KaVo 3D eXam User manual

k990400 September 19, 2007
Cone Beam Volumetric Tomography and
Panoramic Dental Imaging System
Operators’ Manual

Kavo 3D eXam ® Operators’ Manual
k990400 September 19, 2007
Published by Imaging Sciences International
Imaging Sciences International reserves the right to make changes to
both this 17-19 Operators’ 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
Imaging Sciences International, 1910 North Penn Road, Hatfield,
PA 19440.
KaVo 3D eXam® is a registered trademark of Imaging Sciences
International. Other names may be trademarks of their respective
owners.
For more information or an original version of documentation on the
KaVo 3D eXam® Imaging System, by Imaging Sciences
International, please write, call, or fax to Imaging Sciences
International at the above address. This documentation has been
drafted, approved & supplied in the English Language. Imaging
Sciences International 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 Imaging Sciences International. 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 Imaging Sciences International.
Imaging Sciences International
1910 North Penn Road
Hatfield, PA 19440
USA
215.997.5666
215.997-5665/5667 (FAX)

k990400 September 19, 2007 iii
Chapter 1 - Introduction
System Description .......................................................................................... 1-1
Major System Items ......................................................................................... 1-2
About the Operators’ Manual ......................................................................... 1-2
Conventions Used in the User Manual .................................................................................. 1-3
Standard Limited Warranty ............................................................................ 1-3
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
Emergency Stop ...................................................................................................................... 2-4
Warning System ...................................................................................................................... 2-4
Interlock System ...................................................................................................................... 2-5
System Labels .......................................................................................................................... 2-6
Chapter 3 - System Controls and Indicators
Main Control Box ............................................................................................ 3-1
Emergency Stop Control ................................................................................. 3-2
Patient Alignment Panel ................................................................................. 3-2
System Status Indicators ................................................................................. 3-2
Chapter 4 - System Startup and Shutdown
System Startup ................................................................................................. 4-1
System Shutdown ............................................................................................. 4-1
TABLE OF CONTENTS

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iv
Chapter 5 - Managing Patient Data
Patient Information ......................................................................................... 5-1
Add New Patient .............................................................................................. 5-2
Edit Patient Details .......................................................................................... 5-3
Delete a Patient ................................................................................................ 5-5
Hide/Display Patient List ................................................................................ 5-6
Load Patient Data ............................................................................................ 5-6
Chapter 6 - Acquisitioning (Scanning)
Patient Positioning .......................................................................................... 6-1
Acquisitioning .................................................................................................. 6-3
Quick Picks .............................................................................................................................. 6-4
Volume Scan .................................................................................................... 6-6
Preview, Dry Run, and Capture Scans ................................................................................... 6-7
PAN Scan (Optional) ..................................................................................... 6-11
Chapter 7 - Reconstruction of Anatomy
Preview Screen ................................................................................................ 7-1
Adjusting the Panoramic View ............................................................................................... 7-3
Contour Line Setup ................................................................................................................. 7-4
Removing Circumference Artifacts ........................................................................................ 7-6
Adjusting MIP, Centerline and Image Type .......................................................................... 7-6
Selecting MIP or Radiograph Display ................................................................................... 7-7
Adjusting Brightness and Contrast ........................................................................................ 7-7
Pan Feature ............................................................................................................................. 7-7
Zoom Feature .......................................................................................................................... 7-8
Back Tool ................................................................................................................................ 7-8
Filter Settings .......................................................................................................................... 7-8
Taking Measurements ................................................................................... 7-10
Hounsfield Units ................................................................................................................... 7-10
Distance ................................................................................................................................. 7-12
Rotating Views ............................................................................................... 7-14
Saving Views as JPEG Image Files .............................................................. 7-16
Saving and Loading Workups ....................................................................... 7-16
Save a Workup ...................................................................................................................... 7-16
Load an Existing Workup ..................................................................................................... 7-18
Delete an Existing Workup ................................................................................................... 7-19

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Chapter 8 - Detail Screens
Preview Screen .................................................................................................8-1
Implant Planning Screen .................................................................................8-2
Ortho Screen ....................................................................................................8-6
MPR Screen .....................................................................................................8-7
TMJ Screen ....................................................................................................8-11
Chapter 9 - Tools
DICOM Database and DICOM Export Setup ................................................9-1
DICOM Import Controls ........................................................................................................ 9-2
Check Read/Write Access to Image Database ................................................9-2
Export DICOM .................................................................................................9-3
Create CD .........................................................................................................9-4
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 and Quality Assurance
Panel Calibration ...........................................................................................10-1
Geometry Calibration .....................................................................................10-3
QA Phantom Test ...........................................................................................10-6
Line Pair Evaluation ........................................................................................................... 10-10
Distance Measurement Test ............................................................................................... 10-11
Hounsfield Unit (HU) Measurements ................................................................................ 10-12
QA Water Phantom Test ..............................................................................10-14
Noise Level Test .................................................................................................................. 10-17
Uniformity Test ................................................................................................................... 10-18
PAN Phantom Test ......................................................................................10-20
Radiation Output Test ..................................................................................10-23
Measured Dose .................................................................................................................... 10-23
Interpretation ...................................................................................................................... 10-24
Declaration of Conformity ...........................................................................10-24
Equipment Class Determination .................................................................10-26

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vi
Chapter 11 - Radiation Environment Survey
Conditions of Operation – 9 and 27 Second Scans ......................................11-2
Recommended Operating Requirements .......................................................11-4
Dose and Imaging Performance Information ..............................................11-5
Conditions of Operation ....................................................................................................... 11-5
Measurements ....................................................................................................................... 11-6
Sensitivity Profile ...........................................................................................11-7
X-ray Tube Assembly .....................................................................................11-8
Chapter 12 - General Product Information
Technical Specifications ................................................................................12-1
Power Requirements ......................................................................................12-2
Power Cords ...................................................................................................12-2
Environmental Specifications .......................................................................12-3
Operating ............................................................................................................................... 12-3
Transportation and Storage .................................................................................................. 12-3
Acquisition Computer ....................................................................................12-3
Patient Support Chair ....................................................................................12-4
Disposal ..........................................................................................................12-4
Extension Cords .............................................................................................12-4
External Item .................................................................................................12-4
Cleaning .........................................................................................................12-4
Electromagnetic or other Interference
(Emissions and Immunity) ............................................................................12-5
Equipment Standards .....................................................................................12-7
Equipment Class ............................................................................................12-7
Preventive Maintenance Schedule - for Owner / User .................................12-8
Preventive Maintenance Schedule Table ............................................................................. 12-9
Replaceable Parts - Reference List .............................................................12-10
Accessories ...................................................................................................12-11
System Gantry Dimensions ..........................................................................12-12

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Appendix A - Three Dimensional Volume Rendering (3DVR)
Open Database ................................................................................................A-1
Axial Functions ...............................................................................................A-3
Paging ......................................................................................................................................A-3
W/L (Window/Level) ...............................................................................................................A-3
ROI (Region of Interest) .........................................................................................................A-4
Distance ...................................................................................................................................A-5
Identify .....................................................................................................................................A-6
Remove Object .........................................................................................................................A-7
Hounsfield Unit Calibration Offset ................................................................A-8
View Volume ...................................................................................................A-9
Projection Type .....................................................................................................................A-10
Volume Edit ...........................................................................................................................A-11
VR Functions ........................................................................................................................A-12
Pop Up Menu ........................................................................................................................A-15
Appendix B - iCATVision & iCATTransfer Installation
iCATVision ......................................................................................................B-1
File Structure Setup ................................................................................................................B-1
Install iCATVision ..................................................................................................................B-2
iCATVision Setup ....................................................................................................................B-3
iCATTransfer ..................................................................................................B-4
Install iCATTransfer .............................................................................................................B-4
iCATTransfer Passcode ..........................................................................................................B-5
iCATTransfer Setup ................................................................................................................B-5
Configure iCATTransfer ........................................................................................................B-6
Accessing i-CAT® DICOM Data ...........................................................................................B-6
Appendix C - iCATVision Quick Reference
Navigating the i-CATVision Intrerface ..........................................................C-1
Tools for Viewing this Image .................................................................................................C-1
Suggestions for Adjusting Panoramic Map ...........................................................................C-2
Filtering Defaults ....................................................................................................................C-2
Removing Circumference Artifact .........................................................................................C-2
Saving and Loading Workups ................................................................................................C-2

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Implant Planning Screen ................................................................................C-3
Panoramic Map .......................................................................................................................C-4
Axial Slice Position .................................................................................................................C-4
Ortho Screen ...................................................................................................C-5
MPR Screen ....................................................................................................C-5
Install Case Studies from CDs ........................................................................C-6
TMJ Planning Screen .....................................................................................C-6
Create Export CDs ..........................................................................................C-6

k990400 September 19, 2007 1-1
Chapter
1 Introduction
System Description
The System is a Cone Beam Volumetric Tomography and
Panoramic X-ray unit for dental head and neck applications. The
system consists of a CT Gantry and Computer Workstation which is
suitable for an in-office environment.
The Gantry is an open design that allows Patients to sit upright
during a procedure. An electric powered seat is built into the Gantry
for proper Patient positioning.
KaVo 3D eXam®Imaging System
HEAD
SUPPORT
BACKPLATE
CHIN
SUPPORT
GATE
(SWINGS OPEN,
MAGNETS LOCK
IN PLACE)
GANTRY
CONTROL BOX
(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
GANTRY
CONTROL BOX)

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1-2
The system consists of a Gantry and Computer Workstation. In order
for the system to operate, both the Gantry 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.
•iPAN - Optional Conventional Digital Panoramic Feature
CT is a medical imaging technique that uses X-rays to obtain cross-
sectional images of the head or neck. The quality of the images
depends on the level and amount of X-ray energy delivered to the
tissue. CT imaging displays both high-density tissue, such as bone,
and soft tissue. When interpreted by a trained Physician, CT images
provide useful diagnostic information.
Major System Items
The system is comprised of the following major items:
•KaVo 3D eXam Scanner
•Computer Workstation
•Operator Control Box with 30 ft. (9.1m) Cable
•Patient Emergency Stop Box with 10 ft. (3m) Cable
•Interlock Jumper Cable, 8 inch (20cm)
•Chair Connection Cable, 10 ft. (3m)
•Power Cable, 15 ft.(4.6m)
•CAT 5 Ethernet Cable, 10 ft. (3m)
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.

k990400 September 19, 2007
Introduction
1-3
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.”
Standard Limited Warranty
Imaging Sciences International (ISI) 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,
ISI 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 ISI. The original purchaser must promptly notify ISI in writing
if there is a defect in material or workmanship. Written notice in all
events must be received by ISI before expiration of the warranty
period. This warranty is not transferable.
This One-Year Limited Warranty covers normal use. ISI 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;
•Defects 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;

Kavo 3D eXam ® Operators’ Manual
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1-4
•Damage caused by any other abuse, misuse, mishandling, or
misapplication.
•Damage to acquisition computer, software, or operating
system caused by:
o Additions or changes unauthorized by ISI
o Viruses, spy ware, or gaming software
o Damage caused by Network or Operating Engineers
o Damage from the use of this machine or computer
for any other
o Applications other than its intended use
o Damage caused by third party software
o Damage caused by unauthorized changes to the ISI
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 ISI 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 ISI, its agents
or employees shall create a warranty or in any way increase the scope of
this warranty

k990400 September 19, 2007 2-1
Chapter
2 Safety Items
Important Safety Information
Imaging Sciences 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 that you 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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Safety Precautions
WARNING
The X-ray unit 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.
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.
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.

k990400 September 19, 2007
Safety Items
2-3
Mechanical Hazards
WARNING
Do not operate the system with any covers open or removed.
Operating the system with open or removed covers could expose
mechanical operating systems that could cause serious or fatal
personal injury to you or the Patient. Only qualified and authorized
service personnel should remove covers from the system.
Laser Beam Hazards
WARNING
Laser beams can cause optical damage. Do not stare into the laser
beam. Instruct the Patient to avoid looking into the beam. The use of
optical instruments such as eyeglasses with large diopter or mirrors,
increase eye hazard with this product.
Radiation Safety
X-rays are dangerous to both operator and others in the vicinity
unless established safe exposure procedures are strictly observed.
Use the following safety measures to ensure safety to the Patient and
Operator.
The useful and scattered beams can produce serious or fatal bodily
injuries to Patients and persons in the surrounding area if used by an
unskilled operator. Adequate precautions must always be taken to
avoid or reduce exposure to the useful beam or to scattered radiation.
Operators are strongly urged to comply with the current
recommendations of the International Commission on Radiological
Protection and, in the United States, the US National Council for
Radiological Protection.

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2-4
Emergency Stop
This manual contains instructions for safe operation of this dental X-
ray System. In the event of an emergency (any moving component
collides with any parts of the equipment or items in the environment,
or that could cause physical injury to the Patient), the Operator
should utilize the Emergency Stop button to turn off the power to
all moving parts in order for the Patient to be safely removed from
the machine.
Warning System
The System is equipped with provisions for warning lights and/or
audible alarms when X-ray power is energized. There are two
methods available to use this system:
Method 1: Externally provided power
An externally powered warning system can be connected to
terminals 1 and 2 of the X-Ray Interlock printed circuit board inside
the Lower Control Center. A relay contact capable of 250 volts, 50/
60 hertz, and 3 amps is connected between these terminals. When X-
ray power is energized this relay contact is closed and the warning
system energized.
Method 2: Equipment provided power
A warning system may be powered from 12 volts DC within the
System. The warning system cannot exceed 12 volts DC, 3 Amps.
To use this provision connect the warning system as follows:
1. Connect the “common” of the warning system to terminal 6 of
the X-Ray Interlock printed circuit board inside the Lower
Control Center.
2. Connect terminal 1 to terminal 5 on the circuit board.
3. Connectthe “positive”of thewarning systemto terminal2 ofthe
circuit board.
When X-ray power is energized 12 volts DC will be provided
through the relay contact between terminal 1 and 2 of the X-ray
Interlock printed circuit board and energize the warning system.

k990400 September 19, 2007
Safety Items
2-5
NOTE: When using this method; ensure that the factory installed
jumpers between terminals 3 & 5 and 4 & 6 are in place. These
jumpers should only be removed when an interlock system is used.
Interlock System
This System is equipped with provisions for an Interlock Circuit
which, when opened, will turn off X-ray power. This is a low voltage
circuit, 12 volts DC. To use the Interlock Circuit disconnect the
factory installed jumper between terminals 3 & 5 of the X-Ray
Interlock printed circuit board inside the Lower Control Center and
connect door switches and/or emergency stop switches in series
between terminals 3 & 5. Multiple door switches and/or emergency
stop switches can be connected as long as the devices are connected
in series. The entire circuit must be a closed loop when all of the
doors are closed and/or emergency stop switches are in their
normally closed state. Whenever the door switch or switches are
opened or emergency stop button(s) pressed the X-ray power will be
turned off. X-ray power cannot be turned on when the interlock
circuit is open.

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2-6
System Labels
The following labels are attached to the system.

k990400 September 19, 2007 3-1
Chapter
3 System Controls and
Indicators
Controls and Indicators are found on the following system units:
•Main Control Box
•Patient Alignment Panel
•Patient Emergency Stop Control
•System Status Indicators
Main Control Box
ON powers the Gantry and the
POWER indicator lights to show
that the Gantry is ON.
OFF removes power from the
Gantry and the POWER indicators
go OFF.
EMERGENCY STOP
immediately halts all X-ray and
scanning activities.
SCAN initiates Patient X-ray
scanning via the Gantry. (This
allows the Main Control Box to be
mounted in a location different from
the Computer Workstation.) When
scanning is occurring, the X-RAY
ON indicator is lit.
FAULT indicator lights when a
system error occurs (such as an
X-ray exposure problem).

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3-2
Emergency Stop Control
EMERGENCY STOP allows the Patient to halt all
X-ray and scanning activities by pressing the button.
The Emergency Stop Control can either be hung
from the head support mechanism or held in the
Patient’s hand as desired.
Patient Alignment Panel
WARNING
Laser beams can cause optical damage. Do not stare into the laser
beam. Instruct the Patient to avoid looking into the beam. The use of
optical instruments such as eyeglasses with large diopter or mirrors,
increase eye hazard with this product.
ALIGNMENT LIGHT - pressing the button turns ON
the laser alignment lights for three seconds.
Press and hold the button for three seconds turns the
laser lights ON permanently, until the button is again
pressed to turn OFF the laser lights.
PATIENT ALIGN allows the Operator to move the
Patient seat up and down to facilitate Patient alignment
with the Chin Rest.
System Status Indicators
The System Status Indicators are located on both the
overhead of the Gantry and the Main Control Panel.
POWER indicator is lit when the Gantry is ON.
READY indicator is lit when the software Acquire
button is pressed to begin the scanning process.
X-RAY ON indicator is lit during the scanning process.
FAULT indicator lights when a system error occurs
(such as an x-ray exposure problem).