Insightec Exablate 2100V1

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SYSTEM OVERVIEW

Manual Part Number

● Number of phases: Input 3-phase (5 wire)

● Rated power frequency: 50/60Hz

● Rated power input: ~10Kva

● Protection against electric shock: Applied Part Type BF

◼ Exablate Table Specifications:

● Dimensions (L x W x H): 231±1 x 65±1 x 110.5±1 cm

● Height in lowest position: 90cm

● Weight: 230Kg

◼ Cleaning and High-Level Disinfection Cart Specifications:

● Dimensions (L x W x H): 80±1 x 58±1 x 118±1 cm

● Net weight: 25Kg

● Full weight (with liquids): 39Kg

Main Page

Table of Contents4
System Overview13
Introduction13
Document Conventions13
Scope of this Manual13
System Components16
Operating Console16
Patient Table16
Figure 1-1: Operating Console of 2100V116
Figure 1-2: the Patient Table of Exablate 2100V117
Figure 1-3: a Closer Look on the Patient Table17
Figure 1-4: Exablate Prostate Probe17
Positioner18
Probe Shell18
Transducer18
MR Tracking Coils18
Robotic Motion Unit19
Probe Preparation Station19
Figure 1-5: Probe in Preparation Station19
Patient Legs Support20
Figure 1-6: Patient Leg Support20
Equipment Cabinet21
Figure 1-7: Exablate Prostate Equipment Cabinet21
Water System22
Figure 1-8: Exablate Prostate Cooling Unit (2100V1 Forward Production)23
Figure 1-9: Exablate Prostate Secondary Water Circuit23
Power Distribution Unit (PDU)24
Figure 1-10: Exablate Prostate Water System Display24
Figure 1-11: Exablate Prostate Console24
Cleaning and High-Level Disinfection (HLD) Cart25
Exablate Prostate Accessory List25
Figure 1-12: Cleaning and High-Level Disinfection Cart25
Safety27
Exablate Safety Considerations27
Use of Exablate System Within the MRI Environment28
Use of MR Equipment28
System Service28
Symbols Used in the System28
Safety Instructions32
MR Coils33
Patient Positioning33
Patient Protection33
Patient Emergencies35
Patient Emergency Release35
System Stability36
Water System Precautions37
Temperature Rise Precautions37
Balloon Volume Precautions37
Operator Precautions38
System Security and Malware Protection39
Electromagnetic Compatibility (EMC) Precautions40
Summary of EMC Test Results41
Cyber-Security42
Cyber-Security Related Precautions42
Cyber-Security Related Notes and Instructions43
Environmental Requirements44
Getting Strted45
System Power on45
Probe Preparation for Treatment49
Patient Preparatory Procedures51
Patient Positioning and Probe Insertion51
Patient Release54
Shutdown54
Daily Quality Assurance (DQA) Test Procedure55
DQA Set up Procedure55
Storage and Maintenance of the DQA Phantom Gel57
System Start-Up58
Start-Up Screen58
Treatment Options58
Figure 4-1: Start-Up Screen58
Start Treatment59
Command Buttons59
Status Bar59
Figure 4-2: Device and MR Status Bar59
Begin Treatment Procedure60
Figure 4-3: Treatment Data Dialog Box60
Treatment Tools61
Treatment Tools - Overview61
Treatment Screen61
Figure 5-1: Treatment Screen61
Exablate Main Toolbar62
Treatment Stages62
Planning Stage62
Figure 5-2: the Exablate Main Toolbar62
Treatment Stage63
Evaluation Stage63
Information Area63
Utilities63
Image Strips63
Selected Image Window64
Imaging Tools64
Overlays66
Navigation Tools67
Image Overlays68
Image Annotations68
Cursor Coordinates68
Figure 5-3: Cursor Coordinates68
Shadow Cursor69
Three-Dimensional Display69
Figure 5-4: Three-Dimensional Display Screen69
Planning Stage71
Planning Stage - Overview71
Planning Stage General Action Elements72
Figure 6-1: Planning Screen72
Baseline Thermometry73
Positioning Verification73
Validate Treatment Envelope Coverage74
Figure 6-2: Treatment Envelope (Blue) Displayed on Sagittal Positioning Image (Left) and on Axial Positioning74
Acquire Calibration Scans75
Verify Acoustic Coupling75
Approve Positioning77
Acquisition of MR Planning Images77
Figure 6-3: Air Bubbles as Seen in a Bubble Detection Scan77
User Interface Elements78
Define the Scanning Range78
Automatic Acquisition of Planning Images79
Figure 6-4: Scan Range Lines79
Manual Acquisition of MR Planning Images80
Reformat of Axial Planning Images81
Figure 6-5: Planning Stage - Loading Form81
Loading Additional Planning Images (Optional)82
User Interface Elements82
Loading Prior Exams (Optional)83
Acquisition of Baseline Anatomy Scans83
User Interface Elements84
Defining a Treatment Plan84
Action Tools85
Draw the Rectal Wall85
Draw the Prostate Capsule86
Define the Region of Treatment (ROT)87
Automatic Balloon Boundaries Detection88
Draw Limited Energy Density Regions (Ledr's) - Optional90
Figure 6-6: Balloon Boundaries (Yellow Arc)90
Selecting a Treatment Protocol (Optional)92
Figure 6-7: Planning Images with Drawing Overlays (Left - Axial, Right - Coronal)92
Figure 6-8: Treatment Protocol Control92
Changing Treatment Protocol Parameters93
Figure 6-9: Treatment Protocol Dialog93
System Preset Treatment Protocols96
Re-Draw / Dose Transfer (Optional)97
Acquiring New Planning Images97
Dose Transfer Procedure97
Figure 6-10: Dose Transfer Procedure98
Advancing to Treatment Stage99
Treatment Stage100
Overview100
Treatment Stage Main Screen101
Action Tools101
Figure 7-1: Treatment Stage Main Screen101
Treatment Modes102
Spot Parameters Frame102
Scan Parameters Frame103
General Parameters Frame104
Treatment Parameters Frame104
Spot Colors105
Current and Previous Anatomy Scans105
Automatic Movement Detection106
Deformation Mode108
Figure 7-2: Movement Detection Fiducials108
Handling Probe Movements110
Thermal Evaluation Screen111
Image Strips111
Thermal Evaluation Action Tools112
Continue Treatment Tools113
Temperature Scaling Tools113
Measured Sonication Parameters Indicators114
Temperature Graph114
Acoustic Spectrum115
Treatment Procedure115
General Sonication Flow115
Adding a New Sonication Spot118
Geometric Verification (Align Mode)119
Perform a Geometric Verification Sonication119
Geometric Adjustment120
Thermal Dose Verification (Treat Mode)123
Performing Macro-Spot Sonications126
Repeat Under-Heated Regions (Optional)129
Conclusion of the Treatment Session132
Evaluation Stage133
Overview133
Action Tools134
Automatic Evaluation Scan Acquisition134
Manual Evaluation Scan Acquisition135
Volume Measurement135
Exit Evaluation Stage135
Replay Stage136
Overview136
Replay Action Tools137
Exit Replay137
Utilities138
Overview138
Utilities Action Tools138
Utilities Procedures139
Select Exam139
Setup MR Protocols140
Optimize Coil Signal140
Turn System Hardware On/Off140
Connect/Disconnect to the Site Network141
Change Macro-Spot Planner Configuration141
Copyright Notice142
Exit Utilities142
Data Management143
Overview143
Selecting a Patient144
Action Tools144
Export to CD or USB Storage Device145
Import Treatment Records from CD or USB Storage Device146
Screen Dump to CD or USB Storage Device146
Erase Selected Treatment Record146
Technical Export to CD or USB Storage Device147
Download MR Images147
External Database (Optional)149
Action Tools149
Select Database150
Delete Complete Treatment Record150
Records Management150
Exit Data Management150
Appendix A. Advanced Option Mode151
Overview151
Sonication Parameters152
MR Scan Parameters153
Changing MR Parameters153
Profile Parameters Elements154
Parameter Settings155
APPENDIX B. WATER SYSTEM CLEANING and HIGH-LEVEL DISINFECTION Overview156
Water System Troubleshooting156
Handling Water System Errors156
Water System Troubleshooting Table156
Appendix C. High-Level Disinfection Procedure159
Introduction159
List of Materials Required for Cleaning159
HLD Procedure160
Cleaning and Disinfection Cart Preparation160
Post-Treatment Procedure161
Probe Cleaning161
Probe Disinfection162
Probe Rinsing163
Post-HLD163

Insightec Exablate 2100V1 - Page 15

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