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CONTROLLED DOCUMENT: 032-0329-EN


DOCUMENT TITLE: i-CAT FLX User Manual (English)
DOCUMENT NOTES:
1.009.9692

Controlled Document

Document Information
Revision: Vault:
K ISI-Manuals-Release

Status: Document Type:


Release Manual-Instruction

Date Information
Creation Date: Release Date:
17 Aug 2016 22 Aug 2016

Effective Date; Expiration Date:


22 Aug 2016

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Author: Owner:
CONNIE.REILLY ISI-PCN Packet Review

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ECN 105054 ECN 107452

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!"
!"

Cone Beam 3D +
2D Panoramic Dental
Imaging System

Us er Ma n ua l

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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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i-CAT FLX User Manual

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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i-CAT FLX User Manual

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Chapter Introduction
1
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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i-CAT FLX User Manual

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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Introduction

• 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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i-CAT FLX User Manual

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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Introduction

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 Getting Started


2
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

• Open and View Images


• SmartScan STUDIO Manager,
DEXIS, PM system, or PACS
• TxSTUDIO

• Select Scan Protocol


• Schedule a Patient Exam
• Position the Patient
• SmartScan STUDIO Manager, DEXIS,
• Take a Scout Scan PM system, or Modality Worklist
• Take a Scan
• Release the Patient

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i-CAT FLX User Manual

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 Scheduling a Patient Exam


3
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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i-CAT FLX User Manual

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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Scheduling a Patient Exam

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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i-CAT FLX User Manual

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. Error in one or more results while populating list view of
Please check log. the query results received.
No record found against request Cannot find patient(s) that matches the selected criteria.
Modality Worklist Querying MWL query canceled before completion.
canceled by user.
Modality Worklist Querying failed. PACS MWL was unable to communicate with the RIS.
Please check log for error. Please check logs for more details on error occurred.

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Scheduling a Patient Exam

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

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Chapter Selecting a Protocol


4
Dose Control
It is important to put the patient’s
health first when selecting a protocol
for the scan. Keep the following in
mind when selecting a protocol:
• Multiple low dose scan settings
provide responsible patient-
focused care. FOV 8 cm x 5 cm FOV 8 cm x 8 cm FOV 16 cm x 4 cm
• Choose a height to narrow the
image and the applied dose to
only the anatomy of interest.
• Preset fields of view simplify the
imaging process to more
efficiently focus on capturing the
anatomy to fit each patient’s
unique case. Target specifically
desired views including maxilla FOV 16 cm x 6 cm FOV 16 cm x 6 cm FOV 16 cm x 8 cm
Maxilla Mandible
or mandible single arch, both
arches, and temporomandibular
joints, cephalometric views, and
full skull.
• Customize the scan so patients’
anatomy is not exposed outside
the selected field of view.
• Capture information critical to
treatment through a clinically FOV 16 cm x 10 cm FOV 16 cm x 11 cm FOV 16 cm x 13 cm
responsible approach that
controls radiation exposure to
the patient. Disclaimer: These graphics are
only representations. The actual
NOTE: Use the PAN 2D panoramic imaged anatomy is dependent on
imaging when CT 3D information is the size and position of the patient
not required. being scanned. FOV options vary
by system option purchased and
are upgradeable.
FOV 23 cm x 17 cm

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i-CAT FLX User Manual

Default Favorites
Default protocol favorites are pre-loaded in SmartScan STUDIO for CT and PAN scans.

i-CAT FLX V17 Favorites


Volume Size Voxel Scan Time DAP
CT Favorite Name (Diameter x Height) (mm) (Seconds) (mGy cm2)
3D Ceph 16 x 13 0.3 8.9 623.9
3D Ceph Quick Scan (Low Dose) 16 x 13 0.3 4.8 349.4
3D Ceph Quick Scan+
(Ultra Low Dose) 16 x 13 0.6 4.8, reduced mA 99.2
Expanded 3D Ceph 23 x 17 0.3 17.8 877.6
Airway Quick Scan (Low Dose) 16 x 13 0.3 4.8 349.4
TM
Airway i-clAIRity 16 x 10 0.6 4.8, reduced mA 79.6
Arches/TMJ 16 x 10 0.3 8.9 501.3
Arches/TMJ Quick Scan (Low Dose) 16 x 10 0.3 4.8 278.1
Arches/TMJ Quick Scan+
(Ultra Low Dose) 16 x 10 0.6 4.8, reduced mA 79.6
Arches/TMJ HD 16 x 10 0.25 26.9 985.6
Mandible 16 x 6 0.3 8.9 291.4
biased for mandible
Maxilla 16 x 6 0.3 8.9 302.9
biased for maxilla
Mandible HD 16 x 6 0.2 26.9 611.6
biased for mandible
Maxilla HD 16 x 6 0.2 26.9 605.2
biased for maxilla
Arches - small 8x8 0.3 8.9 239
Arches - small Quick Scan
(Low Dose) 8x8 0.3 4.8 134.8
Arches - small Quick Scan+
(Ultra Low Dose) 8x8 0.6 4.8, reduced mA 40
Arches - small HD 8x8 0.2 26.9 500.8
Arches - small UltraHD 8x8 0.125 26.9 500.8
Mandible - small 8x5 0.3 8.9 168
biased for mandible

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Selecting a Protocol

i-CAT FLX V17 Favorites


Volume Size Voxel Scan Time DAP
CT Favorite Name (Diameter x Height) (mm) (Seconds) (mGy cm2)
Maxilla - small 8x5 0.3 8.9 168
biased for maxilla
Mandible - small UltraHD 8x5 0.125 26.9 341
biased for mandible
Maxilla - small UltraHD 8x5 0.125 26.9 341
biased for maxilla
SureSmile Dentition/Full 16 x 13 0.25 26.9 1257
(acquisition and reconstruction)

Second reconstruction follows at: 16 x 8 0.2 n/a n/a


(no manual reprocessing required)
SureSmile Dentition/Full Quick Scan 16 x 13 0.25 14.7 659.9
(Low Dose) (acquisition and
reconstruction)

Second reconstruction follows at: 16 x 8 0.2 n/a n/a


(no manual reprocessing required)
SureSmile Dentition 16 x 8 0.2 26.9 797.4
SureSmile Dentition Quick Scan
(Low Dose) 16 x 8 0.2 14.7 444.3
kVp / Scan Time DAP
PAN Favorite Name Projection mA (Seconds) (mGy cm2)
Panoramic - enhanced Standard 94 / 5 20.0 146.4
Panoramic - small enhanced Standard 84 / 5 18.3 91
Panoramic Standard 94 / 5 20.0 146.4
Panoramic - small Standard 84 / 5 18.3 91

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i-CAT FLX V10 Favorites


Volume Size Voxel Scan Time DAP
CT Favorite Name (Diameter x Height) (mm) (Seconds) (mGy cm2)
Airway Quick Scan (Low Dose) 16 x 10 0.3 4.8 278.1
Airway i-clAIRityTM 16 x 10 0.6 4.8, reduced mA 79.6
Arches/TMJ 16 x 10 0.3 8.9 501.3
Arches/TMJ Quick Scan (Low Dose) 16 x 10 0.3 4.8 278.1
Arches/TMJ Quick Scan+
(Ultra Low Dose) 16 x 10 0.6 4.8, reduced mA 79.6
Arches/TMJ HD 16 x 10 0.25 26.9 985.6
Mandible 16 x 6 0.3 8.9 291.4
biased for mandible
Maxilla 16 x 6 0.3 8.9 302.9
biased for maxilla
Mandible HD 16 x 6 0.2 26.9 611.6
biased for mandible
Maxilla HD 16 x 6 0.2 26.9 605.2
biased for maxilla
Arches - small 8x8 0.3 8.9 239
Arches - small Quick Scan
(Low Dose) 8x8 0.3 4.8 134.8
Arches - small Quick Scan+
(Ultra Low Dose) 8x8 0.6 4.8, reduced mA 40
Arches - small HD 8x8 0.2 26.9 500.8
Arches - small UltraHD 8x8 0.125 26.9 500.8
Mandible - small 8x5 0.3 8.9 168
biased for mandible
Maxilla - small 8x5 0.3 8.9 168
biased for maxilla
Mandible - small UltraHD 8x5 0.125 26.9 341
biased for mandible
Maxilla - small UltraHD 8x5 0.125 26.9 341
biased for maxilla
kVp / Scan Time DAP
PAN Favorite Name Projection mA (Seconds) (mGy cm2)
Panoramic - enhanced Standard 94 / 5 20.0 146.4
Panoramic - small enhanced Standard 84 / 5 18.3 91

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Selecting a Protocol

i-CAT FLX V10 Favorites


Volume Size Voxel Scan Time DAP
CT Favorite Name (Diameter x Height) (mm) (Seconds) (mGy cm2)
Panoramic Standard 94 / 5 20.0 146.4
Panoramic - small Standard 84 / 5 18.3 91

i-CAT FLX V8 Favorites


Volume Size Voxel Scan Time DAP
CT Favorite Name (Diameter x Height) (mm) (Seconds) (mGy cm2)
Arches - small 8x8 0.3 8.9 239
Arches - small Quick Scan
(Low Dose) 8x8 0.3 4.8 134.8
Arches - small Quick Scan+
(Ultra Low Dose) 8x8 0.6 4.8, reduced mA 40
Arches - small HD 8x8 0.2 26.9 500.8
Arches - small UltraHD 8x8 0.125 26.9 500.8
Mandible - small 8x5 0.3 8.9 168
biased for mandible
Maxilla - small 8x5 0.3 8.9 168
biased for maxilla
Mandible - small UltraHD 8x5 0.125 26.9 341
biased for mandible
Maxilla - small UltraHD 8x5 0.125 26.9 341
biased for maxilla
kVp / Scan Time DAP
PAN Favorite Name Projection mA (Seconds) (mGy cm2)
Panoramic - enhanced Standard 94 / 5 20.0 146.4
Panoramic - small enhanced Standard 84 / 5 18.3 91
Panoramic Standard 94 / 5 20.0 146.4
Panoramic - small Standard 84 / 5 18.3 91

NOTE:
• 8 x 5 and 8 x 8 scans capture a smaller field of view. Use a larger volume size when the
anatomical area being scanned is greater than 8 x 5 or 8 x 8.

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• You can build a custom protocol for a CT scan and save it as a favorite, as described in
Build a Custom Protocol Workflow in SmartScan STUDIO (page 6-24).
• Default PAN protocols have both an enhanced and non-enhanced version. The
enhanced protocols apply a filter during image processing and typically provide a better
image. If you reprocess any PAN scan, this filter will not be applied.
• You can add or remove protocols from the protocol menu. Refer to Using Favorites
Manager (page 8-4).

Choosing the Best Scan Option for the Patient


To acquire the best scans, select the appropriate scan protocols and options for the patient and
the case. Use the following guidelines when selecting scan options:
• A longer scan time results in better image detail, but more dose to the patient. No
patient movement will ensure best results.
• A shorter scan time results in less dose to the patient.
• Collimate down whenever possible for optimal image quality.
• Use a Quick Scan option if the patient is prone to movement during the scan.
• For pediatric patients, use a Quick Scan or Quick Scan+ option to reduce the scan time
and dose. Select a protocol that provides adequate image quality at the lowest possible
dose.
• For Ears, Nose, Throat imaging, use 3D Ceph (Standard, Expanded, or Quick Scan).
For Nose only imaging, use Arches/TMJ (Standard or Quick Scan).
• One option does not fit all: keep dose as low as reasonably achievable.
• Always choose scan options before positioning the patient.

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Selecting a Protocol

Resolution Scan Time


Scan Type Height (cm) (voxel size) (seconds)

Follow Up V17: 13, 11,


Progress Records 10, 8, 6, 5, 4
Quick Scan+
Quick Scan TMJ 0.6, 0.4, 0.3* 4.8
(Lower Dose) 3rd Molars V10: 10, 8,
Children 6, 5, 4
Prone to Movement
Cephalometrics V8: 8, 5
Ears, Nose, Throat

V17: 13, 11,


Implants 10, 8, 6, 5, 4
Standard 3rd Molars 0.4, 0.3* 8.9
Cephalometrics V10: 10, 8,
Ears, Nose, Throat 6, 5, 4

V8: 8, 5

Endo V17: 13, 11,


Quick Scan HD Root Fractures 10, 8, 6, 5, 4 0.25, 0.2*, 14.7
HD Pathology 0.125 26.9
(Hi Resolution) Impactions V10: 10, 8,
Supernumerary 6, 5, 4
Periodontal Conditions
V8: 8, 5

Cephalometrics for Large Skulls 0.3 Enhanced* 17.8


Expanded 3D
Ceph Orthognathic Surgery V17 only: 17
Ears, Nose, Throat 0.3, 0.4 8.9

*suggested option
NOTE: See the i-CAT website for information about the use of 3rd Party software with the i-CAT.

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Chapter Positioning the Patient


5
Patient Positioning For CT Scans - At A Glance

Position the patient for minimal movement and maximum image quality. To prevent patient
movement:
• When possible, use the head support, strap and chin cup.
• Stabilize patient’s feet with a foot stool if needed.
• If shoulder clearance is a concern, lower the chair elevation and tilt chin up.
• Do a Dry Run to test for shoulder clearance.

1. Adjust chair height. Tips:


Chair seat is typically If Gate won’t close:
in top slot. Set • Use the head support/strap
elevation with without the chin cup. Keep gate
horizontal laser light open and remove metal chin
at patient’s smile line. support mechanism.
OR
2. Close the gate. • Take out head support and use
just the chin cup.
3. Ensure the patient’s OR
chin is sitting • Slide patient slightly forward
comfortably yet firmly allowing room to lean back into
in the chin cup. scanner with chair in upper slots.

4. Secure patient in For Orthodontics:


head support and • Use just head support/strap so
attach head strap the chin cup is not visible.
around forehead. Remove metal chin support
mechanism.
5. Adjust tilt of jaw. Instruct Patient Prior to Scan
Occlusal plane
should be horizontal. • Do not swallow during the scan.
External reference: • Slow shallow breaths during the
tragus-ala line scan.
horizontal. • Close eyes during the scan.
• Stay as still as possible.

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i-CAT FLX User Manual

Patient Positioning For PAN Scans - At A Glance

1. Place chair in the upper slots so that chair back does not impede
patient’s ability to sit with an erect posture.

2. If head support is installed, loosen locking knob and remove head


support. Slide PAN head holder into place and tighten locking knob.

Temple Locking
Pads Knob
3. Insert the narrow edges of bite tip down into bite tip holder uprights.
Turn the bite tip a ¼ turn to lock into place.
Narrow 4. Insert the chin rest and bite tip holder into the positioning block.
Edge
5. Seat the patient in the chair with an erect posture. The neck must be
stretched up and as straight as possible to avoid the spine getting in
the view. Close the gate.

6. Adjust chair height so that the


Patient Tilted patient’s chin is on the chin rest,
Downward but erect posture is maintained.
10o
7. Tilt the patient’s head downward
so that the occlusal plane forms
Horizontal Laser roughly a 5o to 10o angle to the
Occlus horizontal laser line.
al Plan
e
8. Use the sagittal laser (front center
laser) to ensure that the patient is
centered and facing straight
Bite Tip forward.
Chin Rest Holder

9. Instruct patient to bite in the groove of the bite tip and to close lips around the bite tip as if using a straw.
Adjust height of bite tip holder as needed.
10. Close head holder arms so temple pads fit to patient’s temples. If necessary, loosen head support knob
and adjust head holder forward or backward as needed to fit head holder to patient. Tighten knob.

11. Instruct patient to swallow and hold, put the tongue to the roof of the mouth and hold for the duration of
the exposure.

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Positioning the Patient

Patient Positioning - in Detail

Positioning the patient properly and minimizing patient movement are the keys to optimal scan
results. Several scanner features can be used to assist with patient positioning to ensure that all
intended anatomical attributes are in the field of view, including those of ENT interest.
The figure below shows the location of these features and the order in which they are generally
used to position a patient.

5. Use Laser Lights to 4. Adjust Head Support and


check positioning use Head Strap as needed

2. Close Gate
3. Adjust Chin
Support and
Chin Cup as
1. Adjust Chair needed
Height

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i-CAT FLX User Manual

Patient Chair

Patient Align
Buttons

Sensor Panel

Gate

Chair
Mounting
Slots

There are two sets of mounting slots for the chair. Use the following table as a guideline for
initial placement of the chair:

Patient Height Chair Position


6’ 0” and Taller Lower Slots
Under 6’ 0” Upper Slots

NOTE: Ensure chair is fully seated in slots to prevent movement when chair is used.
The chair height can be adjusted using the PATIENT ALIGN buttons on Patient Alignment
Panel. These controls allow movement of the chair, up (!) and down ("), to facilitate patient
alignment with the chin support.
Other factors to consider when positioning the patient in the chair are:
• Very tall patients (over 7’) may be required to slide down in the chair to gain the
proper alignment with the sensor panel.
• Shorter adults or children may require a foot stool to stabilize the feet.
• Children may need a booster seat to gain proper alignment.

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Positioning the Patient

Gate
The gate swings open to allow patient seating. The patient should be seated facing forward
with hands in lap.
NOTE: Closing the gate creates a pinch point. Keep hands and other body parts clear when
closing gate.
Close gate prior to scanning, making sure the magnet is secured in its locked position. If gate
will not close:
• Move head support to the rearmost position. With chair in the upper slot, have
patient slide forward in seat and then lean back into scanner.
• Use head strap without the chin cup.
• Keep gate open and remove entire chin support.

Chin Support
The chin support is comprised of several
components to help facilitate correct
positioning of the patient for CT scans.
For most studies, the chin cup should be
aligned with the bottom of the sensor
panel.
To Adjust the Chin Cup: Chin Cup

1. Insert the slide in the slide block.

2. Insert the chin cup.

3. Raise or lower the chin cup to


desired height, then tighten
adjusting knob to secure in
place. Slide Adjusting Knob

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Head Support and Head Strap

Head Support
Locking Knob

Head Support

Head Support
Adjusting Knob

The head support slides forward or backward for head stabilization. The patient’s head
should be supported firmly between the chin cup and head support. Loosen the head support
adjusting knob, then use the knob to slide the head support forward or backward to move it
into the proper position. When positioned, tighten knob.
A head strap can also be used to help stabilize the head. A velcro head restraint kit comes
with the scanner. For initial use of the head strap, the velcro pads in the kit must be attached
to the back of the head support.
For PAN scans, use the PAN head holder to support the patient’s head.

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Positioning the Patient

To Install Velcro Pads:


Velcro Pads
1. Loosen the locking knob and remove the head
support.

2. Attach pads and, if necessary, trim to fit.

3. Insert head support and tighten locking knob.

To Use the Head Strap:

1. Attach one end of the head strap to one side of


the head support.

2. Wrap head strap around patient’s forehead and


secure to other side of head support.

For scans that are specific to TMJ or orthodontics, only the head support and head strap
should be used. It is recommended that the chin support not be used because it can affect
the Condylar position in Fossa and interfere with soft tissue at the chin.
NOTE: The gantry does not move into position for a selected protocol until the Scan button
is pressed. The crosshair laser may not be beneficial to patient positioning until a Scout or
Scan has been performed for the selected protocol.

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Alignment Light

Alignment Sagittal Laser Light


Light Button

Crosshair Laser Light

NOTE: 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.
The Alignment Light button projects a horizontal and vertical crosshair laser light from the
side of the scanner and a vertical Sagittal laser light down the center of the chair to assist with
patient positioning. Pressing the button turns on the laser alignment lights for two minutes, or
until the button is toggled off.
In general, the alignment lights should be positioned as follows:
• Horizontal light - Position at the Occlusal Plane between the lips (smile line).
• Vertical light - Position at 1.5 inches in front of condyles.
• Sagittal light - Typically runs down the center of the patient’s head and the chin
support.
The position of the horizontal alignment light may vary slightly depending on the patient’s
position and the selected height of scan. Final position of the vertical alignment light may also
vary, depending on patient’s anatomy and if the full soft tissue profile is desired.

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Positioning the Patient

Occlusal Plane Flat,


Frankfurt Plane tilted
up slightly.

Position of Alignment Lights:


Horizontal: Occlusal plane between the lips.
Vertical: 1.5 inches in front of condyle (chin support adjusted to acquisition position).

Scouts and Dry Runs


NOTE: Scout scans and Dry Runs are described in detail in the Taking a Scan chapter.
It is recommended that a Scout scan be performed to verify patient positioning. A Scout scan
exposes the patient to a fraction of a second of radiation, but provides an image that can be used
to verify that the patient is positioned to capture desired field of view (FOV).
A Dry Run is recommended for patients who want a demonstration of the machine motion, and
to check shoulder clearance. A Dry Run simply rotates the gantry in the exact manner that is
required for the selected protocol, but does not expose the patient to any radiation.

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i-CAT FLX User Manual

Instruct Patients Prior to the Scan


Inform patients of what to expect during a scan so that they are prepared and avoid movement
during the scan.
NOTE: When working with pediatric patients, explain carefully the following instructions.
• The gantry rotates around the head during the scan.
• The exposure buzzer sounds for the duration of the rotation.

Instruct patients to perform the following prior to or during the scan:


• Remove all metal objects from the shoulders up, including glasses.
• Place hands in lap or hold on to the bottom of chair.
• Do not swallow during scan.
• Breathe through nose during scan.
• Stay as still as possible until the gantry has finished moving.
• Close eyes during scan.
• Keep teeth gently together and in same position.
NOTE: Always use a lead apron on the patient when taking a scan.

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Chapter Taking a Scan


6
Scanning Workflow in SmartScan STUDIO

SmartScan STUDIO uses a simple touch screen interface that enables you to quickly take a scan
for a patient exam. The typical workflow guides you through the following steps.

Step Purpose Display

1 Choose a Patient Exam (page 6-8)

2 Choose a Protocol (page 6-9)

3 Choose Type (page 6-12)

4a Perform a Dry Run (page 6-13) (optional)

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i-CAT FLX User Manual

4b Perform a CT Scout Scan (page 6-14)

OR Perform a PAN Scout Scan (page 6-21)

4c Perform a Scan (page 6-17)

5 Review Exam Images (page 6-18)

OR Review PAN Image (page 6-22)

6 Complete/Incomplete Exam (page 6-23)

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Taking a Scan

Using SmartScan STUDIO Step-by-Step

Use the following step-by-step instructions for the desired workflow:


• Perform a CT Scan (page 6-3)
• Perform a PAN Scan (page 6-5)
• Build a Custom Protocol (page 6-7)

Perform a CT Scan
1. In SmartScan STUDIO, select exam entry in scheduled exams list.

2. Press to access protocols.

3. Select desired protocol.

4. Review scan protocol information in header.

5. Position patient for scan. Refer to Patient Positioning For CT Scans - At A Glance.

6. Press to continue.

7. Select (scout scan) and press to continue. The scanner initializes.

8. Instruct the patient to hold still, swallow before the scan, take shallow breaths during
the scan and close his/her eyes so as not to follow the gantry during the scan.

9. When prompted, press the Scan button on the operator control box.
An audible alarm is sounded and the X-ray ON light is illuminated during radiation
exposure. The scanner acquires the data and creates the images.

CAUTION
If the optional deadman handswitch is installed on the scanner, press and hold
handswitch before pressing the Scan button, and continue to hold handswitch down for
the duration of the exposure (X-ray light on). Early release of the handswitch stops the
exposure and the Fault light turns on. The patient will have to be re-scanned.

10. Review scout image. To ensure the scan captures the entire anatomy desired, the
anatomy should appear within a 1 cm border of the edge of the scout scan. Use
visualization controls as needed.

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i-CAT FLX User Manual

11. If patient position is not correct, re-position patient or use Front/Back slider control
or up/down buttons to move panel into proper position.

Press and repeat steps 7 - 10 to perform another scout.

12. If patient position is correct for scan, press .

13. Select (full scan) and press to continue. The scanner initializes.

14. Instruct the patient to hold still, swallow before the scan, take shallow breaths during
the scan and close his/her eyes so as not to follow the gantry during the scan.

15. When prompted, press the Scan button on the operator control box.
An audible alarm is sounded and the X-ray ON light is illuminated during radiation
exposure. The scanner acquires the data and creates the images.

CAUTION
If the optional deadman handswitch is installed on the scanner, press and hold
handswitch before pressing the Scan button, and continue to hold handswitch down for
the duration of the exposure (X-ray light on). Early release of the handswitch stops the
exposure and the Fault light turns on. The patient will have to be re-scanned.

16. Review image to ensure adequate quality. The view on the right side of the screen
rotates to provide a quick check of the image. Use controls as needed to aid with
visualization.

17. Press to continue.

18. If CT scan is not acceptable, reposition and re-scan the patient.

19. If CT scan is acceptable:


• Ensure scanner is reset.
• Remove the head strap and move head support back.
• Ask patient to sit back out of chin cup, open the gate gently and release the
patient.

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Taking a Scan

Perform a PAN Scan


1. Prepare the scanner for a PAN scan. Refer to Patient Positioning For PAN Scans -
At A Glance.

2. In SmartScan STUDIO, select exam entry in scheduled exams list.

3. Press to access protocols.

4. Select a protocol.

5. Position patient for scan. Refer to Patient Positioning For PAN Scans - At A Glance.

6. Select (scout scan) and press to continue. The scanner initializes.

7. Instruct the patient to swallow and hold, put the tongue to the roof of the mouth and
hold for the duration of the exposure.

8. When prompted, press the Scan button on the operator control box.
An audible alarm is sounded and the X-ray ON light is illuminated during radiation
exposure. The scanner acquires the data and creates the images.

CAUTION
If the optional deadman handswitch is installed on the scanner, press and hold
handswitch before pressing the Scan button, and continue to hold handswitch down for
the duration of the exposure (X-ray light on). Early release of the handswitch stops the
exposure and the Fault light turns on. The patient will have to be re-scanned.

9. Review scout scan to ensure the following:


• Verify patient is positioned properly at a 10o
angle. Press and drag the button for the
Occlusal (yellow) plane line to position it over
the patient’s Occlusal plane on the scout scan.
The line should roughly align from the back of
the smile line to the point where the patient is
biting on the bite tip. Use the slide controls to
adjust the brightness and contrast buttons as
needed.

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i-CAT FLX User Manual

• Ensure bite tip is horizontal and bite tip holder is vertical.


• Ensure patient’s lips are together and both upper and lower teeth are in notches
of the bite tip.
• Ensure chin is not cut off or too low. Leave a 5 mm gap between the lower
border of the chin and border of the scout scan.

10. If patient position is not correct, use Patient Alignment Panel buttons to lower or raise
the chair. To lower the degree of the angle, lower the chair. To raise the degree of the
angle, raise the chair. You may need to adjust the head holder and bite tip holder
appropriately.

Press and repeat steps 6 - 9 to perform another scout.

11. If patient position is correct for scan, press .

12. Select (full scan) and press to continue. The scanner initializes.

13. Instruct patient to close lips around the bite tip as if using a straw, swallow and hold,
put the tongue to the roof of the mouth and hold for the duration of the exposure.

14. When prompted, press the Scan button on the operator control box.
An audible alarm is sounded and the X-ray ON light is illuminated during radiation
exposure. The scanner acquires the data and creates the images.

CAUTION
If the optional deadman handswitch is installed on the scanner, press and hold
handswitch before pressing the Scan button, and continue to hold handswitch down for
the duration of the exposure (X-ray light on). Early release of the handswitch stops the
exposure and the Fault light turns on. The patient will have to be re-scanned.

15. Review image to ensure adequate quality. Use controls as needed to aid with
visualization.

16. Press to continue.

17. If PAN scan is not acceptable, reposition and re-scan the patient.

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Taking a Scan

18. If PAN scan is acceptable:


• Ensure scanner is reset.
• Press the Push to Release lever on the head holder to open the arms. Do not
manually force arms open. Open gate.
• Ask patient to sit back out of bite stick and chin rest, open the gate gently and
release the patient.
• If you are done performing PAN scans, remove head holder and re-install the
head support.

Build a Custom Protocol


Refer to Using Favorites Manager (page 8-4) for information about managing protocol
favorites.

1. Access protocol screen and select .

2. From filmstrip, select anatomy to be captured. Press .

3. Select resolution for the scan. Press .

4. Select dose for the scan. Options available vary based on selections made in the two
previous steps.

5. Press . On dialog box, enter a unique name for the protocol. Press
to save custom protocol. Default values for acquisition type will be used.
NOTE: To save a scout scan as the acquisition type, select on Choose Type, then
follow step 5 above to save the protocol.

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i-CAT FLX User Manual

SmartScan STUDIO Details

Choose a Patient Exam

Select a patient exam from the exam list.


The list shows all exams currently scheduled. Exam requests are scheduled on a clinical
workstation using SmartScan STUDIO or DEXIS.
Touch and drag to scroll through the list as needed and select an exam entry.

Continue with selected exam.


Go to Utilities.

Note: This is the only user access point to the Utilities menu.
Exit the application. A confirmation dialog box results.
to confirm exit or to cancel and return.

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Taking a Scan

Choose a Protocol

V17 Option

V10 Option

V8 Option

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i-CAT FLX User Manual

Select a protocol to use for the exam. Touch and drag to scroll through the options as needed.
The scan parameters defined for the protocol are displayed in the header.
The protocol menu includes both default and custom protocols. Default protocols are
provided with SmartScan STUDIO. Custom protocols are user-defined protocols created
using the Build a Custom Protocol Workflow in SmartScan STUDIO (page 6-24).

Header Parameter Definition


Logged in as User name of current user.
Patient Name Name and date of birth of patient selected.
Total absorbed dose of all scouts and scans taken during
this patient’s current exam session in DAP (dose area
Total Exam DAP product) mGy*cm2 (milliGray centimeters squared).
Modality Type of exam requested: PAN or CT.
Volume Size (CT) Diameter and height of scan in centimeters.
Projection (PAN) Standard or Small
Voxel Size (CT) 0.6, 0.4, 0.3, 0.25, 0.2, or 0.125 in millimeters.
Patient Size (PAN) Large or Small
Total scan time in seconds. For CT scans, X-rays are
Scan Time pulsed. Patient is not exposed to X-rays for the entire scan
time.
Protocol Name Name of protocol selected.
Exposure Time Length of time in seconds of the exposure.
kV KiloVolt setting for the scan.
mA MilliAmpere setting for the scan.

Scan DAP Scan, scout, or dry run dose in DAP mGy*cm2.


Scout DAP The DAP value for a dry run is 0.
Dry Run DAP

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Taking a Scan

Continue with selected protocol.


Go back and select another exam. A confirmation dialog box
results.
to confirm or to cancel and return to current exam.

Create a custom protocol for a CT scan. Refer to Build a Custom


Protocol Workflow in SmartScan STUDIO (page 6-24).

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i-CAT FLX User Manual

Choose Type

Select a scan type.

Dry Run (not available for PAN scans or Utilities) - rotates the
gantry in the exact manner that is required for the selected
protocol, but does not expose the patient to any radiation. Use a
Dry Run to give the patient a demonstration of the machine motion
and/or to check shoulder clearance. DAP value for a dry run is 0.
Scout Scan - preview scan that exposes the patient to a small
amount of radiation. It is used to check that the patient is properly
positioned to capture the desired anatomy for the scan. DAP value
for the scout scan is displayed in the header.
Full Scan - full scan used for diagnostic purposes. This can be
either a CT scan or a PAN scan. DAP value for the scan is
displayed in the header.

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Taking a Scan

Continue with selected type. The scanner initializes.


You have two minutes to press Scan on the operator control box
before the scanner times out. If the scanner times out, the scan is
incomplete. Begin the workflow again.

Go back to select a different protocol.

Perform a Dry Run

Position patient for the scan. Instruct the patient that the gantry will rotate to check for
clearance, but no images will be acquired. DAP value is 0 for a dry run.

Continue to Choose Type.

Cancel scan and exit workflow. Dry Run is complete.

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i-CAT FLX User Manual

Perform a CT Scout Scan

V17 Option

V10 Option

V8 Option

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Taking a Scan

Take a scout scan to check for proper patient positioning to ensure desired anatomy will be
captured.
Instruct the patient to hold still, swallow before the scan, take shallow breaths during the scan
and close his or her eyes.
If multiple scouts are taken during a patient session, the cumulative DAP value is displayed
in the header under Total Exam DAP.
To ensure the scan captures the entire anatomy desired, the anatomy should appear within
a 1 cm border of the edge of the scout scan.

Continue to Choose Type.

Cancel scan and exit workflow. Scout scan is complete.


Adjusts the shutter position to move the field of view up or
down to help capture intended anatomy. Buttons are not
active on larger field of view protocols.

Center line indicates center of X-ray beam. Line is not user


interactive.

Page through scout scans captured during current patient


session.

Save custom scan parameters (anatomy, resolution, dose,


and acquisition type). On dialog box, enter a unique name
for the protocol.

to save custom protocol or to cancel.

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i-CAT FLX User Manual

Moves panel back or front. Can be used after a scout scan


has been taken to adjust the field of view to ensure anterior
or posterior anatomical attributes are captured without
repositioning the patient.
Slider position indicates where the next scan will be taken.
Arrow indicates panel position when a scout image is
captured. Useful when multiple scouts are captured as it
provides a point of reference for adjustment.

Adjusts brightness of image.

Adjusts contrast of image.

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Taking a Scan

Perform a Scan

Take a full scan when patient is properly positioned.


Instruct the patient to hold still, swallow before the scan, take shallow breaths during the scan
and close his or her eyes.

Displays when an HD, Standard, or Enhanced CT scan is acquired.


Toggle to view first and last frame of scan to check for patient
movement. Frames are the same if the patient did not move.
Consider re-scan if movement is detected.
Cancel image processing. Displays until image creation is
complete. Patient has been exposed to X-rays.

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i-CAT FLX User Manual

Review Exam Images

V17 Option

V10 Option

V8 Option

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Taking a Scan

Review image to ensure a quality scan was acquired.


Use controls as needed to help with visualization.

Continue to Complete dialog box with


options for next scan.
Adjusts brightness of image directly above
slider. Individual controls are provided for
left and right image display.
Adjusts contrast of image directly above
slider. Individual controls are provided for
left and right image display.

Toggle to display or hide axial indicator


line.
MIP View (maximum-intensity projection).
Initial view after scan completes.

Right view rotates continuously from


Left Viewport Right Viewport
-90o to +90o position to provide a quick
Axial MIP
check of the image. Touch image to stop
the rotation (cannot be restarted).

Image can be rotated manually with a


swipe.

Axial Slice MIP Rotation Drag indicator line in right viewport up or


down to view axial slices in left viewport.

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i-CAT FLX User Manual

Select Coronal View.

Drag indicator line in right viewport up or


Left Viewport Right Viewport down to view axial slices in left viewport.
Axial Coronal
Drag indicator line in left viewport up or
down to view coronal slices in right
viewport.

Axial Slice Coronal Slice

Select Sagittal View.

Drag indicator line in right viewport up or


Left Viewport Right Viewport down to view axial slices in left viewport.
Axial Sagittal
Drag indicator line in left viewport left or
right to view sagittal slices in right viewport.

Sagittal Slice
Axial Slice

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Taking a Scan

Perform a PAN Scout Scan

Take a PAN scout scan to check for proper patient positioning to ensure desired anatomy will
be captured.
Instruct the patient to close lips around the bite tip as if using a straw, swallow and hold, put
the tongue to the roof of the mouth and hold for the duration of the exposure.
If multiple scouts are taken during a patient session, the cumulative DAP value is displayed
in the header under Total Exam DAP.
Use yellow occlusal plane line control to help check for patient positioning.

Continue to Choose Type.

Cancel scan and exit workflow. Scout scan is complete.


Drag the yellow occlusal plane line control to position it
over the patient’s occlusal plane on the scout scan. The
line should roughly align from the back of the smile line to
the point where the patient is biting on the bite tip.

Page through scout scans captured during current patient


session.

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i-CAT FLX User Manual

Adjusts brightness of image.

Adjusts contrast of image.

Review PAN Image

Review PAN image to ensure a quality scan was acquired.


Use controls as needed to help with visualization.
NOTE: If an enhanced PAN image has unexpected artifacts, try reprocessing the PAN image,
which will remove the filter it was processed with. Refer to Reprocessing an Exam (page 8-3).

Continue to Complete dialog box with options for next scan.

Adjusts brightness of image directly above slider. Individual


controls are provided for left and right image display.

Adjusts contrast of image directly above slider. Individual


controls are provided for left and right image display.

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Taking a Scan

Complete/Incomplete Exam

Complete - Acquire workflow is completed for the exam.


Incomplete - Acquire workflow did not complete for the exam.

New Exam - Go to Scheduled Exams and select another exam.


Confirmation dialog box results.
to confirm or to cancel.

Same Exam - Continue with existing exam and return to the


protocol menu.

Close exam and logout. Exam is removed from Scheduled Exams


list.
to confirm or to cancel.

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i-CAT FLX User Manual

Build a Custom Protocol Workflow in SmartScan STUDIO

The Custom Protocol workflow enables you to build a custom protocol for CT scans by selecting
the anatomy (diameter and height), resolution (voxel size), and dose for the protocol.

Press on the protocol menu to start building a custom protocol.

Step Purpose Screen

1 Choose Anatomy (page 6-25)

2 Choose Resolution (page 6-28)

3 Choose Dose (page 6-29)

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Taking a Scan

Choose Anatomy

V17 Option

V10 Option

V8 Option

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i-CAT FLX User Manual

Select anatomy for the scan protocol. The Volume Size header parameter highlights the
selected value.
Scan DAP is not displayed until the dose is selected on the Choose Dose screen.

Options Available On
Anatomy Diameter x Height (cm) V17 V10 V8

Mandible - small 8 x 5 mandible X X X

Maxilla - small 8 x 5 maxilla X X X

Both Arches - small 8x8 X X X

Single Arch 16 x 4 X X

Mandible 16 x 6 mandible X X

Maxilla 16 x 6 maxilla X X

Both Arches 16 x 8 X X

Arches/TMJ 16 x 10 X X

Arches/TMJ - large 16 x 11 X

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Taking a Scan

3D Ceph 16 x 13 X

Expanded 3D Ceph 23 x 17 X

Continue to Choose Resolution.

Go back to Protocol menu.

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i-CAT FLX User Manual

Choose Resolution

Select resolution for the scan. Resolution options available depend on the anatomy chosen.
The Voxel Size header parameter highlights the selected value.
Scan DAP is not displayed until the dose is selected on the Choose Dose screen.

Select voxel size


(in millimeters).
0.6 0.4 0.3 0.25 0.2 0.125
Continue to
Choose Dose.
Go back to
Choose Anatomy.

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Taking a Scan

Choose Dose

Select the dose for the protocol.


The Scan Time, Exposure Time, kV, mA, and Scan DAP header parameters highlight the
resulting values based on the options selected on all custom protocol screens.
Options available vary based on custom protocol selections.
NOTE: V8 systems are limited to 8cm diameter scan options.
For 8cm and 16cm Diameter, 0.6 voxel scans:
Quick Scan+ - lowest dose scan mode. Uses a half rotation and reduced mA. Image clarity
is lower than Quick Scan.
For 8cm and 16cm Diameter, 0.3 and 0.4 voxel scans:
Quick Scan+ - lowest dose scan mode. Uses a half rotation and reduced mA. Image clarity
is lower than Quick Scan.
Quick Scan - lower dose than standard mode. Uses a half rotation. Image clarity is generally
lower than standard mode.
Standard - uses standard time settings for maximum image clarity.
For 8cm and 16cm Diameter, 0.125, 0.2 and 0.25 voxel scans:
Quick Scan HD - uses a shorter exposure time and delivers less dose to patient than HD
scan, but at a lower resolution.

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i-CAT FLX User Manual

HD - uses longer exposure time settings for high resolution image quality.
For 23cm Diameter, 0.3 and 0.4 voxel scans (V17 option only):
Standard - uses standard exposure time settings.
Enhanced - uses longer exposure time settings for maximum image quality.

Save selected scan parameters (anatomy, resolution, dose, and


acquisition type) as a custom protocol. On dialog box, enter a
unique name for the protocol.

to save custom protocol or to cancel.

Continue to Choose Type.

Go back to Choose Resolution.

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Chapter Opening Images


7
Introduction
Depending on your site’s workflow, you may use SmartScan STUDIO Manager, DEXIS software,
a Practice Management (PM) system, or SmartScan STUDIO Query/Retrieve (PACS) software
to access patient exam images.

Locate Exam Images in SmartScan STUDIO Manager


1. At the clinical workstation, start
SmartScan STUDIO Manager.

2. Select Exam List.

3. Locate the patient from the list. Use


the search feature as needed to help
find the patient.
4. Select arrow to expand the exam data
for the patient, then select the exam.

5. Double-click the desired exam.


Modalities are:
CT - Full CT (3D) scan
RAW_CT - Raw data from CT scan
(cannot be opened in
TxSTUDIO)
DX - Scout scan (2D image)
PX - PAN scan (2D image)

6. Exam opens in TxSTUDIO. For 2D


images, the images can be viewed,
but the 3D functions are turned off.

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i-CAT FLX User Manual

Locate Exam Images in DEXIS


NOTE: DEXIS is optional software and is not available in all countries.
If your site uses DEXIS Eleven (11.2), enter patient data in the DEXIS Administration program.
Refer to your DEXIS Software Manual for additional information.

1. In DEXIS, locate patient, then click to open the Extra-oral display.

2. Double-click the i-CAT box to start TxSTUDIO and load patient


exam.

3. View scan in TxSTUDIO.

Locate Exam Images in a Practice Management System


If your site uses a supported PM system to locate and retrieve images, the optional SmartScan
STUDIO PM interface software must be installed. This software enables your PM system to open
a patient exam acquired in SmartScan STUDIO with TxSTUDIO or Dolphin 3D viewer. If you have
more than one supported viewer on your workstation, you will be prompted to select the viewer
to use for each exam.
The PM interface was configured at installation. If you have a problem, you can check status
messages for the PM Interface at your site server. Go to Control Panel, select SmartScan
STUDIO Integration Services, then select the PM Interface tab.

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Opening Images

NOTE:
• If exams are not being returned to your PM system as expected, make sure that the
Disable All PM Exam Output checkbox is not checked.
• If an error prevents completed exams from being returned to the PM system, you can
reprocess the exam, and do not need to re-scan the patient. Refer to Reprocessing an
Exam (page 8-3).
PM Interface Status Messages

Message Action Possible Cause


The PM plugin is The service stopped or has not yet started
NOT running. (unexpected software error).
The file location is Check that site The PM.xml folder cannot be used by the PM
NOT accessible. servers and the interface because the folder path is invalid,
scanner controller are cannot be found, or Integration Services does
up and operational. not have authorized access.
Coordinate with your
The scanner is NOT The connection to the scanner controller
PM administrator and
reachable. cannot be established, usually because
Technical Support to
scanner controller is down or web service is
resolve issue.
not running.
The file location is The PM.xml folder is accessible, but the
accessible but no PM.xml file does not exist or no exam entry is
exam is submitted. found in the PM.xml file.
PM is requesting X Information only. A number of valid exam entries are found in
exam(s). the PM.xml; PM system is submitting exams.

Store and Retrieve Images on a PACS


If your site uses a PACS (Picture Archiving and Communication System) for storing images, you
may have the optional SmartScan STUDIO PACS software installed on your clinical workstations.
This software enables you to:
• monitor storage of exam images taken with SmartScan STUDIO on a PACS
• query for and retrieve exam images from a PACS, where they can be viewed with
TxSTUDIO or other supported viewers on a clinical workstation.

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i-CAT FLX User Manual

Monitor Image Storage from SmartScan STUDIO to a PACS


1. At the clinical workstation, start SmartScan STUDIO Manager.

2. Select Exam List and locate the study to be monitored.

3. In the PACS Status column, image status for a study is listed. Entries are:

Status Description
Sent Study sent to remote successfully.
Committed Storage commit performed successfully
Send Failed Failed to send study to PACS.
Commit Failed Study sent to PACS but failed to perform Storage Commit.

4. To manually queue a study to be sent to the PACS, select next to the study. The
following message is displayed: “Queuing study for sending to selected PACS,
Please wait.”
If the queue fails, the following message is displayed: “Failed to queue study for
sending to selected PACS. Please check network connectivity and if needed, call
Tech Support.”
5. If an image fails to be sent or committed successfully to the PACS, contact your local
PACS administrator.

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Opening Images

Retrieve Images from a PACS


1. Start SmartScan STUDIO
QR.

2. Query for patient studies by


entering one or more of the
following: Patient ID,
Accession Number, Last
Name, First Name,
Scheduled Procedure Start
Date Range (From – To),
Study ID.

3. Select Query. Query


results are listed. See table
below for status messages
that may be displayed in the
query field.

4. View results and select the desired entry from the list. Select Retrieve to retrieve
patient study and copy it to the local workstation where it can be opened in a
supported viewer (TxSTUDIO).

5. Select View Log as needed to review transactions that were completed or check for
failures. If a failure occurs, contact your local PACS administrator.

Query/Retrieve Status Messages

Message Action
PACS server list can not be No server configured for Q/R. Go to ‘Config’ option and
empty add Server configuration. Contact local PACS
administrator.
Invalid date range “From Date” value is more than “To Date” value.
Error in list view population. Error in one or more results while populating list view of
Please check log for error. the query results received.
No record found against request Cannot find patient(s) that matches the selected criteria.
Querying canceled by user Query canceled before completion.

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i-CAT FLX User Manual

Message Action
Querying Failed. Please check PACS QR was unable to communicate with the Server.
log for error. Please check logs for more details on error occurred.
Contact local PACS administrator.
Querying performed successfully. Requested Query was completed successfully.
Dataset retrieved successfully for Dataset with specified patient ID and modality retrieved
Patient ID: {0} with Modality: {1}. successfully.
Retrieving failed. Please check PACS QR was unable to communicate with the Server.
log for error. Please check logs for more details on error occurred.
Contact local PACS administrator.
Retrieving records, Please wait... PACS QR retrieving the results of Query requested.
Retrieving dataset, Please wait... PACS QR retrieving the requested Dataset.
Deleted. Selected server configuration deleted from the settings.
C-ECHO failed. PACS QR 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.
DICOM settings entry does not Specified server configuration does not exist. Contact
exist. local PACS administrator.
The AE title entered is no longer valid. Please enter a
Please enter valid AE title. valid AE title. Contact local PACS administrator.
Server configuration values entered for saving
configuration is not valid or is incomplete. Contact local
Invalid remote configuration. PACS administrator.
IP Address of the server is not valid as per IPv4
IP address entered is invalid. conventions.
Port number entered for saving remote server
configuration is not valid. Contact local PACS
Please enter valid port number. administrator.
Saved Server configuration saved successfully in Registry.
The station name field is left blank. Please enter a station
Please enter station name. name.

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Opening Images

Using TxSTUDIO
Refer to TxSTUDIO Reference Manual for information on using TxSTUDIO.

CAUTION
At installation, TxSTUDIO was configured to save all workup data to the workstation or a
common TxSTUDIO Cases folder. Do NOT save workup data to the ImageRoot folder,
as this will overwrite the original scan data.

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i-CAT FLX User Manual

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Chapter Calibration and Maintenance


8
Commonly-Used Utilities

The Utilities menu contains options for running various calibration and quality assurance tests, as
well as options for reprocessing an exam and managing protocol favorites that are user-created.

In SmartScan Studio, press to access the Utilities menu. The following are the most
commonly-used options. Refer to the i-CAT FLX Technical Guide for information on the other
Utilities menu options.

Option Description
PanelCal Panel calibration should be performed once a week.

ShutterCal Shutter calibration should be performed once a week to


ensure optimal image quality.

Reprocess Exam Reprocess an acquired scan for which there is raw data
available on the scanner controller.
Favorites Manager Options to manage protocol favorites.

CAUTION
If the optional deadman handswitch is installed on the scanner, press and hold
handswitch before pressing the Scan button, and continue to hold handswitch down for
the duration of the exposure (X-ray light on). Early release of the handswitch stops the
exposure and the Fault light turns on. The patient will have to be re-scanned.

Panel Calibration
It is recommended that Panel Cal be performed once a week.
The Panel Cal is performed in both landscape and portrait (V17 systems only) positions for
4 x 4 and 2 x 2 resolutions. Several tests run as part of the panel calibration. A pie chart
displays status.

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i-CAT FLX User Manual

Run Panel Calibration


1. Select PanelCal.

2. Ensure the field of view on the scanner is clear.

3. Press . The scanner initializes.

4. When prompted, press the Scan button on the operator control box. An audible alarm
is sounded and the X-ray ON light is illuminated during radiation exposure.

5. You will be prompted to press the Scan button for each test.
NOTE: The panel will rotate to the portrait position at the start of the portrait tests (V17
systems only).

6. When Panel Cal is complete, Calibration Complete is displayed.

7. Press to display Complete screen and select another option.

Panel Calibration Failure


If the calibration fails, the following message is displayed:
Panel Calibration Processing Failure

Press to exit.
Check that the field of view is clear of all objects and that there are no obstacles to the
rotation of the gantry. Re-run Panel Cal.
If failure persists, contact Technical Support.

Shutter Calibration
It is recommended that Shutter Cal be performed once a week to ensure optimal image
quality. This calibration is also necessary if a mechanical adjustment is made to the beam
limiter or if image quality has degraded.
The Shutter Cal runs several tests in both landscape and portrait (V17 systems only)
positions. A pie chart displays status.

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Calibration and Maintenance

Run Shutter Calibration


1. Select ShutterCal.

2. Ensure the field of view on the scanner is clear.

3. Press . The scanner initializes.

4. When prompted, press the Scan button on the operator control box. An audible alarm
is sounded and the X-ray ON light is illuminated during radiation exposure.

5. You will be prompted to press the Scan button for each test.
NOTE: The panel will rotate to the portrait position at the start of the portrait tests (V17
systems only).

6. When Shutter Cal is complete, Calibration Complete is displayed. Thumbnail


images of each Shutter Cal test are available to view.

7. If desired, select a thumbnail to view.

8. Press to display Complete screen and select another option.

Shutter Calibration Failure


If the calibration fails, the following message is displayed:
Shutter Calibration Processing Failure

Press to exit.
If prompted, re-run Panel Cal, then re-run Shutter Cal. Otherwise, check that the field of
view is clear of all objects and that there are no obstacles to the rotation of the gantry.
Re-run Shutter Cal. If failure persists, contact Technical Support.

Reprocessing an Exam
The Reprocess Exam list contains acquired scans for which there is raw data available on the
scanner controller. Raw data is maintained on the scanner controller for a short period of time.
The exam data is deleted from the scanner controller only when the data has been moved
successfully.

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It may be necessary to reprocess an exam if there is a problem with reconstruction of a scan


that was acquired successfully. CT exams are reprocessed using the same settings with
which they were acquired. PAN exams are reprocessed without the filter that may have been
applied during initial processing. The list is ordered with the most recent scan at the top of the
list.

1. Select Reprocess Exam.

2. Select an exam from the list and press . Image is created.

3. Review image. Refer to Review Exam Images (page 6-18) (CT scans) or Review
PAN Image (page 6-22) (PAN scans).

4. Press to go back to Reprocess Exam list.

Using Favorites Manager


The Favorites Manager enables you to change the order of protocols on the protocol menu,
and rename and delete favorites that were previously created. You can also choose to add
default protocols that were provided with SmartScan STUDIO.

Moves a selected favorite up or down in the list. This is the order the
protocols will appear in the protocol menu.

Enter a new name for selected favorite.

Delete selected favorite.


Displays a list of default favorites provided with SmartScan STUDIO.

Select a favorite and press to add it. May be necessary if a


default was deleted or renamed. Also, any new favorites that are added
to SmartScan STUDIO from a software update can be added to the
protocol menu with this option.

Go back to Utilities menu.

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Calibration and Maintenance

Routine Cleaning
Routinely clean and disinfect all items which come in contact with the patient, using one of the
products listed, or equivalent cleaner and disinfectant:
Opti-Cide3® Solution and/or Wipes from Biotrol International
CaviCide® from Metrex (DIN:02161656)
Saturate with disinfectant and allow surface to remain wet for three minutes at room temperature
(69oF / 20oC), and then wipe dry using a clean paper or cloth towel. See the label of the
disinfectant for full instructions.
The following items may come in physical contact with the patient during a scan:
• Patient Emergency Stop
• Head Support
• Chin Cup/Chin Rest
• PAN Head Holder
• Booster Seat/Foot Stool
• Bite Tips
Clean the equipment surfaces frequently, especially if corroding chemicals are present. Unless
otherwise instructed, use a cloth moistened with warm water and mild soap and wipe all surfaces
to remove surface dirt and marks. Do not use strong cleaners and solvents as these may damage
the finish. It is recommended to power off equipment before cleaning. Be careful to avoid liquid
leaking inside the gantry.

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Chapter Shutdown
9
Scanner Shutdown
Log out
1. Press . This button is accessible from Scheduled Exams or at the conclusion
of the scanning workflow.

2. On the logout confirmation dialog, press to close exam and log out. A menu
displays with the following options:
• Acquire - Start the scanning workflow.
• Technical Support - Access Technical Support website.
• Remote Assistance - Access website for remote Helpdesk assistance.

3. Press to log out of SmartScan STUDIO. The log in screen is displayed.

Power Off
1. Power off scanner: Press the OFF button on the operator control box.
The scanner shuts down and the POWER indicators on the operator
control box and scanner go OFF.

2. Power off scanner controller and touch screen: Press power button
on the touch screen to power off both the touch screen and scanner
controller. On the shutdown confirmation dialog, press to
shutdown.

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Appendix Safety Guidelines


A
Radiation Safety
The scanner provides a high degree of protection from unnecessary radiation. However, no
practical design can provide complete protection nor prevent operators from exposing
themselves or others to unnecessary radiation. It is important to restrict use and follow all
applicable government radiation protection regulations.
Pregnant women should not be exposed to X-rays unless necessary. Proper safety precautions
should be taken to minimize dose to the fetus.

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, especially for pediatric patients.
• Use protective clothing (lead apron, etc.) for all patients.
• When scanning children, be aware that, due to their physical constitution, they react
more sensitively to X-ray radiation.
• Wear a PEN dosimeter and/or film badge.
• The physician is responsible for protecting the patient from unnecessary radiation.

Safety Precautions

WARNING
Failure to follow instructions below may result in serious bodily injury or death.

• The X-ray scanner may be dangerous to the patient and operator if you do not
observe and follow operating instructions. Do not operate this scanner unless you
have received training to perform a procedure.
• The X-ray scanner may potentially cause detrimental interaction with active
implantable medical devices and body worn active medical devices. Contact the
manufacturer of such devices for more information.

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• Use of controls or adjustments or performance of procedures other than those


specified herein may result in hazardous radiation exposure.
• No modification of this scanner is allowed except by parties that are authorized by
the manufacturer. Use only the software and hardware provided with the scanner.
• Do not remove covers or cables on scanner or operate the scanner with any covers
open or removed. High voltage is present in the scanner. Operating the scanner
with open or removed covers could expose mechanical operating systems or
increase risk of electrical shock that could cause serious or fatal personal injury to
the operator or the patient. Only qualified and authorized service personnel should
remove covers from the scanner.
• To avoid any potential hazard or danger to operators and patients, contact your
authorized Service Representative immediately if you experience any unusual
operation, non-recoverable faults, or equipment malfunctions or failures.
• Laser beams can cause optical damage. Instruct the patient to close eyes to avoid
looking into the beam.
• Viewing the laser output with certain optical instruments (for example, eye lopes,
magnifiers and microscopes) within a distance of 100 mm may pose an eye hazard.
Viewing the laser output with certain optical instruments designed for use at a
distance (for example, telescopes and Binoculars) may pose an eye hazard.
• Always follow the manufacturer’s instructions for proper use and cleaning of the
scanner to prevent cross contamination among patients.
• Do not allow liquids in the vicinity of the scanner.
• Closing the gate creates a pinch point. Keep hands and other body parts clear when
closing gate.
• To avoid the risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.
• In the event of an electrical fire, only use extinguishers that are labeled for that
purpose. Using water or other liquids on an electrical fire can lead to fatal or 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.
• Equipment not suitable for use in the presence of a flammable anesthetic mixture
with air or with nitrous or oxygen enriched atmospheres.

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CAUTION
Failure to follow instructions below may result in minor or moderate bodily injury or
damage to the device.

• To attain optimal image quality, instruct patients to close their eyes, use shallow
breaths, stay as still as possible, and not swallow during the scan. Explain this
carefully to children.
• If the optional deadman handswitch is installed on the scanner, press and hold
handswitch before pressing the Scan button, and continue to hold handswitch down
for the duration of the exposure (X-ray light on). Early release of the handswitch
stops the exposure and the Fault light turns on. The patient will have to be re-
scanned.
• 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.

Safety Devices
Warning System
The scanner is equipped with provisions for warning lights and/or audible alarms when X-ray
power is energized.

Interlock System
The scanner is equipped with provisions for an interlock circuit which, when opened, will turn
off X-ray power. Use of the interlock circuit is optional based on site requirements.
The interlock circuit can be used for a door switch, a deadman handswitch, or both. If a door
switch is installed on the room door where the scanner is located, the exposure will stop if the
door is opened. If a deadman handswitch is installed, the handswitch must be pressed and
held through the duration of the scan. Early release will stop the exposure.

Emergency Stops
In the event of an emergency, the operator and/or patient should use the Emergency Stop
buttons to turn off the power to all moving parts in order for the patient to be safely removed
from the scanner. Emergency Stop buttons are located on the operator control box and the
Patient Emergency Stop control. An emergency could arise if any moving component collides

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with any parts of the scanner or items in the environment, or if the patient moves or needs
immediate assistance for some reason.

Emergency Removal of a Patient


1. Press an Emergency Stop button.
2. When you have determined that you can safely remove the patient, grasp and pull
the gate outward. Make sure the patient’s head will not touch the top of the gantry
and help the patient off the patient chair.
3. To reset an Emergency Stop button, turn button clockwise.
4. In SmartScan STUDIO, a message The Emergency Stop button was activated is
displayed. Ensure button is reset and patient environment is clear.
5. Press on the message dialog box. The scanner automatically recovers and
returns to a ready state.

Collision Recovery
1. In SmartScan STUDIO, a message A scanner stall was detected is displayed.
2. If a patient scan was in progress, determine that you can safely remove the patient,
then grasp and pull the gate outward. Make sure the patient’s head will not touch the
top of the gantry and help the patient off the patient chair.
3. If the collision was caused by obstructions in the area, not by a patient, clear all
obstructions.
4. Press on the message dialog box. The scanner automatically recovers and
returns to a ready state.

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Appendix Status Indicators and


B Operational Messages
Status Indicators
SmartScan STUDIO Manager displays three status indicators in the top, right-hand corner of the
display. Move the mouse over the indicator to display more detail about the status condition.
Scanner - indicates status of the connectivity between the
workstation running SmartScan STUDIO Manager and the scanner
controller.
Database -
• The first indicator shows status of the communication
between the workstation running SmartScan STUDIO
Manager and the SmartScan STUDIO Integration
Services web service.
• The second indicator shows status of the communication
between the workstation running SmartScan STUDIO
Manager and the Image Root folder.
If a status check fails, the status indicator changes to a red X.
Refer to i-CAT FLX Installation Manual for information on
troubleshooting failed status indicator conditions. Contact
Technical Support if an error persists.

Product Information
The current installed version number of SmartScan STUDIO can be accessed from the Login
screen.
On the Login screen, select to access the System Information window. This window displays:
• System Serial Number
• SmartScan STUDIO PC base image version
• SmartScan STUDIO software version

The currently installed version number of SmartScan STUDIO Manager can be found on the
SmartScan STUDIO Manager Settings window.
In SmartScan STUDIO Manager, select to access the Settings window.

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Operational Messages
SmartScan STUDIO may display system message in a dialog box. These messages may be
informational only or may indicate the need to recover from an error. Follow instructions in the
message dialog box. If problems persist after performing the indicated actions, call Technical
Support.

Message Action Possible Cause


The Emergency Stop button was Press OK once the E-Stop button E-Stop button pressed.
activated. is reset and Patient Environment
is ready to be reset.
The machine is turned off. Turn scanner on. Scanner powered off.
The system has timed out. Retry scan. Scan button not pressed within
two minutes after scanner
initialization.
Images were successfully saved. Information only. Raw data was captured and
saved.
Image processing was canceled Information only. If image User canceled image
by user. processing is desired, use processing.
Reprocess Exam.
A scanner stall was detected. Press OK once the Patient Scanner stall.
Environment is ready to be reset.

Images were successfully saved. If image processing is desired, User canceled image
Images can be reprocessed use Reprocess Exam. processing after successful
using the Reprocess Exam scan.
Feature.
X-ray exposure aborted due to Press Reset Scanner on dialog Door was opened or deadman
door opening or early release of box. When scanner is reset, handswitch was released
X-ray switch. initiate re-scan of the patient. during the exposure.

The scanner Ethernet cable was If possible, reconnect Ethernet Scanner Ethernet cable was
disconnected during scan. cable at back of scanner disconnected.
controller and back of scanner.
Initiate scan when operational.

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Message Action Possible Cause


A scanner fault was detected X-ray fault from X-ray
(1000) controller.
Follow instructions on dialog.
Scanner reset required (1001) Platform needs to be homed.
Scanner reset required (1002) Rotation needs to be homed.
A scanner fault was detected Beam limiter not initialized.
(1003)
A scanner fault was detected Panel position error.
(1004)
A scanner fault was detected X-ray tube short.
(1005)
A scanner fault was detected X-ray watchdog time-out.
(1006)

A scanner fault was detected Linux watchdog error.


(1007)

A scanner fault was detected Acquisition error.


(1008)
A QA fault was detected (1009) QA scan is invalid or corrupted.

QA MTF fault was detected Call Technical Support. Image Quality error. QA MTF
(1010) spatial resolution failed.

Panel Calibration fault detected Call Technical Support. Panel calibration gain medians
(1011) are out of range.
Scanner Reset Successful Information only. Recovery was successful.
Retry scanner reset? Try scanner recovery again if Scanner recovery failed.
desired.
Retry original scan? Continue with scan if desired. System has recovered, but
failure occurred prior to
obtaining scan.
Scanner reset failed. Call Technical Support. Recovery failed.

Disk space is insufficient. Please Call Technical Support. Insufficient disk space.
call Technical Support.

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Message Action Possible Cause

An error requiring special Call Technical Support. Problem creating recovery job.
assistance has been
encountered. Please call
Technical Support.

Patient information is missing. Call Technical Support. Patient information missing


Please call Technical Support. from scan.

An error occurred while retrieving Call Technical Support. Error retrieving raw data.
images. Please call Technical
Support.

An error in scan initiation was Call Technical Support. Acquisition error prior to
detected. pressing scan button.

An error in image processing was Call Technical Support. Reconstruction error or error
detected. processing recon output data.
A system error has occurred. Call Technical Support. Unknown error.
Device Not Calibrated. Please Device can be used, but it is Calibration should be
perform Calibrations. recommended that calibrations performed.
are performed.
Calibration Processing Failure Retry calibration. Call Technical Acquisition for calibration was
(Panel, Shutter, or Geometric) Support if calibration fails again. successful, but the
computations failed.
Please redo the PanelCal and Redo Panel Calibration, then Bad or out-of-date panel
then repeat the ShutterCal. redo Shutter Calibration. Call calibration results in shutter
Technical Support if issue is not calibration failure.
resolved.

Calibration (Panel, Shutter, or Follow instructions on dialog. Calibration completed


Geometric) was completed successfully, but recovery is
successfully. Scanner reset required.
required.

Calibration (Panel, Shutter, Chair Continue with calibration. Calibration completed


or Geometric) and Scanner successfully, and recovery
Reset Successful succeeds.
Retry (Panel, Shutter, Chair, or Continue with calibration. Calibration failed but recovery
Geometric) calibration? is successful.

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Message Action Possible Cause


Please calibrate the scanner. Call Run calibrations. Call Technical Requested shutter positions
Technical Support for additional Support if problem persists. are out of range from normal
assistance. sizes.
Continue with calibration? Continue with calibration if Current step of calibration
desired. completed successfully with
errors, but more steps are
required.
The phantom is not the correct Position the correct phantom. Wrong phantom or phantom is
type, or is not positioned Refer to the i-CAT FLX not centered.
properly. Installation Manual.
The phantom is tilted or not Position the phantom correctly. Phantom is not vertical or is not
centered. Refer to the i-CAT FLX centered.
Installation Manual.
The phantom is not centered. Position the phantom correctly. Phantom is not centered.
Refer to the i-CAT FLX
Installation Manual.
Calculated detector pivot out of Adjust detector pivot. Contact Detector pivot out of
range. Allowed: +/- xxx degrees Technical Support. adjustment.
Actual: yyy degrees.

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Manufactured by:

Imaging Sciences International LLC


1910 North Penn Road
Hatfield, PA 19440 USA
Tel: 1-215-997-5666
Fax: 1-215-997-5665

032-0329-EN Rev K 2016 August 1


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