i-CAT FLX V Series User manual

User M anual
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.
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 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
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 Dental Imaging
Technologies Corporation.

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TABLE OF CONTENTS
Chapter 1 - Introduction
Welcome to Your New i-CAT FLX V-Series Imaging System ..................................... 1-1
Description .................................................................................................................. 1-2
i-CAT FLX Imaging System ............................................................................................. 1-2
Operator Control Box ...................................................................................................... 1-3
Patient Emergency Stop Control ..................................................................................... 1-4
SmartScan STUDIO Software ......................................................................................... 1-4
TxSTUDIO Treatment Planning Software ....................................................................... 1-4
Indications for Use/Intended Use ................................................................................1-4
Chapter 2 - Getting Started
Workflow At A Glance ................................................................................................. 2-1
Scanner Startup .......................................................................................................... 2-2
Power Up ......................................................................................................................... 2-2
Log in ............................................................................................................................... 2-2
Chapter 3 - Scheduling a Patient Exam
Introduction ................................................................................................................. 3-1
Using SmartScan STUDIO Manager to Schedule a Patient Exam .............................3-1
Schedule a New Patient for an Exam .............................................................................. 3-1
Schedule an Existing Patient for a New Exam ................................................................ 3-2
Using DEXIS to Schedule a Patient Exam .................................................................. 3-2
Schedule a New Patient for an Exam .............................................................................. 3-2
Schedule an Existing Patient for an Exam ...................................................................... 3-3
Using a Practice Management System to Schedule a Patient Exam ......................... 3-3
Using a Modality Worklist to Schedule a Patient Exam .............................................. 3-3
Chapter 4 - Selecting a Protocol
Dose Control ............................................................................................................... 4-1
Default Favorites ......................................................................................................... 4-2
Choosing the Best Scan Option for the Patient .......................................................... 4-6

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Chapter 5 - Positioning the Patient
Patient Positioning For CT Scans - At A Glance ........................................................ 5-1
Patient Positioning For PAN Scans - At A Glance ..................................................... 5-2
Patient Positioning - in Detail ..................................................................................... 5-3
Patient Chair ................................................................................................................. 5-4
Gate ................................................................................................................................. 5-5
Chin Support .................................................................................................................... 5-5
Head Support and Head Strap ....................................................................................... 5-6
Alignment Light .............................................................................................................. 5-8
Scouts and Dry Runs ................................................................................................. 5-9
Instruct Patients Prior to the Scan ............................................................................ 5-10
Chapter 6 - Taking a Scan
Scanning Workflow in SmartScan STUDIO ............................................................... 6-1
Using SmartScan STUDIO Step-by-Step ................................................................... 6-3
Perform a CT Scan .......................................................................................................... 6-3
Perform a PAN Scan ....................................................................................................... 6-5
Build a Custom Protocol .................................................................................................. 6-7
SmartScan STUDIO Details ....................................................................................... 6-8
Choose a Patient Exam ................................................................................................... 6-8
Choose a Protocol .......................................................................................................... 6-9
Choose Type ................................................................................................................ 6-12
Perform a Dry Run ......................................................................................................... 6-13
Perform a CT Scout Scan ............................................................................................. 6-14
Perform a Scan .............................................................................................................. 6-17
Review Exam Images ................................................................................................... 6-18
Perform a PAN Scout Scan .......................................................................................... 6-21
Review PAN Image ...................................................................................................... 6-22
Complete/Incomplete Exam .......................................................................................... 6-23
Build a Custom Protocol Workflow in SmartScan STUDIO ...................................... 6-24
Choose Anatomy .......................................................................................................... 6-25
Choose Resolution ....................................................................................................... 6-28
Choose Dose ................................................................................................................ 6-29

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Table of Contents
Chapter 7 - Opening Images
Introduction ................................................................................................................. 7-1
Locate Exam Images in SmartScan STUDIO Manager ............................................. 7-1
Locate Exam Images in DEXIS .................................................................................. 7-2
Locate Exam Images in a Practice Management System .......................................... 7-2
Store and Retrieve Images on a PACS ...................................................................... 7-3
Monitor Image Storage from SmartScan STUDIO to a PACS ......................................... 7-4
Retrieve Images from a PACS ......................................................................................... 7-5
Using TxSTUDIO ........................................................................................................ 7-7
Chapter 8 - Calibration and Maintenance
Commonly-Used Utilities ............................................................................................ 8-1
Panel Calibration .............................................................................................................8-1
Shutter Calibration ...........................................................................................................8-2
Reprocessing an Exam .................................................................................................... 8-3
Using Favorites Manager ................................................................................................. 8-4
Routine Cleaning ........................................................................................................ 8-5
Chapter 9 - Shutdown
Scanner Shutdown ..................................................................................................... 9-1
Log out ............................................................................................................................. 9-1
Power Off ......................................................................................................................... 9-1
Appendix A - Safety Guidelines
Radiation Safety .........................................................................................................A-1
Radiation Protection Measures ........................................................................................A-1
Safety Precautions .....................................................................................................A-1
Safety Devices ............................................................................................................A-3
Warning System ..............................................................................................................A-3
Interlock System ..............................................................................................................A-3
Emergency Stops ............................................................................................................A-3
Appendix B - Status Indicators and Operational Messages
Status Indicators .........................................................................................................B-1
Product Information ....................................................................................................B-1
Operational Messages ................................................................................................B-2

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Chapter
1 Introduction
Welcome to Your New i-CAT FLX V-Series Imaging System
Welcome to the i-CATTM Family! And thank you for your recent investment in award-winning i-CAT
Cone Beam 3D Imaging. We hope you will have an extraordinary experience with our products
and services.
Praised by owners, esteemed educational organizations and the dental community at large,
i-CAT technology is widely regarded as the cone beam industry standard. i-CAT and its treatment
planning software continue to revolutionize the landscape of 3D dental and maxillofacial
radiography with ultimate efficiency and flexibility for maximum clinical control.
Your new i-CAT FLX V-Series imaging system is an upgradeable system which provides three
product options for scanning size depending on the needs of your practice: the i-CAT FLX V8,
i-CAT FLX V10, and i-CAT FLX V17. Along with low dose imaging, easy workflow, and consistent
patient positioning, the i-CAT V-Series enables you to select a product option that best fits your
needs without compromising image quality.
Proprietary tools such
as SmartScan
STUDIOTM touch
screen control,
TxSTUDIOTM
diagnostic and
treatment planning
software, and Quick
Scan low-dose
imaging put flexibility
in your hands.
Our goal is that you will
optimize workflow
efficiency with
remarkably rapid scan
and reconstruction
rates and practical
office/network
integration.

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As with all new clinical tools, training is necessary for the practice to become proficient with the i-
CAT system. In addition to training with a certified i-CAT instructor, we recommend that you and
your clinical team review this manual for a thorough understanding of how to use i-CAT
technology to its potential in your practice, both safely and effectively.
Description
The following major items comprise the i-CAT FLX imaging system:
•Scanner
•Scanner Controller
•Touch screen with SmartScan STUDIO software
•Keyboard
•Operator Control Box
•Patient Emergency Stop Control
•SmartScan STUDIO Manager software
•DEXISTM Eleven (11.2) software (DEXIS is optional software and is not available in all
countries.)
•TxSTUDIO Treatment Planning Software
i-CAT FLX Imaging System
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. 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.
Cone Beam Volumetric Tomography is a medical imaging technique that uses X-rays to
obtain cross-sectional images of the head or neck. Quality of the images depends on the level
and amount of X-ray energy delivered to the tissue. Imaging displays both high-density
tissue, such as bone, and soft tissue. When interpreted by a trained physician, these images
provide useful diagnostic information.
The scanner captures data for 3D skull reconstruction for the following procedures:
•Implants
•TM Joints
•Reconstructed Panoramic

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•Reconstructed Cephalometrics
•Airway / Sinus, etc.
•Nerve Canal
•PAN - Optional Conventional Digital Panoramic Feature
i-CAT FLX Imaging System with Touch Screen
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.

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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.
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.
SmartScan STUDIO Software
SmartScan STUDIO software is used for taking scans on the i-CAT FLX 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 DEXIS 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. 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.
Indications for Use/Intended Use
Devices of the i-CAT family consist of an X-ray system that uses a cone beam with a rotational
sequence, providing two dimensional images and three dimensional volume reconstructions of
the head area, which includes ENT and maxillofacial areas (such as TM Joint studies, mandible
& maxilla for implant planning, sinuses), for use in planning and diagnostic support in adult and
pediatric care.
Devices of the i-CAT family comprise a package of software modules capable of handling 2D and
3D data. This includes 3D reconstruction. storage, retrieval, viewing, and processing of 2D and
3D-image data.

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CAUTION
U.S. Federal Law (USA) restricts the sale of this device to or on the order of a dentist or
other licensed practitioner.
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.

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Chapter
2 Getting Started
Workflow At A Glance
The i-CAT FLX imaging system and the software tools SmartScan STUDIO, DEXIS or
SmartScan STUDIO Manager, and TxSTUDIO enable you to quickly capture patient exam data
and view images for treatment planning. The main steps of the workflow are:
•Schedule a Patient Exam
•Select a Scan Protocol
•Position the Patient
•Take a Scout Scan to Assess Patient Positioning
•Take a Scan
•Release the Patient
•Open and View Images
•Select Scan Protocol
•Position the Patient
•Take a Scout Scan
•Take a Scan
•Release the Patient
•Schedule a Patient Exam
•SmartScan STUDIO Manager, DEXIS,
PM system, or Modality Worklist
•Open and View Images
•SmartScan STUDIO Manager,
DEXIS, PM system, or PACS
•TxSTUDIO

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Scanner Startup
The scanner and scanner controller are powered independently, Both must be on to function
properly and are available for use immediately after startup. No warm up is required.
Power Up
1. Power up the scanner: press the ON button on the operator control
box. The POWER indicator on the operator control box and scanner
should light.
2. Power up scanner controller and touch screen: press the power
button on the front of the scanner controller. The log in screen is
displayed.
CAUTION
If the scanner or the scanner controller is powered off, at scanner power up or scanner
controller boot up, when the first scan is initiated (scout or full scan), the system
performs a reset procedure that may delay the start of first scan.
Log in
To log in to SmartScan STUDIO on the touch screen:
1. Enter your user name and password.
2. Press to log in. Scheduled Exams are displayed.

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Chapter
3 Scheduling a Patient Exam
Introduction
Depending on your site’s workflow, you may use SmartScan STUDIO Manager, DEXIS software,
Practice Management (PM) software, or SmartScan STUDIO Modality Worklist software to
schedule patient exams.
Using SmartScan STUDIO Manager to Schedule a Patient Exam
Using SmartScan STUDIO Manager at the clinical workstation, you can schedule a new patient
for an exam or select an existing patient to schedule a new exam. If you need to modify any
patient data after it has been entered and saved, contact your site administrator.
Schedule a New Patient for an Exam
1. At the clinical workstation, start
SmartScan STUDIO Manager.
2. Select New Exam for a New
Patient.
3. Enter data for the patient and exam.
At a minimum, Patient ID and Family
Name must be completed. If a Patient
ID is entered that is already in use, a
Duplicate Patient ID message is
displayed.
NOTE: Entries added to the drop-down
menus are only stored on the local
workstation. They will not display on
another workstation unless they are
added to that workstation.

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4. Select . The exam request is sent to SmartScan STUDIO and is displayed in
the Scheduled Exams list on the touch screen.
Schedule an Existing Patient for a New Exam
1. At the clinical workstation, start
SmartScan STUDIO Manager.
2. Select New Exam for an Existing
Patient.
3. Select the patient from the list. Use
the search feature as needed to help
locate the patient.
4. Select the type of new exam, PAN or
CT.
5. Select . The exam request is
sent to SmartScan STUDIO and is
displayed in the Scheduled Exams
list.
Using DEXIS to Schedule a Patient Exam
NOTE: DEXIS is optional software and is not available in all countries.
If your site uses DEXIS Eleven (11.2) to schedule patient exams, enter patient data in the DEXIS
Administration program. Refer to your DEXIS Software Manual for additional information.
Schedule a New Patient for an Exam
1. At the clinical workstation, start DEXIS.
2. On the DEXIS Administration screen, select New Patient.
3. Enter data for the patient and exam.
4. Select OK.

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5. Click (Extra-oral).
6. Click . A pop-up message displays that patient is scheduled for acquisition.
7. Click OK to dismiss pop-up.
Schedule an Existing Patient for an Exam
1. At the clinical workstation, start DEXIS.
2. On the DEXIS Administration screen, select patient from list or enter search criteria
to locate and select patient.
3. Click (Extra-oral).
4. Click . A pop-up message displays that patient is scheduled for acquisition.
5. Click OK to dismiss pop-up.
Using a Practice Management System to Schedule a Patient
Exam
SmartScan STUDIO can work with supported PM systems using PM interface software. If your
site uses a supported PM system, the optional SmartScan STUDIO PM Interface software must
be installed. Use your PM system to request an exam, and the PM Interface automatically
schedules it. You can then select the exam from the Scheduled Exams list in SmartScan
STUDIO.
NOTE: If you have a problem with the PM Interface, refer to Locate Exam Images in a Practice
Management System (page 7-2) for additional information.
Using a Modality Worklist to Schedule a Patient Exam
If your site uses a RIS (Radiology Information System) to maintain patient data, you may have
the optional SmartScan STUDIO MWL software installed on your clinical workstations. This
software enables the import of patient demographic details from a RIS server for scheduling
scans.

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1. Start SmartScan STUDIO
MWL.
2. Query for scheduled
patients by entering one or
more of the following:
Patient ID, Accession
Number, Last Name, First
Name, Scheduled
Procedure Start Date
Range (From – To),
Modality (CT/DX/PX/
None), Station Name,
Procedure Code.
3. Select Process. Query
results are listed. See table
below for status messages
that may be displayed in
the process field.
4. View results and select the desired entry from the list. Select Schedule to schedule
the patient for the exam. The exam request is sent to SmartScan STUDIO and is
displayed in the Scheduled Exams list.
5. If a failure occurs, contact your local PACS administrator.
Modality Worklist Status Messages
Message Action
Error adding records to list.
Please check log.
Error in one or more results while populating list view of
the query results received.
No record found against request Cannot find patient(s) that matches the selected criteria.
Modality Worklist Querying
canceled by user.
MWL query canceled before completion.
Modality Worklist Querying failed.
Please check log for error.
PACS MWL was unable to communicate with the RIS.
Please check logs for more details on error occurred.

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Modality Worklist Querying
performed successfully.
Requested Query was completed successfully.
Retrieving records, Please wait... PACS MWL retrieving the results of Query requested.
Deleted. Selected server configuration deleted from the settings.
C-ECHO failed.
PACS MWL was unable to perform C-ECHO request for
the selected server. Contact local PACS administrator.
C-ECHO successful.
Requested C-ECHO operation was successfully
performed.
Unable to find server
configuration for {0}.
Specified server configuration doesn’t exist. Contact local
PACS administrator.
IP address entered is invalid.
IP Address of the server is not valid as per IPv4
conventions. Contact local PACS administrator.
Invalid remote configuration.
Server configuration values entered for saving
configuration is not valid or is incomplete. Contact local
PACS administrator.
Please enter valid port number.
Port number entered for saving remote server
configuration is not valid. Contact local PACS
administrator.
Saved. Server configuration saved successfully in Registry.
Exception while scheduling
patient for scan. Please check
log.
Exception while scheduling patient for Acquisition. Please
check logs for more details on error occurred.
Patient with ID: {0}, Modality: {1}
successfully scheduled for
acquisition.
Patient with specified ID and Modality scheduled
successfully for acquisition.
Please enter station name.
The station name field is left blank. Please enter a station
name. Contact local PACS administrator.
Please enter valid AE title.
The AE title entered is no longer valid. Please enter a
valid AE title. Contact local PACS administrator.
Message Action

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