BTG Visual-ICE User manual

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™ Cryoablation System i
Table of Contents i
List of Figures iv
List of Tables v
List of Screens vi
Symbols ix
1 SYSTEM OVERVIEW 1-1
1.1 Brief Description 1-1
1.2 Intended Use 1-2
1.3 How Supplied 1-2
1.3.1 Contents 1-2
1.3.2 Accessory Products Used to Conduct Cryoablation Procedures 1-3
1.3.3 Storage 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 1-7
1.7.4 After Use 1-8
1.8 Potential Adverse Events 1-9
2 SYSTEM DESCRIPTION 2-1
2.1 Touch Screen Monitor 2-3
2.2 Communication Ports 2-4
2.3 Mouse Track Pad 2-4
2.4 Storage Compartment 2-4
2.5 Brake Pedal 2-5
2.6 ArgonShuto󰀨Valve 2-5
2.7 Gas Inlets 2-5
2.8 ManualVentValve 2-5
2.9 Needle Connection Panel 2-6
2.9.1 MTS Connection Ports 2-6
2.9.2 Software Reset 2-7
2.9.3 Power Control Knob 2-7
2.9.4 Needle Channels 2-7
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 Context Sensitive Help 3-5
3.3.3 User-Selected Self Help 3-5
3.3.4 Channel Controls 3-5
3.3.5 Channel Status 3-7
Table of Contents

ii User Manual
3.3.6 Enlarge and Reposition Timers 3-8
3.3.7 Temperature Sensors 3-9
3.3.8 Organ Map 3-10
3.4 ViewReports 3-12
3.5 CongureSettings 3-14
3.6 Service Screen 3-15
3.7 Remote Upload / Download 3-15
4 SYSTEM OPERATION 4-1
4.1 Preparation for Use 4-1
4.1.1 System Set-up 4-2
4.1.2 Connecting Gas Cylinders 4-6
4.1.3 Gas Line Flushing 4-9
4.1.4 Pre-Procedure Testing 4-10
4.2 Performing a Cryoablation Procedure 4-14
4.3 Reports 4-16
4.4 System Shutdown 4-18
4.5 Changing Gas Cylinders during a Procedure 4-19
4.5.1 Standard Gas Cylinder Setup 4-19
4.5.2 Disconnecting a Helium Cylinder 4-19
4.5.3 Dual Gas Cylinder Connection 4-20
4.6 Advanced Thaw Controls 4-20
4.6.1 i-Thaw and FastThaw Control for CX-type Needles 4-20
4.6.2 Cautery Control for Track Ablation 4-22
4.6.2.1 Cautery Control for 1.5 CX Needles 4-22
4.6.2.2 Cautery Control for 2.1 CX Needles 4-24
4.7 Advanced Channel Controls 4-25
4.7.1 Select Needle Type Control 4-25
4.7.2 Link Channels Control 4-25
4.7.3 Cycle Programming Control 4-26
4.8 Advanced Temperature Sensor Controls 4-29
5 ADMINISTRATIVE FUNCTIONS 5-1
5.1 CongureSettings 5-1
5.1.1 Manual Software Update 5-4
5.1.2 CongureEthernet 5-4
6 SYSTEM CARE and MAINTENANCE 6-1
6.1 System Installation 6-1
6.2 Cleaning 6-1
6.2.1 CleaningtheVisual-ICESystem 6-1
6.2.2 Cleaning the Stylus 6-1
6.3 Service and Preventive Maintenance 6-1
6.4 Technical Information 6-2
6.5 System Disposal 6-2
7 TROUBLESHOOTING 7-1
7.1 Software Recovery 7-1
7.2 Electronics, Electrical and User Error Related Issues 7-3
7.2.1 Replacing Fuses 7-4

Visual-ICE™ Cryoablation System iii
7.3 Gas Issues 7-6
7.4 Mechanical Issues 7-9
7.5 Gas Cylinders and Gas Supply Lines 7-9
7.6 Needles 7-10
7.7 Displayed Messages 7-11
8 SYSTEM SPECIFICATIONS 8-1
8.1 Operating Conditions 8-1
8.2 Storage Conditions 8-1
8.3 Transportation Conditions 8-1
8.4 MechanicalSpecications 8-1
8.5 External Gas Supply 8-1
8.6 GasCylinderSpecications 8-2
1.1 AccuracyofDisplayedValues 8-2
8.7 ElectricalSpecications 8-2
8.7.1 Electromagnetic Compatibility and Immunity (EMC and EMI) 8-2
9 REFERENCES 9-1
9.1 Patents 9-1
9.2 Trademarks 9-1
9.3 Contact 9-1
10 DISCLAIMER OF WARRANTY 10-1

iv User Manual
List of Figures
Figure2-1.Visual-ICECryoablationSystemFrontView 2-2
Figure2-2.Visual-ICECryoablationSystemRearView 2-3
Figure 2-3. Monitor Storage Compartment 2-4
Figure2-4.Visual-ICECryoablationSystemNeedleConnectionPanel 2-6
Figure2-5.Visual-ICECryoablationSystemNeedleChannel 2-6
Figure4-1.Visual-ICESystemGasConnections 4-6
Figure 4-2. Gas Cylinder Set-up 4-7
Figure 4-3. EZ-Connect2 Dual Cylinder Adapter 4-8
Figure 4-4. Locking Needle into Channel 4-11
Figure 4-5. MTS Connection 4-14

Visual-ICE™ 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. Organ Map Controls 3-11
Table3-5.CongureSettingsOptions 3-14
Table 4-1. Cryoablation Procedure Flow 4-1
Table 4-2. Working Gas Pressures 4-9
Table5-1.CongureSettingsControls 5-1
Table 8-1. Cable Lengths 8-3
Table 8-2. Electromagnetic Emissions 8-3
Table 8-3. Electromagnetic Immunity 8-4
Table 8-4. Electromagnetic Immunity for Systems that are Not Life-supporting 8-5
Table 8-5. Recommended separation distances between
portableandmobileRFcommunicationsequipmentandtheVisual-ICESystem 8-6

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. Active Thaw Channel Status section 3-7
Screen 3-7. Needle Tip Temperature Display 3-7
Screen 3-8. Enlarged Timer 3-8
Screen 3-9. Repositioned Enlarged Timers 3-8
Screen 3-10. Temperature Sensors section 3-9
Screen 3-11. Organ Map section 3-10
Screen 3-12. Procedure Report Example 3-12
Screen3-13.ViewReportsScreen 3-13
Screen 3-14. Export Report Screen 3-13
Screen3-15.CongureSettings 3-14
Screen 3-16. Remote Upload / Download Screen 3-16
Screen 3-17. Successful Upload / Download 3-16
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 4-9
Screen 4-9. Optimizing Lines message 4-10
Screen 4-10. Procedure Screen 4-10
Screen 4-11. Thawing Mode message 4-11
Screen 4-12. Needle Past Expiration Date message 4-12
Screen 4-13. Select Needle Type Menu 4-12
Screen 4-14. Gas Time Remaining 4-15
Screen 4-15. Export Report screen 4-17
Screen 4-16. Report Exported message 4-17
Screen 4-17. Advanced Thaw Controls FastThaw 4-20
Screen 4-18. Advanced Thaw Controls i-Thaw 4-21
Screen 4-19. Advanced Thaw - Needle Warming 4-21
Screen 4-20. Advanced Thaw - Temperature Display During Thawing 4-22
Screen4-21.CauteryConrmationmessage 4-23
Screen 4-22. 1.5 CX Needle Warming 4-23
Screen 4-23. 1.5 CX Needle Cautery In Progress 4-23
Screen 4-24. Advanced Channel Controls 4-25
Screen 4-25. Linked Channels 4-25
Screen 4-26. Advanced Cycle Controls 4-26
Screen 4-27. Cycle Sequence Controls 4-27
Screen 4-28. Saved Sequence Controls 4-28

Visual-ICE™ Cryoablation System vii
Screen 4-29. Advanced Temperature Sensor Controls 4-29
Screen5-1.CongureSettings 5-1
Screen5-2.SoftwareUpdateConrmation 5-4
Screen 7-1. Software Recovery Screen 7-1
Screen7-2.InvalidCongurationMessage 7-2

viii User Manual
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Visual-ICE™ Cryoablation System ix
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
3
Do Not Push
5
Helium Gas
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
Symbols

x User Manual
only8
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. USB Implementors Forum, Inc. standard icon.
4. IEC TR 60878-3: 2015 Graphical symbols for electrical equipment in medical practice
5. Symbols 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))

Visual-ICE™ 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™ 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 Cryoablation System is a mobile 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 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 System uses high-pressure argon gas that circulates through closed-tip cryoablation
needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through
the needles or, alternatively, by the use of a heating element inside the cryoablation needle which
can be energized to cause thawing (i-Thaw™ Technology). The Visual-ICE System also controls the
heating element inside CX-type needles to provide active helium-free thawing (i-Thaw or FastThaw™)
and track ablation (Cautery).
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 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
via 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 tip temperature display for CX-type needles provides a visual means to monitor needle
performance.
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.

1-2 User Manual
1.2 Intended Use
The Galil Medical Visual-ICE 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 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.
1.3 How Supplied
The Visual-ICE System is supplied non-sterile. Galil Medical accessory products required to perform
the cryoablation procedure are supplied separately.
1.3.1 Contents
•Visual-ICE Cryoablation System
•Visual-ICE Cryoablation System User Manual: The User Manual describes the system and
provides instructions for system operation and maintenance.
•Visual-ICE 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 Console. Reference Table 8-1.
•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 Console. Reference Table 8-1.
•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 long gas supply line with system
connection, short gas supply line with cylinder connection. Reference 4.5.3 for instructions on
using the EZ-Connect2 Adapter.
•Console cover: Protects the Console 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.

Visual-ICE™ Cryoablation System 1-3
1.3.2 Accessory Products Used to Conduct Cryoablation Procedures
The following items used with the Visual-ICE System are sterile, single-use only devices. Do not re-
sterilize or reuse.
•Galil Medical Cryoablation Needles: The Visual-ICE 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.
•Cryoablation Needle 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. The cryoablation needles and MTS are supplied sterile
in procedure kits or in needle kits.
•Galil Medical Urethral Warming Set: The single use, disposable Urethral Warming Set is the
conduit that circulates warm saline through the urethra during a prostate cryoablation procedure.
•CIVCO Percutaneous Instrument Template
The following items used with the Visual-ICE System are re-usable and should be cleaned and/or
sterilized in accordance with the Instructions for Use that accompanies each product.
•Galil Medical Prostate Procedure Template: The Prostate Procedure Template is used to
guide needle placement during a prostate cryoablation procedure.
•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)
•Helium gas cylinder(s) if using helium for thawing
NOTE: The argon and helium gases must meet the purity requirements specied in Section 8.4.
•A uid warmer and pump system when using the Galil Medical Urethral Warming Set
Galil Medical recommends the use of a sterile drape (customer supplied) to cover the touch screen if
the system will be operated by members of the sterile team.
1.3.3 Storage
Store the Visual-ICE System in a cool, dry, secure location. Storage conditions should be within
-15°C to +50°C and 10% to 90% relative humidity.

1-4 User Manual
1.4 Indications
The Visual-ICE 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 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, hemorroids, 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, and hemorroids
1.5 Contraindications
There are no known contraindications specic to the use of the Galil Medical Visual-ICE Cryoablation
System.

Visual-ICE™ 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 a Visual-ICE Cryoablation System near magnetic resonance imaging (MRI)
equipment.
•Do not start a cryoablation procedure before verifying that the Visual-ICE 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 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
System 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.
•Lock the wheels on the Visual-ICE System 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 from the system while under gas pressure.
•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 chassis of the Visual-ICE Cryoablation System 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 Visual-ICE Cryoablation System in any way. Only authorized Galil Medical
personnel or Galil Medical-trained authorized personnel are to service a Visual-ICE 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 Visual-ICE Cryoablation System should not be operated in the presence of ammable fumes,
e.g., ammable anesthetics or volatile substances.
•The Visual-ICE Cryoablation System should be inspected and serviced periodically according
to the system specications. Service must be performed by authorized service engineers.
Reference Section 6 for system care and maintenance information.

1-6 User Manual
1.7 Precautions
1.7.1 General
•Training on appropriate use of the Visual-ICE 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 System and the user interface are non-sterile. Contact with any part of the
system or the user interface 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 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 System to minimize the potential for tripping.
•Conrm that the Manual Vent Valve is closed before connecting the gas lines to the system.
•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 Visual-ICE 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. The weight limit is 9 kg (20 lbs).
•Portable and mobile radiofrequency (RF) communications equipment can a󰀨ect the Visual-ICE
Cryoablation System, causing it to operate improperly. Keep such equipment away from the
system (reference Section 8.7).
•Use only Galil Medical supplied components and accessories with the Visual-ICE System.
•Do not connect any other USB equipment to the Visual-ICE Cryoablation System USB port.
•Use Galil Medical USB ash drive only to export reports or update software. Other data or
software may corrupt the Visual-ICE System.

Visual-ICE™ Cryoablation System 1-7
•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 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
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 System by pulling on the system using the rear handle.
•Handle the Visual-ICE 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 Cryoablation System.
•Lift the Visual-ICE 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.
•Do not roll the Visual-ICE System over the gas supply lines; such activity may damage the lines.
•The Visual-ICE Cryoablation System is non-sterile. When attaching cryoablation needles to the
system, do not contaminate the sterile eld or the sterile cryoablation needle. Avoid contact with
the distal portion of the cryoablation needle.
•Position the Visual-ICE 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.
•Use care to avoid electrostatic discharge (ESD) events when removing the cover from the Visual-
ICE System. Galil Medical recommends that the operator touch one or more metal parts on the
rear of the system prior to touching anything on the Needle Connection Panel.
•Do not store liquids in the storage compartment. The storage compartment is not water tight.
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 Visual-ICE System within the working pressure limits indicated on the user
interface (Table 4-2) may a󰀨ect the cryoablation procedure.
•Needle handles frost during freezing. Avoid prolonged contact with frosted portions of a needle
handle to avoid unintended thermal tissue damage to the patient or clinician.

1-8 User Manual
•Position the Visual-ICE 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.
•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.
•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.
1.7.4 After Use
•Depressurize the system after the cryoablation procedure is completed (reference Section 4.4).
•Warn people near the system about loud noise before manually depressurizing the system.
•Cut the needle and MTS tubing and dispose of used needle and MTS in a biohazard container in
accordance with hospital and safety regulations.
•Clean the Visual-ICE System per the instructions in Section 6.2. 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