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.