1. SYSTEM OVERVIEW 13
1.1. Introduction .................................................................................................................................. 13
1.2. Document Conventions ................................................................................................................ 13
1.3. Scope of This Manual ................................................................................................................... 13
1.4. System Components ..................................................................................................................... 16
1.4.1. Operating Console ..................................................................................................................... 16
1.4.2. Patient Table ............................................................................................................................. 16
1.4.2.1. Positioner ....................................................................................................................... 18
1.4.2.2. Probe Shell ..................................................................................................................... 18
1.4.2.3. Transducer ..................................................................................................................... 18
1.4.2.4. MR Tracking Coils ........................................................................................................... 18
1.4.2.5. Robotic Motion Unit ...................................................................................................... 19
1.4.2.6. Probe Preparation Station ............................................................................................. 19
1.4.2.7. Patient Legs Support ...................................................................................................... 20
1.4.3. Equipment Cabinet .................................................................................................................... 21
1.4.4. Water System ............................................................................................................................ 22
1.4.5. Power Distribution Unit (PDU) ................................................................................................... 24
1.4.6. Cleaning and High-Level Disinfection (HLD) Cart ....................................................................... 25
1.5. Exablate Prostate Accessory List ................................................................................................... 25
2. SAFETY 27
2.1. Exablate Safety Considerations .................................................................................................... 27
2.1.1. Use of Exablate System within the MRI Environment................................................................ 28
2.1.2. Use of MR Equipment ................................................................................................................ 28
2.1.3. System Service ........................................................................................................................... 28
2.2. Symbols Used in the System ......................................................................................................... 28
2.3. Safety Instructions ........................................................................................................................ 32
2.3.1. MR Coils ..................................................................................................................................... 33
2.3.2. Patient Positioning..................................................................................................................... 33
2.3.3. Patient Protection ..................................................................................................................... 33
2.3.4. Patient Emergencies .................................................................................................................. 35
2.3.4.1. Patient Emergency Release ............................................................................................ 35
2.3.5. System Stability ......................................................................................................................... 36
2.4. Water System Precautions ........................................................................................................... 37