ADDENDUM HALF LIFE VERIFICATION INSTRUCTIONS MOLY ASSAY INSTRUCTIONS ADJUSTING BACKGROUND TIME INSTRUCTIONS FOR ATOMLAB 500 DOSE CALIBRATOR, ATOMLAB 500PLUS AND ATOMLAB WIPE TEST COUNTER SOFTWARE VERSION 1.33 086-330 086-331 086-332 BIODEX Biodex Medical Systems, Inc. 20 Ramsey Road, Shirley, New York, 11967-4704, Tel: 800-224-6339 (Int’l 631-924-9000), Fax: 631-924-9241, Email: info@biodex.com, www.biodex.com FN: 14-027 2/14 Table of Contents INTRODUCTION ............................................................................................................................ 3 CHAPTER 1 - HALF LIFE VERIFICATION APP FOR ATOMLAB DOSE CALIBRATOR ................................................................................... 4 Intended Use ................................................................................................... 4 Indications For Use .......................................................................................... 4 Half Life Verification ........................................................................................ 4 Performing a Half Life Verification .................................................................... 5 Formula for Calculating Half Life ...................................................................... 12 Formula for Half Life Variance .......................................................................... 12 CHAPTER 2 - DOSE CALIBRATOR SETTABLE BACKGROUND COUNTING TIME ........................................................................................................................ 13 Information ...................................................................................................... 13 Procedure to Adjust the Background Counting Time ........................................ 13 CHAPTER 3 - MOLY ASSAY FOR THE ATOMLAB DOSE CALIBRATOR ..................... 15 Description ...................................................................................................... 15 Procedure Addition .......................................................................................... 16 CHAPTER 4 - DOSE CALIBRATOR ADDITIONAL ISOTOPE ........................................... 19 Additional isotope, Ra-223, added to Dose Calibrator Isotope List ................... CHAPTER 5 - ATOMLAB WIPE TEST COUNTER ADDITIONAL ISOTOPES ............... 20 Information ...................................................................................................... 20 Isotope Settings ............................................................................................... 21 2 Biodex Medical Systems, Inc. © 2012 Introduction This new software version addendum for the Atomlab 500 Dose Calibrator is an update to the production version 1.31 software. It works with the WinCE Operating System in the Atomlab 500 Dose Calibrator. The new version is software version 1.33 2/14/2014. This addendum adds three things to the present Atomlab 500 Dose Calibrator: 1. The new application is a Half Life Verification APP used in Nuclear Pharmacies. 2. It allows the user to set the system’s background counting time to be either 30, 60 or 100 seconds. The current version is a 100 second count. If you are measuring sources less than 20 µCi of Tc-99m increasing the background to 100 seconds will improve your accuracy. 3. The Moly Assay Program has had a slight modification in that the background counting time can be adjusted for 30, 60 or 100 seconds. Changing the Moly background counting time in the Moly Assay Program will change the background time for Dose Calibrator Zero Background Functions. 4. Ra-223 is added to the Isotope List in the Atomlab 500 Dose Calibrator Program. This addendum adds two isotopes, Lu-­‐177 and Ra-­‐223, to the Wipe Counter Isotope List including the Region of Interest and the Isotope Efficiencies. The detailed sections of this addendum describe how to use the changes for each of these items. NOTE: This addendum is not a complete manual for the Atomlab 500. ATOMLAB DOSE CALIBRATOR 500, 500PLUS AND WIPE TEST COUNTER ADDENDUM 3 1. Half Life Verification APP for Atomlab 500 Dose Calibrator Intended Use The Half Life Verification APP is intended to check a radioactive isotope to determine the actual Half Life of the isotope sample. Indications For Use In a Nuclear Pharmacy it is common practice to test certain isotopes for contamination from other isotopes before use. This test is typically performed for PET isotopes such as F-18. The Half Life is calculated from either two or three timed activity readings in the dose calibrator. The system then calculates the actual Half Life of the sample and shows the variance percentage to the system listed isotope Half Life. It is the user’s responsibility to determine if this variance is acceptable. Half Life Verification (See Figures 1.1 and 1.2.) The Half Life Verification APP allows the user to select the isotope, set test parameters; select either 2 or 3 readings and set the elapsed time between the readings. The time can be set between 1 minute and 60 minutes. You can also enter the lot number. When the test is complete, print your results. The results show the preset Half Life for the isotope selected and the calculated Half Life from the two or three activity readings. NOTE: The dose calibrator does not store the Half Life calculation. You can print the results. NOTE: It is up to the user to decide if this variance is acceptable or if there are too many contaminants in the isotope to use it. Figure 1.1. Nuclear Pharmacy screen. 4 Biodex Medical Systems, Inc. © 2012 Figure 1.2. Half Life screen. To Perform a Half Life Verification: 1. At the Home screen, select <Nuclear Pharmacy>. The Nuclear Pharmacy screen is now displayed. 2. Select <Half Life Verification>. The Half Life Verification APP is now displayed. 3. Make sure there are no sources near the dose calibrator chamber. 4. Press <Select Isotope> to change the isotope from the isotope displayed at the top of the screen. You can select any isotope from the isotope list that is in the dose calibrator. 5. To select the isotope use the scroll arrows to display the isotope you want, touch the isotope name to highlight it and then select <Enter>. The isotope you have selected is now displayed on the Half Life Verification screen, including the system defined Half Life. 6. Select <Set Test Parameters> to display the Half Life Verification parameters. (See figure 1.3.) ATOMLAB DOSE CALIBRATOR 500, 500PLUS AND WIPE TEST COUNTER ADDENDUM 5 Figure 1.3. Half Life Verification Setting Test Parameters screen. 7. Select either <2> or <3> for the number of readings. If the number is already highlighted, you do not need to select it. (See figure 1.3.) 8. Use the up/down arrows <▲ ▼> to set the time between readings. If the number displayed is what you desire for your test, you do not have to adjust it. The time can be adjusted between 1 minute and 60 minutes. Select <Enter Lot Number> if you want to enter a lot number for this test. When you select <Enter Lot Number>, the alpha numeric keyboard is displayed. Once you have entered the desired lot number, select <Enter>. 9. The Half Life Verification screen is displayed with the parameters you have selected. Select <Enter> to proceed to the screen to start the verification test. 10. If desired, select <Zero Background> along the bottom menu. This brings you to the Zero Background screen. Select <Zero Background> and the background count will begin. If there has been no activity in the chamber, it will immediately say “completed” and take you back to the Half Life Verification screen. 11. Place the isotope sample into the dose calibrator chamber. 6 Biodex Medical Systems, Inc. © 2012 Figure 1.4. Half Life Verification for 2 Activity Readings. Figure 1.5. Half Life Verification Counting screen. 12. Select <Start Recording> to take the first reading. The program will automatically record the first activity and record the next activity reading at the time you have programmed. Leave the source in the chamber and the system will complete the test. The time remaining is displayed for each reading. ATOMLAB DOSE CALIBRATOR 500, 500PLUS AND WIPE TEST COUNTER ADDENDUM 7 13. If you select <Abort Recording> the test you have started counting will be aborted and take you back to the Half Life Verification screen. You can restart the test by selecting <Start Recording>. If you need to change your test parameters or isotope, you can do it at this point. (See figure 1.5.) 14. When ready select <Start Recording>. The Half Life Verification APP will begin. NOTE: If you select <End Recording>, the Half Life Verification APP will end and use the elapsed time for the calculation. If the counting time is not long enough, it could affect the results. It is recommended to have the count complete the preset time. Figure 1.6. Two Count Half Life Verification Results screen. 15. When the test is complete, the results are shown on the screen. The results include the calculated Half Life and the variance percent from the published Half Life of the isotope. Select <Print> to print your results (See figure 1.8.) If you select <Back>, a message will be displayed that if you proceed your data will be lost. Select <No> not to exit; select <Yes> to exit and lose the test data. 16. If you desire to start another Half Life Verification, you must select <Set Test Parameters> and review the parameters and then select <Enter>. At this point you can start another test. 17. To perform a three reading test, it is performed the same way as the two reading test except that three readings will be taken at the time interval you have set. When the test is complete, the system calculates the Half Life between the first and second reading, between the second and third reading, and between the first and third reading and shows the average Half Life for the readings. The variance to the listed preset isotope Half Life is calculated. To return to the Home screen, select <Back> and then <Home>. (See figures 1.7 and 1.9.) 8 Biodex Medical Systems, Inc. © 2012 Figure 1.7. Three Reading Half Life Verification Results. 18. After the APP ends you can print the report for the half life verification. Select <Print> and the three reading report prints. (See Figure 1.9.) NOTE: The system does not store the half life calculation. You must print the results. ATOMLAB DOSE CALIBRATOR 500, 500PLUS AND WIPE TEST COUNTER ADDENDUM 9 Figure 1.8. Printout For Two Count Half Life Verification Results. 10 Biodex Medical Systems, Inc. © 2012 Figure 1.9. Printout For Three Count Half Life Verification Results. ATOMLAB DOSE CALIBRATOR 500, 500PLUS AND WIPE TEST COUNTER ADDENDUM 11 Formula for Calculating Half Life d = measurement d start = starting measurement d end = ending measurement calculate Half Life = log 10 (2.0) x d time log 10 (d start/d end) Example for F-18: starting measurement: ending measurement: counting time: 4122 3860 10 min calculate Half Life = log 10 (2.0) x 10 min log 10 (4122 / 3860) = 3.0103 min 0.0285207 = 105.54796 min / 60 calculate Half Life = 1.759 hr Variance Formula Half Life Variance = calculated Half Life – isotope Half Life Isotope Half Life x 100 Example for F-18: Half Life Variance = 1.76 – 1.83 1.83 x 100 Half Life Variance = 3.8% lower 12 Biodex Medical Systems, Inc. © 2012 2. Dose Calibrator Settable Background Counting Time The background counting time used for the dose calibrator and Zero Background can now be set for 30, 60 or 100 seconds. In previous software versions background count was fixed at 100 seconds. This background counting time is used for the dose calibrator Zero Background and Moly Assay Background counting time. Adjusting the Background Counting Time: (See Figures 2.1 and 2.2.) 1. At the Home screen, select <Utilities>. 2. On the Utilities screen, select <Dose Calibrator Configuration>. 3. On the Dose Calibrator Configuration screen, select <Set Background Time>. Figure 2.1. Dose Calibrator Configuration screen. ATOMLAB DOSE CALIBRATOR 500, 500PLUS AND WIPE TEST COUNTER ADDENDUM 13 Figure 2.2. Set Background Time. 4. You will now have to enter the system’s password to proceed. 5. Set Background Time screen is now displayed. The center of the screen displays the current Background Time in seconds (30, 60 or 100). By selecting the current setting a pull down menu is displayed and you can choose a new background counting time. Then select <Enter>. NOTE: The factory default background count time is 30 seconds. If you are measuring sources less than 20 µCi of Tc-99m, increasing background count time to 100 seconds will improve accuracy. 6. 14 Select <Enter> to return to the Dose Calibration Configuration screen. The background counting time is now changed. Select <Home> to return to the Home screen. Biodex Medical Systems, Inc. © 2012 3. Moly Assay for the Atomlab Dose Calibrator (See Figures 3.1, 3.2, 3.3 and 3.4.) Figure 3.1. Nuclear Pharmacy screen. NOTE: The update to the Moly Assay Program allows the user to change the Background Counting Time when starting the Moly Assay test. ATOMLAB DOSE CALIBRATOR 500, 500PLUS AND WIPE TEST COUNTER ADDENDUM 15 Figure 3.2. Moly Assay Background screen. To Perform a Moly Assay Test: 1. At the Home screen select <Nuclear Pharmacy>. 2. Select <Moly Assay> to start the Moly Assay Test. 3. The Moly Assay Background screen allows the user to change the background counting time. The screen displays the current background time. To change the background counting time, select <Change Background Time>. A message will be displayed stating, “Changing Background Time Will Be Retained And Have A Global Effect Throughout The System.” Select <Continue>. NOTE: If you do not want to change the background time, select <Cancel> and go to Step 5. 16 Biodex Medical Systems, Inc. © 2012 Figure 3.3. Set Background Time screen. Figure 3.4. Set Background Time. ATOMLAB DOSE CALIBRATOR 500, 500PLUS AND WIPE TEST COUNTER ADDENDUM 17 NOTE: When you change the background counting time it changes the Moly Background Time and the Dose Calibrator background counting time. 4. The Set Count Background Time screen is displayed. (See figure 3.4.) Select the number after Background Count Time. A pull-down menu is displayed with 30, 60 or 100 seconds. Select to highlight the time that you desire and select <Enter>. The Moly Assay Background Counting screen will be displayed with the new background counting time. (See figure 3.5.) Figure 3.5. Moly Background Reading 5. Select <Zero Background> to begin a background count time lasting 30, 60 or 100 seconds depending on what you have selected for your background time. Once the zero background is completed the Moly Assay Test continues as instructed in the Atomlab 500 manual. NOTE: See Atomlab 500 manual Chapter 5 for Moly Assay. 18 Biodex Medical Systems, Inc. © 2012 4. Dose Calibrator Additional Isotope Radium 223 has been added to the Dose Calibrator Isotope List. Symbol: Ra-223 Dial Value: 17.8 Half Life: 11.43 days Dial value determined using a standard from Algeta. ATOMLAB DOSE CALIBRATOR 500, 500PLUS AND WIPE TEST COUNTER ADDENDUM 19 5. Atomlab Wipe Test Counter Additional Isotopes The two (2) isotopes added to the Factory Isotope List are Lu-177 and Ra-223. The Factory Preset Region of Interest (ROI) and the Isotope Efficiency are included in the Wipe Isotope List. Isotope Name Lu-177 Ra-223 Region of Interest (ROI) 37-360 KeV 40-430 KeV Efficiency 7.8% 135.9% These isotopes can be added to your wipe test locations following the procedures listed in your Atomlab Wipe Test manual. The software update will add the Lu-177 and Ra-223 into the Alphabetical Isotope List. (See Figure 5.1.) Figure 5.1. Alphabetic Isotopes List. 20 Biodex Medical Systems, Inc. © 2012 Atomlab Wipe Test Counter Isotope List Analytically Determined Detector Efficiencies Please refer to this table below for Analytically Determined Detector Efficiency (%) settings on the Atomlab Wipe Test Counter. Well Efficiency settings that have an * are empirically measured. Left Right Half Well Wide Window (25-800 keV) ROI ROI Life Efficiency % Efficiency % Am-241 50 69 434.7 yrs 35.7 -Au-198 349 474 2.69 days 28.0 -Ba-133 305 515 10.54 yrs *36.8 *83.93 Co-57 85 158 271.77 days *90.9 *90.9 Co-58 434 933 70.9 days --Co-60 997 1533 5.271 yrs *23.03 *26.03 Cr-51 272 368 27.7 days 4.5 -Cs-137 561 761 30 yrs *12.97 *36.4 F-18 420 600 1.83 hrs *28.25 -Fe-59 934 1486 44.5 days 3.8 -Ga-67 53 424 3.261 days 53.8 -Hg-197 56 90 2.67 days 89.1 -Hg-203 237 322 46.6 days 44.8 -I-123 134 183 13.2 hrs 75.4 -I-125 23 80 60.14 days *40 -I-131 309 420 8.04 days *28.7 *45.19 In-111 146 490 2.807 days *60.0 *70.0 Ir-192 250 703 73.83 days --K-42 1296 1754 12.4 hrs --Lu-177 37 360 6.71 days *7.8% 6.71 days Na-22 400 600 2.6 yrs *23.6 *56.59 Na-24 1162 3167 15 hrs --Pd-103 17 27 10 min 62.3 -Ra-223 40 430 11.43 days *135.9% 11.43 days Se-75 102 461 119.8 days --Sr-85 437 591 64.84 days 18.2 -Tc-99m 119 162 6.007 hrs *81.66 *83.95 Tc99-Tl-201 50 200 3.046 days *68.3 -Tl-201 50 100 3.046 days *50.5 -Yb-169 41 228 32 days --NOTE: It is recommended that users use the Empirical testing procedures for setting detector efficiency. Isotope ATOMLAB DOSE CALIBRATOR 500, 500PLUS AND WIPE TEST COUNTER ADDENDUM 21 22 Biodex Medical Systems, Inc. © 2012 ATOMLAB DOSE CALIBRATOR 500, 500PLUS AND WIPE TEST COUNTER ADDENDUM 23 24 BIODEX Biodex Medical Systems, Biodex Medical Systems, Inc. 20 Ramsey Road, Shirley, New York, 11967-4704, Tel: 800-224-6339 (Int’l 631-924-9000), Fax: 631-924-9241, Email: info@biodex.com, www.biodex.com Inc. © 2012