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Digital Radiography System MAXXray User Manual

1. sss entente eene tenete eene nene 15 2 3 Component description sees eene ens 15 System Specification sse nnns 15 c a o EAT E E A EE E EE 15 3 2 Area of ce hen NER 15 SCHMACON 15 3 4 Time of I mage Capture and Transmission sees 15 3 5 Time of I mage Capture and I mage 15 3 5 CCD Cooling 5 5 15 3 6 I mage 5 15 3 7 Black Level RI RR ERU E 15 3 8 Resolution eee en e re et 15 3 9 15 3 10 Operation Environmental Condition eese 15 MAXXray User Manual RQP 501 1r0 V Page 5 of 108 Date 05 16 2008 Doc No RA21 085 003 3 11 Transport and Storage Environmental 15 3 12 Electrical Specification s sss 15 3 12 1 AC Power Input PSU sess eene nennen nnns 15 3 12 2 Power Consumption esses 15 3 13 Interface en eee 15 4
2. seen 15 10 3 DI COM parameter 5 tenerent 15 10 3 1 Worklist tree eee 15 10 3 2 File worklist necesse eintreten iren EE SERERE ERR 15 11 Trouble 5 eee tete teria etin i fener 15 11 1 Failure Mode esent eee ete HE EHE ee be ERR RE 15 11 2 Repairing Power Failure entente tenen 15 11 3 Repairing Serial communication Failure sss 15 11 4 CCD Cooling Test Failure sse tenen 15 11 5 Black Level Test Failure sse tenen 15 11 6 Flat Field Test Failure essere 15 11 7 Resolution Test sss terne 15 12 WARRANTY ones deiade E UU EHE 15 Appendix A Interconnection 15 Appendix B Symbols 11 vostre 15 Appendix How to use line esses 15 Appendix D Quality Control 1 esee enne 15 MAXXray User Manual RQP 501 1r0 V Page 7 of 108 Date 05 16 2008 Doc No RA21 085 003 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 m
3. lt File worklist gt File worklist structure Delimiter Date format VY YY MM DD Time format 55 AGE ACCESS_NUMBER BIRTHDAY EXAMINED_BODYPART REFERRING_PHYSICIAN NCOCNDAAIRIS NUVOICIARL MAXXvue use internally defined tag name related patient information for DICOM these 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 MAXXvue receive order from the worklist server that might not be the standard DICOM tag so MAXXvue has DICOM tag converting function to make standard DICOM file MAXXray User Manual Page 80 of 108 Date 05 16 2008 Doc No RA21 085 003 10 3 1 Worklist 1 Definition Incoming Receiving tag from the worklist server Internal Internally defined field name of the patient information and study order in MAXXvue 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 lt lt button Select outgoing tag from the list and register it by clicking gt gt button 10 3 2 File worklist The format of file worklist should be text file and the field should be separated by del
4. Include this location in the search LARXDN USB2M Don t search will choose the driver to install Choose this option to select the device driver from a list Windows does not guarantee that the driver you choose will be the best match for your hardware E Note The drive name be different from above it is shown for example User Manual W Page 43 of 108 Date 05 16 2008 Doc RA21 085 003 4 Click Continue Anyway button Hardware Installation The software you are installing for this hardware RXDN USB2M has not passed Windows Logo testing to verify its compatibility with Windows Tell me why this testing is important Continuing your installation of this software may impair or destabilize the correct operation of your system either immediately or in the future Microsoft strongly recommends that you stop this installation now and contact the hardware vendor for software that has passed Windows Logo testing 1 STOP Installation 4 Click Finish button Found New Hardware Wizard Completing the Found New Hardware Wizard The wizard has finished installing the software for RADN USB2M Click Finish to close the wizard a Finish User Manual W vieworks Page 44 of 108 D 05 16 2008 Doc No RA21 085 003 5 MAXXvue I nstallation 1 Insert MAXXvue CD in CD Drive 2 Run Setup exe program then Install
5. Comment Resolution Test Record result and Activity Done Resolution Ip mm Activity Done Comment MAXXray User Manual 4 106 108 Date 05 16 2008 Doc No RA21 085 003 Annual Report Form Installation Site Information Date Operator Calibtration Record equipment result and Activity Done X ray Generator X ray Tube X ray Exposing Data 20 Flat Image KV mAs 40 Flat Image KV mAs 60 Flat Image KV mAs Result Comment Flat Field Test after Calibration Record result and Activity Done Flat Field Acquisition OK NG Flat Level Activity Done Comment User Manual 4 107 108 Date 05 16 2008 Doc No 21 085 003 System Discrepancy Form Installation Site Information Date Published by System Information X ray Generator X ray Tube X ray grid Information Model of Detector RXDN 6000D RXDN 6500D Serial Number of Detector Serial Number of Power Supply Unit Version of MAXXvue Version of MAXXvueConfigure Version of MAXXrayCalibration Comment System Discrepancy Date of finding Operator How is it found Comment Contact Information Address Vieworks Co Ltd 604 Suntechcity II 307 2 Sangdaewon dong Jungwon gu Seongnam city
6. 500 7 16000 HOD ee 400 800 1600 By clicking the Save Current Image button save current image as Pre_resolution raw 8 10 Save Result of Diagnosis By clicking the Save Diag Result button save diagnostic result as Diag_result txt MAXXray User Manual i W Page 63 of 108 Date 05 16 2008 Doc No RA21 085 003 9 Calibration Calibration procedure compensates defect pixels and 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 Procedure of Calibration 1 Acquire Black image 2 Acquire 20 flat filed image 3 Acquire 40 flat filed image 4 Acquire 60 flat filed image 5 Distortion correction 6 Adjust FOV 7 Generate calibration data 8 Test calibration data 9 1 Preparation for Calibration Run Calibration software Input password Establish RS232 connection by clicking Open Port button Click the Serial Communication Test button MAXXray User Manual W vieworks Page 64 of 108 D 05 16 2008 Doc No RA21 085 003 Select Cooling monitor tab Read CCD temperature by clicking Start Temp Monitor button and wait until CCD temperature is under degree then click Stop temp Monitor button Serial comensnication port seting 7 Grange Porma Sese Ding Renan
7. 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 turn on the system in hazardous substances are detected in the environment If flammable substances are detected after the system as 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 injury 1 3 Owner s Responsibility Caution Do not use the system if unsafe conditions are known to exist In case of a 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 any one using the system reads and understand the Service Manual and other rel
8. Check cable between main PCB and CCD Block if not plug connector and lock screw tightly If not repaired replace main PCB If still the failure is not repaired replace Detector 11 6 Flat Field Test Failure Check x ray is exposed properly If x ray is exposed properly Check Generator Interface Cable is connected properly If not repaired replace main PCB If not repaired replace Detector 11 7 Resolution Test Failure If resolution is less than specification then the detector cannot be repaired in the field so in this case please contact Vieworks Co Ltd MAXXray User Manual Page 83 of 108 Date 05 16 2008 Doc No RA21 085 003 12 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 warranty period Vieworks Co at it s 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 th
9. Detector Create X ray image by using CCD camera and output the result in RS 644 format 2 Power supply unit Supply DC power to detector 3 MAXXvue Software to view X ray image Get image from detector process it to ease the diagnostic save it in database and manage it 4 MAXXrayCalibration Diagnose detector and report the result Calibrate the system 5 MAXXvueConfigure Configure parameters for MAXXray Digital Imaging System MAXXray User Manual 4 20 108 Date 05 16 2008 Doc No 21 085 003 3 System Specification 3 1 CCD CCD FFT Full Frame Transfer CCD Effective Pixel Number 2040 x 2478 RXDN 6000D 2040 X 2780 RXDN 6500D Cell pitch 9 um x9 Fill factor 100 3 2 Area of Image 14 X 17 RXDN 6000D 12 X 16 RXDN 6500D 3 3 Scintillator Gadolium or CsI 3 4 Time of I mage Capture and Transmission Shorter than 3 5 second 3 5 Time of I mage Capture and I mage Processing Shorter than 10 second 3 5 CCD Cooling System CCD cooling system cools CCD to reduce thermal noise of the image 1 Cooling Element Thermoelectric Cooler TEC 2 Operation Temperature CCD Maintain 5 1 C at 25 C of surrounding temperature 3 Cooling Speed CCD be kept 5 1 Cwithin 15 minutes after power on at 25 of surrounding temperature 3 6 Image Specification 1 Image Format 2040 X 2478 RXDN 6000D 2040 X 2780 RXDN 6500D 2 Field of View Captured image should reflect 10042
10. the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the EUT is used exceeds the applicable RF compliance level above the EUT should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the EUT P Over the frequency range 150kHz to 80MHz field strengths should be less than V V m MAXXray User Manual RQP 501 1r0 V Page 14 of 108 Date 05 16 2008 Doc No RA21 085 003 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 t
11. Detective pixel Factor Factor 15 Hp View Detective Lise Pirels Dark Labelad miae Save enhbrmhon intormaton User Manual V Page 73 of 108 Date 05 16 2008 Doc No RA21 085 003 9 9 Test Calibration Data Select Post resolution test tab Check Apply dead data and Apply gain data If you make an x ray exposure image will be displayed after being applied calibration data Apply dead data is an option applying dead pixel compensation Apply gain data is an option applying CCD pixel gain compensation Apply Distortion correction is an option applying distortion correction After changing options click Reprocess button then you will get image processed with selected options By clicking the Save Current Image button you can save current image MAXXray User Manual 4 74 108 Date 05 16 2008 Doc No RA21 085 003 10 MAXXvue Configuration 10 1 What is Configuration Using configuration software we can set the various parameters that is used in the MAXXvue so the proper setting of parameter is important Configuration of MAXXvue is needed when the MAXXray is installed and this job should be performed before using MAXXvue Configuration of MAXXvue is consist of two parts General parameter setting Basic information used by MAXXvue Dicom parameter setting Worklist related DICOM header setting Mobi
12. Factor 15 Hep View Detectve Lise Pixels EAN Fie20_Labelec _Lebeiea Flet6o_Labeted Click Save calibration information button then calibration software will generate calibration data file and then will display the following message box MAXxXHayCalibration Calibration data saved Click OK button to finish calibration If click Dark Labeled then detected defect pixel and defect line will be indicated with 4 marker in dark image If click flat20 Labeled then detected defect pixel and defect line will be indicated with 4 marker in User Manual W vieworks Page 72 of 108 Date 05 16 2008 Doc No RA21 085 003 Flat20 image If click flat40 Labeled then detected defect pixel and defect line will be indicated with marker in Flat40 image If click flat60 Labeled then detected defect pixel and defect line will be indicated with marker in Flat6 0 image __ Change Pesswoet Seve Ding Posnword 1 Communicaton 2 System Perseneter 3 Coolng monitor 4 Pre Test 5 Dark acqushon 6 20 ecquation 7 40 acqueriion 8 60 flat acquisition 9 Distortion Comecton 9 adjar 10 Goin generetion 11 Post teat Virtual Gain Avg Filter Datactre line Fector Deadline for 6 0 Help DeadLine Foctoe 110 L Heip
13. Gyeonggi do 462 806 South Korea Phone 82 70 7011 6161 Fax 82 31 737 4954 e mail vieworks vieworks com User Manual 4 108 108 Date 05 16 2008 Doc No 21 085 003 Modification Request Form Date Published by System Information X ray Generator X ray Tube X ray grid Information Model of Detector RXDN 6000D RXDN 6500D Serial Number of Detector Serial Number of Power Supply Unit Version of MAXXvue Version of MAXXvueConfigure Version of MAXXrayCalibration Comment Modification Request Software Name Request Comment Contact Information Address Vieworks Co Ltd 604 Suntechcity II 307 2 Sangdaewon dong Jungwon gu Seongnam city Gyeonggi do 462 806 South Korea Phone 82 70 7011 6161 Fax 82 31 737 4954 e mail vieworks vieworks com User Manual
14. Imaging Products in the following folder To install to this folder click Next To install to a different folder click Browse and select another folder Destination Folder C Program FilessMatros Imaging Browse User Manual W vieworks Page 26 of 108 0 05 16 2008 Doc No RA21 085 003 6 Click Next button compiler directory Please enter the path to your compiler Browse 7 Click No button to continue Compiler cannot be found The compiler cl exe cannot be Found at the specified directory Wr CAMSDEVbin Do you want to select another directory User Manual W vieworks Page 27 of 108 0 05 16 2008 Doc No RA21 085 003 8 Check Meteor TI Digital and VGA then click Next button Matrox Imaging Driver Select the board driver s that you want to install Coronadl VGA CronosPlus Genesis LC Meteor Il Camera Link Meteor ll Standard Meteor 21394 Orion Orion for 4Sight ll eg Information Meteor Il Digital lt Back Cancel 9 Click No button MGI Display Driver If you have a Matrox graphics board It is strongly recommended to install the MGA driver Do you want to proceed User Manual W vieworks Page 28 of 108 D 05 16 2008 Doc No RA21 085 003 10 Click OK button Meteor Il Digital setup Setup has detected tha
15. Monitor menu 5 Click Start temp monitor button 6 Check that CCD temperature is under 4 within 15 minutes Performance and Corrective Action Confirm that CCD cooling is operating normally If CCD temperature is not under 4C even though 15 minutes passed confirm that the fan filter is clean and x ray generator interface is correct If still CCD Cooling test fail then require service assistance Record result on Monthly Report Form MAXXray User Manual W Page 99 of 108 Date 05 16 2008 Doc No RA21 085 003 Black Level Test Objective To confirm the dark level of image Frequency Monthly Equipment MAXXrayCalibration S W Monthly Report Form Procedure 1 Turn on the power of system 2 Run MAXXrayCalibration 3 Click port open button 4 Select Pre resolution test menu 5 Click get test dark frame button 6 Confirm that dark image is captured and center level of avg value is between 0 1000 Performance and Corrective Action Confirm that dark image is captured and the center level is within 0 1000 If dark image is not captured then confirm cable connection If still dark image is not captured or center level of dark image is not in the spec then require service assistance Record result on Monthly Report Form MAXXray User Manual w Page 100 of 108 Date 05 16 2008 Doc No RA21 085 003 Flat Field Test Objective To confirm the flat image is captured and the artifact is compensated Fre
16. a UPS Uninterrupted Power Supply should be installed to avoid loss of data 7 If the product 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 values in case of doubt please consult a Vieworks representative 1 2 General Hazards 1 2 1 Radiation hazards 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 MAXXray User Manual RQP 501 1r0 4 Page 8 of 108 Date 05 16 2008 Doc No RA21 085 003 1 2 2 Electric shock hazard
17. g Password 1 Earn 1 Communicaton Text 2 Syrom Paramotor 3 Cooling lt Fre Test 5 Dark ecquistion 6 20 fat 7 40 flat scquisiton 8 60 flat scquisiton 9 Distorton Comection 9 FOV edjust 10 Gain generation 11 Post twat Time Elapsed Temperature Ambient Temperature O Min S Sec 44 322 OMin10Sec A6 2 Disploy end ambient tamparsture every 5 seconds Set SID to 1 8m or 1m 9 2 Acquire Black image Select Dark Frame Acquisition tab Serial comenanicabon port eating _PonGiose change Pesswoed See OingResut Password 1 Communication Test 2 System Parameter 3 Cookng monitor 4 5 Dark amp 20 fat acqus on 7 40 flat ecquaiton 8 60 fla acquisitern 9 Distorton Comecton 9 edjust 10 Gen generation 11 Post teat PAN Get Test Dark Frame Meere 89 ZOOM Save Curent image Confer pixels avg leval 2962 Normal Derk Level Range 2700 3300 Norme Fiet Level Range 10000 0000 User Manual W vieworks Page 65 of 108 D 05 16 2008 Doc No RA21 085 003 Click Test Shot button in Dark Data Acquisition area to get black image and make sure black center value is 500 500 Input Dark Accumulation Time data the data means the number of dark frames used in calibration The recommended data is 20 Click Get Dark butto
18. includes local paths and removable media The best driver found will be installed Search removable media floppy CD ROM 2 Include this location the search Don t search will choose the driver to install Choose this option to select the device driver from a list Windows does not quarantee that the driver you choose will be the best match for your hardware User Manual W vieworks Page 42 of 108 Date 05 16 2008 Doc No RA21 085 003 3 Select folder in which driver file of RXDN USB2M is located then click OK button Browse For Folder Select the Folder that contains drivers for your hardware Desktop 8 My Documents X My Computer Local Disk C Local Disk D b MAXXvue L O MAXXvueData E C program Files 1 12 EIE SS RXDN LISB2N H C System32 Local Disk Z 73 Shared Documents C3 vieworks s Documents EN c To view any subfolders click a plus sign above Note The drive name be different from above it is shown for example If the following window will be displayed click Next Button Found New Hardware Wizard Please choose your search and installation options gea Use the check boxes below to limit or expand the default search which includes local paths and removable media The best driver found will be installed C Search removable media floppy CD ROM
19. locations Use the check boxes below to limit or expand the default search which includes local paths and removable media The best driver found will be installed C Search removable media floppy CD ROM Include this location in the search LARXDN USB2N Don t search will choose the driver to install Choose this option to select the device driver from list Windows does not guarantee that the driver you choose will be the best match for your hardware Cancel Note The drive name can be different from above it is shown for example User Manual W Page 39 of 108 Date 05 16 2008 Doc RA21 085 003 4 Click Continue Anyway button Hardware Installation The software you are installing for this hardware Grabber DevO has not passed Windows Logo testing to verify its compatibility with Windows Tell me why this testing is important Continuing your installation of this software may impair or destabilize the correct operation of your system either immediately or in the future Microsoft strongly recommends that you stop this installation now and contact the hardware vendor for software that has passed Windows Logo testing 1 L Continue anyway STOP instalation 4 Click Finish button Found New Hardware Wizard Completing the Found New Hardware Wizard The wizard has finished installing the software for Gr
20. of detector then the parameters of detector will be displayed on the parameter field 1 Communicaton Teit 2 System 3 Cooling moestor 4 Pre Test 5 Dark acquisition 6 20 fiat acquisition 7 40 flat acquisition 8 60 flat acquisition 9 Distorton Comecton 9 FOV adjust 10 Gain generation 11 Posttest Current Temperature CCD 50 C Ambient 321 C rigger Sour Trigger Sowce Select Une Photo Diode Line Trigger Polarity Active High Active Low O 2CCeaing amp C Coole intret System I Vale Select Line Trigger Polarity and Target Temperature for proper one Current temperature field display temperature of CCD and the ambient temperature 8 6 CCD Cooling Test Wait for 15 minutes after turning on power because CCD cooling requires some time to reach the set temperature Select Cooling monitor tab Click Start Temp Monitor button then the temperature of CCD and ambient temperature will be displayed every 5 second Click Stop Temp Monitor if the CCD temperature is under 4 degree MAXXray User Manual 14 vieworks Page 60 of 108 0 05 16 2008 Doc No RA21 085 003 Sonal ceememanicabon sanng __PoaCiose change Password Seve Ding Recut Password 3j Ext 1 Communication Test 2 Syviam Pameater 3 Cooling monitor 4 Fre Tet 5 Dark acquisition 6 20 fit ecquisnon 7 40 fiat scquisiton 60 flat acquisi
21. the resolution is under 2 8lp mm then test again with adjusting mAs from 5mAs to 20mAs If still resolution is under 2 8lp mm then require service assistance Record result on Monthly Report Form MAXXray User Manual Page 102 of 108 Date 05 16 2008 Doc No RA21 085 003 Calibration Objective To compensates defect pixels and calibrates pixel gain using the installed x ray generator and x ray tube Frequency Annually When X ray generator replaced When X ray tube rreplaced Equipment MAXxXrayCalibration S W Annual Report Form Procedure 1 Turn on the power of system Run MAXXrayCalibration Click port open button Acquire Black image Acquire 20 flat field image Acquire 40 flat field image Acquire 60 flat field image Generate calibration data Do flat field test Ce Bs opa fs PP Performance and Corrective Action Confirm that calibration data is generated by testing flat field test If flat field test after calibration failed then require service assistance Record result on annual Report Form User Manual Page 103 of 108 Date 05 16 2008 Doc No RA21 085 003 SECTION II The maintenance guides for USER and the forms MAINTENANCE Contact VIEWORKS CO LTD at the following number TEL 82 70 7011 6161 FAX 82 31 737 4954 For optimal performance VIEWORKS recommends that the working area be kept clean There are no specific cleaning requirements for the MAXXray beyond n
22. 3 14 Click Next button Digitizer Format Select the digitizer format Manufacturers Available DCFs rs170c dcf rs170cn dcf rs 7 cs dcf rs1 7Un dcf 15 Select Custom and input 128 into the edit box and Click Next button Matrox DMA Manager To grab to host system meory via the PCI bus buffers must be allocated in physically contiguous memory called non paged memory Select the number of megabytes MB of non paged memory to reserve C 1Mb C 2Mb C 4Mb C 8Mb C Maximum Custom Type in the number of Mb 128 Mb lt Back Cancel User Manual vieworks Page 31 of 108 Date 05 16 2008 Doc No RA21 085 003 16 Click Next button InstallShield Wizard Start Installing Files Setup has enough information to install the program files If you want to review or change any settings click Back If you are satisfied with the settings click Next to begin the installation Current Settings Installing in folder C Program FilessMatrox Imaging gnl Using the default DCF rs170 dcf Using 131072 Kb buffer InstallShield 17 Click Finish button InstallShield Wizard InstallShield Wizard Complete The InstallShield Wizard has successfully installed Meteor Il Digital CL Library Click Finish to exit the wizard Cancel User Manual W vieworks Page 32 of 108 0 05 16 2008 Doc No RA21 085 003 18 C
23. 8 Doc No RA21 085 003 8 3 Password Input Input Password only after inputting password this software will operate The default password is vieworks Caution The password of the following program is same and if you change the password in the one of those program the password of those program will be changed simultaneously MAXXvue exe MAXXrayCalibration exe MAXXvueConfigure exe 8 4 Serial Communication Test Select a communication port and click Port Open button to establish RS232C connection The selection of a communication port varies depending on the selection of Image Grabber 1 If you chose RXDN USB2M Serial communication port setting PORTO 2 If you choose RXDN USB2N Serial communication port setting OcoMm4 Select an appropriate port and device and click Serial Communication Test button Then the test result will be displayed on the text box User Manual Ww Page 59 of 108 Date 05 16 2008 Doc No RA21 085 003 change 50 Diog Rest 1 Communication Test 2 System Parameter 3 Cooking monitor 4 Pre Test 5 Dark aequishion amp 20 fat ecquaiton 7 40 flat acquaiton 8 60 fiat acquisition 9 Distortion Comecton 8 5 Set parameter of Detector Select System Parameter tab Click Refresh System Control Value button to get parameter
24. 85 003 1 14 3 Guidance 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 Immunity test IEC 60601 Compliance Electromagnetic environment guidance test level level Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications 61000 4 150 kHz to 150 kHz to equipment should be used no closer to 6 80MHz 80MHz any part of the EUT including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter 3 V m 3 V m Recommended separation distance Radiated RF 80 MHz to 80MHz to IEC 61000 4 2 5GH 2 5GH 7 2 3 JP 4 d 12915 to MHz E1 7 d HP 800 MHz to 2 5 GHz 1 where 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 deter mined by an electromagnetic site a survey should be less than the compliance level in each frequency range i Interference may occur in the vicinity of equipment marked with the following symbol Cp MAXXray User Manual RQP 501 1r0 V Page 13 of 108 Date 05 16 2008 Doc RA21 085 003 NOTE 1 At 80MHz and 800MHz
25. Accumulation Time data the data means the number of flat field images used in calibration The recommended data is 20 Wait until Ready of Nth expose message box appear then make an x ray exposure to get another flat field image Repeat getting the number of flat field image you selected 9 4 Acquire 40 flat field image Select 40 Saturation Flat Image Acquisition tab ___Ponciose Grange Pessword Seve OingResur Password 1 Communication Test 2 System Parametar 3 Cookng monitor 4 Pre 5 Dark acquretion amp 20 fat acquisition 7 40 flat ocquiniton 8 60 flat acquimibon 9 Distortion Comectan 9 FOV adjust 10 Gan geeersbon 11 Test Shot PistAccumulaton imo 20 Flat Average velo 20161 Fiet Average target valve 25199 30800 Adjust x ray generator dose Click Test Shot button and make an x ray exposure to get a flat field image and then you can see center value in the flat Average value text box User Manual W vieworks Page 67 of 108 Date 05 16 2008 Doc No RA21 085 003 Make sure the value in flat Average value text box should exist within the difference of 10 of the value in Flat Average Target value text box if not adjust the x ray dose and repeat getting a flat field image until you get the flat level of the flat field image within the recommended level Input Flat Accumulat
26. C Add In in Tools CustomizeAdd ins and Macro files menu For more information see the file in the Matrox Imaging Library item of the Windows start menu 23 Check Yes I want restart my computer now and click Finish button Setup complete Setup has successfully installed the Matrox Imaging Products to your computer Before you can use it you must restart your computer No will restart my computer later Thank you for choosing Matrox Imaging Products Then the computer will restart automatically MAXXray User Manual W vieworks Page 35 of 108 Date 05 16 2008 Doc No RA21 085 003 24 Run the Start gt Program gt Matrox Imaging Products gt Intellicam gt Intellicam When the following window display click the Close Button Tip of the Day Did you know You can create a DCF even if you do not have a physical board Just select a virtual system in the menu Options System Selection 25 When the following window display confirm that Meteor II Dig Device 0 is activated It means that Meteor II Digital has been successfully installed System Selection Available systems Metear Il Dig Allneate 2a 3 Meteor Il Dig Virtual Device Free Orion 4 Orion Virtual Device Make Active Pulsar Info Pulsar Virtual Device VGA VGA Device VGA Virtual Device Note If you can not see the w
27. Cable Comment Visual Inspection Check and record result as OK or describe the result and Activity done Visual Inspection Activity Done Fan Filter Cleaning Record Fan filter status and record activity done Fan Filter Status Activity Done Hard Disk Free Space Record Indication and record activity done Indication Activity Done Worklist Connection Record result and activity done Result Activity Done PACS Server Connection Record result and activity done Result Activity Done Printing Test Record result and activity done Result Activity Done Study Performing Test Record result and activity done Result Activity Done MAXXray User Manual 4 105 108 Date 05 16 2008 Doc No 21 085 003 Monthly Report Form Installation Site Information Date Operator Serial Communication test Record result and Activity Done Result Error Message Activity Done Comment Cooling Test Record result and Activity Done CCD Temperature after 15 Minute Activity Done Comment Black Level Test Record result and Activity Done Dark Image Acquisition OK NG Black Level Activity Done Comment Flat Field Test Record result and Activity Done Flat Field Acquisition OK NG Flat Level Activity Done
28. Connection Printing Test Daily Confirms Printer connection Study Performing Daily Confirms that new study can be performed normally Serial Monthly Confirms serial communication between Detector and workstation Communication Test is working Cooling Test Monthly Confirms CCD Cooling Black Level test Monthly Confirms black level of image Flat Field Test Monthly Confirms flat image Resolution Test Monthly Confirms resolution Calibration Annually Calibrate system MAXXray User Manual Page 89 of 108 Date 05 16 2008 Doc No RA21 085 003 Check Cabling Objective To confirm that the system is properly installed and the system is ready to use Frequency Daily Equipment Daily Report Form Procedure 1 Check AC Power Cable is connected firm 2 Check DC Power Cable is connected firm 3 Check Camera Interface Cable is connected firm 4 Check Control Cable is connected firm Performance and Corrective Action Connect cables firm and record result on the Daily Report Form User Manual Page 90 of 108 Date 05 16 2008 Doc No RA21 085 003 Visual Inspection Objective To confirm that there is no defect or damages of the parts that 1s visible and that the system is ready to use Frequency Daily Equipment Daily Report Form Procedure 1 Confirm that Detector is installed firm on the X ray stand or table 2 Confirm that the skin of detector is not damaged 3 Confirm that the screen ha
29. EC 60601 Compliance Electromagnetic environment guidance test level level Conducted 3 Vrms 3 Vrms The EUT must be used only in a shielded RF 150 kHz to 150 kHz to location with a minimum RF shielding IEC 61000 4 80MHz 80MHz effectiveness and for each cable that 6 enters the shielded location with a minimum RF shielding effectiveness and for each cable that enters the shielded location Radiated RF Field strengths outside the shielded IEC 61000 4 location from fixed RF transmitters as 3 determined by an electromagnetic site survey should be less than 3V m Interference may occur in the vicinity of equipment marked with the following symbol Cp MAXXray User Manual RQP 501 1r0 4 16 108 Date 05 16 2008 Doc No RA21 085 003 NOTE 1 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NOTE 2 It is essential that the actual shielding effectiveness and filter attenuation of the shielded location be verified to assure that they meet the minimum specification Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site
30. High Mode A Standby x ray is not exposing so the detector is waiting x ray exposure Flow current through the LED TLP281 while x ray is exposing To make above condition apply voltage between 7 and Expose while x ray is exposing B Exposure X ray is exposing Do not flow current through the LED TLP281 To make above condition do not apply voltage between VCC EXT and Expose 4 External trigger timing X Ray exposure 05 External trigger gt B lt Fig 5 1 gt A A should begin before or concurrently with should be terminated after or concurrently with 5 Software setting Run QXvueCalibration and select line trigger polarity User Manual 4 88 108 Date 05 16 2008 Doc No RA21 085 003 Appendix D Quality Control SECTION 1 Quality Control testing Quality Control Test and Frequency Test Item Frequency Purpose Check Cabling Daily Confirms the connections of the cables to make sure the system is ready to operate Visual Inspection Daily Confirms that no parts are damaged Fan Filter Cleaning Daily Confirms that the filter in front of ventilation fan is clean to ensure cooling of CCD Check Hard Disk Daily Confirms that free space of hard disk is enough free space Worklist Connection Daily Confirms Worklist connection PACS Server Daily Confirms PACS Server connection
31. Interface 1 Image data 2 System Control 3 RS 232 RS 644 RS 232C Baud rate 19 200 bps Parity bit Even Data bit 8 bit Stop bit 1 bit User Manual W vieworks Page 23 of 108 Date 05 16 2008 Doc No RA21 085 003 4 System Installation MAXXray system use Matrox Meter II Digital frame grabber RXDN USB2N RXDN USB2M as image grabber Refer to 4 1 for Matrox Meter II Digital Image grabber Installation Refer to 4 2 for RXDN USB2N Refer to 4 3 for RXDN USB2M Caution The product should be installed by qualified maintenance personnel approved by Vieworks 4 1 Matrox Meter 11 Digital I mage Grabber nstallation 4 1 1 Install Matrox Meter 11 Digital 1 Install Image grabber board Meteor II Digital 4L into one of the PCI slots 4 1 2 Install Matrox Meter 11 Digital Driver 1 Insert the MilLite 7 5 CD into the CD ROM drive 2 Select Matrox Imaging Library and Intellicam Then Click Continue MAXXray User Manual vieworks Page 24 of 108 D 05 16 2008 Doc No RA21 085 003 52 Matrox Imaging Master Setup Development Click or move the mouse over Matrox Imaging Library MIL the buttons to select products ActiveMIL or obtain descriptions Intellicam Genesis Native Library GNL Bl MG Display Drivers Acrobat Reader Continue xit MATROX Copyright Matrox Electronic Systems Ltd 1993 2002 IMAGING Cautio
32. N_NAME Dummy fields display name Dummyl UserDefined_1 Dummy2 UserDefined_2 Dummy3 UserDefined_3 Dummy4 UserDefined_4 Dummy5 UserDefined_5 Dummy6 UserDefined_6 Patient comparison condition 10 Access Number Name Study Instance U File worklist location Dir Cw MAXXray User Manual 4 55 108 Date 05 16 2008 Doc No RA21 085 003 7 2 Calibration Refer to clause 9 7 3 Configuration of MAXXvue Refer to clause 10 MAXXray User Manual W Page 56 of 108 Date 05 16 2008 Doc RA21 085 003 8 Diagnosis After the installation of the Detector check if the detector is operating normally This diagnostic procedure will check operating state of detector and will generate diagnostic file for reporting about installed detector Diagnostic will be performed in following sequence with the diagnostic software 8 1 Procedures of Diagnosis 1 Serial Communication Test 2 Set Parameter of Detector 3 CCD Cooling Test 4 Black Level Test 5 Flat Field Test 6 Resolution Test 8 2 Preparation for Diagnosis 1 Pull out protect cover of Power Supply Unit MAXXray User Manual W vieworks Page 57 of 108 Date 05 16 2008 Doc No RA21 085 003 2 Turn on the power of power supply unit 3 Close protect cover of Power Supply Unit 4 Run MAXXrayCalibration Software MAXXray User Manual A 58 of 108 Date 05 16 200
33. No RA21 085 003 Appendix C How to use line trigger 1 Scope This document explain how to operate QXR using external trigger To take a picture of patient the x ray will be exposed to the patient and at the same time the CCD in the QXR should be operated to receive the light from the screen For the CCD to receive light and generate an image of patient QXR should know the starting time and the ending time of the x ray exposure The external trigger function is used for the QXR to know the starting time and the ending time of the x ray exposure 2 Interface Circuit 3 3V Generator Interface Cable EXT VCC 2 2K Ohm 2 2K Ohm Internal Trigger lt gt TLP281 EXPOSE Note To activate trigger function the current through LED of TLP281 should be in the range of 5 5mA to 16mA so the voltage between VCC EXT and Expose pin should be in the range of 12V to 36V MAXXray User Manual a V y Page 87 of 108 Date 05 16 2008 Doc No RA21 085 003 3 Operation mode of trigger function 1 Active Low Mode A Standby x ray is not exposing so the detector is waiting x ray exposure Do not flow current through the LED TLP281 To make above condition do not apply voltage between VCC EXT and Expose B Exposure X ray is exposing Flow current through the LED TLP281 while x ray is exposing To make above condition apply voltage between EX7 and Expose while x ray is exposing 2 Active
34. Shield Wizard will be displayed click Next button Welcome to the InstallShield Wizard for MAXXvue The InstallShield R Wizard will install MAXXvue on your computer To continue click Next WARNING This program is protected by copyright law and international treaties Customer Information Please enter your information User Name User Organization hospital Install this application For Anyone who uses this computer all users Only for me user Installshield lt Back Cancel User Manual W vieworks Page 45 of 108 Date 05 16 2008 Doc No RA21 085 003 4 Select setup type as Complete then click Next button vue InstallShield Wizard Customer Information Please enter your information User Name User Organization hospital Install this application For Anyone who uses this computer all users C Only for me user InstallShield Back Cancel 5 Ready to Install the Program window will be displayed press Install Button vue InstallShield Wizard Ready to Install the Program The wizard is ready to begin installation Click Install to begin the installation If you want to review or change any of your installation settings click Back Click Cancel to exit the wizard InstallShield Cancel User Manual W vieworks Page 46 o
35. System Installation sess tenete nnne tette nnne nennen 15 4 1 Matrox Meter 11 Digital Image Grabber Installation 15 4 1 1 Install Matrox Meter 11 Digital sss 15 4 1 2 Install Matrox Meter 11 Digital sss 15 4 2 RXDN USB2N I nstallation esses 15 4 2 1 Hardware I nstallation sess 15 4 2 2 Software Installation sss eee 15 4 3 RXDN USB2M Installation sss etes 15 4 3 1 Hardware nstallation sss 15 4 3 2 Software Installation sss eee 15 5 MAXXvue Installation sss nnns 15 6 Hardware I sess 15 6 1 Connect DC Power cable to Detector sese 15 6 2 Connect Data cable to Detector sss sss sss 15 6 3 Connect RS232C cable to osse 15 6 4 Connect DC Power cable to Power Supply Unit 15 6 5 Connect Data cable to capture board in workstation 15 6 6 Connect Data cable to RXDN USBAN sess 15 6 7 Connect Data cable to RXDN USBA2M sess 15 6 8 Conn
36. THE POSSIBILITY OF SUCH DAMAGES There are no warranties which extend beyond the description mentioned in this document MAXXray User Manual 4 Page 84 of 108 Date 05 16 2008 Doc No RA21 085 003 Appendix A Interconnection Diagram Using RXDN USB2M I mage Grabber Optional Component Image Grabber Workstation System Component 1 RS 232 Cable Camera Interface Cable AC Power Cable gt Power Supply lt gt Detector DC Power Cable Generator Interface Cable Optional Component X ray Generator Using RXDN USB2N I mage Grabber Optional Component Image Grabber Workstation A System Component Camera Interface Cable RS232 Cable AC Power Cable Generator gt Power Supply lt gt Detector Interface Cable DC Power Cable tyr Optional Component X ray Generator MAXXray User Manual 4 85 108 Date 05 16 2008 Doc No RA21 085 003 Appendix Symbols DIRECT CURRENT ALTERNATING CURRENT PROTECTIVE EARTH GROUND EQUIPOTENTIALITY OFF POWER DISCONNECTION FROM THE MAINS ATTENTION CONSULT ACCOMPANYING DOCUMENS ON POWER CONNECTION FROM THE MAINS TYPE BF APPLIED PART User Manual w Page 86 of 108 Date 05 16 2008 Doc
37. USB2M x If you are provided with Matrox Meteor II dig Grabber or RXDN USB2N skip this section 6 8 Connect RS232C cable to COM port of the workstation x If you are provided with RXDN USB2M skip this section MAXXray User Manual W Page 53 of 108 Date 05 16 2008 Doc RA21 085 003 6 9 Connect RS232C cable to COM port of the RXDN USB2M x If you are provided with Matrox Meteor II dig Grabber or RXDN USB2N skip this section RS 232C 1 MAXXray User Manual 54 of 108 Date 05 16 2008 Doc No RA21 085 003 7 Preparation for operating system To operate MAXXRAY system following step should be executed 1 Select USB Image Grabber and detector 2 Diagnostics and calibration 3 Configuration of MAXXvue 7 1 Select USB I mage Grabber and Detector 1 Run MAXXvueConfigure in C Wprogram filesWMAXXvue folder 2 Select Image Grabber O Configure General Dicom Hospital information Name Address Grabber C RXDN USB 2N USB2 0 Grabber C RXDN USB2M C Matrox Meteor dig DDC Board Pixel Clock C eMHz C BMHz Hardware direction compensation cw 0 21 CCW 0 H MIRROR OFF z V MIRROR OFF Thumbnail tab information Bodypart Birthday Age Access Number Expansion Setting Minimize Button Secondary monitor Dicom header info Detector Unique Number TAG_STATIO
38. V Page 1 of 108 Date 05 16 2008 Doc No RA21 085 003 Digital Radiography oystem MAXXray User Manual for veterinary use Rev 0 0 Vieworks Co Ltd 2008 05 16 Manufacturer vieworks Co Ltd 604 Suntechcity 307 2 Sangdaewon dong J ungwon gu Seongnam city Gyeonggi do 462 806 South Korea TEL 482 70 7011 6161 FAX 482 31 737 4954 www vieworks com MAXXray User Manual RQP 501 1r0 V Page 2 of 108 Date 05 16 2008 Doc No RA21 085 003 Revision History Rev 0 0 16 May 2008 First release MAXXray User Manual 501 1 0 V Page 3 of 108 Date 05 16 2008 Doc No RA21 085 003 Accident Reporting The CE Council Directive 93 42 EEC concerning Medial Devices require that the manufacturer of medical devices submit a report to Local competent authorities whenever he becomes aware of information that reasonably suggests that one of his installed devices e may have caused or contributed to a death or serious injury or e 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 Includi
39. abber Dev Click Finish to close the wizard Cancel MAXXray User Manual W vieworks Page 40 of 108 Date 05 16 2008 Doc No RA21 085 003 4 3 RXDN USB2M Installation x If you have RXDN USB2N skip this section 4 3 1 Hardware nstallation 1 Connect the power cable and USB cable to RXDN USB2M RS 232C 0 RS 232C 1 POWER DIGITAL DATA 0 2 Turn on the power switch of RXDN USB2M 3 Connect the other end of the USB cable to the PC MAXXray User Manual W vieworks Page 41 of 108 Date 05 16 2008 Doc No RA21 085 003 4 3 2 Software nstallation If you connect the USB cable with RXDN USB2M powered on the following installation wizard will be executed automatically 1 Select Install from a list or specific location Advanced then click Next button Found New Hardware Wizard Welcome to the Found New Hardware Wizard This wizard helps you install software for RAXDN USB2M If your hardware came with an installation CD or floppy disk insert it now What do you want the wizard to do Click Next to continue 2 Select Search for the best driver these location and check Include this location the search and click Browse button Found New Hardware Wizard Please choose your search and installation options gt 1 Search for the best driver in these locations Use the check boxes below to limit or expand the default search which
40. anufactured to ensure maximum safety of operation and to meet all the safety requirements applicable to electronic 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 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
41. e 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 digital techniques 2 2 System components MAXXray system consists of detector image transfer device power supply unit software and its accessories And there are two kind of detectors MAXXray system components Detector RXDN 6000D RXDN 6500D Power Supply Unit RXDN 6000P 15 Software Viewer MAXXvue Configuration MAXXvueConfigure Calibration and Diagnostic MAXXrayCalibration Accessories Camera Interface Cable P N 1110 3517 01A DC Power Cable 1200 43407 01A Generator Interface Cable P N 1170 3417 01A RS232 Cable P N 1170 3414 01A AC Power Cable P N 1190 6203 01A Image Grabber Recommended not part of MAXXRAY Matrox Meter IT dig RXDN USB2N RXDN USB2M User Manual Page 19 of 108 Date 05 16 2008 Doc No RA21 085 003 Workstation Recommended not part of MAXXray OS Windows XP professional CPU Minimum Pentinum 4 3 0 GHz Memory Minimum 2G Byte Hard Disk Minimum 80G Byte Ethernet Minimum 100 Mbit s Monitor 1600x1200 Color CD Rom CD or DVD R W 2 3 Component description 1
42. e 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 difficulty 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
43. e warranty section 10 of this manual for more details 11 1 Failure Mode Power LED is not lit Refer to 9 2 Serial Communication Test Failure Refer to 9 3 CCD Cooling Test Failure Refer to 9 4 Black Level Test Failure Refer to 9 5 Flat Field Test Failure Refer to 9 6 Resolution Test Failure Refer to 9 7 11 2 Repairing Power Failure Check AC cable of Power Supply Unit is plugged securely if not plug securely Check power switch in turned on if not turn on power switch If not repaired then replace Power Supply Unit MAXXray User Manual 4 82 108 Date 05 16 2008 Doc No RA21 085 003 11 3 Repairing Serial communication Failure Check Control Cable is installed securely if not secure screw of cable tightly Run calibration program and perform Serial Communication Test procedure If the failure is not repaired Check RS232 port of workstation If RS232 port of workstation id OK replace Control Cable If still the failure is not repaired replace main PCB If still the failure is not repaired replace Detector 11 4 CCD Cooling Test Failure Check fan is operating if fan is not operating check connector of fan is plugged correctly If still the failure is not repaired Check connector of TEC fan is plugged correctly If still the failure is not repaired replace main PCB If still the failure is not repaired replace Detector 11 5 Black Level Test Failure
44. ect RS232C cable to COM port of the workstation 15 6 9 Connect RS232C cable to COM port of the 2 15 6 10 Plug in AC Power cable to power supply 15 7 Preparation for operating MAXXray 15 7 1 Select USB Image Grabber and Detector 15 7 2 Calibration es 15 7 3 Configuration of MAXXvue sss nnns 15 E IH 15 8 1 Procedures of Diagnosis etes 15 8 2 Preparation for Diagnosis sss etes 15 8 3 Password one RRRRERUIRUR tie LPS 15 8 4 Serial Communication Test sess enne 15 8 5 Set parameter of Detector s sees 15 8 6 CCD Coolirig Test iones pecore tei diee qe ere rs 15 8 7 Black Level Test nodo eee eere EE e oeste uti 15 8 8 Flat Field Test s sesueeideeeectaseenased dedi daa qae eee er e HRS 15 6 9 Resolution Test ees sissies eee ees dai E 15 8 10 Save Result of Diagnosis tenente nenne 15 9 Calibration eee ee 15 9 1 Preparation for Calibration essent nnne 15 9 2 Acq
45. er 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 I mages Back up To avoid the possibility of loosing 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 Limitations The MAXXvue 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 is 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 t
46. evant 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 MAXXrayCalibration software runs a system diagnostic Run MAXXrayCalibration 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 User Manual RQP 501 1r0 V Page 9 of 108 Date 05 16 2008 Doc No RA21 085 003 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 Distances measurements in millimeters are possible only after distance calibration has been performed using a reference object 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 1 7 Left Right Mark
47. f 108 0 05 16 2008 Doc No RA21 085 003 6 Installing MAXXvue will be displayed Now the InstallShield is installing MAXXvue vue InstallShield Wizard Installing MAXXvue The program Features you selected are being installed Please wait while the InstallShield Wizard installs This may take several minutes Status D InstallShield 7 After finishing installation of MAXXvue InstallShield Wizard Completed window will be displayed Then press Finish button The InstallShield Wizard has successfully installed MAXxXxvue Click Finish to exit the wizard 3 Cancel User Manual W Page 47 of 108 Date 05 16 2008 Doc RA21 085 003 8 The following message box will be displayed press Yes button to restart computer Installer Information xj changes made to MAXXvue to take effect Click Yes to AN You must restart your system for the configuration restart now or No if you plan to restart later Now the MAXXVvue software is successfully installed to the following directory Software c Wprogram filesWMAXXVvue Data d WMAXXVueData Executable File List MAXXvue exe Viewer program MAXXrayCalibration exe Diagnosis and Calibration program MAXXvueConfigure Configure program MAXXray User Manual W Page 48 of 108 Date 05 16 2008 Doc No RA21 085 003 6 Hardware nstallation Keep the following step to connect cable
48. he EUT as recommended below according to the maximum output power of the communications equipment Rated Separation distance according to frequency of transmitter maximum output power 150kHz to 800MHz to of transmitter 80MHz 2 5GHz 7 a Ei 3 6872 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the 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 800 the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people User Manual RQP 501 1r0 V Page 15 of 108 Date 05 16 2008 Doc No RA21 085 003 1 14 5 Immunity and Compliance Level Immunity test IEC 60601 Test Actual Immunity Compliance Level Level Level Conducted RF 3Vrms IEC 61000 4 6 150kHz to 80MHz Radiated RF 3Vrms IEC 61000 4 3 80MHz to 2 5GHz 1 14 6 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 electromagnetic environment Immunity test I
49. he 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 MAXXray User Manual RQP 501 1r0 V Page 10 of 108 Date 05 16 2008 Doc No RA21 085 003 1 12 Electrical fire e This equipment is not suitable for use in the presence of a flammable an aesthetic mixture with air or with oxygen or nitrous oxide e 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 e 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 device 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 I nformation 1 14 1 Guidance and manufacturer s declaration electromagnetic emissions The EUT is intended for use in the electromagnetic environment specified below The customer or the
50. imiter 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 single digit minutes SS Seconds with leading zero for single digit seconds MAXXray User Manual 4 81 108 Date 05 16 2008 Doc No RA21 085 003 11 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 th
51. indow you can open it running Options gt System Selection Click Close button Now the installation of the frame grabber driver is finished User Manual W vieworks Page 36 of 108 D 05 16 2008 Doc No RA21 085 003 4 2 RXDN USB2N Installation x If you have RXDN USB2N skip this section 4 2 1 Hardware nstallation 1 Connect the power cable and USB cable to RXDN USB2N Grabber 2 Turn the RXDN USB2N power on 3 Connect the USB cable to the PC F 18 f 7 4 2 2 Software nstallation If USB cable is connected with the RXDN USB2N powered on the following installation wizard will be MAXXray User Manual W vieworks Page 3 of 108 Date 05 16 2008 Doc No RA21 085 003 executed automatically The Driver of the USB Image Driver is provided in the S W Package CD by vieworks co Ltd 1 Select Install from a list or specific location Advanced then click Next button Found New Hardware Wizard Welcome to the Found New Hardware Wizard This wizard helps you install software for raysis SCANNER If your hardware came with an installation CD lt QP or floppy disk insert it now What do you want the wizard to do O Install the software automatically Recommended Click Next to continue 2 Dec T 2 Select Search for the best driver in these location and check Include this location in the search and click Browse button Found New Hard
52. ion 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 1 CLASS I EQUIPMENT 2 BF Type 3 NO protection against ingress of water 4 NOT suitable for use in the presence of a flammable an aesthetic mixture with air or with Qxide 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 MAXXray User Manual V Page 18 of 108 Date 05 16 2008 Doc No RA21 085 003 2 System Description 2 1 ntended use MAXXray system is indicated for digital imaging solution designed for general radiographic system for human use It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures It controls x ray exposur
53. ion Time data the data means the number of flat field images used in calibration The recommended data is 20 Click Get 40 Flat button to get flat field images then Ready of Nth expose message box will appear and then make an x ray exposure then calibration software will get a flat field image and will display Nth expose made Wait until Ready of Nth expose message box appear then make an x ray exposure to get another flat field image Repeat getting the number of flat field image you selected 9 5 Acquire 60 flat field image Select 60 Saturation Flat Image Acquisition menu 1 Communication Test 2 System Parameter 3 Cooling moestor 4 Pre 5 Dark acquisition 6 20 flet acquisition 7 40 fat ecquisition 60 flat acquisition 9 Distortion Correction 3 FOV adjust 10 Gain generasion 11 Posttest Test Shot Fist Accumulation tma 20 Gat60 Fin Fist Average valaa 42071 Flat Avernge target 36449 44550 Adjust x ray generator dose Click Test Shot button and make an x ray exposure to get a flat field image and then you can see center value in the flat Average value text box User Manual Page 68 of 108 Date 05 16 2008 Doc No RA21 085 003 Make sure the value in flat Average value text box should exist within the difference of 10 of the value in Flat Average Target value text box if not adjust the x ray dose and repeat get
54. kV differential mode 2kV common mode lt 5 UT gt 95 dip in Ur for 0 5cycle 40 UT 6096 dip in Ur for 5 cycle 70 Ur 30 dip in UT for 25 cycle 596 Ur 959 dip in Ur for5s 6kV Contact 8kV air 2kV for power supply lines 1kV for input output lines 1kV differential mode 2kV common mode lt 5 UT gt 95 dip in Ur for O 5cycle 40 UT 6096 dip in Ur for 5 cycle 7096 UT 3096 dip in UT for 25 cycle lt 5 UT 9596 dip in Ur for5s Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 3096 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the EUT image intensifier requires continued operation during power mains interruptions itis recommended that the EUT image intensifier be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Ur is the a c mains voltage prior to application of the test level MAXXray User Manual 501 1 0 4 12 108 Date 05 16 2008 Doc RA21 0
55. le parameter setting specific parameters for mobile application The configuration software is located at C Wprogram filesWMAXXvue folder MAXXray User Manual Ww viewc Page 75 of 108 Date 05 16 2008 Doc No RA21 085 003 10 2 General parameter setting O Configure General Dicom Hospital information Name Addess XA SS Tel o Grabber C RXDN USB2N USB2 0 Grabber C RXDN USB2M C Matrox Meteor dig DDC Board Pixel Clock C MHz C BMHz Hardware direction compensation cw 0 v CCW 0 H MIRROR OFF V MIRROR OFF Thumbnail tab information Vv Bodypart Birthday Age Access Number Expansion Setting Minimize Button Secondary monitor Dicom header info Detector Unique Number TAGSTATONNAME Dummy fields display name Dummy1 UserDefined 1 Dummy2 UserDefined 2 Dummy3 UserDefined_3 Dummy4 UserDefined_4 Dummy5 UserDefined_5 Dummy UserDefined 5 Patient comparison condition 10 Access Number H Name Study Instance UID je File worklist location 10 2 1 Hospital information They are the name address and telephone number of the hospital in which the MAXXray 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 MAXXray User Manual A
56. lick Next button Meteor Il Digital setup Select the display mode for the default board Desktop extended desktop Ausiliary 19 Click Next button Meteor Il Digital setup Do you have a floppy disk labelled MIL Driver for Meteor Il Digital more recent than MIL7 50 build 384 C Yes e No MAXXray User Manual W vieworks Page 33 of 108 0 05 16 2008 Doc No RA21 085 003 20 Click Ok button Setup Sumary Setup is ready to install files to the system Click Back to change settings or Ok to start the installation 1 C Program Files Matrox Imaging gt MIL C Meteorll Digital is the default board used Use the Meteor Il Digital Native Library settings hy Desktop extended desktop display mode Space Required 40 MB Space Available 2047 MB 21 Click Ok button Acrobat Reader setup To be able to use the Matrox Imaging Products manuals Acrobat Reader Version 4 05 or later must be installed on your system Once this setup is completed you can install Acrobat Reader from the Matrox Imaging Master Setup or from the directory on this CD ROM MAXXray User Manual W vieworks Page 34 of 108 Date 05 16 2008 Doc No RA21 085 003 22 Click Ok button Matrox Imaging Library help To enable MIL ActiveMIL context sensitive help using the lt CTRL F1 gt key inside Visual C C activate the Matrox MIL
57. lly with Worklist and can register study by querying from Worklist server Frequency Daily Equipment MAXXvue S W Worklist Server Daily Report Form Procedure 1 Turn on the power of system Run MAXXvue Select Exposure Mode Select Registration Menu Select Worklist Menu Select Configure Menu Select Worklist server 0 um amp YN Click Test button Performance and Corrective Action Check the connection status that is displayed in test result window If connection test failed check Worklist server is operating and configuration of Worklist server connection is correct If still Worklist connection fail then require service assistance Record result on Daily Report Form MAXXray User Manual W Page 94 of 108 Date 05 16 2008 Doc No RA21 085 003 PACS Server Connection Objective To confirm that MAXXvue is connected normally with PACS Server and can send performed study data to PACS server Frequency Daily Equipment MAXXvue S W PACS Server Daily Report Form Procedure Turn on the power of system Run MAXXvue Select Database Mode Select Dicom transfer Menu Select Configure Menu Select PACS Server Click Test button In n Bor Performance and Corrective Action Check the connection status that is displayed in test result window If connection test failed check PACS server is operating and configuration of PACS server connection is correct If still PACS server connection fail then re
58. n If autorun is not enabled in your computer browse the contents of the MilLite 7 5 and double click the Setup exe file to run the CD 3 Click Next button Setup will install MILLite 50 build 384 and Intellicam2 07 It is strongly recommended that you exit all Windows programs before running Setup Click Cancel to quit Setup and then close any programs you have running Click Next to proceed Setup 4 Click I Agree button User Manual Ww vieworks Page 25 of 108 D 05 16 2008 Doc No RA21 085 003 License Agreement Please read the following license agreement Using the scroll bar to view the hidden text Matrox Imaging Library Lite MIL Lite ActiveMIL Lite Intellicam MATROX SOFTWARE ENTERPRISE LICENSE AGREEMENT Agreement IMPORTANT PLEASE READ CAREFULLY THIS IS ALEGAL AGREEMENT BETWEEN YOU THE LICENSEE AND MATROX ELECTRONIC SYSTEMS LTD LICENSOR CONCERNING THE PRODUCT ACCOMPANYING THIS AGREEMENT BY CLICKING THE I AGREE BUTTON YOU AGREE TO BE LEGALLY BOUND BY THE TERMS OF THIS AGREEMENT IF YOU DO NOT AGREE TO THE TERMS OF THIS AGREEMENT CLICK ON THE DO NOT AGREE BUTTON AND RETURN THE SOFTWARE ALONG WITH ALL ASSOCIATED ITEMS WITHIN TEN 10 DAYS TO MATROX ELECTRONIC SYSTEMS LTD 1055 ST REGIS BOUL DORVAL QUEBEC CANADA 2T4 1 KEY TERMS v DO NOT AGREE 5 Click Next button Matrox Imaging Products Setup will install the Matrox
59. n corrected image will be displayed If disable Enable Distortion Correction then distortion will not be corrected User Manual W Page 70 of 108 Date 05 16 2008 Doc No RA21 085 003 9 7 Adjust FOV Field of view Select FOV Adjust tab 1 Communication Test 2 System Perseneter 3 Cooking 4 Pre Test 5 Dark acquisition 6 20 fiit mcqusiion 7 40 flat scquaiton 8 60 flat acquimibon 9 Distortion Comecton 9 FOV edjust 10 Gan generation 11 Posttest Adjust Window Level to see image clearly Adjust right or left line of the red square to locate vertical red line just inside of the white part of the image by dragging the mouse Adjust top or bottom line of the red square to locate horizontal red line just inside of the white part of the image by dragging the mouse MAXXray User Manual W Page 71 of 108 Date 05 16 2008 Doc RA21 085 003 9 8 Generate Calibration Data Select Gain generation tab Force Grange Pesswoed 1 Communication Test 2 System Parameter 3 Cookng monitor 4 Pre Test 5 Dark acqurstion 6 20 fal mequistion 7 40 mcqueriton 8 60 flat acquieibon 9 Distorton Comecton 9 FOV adjust 10 Goin generetion 11 Post teat Virtual Gain Avg Filter line Fector Deadline for Dark 16 0 Help Deadline For Fiesta 110 Detective pixel Factor DeedPseel
60. n to get dark frame data automatically then the calibration software will get dark frame data automatically During the test of the Calibration you can control the Window Level by dragging the mouse And you can change the level rapidly by dragging and pressing the SHIFT key at the same time 9 3 Acquire 20 flat field image Set x ray generator to 60KV 5mas Select 20 Saturation Flat Image Acquisition tab Dr _____ Serial communication seting change Paseword Save Dag Rana Password i 1 Communication Tett 2 System Parameter 2 Cooling 4 Pre 5 Dark acquigtion 6 20 flat ocquaiton 7 40 flat acquisition 8 60 fat acquisition 9 Distortion Comacton 10 adjust 11 Gain ganarasoa 12 Twat Sto FlatAccumulation eme 8 C Sezona FlatAverage value 3647 Flot Average inrgetvalue 3541 4320 Click Test Shot button and make an x ray exposure to get a flat field image and then you can see center value in the flat Average value text box MAXXray User Manual W vieworks Page 66 of 108 Date 05 16 2008 Doc No RA21 085 003 Make sure the value in flat Average value text box should exist within the difference of 10 of the value in Flat Average Target value text box if not adjust the x ray dose and repeat getting a flat field image until you get the flat level of the flat field image within the recommended level Input Flat
61. nce UID and SOP Instance UID If you run MAXXrayCalibration the field is automatically filled in 2 TAG_STATION_NAME A string for station name tag This is used to distinguish the detectors if two or more detectors are installed in the same hospital 10 2 7 Device Name If Two detector were selected you can enter the names for each detector that will be displayed in detector select buttons in MAXXvue 10 2 8 Dummy fields display name Dummy field is used for the connection with the worklist server If the worklist server send some information that is not mentioned in the DICOM standard then MAXXvue can receive that information using dummy fields Dummy field will be displayed as set name in the order list MAXXray User Manual Page 78 of 108 Date 05 16 2008 Doc No RA21 085 003 10 2 9 Patient comparison condition MAXXvue 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 MAXXvue 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 10 2 10 File worklist location If worklist server is no
62. nd the triggering with x ray generator is properly configured If still image acquisition fail then require service assistance Record result on Daily Report Form User Manual W Page 97 of 108 Date 05 16 2008 Doc No RA21 085 003 Serial Communication Test Objective To confirm that interface of serial communication between workstation and Detector is running normally Frequency Monthly Equipment MAXXzrayCalibration S W Monthly Report Form Procedure Turn on the power of system Run MAXXrayCalibration Click port open button Select Communication Test menu Click Serial communication test button Nw PF WYN Check the result displayed is OK and the parameter of the system is displayed Performance and Corrective Action Confirm that serial communoication between workstation and detect is operating normally If serial communication test failed check the RS232 on workstation is operating and the control cable connection If still serial communication test fail then require service assistance Record result on Monthly Report Form User Manual W Page 98 of 108 Date 05 16 2008 Doc No RA21 085 003 Cooling Test Objective To confirm that CCD cooling is operating normally Frequency Monthly Equipment MAXXrayCalibration S W Monthly Report Form Procedure 1 Turn on the power of system 2 Run MAXXrayCalibration 3 Click port open button 4 Select Cooling
63. ng whether any serious injury or death has been occurred 3 Identification of the person who is submitting the information including phone number and fax number if available Reference to standards EN60601 1 Medical electrical equipment Part 1 general requirements for safety EN60601 1 1 Medical electrical equipment Part 1 General requirement for the safety Collateral standard Safety requirement for medical electrical systems EN60601 1 2 Medical electrical equipment Part 2 electromagnetic compatibility requirements and tests Authorized representatives If you have any accident please contact the authorized representatives MAXXray User Manual RQP 501 1r0 V Page 4 of 108 Date 05 16 2008 Doc No RA21 085 003 Table of Contents Revision entente nnne nnne tnnt nentes 2 Accident sess nennen tenerent nennen 3 Reference to standards 12 sse tenente 3 Authorized representatives erret 3 Table of Corntents eee feeit derbi ede ied 4 7 1 1 Safety Guidelines sss netten nnns 7 1 2 General 2 5 eerie qe ret Re idee diae 7 1 2 1 Radiation hazards 7 1 2 2 Electric shock hazard sss 8 1 2 3 Explosion Hazard sse tnnt tentent nennen 8 1 2 4 I mplosion Ha
64. of scintillator size User Manual 4 21 108 Date 05 16 2008 Doc No RA21 085 003 Scintillator size 14 X 17 RXDN 6000D 12 X 16 RXDN 6500D 3 7 Black Level 1 Definition It is the average pixel value of the pixels located within diameter of 20 pixels from the center of the dark image Dark image should be captured using MAXXrayCalibration software after cooling CCD enough 2 Specification It should be 2500 1500 3 8 Resolution It should be more than 2 8 Ip mm RXDN 6000D 3 3 Ip mm RXDN 6500D 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 is the resolution 3 9 Measurement Distance 1 Angle 1 3 10 Operation Environmental Condition Temperature 10 C 30 Humidity 10 70 Atmospheric Pressure 500 1060 hpa 3 11 Transport and Storage Environmental Condition Temperature 30 70 C Humidity 10 9096 Atmospheric Pressure 500 1060 hpa 3 12 Electrical Specification 3 12 1 AC Power I nput PSU 100 240VAC 1096 50 60Hz MAXXray User Manual 4 22 108 Date 05 16 2008 Doc No RA21 085 003 3 12 2 Power Consumption Less than 95W Detector itself 3 13
65. ormal and attention for aesthetic appearances Caution Federal law restricts this device to sale by or on the order of a physician PRODUCT COMPLAINT Any health care professional e g customer or user of this system of products who has any complaints or has experienced any dissatisfaction in the quality durability reliability safety effectiveness and or performance of this product should notify Vieworks If the device malfunctions and may have caused or contributed to a serious injury of a patient Vieworks should be notified immediately by telephone fax or written correspondence CARE and CLEANING Wipe external surface with an approved cleaning liquid from the list below Use a non abrasive soft cloth Wipe the cleaned surface with a cloth lightly moistened with clean water to remove residual cleaner and dirt The outer surface and patient contact surfaces may be cleaned with the one of the following preferred materials most alcohol and ammonia based cleaners mild non abrasive cleaners Note Never use the following cleaning tools chemicals hard brushes or scrapers of any kind strong acids or alkaloids MAXXray User Manual 4 Page 104 of 108 Date 05 16 2008 Doc No RA21 085 003 Daily Report Form Installation Site Information Date Operator Check Cabling Check and record result as OK NG AC Power cable DC power Cable Camera Interface Cable Control
66. quency Monthly Equipment MAXXrayCalibration S W Monthly Report Form Procedure 1 Turn on the power of system Run MAXXrayCalibration Click port open button Select Post resolution test menu Expose X ray with the condition of 60Kv 5mAs Ux odo m Confirm that flat image is captured and artifact is not appeared Performance and Corrective Action Confirm that flat image is captured and artifact is compensated If flat image is not captured then confirm cable connection If still flat image is not captured require service assistance If artifact is appeared then do calibration and test again If still artifact is appeared then require service assistance Record result on Monthly Report Form MAXXray User Manual W Page 101 of 108 Date 05 16 2008 Doc No RA21 085 003 Resolution Test Objective To confirm the resolution of the detector Frequency Monthly Equipment MAXXrayCalibration S W Resolution Chart Nuclear Associate model 07 523 2 Monthly Report Form Procedure 1 Turn on the power of system Run MAXXrayCalibration Click port open button Select Post resolution test menu A e 09 Attach resolution chart Nuclear Associate model 07 523 2 on the center of a detector in diagonal direction Set x ray generator to 60K V 10mas and SID to 1m 6 Expose X ray 7 Confirm that the resolution is over 2 8lp mm Performance and Corrective Action Confirm that the resolution is over 2 8lp mm If
67. quire service assistance Record result on Daily Report Form MAXXray User Manual W Page 95 of 108 Date 05 16 2008 Doc No RA21 085 003 Printing Test Objective To confirm that MAXXvue is connected normally with Printer and can print images Frequency Daily Equipment MAXXvue S W Dicom Printer or Paper Printer that is installed Daily Report Form Procedure 1 Turn on the power of system 2 Run MAXXvue 3 Select Database Mode 4 Search database and open patient 5 Select Viewer mode 6 Select image and click Add to Document mode menu 7 Prntimage Performance and Corrective Action Confirm that the image is printed normally If printing failed check printer is operating and configuration of printer If still printing fail then require service assistance Record result on Daily Report Form MAXXray User Manual W Page 96 of 108 Date 05 16 2008 Doc No RA21 085 003 Image Acquisition Objective To confirm that MAXXvue is running normally and system is operating with no error Frequency Daily Equipment MAXXvue S W Daily Report Form Procedure Turn on the power of system Run MAXXvue Select Exposure Mode Register patient Expose X ray with the condition of 50KV 5 mAs 9o ode Check flat Image is acquired and displayed on monitor Performance and Corrective Action Confirm that system is operating normally If image acquisition failed check the X ray is exposed normally a
68. ray generator to 60KV 5mas Make an x ray expose without any target then the flat field frame image and the center flat level will be displayed If the center flat level is not within 500 16000 then the detector is abnormal __FoaGose Grange Pesswoed Seve Ding Resur Poasword 1 Communication 2 System Parsenwter 3 Cooling monitor 4 Pro Tort 5 Dark acqurstion 6 20 fot 7 40 fiat ecquaviton 8 60 acqursitan 9 Distorton Comecton 9 FOV adjust 10 Gen generation 11 Post teat PAN Gel Test Dark Frame Intagiabon Time 100 Get Set ZOOM Corer pixels avg leval 18394 Normal Derk Level Range 2700 3300 Namal Fiet Level Range 10000 50000 By clicking the Save Current Image button save current image as Flat raw 6 9 Resolution Test Attach resolution chart Maker Nuclear Associate model 07 523 2 on the center of detector in diagonal direction Set x ray generator to 60KV 10mas and SID to 1m Make an x ray expose then the resolution chart image will be displayed on the image window Check the best resolution with adjusting Zoom W L and PAN MAXXray User Manual W vieworks Page 62 of 108 D 05 16 2008 Doc RA21 085 003 J Get Test Dark Frome iiagratonTima 100 Sat Comer pixels evalevel 2222 Normal Derk Level Range 100 200 Normal Level Range
69. s between Detector and PC If the system is used with High Frequency x ray generator the interface between x ray generator and Detector is not needed but this system is used with single phase x ray generator x ray generator should be interfaced with the detector If this system is used with single phase x ray generator after finishing procedure mentioned in chapter 4 do the additional installation procedure following Appendix C F W Upgrade Connector DC Power Connector POWER ON Data Connector Control Connector RS232 Connector Connector Layout MAXXray User Manual W awor vieworks Page 49 of 108 Date 05 16 2008 Doc No RA21 085 003 6 1 Connect DC Power cable to Detector NO 4 6 2 Connect Data cable to Detector MAXXray User Manual W vieworks Page 50 of 108 Date 05 16 2008 Doc No RA21 085 003 6 3 Connect RS232C cable to Detector 6 4 Connect DC Power cable to Power Supply Unit MAXXray User Manual W vieworks Page 51 of 108 Date 05 16 2008 Doc No RA21 085 003 6 5 Connect Data cable to capture board in workstation x If you are provided with RXDN USB2N or RXDN USB2M skip this section 6 6 Connect Data cable to RXDN USB2N x If you are provided with Matrox Meteor II dig Grabber RXDN USB2M skip this section User Manual W vieworks Page 52 of 108 D 05 16 2008 Doc No RA21 085 003 6 7 Connect Data cable to RXDN
70. s no defect or has not damaged Performance and Corrective Action Install detector firm Record result on Daily Report Form If some parts is damaged require service assistance MAXXray User Manual 4 91 108 Date 05 16 2008 Doc No 21 085 003 Fan Filter Cleaning Objective To confirm that air ventilation for cooling CCD has no problem Frequency Daily Equipment Vacuum cleaner Daily Report Form Procedure 1 Confirm that fan filter is clean 2 Clean fan filter using vacuum cleaner Performance and Corrective Action Record result on Daily Report Form User Manual Page 92 of 108 Date 05 16 2008 Doc No RA21 085 003 Check Hard Disk Free Space Objective To confirm that new study can be performed and stored to hard disk drive of workstation Frequency Daily Equipment MAXXvue S W Daily Report Form Procedure 1 Turn on the power of system 2 MAXXvue 3 Check hard disk free space indication is not red light Performance and Corrective Action If the hard disk free space indication is not red new study can be performed If the hard disk free space indication is red delete old study to make free hard disk space enough to perform new study Record result on Daily Report Form User Manual W Page 93 of 108 Date 05 16 2008 Doc No RA21 085 003 Worklist Connection Objective To confirm that MAXXvue is connected norma
71. survey should be considered If the measured field strength outside the shielded location in which the EUT is used exceeds 3V m the EUT should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as relocating the EUT or using a shielded location with a higher RF shielding effectiveness and filter attenuation 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 A 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 User Manual 4 17 108 Date 05 16 2008 Doc No RA21 085 003 1 18 Others Caution No User Serviceable Parts Inside 1 19 Appropriation Caut
72. t available and the study ordering system is providing study order using text file MAXXvue can receive patients list from that file MAXXvue check assigned folder and if there is new order file MAXXvue will load study order from that file and after loading MAXXvue will delete that file MAXXray User Manual Ww vieworks Page 79 of 108 Date 05 16 2008 Doc No RA21 085 003 10 3 DI COM parameter setting Configure General Dicom lt Worklist amp PACS gt Worklist matching report Incoming Internal Outgoing AGE ACCESS_NUMBER BIRTHDAY Same as incoming Same as incoming Same as incoming Same as incoming Same as incoming Same as incoming EXAMINED_BODYPART REFERRING PHYSICIAN PERFORMING PHYSICIAN Same as incoming Same as incoming Same as incoming RER O0O0 O0 05 2 9108 5 com ooogmgmoococococo 2 2c29 c9c29 C909 00 0D CO C3 4 1 1 COMMENT TELEPHONE ADDRESS HEIGHT WEIGHT SCHEDULED_DATE SCHEDULED_TIME DUMMY TEXTINFO1 DUMMYTEXTINFO2 DUMMYTEXTINFO3 DUMMY TEXTINFO4 DUMMY TEXTINFOS Same as incoming Same as incoming Same as incoming Same as incoming Same as incoming Reserved Reserved Same as incoming Same as incoming Same as incoming Same as incoming Same as incoming Outgoing Code Nam Incoming Code Name
73. t the Meteor Il Digital Native Library 3 10 or higher is not installed on your system This library must be installed in order to use MIL with the Meteor l Digital drivers Press Ok to install the Meteor ll Digital Native Library now 11 Click Yes button InstallShield Wizard License Agreement Please read the following license agreement carefully Please read the following license agreement using the scroll bar to view the hidden portion Matrox Imaging Library MIL MIL Lite Matrox Genesis Native Library Matrox Genesis Native Library Developer s Toolkit Matrox Inspector SOFTWARE LICENSE AGREEMENT IMPORTANT PLEASE READ CAREFULLY THIS 15 LEGAL AGREEMENT BETWEEN YOU LICENSEE AND MATROX ELECTRONIC SYSTEMS LTD MATROX FOR THE PACKAGE ACCOMPANYING THIS AGREEMENT WHICH CONSISTS OF COMPUTER SOFTWARE AND ASSOCIATED MEDIA AND PRINTED MATERIALS AND MAY INCLUDE ON LINE Do you accept all the terms of the above license agreement If so click Yes If you click No Setup will terminate InstallShield User Manual Ww vieworks Page 29 of 108 D 05 16 2008 Doc No RA21 085 003 12 Click Next button InstallShield Wizard Program Folder 1 13 Click Next button InstallShield Wizard Select the DCF to be included in genesis ini MAXXray User Manual wW vieworks Page 30 of 108 D 05 16 2008 Doc No RA21 085 00
74. ting the flat field image until you get the flat level of the flat field image within the recommended level Input Flat Accumulation Time data the data means the number of flat field images used in calibration The recommended data is 20 Click Get 40 Flat button to get flat field images then Ready of Nth expose message box will appear and then make an x ray exposure then calibration software will get a flat field image and will display Nth expose made Wait until Ready of Nth expose message box appear then make an x ray exposure to get another flat field image Repeat getting the number of flat field image you selected MAXXray User Manual W vieworks Page 69 of 108 Date 05 16 2008 Doc No RA21 085 003 9 6 Distortion Correction Select Distotion correction tab Put object that is straight on the sides and expose x ray Serial cormencicabon port seing Ferme 1 Communication Test 2 System Parametar 3 Cooling monitor 4 Pre Test 5 Dark acquistion 20 fat acquisition 7 40 flat ecquisiton 8 60 flat acquisiton 9 Distortion Corection 9 FOV 10 Gen generashon 11 Post test 9 qan Get Lens Type Enable Distortion Correction Optical Ceeter 4 via s Conect Distortion Rew image Distortion corrected image will be displayed If the distortion is not corrected then change Lens Type and click Correct Distortion button then distortio
75. tion 3 Distortion Correction 3 FOV adjust 10 Gain generation 11 Posttest Elapsed Temperature Ambiant Tompereture 44 322 O Min 10 Sac 46 x Dvaplay eed ambrent every 5 seconds If the elapsed time is over 15 minutes and CCD temperature is over 4 degree then the CCD cooling is abnormal 8 7 Black Level Test Select Pre resolution Test tab Click Get Test Dark Frame button then dark frame image and the center dark level will be displayed If center dark level is not within 0 to 1000 then the detector is abnormal port seing _Poatiose GhongePesewors Sove Diag Resu 1 Communication 2 System Parsenater 3 Coong monitor 4 Pre Tost 5 Dark acqas on 6 20 acqusion 7 40 flat acquniton 8 60 flat acquisiton 9 Distoton Comection 9 FOV adjust 10 Geen generation 11 Posttest PAN Get Test Dark Frame magan tne Cerner pixels avg level 2962 Normal Deck Level Range 2700 3300 Normal Fiet Level Range 10000 50000 100 200 800 1600 By clicking the Save Current Image button save current image as Dark raw MAXXray User Manual W vieworks Page 61 of 108 Date 05 16 2008 Doc No RA21 085 003 8 8 Flat Field Test Set SID is 1m then set x
76. uire Black netten entente nennen nnn nnns 15 9 3 Acquire 20 flat field image 15 9 4 Acquire 40 flat field image 15 9 5 Acquire 60 flat field image 15 MAXXray User Manual RQP 501 1r0 V Page 6 of 108 Date 05 16 2008 Doc No RA21 085 003 9 6 Distortion Correction sss tenete nennen nennen nnne 15 9 7 Adjust FOV Field of view sss 15 9 8 Generate Calibration Data sss 15 9 9 Test Calibration sss ener nennen nnne 15 10 1 What is Configuration entree nenne 15 10 2 General parameter setting sss 15 10 2 1 Hospital information sss 15 10 2 2 I mage Grabber Selection sess 15 10 2 3 Hardware direction 15 10 2 4 Thumbnail tab information eese 15 10 2 5 Expansion 5 0 essent tenen 15 10 2 6 Dicom header info sse tenen 15 10 2 7 Device Name 5 e ncenieeneineie nitet vides 15 10 2 8 Dummy fields display name sss 15 10 2 9 Patient comparison condition essere 15 10 2 10 File worklist location
77. user of the EUT should assure that it is used in such an environment RF Emissions Group 1 The EUT uses RF energy only for its internal CISPR 11 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions Class B The EUT is suitable for use in ail establishments CISPR 11 including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic Class A emissions IEC 61000 3 2 Voltage Complies fluctuations Flicker emissions IEC 61000 3 3 MAXXray User Manual RQP 501 1r0 V Page 11 of 108 Date 05 16 2008 Doc No RA21 085 003 1 14 2 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 Immunity test IEC 60601 Compliance level Electromagnetic Test level environment guidance Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60Hz magnetic field IEC 61000 4 8 6kV Contact 8kV air 2kV for power supply lines 1kV for input output lines 1
78. ware Wizard Please choose your search and installation options lt 1 R Search for the best driver in these locations Use the check boxes below to limit or expand the default search which includes local paths and removable media The best driver found will be installed C Search removable media floppy CD ROM 2 Include this location in the search 3 v Don t search will choose the driver to install Choose this option to select the device driver from a list Windows does not guarantee that the driver you choose will be the best match for your hardware MAXXray User Manual Ww vieworks Page 38 of 108 Date 05 16 2008 Doc No RA21 085 003 3 Select folder in which driver file USB2 0 Grabber is located then click OK button Browse For Folder Select the Folder that contains drivers For your hardware Desktop 8 B My Documents Y My Computer Se Local Disk C H S Local Disk D 5 MAXXvue L O Manual amp G MAXXvueData 3 program files CO RXDN USB2M 1 ESSERE H O System32 Se Local Disk Z E O Shared Documents D To view any subfolders click a plus sign above 2 1093 Note The drive name can be different from above it is shown for example Then following window will be displayed Click Next Button Found New Hardware Wizard Please choose your search and installation options a S Search for the best driver in these
79. y 7 y Page 76 of 108 Date 05 16 2008 Doc No RA21 085 003 10 2 2 Image Grabber Selection Matrox Meter II dig If you installed Matrox Meter II dig for the image grabber device choose this one RXDN USB2N If you installed RXDN USB2N for the image grabber device choose this one RXDN USB2M If you installed RXDN USB2M for the image grabber device choose this one 10 2 3 Hardware direction compensation This is used to set the image direction The image direction can be checked using MAXXrayCalibration program CW means rotate 90 degree clockwise CCW means rotate 90 degree counter clockwise H MIRROR means horizontal mirroring V MIRROR means vertical mirroring 10 2 4 Thumbnail tab information 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 MAXXray User Manual W vieworks Page of 108 Date 05 16 2008 Doc No RA21 085 003 10 2 5 Expansion setting If the Minimize Button check box is set you will have the Minimize button above the Exit button If the Secondary Monitor check box is set the processed image will be displayed to secondary monitor 10 2 6 Dicom header info 1 Detector Unique Number The 12 digit number unique for each detector which constitutes Study Instance UID Series Insta
80. zard sess 8 1 3 Owner s esses 8 1 4 System Diagnostic sss ete tnnt nennen ennt 8 1 5 nne dic ca e Ceo HER IEEE REG n nds 8 1 6 Distances measurements sess nennen nnns 9 1 7 Left Right Marker eee siseeieredeeteceeetdtesnd dette 9 1 8 Images gone Ur RR IG ERR SH ene 9 1 9 User Limitations sess ener tene nre nnne nns 9 1 10 Cleaning the system sess eterne ener nennen 9 1 11 Overheating oet GERBER aca EU diem ird 9 1 12 Electrical fire ere ere e t RH TR AERE 10 1 13 EMI EMC Precaution 7 nnne nnns 10 1 16 15 1 17 Changing RERO RERO IHE RERO EQUITES 15 1 18 Oth rts eee tae aetna e epe teet tant a er Pape te ip erro 15 1 19 Appropriation teneret tenete eterne nennen nennen 15 1 20 Using together with other sess 15 1 21 Classification 5st entente tenent tenerent ennt nns 15 1 22 Installation and Maintenance eese enne 15 2 System Description sss nennen eee 15 2 1 Intended esses entrent tete retten 15 2 2 System

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