Agilent 5DX System. X-ray Safety Test Procedure. for use with Software Release 8.20 and later

Transcription

1 Agilent 5DX System for use with Software Release 8.20 and later Agilent Technologies, Inc Agilent

2 Safety and Regulatory Information: Restricted Rights Notice If software is for use in the performance of a U.S. Government prime contract or subcontract, Software is delivered and licensed as Commercial computer software as defined in DFAR (June 1995), or as a commercial item as defined in FAR 2.101(a) or as Restricted computer software as defined in FAR (June 1987) or any equivalent agency regulation or contract clause. Use, duplication or disclosure of Software is subject to Agilent Technologies standard commercial license terms, and non-dod Departments and Agencies of the U.S. Government will receive no greater than Restricted Rights as defined in FAR (c)(1-2) (June 1987). U.S. Government users will receive no greater than Limited Rights as defined in FAR (June 1987) or DFAR (b)(2) (November 1995), as applicable in any technical data. Safety Notices and Definitions WARNING denotes a hazard. It calls attention to an operating procedure, practice, or the like that, if not correctly performed or adhered to, could result in personal injury or death. Do not proceed beyond a WARNING notice until the indicated conditions are fully understood and met. CAUTION denotes a hazard. It calls attention to an operating procedure, practice, or the like that, if not correctly performed or adhered to, could result in damage to the product or loss of important data. Do not proceed beyond a CAUTION notice until the indicated conditions are fully understood and met. Example of Warning and Caution notices appearing in this document: WARNING: If any reading exceeds 0.15 mr/hr (1.5 µs/hr) when measured with the Ion Chamber, immediately follow the process in the X-ray Safety Test Report titled What if the Reading Exceeds Agilent's Specification. CAUTION: If you must stop scanning the system for a period of time, do not allow this routine to continue to run. Serious system damage could occur. Press any key to stop the routine. Technology License The hardware and/or software described in this document are furnished under a license and may be used or copied only in accordance with the terms of such license. Warranty Statement The material contained in this document is provided "as is", and is subject to being changed, without notice, in future editions. Further, to the maximum extent permitted by applicable law, Agilent disclaims all warranties, either expressed or implied with regard to this manual and to any of the Agilent products to which it pertains, including but not limited to the implied warranties of merchantability and fitness for a particular purpose. Agilent shall not be liable for errors or for incidental or consequential damages in connection with the furnishing, use, or performance of this document or any of the Agilent products to which it pertains. Should Agilent have a written contract with the User and should any of the contract terms conflict with these terms, the contract terms shall control. Page 2 of 18

3 for Software Release 8.2 or later: Purpose This procedure provides instructions to check the operation of the safety interlocks and to measure the X-ray emission at all points outside the external surfaces of the 5DX X-ray system cabinet using Software Release 8.20 or later. Ref. 21 CFR, paragraph (c) Note: Use Agilent Part Number when using a software release prior to Software Release 8.2. Training Requirements: Attending the Agilent Internal 5DX CE Training Class is required before performing an X-ray Safety Test. Procedure and Report Usage According to this, an X-ray Safety Test Report must always be completed. Be sure you have the most recent copy of the and X-ray Safety Test Report. These are located on the MSD website at: If you cannot access this URL, call AXI Hardware Support or call your local Agilent support representative to order one. Pass Specification Readings must not exceed 0.15 mr/hr (1.5 µs/hr) when measured with the Ion Chamber. Any confirmed reading above 0.15 mr/hr (1.5 µs/hr) shall be considered a failure of the cabinet X-ray system. Required Tools E Series I, II X-ray Safety Test Report or N Series 2L, 3 and 5000 X-ray Safety Test Report E Thickness gauges for access panels and loader barriers E Series 2L, 3 and 5000 Inner barrier interlock adjustment tool kit Page 3 of 18

4 Meter Requirements One GM Meter and one Ion Chamber must be chosen for use from the following lists: GM (Geiger-Mueller) Meter Test Probe Ion Chamber Victoreen/Inovision C or D Victoreen/Inovision 440RF P-8 Neon NA Victoreen/Inovision 450P Victoreen/Inovision C or Victoreen/Inovision 451P D Berthold TOL/F (Europe Only) Berthold TOL/F (Europe Only) Note: The Radiation Alert Inspector GM meter is no longer an Agilent Approved GM meter. Do not use this meter when performing an X-ray Safety Test. Any X-ray Safety Test completed using the Radiation Alert Inspector will be invalid. Note: All meters must be regularly calibrated. Surveys completed with meters that have expired calibration dates are NOT valid. See "Instrument Check" for calibration schedules. Note: 5DX Series II and 2L Systems It is acceptable to perform only a visual inspection of the Rotary Servomotor Shield after it has been removed and replaced. A visual inspection includes verifying that the shield is not damaged and verifying that it is properly re-installed after servicing. An X-ray Safety Test is not required after removing the Rotary Servomotor Shield for the purpose of replacing the Rotary Servomotor brushes. 5DX Series 3 and 5000 Systems Do not remove the Rotary Servomotor Shield when replacing the Rotary Servomotor. An X-ray Safety Test is not required after replacing the Rotary Servomotor. Page 4 of 18

5 Meter Use Follow these specifications for proper use of the meters: Technique Parallel Scanning 190 or 290 GM Meter Overlap the scans 1.5 in. (3.8 cm) P-8 Neon Ion Chamber Make one pass of 5DX side with Meter. Then move meter 1.5 in (3.8 cm) and make another pass of 5DX side. N/A Finding the Angle of Emission Scan Rate Meter Clearance N/A N/A The meter must be turned to various angles to the system to find the point and angle of X-ray emission. This angle may be the straight-line path from the X-ray tube to the point of emission. 2.0 in/sec (5cm/sec) 2.0 in/sec (5cm/sec) 5 second Dwell Time (Hold the meter still for 5 sec.) After scanning an area with higher emissions, allow the meter to return to background radiation levels before continuing to scan. Maintain a gap of between 0.0 in (0 mm) gap and 0.4 in (10mm) between the meter and surface under test. Note: Turn on the GM Meter audio. The clicking sound from the detector represents the real time events of the detector. An increase in the clicking sound indicates an immediate increase in emissions. Page 5 of 18

6 Instrument Check Verify the operation of the instruments that will be used for this survey: Step Action 1. Check the calibration dates on the meters. If these have expired, the meters cannot be used until they have been calibrated. All GM Meters and Ion Chambers must be calibrated every 12 months or according to local regulations, whichever is shorter. 2. Turn on the meters and let them warm up for at least 2 minutes. 3. Check the GM Meter using its operational source, if applicable. 4. Check the batteries in the GM Meter and the Ion chamber. 5. -Set the 190 or 290 Meter to the most sensitive scale (0.1 mr/hr or 1.0 µs/hr). -Set the P-8 Neon sensitivity switch to the Alert setting. 6. Measure the background radiation level using the Ion Chamber and record it on the X-ray Safety Test Report. Page 6 of 18

7 This procedure shall be utilized in the following manner: Note: This procedure is to be used with 5DX Software Release 8.2 or later. If you are not using Software Release 8.2 or later, then you should follow the procedures contained in Agilent Part Number Note: Screenshots are taken from the All and Semi-annual procedures for a Series 3/5000. Screenshots for other procedures or systems may vary slightly. Selecting a Procedure Select the type of X-ray Safety Test you would like to run: Step Action 1. From the 5DX Main Menu, select Confirm and Adjust. 2. Select X-ray > X-ray Safety Test Page 7 of 18

8 3. Select one of the test options according to the table, below. To perform the following X-ray Safety Test: System Installation, System move, System re-certification, or "First Time" power up in 5DX Production Semi-annual X-ray Safety Test X-ray tube, HVPS, or IHVPS replacement Repair, replacement or adjustment of Lead Shielding Repair, replacement or adjustment of Inner Barrier Select the following menu option: All Semi-annual Replaced X- ray/hvps Replaced Lead Shield Replaced Inner Barrier Which will take you through the following sections of this procedure: Entire Procedure Preparation Interlock Verification High Power Test 1 High Power Test 2 Preparation High Power Test 1 High Power Test 2 Preparation Interlock Verification and Adjustment only on interlocks in contact with the affected assembly Low Power Test 1 of repaired Lead shielding Low Power Test 2 of repaired Lead shielding High Power Test 1 of repaired Lead shielding High Power Test 2 of repaired Lead shielding Note: Perform the test on the affected area or assembly and the area 12 inches (30.5 cm) out from edge of the affected assembly or area. Preparation Interlock Verification and Adjustment only on interlocks in contact with the affected assembly Low Power Test 2 of X-ray tower and opened outer barriers High Power Test 2 of X-ray tower and opened outer barriers High reading Normal Power Follow What if the reading exceeds Agilent s specifications? in the X- ray Safety Test Report Repaired X-ray emission High Power High Power Test 1 High Power Test 2 Note: When performing a spot test, circle the area tested on the X-ray Safety Test report and describe what was done in the This Test Report Includes section of the report. Note: No X-ray survey is necessary following routine use of the access panels to access the interior of the 5DX cabinet. The interlocks ensure the Access Panels have been returned to the correct position. Page 8 of 18

9 X-ray Survey: Long-Term Shutdown Step Action 1. Wait for completion of Long Term Shutdown. 2. On 5DX Series II and 2L system s, turn Motion Control Assembly off. Page 9 of 18

10 Preparation Follow these steps to visually inspect the system and prepare it for the survey: Step Action 1. Visually inspect the interior and exterior of the 5DX system cabinet for any damaged or missing shielding, seals, safety wires or safety screws. If any are found: Inform your manager/supervisor and Agilent 5DX Hardware Support. Perform a spot test of effected area using "What if the Reading Exceeds Agilent's Specifications" section of the X-ray Test Report. Repair or replace any parts that are damaged or missing. 2. Verify that all X-ray related service notes have been performed on this 5DX system: 5DX-39-S 5DX Serial Numbers DX-48A 5DX Series Numbers DX-50-S 5DX Series Numbers These Safety and Service Notes can be obtained on this website: Select Technical Support Select Service Notes Page 10 of 18

11 Interlock Verification and Adjustment Verify the operation of all safety interlocks by following these steps: 1. Check the actuation point and operation of each safety interlock switch on each moveable barrier and access panel using the tool kits listed in the "Required Tools" section of this document. 3. If any safety interlock switch does not meet the actuation distance requirements listed in the Safety Interlock Function and Adjustment tables in the X-ray Safety Test Report, adjust the switch until the requirements are met. 4. Write your initials in the tables when each specification is met. 5. Close and fasten all access panels that were opened for inspection. 6. As a precautionary measure, request all other people to stay at least one-meter away from the system during the X-ray Safety Test. Page 11 of 18

12 Low Power Test 1 Use these steps to scan the system at low power with the inner barrier(s) opened and the outer barriers closed, moving the stage up and down. (Low power test is done at 165 kv and 20 µa.) WARNING: If any reading exceeds 0.1 mr/hr (1.0 µs/hr) when measured with the GM Meter, immediately shutdown 5DX. Pressing the escape key will bring down the X-ray Current to 0 micro amps. Then shutdown the system, and use appropriate "Lock Out / Tag Out" Procedures. Notify your supervisor and Agilent 5DX Hardware Support. Step Action 1. To check for major X-ray emissions scan all cabinet surfaces using: The 190 or 290 GM Meter set to the most sensitive scale (0.1 mr/hr or 1.0 µs/hr) to check for major X-ray emissions. or Set the P-8 Neon sensitivity switch to the Alert setting. 2. After the entire exterior of the cabinet has been scanned, press any key to continue. Page 12 of 18

13 Low Power Test 2 Use these steps to scan the system at low power with the inner barrier(s) closed and outer barriers opened, and stage stationary. (Low power test is done at 165 kv and 20 µa.) WARNING: If any reading exceeds 0.1 mr/hr (1.0 µs/hr) when measured with the GM Meter, immediately shutdown 5DX. Pressing the escape key will bring down the X-ray Current to 0 micro amps. Then shutdown the system, and use appropriate "Lock Out / Tag Out" Procedures. Notify your supervisor and Agilent 5DX Hardware Support. Action To check for major X-ray emissions scan all cabinet surfaces using: The 190 or 290 GM Meter set to the most sensitive scale (0.1 mr/hr or 1.0 µs/hr) to check for major X-ray emissions. or Set the P-8 Neon sensitivity switch to the Alert setting. If Series II: Series 2L, 3 or 5000: Then Rescan all loader assembly surfaces. Rescan the X-ray tower and outer barrier surfaces. Page 13 of 18

14 High Power Test 1 Use these steps to test the system at high power with the inner barrier(s) opened and the outer barriers closed, moving the stage up and down. (High power test is done at 165 kv and 125 µa.) WARNING: If any reading exceeds 0.15 mr/hr (1.5 µs/hr) when measured with the Ion Chamber, press the escape key to bring down the X-ray Current to 0 micro amps. Follow the process in the X-ray Safety Test Report titled What if the Reading Exceeds Agilent's Specification. Step Action 1. Before proceeding to scan the system, read steps 2-5 below to become familiar with the scanning process. 2. Scan the system with the: 190 or 290 GM Meter set to the most sensitive scale (0.1 mr/hr or 1.0 µs/hr). or Set the P-8 Neon sensitivity switch to the Alert setting. If the meter reacts to an area, slow down the scan rate and rescan the area to isolate the location. Page 14 of 18

15 3. If the GM Meter reading exceeds 0.1 mr/hr or 1.0 µs/hr place a colored paper label on the location of the reading on the system. Example of paper labels Example of paper label locations 4. Turn the 190 or 290 GM Meter (if applicable) to the next higher scale (1.0 mr/hr or 10 µs/hr). Set the P-8 Neon sensitivity switch to the higher setting. 5. Recheck the location: If the GM Meter exceeds 1.0 mr/hr or 10 µs/hr. Immediately verify the reading with the Ion Chamber. WARNING: If any reading exceeds 0.15 mr/hr (1.5 µs/hr) when measured with the Ion Chamber, press the escape key to bring down the X-ray Current to 0 micro amps. Follow the process in the X-ray Safety Test Report titled What if the Reading Exceeds Agilent's Specification. If not, turn the 190 or 290 GM Meter back to the most sensitive scale and continue scanning. If not, set the P-8 Neon sensitivity switch back to the Alert setting. 6. When the entire system has been scanned: Mark an "X" on the test report for each location identified with the GM meter (paper labels). Re-check all marked locations with the Ion Chamber. Write the value of the Ion Chamber readings (including the unit) on the X-ray Safety Test Report. 7. Measure six locations on 5DX System using the Ion Chamber. Record the highest reading in that area. There is one location per side. These are shown on the Report. Write the highest reading from each of these locations onto the X-ray Test Report. 8. Press any key to continue. Page 15 of 18

16 High Power Test 2 Use these steps to test the system at high power with the inner barrier(s) closed and the outer barriers opened, and stage stationary. (High power test is done at 165 kv and 125 µa.) WARNING: If any reading exceeds 0.15 mr/hr (1.5 µs/hr) when measured with the Ion Chamber, press the escape key to bring down the X-ray Current to 0 micro amps. Follow the process in the X-ray Safety Test Report titled What if the Reading Exceeds Agilent's Specification. Action Before proceeding to scan the system, read steps 2-5 in High Power Test 1 to become familiar with the scanning process. If Then Series II: Rescan all loader assembly surfaces using the GM Meter following steps 2-6 of High Power Test 1. Series 2L, 3 or 5000: Rescan X-ray tower and outer barriers using the GM Meter following steps 2-6 of High Power Test 1. Page 16 of 18

17 Final Results Step Action 1. Complete the X-ray Safety Test Report. 2. Send the completed X-ray Safety Test Report to the AXI Hardware Support Manager. The address for the AXI Hardware Support Manager is located in the X-ray Safety Test Report. Note: If this survey was performed as part of the production process at the Agilent 5DX production facility, store the X-ray Safety Test Report in the System Log Book. End of Document Page 17 of 18

18 N Document Revision Record Change Authorization Process All changes to this manual must have original organization approval. All changes are made through the Agilent Production Change Order (PCO) procedure. Hard copies are uncontrolled and are not subject to updates unless authorized and issued by Document Control. Approval MSD R&D Hardware Manager Soh Ling Loke 1/25/2008 MSD R&D Radiation Safety Officer Soon Kong Kok 1/25/2008 EMG Radiation Safety and Siang Muh Tan 1/25/2008 Regulatory Engineer Revision Description PCO # Release Date Initi als A NEW MANUAL - Log #1 - first issue /07/03 JTR B UPDATE Added P-8 Neon GM meter as a new ECR /5/2007 GES approved meter. Removed the Radiation Alert Inspector GM meter from the approved list of meters. Cleaned up other sections of the document C UPDATE Added new approvers and cleaned up other sections of the document. NA 1/25/2008 GES Page 18 of 18