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i-CAT FLX V Series Technical Manual Download Page 85

B-25

Product Information 

032-0328-EN   Rev K 

Equipment Standards

The scanner was tested and/or evaluated against and found compliant to the following standards/
requirements:

Equipment Class

Protection against electric shock: Class I

Applied part has degree of protection against electric shock: Class B

Class of equipment against ingress of liquids: Ordinary Equipment, IPX0

Radiated emissions: Class A

Equipment Cables

The following table lists cables to be used with the scanner.

CAUTION

Use supplied cables only. The use of an accessory, transducer, or cable with the 
scanner other than those specified may result in increased emissions or decreased 
immunity of the scanner. 

UL STD 60601-1

IEC 60601-1-4

IEC 60601-2-44

ANSI/AAMI ES60601-1

IEC 60601-1-6

IEC 62366

IEC 60601-1

IEC 60601-2-7

IEC 60825-1

IEC 60601-1-1

IEC 60601-2-28

CAN/CSA STD C22.2 No. 60601-1

IEC 60601-1-3

IEC 60601-2-32

CAN/CSA STD C22.2 No. 601.1-M90

Complies with ME Equipment for Dental Extra-Oral Radiography i-CAT FLX  
IEC 60601-2-63:2012

Summary of Contents for FLX V Series

Page 1: ...Technical Guide 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 ...

Page 2: ...to any electronic medium or machine readable form without prior consent in writing from Dental Imaging Technologies Corporation i CATTM is a registered trademark of Imaging Sciences International Other names may be trademarks of their respective owners No part of this document may be reproduced or transmitted in any form or by any means electronic or mechanical for any purpose without prior writte...

Page 3: ...s 1 3 Chapter 2 Startup and Shutdown Scanner Startup 2 1 Power Up 2 1 Log in 2 1 Scanner Shutdown 2 2 Log out 2 2 Power Off 2 2 Cycle Scanner Power 2 2 Chapter 3 Calibrations and Quality Assurance Run Calibration and QA Tests 3 1 Panel Calibration 3 2 Run Panel Calibration 3 2 Panel Calibration Failure 3 2 Shutter Calibration 3 3 Run Shutter Calibration 3 3 Shutter Calibration Failure 3 3 Geometri...

Page 4: ...ir Water Test 3 14 Set Up QA Air Water Phantom 3 14 Run QA Air Water Test 3 14 QA Air Water Test Evaluation 3 15 QA PAN Test 3 20 Install PAN Phantom 3 20 Run QA PAN Test 3 20 QA PAN Test Evaluation 3 21 Radiation Output Test 3 22 Measured Dose 3 22 Interpretation 3 23 Chapter 4 Site Administration Site Administrator Account 4 1 Configurator 4 2 Accounts 4 2 Institution 4 3 Network 4 3 Maintenance...

Page 5: ...on Important Safety Information A 1 Electrical Hazards A 3 Explosion Hazard A 3 Mechanical Hazards A 3 Collision System A 3 Tube Head Leakage A 4 Laser Beam Hazards A 4 Radiation Safety A 4 Radiation Protection Measures A 5 Safety Devices A 5 Emergency Stops A 5 Warning System A 5 Interlock System A 6 Site Layout A 6 Cabling Requirements A 6 Appendix B Product Information Essential Performance B 1...

Page 6: ...lanned Maintenance 12 Month Schedule B 20 Planned Maintenance Checklist B 20 Replaceable Parts B 21 Supplemental Components B 22 PAN Scan Components B 24 Equipment Standards B 25 Equipment Class B 25 Equipment Cables B 25 Manufacturer s Declaration B 26 Acknowledgements B 33 Appendix C Radiation Information Recommended Operating Requirements C 1 Scan Times and Settings C 2 Scatter Radiation C 2 Co...

Page 7: ...tion The i CAT FLX is a Cone Beam Volumetric Tomography and Panoramic imaging system used for dental head and neck applications It consists of a scanner scanner controller touch screen and keyboard which is suitable for an in office environment i CAT FLX Imaging System with Touch Screen ...

Page 8: ...formation Operator Control Box The operator control box must be located outside of the patient environment and can be placed on a desktop or wall mounted The site layout must provide a means for audio and visual communication between the operator and patient during scanning ON powers the scanner and the POWER indicator lights to show that the scanner is ON OFF removes power from the scanner and th...

Page 9: ...STUDIO Software SmartScan STUDIOTM software is used for taking scans on the i CAT FLX imaging system and runs on the scanner controller SmartScan STUDIO Manager software is used to enter patient data and access patient studies It is loaded on a clinical workstation Optionally your site may choose to use DEXISTM software instead of SmartScan STUDIO Manager for patient administration TxSTUDIO Treatm...

Page 10: ...rkstation Graphics Card NVidia GeForce GT series or higher AMD RadeonTM 6450 or higher Monitor 17 high resolution widescreen LCD with a contrast ratio of 10 000 1 or better Note LCD monitors should be used in native resolution and must display all shades of gray accurately USB USB 2 0 Network Card 1000 baseT network cards Note Wireless networks are not recommended DVD Drive 16x or higher Internet ...

Page 11: ...he scanner or the scanner controller is powered off at scanner power up or scanner controller boot up when the first scan is initiated scout or full scan the system performs a reset procedure that may delay the start of first scan Log in Two log in account types are available for site use The site administrator will assign the account type to site personnel A typical user will log in directly to S...

Page 12: ... scanner Press the OFF button on the operator control box The scanner shuts down and the POWER indicators on the operator control box and scanner go OFF 2 Power off scanner controller and touch screen Press power button on the touch screen to power off both the touch screen and scanner controller On the shutdown confirmation dialog press to shutdown Cycle Scanner Power If at any time the Ethernet ...

Page 13: ...needed if the image quality is degraded QA Line Pair QA Line Pair test checks the spatial resolution using the QA phantom Perform annually or when image quality is degraded QA Material QA Material test checks consistency of measurements in various materials using the QA phantom Perform annually or when image quality is degraded QA Air Water QA Air Water test is a noise level and uniformity test HU...

Page 14: ... From Utilities menu 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 s...

Page 15: ...sounded and the X ray ON light is illuminated during radiation exposure 5 You will be prompted to press the Scan button for each test NOTE The panel will rotate to the portrait position at the start of the portrait tests V17 systems only 6 When Shutter Cal is complete Calibration Complete is displayed Thumbnail images of each Shutter Cal test are available to view 7 If desired select a thumbnail t...

Page 16: ... Run Geometric Calibration NOTE If you get the message Geometric Calibration Processing Failure during this procedure contact Technical Support 1 From Utilities menu select GeoCal 2 Verify GeoCal fixture installation then press The scanner initializes 3 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...

Page 17: ...hantom on platform Use a piece of foam beneath the phantom to elevate it Make sure phantom is level 3 Center the QA phantom on the platform with the air hole positioned at the left rear of the gantry The embedded metal strips should align left to right 4 Using the Alignment Lasers adjust the platform height so that the horizontal laser is positioned at the center of the QA phantom AIR HOLE ACRYLIC...

Page 18: ...tton on the operator control box An audible alarm is sounded and the X ray ON light is illuminated during radiation exposure 5 Review the scout image The phantom must be centered and level Adjust the phantom platform as needed to achieve the proper height 6 To move the phantom to the right or left use the Front Back slider control If required make adjustments then press to run again Repeat as requ...

Page 19: ...ate quality Press to display Complete screen and select option to go Back to Utility QA Line Pair Evaluation 1 At a clinical workstation start SmartScan STUDIO Manager and select Exam List 2 On Exam List locate QA 3D_1 Line Pair exam with most current date Double click CT entry to load study in TxSTUDIO NOTE If a pop up message displays stating Tru Pan failed to process click OK and continue 3 Whe...

Page 20: ...sor up or down to zoom in or out as needed To pan move the mouse cursor in the center of the image hold down the Shift key press left mouse button and drag the image 6 Select Hard from drop down menu 7 Adjust Brightness and Contrast levels for the best viewing of line pairs NOTE To better view image select to turn off cursor lines 8 Evaluate the image Line Pairs 10 through 16 are displayed in the ...

Page 21: ...re measurement accuracy this procedure checks Distance measurements 1 Select to activate Distance tool NOTE To better view image select to turn off cursor lines 2 Click on the outside line of set 16 and then click on the outside line of set 10 to draw a line as shown 3 The measurement should be between 41 and 42 mm 4 When finished save the file and close TxSTUDIO 11 10 12 13 14 15 16 Distance Line...

Page 22: ...d and level Adjust the phantom platform as needed to achieve the proper height 6 To move the phantom to the right or left use the Front Back slider control If required make adjustments then press to run again Repeat as required until phantom is properly aligned 7 When phantom is aligned select and press 8 When prompted press the Scan button on the operator control box An audible alarm is sounded a...

Page 23: ...D_2 Material exam with most current date Double click CT entry to load study in TxSTUDIO NOTE If a pop up message displays stating Tru Pan failed to process click OK and continue 3 When exam is loaded select Section tab at top of display 4 In the upper right corner view click where the vertical and horizontal cursor lines cross and drag to the center of the material plugs as shown below ...

Page 24: ...easurements select to turn off display information 10 Draw a box with an area of at least 40mm2 but less than 46mm2 in the center of each circle of the four material areas in the phantom image NOTE The dimension of each measurement is very important Be consistent for each assessment to achieve the minimum deviation a Click and release at starting point A red circle displays b Move cursor to draw b...

Page 25: ...ed values should fall within the lower and upper limits 12 When finished save the file and close TxSTUDIO Material Mean Scan Value Hounsfield Units Lower Limit Upper Limit Mean Air Black lower left 1000 980 990 Acrylic Light Gray lower right 50 200 75 LDPE Dark Gray upper right 250 50 150 Teflon White upper left 580 1160 870 ...

Page 26: ...t QA Air Water 2 Ensure phantom is set up properly then press 3 Select then 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 Review scout image The phantom must be centered Adjust the phantom platform as needed to achieve the proper height 6 To move the phant...

Page 27: ... Air Water Test Evaluation 1 At a clinical workstation start SmartScan STUDIO Manager and select Exam List 2 On Exam List locate QA 3D_3 Air Water exam with most current date Double click CT entry to load study in TxSTUDIO NOTE If a pop up message displays stating Tru Pan failed to process click OK and continue 3 When exam is loaded select Section tab at top of display 4 In the upper right corner ...

Page 28: ...ove the mouse cursor in the center of the image hold down the Shift key press left mouse button and drag the image 6 In Slice Thickness enter 0 4 mm 7 Select to activate HU tool 8 Draw a box with an area of approximately 400 mm2 in the center of the water in the phantom image as shown below a Click and release at starting point A red circle displays b Move cursor to draw box c When correct area is...

Page 29: ...17 Calibrations and Quality Assurance 032 0328 EN Rev K 9 Record the Water HU Mean value in the table below 10 In the upper right image slide the vertical and horizontal cursor lines above the water level ...

Page 30: ...ick where the vertical and horizontal cursor lines cross and drag to the center of the water height and width NOTE To better view measurements select to turn off display information 14 Select to activate HU tool 15 Draw a box with an area of approximately 400 mm2 in the upper left quadrant of the phantom image as shown below a Click and release at starting point A red circle displays b Move cursor...

Page 31: ...ow 18 Remove measurements by clicking each one then press the Delete key on the keyboard 19 Subtract each Mean Value from the Mean Value of the center measurement If the difference is greater than 90 make sure phantom is correctly centered in the field of view and re measure 20 When finished save the file and close TxSTUDIO Measured Values Upper Left Upper Right Lower Left Lower Right Center Mean ...

Page 32: ... tip should rest on top of the platform 3 Place PAN phantom on platform with balls facing up and top of arch resting on bite tip 4 Use the Alignment Lasers to position the phantom Use the horizontal laser to adjust the height of the phantom as shown below Use the vertical laser to center the phantom on the platform Run QA PAN Test 1 From Utilities menu select QA PAN 2 Ensure phantom is set up prop...

Page 33: ...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 data and a status indicator shows acquisition and image creation progress When image processing is complete image is displayed QA PAN Test Evaluation 1 Review image Use brightness and contrast controls as needed to enhance image...

Page 34: ...orizontal axial lasers intersect 2 Perform a 16 cm diameter x 13 cm height scan 8 9 second 0 4 voxel and record time and dose from meter Measured Dose The table below shows measurements performed on the detector for a landscape mode standard scan Tube Potential kV 120 Selected Scan Time seconds 8 9 Number of Frames 309 Approximate Exposure Time seconds 3 7 Measured Exposure at Detector mR 188 Meas...

Page 35: ...r Number of Frames Where Number of Frames 309 for 8 9 second scan 619 for 26 9 second scan 2 The tube output per mAs may be normalized to 1m using the inverse square law for the purposes of assessing consistency of tube output Tube Output Gy mAs Dose at Detector x Source to detector distance 2 Displayed mAs Where Source to detector distance 0 714 m 71 4 cm for the scanner ...

Page 36: ...3 24 i CAT FLX Technical Guide 032 0328 EN Rev K ...

Page 37: ...e Configurator Add edit or delete user accounts Add or enter institution name Enter or view network information Image data maintenance View and export dose logbook View and export activity log Technical Support Access Technical Support website for your region Remote Assistance Access website for remote Helpdesk assistance for your region Date and Time Change the system date time and time zone ...

Page 38: ...Description description of user account type Password user selected password Password confirmation re enter user password 2 Press Create NOTE Press X to close window without saving changes Edit Accounts Use this option to edit user information and or to reset a user password 1 Select user account from Accounts list and press Edit 2 Make changes to the following fields as needed Display Name Descri...

Page 39: ...can STUDIO Integration Services Configuration window Access this window from Control Panel SmartScan STUDIO Integration Services on the computer serving as the long term storage device and select the new name in the Scanner Connection field Enter information and press Save Network Use this option to enter or update the scanner network configuration and review network information NOTE If you use Ob...

Page 40: ...e the file enter a name for the file and select a location to save it on the scanner controller Device Activity Log Use this option to export device activity logs 1 Select the log category All diagnostic audit and patient exam logs Diagnostic Logs records all error conditions encountered Audit Logs records device activity such as user actions Patient Exam Logs records patient scan history 2 Select...

Page 41: ...ill be displayed if more than one user tries to use either utility at the same time on the same Image Root Do not change patient data with either utility if the patient is scheduled for an exam Wait for the exam to be completed before changing the data Or cancel the exam make the changes and then re schedule the exam You must have Administrator permissions to update the Image Root Do not change th...

Page 42: ...hat workstation for the Export to DEXIS Core function to work 1 Insert SmartScan STUDIO Server Installation media in drive 2 On AutoPlay pop up select Run SssInstallerExecutive exe If AutoPlay pop up does not display navigate to the media drive right click and select Open AutoPlay 3 On the SmartScan STUDIO Installer Executive select Data Utility checkbox and select Install If the required Visual C...

Page 43: ... ImageRoot 11 Select the Image Root and click OK 12 To configure the DEXIS Core server for use with the Data Utility select File Configure DEXIS Core 13 On the pop up click button next to Practice URL 14 Select the DEXIS Core URL then click Select 15 Enter username and password for the DEXIS Core server and click OK 16 On the pop up click Test to verify connection then close pop up Using the Data ...

Page 44: ...elong to the same patient If not move files to the correct patient ID or create a new patient ID and move the files to the new ID 3 Use procedures below to correct conflicts It is recommended that you perform all Move to Patient operations first When you have confirmed that all patient studies under a single patient ID are for the same patient you can use the Fix Keys operation to change all these...

Page 45: ...th John A Jr Mr 4 Click OK The DICOM files are updated with the requested changes A progress bar displays and changes are logged at the bottom of the window 5 When the changes are completed the Database list is updated with the change Move a Patient Study to a New Patient ID 1 Select patient from the Database list then select Move to Patient 2 On the Move to Patient pop up select the New Patient r...

Page 46: ... the example below patient Smith Jon and related studies will be moved to new patient ID 142 4 Click OK The DICOM files are updated with the requested changes A progress bar displays and changes are logged at the bottom of the window 5 When the changes are completed the Database list is updated with the change ...

Page 47: ...s will be used to update all patient data and studies under this patient ID In the example below all patient data and studies under patient ID 123 will be updated to patient name John A Smith Sr with the date of birth 11 16 1922 3 Click Fix Keys A pop up is displayed showing the data fields that will be changed 4 Click Yes to confirm The DICOM files are updated with the requested changes A progres...

Page 48: ...a specific patient study that were captured on the i CAT FLX 1 Click next to patient s name to expand the record and display the study entries 2 Click next to a study entry to expand the record and display the Series entries 3 Click on any of the following Series entries to display the image Raw Volume or Volume ...

Page 49: ...exported will determine how long the operation will take Patient Data Utility NOTE All database conflicts must be resolved using the Data Utility prior to using this utility The Patient Data Utility enables you to edit the following existing patient information in the Image Root Patient name prefix First Name Middle Name Last Name Patient name suffix Date of Birth Changes will also be applied to t...

Page 50: ...When Complete window is displayed click Finish Close the SssInstaller Executive 7 After the utility has been installed select the Start menu and right click Patient Data Utility on the menu Select Properties then select the Compatibility tab Select the Run this program as an administrator and click OK The utility will now run with administrator privileges every time it is launched NOTE It is recom...

Page 51: ... entry to edit then click Open 2 On the main window edit the patient name fields as needed Changed fields will display in blue until they are saved To change the date of birth click on day month or year and enter the correct date or scroll through the calendar drop down menu to select the correct date of birth NOTE You can view thumbnail images for a specific patient study that were captured on th...

Page 52: ... fields in the DICOM data that will be changed 4 Click OK to continue The DICOM files are updated with the requested changes A progress bar displays and changes are logged at the bottom of the window 5 Select File Open Patient to select another patient to edit When finished click Done or File Exit to close the utility ...

Page 53: ...n 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 ...

Page 54: ... an electrical fire to reduce the risk of electrical shock try to isolate the equipment from the electric source before attempting to extinguish the fire Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with nitrous or oxygen enriched atmospheres CAUTION Failure to follow instructions below may result in minor or moderate bodily injury or damage to the d...

Page 55: ...an environment for which it is not designed can lead to fire or explosion If hazardous substances are detected while the scanner is turned on do not attempt to turn off the scanner Evacuate the area and then remove the hazards before turning off the scanner Mechanical Hazards Carefully observe the patient during the scanning procedure to ensure that when the scanner gantry moves the patient does n...

Page 56: ...patient is in the chair warn the patient that the laser beam could be harmful Advise the patient that laser beams can cause optical damage Instruct the patient not to stare at the laser beam and to avoid looking into the beam Radiation Safety The scanner produces X rays useful for producing dental images X rays are electromagnetic radiation with wavelengths in the 10 to 0 01 nanometer range X rays...

Page 57: ...ved 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 environment or if the patient moves or needs immediate assistance for some reason If the Emergency Stop button is pressed the message The Emergency Stop button was activated...

Page 58: ...al communication between the operator and patient The patient emergency stop control which can stop the operation of the X ray device must be within reach of the patient when scanning occurs IEC 60601 1 defines the patient environment as any volume in which intentional or unintentional contact can occur between a patient and parts of the ME Equipment or ME System or between a patient and other per...

Page 59: ...lyze evaluate and control these risks 3 Subsequent changes to the network data coupling could introduce new risks and require additional analysis 4 Changes to the network data coupling include changes in network data coupling configuration connection of additional items to the network data coupling disconnecting items from the network data coupling update of equipment connected to the network data...

Page 60: ...A 8 i CAT FLX Technical Guide 032 0328 EN Rev K ...

Page 61: ...he patient The ability of i CAT models to provide mechanical safety and stability to provide optimum and consistent images avoid any injury to the patient and prevent the need for a re scan that would present an unacceptable risk to the patient The ability of i CAT models to meet electromagnetic compatibility requirements for emissions and susceptibility where inability to meet EMC performance req...

Page 62: ...ctive measures such as hearing aids is permitted General physical impairments involving the arms legs and or motor skills are permissible as long as the operator can perform all of the tasks required for proper operation of the scanner as described in the accompanying documentation Service The expected service life of the scanner is five years Incorrect operation or failure to maintain the scanner...

Page 63: ...mum Rated Pulsed Tube Operation 130 kVp 1mA NOTE Leakage technique factors are measured at the maximum specified energy Maximum Deviation 5 kV mA 10 Timer 0 01 seconds or 5 whichever is greater Maximum Excursion 15 kV at 120 kV X ray Beam Size Rectangular cone 23 8 cm width x 5 cm to 19 2 cm height at panel PAN option Rectangular cone 1 cm width x 10 cm height Automatically collimated not to excee...

Page 64: ...al Electrical Power 300W for Volume Scan pulsed operation at 120kV 5mA and scan time of 8 9s with a duty cycle of 42 470W for PAN Scan at 94kV 5mA Scanner Controller Requires a dedicated line and a surge protector is recommended Apparent Resistance of Supply Mains For the purpose of obtaining the apparent resistance of supply mains resistance is determined according to the following formula Circui...

Page 65: ...ht 125 lbs 56 7 kg Seat height adjustment 35 65 cm to 73 7 cm Maximum patient weight 400 lbs 181 kg Complies with IEC 60601 2 32 1994 Environmental Specifications Operating 50 to 95 degrees Fahrenheit 10 to 35 degrees Celsius 10 to 90 Relative Humidity non condensing 70 to 106 kPa Air Pressure Transportation and Storage 4 to 158 degrees Fahrenheit 20 to 70 degrees Celsius 10 to 90 Relative Humidit...

Page 66: ...Refer to Symbol Glossary page D 1 for more information on symbols Label Definition and Location Symbol Definition Patient Emergency Stop Panel Label Location Can either be hung from the chair support mechanism or held in the patient s hand Indicator Panel Label Location Front Overhead EMERGENCY STOP POWER READY X RAY ON FAULT ...

Page 67: ...E DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS OPERATING INSTRUCTIONS AND MAINTENANCE SCHEDULES ARE OBSERVED Location Operator Control Box Label Definition and Location Symbol Definition Turns Unit On Turns Unit Off Starts the Scan Power Ready X Ray Fault Emergency Stop Warning Ionizing Operating X Ray Radiation Radiation Instructions ...

Page 68: ...R RADIATION DO NOT STARE INTO BEAM 1mW 635nm CLASS II LASER PRODUCT Location X Ray Source CAUTION LASER RADIATION DO NOT STARE INTO BEAM 1mW 670nm CLASS II LASER PRODUCT Location Gantry Label Definition and Location Symbol Definition Warning Laser Warning Laser ...

Page 69: ...EN Rev K PANEL ONLY TO BE REMOVED BY ISI TRAINED SERVICE PERSONNEL Location Beam Limiter Panel Patient Alignment Panel Location X Ray Source Assembly Label Definition and Location Symbol Definition Warning Seat Height Laser Adjustment ...

Page 70: ...l MAXIMUM LIFTING CAPACITY 182 KG 400 LBS Location Chair Assembly Chair Label WARNING PINCH POINT KEEP HANDS CLEAR Seat Weighs 6 8 KG 15 LBS Location Seat Assembly Label Definition and Location Symbol Definition Maximum Lifting Capacity Warning Seat Weight Pinch Point ...

Page 71: ...B 11 Product Information 032 0328 EN Rev K Gate Label WARNING PINCH POINT KEEP HANDS CLEAR Location Chair Gate Label Definition and Location Symbol Definition Pinch Point Warning ...

Page 72: ...Location Rear Overhead Label Definition and Location Symbol Definition Electrical Hazard Non Ionizing Not For General Chair Cable Control Box Cable Interlock Cable Warning Cable Network Cable AC In Breaker Switch Radiation On Off Warning Complies With Type B Body Output for Interlock Continuous Intermittent Waste ...

Page 73: ...Overhead X Ray Power Supply Label MODES OF OPERATION CONTINUOUS INTERMITTENT COMPLIES WITH IEC 60601 2 7 AND IEC 60601 2 28 Location X Ray Power Supply Label Definition and Location Symbol Definition Door Interlock X Ray On X Ray Supply Lamp Fuse Continuous Intermittent ...

Page 74: ...g Label Capacitor Has 300VDC Wait 5 minutes for capacitor discharge before handling Location X Ray Power Supply Capacitor Caution Label DO NOT USE GROUNDED TEST EQUIPMENT ON THIS UNIT Location X Ray Power Supply Label Definition and Location Symbol Definition Warning ...

Page 75: ...28 EN Rev K CE ETL Label Location Leg Serial Labels Location Leg Location Tube Head Assembly and Packing Crate Label Definition and Location Symbol Definition Manufactured By Model No Serial No Filtration Focal Spot Manufactured Date ...

Page 76: ...should be regarded as non environmental friendly waste product The scanner does not generate or require the use of any materials that require special disposal instructions as part of regular operation The manufacturer of this product is concerned to help protect the natural environment and to help ensure continued safe and effective use of this product through proper support Do Not Use with i CAT ...

Page 77: ... local authority for further details of your nearest designated collection point Penalties may be applicable for incorrect disposal of this waste in accordance with national legislation Passing the Product on to Another User If this product passes to another user it must be in its complete state including all product support documentation Make the new user aware of the support services that the ma...

Page 78: ...B 18 i CAT FLX Technical Guide 032 0328 EN Rev K Scanner Dimensions TOP VIEW FRONT VIEW ...

Page 79: ...hoice who has adequate training in those aspects of the Performance Standards of the Radiation Control for Health and Safety Act of 1968 that are applicable to this equipment Neither the inspection nor service is part of the equipment warranty Please arrange for preventive maintenance with the Dealer s Service Department Cleaning Routinely clean and disinfect all items which come in contact with t...

Page 80: ...equires normal periodic inspection and maintenance Scheduled periodic inspections are necessary to detect problems which can result from excessive wear loose items chafing wires and mis adjusted parts from continual scanner use In addition to mechanical inspection and calibration a series of image performance tests are to be conducted These tests verify that the scanner meets or exceeds operationa...

Page 81: ... Chair Calibration Check Patient Chair Center Alignment Check Patient Chair Level Check Laser Alignments Check Centerline Alignment Check Crosshair Laser Inspect Tube Housing Components Certification Label Warning and Indicators Oil Leaks Physical Damage Scanner Mounting Stability Inspect Beam Limiting Device Physical Damage Certification Label Check Inspect X Ray Controller Visual Warning Indicat...

Page 82: ...art 27 0 Quantity 1 Glide Part 910 24 Quantity 4 Head Restraint Band Part 27 1 Quantity 50 Tool Kit Part 910 22 Quantity 1 Velcro Head Restraint Kit Part 903 0 Quantity 1 Booster Seat Part 1000196 Quantity 1 Available on request Foot Stool Part 1000197 Quantity 1 Chin Cup Part 9140 0026 0006 Quantity 1 Foam Disk Part 1000323 Quantity 1 ...

Page 83: ... Fixture Part 26 16 Quantity 1 Handswitch optional Part 1 010 3959 Quantity 1 Cord Retention Bracket Part 1 012 6471 Quantity 1 Overhead Cord Bracket Part 1 012 5468 Quantity 1 GeoCal Fixture Part 14 1 0 Quantity 1 QA Phantom Part 13 00 Quantity 1 Water Jar Phantom Part 1000224 Quantity 1 Chin Rest Slide Straight Part 36 1 0 Quantity 1 ...

Page 84: ...Rev K PAN Scan Components Bite Tip Holder Part 980220 Quantity 2 PAN Head Holder Part 33 0 Quantity 1 Position Alignment Tool Part 33 19 Quantity 1 Bite Tip Part 26 15 Quantity 25 Pan Phantom Part 12 0 Quantity 1 Chin Rest Part 26 12 Quantity 1 ...

Page 85: ...pment Cables The following table lists cables to be used with the scanner CAUTION Use supplied cables only The use of an accessory transducer or cable with the scanner other than those specified may result in increased emissions or decreased immunity of the scanner UL STD 60601 1 IEC 60601 1 4 IEC 60601 2 44 ANSI AAMI ES60601 1 IEC 60601 1 6 IEC 62366 IEC 60601 1 IEC 60601 2 7 IEC 60825 1 IEC 6060...

Page 86: ...bles other than those sold by ISI and specified as replacement parts for internal components may result in increased emissions or decreased immunity of the i CAT FLX Description Length Shielding Ferrite Connection From To AC Power Cable 12 ft None None AC Power Source Scanner AC Power Input Ethernet Cable 50 ft None Yes Scanner Controller Ethernet Port on Scanner Controller Cable 50 ft None None P...

Page 87: ...ons Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The i CAT FLX uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The i CAT FLX is suitable for use in all establish ments other than domestic and may be used in domestic es...

Page 88: ...tact 8 kV air 2 4 6 kV contact 2 4 8 kV air Floors should be wood con crete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial o...

Page 89: ...tion during power mains interruptions it is recommended that the i CAT FLX be powered from an unin terruptible power supply or a battery Power frequency 50 60 Hz mag netic field IEC 61000 4 8 3A m 3A m Power frequency magnetic fields should be at levels char acteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the...

Page 90: ...it is used in such an environment Immunity Test IEC 60601 Test Level Compli ance Level Electromagnetic Environment Guidance Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3 V Portable and mobile RF communications equipment should be used no closer to any part of the i CAT FLX including cables than the recommended separation distance calculated from the equation applicable to the frequency of ...

Page 91: ...e Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location...

Page 92: ...utput Power of Transmitter W Separation Distance according to Frequency of Transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 74 1 1 2 1 2 2 3 10 3 8 3 8 7 4 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequ...

Page 93: ...on sourceforge net LGPL v2 1 http www gnu org licenses lgpl 2 1 html jQuery jquery com MIT License http opensource org licenses MIT DCMTK dcmtk org BSD http opensource org licenses bsd license php JSON NET json codeplex com MIT License http opensource org licenses MIT libqxt libqxt org LGPL v2 1 http www gnu org licenses lgpl 2 1 html log4cplus log4cplus sourceforge net Apache Software License 2 0...

Page 94: ...w firebirdsql org IPL http www firebirdsql org en interbase public license IDPL http www firebirdsql org en initial developer s public license version 1 0 openssl www openssl org openssl http www openssl org source license html Library Product Name Homepage License ...

Page 95: ...tomical areas of the medical personnel working in the areas exposed to radiation The operator control box and scanner controller shall be located within 1 meter 3 28 ft from a door If not an interlocked door may be required A room door may be required Radiation warning signs may be required next to the entrance to the room A warning light may be required by the entrance to the room A shielding pla...

Page 96: ...d in concentric circles of radii listed in table below A 16 cm AAPM head phantom was placed within the beam to act as the scattering agent The center of the ion chamber was placed at the same height as the center of the beam which was verified to be the location of highest scatter Locations listed in the table are for 0 45 90 135 180 225 270 and 315 Looking out from the scanner 0 was located direc...

Page 97: ...29 0 98 2 45 4 90 9 2 73m 0 046 45 7 2 47 0 46 1 14 2 29 135o 3 0 91m 0 346 346 0 18 66 3 46 8 65 17 30 6 1 82m 0 087 86 5 4 67 0 87 2 16 4 33 9 2 73m 0 038 38 4 2 07 0 38 0 96 1 92 180o 3 0 91m 0 393 393 0 21 20 3 93 9 83 19 65 6 1 82m 0 098 98 3 5 30 0 98 2 46 4 91 9 2 73m 0 044 43 6 2 35 0 44 1 09 2 18 225o 3 0 91m 0 342 342 0 18 45 3 42 8 55 17 10 6 1 82m 0 086 85 5 4 61 0 86 2 14 4 28 9 2 73m...

Page 98: ... 5 6 28 0 64 1 59 3 18 9 2 73m 0 028 28 2 2 79 0 28 0 70 1 41 135o 3 0 91m 0 220 220 0 21 76 2 20 5 50 11 00 6 1 82m 0 055 55 0 5 44 0 55 1 38 2 75 9 2 73m 0 024 24 4 2 42 0 24 0 61 1 22 180o 3 0 91m 0 229 229 0 22 65 2 29 5 73 11 45 6 1 82m 0 057 57 3 5 66 0 57 1 43 2 86 9 2 73m 0 025 25 4 2 51 0 25 0 64 1 27 225o 3 0 91m 0 187 187 0 18 50 1 87 4 68 9 35 6 1 82m 0 047 46 8 4 62 0 47 1 17 2 34 9 2...

Page 99: ... 13 3 2 17 0 13 0 33 0 66 9 2 73m 0 006 5 9 0 96 0 06 0 15 0 29 135o 3 0 91m 0 047 47 0 7 70 0 47 1 18 2 35 6 1 82m 0 012 11 8 1 93 0 12 0 29 0 59 9 2 73m 0 005 5 2 0 86 0 05 0 13 0 26 180o 3 0 91m 0 048 48 0 7 87 0 48 1 20 2 40 6 1 82m 0 012 12 0 1 97 0 12 0 30 0 60 9 2 73m 0 005 5 3 0 87 0 05 0 13 0 27 225o 3 0 91m 0 039 39 0 6 39 0 39 0 98 1 95 6 1 82m 0 010 9 8 1 60 0 10 0 24 0 49 9 2 73m 0 00...

Page 100: ... 08 5 19 10 38 9 2 73m 0 092 92 1 2 49 0 92 2 30 4 61 135o 3 0 91m 0 688 688 0 18 56 6 88 17 20 34 40 6 1 82m 0 172 172 0 4 64 1 72 4 30 8 60 9 2 73m 0 076 76 4 2 06 0 76 1 91 3 82 180o 3 0 91m 0 799 799 0 21 55 7 99 19 98 39 95 6 1 82m 0 200 199 8 5 39 2 00 4 99 9 99 9 2 73m 0 089 88 7 2 39 0 89 2 22 4 43 225o 3 0 91m 0 684 684 0 18 45 6 84 17 10 34 20 6 1 82m 0 171 171 0 4 61 1 71 4 28 8 55 9 2 ...

Page 101: ... 6 27 1 27 3 18 6 35 9 2 73m 0 056 56 4 2 78 0 56 1 41 2 82 135o 3 0 91m 0 442 442 0 21 81 4 42 11 05 22 10 6 1 82m 0 111 111 0 5 48 1 11 2 78 5 55 9 2 73m 0 049 49 1 2 42 0 49 1 23 2 45 180o 3 0 91m 0 466 466 0 22 99 4 66 11 65 23 30 6 1 82m 0 117 116 5 5 75 1 17 2 91 5 83 9 2 73m 0 052 51 7 2 55 0 52 1 29 2 59 225o 3 0 91m 0 376 376 0 18 55 3 76 9 40 18 80 6 1 82m 0 094 94 0 4 64 0 94 2 35 4 70 ...

Page 102: ...0 3 4 33 0 80 2 01 4 01 9 2 73m 0 036 35 6 1 92 0 36 0 89 1 78 135o 3 0 91m 0 307 307 0 16 56 3 07 7 68 15 35 6 1 82m 0 077 76 8 4 14 0 77 1 92 3 84 9 2 73m 0 034 34 1 1 84 0 34 0 85 1 70 180o 3 0 91m 0 384 384 0 20 71 3 84 9 60 19 20 6 1 82m 0 096 96 0 5 18 0 96 2 40 4 80 9 2 73m 0 043 42 6 2 30 0 43 1 07 2 13 225o 3 0 91m 0 302 302 0 16 29 3 02 7 55 15 10 6 1 82m 0 076 75 5 4 07 0 76 1 89 3 78 9...

Page 103: ... 4 34 1 61 4 03 8 05 9 2 73m 0 071 71 5 1 93 0 71 1 79 3 57 135o 3 0 91m 0 612 612 0 16 50 6 12 15 30 30 60 6 1 82m 0 153 153 0 4 12 1 53 3 83 7 65 9 2 73m 0 068 67 9 1 83 0 68 1 70 3 40 180o 3 0 91m 0 776 776 0 20 92 7 76 19 40 38 80 6 1 82m 0 194 194 0 5 23 1 94 4 85 9 70 9 2 73m 0 086 86 1 2 32 0 86 2 15 4 31 225o 3 0 91m 0 599 599 0 16 15 5 99 14 98 29 95 6 1 82m 0 150 149 8 4 04 1 50 3 74 7 4...

Page 104: ...0 0 31 0 31 0 78 1 55 9 2 73m 0 014 13 8 0 14 0 14 0 34 0 69 135o 3 0 91m 0 172 172 0 1 72 1 72 4 30 8 60 6 1 82m 0 043 43 0 0 43 0 43 1 08 2 15 9 2 73m 0 019 19 1 0 19 0 19 0 48 0 95 180o 3 0 91m 0 199 199 0 1 99 1 99 4 98 9 95 6 1 82m 0 050 49 8 0 50 0 50 1 24 2 49 9 2 73m 0 022 22 1 0 22 0 22 0 55 1 10 225o 3 0 91m 0 122 122 0 1 22 1 22 3 05 6 10 6 1 82m 0 031 30 5 0 31 0 31 0 76 1 53 9 2 73m 0...

Page 105: ...voxel of tissue from contributions of dose from all slices in a multi slice protocol This measurement uses a 100 mm ionization chamber and approximates the dose from the primary beam and slices adjacent in a single scan single slice For the measurement to be valid the X ray width should be much less than 100 mm This measure takes into account the sum of 1 3 of the phantom central dose and 2 3 of t...

Page 106: ...or in a 16 cm AAPM head phantom All dose values are in mGy Scan Time sec kVp mA mAs 13 cm Height 11 cm Height 10 cm Height CTDIw CTDI Free air Mid Scan Dose CTDIw CTDI Free air Mid Scan Dose CTDIw CTDI Free air Mid Scan Dose 8 9 120 5 18 54 1 9 2 5 2 1 1 9 2 5 1 9 1 9 2 5 1 9 4 8 120 5 10 11 1 0 1 3 1 2 1 0 1 3 1 1 1 0 1 3 1 0 4 8 90 3 6 1 0 3 0 4 0 3 0 3 0 4 0 3 0 3 0 3 0 3 26 9 120 5 37 07 3 8 4...

Page 107: ...oses The curve also indicates that the device can resolve detail down to 1 line pair per millimeter lp mm This means that the sensor panel exhibits no reduction in resolution over the input dose range from 390 to 3500 nGy The graph below shows a typical DQE for the 2520DX sensor panel DQE as a function of spatial frequency for a range of X ray doses from 61 to 3171 nGy for a high resolution scan T...

Page 108: ...de Heat Content HU KvP x mA x Time in Seconds 30 000 HU X Ray Tube Single Load Rating 120kV 5mA Max X Ray Tube Assembly Heat Content 120K HU Max Continuous Heat Dissipation of Tube Assy 65W High Voltage Supply Requirements 120 VAC at 10 amps Loading Factors Concerning Leakage Radiation CT Scan 120kV 5mA 12 mS x 618 or 309 PAN Scan 94kV 5mA 61 nGy 341 nGy 667 nGy 1326 nGy 2110 nGy 3171 nGy ...

Page 109: ...perating voltage 130 kVp Full wave rectified Inherent Filtration 1 1 mm Al equivalent Glass Cooling Method High dielectric transformer oil Conditioning of Tube Head Must be at or above 22oC before first scan Allow scanner to acclimatize for two hours if operating environment was out of range or scanner was stored out of range X Ray Tube Voltage X Ray Tube Current Electrical Power 90 kV 3mA 270W 84...

Page 110: ...120V 10A 1536 X Ray Power Supply Cable J21 1203 System Board no other additional accessories tested supplied from a secondary of the Isolation Transformer HEATING COOLING TEMPERATURE o C X Ray Tube Head Heating and Cooling Chart TIME min CONDITIONS FOR X RAY TUBE HEAD HEATING AND COOLING TEST MACHINE CYCLED IN PAN MODE 1 SCAN EVERY 5 MINUTES PAN MODE SETTINGS 94KV 5mA 20SEC SCAN AMBIENT TEMPERATUR...

Page 111: ...C 17 Radiation Information 032 0328 EN Rev K 28 1 in 71 4 cm 10o 10o 9 6 in 24 4cm Target Angle to Specific Reference Axis ...

Page 112: ... polar FILAMENT CURRENT AMP TUBE CURRENT mA FILAMENT VOLT AMPS CHARACTERISTICS 60 Hz AC DC VOLTS AMPS ANODE HEATING COOLING CURVE ANODE HEAT STORAGE CAPACITY HU X 1000 TIME IN MINUTES H U Heat Units kVp Kilovolts Peak Joules 707 x H U x mA eff x Time sec ANODE HEAT STORAGE CAP 30 000 H U MAX ANODE HEATING OIL SUBMERGED ONLY COOLING RATE 165 HU PER SECOND ...

Page 113: ...erating the device or control close to where the symbol is placed or to indicate that the current situation needs operator awareness or operator action in order to avoid undesirable consequences Caution Warning laser beam W004 ISO 7010 To warn of a laser beam Laser Stand by 5009 IEC 60417 To identify the switch or switch position by means of which part of the equipment is switched on in order to b...

Page 114: ...l operating instructions 1641 ISO 7000 To identify the location where the operator s manual is stored or to identify information that relates to the operating instructions To indicate that the operating instructions should be considered when operating the device or control close to where the symbol is placed Follow Operating Instructions for Use ON for a part of equipment 5264 IEC 60417 To indicat...

Page 115: ...SO 7000 To identify the control that raises and lowers the dental chair without changing the angle of the seat Seat Height Adjustment Body Weight 5665 IEC 60417 To identify the control or the indicator to enter or call up the body weight of a person Maximum Lifting Capacity X ray source assembly emitting 5339 IEC 60417 To indicate the emission or the imminent emission of X radiation X Ray On Warni...

Page 116: ...e RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment Non Ionizing Radiation Marking of electrical and electronic equipment N A BS EN 50419 This symbol indicates that when the end user wishes to discard this product it must be sent to separate collection facilities for recovery and recycling Not for General Waste Chair Cable N A N A N A Chair Cable Cont...

Page 117: ...ts and outputs Output for Interlock Rated power input a c 6045 IEC 60417 To indicate an a c rated power input AC In Manufacturer 3082 ISO 7000 To identify the manufacturer of a product This symbol shall be used filled in all applications to differentiate it from ISO 7000 2497 Manufactured By Date of Manufacture 2497 ISO 7000 To indicate the date on which a product was manufactured Manufactured Dat...

Page 118: ...0417 To indicate a reference to a radiation filter or a value of filtration Filtration Small focal spot 5325 IEC 60417 To identify controls or indicators associated with the selection of a small focal spot or the connections for the corresponding filament Focal Spot Locking general 5569 IEC 60417 To identify on a control that a function is locked or to show the locked status Interlock Fuse X ray s...

Page 119: ...rol by which a pulse is started Intermittent Intertek ETL Listed Canada USA N A N A The Marks are evidence that the model product conforms to applicable standards and that there is a program of ongoing factory inspections CE Mark N A N A The product meets all the legal requirements for CE marking and can be sold throughout the European Economic Area Symbol Title of Symbol Reference Number Standard...

Page 120: ...D 8 i CAT FLX Technical Guide 032 0328 EN Rev K ...

Page 121: ......

Page 122: ...032 0328 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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