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Installation, Calibration & Service Manual - i-Cat

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5. 13 Illustrated GOImbDbOHEODIS 13 Replacement Palls uum ie 14 Chassis 15 Base Chassis back amp Detector Power 15 Base Chassis back amp Detector Power 16 Image Receptor Carriage nennen nennen nnns nennen 18 Tube Head ASSeRIDIV in cases at 18 Beam Nero mme 19 s 20 Hand Controls Refer to 25 for connection locations 21 MP 21 Ghapter 2 Machine N 22 Required tools for installation and 23 Chapter 3 a ed adest 24 LCATO Complete ASSSGImIDIiyuu 24 Chapter 4 Alignment and Calibration nnne 36 14 1910 218110 2128 om tenets Ounces E HE 36 Bean 44 Geometric Alignment Phantom Alignment 46 Extended Field of View EFOV di hd po ose
6. 51 Overhead POS MOM a oae A 54 OF VIE dsulelTielliS 54 Image Receptor Sensor Calibration Offset Gain 56 Chapter 5 Enabling i CAT Software for Report Service 57 Chapter 6 Machine Control Software 58 Field Calibration For CT X ray Power Supply and X ray Tube 60 Chapter 7 Galibratiort PFrOGOdUle watas 60 Calibrate Tube Head amp Power 61 Chapter 8 i CAT Troubleshooting cernerent 63 Stall WP u u uuu ceris 63 SONWALE ENOS RETI EP 66 Beam Colimator 67 Blurry or Noisy Scans non anatomic 68 made DION 68 aui 69 Chapter 9 Schematics amp ecu clued ox dob E tue ce o eut eu 72 wed me a Cav tran 88 Assembl
7. 13 If the system has Extended Field of View EFOV proceed with to next section Extended Field of View Calibration Otherwise go to page 54 Confirmation of Overhead Position Extended Field of View EFOV 1 When in the test factory patient in i CAT software click Acquire New and select the Extended Height 20 20 protocol the phantom should already be in proper position but if not please refer to Phantom Positioning section page 46 Click Start Acquisition to acquire the scan The Extended field of view scan sequence is as follows First 20 second scan rotation Elevation Raises Rotation Rewinds to home 10 seconds Second 20 second scan rotation Elevation goes down to original position Rotation Rewinds to home The total height of an EFOV scan is 22 cm 2 Click Abort when the scan starts to Reconstruct 3 Close the i CAT program 4 Configure the software into Service or Report Mode To do this follow steps in Ch 5 Enabling i CAT software into Report service Mode edit the Xoran xml file by inserting XoranStart iCA T 5 Start i CAT program again and open the Raw data from the last scan Part 990307 Page 51 of 90 March 29 2007 6 Type to locate highlight the BB s red Then click the Reconstruction Parameters button Then click on the Ceph Calibration tab Heconstruction Param Cephalometric calibration Save parameters
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9. Click Reconstruction Parameters to display and access the Calculator tools Info Panel Part 990307 Page 48 of 90 March 29 2007 5 Calculate Parameters e Click on the first Calculator tool named Calculate Parameters This will calculate and display a series of parameters below OD SD CS Beta Average Error Correction standard deviation central slice Tau detection Tau correction PARETARA Estimating parameters 272 BSHSGBSBSHOBSRSRSBSUS WARNING Distances are not to scale Calculated parameters are OD 225 31 SD 704 18 CS 245 2 t_d 0 00 1 2 1508 Beta 0 0000 radians 0 001 Orbit Angle 360 11 Average Error 0 2227 pixels 0 3 Beta within acceptable range 0 001 Calibration complete EXCELLENT The Beta and Error Correction are the parameters that will be observed Beta should be between or 0 0010 ideally it would be 0 0000 Error correction should be under 0 30 Note If the Beta does not fall into range then follow the steps below Mechanical Alignment of Image Receptor If the Error Correction is out of tolerance check for mechanical vibrations gear mesh bearing contact system stability Part 990307 Page 49 of 90 March 29 2007 6 Mechanical Adjustment of Image Receptor the Beta does not fall within the range then the Image senor needs a mechanical alignment
10. XoranCAT Install XoranUpdate xml gt lt Language Override Language xml gt lt Language gt Note This will be adding the part in the second line of text that reads XoranStartz iCAT There needs to be one space between xml and Xoran BEFORE Xoran xml Notepad Edit Format View Help lt xml versdon 1 0 encoding Iso 8858 1 7 lt Installs xorantlpdate xml gt Language Override Language xml z Languages AFTER 4 Xoran xml Notepad File Edit Format View Help lt xml versdon 1 0 encoding Is0 8859 1 7 Install so0ranUpdate xml xoranstarts 1 gt lt Lanquage Oyerride Language xml gt lt 1 gt lt Seart inns gt Part 990307 Page 57 of 90 March 29 2007 Chapter 6 Machine Control Software The i CAT has a motherboard that contains Flash memory On this Flash memory is saved the Machine Control Software This software controls the functions of the i CAT scanner These functions are Gantry Rotation Beam Collimators Limiter Overhead Position Platform Overhead Position Height Chair Position Exposure a Machine Control commands can be entered into the machine via a keyboard plugged into the back of the machine or through the ISIRemoteControl program see next page for details on ISIRemoteControl The Machine Control Commands are a
11. cn mma Param Estimation Ceph Calibratic Info Panel Part 990307 Page 52 of 90 March 29 2007 7 Next click on the Cephalometric Calibration button and the calculations of parameters will start Save calculated parameters to Settings file Taux iupper 0 28409 mm 0 41885 mm upper 0 92264 mm Phi 8 75000 deg Yes Ma 8 When prompted click Yes to save the calibration numbers 9 Close the i CAT program to save the calibration permanently 10 Restart the i CAT program in normal customer mode 11 Scan the phantom again with the Extended Height protocol and this time let the data Reconstruct Once reconstructed examine the alignment of the highest BB which is covered by both the upper and lower halves of the scan When the phantom is positioned correctly this BB should be at about 11cm height in the sagittal coronal view but should definitely be between 10 and 12cm 100 120mm Examine this BB in the axial view by scrolling the mouse wheel Visually the BB should ideally appear as one but could be 2 BB s with varying degrees of separation with a maximum separation of the diameter of one BB 12 If the separation is more than the diameter of a BB then perform another calibration using the current data set reminder put i CAT back in report mode and open raw data If re calibration is not successful please contact Imaging Sciences
12. 15 LM 90 92 21 23 38 5 31 UU 34 009 50824 071601 0016 9 Ny 13114 sad FONE D LHASNI 2 G 318v NOLLOndOHd 29 2007 Page 83 of 90 990307 lt m gt lt ace 2 5 59 ue Fa 1 5 990307 Page 84 of 90 March 29 2007 FEL NR 910001 275 12 1275 8888 RL1 X RAY INTERLOCK BOARD BOR 2148 1237 8881 O assvs 9140 1237 0000 REV A e gt LL OU Ee dh I e rrt SB 2589 y T 4 k M Part 990307 Page 85 of 90 March 29 2007 omm eu k eure 4 k Part 990307 Page 86 of 90 March 29 2007 55 CHIN LIFT RELAY BD dA 125 2 L bon 05909068 02 622 920008 2 aser 45 Rordrio sa A jx drip sw mdrioj 4 Part 990307 Page 87 of 90 March 29 2007 Forms FDA Form 2579 Sample Procedure 1 Complete areas indicated 2 After completio
13. Turn the Power ON Lower the elevation of the overhead mount assembly to lowest point to allow for mounting of the Overhead When completed Turn the power OFF Level the Uprights before mounting Overhead so that they are in the same vertical plane Attach the overhead assembly with the 10 securing bolts provided 4 each on the backplane and 6 each inside the overhead assembly and 5 on each side Remove the 2 shipping screws Connect the cables in the Overhead assembly Mount the Varian Image Receptor Panel amp counter balance to the receptor housing and connect the 48 Volt power cable amp the CAT5 network cable to the panel Turn the power to the machine ON Verify there is power to the Varian Image Receptor Panel Adjust friction brake in base of machine if needed Attach the wall mounting bar to the wall prior to moving the system against the wall Note Do not attach machine to wall mount until leveling of machine is completed Set up the Acquisition computer and the monitor Check the Ring Gear Bearings in the overhead assembly to insure bearings are making contact throughout the rotation Check the Gantry for Back Lash to insure that the gantry does not bind in rotation nor has too much play in the gear Level the machine using a line level on the Ring Gear in the Overhead Assembly Level the front back and the side side using the feet adjustments When the device is level attach the machine to the wall mount via
14. 990307 Page 10 of 90 Operating Data Available focal spot sizes mm 0 5 Available target angles 15 Anode construction Vacuum cast copper with tungsten target Cathode construction Vacuum tube nickel with tungsten filament Max Tube operating voltage 130 kVp Full wave rectified Inherent filtration Window material 2 0 mm Glass Cooling Method High dielectric transformer oil Filament Rating 3 7 V max 2 15 Amp max March 29 2007 X Ray tube Data Curves EMISSION CHARACTERISTICS Full Wave Rectified Single phase Bi polar FILAMENT CURRENT AMP 8 5 12 13 14 Filament Volt Amps Characteristics BO Hz AC amp DC a 4 0 8 x 22 8 4 Tima In Minutes H U Heat kVp Kilovolts Peak x mA rms x Time sec Joules 707 x H U SXR 130 15 0 5 Part 990307 Page 11 of 90 March 29 2007 Equipment Standards The i CAT model 9140 series has been tested and or evaluated against and found compliant to the following standards and requirements IEC EN 60601 1 IEC EN 60825 1 IEC EN 60601 1 1 CE MDD 93 42 EEC IEC EN 60601 1 2 CMDCAS Canadian Medical Device Regulation IEC EN 60601 1 3 CSA C22 2 No 601 1 IEC EN 60601 1 4 ISO 10993 1 2003 IEC EN 60601 2 7 ISO 14971 2000 IEC EN 60601 2 28 IEC EN 60601 2 32 IEC EN 60601 2 44 UL 60601 1 VFS 2003 11 Swedish regulation transposing the MDD 93 42 EEC The Quality System of Imaging Sci
15. Imaging Sciences International Cone Beam Computed Tomography Dental Imaging System Installation Calibration amp Service Manual Imaging Sciences International 1910 North Penn Road Hatfield PA 19440 Phone 215 997 5666 Fax 215 997 5665 Part 990307 Page 1 of 90 March 29 2007 Table of Contents FGAT UI 3 standard Limited Warranty A 4 5 Radiation Protection occu des 5 5 WARING uu um a aasan n 5 SUSI 6 Machine Markings Symbols uuu unum ua 7 Product Dimensions nrnna 8 E E 9 tial donna cans T 10 tube iri itecto obedit e uuu 11 2 12 EQUIDIMGIT 2 12 Chapter r 0 0124 62245 u Leda
16. O O O O O O O O Under no circumstances shall ISI be liable for any special incidental or consequential damages based upon breach of warranty breach of contract negligence strict liability or any other legal theory Such damages include but are not limited to loss of data loss of profits loss of revenue loss of use of hardware system or any associated equipment cost of capital cost of substitute or replacement equipment facilities or services down time purchaser s time the claims of third party including customers and injury to property Disclaimer of Warranties The warranty stated above is the only warranty applicable to this product all other warranties expressed or implied including all implied warranties of merchantability or fitness for a particular purpose are hereby disclaimed No oral or written information or advice given by Imaging Sciences its agents or employees shall create a warranty or in any way increase the scope of this warranty Part 990307 Page 4 of 90 March 29 2007 Safety Items opecific warning and caution notices are used throughout this manual where applicable Warning Warning as used in this manual is defined as A situation which may possibly be potentially hazardous and may possibly result in serious injury or death Caution Caution as used in this manual is defined as situation which could be potentially hazardous and could result in minor or moderate injury aler
17. me SS Detector Power Supply Detector Power Supply powers the detector mounts in the center on the back of base chassis PS Back View PS Front View Part 990307 Page 16 of 90 March 29 2007 Overhead Assembly Part 990307 Page 17 of 90 March 29 2007 Gantry X ray Tube Head Assembly Part 990307 Page 18 of 90 March 29 2007 Beam Limiting Device Part 990307 Page 19 of 90 March 29 2007 Chair Mechanism a Patient Chair may be removed to accommodate a wheelchair b Maximum patient weight is 300 105 136 kg C Seat height adjustment 12 1 2 in to 21 1 2 in 31 8 cm to 54 6 Part 990307 Page 20 of 90 March 29 2007 Hand Controls Refer to page 25 for connection locations Cables D Part 990307 Page 21 of 90 March 29 2007 Chapter 2 Uncrating the Machine The i CAT ships in a crated skid weighing approximately 1 125 pounds 507 kg with approximate shipping box dimensions of 97 in x 44 in x 55 in 247 cm x 112 cm x 140 cm There are 5 major components and 6 boxes The components are sh prs Two uprights attached to the base Overhead with gantry Chair Legs Wall mounting bracket and chair retaining bracket with wheels The boxes contain 1 2 4 9 6 PC box with system cables data serial and i CAT machine power cable hospital grade is for the machine Monitor box with cables Counter balance weight and
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19. OBSERVED UNAUTHORIZED USE IS PROHIBITED ATTENTION CETTE UNIT DE RAYON X PEUT TRE DANREREUSE POUR LES PATIENTS ET L OP RATEUR MOINS QU ON OBSERVE DES FACTEURS S RS D EXPOSITION AUX MODES OP RATOIRES L UTILISATION NON AUTORIS E EST INTERDITE X ray Caution VOLTS HZ 115 50 60 Max AMPS STANDBY 10 1 5 Typical Input Power Label Protective Earth Ground CAPACIT MAXIMALES DE LEVAGE LA CHARGE DU FAUTEUIL NE DOIT PAS D PASSER 136 kg 300 LBS Chair Maximum Capacity Part 4 990307 Page of 90 March 29 2007 Product Dimensions Dimensions Keyboard 17in Length x 7 in Width F2 00 43cm x 18cm 183 cm Monitor with stand FRONT VIEW 20 LCD Monitor 51cm 17 5 in Height x 13 5 in Length 45cm x 34cm Tower Computer 17 in Height x 18 in Length 8 5 in Width 43cm x 47cm x 22cm Machine Weight 425 lbs 192 kg Specifications are subject to change 246 00 Na 0117 ROTATION 155 VIEW 112 Part 990307 Page 8 of 90 March 29 2007 Technical Specifications The i CAT Imaging System is a Cone Beam Volumetric Tomography and Panoramic x ray machine for Dental head and neck applications and is suitable for an in office environment System Specifications Power Requirements X ray Source Line Voltage 115V or 230V Factory set Tube Voltage 120 kVp Tube Current 3 7 mA Line Vol
20. Over cable o o o p Part 990307 Page 28 of 90 March 29 2007 D 50 Pin cables should be connected last because they will hide other connections 1 Please be sure Re check that all connections are correct and secured 13 Check the Seating of the heat sinks on the motor driver in the Overhead Part 990307 Page 29 of 90 March 29 2007 14 Attach the Image Receptor Sensor to the Sensor Housing Set place as seen below into the Grooves The socket head cap screw at the top is adjusted in the factory so when the sensor is installed it should be properly rotated This may need adjustment later in the calibration procedure Counter balance weight Image Receptor 00 65 Housing C retention mechanism SUM Install the horizontal spring last Make sure the top socket head cap screw is seated against the side bracket The purpose of the spring is to make sure the cap screw makes contact with the bracket Secure the receptor via the receptor retention mechanism by using the small socket head cap screw First insert the large washer then the retention spring and then the smaller washer These 2 screws currently serve no purpose but should be either flush to the surface or removed Part 990307 Page 30 of 90 March 29 2007 15 16 17 18 Plug the Network cable white cable and the S
21. SYM EIE D 037 NO LN3IWCTI 9 5 037 NO Seber O HOLMS 801 5 3 AlddNS 0397 11 037 NO ost O HOLIMS dOLS 3 8 5 O Sf L4 4 29 2007 Page 79 of 90 990307 Part 40000 01 1 09 16 SIL 01 83338 TIVHS 5800834 NI SNOLL2 008434 TI 15 SERROTE AV X C sC C Cage onc s 3 urs x OBN 10 YIN NOSSHL ONY NOLLYWSUJN JHL IVNOLL VNH31 NI OS y 530 N325 9 18 O3HS 338 5 3 SIHL ves ar 4 0 d4344113 121119 qw3H OL NOR 103135 A A TIGNE 2 0 9 01 48 i 20 isd aosa 5055 7054 aee 21 roawioce Jat ro2vilocc vGOIL2A INI f 1 2123138 3000 J 8 amp Uv3H os 309 1104 HOHO a lud 8 5
22. in writing if there is a defect in material or workmanship Written notice in all events must be received by ISI before expiration of the warranty period This warranty is not transferable This One Year Limited Warranty covers normal use ISI does not warrant or cover Damage caused by impact with other objects dropping falls spilled liquids or immersion in liquids e Damage caused by a disaster such as fire flood wind earthquake or lightning Damage caused by unauthorized attachments alterations modifications or foreign objects Damage caused by peripherals Defects caused by failure to provide a suitable environment Damage caused by the use of the hardware system for purposes other than those for which it was designed Damage from improper maintenance Damage from improper electrical connection or supply Damage caused by any other abuse misuse mishandling or misapplication Damage to acquisition computer software or operating system caused by o Additions or changes unauthorized by ISI Viruses spy ware or gaming software Damage caused by Network or Operating Engineers Damage from the use of this machine or computer for any other Applications other than its intended use Damage caused by third party software Damage caused by unauthorized changes to the ISI software Damage caused by unauthorized upgrades additions or deletions Damage caused by internet use or any other unauthorized application
23. radiograph Part 990307 Page 69 of 90 March 29 2007 3 The right side of the radiograph is slightly out of focus This usually happens when the patient is Frankfurt horizontal angle The trick here is that the patient most probably had their head rotated slightly Using the back head rest will discourage the patient in placing their head in the wrong position 4 have observed all of the above criteria but still have defocused radiographs This is possible due to differences in patient anatomy Jaws are slightly different in size density and clear anatomy It has been observed that younger patients show clear anatomy versus older patient Some differences between jaws such as wide jaws elongated heads and other normal variances might contribute to blurry radiographs 5 White horizontal strips across the radiograph The primary reason is typically shadowing The white strip is most likely the contribution of a radio opaque substance such as crowns bridges and large metal objects appearing smeared in the opposite side of where they are supposed to be This is further exasperated by having the jaw out of the focal trough Section 2 System problems 6 Thin horizontal lines across the radiograph The detector uses region strips that span horizontally Each strip is controlled by its own electronics The middle and edges of the strip might slip out of calibration and show up as thin horizontal line artifacts This can easily be cle
24. speed make sure to test for any down drift with the power off Part 990307 Page 31 of 90 March 29 2007 19 Install the mounting bar on the wall centered behind the machine The height of the mounting bar should be approximately 71 12 to 72 12 inches from the floor to the center of the mounting bar However this may vary so please mount at an appropriate height for that particular location Might want to put the L brackets on machine and mark the wall to verify height Use 3 wall anchors screws to mount the bar securely Loosely attach the L brackets to the machine and mounting bar Do not tighten the brackets until leveling Ch 4 is complete Part 990307 Page 32 of 90 March 29 2007 20 Set up the Acquisition Computer and Monitor This may vary depending model of computer that was shipped with the machine Connect all cables in back of PC A Power B PS2 Keyboard connection C PS2 Mouse connection used for Button Box connection D Serial connection cable serial port 1 to back of machine Note The end Labeled PC must go to the Computer Parallel port old style printer connection USB ports for keyboard mouse and software keys DVI monitor connection preferred connection Analog monitor connection blue connector Ethernet connection LAN Ethernet Cross Over cable to scanner image data Note Plug the i CAT Acquisition key dongle into one of the USB ports in th
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26. 0 GB Hard drive 2 GB RAM Video Memory of 128MB minimum 1 serial port 9 pin Field of View standard 6 30 inches diameter x 5 12 inches height maximum 16 cm diameter x 13 cm height maximum Sensor Front Panel Attenuation Value Less than 1mm of aluminum equivalent Patient Support chair Overall dimensions 30 5 d x 29 w x 50 5 h 77 5 cm x 73 7 x 128 3 Extended Field of View optional 6 30 inches diameter x 8 66 inches height maximum Weight 115 16 52 kg 16 cm diameter x 22 cm height maximum Seat height adjustment 12 5 to 21 5 Note Maximum values can be collimated down 31 8 cm to 54 6 cm Maximum patient weight 300 Ibs 136 kg Primary Reconstruction Less than 2 minutes for 20 sec scan 9 0 4 voxel Secondary Reconstruction Real Time Complies with IEC 60601 2 32 1994 The patient must be properly positioned in the Head Support Positioning Mechanism for each patient for all applications in order to have the focal spot to skin distance as large as possible Part 990307 Page 9 of 90 March 29 2007 X ray Tube Specifications Imaging Sciences International utilizes Superior X Ray Tube Co to custom manufacture our high quality X ray head assemblies Q5 52 4 1nn Inr 50 12 7nn 2 00 50 8nn 15 4 83 122 7nn 2 785 70 7nn 50 12 7nn u 622 15 Bnn 10 32 UNF 2B TH D 60 15 2mm DEEP SXR 130 15 0 5 Part
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28. 4 Lock Chair clamps brackets place There 2 screws on each side One goes into the legs and one into the wheel bracket 15 iPAN Position Calibration e n the ISI RemoteControl not via keyboard plugged into back of machine on the Acquisition PC type in XN2 amp click OK the Overhead will shift amp the rotation will go to the start position for Panoramic position Click OK again amp the rotation will go Home but the Overhead platform will stay shifted forward The Platform and only the Platform is now in the start position for an iPAN panoramic scan e Place the Pan Alignment tool into the bite stick hole make sure the bite stick slide on the chinrest is closest to the chinrest hole see picture below Turn on the laser amp check the vertical mark on the tool The goal is for the vertical laser light to hit the notch on the tool e f the vertical laser light does not hit the notch on the tool then measure the distance between the notch and laser in mm and multiply the distance by 10 e g measurement of 8 mm will 80 Now issue an appropriate command in ISIRemoteControl It will be a command the calculated value is greater than 100 multiple commands may be required to be issued the parameter has a limit of 100 PJO xxx where is the calculated value A positive value will shift the Platform back A negative value will shift the platform forward E g PJO 80 will shift the platf
29. 415 9559 10659 29 2007 77 0190 990307 Part Le 1 430D2N3 19 s 40 Hos sid HL 032098438 AI TVNOLLVNS3INI S3ON3IOS NIOVWI v0 BI 2 03511 391 ON AWW MOH AON ONY ON JHL LM 5328325 SM 43 339 S NIMYH 032 04 447 32NY 43701 ATW O 2 540 983 O 88 o 3nr IND C 142 5667 5667 Ji 2 ege 1049 99 2 14 20 QAG r IC 8001 AJ LOO 2 1 5001 SI 5010 110 HOIH 1 70 6 2 4142230 29 2007 78 0190 990307 sp OG 0000 68 09 6 3M Qquvo amp d x00 IH311NI ATH X 1 4 3505 418 14548 00539 H 4149 230 10555055 WSOLSCA 10545055 WSOLECA TWNOLLVNU SJONSIOS DNIDVWI 9076 avo 22970 gt 14 4189 2 9010NH23L 2002 H USYA 33 A 30 JHL 3O LB f d ON 53 90 10NH23L ONY 53243125 Syy 38 38832301 ONY 3H 305 1 YOLLNYNSHN d ALN 532N3l25 9NIS W
30. AlddNs 3 Old ONY 057008 318 3 H3 Od NOILVA3 T3 Schemat Chapter 9 H31fld O2 99215 1 93135 Qv3H Oo000 0zccL OFL6 HOld323H H OL AS or 0000 2011 0 16 HOLOW NOLLY LOH 9921 00 5 Qquvogd AlddNS AHX 0000 0004 0FL 6 0000 5621 O0F16 H3002N3 12 ld ASAZLA0F AB ACL x 1n er s g 113 0015 A ANN 002 NI IVA SI 0000 0081 004 6 13 0000 0684 0846 ANS NOILYLOW 5 UMT A 72 0190 990307 1 e 2 0000 0081 0016 s uw TVNOLLVNH31 53243125 9NI9V 9 3066 402222154 222 32N 13001 9 01 83434 30 9138 TIYHS 59 0 40 HS 30 Lud M 5 10033338 151 30 511949 33 3HL L 0330003333 8 MAYO IHL 035 33 LON AYM MOH MANY M JHL LM 530325 8NIB YIN 3 N338 5 9 AS Q E r ms 1 20 2 4318 0 50 90 PN 5
31. Insufficient Memory Error Message If an Insufficient Memory message appears at any point when in the i CAT software close the program wait about 20 seconds and re launch it If the program will not open again re boot the computer 2 Error Messages If an error message appears that is contributed to a file with a dll extension then re install the MDAC file that is on the i CAT installation CD The file name is MDAC TYP 2 8 exe The dll files are database files 3 Not enough Disk Space Error Message If this error message appears then the machine will not allow for any additional scans because the PC is out of disk space to save the scan data In this case the existing cases need to be Archived or the hard drive should be cleaned up 4 Acquisition Hardware Failed Error message If this error message appears shut down i CAT and the PC Restart i CAT machine wait 2 minutes Then start PC The connections between the two are then reset and should be working again 5 Configuration file corrupted Error message 1 To fix this it is necessary to edit the Xoran xml file in c N Program Files Imaging Sciences International i CAT 2 To do this first make sure the i CAT software is closed Then locate the Xoran xml file by navigating to c N Program Files Imaging Sciences International i CAT 3 Right click on the Xoran xml file and select the item Open With then click on Notepad Edit the second
32. SE make a backup of the file so it can always be placed back into the original file Error initializing detector board Possible causes he receptor panel has not initialized properly to be detected by the Intel Pro The Ethernet connection between the i CAT computer and the receptor panel is open not properly connected or is loose The Intel Pro Board is loose he receptor panel has no power coming in Troubleshooting Reboot the machine and wait 2 min before attempting opening the application this will give the panel enough time to boot up b Check the Ethernet cable from end to end from the back of the computer to the receptor panel specially in the cross over connector inside the overhead panel c Reseat the Intel Pro board d Make sure the power supply cable is plugged in correctly on both end from the receptor panel side and from the Varian Power Supply panel 4 When attempting an x ray calibration the x ray buzzer does not sound Possible causes One or both of the Emergency Stop buttons are depressed 5 The elevation up or down button has no response Possible causes One or both of the Emergency Stop buttons are depressed o the emergency stop buttons are released and the overhead still doesn t move up down is possible that the embedded computer is locked up Reboot the machine is order to re initialize the system Part 990307 Page 65 of 90 March 29 2007 Software Errors 1
33. Technical Support Part 990307 Page 53 of 90 March 29 2007 Confirmation of Overhead Position 1 Take a Scout film with the gate closed and chin cup in place with protocol 13cm 20 seconds 0 4 voxel To evaluate the distance close the acquisition window and expand the list for the test factory patient Find the scout just taken should be the last scout in the list of scans and double click on it to load it Use the Distance Tool Ruler icon to measure the distance between the front edge of the chin cup and the edge of the detector Con firm that this distance is between 25 and 30 mm 2 If this measurement is out of tolerance verify chair position with chair alignment tool problems persist please contact Imaging Sciences Technical Support Confirmation of Measurements To Confirm that the Geometric Calibration was completed correctly scan the Phantom and in the Reconstructed study measure the width of the Phantom For width the distance should measure 110 mm for the inside dimension and 116 mm for the outside dimension Make the measurement using the Distance tool Ruler icon at the widest point s of the phantom Part 990307 Page 54 of 90 March 29 2007 115 00 Es 110 40 Part 990307 Page 55 of 90 March 29 2007 Image Receptor Sensor Calibration Offset Gain Calibration Ideally this calibration is performed on a temperature stable system about a 2 hour warm up from a cold system I
34. The troubleshooting section is divided into two parts The first part primarily addresses concerns over image quality and common positioning problems The second part primarily addresses program issues which might arise because of equipment problems Section 1 Image Quality 1 Image area too blurry There are predominately two reasons for images being blurry The primary reason is that the jaw is not in the focal trough and the secondary reason is that there was patient movement Patient movement is distinguishable from other defocusing problems by showing a defocused area throughout the vertical region Overall guideline to getting a focused image is as follows The user should make sure that the patient is placing the front teeth in the groove of the bite stick not have the bite stick bent forward or backward during the scan use the back head support to guide the patient as the correct head placement 2 The Mandible is fine but the Maxilla is out of focus The primary reason for this defocusing problem is that the patient was not scanned in the Frankfurt horizontal angle Primarily when the Frankfurt horizontal angle is not achieved the maxilla arch is slightly behind the focal trough while the mandible is right on One can imagine a place extending from the maxilla and mandible and that this plane should be vertical otherwise anatomy in maxilla will not appear focused Also with this process observed one will see a slight smile on the
35. a Scan and a Gain Error will result Part 990307 Page 56 of 90 March 29 2007 Chapter 5 Enabling i CAT Software for Report Service Mode In order to access the tools to calculate the Geometric Calibration the i CAT software needs to be in Report mode To accomplish this the Xoran xml file located in the C Program Files Imaging Sciences InternationalNCAT folder needs to be edited Before starting this procedure make sure that the i CAT program is closed Browse to the folder C Program Files Imaging Sciences International iCAT can also get there by right clicking on the i CAT icon selecting Properties and clicking on the Find Target button Right click on the Xoran xml file and choose Copy from the menu Right click some where in the folder and choose Paste from the menu Right click on the new file and rename it to Xoran xml old Right click on the Xoran xml file and choose Open With Choose Program and then choose notepad Do NOT use XML Editor Word WordPad as these will corrupt the file Also please do NOT make a shortcut to the Xoran xml file to the desktop 7 Edit the second line so that it matches the bold text below It is very important to duplicate the text exactly including spaces When complete Close and Save the file Any erroneous text or spaces will result in an error when starting the i CAT Software lt xml version 1 0 150 8859 1 gt
36. achieve maximum opening AB will open just the right and left shutters n1 camera right shutter n2 camera left shutter This will allow for isolation of the side shutters from the top and bottom for observation AD n3 n4 Use a value of 90 for both n3 and n4 to achieve maximum opening AD will open just the top and bottom shutters n3 top shutter n4 bottom shutter This will allow for isolation of the top and bottom shutters from the sides for observation Use the BH command to home the shutters which will bring all four to a closed position 1 Turn Power to Machine off and manually move the shutters They must move freely Observe for any mechanical obstruction etc Part 990307 Page 67 of 90 March 29 2007 2 Shutter s don t move this is most likely caused by a bad driver for that shutters motor and would need to be replaced The motor may possibly be bad but is very unlikely Blurry or Noisy Scans non anatomic artifacts 1 Blurry Scans there are 3 reasons for a blurry scan Patient Movement during the scan look at the raw data to see if there is movement in the vertical plane first frame vs last frame Bad Geometric Calibration phantom alignment perform the geometric calibration again check for any changes in the parameters Gantry imbalance or movement during the scan check the bearings on the ring gear in the Overhead 2 Noisy Scans there are 3 reasons for a noisy scan Line
37. adjustment This adjustment is only required if the Beta is not in range lfthe beta is a value then turn the sensor adjustment screw counterclockwise e Ifthe beta is a value then turn the sensor adjustment screw clockwise If a mechanical adjustment is made to the Sensor re scan the phantom and calculate the parameters again until the Beta value is in the acceptable range Please be aware that after each screw adjustment is made it would be necessary to re scan and calculate the parameters again Dit z 32 Tau Det 4 Tau 4 d nr 8 Now click on the last 39 Calculator Tool named Calculate amp Update Study Click Yes to Save 9 Close 8 re start the i CAT program for the parameters to save permanently 10 Take a final scan of the phantom and this time let the data Reconstruct Then visually look at the bb s in all 3 views for roundness If there are any concerns about the roundness of bb s or the seagull effect which means BIOS needs resetting please contact Imaging Sciences Technical Support the system has EFOV do not remove move phantom yet 11 Once correct Geometric Calibration is achieved make sure the sensor retention screw is turned all the way in Part 990307 Page 50 of 90 March 29 2007 12 The cover for the sensor can now be installed Make sure to plug the fan connection and tape the extra pin to prevent it from shorting out
38. aned up by performing a calibration 7 Vertical lines The sources of vertical lines are many fold The most obvious and evident in all Panoramic imaging modalities is machine vibration The second most obvious Is that the collimators which form a slit are out of alignment The third is contribution of the detectors line noise to generation of the panoramic radiograph The first two can be remedied by service personnel The last can be remedied by slightly increasing the dosage so that the data rises above line noise This should only be done if one observes this phenomenon consistently and have ruled out the first two options 8 After a scan the program error indicates it did not detect 32 pixels then crashes This is primarily the reason for not getting sufficient X ray in the right part of the detector The reasons for this could be sourced from the X ray or the collimator Both problems should be remedied by the service technician 9 The machine performs a scan and then it crashes Usually this happens with the fault light blinking This means that no X ray has been detected The procedure should be repeated without a patient and verify a black radiograph If this is the case the user can re image the patient since the first scan did not Part 990307 Page 70 of 90 March 29 2007 really deliver x rays to the patient The system can remain use however the error should be reported to technical support 10 The program crash
39. bration Tools from the Raw data Once in Report mode go to the test factory patient and open the Raw data for the scan just taken It will be the last item in the list and designated as double click to open Part 990307 Page 47 of 90 March 29 2007 e Next press CTRL or go to menu and click View Show Calculated Points to locate highlight the bb s in Red Then access the Reconstruction Parameter Tools b clicking on the Reconstruction Parameters button at the bottom right hand side of the software screen This will display the 3 Calculator tools upper right CTRL B highlights the bb s Administrator A Log Off Navigation Raw Study Data Reconstruction Param Dist 20 Calculator Tau Det 4 4 Tools 1 2 Tau E 22184 3 Distances 653 2228 16 25 20 270 2346 15 28 21 afl 2307 1428 22 ere coy 1 20014 273 2159 12 28 20 274 2135 12 23 20 275 2335 13 29 18 jefe 2317 11 32 22 2154 LL2 515 fee 2053 09 29 18 22212 DW xu 58 280 2339 10 3217 281 2 211 08 31 18 282 2060 07 30 15 283 1 968 07 28 14 284 2134 06 31 1 5 300 2037 0 8 33 06 301 1 954 1 0 31 0 5 302 1860 08 30 04 303 2119 11 34 04 304 1 958 08 31 01 lE 1 93 1 871 masus 1 11111111111111111
40. ce the legs are attached the upright will now be free standing Tip first turn out the Leveling Feet about a half inch before mounting the legs 4 Attach the Image Receptor Power Supply to the Base back of the machine with the 4 Socket Head Cap screws 2 at top 2 at bottom Image Receptor Power Supply Part 990307 Page 24 of 90 March 29 2007 5 Attach Cables Back of machine Refer to page 21 for pictures of cables Main circuit breaker Main power connection Hospital grade cord Chair elevation motor connection Serial cable from PC Image Receptor Power Supply Power In from machine Patient E stop 24 volt cable to receptor Machine control paddle Overhead up down chair up down amp laser on off Main Control Box machine on off and E stop Embedded PC monitor connection for diagnostic use only Embedded PC keyboard connection for diagnostic use only Part 990307 Page 25 of 90 March 29 2007 6 Verify connection integrity of critical components a Check that the embedded PC motherboard in the base of the machine is seated properly Take the base cover off Open embedded card cage e Verify that the embedded PC motherboard and I O boards are properly seated ES s b Check seating of heat sinks on motor driver base You will also need to check this for the driver in the Overhead once that is mounted 7 Now th
41. click on the i CAT icon select Properties click on the Find Target button and then open the Data folder Double click on the ISIRemoteControl exe file to launch the program The following window will appear IsIRemotetontral X Enter command and click OK Edt Enter Command Manually Ready YS Part 990307 Page 59 of 90 March 29 2007 Field Calibration For CT X ray Power Supply and X ray Tube Head Chapter 7 Calibration Procedure D IMAGING SCIENCES INTERNATIONAL OP 15 013 Rev B FIELD CALIBRATION FOR CT X RAY POWER SUPPLY AND X RAY TUBE HEAD ONLY IF NEEDED Part 990307 Page 60 of 90 March 29 2007 To establish the X ray Power Supply and Tube Housing Assembly is working and Calibrated for i CAT and miniCAT based X Ray systems manufactured by Imaging Sciences International Scope To verify the conformance of the X Ray Power Supply and Tube Housing Assembly working and Calibrated for i CAT and miniCAT based X Ray systems manufactured by Imaging Sciences International Test Equipment Required o Fluke Digital Multimeter DMM Model 77 or equivalent o Keyboard with a PS 2 Interface o Display Monitor with a 15 pin HD D sub connector Calibrate Tube Head amp Power Supply oystems Setup Connect the keyboard and display monitor to back of the machine The machine is label monitor keyboard On the machine over head remove the top rear cover over the X Ra
42. e Type OH amp click OK to rotate the gantry to its home position Part 990307 Page 37 of 90 March 29 2007 The vertical laser light is located on the overhead behind the front cover The cover will have to be removed to access it A total of 10 screws will be removed 7 on the top 3 on the bottom When removing the cover you will have to unplug the LED connector It is not keyed so it is suggested to note or mark the proper orientation for re connecting Part 990307 Page 38 of 90 March 29 2007 First make sure the laser itself is in focus nice sharp line There is focusing ring on the bottom of the barrel that rotates independently to focus the beam To access the focus ring push the actual laser down thru the retaining barrel Once focused push laser back up then adjust the laser angle by rotating the entire barrel to make the laser line vertical parallel to the chin support and not rotated this does not need to be exact at this point yet Adjust the position of vertical laser by loosening the 2 bolts on the mounting bracket and moving the bracket 9 With the Chin Cup in place Center the Chair to the laser light Check the laser rotation alignment from the Chin Cup pit dimple to the front gate Adjust the chair again if necessary Part 990307 Page 39 of 90 March 29 2007 10 Put the overhead front cover back on and verify that the status LEDs are functional i e the power lig
43. e adjustment command would be BJ 20 15 10 5 This would move all shutters outward After any BJ adjustment command is entered retake a Scout View to visualize and assess the movement Make any additional adjustments if required via the ISIRemoteControl program Below would be a desirable beam shutter result with no black borders on any side wx Acquisition Part 990307 Page 45 of 90 March 29 2007 Geometric Alignment Phantom Alignment 1 Positioning the Phantom First select the test factory patient in the i CAT software and click Acquire New Choose the Protocol Full 13 cm 20 sec 0 4 voxel clicking Acquire New will move the Overhead Gantry into i CAT home or start position Then mount the Alignment Platform onto the gate as seen below Level the phantom left to right and front to back utilizing the 2 screws on the mounting bracket Then place the phantom on the platform Position the Phantom as looking at it with the cross hairs on the left and right and the vertical slots in the front and back And the lowest BB on the left rx IT NI IT 055 Cutout Platform for Image Phantom The phantom needs to be centered on the platform To center check the position with the gantry at the home position 0 degrees and from the front 90 degrees position With the Overhead Gantry at this home position turn on the laser light and adjust the phantom so that the cross hair
44. e back of the computer The dongles are located in the back pocket of the i CAT Operators Manual The Acquisition key is labeled or if machine has the EFOV option J Part 990307 Page 33 of 90 March 29 2007 Connect the monitor Digital Video connection Analog video connection typically not used USB connection not used Power comp Boot Up acquisition computer and make sure it communicates with machine by launching the i CAT program The login password is ct lower case letters There should be No error messages when the software opens From the Main Menu click Help About The screen should read i CAT Acquisition Acquisition Ceph for a machine with the EFOV option and display the version number Cone Beam 3D Dental Imaging System Version 3 0 34 Imaging E Enhancing the way you see patients ORAN Acquisition hardware version 3 0 34 Technologies Inc 2005 Part 990307 Page 34 of 90 March 29 2007 21 Overhead Ring Gear Bearings There are 4 bearings one at each corner one is not visible in this photo but is underneath the black cable chain Each bearing should be checked to make sure there is sufficient contact with the gear and not floating Check this by moving the Overhead to the different angles v
45. e keyboard to turn on the X Ray Use the space bar to stop the X run tor more then s Check the volt meter for 0 95V to 1 05V If the voltage is off adjust the 10mA pot R1 on the X control board until it is between 0 95 and 1 05 volts KV Test Move volt meter lead to the SENSE jack on the heat sink and the volt meter lead to the SENSE jack See Figure 1 Type XP then return on the keyboard to turn on the X Ray Use the space bar to stop the X Hay Play THOS 3 Check the volt meter for 12 00V to 12 30V the voltage is off adjust pot R319on logic module board until it is between 12 10V and 12 20 volts See Figure 1 On the X Ray Controller board push the SW3 switch up See Figure 1 at the end of this document ou ful RUN PULSE to Ec TEST PH ON 86 1 Lol SWL Swe 53 PULSE 4 LOGIC MODULE BD d eed TIMMMM k i m INSULATOR CAPACITOR ED um Part 990307 Page 62 of 90 March 29 2007 Chapter 8 i CAT Troubleshooting Start Up Problems 1 When i CAT program is started the following error appears on the screen i CAT lt Error communicating with scanner or scanner is off 100 Error Initializing Detector board There were some errors initializing acquisition hardware Application will now r
46. e power of the machine can be turned ON in order to drop the Elevation and make mounting of the overhead as easy as possible sure the Circuit breaker Part 990307 Page 26 of 90 March 29 2007 switch is UP on lower back rearview Press green ON button from Main Control Box Wait 2 minutes for the Motherboard to boot up and for motors to lock into place motors will only take 30 seconds to lock in tug on turret to see if it moves freely or not Check that the 5V amp 24V lights are on the Image Receptor Power Supply in back With the Hand Control blue Elevation buttons adjust the elevation down to where you would still be able to put the base cover back on Be aware not to go down too far Once this is accomplished please be sure to then turn the POWER OFF 8 Before Mounting the Overhead first Level the two uprights with each other front to back This puts the Uprights on the same plane with each other so that the Overhead won t be twisted once mounted 4 v 9 To MOUNT the OVERHEAD Remove the 2 top covers to the Overhead Lift the Overhead and set into place is recommended to use people to lift the Overhead one on each side and one in the front There are 2 bullets in the back of the Overhead that are used to hang the Overhead onto the upright Push the bullets through the holes on the Upright Once the Overhead is in place be sure to immediately secure it with the 4 14 20 Socket Head Cap screw
47. emergency stop switches in series between terminals 3 amp 5 Multiple door switches and or emergency stop switches can be connected as long as the devices are connected in series The entire circuit must be a closed loop when all of the doors are closed and or emergency stop switches are in their normally closed state Whenever the door switch or switches are opened or emergency stop button s pressed the X ray power will be turned off X ray power cannot be turned on when the interlock circuit is open Part 990307 Page 6 of 90 March 29 2007 Machine Markings Symbols Non ionizing radiation Class B equipment CAUTION DO NOT STARE INTO VISIBLE LIGHT BEAM 1mW 6 0 nm CLASS LASER ATTENTION NE REGARDEZ PAS DANS LE FAISCEAU LUMINEUX EVIDENT 1mW 670 nm LASER DE CLASSE Laser Light Caution CAUTION x Pinch point Keep hands clear ATTENTION Point d invariance Maintenez les mains claires during operation lors du fonctionnement Pinch Point Caution MAXIMUM SEAT LIFTING CAPACITY NOT TO EXCEED 300 LBS 136 kg CAPACIT MAXIMALES DE LEVAGE LA CHARGE DU FAUTEUIL DOIT PAS D PASSER 136 KG 300 LB Chair Maximum Capacity MAXIMUM LIFTING CAPACITY SEAT NOT TO EXCEED 300 LBS 136 kg Attention Warning Danger Electric Shock CAUTION THIS X RAY UNIT BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS AND OPERATING PROCEDURE ARE
48. ences International has been assessed and registered to ISO 13485 2003 and ISO 9001 2000 The Quality System also complies with applicable requirements of the United States Food and Drug Administration applicable sections of 21 CFR parts 800 1050 the European Union Council Directive concerning Medical Devices 93 42 EEC LVFS 2003 11 and Canadian Medical Devices Regulations CMDR relevant sections 2 to 65 for medical devices Equipment Class Protection against electric shock Class Applied part has degree of protection against electric shock Class B Class of equipment against ingress of liquids Ordinary Equipment IPXO Radiated emissions Class A CMDR Canada Class 2 CE MDD 93 42 EEC Class lla Annex 9 Rule 10 FDA Class 2 Part 990307 Page 12 of 90 March 29 2007 Chapter 1 Machine Hardware Illustrated Components Part 990307 Page 13 of 90 March 29 2007 Replacement Spare Parts Pins for plugs male Varian receptor panel Part 990307 Page 14 of 90 March 29 2007 Base Chassis Front X ray Interlock Board Computer Power Supply Floppy Drive Elevation Stepper Motor Power Electric ly B Brake Elevation Motor Embedded computer system under protective case Elevation Friction Brake Toroidal Transformer Part 990307 Page 15 of 90 March 29 2007 Base Chassis back 8 Detector Power Supply Main Power Connector Circuit Breaker
49. ensor Power cable The 3 wire is the Fan cable and must be plugged into the connector on the back Cover The cover does not need to be installed until the calibration procedure is completed 7 m 3 v M E 27 Attach the Counter balance weight to the Sensor Housing above the sensor First attach the Counter weight bracket attached by the 2 top screws on each side only that holds the weight then sit the weight onto the pin and secure with the screws Turn Power to Machine On Make sure Circuit breaker switch is UP on lower back left rearview Press green ON button from Main Control Box Wait 2 minutes for the Motherboard to boot up and for motors to lock into place motors will only take 30 seconds to lock in tug on turret to see if it moves freely or not Check that the 5V amp 24V lights are on the Image Receptor Power Supply and that the Machine Elevation goes up and down Blue Up Down buttons on hand control Keep the Power On so that the Sensor can start warming up Adjust the Friction Brake if necessary located in the right hand corner of the Base It is adjusted with an allen wrench This must be adjusted so that the Elevation works up amp down without stalling but that it does not drift down when the power if Off The elevation is designed to start in slow speed and kick into high speed after a few seconds The stalling grinding noise would normally occur when kicking into high
50. es after a scan This is very uncommon where simultaneous use of the iPan database can cause this To recover from this error just restart the iPan software enter into the patient s folder where the image was taken Enter the Scan window and pull down the acquire image menu and select change visualization option Press to all windows and if the data was recorded this option will generate the Pano radiograph Remember to restart the program once this is done to acquire new images Part 990307 Page 71 of 90 March 29 2007 amp Forms ICS 30 133 10000 0000 071 6 LVO 5022 LO HUM 03300044383 1999 80 310 HM 540120004434 TV 151 03511 39 LON AYIN H3HL ONY NOLLYINSO JHL IM 33 N325 8 HB YIN 339 9 23 2 33001 0000 1011 0 16 80108 1411 gg AY I3H 0000 2681 0FL 6 me 0000 9221 0015 NI H hd AlddNs E H3dd31S 0000 0221 00 5 5 0000 9891 0FL 6 1892 1X3 4ddO NO 19 Sr AX 13H S e seis 0000 922 09 6 0000 8688 0FL 6 er 1X3 310 38 NOILLV A3 T3 avo 4002 0000 2891 0FL 5 H31 13 Mayo 1 3 9015 3 LN3lLVd OSI GIOHOL 062002 0000 2898 0FL 5 0000045 00 5 March 29 2007 NI Ov 009008
51. f a sensor calibration is performed before this time the calibration results will only be valid for a short time The calibration needs to be repeated once the system is warmed up to provide the best image quality Before Calibrating the Sensor make sure to first remove all items out of the field D of view Remove the Chin Cup and Head support or Elevate the Overhead so that the tube head sensor are above the chin cup and head support 1 From the i CAT Main Menu bar click on View Calibration or Press the F9 key on the Keyboard File Patient Study Window Help lie e Side Toolbar Calibration Calibrate I Press Calibrate to start calibration process 2 Click on Calibrate This will initiate the first of 2 measurements This first step will calculate a number called BP bad pixels This number should fall within the range of 20 000 to 35 000 This number should be documented on the Installation Report form If it does not fall within this range please contact Imaging Sciences Technical Support 3 When the first measurement is complete another message will appear on the screen prompting to Turn on X ray When ready click OK and the machine will expose for approximately 20 seconds This will complete the sensor calibration sequence if this second step is canceled and not completed the system will not allow for Acquiring
52. f the chair with 2 screws wheels facing down e Pull out the cable from the base of the chair d by pulling up and out 5 Roll the chair assembly in place wheels must be up against the Uprights Lower the rear feet until the wheels are slightly off the floor This transfers the weight of the chair off of the wheels and onto the feet 6 Level the chair side to side Put the level on the chin support mechanism where the chin cup Will sit 7 Ifthe i CAT software is open close it Open ISlRemoteControl refer to Chapter 6 Page 59 e Enter the following commands o PH to move the platform back o OH to move the gantry to the O position o BS 9090 90 90 to open the shutters to see the laser 8 Determine the position of the midline vertical laser by measuring from the face of the receptor frame to the laser mark take note of the measurement Type SP 180 amp click OK into the ISI remoteControl on the Acquisition PC the gantry will rotate 180 degrees and then measure from the face of the receptor frame to the center laser mark these measurements are not equal distances then you will need to adjust the midline vertical laser The laser is behind the overhead front cover See the next page for instructions for removing this cover If adjusting the laser move the laser left or right to achieve an equal distance The distance should be approx 201 mm 7 amp 29 32 of an inch but may vary 2 mm from machine to machin
53. hese terminals When X ray power is energized this relay contact is closed and the warning system energized Part 990307 Page 5 of 90 March 29 2007 Method 2 Equipment provided power A warning system may be powered from 12 volts dc within the i CAT Imaging System The warning system cannot exceed 12 volts dc 3 amps To use this provision connect the warning system as follows 1 Connect the common of the warning system to terminal 6 of the X Ray Interlock printed circuit board inside the Lower Control Center 2 Connect terminal 1 to terminal 5 on the circuit board 3 Connect the positive of the warning system to terminal 2 of the circuit board When X ray power is energized 12 volts dc will be provided through the relay contact between terminal 1 and 2 of the X ray Interlock printed circuit board and energize the warning system Note When using this method ensure that the factory installed jumpers between terminals 3 amp 5 and 4 amp 6 are in place These jumpers should only be removed when an interlock system is being used Interlock System The i CAT Imaging System is equipped with provisions for an interlock circuit which when opened will turn off X ray power This is a low voltage circuit 12 volts dc To use the interlock circuit disconnect the factory installed jumper between terminals 3 amp 5 of the X Ray Interlock printed circuit board inside the Lower Control Center and connect door switches and or
54. ht should turn ON The connector to the indicator panel is not keyed 11 Turn on the laser amp check if the Side Cross hair Laser light is on the center of the hash marks on the sensor frame If out of alignment re adjust the Cross hair Laser light This laser is located behind the beam collimator and uses a mirror reflection Part 990307 Page 40 of 90 March 29 2007 Adjust the Vertical line of the cross hair with the 2 bolts at the top Adjust the Horizontal line of the cross hair with the bolt at the bottom this will be accessed through a hole in the beam collimator board Adjust the angle of the laser light by using pliers on the laser housing to rotate the light assembly Part 990307 Page 41 of 90 March 29 2007 The Remaining Steps this section require the use of these 2 Tools 12 Adjusting Chair Tilt Place the Chair Alignment tool in the chin rest hole amp align the lowest portion of the Mark to the top of the Chin rest holder Turn on the laser amp adjust the front feet on the chair up or down so the laser strikes the alignment tool s vertical line on the Adjust the feet as a pair to maintain level left to right 13 Setting the Down Stop Position Adjust the Elevation of the Overhead until the laser strikes the Chair Alignment tool s horizontal line on the amp set the Down Stop Bracket height so it strikes the switch Part 990307 Page 42 of 90 March 29 2007 1
55. ia Machine Control or pressing down the E stop and manually moving the rotation d If adjustment is needed loosen the two screws on the corresponding plate and lightly tap the plate down to achieve contact between the bearing and gear ring Careful with this adjustment The bearings need to contact the gear ring but we do not want to create a point by forcing the bearing down too hard This would result in the gear ring being forced down at that location and causing an uneven rotation of the gantry 22 Ring Gear Backlash This should not have to be done in the field unless the gear is really loose or binding up Check the ring gear backlash against the Rotational motor gear underneath the overhead chassis Make sure the gears mesh when _ rotating Part 990307 Page 35 of 90 March 29 2007 Chapter 4 Alignment and Calibration Mechanical Alignment 1 Double check to make sure the 2 Uprights are still level with each other front to back on the same plane with each other 2 Level the large gear in the Overhead by adjusting the feet in pairs adjusting the feet in pairs keeps the two uprights on the same plane 3 Mount the Machine to the wall Once the machine is level it can now be secured to the wall mount L brackets tighten bolts Part 990307 Page 36 of 90 March 29 2007 4 Prepare the Chair for installation e Attach the wheels to the base o
56. ixels gt Entry Name DefaultBadPixels Valuez XDataMnnf defect map raw gt lt Entry gt The PATH should correspond to the serial number of the current receptor panel For example 7704 13 Therefore the line would be 8 Xoran ml Notepad 91 File Edit Format Help Entry Name 200 Value 200 ms gt lt Entry gt Entry Name 400 Value 400 ms gt lt Entry gt lt Entry Name 800 Value 800 ms gt lt Entry gt lt Section gt lt Section Name Detectors Selected Varian2520 gt Entry Name Varian2520E Rows 768 Cols 960 ImagersPath CWMAGCERSW NumBuffers 500 gt lt Entry gt Entry Name Varian2520 Rows 768 Cols 960 ClientAddress 172 20 20 21 ServerAddress 172 20 20 20 Entry Entry Name PerkinElmer Rows 512 Cols 512 gt lt Entry gt lt Section gt Section Name DetectorPositions gt Entry 1 Det Pos Valuez 52000 0 1 944 Entry Entry Name 2 Det Pos Value 42874 417 96 512 20252 0 1 417 gt lt Entry gt Entry Name 3 Det Pos 20000 900 1 438 28346 450 1 450 28346 0 1 450 gt lt Entry gt lt Section gt Section Name BadPixels gt Entry Name DefaultBadPixels Valuez iDataWnnf defect gt lt gt Part 990307 Page 64 of 90 March 29 2007 b Before making any changes to the file for example when adjusting the overhead position value adding the institution name etc PLEA
57. line of the file by adding the following text to the very end of the line in between the and PleaseStart i CAT The Xoran xml will originally look like this Please be aware that on certain units it could be the first line in the file Simply look for the line starts with _ File Edit Format Visi lt xml version z 1 0 encoding Iso 8859 1125 Install xml Pleasestart 1CAT gt Language overrides Lanquage xm gt lt Part 990307 Page 66 of 90 March 29 2007 After Editing the Xoran xml file should look like this Save and close this file then start the i CAT program The error should go away If it does not then please contact technical support It might be beneficial to simply e mail this file for analysis to the appropriate address supplied by the support person Beam Collimator Errors The Beam collimator board has 4 shutters that are operated 4 individual motors that are driven by driver chips 1 There is a grinding sound coming from the collimator when it attempts to home or move to a new shutter size This is most likely caused by a mechanical jam or bind Troubleshooting 1 Open the shutters all the way and observe for normal movement They can be opened via the following Machine Control commands AB n1 n2 Use a value of 90 for both n1 and n2 to
58. llowing error message appears at start up Error initializing detector board 81 There were some errors initializing the acquisition hardware Application will now run in VIEW mode only Possible causes The i CAT software is not recognizing the receptor panel Changes were made in the Xoran xml file and an unknown character was entered for example amp Or a blank line extra space was entered by mistake Troubleshooting a Check in the Xoran xml file under the section named Detectors Xoran xml Notepad File Edit Format Help Entry 7200 Valuez 200 ms gt lt Entry gt Entry Name 400 Valuez 400 ms gt lt Entry gt Entry Namez 800 Valuez 800 ms Entry lt Section gt Section Name Detectors Selected Varian2520 gt Entry Name Varian2520E Rows 768 Cols 960 NumBuffers 500 gt lt Entry gt Entry Name Varian2520 Rows 768 Cols 960 ClientAddress 172 20 20 21 ServerAddress 172 20 20 20 gt lt Entry gt Entry Name PerkinElmer Rows 512 Cols 512 gt lt Entry gt lt Section Section Name DetectorPositions gt Entry 1 Det Pos Value 52000 0 1 944 gt lt Entry gt Entry Name 2 Det Pos Valuez 42874 417 96 512 20252 0 1 417 gt lt Entry gt Entry Name 3 Det Pos Value 20000 900 1 438 28346 450 1 450 28346 0 1 450 Entry lt Section gt Section Name BadP
59. mounting bracket oystem supplies and accessories Phantom chin cup anterior support bracket overhead mounting bolts service platform 1 Operations Manual with all license keys dongles Acquisition 2 workstations 3DVR etc Varian detector and detector power supply Detector cover panel with fan The wall bracket and chair retaining bracket are screwed to the skid They must be unscrewed before discarding the skid Open the crate on the truck and carry in all components and boxes Part 990307 Page 22 of 90 March 29 2007 Required tools for installation and service 1 set ball type Allen wrenches Standard Inch T handle Allen wrenches 1 8 5 32 3 8 5 16 Digital Multi Meter DMM Alignment Tools Chair iPAN supplied during training by Imaging Sciences 6 torpedo level or equivalent Line Level Half inch open ended wrench Needle nose pliers oide cutters Wall anchors Tape Measure or Ruler with metric graduations 0D OD D D D D L Furniture Sliders Part 990307 Page 23 of 90 March 29 2007 Chapter 3 Assembly i CAT Complete Assembly 1 Uncrate and remove all components from the packaging 2 Set down the legs in or close to the location of installation Leave ample room for connecting items in the back of the machine 3 Place the Upright in position of the legs and then attach the legs to the Upright using the 4 screws for each side these screws ship in the uprights On
60. n detach Purchaser copy Pink and provide to customer Forward remaining copies back to Imaging Sciences OF SEALTH AMI KUMAN PC AHO HA ADAST PA 2 X FA SFEIL N 1 LOCATEOW 15 mm ea pa mom m cpu peur Enn pr pru PV TERIS amamus suec Lorem 1 ma LL N mura pom soo EEE Dupi hainn miah yra edad _ _ ___ _ syr __ _ _______ uy m amc E i gi iem FOAM 2575 pee eee Fa em Part 990307 Page 88 of 90 March 29 2007 Assembly amp Calibration Check List Customer Installation Date Complete the following checklist for assistance in the assembly and calibration of the mE 10 Li 111 1 UU Attach the legs to the Uprights Attach the Varian Image Receptor Power Supply and connect all the Cables in the back of the machine Remove the Base Cover and check that the embedded computer and the boards properly seated
61. orm backwards by approx 8 mm once the XN2 command is re entered Issue the XN2 command again 2 times and re check the laser position to the notch Repeat process of necessary to achieve alignment 77 c 2 L f T 7 2 Part 990307 Page 43 of 90 March 29 2007 Beam Alignment The beam contains 4 shutters 2 sides top and bottom Each shutter must be aligned to the appropriate position so that there are No black borders on any of the edges of a Scout film e First take a Scout Film in the i CAT software do this go to the test factory patient and click Acquire New Select a 13cm height protocol Now click Scout Click OK to take the exposure If there is a black border on any of the edges an adjustment to the collimation will have to be made Use commands in 151 to adjust them See below This is a very exaggerated example of the shutters being too far inward AC he Beam Collimator command sequence is BJ rr Il tt bb where stands for Beam Adjustment camera right shutter camera left shutter tt top shutter bb bottom shutter A value of 5 equals about a 2 5 mm adjustment on the screen A positive value Part 990307 Page 44 of 90 March 29 2007 means the shutters will move outward open negative value means the shutters will move inward close For the above example a possibl
62. s follows Head Revision HR Displays Machine Control software version number Beam Limiter BH Beam Home position BSrrllttbb Go to a destination rr camera shutter right 90 is open 1 camera shutter left 90 is open camera shutter top 90 is open bb camera shutter bottom 90 15 open BJ rr lIi ttbb Absolute Adjustment to the home position for right left bottom beam shutters ex BJ 0 2 0 0 positive numbers adjust outward negative numbers adjust inward Rotation OH Rotation Home position SP nn Go to an absolute destination in degrees 0 to 360 OJ nn Absolute Adjustment of the home position 10 1 degree this 15 rarely used Overhead Platform PH Overhead or Platform Home Go to a destination is a signed number representing linear position in mm PJ aa bb Absolute Adjustment to the home position of the Overhead or Platform aa is always 0 bb is a signed number Part 990307 Page 58 of 90 March 29 2007 XS kVp mA set exposure to described settings 80 120 mA 1 2 or 3 mA settings must be typed in as the number 1 3 mA number 2 7 mA number 3 z 5 mA XP Initiates Exposure using above settings MUST hit a key on keyboard to STOP exposure or the XQ command XQ Exposure Quit stops exposure The ISIRemoteControl program is an executable file located on the PC in c Program Files Imaging Sciences InternationaliCAT data or right
63. s in the back of the Upright Tighten the 4 screws then break them loose 1 2 turn This will seat the Overhead and allow it to be secure while the other screws are attached Mounting There a total of 10 14 20 Socket Head Cap screws that will mount the Overhead There will be 4 on the Outside Back 3 inside top right rear 3 inside top left rear Bullets on back of Overhead Overhead mounted on Upright rear view pe bullets Ki Part 990307 Page 27 of 90 March 29 2007 Next attach the 6 Socket Head Cap screws inside the Overhead on each side Inside top right rear Inside top left rear Then re tighten the 4 screws in the back of the Upright the inside front of the Overhead w 10 Remove the 2 Red Shipping Screws from 11 Fish the cables from the Upright through the bottom of the Overhead First Please double check to make sure the POWER is OFF 4 2A 1 tha Upright throug L L 2 lt J 54 910 U 2l 12 Attach all the cables in the Overhead Overhead cables P32 Laser Pulse Interface cable to L1 L2 PLS P8 to Distribution board J4 cable 34 UDC to Distribution board P1 Ribbon cable 50 pin to Distribution board J1 Ribbon cable 50 pin to Distribution board 110v 9100 1549 0000 to X ray Power supply Controller J4 Ground to Ground screw on chassis Connect Sensor Power Canon plug in chassis Ethernet Cross
64. s of the laser lights shine through the cross hairs on the phantom Also check that the front vertical laser light shines through the front vertical slot on the phantom Once this is completed it is necessary to verify the phantom position with the gantry at the 90 degree position To achieve 90 degrees close the i CAT software and open ISlIRemoteControl program Type in the command SP 90 and click OK then turn on the laser light and check that the vertical laser goes through the front slot achieved rotate the gantry back to home position by typing into ISIRemoteControl the command OH and click OK Part 990307 Page 46 of 90 March 29 2007 Now close the ISIRemoteControl program and open the i CAT program Again select the test factory patient and click on Acquire New Now click on Scout and take the scout exposure of the phantom 2 Acquiring the Raw Data f the phantom is centered in the beam acquire the data of the phantom do this click Start Acquisition If not re position and take another Scout e When the machine has finished the exposure sequence the software will begin the Reconstruction process At this point click Abort to cancel the reconstruction of the data 3 Puti CAT software into Report Mode Now put i CAT software into Report or Service Mode Refer to Chapter 5 pg 57 to achieve report mode edit the Xoran xml file with XoranStart iCAT 4 Access the Cali
65. s or Rings in the Image this is caused by either a bad Gain Calibration x ray so Repeat the Calibration sequence View Calibrate or bad pixels If there are bad pixels the bad pixel map may need editing In this case contact Imaging Sciences e Umbrellas on top or bottom of scan this requires an adjustment in the Xoran xml file In this case contact Imaging Sciences Rings outside of the anatomy this is a problem with the attenuation factors in the Xoran xml file In this case contact Imaging Sciences this should already be addressed in any new systems Image Receptor White Scout a scout image results in a white screen and re calibrating gain or re booting the entire system does not resolve the problem then take an image in the Viva software Use the Viva program to troubleshoot any potential issues with the image Receptor The icon is located on the Desktop Part 990307 Page 68 of 90 March 29 2007 Capturing an image Viva may result the following Grayed Salt Pepper Black 2770 FRO GEN Z U 769 a diei 17952909 IL CRUS s 2 t 1 0 Troubleshooting Below are known causes of error software This software emulates Panoramic image capture by illuminating a slit of X ray on the detector and making a rotation about the head that will define a focal trough
66. t against unsafe practices that may cause equipment and or property damage Note Note as used in this manual is defined as Animportant point to be brought to the attention of the operator Radiation Protection Guidelines Dental X ray equipment may cause injury if used improperly All included operating instructions regarding the use of the i CAT Imaging System must be followed government and local regulations pertaining to radiation safety must be observed Maintain safe distance from the x ray source Refer to the operator manual for details Emergency Stop This manual contains instructions for safe operation of this dental x ray system In the event of an emergency any moving component collides with any parts of the equipment or items in the environment or that could cause physical injury to the patient the operator should utilize the Emergency Stop button to turn off the power to all moving parts in order for the patient to be safely removed from the machine Warning System The i CAT Imaging System is equipped with provisions for warning lights and or audible alarms when X ray power is energized There are two methods available to use this system Method 1 Externally provided power An externally powered warning system can be connected to terminals 1 and 2 of the X Ray Interlock printed circuit board inside the Lower Control Center A relay contact capable of 250 volts 50 60 hertz and 3 amps is connected between t
67. tage Regulation requirement 10 Voltage Wave shape Constant Potential Focal Spot 0 0197 inches 0 5 mm Line Current 10 Amps 115V or 5 Amps 230V Duty Cycle 396 Line Frequency 50 Hz 60 Hz Source to Sensor distance 27 inches 68 58 cm Phase Single Source to Patient distance 18 inches 45 72 cm center of rotation Main Circuit Breaker 10 Amps 115V or Minimum Filtration at 120 kVp mm of aluminum equivalent 10 mm or greater 5 Amps 230V Maximum Specified Energy Input for 1 hour 120 kVp 5 mA Environmental Conditions Note Leakage technique factors are measured at the maximum specified energy Operating 50 to 95 degrees Fahrenheit Maximum Deviation kVp 5 kVp 10 to 35 degrees Celsius mA 10 4596 to 7596 humidity Timer 01 seconds or 5 whichever is greater Transportation and Storage X ray Beam Size Rectangular cone 9 37 width x 1 97 to 7 56 height 32 to 104 degrees Fahrenheit 23 8 cm width x 5 cm to 19 2 cm height 0 to 40 degrees Celsius 3096 to 8096 humidity option Rectangular cone 0 39 width 6 30 height 1cm width x 16 cm height Automatically collimated not to exceed image detector readable area Image Detector Amorphous Silicon Flat Panel readable area 9 37 width x 7 56 height Minimum Specifications for Acquisition Computer 23 8 cm width x 19 2 cm height Provided with the System Pentium 4 Processor 3 8 GHz minimum Windows XP Professional w SP2 12
68. the brackets Move the patient chair into position Level the chair left to right Part 990307 Page 89 of 90 March 29 2007 Check the Vertical mid line laser for centering and adjust if necessary Center the chair to the Vertical mid line laser Check the cross hair lasers for centering and adjust if necessary Using the Chair Alignment tool and cross hair lasers adjust the tilt of the chair so the vertical cross hair matches the vertical hash mark in the tool Install the Down Stop position bracket To the location of where the horizontal cross hair laser hits the horizontal hash mark on the chair alignment tool Lock the Chair clamps to the legs of the machine Set the iPAN position using the iPAN Alignment tool Check the Beam Alignment Perform the Geometric Calibration Perform the Geometric Calibration for EFOV if the system has this option Confirm the chin cup position and the measurements Perform a Gain air Calibration Complete the FDA 2579 Form and leave Pink copy with the customer Photo copy the form for the Trainer Fax a copy to ISI at 215 997 5665 LJ dog ER GEM I EX dl Complete the Imaging Sciences Report of installation Leave a copy for the Trainer Fax copy to ISI at 215 997 5665 Part 990307 Page 90 of 90 March 29 2007
69. un in View mode only If you do not expect such problems please contact Customer Service The above typically appears if The main i CAT unit has no power The power was turned on but sufficient time was allowed for the system to boot up Diagnosis troubleshooting Check if the power light is lit on the Control Panel and the front of the i CAT overhead gantry at least 1 of the 2 If yes then close the i CAT program then retry after one minute If the above error message does not re appear then everything is normal If the power light is not ON then a Check incoming power to the unit 110V or 220V b Take the bottom cover off and check replace the switching power supply 2 Following error message appears at start up Error communicating with scanner or scanner is off 100 Possible causes The main i CAT unit has no power or insufficient time has been allowed since Power ON see section above The serial communication link is broken The embedded computer inside the main i CAT system is not booting up properly Part 990307 Page 63 of 90 March 29 2007 Troubleshooting a Check the serial cable connection between the main i CAT unit and the i CAT computer on both ends b Attach a VGA monitor to the back of the main unit and examine the display which would likely provide a good indication of the problem f everything is normal a message is displayed Ready on the screen 3 Fo
70. y amp Calibration Check List nn nennen 89 Part 990307 Page 2 of 90 March 29 2007 Introduction The i CAT Imaging System is a Cone Beam Computed Tomographic and Panoramic imaging system It is designed for straightforward installation ease of maintenance and service lt is a high frequency constant potential fixed anode X Ray source 120 kVp 3 8 mA incorporates a flat panel amorphous silicon image detector at 20 cm x 25 cm with a cesium iodide conversion layer Scan dimensions are 17 cm x 13 cm A larger field of view option for increased height is available 17 cm x 22 cm There is an on board computer within the unit to control the robotic system The i CAT is connected to a desktop computer to provide the user interface and data processing The main unit consists of two Uprights an Overhead Gantry and a Base The unit is designed to be free standing utilizing floor mounting legs A wall mounted stabilizing bracket is included for added stability The base contains the on board computer and the main power input module The two uprights are attached to either side of the base The base also contains the Elevation stepper motor and driver The Elevation lifts and lowers the top section Overhead to the desired height When activated the stepper motor will move the lead screw contained in right upright The Base also contains on the back side the power input circuit breaker detector power suppl
71. y floppy drive and various connections for controls and data The Overhead is attached to the Uprights It houses the X ray controller the rotational drive assembly and the robotic assembly Gantry which is suspended from the Overhead There is 1 stepper motor amp driver in the Overhead to drive the Y direction and 1 stepper motor amp driver to drive the full 360 degree rotation of the robotic assembly Gantry The Gantry supports the x ray head assembly and the detector There are 4 beam shutter motors contained in the x ray Head assembly Each of the 4 motors has its own optical sensors to define the limits and zero positions There are 2 LED laser positioning lights The unit is wheelchair accessible The main components of the system are depicted in Chapter 1 Machine Hardware Part 990307 Page 3 of 90 March 29 2007 Standard Limited Warranty Imaging Sciences International ISI warrants the original purchaser that this hardware system will be free from defects for a period of one 1 year from the date of delivery During the warranty period ISI will correct any defects in material or workmanship at no charge for materials Any replacement parts shall be new or serviceable used parts and are warranted for the remainder of the original warranty or thirty 30 days whichever is longer The warranty period is not extended as a result of purchasing any additional parts from 151 The original purchaser must promptly notify ISI
72. y Power Supply Connect the digital multimeter to the Logic Module lead to the white jack and the lead to the red jack Set range on the volt meter to read 15V DC See the drawing at the end of this document Fig 1 15V Power Test Turn the AC power on to the machine OK if voltage is between 14 9 and 15 1 volts If voltage is off use Pot R11 to adjust Move volt meter lead to the ma jack on the heat sink and the volt meter lead to the ma jack Preheat Adjust On the X Ray Controller board push the SW1 SW2 8 SW3 switch down See Fig 1 at the end of this document On the keyboard type XS 120 3 then return to set the X Ray power supply to 120KV at 5ma remember for mA that the setting number 3 2 5 mA Then type XP then return This will turn on the X Ray Use the space bar to stop the X Ray Note Don t let the X Ray run for more then seconds Check the volt meter for 0 95V to 1 05V Adjust Pot R2 Try again until the preheat volts are between 0 95V and 1 05V If the volt meter reads between 1 20V to 1 50V and adjusting Pot R2 does not change the preheat volts then the tube head or the power supply is in current limit The tube head and power supply must be sent back to Imaging Sciences International for repair On the X Ray Controller board push the SW1 amp SW2 switch up See Fig 1 at the end of this document Part 990307 Page 61 of 90 March 29 2007 Control Test Type XP then return on th

Installation, Calibration & Service Manual - i-Cat

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Installation, Calibration &amp; Service Manual - i-Cat

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Installation, Calibration & Service Manual - i-Cat