BRAINLAB
CRANIAL ENT Software User Guide Vol 1-2 Rev 1.2
Software User Guide
394 Pages
Preview
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CRANIAL ENT Version 2.1
Software User Guide, Volume 1/2 Revision 1.2 Copyright 2011, Brainlab AG Germany. All rights reserved.
TABLE OF CONTENTS
TABLE OF CONTENTS GENERAL INFORMATION... 13 Chapter Overview... 13 Contents... 13
Contact Data and Legal Information... 14 Contact Data... 14 Legal Information... 15
Symbols... 16 Symbols Used in This Guide... 16
Intended Use... 17 Using the System... 17
Compatibility with Medical Devices... 20 Brainlab Medical Instruments... 20 Brainlab Software... 21 Non-Brainlab Medical Devices... 22 Non-Brainlab Software... 24
Training and Documentation... 25 Training... 25 Documentation... 26
SYSTEM SETUP... 27 Chapter Overview... 27 Contents... 27
Setting up the System... 28 Overview... 28 Camera Positioning... 29
SOFTWARE OVERVIEW... 31 Chapter Overview... 31 Contents... 31
Introduction... 32 Overview... 32
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TABLE OF CONTENTS
Beginning a Session... 33 Starting the Software... 33 Fusing Images... 34
Shutting Down and Restoring a Session... 39 Closing the Software and Shutting Down the System... 39 Restoring a Session... 40
User Interface... 41 Main Screen... 41 Menu Bar Functions... 43 General Dialog Buttons... 47 Toolbar Functions for Data Management... 48 Dialog Display Using Two Monitors... 49
Tracking System... 50 Tracking Status Displays... 50 Tracking Instruments... 53 Camera Positioning... 54
System Information and Configuration... 55 Overview... 55 Adjusting Settings... 56 Configuring a Video Connection... 59
REGISTRATION OVERVIEW... 63 Chapter Overview... 63 Contents... 63
Introduction... 64 Overview... 64 Preparation for Registration... 66 Restoring a Previous Registration... 68
STANDARD REGISTRATION... 69 Chapter Overview... 69 Contents... 69
Introduction to Standard Registration... 70 Overview... 70 Registration Instruments and Software Cues... 72 Activating Standard Registration... 73
Planning Registration Points... 74 Overview... 74 Planning Sphere Markers... 75 Planning Donut Markers... 78
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Additional Features for Registration Points Planning... 81
Unsequential and Sequential Registration... 83 Performing Unsequential Registration... 83 Performing Sequential Registration... 85
Registration Precision... 87 Overview... 87 Verifying Precision... 88 Verifying Accuracy: Overview of Advanced Features... 89 Detailed Registration Accuracy Information... 90
SURFACE MATCHING REGISTRATION... 93 Chapter Overview... 93 Contents... 93
Introduction to Surface Matching Registration... 94 Overview... 94 Surface Matching Registration Workflow Options... 96
Activating Surface Matching Registration... 97 Selecting Registration and Verifying the Scannable Surface... 97 Adjusting Threshold Settings and Image Set Selection... 100
Softouch Registration... 102 Performing Softouch Registration... 102
z-touch Registration... 104 Performing z-touch Registration... 104
Guided Registration... 106 Using Guided Registration... 106
Surface Matching Registration Precision... 111 Overview... 111 Verifying Precision: Standard Procedure... 112 Verifying Accuracy: Overview of Advanced Features... 114 Verifying Accuracy Using Advanced Features... 115
Guidelines for z-touch Registration... 116 Ensuring Successful z-touch Registration... 116 Additional Point Acquisition... 118 Effects of Scan Areas on Accuracy... 121
INTRAOPERATIVE LANDMARK REGISTRATION... 123 Chapter Overview... 123 Contents... 123
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TABLE OF CONTENTS
Introduction... 124 Overview... 124 Registration Instruments and Software Guidance... 125
Acquiring and Registering Intraoperative Landmarks... 126 Acquiring Intraoperative Landmarks... 126 Registering Intraoperative Landmarks... 128
CONFIGURING VIEWS... 131 Chapter Overview... 131 Contents... 131
Navigation Views... 132 Overview... 132 Magnifying Images... 136
Configuring Main Screens... 137 Overview... 137 Preconfigured Layouts... 139 Custom Layouts... 142 Image Orientation... 143 View Orientation... 144
Configuring Individual Views Using the Eye Icon... 145 Configuring Individual Views... 145
Assigning 2D and 3D Images for Individual Views... 147 2D Views... 147 3D Views... 151
Defining Other Individual Views... 159 Selecting Views... 159 Displaying Video Views... 160 Auto-Pilot View... 161
Defining Image Settings... 163 Selecting Image Sets... 163 Adjusting Windowing... 164 Viewing Image Set Properties... 166 Adjusting Image Set Alignment... 167
IMAGE FUSION... 169 Chapter Overview... 169 Contents... 169
Introduction... 170 Overview... 170
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Fusing Image Sets... 171 Creating a New Image Fusion... 171 Modifying an Image Fusion... 173
GENERAL NAVIGATION FUNCTIONS... 175 Chapter Overview... 175 Contents... 175
Accuracy Checks... 176 Overview... 176 Verifying the Pointer and Softouch... 178
Screenshots... 179 Taking and Viewing Screenshots... 179
Objects and Overlays... 181 Overview... 181 Objects... 183 Fiber Objects... 185 Object Shift... 187 Overlays... 190 Managing Objects and Overlay in Individual Views... 193
Points and Trajectories... 194 Point and Trajectory Acquisition... 194 Managing Points... 196 Ultrasound Landmarks... 202 Managing Trajectories... 203 Display Options for Points and Trajectories... 208
Freeze and Target... 209 Using Freeze and Target Modes... 209
Measurement Functions... 210 Accessing Measurement Functions... 210 Displaying a Ruler... 211 Displaying Distances... 212
Tooltip Offset... 213 Setting a Tool Tip Offset... 213
Instrument Settings... 216 Accessing Instrument Settings... 216 Pivoting Detection... 217 3D Tools... 218 Big Instrument Crosshair... 219
INDEX... 221 Software User Guide Rev 1.2 Cranial/ENT Ver 2.1
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TABLE OF CONTENTS
CALIBRATING INSTRUMENTS... 241 Chapter Overview... 241 Contents... 241
Introduction to Calibration... 242 Overview... 242 Handling Instrument Adapters... 244 Activating Calibration... 245 Restoring a Calibration... 246
Calibration Using the Reference Array... 247 Introduction... 247 Instrument Axis... 248 Performing Calibration... 249
Calibration Using the ICM4... 251 Overview... 251 Instrument Axis... 252 Calibration and Verification Using Pivot Points... 254 Calibration and Verification Using Receptacles (Holes)... 255 Calibration and Verification Using the V-Inset (Notch)... 257 Calibrating Suction Tubes... 259
Precalibrated Instruments... 260 Loading Precalibrated Instruments... 260
Accessing Calibrated Instruments... 262 After Calibration... 262
EXTERNAL ULTRASOUND... 265 Chapter Overview... 265 Contents... 265
Introduction to External Ultrasound... 266 Overview... 266
Starting External Ultrasound... 267 Activating External Ultrasound... 267 Selecting the Ultrasound Probe... 268 Verifying the Probe Calibration... 269 Calibrating a New Ultrasound Probe... 271 Recalibrating an Ultrasound Probe... 282
External Ultrasound Tools... 283 Accessing Tools... 283 Image Settings... 284
3-D Ultrasound Acquisition... 285 Introduction... 285 8
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Ultrasound Images... 287 Overview... 287 Ultrasound Inline View... 289 Ultrasound View Configuration... 292
PAINT NAVIGATION... 293 Chapter Overview... 293 Contents... 293
Introduction... 294 Overview... 294
Calibrating and Verifying Paint Instruments... 295 Overview... 295
Using Painter... 296 Navigation... 296 Modifying Paint Object... 297 Managing Paint Objects... 298
NAVIGATING ALIGNMENT INSTRUMENTS... 301 Chapter Overview... 301 Contents... 301
VarioGuide... 302 Introduction... 302 Verifying Instruments... 303 Accessing the VarioGuide Wizard... 304 Defining the Initial Position and Performing Rough Adjustments... 305 Performing Fine Adjustments... 307 Verifying Accuracy... 309 Navigating General Instruments with the VarioGuide... 310 Navigating the Disposable Biopsy Needle with the VarioGuide... 311
Frameless Biopsy System... 313 Introduction... 313 Verifying Instruments... 314 Aligning the Biopsy Tube and Calculating the Instrument’s Insertion Depth... 315
Disposable Biopsy Needle Type A... 318 Introduction... 318 Verifying the Disposable Biopsy Needle... 319 Navigating the Disposable Biopsy Needle... 321
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TABLE OF CONTENTS
DISPOSABLE STYLET NAVIGATION... 325 Chapter Overview... 325 Contents... 325
Introduction... 326 About the Disposable Stylet... 326
Using the Disposable Stylet... 327 Calibrating and Verifying the Disposable Stylet... 327
Navigating the Disposable Stylet... 329 Overview... 329
MICROSCOPE NAVIGATION... 333 Chapter Overview... 333 Contents... 333
Introduction to Microscope Navigation... 334 About Microscope Navigation... 334
Initializing the Microscope... 335 Activating and Selecting the Microscope... 335
Verifying the Microscope... 337 Introduction... 337 Verifying the Calibration... 338 Recalibrating the Microscope... 339
Microscope Navigation... 341 Accessing Navigation... 341 Navigation Views... 342
Microscope Tools... 344 Introduction... 344 Microscope Options... 345 Handle Control... 349 Available Options According to Microscope Model... 351 Configuring Microscope Video... 353
Microscope Images... 355 Displaying Microscope Video Views... 355 Displaying Microscope Depthview... 357
INTRAOPERATIVE IMAGING... 359 Chapter Overview... 359 Contents... 359
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Introduction... 360 About Intraoperative Imaging Features... 360
Intraoperative Data Transfer... 361 About Intraoperative Data Transfer... 361 Fusing Images... 363
Registering Intraoperative Data... 365 Introduction... 365 Automatic Image Registration MR... 366 Registration Based Image Fusion... 372 Automatic Image Registration iCT Cranial... 373
IGTLINK... 383 Chapter Overview... 383 Contents... 383
Introduction to IGTLink... 384 About IGTLink... 384
Using IGTLink... 385 Enabling IGTLink... 385 Connecting a IGTLink Client... 386
INDEX... 387
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TABLE OF CONTENTS
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GENERAL INFORMATION
1
GENERAL INFORMATION
1.1
Chapter Overview
1.1.1
Contents
Topics Covered Section
See
Contact Data and Legal Information
Page 14
Symbols Used in This Guide
Page 16
Intended Use
Page 17
Compatibility with Medical Devices
Page 20
Training and Documentation
Page 25
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Contact Data and Legal Information
1.2
Contact Data and Legal Information
1.2.1
Contact Data
Support
Feedback
If you cannot find information you need in this guide, or if you have questions or problems, contact Brainlab support: Region
Telephone and Fax
United States and Canada
Tel: (800) 597-5911 Fax: (708) 409-1619
Africa, Asia, Australia, Europe
Tel: +49 89 991568-44 Fax: +49 89 991568-811
Latin America
Tel: +55 11 33 55 33 70 Fax: +55 11 33 55 33 79
Japan
Tel: +81-3-3769-6900 Fax: +81-3-3769-6901
France and French-speaking regions
Tel: +33-800-67-60-30
Despite careful review, this manual may contain errors. Please contact us at [email protected] if you have suggestions as to how we can improve this manual.
Manufacturer
Brainlab AG Kapellenstr. 12 85622 Feldkirchen Germany
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GENERAL INFORMATION
1.2.2
Legal Information
Copyright
This guide contains proprietary information protected by copyright. No part of this guide may be reproduced or translated without express written permission of Brainlab.
Brainlab Trademarks
• BrainSUITE® is a registered trademark of Brainlab AG in Germany and/or the US. • IGSonic® is a registered trademark of Brainlab AG in Germany and/or the US. • Kolibri® is a registered trademark of Brainlab AG in Germany and/or the US. • Softouch® is a registered trademark of Brainlab in Germany and/or the US. • StarLink® is a registered trademark of Brainlab AG in Germany and/or the US. • VarioGuide® is a registered trademark of Brainlab AG in Germany and/or the US. • VectorVision® is a registered trademark of Brainlab AG in Germany and/or the US. • z-touch® is a registered trademark of Brainlab AG in Germany and/or the US.
Non-Brainlab Trademarks
• Doro® is a registered trademark of pro med instruments GmbH. • Mayfield® is a registered trademark of OMI, Inc. • Microsoft® and Windows® are registered trademarks of Microsoft Corporation in the United States and other countries. • MultiVisionTM is a trademark of Carl Zeiss Meditec AG. • OPMI®, Pentero®, and PENTERO® are registered trademarks of Carl Zeiss Meditec AG.
Integrated 3rdParty Software
This software is based in part on the work of the Independent JPEG Group.
CE Label The CE mark shows that the Brainlab products comply with the essential requirements of the Medical Device Directive. According to the MDD (Council Directive 93/42/EEC): • Cranial/ENT is a Class IIb product. • IGSonic 10V5 and IGSonic 3000 are Class IIa products.
Disposal Instructions
Only dispose of electrical and electronic equipment in accordance with statutory regulations. For information regarding the WEEE (Waste Electrical and Electronic Equipment) directive, visit: http://www.brainlab.com/weee
Sales in the US
US federal law restricts this device to sale by or on the order of a physician.
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Symbols
1.3
Symbols
1.3.1
Symbols Used in This Guide
Warnings
Warnings are indicated by triangular warning symbols. They contain safety-critical information regarding possible injury, death, or other serious consequences associated with equipment misuse. Cautions
Cautions are indicated by circular caution symbols. They contain safety-critical information regarding possible problems with the device. Such problems include device malfunctions, device failure, damage to device or damage to property. Notes
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NOTE: Notes are formatted in italic type and are used to indicate additional useful hints.
Software User Guide Rev 1.2 Cranial/ENT Ver 2.1
GENERAL INFORMATION
1.4
Intended Use
1.4.1
Using the System
Indications for Use
The Cranial/ENT system is intended to be an intra-operative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to a virtual computer image space on patient image data being processed by the IGS workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, CTA, X-ray, MR, MRA and ultrasound based model of the anatomy. Example procedures include but are not limited to: Cranial Procedures: • • • • • • •
Tumor resections Skull base surgery Cranial biopsies Craniotomies/Craniectomies Pediatric Catheter Shunt Placement General Catheter Shunt Placement Thalamotomies/Pallidotomies
ENT Procedures: • • • • • • •
Transphenoidal procedures Maxillary antrostomies Ethmoidectomies Spheno-idotomies/ sphenoid explorations Turbinate resections Frontal sinusotomies Intranasal
Place of Use
The Cranial/ENT system shall be used in a hospital environment, specifically, in rooms appropriate for surgical interventions (e.g., operating rooms).
Intended Audience
This user guide is intended for neuro and ENT surgeons or their assistants when using a Brainlab navigation system.
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Intended Use
Instrument Contact to Brain Tissue and Spinal Fluid Only specified Brainlab instruments are intended for direct contact with brain tissue and spinal fluid. For a list of such instruments, refer to the Instrument User Guides. What is the risk? Direct contact to brain tissue and cerebrospinal fluid by instruments not intended for such contact may cause damage to the patient’s brain or severe shock by delivering endotoxic substances to the patient’s body. Brainlab instruments are designed and manufactured to minimize the risk of damage to the patient’s brain tissue. Therefore, it is unlikely that patient injury will occur during normal instrument use. However, misuse of instruments or the use of damaged instruments, can cause severe patient injury. Standard reprocessing methods are not fully effective for endotoxic contaminated instruments. Endotoxic contamination can only be removed using aggressive treatments, e.g., very high temperatures. Such parameters may damage highly accurate manufactured instruments. Contact to brain tissue or cerebrospinal fluid with instruments that are not intended for such contact can cause severe patient injury. In which situations might unintentional contact occur? Situations where unintentional contact to brain tissue may occur are in general all situations in which instruments are used in close proximity to brain tissue. Examples are using the navigation pointer inside of the cranial cavity, e.g., for distance measurement or point collection. How to reduce the likelihood: Fully reprocess instruments as described in the Cleaning, Disinfection and Sterilization Guide. Store and handle instruments as described. Except in the case of specified instruments, avoid direct instrument contact to brain tissue and contact to cerebrospinal fluid. Careful Handling of Hardware System components and accessory instrumentation comprise precise mechanical parts. Handle them carefully.
Only trained medical personnel may operate system components and accessory instrumentation.
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GENERAL INFORMATION
Symbols on the System Hardware Components
The following symbols may be found on the system or on the instruments. Symbol
Explanation Type B Applied Part according to IEC 60601-1
Type BF Applied Part according to IEC 60601-1
Attention! Consult accompanying documents
Potential equalization point
MR Unsafe
MR Conditional: The number shown on each label specifies the MR environment in which the device can be used with caution
<XYmT Plausibility Review
Before patient treatment, review the plausibility of all information input to and output from the system.
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Compatibility with Medical Devices
1.5
Compatibility with Medical Devices
1.5.1
Brainlab Medical Instruments
Compatible Brainlab Medical Instruments
Cranial/ENT is compatible with: • • • • • • • • • •
• • • • • • • • • • • • • • • • • •
Biopsy Alignment Array and Biopsy Tube Blakesley Clamp Disposable Reflective Marker Spheres Disposable Registration Marker CT, MR, OR Disposable Stylet Frameless Biopsy System Headholder Adapter iOP Imaging DO/MF Headholder Adapter iOP Imaging GE Healthcare Headholder Clamp iOP Imaging MF Instrument Adapter Kit: - Instrument Adapter Arrays (sizes M, ML, L, XL) - Instrument Adapter Clamps (sizes S, M, L, XL) Instrument Calibration Matrix 4.0 (ICM4) Microscope Adapters and Microscope Arrays Multiple Tip Pointers including Paint Pointer Tips Pointer with Blunt Tip Pointer with Sharp Tip Reference Arm for Mayfield Headholder Reference Array iOP Imaging Kit Reference Clamp Universal Reference Headband and Reference Headband Array Skull Reference Set Softouch Standard Cranial Reference Array Sterilization Trays (Cranial, ENT, Frameless Biopsy System, VarioGuide) Suction Tube Ultrasound Adapters Ultrasound Registration Phantom VarioGuide z-touch
Compatible Intraoperative Imaging Instruments
Cranial/ENT is compatible with:
Other Brainlab Instruments
Additional instrumentation may become available after release of this manual. Contact Brainlab support if you have any questions regarding instrument compatibility with Brainlab software.
• • • •
Adhesive Flat Markers iCT BrainSUITE iMRI Reference Package - Noras Headholder and Coil Calibration Phantom iCT Kit iCT Scan Drape
Only use instruments and spare parts specified by Brainlab with Cranial/ENT. Using unauthorized instruments/spare parts may adversely affect safety and/or effectiveness of the medical device and endanger safety of patient, user and/or environment.
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GENERAL INFORMATION
1.5.2
Brainlab Software
Authorization
Only authorized Brainlab employees may install software on the Brainlab system. Do not install or remove any software applications. Compatible Brainlab Medical Software
Cranial/ENT is compatible with:
Compatible Brainlab NonMedical Software
Cranial/ENT is compatible with the Application Switch Software.
Other Brainlab Software
If you are running software versions other than those specified above, please contact Brainlab support for clarification regarding compatibility with Brainlab devices.
• • • • • • • • • •
BrainSUITE NET 1.5 Content Manager 1.0 Digital Lightbox 2.0 Interactive DICOM Viewer 1.0 iPlan CMF Version 3.0 iPlan Cranial Version 3.0 iPlan ENT Version 3.0 iPlan Stereotaxy Version 3.0 Patient Browser 2.1 Patient Browser 3.0
Only Brainlab medical software specified by Brainlab may be installed and used with the system.
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