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))