[go: up one dir, main page]

100% found this document useful (1 vote)
109 views251 pages

O-Arm User Manual

Medtronic O-arm User Manual

Uploaded by

marksupanich
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
100% found this document useful (1 vote)
109 views251 pages

O-Arm User Manual

Medtronic O-arm User Manual

Uploaded by

marksupanich
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 251

User Manual

O-arm® Imaging System

BI-500-00171

Revision 02
2014-03
User Manual
O-ARM® IMAGING SYSTEM

BI-500-00171
Revision 02
2014-03
Copyright © 2014 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 and Iso-wag are registered trademarks of Medtronic Navigation, Inc. All other product or service names
are the property of their respective owners.

Revision Release Date Application

Revision 02 2014-03 Describes the operation of the O-arm® Imaging System with
software version 3.2. If you have a later version of software,
please check the release notes to determine if this manual is
still current for your version.

iii O-arm Imaging System User Manual


Contents

Contents
Preface
About This Manual ......................................................................................1-ix
Conventions Used in This Manual............................................................1-x
Related Documents and Contact Information .........................................1-xi

1. General Information and Safety


Indications for Use, Compliance, and Patient Environment......................... 1-2
Indications for Use and Responsibilities ................................................. 1-2
Technical Support and Ordering Accessories ......................................... 1-4
Regulations and Standards Compliance................................................. 1-5
Patient Environment ................................................................................ 1-6
Safety .......................................................................................................... 1-8
Overview ................................................................................................. 1-8
Personnel Safety ..................................................................................... 1-9
Radiation Safety.................................................................................... 1-14
Use of Images in Image-Guided Treatments......................................... 1-15
Imaging Patients With Electronic Medical Devices ............................... 1-16
Electromagnetic Compatibility............................................................... 1-17
Electrical Safety .................................................................................... 1-18
Mechanical Safety................................................................................. 1-20
General Use Safety ............................................................................... 1-22
Emergency Procedures......................................................................... 1-24

2. System Overview
Introduction to the System........................................................................... 2-2
Overview ................................................................................................. 2-2
The Image Acquisition System (IAS) ...................................................... 2-3
The Mobile View Station (MVS) .............................................................. 2-4
Acquisition Modes ................................................................................... 2-5
X-ray Options .......................................................................................... 2-7
Patient Exam Data Capabilities............................................................... 2-8

3. Controls & Indicators


IAS Controls and Indicators......................................................................... 3-2
IAS Connector Panel............................................................................... 3-3
The Power Control Panel ........................................................................ 3-4
The Pendant............................................................................................ 3-6
Hand and Foot Switches ......................................................................... 3-8
MVS Components ..................................................................................... 3-10
The Mobile View Station ....................................................................... 3-10
The Monitor ........................................................................................... 3-12
The Keyboard and Wireless Mouse ...................................................... 3-13
Locking casters.......................................................................................... 3-15

O-arm Imaging System User Manual iv


Contents

4. Powering Up and Configuring the System


Connecting and Powering Up the System................................................... 4-2
Cable Connections.................................................................................. 4-2
Configuring the System ............................................................................... 4-3
Configuring Interface Language and Units.............................................. 4-5
Configuring Date and Time ..................................................................... 4-6
Setting Up DICOM Export Configurations............................................... 4-7
Connecting to the Network...................................................................... 4-7
Configuring a Worklist Server ................................................................. 4-9
Connecting and Configuring an IGS System Connection ..................... 4-11
Configuring the DICOM Store Server ................................................... 4-15
Adding to and Modifying the Physicians List......................................... 4-17
Optimizing the Monitor Display ............................................................. 4-19

5. Setup in the OR
Moving the System ...................................................................................... 5-2
Moving the IAS........................................................................................ 5-2
Powering Up the System ............................................................................. 5-4
Unpacking and Activating the Mouse ...................................................... 5-6
Entering Patient Information ........................................................................ 5-8
Entering New Patient Data at Time of Examination ................................ 5-9
Patients in the Scheduled Exams Page ................................................ 5-11
Acquiring Patient Information from Outside Sources ............................ 5-14
Applying a Sterile Drape to the Gantry...................................................... 5-17
General Information .............................................................................. 5-17
The Tube Drape .................................................................................... 5-18
The Non-Laser Tube Drape, (BI-900-00034) ........................................ 5-25
The Bar Drape....................................................................................... 5-26

6. Positioning the Gantry


Introduction to Imaging................................................................................ 6-2
Imaging Overview ................................................................................... 6-2
Using the Door and Preparing the Gantry................................................... 6-3
Work Flow Recommendations For Using the O-arm® Door.................... 6-3
Positioning the Gantry ................................................................................. 6-4
Positioning the Gantry For Imaging......................................................... 6-6
Pendant Buttons for Gantry Movement and Beam Positioning ............... 6-9
Gantry Movements .................................................................................... 6-12
The Gantry Docked Position ................................................................. 6-13
Gantry Tilt Control................................................................................. 6-14
Gantry Up and Down Control................................................................ 6-15
Gantry Iso-wag Control ......................................................................... 6-16
Gantry Wag Control .............................................................................. 6-17
Gantry Transverse (In/Out) Control ....................................................... 6-18
Gantry Longitudinal (Left/Right) Control ............................................... 6-19
Aligning the X-ray Beam Path.................................................................... 6-20
The Laser Alignment Kit (LAK) ............................................................. 6-22

v O-arm Imaging System User Manual


Contents

Moving the Gantry Out of the Way ............................................................ 6-25


Positioning the Gantry Out of the Way for Surgery ............................... 6-25
Moving the IAS Laterally ....................................................................... 6-26
Moving the IAS Away from the Operating Table.................................... 6-27

7. Imaging
Imaging Modes ............................................................................................ 7-2
Imaging Overview ................................................................................... 7-2
Image Control Buttons ............................................................................ 7-3
Image Storage Capacity .............................................................................. 7-4
Using the 2D Mode...................................................................................... 7-7
General Information ................................................................................ 7-7
Acquiring 2D Images............................................................................... 7-8
Optimizing 2D Image Quality Using the Softkeys ................................... 7-9
Manipulating Image Display in the 2D Mode......................................... 7-10
Viewing a Region of Interest (ROI) ....................................................... 7-12
Storing Positions and Acquisition Settings ............................................ 7-14
Using the Multi-plane 2D Mode ................................................................. 7-15
General Information .............................................................................. 7-15
M-2D Image Acquisition ........................................................................ 7-16
Image Manipulation in M-2D Mode ....................................................... 7-17
Using 3D Modes ........................................................................................ 7-18
General ................................................................................................. 7-18
3D Image Acquisition ............................................................................ 7-20
Selecting Acquisition Settings ............................................................... 7-21
Acquiring a 3D Scan ............................................................................. 7-24
Image Manipulation in the 3D Mode ..................................................... 7-26
Advanced Imaging Features in 3D Mode .............................................. 7-29
Dose Reporting ......................................................................................... 7-31
Overview ............................................................................................... 7-31
Viewing, Saving and Exporting Dose Reports ...................................... 7-33

8. Handling Patient Data


Handling Patient Data.................................................................................. 8-2
Accessing and Reviewing Patient Exams ............................................... 8-2
Exporting Patient Studies and Images .................................................... 8-8
Exporting Images Across a Network....................................................... 8-9
Editing and Deleting Database Entries...................................................... 8-11
Correcting Patient Data Entry Errors..................................................... 8-11
Deleting Entries from the Database ...................................................... 8-14
Image Annotation ...................................................................................... 8-15
Using the Annotation Editor I —General ............................................... 8-16
Annotation Toolbars .............................................................................. 8-17
Using the Annotation Editor II — Text and Markers .............................. 8-20
Using the Annotation Editor III — Lines and Arrows ............................. 8-21
Image Stitching.......................................................................................... 8-22

O-arm Imaging System User Manual vi


Contents

9. Maintenance and Troubleshooting


Powering Down and Storing the System ..................................................... 9-2
Powering Down ....................................................................................... 9-2
Cleaning .................................................................................................. 9-3
Storing the System.................................................................................. 9-5
Charging the Batteries ............................................................................ 9-6
Performance Checks and Maintenance ...................................................... 9-7
Overview ................................................................................................. 9-7
User Performance Checks ...................................................................... 9-8
Periodic Maintenance - Gain Calibrations ............................................. 9-11
Emergency Procedures............................................................................. 9-18
Opening the Gantry Door When the System is Unresponsive .............. 9-18
Moving the Gantry When Battery Power is Low.................................... 9-21
Emergency Shutdown ........................................................................... 9-22
Troubleshooting ......................................................................................... 9-23

10. Labels and Technical Reference


Labels and Symbols .................................................................................. 10-2
Specifications ............................................................................................ 10-7
Safety Classifications and Standards ...................................................... 10-16
Electromagnetic Compatibility ................................................................. 10-17
Dose Evaluation Methods........................................................................ 10-21
Dose Evaluation in 3D Modes............................................................. 10-21
Dose Evaluation in 2D Fluoroscopy Modes ........................................ 10-21

vii O-arm Imaging System User Manual


Preface 0

This preface describes the conventions used in this manual and provides contact information.

About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix


Conventions Used in This Manual ..............................x

Related Documents and Contact Information . . . . . . . . . . . . . . . . . . . . xi

O-arm Imaging System User Manual viii


About This Manual

About This Manual


Use of This Manual This user manual describes the operation of the Medtronic O-arm® Imaging System consisting of
the Image Acquisition System (IAS) and the Mobile View Station (MVS). It is not designed to
replace or substitute for certified training in the radiological or medical field.

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 O-arm® Imaging System, all users should read this manual and
the labels on both units of the system.

ix O-arm Imaging System User Manual


About This Manual

Conventions Used in This Manual

Cautions and
Warnings
Cautions are indicated by the symbol at left.
Failure to observe a caution could result in damaged equipment, forfeited
time or effort, or the need to abort use of the system.

Warnings are indicated by the symbol at left. Failure to observe a warn-


ing may result in physical injury to the patient or operator. Pay special
attention to these items.

Notes Note: Notes identify important points, helpful hints, special circumstances, or alternative
methods.

Instructions and ■
References to buttons on the display are enclosed in square brackets. For example:
References to the Click [Edit...].
System ■ References to titles of windows and dialog boxes are denoted by italics.

References to menu options, tabs, and drop-down selections are in bold letters. For example:
On the System Technical Service Console, click on the MVS Station tab.

References to keys on the keyboard are enclosed in arrow brackets. For example:
Type in your password and press <Enter>.
■ Sequential steps are indicated by a numbered list.

Non-sequential but related items are indicated by a bulleted list.

The instruction “click” on an object means to place the pointer over the object using the
system mouse, and press and release the left mouse button.
■ “Select” and “Highlight” are used interchangeably.

“Right-click” means click with the right button instead of the left button.

“Double-click” means click twice in rapid succession.

O-arm Imaging System User Manual x


About This Manual

Buttons and Switches Buttons on the Pendant and switches on the power control panels are identified by icons. The
icon for each button or switch may appear in their references. For example:

Press the Open Door button on the Pendant to open the gantry door.

Turn the power switch on the IAS to the Start position.

Related Documents and Contact Information

Related Documents
Document Name Purpose Document Number

O-arm® Imaging System Describes troubleshooting, BI-500-00080


Service Manual maintenance, calibration, and field
replaceable units of the system.

O-arm® Imaging System Provides a quick reference of the BI-700-00027-016


Pendant Control Panel functions of buttons on the Pendant.
Quick Reference Guide

O-arm® Imaging System Provides a quick reference of the BI-700-00027-025


MVS Keyboard Quick functions of the special key
Reference Guide assignments on the MVS keyboard.

Contact Information Within the United States


Toll-free dial (800) 595-9709
Fax: (720) 890-3500

International
Telephone: (720) 890-3200
Fax: (720) 890-3500

Medtronic Authorized Representative in the E.C.


Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
NETHERLANDS
Tel. 31 45 566 80 00

World Wide Web


www.medtronicnavigation.com

Regular Mail
Medtronic Navigation, Inc.
Attn: Customer Care
826 Coal Creek Circle
Louisville, CO, U.S.A.
80027

xi O-arm Imaging System User Manual


General Information and
Safety 1 1
This chapter describes the intended use and regulatory compliance of the O-arm® Imaging System
and provides comprehensive information on its safe handling and operation.

Indications for Use, Compliance, and Patient Environment . . . . . 1-2


Indications for Use and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

Technical Support and Ordering Accessories . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

Regulations and Standards Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

Patient Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6

Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Personnel Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9

Radiation Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14

Use of Images in Image-Guided Treatments . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15

Imaging Patients With Electronic Medical Devices . . . . . . . . . . . . . . . . . . . . . 1-16

Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17

Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18

Mechanical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20

General Use Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22

Emergency Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24

O-arm Imaging System User Manual 1-1


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

Indications for Use, Compliance, and Patient Environment

Indications for Use and Responsibilities

Indications for Use The O-arm® 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® Imaging System is compatible with certain Image Guided Surgery Systems.
Note: United States law restricts this device to sale, distribution, and use by or on the order of a
physician.

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

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

Equipment users Users of the O-arm® Imaging System should be trained, licensed, and/or certified in the proper
use of medical X-ray equipment and its medical applications. Users should read this user manual
and the labels on the Image Acquisition System (IAS) and the Mobile View Station (MVS).

Owner
Responsibilities
WARNING - No unauthorized modification
Do not modify the O-arm® Imaging System unless authorized by Medtronic Navigation,
Inc. Unapproved modifications could have hazardous consequences or impact confor-
mance 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.

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

1-2 O-arm Imaging System User Manual


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

■ 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 situations, if any, and of related
product corrections.

O-arm Imaging System User Manual 1-3


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

Technical Support and Ordering Accessories

Technical Support For technical assistance, contact Medtronic Navigation Inc.


• Within the United States:
– Toll-free dial (800) 595-9709
– or dial (720) 890-3200
• Worldwide: dial +1-720-890-3200

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

Accessory Description Part Number


Control Pendant Optional Remote Pendant 9732720
Sterile Laser Tube Drape, Case A case of twenty (20) 9732722
Sterile Non-Laser Tube Drape, A case of twenty (20) BI-900-00034
Case
Sterile Bar Drape, Case A case of twenty (20) 9733023
Sterile 1-D Mouse, Case A case of ten (10) 9732721
Patient Spacer One (1) BI-400-00015
Laser Alignment Kit One (1) BI-710-00039

To order any of the accessory items, call Medtronic Navigation Inc. technical support.

1-4 O-arm Imaging System User Manual


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

Regulations and Standards Compliance

Regulatory Affairs Address questions and comments regarding regulatory affairs to the representatives listed below.
Contacts
In the United States
Contact the Quality and Regulatory Affairs Department, telephone 1-866-THE-OARM (1-866-
843-6276).

International
Contact the Quality and Regulatory Affairs Department, telephone 1-978-698-6000.

Europe
Contact the European Union Authorized Representative:
Director, Regulatory Affairs–Europe
Medtronic B. V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands

DICOM Conformance To obtain a copy of the DICOM Conformance Statement (BI-700-0028-030), contact Medtronic
technical support.

Device Compatibility 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 (or national equivalents).
• When used outside of the patient environment, each externally connected device must
comply with applicable IEC/ISO requirements for that device.
• Do not allow the combination of all externally connected equipment to cause the leakage
current of any device used within the patient environment (see below) to exceed the limits
stated in IEC 60601-1-1 (or national equivalents).
• Select the operating table and its attachments to minimize the effect on the X-ray beam
passing through the table.

O-arm Imaging System User Manual 1-5


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 may come in contact with the patient,
or likely to be contacted by the patient, as described in the following paragraphs.

In the United States In the United States the patient environment is defined by NFPA 99 and UL 60601-1.

6.00 ft.

6.00 ft. 6.00 ft. 7.50 ft.

Figure 1-1 Patient Environment In the United States (Top: top view, Bottom: side view)

For surgery, the patient environment encompasses the space 6 feet beyond the perimeter of the
operating table 1 in its intended location and extends vertically 7.5 feet above the floor.

1-6 O-arm Imaging System User Manual


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

Outside the United Outside the United States the patient environment is defined by IEC 60601-1.
States

1.5 m

1.5 m 1.5 m 2.5 m

Figure 1-2 Patient Environment Outside the United States (Top: top view, Bottom: side view)

For surgery, the patient environment encompasses the space 1.5 meters beyond the perimeter of
the operating table 1 in its intended location and extends vertically 2.5 meters above the floor.

O-arm Imaging System User Manual 1-7


General Information and Safety
Safety

Safety

Overview

Potential hazards exist in the use of medical electronic devices and X-ray systems such as the O-
arm® Imaging System. Personnel using the equipment should understand the safety issues,
emergency procedures, and the operating instructions provided herein.
Address questions and comments regarding safety to the Regulatory Affairs representative listed
under “Regulatory Affairs Contacts” on page 1-5.

Safety Hazard Alerts in Throughout this guide, the warning symbol indicates important safety information.
This Guide
Warnings are indicated by the symbol at left. Failure to observe a warning
may result in physical injury to the patient or operator. Pay special atten-
tion to these items.

Safety Symbols on the The following safety symbols appear on the system.
Equipment

Electrical Shock Hazard

Refer to User Instructions

Pinch Hazard

Do Not Push

Keep clear of the door when it is partially open or while opening or closing.
Do not move the O-arm over the patient unless the door is fully opened.

1-8 O-arm Imaging System User Manual


General Information and Safety
Safety

Personnel Safety

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

Occupancy Zones

3
2 2

1 1

7 6
1 1
5
2 2
3
Figure 1-3 O-arm® 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 5end.

Zone Occupancy Personnel can occupy any of the zones when fluoroscopic procedures are performed, but should
During Fluoroscopic be positioned such that no part of the body will be struck by the X-ray useful beam, unless
Procedures protected by 0.5 mm lead equivalent.
• 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 Scatter rates around the O-arm® gantry have been measured along a horizontal (Figure 1-4 and
Patterns Figure 1-5) and vertical planes (Figure 1-6 and Figure 1-7) at -height using the body and head
dosimetry phantoms. Iso-kerma maps in Figure 1-4 through Figure 1-7 were generated using 120
kVp with collimators fully opened.

O-arm Imaging System User Manual 1-9


General Information and Safety
Safety

Typical shape of the isodose curves for a body scan indicates the optimum position for the
operator is behind the IAS cabinet 2. This is the point of least scatter radiation.Figure 1-7

Figure 1-4 Isokerma map for vertical beam at 1.0 meter height (uGy per Gy*cm^2)

1 Patient table
2 IAS cabinet
3 X-ray focal spot

1-10 O-arm Imaging System User Manual


General Information and Safety
Safety

Figure 1-5 Isokerma map for vertical beam at 1.5 meter height (uGy per Gy*cm^2)

1 Patient table
2 IAS cabinet
3 X-ray focal spot

O-arm Imaging System User Manual 1-11


General Information and Safety
Safety

Figure 1-6 Isokerma map for horizontal beam at 1.0 meter height (uGy per Gy*cm^2)

1 Patient table
2 IAS cabinet
3 X-ray focal spot

1-12 O-arm Imaging System User Manual


General Information and Safety
Safety

Figure 1-7 Isokerma map for horizontal beam at 1.5 meter height (uGy per Gy*cm^2)

1 Patient table
2 IAS cabinet
3 X-ray focal spot

Protective Clothing Removable protective devices are recommended consistent with the facility’s radiation
protection policy:
• Protective shielding (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
cabinet, as illustrated in Figure 1-4. 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.

O-arm Imaging System User Manual 1-13


General Information and Safety
Safety

Radiation Safety

Operating Precautions
Warning: The O-arm® Imaging System produces ionizing radiation.
Follow these safety practices during its operation.

• 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.
• 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 “Positioning the Gantry” on page 6-4 for more information about how to use the patient
spacer.
• Use the Radiation Disable button (“Radiation Disable Button” on page 3-7) or Emergency
Stop button on the power control panel (“Emergency Stop” on page 3-5) or pendant
(“Emergency Stop and Reset Buttons” on page 3-7) whenever the system is not being
moved or actively used to image anatomy.

General Exposure X-rays are potentially hazardous. Take every precaution to reduce the radiation dose that patients
Precautions 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
• 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 • Avoid excess exposure, which can cause acute skin burns or hair loss in patients.
Exposure
• Avoid prolonged exposure. The O-arm® Imaging System is not intended for prolonged
radioscopically guided procedures, such as cardiac catheterization.

Source-to-Skin The O-arm® Imaging System comes with a patient spacer to measure minimum X-ray source–
Distance patient skin distance. Use the spacer to ensure that the patient is positioned at a proper distance
from the inside surface of the gantry (refer to “Positioning the Patient Spacer” on page 6-5).

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 Dose Limits” on page 10-14 for more information about local skin dose
level.

1-14 O-arm Imaging System User Manual


General Information and Safety
Safety

Use of Images in Image-Guided Treatments

Images acquired on the O-arm® 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 position displayed in images. Use these to verify
the correct orientation of the images and the accuracy of the system during navigation.

Warning: Frequently confirm navigation 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. If accuracy degrades,
re-register the patient.

Warning: Abort usage of the O-arm® Imaging System and contact


Technical Service if images are unintentionally rotated or smeared.

Warning: 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.

Consult a qualified medical physicist to ensure that materials in the X-ray beam comply with this
standard. See “Attenuation Equivalents” on page 10-15 for more information.

O-arm Imaging System User Manual 1-15


General Information and Safety
Safety

Imaging Patients With Electronic Medical Devices

Patients with The FDA has reported that X-ray imaging machines can cause adverse effects on patients with
Electronic Medical implanted electronic medical devices such as:
Devices
• Pacemakers
• Defibrillators
• Neurostimulators
• Drug Infusion pumps

Precautions During Before taking images or beginning a scan, the operator should use scout views to determine if
Imaging 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 the device 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 had been 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.

1-16 O-arm Imaging System User Manual


General Information and Safety
Safety

Electromagnetic Compatibility

General The O-arm® 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.

Warning: Any equipment using high frequency signals can cause


interference with pacemakers. Although the possibility of such
interference from the O-arm® Imaging System is small, users must be
aware of the potential hazard.

Electrical Interference If interference from other devices affects the O-arm® Imaging System or the system experiences
From Other Devices unintended motor or X-ray actuation, immediately press the Emergency Stop button to shut down
the system (see “Emergency Shutdown” on page 1-24).

Radio Frequency Portable and mobile RF communications equipment can affect medical electrical equipment.
Equipment

Electrical Interference If the O-arm® Imaging System seems to be causing interference with other devices, try the
with Other Devices following steps:
■ To verify that the O-arm® 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® 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 circuits from the O-arm® Imaging System.

Caution: Critical devices should not be plugged into the same branch
circuit as the O-arm® Imaging System, because the system’s maximum
current rating may be exceeded (see “Electrical Safety” on page 1-18).

■ Check that the original power and umbilical cables have not been damaged or replaced.
If the interference problem still exists, call the Medtronic technical support desk for assistance
(see “Technical Support” on page 1-4) for telephone numbers.

O-arm Imaging System User Manual 1-17


General Information and Safety
Safety

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.
• Do not connect the O-arm® Imaging System to the same branch circuit that is supplying
other critical devices; its maximum current rating will use most of the branch circuit’s
capacity.
• Make electrical connections to other equipment while outside the patient environment.

Warning: Be aware that the IAS contains storage batteries which are a
source of strong electrical current, even when AC power is removed.

Wired Network The O-arm® Imaging System should not be connected to a wired network while in the patient
Connections vicinity to avoid electric coupling to non-medical equipment.

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 9-2 for cleaning instructions).

Isolating the Mains Mains power can be disconnected from the O-arm® chassis by disconnecting the interconnect
Power supply from the MVS at the IAS Connector Panel. See “IAS Connector Panel” on page 3-3 for more
information. However, MVS remains powered as long as it is still 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 five
minutes or less.

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 support desk for assistance (see “Technical Support” on
page 1-4).

Caution: When working in the vicinity of the O-arm® IAS and MVS, use
care to avoid tripping over the power and umbilical cables.

1-18 O-arm Imaging System User Manual


General Information and Safety
Safety

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

1. Remove electrical power to the system by placing the power switches on the IAS and MVS
to their off positions.
2. Unplug the MVS power cord from the AC wall receptacle.
3. Evacuate personnel from the area.
4. Use a fire extinguisher that is approved for use on electrical fires.

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


electrical fire is available in the room where the O-arm® Imaging System
is used. Use of the wrong type of fire extinguisher can result in electrical
shock and burn hazards.

5. Call the local fire department for help.

O-arm Imaging System User Manual 1-19


General Information and Safety
Safety

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®
IAS:
■ 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: When the IAS is not in use, or unattended, engage the


Emergency Stop button (see “Emergency Shutdown” on page 1-24)

Warning: Keep clear of the door when it is partially open or while


opening or closing. Do not move the O-arm over the patient unless the
door is fully opened.

Warning: Do not drive the IAS or move the gantry without being aware of
all objects, equipment, obstacles or persons that may collide with the
device as it moves.

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.

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® IAS from the side—always stand to the rear.

Caution: Transportation of the O-arm® Imaging System between facilities


in a truck requires special handling, packing, and strapping procedures to
prevent injury to movers or damage to the equipment. Contact Medtronic
Technical Support for detailed instructions.

Warning: Move the IAS slowly to get a feel for the control mechanism.
The IAS weighs approximately 1,950 lbs (885kg) and could cause serious
injury to people and damage to itself and other objects if it collides with
anything.

Caution: The gantry must be docked when you move the IAS. Use special
care on steep slopes and when crossing ramps and thresholds.

1-20 O-arm Imaging System User Manual


General Information and Safety
Safety

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.

O-arm Imaging System User Manual 1-21


General Information and Safety
Safety

General Use Safety

Lasers The wireless mouse emits Class 1 laser light. The optional laser alignment kit emits Class 1M
laser light.
Do not view the beam of the laser alignment kit directly with optical instruments (binoculars,
telescopes, or microscopes).

Caution: The laser alignment kit emits Class 1M laser radiation. Do not
view directly with optical instruments.

Infection Safety The O-arm® Imaging System is intended to be used in surgical procedures. The MVS and chassis
should be cleaned as described in “Cleaning” on page 9-3.
To protect the sterile field, the O-arm® gantry should be draped as described in the “Using the
Door and Preparing the Gantry” on page 6-3.

Burn Safety Extended use of imaging equipment may cause components, such as the X-ray tube housing, to
reach high temperatures. Use care when positioning equipment to avoid placing hot components
in close proximity to patients and personnel. An anesthetized or unconscious patient is incapable
of sensing and reacting to a hot component.

Explosion Safety

Warning: Do not operate the O-arm Imaging System in the presence of


flammable or explosive liquids, gases, or anesthetics. 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 Imaging System is not intended for use in an


oxygen rich environment.

If the presence of flammable or explosive liquids, gases, or anesthetics are detected in the
vicinity of the O-arm Imaging System, cease operations immediately.
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.

Avoiding Ingress of Fluids, such as antiseptics, cleaning solutions, or bodily fluids, may damage internal components
Fluids 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 bioburdern control
or exposure to fluids is expected. Remove the drapes as soon as the procedure allows.

Warning: The O-arm Imaging System is not rated for watertight


operation. If liquids drip into the equipment, remove power and
disconnect the MVS power cord. Do not operate the system until it can be
cleaned and inspected by a qualified service engineer.

1-22 O-arm Imaging System User Manual


General Information and Safety
Safety

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.

O-arm Imaging System User Manual 1-23


General Information and Safety
Safety

Emergency Procedures

Preparation and Have all personnel who use the O-arm Imaging System learn and practice the procedures for
Training 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 (see “Gantry Movements” on page 6-12)
move the gantry into a position that allows sufficient access for CPR.
– Using the Lateral Shift capability, push the IAS out of the way of persons performing
CPR.
Follow the directions on page 6-4 for positioning the gantry to allow CPR.

In Case of Emergency • Ensure the safety of the patient 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 explosive or flammable gases or liquids—see “Explosion
Safety” on page 1-22).
• 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 a circuit breaker
trips:
■ Cut electrical power to the system by placing the power switches on the IAS and MVS to their
off positions.
• Unplug the MVS power cord from the wall.

Warning: The IAS contains storage batteries that are a source of strong
electrical current, even when AC power is removed.

■ Notify the Medtronic technical support desk (see “Technical Support” on page 1-4).
■ Do not operate the equipment until the service technician confirms that it is operating
properly.

Emergency Shutdown The operation of the system can be completely shut down at any time by pressing either of the
Emergency Stop buttons.
One is located on the Pendant .
Another is located on the IAS Power Control panel .

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

Reset after Shutdown To return the system to normal operating conditions, press the Emergency Stop Reset button
on the Pendant.

1-24 O-arm Imaging System User Manual


System Overview 2

2
This chapter gives an overview of the main O-arm® Imaging System components and capabilities.

The Image Acquisition System (IAS) . . . . . . . . . . . . . . . . . . . . . . . . 2-3

The Mobile View Station (MVS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

Acquisition Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Low Dose 3D Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Patient Exam Data Capabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

O-arm Imaging System User Manual 2-1


System Overview
Introduction to the System

Introduction to the System

Overview

The O-arm® Imaging System is a mobile X-ray system designed for surgical applications, pre-
operative planning, intraoperative imaging and post-operative assessment. The system provides
basic fluoroscopy and multi-plane 2D imaging, and features 3D volumetric imaging with fast 3D
reconstruction displays in three orthogonal views.

Main Components

Figure 2-1 The O-arm® Imaging System (Left: IAS, Right: MVS)

The system, shown in Figure 2-1, consists of two main assemblies:


• The Image Acquisition System (IAS)
• The Mobile View Station (MVS)
The IAS and MVS are connected by a single cable (not shown) that provides power to the IAS
and transmits signal data between the systems.
The IAS has a motorized battery-powered transport system for ease of movement and
positioning.

2-2 O-arm Imaging System User Manual


System Overview
Introduction to the System

The Image Acquisition System (IAS)

Main Components The main components of the O-arm® IAS are shown in Figure 2-2.

2 3

4
5

6
1
7
Figure 2-2 The O-arm® IAS

The Gantry The gantry 1 contains an inner ring with a rotor unit that includes the X-ray generator and
detector. The outer portion contains a telescoping door 2, shown open, which accommodates
lateral patient access and positioning over the operating table.
A Light Ring on the gantry indicates the position of the X-ray source and the detector so that you
can align X-ray beam path.

The Cabinet The cabinet 6 has the user interface - the Pendant 4, the robotic motion control unit,
motorized mechanics assembly, and an energy storage unit containing the battery power supply.
Using the buttons on the Pendant, you can move the gantry in lateral, longitudinal, up and down,
wag, Iso-Wag, and tilt directions (refer to “Gantry Movements” on page 6-12).

Positioning Battery-powered rear wheels 7 allow you to move the IAS by means of the transport handle
Capabilities 5 (refer to page 5-2).
For extra maneuverability in tight quarters, an additional pair of wheels can be activated to allow
the IAS to be manually moved sideways (refer to “Moving the IAS Laterally” on page 6-26).

Standalone Mode In normal operation, the IAS receives its power via the interconnect cable from the MVS. When
disconnected from the MVS, the IAS operates in standalone mode. In this mode, the IAS
receives its power from 40 lead-acid storage batteries to perform all positioning and movement
functions. The X-ray generator is deactivated in the standalone mode, so it is not possible to take
images.

Laser Positioning A laser positioning kit with laser positioning lights is available optionally for the O-arm IAS.
Lights (Optional) See “The Laser Alignment Kit (LAK)” on page 6-22.

O-arm Imaging System User Manual 2-3


System Overview
Introduction to the System

The Mobile View Station (MVS)

General Components The MVS includes an image processor and user interface that displays the images produced by
the Image Acquisition System.

4 7

Figure 2-3 The MVS

Hand Grips and Two hand grips 3 and four swivel wheels 1 help you to move the MVS. The wheels have
Wheels foot pressure brakes to lock the unit in place.

Monitor The 30-inch, high definition, LCD, flat panel monitor 6 displays patient exam data and images.
(see “The Monitor” on page 3-12). A second monitor can be connected for remote viewing (see
“Connecting a Second Monitor” on page 5-5).

Keyboard The MVS has a standard keyboard 4 for data entry, with special keys for manipulating display
and imaging parameters, and a touch pad that allows you to move the cursor and make selections
(see “The Keyboard and Wireless Mouse” on page 3-13).

Video Graphics Printer An optional Sony UP-980 printer 2 may be included in your system. It prints the active image
(Optional) on the MVS monitor onto transparency film or paper.

Power Control Panel The Power Control Panel 7 contains a DVD/CD RW drive, the power-on switch and associated
indicators (see page 3-11).

USB Ports Two (2) USB ports on the connector panel allow you to export images to removable storage
media (refer to “When you are satisfied with the alignment of the images, Press [Save and Exit].
This saves as the stitched image the largest rectangle that bounds all images.” on page 8-25).

2-4 O-arm Imaging System User Manual


System Overview
Introduction to the System

Acquisition Modes

Overview The O-arm® Imaging System has three main acquisition modes that produce ultra-high resolution
fluoroscopic and 3D images:
• 2D Fluoroscopy Mode (2D)
• Multi-plane 2D Mode (M-2D)
• 3D Mode (3D)
When not acquiring images, you can use the system to set up patient exam information, review
and annotate patient images, and export patient data.

Dose Reporting Dose Reporting is an optional feature that tracks patient exposure to radiation generated by the
(Optional) O-arm® Imaging System. For more information, see “Dose Reporting” on page 7-31.

2D Modes
2D Fluoroscopy Mode This acquisition mode uses pulsed X-rays at up to 30 frames per second to produce high
resolution, real time images. You can use either the hand or foot switch to select either standard
fluoroscopy (the default) or High Level Fluoroscopy (HLF).
A Last Image Hold (LIH) option in 2D mode leaves the last live image of the pulsed sequence on
the MVS screen once scanning is completed, or if the user discontinues scanning. The last image
can be saved and recalled at a later time for review.
These image processing functions are available in the 2D mode in both the live fluoroscopic
mode and LIH:
• Edge enhancement
• Rotation/Mirroring
• Contrast/brightness
• Video invert
Refer to “Using the 2D Mode” on page 7-7 for a detailed description of operating this mode.

Low Level Low level fluoroscopy provides reduced dosage imaging in the 2D Fluoroscopy mode. This
Fluoroscopy Mode lower level of radiation, approximately half the dosage, is achieved by changing the pulse rate
from 30 per second to 15 per second.
Image quality may be affected especially in patients where body mass or thickness requires
increased radiation for effective imaging. For this reason, Low Level Fluoroscopy should only be
used in situations where image quality does not affect navigational accuracy, such as scout shots.

Multi-plane 2D Mode In this acquisition mode, you can acquire a set of 2D pulsed fluoroscopy images (either standard
or HLF) at previously stored gantry positions.
You can store up to four separate gantry positions and associated settings for later call-up. You
can set a fifth preset ‘Park’ position for the gantry away from the surgeon’s area. Refer to
“Storing Positions and Acquisition Settings” on page 7-14 for a detailed description on the use of
these buttons.
All the image processing functions available in the standard 2D mode are also available in this
mode.

O-arm Imaging System User Manual 2-5


System Overview
Introduction to the System

3D Modes
General In 3D acquisition modes, the O-arm® IAS creates a series of pulsed X-ray exposures throughout
a complete 360-degree rotation of the gantry rotor. The system stores these exposures and uses a
reconstruction algorithm to develop a 3-dimensional image of the patient’s anatomy from them.
The image is displayed on the MVS monitor screen as a high resolution display in the Axial,
Coronal, and Sagittal planes.
The reconstructed volume used by the reconstruction algorithm is a cylinder with a diameter of
200 mm and a length of 150 mm.

Special Modes for In addition to standard 3D mode, the O-arm® Imaging System has two modes that offer enhanced
Enhanced Image image quality.
Quality
High Definition 3D (HD3D)
High Definition 3D (HD3D) mode provides improved image quality over that of regular 3D. In
this mode, the rotor spins at 15 degrees per second, while acquiring images at a rate of 30 frames
per second, thus capturing approximately 740 projections.

Enhanced Cranial 3D Mode (Optional)


Enhanced Cranial 3D mode is an optional feature that enables you to take images of higher
quality than those acquired in regular 3D mode. It has the same spin velocity and frame rate as
HD3D mode, but uses different kVp and mA settings and a different reconstruction algorithm. It
is designed for cranial images only (see “Targeted Anatomy Chart for Enhanced Cranial 3D
Mode” on page 7-23).

Optional 3D Features Oblique Slicing in 3D


This feature allows you to make adjustments to images taken in 3D mode when the patient’s
body and the imaging axes were slightly misaligned. Adjustments can be made to the Axial,
Coronal, and Sagittal views (refer to “Advanced Imaging Features in 3D Mode” on page 7-29).

Storing Collimator Positions in 3D


In normal 3D mode, the collimator is wide open and not adjustable. This feature allows you to
adjust the Collimator and store that Collimator position in memory to be used later. This is useful
when you want to isolate a small specific area of interest of the anatomy. It also reduces the
amount of scatter in the room and the amount of radiation exposure to the patient (refer to “Using
Preset Collimation Settings” on page 7-20).

Maximum Intensity Projection (MIP) View in 3D


MIP is a 3D rendering of the volume that provides a 360° view for advanced viewing. MIP is
available in the 3D mode display (refer to “Advanced Imaging Features in 3D Mode” on page 7-
29).

Low Dose 3D Mode Low Dose 3D mode is designed to provide an additional preset setting for standard 3D
acquisitions with a lower overall dose. It uses the same motion settings as the standard 3D mode,
but has a lower mA and mAs setting.The Low Dose mode is only available for use on the
Chest/Spine and Lumbar Spine/Hip anatomies. For more information on Low Do“Low Dose 3D
Mode” on page 7-18se, see “Low Dose 3D Mode” on page 7-18.

2-6 O-arm Imaging System User Manual


System Overview
Introduction to the System

X-ray Options

The two X-ray types used by the system are:


• Pulsed Fluoroscopy - used for both the 2D and 2D multi-planar application modes
• Pulsed Exposure - used for the 3D rotational mode

Pulsed Fluoroscopy Both standard fluoroscopy and High Level Fluoroscopy (HLF) are available in the pulsed
fluoroscopy modes.
Standard fluoroscopy is the default. For improved image quality, you can use either the hand or
foot switch to select HLF.
• The pulse rate for both standard fluoroscopy and HLF is 30 pulses/second.
• Continuous HLF time is limited to 30 seconds. Once that time is reached, the X-ray
exposure is automatically stopped.

Pulsed Exposure Pulsed exposure fluoroscopy is used for 3D imaging to reduce motion blur and is produced by
reducing the X-ray pulse width and increasing the exposure.
The pulse rate for pulsed exposures is 30 pulses/second.
Pulsed exposure time is limited to 13 seconds per single panel scan. Once that time is reached,
the X-ray exposure is automatically stopped.

O-arm Imaging System User Manual 2-7


System Overview
Introduction to the System

Patient Exam Data Capabilities

Data Entry Screens on the monitor enable you to input patient exam information from the MVS keyboard
(refer to “Entering Patient Information” on page 5-8). Options are: entering the names of the
patient and physician, placing the patient into a scheduled exams list, and integrating the patient’s
images into saved exams records that are stored in the system’s database.

Patient Data Recall For each patient, you can recall the complete exam record, which lists each of the studies that
and Review were performed on that patient (refer to “Accessing and Reviewing Patient Exams” on page 8-2).
The system allows you to open an individual patient study to view the image series for that study,
and to select individual images to open for review. You can export images to external media or
across a network in DICOM format, save them to a snapshot file, or print them, if you have a
video graphics printer on your system.

DICOM Export The system has the capability of exporting both 2D images and 3D data sets in DICOM format
Capability across a network to a picture archiving and communication systems (PACS) server or to another
DICOM device.
You export DICOM images via the MVS user interface. See “Exporting Images to External
Media” on page 8-8 for complete details.

Export to External You can save any image appearing on the MVS monitor screen to a snapshot file and later
Memory Devices transfer these “snapshots” to a CD or a USB flash drive storage device (see “Exporting Images to
External Media” on page 8-8).

Image Annotation All X-ray images produced by the system are displayed on the MVS with the following data:
■ Patient Information - patient name and ID
■ Exam Information: date and time of the exposure
■ X-ray Information: dose rate and cumulative dose display
■ Image Processing: brightness and contrast values
You can also add annotations to images, using the annotation feature (see “Image Annotation” on
page 8-15). These annotations are saved with images as an overlay.

Image Stitching The O-arm® Imaging System software offers image stitching capabilities for 2D images, so that
images can be stitched together to create a longer image of the patient’s anatomy than can be
acquired in one exposure (see “Image Stitching” on page 8-22).

Image Guided Surgery The O-arm® Imaging System can be used in conjunction with Medtronic Image Guided Surgery
(IGS) Systems to provide IGS capabilities in surgical procedures. The setup for this requires an
O-arm® Tracker Kit (9733303), and a network interface procedure (see “Connecting and
Configuring an IGS System Connection” on page 4-11).

Video Graphics Printer An optional Sony UP-980 printer, located in the MVS, can print any image appearing on the
(Optional) active pane of the MVS monitor onto transparency film or paper. See “Video Graphics Printer”
on page 3-11.

2-8 O-arm Imaging System User Manual


Controls & Indicators 3

3
This chapter describes the controls and indicators on the O-arm Image Acquisition System and
Mobile View Station.

IAS Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2


IAS Connector Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3

The Power Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4

The Pendant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6

Hand and Foot Switches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8

MVS Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10


The Mobile View Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

The Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

The Keyboard and Wireless Mouse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

Locking casters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15

O-arm Imaging System User Manual 3-1


Controls & Indicators
IAS Controls and Indicators

IAS Controls and Indicators


Control Locations Figure 3-1 shows the locations of controls on the O-arm® Image Acquisition System.

2
3

5
Figure 3-1 Location of IAS Controls and Indicators

No. Component Functions

1 Pendant Gantry Positioning, X-ray operations

2 Hand switch X-ray operations

3 Transport handle IAS positioning

4 Power control panel Power on/off

5 IAS connector panel Miscellaneous

The foot switch is not shown in Figure 3-1. It connects at the O-arm IAS connector panel, but
can be disconnected and stored away when not in use.

3-2 O-arm Imaging System User Manual


Controls & Indicators
IAS Controls and Indicators

IAS Connector Panel

Overview The connector panel is at the bottom rear of the O-arm® IAS. It has the key switch, the port for
connecting the interconnect cable to the MVS, and the port for the foot switch.

2
3
4
Figure 3-2 The O-arm® IAS Connector Panel

No. Element

1 Key Switch

2 Interconnect Cable Port

3 Foot Switch Port

4 Equipotential Ground point

The Key Switch The key switch 1 is the “master switch” for the IAS.

In its (Off) position, all IAS functions are disabled.

Turning the key to the (On) position allows power to be applied to the O-arm® IAS.
To operate the IAS, you must turn the key switch to the On position. You can leave the key in, or
remove it. Likewise, after turning the key switch to Off, you can remove the key to prevent
unauthorized use of the system.

O-arm Imaging System User Manual 3-3


Controls & Indicators
IAS Controls and Indicators

The Power Control Panel

Overview The O-arm® IAS Power Control Panel is directly in front of the transport handle. It has the power
On/Off switch for the IAS, an Emergency Stop button, and indicators for the state of the system.

1 2 3 4 5 6
Figure 3-3 The IAS Power Control Panel

No. Name & Description Function

1 Emergency Stop Button When pressed, immediately shuts down all motion and X-ray
functions.
Red/Spring-loaded Can only be reset by the reset button on the Pendant (see
push button Figure 3-4).

2 Movement Enable
Indicator
When lit, indicates that the gantry and Power Assist Transport
system are enabled.
Lit when the key switch is in the On position. The IAS does not
need to be connected to the MVS.

3 System On Indicator When lit, indicates that the key switch is turned on. The IAS
does not need to be connected to the MVS.

4 Power On/Off Switch When turned to the right, places the IAS in the active state.
When turned to the left, places the IAS in the standalone state.
To activate the IAS, the key switch must be turned on.

5 Battery Charging
Indicator
When lit, indicates that the IAS batteries are being charged.

6 Battery Levels
Indicators
The M level indicator monitors the Motor battery banks. The X
level indicator monitors the X-ray battery banks. See “Battery
Level Indicators” on page 3-5.

Power Control Panel The state (On or Off) of the Power Control Panel indicators at any given time is affected by a
Indicators combination of system factors that include:
• The key switch position
• The interconnect cable connections
• The MVS power state

3-4 O-arm Imaging System User Manual


Controls & Indicators
IAS Controls and Indicators

System States
Table 3-1. System States

State System Battery- Battery Interconnect IAS Key Emergency


On Powered Charging Cable Switch Stop Button
Transport Connected* Turned On Pressed
Enabled

1 no no no no no no

2 no no no no no yes

3 yes yes no no yes no

4 yes no no no yes yes

5 no no yes yes no no

6 no no yes yes no yes

7 yes no yes yes yes yes

8** yes yes yes yes yes no

*Assumes that the MVS power cable is plugged into a suitable power outlet.
**This row represents the “ready to X-ray” state of the system.

Battery-Powered As Table 3-1 shows, the IAS can be moved using its battery powered transport assist system only
Transport Activation in the following two states:
• State 3, when it is disconnected from the MVS and the key switch is turned on - this is the
Standalone mode (see page 2-3).
• State 8, its standard setup condition, with the key switch turned on, connected to the MVS,
and the MVS power cable is plugged into a suitable power outlet.
See “MVS Component Locations” on page 3-10 for operating instructions on the powered
transport assist system.

Battery Charging Note that the IAS batteries are being charged whenever the MVS is plugged into an active power
outlet and connected via the interconnect cable to the IAS. It is not necessary for the key switch
to be turned on or for the MVS to be running (see “Charging the Batteries” on page 9-6).

Battery Level The two columns of yellow LED lights indicate the battery level for the motion batteries (M) and
Indicators the X-ray batteries (X). See “Battery Charge Level Indicators” on page 9-6 for more information
about battery charge levels represented by the scrolling LEDS.
For the IAS to function normally, a minimum of four LEDs in the M column and four LEDs in
the X column must be illuminated.

Complete System For the system to be fully functional, the IAS and the MVS must both be switched on. To shut
Startup & Shutdown down completely, they must both be shut down individually. The IAS enters the standalone mode
whenever it is on and the MVS is switched off. Refer to Chapters 5 and 9, respectively, for details
regarding startup and shutdown.

Emergency Stop Pressing the Emergency Stop button on the Power Control Panel disables the X-ray and motion
functions. After an Emergency stop, you must press the Emergency Stop Reset button on the
Pendant before you can restart the system.

O-arm Imaging System User Manual 3-5


Controls & Indicators
IAS Controls and Indicators

The Pendant

General Information With the exception of powering on, you control all functions pertaining to the gantry, from the
Pendant.
From the Pendant, you can control the gantry’s motion, the X-ray modes and all factors
pertaining to the X-ray image.

2
1 3

4 6
5
7
8
9
0
-
=
Figure 3-4 The Pendant

No. Buttons/Elements

1 Emergency Stop and Reset Buttons

2 Image Mode Selection Buttons

3 Transport Brake Set/Release

4 X-ray Tube/Detector Orbital Rotation

5 Store Image

6 Softkeys and Display

7 Gantry and IAS Positioning Controls

8 Flip Image, Contrast and Brightness

9 X-ray Generator Controls and Indicators

0 Radiation Disable Switch

- Collimator Adjustment Controls

3-6 O-arm Imaging System User Manual


Controls & Indicators
IAS Controls and Indicators

No. Buttons/Elements

= Memory Preset Buttons

Emergency Stop and Emergency Stop — Stops all X-ray and motion functions. Refer to “Emergency Shutdown” on
Reset Buttons page 9-22 for further information.
Emergency Stop Reset — Restores the IAS functions to operation following an emergency
shutdown.

Image Mode Selection Pressing 2D selects the 2D Pulsed Fluoroscopy Mode. Allows real-time X-ray viewing of the
Buttons patient with high temporal resolution up to 30 frames per second.
Pressing M-2D selects the Multi-plane 2D Mode. Allows up to four independent gantry
positions with their associated settings to be acquired and displayed automatically.
Pressing 3D selects the 3D Mode. In this mode the system creates a sequence of pulsed X-ray
exposures throughout a 360-degree rotation. The resulting exposures are reconstructed as Axial,
Sagittal, and Coronal images of the patient’s anatomy.

Tube Detector Tube/Detector Rotation (left-hand control) Rotates the gantry rotor to change the angle of the
Rotation tube/detector (X-ray beam path). Refer to “Aligning the X-ray Beam Path” on page 6-20.

Pendant Softkeys The softkeys are discussed in the following sections:


• For the 2D mode, refer to “Using the 2D Mode” on page 7-7.
• For the M-2D mode, refer to “Using the Multi-plane 2D Mode” on page 7-15.
• For the 3D mode, refer to “Using 3D Modes” on page 7-18.

Gantry and IAS Yellow-colored buttons on the Pendant buttons are for positioning the gantry and the X-ray
Positioning Controls beam. The use of these buttons is described in Chapter 7.

X-ray Generator The X-ray Generator Control buttons allow you to adjust the kV and mA settings for the X-ray
Controls and generator, to suit the region and size of patient being scanned.
Indicators
The X-ray indicator lights up when an X-ray acquisition mode is active.
See Table 7-10 on page 7-23.

Radiation Disable Radiation Disable Switch is safety measure that, when activated, prevents the O-arm® Imaging
Button System from emitting radiation, even when the handswitch or footswitch are activated.

Indicates that the system is ready to acquire images by emitting radiation from
the X-ray tube.

Indicates that the system’s ability to emit radiation has been disabled.

Collimator Adjustment These buttons allow you to adjust the collimator to optimize images. See “Manipulating Image
Controls Display in the 2D Mode” on page 7-10.

Memory Preset These buttons allow you to save gantry positions and settings. See “Storing Positions and
Buttons Acquisition Settings” on page 7-14.

O-arm Imaging System User Manual 3-7


Controls & Indicators
IAS Controls and Indicators

Hand and Foot Switches

General Information The O-arm® Imaging System has both a hand switch and a foot switch that can be used to
activate either of the three X-ray modes of operation. Both of these controls are connected to the
IAS.
The choice of which to use depends on the personal preference of the user.

The Hand Switch

Figure 3-5 Hand Switch

The hand switch is permanently connected to the IAS and can be hooked over the transport
handle when not in use.
The hand switch button actions are described in Table 3-2.

The Foot Switch The foot switch has three pedals that are analogous to the buttons on the hand switch. The actions
of the pedals are described in Table 3-2.
A footswitch protective cover can be lifted easily with a toe.
NOTE: Older model O-arm systems are equipped with a footswitch that has identical functions
but with no cover.

3-8 O-arm Imaging System User Manual


Controls & Indicators
IAS Controls and Indicators

Hand and Foot Switch


Functions
Table 3-2. Hand switch and foot switch functions

Acquisition
Mode

2D Fluoro Execute with standard Execute with HLF Copy live image to
fluoroscopy right pane of MVS
monitor and save to
database

2D Multi- Returns to 2D Fluoro Execute Save captured


planar Fluoro mode & takes one image images to the
at present position with database
standard fluoroscopy

3D Rotational Returns to 2D Fluoro *Execute Not available


mode & takes one image
at present position with
standard fluoroscopy

*Press and hold for the duration of the acquisition. Premature release terminates the
operation.

O-arm Imaging System User Manual 3-9


Controls & Indicators
MVS Components

MVS Components

The Mobile View Station

The Mobile View Station (MVS), shown in Figure 3-6, contains the monitor, keyboard, power
control panel and an optional printer. A separate wireless mouse is included.

4
1

7
Figure 3-6 MVS Component Locations

No. Component See

1 Keyboard page 3-13

2 30 inch LCD Monitor page 3-12

3 X-ray Activation Indicator page 3-13

4 Receiver for Wireless Mouse page 3-14

5 Power Control Panel page 3-11

6 Video Graphics Printer (optional) page 3-11

7 Locking casters page 3-15

3-10 O-arm Imaging System User Manual


Controls & Indicators
MVS Components

The MVS Power


Control Panel
1 2 3 4

Figure 3-7 MVS Power Control Panel

No. Components

1 DVD/CD RW drive

2 System On indicator - Lit when power is applied to the MVS

3 On/Off switch - controls power to the MVS.

4 Line Power indicator - Lit when the MVS is plugged into an active wall outlet.

Video Graphics Printer The optional Video Graphics Printer (Figure 3-8) is a Sony UP-980.

Figure 3-8 The Video Graphics Printer

If you have a Video Graphics Printer on your system, you can print any image appearing on the
MVS monitor by turning the printer on and pressing the Print button on the printer.

The MVS Connector


Panel
1 2 3

Figure 3-9 The MVS Connector Panel

At the bottom rear of the MVS is the Connector panel, which contains the ethernet jack 1, a
VGA and an S-Video Jack 2, and two USB ports 3.

O-arm Imaging System User Manual 3-11


Controls & Indicators
MVS Components

The Monitor

Overview The MVS monitor has a 30 inch (76.2 cm), flat-panel, LCD display for:
• Viewing images captured by the system
• Patient Database Interface
• Image annotating

Image Display When start-up is complete, the right pane displays the patient Exam Information page (refer to
“Entering New Patient Data at Time of Examination” on page 5-9).
■ In 2D mode, the left pane shows the active image, and the right pane the reference image. The
right pane can be switched between an X-ray image and the Exam Information page
whenever the system is not in an active 2D mode.
■ In M-2D mode, the monitor displays up to four separate images, taken at each of the preset
positions and conditions.
■ In 3D mode the monitor shows reconstructed images of the subject anatomy in three
orthogonal planes. The display can be toggled between default 2-and-1, a single enlarged
image, and a lightbox display.
Full descriptions of the images appearing in all three modes are in Chapter 7.

X-ray Activation Light The activation light on the top of the monitor illuminates whenever any of the three imaging
modes are activated. It remains lit until the active imaging session is finished.

3-12 O-arm Imaging System User Manual


Controls & Indicators
MVS Components

The Keyboard and Wireless Mouse

The Keyboard

Figure 3-10 The MVS Keyboard

The MVS contains a US-standard QWERTY keyboard for text entry. and to perform functions
like opening and closing certain windows.

The Touch Pad The touch pad and two buttons (Figure 3-11) allow you to move the cursor and make selections
on the monitor screen.

2 3
Figure 3-11 The MVS Keyboard Touch Pad

No. Components

1 Touch Pad -moves the cursor

2 Left button - selects the active image pane (yellow highlight)

3 Right button - toggles the display as does the right-hand mouse button.

O-arm Imaging System User Manual 3-13


Controls & Indicators
MVS Components

Special Keys Special function keys allow you to perform various operating functions from the MVS.
Additional functionality of these keys is explained in the respective sections on manipulating the
display in 2D (page 7-10), M2D (page 7-17), and 3D modes (page 7-26).

Figure 3-12 The MVS Special Key Assignments

Key /Icon Function


Esc Toggles the patient Exam Information display on/off. Refer to “Entering New
Patient Data at Time of Examination” on page 5-9.
F1 - 2D Selects the 2D Pulsed Fluoroscopy mode
F2 - M-2D Selects the 2D Multi-planar Pulsed Fluoroscopy mode
F3 - 3D Selects the 3D mode
F9 Inverts the Video Image

Saves the image on the MVS screen to a .TIFF file in the MVS database
Prt Sc

The Wireless Mouse A sterile wireless mouse (Figure 3-13) allows you to select and manipulate images on the MVS
monitor screen and serves as a laser pointer. Wireless mouses can be ordered in a case of ten (10)
(see “Ordering Accessory Items” on page 1-4).

Figure 3-13 Wireless Mouse

For information on mouse components and setting up the mouse for use, see “Unpacking and
Activating the Mouse” on page 5-6.
For information on using the mouse to manipulate the image on the MVS screen in 2D, M-2D
and 3D modes, see pages 7-10, 7-17 and 7-26 respectively.

3-14 O-arm Imaging System User Manual


Controls & Indicators
Locking casters

Locking casters
The MVS is equipped with four locking casters. In order to prevent lateral movement while the
MVS is in use, all four casters must be locked.

Figure 3-14 MVS locking casters

1. Position the MVS according to surgical needs.

2. Press down firmly 1 on the locking lever for each caster.

3. To unlock the caster, lift 2 each locking lever until it is horizontal.

O-arm Imaging System User Manual 3-15


Controls & Indicators
Locking casters

3-16 O-arm Imaging System User Manual


Powering Up and
Configuring the System 4 4
This chapter describes how to connect, power up, and configure the O-arm® Imaging System.

Connecting and Powering Up the System . . . . . . . . . . . . . . . . . . . 4-2


Cable Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2

Powering Up the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2

Configuring the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3


Configuring Interface Language and Units . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5

Setting Up DICOM Export Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7

Connecting to the Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7

Configuring a Worklist Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9

Connecting and Configuring an IGS System Connection . . . . . . . . . . . . . . . 4-11

Configuring the DICOM Store Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15

Adding to and Modifying the Physicians List . . . . . . . . . . . . . . . . . . . . . . . . . 4-17

Optimizing the Monitor Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19

O-arm Imaging System User Manual 4-1


Powering Up and Configuring the System
Connecting and Powering Up the System

Connecting and Powering Up the System

Cable Connections

In order to power up the complete system (MVS and IAS), the MVS must be plugged into a
power source and the IAS must be plugged into the MVS via the interconnect cable.

Caution: Prior to operation, ensure that the equipment is thoroughly dry


from any condensation that may have formed during transport or storage.

The MVS Power Cable The MVS power cable is 20 feet (6.1 m) in length and requires a 3-wire wall outlet rated at 110
VAC, 15 Amps (or 220 VAC, 8 amps) to plug into. Confirm the voltage rating listed on the MVS
product label, located near the point where the power cord enters the MVS.

Connecting Cables 1. Position the MVS so that its power cable can reach a wall outlet.
2. Plug the MVS power cable into the wall outlet.
3. Uncoil the interconnect cable at the MVS and stretch it out on the floor.
4. If necessary, reposition the IAS so that the interconnect cable connector will reach it.
5. Plug the interconnect cable into the IAS connector panel at the lower rear, right-hand corner
of the unit.
The IAS receives its line voltage through the interconnect cable from the MVS. When the
interconnect cable is disconnected or the MVS power cable is unplugged from the wall outlet, the
IAS is in standalone mode and draws on its storage batteries to perform transport and motion
functions.

Powering Up the Once the MVS and IAS are connected, you can turn the system on. Power to the IAS is
System controlled by a combination of the key switch on the connector panel (see Figure 3-2), and the
Start switch on the Power Control Panel (see Figure 3-3). Application of power to the MVS is
controlled by the power switch on the power panel.

1. Turn the key on the IAS connector panel to the unlocked position.
2. Turn the power switch on the IAS power panel to the (Start) position.

3. Turn the power switch on the MVS power panel to the |(On) position.
The system takes about 3 minutes to boot up and run through its power on self-test. Once the
system successfully completes the self-test it is ready for use.
If a warning or failure message appears on the Pendant or the MVS screen, contact the Medtronic
Navigation service desk (refer to “Technical Support” on page 1-4).

4-2 O-arm Imaging System User Manual


Powering Up and Configuring the System
Configuring the System

Configuring the System


Configuration The system should be configured before first-time use. Your service technician may perform
Overview these steps, but information is provided here in case you need to make any changes.
All configuration steps are performed through the System Technical Service Console. This page
is password protected. To gain access to it you must have administrative privileges. See your
system administrator for details.

Configuration Step See


Setting the interface language page 4-5
Setting measurement units for patient information page 4-5
Entering the date, time, time zone and daylight savings page 4-6
Configuring DICOM server connections: page 4-7
• The Worklist Server Connection • page 4-9
• The IGS Server Connection (if the O-arm® Imaging System will be used • page 4-11
with an IGS system)
• The DICOM Store Server • page 4-15
Adding Physicians to the Physicians List page 4-17
Calibrating the monitor display page 4-19

Opening the System 1. Press <Ctrl–Alt–Home> on the keyboard to open the user access popup.
Technical Service
2. Type in your password and press <Enter>.
Console

O-arm Imaging System User Manual 4-3


Powering Up and Configuring the System
Configuring the System

Figure 4-1 System Technical Service Console

Hiding and Closing ❱❱ To hide the System Technical Service Console, press the Windows key .
the System Technical
Service Console ❱❱ To close the System Technical Service Console, press <Ctrl–Alt–Home>, type in your
password, and press <Enter>.

4-4 O-arm Imaging System User Manual


Powering Up and Configuring the System
Configuring the System

Configuring Interface Language and Units

User Interface The UI tab in the System Technical Service Console gives you access to a drop-down list where
Language you can select the user interface (UI) language. Available languages are:
English (US)
German (Germany)

1. On the System Technical Service Console, click on the UI tab.

Figure 4-2 Interface Language Selection

2. Use the drop-down list to select the language.


3. Cycle system power to save the Language setting.

Patient Information Values for patient height and weight may be displayed in Standard or Metric units. The default
Measurement Units units are Standard. To change the displayed units to metric, check the Display Patient Info in
Metric Units checkbox.

O-arm Imaging System User Manual 4-5


Powering Up and Configuring the System
Configuring the System

Configuring Date and Time

Date and Time Date and Time formats shown in patient data displays follow those selected under the UI tab in
Formats the System Technical Service Console.

How to Configure Date 1. On the System Technical Service Console, click on the MVS Station tab.
and Time Settings
2. Use the drop-down calendar under Date and Time Settings to select the date.

Figure 4-3 Date Selection

3. In the Date and Time field:


• Highlight the hour and enter the hour
• Highlight the minutes and enter the minutes
• Highlight AM/PM and enter AM or PM.
4. Use the Time Zone drop-down list to select the desired zone.
5. Check the box to automatically adjust the clock for daylight saving changes.
6. Click [Save] to save your changes.

4-6 O-arm Imaging System User Manual


Powering Up and Configuring the System
Configuring the System

Setting Up DICOM Export Configurations

Connecting to the Network

Prior to configuring the MVS to export images to a DICOM server, the MVS must be physically
connected to the hospital’s DICOM network, and the MVS must be identified by a station name.

Connecting the
Network Cable 1

Figure 4-4 MVS Connector Panel

1. Connect one end of the network cable to the ethernet jack 1 on the MVS connector panel.
2. Connect the opposite end of the network cable to the hospital’s ethernet wall jack.
3. Ensure that both connectors are locked in place.

Warning: The network cable should not be connected to the ethernet jack
during a surgical case.

Assigning the MVS a In order to export images from the O-arm® Imaging System to a DICOM server, the MVS must
Station Name be assigned a station name so that it will be recognized on your hospital network.

1. Open the System Technical Service Console (see page 4-3).


2. Click on the MVS Station tab.

O-arm Imaging System User Manual 4-7


Powering Up and Configuring the System
Configuring the System

Figure 4-5 MVS Station configuration

3. Click [Edit]. This allows you to fill in the text boxes.


4. In the Hospital Name field, type the name of the hospital.
5. In the Station Name box, type the name of the workstation assigned to this MVS.
6. In the DICOM AE Title field, type the title assigned to this MVS.
7. Click [Save].
8. Cycle system power to save the Hospital Name setting.

4-8 O-arm Imaging System User Manual


Powering Up and Configuring the System
Configuring the System

Configuring a Worklist Server

About Worklist In order to access patient information residing on databases external to the O-arm® Imaging
Servers System (refer to Acquiring Patient Information from Outside Sources on page 5-13), you must
configure the O-arm® Imaging System so that it is connected to a server on the hospital network,
known as a worklist server.

How To Configure the 1. Ensure that an Ethernet connection exists to the MVS connector panel (see “Connecting the
Worklist Server Network Cable” on page 4-7).
Connection
2. Open the System Technical Service Console (see page 4-3).
3. Click on the DICOM Servers tab.

Figure 4-6 DICOM Servers page

4. On the DICOM Servers page, under “Worklist Servers”, click [New].


This opens the Worklist Server configuration dialog (see Figure 4-7).

O-arm Imaging System User Manual 4-9


Powering Up and Configuring the System
Configuring the System

Figure 4-7 Worklist Server Configuration dialog

5. Fill in the Worklist Server configuration dialog as follows:


Server Alias: A unique name that you assign to identify the Worklist Server.
AE Title: The Worklist Application Entity (AE) title
Server: The IP address assigned to the Worklist Server
Port: The number of the port assigned to the Worklist Server
Obtain any necessary information from your network administrator to complete this step.
6. Click [Verify] to confirm that you entered the information correctly and to verify the
connection between the O-arm® Imaging System and the server. If an error message
appears, review the entries, make the necessary corrections and re-verify the connection.
You can cancel out of the Worklist Server configuration dialog at any time by clicking
[Cancel].
7. Click [OK] to save the information and return to the System Technical Service Console.

Editing a Worklist 1. To edit an existing Worklist Server configuration, highlight the subject server listed under
Server Configuration “Worklist Servers”, and click [Edit].
2. Make the desired changes to the entries in the Worklist Server configuration dialog.
3. Click [Verify] to verify the connection between the O-arm® Imaging System and the server.
4. Click [OK].

Deleting a Worklist ❱❱ To delete an existing Worklist Server from the list, highlight the subject server listed under
Server Configuration “Worklist Servers” and click [Delete].

4-10 O-arm Imaging System User Manual


Powering Up and Configuring the System
Configuring the System

Connecting and Configuring an IGS System Connection

About the IGS System In order to use the O-arm® Imaging System with a StealthStation® system, also known as an
Connection Image-Guided Surgery (IGS) system, you must:
• Connect the systems together using a standard network cable or a crossover cable (see
below).
• Configure the O-arm Imaging System so that it can communicate with the StealthStation®
System (2 steps - see page 4-12).

Connecting the
Network Cable 1

Figure 4-8 MVS Connector Panel

1. Connect one end of a network cable or crossover cable to the network jack 1on the MVS
connector panel.
2. Connect the other end of the cable to the StealthStation® System network jack.

Configuring the IGS The configuration steps to establish communication between the O-arm® Imaging System and
System Connection any StealthStation® system are:
• Assign the O-arm® Imaging System a network identity (IP Address, etc.).
• Enter the network identity of the StealthStation® System into the MVS.
Configuration is performed through the System Technical Service Console. Access is password
protected. Administrator privileges are required.

Assigning a Network To export images from the O-arm® Imaging System, an identity must be set on the MVS so that
Identity to the MVS other systems can recognize it and receive data from it. This step is usually performed by the
Medtronic Service Technician during installation of the O-arm® Imaging System.
To verify that the identity has been set, click on the MVS Station tab in the System Technical
Service Console and review the information. A Station Name, DICOM AE Title, and an IP
Address must be set.
If this information is not displayed on the MVS Station tab page, enter it at this time. Click [Edit]
to fill out the fields. See Figure 4-5 for reference.

Entering the Tell the MVS where to send images that it collects, by entering the StealthStation® System
StealthStation Identity information.
into the MVS
1. On the System Technical Service Console, click the DICOM Servers tab.

O-arm Imaging System User Manual 4-11


Powering Up and Configuring the System
Configuring the System

2. Under IGS Servers, click [New].


3. Fill in the information about the StealthStation® System.
• Server Alias: a unique name you assigned to identify the StealthStation® System
• AE Title: The StealthStation® System Application Entity (AE) title
• Server: The IP Address assigned to the StealthStation® System
• Port: The number of the port assigned to the StealthStation® System.
4. Click [Verify] to check the connection.
– If an error message appears: review the entries, make any necessary corrections and
reverify the connection. If the error is not resolved, check the cable connection.
5. Click [OK] to save the information.
– If you do not want to save your entries, cancel out of the dialog by clicking [Cancel].

Checking or Editing an 1. To check or edit an existing StealthStation® System configuration, highlight the system
Existing Configuration name listed under IGS Servers, and then click [Edit].
2. Make any desired changes.
3. Click [Verify] to confirm the connection.
4. Click [OK] to save the changes.

Deleting an Existing ❱❱ To delete the StealthStation® System from the list, highlight the system name under IGS
Configuration Servers, and then click [Delete].

iOR The integrated Operating Room (iOR) allows a surgical team to optimize space and intra-
operative decisions by integrating video, audio, communications, and devices over a common
network.

iOR Connections
When Medtronic personnel enable the iOR feature, the user can connect the O-arm system to an
IGS system available on the network.

4-12 O-arm Imaging System User Manual


Powering Up and Configuring the System
Configuring the System

Upon initialization, the user selects the IGS system to export images to as shown on the list
provided. See below.
Figure 4-9 Select an IGS Server

O-arm Imaging System User Manual 4-13


Powering Up and Configuring the System
Configuring the System

On the MVS station Tab, the Navigation Connection field will display the selected IGS system.
Figure 4-10 IGS selected

To change the connection, select the [Change...] button to see the list of available IGS systems
again and choose the new connection.

4-14 O-arm Imaging System User Manual


Powering Up and Configuring the System
Configuring the System

Configuring the DICOM Store Server

Prior to exporting O-arm®images, you must configure the MVS so that it is connected to the
DICOM store server to which you want to export the images.
Note: The term “store server” is used to identify a type of network storage device used to archive
images in DICOM format.

How to Configure a 1. Click on the DICOM Servers tab to open the DICOM Server page(Figure 4-11).
DICOM Store Server
2. Under DICOM Store Servers, click [New]. This opens the DICOM Server dialog.

Figure 4-11 DICOM Server dialog

3. Fill in the fields as follows:


Server Alias: A unique name that you assign to the MVS that it will use to identify the
DICOM Store Server.
AE Title: The DICOM Application Entity (AE) title
Server: The IP address assigned to the DICOM Store Server
Port: The number of the port assigned to the DICOM Store Server
• Modality: The type of fluoroscopy image modality supported by the MVS — two types XA
(X-ray Angiographic) and RF (Radio Fluoroscopic). XA is the default.
• Bits Stored: The word size of the stored image. 12 is the default for both Fluoro and CT.
• Structured Reports Sent: Check the Radiation Dose checkbox if the server is capable of
accepting structured dose reports. If checked, this server is displayed in the Send To dialog
for DICOM server selections.

O-arm Imaging System User Manual 4-15


Powering Up and Configuring the System
Configuring the System

4. Click [Verify] to ensure that the information was entered correctly and to confirm the
connection between the MVS and the server. If an error message appears, review the entries,
make the necessary corrections and re-verify the connection.
5. Click [OK] to save the information and return to the System Technical Service Console.
Note: To close the dialog without saving, click [Cancel].

Editing an Existing 1. On the DICOM Servers page, click on the server’s name under DICOM Store Servers (see
DICOM Server Figure 4-6 on page 4-9) and then click [Edit].
Configuration
2. Make any desired changes.
3. Click [Verify] to ensure that the information was entered correctly and to confirm the
connection between the MVS and the server.
4. Click [OK] to save the information and return to the System Technical Service Console.

Removing a DICOM ❱❱ To delete a DICOM Server from the list, click on the subject server listed under DICOM
Server From the List Store Servers and click [Delete].

When you are finished with all changes, press the Windows key to exit the System
Technical Service Console.

4-16 O-arm Imaging System User Manual


Powering Up and Configuring the System
Configuring the System

Adding to and Modifying the Physicians List

Accessing the 1. Open the System Technical Service Console.


Physicians List
a. Press <Ctrl–Alt–Home> on the keyboard to bring up the user access popup.
b. Type in your password and press <Enter>. The System Technical Service Console opens.
2. Click on the Physicians tab.
The Physicians List (Figure 4-12) opens.

Figure 4-12 Physicians List

You can add a new physician to the list, edit an entry, or delete a name from the list.

O-arm Imaging System User Manual 4-17


Powering Up and Configuring the System
Configuring the System

Adding a New 1. With the Physicians List open, click [New].


Physician to the List The Physician dialog box (Figure 4-13) opens.

Figure 4-13 Physician dialog box

2. Type in the physician’s Last and First names in their respective fields. A middle name is not
mandatory, but may be entered in the Middle Name field.
Note: You can cancel and close the Physician dialog at any time by clicking [Cancel].
3. Click [OK] to add the physician’s name and return to Physicians List (Figure 4-12).
4. Check that the physician that you entered appears in the list.

5. Press the Windows key on the keyboard to exit the System Technical Service Console.

Editing Entries 1. With the Physicians List open, scroll through the list to locate the entry to be changed and
click on it.
2. Use the <Backspace> key to remove erroneous data, and type in the corrections.
3. Review the corrected entry and press <Enter>.

Deleting a Name from 1. With the Physicians List open, select the name you wish to delete.
the Physicians List
2. Click [Delete].

4-18 O-arm Imaging System User Manual


Powering Up and Configuring the System
Configuring the System

Optimizing the Monitor Display

Calibrating the The system offers a calibration test pattern to optimize brightness, contrast and gamma settings.
Brightness, Contrast To access the calibration page:
and Gamma
1. Open the System Technical Service Console.
a. Press <Ctrl–Alt–Home> on the keyboard to bring up the user access popup.
b. Type in your password and press <Enter>. The System Technical Service Console opens.
2. Open the Maintenance tab.

Figure 4-14 Maintenance Tab page

3. Press [Adjust Display Settings] in the “Monitor Calibration” field to open the
calibration page.

O-arm Imaging System User Manual 4-19


Powering Up and Configuring the System
Configuring the System

1 2

4 3
Figure 4-15 Monitor Calibration page

4. Use the Brightness, Contrast and Gamma slider bars 3 to adjust the settings.
Recommended setting is when both a somewhat lighter square is visible in the dark box 1
and a somewhat darker square is visible in the light-colored box 2.

5. When you are satisfied with the calibration, press [OK] 4 to close the calibration window.

6. Press the Windows key on the keyboard to exit the System Technical Service Console.

4-20 O-arm Imaging System User Manual


Setup in the OR 5

5
This chapter describes the procedures to set up the O-arm Imaging System in the OR.

Moving the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2


Moving the IAS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2

Powering Up the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4


Unpacking and Activating the Mouse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6

Entering Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8


Entering New Patient Data at Time of Examination . . . . . . . . . . . . . . . . . . . . . .5-9

Patients in the Scheduled Exams Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

Acquiring Patient Information from Outside Sources . . . . . . . . . . . . . . . . . . . 5-14

Applying a Sterile Drape to the Gantry . . . . . . . . . . . . . . . . . . . . . 5-17


General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17

The Tube Drape . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18

The Non-Laser Tube Drape, (BI-900-00034) . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-25

The Bar Drape . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26

O-arm Imaging System User Manual 5-1


Setup in the OR
Moving the System

Moving the System

Moving the IAS

Safety Precautions Due to its mass, the IAS has battery-powered wheels to assist in its movement and positioning.

Warning: Move the IAS slowly to get a feel for the control mechanism. It
weighs approximately 1,950 lb (885 kg) and could cause serious injury to
people and damage to itself and other objects if a collision occurs.

Caution: The gantry must be in the docked position before you move the
IAS. Use special care on steep slopes and when crossing ramps and
thresholds.

Using The Transport


Handle

1
Figure 5-1 Transport Handle Control (IAS Stand, partial top view)

The Transport Handle 1 on the IAS cabinet has a control bar 2 that you squeeze to apply
power to the rear wheels of the IAS.
To move the IAS, squeeze the control bar and then push or pull the transport handle. When you
release the bar, the wheels stop moving. Therefore, stop movement before you release the bar.
■ Squeezing the control bar and pushing on the handle moves the IAS forward.
■ Squeezing the control bar and pulling on the handle moves the IAS backward.

Turning the IAS to the By applying differential pressure to either side of the handle, you can steer the IAS left or right.
Left or Right
To Turn Right
Squeeze the bar and push the left-hand side of the handle without applying pressure to the right-
hand side.

To Turn Left
Squeeze the bar and push the right-hand side of the handle without applying pressure to the left-
hand side.

5-2 O-arm Imaging System User Manual


Setup in the OR
Moving the System

Moving The MVS 1. Press down on the wheel brake release bars to unlock the wheel brakes.
2. Grasp the handle on either side of the MVS and carefully maneuver it to its destination.

Caution: Use two people to move the MVS up or down an incline. Never
attempt to move the MVS down steps or stairs.

3. Press down on the wheel brakes to lock the wheels once the MVS is in its final location.

O-arm Imaging System User Manual 5-3


Setup in the OR
Powering Up the System

Powering Up the System


For the IAS and the MVS to function as a system, they must be physically connected to one
another. This is accomplished by a single interconnect cable that supplies power to the IAS and
allows signal and data transfers between the two units.

Connecting the IAS 1. Plug one end of the interconnect cable into the receptacle on the IAS connector panel (refer
and MVS and to Figure 3-2 on page 3-3).
Powering Up the
2. Plug the MVS power cable into a suitable wall outlet—one that is properly grounded and
System
matches the power rating listed on the MVS label.

Note: The interconnect cable can be connected and disconnected regardless of whether the
line voltage is applied to the MVS.
3. Turn the key switch on the IAS connector panel to the On position.

4. Turn the power switch on the IAS Power Control Panel (refer to Figure 3-3 on page 3-4) to
the (Start) position.

5. Turn the power switch on the MVS power control panel (refer to on page 3-12) to the | (On)
position.

The system takes about 3 minutes to boot up and run through its power on self-test. During
the initializing period, the Pendant display looks like that shown in Figure 5-2.

Figure 5-2 Startup Progress Display

Once the system successfully completes the self-test it is ready for use.
Note: If any warning or failure messages appear on the MVS display or the Pendant screen,
contact technical support (refer to “Technical Support” on page 1-4).

Locating Home The issue described here is not normal operation, it should only arise if there is a problem.
Position
Upon startup, you may need to reset the gantry home position (the “zero” position of each of the
three [x, y, z] axes). In this case the Pendant displays a message such as “To calibrate motion,
hold “M” button. Press door icon to open door”.

5-4 O-arm Imaging System User Manual


Setup in the OR
Powering Up the System

❱❱ Press and hold the M button on the Pendant until the gantry’s motion ceases and the system
assumes its 2D fluoro default mode.
If the IAS is not connected to the MVS, the Pendant displays a message that the IAS is in the
“Standalone Mode (see “Standalone Mode” on page 2-3).

Connecting the Foot When not in use, the foot switch is normally stored in its holder located on the bottom left-hand
Switch side of the MVS. The attending surgical team may choose to use the foot switch or not.

❱❱ To connect the foot switch, remove it from the holder and plug it into its receptacle at the
IAS Connector Panel (refer to Figure 3-2 on page 3-3).

Connecting a Second A second video display using either S-video or VGA signals can be connected to the MVS for
Monitor remote viewing of the same display appearing on the MVS main monitor. Connect this monitor
into the MVS Connector panel using the appropriate cable type and jack (Figure 3-9 on page 3-
11).
Note: The second monitor display will not update the image at the same frame rate as the main
MVS monitor, but it will match the original display when updating and scrolling ends.

O-arm Imaging System User Manual 5-5


Setup in the OR
Powering Up the System

Unpacking and Activating the Mouse

About the Mouse Medtronic Navigation supplies a sterile customized wireless mouse for use in the OR. It is
designed for single use, to be disposed of at the completion of the surgical procedure.Reuse could
pose a risk of infection to the patient
Be sure the sterilization barrier or packaging are not compromised. Before the mouse can be
used, it must be removed from its sterile package, and activated so that the O-arm® Imaging
System recognizes it.

Warnings
Warning: DO NOT USE IF PACKAGE IS DAMAGED.

Warning: DO NOT REUSE.

Warning: DO NOT RESTERILIZE

Warning: Once you have removed the mouse from the sealed bag, do not
take the mouse out of the sterile field. If the mouse is removed from the
sterile field, it will be contaminated, and must not re-enter the sterile field.

Unpacking the Mouse The wireless mouse, Part No. 9732721, is supplied sterile in a sealed polyurethane bag. Use
and Maintaining standard OR sterile field procedures to remove the mouse from the bag once the sterile field has
Sterility been created.
The activation procedure for the mouse requires two people: one sterile person holding the
mouse within the sterile field and a second person outside the sterile field at the MVS.

5-6 O-arm Imaging System User Manual


Setup in the OR
Powering Up the System

Wireless Mouse

1
3
2
4

Figure 5-3 Wireless Mouse (Left) and Receiver (Right)

Activating the Mouse 1. Push the On/Off switch 2 to On.

2. Press the “connect” button 3 on the mouse receiver at the base of the post supporting the
MVS monitor.

The LED on the mouse receiver 4 begins flashing.


3. Within 20 seconds of pushing the “connect” button, press and hold the right mouse button
1 until the LED on the receiver goes out. This should take about 5 seconds.
4. When the LED on the receiver goes out, communication has been established between the
receiver and the mouse. The mouse is now ready for use. Refer to pages 7-10, 7-17 and 7-26
on the use of the mouse.

Note: If the LED on the receiver does not go out, repeat the procedure. This may be necessary for
the mouse to find a clear communications channel. There are five possible channels.
If a clear channel cannot be obtained, the touch pad and function keys on the MVS keyboard can
be substituted for the mouse.

Wireless Interference During use of the mouse, you may encounter interference from other wireless devices operating
of the Mouse in the area. This is indicated by slow response to motion commands, or missed commands. If this
happens, repeat steps 2-4 of “Unpacking and Activating the Mouse”.

Using the Mouse’s ❱❱ To use the mouse as a pointing device, point the front of the mouse at the target and press the
Laser Pointer laser pointer trigger on the underside of the mouse.

O-arm Imaging System User Manual 5-7


Setup in the OR
Entering Patient Information

Entering Patient Information


Opening The Exam When the system powers up, the Exam Information page opens. If it does not appear, press
Information Page <Esc> on the keyboard.

Figure 5-4 Exam Information Page

Options for Entering The following options apply to entering patient data:
Patient Data
• Enter new patient data at the time of the patient’s examination.
• Enter data ahead of the patient’s examination and place the patient in the Scheduled Exams
List (Figure 5-5 on page 5-11).
• Open the Exam Information page to edit previous data entries (page 5-9).

5-8 O-arm Imaging System User Manual


Setup in the OR
Entering Patient Information

Entering New Patient Data at Time of Examination

The Exam Information The Exam Information page (see Figure 5-4) allows you to enter new patient data and access
Page existing patient records from the system’s database.
Use the MVS keyboard to type patient information into the text fields. A flashing cursor
indicates which text field you are in.
Use the <Tab> key or the touch pad to move between entries, and the <Backspace> key to
correct any typing errors.

How to Enter Data for 1. Under Patient Info enter the following data:
a New Patient • Last Name
• First Name
• Middle name (not required)
• Patient ID
• Date of Birth: type in the month, the day, and the year. The software assigns two digits for
the day and month.
• Sex: select Female, Male, or Other.
• Height
• Weight
2. Select Prevent Deletion to ensure that the patient’s exam information cannot be
automatically deleted from the system’s database (refer to “Automatic Patient Deletion” on
page 8-14).

3. Under Examination Info, enter the following data:

• Accession Number
• Study Description (up to 64 characters)
• Performing Physician: Use the scroll bar to locate the physician’s name (refer to page 4-17
to add a physician’s name to the list). If you enter a name that is not in the list, a dialog asks
if you want to add the name to the list. Press [OK].
4. Review the information you entered to insure its accuracy and make any necessary
corrections.

5. Click [Accept] to begin the examination process.

Note: Even if you do not click [Accept], if you acquire images, the information is saved to the
system’s database.

Editing Patient Once the Exam Information page leaves the screen, you cannot alter text fields without using the
Information Edit button.
When a new patient is entered into the patient database, preset memory locations are reset to their
default settings.

When You Don’t Have Situations may arise when you do not have time to enter the new patient’s data into the Exam
Time to Enter Patient Information page before starting the exam. In such cases do the following:
Data

O-arm Imaging System User Manual 5-9


Setup in the OR
Entering Patient Information

1. Press <Esc> on the keyboard to open the Exam Information page.


2. Make sure that the Exam Information tab is selected.

3. Click [Accept] to begin the examination session.

If no patient information is entered in the Exam Information page when you click [Accept], the
system automatically creates a new patient sheet and places a date/time stamp in the Last Name
block.
There are two options available to you for completing the information:
• If a lull occurs in the imaging session, press the <Esc> key to re-open the date/time stamped
Exam Information page. Click [Edit] to fill in the patient information.
• Any time after the exam, you can open the Saved Exams page (refer to “Opening the Saved
Exams Page” on page 8-2), select the entry with the date/time stamp of the exam, and open
it to complete the patient information record.

5-10 O-arm Imaging System User Manual


Setup in the OR
Entering Patient Information

Patients in the Scheduled Exams Page

Posting Patients to the You can post new patient data to the Scheduled Exams page and then call it up at a later time.
Scheduled Exams This is a way of entering one or more patient’s data ahead of their examination date to avoid
Page having to do it just prior to the start of the examination process. To do this:

1. Perform steps 1-4 described above, to enter the patient’s data into the Exam Information
page.
2. Click [Schedule]. This enters the patient’s data into the system’s database and places the
patient’s name into the Scheduled Exams page (see Figure 5-5).

3. Repeat this process for each additional patient you want to schedule for a future
examination. The exam date is not required for these entries. You are simply compiling a list
of patient’s whose exams will occur at a future time.

The Scheduled Exams


Page

Figure 5-5 Scheduled Exams page

O-arm Imaging System User Manual 5-11


Setup in the OR
Entering Patient Information

Selecting a Patient If you have previously posted a patient into the Scheduled Exams page (see above), you can
from the Scheduled select his records from the system database prior to the start of the exam.
Exams Page
1. If the patient Exam Information page (see Figure 5-4) is not open, press <Esc>.
2. Click on the Scheduled Exams tab. This opens the Scheduled Exams page.

3. Click on the patient’s name to highlight the row for that patient.

4. Click [Start Exam].


All images acquired during the exam are saved in that patient’s file in the system database.

Once imaging of the patient is finished, the patient’s data is transferred to the Saved Exams list
(refer to Figure 8-1 on page 8-3).

Exam Information
Page Filled In

Figure 5-6 Exam Information Page Filled In

5-12 O-arm Imaging System User Manual


Setup in the OR
Entering Patient Information

Editing Patient If a patient’s exam information has been entered in the system database and posted to the
Information Scheduled Exams page (see “Patients in the Scheduled Exams Page” on page 5-11), you can
retrieve it to review it or edit it.

1. In the Exam Information page, click on the Scheduled Exams tab to open the Scheduled
Exams page.
2. Click on the patient’s name.

3. Click [Edit Exam]. This opens the Exam Information page (Figure 5-4) for the selected
patient.

4. Review the information to insure its accuracy and make any necessary changes. Use <Tab>
to move between fields and <Backspace> to correct any errors.

5. Click [Save Changes] to save it to the patient database.

Note: To review existing exams for a patient, refer to “Accessing and Reviewing Patient Exams”
on page 8-2.
Note: Study information received from the worklist server cannot be edited.

O-arm Imaging System User Manual 5-13


Setup in the OR
Entering Patient Information

Acquiring Patient Information from Outside Sources

Outside Sources of You can transfer patient information to the O-arm® Imaging System from external databases.
Patient Information One place where patient information may be stored is on a “worklist server” on the hospital’s
ethernet.
Note: In order to access patient information on a worklist server, the server must be on the
hospital network and the connection to that server must be configured on the O-arm Imaging
System (refer to “Configuring a Worklist Server” on page 4-9).
Note: Patient study information from a worklist server cannot be edited.

Opening the Worklist 1. If the Exam Information page is not open, press <Esc> on the keyboard.
Query Dialog
2. Click on the Scheduled Exams tab to open the Scheduled Exams page.

3. Click [Worklist] to open the Worklist Query dialog.

Figure 5-7 Worklist Query page (top portion)

The Worklist Query dialog allows you to search the selected worklist server to locate and transfer
individual patient information. It offers the option of searching by predetermined time intervals
or by a date range that you select.

Performing a Patient 1. Type in the listed patient information:


Information Query
• Last Name
• First Name
• Patient ID
• Accession #
Note: If you are rushed for time or lack information, both the Last & First Name entries offer a
“wild card” search capability.
2. Determine your search criterion as follows:

– To search by a predetermined time interval, click [By Interval] and use the drop-down list
to select one of the three intervals.

5-14 O-arm Imaging System User Manual


Setup in the OR
Entering Patient Information

– To search by an interval of your choice, click [By Date Range] and type in the ‘from-to”
dates in the two text boxes.
– You can add a third search criterion–”modality” by clicking the Modality checkbox and
selecting any of the three selections: CT, XA, RF, or all of them with All Modalities.
3. Click [Get]. The system performs a search and returns the results to the Worklist Query
dialog as shown in Figure 5-8.

Figure 5-8 Expanded Worklist Query Dialog

4. Select the patient’s name and click [Details] to view the details of the patient’s record (see
Figure 5-9).

O-arm Imaging System User Manual 5-15


Setup in the OR
Entering Patient Information

Figure 5-9 Patient Details

5. Click [OK] to return to the Worklist Query dialog.

6. To perform another patient query, repeat steps 1 through 5.

7. When you are finished, select the patient(s) to be placed on the Scheduled Exam page and
click [OK] on the Worklist Query dialog.

5-16 O-arm Imaging System User Manual


Setup in the OR
Applying a Sterile Drape to the Gantry

Applying a Sterile Drape to the Gantry

General Information

In most surgical circumstances, you need to apply a sterile drape to the portion of the O-arm
gantry that is exposed to the sterile field (refer to “Patient Environment” on page 1-6).

Proper Disposal The sterile drapes are considered medical waste. After use, dispose of the sterile drapes in
accordance with all local regulations. Reuse of the drapes could pose a risk of infection to the
patient.

Drape Options Medtronic Navigation supplies three types of sterile drapes for use with the O-arm Imaging
System:
■ The Tube Drape - a sleeve type drape that slips over the gantry (pn 9732722)
■ The Non-Laser Tube Drape - an alternative tube drape with a looser fit. This drape is not
compatible with the laser positioning feature. (pn BI-900-00034)
■ The Bar Drape - a drape that attaches to the top of the gantry and to the patient drape (pn
9733023) to isolate the operating area
Drapes can be ordered from Medtronic Navigation (refer to “Ordering Accessory Items” on
page 1-4).
The decision of which type of drape to use is up to the surgical team and OR requirements.
The application of each is described below.

Warnings
Warning: DO NOT REUSE.

Warning: DO NOT RESTERILIZE.

Warning: DO NOT USE IF PACKAGE IS DAMAGED.

Warning: When installing drapes on the system, take care not to snag and
tear the drapes on the laser fixtures.

O-arm Imaging System User Manual 5-17


Setup in the OR
Applying a Sterile Drape to the Gantry

The Tube Drape

The Tube drape is part number 9732722. Check the revision number on the package and follow
the instructions that apply.

Installing the Tube Before you begin, have the O-arm system operator open the door of the gantry.
Drape, Revision 5
1. Sterile staff removes the drape from the sterile pack and places it on a sterile table with the
left hand label up and facing you.
2. Grip the drape under the fold beneath the Left-hand label with your left hand and unfold it to
the left, and then grip the drape under the Right-hand label fold with your right hand and
unfold it to the right..

Figure 5-10 Lay drape on sterile table, unfold to right, then to left

3. Unfold the top fold of the drape toward you.

Figure 5-11 Unfold the top fold toward you

5-18 O-arm Imaging System User Manual


Setup in the OR
Applying a Sterile Drape to the Gantry

4. Following the hand indicators, put your hands into the drape main fold.

Figure 5-12 Insert hands into remaining fold as deeply as you can

5. Raise your hands and lift the drape up, allowing the drape to hang open in front of you.
Note: For best results, don't grip the drape; just tilt your fingertips up as you lift.

Figure 5-13 Carefully holding the open drape, move toward the O-arm

6. Walk to the opening of the gantry and hold the drape so that the opening aligns with the
upper part of the gantry.

7. A non-sterile assistant takes ahold of the drape at a "GRIP HERE" tab on one side of the
gantry, and pulls the drape over the top of the gantry to the positioner, following the "THIS
END OVER UNIT" indicator. It helps if another non-sterile assistant does this at the same
time on the other side.

Figure 5-14 Hold one end and pull the other over the upper arch of the gantry

O-arm Imaging System User Manual 5-19


Setup in the OR
Applying a Sterile Drape to the Gantry

8. At the positioner end of the gantry, there is a piece of tape with backing. The non-sterile
assistant removes the tape backing and applies the tape to the positioner, near the top.

Figure 5-15 Tape the end of the drape to the gantry positioner

9. If the side folds of the drape are held up by tabs, break the tabs and let the drape hang down.
There are also pieces of tape on the bottom of the side folds that can be used to attach the
drape to the underside of the gantry (not to the cart chassis).

Figure 5-16 Tape the bottom of the drape to the underside of the gantry

10. Have the operator position the gantry over the patient.

11. (Sterile) Break the perforation between the green arrows on the two (2) door tear tabs, and
gently shake the drape folds out.

5-20 O-arm Imaging System User Manual


Setup in the OR
Applying a Sterile Drape to the Gantry

12. Have the O-arm operator start to close the gantry door, while the sterile person holds the
drape so that it hangs down just below the closing door. Note: As the door closes,
communicate with the operator to stop closing it if there is danger of the drape snagging,
tearing, or getting caught inside the closing door.

Figure 5-17 Unfold drape and close gantry door

Caution: Carefully watch while the door closes to make sure that no part
of the drape is caught inside the door. This could cause internal failure of
the components.

13. As the door reaches the bottom part of the gantry, a non-sterile assistant makes sure that the
drape opening fits around the lower portion of the gantry, and is kept clear of the door as the
door closes.

O-arm Imaging System User Manual 5-21


Setup in the OR
Applying a Sterile Drape to the Gantry

14. The sterile person now tapes up the drape slack. If you are using the O-arm system with a
StealthStation® navigation system, do this on the side of the gantry opposite from where the
StealthStation camera will be positioned during imaging.

Figure 5-18 Tape slack on side opposite camera

To tape up the slack, break the perforation between the green arrows on the poly ties, remove
the tape backing near the bottom of each tie, and use the tape to cinch up the excess drape.

Figure 5-19 Make sure the drape is smooth over the tracker

15. On the side of the gantry where the StealthStation camera is, ensure that the drape is smooth
over the tracker. Remove any poly ties that cover the tracker LEDs, so that the camera can
detect the tracker.

5-22 O-arm Imaging System User Manual


Setup in the OR
Applying a Sterile Drape to the Gantry

Removing the Tube 1. Release the poly ties holding the slack on the top of the drape above the patient.
Drape

Figure 5-20 Releasing the poly ties

2. Have the operator open the door of the gantry, while the assistant holds the drape in place as
the door opens.

Figure 5-21 Opening the door of the gantry

3. Have the sterile assistant locate the perforation at table height and tear the drape by holding
it above the perforation while a non-sterile assistant pulls below the perforation. Note: The
perforation is indicated by a “TEAR AWAY AFTER USE” sticker.

Figure 5-22 Tearing the drape at the perforation

O-arm Imaging System User Manual 5-23


Setup in the OR
Applying a Sterile Drape to the Gantry

4. (Sterile) Carefully roll up and stuff the sterile remainder of the drape above the perforation
into the opening at the top of the door opening. A second pair of gloves may help for this
step. They can be peeled off during stuffing into the cavity.

Figure 5-23 Rolling up the drape

5. Position the gantry away from the patient until the system is removed from the sterile field.

6. Remove the tape on the rear cabinet and pull the drape off of the gantry.

5-24 O-arm Imaging System User Manual


Setup in the OR
Applying a Sterile Drape to the Gantry

The Non-Laser Tube Drape, (BI-900-00034)

Installing the Tube 1. Open the door of the gantry.


Drape
2. Remove the drape from the sterile pack and place it on a sterile table with the right and left
arrows facing up.

3. Find the two (2) green hand icons in the folds of the drape and the “up” arrow, and place
your hands into the drape as indicated.

4. Walk to the opening of the gantry and hand the part of the drape with the “top” arrow
indicator, to a circulating nurse to pull on to the upper portion of the gantry, completely over
the top to the rear vertical support. Peel off the tape backing and apply the tape to the rear
cover.

5. Keep pushing the drape toward the top of the gantry until no slack hangs over the gantry
opening.

6. Close the gantry door to within the last 2-3 inches of the door closure. The circulating nurse
unfolds the drape to bring it down over the bottom part of the O.

7. Have the sterile nurse hold the drape above the perforation while the circulating nurse tears
off the bottom of the drape at the perforation line.

8. Close the gantry door. Carefully watch while the door closes to make sure that no drape
fragment is caught inside the door. This could cause internal failure of the components.

9. Remove the tape backing and tape the drape in two locations at the door.

10. Have the sterile nurse pull up the slack on the top 1/3 of the drape above the patient and
secure it using sterile tape on the side of the gantry opposite to where the reference markers
are.

Removing the Tube 1. Remove the sterile tape holding the slack on the top 1/3 of the drape above the patient.
Drape, Revision 4
2. Open the door of the gantry.

3. Have the sterile nurse locate the perforation at table height and tear the drape by pulling
above the perforation while the circulating nurse pulls below the perforation.

4. Stuff the sterile remainder of the drape above the perforation into the opening at the top of
the door opening.

5. Position the IAS away from the patient until it is removed from the sterile field.

O-arm Imaging System User Manual 5-25


Setup in the OR
Applying a Sterile Drape to the Gantry

The Bar Drape

About the Bar Drape The Bar drape offers an alternative to the Tube drape. It fits over the top and sides of the gantry.
An adhesive backing runs along one edge of the Bar (built up) side of the drape, to attach the
drape to the patient’s sterile sheet, making a continuous sterile barrier between the operating area
and the gantry.
Once the bar drape is in place, the patient’s upper or lower torso and the end of the operating
table are covered and out-of-sight from the surgeon’s field of vision.

Applying the Bar 1. Use the gantry positioning controls to position the gantry along the patient table, as far from
Drape the operating area as possible. This should be toward the non-sterile end of the operating
table. Ideally, the entire sterile-draped area of the patient will be well away from the inside
of the gantry.
2. Using sterile procedure, remove the drape from the sterile pack and place it on the sterile-
draped patient with the “TO” label towards the O-arm® gantry.

3. You will see peel-off tape on two opposite edges of the drape. Unfold the drape in the
direction of the “UNFOLD” arrow, so the side with the tape is facing the O.

4. Remove the tape backing on the thick tape closest to the patient and stick it to the patient
drape above the operating area.

5. Have the sterile operators hold each end of the bar drape inside the fold where the two (2)
green hands are depicted, and raise the drape to cover the entire top half of the gantry.

6. Have the circulating nurse remove the backing on the tape strips at the top of the gantry to
secure it to the top of the O.

Warning: Once the Bar drape is attached to the patient’s sheet, do not
attempt to move the IAS by lowering the lateral position wheels and
pushing the stand sideways along the operating table. This could dislodge
the patient’s sheet and interrupt the surgical procedure.

5-26 O-arm Imaging System User Manual


Positioning the Gantry 6

6
This chapter describes how to position the gantry for imaging, and how to move it out of the way
during surgery.

Introduction to Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2


Using the Door and Preparing the Gantry . . . . . . . . . . . . . . . . . . . . 6-3
Work Flow Recommendations For Using the O-arm® Door . . . . . . . . . . . . . . .6-3

Positioning the Gantry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4


Positioning the Gantry For Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-6
Pendant Buttons for Gantry Movement and Beam Positioning . . . . . . . . . . . .6-9

Gantry Movements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12


The Gantry Docked Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
Gantry Tilt Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14
Gantry Up and Down Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Gantry Iso-wag Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
Gantry Wag Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
Gantry Transverse (In/Out) Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
Gantry Longitudinal (Left/Right) Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19

Aligning the X-ray Beam Path . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20


The Laser Alignment Kit (LAK) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-22

Moving the Gantry Out of the Way . . . . . . . . . . . . . . . . . . . . . . . . . 6-25


Positioning the Gantry Out of the Way for Surgery . . . . . . . . . . . . . . . . . . . . . 6-25
Moving the IAS Laterally . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26
Moving the IAS Away from the Operating Table . . . . . . . . . . . . . . . . . . . . . . . 6-27

O-arm Imaging System User Manual 6-1


Positioning the Gantry
Introduction to Imaging

Introduction to Imaging

Imaging Overview

After you complete the initial setup (Chapter 5), you can initiate the imaging process. The
imaging process varies from site-to-site, depending upon the working arrangements instituted by
individual surgical teams using the O-arm® Imaging System.
This chapter describes how to position the gantry for imaging and how to move it out of the way
for surgery. The following chapter describes how to use the three imaging modes to acquire
images.

Main Procedure Steps

Positioning the gantry Described in this chapter


Aligning the X-ray source Described in this chapter
Taking scout images in the 2D fluoro mode Described in the next chapter
Storing scout images and park position Described in the next chapter
Using the M-2D mode Described in the next chapter
Using the 3D imaging mode Described in the next chapter
Parking the gantry or moving the entire IAS to an Described in this chapter
out-of-the-way position before starting surgery

6-2 O-arm Imaging System User Manual


Positioning the Gantry
Using the Door and Preparing the Gantry

Using the Door and Preparing the Gantry

Work Flow Recommendations For Using the O-arm® Door

Best Practices These work flow instructions are intended to serve as best practices when using the O-arm®
Imaging System door mechanism.

1. Always transport the O-arm with the door in the fully opened or fully closed position.

Warning: Before opening or closing the O-arm door always confirm that nei-
ther the patient nor any one else is in the path of the moving door.

2. The door should always be in the fully open position while the Tube Drape is being installed
on the upper section of the O-arm.
3. The door should always be in the fully open position while the O-arm is being positioned
over the patient. See below.
4. During the installation of a tube drape, care should be taken to ensure those performing the
draping procedure keep their hands and their body out of the path of the door.
Figure 6-1 Gantry Door Fully Open-Back and Side View

O-arm Imaging System User Manual 6-3


Positioning the Gantry
Positioning the Gantry

Positioning the Gantry


Positioning the Gantry Prior to beginning any procedure, consider your ability to perform CPR on the patient, if
for CPR necessary. Pre-planning the movement of the gantry saves time and effort during an emergency.
Take into account the gantry’s full range of motion when positioning the IAS cabinet and
determining the CPR position.

1. Position the O-arm® Imaging System as needed to image the region of interest.
2. Place tape on the floor to mark the position of the imaging system.
This permits you to return the system to its original placement if the system must be moved
during the procedure.
3. Using only wag, tilt, and longitudinal controls (see “Gantry Movements” on page 6-12)
move the gantry into a position that allows sufficient access for CPR.
Depending on the anatomy being imaged, and the position of the patient on the table,
movement toward the head or legs may provide better, or more expedient, access to the
patient for CPR. Consider movement in all three axes
4. Store this gantry position by using a Memory Preset button.
See “Storing Positions and Acquisition Settings” on page 7-14 for directions on storing a
preset. Consider using the Park preset button as the CPR position.
Note: If the system loses power, all Memory presets, including the store CPR position, are
erased.
5. Press the Memory Preset button stored in step 4 to move the gantry if the patient requires
CPR.
If you release the preset button before the gantry has reached that position, the gantry will stop
mid-motion.
Note: If the O-arm imaging system is moved out of the field during the course of a procedure,
then returned, the stored position may no longer be the optimal for performing CPR.

Positioning the IAS for The O-arm® Imaging System may be positioned for CPR by using the system’s Lateral Shift
CPR using Lateral capability. See “Moving the IAS Laterally” on page 6-26 for information about moving the
Shift imaging system laterally. Moving the IAS using the Lateral Shift capability is not as quick as
using a Preset memory location.
Take into account equipment in the area when moving the IAS laterally to perform CPR.

1. Position the O-arm® Imaging System as needed to image the region of interest.
2. Place tape on the floor to mark the position of the imaging system.
This permits you to return the system to its original placement if the system must be moved
during the procedure.
3. Determine where to move the IAS in the event the patient requires CPR.
Lateral Shift allows the IAS to move longitudinally, or along the long axis of a patient
positioned on the patient table.
Consider all equipment that is present during the procedure, including the patient table. This
equipment and the persons using this equipment might represent obstacles to the lateral
movement of the IAS.

6-4 O-arm Imaging System User Manual


Positioning the Gantry
Positioning the Gantry

4. Place tape on the floor to mark the position of the imaging system if CPR is required.
This marked location is the destination for the IAS in the event the patient requires CPR.
5. Follow the directions in “Moving the IAS Laterally” on page 6-26 to move the IAS to the
destination if the patient requires CPR.

Positioning the Gantry The movement controls used in conjunction with the gantry light ring to position the X-ray beam
to Take Images (see “Positioning the X-ray Beam Path” on page 6-21) allow the surgeon to obtain an exact
image of the region of interest.

Warning: You must use the patient spacer each time you reposition the
gantry with respect to the patient. Maintain the minimum space between
the X-ray source and the patient at all times during X-ray activation.
Failure to do so may result in harmful skin burns to the patient.

You can use any one of the movement controls, or a combination of them, (described on the
following pages), to position the gantry in relation to the patient.

The Patient Spacer Medtronic Navigation provides a Patient Spacer (see Figure 6-2) to ensure that the patient is
positioned the proper distance from the X-ray source. It is composed of stainless steel and is 5
1/4 inches (13.33 cm) in length, with tapered ends.
Note: The Patient Spacer must be sterilized prior to each use. Flash sterilization is acceptable.

Figure 6-2 The Patient Spacer

Warning: Always use the patient spacer to maintain the proper distance
between the patient and the X-ray source. Failure to maintain the
minimum source-to-skin distance may increase radiation exposure to the
patient.

Positioning the Patient 1. Place the patient spacer against the inner wall of the gantry so that it is pointing towards the
Spacer patient and lies between the patient and the X-ray tube.
2. If the spacer does not contact the patient, the patient is at a safe distance from the X-ray
source, and does not need to be repositioned.
3. If the spacer is in contact with the patient, reposition the patient so that the he/she is slightly
beyond contact with the spacer (the smaller array of orange LEDs).

Verifying Position with After each movement of the gantry, perform a 2D fluoro scout shot (see “Acquiring 2D Images”
Scout Shots on page 7-8) to verify that you have positioned the gantry appropriately.

O-arm Imaging System User Manual 6-5


Positioning the Gantry
Positioning the Gantry

Positioning the Gantry For Imaging

2-D Imaging For 2-D imaging, maximize the distance between the X-ray tube (smaller array of orange LEDs)
and the patient.

2
Figure 6-3 Correct gantry positioning for 2-D imaging: PA shots

1. Open the gantry door and bring the IAS into position around the operating table (see
“Gantry Movements” on page 6-12).

2. Position the X-ray beam so that the detector 2 is as close as possible to the side of the O
(the larger array of orange LEDs) that the patient is on.
■ For PA shots (see Figure 6-3):
– Bring the gantry up as close to the bottom of the operating table as possible.
– Use the beam positioning button to position the X-ray tube at the top of the O.
■ For AP shots:
– Bring the gantry down as far as possible.
– Raise the operating table to the top of the O to maximize the distance from the X-ray tube
to the patient.
– Position the X-ray tube at the bottom of the O.

6-6 O-arm Imaging System User Manual


Positioning the Gantry
Positioning the Gantry

2
1

Figure 6-4 Example of correct gantry positioning for 2-D imaging: Lateral shots

■ For Lateral shots:


– Move the gantry as close to the side of the operating table as possible.
– Position the X-ray detector 2 at the side of the O closest to the patient.
3. Acquire 2-D images.
4. Adjust the collimators, imaging techniques and ROI and retake image as needed.
5. Store the position (see “Storing Positions and Acquisition Settings” on page 7-14).
6. If you are now going to take a 3-D scan, reposition the gantry so that the patient is iso-center
in the O.

O-arm Imaging System User Manual 6-7


Positioning the Gantry
Positioning the Gantry

3D Imaging

Figure 6-5 Iso-center positioning of the patient for 3-D scans

1. Check orientation, anatomy, and body size settings on the Pendant in 3D mode.
2. Move the gantry so that the anatomy of interest on the patient is iso-center in the “O”.
3. Acquire the 3D scan.

6-8 O-arm Imaging System User Manual


Positioning the Gantry
Positioning the Gantry

Pendant Buttons for Gantry Movement and Beam Positioning

Slowing Gantry The default speed for gantry linear movements is 2 inches per second (5 cm per second). For
Movement Speed greater control when positioning the gantry precisely, or in any situation where fast movement
might be dangerous, you can use the M button (memory store) on the Pendant to slow the speed
of gantry movement 10-fold.

Figure 6-6 Slow Motion Mode

Press the M button (2 in image below) on the Pendant to slow gantry movement. Press it again
when you want to resume normal speed. The LED beside the M button is lit if you have toggled it
for slow movement.

Pendant Buttons

Figure 6-7 X-ray beam and gantry positioning controls

O-arm Imaging System User Manual 6-9


Positioning the Gantry
Positioning the Gantry

Pendant buttons for positioning the X-ray beam 1 and the gantry 3 are colored yellow. The
use of these buttons is described in Table 6-1.

6-10 O-arm Imaging System User Manual


Positioning the Gantry
Positioning the Gantry

Gantry Positioning
Button Overview
Table 6-1. Gantry Positioning Buttons Functionality

Dock Returns the gantry from its adjusted position to its normal transport
position—90° vertical with minimum longitudinal extension, 0° tilt and
wag.

Door
opens the gantry door. closes the gantry door.

Tilt Tilts the gantry.

Refer to “Gantry Movements” on page 6-12.

Up/Down Moves the gantry vertically up or down.

Refer to “Gantry Up and Down Control” on page 6-15.

Iso-wag Control Rotates the gantry around its iso-center point.

Refer to “Gantry Iso-wag Control” on page 6-16.

Regular Wag Moves the gantry in a regular wag motion.

Refer to “Gantry Wag Control” on page 6-17.

Longitudinal & Moves the gantry in the longitudinal and transverse directions relative
Transverse to the patient.
Control
For Transverse movement, refer to “Gantry Transverse (In/Out)
Control” on page 6-18

For Longitudinal (lateral) movement, refer to “Gantry Longitudinal


(Left/Right) Control” on page 6-19.

O-arm Imaging System User Manual 6-11


Positioning the Gantry
Gantry Movements

Gantry Movements
Types of Movements This section describes the ways that you robotically position the gantry. The basic movements
and where to find instructions for them are shown in Table 6-2.
Table 6-2. Gantry Movement Instructions

Movement See
Docking and Undocking page 6-13
Tilt page 6-14
Up and down page 6-15
Iso-wag page 6-16
Regular wag page 6-17
Transverse (in/out) page 6-18
Longitudinal (left/right) page 6-19

You can use any combination of positioning controls, up to their maximum ranges, to position
the gantry in relation to the patient.
Note: If you initiate any gantry movement that could result in an internal collision whereby the
gantry could hit another part of the system, a warning message appears on the Pendant and the
gantry will not move in the selected direction.

6-12 O-arm Imaging System User Manual


Positioning the Gantry
Gantry Movements

The Gantry Docked Position

The Docked Position The gantry has a docked position, in which two pins at the bottom of the gantry fit into two holes
at the base. The gantry should be in the docked position at all times when transporting or moving
the IAS.
When the docking pins are seated in the holes, the Pendant displays a message that the system is
docked.

Figure 6-8 Dock Button

Undocking the Gantry In the docked position, the gantry can only move upwards.
Use the up control (see “Gantry Up and Down Control” on page 6-15) to lift the gantry up out of
the docking holes. Once the gantry pins have cleared the docking holes, other gantry movements
are possible.

Docking the Gantry To dock the gantry, press and hold the Dock button on the Pendant (see Figure 6-8) until all
gantry axes return to zero and the gantry pins are seated in the docking holes.
Note: The final movement of the gantry as the docking pins settle into the holes is slower than
other up/down motions. Be sure to keep the Dock button pressed until all movement has stopped
and the pendant displays the “System docked” message.

O-arm Imaging System User Manual 6-13


Positioning the Gantry
Gantry Movements

Gantry Tilt Control

Gantry Tilt Range and You can tilt the gantry ±45° around its center axis. For 3D image acquisition, however, the gantry
Direction may not be tilted more than ±15°.
When viewing the gantry from the rear, the gantry tilts in the direction indicated by the arrows on
the tilt button (Figure 6-9).

Figure 6-9 Tilt Button

Tilting the Gantry

Figure 6-10 Gantry Tilt, rear view (L: negative tilt, R: positive tilt)

Press the left side of the button to tilt the top of the gantry to the left (viewed from the rear),
as shown on the left in Figure 6-10.

Press the right side of the button to tilt the top of the gantry to the right, (viewed from the
rear), as shown on the right in Figure 6-10.
Observe the motion of the gantry when you press the tilt button, and release the button when the
gantry reaches the desired position.
Note: The gantry will not tilt if the gantry door is open.

6-14 O-arm Imaging System User Manual


Positioning the Gantry
Gantry Movements

Gantry Up and Down Control

Range The gantry has a maximum up/down range of 18 ± 0.25 inches (45.7 ± 0.64 cm) You can raise
the gantry a maximum of 9 ± 0.125 inches (22.9 ± 0.32 cm) vertically, above its docked position.
When it is extended past its docking platform, it can be lowered to a height 24 inches (61 cm)
above the floor (measured from the bottom of the gantry).

The Up/Down Button The up/down button (Figure 6-11) is on the center right-hand side of the Pendant.
The gantry moves up or down in the direction indicated by the arrows on the button.

Figure 6-11 Up/Down Button

Moving The Gantry Up


and Down

18” (45.7cm)
9” (22.9cm)
2’ (61cm)

Figure 6-12 Moving the gantry up and down

Press and hold the top part of the button to move the gantry linearly upward.
Press and hold the bottom part of the button to move the gantry downward. To move the gantry to
its lowest position, it must first be transversely extended to its maximum distance away from the
cabinet, in order to clear its docking platform, as shown on the right in Figure 6-12 (see “Moving
the Gantry in a Transverse Direction” on page 6-18).
Observe the motion of the gantry with either part of the button pressed. For better control of the
movement, use the M button to slow movement speed (see “Positioning the Gantry For Imaging”
on page 6-6). Release the button when the gantry reaches the desired position.

O-arm Imaging System User Manual 6-15


Positioning the Gantry
Gantry Movements

Gantry Iso-wag Control

Iso-wag Button and You can wag the gantry about its geometric center. This motion is controlled by the Iso-wag
Range button on the center right-hand side of the Pendant.

Figure 6-13 Iso-wag Button

Viewed from above, the gantry can rotate ±12° about its vertical axis in the direction indicated by
the arrows on the side of the button.

Using the Iso-wag


Control

1 1

Figure 6-14 Iso-wag (top view) (L: negative, R: positive)

Press and hold the left side of the button to iso-wag the gantry to a maximum of 12° from
iso-center 1 in a counter-clockwise (negative) direction as viewed from above the IAS
(Figure 6-14, left).
Press and hold the right side of the button to iso-wag the gantry to a maximum of 12° from
iso-center 1 in a clockwise (positive) direction as viewed from above the IAS (Figure 6-14,
right).
Observe the motion of the gantry while pressing the button, and release the button when the
gantry reaches the desired position.

6-16 O-arm Imaging System User Manual


Positioning the Gantry
Gantry Movements

Gantry Wag Control

You can wag the gantry ±15° in regular wag positioning motion, using the wag button on the
lower right-hand side of the Pendant.

Figure 6-15 Wag Button

Wagging the Gantry

Figure 6-16 Gantry Wag, top view (L: negative, R: positive)

Press and hold the left side of the button to wag the gantry up to a maximum of 15° in a
counter-clockwise (negative) direction as viewed from above.

Press and hold the right side of the button to wag the gantry up to a maximum of 15° in a
clockwise direction as viewed from above.
Observe the motion of the gantry when the button is pressed, and release the button when the
gantry reaches the desired position.

O-arm Imaging System User Manual 6-17


Positioning the Gantry
Gantry Movements

Gantry Transverse (In/Out) Control

Transverse Movement You can move the gantry 9 ± 0.25 inches (22.9 ± 0.64 cm) in a transverse direction relative to the
Range and Button patient. This is movement away from/toward the cabinet.

Figure 6-17 Gantry Transverse Motion Buttons

The transverse movement buttons are at the lower right-hand corner of the Pendant.

Moving the Gantry in a


Transverse Direction

1 2

Figure 6-18 Transverse Motion (top view)

Press and hold the top of the button to move the gantry transversely (out) away from the cabinet
1.
Press and hold the bottom of the button to move the gantry transversely (in) towards the cabinet
2.
Observe the motion of the gantry when the button is pressed, and release the button when the
gantry reaches the desired position.
Note: For better control of the movement, use the M button to slow movement speed (see
“Slowing Gantry Movement Speed” on page 6-9).

6-18 O-arm Imaging System User Manual


Positioning the Gantry
Gantry Movements

Gantry Longitudinal (Left/Right) Control

Longitudinal You can move the gantry left or right a distance up to 7 ± 0.25 inches (17.8 ± 0.64 cm) from its
Movement Range and center position.
Control

Figure 6-19 Longitudinal Movement Buttons

The buttons at the lower right-hand corner of the Pendant control this motion.

Moving the Gantry in a


Longitudinal Direction

Figure 6-20 Gantry Longitudinal Motion, top view (Left: leftward, Right, rightward)

Pressing the left side of the button moves the gantry longitudinally to the left as viewed
from rear of the IAS (Figure 6-20).

Pressing the button moves the gantry longitudinally to the right as viewed from the rear of
the IAS (see Figure 6-20).

O-arm Imaging System User Manual 6-19


Positioning the Gantry
Aligning the X-ray Beam Path

Aligning the X-ray Beam Path


If you have the optional Laser Alignment Kit (LAK) with your O-arm® Imaging System, you can
use it for more precise alignment of the X-ray beam path (see “The Laser Alignment Kit (LAK)”
on page 6-22). Otherwise, follow the general alignment steps below and then take 2D
fluoroscopic images to refine the positioning of the beam.

Using the Light Ring

3
4
2

1
Figure 6-21 Gantry Light Ring LEDs

A Light Ring 4 on the gantry contains LEDs that indicate the position of the X-ray tube 3 -
smaller group of LEDs, and the detector 1 - larger group of LEDs. The LEDs serve as a visual
guide for you to adjust the path of the beam.
Prior to X-ray activation, align the X-ray beam path 2, using the LEDs to approximate the path
the X-ray beam will take through the patient.
The position of the X-ray tube 3 and detector are always separated by 180° so that the beam
path 2 passes through the center point (iso-center) of the gantry ring.
Note: Whenever you take an AP image, put the X-ray source and detector in positions 180° from
the positions shown in Figure 6-21 — you want the tube to be on the bottom in order to reduce the
scatter effect.

Controlling the X-ray


Beam Path Position

Figure 6-22 Tube/Detector Orbital Rotation Button

The X-ray tube/detector orbital rotation button (Figure 6-20) in the upper left-hand corner of the
Pendant controls X-ray beam positioning.

6-20 O-arm Imaging System User Manual


Positioning the Gantry
Aligning the X-ray Beam Path

Positioning the X-ray


Beam Path
2
2

Figure 6-23 Positioning the X-ray Beam Path (L: positive direction, R: negative direction)

Press the top portion of the button , to move the X-ray beam path 2 in a clockwise
(positive) direction, viewed from the left side of the IAS as shown in Figure 6-23.

Press the bottom portion of the button , to move the X-ray beam path in a counter-
clockwise (negative) direction when viewed from the left side of the IAS.
The LEDs on the light ring show the beam movement.

O-arm Imaging System User Manual 6-21


Positioning the Gantry
Aligning the X-ray Beam Path

The Laser Alignment Kit (LAK)

Overview The Laser Alignment Kit (BI-710-00039) aids in positioning the path of the O-arm® Imaging
System X-ray beam on the anatomy you want to scan, thereby reducing the need for fluoroscopic
“scout” images and reducing radiation exposure.

Caution: The LAK emits Class 1M laser radiation. Do not view directly
with optical instruments.

A Medtronic service engineer calibrates the laser light positions when they are installed.

Warning: The patient alignment lasers are not user-serviceable. Contact


Medtronic Service for support. Use of controls or adjustments other than
specified herein may result in hazardous exposure.

Description of The LAK consists of four laser light sources that produce lines of red light along specific axes:
Positioning Lasers ■ One defining each end of the scan plane
■ One sagittal
■ One coronal
Note: The distances from iso-center are measured on your specific system. Please refer to the
form “Positioning Distance Information” from your service engineer, that indicates distances for
your specific system or contact technical support for more information.

Turning the Laser The laser indicator lights can be toggled on and off via the Pendant.
Lights On and Off
When the IAS computer starts up, the laser lights are off. Once a connection is established
between the MVS computer and IAS, you can use the Lasers softkey on the Pendant screen to
toggle the laser lights on and off.
When the laser lights are activated, the Lasers softkey shows a green check mark as in
Figure 6-24, and the red lights show up against the backdrop of any object inside the gantry. You
then use the gantry positioning controls to position the gantry so that the laser lights define the
desired scan area.

Laser Light Timing The laser lights remain on for a predetermined amount of time (default is 30 seconds) that is
configured into the software, and then they turn off automatically. To extinguish the lights before
the time has elapsed, press the softkey. If the lights turn off before you are finished positioning
the patient, press the softkey again to turn them on for another 30 seconds.

6-22 O-arm Imaging System User Manual


Positioning the Gantry
Aligning the X-ray Beam Path

3
4
Figure 6-24 The Lasers softkey

1 Laser On/Off Softkey

2 (Green) Vertical controls. Move the gantry up or down

3 (Pink) Extension controls. Move the gantry away from and toward the cabinet

4 (Blue) Lateral controls. Move the gantry left and right

Figure 6-25 Laser Alignment Lights on

5 Light defining one end of the scan plane

6 Sagittal light

7 Coronal light

O-arm Imaging System User Manual 6-23


Positioning the Gantry
Aligning the X-ray Beam Path

Aligning the Patient Refer to Figure 6-24 and Figure 6-25 on page 6-23. Make sure the gantry is undocked before
Using the Lasers you try to position it.

1. Press the Lasers softkey 1 to turn on the lasers.

2. Use the gantry extension controls 3 to position the gantry so that the sagittal laser light line
6 runs through the center of the scan area of the anatomy of interest.
3. Use the gantry up/down controls 2 to position the gantry so that the coronal laser light line
7 runs through the center of the anatomy of interest.
4. Use the left/right controls 4 to position the gantry so that the anatomy of interest falls
between the scan plane end lines.

Positioning Distance
Information Table
Right-side scan-plane light offset from plane through iso-center: 225 mm +/- 7 mm
Left-side scan-plane light offset from plane through iso-center: 225 mm +/- 7 mm
Sagittal light offset from plane through iso-center: 0 mm +/- 7 mm
Coronal light offset from plane through iso-center: 0 mm +/- 7 mm

6-24 O-arm Imaging System User Manual


Positioning the Gantry
Moving the Gantry Out of the Way

Moving the Gantry Out of the Way

Positioning the Gantry Out of the Way for Surgery

Consideration of the Some pre-planning with regard to the patient’s position on the operating table will aid in
Park Position determining the park position for the IAS during the surgical procedure.
Move the IAS to a position (parked) where it will not hinder the surgical team during surgery.
For most spinal surgeries, the best park position will be toward the head end of the operating
table. However, factors that determine the best position vary from site-to-site.
The main factors involved are:
• Draping method
• Patient position

Draping Method The type of drape used to shield the gantry from the sterile field affects the park position. The
Tube drape provides more leeway in moving the gantry to its park position. The Bar drape limits
the amount of distance the gantry can be moved since the drape is taped to the patient’s covering.

Patient Positioning For cervical or upper thoracic spine surgery, the recommended position for the patient is offset
from the center of the operating table toward the foot end by 12 inches (30 cm) or more. This
allows the maximum amount of room to park the gantry towards the head end of the operating
table away from the operative field. Where arm boards are required, choose a park position on a
case-by-case basis.
Note: When possible, to assure sufficient gantry clearance, as well as to clear potential artifact-
producing materials out of the imaging area, test both the park and imaging positions, prior to
draping the patient.

Warning: Before opening or closing the O-arm door always confirm that
neither the patient nor any one else is in the path of the moving door.

O-arm Imaging System User Manual 6-25


Positioning the Gantry
Moving the Gantry Out of the Way

Moving the IAS Laterally

“Lift and Shift” - To move the IAS further out of the surgeon’s way without taking it away from the operating
Lateral Movement table, the IAS has a set of “lift and shift” wheels that can be lowered to move the IAS laterally.

Before You Begin


Warning: If a Bar drape is in use, unfasten it from the gantry before mov-
ing the IAS. Because the drape attaches to the patient’s sheet, Moving the
IAS without unfastening the drape could dislodge the sheet.

Note: If you have saved positions in memory, then before moving the IAS laterally, place strips
of tape on the floor to mark the position of the wheels so that the IAS can be returned to its
original position.

Figure 6-26 Lateral Shift Button

Shifting the IAS 1. To move the entire IAS laterally, press the Lateral Shift button on the Pendant to lower the
Laterally wheels that allow lateral movement.
When the wheels are lowered to the floor the LED beside the button illuminates, and the
system emits a “chirp” sound every seven seconds until the wheels are returned to their
raised position.
Note: The system cannot take images while the lift and shift wheels are extended.
2. Carefully push the IAS to the desired position. Lateral movement of the Chassis is not
battery assisted, so it requires effort. Have more than one person assist to move the IAS
laterally, one on either side of the operating table.
3. As soon as you have finished shifting the IAS, press the Lateral Shift button a second time.
This raises the lift and shift wheels and settles the IAS in position.
Note: Lower the IAS to the floor as soon as you have finished shifting it. Keeping the shift
wheels extended uses battery power. Loss of batter power may cause the O-arm® Imaging System
to shut down and lower the IAS to the floor.

6-26 O-arm Imaging System User Manual


Positioning the Gantry
Moving the Gantry Out of the Way

Moving the IAS Away from the Operating Table

Once the initial surgical procedure is completed, you may need to temporarily move the IAS
away from the operating table. The steps to do so depend on the type of sterile drape (Tube or
Bar) attached to the gantry.
Note: If a park position was established (refer to “Storing a Park Position” on page 7-14), return
the gantry to the park position before proceeding.

With a Tube Drape To move the IAS away from the operating table when the IAS is draped with a tube drape,
proceed as follows:

Warning: Before opening or closing the O-arm door always confirm that
neither the patient nor any one else is in the path of the moving door.

1. Press the button on the Pendant to fully open the gantry door. The drape remains in
place after the door has opened.
2. Locate the colored separation line on the drape. It should be in the approximate center of the
door opening area.

Caution: Check that the Velcro buttons at the bottom and top of the
stationary gantry cover beyond the open edges, are firmly attached before
you tear the drape in half.

3. Grasp the drape on both sides of the separation line and tear it into two pieces so that the top
and bottom of the drape are separated from each other at the door opening.
4. Release the two pieces of the drape. The bottom half will drop to the floor. Roll up and stuff
the sterile remainder of the drape above the perforation into the opening at the top of the
door opening.
5. Check that the edges (top and bottom) of the gantry door will clear the patient and the
operating table. To get maximum clearance around the patient and operating room table,
make sure the gantry door is fully opened.
6. If necessary, use the up/down buttons on the Pendant to position the gantry door opening so
that the gantry can be moved unimpeded across the operating table and patient.

Caution: Before moving the IAS, make sure that the gantry will not con-
tact either the patient or the operating table. Clear the area behind the
IAS of all obstacles before moving it.

7. Squeeze the transport handle and gently back the IAS away from the operating table until
the open gantry door is past the edge of the operating table.
If you move the IAS back into position later, you must install a new Tube Drape on the gantry.

O-arm Imaging System User Manual 6-27


Positioning the Gantry
Moving the Gantry Out of the Way

With a Bar Drape The following is a general procedure for moving the IAS when it is covered with a Bar drape
(Part No. 9733023). The exact procedure will vary from site-to-site. The bar drape must stay with
the patient, because it may be an integral part of the sterile field.

Warning: Unfasten the Bar drape from the gantry before moving the
IAS. Moving the IAS without unfastening the drape could dislodge the
patient’s sheet.

1. Two people should unfasten the drape from the back side of the gantry.
2. Hold the drape up while the gantry is positioned so that the gantry door will not contact the
patient or table when the IAS is moved.
3. Fold and fit the loose ends of drape over the patient (non-sterile parts) so as not to
contaminate the sterile field.
4. If necessary, use the up/down movement buttons on the Pendant to position the door
opening so that gantry can move unimpeded across the operating table and patient (see
“Gantry Up and Down Control” on page 6-15).
5. Squeeze the transport handle and gently back the IAS away from the operating table until
the open gantry door is past the edge of the operating table.

6-28 O-arm Imaging System User Manual


Imaging 7

7
This chapter describes how to operate the O-arm® Imaging System in the three imaging modes.

Imaging Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Image Storage Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

Using the 2D Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7


Acquiring 2D Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-8

Optimizing 2D Image Quality Using the Softkeys . . . . . . . . . . . . . . . . . . . . . . .7-9

Manipulating Image Display in the 2D Mode . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10

Viewing a Region of Interest (ROI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12

Storing Positions and Acquisition Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14

Using the Multi-plane 2D Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15


General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15

M-2D Image Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16

Image Manipulation in M-2D Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17

Using 3D Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18


3D Image Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20

Selecting Acquisition Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-21

Acquiring a 3D Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-24

Image Manipulation in the 3D Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-26

Advanced Imaging Features in 3D Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-29

Dose Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-31

O-arm Imaging System User Manual 7-1


Imaging
Imaging Modes

Imaging Modes

Imaging Overview

After you complete the initial setup (Chapter 5), you can initiate the imaging process. The
process varies from site-to-site, depending upon the working arrangements instituted by
individual surgical teams using the O-arm® Imaging system.
This chapter describes how to use the various imaging modes. Typically your use of the system
will intersperse positioning and repositioning of the gantry (see chapter 6a) with imaging.

Imaging Modes The 2D mode allows real-time X-ray viewing of the patient with high temporal resolution up to
30 frames per second.
The M-2D mode allows up to four independent gantry positions with their associated settings to
be acquired and displayed automatically.
In 3D modes the system takes a sequence of pulsed X-ray exposures throughout a 360-degree
rotation. The resulting exposures are reconstructed as Axial, Sagittal, and Coronal images of the
patient’s anatomy.

Mode Selection You can select the imaging mode from the Pendant, from the mouse, or by using the special keys
on the keyboard.

Figure 7-1 Image Mode Selection

7-2 O-arm Imaging System User Manual


Imaging
Imaging Modes

Image Control Buttons

Overview From the Pendant, you can adjust brightness and contrast of images and improve image quality by
adjusting the collimator settings. Many of the functions of these buttons are duplicated by special
function keys on the keyboard (see “The Keyboard and Wireless Mouse” on page 3-13).

Pendant Buttons for


Manipulating Images Table 7-1. Pendant Buttons for Manipulating Images

Button/Indicator Function

Store Image Sends a copy of the active X-ray image on the MVS screen to the
system’s database.

Mirror Image Flips the image.

When pressed, flips (mirrors) the image horizontally. The LED


remains lit until the image is flipped back to its original position.

When pressed, flips (mirrors) the image vertically. The LED


remains lit until the image is flipped back to its original position.

Contrast Allows manual adjustment of image contrast.


Control
Pressing the center of the button toggles between automatic and
manual contrast control modes.
In manual mode:

Pressing the left-hand side of the button decreases contrast.

Pressing the right-hand side increases contrast.

Brightness Allows manual adjustment of image brightness.


Control • Pressing the center of the button toggles between automatic
brightness control and manual brightness control.
• Pressing the left-hand side decreases image brightness.
• Pressing the right-hand side increases image brightness.

Collimator Allows manual adjustment of the collimator shutters.


Adjustments The Pedant displays the position of the collimator shutters when the
collimator adjustment is used.
• Pressing the top moves the longitudinal shutters outward; pressing the
bottom button moves them inward.
• Pressing the left button moves the lateral shutters inward.; pressing
the right button moves them outward.
• Pressing the center button resets the collimator shutters to their
maximum aperture settings.

O-arm Imaging System User Manual 7-3


Imaging
Image Storage Capacity

Image Storage Capacity


The O-arm® system monitors the hard disk capacity available for storing images (2D, 3D,
snapshots, dose reports). The storage capacity status is displayed on both the pendant and the
MVS. This status indicates when the storage capacity is low, or insufficient to store images from
the current imaging mode.
As a safety measure, the system prevents images from being taken until sufficient space to store
the acquired images is made available.

Image Storage Image storage capacity 1 is displayed at the bottom left of the MVS screen. Status is
Capacity Status represented by a colored status indicator.

Figure 7-2 MVS screen illustrating image storage capacity status

7-4 O-arm Imaging System User Manual


Imaging
Image Storage Capacity

Table 7-2. Image capacity status

Indicator Explanation
Status indicator is green. Sufficient disk space to store images.
The amount of available disk space is displayed.

Status indicator is yellow. Low storage space. Cannot acquire


images in 3D mode, but a limited number of 2D images may be
acquired.
Status indicator is red. Insufficient free space to acquire and save
images in 2D or 3D mode.

Image Storage When the system has insufficient space to store images in a specific mode, a message appears on
Capacity Warnings the pendant (Figure 7-3).

Figure 7-3 Pendent warning that insufficient storage capacity is available

This message persists until space is freed on the hard disk. At the same time, a message (Figure 7-4)
appears on the MVS screen. This message persists until the user acknowledges the message by
clicking the [OK] button.After acknowledging the message, the user can continue using the MVS.

Figure 7-4 MVS warning the insufficient storage capacity is available.

O-arm Imaging System User Manual 7-5


Imaging
Image Storage Capacity

When the pendant displays the warning message shown in Figure 7-3, the system prevents the
active acquisition of X-ray images. If the handswitch or foot switch is depressed while this
message is displayed on the pendant, a new message displays.

Figure 7-5 Pendant message that acquisition was aborted

The system prevents the active acquisition of X-ray images when the system’s hard disk has
insufficient space to store the images. On the MVS, this message is displayed.

Figure 7-6 MVS message the acquisition was aborted

This safety measure prevents exposing the patient and staff to X-rays when the system cannot
store the images. After acknowledging the warning on the MVS screen, you may free hard disk
space by deleting or transferring existing images. See “Handling Patient Data” on page 8-2.

7-6 O-arm Imaging System User Manual


Imaging
Using the 2D Mode

Using the 2D Mode

General Information

2D Mode Uses The 2D mode is normally used to find the angles of the patient’s anatomy that the surgeon wants to
refer to during the operation.
You can also use the 2D mode as a standard fluoroscopy tool, and to take scout images prior to
surgery. In this case, you may find it useful to use the memory preset buttons on the Pendant.

Application Notes Before initiating a 2D imaging session, read the following application notes. All surgeons,
radiologists, nurses, and other operating room personnel should be aware of their content.

Taking AP Images
Whenever you take an AP image, the X-ray source and detector should be reversed 180° from the
position shown in Figure 6-21 on page 6-20 — you want the source to be on the bottom in order to
reduce the scatter effect.

Taking Lateral Images


Whenever a lateral image is taken, all operating personnel should be on the opposite side from the
X-ray source to minimize the effect of X-ray absorption resulting from the scatter effect.

Warning: The scatter effect is 20 to 25% more prevalent on the tube


(source) side of the gantry during a lateral X-ray acquisition cycle.
Observe the light ring on the gantry (see page 6-20) to determine the posi-
tion of the X-ray tube.

O-arm Imaging System User Manual 7-7


Imaging
Using the 2D Mode

Acquiring 2D Images

Before You Begin Before acquiring images, make sure that you have positioned the gantry appropriately (see
“Positioning the Gantry For Imaging” on page 6-6) and have aligned the X-ray source to the
desired orientation for the first scout shot (see “Aligning the X-ray Beam Path” on page 6-20).

How To Acquire 2D 1. Press the 2D button on the Pendant, on the MVS keyboard, or on the mouse.
Images The Pendant’s X-ray On indicator lights up to indicate that the system is ready to execute
fluoroscopy
Note: The 2D acquisition mode is selected automatically by the system as the default at start
up.

2. Choose the X-ray dose to apply (standard fluoro or HLF ) and press the
applicable button on the hand switch, or pedal on the foot switch.
An alarm beeps and the indicator on top of the MVS monitor (see “The Mobile View
Station” on page 3-10) illuminates during the exposure time of the X-ray.
Note: After 30 seconds of HLF, X-ray exposure ceases and can only be restarted by releasing
the hand or foot switch and pressing it again.
Note: The X-ray alarm (beeping) sounds after each 5 minutes of continuous fluoroscopic
imaging.
Press the Alarm Reset button on the Pendant to stop the beeping.

Caution: Prolonged use of the system or continuous fluoroscopic imaging


(> 10-15 minutes) can cause the X-ray tube to reach its maximum heat
load. If this occurs, the system will not take further images until the X-ray
tube cools again.

3. Review the image in the MVS monitor. If the position and quality of the image are adequate,
you may want to save the position as a preset (see “Storing Positions and Acquisition
Settings” on page 7-14,) otherwise continue to step 4.
Note: We recommend that you take one A/P and one lateral X-ray image to make sure the
patient’s anatomy of interest is positioned in the iso-center of the O.
4. Adjust the position of the gantry and X-ray source to improve the image.
5. Make any adjustments needed to image settings (see “Optimizing 2D Image Quality Using
the Softkeys” on page 7-9).
6. Repeat steps 2 through 5 as necessary until you obtain the optimal image.

Storing Screen Images To store the image on the monitor in the system database, press the Store Image button on

the Pendant or the button/pedal on the hand switch or foot switch.

7-8 O-arm Imaging System User Manual


Imaging
Using the 2D Mode

Optimizing 2D Image Quality Using the Softkeys

Softkey Functions You can use the softkey functions as outlined in the table below to optimize image quality.

Figure 7-7 The 2D Mode Softkeys

Table 7-3. 2D Softkey Functions

Softkey Function Activation Application


Noise Reduces noise to create a Four settings: Off, Low, Live image
Reduction smoother image Medium, & High, shown on processing
level bar
Auto Automatically adjusts dose control A check mark indicates the Live image
Brightness for the anatomical area of interest feature is on. To toggle it on processing
and contrast/brightness for the and off, press the softkey.
best display (see ROI, below)
Edge Sharpens the edges of an image Cycles through five settings Both live and
Enhance stored images
Image These keys digitally rotate the To rotate the image cw press Both live and
Rotation displayed image clockwise (cw) the left-hand softkey. To stored images
and counterclockwise (ccw). rotate the image ccw press
the right-hand softkey
Region of Allows you to adjust an area on Press the softkey to view a Live image
Interest the collimated image to be ROI. The ROI diminishes by processing
(ROI) sampled and used to adjust 12% each time the softkey is
automatic brightness (dose) and pressed. Seven increments
window/level grey scale are possible.
Gamma Toggles the gamma level to Press the softkey to Toggle Live image
enhance dark or light areas. between -0.5, 0.0 and +0.5. A processing
Use when metal retractors cause small green arrowhead
the image to brighten, or when the moves from left to right
image darkens from too much air (under the “-”, “0” and “+”) as
being sampled in a ROI. the gamma level increments.

O-arm Imaging System User Manual 7-9


Imaging
Using the 2D Mode

Manipulating Image Display in the 2D Mode

Enlarging and You can use the wireless mouse (refer to page 3-14) or keyboard keys to vary the standard 2D
Diminishing Image image presentation (shown in Figure 7-8).
Size

Figure 7-8 Standard (default) 2D Image Presentation

To enlarge the active image, (see Figure 7-9), do any of the following:
■ Rotate the mouse wheel clockwise
■ Press the Page Up special key
■ Press the up arrow key.

Figure 7-9 Enlarging the Active Image

Conversely, to diminish the active image:


■ Rotate the mouse wheel counterclockwise
■ Press the Page Down special key
■ Press the down arrow key.

Toggling Between To change which image is active (highlighted by a yellow frame), press the left mouse button.
Images The default position for the yellow frame is the left-hand pane.

Changing Image You can use the enhancement softkeys to improve the quality of the active image (see
Quality “Optimizing 2D Image Quality Using the Softkeys” on page 7-9). You can also use special keys
on the MVS keyboard to manipulate the image, as described below.

7-10 O-arm Imaging System User Manual


Imaging
Using the 2D Mode

Special Keyboard The special keys on the MVS keyboard allow you to change the image display as outlined in the
Keys table below.

Figure 7-10 MVS Special Keys

Table 7-4. Special Key Functions

Key / Icon Function in 2D Mode


F4 Increases edge enhancement levels

F5 Increases brightness

F6 Increases contrast

F7 Flips the active image along a vertical plane

F8 Flips the active image along a horizontal plane

F10 Decreases edge enhancement levels

F11 Decreases brightness

F12 Decreases contrast

Insert Rotates the image clockwise.


Delete Rotates the image counter-clockwise.
Page Up Increases the relative size of the left-hand image on the screen
Page Down Decreases the relative size of the left-hand image on the screen
Saves the image on the MVS screen to a .TIFF file in the MVS database
Prt Sc

O-arm Imaging System User Manual 7-11


Imaging
Using the 2D Mode

Viewing a Region of Interest (ROI)

Manually Adjusting of The Region of Interest softkey (see Figure 7-7 on page 7-9), used in conjunction with the
the Region of Interest collimator adjustment buttons on the Pendant, allows you to manually adjust an area inside the
collimated image and then use it to adjust the automatic brightness (dose) and window/level grey
scale of the image.
Use the ROI softkey when the large field of the flat panel detector is preferred but the region of
interest is located within the uncollimated area.
An example of this is illustrated in the following pages.
Note: During collimation, the image is surrounded by a green and yellow dashed frame
indicating that the region of interest is the same size as the collimated area.

Image Adjustment Figure 7-11 shows an uncollimated image of the patient’s anatomy.

Figure 7-11 Uncollimated Image

In Figure 7-12, the collimator was partially closed. Auto brightness adjusted the image to show
more spine in the image and less soft tissue.

Figure 7-12 Collimation Applied to Image

7-12 O-arm Imaging System User Manual


Imaging
Using the 2D Mode

In Figure 7-13, the ROI softkey has been pressed and a green ROI frame surrounds a smaller area
within the collimated area. Now more spine and even less soft tissue are visible. Also, notice the
contrast improvement of the spine.

Green
Frame

Figure 7-13 Smaller ROI

Each successive press of the ROI softkey diminishes the size of the green frame further as shown in
Figure 7-13. Once the ROI reaches its minimum size, pressing the ROI softkey again restores it to
full size.
Comparing the images in Figure 7-11, Figure 7-12, and Figure 7-13 shows the value of collimation
and the further benefits of having ROI control of the area within collimation.

O-arm Imaging System User Manual 7-13


Imaging
Using the 2D Mode

Storing Positions and Acquisition Settings

About This Feature You can use the memory preset buttons on the Pendant to store up to four gantry positions with
associated fluoroscopic settings and a “park” position. You can then:
• Return the gantry to a preset position at the touch of a button
• Set up an M-2D mode sequence that includes any of the preset positions (see “Using the
Multi-plane 2D Mode” on page 7-15).
Storing a preset location saves the gantry position and the selected values for the collimated area,
image rotation, automatic brightness (dose), window/level, and edge enhancement.

Storing Imaging 1. Position the gantry where you want it and make any adjustments to the imaging settings.
Positions and Settings
2. Press the M (memory mode) button on the Pendant. The LED next to it lights up, indicating
that it is ready to store a setting.

Figure 7-14 Memory Preset Buttons

3. Press a memory preset button (1 - 4) to store that gantry position.


Once selected, the memory preset button LED lights up.

Storing a Park Before starting surgery, you may wish to move the gantry to an out-of the way position towards
Position one end of the operating table. You can store the location of the gantry at that position so that
after any imaging, you can swiftly re-position the gantry out of the way.

1. Use the Pendant buttons to position the gantry so that it is in a straight 90° (up/down)
position and centered horizontally and vertically to the operating table.
2. Use the longitudinal positioning buttons on the Pendant (see “Gantry Longitudinal
(Left/Right) Control” on page 6-19) to move the gantry to its maximum longitudinal
extension (either left or right).
3. Press the M memory mode button on the Pendant. The LED next to it lights up.
4. Press the P (park) button on the Pendant.

Returning To a Stored ❱❱ To return the gantry to a stored position, press and hold the preset button (1 - 4 or P for Park)
Position for that position until the position is reached.
Note: If you release the preset button before the gantry has reached that position, the gantry will
stop mid-motion.

7-14 O-arm Imaging System User Manual


Imaging
Using the Multi-plane 2D Mode

Using the Multi-plane 2D Mode

General Information

About this Mode The Multi-plane 2D Mode (M-2D) automatically moves the gantry through a sequence of selected
stored pre-set positions and takes a 2D fluoro image at each position. Upon completion of the cycle,
the images are displayed on the MVS monitor.

Selecting Stored 1. Store positions and settings for which you want to acquire images (see “Storing Positions and
Positions For an M-2D Acquisition Settings” on page 7-14).
Sequence.
2. Press the M-2D button on the Pendant.
3. For each stored position that you want to include in the sequence, press the Preset softkey of
the same number as the memory preset button for that position.
A check mark appears indicating the softkey is active. In Figure 7-15, Preset #1 position is set
to be part of the sequence, and the green LED next to the memory preset button blinks to indicate
that the preset is active.
Note: If a position has not been stored for a preset button, the softkey for that button will be
grayed out.

Figure 7-15 M-2D Mode Preset Softkeys

Deactivating a Preset To deactivate a preset, press the softkey so that the check mark disappears.

O-arm Imaging System User Manual 7-15


Imaging
Using the Multi-plane 2D Mode

M-2D Image Acquisition

Before you Begin Make sure you have selected the preset positions that you want to include in the sequence (see
“Storing Positions and Acquisition Settings” on page 7-14).
Make sure that the gantry is free to move to each position without encountering any obstacle.

Acquiring an M-2D In M-2D mode, press and hold the middle button on the hand switch or the middle pedal on the
Image Set foot switch.
The gantry and internal rotor drive will sequentially move to each of the preset anatomic
positions and acquire and display the LIH.
An alarm beeps and the indicator on top of the MVS monitor (see “The Mobile View Station” on
page 3-10) illuminates during the exposure time of the X-ray.

Figure 7-16 Standard (default) M-2D Image Presentation

As the O-arm® IAS acquires each image, a multi-paned display of images (Figure 7-16) appears
sequentially from left-to-right, top-to-bottom on the monitor.
If you stored a park position (see page 7-14), the gantry moves to that position when the imaging
cycle completes.
Note: A full (four-image) multiplane 2D cycle takes 75 seconds.

Storing Screen Images Press the store image button on the Pendant or on the hand switch or foot switch to
store the image on the monitor in the system database.

7-16 O-arm Imaging System User Manual


Imaging
Using the Multi-plane 2D Mode

Image Manipulation in M-2D Mode

Manipulating Images You can manipulate the M-2D image presentation, using the wireless mouse and the special
keyboard keys.

Switching the Active To switch the active image pane (the one with the yellow border), rotate the mouse wheel. Rotating
Image it counterclockwise shifts the active pane (upper left-hand) to the top right-hand pane.

Figure 7-17 M-2D Enlarged Active Image

Viewing an Image Full To view an image in the full screen (as in Figure 7-17), select it as the active image, and then press
Screen the right-hand button on the mouse. To return to standard presentation (Figure 7-16) press the right-
hand mouse button a second time.

Saving Screen Images To save the image on the monitor to a snapshot file, press <Prt Sc> on the MVS keyboard. The
to a Snapshot File snapshot images can be recalled to the screen for review at a later time and selected for
downloading to a CD or USB memory device in TIFF format (refer to “Exporting Images to
External Media” on page 8-8).

O-arm Imaging System User Manual 7-17


Imaging
Using 3D Modes

Using 3D Modes

General

3D Mode Operation In the 3D volumetric imaging modes the gantry rotor moves through a complete 360-degree
rotation as the X-ray source is pulsed continuously, to capture a series of exposures. The system
stores the exposures and uses them to reconstruct 3D images of the anatomy that are displayed on
the MVS monitor in the three orthogonal planes.
The Standard 3D acquisition parameters are automatically set to 100 mA, 10 millisecond pulse
width per exposure at 120 kV. You should modify these parameters according to the individual
patient and procedure using the softkeys on the pendant as described in Table 7-10 on page 7-23.

High Definition 3D High Definition 3D (HD3D) mode provides improved image quality over that of regular 3D. In
(HD3D) Mode this mode, the rotor spins at 15 degrees per second, while acquiring images at a rate of 30 frames
per second, thus capturing approximately 740 projections.
As with the 3D mode, you can modify parameters through the softkeys on the Pendant (refer to
“Targeted Anatomy Chart for HD 3D Mode” on page 7-22).

Enhanced Cranial 3D Enhanced Cranial 3D mode is designed to optimize image resolution for cranial anatomy. It uses
Mode the same rotor speed and frame rate as HD3D, but different kVp and mA settings and a different
reconstruction algorithm.
In Enhanced Cranial 3D mode the acquisition parameters are fixed; you cannot modify them
(refer to Table 7-9 on page 7-23). Similarly, since Enhanced Cranial 3D mode is optimized for
imaging the cranial area, selection of other anatomies is disabled in this mode.

Low Dose 3D Mode Low Dose 3D mode is designed to provide an additional preset setting for standard 3D
acquisitions with a lower overall dose. It uses the same motion settings as the standard 3D mode,
but has a lower mA and mAs setting (refer to Table 7-5 “Targeted Anatomy Chart for 3D mode”).
The Low Dose mode is only available for use on the Chest/Spine and Lumbar Spine/Hip
anatomies. These parameters can be modified by using the softkeys on the Pendant.
Figure 7-18 Pendant Setting in Low Dose 3D Mode

7-18 O-arm Imaging System User Manual


Imaging
Using 3D Modes

3D Mode Parameters
Table 7-5. 3D Mode Parameters

Data 3D
Voxel Resolution Number of
3D Mode Acquisition Reconstruction
Format (in mm) Projections
Time Time

Low Dose < 16 s < 30 sec 512 x 512 0.415 x 0.415 Above 270
3D Typical: 14 s Typical: 25 s x 192 x 0.833 Typical: 391

Standard < 16 s < 30 sec 512 x 512 0.415 x 0.415 Above 270
3D Typical: 14 s Typical: 25 s x 192 x 0.833 Typical: 391

HD3D* < 30 s < 50 sec 512 x 512 0.415 x 0.415 Above 540
Typical: 27 s Typical: 47 s x 192 x 0.833 Typical: 745

Enhanced < 30 s < 50 sec 512 x 512 0.415 x 0.415 Above 540
Cranial* Typical: 27 s Typical: 48 s x 192 x 0.833 Typical: 745

*HD3D and Enhanced Cranial 3D mode are optional features.

O-arm Imaging System User Manual 7-19


Imaging
Using 3D Modes

3D Image Acquisition

Gantry Position You can perform a navigated 3D mode scan from any gantry position except for a gantry tilt of
more than ±15°. You can take a non-navigated scan at up to +\-45 degrees from vertical.

Image-Guided Surgery The 3D mode can be used for surgical navigation by connecting a network cable between the
MVS and the navigation system. Once the systems are connected, a confirmation icon appears in
the center of the pendant. A green check mark indicates that the navigation system is on; a red
“x” indicates that it is off.

Selecting and To use any of the 3D imaging modes, press the 3D button on the Pendant or the mouse, or press
Activating 3D Modes the 3D key on the keyboard.

When the hand switch is pressed the Pendant’s X-ray On indicator lights up to indicate
that the system is ready to execute a 3D scan, and the X-ray source detector moves to its start
(default) position.
To activate acquisition in the 3D Modes, you press and hold down the middle pedal on the foot
switch or middle button of the hand switch until the cycle is finished.

Using Saline Solution Whenever possible, fill the surgical opening with saline solution prior to initiating a 3D imaging
session. This helps to reduce the reflective properties of any exposed bone structure which in turn
improves the resulting image quality.

Pausing Respiration Any patient movement during the rotation of the X-ray source occurs will degrade the quality of
the resulting image. Therefore, whenever possible, the attending anesthesiologist should be
advised to halt the patient’s respiratory process for the 13 second time period of the 3D excitation
cycle.

Using Preset Before acquiring a 3D image you can adjust the collimator to a specific position and then store
Collimation Settings that position into memory

1. Select the 3D mode (see “Mode Selection” on page 7-2).


2. Put the collimators in the desired position (see “Collimator Adjustments” in Table 7-3, “2D
Softkey Functions,” on page 7-9).
Note: 3D collimation only occurs in the longitudinal orientation (for example, the patient's
long axis).
3. Press the M (memory mode) button on the Pendant.
4. Press the preset 4 button on the Pendant.
5. Select the 3D mode (see “Mode Selection” on page 7-2) and initiate 3D scan when desired.
Once a collimator position is stored, you can recall it for use at any time by pressing the preset 4
button. During normal operation, a collimated scan message appears on the pendant display any
time that the position is the same as memory preset 4, indicating that a collimated scan can be
acquired. If you do not want collimation, manually override by using the Softkey function to
open the collimator.
The memory preset 4 button retains its other functions in addition to the Collimation function.

7-20 O-arm Imaging System User Manual


Imaging
Using 3D Modes

Selecting Acquisition Settings

Selecting Settings for 1. Select 3D imaging mode. (Press the 3D button on the Pendant or on the mouse, or press the 3D
3D Acquisition key on the MVS keyboard).

Figure 7-19 The 3D Mode Softkeys

2. Use the lower left softkey to select the 3D imaging definition (Standard, HD3D, or Enhanced
Cranial). Pressing the softkey toggles through the options in the order shown below.

3. Select the Patient Orientation using the upper left Pedant softkeys (see Figure 7-19). There
are sixteen patient orientation options. Each press of the softkey changes the patient’s
orientation as indicated by the display. The top softkey flips the patient from head-to-toe and
toe-to-head. The middle softkey rotates the patient clockwise (cw) by 45° increments. The
bottom softkey rotates the patient counter clockwise (ccw) by 45° increments.
4. Press the Anatomy Selection softkey to select the patient anatomy being imaged (not
selectable in Enhanced Cranial 3D mode). There are four patient anatomy selections: head,
upper torso, lower torso, legs. Each press of the softkey changes the anatomy selection as
indicated by the picture next to the softkey.
Note: “Head” is preselected in Enhanced Cranial 3D mode.
5. Press the Patient Thickness softkey to select the approximate size of the patient. The four
selection are: S (small), M (medium), L (large), XL (extra large).
6. Review the targeted anatomy charts (Table 7-6 through Table 7-9) to determine the correct X-
ray exposure, and use the X-ray Generator Control buttons (Table 7-10) to select the settings
indicated.
Low Dose (Table 7-7), HD3D (Table 7-8), and Enhanced Cranial 3D (Table 7-9) modes are
optional.

O-arm Imaging System User Manual 7-21


Imaging
Using 3D Modes

For more information about dose evaluations and patient sizes, see “Dose Evaluation
Methods” on page 10-21.

Table 7-6. Targeted Anatomy Chart for 3D Mode

Patient Anatomy Patient Size kVp mA mAs CTDIvol

Head/ Small 120 25 100 14.54


Neck Medium 120 25 100 14.54
Large 120 32 128 18.80
120 40 160 23.29
XLarge

Chest/ Small 120 32 128 9.99


Spine Medium 120 40 160 12.48
Large 120 50 200 15.38
120 80 320 24.68
XLarge

Lumbar Spine/ Small 120 32 128 10.01


Hip Medium 120 50 200 15.66
Large 120 80 320 24.89
120 100 400 30.37
X Large

Extremity Small 120 12 48 N/A


Medium 120 16 64
Large 120 20 80
120 25 100
XLarge

Table 7-7. Targeted Anatomy Chart for Low Dose 3D Mode

Patient Anatomy Patient Size kVp mA mAs CTDIvol

Head/Neck Small
Medium
N/A N/A N/A N/A
Large
XLarge

Chest/Spine Small 120 25 100 6.94


Medium 120 32 128 9.17
Large 120 40 160 11.49
XLarge 120 64 256 18.02

Lumbar Spine/Hip Small 120 25 100 7.00


Medium 120 40 160 11.26
Large 120 64 256 18.06
X Large 120 80 320 22.07

Extremity Small
Medium
N/A N/A N/A N/A
Large
XLarge

Table 7-8. Targeted Anatomy Chart for HD 3D Mode

Patient Anatomy Patient Size kVp mA mAs CTDIvol

Head/Neck Small 120 20 150 22.15


Medium 120 20 150 22.15
Large 120 25 187 27.87
120 32 240 36.25
XLarge

Chest/Spine Small 120 25 187 13.43


Medium 120 32 240 17.32
Large 120 40 300 22.11
120 64 480 34.87
XLarge

7-22 O-arm Imaging System User Manual


Imaging
Using 3D Modes

Table 7-8. Targeted Anatomy Chart for HD 3D Mode (Continued)

Patient Anatomy Patient Size kVp mA mAs CTDIvol

Lumbar Spine/Hip Small 120 25 187 13.26


Medium 120 40 300 21.96
Large 120 64 480 34.23
120 80 600 48.37
X Large

Extremity Small 120 12 90 N/A


Medium 120 12 90
Large 120 16 120
120 20 150
XLarge

Table 7-9. Targeted Anatomy Chart for Enhanced Cranial 3D Mode

Patient Anatomy Patient Size kVp mA mAs CTDIvol

Head/Neck Small 100 80 600 58.93


Medium 100 100 750 71.69
Large 110 80 600 74.71
120 64 480 73.78
XLarge

In Table 7-6 through Table 7-9, CTDIvol values are retrieved from a stored look-up table that
carries these values depending on kVp, mAs, and the part of the body examined (chest/abdomen
and head). These values are, initially, based on factory calibrations, then on periodic calibrations.

Pendant Buttons and


Indicators for X-rays Table 7-10. Pendant X-ray Buttons and Indicators

Radiation Prevents the system from emitting radiation when the handswitch or
Disable footswitch is activated. This button is a toggle and both disables, then re-
enables radiation as it is pressed.
See “Radiation Disable Button” on page 3-7 for additional information.

X-ray Generator X-ray Generator voltage (kV) and current (mA) adjustment.
Control Buttons These buttons adjust the X-ray Generator voltage and current values in
3D mode.

The left-hand button adjusts the kV value.


• Pressing the top increases the voltage.
• Pressing the bottom decreases the voltage.

The right-hand button adjusts the mA value.


• Pressing the top portion of the button increases the current.
• Pressing the bottom portion of the button decreases the current.

Alarm Stops the audible warning alarm (beeping) that sounds after every 5
Reset minutes of continuous fluoroscopic imaging.

O-arm Imaging System User Manual 7-23


Imaging
Using 3D Modes

Acquiring a 3D Scan

1. Have all non-essential operating room personnel leave the area of X-ray scatter.

2. Press and hold the middle button on the hand switch or middle pedal on the foot
switch.
Note: An alarm beeps and the indicator on top of the MVS monitor (see “The Mobile View
Station” on page 3-10) illuminates during the exposure time of the X-ray.

Caution: Hold down the middle button/pedal for the duration of the 3D
scan cycle. Releasing the button/pedal terminates the scan.

3. Once the scan is complete and the gantry rotor motion stops, release the button or foot pedal.
4. Observe the display on the MVS monitor. Three orthogonal MPR images (Axial, Sagittal,
and Coronal) appear (see Figure 7-20). The yellow frame around the Axial image indicates
that it is active.

Figure 7-20 Standard (default) 3D Image Presentation (Axial Active)

Caution: Do not initiate a second image acquisition (either 2D or 3D)


while an existing 3D reconstruction is in progress. If you do, the system
does not display the second image attempt.

Failure of 3D Scan If the 3D button is released too quickly and acquisition is not completed or, if the X-ray
generator has an internal error, the following error messages may appear.

Table 7-11. Failure of 3D Scan


Error Message Failure Mode

This error message appears if the scan is interrupted


while it is between the angles of 200-355 degrees.

7-24 O-arm Imaging System User Manual


Imaging
Using 3D Modes

Table 7-11. Failure of 3D Scan


Error Message Failure Mode

This error message appears if the scan is at less than


200 degrees.

This error message appears if the scan is at less than


200 degrees. Navigation will not be allowed.

The generator had an internal error and X-rays have


stopped. This error message appears if the scan is
interrupted while it is between the angles of 200-355
degrees.

The generator had an internal error and X-rays have


stopped. This error message appears if the scan is at
less than 200 degrees.

The generator had an internal error and X-rays have


stopped. This error message appears if the scan is at
less than 200 degrees. Navigation will not be allowed.

O-arm Imaging System User Manual 7-25


Imaging
Using 3D Modes

Image Manipulation in the 3D Mode

Manipulating the To view images produced in 3D modes, you can use either the wireless mouse or the keyboard.
Image Display The options are shown in Table 7-12.

Table 7-12. Manipulating the Image Display

Desired Action Mouse or Arrow keys Special


Touch Pad keys

Shift the active pane (yellow frame) Left mouse button or none none
through the images (axial, coronal, left button on the
sagittal) keyboard touch pad

Scroll through the images Mouse wheel up and down Page Up


clockwise or and Page
counterclockwise Down

Cycle the image display between: Right mouse button none none
default 2-and-1 or right button on the
full-screen display keyboard touch pad
lightbox presentation

Toggling the Active Pressing the left mouse button toggles the active pane (yellow border) between the axial, coronal
Pane (Figure 7-21), and sagittal images.
Rotating the mouse wheel scrolls the display forward and backward through the dataset (slices)
in the active image plane.

Figure 7-21 3D Image with Coronal Pane Active

Toggling the Display The right mouse button allows you to toggle the display format from standard 2-and-one, to full-
Format screen and lightbox.
With the screen in the layout shown in Figure 7-21, if you click once on the right mouse button,
the active coronal image zooms to fill the entire image pane (see Figure 7-22).

7-26 O-arm Imaging System User Manual


Imaging
Using 3D Modes

Figure 7-22 3D Coronal Image Enlarged

If you click the right mouse button a second time, the zoomed image of Figure 7-22 becomes a light
box presentation as shown in Figure 7-23. Notice that the yellow frame highlights the coronal slice
that was selected in Figure 7-22.

Figure 7-23 3D Coronal Image Lightbox

O-arm Imaging System User Manual 7-27


Imaging
Using 3D Modes

The MVS Special Key


Functions in 3D Mode

Figure 7-24 The MVS Special Keys

Table 7-13. MVS Special Key functions in 3D

Key /Icon Function in 2D Mode


F4 Increases edge enhancement levels

F5 Increases brightness

F6 Increases contrast

F7 Flips image along the vertical plane

F8 Flips image along the horizontal plane

F9 Inverts Video Image

F10 Decreases edge enhancement levels

F11 Decreases brightness

F12 Decreases contrast

Insert Rotates the image clockwise.


Delete Rotates the image counter-clockwise.
Home Performs slice average function for 3D images.
Increases the level of noise filtering and creates a smoother 3D image.
End Performs slice average function for 3D images.
Decreases the level of noise filtering.
Page Up Viewing planes: scrolls through the images
When displaying the 3D model (MIP view): rotates the image clockwise around
the selected axis
Page Down Scrolls through the images
When displaying the 3D model (MIP view): rotates image counterclockwise
Saves the image on the MVS screen to a .TIFF file in the MVS database.
Prt Sc

7-28 O-arm Imaging System User Manual


Imaging
Using 3D Modes

Advanced Imaging Features in 3D Mode

Advanced Imaging After acquiring a 3D image you may want to use one of these advanced features:
Features ■ Oblique Slicing — allows you to adjust oblique slices when the patient’s body in the image is
not “true”
■ Maximum Intensity Projection (MIP) View — a 3D rendering of the volume that provides a
360° view for advanced viewing

Oblique Slicing If the axis of the patient’s body is misaligned in the images, you can adjust it using the arrow keys
to the left of the touch pad on the MVS.

❱❱ Select the desired pane and use the right arrow key to rotate the crosshairs in the active image
clockwise (cw), or use the left arrow key to rotate the crosshairs counter clockwise (ccw).
The adjustment angle is limited to ±45°. To reset the image to the original oblique slice, press the
Zero key (0).
Pressing the left button advances the active image (yellow frame) through the axial, coronal, and
sagittal views.

Figure 7-25 3D Oblique Slicing Image

MIP View Access this mode by pressing the mouse wheel straight down, or by pressing the left and right
buttons under the touch pad simultaneously.
Use the up arrow and down arrow keys or the <Page Up> and <Page Down> keys to rotate the MIP
views. The left and right arrow keys adjust the threshold.
To toggle the selected axis between vertical and horizontal, press the left mouse button or keypad
button.
Use the mouse wheel to rotate the MIP view. Figure 7-26 shows a MIP view in 3D.

O-arm Imaging System User Manual 7-29


Imaging
Using 3D Modes

Figure 7-26 MIP View Image

7-30 O-arm Imaging System User Manual


Imaging
Dose Reporting

Dose Reporting

Overview

Dose Reporting is an optional feature that allows you to track patient exposure to radiation emitted
by the O-arm® Imaging System.
Dose reports contain a header and two sections: a Fluoroscopy Dose section tallying exposure to 2D
fluoroscopy imaging, and a 3D Dose section tallying exposure to 3D imaging.
The CTDIvol value is retrieved from a stored look-up table that carries these values depending on
kVp, mAs, and the part of the body examined (chest/abdomen and head). These values are, initially,
based on factory calibrations, then on periodic calibrations.
Doses are not measured at exposure time.

The Dose Report The dose report header contains the following information:
Header
Table 7-14. Dose Report Header

Column Label Description

Generated on Date and time the report is generated on


Institution Name Hospital name as set in MVS Technical Service
Station name Station name as set in MVS Technical Service
Patient Last Name Patient’s last name as entered in “Exam Information”
Patient First Name Patient’s first name as entered in “Exam Information”
Patient Middle Name Patient’s middle name as entered in “Exam Information”
Patient ID Patient’s ID as entered in “Exam Information”
Birthdate Patient’s date of birth as entered in “Exam Information”
Sex Patient’s gender as entered in “Exam Information”
Study Date Start Date of the study
Accession number As entered in “Exam Information”
Study Description As entered in “Exam Information”
Performing Physician As entered in “Exam Information”

Height1 Patient’s height as entered in “Exam Information”

Weight Patient’s weight as entered in “Exam Information”

1 Height and weight are displayed either in English or Metric units as specified on the System Technical Services Console UI
tab.

Fluoroscopy Dose The Fluoroscopy Dose section is updated after each exposure in 2D or M-2D mode. It contains the
Section following details:

O-arm Imaging System User Manual 7-31


Imaging
Dose Reporting

Table 7-15. Dose Report - Fluoroscopy Dose Section

Exposure Time Exposure


Mode of Operation DAP (R cm2*)
(sec) (R*)
Low Level Fluoro #.## #.## #.##
Fluoro #.## #.## #.##
High Level Fluoro #.## #.## #.##
Total #.## #.## #.##

The dose area product (DAP) is a measure of radiation emitted by the X-ray tube. It is calculated
by multiplying the dose during the exposure by the area of the exposure as measured by the
collimator’s open area. This does not represent the radiation absorbed by the patient.
Note: Should the collimator setting change during the 2D exposure, the collimator setting at the
end of the exposure is used to calculate DAP.
All indications of dose area product values are accurate to within ±50%

3D Dose Section The 3D dose section is updated after each new 3D scan. A new row is added for each scan and
the total updated to include the new data.

Table 7-16. Dose Report - 3D Dose Section

ID kVP mAs CTDIvol DLP Phantom


(mGy or R) (Dose Line Product) (cm)
(mGy cm or R cm)
<text Vol #> # # #.## #.## <text>

Total # # #.## #.## <text>

For 3D volumes the dose line product is calculated from the number of slices in a volume (not
projections), the slice thickness, and the CTDIvol value.
All indications of dose line product values are accurate to within ±40%.

7-32 O-arm Imaging System User Manual


Imaging
Dose Reporting

Viewing, Saving and Exporting Dose Reports

Viewing and Saving


the Current Dose
Report

Figure 7-27 Viewing the Current Dose Report

To view the current dose report:

1. Open the Exam Info page.


2. Click on [Dose...]. The current dose report opens in the left-hand window.
■ To save the report to the exam database and close it, click [Save and Close].
■ To close it without saving, click [Close].
Note: When you save the report, the system saves an image of the current report to the exam
database. If the report changes, you must save it again to have a copy with the latest data; it does not
automatically update.

O-arm Imaging System User Manual 7-33


Imaging
Dose Reporting

Previewing a Dose You can re-open any saved dose report, and then export it in DICOM format, over a PACS
Report to Export network.

Figure 7-28 Viewing a Saved Dose Report

To view a saved dose report:

1. Open the Saved Exams page.


2. Select the thumbnail for the dose report that you want to open. A preview of the report
appears in the left-hand pane.

Exporting a Saved If you are exporting to external media, before you begin, insert a disk in the DVD/CD RW drive
Dose Report or plug your USB drive into one of the ports in the MVS Connector Panel at the rear of the MVS.

1. Open the Saved Exams page.


2. Select the thumbnail for dose report that you want to open.
3. Click [Send To...] to open the export dialog.

7-34 O-arm Imaging System User Manual


Imaging
Dose Reporting

Figure 7-29 Export Dialog - Export to a DICOM Store Server

4. Select as appropriate:
■ The CD-ROM or the Removable Storage Device radio button, if you are exporting to external
media.
■ The DICOM Store Server radio button, if you are exporting across a network, and then in the
list under Server Alias, click on the server to which you are sending the images.
5. Click [Send]. A popup indicates the progress of the transfer.

O-arm Imaging System User Manual 7-35


Imaging
Dose Reporting

7-36 O-arm Imaging System User Manual


Handling Patient Data 8

8
This chapter describes accessing and reviewing patient exams, exporting them, and deleting them.
It also describes the image annotation and image stitching features.

Handling Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2


Accessing and Reviewing Patient Exams . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2

Exporting Patient Studies and Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-8

Exporting Images Across a Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-9

Editing and Deleting Database Entries . . . . . . . . . . . . . . . . . . . . . 8-11


Correcting Patient Data Entry Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11

Deleting Entries from the Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14

Image Annotation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-15


Using the Annotation Editor I —General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16

Annotation Toolbars . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-17

Using the Annotation Editor II — Text and Markers . . . . . . . . . . . . . . . . . . . . 8-20

Using the Annotation Editor III — Lines and Arrows . . . . . . . . . . . . . . . . . . . 8-21

Image Stitching . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-22

O-arm Imaging System User Manual 8-1


Handling Patient Data
Handling Patient Data

Handling Patient Data

Accessing and Reviewing Patient Exams

General Information You can access saved patient exams from the Saved Exams page.
From the Saved Exams page you can open an exam to:
■ Edit patient information
■ Review images and snapshots
■ Annotate images and snapshots
■ Stitch 2D images (optional feature)
■ Export full exams, selected images and snapshots to external media or across a network.

Opening the Saved 1. Open the Exam Information page. (Press <Esc> on the keyboard.)
Exams Page
2. Click on the Saved Exams tab to open a list of patient exams. The list is in chronological
order from most recent to oldest. The first exam in the list is highlighted and images from
that exam appear in the display below.
Note: When the patient’s information was not entered before starting the exam, images
acquired during the session are saved under the default “date/time”.

8-2 O-arm Imaging System User Manual


Handling Patient Data
Handling Patient Data

Figure 8-1 Saved Exams Listing

Note: If the length of the list is longer than the allotted space on the screen, a scroll bar appears
to allow you to scroll through the list.

Editing Information in To edit patient information in a saved exam:


Saved Exams
1. Highlight the exam in the list, and click [Edit Exam]. This opens the Exam Information page
(refer to Figure 8-10).
2. Make the changes you want to make in the data fields, and click [Save Changes].

O-arm Imaging System User Manual 8-3


Handling Patient Data
Handling Patient Data

Opening Patient Exam 1. Scroll through the list of saved exams and highlight the patient whose images you want to
Images review.
2. Double click on the patient’s name or press <Enter> on the keyboard. This opens a list of
the exams saved for that patient (see Figure 8-2).

Figure 8-2 Patient Exam List

3. Double click on the exam you want to review or highlight it and press <Enter>. This opens
a list of the image series for that study (see Figure 8-3).

8-4 O-arm Imaging System User Manual


Handling Patient Data
Handling Patient Data

Figure 8-3 A Series of 2D Images

4. Click on a thumbnail image to view the image at full size (Figure 8-4).

O-arm Imaging System User Manual 8-5


Handling Patient Data
Handling Patient Data

Figure 8-4 Preview of 2D Image

The format of the display in the left-hand pane for an M-2D or 3D series reflects the standard
(default) presentation for each of those modes (refer to Figure 7-16 and Figure 7-20,
respectively).

Opening Snapshots 1. Open the study for which you want to view the snapshots (follow the instructions for
“Opening Patient Exam Images” on page 8-4).
2. Double click on the study or highlight it and press <Enter> on the keyboard. This opens a
list of the image series for that study (see Figure 8-3).
3. Select the line listed as Snapshots under Series Type.
4. Thumbnails of all the snapshots taken for the selected series show in the lightbox area of the
page.

8-6 O-arm Imaging System User Manual


Handling Patient Data
Handling Patient Data

Figure 8-5 Opening a Snapshot Image

5. Double-click on the thumbnail of the snapshot you’d like to view. It opens in the left-hand
pane.

Manipulating the You can manipulate the preview display by using the wireless mouse or the arrow keys or <Page
Display Up>/<Page Down> keys on the keyboard.
Refer to pages 7-10, 7-17, and 7-26, for 2D, M-2D, and 3D modes, respectively.

O-arm Imaging System User Manual 8-7


Handling Patient Data
Handling Patient Data

Exporting Patient Studies and Images

Export Options You can export a complete exam, an image series, or individually selected images, (including
snapshots), from the system database. You can transfer images to external media, over a network,
or to a navigation station. Patient images are exported in DICOM format, snapshots are exported
as .TIFF files.
To export images over a network, you must connect the MVS to the network and configure it (see
“Setting Up DICOM Export Configurations” on page 4-7).
To export images to a navigation station, you must connect the MVS to the navigation station and
configure it (see “Connecting and Configuring an IGS System Connection” on page 4-11).

Exporting Images to 1. Insert a disk in the DVD/CD RW drive on the MVS Power Control Panel or plug your USB
External Media drive into one of the USB ports in the MVS Connector Panel at the rear of the MVS.
2. Perform the steps in “Accessing and Reviewing Patient Exams” on page 8-2 to select either
a patient’s exam, a single image, or snapshots.
3. Click [Send To...] to open the export dialog.

Figure 8-6 Export Dialog - Export to a CD

4. Select either the CD-ROM or the Removable Storage Device radio button.
5. Under Options, select either Send Patient Images, Send Snapshots or both.
6. If you do not want patient information to appear on the transferred images, select
[Anonymize].
This causes the following fields on images to be replaced with the word “ANONYMIZED”:
Patient Name, Patient ID, Accession Number, and Study Description. The Date of Birth
field will only indicate <Year>.
7. Click [Send]. A popup indicates the progress of the transfer.

8-8 O-arm Imaging System User Manual


Handling Patient Data
Handling Patient Data

Exporting Images Across a Network

Overview You can export a complete image series, or a single image from the O-arm® Imaging System to a
Store Server or a Navigation Station. You cannot export snapshots across a network.
To export DICOM images over a network, the MVS must first be connected and configured to
the facility DICOM network.

Exporting Images to a 1. Perform the steps in the section “Accessing and Reviewing Patient Exams” on page 8-2 to
DICOM Store Server select either an entire study (see Figure 8-3) or a single image (see Figure 8-4) on the Saved
Exams page.
2. Click [Send To...] to open the export dialog.

Figure 8-7 Export dialog

3. Select the DICOM Store Server radio button.


4. In the list under Server Alias, click on the server to which you are sending the images.
5. If you do not want patient information to appear on the transferred images, select
[Anonymize].
6. Click [Send] to export the images.
Note: If the target server is not in operation or not connected, an error message informs you
that sending was not successful.

O-arm Imaging System User Manual 8-9


Handling Patient Data
Handling Patient Data

Exporting Images to a If a navigation station is connected and configured prior to acquisition, images are automatically
Navigation Station transferred to it once they are acquired at the IAS and appear on the MVS monitor.
To transfer previously-acquired images to a navigation station, set up and configure the
connection (“Connecting and Configuring an IGS System Connection” on page 4-11), and then
perform these steps.

1. Perform the steps in the section “Accessing and Reviewing Patient Exams” on page 8-2 to
select either an entire study (see Figure 8-3) or a single image (see Figure 8-4) on the Saved
Exams page.
2. Click [Send To...] to open the export dialog.

Figure 8-8 Export dialog

3. Select the Navigation Station radio button.


4. In the list under “Server Alias”, select the navigation station to which you are sending the
images.
5. If you do not want patient information to appear on the transferred images, select
[Anonymize].
6. Click [Send] to export the images.

8-10 O-arm Imaging System User Manual


Handling Patient Data
Editing and Deleting Database Entries

Editing and Deleting Database Entries

Correcting Patient Data Entry Errors

Patient Data Entry Inadvertent errors can occur while entering new patients in the Exam Information page (see
Errors “Entering New Patient Data at Time of Examination” on page 5-9). Typical scenarios might
involve:
■ Two patients are given the same patient ID
■ One patient is assigned two different IDs
The methods for correcting these situations are addressed below.
Note: Study information from a worklist server cannot be edited.

Duplicate Patient ID The system detects when a second patient is assigned an ID that was assigned to a previously
entered patient. If this happens, the Update Patient Information dialog (Figure 8-10) opens on the
MVS monitor.

Figure 8-9 Update Patient Information Dialog

To give the patient a new ID, do the following:

1. Click [Cancel]. This opens the Exam Information page.

O-arm Imaging System User Manual 8-11


Handling Patient Data
Editing and Deleting Database Entries

Figure 8-10 Exam Information Page

2. Enter the correct ID number in the Patient ID: text box.


3. Click [Accept].
The second patient is now accepted into the database.

8-12 O-arm Imaging System User Manual


Handling Patient Data
Editing and Deleting Database Entries

One Patient with Two If a new patient was entered into the system and had an exam (with images taken), then at a later
Different IDs date the same patient had a second exam, but was re-entered as a new patient with a different
patient ID, the Saved Exams page lists the two different exams for the same patient, but with
different Patient IDs.
To correct this situation:

1. Click on the second (most recent) listing for the patient.


2. Click [Edit Exam]. This opens the Exam Information page (refer to Figure 8-10).
3. Enter the correct ID number in the Patient ID: field.
4. Click [Save Changes].
5. The Update Patient Information dialog (Figure 8-9 , Update Patient Information Dialog)
opens. It lists the patient that was initially entered, with the correct ID and offers you two
choices:
– Use the Existing Patient Information—the existing database information will remain as
is.
– Update Existing Patient Information—the database will change to reflect the changes to
patient information.
6. Select Update Existing Patient Information and click [OK]. This updates the patient
database, combining both studies under the original patient ID.
7. To verify the corrections, return to the Saved Exams page and review the studies (see
“Accessing and Reviewing Patient Exams” on page 8-2).

O-arm Imaging System User Manual 8-13


Handling Patient Data
Editing and Deleting Database Entries

Deleting Entries from the Database

Patient exams can be deleted from the system database.

Automatic Patient Once the database is completely filled, the system begins removing patients automatically
Deletion (beginning with the oldest entry first and working backwards in a reverse chronological
sequence). It only deletes patient entries that did not have the Prevent Deletion box checked.
If all patient entries in the database are checked to prevent deletion and the database is
completely filled, the system will not be able to acquire new images.

Manually Deleting 1. Press <Esc> on the keyboard to open the Exam Information page.
Patients from the
2. Click on the Saved Exams tab to open a list of saved patient exams. Exams are listed from
Database
most recent to oldest.
3. Scroll through the list and locate the patient you want to delete.
4. If the Prevent Deletion box is checked for that exam, click on it to remove the check mark.
5. Click [Delete Patient]. A popup dialog asks you to verify the deletion.
6. Click [Yes] to delete the patient from the system database.

8-14 O-arm Imaging System User Manual


Handling Patient Data
Image Annotation

Image Annotation
About this Feature The O-arm® Imaging System software enables you to annotate 2D images generated by the
system. On the Annotation Editor screen you can add text, lines and arrows of different colors, as
well as “L” and “R” patient side indicators.
You can annotate any of the following:
■ 2D images acquired in 2D or M-2D mode
■ A stitched image
■ A snapshot
You cannot annotate:
■ Images imported into the system
■ 3D images

Viewing Annotations Saved annotations appear on full-screen and split-screen previews of the images.
Saved annotations appear on thumbnails of the images.
Annotations are saved with the image. Images with annotations can be re-opened for further
annotating and editing of existing annotations.
Annotation only shows in the Right-hand window when the image shows two panes of one
image. This is because the left-hand image is replaced when a new image is acquired.
Annotations can be viewed outside of the O-arm® Imaging System software.

Launching the You can launch the annotation editor in any of the following ways:
Annotation Editor ■ To annotate the image in the right pane in 2D mode, first click the image pane. The
appearance of a yellow border denotes the pane is selected. Then press <A> on the keyboard
to annotate.
■ To annotate the active image in the right pane in M-2D mode, first click the image pane. The
appearance of a yellow border denotes the pane is selected. Then press <A> on the keyboard
to annotate.
■ From the Saved Exams page, press [Annotate Image] when an annotatable image is selected.
■ From an image preview, press <A> on the keyboard. To open a preview:
a. Open the Saved Exams tab.
b. In the exam list, locate the patient’s name and double click on it to open the exam data.
c. Double click on the study with the image(s) you want to annotate.
d. Open the image you want to annotate.
When you open an image in the editor, it opens at maximum size.
Note: Live images (in the left pane) cannot be annotated.

O-arm Imaging System User Manual 8-15


Handling Patient Data
Image Annotation

Using the Annotation Editor I —General

General On the Annotation Editor page you can add the following elements to images:
■ Text (see page 8-20)
■ “L” and “R” markers (see page 8-20)
■ Lines (see page 8-21)
■ Arrows (see page 8-21)
You can edit annotations, including those you previously added — moving them, changing their
size, color, front-back level, or orientation, or deleting them.

Figure 8-11 Annotation Editor

8-16 O-arm Imaging System User Manual


Handling Patient Data
Image Annotation

Annotation Toolbars

Toolbar Button The main toolbar runs along the top of the image. A “context” toolbar runs along the left-hand
Functions side.

No. Button
1 Zoom in

1 2 34 5 6 7 8 2 Zoom out

3 Fit to Page

4 Create Line

9 5 Create Arrow

6 Create Text
0 7 Place L Symbol

- 8 Place R Symbol

= 9 Send Backward

0 Bring Forward
q
- Move Left

w = Move Right

e q Move Up

w
r
Move Down

e Color Palette
t r Text Color Palette

y t Enlarge Text

u y Decrease Text Size

u Rotate Clockwise
i
i Rotate Counterclockwise

o o Delete

Figure 8-12 Annotation Toolbars

O-arm Imaging System User Manual 8-17


Handling Patient Data
Image Annotation

Imaging Magnification When you open an image in the editor, it opens at full screen. If you have changed its
magnification, and wish to return it to full size, press the Fit to Page button 3.
To zoom in on a portion of the image, do any of the following:
■ Click on the Zoom in button 1
■ Press the Page Up key on the keyboard
■ Roll the mouse wheel forward
To zoom out, do any of the following:
■ Click on the Zoom out button 2
■ Press the Page Down key on the keyboard
■ Roll the mouse wheel backward
When an image is magnified beyond the size of the screen, use the vertical and horizontal scroll
bars to navigate to the part of the image you want to view.

Selecting Elements
To select... Do this:
A single element Click on the element
Multiple elements Press <Ctrl> and Click on all the elements you want to select
All elements Press <Ctrl + A> on the keyboard

Moving Elements To move an element, either:


■ Select it and drag it to where you want it
■ Select it and then use the Move Left -, Right =, Up q, and Down w buttons to position
it
■ Select it, and then use the respective arrow keys on the keyboard to move it left, right, up or
down. Pressing <Shift> together with the arrow key moves the element in larger steps.
To move many elements together, select the elements you want to move, and then either drag
them where you want them, or use the Move Left -, Right =, Up q, and Down w buttons
or the arrow keys to position them.

Changing Element A newly-added element will overlay previously-added elements.


Layers
To move an element from the front layer to back, or back to front, select it and then click on the
front-to-back 9 or back-to-front 0 button.
When you open a previously-annotated image, all annotations are at the top layer of the image.

Rotating Elements To rotate any element around its center axis, select it, and then press either the clockwise u or
counterclockwise button i in the left-hand tool bar.

Deleting Elements To delete one or more annotation elements, select it (or them) and then either:
■ Press <Delete> on the keyboard
■ Click the delete button o in the left-hand tool bar

Undoing All Changes To undo all changes you have made and return the image to the state it was in when you opened
it, click the [Reset] button.

8-18 O-arm Imaging System User Manual


Handling Patient Data
Image Annotation

To cancel all changes and close the Annotation Editor, press [Cancel].

Saving and Exiting To save your annotations and exit the Annotation Editor, press [Save and Exit].
Annotated Images
Note: If an image is acquired while the Annotation Editor is open, a dialog prompts you to
choose: continue annotating, save changes and close, or close without saving changes.

O-arm Imaging System User Manual 8-19


Handling Patient Data
Image Annotation

Using the Annotation Editor II — Text and Markers

Note: The text annotation functionality supports characters for German text.

67 8

Adding Text You can add multiple text fields. Each text field can have up to 200 characters.
To add text:

1. Left-click on the text button in the top toolbar 7. The cursor shows as a “T” icon when text
annotation is selected.
2. Left-click on the point on the image where you wish the text to start. A text entry box opens.
3. Enter text, using the keyboard.
4. Click elsewhere on the image to “set” the text and close the text entry box.

Changing Text Color Initial text color is the saved configuration color (whatever was last selected).
To change the color of text:

1. Select the text element.


2. Click the small down arrow on the Text color palette button in the left-hand toolbar, then
click “Select Text Color” to open the palette.
3. Select the desired color.

Changing Text Size To change the size of a text element:

1. Select the text element.


2. Click [A▲] in the left-hand toolbar to increase the size of the text or [A▼] to decrease the
size of the text.

Adding L and R You can place a L (left) and a R (right) marker on an image to mark the right and left sides. You
Markers can place only one of each.
To do so:

1. Click on the L 7 or R 8 button in the upper tool bar.


2. Click on the image where you would like the marker to appear.
You cannot change the marker “text” or font. However, once a marker is placed, you can move it
or change its color as you would text elements.

8-20 O-arm Imaging System User Manual


Handling Patient Data
Image Annotation

Using the Annotation Editor III — Lines and Arrows

Note: refer to “Toolbar Button Functions” on page 8-17.

45

Adding Lines To add a line or arrow to an image:

1. Click on the line 4 or arrow 5 button in the top toolbar.


2. Click on the image where you want the line or arrow to start, and drag it to where you want
the line or arrow to end. For an arrow, this will be where the tip of the arrow points.

Changing Line or Initial line color is the saved configuration color (whatever was last selected).
Arrow Color
To change the color of a line or arrow:

1. Select the line or arrow element.


2. Click the line color button in the left-hand toolbar to open the palette.
3. Select the desired color.

Changing the Length To change the length or direction of a line or arrow:


and/or Direction of a
Line or Arrow 1. Select the line or arrow element.
2. Left-click on the vector box at either end of the line or arrow.
3. While holding the left mouse button down, drag the end of the line or arrow to the new
desired endpoint.

O-arm Imaging System User Manual 8-21


Handling Patient Data
Image Stitching

Image Stitching
About this Image Stitching is available for all 2D images that have not been stitched. It allows you to
Functionality manually align from two to nine individual images and merge them into a single, longer
“stitched” image showing a more or less continuous view of the patient’s anatomy.
Stitching creates a new series type in the study list called “Stitched images.”

Do not use stitched images to navigate patient anatomy in image-guided


surgery.

Stitching Restrictions You cannot stitch:


■ 3D images
■ Already stitched images
■ Snapshots
■ More than nine images into one stitched image
If you attempt to stitch any of these, the software alerts you that it cannot complete the action.

Stitching Overview Stitching Images consists of the following main steps:

1. Selecting the images


2. Ordering the images (gross alignment)
3. Aligning the images (fine alignment)
4. Having the software generate the stitched image

Selecting Images to You must be at the “study” level in the Saved Exams tab to be able to select images to stitch.
Stitch
1. Open Saved Exams, and open the patient name.
2. Open an exam from the list.
3. Select up to nine thumbnails of 2D images.
■ To select sequential images, select the first image, press the <Shift> key, and then select the
last image
■ To select non-sequential images, select the first image, and then press and hold the <Ctrl> key
while selecting additional images
Once you have selected more than one thumbnail, the [Stitch Image] button becomes orange
(enabled).
4. Click [Stitch Image].
An “Ordering” window opens showing all the images displayed in a row.

8-22 O-arm Imaging System User Manual


Handling Patient Data
Image Stitching

Ordering the Images


(Gross Alignment)

Figure 8-13 Stitching - Ordering Window

In the Ordering window you can place images in the order you wish to stitch them. You can also
delete any images you do not wish to include in the stitching.
To move an image, select it and use the right and left arrows on the keyboard to move it to the
placement you want.
Note: Once the selected image is as far as it can go in one direction of the series, the button to
move it in that direction produces no further movement.

Deleting Images To delete an image, select the image, then press the <Delete> key.
Note: You must keep at least two images to proceed.
Once you have put the images in the order you want to stitch them, press [Next] to move to the
fine alignment screen.

O-arm Imaging System User Manual 8-23


Handling Patient Data
Image Stitching

Fine Alignment

1 2345

6
7
8

9
0
Figure 8-14 Stitching - Image Fine Alignment (Inset: Toolbars)

On this screen, you can move and rotate the images with fine control, to align the patient
anatomy precisely before stitching.
To increase or decrease image magnification, use the Zoom in 1 or Zoom out 2 button in
the upper toolbar. To restore the display to full-screen, click the Fit to Screen button 3.
To rotate the entire display set by 90º, click the rotate left 4 or rotate right 5 button in the
upper tool bar.
Note: To learn the function of a button, let the cursor “hover” over it. A description of the button
function appears.

Positioning Images in To bring an image forward or back, use the Move to Back 6 or Move to Front 7 button.
the Stack

8-24 O-arm Imaging System User Manual


Handling Patient Data
Image Stitching

Figure 8-15 Image After Fine Alignment

Moving and Rotating To move an image, do any of the following:


Images ■ Select it and drag it to where you want it
■ Select it and then use the left, right, up, and down buttons 8 in the left-hand tool bar to move
it left, right, up, or down
■ Select it, and then use the respective arrow keys on the keyboard to move it left, right, up or
down
If the anatomy in one image is misaligned with that in other images, you can use the rotate
clockwise and counterclockwise buttons 9 to rotate it in increments of 1 degree (up to 5º) to
correct its alignment.

Completing Image When you are satisfied with the alignment of the images, Press [Save and Exit]. This saves as
Stitching the stitched image the largest rectangle that bounds all images.

O-arm Imaging System User Manual 8-25


Handling Patient Data
Image Stitching

8-26 O-arm Imaging System User Manual


Maintenance and
Troubleshooting 9 9
This chapter describes powering down and storing the O-arm Imaging System, maintenance and
performance checks, emergency procedures and troubleshooting tips.

Powering Down and Storing the System . . . . . . . . . . . . . . . . . . . . . 9-2


Powering Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-3

Storing the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-5

Charging the Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-6

Performance Checks and Maintenance . . . . . . . . . . . . . . . . . . . . . . 9-7


Periodic Maintenance - Gain Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11

Emergency Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-18


Opening the Gantry Door When the Battery is LowSystem is Unresponsive 9-18

Moving the Gantry When Battery Power is Low . . . . . . . . . . . . . . . . . . . . . . . 9-21

Emergency Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-22

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-23

O-arm Imaging System User Manual 9-1


Maintenance and Troubleshooting
Powering Down and Storing the System

Powering Down and Storing the System

Powering Down

Once all use of the O-arm®Imaging System is finished for the day, the system should be powered
down and stored.
Inspect the system before storing it. If the IAS or MVS is scuffed or stained, clean and disinfect
the covers and panels before putting it into storage.

Docking the Gantry 1. Place the gantry in its docked position before moving the IAS. Press and hold the “dock”

button to dock the gantry.


2. Leave the gantry door closed while moving it. If space allows, leave the gantry door closed
during storage too. This prevent damage or contamination to the interior of the gantry during
storage.
3. If space constraints do not allow adequate room for the O-arm®Imaging System to be stored
closed, you can gain approximately 30 mm by storing it with the gantry door open.
However, if you choose to store the IAS with the gantry door open, you should cover the
open door with a drape or other object to prevent damage or contamination. To store with

the gantry door open, press the “Open” button on the Pendant to open it.

Powering Down the Perform the following steps to power down the system.
System to Move it.
1. Turn off the power switch on the MVS power control panel. Wait until the yellow System
On indicator light stops blinking and turns off.

2. Unplug the power cord from the wall outlet.


3. Disconnect the interconnect cable from the IAS.
4. Wrap and store the interconnect cable in the holder on the side of the MVS.
The IAS is now in standalone mode. Both units are now ready to be moved.
Note: If the IAS is left in the standalone mode, it powers itself down in one hour.

9-2 O-arm Imaging System User Manual


Maintenance and Troubleshooting
Powering Down and Storing the System

Cleaning

Clean the O-arm® Imaging System in a location away from the patient environment, or
immediately after use. Consider that biological contaminants may be removed during this
cleaning. To mitigate cross-contamination and avoid exposure to blood-borne pathogens and
chemicals, use Personal Protective Equipment.

Read the labels on all cleaning agents, solvents and detergents and use them only according to the
manufacturer’s instructions.

Caution: The IAS and MVS are not waterproof. If water or cleaning
liquids enter the equipment, electrical short circuits can result once power
is returned to the units.

Caution: The use of sprays to disinfect a medical equipment room is not


recommended. The vapor from the spray can enter the equipment and
cause electrical short circuits and corrosion.

Warning: Do not use flammable or potentially explosive disinfectant


sprays. The use of such sprays can create vapors that cause explosion and
fire resulting in serious personal injury or death.

Cleaning exterior Prior to cleaning the exterior of the system, remove single-use drapes and dispose of them
surfaces according to national regulations.
To clean the exterior surfaces of the O-arm® Imaging System, follow these instructions:

1. Raise the gantry from the docked position.


This allows you to clean under the O-arm® gantry.
2. Close the gantry door.
3. Turn off the O-arm® Imaging System.
4. Unplug the MVS power cord from the wall outlet.

Warning: Never attempt to clean the equipment while it is connected to a


power source. To prevent the possibility of electrical shocks, always
unplug the MVS power cord from the wall outlet before cleaning the MVS
or IAS.

5. Inspect surfaces that would normally be above the patient for dust particulates and
biological contamination.
You should pay particular attention to
– The top of the gantry
– The gantry door and sidewalls
– The active tracker assembly
– Seams and transitions between covers
– The Laser Alignment Kit, if installed

O-arm Imaging System User Manual 9-3


Maintenance and Troubleshooting
Powering Down and Storing the System

6. Prepare a lint-free cloth and a mild disinfectant recommended for hard surfaces per the
disinfectant manufacturer’s instructions.
These mild disinfectants include isopropyl alcohol at 70–90% concentration; bleach or
sodium hypochlorite-based solutions; or quaternary ammonium.
Avoid the use of phenol-based, corrosive or solvent disinfectants that may discolor the
equipment’s surface material.
7. Using the cloth and disinfectant, wipe all surfaces that would normally be above the patient.
Wipe away from the door seams to avoid introducing contaminants into cover seams. After
cleaning heavily soiled areas, use another clean cloth to mitigate cross-contamination.
8. Wipe all surfaces that would normally be below the patient.
Wipe way from the door seams to avoid introducing contaminants into this void.
9. Inspect surfaces that have been cleaned.
10. Repeat cleaning from step 6 if dust or contamination remains.

Cleaning interior Complete the instructions above for “Cleaning exterior surfaces” prior to cleaning the interior
surfaces surfaces.

1. Plug the MVS power cord into a wall outlet.


2. Turn on the O-arm® Imaging System.
3. Open the gantry door.
4. Turn off the O-arm® Imaging System.
5. Unplug the MVS power cord from the wall outlet.

Warning: Never attempt to clean the equipment while it is connected to a


power source. To prevent the possibility of electrical shocks, always
unplug the MVS power cord from the wall outlet before cleaning the MVS
or IAS.

6. Inspect the revealed surfaces for dust or contamination.


7. Clean these surfaces, as necessary.

Cleaning the MVS and 1. Inspect the IAS cabinet and MVS paying particular attention to wheels and casters.
IAS cabinet
2. Clean these surfaces as described above to remove dust particulates and biological
contamination.
3. Dispose of all cleaning cloths according to national regulations.

9-4 O-arm Imaging System User Manual


Maintenance and Troubleshooting
Powering Down and Storing the System

Storing the System

Moving The MVS 1. Release the lock lever on the foot pedals to unlock the wheel brakes.
2. Grasp the handle on either side of the cart and carefully maneuver it to its storage
destination.

Caution: Use two people to move the MVS up or down an incline. Never
attempt to move the MVS down steps or stairs.

3. Press down the lock lever on the foot pedals to lock the wheel brakes once the MVS is in its
final location.

Moving The IAS 1. Make sure the power switch on the power panel is in the Start position. This allows battery
power to be applied to the IAS.

2. If the transport brakes were set, press the “transport brake” button on the Pendant
to release the transport wheel brakes. The brakes are released if the LED next to the button is
not illuminated.

Warning: Move the IAS slowly when using the power assisted transport
wheels. Use special care when crossing thresholds and moving up or down
ramps. Be aware of all obstacles and people along the intended path.
Collision with people or physical objects can result in personal injury or
equipment damage.

3. Squeeze the IAS transport handle and push on it to move the unit forward, or pull on it to
move backward. Pushing on either side of the handle turns it.
4. Steer the IAS to its storage location and then release the transport handle.
5. Press the “transport brake” button on the Pendant to set the transport brake.
6. Turn the key switch on the IAS connector panel to its Off position.If the system is to be
stored in a location where it can be accessed by unauthorized persons, the key should be
removed and stored in a secure place.
Note: Ensure the system is plugged in overnight to recharge the batteries for next day operation.
To charge the batteries, the IAS must be connected to the MVS, and the power cord of the MVS
must be plugged into the mains power outlet.

O-arm Imaging System User Manual 9-5


Maintenance and Troubleshooting
Powering Down and Storing the System

Charging the Batteries

Assuring Full Charge To assure the full charge of the IAS batteries, make sure the MVS is plugged into a power outlet,
then connect the interconnect cable to the IAS. Make sure the system remains plugged in for six
(6) hours.

LED Indicators Whenever the system is plugged in, both columns of the LED battery indicators illuminate and
scroll up (from the current battery charge level to 100%).

Battery Charge Level After disconnecting the system from the mains or after taking an X-ray, the battery indicator
Indicators requires 30 seconds to register a stable reading.

Table 9-1. IAS Battery Indicators

MOBILE UNIT MOBILE UNIT UNPLUGGED FROM MAINS


PLUGGED TO MAINS

KEY IN “OFF” or “ON” KEY IN “OFF” KEY IN “ON” KEY IN “ON”


POSITION POSITION POSITION and MVS POSITION and
Turned ON MVS Turned OFF

The indicators show the All indicators The indicators show The indicators for
current Battery charge level are OFF. the respective Generator are OFF.
(lit steadily) and scroll up battery charge level. The indicators for
continuously. Motors show the
battery charge level.

The percentage of the battery charge level versus battery voltage (minimum value) is indicated
in the following table.

Table 9-2. Percentage of Battery Charge Level Versus Battery Voltage


A minimum of three LEDs (373V) is required to complete an X-ray exposure.

MOTORS GENERATOR
LED Light Battery Battery LED Light Battery Battery
On Charge Voltage On Charge Level Voltage
Level (minimum) (minimum)
10 100% 102.0 V 10 100% 382 V
9 90% 100.5 V 9 90% 380 V
8 80% 98.9 V 8 80% 378 V
7 70% 97.4 V 7 70% 377 V
6 60% 95.8 V 6 60% 376 V
5 50% 94.3 V 5 50% 375 V
4 40% 92.5 V 4 40% 374 V
3 30% 91.0 V 3 30% 373 V
2 20% 89.4 V 2 20% 372 V
1 10% 88.0 V 1 10% 371 V
None 0% < 88 V None 0% <371 V

9-6 O-arm Imaging System User Manual


Maintenance and Troubleshooting
Performance Checks and Maintenance

Performance Checks and Maintenance

Overview

Frequency Guidelines Perform routine performance checks on the O-arm® Imaging System. The frequency of checks
should be dictated by amount of use and by unusual circumstances such as accidents during
transport or ingress of fluids into the system.
Performance checks are not a substitute for scheduled planned maintenance, which must be
performed by a trained Medtronic Navigation Service representative. Planned maintenance is
needed annually
Refer to (“Technical Support” on page 1-4) for contact information to arrange for periodic
maintenance.
Before performing any checks, familiarize yourself with potential hazards of working with the
system. Review the Safety section in Chapter 1 (page 1-8).
Periodic maintenance performed by the user consists of Fluoro calibration, RAD gain calibration,
and door cable inspection. Conduct these at 30-day intervals.

Initial Setup These performance checks should be performed in a safe operating environment. If possible,
move the system to an area that is clear of people and other equipment. Observe all radiation
safety precautions while performing the checks.
To perform these checks, the IAS and MVS must be connected and powered up (refer to
“Powering Up the System” on page 5-4).

Warning: Do not remove any covers, or perform any type of service task.
Circuits inside the equipment use voltages that are capable of causing
serious injury or death from electrical shock.

O-arm Imaging System User Manual 9-7


Maintenance and Troubleshooting
Performance Checks and Maintenance

User Performance Checks

System Performance The table below lists O-arm Imaging System performance checks. The last column in
Checks the table “Method” contains numbers that are keyed to a second table that describes the
method of testing for each type of performance check.

Table 9-3. User Performance Checks

Type Check Description Frequency Method

General Accessories Availability & integrity Before case 1

General X-ray activation Ensure correct function Before case 3


alarm and light

General Brakes, wheels & Ensure correct function Before case 1


steering

General Cable Deflectors Check for presence & damage Before case 1

General Cabling Inspect all cables for kinks & Before case 1
cracks

General Connectors Check for secure connections & Before case 1


damage

Movement Gantry Movement Check for correct function, ease of Before case 4
movement, stop, lack of excssive
play

Operation Printer Check for paper Before case 1

Operation X-ray Ensure correct function Before case 3

Operation X-ray Check beep and lamp Before case 3

Operation X-ray Collimator settings and position Before case 3

Operation X-ray Check correct function of the Before case 1


system lock

Operational Battery Charge Check for proper battery charge Before case 1

Start-up Power on: Check correct function of keys, Before case 1


Pendant view display for error messages

Start-up Power on: system Check Pendant & MVS monitor for Before case 2
error messages

Operational Calibration Check Fluoro & RAD gain Monthly 8&9

Operational Alignment Collimator alignment Yearly (PM) 7

Operational Dose indication X-ray Quality Assurance Testing Yearly (PM) 6

Operational Image quality Check performance Yearly (PM) 1

Operational Labels Check for legibility Yearly (PM) 1

Operational Mechanical Fasteners, cables, all mechanical Yearly (PM) 1


stops, wheels, wheel alignment,
cable deflectors, brakes and locks

Operational X-ray control X-ray quality assurance testing Yearly (PM) 6

9-8 O-arm Imaging System User Manual


Maintenance and Troubleshooting
Performance Checks and Maintenance

Performance Check Table 9-4 correlates the “Method” column of Table with the method to be performed for
Methods each type of check.

Table 9-4. User Performance Checks

Method Type Description

1 General Visual and/or audible

2 Start-up Review Service Manual or contact Customer Service

3 General & X-ray operational checks:


Operation
a. Using the rotor positioning buttons on the pendant, align the X-ray
source directly above the X-ray detector. The X-ray source, indicated by
the narrower array of LEDs, should be at the top of the gantry ring.
b. Place a suitable test object on the bottom , inside surface of the gantry
ring.
c. Verify that 2D mode is selected.
d. Press the top button on the hand switch, or the left-most pedal on the
foot switch.
e. Verify that a digitized fluoroscopic image of the object appears in the
left-hand pane of the MVS monitor & remains there after the exposure
is terminated.
f. Repeat step d and verify that the Image Mirror
buttons on the Pendant flip the image (left for right
and top for bottom) on the MVS monitor during
live fluoroscopy and LIH.
g. Repeat step d (above) and verify that the collimator
adjustment buttons on the Pendant operate the
shutters in the appropriate directions.
h. Perform a fluoroscopy without any object in the
X-ray beam and close the collimator to about half
size on each axis.
i. View the image from step h on the left pane of the MVS monitor and
verify that the image is cropped (collimated).

4 Movement • Check specified movement by pressing the appropriate button on


the Pendant.
• Ensure that the specified movement stops when the Pendant button
is released.

O-arm Imaging System User Manual 9-9


Maintenance and Troubleshooting
Performance Checks and Maintenance

Table 9-4. User Performance Checks (Continued)

Method Type Description

5 Emergency Routinely perform this check ensure that the Emergency Stop safety
Shutdown feature is functioning properly.
(E-Stop)
Also, perform this check whenever the system is returned from long-
term storage or has been exposed to liquid spills.
a. Press and hold down any of the gantry movement buttons.
b. While the gantry is in motion, press the Emergency Stop
button.
c. Verify that:
• The gantry motion stops.
• Emergency Stop has been activated. This is confirmed with a
message on the Pendant.
• Both the hand and foot switches are disabled.

d.Press the E-Stop Reset button to reactivate the system.

6 X-ray Perform X-ray system testing as required by local, state, and national
Quality and/or international regulation.

7 Collimator Performed during yearly PM.


Alignment

8 Fluoro Gain See “Fluoro Gain Calibration” section.


Calibration

9 RAD Gain See “RAD Gain Calibration” section.


Calibration

10 Door Cable See “Door Cable Inspection” section.


Inspection

9-10 O-arm Imaging System User Manual


Maintenance and Troubleshooting
Performance Checks and Maintenance

Periodic Maintenance - Gain Calibrations

When either of these calibration procedures is due or overdue, a reminder message appears in the
MVS display at boot-up.

Fluoro Gain 1. Undock the gantry (see “Undocking the Gantry” on page 6-13).
Calibration
2. Open the System Technical Service Console.
a. Press <Ctrl–Alt–Home> on the keyboard to open the user access popup.
b. Type in your password and press <Enter>.
3. Click on the Maintenance Tab to open the Maintenance Tab page.

Figure 9-1 Maintenance Page

4. Click [Run Fluoro Gain Calibration].


5. Remove extraneous items from the X-ray field.
6. Follow the on-line instructions to perform calibration. During this the system moves the
rotor and takes a long exposure, then two short exposures. Windows appear saying
“Working” and “Analyzing”. Analyzing can take a few minutes, resulting either “Success”
or “Failure”. If Failure happens, go to step 7. If successful, move on to step •

O-arm Imaging System User Manual 9-11


Maintenance and Troubleshooting
Performance Checks and Maintenance

7. Check the calibration results. If the “gain median value” is within the prescribed range, click
[Close Window]. If not, proceed to step •
8. If the “gain median value” is...
• below the range, use the Adjust kV button on the Pendant to increase the kVp by 2, and run
the calibration again.
• above the range, use the Adjust kV button on the Pendant to decrease the kVp by 2, and run
the calibration again. It may take an increase or decrease between 1 and 3 kV to locate the
correct setting.
• After a successful calibration, reboot the system to complete the process

.RAD Gain Calibration 1. Undock the gantry (see “Undocking the Gantry” on page 6-13).
2. Press <Ctrl–Alt–Home> to bring up the user access popup.
3. Type in your password and press <Enter>. The System Technical Service Console opens in
the right-hand pane of the monitor.
4. Click on the Maintenance Tab to open the Maintenance page (see Figure 9-1).
5. Click [Run RAD Gain Calibration].
6. Remove extraneous items from the X-ray field.
7. Follow the on-screen instructions.
8. During the calibration process the system moves the rotor and takes a long exposure twice.
Windows appear saying “Working” and either “Success” or “Failure”. If successful, proceed
to step 9. If Failure occurs, go back to step 7.
9. If the “gain median value” is...
• below the range, use the Adjust kV button on the Pendant to increase the kVp by two (2).
• above the range, use the Adjust kV button on the Pendant to decrease the kVp by two (2).
10. Note: It may take an increase or decrease between 1 and 3 kV to locate the correct setting.
Run the calibration again (starting from step 5.).
11. Once you have a successful calibration, reboot the system to complete the process.

Dose Calibration Recurring dose calibration may be checked and managed via the Air Kerma Rate Calibration
Records Records section of the Maintenance tab shown in Figure 9-1. You may view the existing
calibration records, add new records, and edit existing records.

9-12 O-arm Imaging System User Manual


Maintenance and Troubleshooting
Performance Checks and Maintenance

Creating New Calibration Records

New calibration records may be added by pressing the [New] button 1. The Record of
Performed Air Kerma Rate Calibration dialog (Figure 9-2) allows the user to enter the date, the
individual that performed the calibration and comments.

Figure 9-2 Entering a new calibration record

Editing Existing Calibration Records


Existing calibration records may be edited by selecting the record to edited in the Air Kerma
Rate Calibration Records list, then pressing the [Edit] button 2. The Record of Performed
Air Kerma Rate Calibration dialog (Figure 9-2) allows the user to edit the date, the individual
that performed the calibration and any comments that were entered.
Figure 9-3 Entering a new calibration record

Door Cable Inspection These instructions are intended to provide a method for the user of the O-arm® Imaging System
to monitor and inspect the door cable of the gantry door mechanism. Any noted deterioration of
the cable must be evaluated immediately by Medtronic Navigation personnel. Proper
maintenance and periodic inspection of the system will ensure safe use of the system.
Every time the O-arm Door is opened or closed, the operator should listen, if possible, for
unusual sounds (i.e. grinding or crunching) as the door is in motion. If there is any question, the
door cable should be inspected immediately and Medtronic Technical Support should be notified
immediately if any broken stands are noticed.
If you are unsure about performing this procedure, please contact Medtronic Technical Support.
The door open cable should be inspected per the instructions in this document on a monthly
basis.

Warning: Failure to carry-out this inspection or to maintain your device


in accordance with these instructions could result in harm to a patient or
user.

After completion of the inspection, if any broken strands are discovered, stop the use of the
system and contact Medtronic Technical Support immediately

O-arm Imaging System User Manual 9-13


Maintenance and Troubleshooting
Performance Checks and Maintenance

Required Tools
The following tools and materials are required to complete the inspection.
■ Cotton balls
■ Either a pair of tweezers, hemostats, or needle nose pliers
■ Permanent marker pen

Inspection Procedure
1. Using the Pendant, position the gantry for best access.
a. Extend the gantry out in the X direction.
b. Lower it in the Y direction.
c. Move it fully left or right depending upon preference.
2. Close the door completely before performing the next step.
3. Position yourself at the back of the O-arm to view the cable as shown below.

9-14 O-arm Imaging System User Manual


Maintenance and Troubleshooting
Performance Checks and Maintenance

4. Holding the cotton ball with tweezers, needle nose pliers or hemostats as shown below, run
the cotton along the accessible length of the cable. Be sure to keep the door stationary while
performing this step.

Ensure the cotton is brought into contact with all the surfaces of the cable.
5. After running the cotton ball along the cable, inspect the cable for any indications of broken
strands that have pulled off cotton.

O-arm Imaging System User Manual 9-15


Maintenance and Troubleshooting
Performance Checks and Maintenance

6. Inspect the entire length of the door cable in 12 “sections as shown below.

a. Once the accessible length has been inspected, mark the top of the inspected length of the
cable with a permanent marker.
b. Press the Door Open button on the Pendant to advance the cable. Slowly open the door
until the cable has advanced far enough to line up the mark with the pins that are visible
on the O-arm as shown in the following image.

7. Repeat steps 4, 5 and 6 until the door is fully open and you have inspected the entire
accessible length of the cable.
The cable inspection is now complete. If any broken strands are discovered, stop use of the
system and contact Medtronic Technical Support immediately.

9-16 O-arm Imaging System User Manual


Maintenance and Troubleshooting
Performance Checks and Maintenance

Additional Periodic Periodic maintenance other than the gain calibrations described above should be performed by a
Maintenance Medtronic Navigation service engineer (refer to “Technical Support” on page 1-4).

O-arm Imaging System User Manual 9-17


Maintenance and Troubleshooting
Emergency Procedures

Emergency Procedures

Opening the Gantry Door When the System is Unresponsive

Background In order to move the IAS away from the operating table, the gantry door must first be opened.
Safeguards are built into the O-arm® imaging system to ensure that the gantry door can be
opened and the system can be moved in the event that the system batteries have run down too far
for normal operation or that the system has become unresponsive.

Electronically Opening Do not use this procedure when the batteries are low, but only when the o-arm application or the
the Gantry Door pendant become unresponsive. If the batteries are low, the system shuts down and the door must
be opened manually as described in “Manually Opening the Gantry Door” on page 9-18.

Warning: Before opening or closing the O-arm door always confirm that
neither the patient nor any one else is in the path of the moving door.

1. Move the pendant toward the right side (as you stand at the drive handle) of the IAS.

2. Press and hold down the Open Gantry Door button on the pendant.
Note: If you remove your finger from the Open Gantry Door button, the door stops opening.

3. Press and release the Electronic Door Override button on the right side of the gantry.

Manually Opening the The rotor inside the gantry must be aligned before attempting to open the door. Once this is
Gantry Door accomplished, the wrench can be used to open the door sidewalls and raise the door.

Caution: Failure to follow these directions may cause the door


mechanism to jam.

Warning: Before opening or closing the O-arm door always confirm that
neither the patient nor any one else is in the path of the moving door.

1. Press the Emergency stop button on the pendant or the front of the IAS power control
panel.
This prevents unexpected motor or X-ray actuation.
2. Locate the ratchet wrench and the T-shaped rotor alignment pin tool stored on the side of the
MVS.
3. Locate three black plastic covers on the left side of the IAS toward the right lower bottom of
the gantry just in front of the rear cabinet.
4. Remove all black three plastic covers.
This reveals two larger openings in the outer section of the gantry – the rotor alignment nut
1 and the door opening nut 2 – and one small opening located in the inner section– the rotor
alignment hole 3. The two outer openings contain a hex nut (see Figure 9-4) connected to
the drive mechanisms for the rotor 1 and the door 2.

9-18 O-arm Imaging System User Manual


Maintenance and Troubleshooting
Emergency Procedures

2 4
5

1
Figure 9-4 Door Opening Access Points

5. Attach the ratchet wrench in the rotor alignment nut 1.

6. Look inside the rotor alignment hole 3.


– If you see bare metal, the rotor is close to the one of the hard stops. Proceed with step 7.
– If you see orange or green colored metal, proceed with step 8.
– If you see no metal, the rotor is properly aligned and you may proceed with step 9.
7. Slowly turn the alignment nut clockwise until either the hard stop is reached or colored
metal comes into view through the rotor alignment hole.
If the hard stop is reached, reverse the direction you are turning the nut until colored metal
comes into view. Once the colored metal comes into view, continue with step 8.
8. Turn the alignment nut in the direction that corresponds with the color of the metal viewed
through the rotor alignment hole.
That is, if you see green metal through the rotor alignment hole, turn the nut clockwise. If you
see orange metal, turn the nut counter-clockwise.
The rotor is properly aligned when you see no metal through the rotor alignment hole and the
T-shaped rotor alignment pin can be fully inserted into the rotor alignment hole.

9. Insert the alignment pin by pressing the blue release button 4 and inserting it into the rotor
alignment hole (see Figure 9-4).
The alignment pin is properly inserted when the black portion of the handle sits against the
white gantry cover, the blue release button is released, and the pin cannot be removed by
pulling on it.

10. Attach the ratchet wrench to the door opening nut 2.


11. Using the wrench, turn the nut clockwise until the gantry door opens completely.
12. Remove the ratchet wrench from the door opening nut.
13. Remove the rotor alignment pin.
14. Replace the three black plastic covers.
15. Replace the ratchet wrench and the rotor alignment pin on the right-hand side of the MVS.

O-arm Imaging System User Manual 9-19


Maintenance and Troubleshooting
Emergency Procedures

Once the gantry door is open, release the Emergency Stop or unlock the rear wheels to move
the IAS away from the operating table. See “Unlocking the Rear Wheels” on page 9-21.

9-20 O-arm Imaging System User Manual


Maintenance and Troubleshooting
Emergency Procedures

Moving the Gantry When Battery Power is Low

Normally, you drive the IAS by squeezing the control bar on the inside of the transport handle to
supply battery power to the rear wheels. When the batteries are low on charge, the system shuts
down, disabling the drive.

Unlocking the Rear 1. Locate the clutch release lever located at the lower left-hand side of the O-arm® IAS cabinet
Wheels (see Figure 9-5).

Figure 9-5 Clutch Release Lever

The lever is normally in the down position.


2. Lift up the lever to unlock the wheels.

Removing the Drape 1. Remove the sterile drape from the gantry:
and Moving the Gantry
• If using the tube drape, locate the colored separation line at the door opening and tear the
drape in half.
• If using the bar drape, remove any adhesive tape strips attaching the drape to the gantry and
lift the drape completely off the gantry.

Caution: Before backing the gantry away from the operating table, make
sure that it will not come in contact with either the patient or the
operating table and that the area behind it is clear of all obstacles.

2. Grasp the transport handle with both hands and pull the IAS backwards until the open gantry
door has cleared the patient and the operating table.
3. Once the batteries have been recharged, press down on the clutch release lever (Figure 9-5)
to return it to the normal position and engage the electric drive motors.

O-arm Imaging System User Manual 9-21


Maintenance and Troubleshooting
Emergency Procedures

Emergency Shutdown

Shutting Down the The operation of the O-arm® Imaging System can be completely shut down at any time by
System in an pressing either of the Emergency Stop buttons.
Emergency

One is located on the IAS Pendant .

Another is on the IAS Power Control panel .

Resetting the To return the system to normal operating conditions, press the Emergency Stop Reset button
Emergency Stop

on the Pendant.

9-22 O-arm Imaging System User Manual


Maintenance and Troubleshooting
Troubleshooting

Troubleshooting
MVS
Table 9-5. MVS Troubleshooting

Symptom Cause Solution(s)

Green light not on. No AC Power to MVS 1. Check plug -make sure it’s plugged fully in
to wall and in good condition
2. Check wall voltage at source

Green light on. AC power OK 1. Turn keyswitch.


Yellow light not on. MVS not turned on 2. Check that keyswitch isn’t broken

Green light on. AC power OK 1. Wait four minutes for boot up to complete.
Yellow light MVS not turned on 2. Reboot and watch for Bios messages at
blinking. immediate start up.
Green light on. Unit on, but UPS is 1. AC plug -make sure it’s plugged fully in to
Yellow light on. complaining wall and in good condition
Beeping coming 2. Check wall voltage at source
from inside MVS
1. Check LEDs on front of computer. Call
Unit on, but computer
is complaining MNAV support.

Green light on. Power not reaching 1. Check on/off switch to display
Yellow light on. display 2. Check power connection to display
MVS display
black. Video not reaching 1. Check video connection to display
display.

No video to display, or 1. Shut off system, open back of MVS,


resolution wrong, but
shows Intel screen at disconnect tan VGA cable from computer,
beginning of boot-up turn on system.

Green light on. Windows crash Turn the system off, wait until the yellow light is
Yellow light on. off, and then turn the system back on. If
MVS display blue problem persists after reboot, contact
screen Medtronic Navigation technical support.

Green light on. O-arm® software Turn the system off, wait until the yellow light is
Yellow light on. application crash off, and then turn the system back on. If
MVS display problem persists after reboot, contact
shows a green Medtronic Navigation technical support.
O-arm® screen

Green light on. O-arm® software Record a screenshot either with the snaptshot
Yellow light on. application crash button or a digital camera.
MVS display If this happens at boot-up, make sure the
shows application external network cable is not connected to the
screen with error StealthStation system or PACs, and then
message pop-up reboot.
window If problem persists after reboot, contact MNAV
support.

O-arm Imaging System User Manual 9-23


Maintenance and Troubleshooting
Troubleshooting

Troubleshooting
Table 9-6.

Symptom Cause Solution(s)

Green charging No AC Power 1. Check that MVS plugged into wall.


light not on. from MVS 2. Check that the interconnect cable is connected
between the IAS and the MVS.
3. Check glass fuses in back of MVS
4. If problem persists, call MNAV support.

Green light on. AC power OK 1. Turn keyswitch fully to the right.


Yellow light not MVS not turned 2. Check keyswitch for position in Unlock.
on. on 3. If problem persists, call MNAV support.

Green light on. Booting 1. Wait four minutes for boot up to complete.
Yellow light 2. Check that the Emergency Stop button is not
blinking depressed.
3. Check that the Pendant (and/or remote pendant) is
connected.
4. Check that the interlock dongle is correctly inserted.
5. If problem persists, call MNAV support.

Green light on. Motion 1. Hold the M button down and wait for all axes to
Yellow light on. controllers lost complete movement and for the system to transition
Pendant status track of where to 2D screen.
screen shows gantry was in
three rows, top space.
row says “Hold
M button down
to rehome”

Green light on. Emergency 1. Reset Emergency stop by pressing reset button on
Yellow light stop pressed. the Pendant.
blinking. 2. Check pendant connections.
Pendant status
screen shows 3. Check that the interlock dongle is correctly inserted.
three rows, top 4. If problem persists, call MNAV support.
row shows
scrolling green
line.

Green light on. Motion Make sure no buttons on pendant or X-ray switches are
Yellow light on. controllers not pressed.
Pendant status initialized If problem persists, call MNAV support.
screen shows
three rows, top
row shows
scrolling green
line.

Green light on. X-ray system Reboot.


Yellow light on. not booting up If reboot does not solve the problem, call MNAV support.
Pendant status
screen shows
three rows,
middle row
shows scrolling
green line.

9-24 O-arm Imaging System User Manual


Maintenance and Troubleshooting
Troubleshooting

Table 9-6.

Symptom Cause Solution(s)

Green light on. Interconnect Connect interconnect cable. If this system questions
Yellow light on. cable not cable connection, call MNAV support.
Pendant status connected
screen shows between the
three rows, IAS and MVS.
middle row
shows X-rays
disabled,
bottom shows
MVS not
connected.

Green light on. Imaging chain Turn on MVS and wait for application to start.
Yellow light on. not
Pendant status communicating If application is running, reboot the MVS.
screen shows
three rows, If system continues to show message after reboot, call
bottom row MNAV support.
shows waiting
for MVS to
initialize.

Green light on. IAS computer In lower right corner, check STATUS message.
Yellow light on. and/or software ■ If status is 0001, computer is not booting.
Pendant shows application not
■ If status is 0000, computer booted, but application
“System booting
booting please software is not running. Try reboot.
wait” ■ If reboot fails, call MNAV support.

O-arm Imaging System User Manual 9-25


Maintenance and Troubleshooting
Troubleshooting

9-26 O-arm Imaging System User Manual


Labels and Technical
Reference 10 10
This chapter describes labels on the O-arm® Imaging System and lists the technical specifications to
which the system conforms.

Labels and Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7

Safety Classifications and Standards . . . . . . . . . . . . . . . . . . . . . 10-16

Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17

Dose Evaluation Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-21


Dose Evaluation in 3D Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-21

Dose Evaluation in 2D Fluoroscopy Modes . . . . . . . . . . . . . . . . . . . . . . . . . . 10-21

O-arm Imaging System User Manual 10-1


Labels and Technical Reference
Labels and Symbols

Labels and Symbols


The following are representations of labels and symbols affixed to the O-arm® Imaging System
and its components. Please check your system for the version that applies to your equipment.

Table 10-1. Labels on the O-arm® Imaging System

Label/Icon Location Description

Product label of Attention – Refer


IAS and MVS to Users Manual

Various Electrical Shock


locations Hazard

Various Pinch Hazard


locations

Various Laser Safety


locations Hazard

Bellows Do Not Push

Near product Equipotentiality


label of IAS (Connection for
and MVS POTENTIAL
EQUALIZATION
CONDUCTOR)

At key on IAS Locked and


Unlocked

Rear Cabinet IAS Product


of IAS Label

10-2 O-arm Imaging System User Manual


Labels and Technical Reference
Labels and Symbols

Table 10-1. Labels on the O-arm® Imaging System (Continued)

Label/Icon Location Description

Bottom of MVS Product


panel on rear Label
of MVS

X-ray Lower panel of


Generator telescoping door
opening

Lower panel of Collimator


telescoping
door opening

Lower panel of Anti-Scatter Grid,


telescoping 5:1 ratio
door opening

Lower panel of Anti-Scatter Grid


telescoping 12:1 ratio
door opening

O-arm Imaging System User Manual 10-3


Labels and Technical Reference
Labels and Symbols

Table 10-1. Labels on the O-arm® Imaging System (Continued)

Label/Icon Location Description

Y Stage, Lower Keep clear of the


panel of door when it is
telescoping partially open or
door opening while opening or
closing. Do not
move the O-arm
over the patient
unless the door is
fully opened.

Upper panel of Keep clear of the


telescoping door when it is
door opening partially open or
while opening or
closing. Do not
move the O-arm
over the patient
unless the door is
fully opened.

Accessories Consult
instructions for
use.

MVS above Follow


power switch. instructions for
IAS to the left use.
of the power
switch

Accessories The medical


device has been
sterilized using
irradiation

Accessories The medical


device has been
sterilized using
ethylene oxide

10-4 O-arm Imaging System User Manual


Labels and Technical Reference
Labels and Symbols

Table 10-1. Labels on the O-arm® Imaging System (Continued)

Label/Icon Location Description

Accessories The device is


intended for one
use, or for use on
a single patient
during a single
procedure.

Accessories Do not resterilize

Accessories Indicates the


temperature
limits to which the
device can be
safely exposed

Accessories Do no t use if
package is
damaged or
opened

Accessories Indicates the


manufacturer’s
catalog number

Accessories Quantity

Accessories The
manufacturer’s
batch code so
that the batch or
lot can be
identified.

Accessories Indicates the date


after which the
medical device is
not to be used

O-arm Imaging System User Manual 10-5


Labels and Technical Reference
Labels and Symbols

Table 10-1. Labels on the O-arm® Imaging System (Continued)

Label/Icon Location Description

Accessories Does not contain


natural rubber or
dry natural
rubber latex as a
material of
construction
within the device
or the packaging
of the device

Accessories Does not contain


PVC as a
material of
construction
within the device
or the packaging
of the device

Accessories For US
audiences only

Accessories Federal law


restricts this
device to sale by
or on the order of
a physician.
Accessories Sterile 1D Mouse

Accessories The device


complies with
European
Directive MDD
93/42/ EEC.

IAS near power For US


switch audiences only.
Radiation safety
warning label

10-6 O-arm Imaging System User Manual


Labels and Technical Reference
Specifications

Specifications
General Technical Technical specifications for the O-arm® Imaging System are listed in the tables below.
Specifications
Table 10-2. General Technical Specifications

Category Specification

Physical Dimensions, 98.3” (250 cm) long x 32.0” (81.3 cm) wide x 79.6” (202 cm) high
O-arm IAS
(‘docked’ with door open)
Weight ~ 1950 pounds (885 kg)

Gantry Opening – 27.5” (69.8 cm) at telescoping door (open)


Center of Bore Diameter – 38” (96.5 cm)
Imaging Modality Single Plane 2-D; 30 frames per second
Performance Multi 2-D; Up to 4 2-D images, from pre-set positions
3-D/Volumetric; ~13 seconds to acquire data over 360º

~ 20 seconds to reconstruct volume at 512 x 512 x192 voxels


(0.830mm slice thickness – isotropic, 192 axial)
3D Imaging Volume Cylindrical volume; 15cm (high) X 20cm (diameter)
512 x 512 x 192 voxels resolution
2D Image Enhancements Edge Detection (3 settings)
Recursive Noise Reduction (automatic)
Auto-Brightness Control
Auto Window/Level
Dose Report Accuracy Indications of dosimetric values for Dose Area Product are
accurate to within ±50%

Indications of dosimetric values for Dose Line Product are


accurate to within ±40%
X-ray Tube Varian Model B100 (rotating anode) with A132 insert
X-ray Detector Varian Model Paxscan 4030CB; 2.0K x 1.5 K, pixel pitch of
0.192 mm; amorphous silicon
Alignment Lasers Wavelength: 635 nm
(optional) Optical output power: 3.5 mW
Laser Class: 1M
Collimation ‘X-Y’ Shutters, electronically controlled by user.
Power-Assisted 1.5 miles per hour (2.4 km/h) power drive system, independent
Transport rear wheel drive, handle controlled.

Robotic Motion Controls Linear gantry motion (X,Y,Z) – 2 inches per sec. (5 cm per sec.)
(movement speeds) Rotational ‘Wag’ - 4º per second
Rotational ‘Tilt’ - 8º per second
Gantry Door (open/close) – 9º per second
Gantry rotor (internal) - 60º per second (max.)

Note: gantry linear movement speed can be slowed ten-fold by


pressing the M button.
Robotic Motion Controls Linear gantry (Up/Down – ‘Y’); ±9 ±0.125 inches (22.9 ± 0.32 cm)
(movement ranges from Linear gantry (In/Out – ‘X’);- ±9 inches (22.9 ± 0.64 cm)
docked position) Linear gantry (Left/Right – ‘Z’); ±7 ± 0.25 inches (17.8 ± 0.64 cm)
Rotational ‘Wag’; ±15º
Rotational ‘Iso-wag®; ±12º (nominal)
Rotational ‘Tilt’; ±45º

O-arm Imaging System User Manual 10-7


Labels and Technical Reference
Specifications

Table 10-2. General Technical Specifications (Continued)

Category Specification

Expected Duty Cycle Fluoroscopy: 0.14% (5 seconds/hour)


X-ray Operation Pulsed exposure: 0.6% (60 seconds/3hours)

Expected Duty Cycle for 0.9% of a case


Motor Operation (20 cycles x 5 seconds per cycle)/3 hours per case

10-8 O-arm Imaging System User Manual


Labels and Technical Reference
Specifications

Mobile View Station


Specifications
Table 10-3. The Mobile View Station

Category Specification

Physical 30” (76 cm) deep x 29” (74 cm) wide x 71” (180 cm) high
Dimensions Weight ~ 350 pounds (159 kg)

Display 30” (76 cm) diagonal, ultra-high resolution color; 16:9 aspect ratio;
2560 x 1600 pixels

Printer (optional) Sony Video Graphics (std.)

Storage DVD R/W Drive

Outputs Ethernet
USB
Composite Video
S-Video

Environmental
Specifications
Table 10-4. Environmental Specifications

Category Specification
Operating Storage & Transportation

Temperature 10° – 30° C > 2 day: 0 – 40° C


< 2 day: -25 – 70° C

Humidity 20 – 80% non-condensing 5 – 85% (condensation


possible)

Operating Air 70 – 110 kPa 70 – 110kPa


Pressure

Maximum operating 3,000 m (9,843 ft) 3,000 m (9.843 ft)


altitude

Vibration
• Frequency • 10 – 200 Hz • 4 – 200 Hz
• g value • 0 – 0.5 g • Random: 1.14 g RMS
• amplitude • 0 – 0.15 mm • 0 – 0.15 mm
Shock
• g value • 0 –10 g • 0 –10 g
• pulse duration • 6–10 ms • 6–10 ms

Power Specifications
Table 10-5. Power Specifications

Category Specification

Voltage 100 VAC 115-120 VAC 230-240 VAC


15 A 13A 6.5A

Frequency 50/60 Hz 50/60 Hz 50/60 Hz

Power Requirements <1500 VA

O-arm Imaging System User Manual 10-9


Labels and Technical Reference
Specifications

Tube and Housing


Specifications
Table 10-6. Tube and Housing Specifications

Category Specification
Tube Type Varian A132 (rotating Anode)
Housing Type B100
Tube Rating 150 kV
Focal Spot 0.6 mm and 1.2 mm
Inherent Filtration 0.7 mm Al at 75 kV
Added Filtration Additional filtration added to beam for a total of > 4 mm Al
Leakage Technique Factors 150 kV, 3.3 mA
Housing Heat Storage Capacity 1,250 kHU (926 kJ)
Housing Cooling Rate 250 HU/sec (185 W)
Anode Heat Storage Capacity 300 kHU (222 kJ)
Anode Cooling Rate 70 kHU/min (876W)

X-ray Output
Specifications
Table 10-7. X-ray Output Specifications

Parameters Range Accuracy

Generator Power 32 KW Max

kVp Reproducibility ....... <= 0.05 CV

mAs Linearity ....... <0.05 Adjacent


<0.1 Non-adjacent

Pulsed kVp 40-125 kVp (in 1kVp Steps) ± 10%


Exposure
Mode mA 10, 12.5, 16, 20, 25, 32, 40, ± 20%
50, 64, 80, 100
Exposure Time per 10 ms ± 2%
pulse

Pulsed Fluoro kVp 40-125 kVp (in 1kVp Steps) ± 10%


Mode
mA Reported Value ± 20%

Accumulated Displayed Value ± (1% + 20 ms)


Exposure Time

10-10 O-arm Imaging System User Manual


Labels and Technical Reference
Specifications

X-ray Generator Table 10-8. Rate of Energy Conversion (in kWs) for RAD Mode and Fluoro Mode
Rating
Parameters RAD Mode Fluoro Mode
Peak Power 32 kW 3.25 kW

Average Power 9.6 kW 0.98 kW

kV Range 40 kV to 125 kV 40 kV to 125 kV

mA Range 10 mA to 500 mA 4 mA to 26 mA

X-ray Generator Duty The x-ray generator can be used continuously as long as average power limitations
Cycle described above are satisfied, but is limited by the heat capacity of the x-ray tube.
The remaining heat capacity of the x-ray tube is indicated by the color of the heat
indicator to the left of the radiation symbol on the O-arm Pendant.
Figure 10-1 Heat Indicator on the Pendant

O-arm Imaging System User Manual 10-11


Labels and Technical Reference
Specifications

The colors and the calculated heat capacity remaining are in the table below.
Table 10-9. Remining X-ray Tube Heat Capacity

Tube Heat Capacity Indicator Color


Remaiining

100%-95%
Blue

94%-65%
Green

64%-35%
Yellow

34%-0%
Red

It is recommended that the user stop operation if the indicator shows red (<35%
remaining).

X-ray Current and


Voltage Specifications
Table 10-10. X-ray Current and Voltage Specifications

Category Pulsed Exposure Mode Fluoroscopy Mode (for all modes)


Maximum X-ray Maximum Power: 12.5 kW Maximum Power: 3.25 kW
Tube Voltage
Maximum Voltage: 125 kV Maximum Voltage: 125 kV

Maximum Current: 100 mA Maximum Current: 26 mA

10-12 O-arm Imaging System User Manual


Labels and Technical Reference
Specifications

Table 10-10. X-ray Current and Voltage Specifications (Continued)

Category Pulsed Exposure Mode Fluoroscopy Mode (for all modes)


Lowest Current – 40m As
Time Product
Voltage and Current Voltage: 40–120 kVp Voltage: 40–125 kVp
Ranges
Current: 10–100 mA Current: 7–12 mA
(in High Level mode: 7–24 mA)

In fluoroscopic modes, air kerma rates are modified by kVp only. Tube potential has a maximum
deviation of +/-5%, and tube current has a maximum deviation of +/-3% from indicated values.

X-ray Field Orientation The axis from the X-ray focal spot to the X-ray detector is perpendicular to the plane of the
detector in all modes and beam translations.
The focal spot to detector distance is 116.8 cm (46 inches).
The focal spot to the isocenter distance is 65 cm (25.5 inches).
The focal spot to the air kerma display reference location is 50 cm (19.7 inches).
Air kerma values are determined by placing a probe 15cm (5.9 inches) off in the direction of the
X-ray source.
The maximum radiation field is 40 x 30 cm (15.6 inches x 11.8 inches) at the detector.
The X-Ray beam may be moved in four coordinate directions relative to the patient:
■ Superior to inferior
■ Medial to lateral
■ Anterior to posterior
■ Circumferential.

Maximum Dose Limits Local skin dose levels of 2 Gy may induce skin burns with repetitive or prolonged exposure.

Table 10-11. Maximum Dose Limits according to Fluoroscopy Mode

Low Level Fluoroscopy Standard Fluoroscopy High Level Fluoroscopy


Mode Mode Mode
44 mGy/minute (5 R/min) 88 mGy/min (10 R/min) 176 mGy/min (20 R/min)

Air Kerma Rates Skin entry dose for patient positioned at iso-center.

Table 10-12. Maximum Dose Limits according to Fluoroscopy Mode

Mode Patient Size kVp mA Displayed Air


Kerma rate
mGy/min

Low Level Small 54.0 8.6 11.7


Fluoroscopy
Medium 67.0 9.4 22.2

Large 79.0 10.0 31.4

XLarge 124.0 12.2 109

O-arm Imaging System User Manual 10-13


Labels and Technical Reference
Specifications

Table 10-12. Maximum Dose Limits according to Fluoroscopy Mode (Continued)

Mode Patient Size kVp mA Displayed Air


Kerma rate
mGy/min
Standard Fluoroscopy Small 56.0 8.6 25.7

Medium 69.0 9.4 48.3

Large 83.0 10.2 78.6

XLarge 124.0 12.2 218

High Level Small 56.0 17.0 56.8


Fluoroscopy
(Boost mode) Medium 73.0 18.6 120

Large 86.0 19.6 185

XLarge 124.0 22.8 454

For more information about dose evaluations and patient sizes, see “Dose Evaluation Methods”
on page 10-21.
These specifications fall within the +/- 35% allowable error for displayed air kerma rates
between the range of 6mGy/min and 100 mGy.
The reproducibility of the radiation output is +/- 5%.
CTDIvol values are retrieved from a stored look-up table that carries these values depending on
kVp, mAs, and the part of the body examined (chest/abdomen and head). These values are,
initially, based on factory calibrations, then on periodic calibrations.
Doses are not measured at exposure time.

Attenuation Total attenuation equivalent of all O-arm® system components.


Equivalents
Table 10-13. Attenuation equivalent

Filter Mode of operation mm aluminum equivalent at 70kV

1 2D - Fluoroscopy 4.01

2 3D - Normal and High definition 4.99

3 Not available - Future use 5.95

4 Not available - Future use 7.67

5 Calibration use only 38.61

Measurement Criteria The exposure time per pulse is measured with a Fluke® TRIAD™ TnT Dosimeter/kVp
for All Technique module model 35050AT automatically. According to the User Manual (Rev 01) for the
Factors dosimeter: "The measurement method is based on a kV threshold crossing. The
threshold is set at 75% of the kVp, or the minimum kVp for the filter pack in use,
whichever is greater."

10-14 O-arm Imaging System User Manual


Labels and Technical Reference
Specifications

Leakage Technique The maximum operating factors (leakage technique factors) of the O-arm® System in
Factors for Tube fluoroscopy mode are 125 kVp and 12 mA with a fixed 116.8 cm SID. Under these
Housing Assemblies conditions, the leakage radiation of the radiation source assembly measured is less than
and Beam-Limiting 0.065 mGy/h at one meter distance in any direction from the diagnostic source
Devices assembly. This reading is 12 times lower than FDA’s limit of 0.88mGy/h. Our diagnostic
source assembly is composed of a Varian X-ray tube (A132/B100) and a Huestis Medical
beam limiting device (BI-400-00019).

O-arm Imaging System User Manual 10-15


Labels and Technical Reference
Safety Classifications and Standards

Safety Classifications and Standards


Safety Classifications

Table 10-14. Safety Classifications

Type of protection against electrical Class 1


shock

Alignment Laser Classification Class 1M

Degree of protection against electrical No applied part


shock

Degree of protection against ingress of Ordinary, IPx0


water

Cleaning and Sterilization See “Cleaning” on page 9-3. Sterile mouse and
drapes are single-use, refer to “Ordering Accessory
Items” on page 1-4.

Use in presence of flammable mixtures Not suitable

Mode of operation Continuous use for motor and image processing.


Intermittent use for X-ray exposures, see X-ray
specifications (above).

10-16 O-arm Imaging System User Manual


Labels and Technical Reference
Electromagnetic Compatibility

Electromagnetic Compatibility
The information in this section (such as separation distances) pertains to the O-arm® Imaging
System. The values do not guarantee faultless operation but should provide reasonable assurance
of such. This information may not be applicable to other medical electrical equipment; older
equipment may be particularly susceptible to interference.

General Notes Medical electrical equipment requires special precautions regarding electromagnetic
compatibility (EMC) and needs to be installed and put into service according to the EMC
information provided in this document and other instructions for use for this device.
Cables and accessories not specified as compatible are not authorized. Using other cables and/or
accessories may adversely impact safety, performance and electromagnetic compatibility
(increased emission and decreased immunity).
Care should be taken if the equipment is used adjacent to or stacked with other equipment; if
adjacent or stacked use is inevitable, the equipment should be observed to verify normal
operation in the configuration in which it will be used.

Electromagnetic
Emissions
Electromagnetic Emissions
This equipment is intended for use in the electromagnetic environment specified below. The user
of this equipment should assure that it is used in such an environment.
Emissions Compliance Electromagnetic environment
According to
RF emissions (CISPR 11) Group 1 With the exception of the wireless mouse,
this equipment uses RF energy only for its
internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions (CISPR 11) Group 2 The wireless mouse must emit
with wireless mouse electromagnetic energy in order to perform its
intended function. Nearby electronic
equipment may be affected.
CISPR Emissions A The O-arm® Imaging System is suitable for
Classification use in all establishments other than domestic
and those directly connected to the public
Harmonic emissions N/A low-voltage power supply network that
(IEC 61000-3-2) supplies buildings used for domestic
purposes.
Voltage fluctuations/flicker N/A
(IEC 61000-3-3)

Wireless Mouse The Wireless Mouse (optional) emits electromagnetic energy in order to communicate with the
receiver. The Wireless Mouse transmits on 8 channels between 2402 and 2465 MHz with a
maximum Peak Output Power (ERP) of -8.18 dBm (0.000152 W). The receiver does not transmit
electromagnetic energy, and receives in the same frequency band as the transmitter. The receiver
may be interfered with by transmitters operating within the same frequency band.

O-arm Imaging System User Manual 10-17


Labels and Technical Reference
Electromagnetic Compatibility

Electromagnetic
Immunity
Electromagnetic Immunity
This equipment is intended for use in the electromagnetic environment specified below. The user
of this equipment should assure that it is used in such an environment.
Immunity IEC 60601-1-2 Compliance Electromagnetic environment
Against test level Level (of this
device)
Electrostatic contact discharge: Floors should be wood, concrete of
discharge, ESD ± 6 kV ± 6 kV ceramic tile. If floors are covered with
(IEC 61000-4-2) air discharge ± synthetic material, the relative humidity
8 kV ± 8 kV should be kept at levels to reduce
electrostatic charge to suitable levels.
Electrical fast power supply Mains power quality should be that of a
transients / (IEC lines: ± 2 kV ± 2 kV typical commercial or hospital
61000-4-4) longer input / environment.
output lines ± 1 kV ± 1 kV
Surges on AC Common mode: ± Mains power quality should be that of a
mains lines 2 kV ± 2 kV typical commercial or hospital
(IEC 61000-4-5) Differential mode: environment.
± 1 kV ± 1 kV
Power frequency 3 A/m 3 A/m Equipment which emits high levels of
magnetic field power line magnetic fields (in excess of 3
50/60 Hz (IEC A/m) should be kept at a distance to
61000-4-8) reduce the likelihood of interference.
voltage dips and dip >95%, 0.5 dip >95%, 0.5 Mains power should be that of a typical
short periods per. commercial or hospital environment. If
interruptions on dip 60%, 5 periods user requires continued operation during
AC mains input dip 30%, 25 60%, 5 per. power mains interruptions insure that
lines (IEC periods batteries are installed and charged.
61000-4-11) dip >95%, 5 30%, 25 per. Insure that battery life exceeds longest
seconds anticipated power outages or provide an
>95%, 5 sec. additional uninterruptible power source.

10-18 O-arm Imaging System User Manual


Labels and Technical Reference
Electromagnetic Compatibility

Electromagnetic
Immunity
Electromagnetic Immunity
Conducted and Radiated RF
This equipment is intended for use in the electromagnetic environment specified below. The user
of this equipment should assure that it is used in such an environment.
Immunity test IEC 60601 test Compliance Electromagnetic environment -guidance
level Level
Portable and mobile RF communications
equipment should be used no closer to any
part of the O-arm® Imaging System,
including cables, than the
recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter as below.
Recommended separation distance
Conducted RF 150 kHz - 80
IEC 61000-4-6 MHz: d=1.2/V1] P
Radiated RF d=1.2/ P 80 MHz to 800MHz
IEC 61000-4-3 80 MHz - 2.5
GHz d=2.3 P 800 MHz to 2.5 GHz

where P is the maximum output power


rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
surveya, should be less than the
compliance level in each frequency rangeb.

Interference may occur in the vicinity of


equipment marked with the following
symbol:

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in which the equipment is used
exceeds the applicable RF compliance level above, the equipment should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting
or relocating the equipment.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

O-arm Imaging System User Manual 10-19


Labels and Technical Reference
Electromagnetic Compatibility

Recommended
Separation Distances
Recommended separation distances between
portable and mobile RF communications equipment and the equipment
The O-arm® Imaging System is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The user of the O-arm® Imaging System can help
prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the O-arm® Imaging System as
recommended below, according to the maximum output power of the communications
equipment.
Rated maximum Separation distance according to frequency of transmitters in meters
output power of
transmitter (W) 150 kHz – 80 MHz 80 MHz – 800 MHz 800 MHz – 2.5 GHz
d=1.2 √P d=1.2 √P d=2.3 √P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

10-20 O-arm Imaging System User Manual


Labels and Technical Reference
Dose Evaluation Methods

Dose Evaluation Methods

Dose Evaluation in 3D Modes

Exposure measurements were made on the O-arm® Imaging System using acrylic CT dosimetry
phantoms positioned at the iscocenter. Scans were made for all spine, chest, and head protocols
using 3D, HD-3D, Enhanced-3D, and Low Dose 3D modes. Enhanced 3D is only available for
head protocols.
Exposures were measured at the center and entrance (3 o’clock) locations of the respective
phantoms with the collimators open. Under these conditions, the nominal X-ray beam width at is
150 mm, thereby exposing the entire length of the CT pencil probe. Entrance locations on the
phantoms are at 1 cm depth from the perimeter.

Dosimeter Used Radcal 2026 Radiation Monitor with a 20X6-3CT pencil ion-chamber probe with an active
length of 100 mm was used to record exposures.

Phantoms Used Nuclear Associates 76-415 body phantom (32 cm diameter x 15 cm thick)
Nuclear Associates 76-414 head phantom (16 cm diamter x 15 cm thick)

Dose Evaluation in 2D Fluoroscopy Modes

Skin entry doses in the fluoroscopic mode were measured with the O-arm® Imaging System
configured:
■ Detector positioned the top of the gantry
■ Electrometer probe positioned 30 cm below the carbon fiber skin adjacent to the detector.
■ Attenuation phantoms placed above the probe simulate various patient sizes.

Dosimeter Used Radcal 2026 Radiation monitor with 20X6-6 series ion chamber detector

Phantom Thicknesses Phantoms were 30x40cm in area.

Table 10-15. Phantoms Used to Simulate Patient Sizes

Simulated Patient Size Phantom Thickness

Small 19 mm Al
27.2–54.4 kg (60–120 lbs)

Medium 36 mm Al
54.5–83.9 kg (121–185 lbs)

Large 57 mm Al
84.0–113.4 kg (186–250 lbs)

X-Large 57 mm Al + 2 mm Pb
84.0–113.4 kg (186–250 lbs)

This satisfies the requirement for maximum air kerma rate measurement. The O-arm® Imaging
System was operated with automatic brightness control On, and exposure rates in both normal
and boost modes.

O-arm Imaging System User Manual 10-21


Labels and Technical Reference
Dose Evaluation Methods

10-22 O-arm Imaging System User Manual


Index 0

Numbers Anatomy Selection softkey 7-21 collimation 10-7


annotating images 8-15 in 2D mode 7-12
2D button 3-7, 7-8
annotation 2-8 in 3D mode 2-6, 7-20
2D fluoroscopy mode 2-5, 3-7, 7-7
viewing annotations 8-15 collimator
image enhancements 10-7
AP images operation checks 9-9
2D images
patient position for 6-6 collimator, adjusting 7-3
acquiring 7-8
AP images, taking 7-7 compatibility
presentation 7-10
Auto Brightness softkey 7-9 other devices 1-5
2D mode 7-2
axial image 7-24 compliance
3D images
ongoing regulatory 1-2
manipulation 7-26
regulations and standards 1-5
presentation (default) 7-24 B
configuration
reconstruction 2-6 Bar drape 1-4, 5-26, 6-25
date and time 4-5
3D imaging volume 10-7 and moving the IAS 6-28 DICOM export 4-7
3D mode 2-6, 3-7, 7-2 applying 5-26 editing, DICOM server 4-16
applying 7-18 warning 6-26
system 4-3
collimation 2-6 batteries 3-5
worklist server 4-9
image manipulation 7-26 charge level 9-6 conformance
Maximum Intensity Projection view 2-6 charging 3-5, 9-5, 9-6
DICOM 1-5
oblique slicing 2-6 indicators 3-4
connector panel
parameters 7-19 safety 1-24 IAS 3-2, 3-3
pausing respiration 7-20 beeping, X-ray alarm 7-8, 7-23 MVS 4-7
saline solution 7-20 boot up, system 4-2
contrast 7-3, 7-11
softkeys 7-21 brightness 7-3, 7-11
special keys 7-28
Targeted Anatomy chart 7-22, 7-23 special keys 7-28 coronal image 7-27
3D scan
acquiring 7-24
dose report 7-32
C D
cabinet 2-3
3D volumetric image date and time configuration 4-5
acquisition parameters 7-18 cables
defibrillators, using the system with 1-16
connecting 4-2 DICOM conformance 1-5
calibration DICOM export 2-8
A fluoro gain 9-10, 9-11
configuration 4-7
accessory items, ordering 1-4 RAD gain 9-10, 9-12
DICOM server
acquisition modes 2-5 Calibration Page 9-11 removing 4-16
Adjust kV button 9-12 cleaning solutions 1-22
dimensions
advanced image manipulation 7-29 cleaning the system 1-22
IAS 10-7
MIP view 7-29 clutch release lever 9-21 MVS 10-9
oblique slicing 7-29
Dock button 6-11
Alarm Reset button 7-8, 7-23
docking the gantry 6-13, 9-2

O-arm Imaging System User Manual Index-1


Index

dose area product 7-32 gantry 2-3 interconnect cable 5-4


dose line product 7-32 draping 5-17 interface language 4-5
dose report accuracy 10-7 motion 10-7
dose reporting 7-31 movement ranges 10-7
K
drape movement speed 6-5, 6-9, 10-7
key switch 3-3, 3-5
applying sterile drapes 5-17 positioning controls 3-6
On position 4-2, 5-4
Bar drape 1-4, 5-26 gantry positioning
Tube drape 1-4 docking and undocking 6-13 keyboard 2-4, 3-13
special keys 3-14
drug infusion pumps 1-16 Iso-wag 6-16
DVD/CD RW Drive longitudinal 6-11, 6-19
intended use 1-2 tilt 6-11 L
DVD/CD RW drive 2-4, 3-11 transverse 6-11 Labels 10-2
transverse (in/out) 6-18 LAK 1-22, 6-22
up and down 6-15
E LAK specifications 10-7
wag 6-11, 6-17 language, setting 4-3, 4-5
edge detection 10-7
edge enhancement 2-5, 7-9, 7-11, 7-28 Laser Alignment Kit (LAK) 1-22, 6-20, 6-
H 22
Edge Enhancement softkey 7-9
laser pointer trigger 5-7
electrical interference 1-17 hand grips 2-4
laser radiation 6-22
electromagnetic compatibility 1-17, 10-17 hand switch 3-2, 3-8
Lasers
electromagnetic emissions 10-17 HD3D 7-18
alignment 10-7
electronic medical devices, using the system High Definition 3D mode 7-18
with 1-16 lasers
High Level Fluoroscopy 2-5
safety 1-22
Emergency Procedures dose report 7-32
Lasers softkey 6-23
Emergency Shutdown 1-24, 9-22 High Level Fluoroscopy (HLF) 2-7, 7-8
opening the gantry door Last Image Hold (LIH) 2-5
HLF
manually 9-18 lateral images
executing 3-9
personnel position 7-7
Emergency Shutdown 9-10 HLF, time limit 7-8
positioning the patient for 6-7
Emergency Stop button 1-24, 3-5 housing specifications 10-10
Pendant 3-6 lateral images, taking 7-7
lateral movement, IAS 6-26
Power Control Panel 3-4
testing 9-10
I LEDs
Emergency Stop Reset button 1-24, 3-5, IAS 2-3 battery indicators 9-6
3-6, 9-10 dimensions 10-7 gantry light ring 6-20
Enhanced Cranial 3D mode 2-6, 7-18 moving memory presets 7-14
environmental specifications 10-9 with a Bar drape 6-28 mouse 5-7
equipment failure 1-24 moving away from the operating table 6- Lift and Shift 6-26
ethernet jack 4-7 27 light box presentation 7-27
exporting data moving out of the way 6-26 light ring 2-3, 6-20
to a DICOM store server 8-9 moving with a Tube drape 6-27 LIH 2-5
to external memory devices 2-8, 8-8 Power Control Panel 3-4 line power indicator 3-11
exporting images standalone mode 2-3, 3-5, 4-2 longitudinal movement 6-11
to a navigation station 8-8, 8-10 image adjustment 7-12 Low Dose Fluoroscopy (LDF)
image annotation 2-8 See also hand switch and foot switch
image guided surgery 2-8, 7-20
F
flash drive storage device 2-8
image manipulation
M
in 2D mode 7-10
flip image 3-7, 7-11, 7-28 M-2D button 3-7
in M-2D mode 7-17
fluoro gain calibration 9-11 M-2D mode 2-5
Image Rotation softkey 7-9
foot pressure brakes 2-4 Applying 7-15
image stitching 2-8, 8-22
foot switch 3-8 images image manipulation 7-17
connecting 5-5 image presentation 7-16
exporting to a DICOM Store server 8-9
Maintenance Tab page 4-19
exporting to a navigation station 8-10
Maximum Intensity Projection view 2-6
G storing 7-8
advanced image manipulation 7-29
transferring to external media 8-8
Gamma Medtronic Navigation
imaging modality performance 10-7
display settings 4-19 documentation set 1-xi
imaging modes 7-2
Gamma softkey 7-9 responsibilities 1-2
imaging volume 10-7
memory preset buttons 3-7, 7-14
infusion pumps, using the system with 1-16
MIP view 2-6, 7-29
ingress of fluids 1-22

Index-2 O-arm Imaging System User Manual


Index

Mirror Image button patient data responsibilities


flip image 7-3 acquiring from outside sources 5-14 Medtronic Navigation 1-2
Mobile View Station (MVS) 2-4 patient environment 1-6 owner 1-2
display 10-9 in the United States 1-6 Robotic Motion Controls
outputs 10-9 outside the United States 1-7 movement ranges 10-7
physical dimensions 10-9 patient exam data movement speeds 10-7
Power Control Panel 2-4 entering 5-8 ROI softkey 7-9
printer 10-9 new patient 5-9
storage 10-9 transferring from outside sources 5-14
S
modes of operation 2-5 patient information
2D fluoroscopy mode 2-5 entering 5-8 Safety 1-8
3D mode 2-6 patient positioning 6-25 classifications 10-16
electrical 1-18
Multi-plane 2D mode 2-5 patient spacer 6-5
electrical fire 1-19
monitor 2-4, 3-10, 3-12 ordering 1-4
connecting a second monitor 5-5 Patient Thickness softkey 7-21 environmental 1-23
monitor calibration 4-20 Pendant 2-3, 3-2 fire and explosion 1-22
infection 1-22
monitor display, adjusting 4-19 ordering 1-4
ingress of fluids 1-22
monitor display, optimizing 4-19 Pendant Control Panel 3-6
mouse 3-14, 5-6 performance lasers 1-22
activating 5-7 image modality 10-7 mechanical 1-20
radiation 1-14
manipulating images 7-10 Performance Checks 9-8, 9-9
symbols on equipment 1-8
ordering 1-4 Periodic Maintenance 9-11
unpacking 5-6 Physicians List 4-17 transport 1-20
Safety Classifications 10-16
moving the IAS 5-2 positioning the gantry 6-4
Safety Hazard Alerts 1-8
moving the MVS 9-5 Power Control Panel
MPR images 7-24 IAS 3-2, 3-4 Sagittal image 7-24
Multi-plane 2D mode 3-7 MVS 2-4, 3-11 saline solution
use in 3D mode 7-20
MVS Connector Panel 4-7 power requirements 10-9
scatter effect 7-7
MVS monitor 2-4 power specifications 10-9
MVS power cable 4-2, 5-4 Powered-assisted transport 3-5, 10-7 Scheduled Exams Menu 5-11
MVS Station menu 4-7 powering down 9-2 second monitor 2-4, 5-5
connecting 5-5
MVS Station Name 4-7 powering up 4-2
slowing gantry movement 6-5
powering up the system 4-2, 5-4
Print Screen special key 7-11 snapshot file 7-17
N snapshot images 7-17
printer 2-4, 2-8, 3-11
navigation station 8-10 transferring 8-8
intended use 1-2
transferring images to 8-8 softkeys 3-6
pulsed exposure 2-7, 10-10
network pulsed fluoroscopy 2-7, 10-10 3D mode 7-21
connecting to 4-7 HD3D 7-21
network cable 4-7 source-to-skin distance 1-14
network connection 4-7 R special keys 3-14, 7-28
neurostimulators 1-16 RAD gain calibration 9-12 standalone mode 2-3, 3-5
Noise Reduction softkey 7-9 radiation standard fluoroscopy 2-7, 7-8
protective clothing 1-13 station name 4-7
safety 1-14 station name, assigning 4-7
O
radiation exposure 6-5 sterile drape
oblique slices reducing 2-6 applying 5-17
3D 2-6 radiation exposure, tracking 2-5 sterile mouse 3-14
oblique slicing 7-29
reconstructed volume 2-6 stitching 2-8, 8-22
operational checks 9-9
reconstruction algorithm 2-6 Store Image Button 7-3
Region of Interest (ROI) 7-12
P regulations and standards compliance 1-5
T
pacemakers 1-16 Regulatory Affairs
Targeted Anatomy chart 7-22
pacemakers, using the system with 1-16 contacts 1-5
requirements targeted anatomy chart 7-21
Page Down special key 7-11
Technical Reference 10-7
Page Up special key 7-11 power 10-9
technical support 1-4
park position respiration 7-20
telescoping door 2-3
storing 7-14
touch pad 2-4

O-arm Imaging System User Manual Index-3


Index

transport brake 3-6, 9-5


transport handle 2-3
Transport safety 1-20
transverse movement 6-11
Tube drape 6-25
installing 5-18, 5-25
moving the IAS 6-27
ordering 1-4
revision 4 5-25
revision 5 5-18

U
unlocking the rear wheels 9-21
USB 2-8
user manual conventions 1-x

V
video graphics printer 2-4, 2-8, 3-11
intended use 1-2

W
wag control 6-11
wheel brakes 9-5
wireless mouse 1-4, 3-14, 5-6
activating 5-7
manipulating images 7-10
unpacking 5-6
Worklist Server Configuration dialog 4-10

X
X-ray
pulsed exposure 2-7
pulsed fluoroscopy 2-7
X-ray activation light 3-12
X-ray alarm 7-8, 7-23
X-ray beam
positioning 6-20
positioning button 6-20
X-ray beam path 6-20
X-ray detector 6-20, 10-7
X-ray exposure 7-21
X-ray exposure, setting for 3D modes 7-21
X-ray field orientation 10-11, 10-13
X-ray generator
controls 3-6
current 7-23
specifications 10-10
voltage 7-23
X-ray On/Off indicator 7-8, 7-23
X-ray tube 6-20
distance from patient 6-6
maximum heat load 7-8
model 10-7

Z
zones of occupancy 1-9

Index-4 O-arm Imaging System User Manual


Index

O-arm Imaging System User Manual Index-5


Medtronic Navigation, Inc.
300 Foster Street, Littleton, MA 01460 Voice: +1 (978) 698-6000 FAX: (978) 698-6090

You might also like