O-arm 1000 Imaging System User Manual Rev 4

User Manual O-ARMTM 1000 IMAGING SYSTEM

BI-500-00060 Rev 4

Copyright © 2007 Medtronic Navigation, Inc. All rights reserved. No part of this documentation may be reproduced in any form or by any means or used to make any derivative work (such as translation, transformation, or adaptation) without written permission from Medtronic Navigation, Inc. Medtronic Navigation reserves the right to revise this documentation and to make any changes in content from time to time without obligation on the part of Medtronic Navigation, Inc. to provide notification of such revision or change. Medtronic Navigation, Inc. provides this documentation without warranty, term, or condition of any kind, either implied or expressed, including, but not limited to, the implied warranties, terms or conditions of merchantability, satisfactory quality, and fitness for a particular purpose. Medtronic Navigation, Inc. may make improvements or changes in the product(s) and/or the program(s) described in this documentation at any time. O-arm, Iso-Wag and HD3D are all trademarks of Medtronic Navigation, Inc. All other product or service names are the property of their respective owners.

Technical writing by Cedarwood Associates, Inc. of Chelmsford, MA. Visit us at www.cedarwoodassociates.com

Table of Contents

Preface About this User Manual ... xvii Document Scope... xvii Intended Audience ... xvii Conventions Used Throughout this Manual ... xvii Notes, Cautions, and Warnings ... xviii Cross References ... xviii Menus, Buttons, Switches, and Keyboard References... xix Related Product Documentation ... xx History ... xx

Chapter 1 General Information & Safety Chapter Coverage ... 1-1 General Information ... 1-2 Intended Use of Equipment... 1-2 Video Graphics Printer... 1-2 DVD/CD RW Drive... 1-2 Equipment Users... 1-2 Owners Responsibilities ... 1-2 Medtronic Navigation Imaging Responsibilities... 1-3 Regulations and Standards Compliance ... 1-3 Regulatory Affairs Contacts... 1-3 In the United States ... 1-3 In Europe ... 1-4 DICOM Conformance Statement... 1-4 Device Compatibility... 1-4 Patient Environment ... 1-5 In the United States ... 1-5 Outside the United States ... 1-6 Ordering Accessory Items ... 1-7 Technical Support... 1-7 Safety... 1-8 O-arm User Manual

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Safety Hazard Alerts ... 1-8 Emergency Procedures ... 1-8 Equipment Failure ... 1-9 Radiation Safety... 1-9 Source-to-Skin Distance... 1-10 Electromagnetic Compatibility ... 1-10 Infection Safety ... 1-11 Burn Safety ... 1-11 Ingress of Fluids... 1-12 Mechanical Motion ... 1-12 Electrical Safety ... 1-13 Transportation Safety ... 1-14 Fire Safety... 1-15 Explosion Safety ... 1-15 Environmental Safety ... 1-16 Operator Safety... 1-16 Safety Symbols ... 1-17

Chapter 2 System Overview Chapter Coverage ... 2-1 Introduction to the O-arm™ Imaging System ... 2-2 The O-arm Chassis ... 2-3 Standalone Mode ... 2-4 The Mobile View Station (MVS) ... 2-4 System Capabilities ... 2-6 X-ray Types ... 2-6 Pulsed Fluoroscopy ... 2-6 Pulsed Exposure ... 2-6 Modes of Operation ... 2-7 2D Fluoroscopy Mode ... 2-7 Multi-planar M-2D Mode ... 2-8 3D Mode ... 2-8 Patient Exam Data Capabilities... 2-9 DICOM Export Capability ... 2-10 Export Capability via External Memory Devices... 2-10 Video Graphics Printer ... 2-10 Image Guided Surgery ... 2-10 Image Annotation ... 2-11 X-ray Information - Air Kerma Display ... 2-11

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Chapter 3 Installation Chapter Coverage ... 3-1 Unpacking ... 3-2 Initial Inspection... 3-2 Unpacking the O-arm Chassis ... 3-2 Unpacking the MVS... 3-5 Configuration ... 3-7 Configuring Time Settings ... 3-7 Configuring the Worklist Server Connection ... 3-10 Configuring the IGS Server Connection ... 3-12 System Checkout... 3-15 Cable and Power Connections... 3-15 Powering Up the System... 3-16

Chapter 4 Controls & Indicators Chapter Coverage ... 4-1 The O-arm Chassis Controls and Indicators... 4-2 Application and Removal of Power ... 4-3 The Key Switch ... 4-3 The Power Control Panel... 4-4 Powered Assist Transport System Activation ... 4-6 Battery Charging ... 4-7 Complete System Startup & Shutdown ... 4-7 Emergency Stop ... 4-7 The Pendant Control Panel ... 4-8 The Hand and Foot Switches ... 4-17 The O-arm Hand Switch ... 4-17 The O-arm Foot Switch... 4-17 Hand and Foot Switch Functions ... 4-18 The Power Assist Transport Handle... 4-18 The MVS Controls and Indicators... 4-20 Viewing Monitor... 4-20 The Keyboard... 4-21 Special Key Assignments ... 4-22 The Touch Pad ... 4-24 Using the Touch Pad ... 4-24 The Wireless Mouse... 4-25 Power Control Panel ... 4-27 Video Graphics Printer ... 4-27

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Chapter 5 Initial Setup Requirements Chapter Coverage ... 5-1 Powering Up the System ... 5-2 Locating the Home Position ... 5-3 Connecting the Foot Switch ... 5-3 Connecting a Slave Monitor ... 5-3 Unpackaging and Activating the Mouse ... 5-4 Using the Mouse’s Laser Pointer ... 5-5 Entering Patient Information ... 5-6 Entering New Patient Data at Time of Examination ... 5-7 Posting Patients to the Scheduled Exams Menu ... 5-8 Selecting a Patient from the Scheduled Exams Menu ... 5-8 Editing a Patient from a Scheduled Exam Menu ... 5-9 Acquiring Patient Information from Outside Sources ... 5-11 Performing a Patient Information Query ... 5-12 When There Isn’t Time to Enter Patient Data ... 5-14 Applying the Sterile Drape ... 5-16 Application of the Custom Drape ... 5-16 Installation of the Custom Drape ... 5-16 Removal of the Custom Drape ... 5-17 Application of the Bar Drape ... 5-17 Installation of the Bar Drape ... 5-17 Adjusting the Patient’s Position ... 5-19 Consideration of the O-arm Park Position ... 5-19 The Draping Method... 5-19 The Patient’s Arm Position ... 5-19 Using the Patient Spacer... 5-20

Chapter 6 Typical Imaging Scenario Chapter Coverage ... 6-1 Introduction... 6-3 Positioning the Gantry ... 6-4 Gantry Tilt Control ... 6-5 Gantry Up and Down Control ... 6-6 Gantry Iso-Wag™ Control... 6-7 Gantry Wag Control ... 6-8 Gantry Transverse (In/Out) Control... 6-9 Gantry Longitudinal (Left/Right) Control... 6-10 Using the Gantry Light Ring ... 6-11 vi

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Positioning the X-ray Beam... 6-12 Beam Translate Positioning ... 6-13 Applying the 2D Mode ... 6-15 Application Notes ... 6-15 Taking AP Images ... 6-15 Taking Lateral Images ... 6-15 Acquiring 2D Images ... 6-15 Printing Images ... 6-19 Saving Images to a Snapshot File ... 6-19 Setting Up 2D Preset Stored Images ... 6-20 Image Manipulation In the 2D Mode ... 6-22 Enhancement of the Right-Hand Image ... 6-23 Viewing a Region of Interest (ROI)... 6-23 Applying the M-2D Mode ... 6-26 Application Notes ... 6-26 Acquiring a M-2D Preset Image ... 6-26 Image Manipulation In the M-2D Mode ... 6-28 Printing Images ... 6-28 Saving Images to a Snapshot File ... 6-28 Applying the 3D Mode ... 6-29 Special Application Procedures... 6-29 Use of Saline Solution ... 6-29 Cessation of Respiration... 6-29 Using Collimation in 3D ... 6-29 Acquiring a 3D Volumetric Image ... 6-30 Image Manipulation in the 3D Mode... 6-34 Advanced Imaging Manipulation in 3D Mode... 6-36 Printing Images ... 6-38 Saving Images to a Snapshot File ... 6-38 Parking the O-arm Gantry... 6-39 Setting Up a Stored Park Position ... 6-39 Moving the O-arm Chassis to an Out-of-the-Way Position ... 6-40 Moving the O-arm Chassis Away from the Operating Table ... 6-41 With a Custom Drape ... 6-41 With a Bar Drape... 6-42

Chapter 7 Post Surgical Procedures Chapter Coverage ... Accessing and Reviewing Patient Images... Selecting and Transferring Snapshot Images ...

7-1 7-2 7-5

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Deleting Patients ... 7-7 Automatic Patient Deletion ... 7-8 Correcting Patient Listing Errors ... 7-8 Assigning the Same Patient ID to Two Different Patients ... 7-8 Assigning Two Different IDs to the Same Patient... 7-9 Making Additions and Changes to the Physicians List ... 7-11 Adding New Entries to the Physicians List... 7-11 Making Changes to the Physicians List ... 7-12 Exporting Images in DICOM Format ... 7-14 Setting Up the DICOM Export Configuration ... 7-14 Network Connection ... 7-14 Configuring the DICOM Workstation Connection ... 7-15 Configuring the DICOM Server Connection ... 7-16 Transferring DICOM Images to an External Storage Device ... 7-20 Powering Down and Moving the System... 7-21 Docking the O-arm Gantry ... 7-21 Powering Down ... 7-21 Moving ... 7-22 Inspection and Cleaning ... 7-24 Cleaning ... 7-24 Disinfection ... 7-24

Chapter 8 Performance Checks & Emergency Procedures Chapter Coverage ... 8-1 Performance Checks ... 8-2 Initial Setup ... 8-2 User Performance Checks ... 8-2 Performance Check Methods ... 8-5 Periodic Maintenance ... 8-8 Fluoro Gain Calibration ... 8-8 RAD Gain Calibration... 8-9 Addition Periodic Maintenance ... 8-9 Emergency Procedures ... 8-10 Electronically Opening the O-arm Gantry Door... 8-10 Manually Opening the O-arm Gantry Door ... 8-10 Unlocking the O-arm Chassis Rear Wheels... 8-13 Emergency Shutdown ... 8-14

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Chapter 9 Labels & Technical Reference Chapter Coverage ... 9-1 Labels ... 9-2 Labels (continued)... 9-3 Labels (continued)... 9-5 Labels (continued)... 9-6 Labels (continued)... 9-7 Labels (continued)... 9-8 Labels (continued)... 9-9 Labels (continued)... 9-10 Technical Reference ... 9-11 Safety Classifications... 9-16 X-ray Field Orientation ... 9-16 Agency Approvals... 9-17

Index

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List of Figures

Figure 1-1. Patient Environment Inside the United States ... 1-5 Figure 1-2. Patient Environment Outside the United States ... 1-6 Figure 1-3. O-arm 1000 Significant Zones of Occupancy... 1-16 Figure 2-1. The O-arm Imaging System ... 2-2 Figure 2-2. The O-arm Chassis ... 2-3 Figure 2-3. The MVS ... 2-4 Figure 2-4. Annotation of X-ray Images... 2-11 Figure 3-1. Location of O-arm Shipping Components ... 3-3 Figure 3-2. System Technical Service Menu ... 3-8 Figure 3-3. Date Selection ... 3-9 Figure 3-4. Worklist Server Configuration Menu... 3-11 Figure 3-5. IGS Server Configuration Menu ... 3-13 Figure 4-1. Location of O-arm Chassis Controls and Indicators ... 4-2 Figure 4-2. The O-arm Chassis Connector Panel ... 4-3 Figure 4-3. The O-arm Chassis Power Control Panel ... 4-4 Figure 4-4. The Pendant User Interface ... 4-8 Figure 4-5. Hand Switch ... 4-17 Figure 4-6. Foot Switch... 4-17 Figure 4-7. Transport Handle Control Sequences ... 4-19 Figure 4-8. The MVS Component Locations ... 4-20 Figure 4-9. MVS Viewing Monitor ... 4-21 Figure 4-10. The MVS Special Key Assignments ... 4-22 Figure 4-11. The MVS Keyboard Touch Pad... 4-24 Figure 4-12. Wireless Mouse ... 4-25 Figure 4-13. MVS Power Control Panel... 4-27 Figure 4-14. The Video Graphics Printer ... 4-27 Figure 5-1. Startup Progress Display... 5-2 Figure 5-2. Mouse Power Switch ... 5-4 Figure 5-3. Mouse Receiver ... 5-5 Figure 5-4. Patient Exam Information Menu ... 5-6 Figure 5-5. Scheduled Exams Menu ... 5-9 Figure 5-6. Exams Information Menu Filled In ... 5-10 Figure 5-7. Worklist Query Menu (top portion only) ... 5-12 Figure 5-8. Expanded Worklist Query Menu... 5-13

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List of Figures

Figure 5-9. Patient Details ... 5-14 Figure 5-10. The Patient Spacer ... 5-20 Figure 6-1. Tilt Button ... 6-5 Figure 6-2. Negative Tilt ... 6-5 Figure 6-3. Positive Tilt... 6-5 Figure 6-4. Up/Down Button ... 6-6 Figure 6-5. Gantry Up... 6-6 Figure 6-6. Gantry Down ... 6-6 Figure 6-7. Iso-wag Button ... 6-7 Figure 6-8. Negative Iso-wag ... 6-7 Figure 6-9. Positive Iso-wag ... 6-7 Figure 6-10. Wag Button ... 6-8 Figure 6-11. Negative Wag... 6-8 Figure 6-12. Positive Wag ... 6-8 Figure 6-13. Transverse Movement Buttons ... 6-9 Figure 6-14. Outward Transverse Extension... 6-9 Figure 6-15. Inward Transverse Extension... 6-9 Figure 6-16. Longitudinal Movement Buttons... 6-10 Figure 6-17. Longitudinal Left... 6-10 Figure 6-18. Longitudinal Right ... 6-10 Figure 6-19. The Gantry Light Ring ... 6-11 Figure 6-20. Tube/Detector Orbital Rotation Button ... 6-12 Figure 6-21. Positive Beam Path Position ... 6-12 Figure 6-22. Negative Beam Path Position ... 6-12 Figure 6-23. Tube/Detector Translation button... 6-13 Figure 6-24. Positive Beam Translation ... 6-13 Figure 6-25. Negative Beam Translation... 6-14 Figure 6-26. Example of a 2D A/P Image... 6-16 Figure 6-27. The 2D Mode Softkeys... 6-17 Figure 6-28. M-2D Mode Softkeys... 6-20 Figure 6-29. Standard (default) 2D Image Presentation... 6-22 Figure 6-30. Image Enlargement with cw Spin of the Mouse Wheel... 6-22 Figure 6-31. Image Enlargement with ccw Spin of the Mouse Wheel ... 6-23 Figure 6-32. Uncollimated Image ... 6-24 Figure 6-33. Collimation Applied to Image ... 6-24 Figure 6-34. Smaller ROI... 6-25 Figure 6-35. ROI Area Further Reduced ... 6-25 Figure 6-36. Standard (default) M-2D Image Presentation ... 6-27 Figure 6-37. M-2D Enlarged Active Image ... 6-28 Figure 6-38. The 3D Mode Softkeys... 6-31 Figure 6-39. Standard (default) 3D Image Presentation (Axial Active).. 6-34 Figure 6-40. 3D Image with Coronal Pane Active ... 6-35

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List of Figures

Figure 6-41. 3D Coronal Image Enlarged ... 6-35 Figure 6-42. 3D Coronal Image Lightbox... 6-36 Figure 6-43. 3D Oblique Slicing Image ... 6-37 Figure 6-44. MIP View Image ... 6-38 Figure 7-1. Saved Exams Listing ... 7-2 Figure 7-2. Patient Study Listing... 7-3 Figure 7-3. A 2D Image Series ... 7-4 Figure 7-4. Selected 2D Image... 7-5 Figure 7-5. Selecting a Snapshot Image ... 7-6 Figure 7-6. The Export Menu... 7-7 Figure 7-7. Update Patient Information Dialog ... 7-9 Figure 7-8. Physicians List... 7-11 Figure 7-9. Physicians Fill-in Menu... 7-12 Figure 7-10. MVS Connector Panel... 7-15 Figure 7-11. The MVS Station Menu ... 7-16 Figure 7-12. The DICOM Servers Menu ... 7-17 Figure 7-13. DICOM Server Configuration Menu ... 7-18 Figure 7-14. Transferring DICOM Images to a CD ... 7-20 Figure 8-1. Calibration Menu ... 8-8 Figure 8-2. Door Opening Access Points ... 8-11 Figure 8-3. T-Shaped Rotor Alignment Pin... 8-11 Figure 8-4. Clutch Release Lever ... 8-13

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List of Tables

Table 1. Medtronic Navigation Documentation Set ... xx Table 2. Medtronic Navigation User Manual Revision History... xx Table 1-1. Accessory Items ...1-7 Table 4-1. Power Panel Controls and Indicators ...4-4 Table 4-2. Power Panel Indicator Combinations ...4-6 Table 4-3. Pendant Buttons and Indicators ...4-9 Table 4-4. Hand/Foot Switch Functions...4-18 Table 4-5. Special Key Assignments ...4-22 Table 4-6. Mouse Buttons, Switches, and Indicators...4-26 Table 6-1. Softkey Selections for the 2D Mode ...6-17 Table 6-2. Targeted Anatomy Chart for 3D Mode and HD3D™ Mode ...6-32 Table 8-1. User Performance Checks ...8-3 Table 8-2. Performance Check Descriptions ...8-5 Table 9-1. The O-arm Chassis Specifications ...9-11 Table 9-2. The Mobile View Station Specifications...9-12 Table 9-3. Environmental Specifications ...9-13 Table 9-4. Power Specifications ...9-13 Table 9-5. X-ray Source Assembly Specifications ...9-14 Table 9-6. X-ray Generator Assembly Specifications ...9-15 Table 9-7. FDA Performance Standard Requirements ...9-17

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Preface

About this User Manual This user manual describes the operation of the O-arm™ 1000 Imaging System consisting of the O-arm™ Chassis and the Mobile View Station (MVS). It is not designed to replace or substitute for certified training in the radiological or medical field.

Document Scope The contents of the manual are arranged to acquaint you with the operation and use of the O-arm Imaging System, starting with basic introductory information, followed by installation instructions, providing detailed descriptions of the operating controls and indicators, and then taking you through a complete operational scenario that exercises all the system’s functions. The goal of this manual is to provide all the instructions and data that you will need in order to use the O-arm Imaging System as a highly effective tool during surgical procedures.

Intended Audience The information contained in this manual is intended for qualified medical personnel who have been trained, licensed, and/or certified in the proper use and application of medical x-ray imaging equipment. Prior to operating the Medtronic O-arm Imaging System, all users should read this manual and the labels appearing on both units of the system.

Conventions Used Throughout this Manual There are several conventional styles that are consistently used throughout this manual for addressing the following items: •

Notes, Cautions, and Warnings

•

Cross References

•

Menus, Buttons and Keyboard References

Descriptions of the styles used for each these items are described in the following paragraphs. O-arm User Manual

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Notes, Cautions, and Warnings The following examples show the methods that are used to highlight the conventional note, caution, and warning statements. A description of the purpose for each type of statement is included in the examples. Note: Identifies important points, helpful hints, special circumstances, or alternative methods.

CAUTION Cautions the user regarding actions that may result in operational or data loss, damage to the equipment or to the environment.

WARNING Provides information that can help prevent potential fatal or serious injury to a user, patient, or other persons, or can help prevent misdiagnosis.

Cross References A cross-reference indicates the location of additional information regarding the chosen topic. Cross-references may include either paragraph headings and page numbers, table numbers and page numbers, figure numbers and page numbers, or just page numbers. In most cases, they are enclosed in parentheses. The cross-references take the form of: (see “Paragraph Heading” on page number), or (see “Table number” on page number), or (see “Figure number” on page number), or (see page number), or (page number) In each of the above examples, the portion of the reference that will vary is indicated in italics. References to information in a different chapter will be in the identical form as described above except the word “see” will be replaced by “refer.”

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Menus, Buttons, Switches, and Keyboard References The following information outlines the methods that are used throughout this manual regarding references to menus, buttons, switches and keyboard keys. Menus. In all references to menus, the menu name is in italics. For example: The Exam Information menu, the Saved Exams menu, and so forth. Buttons and Switches All buttons on the Pendant Control Panel and switches on the power control panels are identified by icons. The icon for each button or switch is included in their references. For example: Depress the open door gantry door.

button on the O-arm Pendant to open the

Toggle the power switch on the O-arm Chassis power panel to the (Start) position. All reference to buttons appearing on menus are given in bold face type and repeat the word or acronym appearing on the button. For example: Click on the Next button to clear away... Keyboard. All references to keyboard keys are given in bold face type. For example: Depress the Enter key on the keyboard. Whenever an icon appears next to a key, the icon as well as the key are identified in the reference. For example: Depress the Esc (escape) key

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