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

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