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Digital Imaging System TFlatXR Service Manual

1. Distances measurements in millimeters are possible only after distance calibration has been performed using a reference object see operation manual amp Caution The operator is responsible for performing distance calibration with a reference object and verifying the results of the distance calibration before taking any distance measurements on an image Page 9 of 53 TFlatXR Service Manual RA21 093 002 1 7 Left Right Marker The operator is responsible for the correct and clear marking on the left or right side of the image to eliminate possible errors The software includes an option to mark the image with L left or R right indicator from acquisition phase through printing and archiving If the operator chose for any reason not to use L R markers he must use an alternative way to eliminate any possible mistake 1 8 Images Back up To avoid the possibility of losing images which might result in patient being exposed to additional doses of radiation it is important to back up the images by filming or by using the CD or DVD option This should be done as a routine operation for every patient If the hard disk of workstation is about to full the operator should back up images and delete the images to make room on hard disk for new patient Caution The operator is responsible for backing up images of each patient Do not accumulate images in the system without having a back up 1 9 User L
2. This system can be interfaced to x ray generating equipment Be certain to follow the safety instructions and specifications for wearing proper lead shielding when in the presence of x ray generating equipment All personnel must wear dosimeters during all phases of installation operation and maintenance of the system and the equipment to which it is interfaced 1 2 2 Electric shock hazard A three conductor AC power is supplied with this system to provide the proper electrical grounding To minimize the shock hazard the power cable must be plugged into a UL approved three contact electrical outlet Do not remove or open system covers or plugs The internal circuits of the system use high voltages that can cause serious injury or death from electrical shock The operator should never be allowed to open the panels of the system 1 2 3 Explosion Hazard Do not operate the equipment in the presence of flammable or explosive liquids vapors or gases Do not plug in or turns on the system in hazardous substances are detected in the environment If flammable substances are detected after the system has been turned on do not attempt to turn off the system or unplug it Evacuate and ventilate the area before turning the system off 1 2 4 Implosion Hazard Do not subject the system to serious mechanical shocks as the cathode ray tube CRT can explode if struck or jarred This may result in flying pieces of glass and coating that can cause serious inj
3. 6 1 1 Set configuration tab doeet pe te ibi ta Del tn E El e Pie ene 29 6 1 2 Initialization tab ee cia 30 6 2 Preparation for Calibration sese enne tenerte 32 Page 5 of 53 TFlatXR Service Manual RA21 093 002 6 3 ee e ER 6 4 Initialization o eer ed eet tutta ete nte tese ii 33 6 5 Calibratioi s oo eere ne e etum a A esu PR De P TRES 33 7 QXvue Configuration aree tte eR hr d He Pe es R re Pa perat dE then 34 7 1 What is Configuration ssssssssssssseseseeeeeeneneen ettet nente entente teret tenerent 34 7 2 General parameter setting sese enne enne 34 7 2 1 Hospital information sse tenete nere tnn nnne 35 7 2 2 Number of Detector semet i eed ee Re qb rhe bei retos ch etri 35 7 2 3 Detector type oe Fastest oa e pee tet o HO tus 35 7 2 4 TFlatXR Option DevO eee eem lecce ttem arietes 35 7 2 5 Detector direction compensation sse tete 36 7 2 6 Thumbnail tab mtormaton sese 36 7 2 7 Expansion Settihg WE 36 7 2 8 DICOM header info reo load to bo d a e Ie d iaa 36 7 2 9 Dummy fields display name sse tete 37 7 2 10 Patient comparison condition 37 7 2 11 File worklist location cnn nr nrnr crono racer 37 7 3 DICOM parameter setting ricessi eene nente nn ener enitn retenti eene 38 7 3 1 Worklist BL PACS ciu ORTU I ee t p eR e de e prie 38 7 32 ET E 39 8 Trouble Shooting oo oos odes lid b e UR dieere 40 8 1 Failure Mode oe roo RR HERO Oa e
4. z s osea dU queat a ttti a de a B DES 19 3 7 Electrical Specification no erp eem cnni enia en o Rd nde 19 3 7 1 Flat Panel Sensor Unit obe Re pt e Re reped E 19 3 7 2 Power Supply Unit an ote ia 19 3 8 Interfaces sene ae ii 20 3 9 Image Acquisition Mode Table 20 A System Installation oos eee Rete e pe m bs ie ee reed res peg 21 We Uert Le RE 21 ALO Jet en ERR eoe is 21 4 1 2 Definitions Abbreviations and Shortened Forms see 21 4 2 Before Getting Started A 21 4 2 1 Environmental conditions entente tenente 21 4 2 2 Operating environmentz sse nennen entere eene tenente en 21 4 2 3 Wiring for the D Sub pin sess netten nnne 21 4 2 4 Ethernet environmentz sss tenerent tnter teet nennen 21 4 3 Installing Housing in Apparatus sse ener tenens 21 4 4 Sensor Unit Installation tenente nennen nente nete 22 4 5 Dongle Key Installatioris 1 eoi deat iio edi id 23 4 6 QXvue Installation ei osse esca da eb ea RR e Ra 23 4 7 Sensor unit specific files installation sss 26 e BR e EE 26 5 Preparation for operating TFlatXR system sse tenete 27 5 1 Select Number of Detector and Detector type 27 5 2 General Configuration of QXVUC sss eene eee 28 5 3 Diagnosis and calibration sida leoni ideo n bien imde 28 5 4 DICOM Configuration of ONvue entente teen tenerte eren 28 6 Calibration aitor ibm ai b etit itis 29 6 1 Description of tabs and dialogs sse nennt 29
5. 1 15 Maintenance precautions Do not open enclosures disconnect or connect any cables or accessories Only qualified personnel by Vieworks can do the maintenance 1 16 Disposal This product contains harmful materials such as lead Improper disposal of this product may result in environmental contamination When disposing of this equipment contact Vieworks representative Do not dispose of any part of this equipment without consulting a Vieworks representative first Vieworks does not assume any responsibility for damage resulting from disposal of this equipment without consulting Vieworks 1 17 Changing Fuse Caution For Continued Protection Against Risk of Fire Replace Only with Same Type and rating of Fuse Disconnect Power Before Changing Fuse Use only fuse to meet the specification of the system when you replace fuse with another one 1 18 Others Caution No User Serviceable Parts Inside 1 19 Appropriation Caution Don t make operation except for the intended purpose The system in whole or in part cannot be modified in any way without written approval from Vieworks 1 20 Using together with other equipment Warning When the unit is used together with other equipment in the patient area the equipment shall be connected according to Standard UL 60601 1 and IEC 60601 1 1 21 Classification UL 1 CLASS I EQUIPMENT 2 NO APPLIED 3 NO protection against ing
6. 50 60Hz eura DC24V 1 3A 60W Overall Dimensions seen 126x200x60mm W H xD V xH MIB E M M 1 kg approx B 3 Dimensional Outline Refer to Appendix C Page 44 of 53 TFlatXR Service Manual RA21 093 002 Appendix C Drawings 1 Flat Panel Sensor Unit Unit mm Supply Connector LAN Connector LED Dsub Display for Mode Connector Wired Image Page 45 of 53 TFlatXR Service Manual RA21 093 002 Page 46 of 53 60 8 i o e t wo alas O 5 09 e M4 L 8 q KS E i TFlatXR Service Manual RA21 093 002 Appendix D Interconnection Diagram Detector Control Board e DC 24V AC DC qe Power Supply V Lo Image S m Data amp La a a 3 4 Control PC User E s a El CRE 5 EM ie ES 4 gt 1 0 module p 3 c alf Control Gus Unit User Gate Driver ROIC Unit TFT Panel X ray X ray Tube Caution Do not disconnect Ethernet connection while DC24V is operating and supplying to FPI Page 48 of 53 TFlatXR Service Manual RA21 093 002 Appendix E Image Acquisition Interface E 1 Communication Block Diagram Ethernet PC Connector FPI Command D Sub Connector X rav Controller Communica
7. Positive Voltage Input DC 24V Negative Voltage Input FrameGrund 1 j Page 53 of 53
8. T 3 X ray sync signal External 3 9 Image Acquisition Mode Table Mode Frame rate Binning Non Binning X ray period ms Frame s 3072 lines l approx Non binning Standard 500 Full Scan mode Variable between 50 to 500 Optional 1000 2300 3200 or 4000 Page 20 of 53 TFlatXR Service Manual RA21 093 002 4 System Installation 4 1 Introduction 4 1 1 Objective This document describes the connection method of the X ray Flat Panel Imager FPI model FDX4343R 4 1 2 Definitions Abbreviations and Shortened Forms FPI Flat Panel Imager X ray flat surface detector EXP REQ Image acquisition X ray exposure request signal Input from the user side to the D Sub connector on the FPI EXP OK Exposure OK Image acquisition X ray exposure enabled period signal Outputs the X ray exposure enabled time from the FPI Output from the D Sub connector on the FPI 4 2 Before Getting Started 4 2 1 Environmental conditions For the operating environment the ambient temperature is 100C to 350C For the storage environment the ambient temperature is 150C to 550C 4 2 2 Operating environments Windows XP SP2 4 2 3 Wiring for the D Sub pin Wiring is required for external control D Sub connector pin assignment and signal names on the side of the FPI are described below The EXP OK signal notifies you of the X ray exposure enabled timing 4 2 4 Ethernet environments Although the FPI system can be
9. as incoming 0008 1050 PERFORMING PHYSICIAN Same as incoming 0010 4000 COMMENT Same as incoming 0010 2154 TELEPHONE Same as incoming 0010 1040 ADDRESS Same as incoming 0010 1020 HEIGHT Same as incoming 0010 1030 WEIGHT Same as incoming 0040 0002 SCHEDULED_DATE Reserved 0040 0003 SCHEDULED_TIME Reserved DUMMYTEXTINFO1 Same as incoming DUMMYTEXTINFO2 Same as incoming DUMMYTEXTINFO3 Same as incoming DUMMYTEXTINFO4 Same as incoming DUMMYTEXTINFOS Same as incoming zi Incoming Items Outgoing Name E d 2 Name ESA E i E 0008 E omo lt I w 0012 w 0018 0020 w 0028 0032 0038 o 0034 4 gt 0040 zl gt m lt File warklist gt File worklist structure Delimiter Date format VYYY MM DD E AGE Time format HH MM SS E ACCESS NUMBER BIRTHDAY EXAMINED BODYP ART REFERRING PHYSICIAN zl NCOCODOA AIRS NUVCICLARL QXvue use internally defined tag name related patient information for DICOM this information will be filled when we register patient or receive study order from the worklist server After x ray exposure these information will be stored to the internal database and will be put to the DICOM file as DICOM tag when we make DICOM file When QXvue receive order from the worklist server that might not be the standard DICOM tag so QXvue has DICOM tag converting function to make standard DICOM file 7 3 1 Worklist amp PACS 1 Definition Incoming Receiving tag from the worklist ser
10. local IP address The local IP address of this system is 192 168 95 30 or 192 168 95 31 TBD The IP address of this system can be selected 2 Connect the FPI to the X ray generator Please refer to OPERATION MANUAL OF FDX4343R for more details 3 Connect the FPI to power supply AC DC via the attached power cable 4 Connect the AC power cable to the power box and connect the terminal of the attached AC power cable to the AC power supply Page 22 of 53 TFlatXR Service Manual RA21 093 002 Caution Do not disconnect Ethernet connection while DC24V is operating and supplying to FPI 4 5 Dongle Key Installations QXvue software checks for USB type dongle key to run Please plug the dongle key into any free USB port on PC 4 6 QXvue Installation 1 Insert QXvue CD in CD Drive 2 Run Setup exe program then InstallShield Wizard will be displayed click Next button vue InstallShield Wizard a x The InstallShield R Wizard will complete the installation of QXvue on your computer To continue click Next 9 QXvue InstallShield Wizard Customer Information b Please enter your information User Mame user Organization pee o ooo Install this application For Ze Anyone who uses this computer all users C only for me user InstallShield lt Back Next gt Cancel Page 23 of 53 TFlatXR Service Manual RA21 093 002 4 Select setup type as Complete
11. measurements AAA 9 1 7 Left Right Market 10 1 8 Images Back 10 1 9 User Limitations os pO RISUS e ado 10 1 10 Cleaning the system seen entente nene tenerent retener eene nennen 10 1 11 Overheating se El ERR DR Re Ue b e Re 10 TT 2cBle ACM ORE ERO AER S p ER IR RS 10 1 13 EMI EMC Precauton eene rennen tenente nennen tenete nnn 11 1 14 EMC Information nnl ie 11 1 15 Maintenance precautions nennen ethernet tenete teen tn entren ener nennen 15 1 16 Disposal ood edet te pape PH rap be ide ee pee 15 1 17 Changing TC 15 1 18 Others uno SR HRS ede needed aia ped 15 NK Re ELE 15 1 20 Using together with other equipment sss tenere 15 1 21 Classification UL eee ede the de EE E 15 1 22 Installation and Maintenance 16 2 System Descriptlon edere e ie 17 2 1 Intended USE era a a a O ae a ts ameti touts 17 2 2 System components sone ng e e eite tte e Od 17 2 3 Mee LE EE 18 Page 4 of 53 TFlatXR Service Manual RA21 093 002 2 4 Component description eeina e e ae e A E tette e ertet tenete tenentes 18 Rej c DE 18 3 System Specification terre ned aru ante soon Ped ra D aep Uo iere 19 rM PCI uM EE 19 3 2 Effective field of view FOV size 19 3 3 X ray detection method sss tenerent tette tenente rresten 19 3 4 Time of capture and transmission sse tette 19 3 5 Image Specificato eee re HR EH EAD ERE HH e HDD Pero eer 19 316 Resol tlon
12. person who is submitting the information including phone number and fax number if available Reference to standards IEC EN UL 60601 1 Medical electrical equipment CSA C22 2 No 601 1 Part 1 general requirements for safety KFDA No 2009 1377 EN60601 1 1 Medical electrical equipment Part 1 General requirement for the safety Collateral standard Safety requirement for medical electrical systems IEC EN 60601 1 2 Medical electrical equipment Part 2 electromagnetic compatibility requirements and tests Authorized representatives If you have any accident please contact the authorized representatives Page 3 of 53 TFlatXR Service Manual RA21 093 002 Table of Contents Revision Histoty eei gro g et kee d e idee idle enne dp de dide e eden 2 Accident Reporting s oe Hehe ede oe ede e e P e ltr e e e eti e ur e e ree 3 Reference to standards ose eit n eite id i tei ln e ene 3 Authorized representatives Eeer e dE Reti i e ie eed 3 Table of E EE 4 E EE 7 1 1 Safety Guidelines cnet epe i cede pi ebat e nt ipn 7 1 2 General Hazatds oe RA NR RE e AR UR RE ERR ee 8 12 1 Radiation E DEE 8 1 2 2 Electric shock hazard A 8 1 2 3 Explosion Hazard zeno T A A 8 1 2 4 Implosion Hazard esses 8 1 3 Owner s Responsibility sse tnter tnter tenente netten ener 8 1 4 System Diagnostic eren EEEE NENE EEE te tenete tenete teen entrent EENS 9 1 5 Calibration oU ROT SUR E RE 9 1 6 Distances
13. remote controlled from the user created FPI system driving software via Ethernet it is limited to the communication between this FPI system and user system on a 1 1 basis The FPI system cannot be used in the universal network environment Do not connect it to the universal network environment Followings are requirement for Ethernet Ether Crossover Cable Ethernet 1000BASE TX 4 3 Installing Housing in Apparatus Use the screw holes 16 M4 Depth 8 The screws should be fixed all screw holes of each part Also the screw thread length entering the screw holes should be each depth of holes Installation respect of the device that installs FPI should be smooth It is necessary to clean installation respect of the device before FPI is installed Page 21 of 53 TFlatXR Service Manual RA21 093 002 Tightening torque of screw 1 35 1 65 Nm 4 4 Sensor Unit Installation For connection connect according to this item as shown in a figure below Ethernet Ac AC100 240V Power Supply Box DC24V Get P i AC DC i aq 2 4 X ray generator D Sub 1 Connect the Ethernet terminal on the FPI and User PC via the Ether Crossover Cable This system requires a dedicated local line If Internet is in use on the user PC two lines the Global Ethernet that goes through the DNS server and the Local Ethernet for connecting this system are required For the Ethernet line with this system please allocate a proper address for the user PC s
14. then click Next button ig OXvue InstallShield Wizard Setup Type Choose the setup type that best suits your needs Please select a setup type All program Features will be installed Requires the most disk space C Custom Choose which program Features you want installed and where they will be installed Recommended for advanced users Installshield lt Back Cancel 5 Ready to Install the Program window will be displayed press Install Button Shield Wizard Ready to Install the Program The wizard is ready to begin installation Click Install to begin the installation Tf you want to review or change any of your installation settings click Back Click Cancel to exit the wizard Installshield Page 24 of 53 TFlatXR Service Manual RA21 093 002 6 Installing QXvue will be displayed now the InstallShield is installing QXvue axvue InstallShield Wizard Installing QXvue The program Features you selected are being installed p Please wait while the InstallShield Wizard installs QXwue This may take xs several minutes Status Copying new Files ana InstallShield 7 After finishing installation of QXvue InstallShield Wizard Completed window will be displayed Then press Finish button The wizard was interrupted before Qxvue could be completely installed Your system has not been modified To complete in
15. to make the value Current DV close to the value Target DV A couple of more shots should be made to get an appropriate Current DV value 3 Confirm Calibration Step If you succeeded in getting the desired Current DV value in step O click Confirm Calibration Step to finish the current calibration step 4 Repeat 1 3 until the necessary number of calibration steps has been executed 5 Complete Calibration If the necessary number of calibration steps has been executed Complete Calibration button will be enabled By clicking the Complete Calibration button you can complete the calibration process Page 33 of 53 TFlatXR Service Manual RA21 093 002 7 QXvue Configuration 7 1 What is Configuration Using configuration software we can set the various parameters that are used in the QXvue so the proper setting of parameter is important Configuration of QXvue is needed when the TFlatXR is installed and this job should be performed before using QXvue Configuration of QXvue is consist of two parts General parameter setting by QXvue Configure Basic information used by QXvue DICOM parameter setting by QXvue Configure DICOM Worklist related DICOM header setting The configuration software is located at C Wprogram f 7 2 General parameter setting Q QXvue Configure Number of Detector Detector Type ilesWQXvue folder One Detector C Two Detector C QXR 8 C
16. 2 10 Patient comparison condition QXvue distinguishes among patients by comparing the selected fields of patients when inserting the patients from the worklist server into the local patient list database When we query study order from the worklist server if all selected patient comparison field data is equal to already registered order QXvue ignore that study order If none of comparison field is select then Patient ID will be used as comparison field If any comparison field is selected than only the selected field will be used as comparison field 7 2 11 File worklist location If worklist server is not available and the PACS system is providing order using text file QXvue can receive patients list from that file QXvue check assigned folder and if there is new order file QXvue will load study order from that file and after loading QXvue will delete that file Page 37 of 53 TFlatXR Service Manual RA21 093 002 7 3 DICOM parameter setting al Qxvue Configure Dicom Dicom r Worklist amp PACS gt Worklist matching report intemal Outgoing 0 10 0 0 0 0 1 A 0010 0020 ID Same as incoming 0010 0010 NAME Same as incoming 0010 0040 SEX Same as incoming 0010 1010 AGE Same as incoming 0008 0050 ACCESS_NUMBER Same as incoming 0010 0030 BIRTHDAY Same as incoming 0018 0015 EXAMINED_BODYPART Same as incoming 0008 0090 REFERRING_PHYSICIAN Same
17. Digital Imaging System TFlatXR Service Manual For veterinary use Vieworks Co Ltd 2010 05 27 Manufacturer Vieworks Co Ltd 604 Suntechcity 2 307 2 Sangdaewon dong Jungwon gu Seongnam city Gyeonggi do 462 806 South Korea TEL 82 70 7011 6161 FAX 82 31 737 4954 vieworks vieworks com www vieworks com TFlatXR Service Manual RA21 093 002 Revision History Rev 0 0 27 Mar 2010 first release Draft Page 2 of 53 TFlatXR Service Manual RA21 093 002 Accident Reporting The FDA Medical Device Reporting regulation 21 CFR 803 and the CE Council Directive 93 42 EEC concerning Medical Devices require that the manufacturer of medical devices submit a report to the FDA or Local competent authorities whenever he becomes aware of information that reasonably suggests that one of his installed devices may have caused or contributed to a death or serious injury or has malfunctioned and if the malfunction recurs is likely to cause or contribute to a death or serious injury In order for Vieworks to comply with these requirements all users of this equipment operators and service technicians are required to provide the Quality Assurance Manager at Vieworks with the following information regarding all reportable events as soon as possible 1 Identification of the model and serial number 2 Description of the event including whether any serious injury or death has been occurred 3 Identification of the
18. Max DC Cable 2m GND Cable Page 11 of 53 TFlatXR Service Manual RA21 093 002 1 14 2 Guidance and manufacturer s declaration electromagnetic immunity Guidance and manufacturer s declaration electromagnetic immunit The FP is intended for use in the electromagnetic specified below The customer or the user of the FPI should assure that it is used in such an environment Immunity test Electrostatic discharge ESD IEC61000 4 2 Electrical fast transient burst IEC61000 4 4 Surge IEC61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC61000 4 11 Power frequency 50 60Hz magnetic field IEC61000 4 8 Note IEC60601 Compliance level test level 6kV contact 2 4kV contact 8kV air 2 4kV air 2 kV for power supply lines 1kV for input output lines 1kV differential mode 0 5kV differential mode 2kV common mode lt 5 Ur gt 95 dip in Ur for 5 sec 6kV contact 2 4kV contact 8kV air 2 4 kV air 2kV for power supply lines 1kV for input output lines 1kV differential mode 0 5kV differential mode 2kV common mode lt 5 Ur gt 95 dip in Uy for 5 sec Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material The relative humidity should be at least 30 96 Mains power quality should be that of a typi
19. QXR 15 TFlatxR 9 QXR 8 or QXR 15 Option e EON EUEBPIS ERRON USE TFlatXR Option Dev0 r TFlatXR Option Dev1 IP Address 192 168 95 30 IP Address Saturation Value o Saturation Value XRay Appliable Time XRay Appliable Time Correction Type l Correction Type 192 168 95 31 Detector direction compensation DewD Detector direction compensation Dev1 cw fo y ccw o CW 0 v CCW 0 H MIRROR OFF y V MIRROR OFF Sib H MIRROR S OFF V MIRROR OFF Y Device Name Dev0 y Device Name Devl Devo Devi Dicom header info Detector Unique Number Dev0 T G STATION NAME Hospital information Name Address Tel Save location name as institute name Dummy fields display name Patient comparison condition UserDefined 1 000000000000 Detector Unique Number Dev HOoooooooooo GG ee Expansion Setting Minimize Button Secondary monitor m Thumbnail tab information Dummy ID E ID SE Dummy UserDefined_2 C Name ame Dummy3 UserDefined_3 C Accession Number TF Bodypart Dummy4 UserDefined_4 C Study Instance UID I Birthday Agel Dummy5 JUserdefined5 M Heserverd TF Accession Number Dummy6 UserDefined B M Reserverd m File worklist location Page 34 of 53 TFlatXR Service Manual RA21 093 002 7 2 1 H
20. UB U EXPOSURE I 2 l 2 U DATASTORAGE IRC 1 4 POWER ON EXP REQ EXP_OK period Maximum 40ms EXP REQ DATA STORAGE period Maximum 2 000ms case EXPOSURE 500ms POWER ON EXP REQ period Minimum 520ms Description of the sequence M By receiving EXP REQ during Refresh status proceeds to Exposure after completion of Refresh M Continues EXP OK signal ON during Exposure ON period is defined by Image Acquisition mode table Wi Proceeds to Data Read after completion of Exposure M After Read FPI proceeds to status of Refresh Page 52 of 53 TFlatXR Service Manual RA21 093 002 Appendix F Pin Assignment F 1 D Sub pin Image Acquisition Control interface l 5 OOOO 6 9 Number viewed from insertion port side D Sub connector pin assignment on the side of the FPI PinNo Signalname vO Contents TEST Don t connect This pin is used for TEST 2 EXP REQ Input Image acquisition X ray exposure Request signal Image acquisition X ray exposure EXP OK Output Period signal Not connected Notconnected Dont connect This pin is used for TEST 7 EXP REQ Input Image acquisition X ray irradiation Request signal e EXP OK Output Image acquisition X ray irradiation Period signal Nc NC Notconnected LO F 2 Power Supply Connector PinNo Signalname VO Contents DC 24V Positive Voltage Input DC 24V
21. cal commercial or hospital environment Mains power quality should be that of a typical hospital environment Mains power quality should be that of a typical hospital environment If the user of the FPI requires continued operation during power mains interruptions it is recommended that the FPI be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in atypical commercial or hospital environment 1 Uz is the a c mains voltage prior to application of the test level 2 This angiography X ray system can only allow to use the designated cables and components If the different cables or components are used they may deteriorate the performance of recommended separation distance between portable and mobile RF communications equipment and this system Page 12 of 53 TFlatXR Service Manual RA21 093 002 1 14 3 Guidance and manufacturer s declaration electromagnetic immunity The EUT is intended for use in the electromagnetic environment specified below The customer or the user of the EUT should assure that it is used in such an environment Guidance and manufacturer s declaration electromagnetic immunit The FPI is intended for use in the electromagnetic environment specified below The customer or the user of the FPI should assure that it is used such an environment IEC60601 Compliance Electromagnetic environment Im
22. connection to supply not in USA make sure the power cord is the correct type that is required in your area 2 3 Environment Under delivery and stock Under operating Temperature 15 55 C 410 35 C Humidity 10 9095 30 8596 Non Condensing Non Condensing Pressure 50 106 kPa 70 106 kPa 2 4 Component description 1 Sensor Unit Creates X ray image by using flat panel detector 2 Power supply unit Supplies DC power to sensor unit 3 QXvue Software to view X ray image Get image from detector process it to ease the diagnostic save it in database and manage it 4 TFlatXRCalibration Diagnostic detector and report the result Calibrate the system 5 QXvue Configure amp QXvue Configure DICOM Configure parameters for TFlatXR Digital Imaging System 2 5 Others Caution Accessories and Cables provided by Vieworks should be used Other cables and accessories may negatively affect EMC performance Accessory equipment connected to the analog and digital interfaces must be certified according to the respective EN and IEC standards for examples EN 60950 and IEC 60950 for data processing equipment and EN 60601 1 and IEC 60601 1 for medical equipment Furthermore all configurations shall comply with the system standards EN 60601 1 1 and IEC 60601 1 1 Anyone who connects additional equipment to any signal input or signal output ports configures a medical system and is therefore responsible tha
23. does not operate properly or if it fails to respond to the controls described in this manual the operator should immediately contact Vieworks field service representative report the incident and await further instructions 8 The images and calculations provided by this system are intended to be used as tools for the competent user They are explicitly not to be regarded as a sole incontrovertible basis for clinical diagnosis Users are encouraged to study the literature and reach their own professional conclusions regarding the clinical utility of the system 9 The user should be aware of the product specifications and of the system s accuracy and stability limitations These limitations must be considered before making any decision based on quantitative Page 7 of 53 TFlatXR Service Manual RA21 093 002 values in case of doubt please consult a Vieworks representative 10 This product must be used only in a shielded location with a minimum RF shielding effectiveness and for each cable that exits the shielded locations a minimum RF filter attenuation of shielding effectiveness 11 This product is intended for use by healthcare professionals only This product may cause radio interference or may disrupt the operation of nearby equipment It may be necessary equipment It may be necessary to take mitigation measures such as reorienting or relocating the product or shielding the location 1 2 General Hazards 1 2 1 Radiation hazards
24. e e RU Ope E teer d red 40 8 2 Check the FPI Failure ocasion eere ore ae eee e be edi EH RR S 41 9 WARRANTY epa A AA A ii 42 Appendix A Symbols cocoa data oe de e rei a din ias 43 Appendix B Components and Characteristics sss 44 B LFlat Panel Sensor Unit gebeten OB Eeer be n ada eR AR d eb 44 B 2 Power Supply Unit 5 is A nt uti e de Redi e die b ee red 44 B 3 Dimensional Outline 53a noh ds tea eni eode iban 44 Appendix C Drawings eden iia etaient 45 Appendix D Interconnection Diagram sss nennen 48 Appendix E Image Acquisition Interface sse tenente 49 E 1 Communication Block Diagram s sse tenente nennen 49 E 2 Control Interface Dubai AA A ta eee tait lise Ee 50 E 3 External Control D Sub esa Gs abe Bi eae Ae e dti s ad ie edidic dens 51 E 4 Control Interface Ethernet das BA da e o e earann eaa 52 Appendix E Pin Assignment eee erede eene pet t bie i aaa 53 F 1 D Sub pin Image Acquisition Control interface 53 F 2 Power Supply Connector esse E setae A tata to tents soos 53 Page 6 of 53 TFlatXR Service Manual RA21 093 002 1 Safety 1 1 Safety Guidelines Caution Always be alert when operating this equipment If a malfunction occurs do not use this equipment until qualified personnel correct the problem This Product was designed and manufactured to ensure maximum safety of operation and to meet all the safety requirements applicable to electro
25. ector enter the intial state The dialog will be closed Other buttons A Select Enters the region selection mode To select region to see statistics of the rigion in Information dialog this mode should be selected Fit Adjust the size of image to fit in the image display area C ROI Pickup If you select a region in this mode W L is adjusted according to the pixel values in the region D PAN Enters the mode adjusting the image position in the display area E ZOOM Enters the mode enlarging or shrinking the image size F W L Enters the mode adjusting W L Window Level W L can be adjusted by dragging the mouse with right mouse button pressed at any time G 10096 20096 40096 80096 160096 Adjusts the image size as the selected ratio Page 31 of 53 TFlatXR Service Manual RA21 093 002 H Open Information Information X 1161 Y 1248 X 1897 Y 1778 X 1161 Y 1248 X 1897 Y 1778 391347 Statistics hd Manual coordinate x1y1 1161 1248 x2 y2 1897 1778 Update Center 50X50 Center 100X100 Whole area The dialog displays statistics of the selected region or pixel level of the pixel where the cursor is pointing If you select the Statistics from the Combo box the former is displayed If you select the Pixel from the Combo box the latter is displayed To select a region by dragging the mouse Select mode should be selected as current mode Or you can select a re
26. gion by putting coordinates in the edit boxes and clicking update button i Center 50X50 displays statics of the 50 by 50 wide rectangular region located at the center of the image ii Center 100X100 displays statics of the 100 by 100 wide rectangular region located at the center of the image iii Whole area displays statistics of the whole image 6 2 Preparation for Calibration Run Calibration software Set SID to 1 8m or 1m Caution Do not use x ray grid when do calibration Page 32 of 53 TFlatXR Service Manual RA21 093 002 6 3 Configure Select options referring to 6 1 1 clause and adds removes modifies calibration steps 6 4 Initialization Initialize the detector by clicking Initialize Detector button It takes several seconds to initialize the detector If the initialization is done Enter Calibration Mode button is enabled By clicking Enter Calibration Mode button you can let the detector enter the calibration mode If the detector successfully enters the calibration mode a Calibration dialog will pop up 6 5 Calibration If the Calibration dialog is displayed this means that the detector successfully has entered the calibration mode The procedures of calibration are as follows 1 Get Calibration Step gets information for current calibration step 2 Exposure amp Check real DV After taking the image you should adjust SID KVP and mAs
27. iculty of servicing the product THIS WARRANTY IS GIVEN BY VIEWORKS CO WITH RESPECT TO THIS PRODUCT IN LIEU OF ANY OTHER WARRANTIES EXPRESS OR IMPLIED VIEWORKS CO AND ITS VENDOR DISCLAIM ANY IMPLIED WARRANTIES OF MERCHANTABLILITY OR FITNESS FOR A PARTICULAR PURPOSE VIEWORKS CO RESPONSIBILITY TO REPAIR OR REPLACE DEFECTIVE PRODUCTS IS THE SOLE REMEDY PROVIDED TO THE CUSTOMER FOR BREACH OF THIS WARRANTY VIEWORKS AND ITS VENDORS WILL NOT BE LIABLE FOR ANY INDIRECT SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES IRRESPECTIVE OF WHETHER VIEWORKS CO OR THE VENDOR HAS ADVANCE NOTICE OF THE POSSIBILITY OF SUCH DAMAGES There are no warranties which extend beyond the description mentioned in this document Page 42 of 53 TFlatXR Service Manual RA21 093 002 Appendix A Symbols DIRECT CURRENT disnei ALTERNATING CURRENT PROTECTIVE EARTH GROUND EQUIPOTENTIALITY OFF POWER DISCONNECTION FROM THE MAINS ATTENTION CONSULT ACCOMPANYING DOCUMENS ON POWER CONNECTION FROM THE MAINS Page 43 of 53 TFlatXR Service Manual RA21 093 002 Appendix B Components and Characteristics B 1 Flat Panel Sensor Unit Sensor Protection Plate coccion Carbon Fiber Plate COOMING EE Natural Air Cooling Input utm ces S De LSU a DC24V from AC DC Power Supply Power Consumption see Maximum 20W Overall Dimensions seen 512x495x43mm W H xD V xH KOL EE 16 kg B 2 Power Supply Unit Ig AC100 to 240V
28. igital techniques 2 2 System components TFlatXR system consists of detector power supply unit software and its accessories TFlatXR system components Sensor Unit 16kgx1 Power Supply Unit 1kg approx x1 AC Cable 1 8mx1 DC Cable Sensor Unit Power Supply Unit 10mx1 D Sub Cable 10mx1 Ethernet Cable Crossover 1000BASE TX 15mx1 Ground GND Cable for Sensor Unit 3mx1 Ground GND Cable for Power Supply Unit 3mx1 Dongle Key 1 Software Viewer QXvue Configuration QXvue Configure QXvue Configure DICOM Calibration and Diagnostic TFlatXRCalibration Workstation option OS Windows XP professional CPU Minimum Pentium 4 3 0 GHz Memory Minimum 2G Byte Hard Disk Minimum 80G Byte Ethernet Minimum 1000 Mbit s 2EA Monitor 1600x1200 Color CD Rom CD or DVD R W X ray grid option 10 1 215lines inch Page 17 of 53 TFlatXR Service Manual RA21 093 002 Caution Power Supply Unit amp Sensor Unit It should be used in the Patient Environment AC DC Adapter AC DC Adapter connected to QXR should be tested by IEC 60950 1 Power Cord Set for US Type SJT or SVT 18AWG 3 Conductor VW 1 125V or 250V 10A max 3 0m long One end with Hospital Grade Type MENA 5 15P or 6 15P Other end with appliance coupler CAUTION Grounding reliability can only be achieved when the equipment is connected to an equipment receptacle marked Hospital Only or Hospital Grade Power Cord Set Other Countries For
29. imitations The QXvue software has the technician mode this mode could only be operated with the inputting PASSWORD The technician mode should be operated by the personnel who are qualified by Vieworks 1 10 Cleaning the system Use only isopropyl alcohol to clean surfaces of the system Do not use detergents or organic solvents to clean the system Strong detergent and organic cleaners may damage the finish and cause structural weakening Do not clean the system with turning the power on 1 11 Overheating Do not block the ventilation ports of the detector to prevent overheating of the detector Overheating can cause system malfunction and damages 1 12 Electrical fire O This equipment is not suitable for use in the presence of a flammable an aesthetic mixture with air or with oxygen or nitrous oxide Conductive fluids that drain into the active circuit components of the system may cause short circuits that can result in electrical fire Therefore do not place fluids or food on any part of the system Page 10 of 53 TFlatXR Service Manual RA21 093 002 O To avoid electric shocks and burns caused by use of the wrong type of fire extinguisher make sure that the fire extinguisher at the site has been approved for use on electrical fires 1 13 EMI EMC Precaution During installation of the system care must be taken to prevent the potential risk of electromagnetic interference between this equipment and other devices The de
30. lize Detector ae Ee 1 Initialize Detector button Initializes the detector It may take several seconds to initialize the detector 2 Enter Calibration Mode button Let the detector enter calibration mode If the detector enters calibration mode successfully a dialog will pop up for calibration procedures Page 30 of 53 TFlatXR Service Manual RA21 093 002 6 1 3 Calibration dialog TETD Calibration Calibration Get Calibration Step Step Information m zs Calibration Information Target DV Current times for Current DV mL Total time for current DV Total number of DV Real DV of current image Check real DV Operation Fit ROI Pickup PAN ZOOM Cancel Calibration Get Calibration Step button GetCalibrationStep command is sent to the detector Confirm Calibration Step button Finishes the current step for the calibration ConfirmCalibrationStep command is sent to the detector Complete Calibration button Completes the calibration procedures CompleteCalibrationStep command is sent to the detector Also ExitCalibrationMode command is called This command let the detector enter the intial state The dialog will be closed Cancel Calibration button Cancels out whole calibration procedures AbortCalibration is sent to the detector Also ExitCalibrationMode command is called This command let the det
31. lled state of detector CW 0 CW 0 CW 1 CW 1 CCW 0 CCW 0 CCW 0 CCW 0 H Mirror 1 H Mirror 0 H Mirror 0 H Mirror 1 V Mirror 0 V Mirror 1 V Mirror 1 V Mirror 0 7 2 6 Thumbnail tab information 1 Name Select the item s to be displayed in the thumbnail tab Patient ID and Patient name is default and the additional information can be displayed in the thumbnail tab according to the setting 7 2 7 Expansion setting O li Minimize If the Minimize Button check box is set you will have the Minimize button above the Exit button 7 2 8 DICOM header info 1 Detector Unique Number The 12 digit number unique for each detector which constitutes Study Instance UID Series Instance UID and SOP Instance UID If you run QXvueCalibration the field is automatically filled in 2 TAG STATION NAME Page 36 of 53 TFlatXR Service Manual RA21 093 002 A string for station name tag This is used to distinguish the detectors if two or more detectors are installed in the same hospital 7 2 9 Dummy fields display name Dummy field is used for the connection with the worklist server If the worklist server sends some information that is not mentioned in the DICOM standard then QXvue can receive that information using dummy fields Dummy field will be displayed as set name in the order list 7
32. munity test test level level guidance Portable and mobile RF communications equipment should be used no closer to any part of the FPI including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 124P 150kHz to 830MHz elas law aim d 2 3VP 800 MHz to 2 5 GHz IEC61000 4 3 80 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol DA a Note 1 At 80MHz and 800MHz the higher frequency range applies 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures object and people 3 This angiography X ray system can only allow to use the designated cables and components If the different cables or components are used they may deteriorate the performance of electromagnetic immunity Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios Amateur radio AM and FM radi
33. nfigure Number of Detector RA21 093 002 TAG_STATION_NAME Hospital information Name Address Tel T Save location name as institute name Dummy fields display name Patient comparison condition i Detector Type One Detector C Two Detector C QXR 8 C QXR 16 TFlatXxR 9 QXR 8 or QXR 15 Option ERRONEA C RAON USEM TFlatXR Option Dev0 TFlatXR Option Dev1 IP Address 192 168 95 30 IP Address 192 168 95 31 Saturation Value 11000 Saturation Value fi 1000 Ray Appliable Time 3 XRay Appliable Time y Correction Type H Correction Type H Detector direction compensation DewD Detector direction compensation Dev1 CW 0 CCW 0 CW CCW fo zi H MIRROR OFF y V MIRROR OFF H_MIRROR OFF V MIRROR OFF zi Device Name Dev0 Device Name Devl Devo Dev Dicom header info Detector Unique Number Dev0 000000000000 Detector Unique Number Dev 000000000000 p Expansion Setting Minimize Button Secondary monitor m Thumbnail tab information Dummyl UserDefined 1 C ID E ID SE Dummy UserDefined_2 C Name E Wane Dummy3 UserDefined 3 C Accession Number I Bodypart Dummy4 UserDefined_4 C Study Instance UID Birthday Agel Dummyb UserDefined 5 M fee T Accession Number Dummy6 UserDefined 6 m F m File worklist location DS Page 27 of 53 TFla
34. ngle digit minutes SS Seconds with leading zero for single digit seconds Page 39 of 53 TFlatXR Service Manual RA21 093 002 8 Trouble Shooting Note Trouble shooting must be performed by technician who is trained by the Vieworks Co Ltd or an organization certified by Vieworks Co Ltd If an unqualified person performs troubleshooting on the system resulting in damaging the detector software or hardware then the Vieworks Co or its representative is not responsible for the detector repair even if the warranty is not expired Please refer to the warranty section 9 of this manual for more details 8 1 Failure Mode LED is not lit Refer to 8 2 Page 40 of 53 TFlatXR Service Manual RA21 093 002 8 2 Check the FPI Failure Explanation of details on LED s on the side of the FPI LED1 POWER Green Lit in green When 24V is input LED2 HEALTHY Green Lit in green FPI retains the normal status LED3 NETWORK Green Lit in green Normal communication status lt LED4 IMAGING Green Lit in green Radiography status EXP OK output period Lit in green READOUT Page 41 of 53 TFlatXR Service Manual RA21 093 002 9 WARRANTY Vieworks Co warrants that this product will be free from defects in materials and workmanship for a period of twelve 12 months from the date of delivery If any such product proves defective during this
35. nic medical equipment However anyone attempting to operate the system must be fully aware of potential safety hazards It should be operated and maintained in strict compliance with the following safety precautions and operating instruments contained herein 1 The product should be installed maintained and serviced according to Vieworks maintenance procedures and by Vieworks personnel or other qualified maintenance personnel approved in writing by Vieworks Operation and maintenance should be done in strict compliance with the operation instructions contained in the maintenance manuals 2 The system in whole or in part cannot be modified in any way without written approval from Vieworks 3 Before authorizing any person to operate the system verify that the person has read and fully understand the Service Manual The owner should make certain that only properly trained and fully qualified personnel are authorized to operate the equipment An authorized operators list should be maintained 4 Prevent unauthorized personnel from access to the system 5 It is important that this Service Manual be kept at hand studied carefully and reviewed periodically by the authorized operators 6 The owner should ensure continuous power supply to the system with voltage and current according to the product specifications If power failures are not infrequent a UPS Uninterrupted Power Supply should be installed to avoid loss of data 7 If the product
36. o 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 in which the FPI is used exceeds the applicable RF compliance level above the FPI should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the FPI Over the frequency range 150kHz to 80MHz field strengths should be less than 3V m Page 13 of 53 TFlatXR Service Manual RA21 093 002 1 14 4 Recommended separation distances between portable and mobile RF communications equipment and the EUT The is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the EUT can help Prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the EUT as recommended below according to the maximum output power of the communications equipment Recommended separation distances between portable and mobile RF communications equipment and the FPI The FPI is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the FPI can help prevent electromagnetic interference by maintaining a minim
37. ospital information They are the name address and telephone number of the hospital in which the QXR system is installed The values of the name field and address field is put into the institution name tag and institution address tag respectively when creating DCM files 7 2 2 Number of Detector Select One Detector Supporting Two detector is TBD 7 2 3 Detector type Select TFlatXR 9 7 2 4 TFlatXR Option DevO IP Address The IP address of FPI 192 168 95 30 or 192 168 95 31 TBD A Note FPI address is fixed with 192 168 95 30 192 168 95 31 is not available now PC s network setting has to be changed with same class of FPI address for cross connection Ex IP Address 192 168 95 10 Basic Gateway 192 168 95 1 Saturation Value The Saturation value for digital value 11000 default XRay Appliable Time 9 default Note 0 50ms 1 100ms 2 150ms 3 200ms 4 250ms 5 300ms 6 350ms 7 400ms 8 450ms 9 500ms 19 1000ms 45 2300ms 63 3200ms 79 4000ms others 500 milli second Correction Type 7 default Note 0 without any correction 1 Only apply offset correction 3 apply offset and gain correction 7 Apply offset gain bad pixel correction Page 35 of 53 TFlatXR Service Manual RA21 093 002 7 2 5 Detector direction compensation This is used to set the image direction Set direction according to insta
38. ress of water Page 15 of 53 TFlatXR Service Manual RA21 093 002 4 NOT suitable for use in the presence of a flammable an aesthetic mixture with air or with Oxide 5 Continuous operation 1 22 Installation and Maintenance Caution Only qualified service personnel who have received training from Vieworks should perform this installation and troubling shooting Only qualified service personnel who have received training from Vieworks should perform this installation and trouble shooting Calibration procedures should be performed at the system installation time or if the x ray generator is changed otherwise the system quality is decreased Page 16 of 53 TFlatXR Service Manual RA21 093 002 2 System Description 2 1 Intended use TFlatXR system is indicated for digital imaging solution designed for general radiographic system for human or veterinary anatomy It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures It controls x ray exposure and x ray dosage by means of interfacing with x ray generator Various features of this system enable the operator to diagnose easier and faster than conventional non digital techniques Computerized window image inversion image processing zooming panning window level adjustment contrast adjustment and various features enable the operator to view diagnostic details difficult to see using conventional non d
39. stallation at another time please run setup again Click Finish to exit the wizard i Gantel 8 The following message box will be displayed press Yes button to restart computer i OXvue Installer Information You must restart your system For the configuration changes made to QXwue to take effect Click Yes to restart now or No if you plan to restart later Page 25 of 53 TFlatXR Service Manual RA21 093 002 Now the QXvue software is successfully installed to the following directory Software C WProgram FilesWQXvue Data D WQXvueData Executable File List QXvue exe Viewer program TFlatXRCalibration exe Calibration program QXvue Configure exe General Configure program QXvue Configure DICOM exe DICOM Configure program A To run QXvue East Asian Language option in windows should be selected if not Selected collating sequence not supported by the operating system or the selected order is not supported by this operating system message will be displayed To select this option 1 Start Control Panel gt Regional and Language 2 Check Install files for East Asian languages option and click OK button to install 4 7 Sensor unit specific files installation 1 Please check the following files are included in a separately provided CD ROM disk Defective pixel map TETD Defect YYYYMMSNSNSN map License key code file YYYYMMSNSNSN key 2 Copy TETD Defect YYYYMMSNSNSN map into
40. t the system complies with the requirements of the system standards EN 60601 1 1 and IEC 60601 1 1 Page 18 of 53 TFlatXR Service Manual RA21 093 002 3 System Specification 3 1 Pixel Matrix Effective Pixel Number 3008 x 3072 Pixel pitch 143 um x143 um 3 2 Effective field of view FOV size Horizontal 430 mm 16 9 Vertical 439 mm 17 2 3 3 X ray detection method Cesium Iodide CsI scintillator Amorphous Silicon a Si Photodiode 3 4 Time of capture and transmission Shorter than 6 second 3 5 Image Specification 1 Image Format 3072 W X 3072 H 2 Effective Field of View Horizontal 430 mm 16 9 Vertical 439 mm 17 2 3 6 Resolution It should be more than 3 5 LP at the center of the detector screen The measure resolution follow the below procedure Locate resolution chart Nuclear Associates Model 07 523 or the equivalent at the center of the detector screen with the diagonal position Line pairs that could be separated by adjusting window level are the resolution 3 7 Electrical Specification 3 7 1 Flat Panel Sensor Unit 1 Input Voltage DC 24V 2 Power consumption 20W 3 7 2 Power Supply Unit 1 Input Voltage AC 100 to 240V Single phase 50 60Hz Page 19 of 53 TFlatXR Service Manual RA21 093 002 2 Maximum power 60VA 3 Output power standard DC 24 Vdc 10 3 8 Interface 1 Image data 16 bit Digital Output Ethernet 1000BASE T 2 System control Ethernet 1000BASE
41. tXR Service Manual RA21 093 002 5 2 General Configuration of QXvue Refer to clause 7 2 5 3 Diagnosis and calibration Refer to clause 6 for diagnosis and clause 6 for calibration 5 4 DICOM Configuration of QXvue Refer to clause 7 3 Page 28 of 53 TFlatXR Service Manual RA21 093 002 6 Calibration Calibration procedure calibrates pixel gain using the installed x ray generator and x ray tube The calibration should be performed on the following case Detector installation X ray generator replacement X ray tube replacement 6 1 Description of tabs and dialogs 6 1 1 Set configuration tab TETD Calibration Set configuration Configuration Iv White Image Check Iw Dark Image Check Reference step ProcContent RefrenceP lt Add Delete Move up Move down 1 When this tab is activated The program reads current configuration from the XML file 2 Next button Saves any modified configurations to the XML file 3 Other buttons A Auto Pixel Map B White Image Check C Dark Image Check D Buttons in Reference Step group i Add Adds a reference calibration step ii Delete Deletes selected reference calibration steps iii Move up Moves up selected reference calibration step iv Mode down Moves down selected reference calibration steps Page 29 of 53 TFlatXR Service Manual RA21 093 002 6 1 2 Initialization tab TETD Calibration Initialization Initia
42. the folder D WQxXvueDataWReference 3 Copy YYYYMMSNSNSN key into the folder D WQXvueDataWConfig 4 8 FPI Start 1 Power on and boot the user PC 2 Check the connection between units and input the AC power to the AC power supply DC24V is input to the FPI and the FPI is started 3 If the FPI starts successfully LED1 2 and 3 on the side of the FPI are lit in green For the LED s refer to 8 2 If power is turned on for the first time the FPI starts with the settings made upon shipping from the factory For the second time onward the FPI starts with the settings saved by the setting status save command If the settings are not saved by the setting status save command the FPI starts with the most recently saved settings Page 26 of 53 TFlatXR Service Manual 5 Preparation for operating TFlatXR system To operate TFlatXR system following step should be executed 1 Run QXvue Configure 2 Select Number of Detector with one Detector and Detector type with TFlatXR 9 Supporting Two detector is TBD 3 Do Configuration of general 4 Exit QXvue Configure 5 Run TFlatXRCalibration 6 Diagnosis and calibrate 7 Exit TFlatXRCalibration 8 Run QXvue Configure DICOM 9 Do Configuration of DICOM 10 Exit QXvue Configure DICOM 5 1 Select Number of Detector and Detector type 1 Run QXvue Configure in C Wprogram filesWQXvue folder 2 Select Number of Detector and Detector type Q QXvue Co
43. tion Availability Ethernet Command D Sub Signal Control Signal Name Type Control PC X ray Controller EXP REQ INPUT OK OK EXP OK OUTPUT N A OK EXP REQ Command Response Page 49 of 53 TFlatXR Service Manual RA21 093 002 E 2 Control Interface D Sub D Sub Signal Control Interface Operation Sequence 8 c D FPI Drive EXPREQ lt IN gt 3 1 3 y C t EXP OK ou E E Deg D DE EXPOSURE AAA a a DATA STORAGE Data POWER ON A EXP REQ width Minimum 1ms B Refresh period For line drive 3072 Line scan 36 9ms C EXP period Set value see the Image Acquisition mode table 50 to 500ms 1000ms 2300ms 3200ms amp 4000ms Standard 500ms When you want to change EXP period put in some period Command D Read period For line drive 3072 Line Scan 1222ms Page 50 of 53 TFlatXR Service Manual RA21 093 002 E 3 External Control D Sub 1 Input circuit 1 5V 1ImA max 2 Output circuit Isolated DC DC module High 4 0V min Free SmA max p D Sub 9pin connector Z1 EZJZ1V120KA Matsushita UI PS2801 1 NEC Q1 28C4081T106Q ROHM U2 COSEL SUCSIRSOSOSBP Page 51 of 53 TFlatXR Service Manual RA21 093 002 E 4 Control Interface Ethernet Ethernet Interface Command Control Operation Sequence FPI Drive 1 e Ref Ref EXPREQ lt IN gt l l i EXP OK OUT 2 l 2 DS
44. um distance between portable and mobile RF communication equipment transmitters and the FPI as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum m output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter 1 10 For transmitters rated at a maximum output power listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80MHz and 800MHz the separation distance for the higher frequency range applies 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption by absorption and reflection from structures objects and people 3 The FPI can only allow to use the designated cables and components If the different cables or components are used they may deteriorate the performance of recommended separation distance between portable and mobile RF communications equipment and this system A Caution DO NOT USE THE ELECTROMAGNETIC DEVICE SUCH AS CELLULAR CORDLESS TELEPHONES AND RADIO CONTROLLED TOYS CLOSE TO THIS SYSTEM OTHERWISE IT MAY CAUSE MALFUNCTION OF THE SYSTEM Page 14 of 53 TFlatXR Service Manual RA21 093 002
45. ury 1 3 Owner s Responsibility Page 8 of 53 TFlatXR Service Manual RA21 093 002 amp Caution Do not use the system if unsafe conditions are known to exist In case of hardware failure that could cause hazardous conditions smoke fire and etc turn the power OFF and unplug the power cords of all subsystems The owner is responsible for ensuring that anyone using the system reads and understand the Service Manual and other relevant literature and fully understands them Vieworks makes no representation however that the act of reading this manual renders the reader qualified to operate test and calibrate the system 1 4 System Diagnostic The TFlatXRCalibration software runs a system diagnostic Run TFlatXRCalibration software when install system or every 1 year after installation If an error is detected report detailed error to Vieworks field service representative Caution The owner is responsible for ensuring that diagnostic of system is performed every year Do not try to use the system if system diagnostic is fail 1 5 Calibration To ensure the optimal performances of the system it is important to verify that system is calibrated amp Caution The owner is responsible for ensuring that the system calibration is performed at installation time or if the system is repaired Do not try to use the system if system calibration is not performed 1 6 Distances measurements
46. ver Internal Internally defined field name of the patient information and study order in QXvue Outgoing DICOM tag that will be stored to DICOM file 2 Worklist Matching Select internal field name then currently matched tag will be displayed in the items table Select incoming tag from the list and register it by clicking button Select outgoing tag from the list and register it by clicking gt gt button Page 38 of 53 TFlatXR Service Manual RA21 093 002 7 3 2 File worklist The format of file worklist should be text file and the field should be separated by delimiter The delimiter is user defined and should be registered in the delimiter table Internally defined fields for patient information and study order is listed in the internal field table Set the matching internal field name according to the text order in the worklist file Internal field will be translated to the DICOM tag set at 3 1 2 The delimiter could be one or more characters The date and time format used in worklist file can be selected and all characters located in the place of where star closure exists is ignored Date format YYYY Year represented by full four digits MM Month as digits with leading zero for single digit months DD Day of month as digits with leading zero for single digit days Time Format HH Hours with leading zero for single digit hours 24 hour clock MM Minutes with leading zero for si
47. vice has been tested for EMI EMC compliance but interference can still occur in an electromagnetically noisy environment Attempt to maintain a suitable distance between electrical devices to prevent cross interference 1 14 EMC Information 1 14 1 Guidance and manufacturer s declaration electromagnetic emissions Guidance and manufacturer s declaration electromagnetic emissions The X ray Flat Panel Imager hereafter called FPI is intended for use in the electromagnetic specified below The customer or the user of the FPI should assure that it is used in such an environment RF emissions Group1 The FPI users RF energy only for its internal function Therefore its RF emissions are very low and are not CISPR 11 likely to cause any interference in nearby electronic equipment RF emissions Class A The FPI is suitable for use in all establishments other than domestic and those directly connected to the public CISPR 11 low voltage power supply network that supplies building Harmonic emissions Not applicable used for domestic purposes IEC61000 3 2 Voltage fluctuations Not applicable flicker emissions IEC61000 3 3 The FPI is not allowed to use the cables or components differ from the originally attached If the different cables or components are used they may deteriorate the performance of electromagnetic emissions The limited length of cables for conforming EMC IEC60601 1 2 Ed2 2001 AMD 1 2004 Cable length
48. warranty period Vieworks Co at its option either will repair the defective product without charge for parts and labor or will provide a replacement in exchange for the defective product In order to obtain service under this warranty Customer must notify Vieworks Co of the defect before the expiration of the warranty period and make suitable arrangements for the performance of service Customer shall be responsible for packaging and shipping the defective product to the service center designated by Vieworks Co with shipping charges prepaid Vieworks Co shall pay for the return of the product to Customer if the shipment is to a location within the country in which the Vieworks Co designated service center is located Customer shall be responsible for paying all shipping charges duties taxes and any other charges for products returned to any other locations This warranty shall not apply to any defect failure or damage caused by improper or inadequate maintenance and care Vieworks shall not be obligated to furnish service under this warranty to repair damage resulting from attempts by personnel other than Vieworks Co or its representatives to install repair or service this product to repair damage resulting from improper use or connection to incompatible equipment or power source or to service a product that has been modified or integrated with other products when the effect of such modification or integration increases the time or diff

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