S5100-2002 - GEX Corporation
Contents
1. JP Back 4 Bi i Mame ODEUNST FJ Winamp Acrobat Distiller 5 0 Then click the Windows Start button and navigate to the WINdose for Excel 2002 shortcut NEE Right click the shortcut and select Delete from the E Smart Label Printer menu or change the path to a WINdose for Excel fin EN Extel 2002 J 34 WiNdose for Excel z002 Calibration Specific Workbook file EY Adobe Acrobat 5 0 fi Smead VIEW ables 100 153 082305 2002 GEX CORPORATION Page 7 of 26 Dose Measurement and Control Customizing Facility Information UNAUTHORIZED MODIFICATION OF WINDOSE FOR EXCEL WORKSHEETS CAN VOID THE VALIDATION Contact GEX Corporation for information and requirements related to modification of any of the preformatted worksheets GEX maintains formal change control over the W Ndose for Excel software and will provide users with a controlled means of customizing the software to specific user needs in a controlled manner GEX CORPORATION 7330 S Alton Way Unit 12 l Centennial CO 80134 Phone 303 400 9640 Fax 303 400 9831 Email sales gexcorporation com 100 153 082305 2002 GEX CORPORATION Page 8 of 26 Dose Measurement and Control Basic Operation STARTING THE EQUIPMENT Start your computer before turning the Genesys 20 instrument on The instrument may be turned off and on without rebooting your computer It is good practice to turn the instrument off and on once per day to allow it to2. A Dose Measurement and Control WINdose for Excel 2002 Installation amp Operations Manual Dose Measurement and Control REQUIREMENTS W Ndose for Excel 2002 is designed in a Microsoft Excel platform W Ndose for Excel 2002 was developed and intended for use as a component of the GEX W Ndose Dosimetry System It was designed to provide communication between the Thermo Spectronic Genesys 20 spectrophotometer and an IBM compatible PC with a Microsoft Windows 2000 or high operating system and Microsoft Excel 2000 or higher spreadsheet application program The program contains communication files that are not compatible with older versions of these Microsoft Products DISCLAIMER and GENERAL PRECAUTIONS The WiNdose for Excel software program is intended for use in the preparation of standardized Dose Report forms that are printed reviewed and authorized as documents by the end user The software was not designed to provide database or information storage in any manner The user is responsible for verification of the accuracy of the data contained in the reports generated using the W Ndose for Excel software Users are also responsible for determining the suitability and performance of the software for their specific applications GEX Corporation does not warrant the data input or output associated with this software All dose results and any subsequent usage of the data derived from usage of this software are the sole responsibility of
3. Instrument Note that the cell F13 is highlighted and its formula appears in the Formula Bar Then click on the range and it turns color noting that it is selected Then if you scroll down you will see the range highlighted with a border box like the example below Conveyor Speed ag Rate PPS Scan Frequency Hz Technician Dosimetry Date Average Dose y ERAGE H20 Std Dev 204 CV 15 14 Instrument Correction Factor 1 00 Welength 554 nm Average Thickness t Dosimeter Batch BaWiNdose AA CalibratiotNQate 11 17 01 Initial Average Absorbance Ao Calibration ID GEX DEMO Dose Rang 1 15 65 hoy Distance Irradiated Response Adjusted Relative Dose Dosimeter ID Inches Absorbance Ai ai aojet Dose kGy Dose kGy Adj Dose Ave Do 0 105 3 529 38 ooo0002 0168 7 8148 100 OOO000S 0 246 11 251 144 oooo004 0 257 11847 18 3 OOOOO0S 0 255 11754 13 2 Note in the example below there are two boxes that you must resize for the desired range In this case one Is blue and one Is green Extend or shorten the boxes depending on the modification required to achieve the desired range Conveyor Speed Pulse Rep Rate PPS Scan Frequency Hz Technician Dosimetry Date Average Dose kGy 24AGE H22 H4 Std Dev 2 04 CV 15 14 instrument gt Correction Factor 1 00 Wavelength 554 nm Average Thickness t Dosimeter Batch BaviNdose AA Calibration Date 11 17 01 Initial Average Absorbance Ao Calibration ID G
4. you will receive your calibration specific curve data file with the Calibration Report This Calibration Specific Workbook file will need to be installed into the WINdose for Excel 2002 folder in the Program folder on the Hard Drive You can remove the demo curve at time you install the Calibration Specific Workbook file Hardware Installation Attach the RS 232 cable to the Genesys 20 spectrophotometer and to the COM1 port on the computer The WiNdose for Excel software is set to only recognize the COM1 port Be sure this is set appropriately or the data input function will not work Every time a workbook is opened the program will check for a connection to a Genesys 20 spectrophotometer If it cannot find one a warning message indicating that the spectrophotometer function is disabled will appear after about 30 seconds The W Ndose for Excel software program can also be operated without the computer being connected to the spectrophotometer by manual entry of the absorbance values If used attach the bar code reader GEX P4201 to the computer Unplug the computer keyboard and plug it into the Y adapter supplied with the reader Plug the Y adapter into the keyboard port on the computer The bar code reader does not require any additional software installation 100 153 082305 2002 GEX CORPORATION Page 6 of 26 Dose Measurement and Control Installing your Calibration Specific Workbook The demonstration curve installed automatically
5. cell to the right column D Dosimeter irradiated Response _ Adjusted Dosimeter ID Position Absorbence A ai aopitt Dose kGy Dose kGy 1294567 Reference Place a dosimeter in the spectrophotometer When the value is stable press these three keys simultaneously Ctrl Shift a The absorbance value measured by the spectrophotometer will be placed in the cell the response value doses calculated and a new row inserted with the cursor placed in the Dosimeter ID column Dosimeter Irradiated Response Adjusted Dosimeter ID Position Absorbence Ai ai aoytt Dose kGy Dose kGy 1234567 Reference 0 250 11 475 14 0 14 8 F 0 000 Na 100 153 082305 2002 GEX CORPORATION Page 12 of 26 Dose Measurement and Control The three standard worksheets vary by the number of replicate absorbance values the worksheet uses Above you saw how to fill in the B3000 worksheet In a B3002 worksheet two dosimeter replicates per package use the Ctrl Shift a command to transfer the replicate A absorbance value column D and the cursor moves to the next column E Dosimeter Irradiated Absorb Response Adjusted Desimeter ID Position A B fai aAojit Dose kGy Dose kGy 1234567 Reference Then use Ctrl Shift a again for replicate B From replicate B column E Ctrl Shift a inserts the absorbance value calculates dose and a new row is created with the cursor placed in the Dosimeter ID column ready for a new dosime
6. low level At the low level the above screen will not appear The program will search for the spectrophotometer for up to 30 seconds During this time a message will appear on screen as shown below COMM PORT OPEN Zi ESTABLISHING COMMUNICATIONS with SPECTROPHOTOMETER PLEASE WAIT 100 153 082305 2002 GEX CORPORATION Page 9 of 26 Dose Measurement and Control If the program cannot communicate with the spectrophotometer within 30 seconds the following warning message will appear Close the program and check the RS232 cable connections if a soectrophotometer is connected B3 WiNdose Warning AN Unrecognized Spectrophotometer connected Spectrophotometer function disabled NOTE This is a warning message not an error message It will appear every time the program is started without a Genesys 20 spectrophotometer You may use the program without the computer being connected to the Genesys 20 spectrophotometer but there is up to a 30 second delay required by the software for the spectrophotometer search to complete See Appendix A called Manual Mode Operation for more information STARTING YOUR FACILITY SPECIFIC PROGRAM Open your facility specific file The same operations will occur as when opening the demo file detailed on the previous page The program will search for the spectroohotometer and the message from the previous page will appear During this period the standard Excel edit menus at the to
7. strips were overlapped simply change the distance in the first cell C20 to the actual distance in inches and cell C21 to increment the proper distance Measuring the Strips of Dosimeters Measure the irradiated absorbances of each dosimeter on the strip from end to end as described in the Basic Operation section of this manual For this type of worksheet new rows are not added as in the basic dosimetry worksheets NOTE It is easiest for manual mode users to enter all of the absorbance values and then use the Ctrl Shift d command to calculated doses Calculating the Uniformity The worksheet automatically calculates the dose relative to the entrance dose in column J The relative dose is calculated by dividing the measured dose by the average of the measured doses The worksheet also automatically calculates the average dose the standard deviation of the doses and the coefficient of variance CV of this average The CV is the expressed as a percent For some types of uniformity measurements such as scan width height users may wish to select the flat a portion of the curve and eliminate the overscan tails for the uniformity measurement The example below shows how this may be performed EXAMPLE The following is an example of a scan width height test showing how the electron beam drops off at the end of the scan Uniformity is tested over the area of greatest interest in this situation the width of a product tote 20 inches wide Dosime
8. that were processed 4 Quantity Quantity of the product processed 5 Process Date Date the product was processed 6 Technician Name of the technician performing the dosimetry and filling out the report 7 Dosimetry Date Date the dosimetry for the process run was performed 8 Instrument The name and or serial number of the spectrophotometer used in the dosimetry measurement 9 Process Number Identification number assigned to the specific process run 10 Process Specification Identifier of the Process Specification that defines the master processing specifications 11 Dmin Ref Ratio The ratio of the reference monitoring position to the minimum dose position on the product E Beam or carrier Gamma established during dose mapping 12 Dmax Ref Ratio The ratio of the reference monitoring position to the maximum dose position on the product E Beam or carrier Gamma established during dose mapping 13 Min Dose Spec The determined minimum dose the product must receive as specified in the Product Specification 14 Max Dose Spec The determined maximum dose the product can receive as specified in the Product Specification 100 153 082305 2002 GEX CORPORATION Page 17 of 26 Dose Measurement and Control 15 Max Temp in Process C The maximum temperature that was observed in the process run as determined by finding the maximum temperature in the P8003 Max Temp column 16 Min
9. the Standard Deviation Std Dev by the Average Dose It is then multiplied by 100 so it can be expressed as a percent This formula needs no change as you have already modified the range for the two components that are used to calculate CV Typically a CV demonstrating good uniformity is one that does not exceed the dosimeter calibration uncertainty 100 153 082305 2002 GEX CORPORATION Page 22 of 26 Dose Measurement and Control B3110 Appendix GEX WIiNdose for Excel B3110 Energy Wedge Card Array DESCRIPTION The B3110 product and its associated W Ndose for Excel worksheet were specifically designed for use with the Ris aluminum wedge to estimate energies based on an extrapolated range technique for electron beam accelerator systems with approximate energies of 2 20 MeV The product uses an array of B3W Ndose dosimeters spaced at specific depth intervals on a die cut card with two alignment holes that fit snuggly over the posts on the Ris wedge The B3110 product is specifically designed for use with the Ris HDRL two piece aluminum wedge 12 cm wide by 14 cm long by 2 9 cm thick when assembled with a nominal 16 angle When the dosimeter optical absorbances are read into the worksheet and the corresponding doses calculated an energy can be estimated using certain equations given in ISO ASTM 51649 The worksheet also contains a chart that updates automatically and plots the dose point values per thickness depth A trendlin
10. the worksheet will be recomputed You can also place the cursor in the calculated dose column of the last row and re compute doses by using the Ctrl Shift d command which will re compute doses for the entire worksheet MISSING or DAMAGED DOSIMETERS WARNING Should one dosimeter be damaged out of a group i e 1 replicate out of 2 for the B3002 the following steps MUST be followed to record an accurate measurement 1 The software requires that a value be entered in the first absorbance column if there is more than one on a particular worksheet Therefore in the example of the B3002 even if Replicate A is damaged you must enter Replicate B in the first absorbance column in order for the program to calculate doses 2 Inthe example above you must delete the 0 000 from the Replicate B absorbance column so that the column is blank null The response calculates an average of the two absorbance columns in this case and it will count the 0 000 as a value and divide the sum of the two absorbances by 2 to get the average if you do not make the unused column null See the examples below INCORRECT METHOD Dosimeter Irradiated Absorb Response Adjusted Dosimeter ID Position A B Ai Aojit Dose kGy Dose kGy t234567 Reference 0 250 4 645 na Dosimeter Irradiated Absorb Response Adjusted Position A B Ai Aojit Dose kGy Dose kGy 1234567 Reference 11485 100 153 082305 2002 GEX CORPORATION Page 14 of 26 Dose Measurement and Co
11. 64 17 8 HoOooo5 0 274 12077 17 2 oOOooe 0 263 12 208 15 9 dogni 0 246 11240 144 E O D 4 10 033 127 EME _ KM 6 025 10 3 oo0oo20 o 180 7 634 4 3 F jpoggi 0 153 bis 0 73 F noo0g22 0 132 5 01 5 3 F ao00023 o 108 3738 a F noo0024 EE 2650 27 F p005 0 07 1623 UnderAange F jo00026 O 064 1333 Under Range 153 35 9335 5 i Wii ie i i i a l Depth Points Selected Slope Foints Regression Line Dose kGg 1 50 Depth cm Sample Trendline Editing ie 0 305 14 633 a7 000002 0 305 14 694 EN ooo00013 0 298 14 104 18 8 goooC4 0 286 12 464 178 OOO0015 0 279 ory ma NOOO 0 263 12 208 159 COOOOT 0 246 1 240 14 4 000o0g DY 10 033 127 ooo o 201 8 825 10 5 F oo00g20 OMD 7 634 a3 F pooo02t 0 153 6197 73 F 0000022 0 132 5 011 5 8 F poo0023 0105 3738 P F dogogz4 0 089 2650 O 27 F 0000025 0 070 1623 Under Range F oO00026 o 064 1339 Under Range IE Depth Points Selected Slope Pointe Regression Line a a i TITYS i a Dia A i TYTY 7 t m ii 1 50 Depth cm 100 153 082305 2002 GEX CORPORATION Page 25 of 26 Dose Measurement and Control Select cell C65 Slope formula Click into the formula bar and edit the data range either manually or by dragging all the boxes to the same cells that were selected for the trendline Select cell E65 Y intercept formula Click into the formula bar and edit the data range either manually or by dragging the boxes to the sa
12. Dose in Process The estimated minimum dose in process determined by taking the lowest Adjusted Dose in the process multiplied by the Dmin Ref Ratio from process specification 17 Max Dose in Process The estimated maximum dose in process determined by taking the highest Adjusted Dose in the process multiplied by the Dmax Ref Ratio from process specification 18 Correction Factor A linear correction used to adjust dose calculations based on calibration specific data e g a correction of 0 10 can be used to convert from kGy to Mrad 19 Dosimeter Batch The dosimeter batch that was calibrated and that is valid for use with the Calibration Specific Workbook ID being displayed 20 Calibration ID The GEX assigned calibration ID for the specific best fit curve that the software is using to calculate doses 21 Wavelength The wavelength at which the spectrophotometer must be set to read dosimeters from the Dosimeter Batch 22 Calibration Date The date the dosimeter batch calibration was performed 23 Dose Range The range of doses that the calibration is certified for and thus the range within which the software can estimate doses 24 Average Thickness The average thickness of the dosimeter batch used for the calibration 25 Initial Average Absorbance The initial average background absorbance of the dosimeter batch used for the calibration 26 Software Version The version of the W iNdose for E
13. EX DEMO Dose Range Sto 65 kay Distance Irradiated Response Adjusted Relative Dose Dosimeter ID Inches Absorbance Ai ai aoyre Dose kGy Dose kGy Adj Dose Ave Do 1 0 105 3 520 20 3 6 DOOUOO 0 159 0 148 10 0 OOOO00S 0 246 11 251 i44 oooo004 U 25 411 847 15 3 OOOOO0S 0 258 11 754 15 2 OOOO008 0 244 11 153 14 3 100 153 082305 2002 GEX CORPORATION Page 21 of 26 Dose Measurement and Control Conveyor Speed Pulse Rep Rate PPS Scan Frequency Hz Technician Dosimetry Date Average Dose kGy H22 H49 Std Dev 204 CV 15 18 Instrument Correction Factor 1 00 Wavelength 554 nm Average Thickness t Dosimeter Batch BavViNdose AA Calibration Date 11 17 01 Initial Average Absorbance Ao Calibration ID GEX DEMO Dose Range 510 65 kay Distance Irradiated Response Adjusted Relative Dose Dosimeter ID Inches Absorbance Ai ai acyit Dose kGy Dose kGy Adj Dose Ave Do 0 105 3 529 3 0 3 5 0 26 OOOU002 0 159 5 148 10 0 40 0 0 74 gogooooa 0 246 11 251 144 1 07 poang 0 257 t1547 153 1 14 OOO0005 0 255 11 754 15 2 1 13 ODOOOU008 0 244 11 153 143 1 06 The range now begins at H22 Resize the bottom portion of the box in the same manner until you have the desired range Std Dev formula cell H13 Perform the same actions as for the Average Dose formula They should utilize the same range of dosimeters CV cell J13 The coefficient of variance is calculated by dividing
14. all The enclosed CD contains the installation program for WINdose for Excel 2002 Turn off virus detector software before installing WiNdose for Excel as some files required to establish communication with the spectrophotometer must be written directly into the Windows System folder Virus detectors can be turned on again after the installation is complete WINdose for Excel 2002 must be installed on your computer s Hard Drive Do not install the program over a network as it will not function Installation Using the CD 1 Close all programs and insert the WINdose for Excel CD 2 Open the CD and view contents 3 Read and follow any README files that contain version specific information and additional instruction 4 Double click setup Setup will load the installation program and check your system setup 5 Follow the installation instructions on screen 6 Depending on the existing software components in the computer system Setup may require that the computer be restarted 7 An Adobe Acrobat PDF copy of the WiNdose for Excel Manual is also found on the CD CAUTION Setup installs a demonstration curve during the initial W Ndose for Excel installation This curve is not appropriate for use at your process facility if dose traceability is required Contact GEX to obtain current industry recommendations related to performing a traceable calibration of specific dosimeter batches After you have performed a traceable calibration
15. an IBM compatible computer with a Microsoft Windows operating platform and MS Excel with MS Visual Basic tools to operate Individual process run dosimetry worksheets are used in the customized MS Excel workbooks to provide a means of user data entry for specific GEX products Users complete the preformatted worksheets filling in colored space holders with appropriate data specific to the process run Information includes the technician name date the product information and run identification number process date s etc Dosimeter specific information including batch ID and calibration ID calibration coefficients etc are stored in the specific WINdose for Excel workbook itself After the process information is entered the measurement process begins The WINdose for Excel software uses MS Visual Basic code and custom macros embedded in an MS Excel workbook to transfer absorbance values directly from an integrated spectrophotometer hand entry of the absorbance is also available The W Ndose for Excel 2002 software version was designed to work only with the Thermo Spectronic Genesys 20 model spectrophotometer using an RS2382 bi directional communication link The Genesys 20 display shows the current dosimeter absorbance value that allows the operator visual verification of the data values as they are transferred into the computer software The Genesys 20 is preset at the factory to default to the 554 nm wavelength of the B3 dosimeters at the conclus
16. by the WINdose for Excel 2002 Installation program is for training and practice only It needs to be replaced with your dosimeter batch Calibration Specific Workbook a separate WINdose for Excel 2002 file containing batch specific calibration data supplied by GEX before using WINdose for Excel 2002 at your facility to perform dosimeter batch specific measurements that are traceable to a national standard Please maintain a Master copy of the Calibration Specific Workbook supplied with GEX Calibration Reports on CD ROM in a secured place INSTALLATION Copy your Calibration Specific Workbook s file s to the directory C Program Files WINdose for Excel 2002 on the computer It is recommended that the demo this file is an Excel file named WINdose for Excel 2002 curve workbook file be removed at this time This completes the installation of the Calibration Specific Workbook s W Ndose for Excel will require selection of the appropriate Calibration Specific Workbook file the next time the program is opened As an option create a shortcut to the specific W Ndose for Excel file Use standard Windows methods to create the shortcut Instructions for Removing WINdose for Excel 2002 Demo file Browse to the directory C Program Files WINdose for Excel 2002 Highlight the WINdose for Excel 2002 file as shown in WiNdose for Excel 2002 OES the picture Press the Delete key or drag it to the Recycle Bin File Edit View Favorites T
17. dance with the Installations and Operations Manual An Exception Log was maintained throughout the verification and validation testing to report software exceptions from the specifications and performance requirements All Exception Log items were completed and closed and a revision level software version ID was designated to control future software changes The verification and validation testing demonstrated that the W Ndose for Excel 2002 product meets is full design specifications and operational performance requirements when the software is used with the specified WINdose Dosimetry System components in accordance with the instructions provided in the W Ndose for Excel Installation and Operations Manual and related procedures contained in the GEX 6100 Procedure Template Notebook The verification and validation testing also determined that the master constants used in the software were appropriate for the requirements and intended functionality of the software product and provided verifiable results that are repeatable and reproducible The results of the hazards analysis testing provided several improvements to reduce or eliminate potential function errors or change through misuse abuse or inadvertent user actions In addition several user information advisories and warnings were included that identify potential sources of non conformance conditions as a result of inappropriate or unauthorized user actions Users are instructed to perfor
18. dosimeter on the wedge card from top to bottom in sequential order filling in the worksheet as described in the Basic Operation section of this manual For this type of worksheet new rows are not added as in the standard dosimetry worksheets It may not be necessary to measure all dosimeters on the card the lower the energy the less penetration and therefore fewer dosimeters receive a dose Discontinue making measurements after obtaining two or three absorbance measurements that are near dosimeter background Estimating the Energy The worksheet automatically calculates and plots the dose values against the thickness of the aluminum 100 153 082305 2002 GEX CORPORATION Page 23 of 26 Dose Measurement and Control Extrapolated Range cm NOTE The fitted series Slope amp Y intercept and the Slope 19 92 Y ntercepy42 22 Trend line on the chart defaults to the 15th through 21st dosimeters only The data ranges should be R50 Rex adjusted by the user to incorporate more or fewer Lf data points appropriate to the energy being tested See the Witidose for excel 2002 Installation and Ea Operations manual for detailed instructions Ea and Ep calowefed using oA cTM formuee AS 79 and A310 respectively per ILAR Renod 35 Adjusting the Energy Calculation and Graphical Representation The Extrapolated Range formulas the Estimated Energy formula and the Trendline on the chart are preset to ranges typical for 5 or 10 MeV If needed t
19. e is plotted for the trailing penetration slope to determine the intercept factor used to estimate the energy GENERAL INFORMATION Users should have a working knowledge of basic Microsoft Excel functions and charts in order to use the worksheets and manipulate the charts effectively The template is not completely protected to allow user flexibility Some cells are unlocked to allow a user to adjust the curve fit for use with various energy systems The range of data used for the energy calculations and graphical plotting are preset at GEX These ranges may need to be modified by the user to achieve the desired result For information regarding using the Riso Wedge refer to GEX procedure template 100 260 The GEX website always has the current revisions of GEX procedure templates Measuring the B3110 Wedge Card Array Open the workbook and select the appropriate worksheet from the tabs at the bottom of the screen Enter the processing information in the top section of the worksheet This information should be entered so that beam parameters can be documented A standard set of process parameters should be used to establish a baseline and used for subsequent energy tests thereafter For guidance see ISO ASTM 51649 The dosimeters are provided in sequential order for user convenience Enter the first dosimeter number into cell B20 and the worksheet will automatically fill in the remaining numbers Measure the irradiated absorbances of each
20. erpendicular scan uniformity The B3106 strip cards may be joined to form strips of continuous lengths or staggered overlapped to increase the measurement interval resolution GENERAL INFORMATION Dose uniformity techniques and requirements are described in both ASTM ISO 51649 and ASTM ISO 51818 Users should have a working knowledge of basic Microsoft Excel functions and charts in order to use the worksheets and manipulate the charts effectively Some cells are unlocked to allow users to adjust them for their specific systems For detailed instructions on performing measurements using the B3106 Uniformity Strips see GEX Procedure Template 100 261 in our S6100 Procedure Template Notebook this can be downloaded from the GEX website as with all recommended procedures or your company specific procedure if applicable Measuring the B3106 Uniformity Measurement Strip Open W Ndose for Excel and select the B3106 worksheet from the tabs at the bottom of the screen Enter the processing information in the top section of the worksheet NOTE The specialty worksheets may require modification of formulas from the preformatted state The dosimeters in each strip are provided in sequential order for user convenience Enter the first dosimeter number into cell B20 and the worksheet will automatically fill in the next nine numbers If you are using more than one B3106 strip for one direction s length simply enter the first dosimeter of the nex
21. he user may define the quantity and location of points that are used to estimate the energy Some experimentation may be necessary to determine the ideal fit Depth Dose Curve and Regression Line Depth Points Selected Slope Points Regression Line Dose kisy x Flot Area 1 50 Depth cm Sample of a curve fit before selecting appropriate data range In the example above the points preformatted for the energy calculation are not the most preferred for the test The points used will need to be modified along with the calculations of slope and y intercept It is usually easiest to begin with adjusting the trendline on the chart The trendline on the chart is not linked to the other formulas Adjusting this fit first guides the user in adjusting the calculations 100 153 082305 2002 GEX CORPORATION Page 24 of 26 Dose Measurement and Control The steepest slope for the fitted portion of the depth dose curve should be used for energy analysis The blue spots represent all of the relative doses in the stacks The magenta spots represent only the relative doses selected for the trendline curve fit Click onto one of the magenta spots The active data ranges for the trendline fit are highlighted Select drag or resize the range boxes to ranges that result in a slope that incorporates at least 5 depth and dose measurements oooooT 0 305 14 6595 a7 pongo 0 204 14 634 147 gogz 0 298 404 18 8 ggo D28 13 4
22. ift a command is used When there is no spectrophotometer or communications have been lost Ctrl Shift a will write a zero into the absorbance column cell and still insert a new row as it does when connected to a spectrophotometer If an absorbance value is manually entered using a keyboard the Ctrl Shift a command is still used to calculate doses and create new rows The difference is that the command must be executed from the Response column of the dosimeter you are working on All other operations of the Calibration Specific Workbook remain the same STANDARD WORKSHEETS Follow these steps to use the B3000 B3002 and B3004 worksheets in the manual mode e Start with the first dosimeter measurement in row 20 Fill in the dosimeter number position and the absorbance measurements using the keyboard e Using the arrow key move the cursor to the Response column Press Ctrl Shift a and the doses will calculate and a new row will be created SPECIALTY WORKSHEETS The Ctrl Shift a will work the same in manual mode when executed from the Response column New rows are not inserted on these worksheets when the command is executed You also have the option of using a different command on the worksheets to calculate doses in the manual mode This involves reading all dosimeters using the tab arrow or enter keys to move to the next absorbance and once you have entered all measurements use the Ctrl Shift d command with the cursor o
23. ion of the automated instrument startup process Dosimeter ID s are recorded by the operator along with their specific measurement locations The software program accepts this data via direct input through the computer keyboard or through a keyboard wedge barcode reader The B3 dosimeter packages are then opened the dosimeters removed and transferred into the dosimeter holder and into the readout compartment of the spectrophotometer A digital value of absorbance is displayed on the spectrophotometer Once the readout value is stable and observed as reasonable a computer keyboard command is used to instruct the software program to transfer the spectrophotometer value into the worksheet The operator verifies that the value displayed on the instrument was correctly transferred and inserted into the worksheet As each absorbance value is entered an embedded formula automatically calculates the response value net change in absorbance per dosimeter thickness and the dose from your batch calibration curve coefficients A separate command can be used to calculate doses if absorbance values are manually entered Applicable reference dose position ratios may be applied to calculate a Dmax and Dmin dose for the run The completed process run specific W Ndose for Excel worksheets may then be printed reviewed authorized and archived 100 153 082305 2002 GEX CORPORATION Page 5 of 26 Dose Measurement and Control WINdose for Excel 2002 Quick Inst
24. m an initial verification test of the dose formulae upon receipt of each Calibration Specific Workbook by using absorbance values from the Dose Estimate Table in the associated GEX furnished Calibration Report see GEX procedure template 100 255 for a recommended procedure for verifying the validity of the dose calculations in W Ndose for Excel The estimated dose value obtained should match the dose estimate value in the Dose Estimate Table of the user s Calibration Report within rounding differences of 0 1 kGy Verification of the dosimeter response is accomplished by the calculation R Ai Ao t Where Ai Absorbanc radiated Of the individual dosimeter Ao Absorbance grigina average for the batch t thickness average for the batch Security protection is applied to the critical dose calculation functions and calibration information is provided through GEX managed password controlled functions isolated from user access These calibration identification and curve coefficients are contained in a hidden password protected worksheet This password is maintained by GEX Corporation and available for use only by trained GEX personnel The macros used to calculate doses and communicate with a spectrophotometer are password protected and maintained by GEX The hazards analysis testing resulted in a series of user information warnings related to potential damage 100 153 082305 2002 GEX CORPORATION Page 3 of 26 D
25. me cells that were selected for the trendline and slope in the graph OOOooor Ah OOOO A OOOO 0 495 24 541 31 5 Ae 0000010 O 495 24 649 31 5 Aa DOODT 4 O 454 24 054 30 6 Ae 0000012 O454 22 432 25 2 Ae 0000013 0 430 21 135 26 3 Ah OOO 4 0 396 19 297 25 7 i AA 0000015 0 340 16 270 13 6 Ae OTE 0 290 135 565 16 0 a Aa OOOO 0 229 1 270 11 9 Aes OTS 0 151 7 675 5 5 Ah OOS 0 141 5 514 6 5 Ah 0000020 0 705 3 565 4 0 i AA OOOO oor 2 054 2 5 Ae OOOO Ss 0 060 1 135 1 3 An OOOO 0 049 0 541 o 7 T Ah OOOO 0 046 03r 0 5 os BE Extrapolated Range cm The Fitted series Slope amp Y intercept and the bf Shapes 36 55 f lntercept 3 1 09 1 Trendline onthe chart default to the 15th through Ba 23rd dosimeters only The data ranges should be 65 ASO Rex Rp adjusted by the user to incorporate more or Fewer T 1 09 1 52 1 50 data points appropriate bo the energy being tested Example Selecting Y intercept data range The extrapolated range parameters and estimated energy automatically re calculate when the slope and y intercept are modified Double check that the range used for the trendline on the graph match the ranges used in the slope and y intercept calculations DISCUSSION The aluminum depth values used in the energy calculations were validated using a reference point for measurement based on the method described in ISO ASTM 51649 Appendix A3 The use of other refere
26. n any dosimeter row in the worksheet to calculate all the doses for dosimeters in the spreadsheet RE READ MEASUREMENTS To re read a dosimeter in manual mode follow the description in the previous section for re reading a dosimeter with the following exception When the old absorbance value is deleted enter the value manually and use the steps described above to calculate the doses depending on what kind of worksheet you are working on 100 153 082305 2002 GEX CORPORATION Page 16 of 26 Dose Measurement and Control Appendix B Dosimetry Report Fields D E F G DOSIMETRY REPORT Customer Process Number g Product Process Specification Lot s Dmin Ref Ratio Dmax Ref Ratio Quantity Min Dose Spec Max Dose Spec Process Date Max Temp in Process C 15 Technician B Dosimetry Date Min Dose in Process 16 Max Dose in Process 17 Instrument g Correction Factor 00 18 Wavelength nm 554 21 Dosimeter Batch BaWihidose AA 19 Calibration Date 11 2 02 22 Initial Average Absorbance Ao 0 040 25 Calibration ID GEX DEMO 20 Dose Range 5 to B5 kGy 23 Software Version 13 1 26 P8003 Dosimeter Irradiated Absorb Response Adjusted Max Temp Dosimeter ID Position B Ai Aojit Dose kGy Dose kGy 27 31 32 33 Prepared by Date Reviewed by Date 1 Customer Name of the customer whose product was processed 2 Product Identification of the product processed 3 Lot s Lot or lot numbers
27. nce points may result in different energy estimations Contact GEX for further technical discussion of this issue Also refer to ISO ASTM Note A3 10 for additional information 100 153 082305 2002 GEX CORPORATION Page 26 of 26
28. ntrol OUT OF RANGE MESSAGES Occasionally doses will not compute and the Dose kGy column will look like this 18 Dosimeter Irradiated Absorb Response Adjusted 19 Dosimeter ID Position A B Ai Aojtt Dose kGy Dose kGy 20 0 1234567 Reference 0 04 0043 0 109 Under Range 21 1234568 Reference 0 480 0 580 51 366 Over Range These messages signify that the dosimeter response does not lie within the calibrated range of the dose response curve In the example above the top row is below the calibrated range and the bottom row is above the calibrated range To arrange installation support and or schedule an interactive training support session contact GEX Corporation at 303 400 9640 or e mail us at sales gexcorporation com 100 153 082305 2002 GEX CORPORATION Page 15 of 26 Dose Measurement and Control Appendix A Manual Mode Operation W Ndose for Excel was designed for measuring B3WINdose dosimeters while connected to a Genesys 20 spectrophotometer However it is possible to operate it in manual mode only with certain precautions The worksheets do not contain detailed error trapping and are intended to be used by qualified personnel under controlled conditions All worksheets in the workbook were designed to obtain values from the spectrophotometer when you press the three keys Ctrl Shift a and to insert rows when appropriate If you use the software for manual data entry the only difference is how the Ctrl Sh
29. nventions 100 153 082305 2002 GEX CORPORATION Page 10 of 26 Dose Measurement and Control STANDARD WORKSHEETS Routine Dosimeter Worksheets B3000 Dose Report B3002 Dose Report B3004 Dose Report The operation of these worksheets Reading Method 1 dosimeter replicate per dose point 2 dosimeter replicates per dose point 4 dosimeter replicates per dose point IS discussed in the next section APPLICATION SPECIALTY WORKSHEETS Electron Beam Specialty B3106 X and Y Uniformity B3110 Energy Wedge Card B3112 Energy Wedge Card B3200 B3 Film Energy Stack B3202 B3 Film Energy Stack Testing Method Process uniformity measurement strips 10MeV extrapolated range energy using RIS wedge 5MeV extrapolated range energy using RISO wedge Extrapolated range energy measurement 100 300 keV range Extrapolated range energy measurement 50 120 keV range The operation of these worksheets is covered in individual appendices titled by product worksheet i e B3106 Appendix 100 153 082305 2002 GEX CORPORATION Page 11 of 26 Dose Measurement and Control Using Standard WINdose for Excel Worksheets PROCESSING INFORMATION ENTRIES The top fourteen rows of all worksheets are used to document product and process information Never delete any of rows or insert new rows before the first dosimeter row of a worksheet See the section in this manual titled Customizing Facility Information for details
30. on worksheet modifications Make entries in the colored cells all other cells are locked As information is entered or values change the cell turns white The TAB key will move the cursor to all unlocked cells in the worksheets the arrow keys can be used to move to any cell in the worksheets The routine dosimetry screens appear like this DOSIMETRY REPORT Customer Process Number Product Process Specification Lot s Dmin Ref Ratio Dmax Ref Ratio Quantity Min Dose Spec Max Dose Spec Process Date Technician Min Dose in Process Max Dose in Process Dosimetry Date Instrument Correction Factor 00 Wavelength 554 nm Average Thickness 0 0183 DosimetGr Batch B2V V Ndose AA Calibration Date 11 17 01 Initial Average Absorbance 0 040 Calibration ID GEX DEMO Dose Range 5to 65 kGy Software Version 3 See Appendix B of this manual for a detailed description of each field in the Dosimetry Report MEASURING DOSIMETERS Example is a B3000 Worksheet Enter a dosimeter identification number in the first shaded cell in row 20 column B This may be done manually or through a bar code reader Using the tab or arrow keys move to the next cell to the right column C and enter a dosimeter position Dosimeter Irradiated _ Response _ Adjusted Dosimeter ID Position Absorbence A ai aopit Dose kGy Dose kGy 1234567 Type a position identifier this may be a number or a word and use the tab or arrow keys to move one
31. ose Measurement and Control to the WiNdose for Excel workbooks by applying standard MS Excel functions that permit user freedom in overwriting cell data modifying cell and worksheet formatting and deleting cells rows and columns The full WiNdose for Excel software verification and validation testing and software development history package Is available for customer review and audit at our Denver Colorado USA facility during normal business hours These records will be maintained by GEX for an indefinite period Users may purchase a copy of this package however it is up to the user to request copies of change validations that may occur Users may incur a cost for updates 100 153 082305 2002 GEX CORPORATION Page 4 of 26 Dose Measurement and Control WINdose for Excel Theory of Operation The WiNdose for Excel program was designed and developed as a major component of the WINdose Dosimetry System The function of the W Ndose for Excel software component is to provide the means of recording dosimeter absorbance measurements and preparing standardized dosimetry reports related to the dose measurements made for facility dose mapping product dose mapping and routine process dose monitoring applications W Ndose for Excel utilizes specialized computer code with embedded master constants derived from user specific dosimeter batch calibrations to estimate doses from user entered dosimeter absorbance values The software program requires
32. p of the screen will turn gray and not be functional Do not make any keyboard entries or mouse clicks during this period If the program cannot communicate with the spectrophotometer within 30 seconds the warning message will appear As with the demonstration workbooks you can still run the dose calculation macro but all absorbance reading information will have to be entered manually If you wish to save a dosimetry data file electronically you should immediately use the File gt Save As function to assign a new name to the file and store the file in the appropriate file folder directory The integrity of a file in use can be maintained by making sure the file is marked Read Only in the file s Properties and or by saving the file as a Microsoft Excel template file GEX PRODUCT SPECIFIC WORKSHEETS IN THE WORKBOOK The batch Calibration Specific Workbook contains worksheets for the products that a customer uses This setup is determined at the time of the dosimeter batch calibration Custom worksheet modifications are available at any time by contacting GEX To begin using the software simply open the Calibration Specific Workbook and select the appropriate dosimetry worksheet There are several basic worksheets and for electron beam users several specialty worksheets Worksheets that you do not use that were not removed by GEX from your Calibration Specific Workbook may also be deleted at any time using standard MS Excel co
33. purposes only Your Calibration Specific Workbook s specific to your facility and your dosimeter batch es must be installed separately The dose calculation coefficients from your specific GEX dosimeter batch calibration are embedded into each Calibration Specific Workbook and are traceable to a specific best fit calibration curve This information is hidden and locked and users should not attempt to access this information Users should perform an initial verification of the dose formulae upon receipt of this program using absorbance values from the Dose Estimate Table in your Calibration Report see GEX procedure template 100 255 for a recommended procedure for verifying the validity of the dose calculations in WINdose for Excel UNAUTHORIZED MODIFICATION OF WINDOSE FOR EXCEL WORKSHEETS CAN VOID THE VALIDATION 100 153 082305 Dose Measurement and Control WINdose for Excel 2002 Summary Validation Statement The W Ndose for Excel 2002 software program was developed using generally accepted industrial practices for software development design control that included use of a formal Design Requirements document to guide the design and validation of the software product The completed software product was placed under version and change control and underwent formal verification and validation testing using a protocol that included hazards analysis testing to confirm that the product fulfilled its Design Requirements when used in accor
34. run through its self checks Perform the following Remove the cuvette cup turn on the instrument Allow the instrument to warm up for at least thirty minutes Ensure that the instrument is set to 554 nm Ensure that the instrument is in the Absorbance mode Insert the cuvette cup Insert the sample holder for GEX holders see the particular holder information sheet Close the sample compartment lid and press the 0 ABS button NOTE The worksheet screens shown in this manual are samples only Your screens may have a slightly different appearance depending on your computer setup STARTING THE DEMONSTRATION PROGRAM Click the Windows Start button and go to Programs gt WINdose for Excel Demo When opening the initial template you may be asked if you wish to enable macros Click on Enable Macros to open the workbook Microsoft Excel X The workbook you are opening contains macros Some macros may contain viruses that could be harmful to your computer If you are sure this workbook is From a trusted source click Enable Macros IF you are not sure and want to prevent any macros from running click Disable Macros Tell Me More IV Always ask before opening workbooks with macros i Enable Macros Do Not Open NOTE If your security is set to high in Microsoft Excel the screen above may not appear Use the Tools gt Macros gt Security drop down menus Excel to set your security to the medium or
35. t strip after the last dosimeter of the previous strip The worksheet comes preformatted for a total of 30 dosimeters but can be modified to span over 100 inches NOTE When setting up a uniformity test with the B3106 product be sure to note the positioning of the Strip in the test configuration If you run the strip in a different direction the numbering may not be appropriate for the manner in which the test was run If you are using fewer than 30 dosimeters you can delete the unused rows from the final report by highlighting the rows right clicking on the mouse and selecting delete or by selecting the rows and clicking Edit gt Delete 100 153 082305 2002 GEX CORPORATION Page 19 of 26 Dose Measurement and Control To add rows for longer arrays of strips highlight the first 10 rows 20 29 and select copy using standard Windows methods Highlight the row that you want to inert in front of right click and select Insert Copied Cells You will also need to change the Distance column in the worksheet to accommodate the new cells Place the cursor in cell D49 and click and drag so that the Distance cells for the new rows are all highlighted and use the MS Excel fill down command Ctrl d to fill in the cells with the extended distance numbers When you are done the distances should contain a sequential continuation of the original 30 rows i e 31 32 33 etc If the test has smaller increments of distance because
36. ter reading Dosimeter Irradiated Absorb Response Adjusted Dosimeter ID Position A B Ai Aojrt Dose kGy Dose kGy 1254567 Reference 0 250 0 252 11 530 14 8 14 9 0 000 n In a B3004 worksheet four dosimeter replicates per package you will enter four absorbance values for each dosimeter packet using the Ctrl Shift a command From replicate D the Ctrl Shift a command will invoke the calculations and creation of a new row Dosimeter Irradiated Absorbencies Aji Response Adjusted Dosimeter ID Position a B Cc D Ai Aojit Dose kGy Dose kGy 1254587 Reference 0 250 0 251 0 252 0 250 11 516 14 6 14 6 F 0 000 na In each of the different standard worksheets the dosimeter response is calculated automatically from the formula Final absorbance less Original absorbance divided by Thickness Ai Ao t The Original absorbance Ao and the Thickness t are listed in the Calibration Information gray section on the worksheets The Dose kGy is computed from the embedded curve coefficients Adjusted Dose Min Dose in Process and Max Dose in Process are calculated as follows Adjusted Dose Is the calculated Dose kGy multiplied by the Correction Factor Max Dose in Process Calculates the maximum Adjusted Dose value for the process run multiplied by the Dmax Ref Ratio Min Dose in Process Calculates the minimum Adjusted Dose value for the process run multiplied by the Dmin Ref Ra
37. ters 1 2 and 22 30 were extended past the sides in order to demonstrate that the electron beam in fact overscanned the width of the product The area of greatest interest therefore involves only dosimeters 3 through 21 Average Dose formula cell Cell F15 This formula is preset to incorporate all 30 preformatted rows H20 to H49 To modify select cell F15 and click the mouse in the range H20 H49 that is displayed in the Excel Formula Bar near the top of the screen This highlights both ranges in the formula NOTE both ranges are the same This also highlights the actual column of data with a colored border box Resize the box to incorporate only those points which are of interest for the test You will have to do this twice as there is one box for each range in the formula even though they are the same range Hit the RETURN key when you have the proper range selected For our example we will select H22 to H40 100 153 082305 2002 GEX CORPORATION Page 20 of 26 Dose Measurement and Control v Xv A IF ISERROR AVERAGE HBO 49 AVERAGE H20 H49 A B C AVERAGE number1 number2 F GEX Corporation 7330 5 Alton Way Suite 12 l Centennial CO 80112 303 400 9640 DOSIMETRY REPORT Customer Process Number Test Description Process Specification Process Date Power kW Avg Beam Current pA Conveyor Speed Pulse Rep Rate PPS Technician Dosimetry Date Average Dose kGy ERAGE H20 Std Dev
38. the user Further by acceptance implementation and use the user assumes any and all risks associated with such usage of this user manual and the associated software product W Ndose for Excel workbooks communicate only with Genesys 20 spectrophotometers The use of any other spectrophotometer requires that the software be used in the manual mode see Appendix A Manual Mode Operation Custom communication software programs may be developed and validated separately based on a customer specific set of requirements The WiNdose for Excel worksheets contain unlocked cells These cells are unlocked in order to make certain formulas work properly Users should have a working knowledge of basic Microsoft Windows and Microsoft Excel functions in order to use the worksheets effectively WINdose for Excel users assume complete responsibility for the application of the software product and agree to use the software program in accordance with the information and instructions contained in this user manual The examples given in this manual are based on GEX recommended program uses other uses of the program are possible Contact GEX to discuss your specific application needs USER SPECIFIC WORKBOOKS The WINdose for Excel 2002 installation CD places a demonstration calibration curve file on your computer in the WINdose for Excel 2002 folder inside the Program Files folder on the Hard Drive of the computer This curve is for demonstration and training
39. tio NOTE You must enter values into the Dmin Ref Ratio and Dmax Ref Ratio in order for maximum and minimum doses in process to calculate 100 153 082305 2002 GEX CORPORATION Page 13 of 26 Dose Measurement and Control TEMPERATURE MONITORING If you are using the P8003 Temperature Indicators in a process run the maximum temperature from the indicator can be typed into Column A under P8003 Max Temp The Max Temp in Process C will search the column for the highest temperature in the process report and display the value in cell H11 Quantity Min Dose Spec Process Date Max Temp in Process C Technician Dosimetry Date i i Process Instrument 15 Correction Factor 1 00 Wavelength 554 nm 16 Dosimeter Batch S3 VWiNdose AA Calibration Date 11 17 01 Initial Average A 17 Calibration ID GEX DEMO Dose Range 5 to 85 kay 18 P8003 posimeter irradiated Absorb Response Adjusted 19 Max Temp Dosimete Position A B Ai Aojtt Dose kGy Dose kGy 20 450 T4567 Reference 0 250 0 250 11475 21 322 1234569 Reference 0 148 0148 6902 RE MEASURING A DOSIMETER If it becomes necessary to re read a dosimeter s save the file with a revision name Place the dosimeter back into the spectrophotometer Highlight the appropriate absorbance cell in the worksheet and delete the old value Run the Ctrl Shift a command as normal the program will not insert a new row unless you are on the last row that you had used All doses on
40. xcel Calibration Specific Workbook being used 27 P8003 Max Temp An area to manually enter the maximum temp achieved on the P8003 Temperature Indicator if the indicator was attached to dosimeters for a process run 28 Dosimeter ID The individual identification number of the dosimeter 29 Dosimeter Position The position of the dosimeter during the process run i e Reference Position etc 30 Irradiated Absorbance The absorbance value of the dosimeter as determined with the spectrophotometer 31 Response Ai Ao t The calculated response of the dosimeter per the listed formula 32 Dose kGy The dose calculated by the software from a dosimeter Response value 33 Adjusted Dose The Dose kGy multiplied by the correction factor if one is used Default setting is 1 00 100 153 082305 2002 GEX CORPORATION Page 18 of 26 Dose Measurement and Control B3106 Appendix For automated reading of B3106 10 Inch Uniformity Measurement Strips DESCRIPTION The B3106 associated W Ndose for Excel worksheet is used to read the optical absorbances of the sequentially numbered dosimeters The embedded formulae and macros automatically calculate the response and dose estimates based on the current calibration coefficients in the worksheet The results also update and display a uniformity graph of the dose results These may be used for electron beam applications involving evaluation measurements of horizontal and p
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