i-CAT FLX V Series Quick start guide

Technical Guide
Cone Beam 3D +
2D Panoramic Dental
Imaging System
TM
TM

Copyright © Dental Imaging Technologies Corporation 2013 - 2016
This manual contains original instructions by Dental Imaging Technologies Corporation for
the safe use of the i-CAT FLX imaging system and were originally drafted, approved and
supplied in English. Dental Imaging Technologies Corporation 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.
Thisdocumentmaynot,inwholeorinpart,becopied,photocopied,reproduced,translated,
or reduced to any electronic medium or machine-readable form without prior consent in
writing from Dental Imaging Technologies Corporation.
i-CATTM is a registered trademark of Imaging Sciences International. Other names may be
trademarks of their respective owners.
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 Dental
Imaging Technologies Corporation. 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
beused,copied, or reproducedpursuantto the termsofsuch agreement.Thismanual does
not contain or represent any commitment of any kind on the part of Dental Imaging
Technologies Corporation.

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TABLE OF CONTENTS
Chapter 1 - Introduction
i-CAT FLX V-Series Imaging System Description .......................................................1-1
Operator Control Box ...................................................................................................... 1-2
Patient Emergency Stop Control ..................................................................................... 1-3
Software Description ...................................................................................................1-3
SmartScan STUDIO Software ......................................................................................... 1-3
TxSTUDIO Treatment Planning Software ....................................................................... 1-3
System Requirements .................................................................................................1-3
Chapter 2 - Startup and Shutdown
Scanner Startup ..........................................................................................................2-1
Power Up ......................................................................................................................... 2-1
Log in ............................................................................................................................... 2-1
Scanner Shutdown .....................................................................................................2-2
Log out ............................................................................................................................ 2-2
Power Off ........................................................................................................................ 2-2
Cycle Scanner Power ...................................................................................................... 2-2
Chapter 3 - Calibrations and Quality Assurance
Run Calibration and QA Tests ....................................................................................3-1
Panel Calibration .........................................................................................................3-2
Run Panel Calibration ..................................................................................................... 3-2
Panel Calibration Failure ................................................................................................. 3-2
Shutter Calibration ......................................................................................................3-3
Run Shutter Calibration ................................................................................................... 3-3
Shutter Calibration Failure ............................................................................................... 3-3
Geometric Calibration .................................................................................................3-4
Install Geometric Calibration Fixture ............................................................................... 3-4
Run Geometric Calibration .............................................................................................. 3-4

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QA Line Pair Test ....................................................................................................... 3-5
Setup QA Phantom ..........................................................................................................3-5
Run QA Line Pair Test .....................................................................................................3-6
QA Line Pair Evaluation ..................................................................................................3-7
Distance Measurement Test ............................................................................................3-9
QA Material Test ...................................................................................................... 3-10
Set Up QA Phantom ......................................................................................................3-10
Run QA Material Test ....................................................................................................3-10
QA Material Evaluation ..................................................................................................3-11
QA Air Water Test .................................................................................................... 3-14
Set Up QA Air Water Phantom ......................................................................................3-14
Run QA Air Water Test ..................................................................................................3-14
QA Air Water Test Evaluation ........................................................................................3-15
QA PAN Test ............................................................................................................ 3-20
Install PAN Phantom .....................................................................................................3-20
Run QA PAN Test .........................................................................................................3-20
QA PAN Test Evaluation ...............................................................................................3-21
Radiation Output Test .............................................................................................. 3-22
Measured Dose .............................................................................................................3-22
Interpretation .................................................................................................................3-23
Chapter 4 - Site Administration
Site Administrator Account ......................................................................................... 4-1
Configurator ................................................................................................................ 4-2
Accounts ..........................................................................................................................4-2
Institution .........................................................................................................................4-3
Network ...........................................................................................................................4-3
Maintenance ....................................................................................................................4-3
Dose LogBook .................................................................................................................4-4
Device Activity Log ..........................................................................................................4-4
Regular Backups of Image Data ................................................................................ 4-4

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Chapter 5 - Data Utilities
Introduction .................................................................................................................5-1
Data Utility ..................................................................................................................5-1
Install and Configure Data Utility .....................................................................................5-2
Using the Data Utility .......................................................................................................5-3
Export Database to DEXIS Core .....................................................................................5-9
Patient Data Utility ......................................................................................................5-9
Install and Configure Patient Data Utility .......................................................................5-10
Using the Patient Data Utility .........................................................................................5-11
Appendix A - Safety Information
Important Safety Information ......................................................................................A-1
Electrical Hazards .......................................................................................................A-3
Explosion Hazard .......................................................................................................A-3
Mechanical Hazards ...................................................................................................A-3
Collision System ..............................................................................................................A-3
Tube Head Leakage ........................................................................................................A-4
Laser Beam Hazards ..................................................................................................A-4
Radiation Safety .........................................................................................................A-4
Radiation Protection Measures ........................................................................................A-5
Safety Devices ............................................................................................................A-5
Emergency Stops ............................................................................................................A-5
Warning System ..............................................................................................................A-5
Interlock System ..............................................................................................................A-6
Site Layout ..................................................................................................................A-6
Cabling Requirements ................................................................................................A-6
Appendix B - Product Information
Essential Performance ...............................................................................................B-1
User Proficiency .........................................................................................................B-1
Service ........................................................................................................................B-2
Technical Specifications .............................................................................................B-3
Power Requirements ..................................................................................................B-4
Apparent Resistance of Supply Mains .............................................................................B-4
Weight ........................................................................................................................B-5

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Patient Support Chair .................................................................................................B-5
Environmental Specifications .....................................................................................B-5
Operating .........................................................................................................................B-5
Transportation and Storage .............................................................................................B-5
Labels .........................................................................................................................B-6
Proper Disposal of Electronic Equipment .................................................................B-16
Product Disposal ...........................................................................................................B-16
Passing the Product on to Another User .......................................................................B-17
Scanner Dimensions ..............................................................................................B-18
Preventive Maintenance Schedule - for Owner / User .............................................B-19
Cleaning ...................................................................................................................B-19
Planned Maintenance - 12 Month Schedule ............................................................B-20
Planned Maintenance Checklist ....................................................................................B-20
Replaceable Parts ...................................................................................................B-21
Supplemental Components ......................................................................................B-22
PAN Scan Components ...........................................................................................B-24
Equipment Standards ...............................................................................................B-25
Equipment Class ......................................................................................................B-25
Equipment Cables ....................................................................................................B-25
Manufacturer’s Declaration ......................................................................................B-26
Acknowledgements ..................................................................................................B-33
Appendix C - Radiation Information
Recommended Operating Requirements ...................................................................C-1
Scan Times and Settings ...........................................................................................C-2
Scatter Radiation ........................................................................................................C-2
Conditions of Operation ...................................................................................................C-2
Dose and Sensitivity Profile ......................................................................................C-11
Patient Dose .............................................................................................................C-11
Detective Quantum Efficiency (DQE) .......................................................................C-13
X-ray Tube Assembly ...............................................................................................C-14
Appendix D - Symbol Glossary

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Chapter
1 Introduction
i-CAT FLX V-Series Imaging System Description
The i-CAT FLX is a Cone Beam Volumetric Tomography and Panoramic imaging system used for
dental head and neck applications. It consists of a scanner, scanner controller, touch screen and
keyboard which is suitable for an in-office environment.
i-CAT FLX Imaging System with Touch Screen

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The scanner is an open design that allows patients to sit upright during a procedure. An
electric powered seat is built into the scanner for proper patient positioning. The scanner
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
obtaincross-sectionalimagesof the headorneck.Quality of theimagesdependson 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.
Operator Control Box
The operator control box must be located outside of the patient environment, and can be
placed on a desktop or wall-mounted. The site layout must provide a means for audio and
visual communication between the operator and patient during scanning.
ON powers the scanner and the POWER indicator lights to show that the scanner is ON.
OFF removes power from the scanner and the POWER indicator goes OFF.
SCAN initiates patient X-ray scanning.
EMERGENCY STOP immediately halts all X-ray and scanning activities.
NOTE: The following indicators are also located on the scanner overhead.
POWER indicator is lit when the scanner is ON.
READY indicator is lit when a scan is initiated and the scanner is ready to scan. If the
optional deadman handswitch is installed, this indicator will flash to alert the operator to
press the handswitch.
X-RAY indicator is lit during X-ray exposure.
FAULT indicator lights when a scanner error occurs, such as an X-ray exposure problem
or early release of the optional deadman handswitch.

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Patient Emergency Stop Control
The emergency stop control 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.
Software Description
NOTE: You represent and warrant that you will, at all times, comply with all laws, including the
HIPAA regulations directly or indirectly applicable to you or your organization that may now or
hereafter govern the gathering, use, transmission, processing, receipt, reporting, disclosure,
maintenance, and storage of patient information and use your best efforts to cause all persons or
entities under your direction or control to comply with such laws.
SmartScan STUDIO Software
SmartScan STUDIOTM software is used for taking scans on the i-CAT FLX imaging system
and runs on the scanner controller. SmartScan STUDIO Manager software is used to enter
patient data and access patient studies. It is loaded on a clinical workstation. Optionally, your
site may choose to use DEXISTM software, instead of SmartScan STUDIO Manager, for
patient administration.
TxSTUDIO Treatment Planning Software
TxSTUDIO treatment planning software reconstructs 3D volume rendering from images
acquired on the i-CAT FLX imaging system.TxSTUDIO is offered for exclusive use with the i-
CAT imaging system, which is manufactured by Imaging Sciences. TxSTUDIO may not be
available in all regions.
System Requirements
It is recommended that all computer systems meet the following specifications. Computer
systems not meeting the specifications may have performance impacts.
Item System Requirements
CPU Intel®Dual Core 2.0 GHz or higher
AMD Dual Core 2.0 GHz or higher

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Operating
System Server Only:
Windows®7 Professional, Ultimate, and Enterprise (64-bit) SP1
Windows®8.1 Pro and Enterprise (64-bit)
Windows®10 Pro and Enterprise (64-bit)
Windows®Server 2008 R2 SP1
Windows®Server 2012 (all versions)
Windows®Server 2012 R2 (all versions)
Client Workstation:
Windows®7 Professional, Ultimate, and Enterprise (64-bit) SP1
Windows®8.1 Pro and Enterprise (64-bit)
Windows®10 Pro and Enterprise (64-bit)
Note: Dedicated file servers above are recommended in networks with
more than 5 imaging workstations.
System Memory 4 GB or larger
Hard Disk Drive 1 TB or larger (server), 500 GB or larger (client workstation)
Graphics Card NVidia GeForce®GT-series or higher
AMD RadeonTM 6450 or higher
Monitor 17” high resolution widescreen LCD with a contrast ratio of 10,000:1 or
better
Note: LCD monitors should be used in native resolution, and must display
all shades of gray accurately.
USB USB 2.0
Network Card 1000 baseT network cards
Note: Wireless networks are not recommended.
DVD Drive 16x or higher
Internet
Connection High-speed internet connection required for software updates and remote
diagnostics (1 GB recommended)
Note: The scanner controller is a machine-control computer and is not
configurable. The 1 GB Ethernet port can be configured for use with a
server.
Supported
Viewers
TxSTUDIO 5.3.3 or greater
Dolphin Imaging 11.5 or greater
Note: For workstations running TxSTUDIO or Dolphin, refer to the
vendor’s documentation for additional system requirements.