O-arm O2 User Manual Rev 01

Copyright © Medtronic Navigation, Inc. All rights reserved. Document Title: O-arm™ O2 Imaging System User Manual. Document Number: BI-500-01162 Rev. 01 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. The information contained in this document is accurate at time of publication. Medtronic Navigation, Inc. 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, Isowag, and StealthStation S7 and S8 are trademarks of Medtronic Navigation, Inc. All other product or service names are the property of their respective owners.

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Revision

Release date

Application

01

2020-03

Describes the operation of the O-arm™ O2 Imaging System with software version 4.1.x. If you have a later version of software, please check the release notes to determine if this manual is still current for your version.

Contents 1.General Information and Safety Indications for Use, Compliance, and Patient Environment

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Indications for Use and Responsibilities... 9 Patient Environment ... 13 Safety

... 14

Overview ... 14 Personnel Safety ... 14 Radiation Safety ... 20 Use of Images in Image-Guided Treatments ... 21 Imaging Patients with Electronic Medical Devices ... 21 Electromagnetic Compatibility ... 22 Electrical Safety... 23 Mechanical Safety ... 25 General Use Safety ... 27 Emergency Procedures ... 28 2.System Overview Introduction to the System

... 31

Overview ... 31 The Image Acquisition System (IAS)... 32 The Mobile View Station (MVS) ... 33 Acquisition Modes ... 36 2D Modes ... 36 3D Modes ... 37 Optional 3D Features ... 38 X-ray Options ... 38 Patient Exam Data Capabilities... 39 3.Controls and Indicators IAS Controls and Indicators

... 41

Control Locations ... 41 IAS Connector Panel... 42 The IAS Power Control Panel ... 43 The Pendant... 46 Handswitch and Footswitch ... 48 MVS Components

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The Mobile View Station... 50 The Monitor ... 53 The Keyboard and Wireless Mouse ... 54 Locking Casters... 57 4.Powering Up and Configuring the System Connecting and Powering Up the System

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Cable Connections ... 59 Log in Security with User Authentication... 63 Changing User Authentication Settings... 65 Configuring the System with the Technical Service Console

... 68

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Configuration Overview ...68 Configuring Interface Language and Units ...70 Setting Up DICOM Export Configurations

...73

Connecting to the Network ...73 Configuring a Worklist Server ...74 Connecting and Configuring an Image Guided Surgery (IGS) System ...77 Selecting an IGS, StealthStation™ System, or Navigation Server from a Shared Network ...80 Configuring the DICOM Store Server ...82 Adding to and Modifying the Physicians List ...83 Optimizing the Monitor Display ...85 5.Setup in the Operating Room Moving the System

...89

Moving the IAS ...89 Moving the MVS ...90 Powering Up the System

...90

Connecting the IAS and MVS and Powering Up the System ...90 Unpacking and Activating the Mouse ...92 Entering Patient Information ...94 Entering New Patient Data at Time of Examination...95 Entering Patient Data on the Scheduled Exams Page ...97 Acquiring Patient Information from Outside Sources ...100 Outside Sources of Patient Information

...100

Applying a Sterile Drape to the IAS Gantry

...102

Overview...102 The Tube Drape ...103 The Bar Drape ...109 6.Positioning the Gantry Introduction to Imaging

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Imaging Overview ...111 Using the Door and Preparing the Gantry

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Work Flow Recommendations for Using the O-arm™ Door...111 Positioning the Gantry ...112 Positioning the Gantry for Imaging ...119 Pendant Buttons for Gantry Movement and Beam Positioning ...121 Gantry Movements ...123 The Gantry Docked Position...124 Gantry Door Open/Close Positions...125 Gantry Tilt Control...126 Gantry Up and Down Control...128 Gantry Isowag™ Control (Optional)...129 Gantry Wag Control ...130 Gantry Transverse (In/Out) Control ...132 Gantry Longitudinal (Left/Right) Control ...133 Aligning the X-ray Beam Path...134 The Laser Alignment Lights ...136

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Moving the Gantry Out of the Way

... 139

Positioning the Gantry Out of the Way for Surgery ... 139 Moving the IAS Laterally ... 140 Moving the IAS Away from the Operating Table ... 141 7.Imaging Imaging Modes

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Overview ... 145 Image Control Buttons... 145 Image Storage Capacity... 146 Using the 2D Mode

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Overview ... 148 Acquiring 2D Images ... 150 Optimizing 2D Image Quality Using the Softkeys... 153 Manipulating Image Display in the 2D Mode... 154 Viewing a Region of Interest (ROI)... 156 Storing Positions and Acquisition Settings ... 158 Using the Multi-plane 2D Mode

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Overview ... 160 M-2D Image Acquisition ... 161 Manipulating Image Display in the M-2D Mode... 162 Using 3D Modes

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Overview ... 163 3D Image Acquisition

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Gantry Position... 165 Image-Guided Surgery ... 165 Selecting and Activating 3D Modes... 165 Using Saline Solution ... 166 Pausing Respiration ... 166 Using Preset Collimation Settings ... 166 Selecting Acquisition Settings ... 166 Guidance for Imaging Small Patients ... 170 Acquiring 3D Stereotaxy Scans... 171 Acquiring a 3D Scan... 173 Manipulating Image Display in the 3D Mode... 174 Advanced Imaging Features in 3D Mode ... 177 Dose Reporting ... 179 Viewing, Saving, and Exporting Dose Reports... 181 Transferring Non-Navigated Images to a StealthStation™ System or Navigation Server ... 184 8.Reviewing, Editing, and Annotating Patient Data Reviewing Patient Data

... 189

Accessing and Reviewing Patient Exams ... 189 Editing and Deleting Database Entries... 194 Exporting Patient Studies and Images

... 197

Export Options... 197 Exporting Images to External Media ... 198

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Exporting Images Across a Network

...199

Overview...199 Exporting Images to a DICOM Store Server...199 Exporting Images to an Image Guided Surgery (IGS) System ...200 Printing Images to a Local Printer...201 Image Annotation

...201

Overview...201 Viewing Annotations ...202 Launching the Annotation Editor...203 Using the Annotation Editor Toolbar

...203

Imaging Magnification ...204 Selecting Elements ...205 Moving Elements ...205 Changing Element Layers ...205 Rotating Elements ...206 Deleting Elements...206 Undoing All Changes ...206 Saving and Exiting Annotated Images...206 Adding Text, Line, and Angle Annotations

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Adding Text and Orientation Markers to Images ...206 Adding Lines and Arrows to Images ...207 Adding Angle Measurements to Images ...208 Image Stitching

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Overview...214 Stitching Restrictions ...214 Stitching Overview ...215 Selecting Images to Stitch ...215 9.Maintenance and Troubleshooting Powering Down and Storing the System

...219

Powering Down...219 Cleaning...220 Storing the System ...222 Charging the Batteries ...223 Performance Checks and Maintenance Overview

...224

...224

Frequency Guidelines...224 Initial Setup ...225 User Performance Checks...225 Periodic Maintenance – Gain Calibrations...227 Periodic Maintenance – Home Calibration ...233 Emergency Procedures

...234

Opening the IAS Gantry Door When the System is Unresponsive ...234 Unintended Emergency Shutdown (E-Stop) ...237 Moving the IAS When Battery Power Is Low ...237 Emergency Stop ...239 Troubleshooting ...239

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10.Acronyms, Labels and Technical References Acronyms

... 243

Labels and Symbols

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Specifications ... 252 Safety Classifications and Standards... 265 Electromagnetic Compatibility ... 267 Dose Evaluation Methods ... 273

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General Information and Safety This chapter describes the intended use and regulatory compliance of the O-arm™ O2 Imaging System (REF # BI-700-02000) and provides comprehensive information on its safe handling and operation.

Indications for Use, Compliance, and Patient Environment Indications for Use and Responsibilities Indications for Use The O-arm™ O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm™ O2 Imaging System is compatible with certain Image Guided Surgery Systems.

Contraindications The O-arm™ O2 Imaging System has no known contraindications.

Use of Video Graphics Printer Printouts from the optional Video Graphics Printer are not intended to be used for diagnostic purposes. The printer’s primary use is for physician reference and documentation.

Use of the DVD/CD RW Drive Information stored on DVDs is not intended to be used for diagnostic purposes. The primary use of such information is for physician reference and documentation.

Equipment Users Warning: Users of the O-arm™ O2 Imaging System should be trained, licensed, and/or certified in the proper use of the system. Medtronic provides different training options for users. For details, contact Medtronic technical service. Users should read this user manual and the labels on the Image Acquisition System (IAS) and the Mobile View Station (MVS) prior to using the system.

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General Information and Safety Indications for Use, Compliance, and Patient Environment

Owner Responsibilities Warning: No unauthorized modification. Do not modify the O-arm™ O2 Imaging System unless authorized by Medtronic Navigation, Inc. Unapproved modifications could have hazardous consequences or impact conformance to regulations and standards.

User qualifications Only properly trained, qualified personnel with appropriate credentials should operate the system. Users must follow safety guidelines and warnings. Caution: United States law restricts this device to sale, distribution, and use by or on the order of a physician.

Designated areas Designate areas suitable for safe operation and service of the equipment and ensure that the equipment is only used in the designated areas.

Ongoing maintenance and testing Perform maintenance and testing per manufacturer recommendations and regulatory requirements.

Ongoing regulatory compliance Consult local, state, federal and/or international agencies regarding applicable requirements for use of this equipment.

Medtronic Navigation Responsibilities •

Medtronic Navigation and its products conform to applicable regulations and to the standards listed in the product specification.

•

Medtronic Navigation products conform to listed product specifications.

•

Medtronic Navigation reviews customer communications and service requests for improvement opportunities.

•

Medtronic Navigation investigates communications and incidents related to product safety, effectiveness, and conformance to specification.

•

Medtronic Navigation will notify affected customers of safety-related situations, if any, and of related product corrections.

Technical Service and Ordering Accessories Medtronic Technical Service For technical assistance, contact Medtronic Navigation, Inc. •

For United States: – Toll-free: (800) 595-9709; or – (720) 890-3160

•

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For Worldwide: +1-720-890-3160

General Information and Safety Indications for Use, Compliance, and Patient Environment

Ordering Accessory Items Table 1 lists the accessory items for the O-arm™ O2 Imaging System. Table 1: Accessory items Accessory

Quantity

Optional Remote Pendant

Part Number

One (1)

BI-710-00529

Sterile Laser Tube Drape, Case A case of twenty (20) 9732722 Sterile Bar Drape, Case

A case of twenty (20) 9733023

O-arm™ Wireless Mouse, Case A case of ten (10)

BI-900-00048

Patient Spacer

One (1)

BI-400-00015

O-arm™ O2 Tracker Kit

One (1)

BI-750-00027

Video Graphics Printer

One (1)

BI-750-00024

To order any of the accessory items, call Medtronic technical service.

Specifications for Optional Cables Table 2 lists specifications for two optional cables that may be used with the O-arm™O2 Imaging System: Table 2: List of Optional Cables Cable Type

Description

Shielding Maximum Length (m)

Ethernet

Connects the O2 system to a network. For instructions, see page 73.

Yes

30

DVI

Connects an optional secondary monitor to the MVS. For instructions, see page 92.

Yes

3

Ferrites

Termination

None

MVS

Two (2) MVS One on each side

DICOM Conformance To obtain a copy of the DICOM Conformance Statement, document # BI-160-00194, contact Medtronic technical service.

Device Compatibility Warning: Connect devices only as described in this manual or as approved by an authorized representative of Medtronic Navigation. Connecting incompatible devices to the system may damage it. To ensure patient safety, connect only external equipment that has been approved by Medtronic Navigation. Observe the following guidelines: •

When used within the patient environment, equipment attached to external interface connections must meet the requirements of IEC 60601-1, IEC 60950, or national equivalents.

•

When used outside of the patient environment, each externally connected device must comply with applicable IEC/ISO requirements for that device. 11

General Information and Safety Indications for Use, Compliance, and Patient Environment

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•

Do not allow the combination of all externally connected equipment to cause leakage of current in any device used within the patient environment to exceed the limits stated in IEC 60601-1, or national equivalents.

•

Select the operating table and its attachments to minimize the effect on the x-ray beam passing through the table.

General Information and Safety Indications for Use, Compliance, and Patient Environment

Patient Environment Definition The patient environment is the area within which the patient is normally located and that contains surfaces likely to be contacted by medical personnel, who might subsequently come in contact with the patient. In the United States the patient environment is legally defined by NFPA 99 and UL 60601-1. Outside the United States, the patient environment is defined by IEC 60601-1. Figure 1: Patient Environment (Top view, Side view)

Number

Description

Inside the United States

Outside the United States

1

Patient table

2

Perimeter

1.83 m (6.0 feet)

1.5 m (4.9 feet)

3

Above the floor

2.29 m (7.5 feet)

2.5 m (8.2 feet)

For surgery, the patient environment encompasses the space beyond the perimeter 2 of the patient table and extends vertically 3 above the floor.

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General Information and Safety Safety

Safety Overview Warning: This x-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions, and maintenance schedules are observed. Potential hazards exist in the use of medical electronic devices and x-ray systems such as the O-arm™ O2 Imaging System. Personnel using the equipment should understand the safety issues, emergency procedures, and the operating instructions provided herein.

Safety Hazard Alerts in This Guide Throughout this guide, warning statements indicate important safety information. Warning: Warnings are indicated by the word “Warning”. Failure to heed these warnings could result in serious injury or death. Pay special attention to these items.

Safety Symbols on the Equipment Chapter 10 includes images and descriptions of all the safety symbols and labels that appear on the O-arm™ O2 Imaging System (see page 243 for details).

Personnel Safety Surgical personnel are at close proximity to the patient during normal operation of the O-arm™ O2 Imaging System. There are three significant zones of occupancy.

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General Information and Safety Safety

Occupancy Zones Figure 2: O-arm™ O2 Imaging System significant zones of occupancy

The primary zones 1 on either side of the patient table 7 are 1 m x 1 m (39 in x 39 in). The secondary zone 2 occupies most areas outside the primary zone. The tertiary zones 3 are areas 61 cm (24 in) wide extending away from each end of the IAS at the gantry door end and the cabinet 5 end, and a height of 200 cm from the floor.

Zone Occupancy During Fluoroscopic Procedures Personnel may occupy any of the zones when fluoroscopic procedures are performed, but should position themselves so that no part of their body is struck by the primary X-ray beam, unless that body part is protected by 0.5 mm lead equivalent. Additionally, all personnel in the room must wear protective garments of not less than 0.25 mm lead equivalent for protection from scattered radiation. •

During 2-D imaging, when the x-ray tube, indicated by the short row of lights in the gantry light ring, is lateral to the patient, personnel should occupy the primary zone 1 opposite the tube.

•

During 3-D mode imaging with the tube rotating in the gantry, personnel should occupy the tertiary zones 3 if possible.

X-ray Exposure Patterns Scatter rates around the O-arm™ gantry have been measured along the horizontal planes at 1.0 and 1.5 meter heights. Figures 3 and 4 show scatter patterns with the x-ray tube positions at the bottom of the gantry and the primary beam directed upwards. Figures 5 and 6 show scatters with the x-ray tube oriented laterally, and the primary beam directed toward the gantry door. Note: Isokerma maps in Figure 3 through Figure 6 were generated using 120 kVp with the field of view set to 100 cm. This setup complies with IEC60601-2-43:203.13.4.

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General Information and Safety Safety The typical shape of the isodose curves for a body scan indicates the optimum position for the operator is behind the IAS cabinet 3. This is the point of least scatter radiation. Figure 3: Isokerma map, values in µGy/Gy·cm2, 100 cm height, x-ray tube vertical.

1

2 3

1 Radiation beam orientation, vertical 2 X-ray focal spot 3 IAS Cabinet Note: In Figure 3, the curves are presented for 0.1, 0.25, 0.5, 1, 2, 4, 8, and 16 µGy/Gy·cm2.

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General Information and Safety Safety Figure 4: Isokerma map, values in µGy/Gy·cm2, 150 cm height, x-ray tube vertical.

1

2 3

1 Radiation beam orientation, vertical 2 X-ray focal spot 3 IAS Cabinet Note: In Figure 4, the curves are presented for 0.1, 0.25, 0.5, 1, 2, 4, 8, and 16 µGy/Gy·cm2.

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General Information and Safety Safety Figure 5: Isokerma map, values in µGy/Gy·cm2, 100 cm height, x-ray tube horizontal.

1

2 3

1 Radiation beam orientation, horizontal 2 X-ray focal spot 3 IAS Cabinet Note: In Figure 5, the curves are presented for 0.1, 0.25, 0.5, 1, 2, 4, 8, and 16 µGy/Gy·cm2.

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General Information and Safety Safety Figure 6: Isokerma map, values in µGy/Gy·cm2, 150 cm height, x-ray tube horizontal.

1

2 3

1 Radiation beam orientation, horizontal 2 X-ray focal spot 3 IAS Cabinet Note: In Figure 6, the curves are presented for 0.1, 0.25, 0.5, 1, 2, 4, 8, and 16 µGy/Gy·cm2.

Protective Clothing The following removable protective devices are recommended in the facility’s radiation protection policy: •

Protective shielding such as a lead apron, of not less than 0.25 mm lead equivalent, for protection from stray radiation. Use protective devices such as thyroid collars, leaded glasses, and lead shielding-screens, as necessary.

•

If no lead-shielding screen is available, the operator should stand directly behind the IAS cabinet, as illustrated in Figure 2. Note: Standing in this position is not a substitute for protective clothing such as lead aprons, thyroid collars, and leaded glasses.

•

Personnel should wear dosimetry badges per the facility’s radiation protection policy.

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General Information and Safety Safety

Radiation Safety Operating Precautions Warning: The O-arm™ O2 Imaging System produces ionizing radiation. Follow these safety practices during its operation. Misuse of the system could harm the patient or operator. Warning: Irradiation at high dose rates may interfere with pacemakers or other medical devices if the device is within the x-ray beam. •

Use the equipment only in areas designated for its use.

•

Have all personnel wear appropriate protective clothing and radiation monitoring devices while using the equipment.

•

Refer to the isokerma maps to view the typical x-ray exposure patterns that occur during imaging sessions. For details on these maps, see “X-ray Exposure Patterns” on page 15.

•

Be aware of visible and audible alerts that indicate when ionizing radiation is being produced by equipment in the work area.

•

Use the supplied patient spacer to ensure the patient is a safe distance from the x-ray tube. See “The Patient Spacer” on page 114 for more information about how to use the patient spacer.

•

Use the Radiation Disable button on the pendant (see page 48) or the Emergency Stop button on either the Image Acquisition System (IAS) power control panel or pendant whenever the system is not being moved or actively used to image anatomy. See the “Emergency Stop and Reset Buttons” on page 47.

General Exposure Precautions X-rays are potentially hazardous. Take every precaution to reduce the radiation dose that patients receive. In particular: •

During x-ray examination of pregnant women, take precautions to protect the embryo or fetus.

•

Shield sensitive body organs, such as the eye or gonads.

•

Follow safe operating procedures to avoid chronic radiation injury to users.

Caution: If using a contrast agent, follow the manufacturer’s instructions carefully to ensure highest possible image quality and to avoid having to retake images.

Avoid Prolonged Exposure •

Avoid excessive exposure, which can cause acute skin burns or hair loss in patients.

•

Avoid prolonged exposure. The O-arm™ O2 Imaging System is not intended for prolonged radioscopically guided procedures, such as cardiac catheterization.

Source-to-Skin Distance Before initiating fluoroscopy, make sure there is a minimum of 13 cm distance between the patient and gantry cover on the x-ray source side; this ensures that there is at least 30 cm between the patient and x-ray source.

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General Information and Safety Safety Warning: Exposure increases as the patient is positioned closer to the X-ray source. Failure to maintain the minimum source-skin distance may result in increased radiation exposure to the patient. See also, “Maximum Permitted Exposure Rates” on page 260 for more information about local skin dose level.

Use of Images in Image-Guided Treatments Images acquired on the O-arm™ O2 Imaging System may be used for image-guided surgery. When using O-arm™ images for image-guided surgery: •

Establish landmarks on the patient’s anatomy that you can use to verify the accuracy of the positions displayed in images.

•

Use these landmarks to verify the correct orientation of the images and the accuracy of the system during navigation.

•

Verify that the line-of sight between the tracker and tracking instrument remains clear and free of obstruction.

Warning: Frequently confirm navigational accuracy and system responsiveness during live navigation. Use the probe to touch bony anatomical landmarks and confirm that the locations identified on the images match the locations touched on the patient. Failure to verify the landmark locations on the image match the landmark locations on the patient may result in inaccurate navigation. If accuracy degrades, re-register the patient. Warning: Abort usage of the O-arm™ O2 Imaging System and contact Technical Services if images are unintentionally rotated or smeared. Caution: Materials in the x-ray beam, such as parts of the operating table or other accessories, may have an adverse effect on image quality and increase the dose to the patient. It is important to ensure that the maximum attenuation equivalent of tables, supports, and other accessories in the x-ray beam are as low as reasonably achievable. It is recommended that selection of tables and other accessories to be placed in the X-ray beam be made in consultation with a qualified medical physicist.

Imaging Patients with Electronic Medical Devices Patients with Electronic Medical Devices The FDA has reported that x-ray imaging machines can cause adverse effects on patients with implanted electronic medical devices such as: •

Pacemakers

•

Defibrillators

•

Neurostimulators

•

Drug Infusion pumps

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