BTG ICEfx User manual

ICEfx™ Cryoablation System
User Manual
Only

For assistance, contact:
www.galilmedical.com
USA: Galil Medical Inc., 4364 Round Lake Road, Arden Hills, MN 55112, USA.
Telephone: [phone], Fax [phone]
Galil Medical Inc., 4364 Round Lake Road, Arden Hills, MN 55112, USA.
Telephone: [phone], Fax [phone]
Obelis s.a., Boulevard Général Wahis 53, 1030 Brussels, Belgium.
Telephone: [phone], Fax: [phone], E-mail: [email protected]

ICEfx™ Cryoablation System i
Table of Contents i
List of Figures iv
List of Tables v
List of Screens vi
Symbols vii
1 SYSTEM OVERVIEW 1-1
1.1 Brief Description 1-1
1.2 How Supplied 1-2
1.2.1 Contents 1-2
1.2.2 Accessory Products Used to Conduct Cryoablation Procedures 1-2
1.2.3 Storage 1-3
1.3 Intended Use 1-3
1.4 Indications 1-4
1.5 Contraindications 1-4
1.6 Warnings 1-5
1.7 Precautions 1-6
1.7.1 General 1-6
1.7.2 Handling 1-7
1.7.3 During Use 1-8
1.7.3.1 Thawing 1-8
1.7.4 After Use 1-9
1.8 Potential Adverse Events 1-9
2 SYSTEM DESCRIPTION 2-1
2.1 Console 2-1
2.1.1 Touch Screen Monitor 2-2
2.1.2 Needle Connection Panel 2-2
2.1.2.1 MTS Connection Ports 2-3
2.1.2.2 Needle Channels 2-3
2.1.2.3 Locking Bars 2-3
2.1.3 Handles 2-3
2.1.4 Power Switch 2-3
2.1.5 Communication Ports 2-3
2.1.6 Software Reset 2-3
2.1.7 ArgonShuto󰀨Valve 2-3
2.1.8 VentValve 2-3
2.1.9 Argon Gas Inlet 2-4
2.2 ICEfx Cart 2-4
2.2.1 Wheel Lock Levers 2-5
3 SYSTEM SETUP 3-1
3.1 Preparation for Use 3-1
3.2 Attaching the Console to the ICEfx Cart 3-2
3.3 Setting up the Console 3-3
3.3.1 Login 3-5
3.4 Connecting the Argon Gas 3-6
Table of Contents

ii User Manual
4 GETTING STARTED WITH THE USER INTERFACE 4-1
4.1 Document Conventions 4-1
4.2 Logging In 4-1
4.3 Navigating the User Interface 4-1
4.3.1 SetupandGasVentingWizards 4-1
4.3.2 Title Bar 4-2
4.3.3 Options Menu 4-3
4.4 Starting the Procedure 4-4
4.5 Entering Case Information 4-5
4.6 Using the Procedure Screen 4-6
4.6.1 ViewingtheTimer 4-7
4.6.2 MTS Temperature Sensors 4-9
4.6.3 Initiating Testing 4-10
4.6.4 InitiatingaFreezeCycle 4-11
4.6.5 Initiating a Thaw Cycle (CX needles only) 4-13
4.6.5.1 Thaw Controls 4-14
4.6.6 Using Cautery (CX needles only) 4-15
4.6.6.1 Cautery Controls 4-16
4.6.7 Advanced Channel Controls 4-17
4.6.7.1 Select Needle Type Control 4-17
4.6.7.2 Retest a Needle 4-17
4.6.7.3 Program Cycles Control 4-17
4.7 Reports 4-19
4.7.1 ViewingAllReports 4-19
4.7.1.1 Sorting a Report 4-20
4.7.1.2 Exporting a Report 4-20
4.7.2 ViewingaReportduringaCryoablationProcedure 4-20
4.8 ConguringSettings 4-21
4.8.1 Control Buttons 4-23
4.9 Administrative Options 4-23
4.9.1 Software Update 4-23
4.9.1.1 Remote Upload/Download 4-23
4.9.1.2 Manual Software Update 4-24
4.9.2 Network Setup 4-24
4.9.3 Manage Users 4-24
5 PERFORMING THE CRYOABLATION PROCEDURE 5-1
5.1 Pre-Procedure Needle/MTS Testing 5-2
5.2 Performing a Cryoablation Procedure 5-5
5.2.1 Adding a CX Needle during a Cryoablation Procedure 5-7
5.2.2 Adding a non-CX Needle during a Cryoablation Procedure 5-7
5.3 Changing Argon Cylinders during a Procedure 5-7
5.3.1 Standard Argon Cylinder Setup 5-7
5.3.2 Dual Argon Cylinder Connection 5-8
6 SYSTEM SHUTDOWN 6-1
6.1 Shutting Down the System 6-1
6.2 Removing the Console from the Cart 6-2

ICEfx™ Cryoablation System iii
7 SYSTEM CARE and MAINTENANCE 7-1
7.1 Cleaning the ICEfx™ Cryoablation System 7-1
7.2 Service and Preventive Maintenance 7-1
7.3 System Disposal 7-1
8 TROUBLESHOOTING 8-1
8.1 Software Recovery 8-1
8.2 Electronics, Electrical and User Error Related Issues 8-2
8.2.1 Replacing Fuses 8-3
8.3 Gas Issues 8-5
8.4 Mechanical Issues 8-7
8.5 Gas Cylinder and Gas Supply Line 8-8
8.6 Needles 8-9
8.6.1 CX Needles 8-9
8.7 Multi-Point Thermal Sensors 8-10
8.8 Displayed Messages 8-10
8.8.1 Login Messages 8-10
8.8.2 Procedure Messages 8-13
8.8.3 Gas Messages 8-15
8.8.4 Needle Messages (CX Needles) 8-16
8.8.5 Software Messages 8-18
8.8.6 Reports Messages 8-21
8.8.7 System Messages 8-22
8.8.8 Service Messages 8-25
9 SYSTEM SPECIFICATIONS 9-1
9.1 Operating Conditions 9-1
9.2 Storage Conditions 9-1
9.3 Transportation Conditions 9-1
9.4 MechanicalSpecications 9-1
9.4.1 ICEfx Console 9-1
9.4.2 ICEfx Cart 9-1
9.5 Argon Gas Supply 9-1
9.6 GasCylinderSpecications 9-1
9.7 AccuracyofDisplayedValues 9-2
9.8 ElectricalSpecications 9-2
9.8.1 Electromagnetic Compatibility and Immunity (EMC and EMI) 9-2
9.9 Essential Performance 9-7
10 REFERENCES 10-1
10.1 Patents 10-1
10.2 Trademarks 10-1
10.3 Contact 10-1
11 DISCLAIMER OF WARRANTY 11-1

iv User Manual
List of Figures
Figure2-1.ConsoleFrontView 2-1
Figure2-2.ConsoleRearView 2-2
Figure 2-3. ICEfx Cart 2-4
Figure 2-4. ICEfx Cart - Wheel Lock Levers 2-5
Figure 3-1. Position ICEfx Console on Cart 3-2
Figure 3-2. Tighten Retaining Screw on Cart 3-2
Figure3-3.ArgonShuto󰀨Valve-ONPosition 3-3
Figure3-4.VentValve-FullyClosed 3-4
Figure 3-5. Attach Safety Cable to Console 3-6
Figure 3-6. Connect Argon Gas Supply Line 3-7
Figure 3-7. Gas Cylinder Set-up 3-7
Figure 3-8. Open Argon Gas Cylinder 3-8
Figure 3-9. EZ-Connect2 Dual Cylinder Adapter 3-9
Figure 5-1. Locking Needle into Channel 5-3

ICEfx™ Cryoablation System v
List of Tables
Table 3-1. System Setup Flow 3-1
Table 3-2. Working Argon Gas Pressure 3-9
Table 4-1. Title Bar 4-2
Table 4-2. Options Menu 4-3
Table 4-3. Start Case Screen Controls 4-4
Table 4-4. Edit Case Information Screen Controls 4-5
Table 4-5. Common Procedure Controls 4-6
Table 4-6. Timer Information 4-8
Table 4-7. MTS Controls 4-9
Table 4-8. Test Controls 4-10
Table4-9.FreezeControls 4-11
Table 4-10. Thaw Controls 4-14
Table 4-11. Cautery Controls 4-16
Table4-12.SettingsScreen—CongurableSettings 4-21
Table 4-13. Settings Screen — Control Buttons 4-23
Table 5-1. Cryoablation Procedure Flow 5-1
Table 9-1. Cable Lengths 9-2
Table 9-2. Electromagnetic Emissions 9-3
Table 9-3. Electromagnetic Immunity 9-4
Table 9-4. Electromagnetic Immunity for Systems that are Not Life-supporting 9-5
Table 9-5. Recommended separation distances between portable and mobile RF communications
equipment and the ICEfx System 9-6

vi User Manual
List of Screens
Screen 3-1.Gas Indicator 3-9
Screen 4-1. Title Bar 4-2
Screen 4-2. Options Menu 4-3
Screen 4-3. Start Case Screen 4-4
Screen 4-4. Edit Case Information Screen 4-5
Screen 4-5. Initial Procedure Screen 4-6
Screen 4-6. Timer During FastThaw 4-7
Screen 4-7. Procedure Screen - MTS Temperature Sensors 4-9
Screen 4-8. Procedure Screen during Testing 4-10
Screen4-9.ProcedureScreenduringFreezing 4-11
Screen 4-10. Procedure Screen during Thawing (FastThaw) 4-14
Screen 4-11. Cautery Screen 4-16
Screen 4-12. Needle Type List 4-17
Screen 4-13. Select Programmed Cycle 4-17
Screen 4-14. Program Cycles Dialog 4-18
Screen 4-15. Programming Cycles Screen 4-18
Screen 4-16. Save Cycle Sequence Screen 4-19
Screen 4-17. All Reports Screen 4-19
Screen 4-18. Procedure Report 4-20
Screen 5-1. Procedure Screen 5-2
Screen 5-2. Argon Remaining 5-5

ICEfx™ Cryoablation System vii
1
Catalog Number
1
Caution
1
Serial Number
1
Date of Manufacture
1
Manufacturer
2
MR Unsafe
1
Temperature Limitation
1
Humidity Limitation
1
Consult Instructions for Use
3
USB Port
4
Ethernet Port
5
Argon Gas
4
Alternating Current
4
Protective Earth
4
Unsafe Voltage. Electrical
contacts greater than 40 V AC
4
Type BF Applied Part
4
Power Switch
4
Power O󰀨
4
Power On
1
Authorized Representative in
the European Community
6
Do Not Discard
Return to Galil Medical at end
of service life
7
ETL Product Listing
Only8
Caution: Federal (USA) law
restricts this device to sale by
or on the order of a physician.
1
Nonsterile
Symbols

viii User Manual
4
Do Not Push
Footnotes
1. EN ISO 15223-1:2016 Medical devices –Symbols to be used with medical device labels,
labelling and information to be supplied – Part 1: General requirements
2. ASTM F 2503 – 13 Standard Practice for Marking Medical Devices and Other Items for
Safety in the Magnetic Resonance Environment
3. USB Implementors Forum, Inc. standard icon.
4. IEC TR 60878-3:2015 Graphical symbols for electrical equipment in medical practice
5. Argon symbol created by Galil Medical based on the abbreviation for Argon in the Periodic
Table of Elements.
6. EN 50419:2006 Marking of electrical and electronic equipment in accordance with article
11(2) of Directive 2002/96/EC (WEEE)
7. ETL Product Listing mark indicates the product is in compliance with North American
product safety standards. Compliance is determined through testing and certication by
Intertek Group plc.
8. USA Code of Federal Regulations 21 CFR Part 801 (§ 801.109(b)(1))

ICEfx™ Cryoablation System 1-1
1 SYSTEM OVERVIEW
WARNING. A thorough understanding of the technical principles, clinical applications,
and risk associated with cryoablation procedures is necessary before using this product.
Use of this device is restricted to use by or under the supervision of physicians trained in
cryoablation procedures with a Galil Medical Cryoablation System.
CAUTION. All new users must be trained on the use of the ICEfx™ Cryoablation System and
cryoablation procedures prior to operating the system. Contact your local Galil Medical representative
to schedule training.
CAUTION. Carefully read all instructions prior to use. Failure to observe all warnings and precautions
may result in complications.
1.1 Brief Description
The ICEfx™ Cryoablation System (FPRCH8000) is a portable system intended for cryoablative
tissue destruction using a minimally invasive procedure. The system is computer-controlled with
a touch screen user interface that allows the user to control and monitor the procedure. The
therapy delivered by the system is based on the Joule-Thomson e󰀨ect displayed by compressed
gases. The Joule-Thomson e󰀨ect is a change in the temperature of a compressed gas as it ows
through a narrow orice and expands to a lower pressure. Certain gases, such as argon, decrease
in temperature due to the Joule-Thomson e󰀨ect, while other gases, such as helium, increase in
temperature.
The ICEfx Cryoablation System uses high-pressure argon gas that circulates through closed-tip
cryoablation needles to induce tissue freezing. Freezing is due to the Joule-Thomson e󰀨ect
augmented by a recuperative heat exchanger within the cryoablation needle. Active tissue thawing
is achieved by controlling the heating element inside CX-type needles to provide active helium-free
thawing (i-Thaw™ or FastThaw™) and track ablation (Cautery).
Cryoablation treatments are delivered by small-diameter cryoablation needles that are inserted into
the target lesion, usually under CT image guidance. When multiple cryoablation needles are placed
into or near the target tissue and freezing is initiated, an iceball grows around the distal end of the
needle shafts. In time, the iceballs coalesce and completely engulf and destroy the target tissue.
The cryoablation needle design and the temperature of the argon gas as well as the freeze duration
determine the size and shape of the iceball. Tissue ablation is achieved by repeated freeze and thaw
cycles with both freezing and thawing contributing to cell death. Each freeze-thaw cycle consists of
a freeze cycle followed by a thaw cycle. Generally, multiple freeze-thaw cycles are used to achieve
complete destruction of the target tissue.
An important benet of cryoablation is that imaging procedures, such as ultrasound and CT, are able
to display the location and size of the iceball. This benet of cryoablation is used for proper control of
the therapy. During use, the procedure must be monitored using image guidance to ensure adequate
tissue coverage and to avoid damage to adjacent structures.
In addition to image guidance, Galil Medical provides temperature sensors to aid in monitoring
tissue temperature near the target site and adjacent critical structures. These temperature sensors
can provide quantitative data to supplement the qualitative information provided by the imaging
modality. Needle temperature display for CX-type needles provides a visual means to monitor needle
performance.

1-2 User Manual
1.2 How Supplied
The ICEfx Cryoablation System is supplied non-sterile. Galil Medical accessory products required to
perform the cryoablation procedure are supplied separately.
1.2.1 Contents
•ICEfx Cryoablation Console
•Optional ICEfx Cryoablation Cart: The cart provides storage for up to four cryoablation needle
boxes and provides a hook to hold an accessory bag. When the cart is ordered with the Console,
the Console is attached to the cart prior to shipment.
•ICEfx Cryoablation System User Manual: The User Manual describes the system and provides
instructions for system operation and maintenance.
•ICEfx Cryoablation System Quick Reference Guide: The Quick Reference Guide provides a
visual overview of system setup and operation.
•USB ash drive (4 GB) within an attached pouch: The Galil Medical USB ash drive is used to
transfer procedure reports to a customer’s computer for saving or printing.
•High-pressure argon gas supply line with attached pressure gauge
o To accommodate procedure room variations, the gas supply line is available in alternative
lengths to connect the argon cylinder to the Console. Reference Table 9-1.
•Ethernet cable (3 m): The Ethernet cable is used to connect the Console to a Galil Medical
remote server for uploading reports and diagnostic data and for downloading software updates.
•Wrench: The Wrench is used when connecting or disconnecting the gas supply line.
•Accessory Bag: The Accessory Bag is used for storing the system accessories and can be
attached to the hook on the side of the ICEfx Cart.
•Optional EZ-Connect2 Dual Cylinder Adapter: is an optional device used to connect two argon
cylinders in tandem to the ICEfx System. The dual cylinder adapter consists of a four-way adapter
assembly with argon pressure gauge and auxiliary gas supply connection attached to a long gas
supply line and a short auxiliary gas supply line with gas cylinder connection. Reference Section
3.4 for instructions on using the EZ-Connect2 Adapter.
1.2.2 Accessory Products Used to Conduct Cryoablation Procedures
The following items used with the ICEfx Cryoablation System are sterile, single-use only devices. Do
not re-sterilize or reuse.
NOTE: Single-use accessories are described in separate Instructions for Use.
•Galil Medical Cryoablation Needles: The ICEfx Cryoablation System is used only with Galil
Medical cryoablation needles. The cryoablation needles are available in a range of congurations
that produce various iceball sizes and shapes, allowing the clinician to match the needles to the
desired ablation zone. The cryoablation needles are supplied sterile in procedure kits or in needle
kits.
WARNING. Only use non-MRI needles with the system.
•Cryoablation Needle Labels: Needle labels are a󰀩xed to the needle tubing to provide easier
identication of the needles during a cryoablation procedure. Contact Galil Medical Customer
Service to order labels.
•Galil Medical Multi-Point Thermal Sensor™ (MTS): The Multi-Point Thermal Sensors (MTS)
contain four sensor locations along the distal shaft of the needle to monitor temperature near the
target site and adjacent critical structures.

ICEfx™ Cryoablation System 1-3
•Galil Medical Urethral Warming Set: The Urethral Warming Set is the conduit that circulates
warm saline through the urethra during a prostate cryoablation procedure.
The following items used with the ICEfx Cryoablation System are re-usable and should be cleaned
and/or sterilized in accordance with the Instructions for Use that accompanies each product.
•IV Pole and Bracket for use with a uid warmer and pump system
The following items are needed to conduct cryoablation procedures and are not available from Galil
Medical.
•Argon gas cylinder(s)
NOTE: The argon gas must meet the purity requirements specied in Section 9.5.
•A uid warmer and pump system when using the Galil Medical Urethral Warming Set
1.2.3 Storage
Store the ICEfx Cryoablation System in a cool, dry, secure location. Storage conditions should be
within -15°C to +50°C and 10% to 90% relative humidity.
1.3 Intended Use
The Galil Medical ICEfx Cryoablation System is intended for cryoablative destruction of tissue during
minimally invasive procedures; various Galil Medical accessory products are required to perform
these procedures. The ICEfx Cryoablation System is indicated for use as a cryosurgical tool in the
elds of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with
the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. This system is
designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin
lesions) by the application of extremely cold temperatures.

1-4 User Manual
1.4 Indications
The ICEfx Cryoablation System is indicated for use as a cryosurgical tool in the elds of general
surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of
cardiac tissue), ENT, gynecology, oncology, proctology, and urology. This system is designed to
destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by
the application of extremely cold temperatures.
The ICEfx Cryoablation System has the following specic indications:
•Urology Ablation of prostate tissue in cases of prostate cancer
and Benign Prostate Hyperplasia (BPH)
•Oncology Ablation of cancerous or malignant tissue and benign
tumors, and palliative intervention
•Dermatology Ablation or freezing of skin cancers and other cutaneous
disorders
Destruction of warts or lesions, angiomas, sebaceous
hyperplasia, basal cell tumors of the eyelid or canthus
area, ulcerated basal cell tumors, dermatobromas, small
hemangiomas, mucocele cysts, multiple warts, plantar
warts, actinic and seborrheic keratosis, cavernous
hemangiomas, peri-anal condylomata, and palliation of
tumors of the skin
•Gynecology Ablation of malignant neoplasia or benign dysplasia of
the female genitalia
•General surgery Palliation of tumors of the rectum, anal ssures, pilonidal
cysts, and recurrent cancerous lesions, ablation of breast
broadenomas
•ENT Palliation of tumors of the oral cavity and ablation of
leukoplakia of the mouth
•Thoracic surgery (with the exception of cardiac tissue)
•Proctology Ablation of benign or malignant growths of the anus or
rectum
1.5 Contraindications
There are no known contraindications specic to the use of the Galil Medical ICEfx Cryoablation
System.

ICEfx™ Cryoablation System 1-5
1.6 Warnings
•Do not use this device for any purpose other than the stated intended use and indications for use.
•A thorough understanding of the technical principles, intended use, indications for use and
risk associated with cryoablation procedures is necessary before using this product. Use of
this device is restricted to use by or under the supervision of physicians trained in cryoablation
procedures with a Galil Medical cryoablation system.
•Do not use an ICEfx Cryoablation System near magnetic resonance imaging (MRI) equipment.
•Only use non-MRI needles with the ICEfx Cryoablation System.
•Do not start a cryoablation procedure before verifying that the ICEfx Cryoablation System and all
ancillary equipment are fully operational.
•Verify that the Ethernet cable is disconnected prior to starting a cryoablation procedure. Do not
connect the Ethernet cable during a cryoablation procedure.
•Do not use the ICEfx Cryoablation System if the system is visibly damaged, exposing any internal
components or sharp edges.
•Have su󰀩cient argon gas available to conduct the planned cryoablation procedure: the number
and type of needles, gas cylinder size, pressure and rate of gas ow a󰀨ect the required gas
volume.
•Secure the safety cable at the end of the gas supply line to the Console before connecting the
argon gas supply line to the argon gas inlet. The safety cable provides backup protection if the
gas supply line becomes inadvertently disconnected from the system.
•If the ICEfx Cryoablation Console is mounted on a cart, lock the wheels on the cart prior to using
the system to avoid inadvertent movement of the system during a procedure.
•Each needle must be locked into a needle channel before initiating a cryoablation procedure to
avoid the risk of forceful ejection of the needles while under gas pressure.
•Do not unlock a needle channel until all operations in the channel have completed.
•Before the patient is anesthetized, the Needle Integrity and Functionality Tests on the cryoablation
needles must be completed successfully to verify proper needle operation.
•Do not touch the ICEfx Cryoablation Console while touching the patient to avoid the risk of
shocking the patient if an inadvertent electrical fault exists.
•Do not pull on the power cord. Grasp the plug, not the power cord, to disconnect the device from
the wall socket.
•Do not modify the ICEfx Cryoablation System in any way. Only authorized Galil Medical personnel
or Galil Medical-trained authorized personnel are to service an ICEfx Cryoablation System.
•Do not touch the screen if the touch screen monitor goes blank for more than ve (5) seconds
during a procedure. Immediately turn o󰀨 power to the system and end the procedure to avoid
inadvertent activation of needles.
•High-pressure gas is dangerous if handled improperly. Local laws and safety rules regarding
pressurized gas systems, reservoirs and components should always be observed.
•The ICEfx Cryoablation System should not be operated in the presence of ammable fumes, e.g.,
ammable anesthetics or volatile substances.
•The ICEfx Cryoablation System should be inspected and serviced periodically according to the
system specications. Service must be performed by authorized service engineers. Reference
Section 7 for system care and maintenance information.

1-6 User Manual
1.7 Precautions
1.7.1 General
•Training on appropriate use of the ICEfx Cryoablation System is required prior to conducting a
cryoablation procedure.
•The physician is solely responsible for all clinical use of the cryoablation system and for any
results obtained by use of the system. The physician makes all clinical decisions prior to and
throughout the cryoablation procedure based upon his/her professional opinion.
•The ICEfx Cryoablation Console and user interface are non-sterile. Contact with any part of the
Console by a member of the sterile team requires use of customer supplied sterile accessories,
such as a sterile drape.
•Galil Medical recommends having backup argon cylinders available for each treatment to ensure
su󰀩cient gas is available to complete a treatment. At least one full spare cylinder should be
available for each treatment.
•Do not use the ICEfx Cryoablation System if any moisture or condensation is present on the
surfaces of the system. Powering up the system containing moisture or condensation could result
in permanent damage to the electrical boards, causing the system to be inoperable.
•Direct the high-pressure argon gas supply line towards the oor and secure the line with the clip
located on the rear of the Console to minimize the potential for tripping.
•Conrm the high-pressure argon gas supply is securely connected before opening the gas
cylinder.
•Conrm that the Vent Valve is closed before connecting the gas line to the Console.
•Continuously monitor the cryoablation procedure using image guidance such as direct
visualization, ultrasound, or Computed Tomography (CT) to ensure adequate tissue coverage and
to avoid damage to adjacent structures.
•Galil Medical recommends using the Galil Medical Multi-Point Thermal Sensors (MTS) to monitor
the freeze / thaw temperatures for the intended treatment protocol and to monitor temperatures in
the adjacent organs and structures.
•Ensure that the MTSs are functioning properly before inserting into the patient by verifying that
they are reading a reasonable room temperature.
•Cryoablation freezes and destroys tissue. To limit this e󰀨ect to only the target ablation area, the
physician must determine the means to protect adjacent organs and structures.
•Position the ICEfx Cryoablation System in a manner to avoid draping needle tubing across
the patient. Needle tubing may become extremely cold when conducting freeze cycles during
a cryoablation procedure. It is important that a patient’s skin is protected from direct contact
with needle tubing to avoid the potential for thermal injury to the patient. Ensure an appropriate
insulating barrier is placed as needed (such as towels) or other method is employed to prevent
needle tubing from touching a patient’s skin.
•No data regarding cryoablation in combination with other therapies is available from Galil Medical.
•Do not set heavy objects on the monitor when in the down position or on the monitor storage
basin when the monitor is in the up position.
•Portable and mobile radiofrequency (RF) communications equipment can a󰀨ect the ICEfx
Cryoablation System, causing it to operate improperly. Keep such equipment away from the
system (reference Section 9.8).
•Use only Galil Medical supplied components and accessories with the ICEfx Cryoablation
System.

ICEfx™ Cryoablation System 1-7
•Use Galil Medical USB ash drive only to export reports or update software. Other data or
software may corrupt the ICEfx Cryoablation System.
•Do not connect any other USB equipment to the ICEfx Cryoablation System USB port.
•Do not use a USB extension cable to connect the USB ash drive to the USB port. Connect the
Galil Medical USB ash drive directly to the USB port provided on the ICEfx Cryoablation System.
Use of a USB extension cable may result in electromagnetic emissions exceeding regulatory
limits.
•Do not perform a cryoablation procedure with the Ethernet cable plugged into the ICEfx
Cryoablation System to avoid the potential risk of corrupting the system software. Only use the
Ethernet cable when downloading software updates or when uploading reports to the Galil server.
•Any person who connects external equipment to the Ethernet or USB ports has formed a Medical
Electrical System and is therefore responsible for the system to comply with the requirements. If
in doubt, contact a qualied medical technician or your local representative or Galil Medical.
1.7.2 Handling
•Lift the ICEfx System to clear any threshold that is higher than 2 cm. Two people, one on each
side, should use the handles to lift the system.
•Lift the ICEfx System using the handles to clear any obstacle, either ascending or descending.
•Maneuver the ICEfx Cryoablation System using the handles.
•Handle the ICEfx Cryoablation System with care. Rough handling may damage the system and
cause it to become inoperable.
•When removing the ICEfx Console from the ICEfx Cart, lift the Console using the handles on the
underside of the base. Refer to Section 6.2 for instructions on how to remove the Console from
the ICEfx Cart.
•Do not bend or kink the gas supply line. Sharp bends or kinks may compromise the integrity of
the gas supply line.
•Do not tilt the ICEfx Cryoablation Console.
•Do not roll the ICEfx Cryoablation System over the gas supply line; such activity may damage the
line.
•The ICEfx Cryoablation System is non-sterile. When attaching cryoablation needles to the needle
connection ports, do not contaminate the sterile eld or the sterile cryoablation needle. Avoid
contact with the distal portion of the cryoablation needle.
•Position the ICEfx Cryoablation System in a manner to avoid draping needle tubing across the
patient. Needle tubing may become extremely cold when conducting freeze cycles during a
cryoablation procedure. It is important that a patient’s skin is protected from direct contact with
needle tubing to avoid the potential for thermal injury to the patient. Ensure an appropriate
insulating barrier is placed as needed (such as towels) or other method is employed to prevent
needle tubing from touching a patient’s skin.

1-8 User Manual
1.7.3 During Use
•Use image guidance to monitor needle insertion, iceball formation, needle positioning, and
removal.
•Use Freeze and Thaw operations only when the needle is placed in the target tissue.
•Failure to operate the ICEfx Cryoablation System within the working pressure limits indicated on
the user interface (Table 3-2) may a󰀨ect the cryoablation procedure.
•Needle handles and the gas line may frost during freezing. Avoid prolonged contact with frosted
portions of a needle handle to avoid unintended thermal tissue damage to the patient or clinician.
•Position the ICEfx Cryoablation System in a manner to avoid draping needle tubing across
the patient. Needle tubing may become extremely cold when conducting freeze cycles during
a cryoablation procedure. It is important that a patient’s skin is protected from direct contact
with needle tubing to avoid the potential for thermal injury to the patient. Ensure an appropriate
insulating barrier is placed as needed (such as towels) or other method is employed to prevent
needle tubing from touching a patient’s skin.
•Take precautions to avoid potential electrostatic discharge. If an electrostatic discharge occurs
after touching the monitor, the screen may icker and MTS temperature readings may be
inaccurate for a few seconds. The system will remain functional and the monitor will refresh
momentarily.
1.7.3.1 Thawing
For CX needles:
•Active thawing produces heat along the distal needle shaft. Use care to avoid thermal injury to
non-targeted tissues.
•Track ablation produces heat along the distal needle shaft and may warm the needle handle.
Use care to avoid thermal injury to non-targeted tissues. When conducting FastThaw or when
conducting Cautery for Track Ablation, be alert for the Active Zone Indicator as the needle is
withdrawn to prevent unintended tissue damage from the hot needle.
•If a needle appears to be blocked, press the Thaw button to thaw the needle for at least one
minute to clear the blockage.
For non-CX needles:
•If a needle without CX functionality is connected to the ICEfx System, active thawing is not
possible. Needle release from an iceball will only be achievable with passive thaw. Use image
guidance to ensure adequate thawing.
•If a needle without CX functionality appears to be blocked, wait for any formed ice to passively
thaw. Do not use the needle. Use a new needle to continue the procedure.

ICEfx™ Cryoablation System 1-9
1.7.4 After Use
•Depressurize the system after the cryoablation procedure is completed (reference Section 6.1).
•Warn people near the system about loud noise before manually depressurizing the system.
•Cut the needle and MTS tubing and dispose of the used needle and MTS in a biohazard
container in accordance with hospital and safety regulations.
•Clean the ICEfx Cryoablation System by following the instructions in Section 7.1. Do not use
cleaning agents such as Betadine or bleach solution, which may damage the touch screen.
•To avoid confusion at the beginning of a new procedure, ensure that the
o Vent Valve is closed
o Argon Shuto󰀨 Valve is in the ON position
1.8 Potential Adverse Events
Potential adverse events which may be associated with the use of cryoablation may be organ
specic or general and may include, but are not limited to abscess, adjacent organ injury, allergic/
anaphylactoid reaction, angina/ coronary ischemia, arrhythmia, atelectasis, bladder neck
contracture, bladder spasms, bleeding/hemorrhage, creatinine elevation, creation of false
urethral passage, cystitis, death, deep vein thrombosis (DVT), delayed/non healing, diarrhea,
disseminated intravascular coagulation (DIC), ecchymosis, edema/swelling, ejaculatory dysfunction,
erectile dysfunction (organic impotence), fever, stula, genitourinary perforation, glomerular
ltration rate elevation, hematoma, hematuria, hypertension, hypotension, hypothermia,
idiosyncratic reaction, ileus, impotence, infection, injection site reaction, myocardial infarction,
nausea, neuropathy, obstruction, organ failure pain, pelvic pain, pelvic vein thrombosis,
penile tingling/numbness, perirenal uid collection, pleural e󰀨usion, pneumothorax, probe site
paresthesia, prolonged chest tube drainage, prolonged intubation, pulmonary embolism, pulmonary
insu󰀩ciency/failure, rectal pain, rectourethral stula, renal artery/renal vein injury, renal capsule
fracture, renal failure, renal hemorrhage, renal infarct, renal obstruction, renal vein thrombosis,
scrotal edema, sepsis, skin burn/frostbite, stricture of the collection system or ureters, stroke,
thrombosis/thrombus/embolism, transient ischemic attack, tumor seeding, UPJ obstruction/
injury, urethral sloughing, urethral stricture, urinary stula, urinary frequency/urgency, urinary
incontinence, urinary leak, urinary renal leakage, urinary retention/oliguria, urinary tract infection,
vagal reaction, voiding complication including irritative voiding symptoms, vomiting, wound
complication, and wound infection.

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