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SELF-TEST, PROBE DRIVER ATTACHMENT AND LDP INSERTION Final Trajectory Adjustment in Treat Insert AXiiiS workflow Final Trajectory Adjustment in Treat Insert Non-AXiiiS Workflow Probe Driver (APD and RPD) Attachment and Connections (if Applicable) Laser Delivery Probe (LDP) Size Selection and Insertion MRI CONFIRMATION OF LDP INSERTION THERMAL DELIVERY AND MONITORING (TREAT-TREAT WORKFLOW TASK) ENABLE THE MRI FOR REAL TIME TRANSFER Position Thermal Monitoring Planes in M*Vision Thermal Sequence Prescription on the MRI Initiate Thermal Monitoring in M*Vision ELECTRICAL RACK REQUIREMENTS AND TECHNICAL DATA TECHNICAL SUPPORT CONTACT INFORMATION DISTRIBUTOR/REP CONTACT: MANUFACTURED BY: TIPS AND TROUBLESHOOTING Patent Notice under 35 U.S.C.
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MRI CONDITIONAL STATUS MR IMAGE ARTIFACT POTENTIAL HARMS OR HAZARDS NEUROBLATE SYSTEM SETUP MRI PROTOCOLS AND DICOM IMAGE TRANSFER SETUP CO2 TANKS NEUROBLATE SYSTEM CONTROL WORKSTATION: NEUROBLATE SYSTEM M*VISION SOFTWARE APPLICATION M*Vision Software Concepts M*Vision Graphic User Interface (GUI) Layout Software Boot Up and Launch Screen Main Menu Bar Options Toolbar Description Hardware Interfaces MR Thermal Data Transfer Initiating Data Transfer Interface Thermal Monitoring Slice Planes NEUROBLATE SYSTEM PROCEDURE WORKFLOW PROCEDURE PRE-PLANNING M*Vision Software Start Screen Load and Register Image Data within Plan Register Task Create Region of Interest (ROI) Volumes within the Plan Volumes Task Create Intended Trajectories within the Plan Trajectory Task Saving a Plan Opening a Saved Plan OPERATING ROOM: PRE-PROCEDURE PREPARATION Sterile Probe Delivery Platform Anesthesia Head Fixation Image-Guided Surgery (IGS) System Registration (Non-Sterile) Prepping and Sterile Draping for Trajectory Guidance Devices IGS Registration (Sterile) LDP Delivery Platform Attachment Skull-Mounted Trajectory Devices such as AXiiiS Stereotactic Miniframe Skull Bone Anchor Create a Pathway to the Intended Target LDP Depth Determination IGS (Skull Bone Anchor Procedures) PREP FOR TRANSFER TO MRI INTERFACE PLATFORM (IP) ATTACHMENT/DETACHMENT TABLE OR ATAMA STABILIZATION SYSTEM TRAJECTORY CONFIRMATION AND BEAM FIDUCIAL MARKER DETECTION Scan and Register Data in M*Vision using Plan Register Task Create Region of Interest (ROI) Volumes within Plan Volumes Task Create Trajectories within Plan Trajectories Task - AXiiiS Create Trajectories within Plan Trajectories Task without AXiiiS Identify Beam Fiducial Marker within the Treat Align Task Ĥ 8.6. TABLE OF CONTENTS TABLE OF CONTENTS SYSTEM DESCRIPTION NEUROBLATE SYSTEM DESCRIPTION LASER DELIVERY PROBE (LDP) & PROBE DRIVER DESCRIPTIONS Laser Delivery Probes (LDP) SideFire Directional Laser Probe FullFire and FullFire Select Diffusing Tip Laser Probe Laser Delivery Probe Selection Advanced Probe Driver (APD) and Robotic Probe Driver (RPD) OPERATING MODES INDICATIONS FOR USE CONTRAINDICATIONS WARNINGS, CAUTIONS, & SAFETY REQUIREMENTS IDENTIFICATION LABELS EQUIPMENT LABELS GENERAL WARNINGS Electronics Rack Warnings Advanced Probe Driver, Robotic Probe Driver and LDP Warnings GENERAL CAUTIONS NeuroBlate System Laser Delivery Probes, Advanced Probe Driver and Robotic Probe Driver GENERAL SAFETY REQUIREMENTS LASER SAFETY INSPECTION, CLEANING, DISINFECTION, STERILIZATION OPERATING CONDITIONS STORAGE CONDITIONS ģ 5. Failure to do so may result in patient complications. Observe all contraindications, warnings and cautions noted in these directions. Carefully read all instructions prior to use. 2 INSTRUCTIONS FOR USE CAUTION Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.