Galil Visual-ICE MRI User manual

MRI CRYOABLATION SYSTEM
RXOnly
User Manual

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]

Visual-ICE™MRI 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 1-3
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
1.7.4 After Use 1-9
1.8 Potential Adverse Events 1-9
2 SYSTEM DESCRIPTION 2-1
2.1 Console 2-2
2.1.1 Touch Screen Monitor 2-4
2.1.2 Communication Ports 2-5
2.1.3 Mouse Track Pad 2-5
2.1.4 Storage Compartment 2-5
2.1.5 Software Reset 2-5
2.1.6 Power Control Knob 2-5
2.1.7 Auxiliary Display Port 2-6
2.1.8 Junction Box Harness Sockets 2-6
2.1.9 Brake Pedal 2-6
2.1.10ArgonShuto󰀨Valve 2-6
2.1.11 Gas Inlets 2-6
2.1.12ManualVentValve 2-6
2.2 Mobile Connection Panel 2-7
2.2.1 Needle Interface 2-8
2.2.1.1 Gas Pressure Indicator 2-9
2.2.1.2 STOP ALL Button 2-9
2.2.1.3 Test Channel 8 Button 2-9
2.2.1.4 Needle Channels 2-9
2.2.2 Junction Box Harness Sockets 2-10
2.2.3 Wheel Lock Levers 2-10
Table of Contents

ii User Manual
3 NAVIGATING THE USER INTERFACE 3-1
3.1 Login Screen 3-1
3.2 Startup Screen 3-2
3.3 Procedure Screen 3-3
3.3.1 Navigation Tool Bar 3-4
3.3.2 User-Selected Self Help 3-5
3.3.3 Channel Controls 3-5
3.3.4 Channel Status 3-7
3.3.5 Enlarge and Reposition Timers 3-7
3.4 ViewReports 3-8
3.5 CongureSettings 3-9
3.6 Service Screen 3-10
3.7 Remote Upload / Download 3-11
4 SYSTEM SETUP 4-1
4.1 Preparation for Use 4-1
4.2 Positioning the Mobile Connection Panel in the Magnet Room 4-2
4.3 Setting up the Console in the Control Room 4-2
4.4 Connecting Gas Cylinders 4-6
4.5 Connecting the Junction Box Harness in the Control Room 4-7
4.6 Connecting the Junction Box Harness in the Magnet Room 4-10
4.7 OpeningGasCylinderValves 4-11
5 PERFORMING THE CRYOABLATION PROCEDURE 5-1
5.1 Pre-Procedure Testing 5-2
5.2 Performing a Cryoablation Procedure 5-5
5.3 Reports 5-7
5.4 Changing Gas Cylinders during a Procedure 5-8
5.4.1 Standard Gas Cylinder Setup 5-8
5.4.2 Dual Gas Cylinder Connection 5-9
6 ADVANCED CONTROLS 6-1
6.1 Advanced Channel Controls 6-1
6.1.1 Select Needle Type Control 6-1
6.1.2 Link Channels Control 6-1
6.1.3 Cycle Programming Control 6-2
6.1.3.1 Running a Saved Sequence 6-4
7 SYSTEM SHUTDOWN 7-1
7.1 Shutting Down the System 7-1
8 ADMINISTRATIVE FUNCTIONS 8-1
8.1 CongureSettings 8-1
8.1.1 Manual Software Update 8-3
8.1.2 CongureEthernet 8-4
9 SYSTEM CARE and MAINTENANCE 9-1
9.1 Cleaning 9-1
9.1.1 CleaningtheVisual-ICEMRISystem 9-1
9.2 Service and Preventive Maintenance 9-1
9.3 System Disposal 9-1
9.4 Technical Information 9-1
10 TROUBLESHOOTING 10-1

Visual-ICE™MRI Cryoablation System iii
10.1 Software Recovery 10-1
10.2 Electronics, Electrical and User Error Related Issues 10-3
10.2.1 Replacing Fuses 10-4
10.3 Gas Issues 10-6
10.4 Mechanical Issues 10-9
10.5 Gas Cylinders and Gas Supply Lines 10-9
10.6 Junction Box Harnesses 10-10
10.7 Mobile Connection Panel 10-10
10.8 Needles 10-11
10.9 Displayed Messages 10-12
10.9.1 Login 10-12
10.9.2 Procedure 10-15
10.9.3 Gas 10-20
10.9.4 Software 10-21
10.9.5 Reports 10-24
10.9.6 System 10-25
10.9.7 Service 10-28
11 SYSTEM SPECIFICATIONS 11-1
11.1 Operating Conditions 11-1
11.2 Storage Conditions 11-1
11.3 Transportation Conditions 11-1
11.4MechanicalSpecications 11-1
11.4.1 Console 11-1
11.4.2 Mobile Connection Panel 11-1
11.5 External Gas Supply 11-2
11.6GasCylinderSpecications 11-2
11.7AccuracyofDisplayedValues 11-2
11.8ElectricalSpecications 11-2
11.8.1 MRI Conditional Safety 11-2
11.8.2 Electromagnetic Compatibility and Immunity (EMC and EMI) 11-3
11.9 Essential Performance 11-8
12 REFERENCES 12-1
12.1 Patents 12-1
12.2 Trademarks 12-1
12.3 Contact 12-1
13 DISCLAIMER OF WARRANTY 13-1

iv User Manual
List of Figures
Figure 2-1. Visual-ICE MRI System 2-1
Figure 2-2. Console Front View 2-3
Figure 2-3. Console Rear View 2-4
Figure 2-4. Monitor Storage Compartment 2-5
Figure 2-5. Mobile Connection Panel Front View 2-7
Figure 2-6. Needle Interface 2-8
Figure 2-7. Needle Channel 2-8
Figure 2-8. Mobile Connection Panel - Junction Box Harness Sockets 2-10
Figure 2-9. Mobile Connection Panel - Wheel Lock Lever 2-10
Figure 4-1. Visual-ICE MRI Console Gas Connections 4-6
Figure 4-2. Gas Cylinder Set-up 4-7
Figure 4-3. Connection of Junction Box Harness Gas Line 4-8
Figure 4-4. Connection of Junction Box Harness Fiber Optic Line 4-8
Figure 4-5. Connection of Junction Box Harness Electrical Line 4-9
Figure 4-6. EZ-Connect2 Dual Cylinder Adapter 4-12
Figure 5-1. Locking Needle into Channel 5-2
Figure 7-1. Disconnection of Junction Box Harness Electrical Line 7-2
Figure 7-2. Disconnection of Junction Box Harness Fiber Optic Line 7-2
Figure 7-3. Disconnection of Junction Box Harness Gas Line (Gas Connection Hub in
Unlocked Position) 7-3
Figure 7-4. Protective Covers 7-4

Visual-ICE™MRI Cryoablation System v
List of Tables
Table 3-1. Startup Screen Buttons 3-2
Table 3-2. Navigation Tool Bar 3-4
Table 3-3. Channel Controls 3-5
Table 3-4. Congure Settings Options 3-10
Table 4-1. System Setup Flow 4-1
Table 4-2. Working Gas Pressures 4-12
Table 5-1. Cryoablation Procedure Flow 5-1
Table 8-1. Congure Settings Controls 8-2
Table 11-1. Cable Lengths 11-3
Table 11-2. Electromagnetic Emissions 11-4
Table 11-3. Electromagnetic Immunity 11-5
Table 11-4. Electromagnetic Immunity for Systems that are Not Life-supporting 11-6
Table 11-5. Recommended separation distances between portable and mobile RF
communications equipment and the Visual-ICE MRI System 11-7

vi User Manual
List of Screens
Screen 3-1. Login Screen 3-1
Screen 3-2. Startup Screen 3-2
Screen 3-3. Procedure Screen 3-3
Screen 3-4. Navigation Tool Bar 3-4
Screen 3-5. Channel Controls and Channel Status Section 3-7
Screen 3-6. Enlarged Timer 3-7
Screen 3-7. Procedure Report Example 3-8
Screen 3-8. View Reports Screen 3-8
Screen 3-9. Export Report Screen 3-9
Screen 3-10. Congure Settings 3-10
Screen 3-11. Remote Upload / Download Screen 3-11
Screen 3-12. Successful Upload / Download 3-12
Screen 4-1. Disabled Channel 4-3
Screen 4-2. Vent Gas Message 4-3
Screen 4-3. Login Screen 4-4
Screen 4-4. Incorrect Login 4-4
Screen 4-5. Reset Password Challenge 4-5
Screen 4-6. Password Reset 4-5
Screen 4-7. Emergency Login 4-5
Screen 4-8. No Gas Connected message 4-12
Screen 5-1. Procedure Screen 5-2
Screen 5-2. Select Needle Type Menu 5-3
Screen 5-3. Gas Time Remaining 5-6
Screen 5-4. Export Report Screen 5-8
Screen 5-5. Report Exported message 5-8
Screen 6-1. Select Needle Type 6-1
Screen 6-2. Linked Channels 6-2
Screen 6-3. Advanced Cycle Controls 6-2
Screen 6-4. Cycle Sequence Controls 6-3
Screen 6-5. Saved Sequence Controls 6-4
Screen 8-1. Congure Settings 8-1
Screen 8-2. Software Update Conrmation 8-3
Screen 10-1. Software Recovery Screen 10-1
Screen 10-2. Invalid Conguration Message 10-2

Visual-ICE™MRI Cryoablation System vii
1
Catalog Number
1
Caution
1
Serial Number
1
Date of Manufacture
1
Manufacturer
2
MR Conditional
2
MR Unsafe
1
Temperature Limitation
1
Humidity Limitation
3
Do Not Push
1
Consult Instructions for Use
4
USB Port
4
Ethernet Port
5
Helium Gas
5
Argon Gas
4
Alternating Current
4
Protective Earth
3
Unsafe Voltage. Electrical
contacts greater than 40 V AC
3
Type BF Applied Part
3
Power Switch
3
Power O󰀨
3
Power On
1
Authorized Representative in
the European Community
6
Do Not Discard
Return to Galil Medical at end
of service life
Symbols

viii User Manual
7
ETL Product Listing Mark
9
Caution: Federal (USA) law
restricts this device to sale by
or on the order of a physician.
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. IEC 60878-3:2015 Graphical symbols for electrical equipment in medical practice
4. USB Implementors Forum, Inc. standard icon.
5. Symbols were created by Galil Medical based on the symbols for Helium and 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))
Explanation of MR Symbols
The following symbols are related to the magnetic resonance (MR) environment and are used to
indicate the safety of devices and components in the MR environment.
MR Conditional symbol. The Visual-ICE MRI Mobile Connection Panel, Junction
Boxes, and Junction Box Harnesses are MR Conditional.
MR Unsafe symbol. The Visual-ICE MRI Console is MR Unsafe.

Visual-ICE™MRI 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 Visual-ICE™MRI 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 Visual-ICE™ MRI Cryoablation System is a mobile system intended for cryoablative tissue
destruction using a minimally invasive procedure. The Visual-ICE MRI Cryoablation System has
been designed to permit the delivery of cryoablation treatments under visual guidance in an MR
environment. The system is computer-controlled with a touch screen user interface that allows
the user to control and monitor the procedure. The proprietary i-Flow™Technology controls the
system’s gas ow to maintain consistent gas ow rates for the strongest possible ice, and to
optimize performance for simultaneous activation of multiple needles. Innovative gas dryers produce
consistent iceballs and boost freezing performance for all needles.
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 Visual-ICE MRI Cryoablation System uses high-pressure argon gas that circulates through
closed-tip MRI 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 circulating high-pressure helium gas through the needles and exploiting its
negative Joule-Thomson coe󰀩cient.
When multiple MRI 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. 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 MRI, 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.

1-2 User Manual
1.2 How Supplied
The Visual-ICE MRI Cryoablation System is supplied non-sterile. Galil Medical accessory products
required to perform the cryoablation procedure are supplied separately.
1.2.1 Contents
•Visual-ICE MRI Cryoablation System:
o Visual-ICE MRI Cryoablation Console
o Visual-ICE MRI Cryoablation Mobile Connection Panel
•Visual-ICE MRI Cryoablation System User Manual: The User Manual describes the system
and provides instructions for system operation and maintenance.
•Visual-ICE MRI Cryoablation System Quick Reference Guide: The Quick Reference Guide
summarizes key steps in system 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 Visual-ICE MRI Console. Reference Table
11-1.
•High-pressure helium 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 helium cylinder to the Visual-ICE MRI Console. Reference Table
11-1.
•Junction Box Harnesses for Console and Mobile Connection Panel
The Junction Box Harnesses (one for the Console, one for the Mobile Connection Panel) are
used to connect to the junction boxes installed in the control and magnet rooms.
o To accommodate magnet and control room variations, Junction Box Harnesses are
available in alternative lengths to connect to the junction boxes in the magnet room
and control room (reference Table 11-1). The appropriate length is determined when
the junction boxes and penetration panel are installed. Junction Box Harnesses of the
appropriate length are shipped with the system.
•Console cover: Protects the Console from dust, water, and debris during storage and
transportation.
•Mobile Connection Panel cover: Protects the Mobile Connection Panel from dust, water, and
debris during storage and transportation.
•Ethernet cable (3 m): The Ethernet cable is used to connect the Visual-ICE MRI Console to
a Galil Medical remote server for uploading reports and diagnostic data and for downloading
software updates.
•Optional EZ-Connect2 Dual Cylinder Adapter: is an optional device used to connect two
gas cylinders in tandem to the Visual-ICE MRI 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 4.4 for instructions on using the EZ-Connect2 Adapter.

Visual-ICE™MRI Cryoablation System 1-3
1.2.2 Accessory Products Used to Conduct Cryoablation Procedures
The following items used with the Visual-ICE MRI Cryoablation System are sterile, single-use only
devices. Do not re-sterilize or reuse.
•Galil Medical MRI Cryoablation Needles: The Visual-ICE MRI System is used only with Galil
Medical MRI cryoablation needles. The MRI 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 MRI cryoablation needles are supplied sterile in
procedure kits or in needle kits.
NOTE: The Galil Medical MRI Cryoablation Needles are detailed in separate Instructions for Use.
•Cryoablation Needle Labels
The following items are needed to conduct cryoablation procedures and are not available from Galil
Medical.
•Argon gas cylinder(s)
•Helium gas cylinder(s)
NOTE: The argon and helium gases must meet the purity requirements specied in Section 11.5.
1.2.3 Storage
Store the Visual-ICE MRI 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 Visual-ICE MRI 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 Visual-ICE MRI 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 Visual-ICE MRI 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 Visual-ICE MRI 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 Visual-ICE MRI
Cryoablation System.

Visual-ICE™MRI Cryoablation System 1-5
1.6 Warnings
•Personnel present when making all connections prior to a cryosurgical procedure must be
completely familiar with all routine precautions taken in an MRI environment.
•The Visual-ICE MRI Cryoablation System Console is MR Unsafe. Never place the Console in the
magnet room.
• The Visual-ICE MRI Cryoablation Needles may heat up when the scanner RF eld is active.
Hazards associated with heating can be minimized by using scan sequences with low SAR and
limiting the duration of the scan. It is recommended that the scanner be operated in Normal
Operating Mode with a whole body averaged specic absorption rate (SAR) of ≤1.5 watts per
kilogram (W/kg). It is also recommended that the scan duration be limited to about one minute per
scan if the needle is not operating in freezing mode during the scan.
•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 start a cryoablation procedure before verifying that the Visual-ICE MRI 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 Visual-ICE MRI Cryoablation System if the system is visibly damaged, exposing
any internal components or sharp edges.
•Have su󰀩cient gas (argon / helium) 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 bracket on the Visual-ICE
MRI Console before connecting the gas supply line to the gas inlet. The safety cables provide
backup protection if the gas supply lines become inadvertently disconnected from the system.
•Conrm that the gas connections to the Console and the Mobile Connection Panel are securely
connected.
•Lock the wheels on the Visual-ICE MRI Mobile Connection Panel prior to using the system to
avoid inadvertent movement 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 from the Mobile Connection Panel while under
gas pressure.
•Do not unlock the locking bar for any needle channel if the GAS Pressure Indicator LED is solid
white. Unlocking the locking bars when the channels are under pressure could result in forceful
ejection of the needle connectors.
•Before the patient is anesthetized, the Needle Integrity and Functionality Tests on the MRI
cryoablation needles must be completed successfully to verify proper needle operation.
•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 Visual-ICE MRI Cryoablation System in any way. Only authorized Galil
Medical personnel or Galil Medical-trained authorized personnel are to service a Visual-ICE MRI
Cryoablation System.

1-6 User Manual
•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 Visual-ICE MRI Cryoablation System should not be operated in the presence of ammable
fumes, e.g., ammable anesthetics or volatile substances.
•The Visual-ICE MRI Cryoablation System should be inspected and serviced periodically
according to the system specications. Service must be performed by authorized service
engineers. Reference Section 9 for system care and maintenance information.
•An electrocautery device should never touch a needle or be in close proximity to them when the
needle is connected to the MCP.
1.7 Precautions
1.7.1 General
•Training on appropriate use of the Visual-ICE MRI 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 Visual-ICE MRI Cryoablation System is non-sterile. Contact with any part of the system 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.
•Do not use the Visual-ICE MRI 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 gas supply lines toward the oor and secure the lines with the clips
located on the rear of the Visual-ICE MRI Cryoablation Console to minimize the potential for
tripping.
•Direct the Junction Box Harnesses towards the oor to minimize the potential for tripping.
•Conrm that the Manual Vent Valve is closed before connecting the gas lines to the Console.
•Continuously monitor the cryoablation procedure using image guidance to ensure adequate
tissue coverage and to avoid damage to adjacent structures.
•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.
•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. The weight limit is 9 kg (20 lbs).
•Portable and mobile radiofrequency (RF) communications equipment can a󰀨ect the Visual-ICE
MRI Cryoablation System, causing it to operate improperly. Keep such equipment away from the
system (reference Section 11.8).
•Use only Galil Medical supplied components and accessories with the Visual-ICE MRI
Cryoablation System.

Visual-ICE™MRI Cryoablation System 1-7
•Use the Galil Medical USB ash drive only to export reports or update software. Other data or
software may corrupt the Visual-ICE MRI Cryoablation System.
•Do not connect any other USB equipment to the Visual-ICE MRI 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 Visual-ICE MRI
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 Visual-ICE MRI
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
•Maneuver the Visual-ICE MRI Console by pulling on the system using the rear handle.
•Maneuver the Visual-ICE MRI Mobile Connection Panel using the handles.
•Handle the Visual-ICE MRI Cryoablation System with care. Rough handling may damage the
system and cause it to become inoperable.
•Do not bend or kink the gas supply lines. Sharp bends or kinks may compromise the integrity of
the gas supply lines.
•Do not tilt the Visual-ICE MRI Cryoablation Console or Mobile Connection Panel.
•Lift the Visual-ICE MRI Console 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 Mobile Connection Panel using the handles to clear any obstacle, either ascending or
descending.
•Do not roll the Visual-ICE MRI Console over the gas supply lines; such activity may damage the
lines.
•The Visual-ICE MRI Cryoablation Mobile Connection Panel is non-sterile. When attaching MRI
cryoablation needles to the Mobile Connection Panel, do not contaminate the sterile eld or the
sterile MRI cryoablation needle. Avoid contact with the distal portion of the MRI cryoablation
needle.
•Position the Visual-ICE MRI Mobile Connection Panel 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.
•Use care to avoid electrostatic discharge (ESD) events when removing the covers from the
Visual-ICE MRI Cryoablation Console and Visual-ICE MRI Cryoablation Mobile Connection
Panel.
•Do not store liquids in the storage compartment of the Visual-ICE MRI Cryoablation Console.
The storage compartment is not water tight.

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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.
•While every e󰀨ort has been made to reduce imaging artifacts while using the needles within
the magnet bore, some artifacts may still be present (depending on the imaging resolution and
procedure).
•The Visual-ICE MRI Cryoablation Needles may heat up when the scanner RF eld is active.
Hazards associated with heating can be minimized by using scan sequences with low SAR and
limiting the duration of the scan. It is recommended that the scanner be operated in Normal
Operating Mode with a whole body averaged specic absorption rate (SAR) of ≤1.5 watts per
kilogram (W/kg). It is also recommended that the scan duration be limited to about one minute per
scan if the needle is not operating in freezing mode during the scan.
•If a scan with a high SAR level is performed while the needle is not freezing, hazards associated
with heating can be mitigated by selecting Stick mode from the Freeze Intensity drop-down
menu. When Stick is selected, argon gas is owed through the cryoablation needle at a low duty
cycle to create a very thin layer of ice around the needle shaft.
•Scanning with a high SAR sequence while thawing could result in thermal injury due to needle
heating.
•At the end of the freeze phase, the gas in the Junction Box Harnesses is vented through the
Console. The venting sound might be startling to people in the vicinity. The duration of venting
depends on the combined length of the two Junction Box Harnesses. A typical venting duration
after freezing is about 10 seconds.
•At the end of the thaw phase, the gas in the Junction Box Harnesses is vented through the
Console. The venting sound might be startling to people in the vicinity. A typical duration for
helium gas venting after thawing is about 3 seconds.
•Failure to operate the Visual-ICE MRI Cryoablation System within the working pressure limits
indicated on the user interface (Table 4-2) may a󰀨ect the cryoablation procedure.
•Needle handles and gas lines 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.
•The needle handle becomes cold during cryoablation. If the handle is in contact with skin, the
skin surface should be protected by warm saline irrigation or other means as determined by the
physician.
•The needle shaft becomes cold during cryoablation. Protect the patient’s skin by using warm
saline irrigation or other means as determined by the physician.
•Active thawing produces heat along the distal needle shaft. Use care to avoid thermal injury to
non-targeted tissues.
•Position the Visual-ICE MRI Mobile Connection Panel 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.
•If a needle appears to be blocked, press the Thaw button to thaw the needle for at least one
minute to clear the blockage.
•Take precautions to avoid potential electrostatic discharge. If an electrostatic discharge occurs
after touching the monitor, the screen may icker. The system will remain functional and the
monitor will refresh momentarily.

Visual-ICE™MRI Cryoablation System 1-9
1.7.4 After Use
•Depressurize the system after the cryoablation procedure is completed (reference Section 7.1).
•Warn people near the system about loud noise before manually depressurizing the system.
•Do not unlock the locking bar for any needle channel if the GAS Pressure Indicator LED is solid
white. Unlocking the locking bars when the channels are under pressure could result in forceful
ejection of the needle connectors.
•Cut the needle and dispose of the used needle in a biohazard container in accordance with
hospital and safety regulations.
•Clean the Visual-ICE MRI Cryoablation System by following the instructions in Section 9.1. 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 Manual Vent Valve is closed
o Argon Shuto󰀨 Valve is in the GAS 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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