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i-CAT FLX User Manual

032-0329-EN Rev K

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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Содержание FLX V Series

Страница 1: ...User Manual C o n e B e a m 3 D 2 D P a n o r a m i c D e n t a l I m a g i n g S y s t e m TM TM...

Страница 2: ...o 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...

Страница 3: ...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 Exist...

Страница 4: ...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 Det...

Страница 5: ...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 Sh...

Страница 6: ...032 0329 EN Rev K vi i CAT FLX User Manual...

Страница 7: ...fficiency 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...

Страница 8: ...ning 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 contr...

Страница 9: ...op 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...

Страница 10: ...ss 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 Planni...

Страница 11: ...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 pro...

Страница 12: ...1 6 i CAT FLX User Manual 032 0329 EN Rev K...

Страница 13: ...nning 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 Vi...

Страница 14: ...l 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...

Страница 15: ...isting 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 wo...

Страница 16: ...elect 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 so...

Страница 17: ...rted 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...

Страница 18: ...dule 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 St...

Страница 19: ...alid remote configuration Server configuration values entered for saving configuration is not valid or is incomplete Contact local PACS administrator Please enter valid port number Port number entered...

Страница 20: ...3 6 i CAT FLX User Manual 032 0329 EN Rev K...

Страница 21: ...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...

Страница 22: ...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 1...

Страница 23: ...ll Quick Scan Low Dose acquisition and reconstruction Second reconstruction follows at no manual reprocessing required 16 x 13 0 25 14 7 659 9 16 x 8 0 2 n a n a SureSmile Dentition 16 x 8 0 2 26 9 79...

Страница 24: ...8 9 302 9 Mandible HD 16 x 6 biased for mandible 0 2 26 9 611 6 Maxilla HD 16 x 6 biased for maxilla 0 2 26 9 605 2 Arches small 8 x 8 0 3 8 9 239 Arches small Quick Scan Low Dose 8 x 8 0 3 4 8 134 8...

Страница 25: ...ra Low Dose 8 x 8 0 6 4 8 reduced mA 40 Arches small HD 8 x 8 0 2 26 9 500 8 Arches small UltraHD 8 x 8 0 125 26 9 500 8 Mandible small 8 x 5 biased for mandible 0 3 8 9 168 Maxilla small 8 x 5 biased...

Страница 26: ...ns 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...

Страница 27: ...t Cephalometrics Ears Nose Throat V17 13 11 10 8 6 5 4 V10 10 8 6 5 4 V8 8 5 0 6 0 4 0 3 4 8 Standard Implants 3rd Molars Cephalometrics Ears Nose Throat V17 13 11 10 8 6 5 4 V10 10 8 6 5 4 V8 8 5 0 4...

Страница 28: ...4 8 i CAT FLX User Manual 032 0329 EN Rev K...

Страница 29: ...atient s chin is sitting comfortably yet firmly in the chin cup 4 Secure patient in head support and attach head strap around forehead 5 Adjust tilt of jaw Occlusal plane should be horizontal External...

Страница 30: ...possible to avoid the spine getting in the view Close the gate 6 Adjust chair height so that the patient s chin is on the chin rest but erect posture is maintained 7 Tilt the patient s head downward s...

Страница 31: ...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...

Страница 32: ...ntrols 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 m...

Страница 33: ...tion 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...

Страница 34: ...he 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...

Страница 35: ...head 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...

Страница 36: ...g 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 Occ...

Страница 37: ...y 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 sim...

Страница 38: ...g 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 g...

Страница 39: ...ses 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...

Страница 40: ...ual 032 0329 EN Rev K 4b OR Perform a CT Scout Scan page 6 14 Perform a PAN Scout Scan page 6 21 4c Perform a Scan page 6 17 5 OR Review Exam Images page 6 18 Review PAN Image page 6 22 6 Complete Inc...

Страница 41: ...ake 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...

Страница 42: ...ing 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 bu...

Страница 43: ...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 pr...

Страница 44: ...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 exp...

Страница 45: ...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...

Страница 46: ...eduled 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...

Страница 47: ...6 9 Taking a Scan 032 0329 EN Rev K Choose a Protocol V17 Option V10 Option V8 Option...

Страница 48: ...m DAP Total absorbed dose of all scouts and scans taken during this patient s current exam session in DAP dose area product mGy cm2 milliGray centimeters squared Modality Type of exam requested PAN or...

Страница 49: ...th 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...

Страница 50: ...nt 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 c...

Страница 51: ...ll be acquired DAP value is 0 for a dry run 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 scann...

Страница 52: ...6 14 i CAT FLX User Manual 032 0329 EN Rev K Perform a CT Scout Scan V17 Option V10 Option V8 Option...

Страница 53: ...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...

Страница 54: ...terior 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 i...

Страница 55: ...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...

Страница 56: ...6 18 i CAT FLX User Manual 032 0329 EN Rev K Review Exam Images V17 Option V10 Option V8 Option...

Страница 57: ...tly 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 complete...

Страница 58: ...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...

Страница 59: ...s 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 C...

Страница 60: ...PAN image which will remove the filter it was processed with Refer to Reprocessing an Exam page 8 3 Adjusts brightness of image Adjusts contrast of image Continue to Complete dialog box with options f...

Страница 61: ...lete 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...

Страница 62: ...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...

Страница 63: ...6 25 Taking a Scan 032 0329 EN Rev K Choose Anatomy V17 Option V10 Option V8 Option...

Страница 64: ...ed until the dose is selected on the Choose Dose screen Anatomy Diameter x Height cm Options Available On V17 V10 V8 Mandible small 8 x 5 mandible X X X Maxilla small 8 x 5 maxilla X X X Both Arches s...

Страница 65: ...6 27 Taking a Scan 032 0329 EN Rev K 3D Ceph 16 x 13 X Expanded 3D Ceph 23 x 17 X Continue to Choose Resolution Go back to Protocol menu...

Страница 66: ...ion 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 v...

Страница 67: ...n 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 rotati...

Страница 68: ...ption 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 typ...

Страница 69: ...he 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...

Страница 70: ...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 enable...

Страница 71: ...other supported viewers on a clinical workstation Message Action Possible Cause The PM plugin is NOT running Check that site servers and the scanner controller are up and operational Coordinate with...

Страница 72: ...wing 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 n...

Страница 73: ...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 Retr...

Страница 74: ...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 successfu...

Страница 75: ...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...

Страница 76: ...7 8 i CAT FLX User Manual 032 0329 EN Rev K...

Страница 77: ...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...

Страница 78: ...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...

Страница 79: ...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 dis...

Страница 80: ...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 pre...

Страница 81: ...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 Chi...

Страница 82: ...8 6 i CAT FLX User Manual 032 0329 EN Rev K...

Страница 83: ...ss 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 t...

Страница 84: ...9 2 i CAT FLX User Manual 032 0329 EN Rev K...

Страница 85: ...tions 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...

Страница 86: ...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...

Страница 87: ...irst 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 pro...

Страница 88: ...ge 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 re...

Страница 89: ...tus 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 Installat...

Страница 90: ...ormation only Raw data was captured and saved Image processing was canceled by user Information only If image processing is desired use Reprocess Exam User canceled image processing A scanner stall wa...

Страница 91: ...uisition error A QA fault was detected 1009 QA scan is invalid or corrupted QA MTF fault was detected 1010 Call Technical Support Image Quality error QA MTF spatial resolution failed Panel Calibration...

Страница 92: ...it is recommended that calibrations are performed Calibration should be performed Calibration Processing Failure Panel Shutter or Geometric Retry calibration Call Technical Support if calibration fai...

Страница 93: ...or is not positioned properly Position the correct phantom Refer to the i CAT FLX Installation Manual Wrong phantom or phantom is not centered The phantom is tilted or not centered Position the phanto...

Страница 94: ...B 6 i CAT FLX User Manual 032 0329 EN Rev K...

Страница 95: ......

Страница 96: ...032 0329 EN Rev K 2016 August 1 Imaging Sciences International LLC 1910 North Penn Road Hatfield PA 19440 USA Tel 1 215 997 5666 Fax 1 215 997 5665 Manufactured by...

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