 4 - Federal laws restriction - MLS1000004 Rev. B ....................................25
Figure 5: Label 5 - Follow instructions for use - MLS1000005 Rev. C..............................26
Figure 6: Label 6 - High voltage caution - MLS1000006 Rev. B.......................................26
Figure 7: Label 7 - Line voltage danger - MLS1000007 Rev. B.........................................26
Figure 8: Label 8 - Foot pedal - MLS1000008 Rev. B........................................................26
Figure 9: Label 9 - Risk of Explosion - MLS1000009 Rev. B............................................26
Figure 10: Label 10 - Single use probe - MLP7000001 Rev. F...........................................27
Figure 11: Label 11 - Single use temperature sensor - MLT8000001 Rev. F.....................27
Figure 12: Label 12 - Liquid nitrogen Dewar - MLS1000001 Rev. D................................27
Figure 13 Label 13 –Cold area - MLS1000010 Rev. B......................................................28
Figure 14: Label 14- Empty LN2 Dewars - MLS1000012 Rev. A .....................................28
Figure 15: Label 15- Applied parts - MLS1000014 Rev. A................................................28
Figure 16: Label 16- Shipping Art Work.............................................................................28
Figure 17: Front and back view of the IceSense3™ cryoablation system with numbered
components..........................................................................................................................32
Figure 18: The IceSense3™ transportation rollers & brakes...............................................33
Figure 19: The Emergency Stop button...............................................................................34
Figure 20: The touch screen display before a cryoablation procedure................................35
Figure 21: The flexible hose, cryohandle and connected cryoprobe...................................35
Figure 22: The 90 degrees cryohandle and connected cryoprobe (Not available in some
regions, e.g. USA)................................................................................................................36
Figure 23: Handle plug holder and handle plug. .................................................................37

IceCure Medical Ltd. DSR3000000 rev.L
Confidential User Manual
5
IceSense3™
Figure 24: The foot pedal.....................................................................................................37
Figure 25: The temperature sensor and its components ......................................................38
Figure 26: Temperature display of sensor in the procedure screen (green arrow) ..............39
Figure 27: Dewar storage cases –the correct way to put the Dewars inside the storage
cases.....................................................................................................................................39
Figure 28: The system is loading screen..............................................................................41
Figure 29: The Main Menu screen.......................................................................................41
Figure 30 : Schematic illustration of placement of the system and patient.........................46
Figure 31: The system is loading screen..............................................................................47
Figure 32: The Main Menu screen.......................................................................................47
Figure 33: The Action button as displayed on screen (several of the options)....................48
Figure 34: The active Warm button as displayed on screen................................................48
Figure 35: Last Treatment screen ........................................................................................48
Figure 36: Activating the Settings option from the Main Menu screen ..............................49
Figure 37: The Settings screen.............................................................................................49
Figure 38: The Change Workflow screen with two alternative workflow settings.............50
Figure 39: The Windows™ Date and Time Properties screen............................................51
Figure 40: Preparing the system for treatment by pressing “Prepare for Treatment” (green
arrow) on Main Menu screen...............................................................................................52
Figure 41: The Dewar preparation screen............................................................................54
Figure 42: Experiments in gel results ..................................................................................54
Figure 43: The cryoprobe (the figure is for illustration only)..............................................55
Figure 44: Cryoprobe registration screen ............................................................................55
Figure 45: Cryoprobe connection screen.............................................................................56
Figure 46: Functional test screen.........................................................................................58
Figure 47: Functional test - visual inspection screen...........................................................59
Figure 48: Treatment Selection screen ................................................................................60
Figure 49: Define a treatment protocol by choosing Edit Presets on the Treatment Selection
screen (green arrow) or in the Main Menu screen (yellow arrow)......................................61
Figure 50: Editing an existing protocol (green arrow) or adding a new one (yellow arrow)
.............................................................................................................................................61
Figure 51: Steps for adding a protocol.................................................................................62
Figure 52: Edit Preset screen...............................................................................................62
Figure 53: Choosing the Manual Mode option (green arrow).............................................63
Figure 55: Pause and Play buttons during the freeze cycle. ................................................66
Figure 56: Manual Mode screen: press on Freeze to start the freeze cycle.........................67
Figure 58: Thaw screen in Manual Mode............................................................................68
Figure 59: Warm screen in Manual Mode...........................................................................69
Figure 60: Freeze screen in Automatic mode......................................................................70
Figure 61: The Active warm screen during procedure ........................................................72
Figure 62 : Replace Dewar option question.........................................................................73
Figure 63: Lowering the Dewar...........................................................................................74
Figure 64: The replace Dewar screen and press ok to continue ..........................................74
Figure 65: The replacement done follow up screen.............................................................75
Figure 66: Replacement was completed before the Thaw ended ........................................76
Figure 67: Replacement was completed after the Thaw ended ...........................................77
Figure 68: Replacement during Freeze, in case of empty Dewar........................................77
Figure 69: procedure stopped due to Low Nitrogen............................................................78
Figure 70: Protocol Completed Screen................................................................................79

IceCure Medical Ltd. DSR3000000 rev.L
Confidential User Manual
6
IceSense3™
Figure 71: Protocol Completed screen. Pressing on the “Main Menu” icon (green arrow)
will load the Main Menu screen. .........................................................................................80
Figure 72: The Main Menu screen. To exit the system, press on the “Exit” icon (green
arrow)...................................................................................................................................80
Figure 74: The Emergency Stop button located on the main chassis (green arrow) ...........82
Figure 75: A sample touch screen........................................................................................84
Figure 76: Status message example.....................................................................................85
Figure 77: Warning message format example.....................................................................86
Figure 78: Error message format example...........................................................................86
Figure 79: The cryoprobe components (the figure is for illustration only). ........................88
Figure 80: counter of the remaining procedure before maintenance (green arrow) at the
bottom of the main menu screen..........................................................................................91

IceCure Medical Ltd. DSR3000000 rev.L
Confidential User Manual
7
IceSense3™
1OVERVIEW
1.1 Introduction
IceSense3™ 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 IceSense3™ 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
IceSense3™ cryoablation system is intended for cryogenic destruction of tissue during
surgical procedures by the application of extreme cold temperatures. The IceSense3™
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 IceSense3™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
IceSense3™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 IceSense3™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 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 tumors.
The system may be used for palliative intervention.

IceCure Medical Ltd. DSR3000000 rev.L
Confidential User Manual
8
IceSense3™
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.
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.
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.
The IceSense3™cryoablation system is indicated for patients whom the surgeon has
designated as eligible for cryotherapy.
1.4 Qualified users
You are a qualified IceSense3™ 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 IceSense3™ cryoablation system training course.
You have read and understood all relevant material accompanying the
IceSense3™ cryoablation system.

IceCure Medical Ltd. DSR3000000 rev.L
Confidential User Manual
9
IceSense3™
Warning
If you do not meet the above criteria, you should not use the IceSense3™ cryoablation system.
Practitioners electing to be IceSense3™ 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 IceSense3™ 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 IceSense3™ cryoablation system in special populations, such as pregnant women,
has not been established.
For further details, refer to Section 1.3 –Indications for use.
1.6 Qualified technician
Only a technician trained by IceCure Medical is qualified to service the IceSense3™
cryoablation system.
Servicing includes periodic maintenance and repair of the system.
Warning
Do not modify this equipment without authorization of the manufacturer.
See 9.1

IceCure Medical Ltd. DSR3000000 rev.L
Confidential User Manual
10
IceSense3™
2SAFETY NOTES
While this manual is designed to provide instructions in the use of the IceSense3™ 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.