Medtronic BI70002000 Instructions for Use

O-arm™ O2 Imaging System

BI-700-02000

User

Manual (USA Version)

Read this manual completely before using this device.

Document Title: O-arm™ O2 Imaging System User Manual (USA Version)

Document Number: BI-500-01161 Rev 02

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.

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.

02 2020-04 Update typo.

Contents

1.General Information and Safety

Indications for Use, Compliance, and Patient Environment ...............................9

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 ............................................................................................50

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 .......................................................59

Cable Connections .......................................................................................59

Changing User Authentication Settings........................................................ 65

Configuring the System with the Technical Service Console ........................... 68

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 ...................................................................................111

Imaging Overview .......................................................................................111

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

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

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 ..............................................................................................145

Overview .................................................................................................... 145

Image Control Buttons................................................................................ 145

Image Storage Capacity............................................................................. 146

Using the 2D Mode ........................................................................................148

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 ......................................................................160

Overview .................................................................................................... 160

M-2D Image Acquisition .............................................................................161

Manipulating Image Display in the M-2D Mode.......................................... 162

Using 3D Modes ............................................................................................163

Overview .................................................................................................... 163

3D Image Acquisition ..................................................................................... 165

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 Pediatric or Small Patients......................................170

Pendant Buttons and Indicators for X-rays................................................. 171

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 Naviga-

tion 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

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 ......................................................206

Adding Text and Orientation Markers to Images ........................................206

Adding Lines and Arrows to Images ...........................................................207

Adding Angle Measurements to Images.....................................................208

Image Stitching ...............................................................................................214

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 .........................................................224

Overview ........................................................................................................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

10.Acronyms, Labels and Technical References

Acronyms .......................................................................................................243

Labels and Symbols .......................................................................................244

Specifications ............................................................................................. 252

Safety Classifications and Standards.........................................................265

Electromagnetic Compatibility ....................................................................267

Dose Evaluation Methods .......................................................................... 273

A.User QC Test Procedures

List of User QC Tests ..................................................................................... 275

Contacting Medtronic technical service ..........................................................275

List of test equipment .....................................................................................275

Checking General System Safety .................................................................. 276

Radiation safety.......................................................................................... 276

Electrical safety .......................................................................................... 276

Physical safety ...........................................................................................277

Testing the system startup functionality ..................................................... 277

Safety Inspections ..........................................................................................278

Testing the Emergency Stop......................................................................278

X-ray safety inspection ............................................................................... 279

Mechanical safety inspection ..................................................................... 281

Testing 2D Fluoroscopy Image Quality and Dose ..........................................285

Measuring 2D fluoroscopy output............................................................... 285

Testing the 2D fluoroscopic output............................................................. 286

Testing 3D Volumetric Image Quality and Dose ............................................. 298

3D Dose Accuracy......................................................................................298

3D Image Quality........................................................................................ 303

1 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 for adult and pediatric patients weighing 60 lbs or greater and having an abdominal thickness greater than 16 cm, 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.

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

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.

General Information and Safety

Indications for Use, Compliance, and Patient Environment

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.

General Information and Safety

Safety

Overview

Potential hazards exist in the use of medical electronic devices and x-ray systems such as the

™

O-arm 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

Warning: This x-ray unit may be dangerous to patient and operator unless safe

exposure factors, operating instructions, and maintenance schedules are observed.

O2 Imaging System. Personnel using the equipment should understand the safety issues,

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.

Occupancy Zones

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

General Information and Safety

Safety

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

• During 3-D mode imaging with the tube rotating in the gantry, personnel should occupy the

tertiary zones

3 if possible.

1 opposite the tube.

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 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.

3 and 4 show scatter patterns with the x-ray tube positions at the bottom

Note: Iso-kerma 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.

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 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·cm

General Information and Safety

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

Safety

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·cm

General Information and Safety

Safety

Figure 5: Isokerma map, values in µGy/Gy·cm

, 100 cm height, x-ray tube horizontal.

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·cm

Figure 6: Isokerma map, values in µGy/Gy·cm

General Information and Safety

, 150 cm height, x-ray tube horizontal.

Safety

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·cm

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

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.

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 “

• 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.

X-ray Exposure Patterns” on page 15.

• 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 “ Reset Buttons” on page 47.

Emergency Stop and

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.

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

General Information and Safety

Safety

Images acquired on the O-arm™ O2 Imaging System may be used for image-guided surgery. When using O-arm

• 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

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.

™

images for image-guided surgery:

™

O2 Imaging System and contact Technical Services if images

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

General Information and Safety

Safety

Precautions During Imaging

Before taking images or beginning a scan, the operator should use scout views to determine if implanted or externally worn electronic medical devices are present and if so, their location relative to the programmed scan range.

For procedures in which the medical device is in or immediately adjacent to the programmed scan range, the operator should:

• Determine the device type

• If practical, try to move external devices out of the scan range

• Ask patients with neurostimulators to shut off their devices temporarily while the scan is

performed

• Minimize x-ray exposure to an implanted or externally worn electronic medical device by:

– Using the lowest possible x-ray tube current consistent with obtaining the required image

quality

– Making sure that the x-ray beam does not dwell over the device for more than a few seconds

Warning: For procedures that require continuous scanning over an electronic medical device for

more than a few seconds, attending staff should be ready to take emergency measures to treat adverse reactions if they occur.

Post-imaging

After scanning directly over the implanted or externally worn electronic medical device:

• Have the patient turn the device back on if it was turned off prior to imaging.

• Have the patient check the device for proper functioning, even if the device was turned off.

• Advise patients to contact their health care provider as soon as possible if they suspect their

device is not functioning properly after imaging.

Electromagnetic Compatibility

Overview

The O-arm™ O2 Imaging System emits low levels of radio frequency energy. To avoid interference with or from other devices, use the equipment according to the instructions in this manual.

Complete tables for electromagnetic compatibility are in Chapter 10.

Electrical Interference from Other Devices

If interference from other devices affects the O-arm™ O2 Imaging System or the system experiences unintended motor or x-ray actuation, immediately press the Emergency Stop button to disable x-ray and motion functions. See “

Emergency Shutdown” on page 29.

General Information and Safety

Safety

Radio Frequency Equipment

Portable and mobile RF communications equipment can affect medical electrical equipment.

Electrical Interference with Other Devices

If the O-arm™ O2 Imaging System seems to be causing interference with other devices, try the following steps:

• To verify that the O-arm™ O2 Imaging System is the cause of the problem, turn it off and then

back on again while monitoring the affected device.

• If possible, relocate the affected device with respect to the O-arm™ O2 Imaging System or vice

versa.

• Plug the affected device’s power cord into a different power outlet so that it is on a different

branch circuit from the O-arm

• Check that the original power and MVS interconnect cables have not been damaged or replaced.

If the interference problem still exists, call the Medtronic technical service desk for assistance. See “

Medtronic Technical Service” on page 10 for telephone numbers.

Electrical Safety

Observe the following safety procedures to avoid electric shock or serious injury to users and patients and to avoid system malfunction.

Power Sources

• Only operate systems in designated-use areas with approved AC power outlets.

• Make electrical connections to other equipment while outside the patient environment.

Warning: Be aware that the Image Acquisition System (IAS) contains storage batteries that are a

source of strong electrical current, even when AC power is removed.

Warning: To avoid the risk of electric shock, this equipment must only be connected to a supply

mains with protective earth.

™

O2 Imaging System.

Caution: Do not plug the O-arm

other devices; its maximum current rating will use most of the branch circuit's capacity.

™

O2 Imaging System into the same branch circuit that supplies

Equipment Connections

The O-arm™ O2 Imaging System is only intended for connection to other IEC 60950-1 or IEC 606011 certified equipment. The user is responsible for ensuring that any equipment configuration still complies with 60601-1 system requirements.

General Information and Safety

Safety

Potential Equalization Connector

The IAS and MVS include a equipotential ground point (potential equalization connector), see Figure 14 on page 42, and Figure 27 on page 60. This connector can be used to connect the O-arm to a common ground to reduce potential differences between equipment or facilities. In all cases interconnected equipment used within the patient environment must meet the leakage current requirements of IEC 60601-1, or national equivalents.

Equipment Handling

• Do not remove assembly covers. Only trained service representatives should service or repair

the equipment.

Warning: Do not remove cabinet covers. Certain electrical circuits inside the equipment use

dangerously high voltages. Failure to heed this warning could result in serious injury or death.

• Do not bypass, jumper, or otherwise disable the safety interlocks.

• Do not place food or beverage containers on the equipment. If spilled they can cause short

circuits.

• Remove power to the equipment before cleaning. Refer to “Powering Down and Storing the

System” on page 219 for cleaning instructions.

Isolating the Mains Power supply

Mains power can be disconnected from the IAS by disconnecting the MVS interconnect cable from the IAS connector panel. See “ MVS remains powered as long as it is plugged into the facility power outlet.

Mains power into the MVS may be disconnected from the system by unplugging the AC power cord from the facility power outlet.

Once the MVS is unplugged from the facility power outlet, the MVS remains powered for a short duration to facilitate moving the MVS from one location to another within a time period of 10 minutes or less.

IAS Connector Panel” on page 42 for more information. However, the

Ground Fault Alarm

If the operating room has a ground fault alarm and the alarm is actuated:

• Do not operate the system.

• Call the Medtronic technical service desk for assistance. See “Medtronic Technical Service” on

page 10.

Caution: When working in the vicinity of the O-arm™ IAS and MVS, use care to avoid tripping over

the power and interconnect cables.

Ground Fault Detector on Battery

The O-arm™ O2 Imaging System contains an internal ground fault detector on the battery. If the battery system detects a ground fault (current flowing to the middle of the battery stack), the generator contactor is switched off and an error message is recorded in the system’s log file.

General Information and Safety

Electrical Fire Safety

Ensure that your emergency procedure for handling an electrical fire includes these steps:

1. Press the Emergency Stop button to disable x-ray and motion functions.

2. Remove electrical power to the system by placing the power switches on the IAS and MVS to

their off positions.

3. Unplug the MVS power cord from the AC wall receptacle.

4. Evacuate personnel from the area.

5. Use a fire extinguisher that is approved for use on electrical fires.

Safety

Warning: Make sure that a fire extinguisher approved for use in an electrical fire is available in

the room where the O-arm extinguisher can result in electrical shock and burn hazards.

6. Call the local fire department for help.

Mechanical Safety

Positioning Safety

The O-arm™ IAS (gantry plus positioner) is a motorized assembly that is capable of moving in all three (x, y and z) planes of reference and pivoting about the three axes with tilt and wag motions. It also contains a telescoping door assembly. Follow these precautions when moving the O-arm

• Observe the immediate surroundings when operating the gantry to avoid pinching or collision

with a person or object.

• Use care when working around the gantry to avoid unintentional motor actuation.

• Do not place objects on the gantry or bump or lean against it.

• Observe and prevent articles of clothing from getting caught in moving parts.

Warning: Do not use the O-arm™ O2 Imaging System if the supplied ratchet wrench and T-shaped

rotor alignment tools are not present. These tools are required for opening the Image Acquisition System (IAS) door manually in case of an emergency. These tools are stored in the utility drawer on the Mobile View Station (MVS). For instructions on opening the IAS door manually, see page

235.

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O2 Imaging System is used. Use of the wrong type of fire

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IAS:

Warning: When the Image Acquisition System (IAS) is not in use, or if it is unattended, engage the

Emergency Stop button. See “Emergency Shutdown” on page 29.

Warning: Keep clear of the door when it is partially open or while opening or closing. Do not move

the O-arm

Warning: Do not drive the Image Acquisition System (IAS) or move the gantry without being aware

of all objects, equipment, obstacles or persons that may collide with the device as it moves.

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Image Acquisition System (IAS) over the patient unless the door is fully opened.

General Information and Safety

Safety

Collision Zone Warning

If you move the IAS gantry toward the dock base, a Collision zone warning will appear on the pendant screen to warn the user that further movement of the IAS gantry could potentially collide with the dock base (see Figure motion stops automatically. To restart motion of the IAS gantry, move it up and/or away from the Collision zone by unpressing and pressing the gantry motion buttons on the pendant. For instructions on using the pendant to position the gantry, see “ and Beam Positioning” in Chapter 6.

7). When the IAS gantry enters the Collision zone, the IAS gantry

Pendant Buttons for Gantry Movement

Figure 7: Collision zone warning

Checking the System After A Collision

If a collision occurs during transport or use, confirm functionality of the system using the performance checks detailed in Contact Medtronic technical service if any functionality has been affected by the collision.

Chapter 9 (see “Performance Checks and Maintenance” on page 224 for details).

Transport Safety

When moving the O-arm™ IAS, use care to avoid colliding with or running over objects or people. All users must be familiar with stopping, steering, and movement controls. Never drive the O-arm from the side - always stand to the rear.

Warning: The Image Acquisition System (IAS) weighs approximately 885kg (1,950 lbs). Move the

IAS slowly using the battery-powered drive transport wheels. Do not disengage the drive wheels during transport, especially on an incline. Use special care when crossing thresholds and moving up or down ramps. Be aware of all obstacles and people along the path. Collision with people or physical objects can result in personal injury or equipment damage.

Warning: The gantry must be docked when you move the Image Acquisition System (IAS). Use

special care on steep slopes (>5º) and when crossing ramps and thresholds.

Caution: Transportation of the O-arm

special handling, packing, and strapping procedures to prevent injury to movers or damage to the equipment. Contact Medtronic technical service for detailed instructions.

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O2 Imaging System between facilities in a truck requires

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IAS

Caution: Engage the lateral shift wheels only on a level surface. The IAS will roll sideways if the

lateral shift wheels are engaged on a tilted surface.

Pinch Hazard

Warning: Keep body parts clear of the gantry door whenever the door and door sidewalls are

closing. Keep body parts clear of the gantry itself when it is in motion.

General Use Safety

Lasers

Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice 50, dated June 24, 2007.

The wireless mouse emits Class 2 laser light.

Warning: Do not point laser radiation at audience.

Caution: Laser radiation. Do not stare into beam. Class 2 laser product.

The laser alignment lights emit Class 1M laser light.

General Information and Safety

Safety

Do not view the beam of the laser alignment lights directly with optical instruments such as binoculars, telescopes, or microscopes.

Caution: The laser alignment lights emit Class 1M laser radiation. Do not view directly with optical

instruments.

Infection Safety

The O-arm™ O2 Imaging System is intended to be used in surgical procedures. The MVS and chassis should be cleaned as described in “

To protect the sterile field, drape the O -arm™ gantry as described in “Using the Door and Preparing the Gantry” on page 111.

Warning: To prevent cross-contamination, always handle, transport, and reprocess devices that

contact the central nervous system separately from other devices.

Cleaning” on page 220.

Enclosure Integrity

The X-ray gantry (the “O”) is enclosed in protective enclosures (skins) made of a non-conductive plastic material. This protective enclosure isolates the patient and operator from contact with components that could present risks of electric shock, burns or pinching of fingers or hands. If the protective enclosure is compromised in any way, the system should not be used unless it can be confirmed that the damage is purely cosmetic in nature.

Explosion Safety

Warning: Do not operate the O-arm™ O2 Imaging System in the presence of flammable anesthetics,

explosive liquids or gases. If such substances are detected, follow the instructions below. Failure to heed this warning could result in serious injury or death.

Warning: The O-arm

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O2 Imaging System is not intended for use in an oxygen rich environment.

General Information and Safety

Safety

If the presence of flammable anesthetics, explosive liquids or gases are detected in the vicinity of the O-arm

Do not plug in or turn on the equipment if such substances are detected prior to start up. If they are detected after the system is turned on, do not immediately turn off or unplug the equipment. Evacuate all personnel and ventilate the area before turning off the system.

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O2 Imaging System, cease operations immediately.

Avoiding Ingress of Fluids

Fluids, such as antiseptics, cleaning solutions, or bodily fluids, may damage internal components if they enter the equipment. Conductive fluids that contact active circuits may cause short circuits and electrical fires. To avoid these mishaps:

• Do not apply excessive amounts of fluid when cleaning.

• Use drapes, if necessary, to protect equipment when performing procedures.

Note: Draping equipment may restrict airflow to components and vents that cool the equipment.

Drape equipment and cover vents only during procedures when appropriate for bioburden control or exposure to fluids is expected. Remove the drapes as soon as the procedure allows.

Warning: The O-arm

into the equipment, remove power and disconnect the Mobile View Station (MVS) power cord. Do not operate the system until it can be cleaned and inspected by a qualified service engineer.

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O2 Imaging System is not rated for watertight operation. If liquids drip

Environmental Safety

The batteries and x-ray assembly are hazardous to the environment. Dispose of them in accordance with local environmental regulations. Refer to your local agencies for disposal instructions.

Emergency Procedures

Preparation and Training

Have all personnel who use the O-arm™ O2 Imaging System learn and practice the procedures for both manually and electronically opening the gantry door, so that they can perform them quickly in an emergency.

Patient Requires CPR

Prior to beginning any procedure, consider your ability to perform CPR on the patient, if necessary. The gantry may be moved in two ways that allow access to a patient requiring CPR.

• Using the wag, tilt, and longitudinal controls, move the gantry into a position that allows sufficient

access for CPR. See “

• Using the Lateral Shift capability, push the IAS out of the way of persons performing CPR.

Follow the directions on page 112 for positioning the gantry to allow CPR.

Gantry Movements” on page 123.

General Information and Safety

In Case of Emergency

• Ensure the safety of the patient and medical personnel first, and then the safety of the equipment.

• Do not leave a patient unobserved in the area of the equipment.

• If there appears to be danger to the patient, press either of the Emergency Stop buttons on the

IAS, except in the presence of flammable anesthetics, explosive gases or liquids. See “Explosion Safety” on page 27.

• Follow safety procedures for the situations described in this chapter.

• Contact an authorized Medtronic Service Representative to report the incident and receive

further instructions.

Equipment Failure

If any of the equipment controls fail to respond as indicated in this manual, or if a circuit breaker trips:

• Perform the troubleshooting procedures detailed in Chapter 9. For MVS problems, see page 239.

For IAS problems, see page 241.

• If the equipment problems persist, cut off electrical power to the system. Turn off the IAS and MVS by pressing and holding their Power buttons for 5 seconds.

Safety

• Unplug the MVS power cord from the wall.

Warning: The Image Acquisition System (IAS) contains storage batteries that are a source of

strong electrical current, even when AC power is removed.

• Notify the Medtronic technical service desk. See “Medtronic Technical Service” on page 10.

• Do not operate the equipment until the service technician confirms that it is operating properly.

Emergency Shutdown

To disable the x-ray and motion functions of the O-arm™ O2 Imaging System at any time, press either of the Emergency Stop buttons (see Figure while the other is located on the IAS Power Control panel (2).

Warning: Press the Emergency Stop button any time that unexpected movement or X-ray

actuation occurs.

Familiarize yourself with the control functions for the control panel (on page 43) and the pendant (on page 46) prior to operating the system.

Refer to “Unintended Emergency Shutdown (E-Stop)” for instructions on how to recover from unintended activation of E-Stop.

8). One button is located on the pendant (1),

General Information and Safety

Safety

Resetting the Emergency Stop

Figure 8: Emergency Stop buttons

To return the system to normal operating conditions, press the Emergency Stop Reset button (1) on the pendant.

Figure 9: Emergency Stop Reset button

+ 278 hidden pages

Medtronic BI70002000 Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual

1 General Information and Safety

Indications for Use, Compliance, and Patient Environment

Indications for Use and Responsibilities

Patient Environment

Safety

Overview

Personnel Safety

Radiation Safety

Use of Images in Image-Guided Treatments

Imaging Patients With Electronic Medical Devices

Electromagnetic Compatibility

Electrical Safety

Mechanical Safety

General Use Safety

Emergency Procedures