KaVo 3D eXam User manual

K990400 16 April 2008
Cone Beam Volumetric Tomography and
Panoramic Dental Imaging System
Operators’ Manual

K990400 16 April 2008
Published by KaVo
KaVo reserves the right to make changes to both this Manual and to
the products it describes. Equipment specifications are subject to
change without notice. Nothing contained within this manual is
intended as any offer, warranty, promise or contractual condition,
and must not be taken as such.
This document may not, in whole or in Part, be copied, photocopied,
reproduced, translated, or reduced to any electronic medium or
machine-readable form without prior consent in writing from KaVo.
3D eXam® is a registered trademark KaVo. Other names may be
trademarks of their respective owners.
For more information or an original version of documentation on the
KaVo 3D eXam®, please write, call, or fax to KaVo. This
documentation has been drafted, approved & supplied in the English
Language. KaVo will make available under request any component
parts, calibration instruments, circuit diagrams, etc.
No part of this document may be reproduced or transmitted in any
form or by any means, electronic or mechanical, for any purpose,
without prior written permission of KaVo. The information in this
document and the product it describes are subject to change without
notice. Names and data used in examples herein are fictitious unless
otherwise noted. The software program described in this document
is provided to its users pursuant to a license or nondisclosure
agreement. Such software program may only be used, copied, or
reproduced pursuant to the terms of such agreement. This manual
does not contain or represent any commitment of any kind on the
part of KaVo.

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1-1
What’s New in this Release
Change Description Link to Topic
Quality Control Frames added to
help access quality of captured scan.
First and last frames of a scan can be
compared to determine if patient
moved during the scan.
Using Quality Control Frames on
page 7-3
Study Date drop-down added to
enable filtering by study dates.
Patient Information on page 5-1
Two new options, Reset Window/
Level and Reset All Window/
Levels, added to reset brightness and
contrast to original settings if they
were changed.
Adjusting Brightness and
Contrast on page 7-9
Filter setting Smooth removed.
New filter setting Sharpen Mild
added.
Filter Settings on page 7-11
Preview frames can be viewed for
raw patient images.
Viewing and Reconstructing Raw
Patient Scans on page 7-23
Level Up menu option changed to
Screen option. Screen option
enables selection of any detail
screen without having to access the
Preview screen.
Preview Screen on page 8-1
3D Model view added to the Implant
Planning screen.
To Use the 3D Model View on
page 8-6
New feature added to enable
marking of estimated nerve canal for
left, right, or both canals.
Estimate the Nerve Canal on
page 8-7

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Gridlines added to MPR screen. MPR Screen on page 8-14
Scroll wheel on mouse is activated
to enable scrolling through slices on
Implant Planning and MPR screens.
Implant Planning Screen on page
8-2
MPR Screen on page 8-14
Use Lossy Compression option
added to DICOM Export Properties
and CD Burner Speed dialogs. This
compression type can be used when
exporting patient data across a
network or when creating a CD.
Export DICOM on page 9-2
Create CD on page 9-3
Networking support feature added to
facilitate customer setup of
networked VisionQ and Vision
computers.
Networking Support Setup on
page 14-1
New features added to: 1) enable
import of patient data from a
DICOM worklist or Patient
Management system, and 2) enable
export of DICOM images to a
remote system such as a Picture
Archive and Communications
System.
Remote System Import and
Export on page 15-1
Keyboard shortcuts added to access
top-level menu items from the
keyboard.
Keyboard Shortcuts on page C-2
Calibration separated from VisionQ
application and is accessed from
Calibration icon on the desktop.
Calibration on page 10-1
Change Description Link to Topic

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Table of Contents
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What’s New in this Release .............................................................................1-1
Chapter 1 - Introduction
System Description ...........................................................................................1-1
Major System Items ..........................................................................................1-2
About the Operators’ Manual .........................................................................1-3
Conventions Used in the User Manual .................................................................................. 1-3
Standard Limited Warranty .............................................................................1-4
Chapter 2 - Safety Items
Important Safety Information .........................................................................2-1
Warnings, Cautions, and Notes .............................................................................................. 2-1
Safety Precautions .................................................................................................................. 2-2
Electrical Fire Hazard ............................................................................................................ 2-2
Mechanical Hazards ............................................................................................................... 2-3
Laser Beam Hazards ............................................................................................................... 2-3
Radiation Safety ...................................................................................................................... 2-3
System Safety Devices ......................................................................................2-4
Emergency Stops ..................................................................................................................... 2-4
Warning System ...................................................................................................................... 2-4
Interlock System ...................................................................................................................... 2-4
Sample Site Plan ..............................................................................................2-5
Interlock and Warning System Schematic ............................................................................. 2-6
System Labels ...................................................................................................2-7
Chapter 3 - System Controls and Indicators
Operator Control Box ......................................................................................3-1
Patient Emergency Stop Control .....................................................................3-2
Patient Alignment Panel ..................................................................................3-2
System Status Indicators ..................................................................................3-2
TABLE OF CONTENTS

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Chapter 4 - System Startup and Shutdown
System Startup ..................................................................................................4-1
System Shutdown .............................................................................................4-1
Chapter 5 - Managing Patient Data
Patient Information .........................................................................................5-1
Hide/Display Study List ...................................................................................5-3
Delete Patient Scans ........................................................................................5-3
Add New Patient ...............................................................................................5-4
Edit Patient Details ..........................................................................................5-5
Access Patient Data ..........................................................................................5-7
Delete a Patient ................................................................................................5-7
Chapter 6 - Acquisitioning (Scanning)
Patient Positioning ...........................................................................................6-1
Acquisitioning ..................................................................................................6-3
Preview, Dry Run, and Capture Scans ................................................................................... 6-5
Quick Picks .............................................................................................................................. 6-9
PAN Scan (Optional) .....................................................................................6-11
Chapter 7 - Reconstruction of Anatomy
Preview Screen .................................................................................................7-1
Using Quality Control Frames ............................................................................................... 7-3
Adjusting the Panoramic View ............................................................................................... 7-5
Contourline Setup ................................................................................................................... 7-5
Removing Circumference Artifacts ........................................................................................ 7-7
Adjusting MIP, Centerline and Image Type .......................................................................... 7-8
Selecting MIP or Radiograph Display ................................................................................... 7-9
Adjusting Brightness and Contrast ........................................................................................ 7-9
Pan Feature ........................................................................................................................... 7-10
Rotation Feature ................................................................................................................... 7-10
Zoom Feature ........................................................................................................................ 7-10
Back Tool .............................................................................................................................. 7-10
Filter Settings ........................................................................................................................ 7-11
Taking Measurements ...................................................................................7-13
Hounsfield Units ................................................................................................................... 7-13
Distance ................................................................................................................................. 7-15

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Rotating Views ...............................................................................................7-18
Saving Views as JPEG Image Files ..............................................................7-19
Saving and Loading Workups .......................................................................7-19
Save a Workup ...................................................................................................................... 7-19
Load an Existing Workup ..................................................................................................... 7-21
Delete an Existing Workup ................................................................................................... 7-22
Viewing and Reconstructing Raw Patient Scans ..........................................7-23
Chapter 8 - Detail Screens
Preview Screen .................................................................................................8-1
Implant Planning Screen .................................................................................8-2
Estimate the Nerve Canal .......................................................................................................8-7
Ceph Screen ...................................................................................................8-12
MPR Screen ...................................................................................................8-14
TMJ Screen ....................................................................................................8-18
Chapter 9 - Tools
DICOM Database and DICOM Export Setup ................................................9-1
Check Read/Write Access to Image Database ................................................9-2
Export DICOM .................................................................................................9-2
Create CD .........................................................................................................9-3
Erase CD-RW .......................................................................................................................... 9-5
Output to Folder ...................................................................................................................... 9-5
Reporting ..........................................................................................................9-6
Run Report .............................................................................................................................. 9-6
Create New Report .................................................................................................................. 9-7
Modify Existing Report .........................................................................................................9-11
Chapter 10 - Calibration
Panel Calibration ...........................................................................................10-1
Collimators Calibration .................................................................................10-3
Geometry Calibration .....................................................................................10-4
Chapter 11 - Quality Assurance
QA Phantom Test ...........................................................................................11-1
Line Pair Evaluation ............................................................................................................. 11-5
Distance Measurement Test ................................................................................................. 11-6

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Hounsfield Unit (HU) Measurements .................................................................................. 11-7
QA Water Phantom Test ................................................................................11-9
Noise Level Test .................................................................................................................. 11-13
Uniformity Test ................................................................................................................... 11-14
PAN Phantom Test ......................................................................................11-16
Radiation Output Test ..................................................................................11-19
Measured Dose .................................................................................................................... 11-19
Interpretation ...................................................................................................................... 11-20
Declaration of Conformity ...........................................................................11-21
Equipment Class Determination .................................................................11-22
Chapter 12 - Radiation Environment Survey
Conditions of Operation – 8.9 and 26.9 Second Scans ................................12-2
Scatter Measurements for 8.9 Second Scans ................................................12-2
Landscape 8.9 Second Scan ................................................................................................. 12-3
Portrait 8.9 Second Scan ...................................................................................................... 12-4
Scatter Measurements for 26.9 Second Scan ................................................12-5
Landscape 26.9 Second Scan ............................................................................................... 12-5
Portrait 26.9 Second Scan .................................................................................................... 12-6
Scatter Measurements for PAN Scan ............................................................12-7
Drywall Attenuation .......................................................................................12-8
Recommended Operating Requirements .......................................................12-8
Dose and Imaging Performance Information ..............................................12-9
Conditions of Operation ....................................................................................................... 12-9
Measurements ..................................................................................................................... 12-10
X-ray Tube Assembly ...................................................................................12-11
Chapter 13 - Product Information
Technical Specifications ................................................................................13-1
Power Requirements ......................................................................................13-2
Power Cords ...................................................................................................13-2
Environmental Specifications .......................................................................13-3
Operating ............................................................................................................................... 13-3
Transportation and Storage .................................................................................................. 13-3
Acquisition Computer ....................................................................................13-3
Patient Support Chair ....................................................................................13-4

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Disposal ..........................................................................................................13-4
Extension Cords .............................................................................................13-4
External Item .................................................................................................13-4
Cleaning .........................................................................................................13-4
Electromagnetic or other Interference
(Emissions and Immunity) ............................................................................13-5
Equipment Standards .....................................................................................13-7
Equipment Class ............................................................................................13-7
Preventive Maintenance Schedule - for Owner / User .................................13-8
Planned Maintenance - 12 Month Schedule ................................................13-8
Cleaning ................................................................................................................................ 13-9
Planned Maintenance Checklist ........................................................................................... 13-9
Replaceable Parts - Reference List .............................................................13-11
Accessories ...................................................................................................13-12
System Gantry Dimensions ..........................................................................13-14
Chapter 14 - Networking Support Setup
Networking Support Overview .......................................................................14-1
Networking Data Flow ...................................................................................14-1
Network Support Installation/Setup ..............................................................14-2
Provide Network Storage ...................................................................................................... 14-2
Install Sweeper Service ......................................................................................................... 14-2
Configure Sweeper Service ................................................................................................... 14-3
Migrate from Standalone to Server ...................................................................................... 14-4
Change Image Root Folder .................................................................................................. 14-5
Start the Sweeper ................................................................................................................... 14-5
Sweeper Service ..............................................................................................14-6
Sweeper Controller ................................................................................................................ 14-6
Network Failures ...........................................................................................14-7
No Network Access at Startup .............................................................................................. 14-7
Network Fails During Operations ........................................................................................ 14-8
Limitations of Networking Support ...............................................................14-9
Chapter 15 - Remote System Import and Export
Remote System Import and Export Overview ...............................................15-1
Remote System Import ...................................................................................15-1

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Import Installation and Setup .......................................................................15-2
Set Up DICOM Worklist Interface ....................................................................................... 15-2
Set Up Practice Management Interface ............................................................................... 15-4
Import Patient Data .......................................................................................15-5
Remote System Export ...................................................................................15-6
Export Installation and Setup .......................................................................15-6
RSSM Log ......................................................................................................15-8
Send Patient Data to a Remote System .........................................................15-9
Appendix A - eXamVision Installation
eXamVision .....................................................................................................A-1
Laptop Minimum Requirements .............................................................................................A-2
Workstation Minimum Requirements ....................................................................................A-2
File Structure Setup ................................................................................................................A-2
Install eXamVision ..................................................................................................................A-3
eXamVision Setup ...................................................................................................................A-3
Appendix B - Three Dimensional Volume Rendering (3DVR)
Open Database ................................................................................................B-1
Axial Functions ...............................................................................................B-3
Paging ......................................................................................................................................B-3
W/L (Window/Level) ...............................................................................................................B-3
ROI (Region of Interest) .........................................................................................................B-4
Distance ...................................................................................................................................B-5
Identify .....................................................................................................................................B-6
Remove Object .........................................................................................................................B-7
Hounsfield Unit Calibration Offset ........................................................................................B-8
View Volume ...................................................................................................B-9
Projection Type .....................................................................................................................B-10
Volume Edit ...........................................................................................................................B-11
VR Functions ........................................................................................................................B-12
Pop Up Menu ........................................................................................................................B-15
View Full Screen ...................................................................................................................B-16
Appendix C - eXamVision Quick Reference
Navigating the eXamVision Interface ............................................................C-1
Tools for Viewing this Image .................................................................................................C-1
Suggestions for Adjusting Panoramic Map ...........................................................................C-2

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Filtering Defaults ....................................................................................................................C-2
Removing Circumference Artifact .........................................................................................C-2
Saving and Loading Workups ................................................................................................C-2
Keyboard Shortcuts .................................................................................................................C-2
Implant Planning Screen ................................................................................C-3
Panoramic Map .......................................................................................................................C-4
Axial Slice Position .................................................................................................................C-4
Ceph Screen ....................................................................................................C-5
MPR Screen ....................................................................................................C-5
Install Case Studies from CDs ........................................................................C-6
TMJ Planning Screen .....................................................................................C-6
Create Export CDs ..........................................................................................C-6

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K990400 16 April 2008
1-1
Chapter
1 Introduction
System Description
The system is a Cone Beam Volumetric Tomography and Panoramic
X-ray device used for dental head and neck applications. The system
consists of a Scanner and Computer Workstation which is suitable
for an in-office environment.
This scanning device is an open design that allows Patients to sit
upright during a procedure. An electric powered seat is built into the
device for proper Patient positioning.
KaVo 3D eXa®Imaging System
HEAD
SUPPORT
BACKPLATE
CHIN
SUPPORT
GATE
(SWINGS OPEN,
MAGNETS LOCK
IN PLACE)
PATIENT
ALIGNMENT
PANEL (ADJUSTS
CHAIR UP/DOWN)
HEAD SUPPORT
BACK PLATE
KNOB
(SLIDES TO
ADJUST THE
POSITIONOF THE
HEAD SUPPORT)
MOTORIZED
CHAIR
(MOVES
UP/DOWN VIA
BUTTONS ON
THE SYSTEM
CONTROL BOX)

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The system consists of a Scanner and Computer Workstation. In
order for the system to operate, both the Scanner and Computer
Workstation must be turned ON.
The system captures data for 3D Skull Reconstruction for the
following procedures:
•Implants
•TM Joints
•Reconstructed Panoramic
•Reconstructed Cephalometrics
•Airway / Sinus, etc.
•Nerve Canal
•PAN - Optional Conventional Digital Panoramic Feature
Cone Beam Volumetric Tomography is a medical imaging technique
that uses X-rays to obtain cross-sectional images of the head or neck.
Quality of the images depends on the level and amount of X-ray
energy delivered to the tissue. Imaging displays both high-density
tissue, such as bone, and soft tissue. When interpreted by a trained
Physician, these images provide useful diagnostic information.
Major System Items
The system is comprised of the following major items:
•Scanner
•Computer Workstation
•Operator Control Box with 50 ft. (15.2m) Cable
•Patient Emergency Stop Box with 10 ft. (3m) Cable
•Interlock Jumper Cable, 8 inch (20cm)
•Interlock Cable 50 ft. (15.2m)
•Warning Light Cable 50 ft. (15.2m)
•Chair Connection Cable, 10 ft. (3m)
•Power Cable, 15 ft.(4.6m)
•CAT 5 Ethernet Cable, 50 ft. (15.2m)

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Introduction
1-3
About the Operators’ Manual
This documentation describes the safe and effective operation of the
system. The information is intended to provide trained
Technologists and Physicians the necessary guidance to operate the
system in a safe and effective manner.
Conventions Used in the User Manual
•Keyboard keys are represented in a Bold font.
For example, “Press Start.”
•Menu items and button names on the user interface display
are represented in a Bold font.
For example, “At the Print window, click the Print button.”
•Keyboard entries are represented in bold Courier font.
For example, “Type QA Test in the filename box.”

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Standard Limited Warranty
KaVo warrants the original purchaser that this hardware system will
be free from defects for a period of one (1) year from the date of
delivery. During the warranty period, KaVo will correct any defects
in material or workmanship, at no charge for materials. Any
replacement parts shall be new or serviceable used parts and are
warranted for the remainder of the original warranty or thirty (30)
days, whichever is longer. The warranty period is not extended as a
result of purchasing any additional parts from KaVo. The original
purchaser must promptly notify KaVo in writing if there is a defect
in material or workmanship. Written notice in all events must be
received by KaVo before expiration of the warranty period. This
warranty is not transferable.
This One-Year Limited Warranty covers normal use. KaVo does
not warrant or cover:
•Damage caused by impact with other objects, dropping,
falls, spilled liquids or immersion in liquids
•Damage caused by a disaster such as fire, flood, wind,
earthquake, or lightning
•Damage caused by unauthorized attachments, alterations,
modifications or foreign objects
•Damage caused by peripherals
•Damage caused by failure to provide a suitable environment
•Damage caused by the use of the hardware system for
purposes other than those for which it was designed
•Damage from improper maintenance
•Damage from improper electrical connection or supply
•Damage caused by any other abuse, misuse, mishandling, or
misapplication
•Damage to acquisition computer, software, or operating
system caused by;
o Unauthorized additions or changes
o Viruses, spyware, or gaming software
o Damage caused by Network or Operating Engineers
o Damage from the use of this machine or computer
for any other purpose

K990400 16 April 2008
Introduction
1-5
o Applications other than its intended use
o Damage caused by third party software
o Damage caused by unauthorized changes to the
system software
o Damage caused by unauthorized upgrades, additions
or deletions
o Damage caused by internet use, or any other
unauthorized application.
Under no circumstances shall KaVo be liable for any special,
incidental, or consequential damages based upon breach of
warranty, breach of contract, negligence, strict liability or any other
legal theory. Such damages include, but are not limited to, loss of
data, loss of profits, loss of revenue, loss of use of hardware system
or any associated equipment, cost of capital, cost of substitute or
replacement equipment, facilities or services, down time,
purchaser's time, the claims of third party, including customers, and
injury to property.
Disclaimer of Warranties
The warranty stated above is the only warranty applicable to this product,
all other warranties, expressed or implied including all implied warranties
of merchantability or fitness for a particular purpose, are hereby dis-
claimed. No oral or written information or advice given by KaVo, its
agents or employees shall create a warranty or in any way increase the
scope of this warranty

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K990400 16 April 2008
2-1
Chapter
2 Safety Items
Important Safety Information
KaVo designs its products to meet stringent safety standards.
However, to maintain the safety of Operators and Patients, you must
operate the equipment correctly and properly and ensure the
equipment is properly maintained.
It is essential to follow all safety instructions, warnings, and cautions
specified in this manual to ensure the safety of Patients and
Operators. In addition, read and observe all danger and safety
labelling on the system.
Warnings, Cautions, and Notes
Before attempting to operate the equipment, it is recommended that
you read this manual thoroughly including all cautions and
warnings. This guide uses the following conventions to describe
situations that are potential hazards to the Patient or Operator,
potential loss of data, or potential damage to the equipment.
WARNING
Warnings are intended to alert the user that failure to follow the
procedure could cause fatal or serious injury to the user, Patient, or
any other person, or result in a misdiagnosis.
CAUTIONCAUTION
Cautions are intended to alert the user that failure to follow the
procedure could cause damage to the equipment or cause loss of
data.
ADVISORY: Advisories are used to defined information for the
operator regarding advice towards use of the device or a process.
NOTE: Notes are used to highlight important or unusual points to be
brought to the attention of the operator.

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2-2
Safety Precautions
WARNING
The X-ray device may be dangerous to the Patient and Operator if
you do not observe and follow the safe exposure factors and
operating instructions. Do not operate this system unless you have
received training to perform a procedure.
WARNING
Do not remove covers or cables on system. High voltage is present
in the system. To avoid personal injury from electrical shock, do not
operate the system with any covers open or cables removed.
WARNING
Closing the Gate creates a pinch point. Keep hands and other body
parts clear when closing Gate.
Electrical Fire Hazard
Do not place any liquid or food on any part of the consoles or other
modules of the system.
Observe all fire regulations. Fire extinguishers should be provided
for both electrical and non-electrical fires. All operators should be
fully trained in the use of fire extinguishers and other fire-fighting
equipment and in local fire procedures.
WARNING
In the event of an electrical fire, only use extinguishers that are
labelled for that purpose. Using water or other liquids on an
electrical fire can lead to fatal or other serious personal injury.
WARNING
In the event of an electrical fire, to reduce the risk of electrical shock,
try to isolate the equipment from the electric source before
attempting to extinguish the fire.
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