Gendex GX CB-500 User manual

Service Manual
Service Manual
Service Manual
Service Manual
Service Manual
Cone Beam Volumetric Tomography and
Panoramic Dental Imaging System

Gendex GXCB-500TM Service Manual
G990710 30 June 2008
Published by Gendex® Dental Systems
Gendex® Dental Systems reserves the right to make changes to both
this 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
Gendex®, 901 West Oakton Street, Des Plaines, IL 60018 USA.
Gendex® is a registered trademark, other names may be trademarks
of their respective owners.
For more information or an original version of documentation on the
this Imaging System, by Gendex®, please write, to Gendex®at the
above address or Fax to 1-847-550-1322. 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 Gendex®. 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 Gendex® Dental Systems.

G990710 30 June 2008
Table of Contents
-iii
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 Hazards ................................................................................................................... 2-2
Explosion Hazard .................................................................................................................... 2-3
Mechanical Hazards ............................................................................................................... 2-3
Laser Beam Hazards ............................................................................................................... 2-4
Radiation Safety ...................................................................................................................... 2-5
Radiation Protection Measures .............................................................................................. 2-5
System Safety Devices ......................................................................................2-6
Emergency Stops ..................................................................................................................... 2-6
Warning System ...................................................................................................................... 2-6
Interlock System ...................................................................................................................... 2-6
Sample Site Plan ..............................................................................................2-7
Interlock and Warning System Schematic ............................................................................. 2-8
Cabling Requirements .....................................................................................2-9
Emergency Removal of a Patient ....................................................................2-9
System Labels .................................................................................................2-10
Error Messages ..............................................................................................2-13
TABLE OF CONTENTS

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-iv
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
Chapter 4 - System Startup and Shutdown
System Startup ..................................................................................................4-1
System Shutdown .............................................................................................4-1
Chapter 5 - System Assembly
Initial Preparation ...........................................................................................5-1
Required Tools .................................................................................................5-1
Abbreviations ....................................................................................................5-1
Inventory of Unit Items ....................................................................................5-2
System Assembly ..............................................................................................5-4
Chapter 6 - Leveling and Alignment
Level Gantry .....................................................................................................6-1
Patient Chair Alignment ..................................................................................6-4
Laser Alignments .............................................................................................6-8
Adjust Centerline Laser .......................................................................................................... 6-8
Adjust Crosshair Laser .........................................................................................................6-11
Head Holder Alignment .................................................................................6-14
Chapter 7 - Calibration
Panel Calibration .............................................................................................7-1
Collimators Calibration ...................................................................................7-3
Geometry Calibration .......................................................................................7-4
Chapter 8 - Quality Assurance
QA Phantom Test .............................................................................................8-1
Line Pair Evaluation ............................................................................................................... 8-5
Distance Measurement Test ................................................................................................... 8-7
Hounsfield Unit (HU) Measurements .................................................................................... 8-7
QA Water Phantom Test ................................................................................8-10
Noise Level Test in Landscape Mode ................................................................................... 8-10

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-v
Uniformity Test in Landscape Mode .................................................................................... 8-14
Noise Level Test in Half-Beam Mode .................................................................................. 8-15
Uniformity Test in Half-Beam Mode ................................................................................... 8-18
PAN Phantom Test ........................................................................................8-20
Radiation Output Test ....................................................................................8-23
Measured Dose ...................................................................................................................... 8-23
Interpretation ........................................................................................................................ 8-24
Chapter 9 - Troubleshooting and Adjustments
Detector Pivot Adjustment (Receptor Panel) ..................................................9-1
IEC IC Command Codes .................................................................................9-3
Home Commands .................................................................................................................... 9-3
Movement Commands ............................................................................................................ 9-3
Read Commands ..............................................................................................9-4
X-Ray Commands ............................................................................................9-6
Miscellaneous Commands ...............................................................................9-7
Chapter 10 - Wall Mount Control Box
Wall Mount with Cable Exposed ...................................................................10-1
Wall Mount with Cable Inside Wall ..............................................................10-4
Chapter 11 - Networking Support Setup
Networking Support Overview .......................................................................11-1
Networking Data Flow ...................................................................................11-1
Network Support Installation/Setup ..............................................................11-2
Provide Network Storage ...................................................................................................... 11-2
Install Sweeper Service ......................................................................................................... 11-2
Configure Sweeper Service ................................................................................................... 11-3
Migrate from Standalone to Server ...................................................................................... 11-4
Change Image Root Folder .................................................................................................. 11-5
Start the Sweeper ................................................................................................................... 11-5
Sweeper Service ..............................................................................................11-6
Sweeper Controller ................................................................................................................ 11-6
Network Failures ...........................................................................................11-7
No Network Access at Startup .............................................................................................. 11-7
Network Fails During Operations ........................................................................................ 11-8
Limitations of Networking Support ...............................................................11-9

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Chapter 12 - Remote System Import and Export
Remote System Import and Export Overview ...............................................12-1
Remote System Import ...................................................................................12-1
Import Installation and Setup .......................................................................12-2
Set Up DICOM Worklist Interface ....................................................................................... 12-2
Set Up Practice Management Interface ............................................................................... 12-4
Import Patient Data .......................................................................................12-5
Remote System Export ...................................................................................12-6
Export Installation and Setup .......................................................................12-6
RSSM Log ......................................................................................................12-8
Send Patient Data to a Remote System .........................................................12-9
Chapter 13 - Product Information
Technical Specifications ................................................................................13-1
Power Requirements ......................................................................................13-2
Apparent Resistance of Supply Mains ................................................................................. 13-2
Weight .............................................................................................................13-3
Power Cords required outside of the United States ......................................13-3
Environmental Specifications .......................................................................13-4
Operating ............................................................................................................................... 13-4
Transportation and Storage .................................................................................................. 13-4
Acquisition Computer ....................................................................................13-4
Patient Support Chair ....................................................................................13-5
Disposal ..........................................................................................................13-5
Extension Cords .............................................................................................13-5
External Item .................................................................................................13-5
Cleaning .........................................................................................................13-5
Electromagnetic or other Interference
(Emissions and Immunity) ............................................................................13-6
Equipment Standards .....................................................................................13-8
Equipment Class ............................................................................................13-8
Preventive Maintenance Schedule - for Owner / User .................................13-9
Planned Maintenance - 12 Month Schedule ................................................13-9
Cleaning .............................................................................................................................. 13-10
Planned Maintenance Checklist ......................................................................................... 13-10

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Replaceable Parts - Reference List .............................................................13-12
Accessories ...................................................................................................13-13
Chapter 14 - Illustrated Parts Breakdown
System Assembly ............................................................................................14-2
System Assembly Parts List .................................................................................................. 14-3
Overhead Assembly ........................................................................................14-4
Overhead Assembly Parts List .............................................................................................. 14-5
Rotation Drive Assembly ................................................................................14-6
Rotation Drive Assembly Parts List ...................................................................................... 14-7
X-Ray Source Assembly .................................................................................14-8
X-Ray Source Assembly Parts List ....................................................................................... 14-9
Receptor Panel Assembly .............................................................................14-10
Receptor Panel Assembly Parts List ................................................................................... 14-11
Chair Assembly ............................................................................................14-12
Chair Assembly Parts List .................................................................................................. 14-13
Upper Chair Assembly .................................................................................14-14
Upper Chair Assembly Parts List ....................................................................................... 14-15
Chapter 15 - Radiation Environment Survey
Conditions of Operation – 8.9 and 23.0 Second Scans ................................15-2
Scatter Measurements for 8.9 Second Scans ................................................15-3
Standard (full-beam) Diameter 8.5 - Height 8.5 cm ............................................................ 15-3
Half Beam Diameter 14 - Height 8.5 cm ............................................................................. 15-5
Scatter Measurements for 23 Second Scans .................................................15-7
Standard (full-beam) Diameter 8.5 - Height 8.5 cm ............................................................ 15-7
Half Beam Diameter 14 - Height 8.5 cm Scan .................................................................... 15-8
Scatter Measurements for PAN Scan ............................................................15-9
Scan Times and Settings ..............................................................................15-11
Dose and Imaging Performance Information ............................................15-12
Dose Profile ..................................................................................................15-13
Sensitivity Profile .........................................................................................15-15
Drywall Attenuation .....................................................................................15-16
Recommended Operating Requirements .....................................................15-17
X-ray Tube Assembly ...................................................................................15-18

-viii
Appendix A - iCATVision, iCATTransfer, & RSQM Installation
iCATVision ......................................................................................................A-1
Laptop Minimum Requirements .............................................................................................A-2
Workstation Minimum Requirements ....................................................................................A-2
File Structure Setup ................................................................................................................A-2
Install iCATVision ..................................................................................................................A-3
iCATVision Setup ....................................................................................................................A-4
iCATTransfer ..................................................................................................A-5
Install iCATTransfer .............................................................................................................A-5
iCATTransfer Passcode ..........................................................................................................A-6
iCATTransfer Setup ................................................................................................................A-6
Configure iCATTransfer ........................................................................................................A-7
Accessing i-CAT® DICOM Data ...........................................................................................A-7
RSQM ..............................................................................................................A-8
RSQM Installation and Setup ........................................................................A-8
Query and Retrieve Images ..........................................................................A-10
Status Messages ............................................................................................A-13
Appendix B - i-CATVision Release Notes
Appendix C - Assembly Report Form Sample
Appendix D - System Schematics

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G990710 30 June 2008
Chapter
1 Introduction
System Description
The system is a Cone Beam Volumetric Tomography and
Panoramic X-ray device used for dental 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.
GXCB-500™Imaging System
PATIENT
ALIGNMENT
PANEL (ADJUSTS
CHAIR UP/DOWN)
HEAD SUPPORT
BACK PLATE
KNOB
(SLIDES TO
ADJUST THE
POSITION OFTHE
HEAD SUPPORT)
MOTORIZED
CHAIR
(MOVES
UP/DOWN VIA
BUTTONS ON
THE PATIENT
ALIGNMENT
PANEL)
HEAD
SUPPORT
BACKPLATE
CHIN
SUPPORT
GATE
(SWINGS OPEN,
MAGNETS LOCK
IN PLACE)

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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 - Conventional Digital Panoramic Feature
Cone Beam Volumetric Tomography is a medical imaging
technique that uses X-rays to obtain cross-sectional images. 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
G990710 30 June 2008
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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Gendex GXCB-500TM Service Manual
G990710 30 June 2008
Standard Limited Warranty
Gendex warrants the original purchaser that this hardware system
will be free from damage for a period of one (1) year from the date
of delivery. During the warranty period, Gendex 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 Gendex. The original
purchaser must promptly notify Gendex in writing if there is a defect
in material or workmanship. Written notice in all events must be
received by Gendex before expiration of the warranty period. This
warranty is not transferable.
This One-Year Limited Warranty covers normal use. Gendex 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 Additions or changes unauthorized by Gendex
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

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Introduction
G990710 30 June 2008
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 Gendex 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 Gendex, its
agents or employees shall create a warranty or in any way increase the
scope of this warranty

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2-1
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Chapter
2 Safety Items
Important Safety Information
Gendex 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.
Before attempting to use the equipment for any patient examination,
read, understand, and know how to implement the Emergency Stops
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.

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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.
Safety Precautions
WARNINGWARNING
The X-ray device may be dangerous to the Patient and Operator if
you do not observe and follow the operating instructions. Do not
operate this system unless you have received training to perform a
procedure.
WARNINGWARNING
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 Hazards
Installation and system wiring must meet all requirements of local
governing authorities. Please check your local authorities and local
codes to determine best practices for a safe installation.
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.

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Safety Items
G990710 30 June 2008
WARNINGWARNING
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.
WARNINGWARNING
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.
Explosion Hazard
Do not use the System in the presence of explosive gases or vapors,
including anaesthetic gases. Use of this system in an environment
for which it is not designed can lead to fire or explosion.
WARNING
This unit is not suitable for use in a flammable air mixture
environment.
If hazardous substances are detected while the system is turned on,
do not attempt to turn off the system. Evacuate the area and then
remove the hazards before turning off the system.
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.
Carefully observe the patient during the scanning procedure to
ensure that when the System Gantry moves, the patient does not
collide with the Gantry or other equipment. Ensure that the patient
does not grab or hold any part of the system or nearby equipment.

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Collision System
The Gantry motor is programmed to operate at a rotational force of
< = 15 lbf (66.7N). Interference or incidental contact with the Gantry
during rotation, which results in an interruption in Gantry motion,
will be detected and trigger a system stall event. This will result in a
system fault condition which will cause the following system events
to occur:
•Stepper Motor power is removed
•X-Ray operations cease
•System Fault Light illuminates
•X-Ray Audio and Visual indicators de-energize
Operator intervention is required to recover the system for normal
use.
Laser Beam Hazards
WARNING
Laser beams can cause optical damage. Close eyes when the laser
beam is in use. Instruct the Patient to close eyes 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.
The System Gantry has laser markers to assist you in planning scan
procedures. If you are using the laser markers while a patient is in
the chair, warn the patient that the laser beam could be harmful.
Advise the patient that laser beams can cause optical damage.
Instruct the patient not to stare at the laser beam and to avoid looking
into the beam.

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Safety Items
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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.
Radiation Protection Measures
Use the following measures to protect yourself and the patient from
unintended exposure to radiation. Anyone who is near the patient
during test procedures must observe the following precautions:
•Maintain adequate distance from exposed radiation source.
•Keep exposure times to a minimum.
•Wear protective clothing (lead apron, etc.) to protect the
anatomical areas.
•Wear a PEN dosimeter and/or film badge.
•If you are required in the exam room during a procedure,
stay as far from the scanner as possible or behind a mobile
protective wall.
•The physician is responsible for protecting the patient from
unnecessary radiation.

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System Safety Devices
Emergency Stops
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 and/
or Patient should utilize the Emergency Stop buttons 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.
An externally powered Warning System can be connected to the
cable provided which is capable of 250 volts, 50/60 hertz, and 2.5
amps. When X-ray power is energized the warning system is also
energized.
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 Shorting Plug. Connect the supplied Interlock
Cable to the scanner. Connect door switches (NO/COM terminals)
and/or emergency stop switches (NC/COM terminals) in series
between the other end of the Interlock Cable wires.
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.