WI-0102 / Revision:
B / Approval:
Glenn Crabtree
Title:
NITON Analyzer XLt797 Operation / Higher Reference:
DP-0237
REV / DATE / DCO# /
AUTHOR
/ SYNOPSIS OF CHANGE/PARAGRAPH AFFECTEDA / 06/23/08 / D080193 / Edward C. Fink, Jr. / Initial Release
B / 07/22/08 / D080237 / Edward C. Fink, Jr. / Add paragraph 4.5.2.1 and Table II: Authorized Users. Update paragraph 4.5.4.1 to include RoHS Audits of 1st Piece Lots. Update paragraph 4.5.4.5.5.2 to add Picor Items and First Piece Items. Add paragraph 4.5.4.5.12.4.1 and Figure II: Periodic Table.
1. PURPOSE: This Work Instruction describes the NITON Analyzer XLt 797 Radiation Safety Program, proper operational procedures and operator maintenance procedures.
2. SCOPE: This Work Instruction is applicable to Incoming Inspection, Quality Assurance and the Process Lab.
3. LIST OF RESPONSIBILITIES
3.1. RoHS Compliance Manager.
3.2. BBU/VI Chip BU Quality Assurance.
3.3. Process Lab Supervisor.
3.4. Incoming Inspection.
3.5. Vicor Radiation Program Plan Manager.
4. PROCEDURE
4.1. The NITON XRF Analyzer XLt 797 was procured by Vicor Corporation for the [Quality Assurance]
institution of the RoHS Supplier Provided Material Audit Program and the Tin Whisker Verification Program described in DP-0237 and CST-0012.
4.2. When normally set up for operation, the NITON Analyzer will be connected via USB Cable, or other connecting mechanism, to a dedicated computer system for detector sensor operation and Analyzer Test down loads.
4.2.1. It is important to ensure the Analyzer is not exposed to strong electro-magnetic fields, such as those produced by Computer Monitors and Hard Drives.
4.2.2. Keep a minimum of two feet (0.7 meters) distance between the Analyzer and Electronic Devices.
4.3. This Work Instruction has been written to satisfy three important requirements of these Programs with respect to the NITON Analyzer.
4.3.1. First, this Work Instruction will provide the information required for adequate Radiation Safety, in conjunction with the Vicor Corporation NITON XRF Analyzer Model XLt 797 WZ Radiation Protection Program Plan.
4.3.2. Second, this Work Instruction will present the manufacturer approved NITON Analyzer Operational Procedures for use by the authorized users in normal operation.
4.3.3. Third, this Work Instruction will describe the required Operator Maintenance to be carried out by the authorized users in normal operation.
4.4. Radiation Safety
4.4.1. The NITON XRF Analyzer Model XLt 797WZ utilizes an X-Ray Tube to analyze, by X-Ray Fluorescence, the material make up of Items of concern for RoHS Compliance.
4.4.2. The NITON XLt Analyzer was designed so that virtually no measurable radiation external to any part of the analyzer can escape when the Analyzer is not in analyze mode and the shutter is closed. The NITON XLt Analyzer contains an X-Ray Tube, which emits no radiation at all unless the operator turns the X-Ray tube on.
4.4.3. The Vicor Radiation Safety Program for the NITON XLt 797 Analyzer is described in this Work Instruction and the Vicor Corporation Radiation Protection Program Plan. The Vicor Environmental, Health and Safety Manager has been designated as the individual in charge of the Radiation Protection Program (RPP).
4.4.4. The purpose of the RPP is to keep radiation exposure to operators of the NITON XLt 797 Analyzer to levels that are “As Low As Reasonably Achievable (ALARA)”, and to ensure that use of the NITON XLt Analyzer is in compliance with all State and Federal Regulations.
4.4.5. For any given source of radiation, three factors will assist in minimizing an operator’s radiation exposure: Time, Distance and Shielding.
4.4.5.1. Time
4.4.5.1.1. The longer an operator is exposed to a source of radiation the longer radiation is able to interact with the operator’s body and the greater the dose received. Dose increases in direct proportion to length of exposure.
4.4.5.1.2. Operators will keep time of Analyzer operation to the minimum required to accurately perform analysis.
4.4.5.2. Distance
4.4.5.2.1. The closer an operator is to a source of radiation, the more radiation strikes the operator. Based on geometry, dose increases and decreases with an inverse-squared relation to distance from the source of radiation. The Radiation dose one foot from a source is nine times greater than the dose three feet from the source.
4.4.5.2.2. Operators will keep hands and all body parts away from the front end of the Analyzer when the Shutter is open to minimize exposure, when the three Radiation LED Lights are blinking on and off.
4.4.5.3. Shielding
4.4.5.3.1. Shielding is any material that is placed between the operator and the radiation source. The more material between the operator and the source, or the denser the material, the less the operator will be exposed to radiation from the source.
4.4.5.3.2. The NITON Analyzer will be used by Incoming Inspection in conjunction with the Alloy Test Stand to conduct all material analysis. This Stand allows the Analyzer to be fastened firmly to it and has a shielded box used to hold all materials to be analyzed. The Alloy Test Stand has a Clear Viewing Plate fixed to one side of the containment box, and non-transparent shields affixed by Velcro to the other three sides of the viewing box.
4.4.6. Human Dose to radiation is typically measured in rem, or in one-thousandths of a rem, called millirem (mrem). The allowable limit for occupational exposure in the United States (and
many countries internationally) is 5,000 mrem/year for deep (penetrating) dose and 50,000 mrem/year for shallow (i.e., skin) dose or dose to extremities.
4.4.7. Deep, shallow, and extremity exposure from a properly used NITON XRF Analyzer should be less than 200 mrem per year, even if the analyzer is used as much as 2,000 hours per year, with the Shutter open continuously. The only anticipated exceptions to the 200 mrem maximum annual extremity dose are routine and frequent analysis of plastic samples without use of a Test Stand or improper use where a part of the body is in the primary beam path.
4.4.8. Table 1 illustrates the typical background radiation doses received by members of the American public. The typical dose received from the NITON Analyzer XLt 797 is 200 mrem/year, which is lower than the average annual worker exposure in the United States.
Table 1: Typical Radiation Doses Received
Average total dose in US (annual) / 360
Average worker exposure (annual) / 210
Average exposure for an underground miner / 400
Exposure for Airline Crew (1,000 hours at 35,000 ft) / 500
Additional from living in Denver at 5300’ (annual) / 25
Additional from 4 pCi/I radon in home / 1,000
Typical Chest X-Ray / 6
Typical Head or Neck X-Ray / 20
Typical Pelvis/Hip X-Ray / 65
Typical Lumbar Spine X-Ray / 30
Typical Upper G.I. X-Ray / 245
Typical Barium Enema X-Ray / 405
Typical CAT Scan / 110
4.4.9. Individuals can be monitored for the radiation dose they receive by use of Radiation Dosimetry Devices (Dosimeters). All Vicor Authorized Operators of the NITON Analyzer XLt 797 shall be required to use a Dosimetry Device during all operation of the NITON Analyzer for RoHS Verification Audits.
4.4.9.1. Vicor Dosimetry Devices - Based on recommendations from the Commonwealth of Massachusetts DPH Inspector Vicor personnel will use Whole Body Badges, which should be worn at chest height.
4.4.9.2. These Devices shall be maintained in Dosimetry Device Racks located in the MRB Cage, and all Devices shall be stored in these Racks when not in use.
4.4.9.3. The Dosimetry Device Program shall be operated by the Radiation Protection Program Manager.
4.4.9.4. Vicor NITON XRF Analyzer Operation personnel shall be required to wear Whole Body Dosimeters for one year. It will be determined at the end of one year if this requirement can be discontinued, or if it is required to be maintained.
4.4.9.5. All personnel shall place their assigned badge on their person when they begin a RoHS Audit Inspection or other test and replace the dosimeter in the holder in the MRB Cage when the inspection/test is completed.
4.4.10. Pregnancy Precautions
4.4.10.1. Vicor strives to always ensure the safety of all employees. Any employee with a medical concern is urged to address that concern with their supervisor or manager.
4.4.10.2. With respect to pregnancy concerns and the use of the XRF Analyzer, pregnant Operators may want to take special precautions to reduce their exposure to radiation.
4.4.10.3. Massachusetts Department of Public Health (MDPH)-Regulations for the Control of Radiation 105CMR 120.00 recommend that the radiation dose to a pregnant woman should not exceed a total of 500 mrem during the gestation period.
4.4.10.4. It is the responsibility of the pregnant operator to decide when and whether she will formally declare her condition to her employer. The Massachusetts Department of Public Health Regulations state “A declared Pregnant Woman means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant”
4.4.11. NITON Analyzer Radiation Safe Operation
4.4.11.1. The Vicor Corporation NITON Analyzer XLt 797 is designed to be safe to operate provided it is used in accordance with manufacturers’ instructions and this Work Instruction (WI-0102). According to Thermo Fisher Scientific Corporation, under conditions of normal use, monitored operators seldom receive a measurable dose of radiation and have not been known to receive in excess of ten percent of the annual occupational dose limits. In addition to proper use of the NITON Analyzer XL 797, the following precautions shall be followed to ensure operator’s safety and the safety of all Vicor employees.
4.4.11.1.1. Know where the beam is. The Primary Beam is a directed beam out of the front of the Analyzer via the Kapton Window.
4.4.11.1.2. Know when the beam is on. When the three X-Ray Beam Indicator Lights are flashing, the Primary Beam is on, the Shutter is open, and radiation is being emitted from the front of the Analyzer. This does not include the brief flash of lights when the unit is first turned on.
4.4.11.1.3. Never aim the Primary Beam at yourself or others.
4.4.11.1.4. Never hold a sample for or during testing.
4.4.11.1.5. Handle and use the NITON Analyzer with respect. Avoid holding the front of the Analyzer when the Shutter is open and the X-Ray Tube is energized.
4.4.12. NITON Analyzer Storage and Transportation
4.4.12.1. It is recommended that the NITON Analyzer is kept locked in a secured area. Vicor Corporation shall maintain the NITON Analyzer XLt 797 locked in the MRB Area or locked in an Incoming Inspection Storage Locker when not in use or affixed to the Alloy Test Stand.
4.4.12.2. There are no specific US Department of Transportation (DOT) and International Air Transport Association (ATA) regulations regarding the shipment of the NITON Analyzer XLt 797. It is recommended that the Analyzer is shipped in its hard-plastic case and with an over-pack to protect the sensitive measuring equipment inside the Analyzer.
4.4.13. Emergency Procedures
4.4.13.1. In any case where the Operator suspects that the X-Ray Tube remains on when the measurement is terminated:
4.4.13.1.1. Disconnect the Battery Pack immediately to turn off the X-Ray Tube.
4.4.13.1.2. Call Thermo Fisher Scientific Corporation’s Service Department in the United States, toll free, at (800) 875-1578.
4.5. NITON Analyzer XLt 797 Proper Operation
4.5.1. The NITON Analyzer shall be used to conduct RoHS Compliance Audits of supplied Product in accordance with DP-0237.
4.5.2. The NITON Analyzer shall be operated only by approved users per the NITON Analyzer Radiation Protection Program.
4.5.2.1. The List of Approved Users is shown in Table II:
Table II: List of Approved Users.
4.5.3. The NITON Analyzer shall be operated in accordance with approved Thermo Fisher Scientific Operating Instructions and Users Manuals and this Work Instruction.
4.5.4. Proper NITON Analyzer Usage
4.5.4.1. In accordance with DP-0237, each lot of Supplier provided material, either Incoming Inspection Material or First Piece Inspection Material,properly identified as requiring a RoHS Audit shall be tested for RoHS Compliance by the appropriate personnel using the NITON Analyzer.
4.5.4.2. Prior to beginning each Material Analysis using the NITON Analyzer, the following steps shall be taken:
4.5.4.2.1. The operator will inspect the condition of all Radiation Labels on the NITON Analyzer. All Labels should be fully legible, firmly adhered and free of any contamination.
4.5.4.2.2. The operator will inspect the condition of the Kapton Window. Clean the Kapton Window gently, as required, using a clean cotton swab. The Kapton Window shall be free of frays, nicks and particulate contamination.
4.5.4.2.3. If the Kapton Window becomes frayed, ripped, or contaminated with metal particulates, replace it with a new window per Paragraph 4.6.2.4.
4.5.4.2.4. The operator shall complete the Operator Record of Use Log maintained at the NITON Analyzer Workstation. Refer to the Vicor Radiation Protection Program for instructions on proper completion of the Use Log. The Operator Record of Use Log is shown in Figure 1.
Figure 1: Operator Record of Use Log.
Niton XRF Analyzer – Model XLt 797 WZ
Operator Record of Use Log
XRF Serial # / Date / Start Time / Detector Calibration Result / EndTime / Responsible Individual
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· This Log Sheet shall be saved indefinitely and be available for Regulatory Inspection. A copy of completed log should also be given to Ed Gomes EH&S Manager. If you have any questions or concerns contact Edward Gomes RSO/EH&S Manager at ext. 7730. RSO – Radiation Safety Officer.
4.5.4.2.5. Prior to beginning any inspections using the NITON Analyzer, ensure it is firmly inserted into the Alloy Test Stand and its attendant Computer is properly configured and has been turned on. Complete the following steps:
4.5.4.2.5.1. Insert the Battery Pack
4.5.4.2.5.1.1. Rest Niton Analyzer on a clean surface. Avoid damp or dusty environments.
4.5.4.2.5.1.2. Point the front of the analyzer away from you.
4.5.4.2.5.1.3. Fully insert the battery pack, making sure that it seats properly.