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1. H1 9 1 xo ee gt 9 1 Appendix A Safety Guidelines Intended Use of the Scanner sseesesssssssssesseseeeen nennen nennen nnn nnne n as A 1 Radiation Safety PR RR RE TT A 1 Radiation Protection Measures ccccccecccseececeeeeeceeeceeeceeeeeeeeaeeceneeseeteneeseeeaueteneeaeesaees A 1 DAISY PEOCOIHOFIS paipera a AK ED lle bs pk e aen sud tod RR dM UE A 2 OIG LY DOV ICC sne A 3 MAVEN 15 Mr A 3 lasers qe A 3 ze MM caatibs A 4 Appendix B Status Indicators and Operational Messages Status Indicators RN B 1 PIOGUC pl 08 qnd eR NETT B 1 Operational Messages sivientcsdageewivcpsiionnowsd uae steeandacnunedediadubuuncidneswtianidenuelanadamenalvemalbcuusiesunas B 2 032 0329 EN RevE V I CAT FLX User Manual vi 032 0329 EN Rev E ud Introduction Welcome to Your New i CAT FLX Welcome to the i CAT 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
2. Review Exam Images Review PAN Image 6 2 032 0329 EN RevE Taking a Scan Using SmartScan STUDIO Step by Step Use the following step by step instructions for the desired workflow e Perform a CT Scan e Perform a PAN Scan e Build a Custom Protocol Perform a CT Scan 1 In SmartScan STUDIO select exam entry in scheduled exams list Press 9 to access protocols Select desired protocol Review scan protocol information in header Position patient for scan Refer to Patient Positioning For CT Scans At A Glance Press 9 to continue Select scoutscan and press 7 to continue The scanner initializes 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 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 A 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 shoul
3. 032 0329 EN RevE 5 3 I CAT FLX User Manual Patient Chair Patient Align N 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 A and down V 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 9 4 032 0329 EN RevE 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 i
4. 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 032 0329 EN RevE 5 9 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 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 5 10 032 0329 EN RevE Taking a Scan 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 Purpose Display 11 j Choose a Patient Exam Choose a Protocol Choose Type Perform a Dry Run optional 032 0329 EN RevE 6 1 I CAT FLX User Manual Perform a CT Scout Scan Perform a PAN Scout Scan Perform a Scan
5. 3D information is not required Disclaimer The above graphics are only representations The actual imaged anatomy is dependent on the size and position of the patient being scanned 032 0329 EN RevE 4 1 I CAT FLX User Manual Default Favorites Default protocol favorites are pre loaded in SmartScan STUDIO for CT and PAN scans l Volume Size Voxel Scan Time DAP CT Favorite Name Diameter x Height mm Seconds mGy cm 3D Ceph 16 x 13 0 3 8 9 623 9 3D Ceph Quick Scan 16 x 13 0 3 4 8 349 4 3D Ceph Quick Scan 16 x 13 0 3 4 8 99 2 reduced mA Arches small 8x8 0 3 8 9 239 Arches small Quick Scan 8x8 0 3 4 8 134 8 Arches small Quick Scan 8x8 0 3 4 8 40 reduced mA Arches TMJ 16 x 11 0 3 8 9 543 Arches TMJ Quick Scan 16 x 11 0 3 4 8 301 Arches TMJ Quick Scan 16 x 11 0 3 4 8 86 5 reduced mA Both Arches 16x8 0 3 8 9 388 9 Mandible 16x6 0 3 8 9 291 4 biased for mandible Maxilla 16x6 0 3 8 9 302 9 biased for maxilla Expanded 3D Ceph 23 x 17 0 3 17 8 877 6 SureSmile Dentition Full 16x13 0 25 26 9 1257 acquisition and reconstruction Second reconstruction follows at 16 x8 0 2 n a n a no manual reprocessing required SureSmile Dentition Full Quick Scan 16 x 13 0 25 14 7 659 9 acquisition and reconstruction Second reconstruction follows at 16x8 0 2 n a n a no manual reprocessing required SureSmile Dentition 16x8 0 2 26 9 797 4 Sure
6. Atthe clinical workstation start DEXIS Imaging Suite 2 Onthe DEXIS Administration screen select patient from list or enter search criteria to locate and select patient 3 Click o Extra oral 4 Click e A pop up message displays that patient is scheduled for acquisition 5 Click OK to dismiss pop up 032 0329 EN RevE 3 3 I CAT FLX User Manual 3 4 032 0329 EN RevE M Selecting a Protocol 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 e Multiple low dose scan settings provide responsible patient focused care FOV 8 cm x 8 cm FOV 16cmx4cm FOV 16cmx6 cm e Choose a height to narrow the moe image and the applied dose to only the anatomy of interest e 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 iix cm FOV 16 cm x 8 cm FOV 16 cm x 10 cm or mandible single arch both arches and temporomandibular joints cephalometric views and full skull e Customize the scan so patients anatomy is not exposed outside the selected field of view e Capture information critical to FOV 16cmx 11cm FOV16cmx13cm FOV 23 cmx 17 cm treatment through a clinically responsible approach that controls radiation exposure to NOTE Use the PAN 2D panoramic imaging the patient when CT
7. Exams or at the conclusion of the scanning workflow 2 On the logout confirmation dialog press x to close exam and log out A menu displays with the following options Acquire Start the scanning workflow Technical Support Access i CAT Technical Support website Remote Assistance Access website for remote Helpdesk assistance to log out of SmartScan STUDIO The log in screen is displayed 3 Press 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 ox to shutdown 032 0329 EN RevE 9 1 I CAT FLX User Manual 9 2 032 0329 EN RevE Safety Guidelines Intended Use of the Scanner The Imaging Sciences International ISI Inc i CAT scanner constructs a three dimensional model from images taken during a rotational X ray sequence The scanner is intended to be used whenever a dentist oral surgeon or other physician needs 3D information of high contrast objects The scanner is designed for imaging of TM joint studies mandible and maxilla for implant planning sinuses and other areas of the maxillofacial complex JA CAUTION U S Federal law restricts this device to sale by or on
8. Treatment Planning Software i CAT FLX The i CAT FLX is a Cone Beam Volumetric Tomography and Panoramic scanner 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 e Implants e TM Joints e Reconstructed Panoramic e Reconstructed Cephalometrics e Airway Sinus etc e Nerve Canal e PAN Optional Conventional Digital Panoramic Feature 032 0329 EN RevE Introduction i CAT FLX 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
9. Tx STUDIO Treatment Planning Software Tx STUDIO treatment planning software reconstructs 3D volume rendering from images acquired on the i CAT FLX Tx STUDIO is offered for exclusive use with the i CAT imaging system which is manufactured by Imaging Sciences Tx STUDIO may not be available in all regions 14 032 0329 EN Rev E mes Getting Started Workflow At A Glance iI CAT FLX and the software tools SmartScan STUDIO DEXIS or SmartScan STUDIO Manager and Tx STUDIO enable you to quickly capture patient exam data and view images for treatment planning The main steps of the workflow are e Schedule a Patient Exam e Select a Scan Protocol e Position the Patient e Take a Scout Scan to Assess Patient Positioning e Take a Scan e Release the Patient e Open and View Images OPERATORY CONSULTATION AREA Open and View Images e SmartScan STUDIO Manager or DEXIS e Tx STUDIO SERVER NETWORK Ko RECEPTION AREA 3 e Select Scan Protocol Schedule a Patient Exam Position the Patient e SmartScan STUDIO Take a Scout Scan Manager or DEXIS Take a Scan Release the Patient 032 0329 EN RevE 2 1 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 i
10. acquired Favorites Manager Options to manage protocol favorites A 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 032 0329 EN RevE 8 1 I CAT FLX User Manual Panel Calibration It is recommended that Panel Cal be performed once a week The Panel Cal is performed in both landscape and portrait positions for 4 x 4 and 2 x 2 resolutions Several tests run as part of the panel calibration A pie chart displays status Run Panel Calibration N 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 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 e
11. 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 032 0329 EN RevE 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 x wA 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
12. 9 Instruct Patients Prior to the Scan W ssssseesseseeekekke ekte tek ERE ERE ERE SELER nennen 5 10 Chapter 6 Taking a Scan Scanning Workflow in SmartScan STUDIO W W ssssss esset kk tk ERR ERNE SEERE REE REE ERR ERRES 6 1 Using SmartScan STUDIO Step by Step 2 0 0 ceeceecseeeeeseeeeeseeesesseeeeeseeeeeseeeeeeas 6 3 muitis C m 6 3 PeEnOnmra PAN Peleo REID 6 5 Build a Gustom PIOIOGO raien aa EEA A E AEA AAE ERS 6 7 omartocan STUDIO Detalle titii iain die tacere sa d deni o a Rr E Dea SR Ri 6 8 Choose a Patient EXAM uiro croce erint e nb Ew ho Sen Exe po EX FEE D kn xe a x enat A RNAd CE oa Ee ELE ORA 6 8 CIOOSP d PIOUDDOL SEE Er beu upaSVi aput uH NN NEIN CDU SUD PUE EE 6 9 Soc PRU pc 6 11 Perform a Dry RUN P 6 12 Perform a CT Scout Scan 200 cece ceccccecceceeeceeeceececeececeeeteneeteneeseseeseeetsnseeaeetsneesaeeeaneeenes 6 13 PERO elec T eee ee 6 15 Review Exam Images cccccceseccseseecsesecceeseceessececsnecenscececsueeessuseeseaseessusessegeessegeessnaess 6 16 Perform a PAN Scout Scan 2 0 ccceccccecccceccceeeeceeeeceeeeeeeeteneeeeeeeeeeeeaeseeaneeeaeetseeneeenaeeenes 6 18 Review PAN Image cccccsccccescccsesseseesecceesecensseeecssecensuececsueeeseueeessueeeseeessegeessegeesseaess 6 19 Complete Incomplete Exam ccccccccccessccceceeceeceeceeceeseee
13. HAT um Manual Cone Beam 3D 2D Panoramic Dental Imaging System Copyright Dental Imaging Technologies Corporation 2013 2014 This manual contains original instructions by Dental Imaging Technologies Corporation for the safe use of the i CAT FLX 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 CAT 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 copie
14. P is not displayed until the dose is selected on the Choose Dose screen 6 22 032 0329 EN RevE 032 0329 EN RevE Taking a Scan Continue to Choose Resolution Go back to Protocol menu 6 23 I CAT FLX User Manual Choose Resolution Logged ma i ee Bl Green if Rascals oluma dine oor Tie Beth Arthi ima ee Tire eT A g BH iA TT Decem 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 Ph Ds B A millimeters 0 3 0 25 0 2 0 125 Continue to Choose Dose Go back to Choose Anatomy 6 24 032 0329 EN Rev E 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 For 8cm and 16cm Diameter 0 3 and 0 4 voxel scans Quick Scant 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 sca
15. Smile Dentition Quick Scan 16x8 0 2 14 7 444 3 032 0329 EN RevE Selecting a Protocol Scan Time DAP PAN Favorite Name Projection kVp mA Seconds mGy cm Panoramic Standard 94 5 20 0 146 4 Panoramic small Standard 84 5 18 3 91 NOTE 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 8 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 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 One option does not fit all keep dose as low as reasonably achievable Always choose scan options before positioning the patient 032 0329 EN RevE 4 3 I CAT FLX User Manual Resolution Scan Time i CAT Scan Type Height cm voxel size seconds our gene OOW UP 13 11 10 0 4 0 3 4 8 Quick Scan Progress Records 8 6 4 L
16. andard 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 032 0329 EN RevE 6 15 I CAT FLX User Manual Review Exam Images Review image to ensure a quality scan was acquired Use controls as needed to help with visualization 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 032 0329 EN RevE Left Viewport Axial Axial Slice Axial Slice Left Viewport Axial Axial Slice 032 0329 EN RevE Right Viewport MIP MIP Rotation Right Viewport Coronal Coronal Slice Right Viewport Sagittal Sagittal Slice Taking a Scan MIP View maximum intensity projection Initial view after scan completes Right view rotates continuously from 90 to 90 position to provide a quick check of the image Touch image to stop the rotation cannot be restarted Image can be rotated manually with a swipe Drag indicator line in right viewport up or down to view axial slices in left viewport Select Coronal View Drag
17. at 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 032 0329 EN RevE 8 3 I CAT FLX User Manual 8 4 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 It may be necessary to reprocess an exam if there is a problem with reconstruction of a scan that was acquired successfully Exams are reprocessed using the same settings with which they were acquired 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 9 Image is created 3 Review image Refer to Review Exam Images 4 Press 9 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 the 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 Displa
18. 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 was designed to deliver high definition low dose imaging impressive image quality and clinical control speed and ease of use Proprietary tools such as SmartScan STUDIO touch screen control Tx STUDIO diagnostic and treatment planning software and Quick Scan low dose imaging put the i CAT s flexibility in your hands Our goal is that you will optimize workflow efficiency with remarkably sm rapid scan and CONSULTATION AREA IER reconstruction rates and practical office network integration As with all new clinical i tools training is Fa 9 tERVER MNETVWOREK NA 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 RECEPTION AREA 032 0329 EN RevE 1 1 I CAT FLX User Manual Description The 1 2 following major items comprise the i CAT FLX e CAT FLX Scanner e Scanner Controller e Touch screen with SmartScan STUDIO software e Keyboard e Operator Control Box e Patient Emergency Stop Control e SmartScan STUDIO Manager software e DEXIS software optional e Tx STUDIO
19. 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 active for scan protocols of 10 cm height or less 032 0329 EN RevE 6 13 I CAT FLX User Manual 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 OK to save custom protocol or Q9 to cancel Moves panel back or front to assist with positioning of the patient for the scan 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 6 14 032 0329 EN RevE 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 a HD or St
20. d 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 TABLE OF CONTENTS Chapter 1 Introduction Welcome to Your New i CAT FLX ou cc ccceccesceceeeceneeeneeceeeteceteeceseetaestaneeaeeaeeeaeeeans 1 1 Bree EE 1 2 29234 q 1 2 Operator Control BOX sssrini lise acer etie bus aE orci iare ene Cut bare da ed cH EX eU ele der 1 3 Patient Emergency Stop Control sesssssssssssssseeeeeen nennen nnn 1 4 SmartScan STUDIO Software sessssesssssssssssseeesenn ener ren nennn nnne annes nnns nnns 1 4 Tx STUDIO Treatment Planning Software seessseesssseeeeeeeeenen enn 1 4 Chapter 2 Getting Started Worklow AtA Glance HN 2 1 rez gne qid m NERE 2 2 PONET c 2 2 Kool NT TT P Pe 2 2 Chapter 3 Scheduling a Patient Exam PVE OC ICU OFA M TP 3 1 Using SmartScan STUDIO Manager to Schedule a Patient Exam 3 1 Schedule a New Patient for an Exam sssessssssssssssssssesen enne nnne nenas 3 1 Schedule an Existing Patient for a New Exam sssesssseseenee m
21. d and the X ray ON light is illuminated during radiation exposure The scanner acquires the data and creates the images A 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 6 6 15 Review image to ensure adequate quality Use controls as needed to aid with visualization 16 Press gt to continue 17 If PAN scan is not acceptable reposition and re scan the patient 032 0329 EN RevE 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 for information about managing protocol favorites 1 2 Access protocol screen and select S R From filmstrip select anatomy to be captured Press gt Select resolution for the scan Press gt Select dose for the scan Options available vary based on selections made in the two previous steps Press 2 On
22. d appear within a 1 cm border of the edge of the scout scan Use visualization controls as needed 032 0329 EN RevE 6 3 I CAT FLX User Manual 11 12 13 14 15 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 If patient position is correct for scan press gt Select full scan and press to continue The scanner initializes 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 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 A 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 6 4 16 17 18 19 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 Press 9 to c
23. dialog box enter a unique name for the protocol Press d to save custom protocol Default values for acquisition type will be used NOTE To save a scout scan as the acquisition type select 9 on Choose Type then follow step 5 above to save the protocol 032 0329 EN RevE 6 7 I CAT FLX User Manual SmartScan STUDIO Details Choose a Patient Exam Scheduled Exams PastamiD ON Saure of Paten iD Presiding Phuskias Dalarrizq Firgakcian Healey Exam Comment 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 Go to Utilities Note This is the only user access point to the Utilities menu Exit the application A confirmation dialog box results OK to confirm exit or to cancel and return 6 8 032 0329 EN RevE Taking a Scan Choose a Protocol 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 Header Parameter Definition Logged in as Username of current u
24. e 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 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 cancelled Information only If image User cancelled 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 cancelled 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 an cable at back of scanner d
25. ene 3 2 Using DEXIS to Schedule a Patient Exam ccccccccccseceeeseeeeeeeeeeesaeeeesseeeeseeeeesaeeees 3 2 Schedule a New Patient for an Exam sseesssessssssssseseeee esee enne nnns ns 3 2 Schedule an Existing Patient for an Exam sess 3 3 Chapter 4 Selecting a Protocol PSS AOE ON BTE RT 4 1 Default Favorites cccccccccseccsseceseeeeeeesneceeeeeeeeaaeeeseeseeceseceeeeseeeeseeesaeeeeeteeeeaeeeneeesanss 4 2 Choosing the Best Scan Option for the Patient eeeeeseeseeeeeeeeeeeeeeee 4 3 032 0329 EN RevE I CAT FLX User Manual Chapter 5 Positioning the Patient Patient Positioning For CT Scans At A Glance 00 eccccceeceeeeeeeeeeeeeeeseeeeeseeeesaees 5 1 Patient Positioning For PAN Scans At A Glance 00 ccccceecceceeeeeeeeeeeeneeeeeseeeesaees 5 2 Patient Positioning IN Detall sssasissadukazet d Daemedd anu ataa a ug ARUM IVa A OR aita 5 3 Patient Chair cccccccccssecccsceeceeceneeceececeeeeeeeeeeneeeeneeeaneensneenaeeeaaeeesaeeceaeeteeeseeetseeetaneetanes 5 4 sees tee ES 5 5 CAD k oero UTER RERO NE 5 5 Head Support and Head Strap i tac dere e pini vest kk e Esta e E ERE R netos EE IEEE DESI oU E SU e Rk rn nere 5 6 Menu I DESNE REE 5 8 SCOUTS and Dry RUNS eisendxesissuscs stes dimus tbe te mv ivendutu prm utum Sd E M aer an diua nO DUM 5
26. es 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 032 0329 EN RevE I CAT FLX User Manual 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 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 O for a dry run Continue to Choose Type a Cancel scan and exit workflow Dry Run is complete 6 12 032 0329 EN RevE Taking a Scan Perform a CT Scout 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
27. essaeeessseeesseaeessaeeesseeeeseneeess 6 20 Build a Custom Protocol Workflow in SmartScan STUDIO 6 21 Choose Anatomy ssssssssssssssesesee nennen nnne nennen rr nes NERE ER ERE ERR ELERS ERE ERE nnns 6 22 Choose 5 SO ie ETE 6 24 joo 280 M 6 25 iv 032 0329 EN RevE Table of Contents Chapter 7 Opening Images ALFA ASH ORE TEE e A A E EE E E EAE 7 1 Locate Exam Images in SmartScan STUDIO Manager ccccccceceeeeeeeeeeeeeeeeees 7 1 Locate Exam Images in DEXIS uu eeccceecccceccccecceceeeeceeeeceeeeeeceseeeesseeesseeseeeesseessneeeas 7 2 vond ECIEEIDIOTMER tener 7 2 Chapter 8 Calibration and Maintenance Commonly Used Utilities 0 eeccccceeeeeeeeeeeseeeeeeaeeeesaeeeeeseeeeeeaeeeeeseaeeesaaeeesaaeeeesaes 8 1 Panel Calibration me 8 2 Shutter Calibration cece csecccececcecceeeceeeeceececeeeeseeeeaneeseeeesneeseneesgeseneeetseeteeeteeesaees 8 3 Reprocessing an Exam 325sisaixvsbesu dw Rubri Hoa vasa LEE LEE LEE dada LEE LEE LEE L REELLE ELLER ELLERS 8 4 Using Favorites Manager cccccecccsececeeeeeeeeeseeeeseeeese cece eeseeeeseeeeseueeseeesaueeseeeesaeeeaeesaes 8 4 Routine Cleaning u u u ssssssssseeseeeke ekte kt ERE ERE ERE SEERE RESEN REE ERE E RER ER RER reen kk ans 8 5 Chapter 9 Shutdown Scanner onutdoWE srainnsear Er aE edicit tab sv GN Rad FERAE RE wc NR MG WIE 9 1 OG OUI c
28. he 3D functions are turned off 032 0329 EN RevE 7 1 I CAT FLX User Manual Locate Exam Images in DEXIS If your site uses DEXIS enter patient data in the DEXIS Administration program Refer to your DEXIS Software Manual for additional information 1 In DEXIS Imaging Suite locate patient then click o to open the Extra oral display 2 Double click the i CAT box to start Tx STUDIO and load patient EET E exam CAT 3 View scan in Tx STUDIO Using Tx STUDIO Refer to Tx STUDIO Reference Manual for information on using Tx STUDIO 7 2 032 0329 EN Rev E Calibration and Maintenance 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 CAT FLX Technical Guide for information on the other Utilities menu options Option Deep SS PanelCal PanelCal Panel calibration should be performed once aweek 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 Exams are reprocessed using the same settings with which they were
29. ially cause detrimental interaction with active implantable medical devices and body worn active medical devices Contact the manufacturer of such devices for more information 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 instrumen
30. ient 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 i CAT FLX 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 032 0329 EN RevE A 3 I CAT FLX User Manual A 4 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 with any parts of the scanner or items in the env
31. indicator line in right viewport up or down to view axial slices in left viewport Drag indicator line in left viewport up or down to view coronal slices in right viewport Select Sagittal View Drag indicator line in right viewport up or down to view axial slices in left viewport Drag indicator line in left viewport left or right to view sagittal slices in right viewport I CAT FLX User Manual 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 032 0329 EN RevE Taking a Scan Adjusts brightness of image Adjusts contrast of image Review PAN image to ensure a qua
32. ing 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 Positioning the Patient Velcro Pads 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 032 0329 EN RevE 5 7 I CAT FLX User Manual Alignment Light Alignment Sagittal Laser Light Light Button ie 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 po
33. ips If Gate won t close Use the head support strap without the chin cup Keep gate open and remove metal chin support mechanism OR e Take out head support and use just the chin cup OR e Slide patient slightly forward allowing room to lean back into scanner with chair in upper slots For Orthodontics Use just head support strap so the chin cup is not visible Remove metal chin support mechanism Instruct Patient Prior to Scan e Do not swallow during the scan e Slow shallow breaths during the Scan Close eyes during the scan e Stay as still as possible 5 1 I CAT FLX User Manual Patient Positioning For PAN Scans At A Glance Chin Rest 20 ror ns CN XL NER Sem i Bite Tip Holder Place chair in the upper slots so that chair back does not impede patient s ability to sit with an erect posture If head support is installed loosen locking knob and remove head support Slide PAN head holder into place and tighten locking knob Insert the narrow edges of bite tip down into bite tip holder uprights Turn the bite tip a turn to lock into place Insert the chin rest and bite tip holder into the positioning block 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 i
34. ironment or if the patient moves or needs immediate assistance for some reason Emergency Removal of a Patient 1 2 Press an Emergency Stop button 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 To reset an Emergency Stop button pull and turn button clockwise In SmartScan STUDIO a message The Emergency Stop button was activated is displayed Ensure button is reset and patient environment is clear Press x onthe message dialog box The scanner automatically recovers and returns to a ready state Collision Recovery 1 2 In SmartScan STUDIO a message A scanner stall was detected is displayed 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 If the collision was caused by obstructions in the area not by a patient clear all obstructions Press x onthe message dialog box The scanner automatically recovers and returns to a ready state 032 0329 EN RevE 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 di
35. isconnected exposure controller and back of scanner Initiate scan when operational B 2 032 0329 EN RevE Status Indicators and Operational Messages The panel ethernet cable was Re connect cable if possible Panel ethernet cable was disconnected during an Otherwise call Technical disconnected exposure Support A scanner fault was detected Follow instructions on dialog X ray fault from X ray 1000 controller 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 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 An error requiring special Call Technical Support Problem creating recovery job as
36. lity scan was acquired Use controls as needed to help with visualization 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 032 0329 EN RevE 6 19 I CAT FLX User Manual Complete Incomplete Exam COMPLETE o e Marware Sree Ears 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 OK to confirm or Q9 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 OK to confirm or x to cancel 6 20 032 0329 EN RevE Taking a Scan 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 m iE onthe protocol menu to start building a custom protocol a Choose Anatomy Choose Resolution 032 0329 EN RevE 6 21 I CAT FLX User Manual Choose Anatomy Select anatomy for the scan protocol The Volume Size header parameter highlights the selected value Scan DA
37. n 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 032 0329 EN RevE 5 5 I CAT FLX User Manual 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 5 6 032 0329 EN Rev E To Install Velcro Pads 1 Loosen the lock
38. ndicator on the operator control box and scanner should light 2 Power up scanner controller and touch screen press the power qe RN button on the front of the scanner controller The log in screen is f displayed A 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 i CAT FLX 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 2 to log in Scheduled Exams are displayed 2 2 032 0329 EN Rev E mer Scheduling a Patient Exam Introduction Depending on your site s workflow you May use either SmartScan STUDIO Manager or DEXIS 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 Atthe 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 Pa
39. ns Quick Scan HD uses a shorter exposure time and delivers less dose to patient than HD scan but at a lower resolution HD uses longer exposure time settings for high resolution image quality For 23cm Diameter 0 3 and 0 4 voxel scans Standard uses standard exposure time settings Enhanced uses longer exposure time settings for maximum image quality 032 0329 EN RevE 6 25 I CAT FLX User Manual Save selected scan parameters anatomy resolution dose and acquisition type as a custom protocol On dialog box enter a unique name for the protocol OK to save custom protocol or Q9 to cancel Continue to Choose Type Go back to Choose Resolution 6 26 032 0329 EN RevE E Opening Images Introduction Depending on your site s workflow you may use either SmartScan STUDIO Manager or DEXIS to access patient exam images Locate Exam Images in SmartScan STUDIO Manager 1 Atthe 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 Tx STUDIO DX Scout scan 2D image PX PAN scan 2D image 6 Exam opens in Tx STUDIO For 2D images the images can be viewed but t
40. oned properly at a 10 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 032 0329 EN Rev E 6 5 I CAT FLX User Manual 10 11 12 13 14 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 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 9 and repeat steps 6 9 to perform another scout If patient position is correct for scan press gt Select 639 full scan and press to continue The scanner initializes 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 When prompted press the Scan button on the operator control box An audible alarm is sounde
41. ontinue If CT scan is not acceptable reposition and re scan the patient 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 032 0329 EN RevE 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 In SmartScan STUDIO select exam entry in scheduled exams list Press to access protocols select a v protocol Position patient for scan Refer to Patient Positioning For PAN Scans At A Glance Select scout scan and press 9 to continue The scanner initializes Instruct the patient to swallow and hold put the tongue to the roof of the mouth and hold for the duration of the exposure 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 A 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 positi
42. ower Dose TMJ ard Molars Children Prone to Movement Cephalometrics Standard Implants 13 11 10 0 4 0 3 8 9 3rd Molars 8 6 4 Cephalometrics Quick Scan HD Endo 13 11 10 0 25 0 2 14 7 HD Root Fractures 8 6 4 0 125 26 9 Hi Resolution Pathology Impactions Supernumerary Periodontal Conditions Expanded 3D Cephalometrics for Large Skulls 17 Seen kiss Ceph Orthognathic Surgery 0 3 0 4 8 9 suggested option NOTE See the i CAT website for information about the use of 3 Party software with the i CAT 032 0329 EN RevE Chapter 5 Positioning the Patient Patient Positioning For CT Scans At A Glance Position the patient for minimal movement and maximum image quality To prevent patient movement e When possible use the head support strap and chin cup e Stabilize patient s feet with a foot stool if needed e f shoulder clearance is a concern lower the chair elevation and tilt chin up e Doa Dry Run to test for shoulder clearance 032 0329 EN RevE 1 Adjust chair height Chair seat is typically in top slot Set elevation with horizontal laser light at patient s smile line Close the gate Ensure the patient s chin is sitting comfortably yet firmly in the chin cup Secure patient in head support and attach head strap around forehead Adjust tilt of jaw Occlusal plane should be horizontal External reference tragus ala line horizontal T
43. s on the chin rest DoWhWard but erect posture is maintained 10 7 Tilt the patient s head downward so that the occlusal plane forms roughly a 5 to 10 angle to the horizontal laser line Horizontal Laser Occlusal PI a 8 Use the sagittal laser front center laser to ensure that the patient is centered and facing straight forward 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 5 2 032 0329 EN Rev E 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 and are detailed in the following paragraphs 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
44. ser 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 cm 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 032 0329 EN RevE 6 9 I CAT FLX User Manual Voxel Size CT 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 00000 Exposure Time Length of time in seconds ofthe exposure Ww Kilovott setting for the scan mA MilAmpeesetigfothescan 0 scan DAP Scan scout or dry run dose in DAP mGy cm Scout DAP The DAP value for a dry run is O Dry Run DAP Continue with selected protocol Go back and select another exam A confirmation dialog box results OK to confirm or x 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 6 10 032 0329 EN RevE Choose Type Taking a Scan 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 do
45. sistance has been encountered Please call Technical Support 032 0329 EN RevE B 3 I CAT FLX User Manual Patient Patient information is missing 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 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 complete or Geometric and Scanner successfully and recovery Reset Successful succeeds Retry Panel Shut
46. sitioning 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 5 8 032 0329 EN Rev E Positioning the Patient Occlusal Plane Flat Frankfurt Plane tilted 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
47. splay more detail about the status condition Scanner indicates status of the connectivity between the workstation running SmartScan STUDIO Manager and the i CAT FLX scanner controller Scanner Database Database e The first indicator shows status of the communication between the workstation running SmartScan STUDIO Manager and the SmartScan STUDIO Integration Services web service e 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 Scanner Database 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 e System Serial Number e SmartScan STUDIO PC base image version e SmartScan STUDIO software version The currently installed version number of SmartScan STUDIO Manager can be found on the omartScan STUDIO Manager Settings window In SmartScan STUDIO Manager select O to access the Settings window 032 0329 EN Rev E B 1 I CAT FLX User Manual Operational Messages SmartScan STUDIO may display system message in a dialog box These messages may b
48. ter Chair or Continue with calibration Calibration failed but recovery Geometric calibration is successful 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 B 4 032 0329 EN RevE dd 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 RevE 2014 February 15
49. the order of a dentist or other licensed practitioner 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 e Maintain adequate distance from exposed radiation source e Keep exposure times to a minimum e Use protective clothing lead apron etc for all patients e Wear a PEN dosimeter and or film badge e The physician is responsible for protecting the patient from unnecessary radiation 032 0329 EN RevE A 1 I CAT FLX User Manual Safety Precautions L WARNING A 2 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 potent
50. tient 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 032 0329 EN RevE 3 1 I CAT FLX User Manual Using DEXIS to Schedule a Patient Exam 4 Select The exam request is sent to SmartScan STUDIO and is displayed in Schedule an Existing Patient for a New Exam 1 the Scheduled Exams list on the touch screen At the clinical workstation start SmartScan STUDIO Manager Select New Exam for an Existing Patient Select the patient from the list Use the search feature as needed to help locate the patient Select the type of new exam PAN or Select The exam request is sent to SmartScan STUDIO and is displayed in the Scheduled Exams list If your site uses DEXIS to schedule patient exams enter patient data in the DEXIS Administration program Refer to your DEXIS Imaging Suite Software Manual for additional information 3 2 Schedule a New Patient for an Exam 1 At the clinical workstation start DEXIS Imaging Suite on the DEXIS Administration screen select New Patient Enter data for the patient and exam Select OK Click o Extra oral 032 0329 EN RevE Scheduling a Patient Exam 6 Click e 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
51. ts 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 032 0329 EN RevE Safety Guidelines 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 labelled 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 anaesthetic mixture with air or with nitrous or oxygen enriched atmospheres CAUTION Failure to follow instructions below may result in minor or moderate bodily injury or damage to the device 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 pat
52. xit 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 9 2 032 0329 EN RevE Calibration and Maintenance 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 positions A pie chart displays status 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 6 When Shutter Cal is complete Calibration Complete is displayed Thumbnail images of each Shutter Cal test are available to view T If desired select a thumbnail to view 8 Press 9 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 OK to exit Check th
53. ys a list of default favorites provided with SmartScan STUDIO OK Select a favorite and press to add it May be necessary if a default was deleted or renamed Go back to Utilities menu 032 0329 EN RevE Calibration and Maintenance Routine Cleaning Routinely clean and disinfect all items which come in contact with the patient Use Opti Cide 9 Solution and or Wipes from Biotrol International or equivalent cleaner and disinfectant Saturate with Opti Cide 9 and allow surface to remain wet for three minutes at room temperature 69 F 209C and then wipe dry using a clean paper or cloth towel Refer to Opti Cide 9 label for full instructions The following items may come in physical contact with the patient during a scan e Patient Emergency Stop e Patient Chair e Head Support e Chin Cup Chin Rest e PAN Head Holder e Booster seat Foot Stool e 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 032 0329 EN Rev E 8 5 I CAT FLX User Manual 8 6 032 0329 EN RevE gt Shutdown Scanner Shutdown Log out 1 Press This button is accessible from Scheduled

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