REPAIR PROCEDURE
388S631 REV Q
REPAIR PROCEDURE FOR CENTRAL BONE DENSITOMETERS 388S631
Norland Medical Systems W6340 Hackbarth Road Fort Atkinson, WI USA 53538-8999 Main Phone Line: 1-800-333-8456 1-920-563-8456 FAX 1-920-563-8626 Customer Service: 1-800-444-8456 1-920-568-4206 FAX 1-920-568-4216 E-Mail:
[email protected] NORLAND
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SCOPE........................................................................................................................................................................ 3
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APPLICABLE DOCUMENTS .................................................................................................................................. 3
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DEFINITIONS ........................................................................................................................................................... 3
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RESPONSIBILITIES ................................................................................................................................................. 4
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PROCEDURE............................................................................................................................................................. 4
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SERVICE SOFTWARE ............................................................................................................................................. 5
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TESTING REQUIREMENTS.................................................................................................................................... 7
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TEST PROCEDURE QUICK REFERENCE GUIDE ............................................................................................. 10
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REPLACING THE SOURCE CONTROL BOARD................................................................................................ 14
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SOURCE REPLACEMENT PROCEDURE ............................................................................................................ 14
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FILTER ASSEMBLY REPLACEMENT................................................................................................................. 17
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PMT TUBE IDENTIFICATION AND REPLACEMENT ...................................................................................... 17
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LASER DIODE REPLACEMENT .......................................................................................................................... 18
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MAIN BOARD IDENTIFICATION....................................................................................................................... 18
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MOTOR DRIVER BOARD CONFIGURATION.................................................................................................... 19
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LEVEL SCANNER .................................................................................................................................................. 20
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WIRING DIAGRAMS ............................................................................................................................................. 20
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SOURCE/DETECTOR ALIGNMENT PROCEDURE ........................................................................................... 23
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LASER ALIGNMENT PROCEDURE .................................................................................................................... 29
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SET PMT GAINS..................................................................................................................................................... 29
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SOURCE COUNT RATE CHECK .......................................................................................................................... 34
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BEAM STABILITY TEST....................................................................................................................................... 36
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TABLE (RAIL ALIGNMENT) TEST ..................................................................................................................... 38
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FUNCTION TESTS ................................................................................................................................................. 40
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CURRENT LEAKAGE TEST ................................................................................................................................. 41
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SKIP TEST ............................................................................................................................................................... 41
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FILTER TEST .......................................................................................................................................................... 42
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DAILY CALIBRATION.......................................................................................................................................... 44
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INITIAL CALIBRATION........................................................................................................................................ 45
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QC SPINE PHANTOM SCANS .............................................................................................................................. 47
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FINAL FACTOR...................................................................................................................................................... 49
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REGULATORY LABEL LOCATIONS .................................................................................................................. 50
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PREVENTIVE MAINTENANCE............................................................................................................................ 53
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XMAKEPRD............................................................................................................................................................ 54
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FDA FORM 2579 – USA ONLY ............................................................................................................................. 55
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SERVICE REPORT FORM ..................................................................................................................................... 57
NORLAND
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SCOPE 1.1 To establish a uniform procedure for testing/repairing a X-Ray Bone Densitometer to ensure a properly operating instrument, a satisfied customer, and compliance with regulatory requirements.
2
APPLICABLE DOCUMENTS 2.1 Control of Static Sensitive Material, SOP-G004 2.2 Form 2579 Procedure SOP-R009 2.3 Return Authorization (RA), SOP-N004 2.4 Return Authorization Tag Procedure 900S023 2.5
Completing the Service Report Form 900S064
2.6 Installation Procedure 433S146 2.7 On-site Assembly Procedure 432S055 2.8 Computer Replacement Procedure 398S039 3
DEFINITIONS 3.1
Service Agent: Service personnel that have completed technical training and demonstrated their ability to complete the requirements for installation and service support. This includes Service Center Technicians, Technical Support Engineers, and Third Party Service Engineers.
3.2 Devices: any units, assemblies, and accessories. 3.3 Complaint: Actual or potential safety hazard, death or injury above and beyond the intended use. 3.4 Problem: Software/hardware maintenance and/or repair. 3.5
Certified Component: Any component that would require the unit to have a certification label for that part, and when replaced, would be required to have an FDA 2579 form filled out. (i.e. HV Supply, X-Ray Source, Power Supply Assembly, and M.I.D. Board)
3.6 HID: Hardware Identification Device. 3.7 RA: Return Authorization number. 3.8
4-Channel or QS: Any system using 3.X.X host software, QuikScan device, any scanner equipped with QS hardware.
3.9 2-Channel: Any scanner using 2.5.X or lower revision host software. 3.10 Autoset: Scanners with autoset hardware can be identified by selecting SCOM from the XSST menu and entering AD. If the response is “My” then autoset hardware is installed. 3.11 PMT: Photo Multiplier Tube 3.12
Indicates general caution, safety hazard, or information.
3.13
Indicates radiation from laser apparatus.
3.14 The “READY” light on the scanner front panel indicates the power is applied to the x-ray source. 3.15 The “X-RAY” light on the scanner front panel indicates the shutter is open and x-rays are being emitted. 3.16 The “Laser” light on the scanner front panel indicates the laser is turned on.
NORLAND
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RESPONSIBILITIES 4.1 The Service Agent is responsible for : 4.1.1 Repairing devices in accordance with this document. 4.1.2 Verifying all tests meet the specifications that are listed. 4.1.3 Completing the paperwork. 4.1.4 (USA only) Delivering the completed Form 2579 to Norland within one week of the activity if a certified component has been replaced or a stationary scanner is moved to a different location. A replica of this form is included in this document. 4.1.5 Reporting to Product Support if these assembly instructions do not permit proper support for any device and/or it’s certifiable components for any reason. 4.1.6 Handling static sensitive devices with proper precautions. 4.1.7
Exercising electrical, x-ray and mechanical safety precautions when operating or repairing the device.
4.1.8 Returning all defective devices to Norland with a Return Authorization number. 4.2
5
The Service Agent is not permitted to make any modifications to certified components that could adversely affect their performance.
PROCEDURE 5.1 After a problem is reported and it is determined that on-site support is required a Service Agent is dispatched. 5.2 Customer Service Dispatch will give the Service Agent all necessary repair information. 5.3 All repairs must be authorized by Norland Customer Service 5.4
To obtain the authorization the customer must talk to Norland technical support, to determine that on-site support is necessary.
5.5 An authorization number is given to the Service Agent. 5.6 Once on site, the Service Agent notifies Norland dispatch that they have arrived. 5.7 Service Agent allows the customer to communicate his/her concerns with the equipment. 5.8 The problem is recorded on the Service Report. 5.9
Service Agent begins his/her investigation of the customer’s reported problem, after which the Service Agent determines the failure/malfunction and records the diagnosis on the Service Report. CAUTION: Exercise care whenever working around x-ray sources. Avoid unnecessary x-ray exposure. Do not permit the beam to impinge on any part of your body at any time, especially your hands, arms and head. It is recommended that you wear a radiation dose badge to monitor any radiation exposure. CAUTION: Exercise caution while testing the mechanical movement. Keep hands and all objects clear of the arm assembly while in motion to avoid pinch points. CAUTION: Exercise caution when working with the covers removed. To prevent electrical shock use caution to avoid contact with exposed components.
5.10 Service Agent proceeds to correct the malfunction. The Service Agent will describe the corrective action taken to resolve the problem on the Service Report. Including all parts replaced. 5.11 If applicable, when a filter assembly or a source is replaced, the existing certification label for that component is removed from the scanner. The new label is applied. 5.12 The Service Agent signs the Service Report indicating the scanner is working as intended and the test results meet the listed specifications. Complete the service report using the Service Report Form Procedure, 900S064. NORLAND
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5.13 Identify all unused or defective devices returning to Norland with a Return Authorization tag. Refer to the RA Tag Procedure, 900S023 to complete the RA tag information. 5.14 The Service Agent notifies Norland customer service that the repair is complete before leaving the customer site. 5.15 The authorization number is referenced on the Service Report and invoice. 5.16 The Service Agent sends Norland the appropriate documentation. For USA, send a completed FDA Form 2579 to Norland within seven working days when a stationary scanner is moved or if a source, computer, or beam limiter is replaced. 6
SERVICE SOFTWARE SUPPLIES NEEDED: 388A334 XR-Series Service Disk (for 2-channel scanners) 398A020 Generic Tools Disk (for 4-channel scanners) 433A165 Service Scanner Tools Disk (for 4-channel scanners) 394A067 Service File Tools Disk (all scanners) !
2-Channel: Testing for 2-channel scanners will be performed from C:\BD\XRAY directory, using 388A334 XR-Series Service Disk revision 1.7.0. Type SERVICE to obtain the service tools in the BD\XRAY directory, or change to that directory (cd\bd\xray) and then type SERVICE. To select a command, type the corresponding number and press ENTER. The computer’s communication cable must be on COMM 1 for the 1.7.0 Service tools. If the 1.7.0 Service Disk is re-installed it is also necessary to reinstall the latest revision of the Service File Tools AFTER the 1.7.0 Service Disk. 388A334 XR-Series Service Disk, revision 1.7.0 installation instructions:
!
1.
Place the disk in the 'A' drive.
2.
At the DOS prompt type A:INSTALL, then press the enter key. When the XR Series Service Software Installation screen appears, press any key to continue. Using the up and down arrow keys select appropriate printer, then press ENTER to continue. When the Installation Complete screen appears press any key to return to the DOS prompt.
3.
Install the latest revision of the Service File Tools. See instructions below, under “All Scanners”.
4-Channel: For 4-channel scanners the testing is performed from the Service Scanner Tools menu. Type XSST to access the menu. To select a command, press the corresponding letter. Update all 4-channel scanners to the latest revision of the 433A165 Service Scanner Tools. The latest revision of Generic Tools must be loaded BEFORE the Service Scanner Tools. 398A020 Generic Tools installation instructions: 1.
Insert the 398A020 GT disk into drive 'A'. Type A:INSTALL and press ENTER to begin installation. At the first screen reading “Norland GT Disk Installation”, press any key (except ESC) to continue.
2.
After the installation has finished, press any key to exit to the DOS prompt. Remove the diskette from the drive.
433A165 Service Scanner Tools (SST) installation instructions: 1.
Insert the Service Scanner Tools disk 1 of 2 into the ‘A’ drive. Type A:INSTALL and press ENTER to begin installation. At the installation screen, press any key (except ESC) to continue.
2.
You will be prompted for which type of printer you have installed. Use the arrow keys to select your printer from the menu, and press ENTER. If you have any printer from the HP DeskJet series, select “HP DeskJet 500C”.
3.
At the “tools resolution” screen select “800 X 600” and press ENTER.
4.
The files will decompress to the hard drive.
NORLAND
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5.
Insert disk 2 when prompted.
6.
After the installation has finished, press any key to exit. The software will check your computer configuration for the proper settings. Press ENTER to confirm and ENTER to return to the DOS prompt.
After upgrading the SST software reconfigure the system: 1.
If the file “Service.fil” does not exist in the C:\XR26\SERVICE directory then create one by selecting Servfil –c -s from the XSST menu. Follow the on-screen prompts. If the scanner does not have an arm serial number, press enter to leave it blank.
2.
Redefine table limits by selecting TLimit from the XSST menu.
3.
Perform an initial peak by selecting PeakPick from the XSST menu, then press C to select characterize, and press Y to confirm. When the graph is complete press ENTER to continue. For DOS computers perform the next step before attempting to print.
4.
For computers with a DOS operating system: edit the Autoexec.bat file to place the line “if exists C:\XAUTO.BAT call XAUTO” to the last command. 4.1 At the C:\ prompt type CD\ and press ENTER. 4.2 Type Edit autoexec.bat and press ENTER. 4.3 Use the arrow keys to move to the beginning of the “if exists C:\XAUTO.BAT call XAUTO” line. 4.4 Press the Shift, Cntl, and right arrow keys to select (highlight) that line. 4.5 Press the Shift and Del keys to remove the line. 4.6 Press the Del key again to remove the empty space. 4.7 Use the arrow keys to move the cursor below the last line. 4.8 Press the Shift and Ins keys to reinsert the “if exists C:\XAUTO.BAT call XAUTO” line. It should now be the last line of text. 4.9 Press Alt to activate the menus, press F to select File, press X to exit, and press ENTER to save the changes and exit. 4.10Press Cntl, Alt, and Del keys to reboot the computer.
!
All Scanners: For all scanners, upgrade to the latest revision of Service File Tools software. 394A067 Service File Tools installation instructions: 1. Insert the 394A067 SFT disk into drive 'A'. Type A:INSTALL, and press ENTER. At the installation screen press ENTER to continue. 2. When installation is complete press any key to continue, remove the disk from drive 'A', and reboot the computer. Type XSFT to access the Service File Tools menu. To select a command press the corresponding letter.
!
WIN98 Computers: To obtain a DOS prompt click on the Window’s desktop Tools icon. To re-initiate the host software, enter EXIT at the DOS prompt, and click on the host software icon.
!
DOS Computers: To obtain a DOS prompt (C:\>) click on Exit in the host software. To re-initiate the host software, type XR, and press ENTER.
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TESTING REQUIREMENTS The following is a list of the recommended tests to be performed after replacing major components. Refer to the appropriate section for detail instructions on how to perform the following tests. All test data and calibration files should be copied to a disk after each repair or scanner move. This disk should be created after all the testing has been completed. To create this disk, at the C:\ prompt type XMAKEPRD. This disk should then be labeled with the facility name, scanner serial number, date and reason for the repair. This disk should be included with all the paperwork and sent back to Norland Customer Service.
(The test specifications are in parenthesis.) X-ray Source 1. Source Replacement Procedure 2. Source/Detector Alignment Procedure 3. Laser Alignment 4. Set PMT Gains 5. Source Count Rate Check (Low energy 550k to 750k) 6. Beam Stability Test (Voltage ≤ .1, Current ≤ 1.5 for2channel) (V≤.25 and I ≤ 3.0 for4-channel) 7. Table Test [differential and integral min/max ≤ (+/-) .4] 8. Function Tests 9. Initial Calibration 10. QC Spine Phantom Scans 11. Final Factor ( precision and accuracy ‘OK’) 12. If applicable, remove the existing source certification label from the outside of the scanner and apply the new one. 13. XMAKEPRD 14. Service Report 15. FDA Form 2579
Main Board 1. Function Tests 2. Daily Calibration (precision and accuracy ‘OK’) 3. Function Test – Emergency Shutoff Test – Laser and Xray On Tests 4. Move HID device to new board 5. XMAKEPRD 6. Service Report Motor Driver Board 1. Motor Driver Board Configuration (RA101, RB101, RC101, RD101) 2. Skip Test 3. Daily Calibration (precision and accuracy ‘OK’) 4. XMAKEPRD 5. Service Report Power Tray 1. Function Tests 2. Daily Calibration 3. XMAKEPRD 4. Service Report
NORLAND
Filter Assembly 1. Source/Detector Alignment Procedure 2. Laser Alignment 3. Set PMT Gains 4. Source Count Rate Check (Low energy 550k to 750k) 5. Table Test [differential and integral min/max ≤ (+/-) .4] 6. Remove the existing Beam limiter certification label on the outside of the scanner and apply the new one. 7. Filter Test 8. Initial Calibration 9. QC Spine Phantom Scans 10. Final Factor (precision and accuracy ‘OK’) 11. XMAKEPRD 12. Service Report 13. FDA Form 2579
Power Supply Board 1. Function Tests 2. Daily Calibration (precision and accuracy ‘OK’) 3. XMAKEPRD 4. Service Report Photo Multiplier Tubes 1. Source/Detector Alignment Procedure 2. Set PMT Gain 3. Laser Alignment 4. Source Count Rate Check (Low energy 550k to 750k) 5. Table Test [differential and integral min/max ≤ (+/-) .4] 6. Initial Calibration 7. QC Spine Phantom Scans 8. Final Factor (precision and accuracy ‘OK’) 9. XMAKEPRD 10. Service Report Lower Cable 1. Function Tests 2. Daily Calibration (precision and accuracy ‘OK’) 3. XMAKEPRD 4. Service Report
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REPAIR PROCEDURE Charge Amplifier Board 1. Source/Detector Alignment Procedure 2. Set PMT Gain 3. Laser Alignment 4. Source Count Rate Check (Low energy 550k to 750k) 5. Initial Calibration 6. QC Spine Phantom Scans 7. Final Factor (precision and accuracy ‘OK’) 8. XMAKEPRD 9. Service Report High Voltage Board 1. Source/Detector Alignment Procedure 2. Laser Alignment 1. Set PMT Gain 4. Source Count Rate Check (Low energy 550k to 750k) 5. Initial Calibration 6. QC Spine Phantom Scans 7. Final Factor (precision and accuracy ‘OK’) 8. XMAKEPRD 9. Service Report PMT Bias Board 1. Source/Detector Alignment Procedure 2. Laser Alignment 3. Set PMT Gain 4. Source Count Rate Check (Low energy 550k to 750k) 5. Initial Calibration 6. QC Spine Phantom Scans 7. Final Factor (precision and accuracy ‘OK’) 8. XMAKEPRD 9. Service Report Scanner Move 1. Level Scanner 2. Source/Detector Alignment Procedure 3. Laser Alignment 4. Set PMT Gains 5. Source Count Rate Check (Low energy 550k to 750k) 6. Table Test [differential & integral min/max ≤ (+/-) .4] 7. Function Tests 8. Current Leakage Test 9. Initial Calibration 10. QC Spine Phantom Scans 11. Final Factor (precision and accuracy ‘OK’) 12. FDA 2579 Form 13. XMAKEPRD 14. Service Report
388S631 REV Q Upper Cable 1. Function Tests 2. Daily Calibration (precision and accuracy ‘OK’) 3. XMAKEPRD 4. Service Report
Computer Replacement Refer to the 398S039 Computer Replacement Procedure X-axis Motor or Belt 1. Source/Detectors Alignment Procedure 2. Laser Alignment 3. Daily Calibration or Initial Calibration 4. QC Phantom Scans 5. Final Factor (precision and accuracy ‘OK’) 6. Service Report
Complete PMT Assembly 1. Source/Detector Alignment Procedure 2. Laser Alignment 3. Set PMT Gain 4. Source Count Rate Check (Low energy 550k to 750k) 5. Table Test [Differential & Integral Min/Max ≤ (+/-) .4] 6. Initial Calibration 7. QC Spine Phantom Scans 8. Final Factor (precision and accuracy ‘OK’) 9. XMAKEPRD 10. 10. Service Report Miscellaneous Repairs 1. Daily Calibration 2. XMAKEPRD 3. Service Report
Preventive Maintenance 1. Computer: 1.1 Scandisk and Xfcheck on all storage media 1.2 Optimize hard drives 1.3 Update service software as required 1.4 AnitVirus check if software is available 2. X-ray Source: 2.1. Check desiccant material [Lorad source only] NORLAND
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4. 5.
388S631 REV Q
2.2. Verify proper oil pump operation [Lorad source only] 2.3. Check fan operation. 2.3. Function Test - Radiation leakage check (< 15 mR) 2.4. Perform Beam Stability Test (Voltage ≤ .1, Current ≤ 1.5 for 2-channel) (V≤.25 and I ≤ 3.0 for 4-channel) Scanner: 3.1. Clean and lubricate the rails 3.2. Table Test [differential & integral min/max ≤ (+/-) .4] 3.3. Check Laser Alignment 3.4. Current Leakage Test 3.5. Check all cables for wear and proper connections 3.6. Check belts for proper tension. 3.7. Tighten all hardware and make sure all brackets are installed. 3.8 Check Xdrift for long term performance 3.9. Set PMT Gains 3.10. Source Count Rate Check. 3.11. Perform a Daily Calibration (Precision and Accuracy ‘OK’) XMAKEPRD Service Report
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TEST PROCEDURE QUICK REFERENCE GUIDE This is a quick reference guide for performing the tests. Refer to the appropriate sections for specific details.
SOURCE/ DETECTOR ALIGNMENT CAUTION: EXERCISE CARE WHENEVER WORKING AROUND X-RAY SOURCES. IT IS RECOMMENDED THAT YOU WEAR A RADIATION DOSE BADGE TO MONITOR ANY RADIATION EXPOSURE. DO NOT PERMIT THE BEAM TO IMPINGE ON ANY PART OF YOUR BODY AT ANY TIME, ESPECIALLY YOUR HANDS, ARMS AND HEAD. !
2-Channel Scanners: 1. 2. 3. 4.
Type, SERVICE, then IS to initialize scanner. Type IDLE to bring source to idle power (70 kV). Position scanner arm to middle of table. Type PEAK to run the peak program, press enter twice the graph is complete.
5. 6.
MAKE SURE THE SHUTTER IS CLOSED, THEN PUT THE ALIGNMENT COLLET IN. Type CG to run count graph. Enter min/max. 0,180000. Type Y then press enter for scanner serial number over 600. Align source, detectors, and filter assembly for maximum counts (typically 90,000-180,000)
7. 8. !
MAKE SURE THE SHUTTER IS CLOSED, THEN REMOVE THE COLLET.
4-Channel Scanners: 1. 2. 3. 4.
MAKE SURE THE SHUTTER IS CLOSED, THEN PUT THE ALIGNMENT COLLET IN. Select the ALIGN command from the XSST menu. Align source, detectors, and filter assembly for maximum counts (typically 90,000-180,000). MAKE SURE THE SHUTTER IS CLOSED, THEN REMOVE THE COLLET.
PMT GAIN ADJUSTMENT CAUTION: CARE MUST BE EXERCISED WHILE PERFORMING THIS PROCEDURE TO AVOID UNNECESSARY X-RAY EXPOSURE. STAY CLEAR OF THE BEAM PATH. !
For Scanners With Autoset Hardware: 1. From the XSST service menu select GainPeak. This will ramp the source to full power and move the source to the correct peak location. Verify there is nothing in the beam path. 2.
A peak graph will be drawn. The high-energy (1/FL) peak channel should be 2250 ± 50 and the low energy (1/IL) peak channel should be 1150 ± 50.
3.
If they are correct press Q to quit. Select PeakPick from the XSST menu. Press C to characterize the system. After peak has completed then press P to print. Attach the printout to the Service Report.
4.
If they are not correct, select PAutoSet -R from the XSST menu. This will automatically adjust the gains. When it is finished select PeakPick from the XSST menu. Press C to characterize the system. After peak has completed then press P to print. Attach the printout to the Service Report.
! 4-Channel Scanners Without Autoset Hardware: CAUTION: EXERCISE CAUTION WHEN WORKING WITH THE COVER REMOVED. TO PREVENT ELECTRICAL SHOCK USE CAUTION TO AVOID CONTACT WITH EXPOSED COMPONENTS.
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Scanners with S/N 3600-5000 and 6600-8000: 1. Select GainPeak from the SST menu. 2. Adjust R23 on the Bias Board until the difference between the peaks is approximately 1100. 3. Adjust R1 on the High Voltage Board until 1/FH peak is 2250 ± 50 and the 1/IH peak is 1150 ± 50. 4. Repeat the GainPeak after each adjustment of R23 or R1. 5. When it is finished select PeakPick from the XSST menu. Press C to characterize the system. After peak has completed then press P to print. Attach the printout to the Service Report. Scanners with S/N 1000-2000: 1. Select GainPeak from the XSST menu. 2. Adjust R3 (right) on the PMT HV/Laser PS board until the difference between the peaks is approximately 1100. 3. Adjust R1 (left) on the PMT HV/Laser PS board until 1/FH peak is 2250 ± 50 and the 1/IH peak is 1150 ± 50. 4. Repeat the GainPeak after each adjustment of R1 or R3. 5. When it is finished select PeakPick from the XSST menu. Press C to characterize the system. After peak has completed then press P to print. Attach the printout to the Service Report. ! PMT Gain Adjustment For 2-Channel Scanners: CAUTION: EXERCISE CAUTION WHEN WORKING WITH THE COVER REMOVED. TO PREVENT ELECTRICAL SHOCK USE CAUTION TO AVOID CONTACT WITH EXPOSED COMPONENTS. 1. 2. 3. 4. 5. 6.
Enter the following commands, SERVICE, IS Enter 12 to select Gains from the 1.7.0 Service menu. Position the arm to a convenient location Set the oscilloscope to 1 volt/div., .2 us/div, and AC input coupling Measurement will be taken on the 398A001 main board at TP5 & TP6 and ground at TP1; and at R19 and R37 on the 388A004 main board. Adjust R23 on the PMT Bias board to obtain equal amplitudes, and adjust R1 on the PMT HV Bd to obtain amplitude of 2 volts for 398A001 main board; or 4 volts on the 388A004 main board.
SOURCE COUNT RATE CHECK CAUTION: CARE MUST BE EXERCISED WHILE PERFORMING THIS PROCEDURE TO AVOID UNNECESSARY X-RAY EXPOSURE. STAY CLEAR OF THE BEAM PATH. ! 2-Channel: 1. Place the tabletop on the scanner, and put the calibration standard in place. 2. Position the laser over point A on the calibration standard 3. At the DOS prompt enter SERVICE, then FULL to bring the source to full power, PEAK to run the peak program, press enter twice when the graph is complete, and CR to start the count graph program. 4. When prompted enter 5 for the interval and 7 for the filter number. 5. Let the program run for approx. 6 lines, then press enter to stop the program and press the “Print Screen” key to obtain the printout. 6. The limits for low energy (second column) are 550000 – 750000. !
4-Channel Scanners: 1. Select CRcheck from the XSST menu. 2. With the tabletop in place, position the laser over point A on the calibration standard. Press MARK. 3. Verify the “Init 1” is 550000 – 750000.
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STABILITY TEST CAUTION: CARE MUST BE EXERCISED WHILE PERFORMING THIS PROCEDURE TO AVOID UNNECESSARY X-RAY EXPOSURE. STAY CLEAR OF THE BEAM PATH. ! 2-Channel Scanners: 1. Enter SERVICE, and then FULL to bring the source to full power. 2. Make sure the tabletop is on, place the QC Phantom in the middle of the table, turn the laser on and position it through just the acrylic part of the QC phantom. 3. 4. 5. 6. 7. 8. 9. 10. !
MAKE SURE THE SHUTTER IS CLOSED, THEN PUT THE STABILITY COLLET IN. Type PEAK to run the peak program, press enter twice when the graph is complete. Type PA to set the DAC’s Type MON to start the program, follow the prompts to press ENTER to continue. Press F1 to create a new file, and then enter the source S/N. Let test run for ½ hour. Press ENTER to exit the test. To obtain the printout type MON then press F1 to obtain menu the hidden menu, F1 for auto scaled limit, F4 to view last file, then F7 to print. The limits are voltage should be less than .1 and current less than 1.5 MAKE SURE THE SHUTTER IS CLOSED AND REMOVE THE COLLET.
4-Channel Scanners: 1. Select MON_STAB from the XSST menu. 2. Follow the on-screen prompts, and press Y to characterize the scanner and 0 (zero) for cool down time. 3. 4. 5. 6.
MAKE SURE THE SHUTTER IS CLOSED, THEN PUT THE STABILITY COLLET IN. After 30 minutes press Q to quit. Verify theVoltage ≤ .25 %, and Current ≤ 3.0%. MAKE SURE THE SHUTTER IS CLOSED AND REMOVE THE COLLET.
TABLE TEST (RAIL ALIGNMENT) CAUTION: EXERCISE CAUTION WHILE TESTING THE MECHANICAL MOVEMENT. KEEP HANDS AND ALL OBJECTS CLEAR OF THE ARM ASSEMBLY WHILE IN MOTION TO AVOID PINCH POINTS. CAUTION: CARE MUST BE EXERCISED WHILE PERFORMING THIS PROCEDURE TO AVOID UNNECESSARY X-RAY EXPOSURE. ! 2-Channel Scanners: 1. Type SERVICE and then press ENTER to access the service menu. 2. Type 3 to begin the table test. This will set the x-ray to full power, run the peak program and find the table limits. Follow the on-screen prompts. 3. When prompted for the following questions, press ENTER at each question to accept the default. R for rail alignment, A to acquire, type in the scanner serial number, and C for coarse scan. 4. Follow the on-screen prompts to remove the calibration standard and the tabletop. Press the MARK button to mark the reference point. 5. Upon completion of the graph press F5 differential/integral, press F5 again for min/max, then press F7 to print. When done printing press F9 to exit. The limits are .4/-. 4 for the two bottom graphs. !
4-Channel Scanners: 1. Select TLimit from the XSST menu. 2. Select TABLE –w from the XSST menu. 3. When the test is complete press ENTER twice to display plots. Press P to print. 4. The limits are ± .4.
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SKIP TEST CAUTION: EXERCISE CAUTION WHILE TESTING THE MECHANICAL MOVEMENT. KEEP HANDS AND ALL OBJECTS CLEAR OF THE ARM ASSEMBLY WHILE IN MOTION TO AVOID PINCH POINTS. ! 2-CHANNEL: 1. Enter SERVICE, and then SKIPTEST to begin the program 2. Follow the on-screen prompts, answer Y if it is a full-length table (XR36 or XR26) and N if it is a not a fulllength scanner (Eclipse). Answer N to “loop continuously”. 3. When prompted, mark the reference point. Put a piece of tape on the tabletop and mark where the laser hits it. 4. When the test is done, verify that the laser is back at the marked location. !
4-CHANNEL: 1. Select TLimit from the XSST menu. 2. Select SkipTest from the XSST menu. 3. Enter 1 for number of times to run the test. 4. Enter N to check each portion of test. 5. Enter H for high speed. 6. Mark laser location on tabletop. 7. When the test is done, verify that the laser is back at the marked location.
FILTER TEST !
2-CHANNEL: 1. Enter SERVICE, FULL, PEAK and 10 to select Filttest from the 1.7.0 Service menu. 2. Mark points ‘A’ and ‘B’ on the calibration standard. 3. Perform test and print results (press P) for filter 1, 2, and 3. 4. Verify that filter 1 moves into the beam path in 7 ms and out within 6.5 ms. Verify that filters 2 and 3 move into the beam path in 8 ms and out within 6.5 ms.
!
4-CHANNEL: 1. Select FiltTest from the XSST menu. 2. Enter A for ALL. 3. Mark points ‘A’ and ‘B’ on the calibration standard. 4. On all 4 printouts, verify that the samarium has moved completely into the beam path within 8 ms. (bottom plateau edge). Verify that the samarium has moved completely out of the beam path within 8 ms. (upper plateau edge). Confirm that here is no plateau shift in the 8 to 20 ms timeframe. While viewing the 1-3 max/min plots, verify that there are no count rage variations that exceed 50% of the count rate range. 5. Press any key to continue. 6. Press Q to quit. Press any key to continue. 7. Attach the printouts to the Service Report.
INITIAL CALIBRATION AND FINAL FACTOR 1. 2. 3. 4. 5.
6. 7. NORLAND
At the DOS prompt, type FF_SET. Set the BMC (and optional Fat and Lean) factor to the default of 1.000. The calibration file needs to be renamed. At the C:/XR26 prompt type: REN CALIB.FILL CAL(DATE).FIL. (i.e. ren calib.fil cal1020.fil, if the done on Oct 20th.) Initiate the host software and under the Setup Menu , select FIND TABLE DIMENSIONS When it completes defining the table dimensions, select BEGIN QA to start the calibration. Clear tabletop of everything except for the calibration standard. IMPORTANT: POST SIGNS THAT ARE CLEARLY VISIBLE THAT INDICATE X-RAYS ARE BEING EMITTED AND THE SCANNER MUST NOT BE DISTURBED DURING THE INITIAL CALIBRATION. When the calibration is complete, select CANCEL to cancel the QC Scan. Go to the QA menu and select SCAN QC PHANTOM. Enter 25 for the number of repetitions. . Exit to DOS. At the C:/ prompt type FF_SET, answer Y for yes to have anew BMC Factor (lean and fat if applicable) computed, answer Y again to accept the propose factor. PAGE 13
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388S631 REV Q
Initiate the host software and under the QA menu select Scan QC Phantom. If time permits enter 16, otherwise enter 3 or more. Verify the precision and accuracy for BMD (and optional fat and lean) are OK.
REPLACING THE SOURCE CONTROL BOARD Before replacing the source control board measure the test points listed below to determine if replacing the source control board will fix the problem or ensure the new source control board will not be damaged. 9.1 Measure the following voltages on the source control board. The source can be at full x-ray power or zero power. If any of the voltages are missing, and the correct voltage is at the P10 (red/black and white/green wires), replacing the control board will fix the problem: TEST POINT (TP) 1 19 26 27 31 21 Pin 4 of U18
VOLTAGE RANGE +24 to 40 +9 to 11 +4.98 to 5.02 -9 to –11 -14 to –16 14.9 to 15.1 5.87 to 6.11
DESCRIPTION Main Power Input +10 Volt Reference +5 Volt Reference -10 Volt Supply -15 Volt Supply +15 Volt Supply
9.2 Before replacing the source control board check the components listed below to ensure the new control board does not get damaged. If the following checks fail then replace the entire source. 9.2.1 Verify Q1, Q2, Q3, and Q3 are not shorted: Note: Q1 and Q2 will only have 15 ohms of resistance from leads 1 to 3, Pin 3 of Q3 and Q4 should be at ground potential. All other leads should have at least 5 K ohms when testing from one lead to the other. 9.2.2 Verify the accumulator bag does not have air in it. Note: This can be inspected visually by looking at the tube running from the accumulator bag to the tank of the source. If the tube has more than ½ inch of air there may be air in the source tank. Air in the tank will cause problems with the voltage transformers in the source. 9.3 If the control board is replaced, the following voltages should be checked immediately. If the voltages are incorrect, the system should be powered down and the source replaced. TEST POINT (TP) 20 25 22 29 23 24
10
VOLTAGE RANGE +3.92 to 4.08 -3.6 to –4.4 -4.85 to –5.14 4.77 to 5.23 4.89 to 5.18 4.88 to 5.19
DESCRIPTION X-ray Voltage X-ray Voltage X-ray Current Anode X-ray Current Anode X-ray Current Cathode X-ray Current Cathode
SOURCE REPLACEMENT PROCEDURE
CAUTION: Exercise care whenever working around x-ray sources. It is recommended that you wear a radiation dose badge to monitor any radiation exposure. Do not permit the beam to impinge on any part of your body at any time, especially your hands, arms and head. IDENTIFICATION: Lorad X-ray Source = Model number TXR26 Norland X-ray Source = Model numbers 391A051, 391A051J, or 391A168
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REPLACEMENT PROCEDURE: 10.1 Refer to Source Wiring Diagram Section 10.2 If the original source is a Lorad and has desiccator tubes, turn the valve to the closed position. 10.3 For all models, disconnect and remove the original source from the scanner. 10.4 Place the new x-ray source onto the source mounting plate on the arm carriage. Align the source so the bottom mounting tabs fit into the notches on the source mounting plate. Temporarily center the source on the plate. 10.5 Attach source to the mounting plate, using the following hardware, but do not tighten: #6020371 - Screw - socket hd 1/4"-20 x 1-3/8" (Qty. 2) #6460006 - Washer - 1/4 flat washer, SAE (Qty. 2) 10.6 Remove the source top cover. CAUTION: DO NOT OPERATE THE NORLAND SOURCE WITHOUT THE TOP COVER INSTALLED, BECAUSE THE FAN GUARD IS NOT IN PLACE. 10.7 If replacing a Lorad source with a Norland source configure filter assembly and source correctly: • If it is installed, remove the lead filter plate from the bottom of the filter casting assembly. • Push the roll pin flush to the bottom surface of the filter casting assembly. 10.8 If installing a Norland source into a scanner with S/N lower than 600 (Low Intensity) and that has not been upgraded to High Intensity or High Speed, configure the attenuator plugs accordingly (refer to chart). Remove the snap ring in the well of the source, and remove the samarium canister. For scanner serial numbers less than 500 install the smaller plastic plug provided. If scanner serial number is 500 to 599 install the larger plastic plug. Reinstall the snap ring. Cut one end of R195 on the source control board (not necessary for source 391A051J, the resistor is already cut). R195 is located between R187 and TP33. Secure or protect the resistor from shorting to another component, and cut the resistor so it may be reattached for future use if necessary. SCANNER SERIAL NUMBER Scanner S/N lower than 500 or that has NOT been converted to New Beam Geometry, High Intensity (Mark II) or High Speed. Scanner S/N 500 to 599, or any scanner upgraded to New Beam Geometry. (Finland and USA) Scanner S/N higher than 600 or that has been converted to High Intensity (Mark II) or High Speed.
NORLAND SOURCE Remove the samarium canister, install the smaller of the two plugs provided, and cut one end or R195. Remove the samarium canister, install the larger of the two plugs provided, and cut one end of R195. No change to the source is required.
10.9 Referring to SOURCE WIRING DIAGRAM section, center the filter casting assembly on the source with the filter wiring exiting to the right side of the source. Secure the filter assembly using the following hardware: 6604206 - Screws (Qty 3) 6460006 - Washers (Qty 3) 10.10 Referring to diagrams below, connect the various connectors and wires to specified locations as shown. Secure the middle cable assembly to the source. CAUTION: Exercise caution when working with the cover removed. To prevent electrical shock use caution to avoid contact with exposed components. 10.11 Attach the red connector to the source control board P11. 10.12 Attach the ground wire to the right side of the source with screw and lock washer. NORLAND
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10.13 Attach the red/black and green/white wires. 10.13.1 For sources with the terminal block on the back cover: Loosen the source back cover enough to attach the red/black and green/white wires to the terminal block on the source back cover. The red/black should be on the left side when standing in front of the scanner (same side as the red wire on the terminal below). The green /white wires should on the right side (same side as the white wire).
Red Wire
White Wire
10.13.2 For all other scanners attach the wires directly to P10 of the source control board. The red/black wires go to the top pin and green/white wires go to the bottom. The middle pin is not used. See diagram below.
Green Connector, P10 Red and Black wires Green Connector, P10 Green and White wires Ground Strap Red Connector to P11
10.14 Secure the scanner middle cable to the source back panel using two cable ties. 10.15 Place the lead filter cover over the filter assembly and secure in place with top cover. 10.16 If there is an extra source certification label taped to the top of the source, apply it to the outside of the scanner. If there is an existing source certification label on the scanner it must be removed or covered with the new label. For scanners with S/N 1000-2000 and higher than 8000, apply it to the right side panel, below the last label under the power switch. For scanners with S/N 3000-8000 apply it to the back riser, under the scanner certification label. Refer to the Regulatory Label Location section. NOTE: BEFORE RAMPING UP THE X-RAY TO ANY CURRENT OR VOLTAGE THE X-RAY SOURCE MUST BE ALLOWED TO REACH ROOM TEMPERATURE. FAILURE TO DO SO MAY RESULT IN PERMANENT DAMAGE TO THE X-RAY TUBE. CAUTION: TO PREVENT RADIATION EXPOSURE DO NOT RUN THIS OR ANY OTHER TEST THAT REQUIRES THE X-RAY SOURCE TO OPERATE WITHOUT THE LEAD FILTER COVER IN PLACE. NORLAND
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10.17 Perform the recommended tests as outlined in the “Testing Requirements” section. 10.18 For USA, complete a FDA 2579 form. Send the 2579, printouts, XMAKEPRD, and the Service Report to Norland within 7 days.
11
FILTER ASSEMBLY REPLACEMENT There are three part numbers: 388A053
Mark I (Original Beam Geometry)
388A350
Mark II (New Beam Geometry)
387A044
High Speed (Dynamic Filtration)
These parts are not compatible and the replacement filter assembly must be the same part. The 387A044 is a filter assembly with matching circuit board. The board is attached to the top of the scanner main board. They are matched at the factory and must remain a set. If the filter assembly is replaced the board must also be replaced. 11.1 Remove the original filter assembly, and matching board (only for 387A044). Keep the original hardware. 11.2 If the filter assembly is being replaced in a system with a Lorad source (Model number TXR26) then remove the lower lead cover from the bottom of the original filter assembly and attach it to the new one. CAUTION: TO PREVENT RADIATION EXPOSURE DO NOT OPERATE THE X-RAY SOURCE WITHOUT THE FILTER ASSEMBLY AND THE LEAD FILTER COVER IN PLACE. 11.3 Center the new filter assembly on the source and secure with the original mounting hardware. 11.4 Replace the lead filter cover. 11.5 Remove the original beam limiter certification label from the outside of the scanner. Fill in the appropriate information on the new label and apply it where the original label was removed. 11.6 Perform all the tests listed in the Testing Requirements section of this procedure. 11.7 For USA, complete a FDA 2579 form. Send the 2579, printouts, XMAKEPRD, and the Service Report to Norland within 7 days. 12
PMT TUBE IDENTIFICATION AND REPLACEMENT
IDENTIFICATION:
Top PMT (High Energy) Bottom PMT (Low Energy)
NORLAND PART NUMBERS 4909050 4909051 433D110
MODEL NUMBER PART NUMBER (on label) (on label) 1 XM.276/1.5A-X or 300-1082 300-1128 1 XM. 010/1.5A-XX or 300-1081 300-1127 Only to be used in QS (4-Channel scanners)
If the low energy PMT has a model number “1 XM. 010/1.5A-X” (one X at the end) and a serial number with letters before “JJ” then it can only be used for two channel (non-QS) scanners. If the low energy PMT has a part number 433D110 written on it. It can only be used for QS scanners. All other PMT’s can be used in any scanner. Note: For scanners with S/N prompt type SCANDISK to check the ‘C’ drive. • At the C:> prompt type “Scandisk drive:” to check other drives. Replace “drive” with the appropriate drive letter, i.e. “SCANDISK D:”. • If errors occur contact Norland Customer Service.
33.1.2
Perform Xfcheck on all storage devices to verify the XR file structure. • At the C:> prompt type XFCHECK to check the ‘C’ drive. • At the C: > prompt type “Xfcheck drive:” to check the other drives. Replace “drive” with the appropriate drive letter, i.e. “XFCHECK D:”. • Contact Norland Customer Service if errors occur.
33.2
33.1.3
Optimize the hard drive. Enter DEFRAG at the C>: prompt. (If using DOS version less than 6.2.2 contact Norland Customer Service.)
33.1.4
Update service software as appropriate. Refer to the Service Software section of this procedure.
33.1.5
Perform AntiVirus check if the software is available.
X-RAY SOURCE: 33.2.1
LORAD SOURCE – MODEL NUMBER D-051: • Check the desiccant material. Change the desiccant or entire tube if it is pink. Blue desiccant will still absorb moisture and does not need to be replaced. • At the C:\> prompt enter FULL. Verify pump operates when source is ramped to full power and no air bubbles are present in the oil tubing.
33.2.2
ALL SOURCES: • Verify fan is operating properly. • Check for leakage radiation. Refer to Radiation Leakage Test in the Function Test section of this procedure for instructions. •
33.3
Perform a Beam Stability Test. Verify results are within specifications.
SCANNER: 33.3.1
Clean and lubricate rails.
NOTE: Do not use any type of lubricant containing solvents. The plastic components and permanent lubrication grease in the bearing may be adversely affected. 33.3.2
Perform the Table (Rail Alignment) Test to check for proper rail alignment.
33.3.3
Verify laser beam is in the center of the filter casting aperture. Perform Laser Alignment as necessary.
33.3.4
Perform Leakage Current Test.
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33.3.5
Check all cables connections.
33.3.6
Check all belts and pulleys for proper wear, tension, and alignment. If the belt is re-tightened perform a source/detector alignment, and laser alignment. If the daily calibration does not pass, perform an initial calibration. Refer to the Testing Requirements section of this procedure.
33.3.7
Tighten all hardware and make sure all brackets are installed.
33.3.8
Print XDRIFT to check the long-term scanner performance. • For 4-channel scanner select XDrift from the XSST menu. Press any key to continue. Press P to print. • For 2-channel scanner enter Service and then Xdrift. Press any key to continue. Press P to print.
33.3.9
Check the PMT Gains, and adjust if necessary.
33.3.10 Perform a Source Count Rate Check. 33.3.11 Perform a Daily Calibration and verify the precision and accuracy of the scanner are okay. If the daily calibration fails then perform an Initial Calibration, QC Spine Phantom Scans, and set a Final Factor. 33.4 XMAKEPRD: 33.4.1
Make a problem-reporting disk and send it back to Norland. Insert a blank formatted disk and at the C:\> prompt enter XMAKEPRD.
33.4.2
Label the disk with facility name, scanner serial number, date, and “preventive maintenance”. Return the disk with the Service Report to Norland as soon as possible.
33.5 SERVICE REPORT: Completely fill out a Service Report. Return it to Norland as soon as possible with the XMAKEPRD and printouts. Refer to the Service Report Form section of this procedure for details.
34
XMAKEPRD
A problem-reporting disk should be made after a repair or preventive maintenance check has been performed on the scanner. This disk should be created after all the testing has been completed. The “XMAKEPRD” command will automatically copy all the calibration and testing data to a diskette. SUPPLIES NEEDED: 1.44 Formatted diskette 34.1 To create this disk, insert a blank formatted diskette and at the C:\ prompt (use the Tools icon in Win98 setups) type XMAKEPRD. 34.2 Follow the on-screen instructions. When prompted to perform ‘Xfcheck’ press Y for yes if xfcheck was not previously performed as part of the preventive maintenance. For large patient databases this may take some time. After the xfcheck more files will be copied. If the files do not fit on a single diskette, follow the on-screen instructions to insert a second diskette and continue. If more than one disk is needed, consider deleting the C:\xr26\caltrace\errors.his and C:\xr26\errors.log files, after the files have been copied to the disk. 34.3
Remove the disk when the prompt reappears.
34.4 Labeled disk with the facility name, scanner serial number, date, and reason for the repair or just preventive maintenance. This disk should be included with all the paperwork and sent back to Norland Customer Service.
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FDA FORM 2579 – USA ONLY
Complete this form if a certified component (computer, scanner, x-ray source, or filter assembly) has been replaced or if a stationary scanner has been relocated. Send it to Norland Medical Systems within 7 working days of the service activity. PROCEDURE: Use the example and the detailed instructions for the corresponding numbers below to properly fill out a 2579 form. Return the complete form within one week to Norland Medical Systems. 1.
EQUIPMENT LOCATION Enter the information for the facility. Fill in all the blanks.
2.
ASSEMBLER INFORMATION Fill in Norland’s name and address.
3.
GENERAL INFORMATION a. Mark ‘RE-ASSEMBLY-FULLY CERTIFIED SYSTEM’ if moving a scanner, or mark ‘REPLACEMENT COMPONENTS IN AN EXSITING SYSTEM’ if replacing a certified component. b. Mark ‘BONE MINERAL ANALYSIS’ c. Mark ‘STATIONARY’ unless the scanner is in an mobile van then mark ‘MOBILE’ d. If the scanner is stationary enter the room number or room description where the computer is located, for example “Bone Density Room” e. Enter date of repair.
4.
COMPONENT INFORMATION a. Mark ‘A NEW INSTALLATION’ if the computer is replaced, otherwise mark EXISTING (Certified)”. b. Enter ‘NORLAND’ c. Enter model number from the computer certification label d. Enter computer serial number from the computer certification label e. Enter date manufactured from the computer certification label. f. Leave blank. g. BEAM LIMITING DEVICE – Enter ‘NORLAND’ as Manufacturer, Model Number and date from the filter assembly certification label. h. Enter ‘1’ in ‘X-RAY CONTROL’ and ‘ OTHER’. (Define ‘other’ in comments.)
5.
ASSEMBLER CERTIFICATION a. Print your name b. Sign your name c. Enter the date you signed
6.
COMMENTS Enter ‘4h Combination Tube Housing and High Voltage Supply’. Enter the scanner type; for example ‘Eclipse’, ‘XR36’…. The reason for service activity; for example ‘replaced source’ or ‘relocated scanner’ etc. Enter the scanner serial number. Any state registration number if required, for example Kentucky.
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SERVICE REPORT FORM The Norland Service Report form must be completed after any servicing of the equipment has been performed. For field service, the customer must sign and date the Service Report form. The pink copy of the Service Report should be left with the customer, the Service Representative should keep the yellow copy, and the white copy must be returned to Norland Customer Service with all other appropriate documentation. The attached form is an example of the Service Report form. Refer to the 900S064 Completing the Service Report Form procedure for detailed instructions. Within one week of the repair send the documentation to: Norland Medical Systems W6340 Hackbarth Road Fort Atkinson, WI 53538 USA Attention: Customer Service
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W6340 Hackbarth Road Fort Atkinson, WI 53538 Phone: 800-444-4856 Fax: 920-568-4216
Authorization / Call #
SERVICE REPORT Equipment Type:
Serial Number:
Date Contacted:
Facility Name:
Date Repaired:
Contact Name:
Address:
" Warranty Customer Complaint:
"
Non Warranty
"
Service Contract
"
"
Sales / Marketing
Other
Problem Found:
Actions Taken:
FDA 2579 Required " Yes " No
FDA 2579 Filled Out By:
Initials:
Indicate Parts Used Below Part Number
Description
Old S/N
New S/N
Labor
Hours
Travel Onsite In-House Additional Comments:
Customer Signature / Date
Authorized Service Agent Signature / Date
White-Pro Tech NORLAND
Yellow Copy-Service Agent
Print Name / Company
Pink Copy-Customer
FRM-107 Rev. B PAGE 58
