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.

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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

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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

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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

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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

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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

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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.

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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.

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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

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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.

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Warning
Never allow untrained personnel to operate the IceSense3™ cryoablation system.
Warning
Never enter the Technician mode screen. Only an IceCure 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.
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.
See 9.1
See 5.2.6
See 9.1

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2.2.5 Clinical assessment
Warning
Practitioners should be aware of the possibility of mammographic findings at the site of a
cryoablated fibroadenoma. Practitioners should enquire 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 IceSense3™ cryoablation system in pregnant women has not
been established. Physicians should exercise caution when using IceSense3™ cryoablation
system in pregnant women.
Warning
The handle and hose portions of the IceSense3™ 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 IceSense3™ 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
See 5.2.2
See 5.2.2

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Warning
Do not rely solely on the temperature sensor measurement. Always monitor the procedure using
Ultrasound or other appropriate imaging system.
Warning
Temperature sensor insertion and navigation within tissue MUST be done under guidance of an
appropriate imaging device.
2.2.6 Installation and setup
Warning
The IceSense3™ 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 IceSense3™ 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.
See 3.8.8
See 3.8.8
See 4.2
See 4.2
See 4.2
See 4.2
See 8.3
See 5.2.6

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2.2.7 Proper use
Caution
Do not use the workstation or the liquid nitrogen Dewar for any purpose other than operating the
IceSense3™ cryoablation system.
Caution
The liquid nitrogen Dewar supplied with the IceSense3™ cryoablation system is a dedicated
system part and should not be used for any other purpose.
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 IceSense3™ cryoablation
system.
Warning
Always turn off the IceSense3™ cryoablation system and lock the wheels when not in use.
Before you start a procedure lock two of the four wheels.
Caution
The IceSense3™ cryoablation system should be moved with care in order to avoid damage to the
system or other clinical equipment.

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Warning
If one or more of the wheels is damaged, do not use the system.
Warning
Cryoprobes are fragile and can be damage 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 instruction 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 open the Dewar storage- when you want to replace a Dewar.
Caution
The system will not allow additional treatment when zero procedures left to maintenance. Make
sure to call IceCure Medical service representatives in time.
2.3 Operating warnings
Warning
The cryoprobe tip must be covered when not within the target tissue.
See 5.2.6
See 4.2
See 5.2.7
See 5.2.7
See 8

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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 tip must be in the target tissue BEFORE starting the freeze treatment.
Warning
The practitioner must hold the cryohandle for the duration of the cryoablation procedure.
Warning
If the procedure is not yet underway after a cryoprobe is screwed onto the cryohandle, hang the
cryohandle in its holder 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 hematoma.
Continue the Warm step or wait for passive thaw until the cryoprobe can be withdrawn easily
See 5.2.7
See 5.2.7

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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.
Warning
DO NOT push the warm 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 required 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 active Warm process isn't available, wait for passive Thaw.
Warning
In case of frost on shaft, if possible start active Warm. If not, wait for passive Thaw. In both cases
use skin protection techniques.
See 5.4.1
See 5.3.7
See 5.2.7
See 8.1
See 5.2

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2.4 Liquid nitrogen
Nitrogen gas is a potential asphyxiant. In the event of a large liquid nitrogen spill, personnel should
adhere to a predetermined evacuation plan. Seek medical help immediately if breathing problems
occur.
Warning
If a liquid nitrogen leak is detected at any time, PUSH the Emergency Stop button immediately.
2.4.1 Danger - explosion and fire hazard
Warning
The IceSense3™ cryoablation system includes electronic devices that may emit sparks and should
therefore not be operated in the presence of ANY flammable material.
IceSense3™ cryoablation system should be kept away from flammable fumes, e.g., flammable
anesthetics or volatile substances. An easily accessible fire extinguisher in the vicinity of the unit is
recommended.
2.4.2 Opening the Dewar compartment
Caution
Never open the Dewar compartment while running a cryoablation procedure. Do not use the system
while the Dewar compartment is open.
Warning
Do not transfer a Dewar with Liquid nitrogen unless it is covered with a lid.
Caution
Follow the specific instructions on how to fill and transfer a Dewar as described in section 5.2.7.1 –
Dewar.
See 5.5

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2.4.3 Voltage and power ratings
Caution
Verify that the IceSense3™ cryoablation system complies with the local voltage line.
2.4.4 Liquid nitrogen Safety
Warning
Liquid nitrogen may cause serious injury or burn if handled improperly. Local laws and safety rules
regarding the maintenance and handling of liquid nitrogen Dewars should always be observed.
Maintenance of liquid nitrogen Dewars should be performed by authorized personnel only.
Warning
Do not use a liquid nitrogen Dewar if it is damaged.
You can tell that a Dewar is damaged if after filling it, frost appears on the outer wall of the
container. Return the Dewar to IceCure technician or an authorized distributor for inspection
Standard guidelines for safe handling and storage of liquid nitrogen are available from the supplier
and must be carefully observed.
The following is a list of general safety points that should be followed at all times:
Handle liquid nitrogen with care. Contact with skin may cause serious frostbite. Do not allow objects
cooled by liquid nitrogen to touch your bare skin. Objects cooled by liquid nitrogen may stick to the
skin and tear flesh when attempting removal.
Protective clothing can reduce the hazards of handling liquid nitrogen. Insulated or heavy leather
gloves should always be worn when handling any object that has been in contact with liquid
nitrogen. Loose fitting gloves are recommended so that they may be discarded quickly in the event
that any liquid nitrogen splashes into them. If you are working with open containers of liquid
nitrogen, boots should be worn and trousers should not be tucked into boots, but worn outside.
Personal protective equipment is essential and can save you from liquid nitrogen’s risks. Full face
shield and safety glasses are recommended for eyes/face protection.
Fill the container slowly to avoid the expansion stress that occurs as a result of the rapid cooling. Too
much pressure can damage the container.
Do not seal the containers tightly. The use of a tight-fitting stopper or plug that prevents the
adequate venting of gas allows a build-up of pressure that could severely damage or even burst the
container. Even an accumulation of ice or frost on the lid can interfere with proper venting. To assure
safe operation, only use the original sponge lid supplied with the Dewar.
See 3.4

IceCure Medical Ltd. DSR3000000 rev.L
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Liquid nitrogen containers should always be stored in an upright position. Tipping the container or
letting it lie on its side can result in spillage and may damage the container. Dropping the container
or subjecting it to severe vibration may damage the vacuum insulation system.
Transfer liquid nitrogen with care. Spilling and splashing are the primary hazards of transferring
liquid nitrogen from one container to another. NEVER overfill the containers. Filling above the
specified level is likely to produce spillage when the lid is replaced. Transportation of liquid nitrogen
must always be done in the original container and in accordance with local laws and safety rules.
Do not attempt to dispose of residual or unused quantities of liquid nitrogen. For safe disposal
contact your supplier. For emergency disposal, discharge slowly to the atmosphere in a well-
ventilated room or outdoors.
If spilled liquid nitrogen causes a cloud to form, the room must be evacuated and ventilated
immediately. Anyone experiencing headache, dizziness, difficulty breathing, or other symptoms of
hypoxia should receive immediate medical attention.
Do not use a liquid nitrogen Dewar if it is damaged. You can tell that a Dewar is damaged if after
filling it, frost appears on the outer wall of the container. Return the Dewar to an IceCure technician
or an authorized distributor for inspection.
Warning
Before beginning a procedure on a new patient, the Dewar MUST be completely filled and placed
in the system as described in section 5.2.7.1 of this manual.
2.4.5 Burn hazards
The Cryoprobe tip can reach very low temperatures.
Warning
Portions of the cryoprobe other than the freeze zone, including the plastic cover that is located
near the cryoprobe handle, may become cold and cause tissue damage. If unwanted freezing
occurs, stop the pre-test process by pressing "Cancel".
Warning
Portions of the cryoprobe other than the freeze zone, including the plastic cover that is located
near the cryoprobe handle, may become cold and cause tissue damage. If unwanted freezing
occurs, immediately stop the freezing process.
To prevent injury, cryoprobes must be closely observed during use for signs of unwanted freezing.