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ATOMLAB 400 DOSE CALIBRATOR

1. ssessssesseeeeeeeertttttttrrirrnnnnnnnnnnnnnenne B 5 C ATOMLAB 400 DOSE CALIBRATOR SPECIFICATIONS ssssaasssssnnnnnnnnnn C 1 SE C 1 Measurement Range cccccccccccccccnnnnnnnnnnnnnnnnnnccoconcncnnrnnnnnnnnnrnrrr nana C 1 Display RANGES EE C 1 Gel NEE C 1 ACCULACY EE C 2 Detector Linearity E C 2 Electrometer Be EE C 2 Electr meter ACCUAE CY nent en en ot Geena en C 2 A ae E a a E a EA EE Eae EE EANTA ES C 2 SC et e EE C 2 Energy RANG esas uae ia corto eli C 2 S ISOLODE Selection snepi neii E aaa E a eaii C 3 Calibration Value Display usina eineenhes anse un desert test 5d C 3 D tecl r TY Pe EE C 3 Environmental Operating Conditions oooooonccccccnnncccnancninononanancnnnnnanana noo C 3 Physical Data cuna AA ANR C 3 e EE C 4 De tector Cable EE C 4 Graphie Dis pliss ltd de C 4 Calibrator Constancy Isotope Keys oococcccccoccccccccccnnocannncnncnnnnnnnncnnnnnnnnnnnos C 4 Electromechanical Compatibility C 4 ETL BE WE C 4 Biodex Medical Systems IV ATOMLAB Dose Calibrator Operation Manual Table of Contents D DECAY CALCULATIONS issued D 1 O A eer E D 1 Decay Calculation Methods Calculator Method D 1 Alternate Decay Calculation Method o ooccccccocccccccccncncnonnnnnccnnnnnnncnnnnnnnnnnn nos D 2 Decay Factor Method EE D 3 Decay el D 5 Explanation of Decay Calculation Methods D 7
2. Figure 1 Atomlab Photon Sensitivity Curve o Sensitivity nA mCi photon energy MeV Biodex Medical Systems 1 2 ATOMLAB Dose Calibrator Operation Manual Appendix The accuracy for dial value calculation depends upon not only the accuracy of the sensitivity curve and the photon emission intensity data but also upon the sample configuration due to low energy photon absorption see Radioisotope container below The photon sensitivity curve displayed is for sources with configurations similar to the NIST ampoule configuration noted above All Atomlab dose calibrators are calibrated with NIST traceable Co 60 Ba 133 Co 57 and Cs 137 sources Each dose calibrator is certified to measure the correct activity of the calibration sources to within the specified accuracy The following factors can affect measurement accuracy and should be taken into consideration when using the Atomlab dose calibrator Lead Shield A lead shield is necessary to protect personnel from exposure to the radiation produced by radioactive isotopes This lead shield is integrally installed as part of the Atomlab dose calibrator However photon backscatter occurs from the lead shield resulting in increased chamber sensitivity in the 88 200 keV photon energy range This increase in sensitivity is already included in the sensitivity curve above and it can be easily seen in the peak at 88 keV However if for any re
3. Rev F 2 15 10 15 February 2010 Biodex Medical Systems ATOMLAB Dose Calibrator Operation Manual Geometry Geometry Independence means that the indicated activity does not change with volume or configuration of the source material This test should be done using a syringe that is normally used for injec tions The following test assumes injections are done with 3 ml plastic syringes and that radio pharmaceutical kits are made in 30 ml glass vials If you do not use these change the procedure so that your syringes and vials are tested through out the range of volumes commonly used If a significant volume correction results from these procedures the tests should be repeated to verify AtomLab dose calibra tors have been tested for volume dependence in beta measurements which are expected to be worst case and the results were 0 13 ml Syringe Test example 1 Ina small vial mix 2 0 ml of a solution of Tc 99m with an activity concentra tion between 1 and 10 mCi ml 2 Set out a second small vial containing non radioactive saline solution 3 Draw 0 5 ml of the Tc 99m solution into the syringe and assay it 4 Record the volume and activity of the first assayed sample Figure 2 2 See Accurate Dose Calibrator Activity Mea surement of Y 90 Ibritumomab Tiuxetan J A Sie gel et al J Nucl Med 2004 45 450 454 5 Remove the syringe from the calibra tor draw an additional 0 5 ml of non radioactiv
4. empty plastic syringe for residual activity record as Plastic Syringe Activity 2 5 Calculate the Container Dial Value for use with isotope assayed in that type of container CDV DV PSAI PSA2 Container Activity where PSA Plastic Syringe Activity Container with source material 1 Assay Container with the isotope source material record as Container Activity 1 2 Transfer part or all of the source material from the Container into a plastic syringe nominal wall thickness of 1mm 3 Assay the plastic syringe with the isotope source material record as Plastic Syringe Activity 4 Assay the partial or empty Container for residual activity record as Container Activity 2 5 Calculate the Container Dial Value for use with isotope assayed CDV DV PSA CAI CA2 where PSA Plastic Syringe Activity and CA Container Activity Typically for glass wall source Containers CDV will be higher than DV when the isotope has a significant portion of low energy photons in its emission spectrum Scheme EC Electron Capture IT Isomeric Transition NOTES 1 Isotope A B implies that B is in equilibrium with A 2 Half Life s seconds m minutes d days y years 3 Scheme EC Electron Capture B Beta decay IT Isomeric transition A Alpha Decay 4 5 Cal Value Atomlab Dose Calibrator dial setting to calibrate for corresponding isotope Notes H r Half life ratio of daughter over parent implies daughter is ignore
5. 0 05 Ci If not use the lt Zero Background gt key to correct for the change in background radiation thus zeroing the background 3 Place the vial syringe dipper into the Chamber Well 4 Press lt Select Isotope gt then lt Toggle List gt to dispay Mo 99 5 Press the lt Screen gt key next to Mo 99 to begin 30 sec countdown If after the 30 second countdown on the Display the activity is gt 2uCi set the vial syringe dipper aside Repeat test steps 1 5 the next day or after a weekend If after the repeat test the activity is still gt 2uCi you need to order a replacement vial syringe dipper because of contamination 6 If the activity is lt 2uCi place the vial syringe dipper back in the Chamber Well and if the activity value now reads greater than 0 05 pCi press lt Zero Background gt again 7 You can now use the dipper Detector Liner Check Repeat the above procedure but only remove and replace the Well Liner Do not use the dipper for this test Biodex Medical Systems 3 11 ATOMLAB Dose Calibrator Operation Manual Chapter 4 CHAPTER 4 ATOMLAB 400 UTILITIES THE UTILITIES MENU See Figure 4 1 ATOMLAB 400 pose catisrator Utilities A D Toggle List Backlight Time Beep ON f OFF EA BIODEX Select Isotope Zero Background Figure 4 1 The Utilities Menu Use the lt Toggle List gt keys to view additional Utility Menu options Selecting lt Utilities gt from the Home Menu allows access
6. Dy 165 Ho 166 Yb 169 Lu 177 Ta 178 W 178 W Ta 178 Re 186 Re 188 W Re 188 Os 191 Ir 192 Pt 195m Ir 196 Ir 196p Hg 197 Pt 197 Au 198 Au 199 TI 201 Hg 203 Pb 203 Bi 213 Y 90v New Iso 1 or 1st Custom New Iso 2 or 2nd Custom Appendix G 03 11 2009 ATOMLAB Dose Calibrator Operation Manual Appendix H APPENDIX H ELECTROMAGNETIC COMPATIBILITY NOTE This MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS See chart on next page NOTE Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT NOTE Contact Biodex Medical Systems for additional EMC information Biodex Medical Systems H 1 Appendix H ATOMLAB Dose Calibrator Operation Manual AP S9 JOP Sa SPOYIA DP 20014 ARA OOr ALLOY 30 p1 2190 S IBJP 10 S NSOI 159 SOUSIAJOY ye Spe9 JaMmog A puna o3 1ng udd 39N sod SUOUOT AY 7 EYUP ay I 400S A 9DURULIOJI1Id JO uonepeisop ou S 00019 DAI I dnoin geen ZHOI ZHN 0 SUOISSIU poyeIpey IT ad SIO w 01 WANP LE OE AV ANdP 94 96 dO Anqp 95 99 1 dro g SSI ZHI 0 ZHX 0ST SUOISSIUIJ POIONPUO IL YASIO s6 lt 29501 smed oasuiooosm 0 505 01 ssned oasugos Mm 09 sesoresned oasugor gl s6 lt 05 01 ssned seen wi S uononpe t U32
7. The Dial Values screens allow the user to change the dial setting for each isotope The dial value is the calibration value for each isotope 1 Press the lt Screen Key gt opposite the Dial Values prompt to access the Dial Values screens 2 Use the lt Toggle List gt Keys to scroll though the isotope list until the desired isotope is displayed 3 Press the lt Screen Key gt next to the desired isotope to display the dial value 4 Use the lt Toggle List gt keys to increase or decrease the value displayed for the selected isotope 5 Press lt OK gt to select the displayed isotope and value or lt Cancel gt to return to the original dial value displayed 6 If you change the dial value and press lt OK gt a confirmation screen is displayed Respond lt OK gt to the Are you sure prompt to change the desired value Press lt Cancel gt to return to the previously set dial value If you pressed lt OK gt the system will now return to the Dial Values screen From here you can select another isotope to change or press lt Back gt to return to the Utilities Menu Biodex Medical Systems 4 7 ATOMLAB Dose Calibrator Operation Manual Chapter 4 ATOMLAB 400 post catisrator Dial Value i Ba 133 ei 4 to Adjust Dial Value Cancel eil BIODEX Back Select Isotope Zero Background Figure 4 8 After selecting an isotope from the Dial Values screen use the lt Toggle Keys gt to adjust the value Biodex Medical Syste
8. The test of a dose calibrator to see how close the displayed activity values are to the true values Averaging Period The time the Atomlab takes to display a stable activity reading Background Correction The function of the Atomlab initiated by pressing the lt Bkgnd gt key which stores a value for the ambient activity This value is automatically subtracted from all subsequent activity measurements to compensate for the background activity level Becquerel Bq The international unit of activity corresponding to one dps disintegration per second or one nucleus decaying per second The Atomlab displays activity values in units of MBq million Bq or GBq billion Bq Calibration The use of calibrated activity sources traceable to the National Institute of Standards amp Technology to calibrate each Atomlab unit and verify the accuracy of the activity values it displays Calibration Value The value set on the Dial Value Display to adjust the Atomlab to correctly respond to a particular radioisotope See Response lonization Chamber Calicheck A sleeve shield package to perform linearity tests on dose calibrators Chamber Bias The high voltage applied to the chamber which causes ions in the argon gas to move to the collector electrode Constancy Check Performing daily checks using a radioisotope with a long half life to ensure that the activity values a dose calibrator displays is stable over a long period of time B
9. to the right of the desired isotope 5 Press the lt Screen Key gt to the right of the OK prompt to set the selected isotope and add it to the Routine List Press the lt Screen Key gt next to the Cancel prompt to return to the full list See figure 3 5B 6 If you have selected to set the isotope the system returns to the Measure screen with the selected isotope displayed If you cancelled the set operation the system returns to the Full List ATOMLAB 400 _ pose catisrator Routine List 3 1 123 Mo 99 Select From List Set d W BIODEX Back Select Isotope Zero Background Figure 3 5A Set Button Selection showing first set button prompt ATOMLAB 400 _ pose causraror Do You Want To Set This Button To This Isotope DN C 11 Toggle List Cancel Back Select Isotope Zero Background Figure 3 5B The Set Button Confirmation screen Biodex Medical Systems 3 5 ATOMLAB Dose Calibrator Operation Manual Chapter 3 DEFINING AN ISOTOPE See Figure 3 6 The Atomlab 400 allows two user defined isotopes To define an isotope 1 Press lt Select Isotope gt The Routine List is displayed 2 Use the lt Toggle List gt keys to scroll to either of the New Isotope prompts 3 Press the lt Screen Key gt to the right of New Isotope to access the Dial Value screen 4 Use the lt Toggle List gt keys to dial in the value desired Hold the toggle keys down to increase scroll speed 5
10. 15 24 cm 15 24 x 39 37 cm Weight 3 6 Ib 1 64 kg 38 Ib 17 3 kg POWER APS Advanced Power Solutions Power Supply for Medical Use Model APS22ES 150160 Line Voltage 100 to 240 VAC 0 6 0 3 Amp Line Frequency 50 60 Hz Detachable line cord Built in EMI filter and transient suppression NOTE Before inserting or removing connectors turn system power OFF Biodex Medical Systems C 3 ATOMLAB Dose Calibrator Operation Manual Appendix C DETECTOR CABLE Length Standard 8 ft 2 488 m custom cable lengths available up to 20 meters Conductors Six total two for power two for chassis ground two for serial data Connectors RJ 12 Auxillary Port RS 232 connector GRAPHIC DISPLAY 160 x 160 pixels monochrome LCD display 2 5 x 2 5 in size CALIBRATOR CONSTANCY ISOTOPES Co 57 and Cs 137 E vials are normally used for accuracy and constancy checks NOTE Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying documents Appendeix H EMC chart Portable and mobile RF communications equipment can affect medical electrical equipment NOTE The use of accessories and cables other than those specified with the exception of cables sold by manufacturer may result in increased or decreased immunity of the equipment or system ELECTROMECHANICAL COMPATIBILITY As per CISPR 11 complies with Group 1 Cla
11. 3 2 ATOMLAB Dose Calibrator Operation Manual Chapter 3 CHANGING ISOTOPES See Figures 3 3 and 3 4 ATOMLAB 400 pose catisrator Routine List Tc 99m ES TI 201 Toggle List Co 57 ca MM OD BIODEX Back Select Isotope Zero Background Figure 3 3 The Routine List The selected isotope can be changed at any time and the display will immediately read the new isotope selected There are two lists from which isotopes can be selected The Routine List displayed when you press lt Select Isotope gt shows 10 commonly used preset isotopes seven lt Set Button gt keys that isotopes can be assigned to plus two user defined custom isotopes The Full Alphabetical List is accessed by choosing Select From List below the Routine List This list shows an alphabetical listing of all isotopes having an analytically determined dial value which the Atomlab 400 is designed to measure Figure 3 4 To Change Isotopes 1 Press lt Select Isotope gt The Routine List is displayed 2 Use the lt Toggle List gt keys to scroll up and down through the isotope list 3 Press the lt Screen Key gt to the right of the desired isotope The system returns to the Measure screen with the selected isotope displayed Biodex Medical Systems 3 3 ATOMLAB Dose Calibrator Operation Manual Chapter 3 To Access the Alphabetical List and Select an Isotope 1 Press lt Select Isotope gt The Routine List is now displayed 2 Use t
12. Biodex Medical Systems B 2 ATOMLAB Dose Calibrator Operation Manual Appendix B Following is the possible displayed values CPU Functions RAM Tests Firmware Check Program Load Biodex Medical Systems PASS all tests passing FAIL at least 1 of the tests of the processor detected an error PASS all 4 memory tests passing FAIL Code n a memory test failed see values below n 1 Stuck Bit test for O failed n 2 Stuck Bit test for 1 failed n 3 Alternating Bit test failed n 4 Addressing test failed PASS all 3 programs were read and verified using CRC 16 WARN Code n Error detected in Boot Program see values below FAIL Code n n n Error detected in Boot Main 1 and or Main 2 n 0 no error detected n 1 Parameter Block inconsistency n 2 Parameter Block CRC 16 error detected n 3 Program CRC 16 error detected PASS Loaded Program n n is 1 or 2 WARNING Code n n error detected see values below 1 0 Boot Configuration inconsistency 2 0 Boot Configuration CRC 16 error detected 0 1 the default program 1 or 2 was invalid for some reason so the alternate program had to be loaded 1 1 combined errors Boot Configuration inconsistency and invalid default 2 1 combined errors Boot Configuration CRC 16 error and invalid default B 3 ATOMLAB Dose Calibrator Operation Manual DETECTOR DIAGNOSTICS DISPLAY LOWER HALF There are several properties of a Dose Calibrator cham
13. Communication Error at the bottom of the display screen If a Fail message is displayed for the CPU RAM Firmware or Program tests disconnect the power supply reconnect the power and allow another system test to complete If the tests still fail contact the Biodex Medical Systems Service Department Biodex Medical Systems 4 5 ATOMLAB Dose Calibrator Operation Manual CHANGE UNITS See Figure 4 6 ATOMLAB 400 post caLisraror Toggle List BIODEX Change Units Becquerels Zero Background Select Isotope Chapter 4 Figure 4 6 The Change Units function allows the user to select Curies Ci or Bequerels MBq as the units of measure The Change Units function allows the user to select Curies Ci or Becquerels MBq as the units of measure 1 Press the lt Screen Key gt opposite the Change Units prompt to access the Change Units screen 2 Press the lt Screen Key gt opposite the desired unit of measure The system enables the selected unit type and returns to the Utilities Menu NOTE If you do not change units you must press lt Back gt to return to the Utilities Menu Biodex Medical Systems 4 6 ATOMLAB Dose Calibrator Operation Manual Chapter 4 DIAL VALUES See Figures 4 7 and 4 8 ATOMLAB 400 pose causraror Dial Values Toggle List ce ECH W i BIODEX Select Isotope Zero Background Figure 4 7 The Dial Values screen
14. For User Defined Isotopes 1 Press the lt Screen Key gt opposite the Reset Iso Button prompt The Reset Isotope Screen is displayed 2 Use the lt Toggle List gt keys to scroll through the Set prompts list 3 Press the lt Screen Key gt opposite the lt Set gt prompt to access a full alphabetical listing of isotope values 4 Use the lt Toggle List gt keys to scroll the list to display the desired isotope 5 Press the lt Screen Key gt opposite the desired isotope from the Full Isotope List 6 Press the lt Screen Key gt next to the OK prompt to set the lt Set gt button for the desired isotope and return to the Reset Isotope Button selection screen or press the lt Screen Key gt next to Cancel to exit without changing the key value 7 Press lt Back gt to return to the Utilities Menu B Resetting Initial Set Button Values For User Previously Defined Isotopes 1 Press the lt Screen Key gt opposite the Reset Isotope Button prompt The Reset Isotope Screen is displayed 2 Press the lt Screen Key gt opposite the desired lt SET gt button your want to change 3 Press the lt Screen Key gt next to the OK prompt to respond to the Do You Want To Re Set This prompt 4 The display now shows a full alphabetical listing of isotope values 5 Use the lt Toggle List gt keys to scroll the list to display the desired isotope 6 Press the lt Screen Key gt opposite the desired isotope from t
15. Press the lt Screen Key gt next to OK to select the value entered and return to the Measure screen with the new isotope selected Press the lt Screen Key gt next to Cancel to cancel the operation and return to the Routine List ATOMLAB 400 post catisraror Routine List 3 Set F 18 Set New Isotope 1 New Isotope 2 DP AS BIODEX Select Isotope Zero Background Figure 3 6 New Isotope settings on the Routine List allow the user to define two custom isotopes Biodex Medical Systems 3 6 ATOMLAB Dose Calibrator Operation Manual Chapter 3 ZERO BACKGROUND See Figure 3 7 ATOMLAB 400_ pose catisrator 1 91 Ki uCi Tc 99m ee Zeroing in 94 Secs Zero Background cr E sox Back Select Isotope Zero Background Figure 3 7 The Zero Background feature is used to zero the background reading before measuring an isotope The Zero Background screen is accessed by simply pressing the lt Zero Background gt key The isotope displayed is always the last one selected or Tc 99m if no isotope has been selected Measurement units default to the last selected Curies or Becquerels or to Curies if no measurement units have been selected If no isotopes have been put into or taken out of the chamber within the last 100 seconds chamber poles pressing lt Zero Background gt displays the Zero Background screen for one second the background is reported as 0 and the system returns immediately to the
16. Return Materials Authorization number R M A by us Pack the system in the carton that it was originally shipped in or pack it safely and securely to avoid shipping damage It is the customer s responsibility for any damage that occurs during shipping Non warranty non service contract charges for repair are as follows a Materials b Time c Shipping Charges 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 ATOMLAB Dose Calibrator Operation Manual Packing Slip PACKING SLIP Shipping Cartons The Atomlab 400 Dose Calibrator and its respective components comes carefully packed in two cartons inside a large single shipping box One carton contains the Display Unit in a carton and the Vial Syringe Dipper in a foam holder and the power pack and Warranty cards in a small box The other carton contains the Detector unit NOTE Prior to removing any of the cartons from the shipping box visually inspect the box and the inside packing for damage If any damage is noted do not unpack the contents Notify the carrier immediately so that a claim can be made if necessary and contact your Biodex Medical Systems Sales Representative If there is no visible damage remove the cartons and place them on a table or to the side We suggest removing the DISPLAY UNIT carton first NOTE Before deciding on a lo
17. be scheduled to run upon the next reset Same as the command displays all available commands with a brief description Biodex Medical Systems G 2 ATOMLAB Dose Calibrator Operation Manual Appendix G ISO MEAS RESET SETID SSAV STAT 1 0 VER Displays or sets the Isotope for activity measurement The parameter is an isotope index number 1 to 88 for the default isotopes 89 and 90 for custom isotopes Refer to the separate Isotope Index List at the end of Appendix G for details If no parameter is given the current assigned isotope is displayed Use this command with great care Example of a command ISO 43 sets isotope Tc 99m for detector 2 The Following errors may be returned ERROR Invalid Isotope Index a number greater than 90 was specified ERROR Measure Screen Not Active the Measure screen must be on view for this command to work When this command is received the newly selected isotope will be displayed and the activity changed accordingly However if any screen other than the Measure screen is on view the isotope cannot be changed and the displayed screen will not be affected Displays the Main Messure screen unconditionally Immediately reset and reboots the Atomlab display It will be at least 110 seconds before activity readings can be taken in the chambers Changes a detector Id specified as from to Valid Id s are 2 4 6 8 10 12 and 14 Sets the sc
18. calculated failed to match the checksum stored for the appropriate stored data Continuing to operate the chamber would be at risk The chamber should be serviced Code 5 Chamber Gas Low Correctable WARNING If grams of Argon drops more than 5 of the initial factory measured value this error code is set There is no correction done when this error code is active Code 6 Chamber Gas Too Low to Use FAIL If the grams of Argon drops more than 10 of the initial factory measured value this error code is set There is no correction done when this error code is active The chamber should be serviced Code 7 Communications Error FAIL This error code is set when repeated attempts of the display unit to communicate with a chamber failed Once this error code is set the display unit will no longer attempt to communicate with the chamber This could be caused from a bad chamber or a bad or disconnected cable between the chamber and the display unit Code 8 Chamber Bias Voltage Anomaly FAIL Chamber voltage bias must be out of the range of 325V 375V for this error code to be set The chamber should be serviced Code 9 Electrometer Monitor Voltage Anomaly FAIL Electrometer voltage must be out of the range of 2 375V 2 55V for this error code to be set The chamber should be serviced Code 10 OverRange Chamber Reading Too High WARNING The detected chamber activity reading has exceeded the capability of what the chamber c
19. example when measuring syringe doses when the volume is unimportant The chamber has electronics and the calibration built into it Therefore you can connect any Atomlab 400 display to a chamber and have a calibrated system Biodex Medical Systems 5 1 ATOMLAB Dose Calibrator Operation Manual Chapter 5 CHAMBER WELL LINER Placed within the well is a plastic liner to protect the chamber from contamination in the event of the source leaking during measurement The dose calibrator should always be used with the well liner SOURCE HOLDER Radioactive sources are measured by placing them within the well opening of the ionization chamber using the vial syringe dipper The vial syringe dipper places the radioactive source in the location which is at the proper measurement geometry within the chamber Samples contained within vials should be held in the bottom cup of the vial syringe dipper Samples within syringes should be placed in the syringe holder ring on the vial syringe dipper Sources should be orientated vertically in the source holder Sources should be placed in the dose calibrator well within 5 to 15 cm from the bottom of the chamber well as measured without the well liner in place The response of the dose calibrator varies 0 5 within this region CURRENT MEASUREMENT The ionization current is measured by a microprocessor controlled high impedance electrometer located within the base of the Detector Unit REAR PANEL On
20. found to be 374 This falls outside the range and is 1 5 higher than 368 The constancy measurement shows a 2 5 change since the Dose Calibrator was installed Their sum is 1 5 2 5 1 0 which within 2 and 2 The dial value of 374 should be used NOTE For all Dose Calibrator Models the well liner must be installed before making measurements The well liner provides attenuation for the Y 90 betas that would otherwise enter the chamber and cause high readings NOTE The dial value range provided above is for use with plastic syringes due to the wide variation in styles between vials it is recommended that the user determine the dial value for vials themselves This can be done using a vial containing a known activity of Y 90 by changing the dial value until the activity read using the Y 90 button matches the known activity within the vial Biodex Medical Systems E 7 ATOMLAB Dose Calibrator Operation Manual Appendix F APPENDIX F ATOMLAB DOSE CALIBRATOR CALIBRATION AND TRACEABILITY This appendix describes the calibration procedures performed on your Atomlab Dose Calibrator and their traceability to the National Institute of Standards amp Technology CALIBRATION amp TRACEABILITY The calibration of the Atomlab Dose Calibrators is directly traceable to the National Institute of Standards amp Technology formerly the National Bureau of Standards NBS This is achieved through the establishment of a set of workin
21. in a laboratory setting To allow easy fingertip control of the keys the front panel slopes gradually providing an optimum viewing angle On the rear panel of the unit are the power and communication connectors which remain out of the way as they are infrequently adjusted MEASUREMENT METHOD The current from the chamber is measured in one of three ways depending upon the order of magnitude of the current At low currents the current from the chamber is collected upon a capacitor in the feedback loop of the electrometer whose capacitance is stable and measured to a high degree Voltage measurements are made upon this capacitor many thousands of times per second The time period between measurements is accurately calibrated The second of two successive values is subtracted from the first which yields the net voltage change of the capacitor over that short period of time Thousands of successive differences are averaged over the course of one second in order to determine the chamber current during that second After a sufficient rise in voltage the charge on the capacitor is emptied reducing the charge and voltage by a calibrated amount At medium currents the capacitor will reach its maximum voltage value very quickly and the capacitor must be emptied quite often At these currents the number of times the capacitor is emptied per unit time is used to calculate the current from the chamber At high currents the capacitor cannot be em
22. location If you ever need to return your dose calibrator for updates calibration or repair use the original shipping carton boxes and shipping material MAINTENANCE General Cleaning Instructions As required wipe down the exterior of the unit using a soft rag slightly dampend with alcohol or a mild soap solution Quality Assurance Testing To properly maintain your Atomlab Dose Calibrator quality assurance should be performed as suggested in Appendix J Quality Assurance Testing of Atomlab Dose Calibrators Biodex Medical Systems 2 6 Release 2 0 ATOMLAB Dose Calibrator Operation Manual Chapter 3 CHAPTER 3 OPERATION KEY FUNCTIONS See Figure 3 1 ATOMLAB 400 pose catisrator Toggle List BIODEX Select Isotope Zero Background amp C Measure Utilities Figure 3 1 Atomlab 400 key functions Compact and easy to use the Atomlab 400 makes use of simple keys that interact with the internal firmware program Key functions are as follows lt Back gt Return to the previous screen lt Select Isotope gt Allows selection of a specific isotope from the isotope list lt Zero Background gt Used to zero the background reading before performing a measurement lt Screen Keys gt These are the four keys located immediately to the right of the display screen Press any key to select the adjacent prompt Only keys adjacent to a prompt are active lt Toggle List gt Allows the user to scroll through a
23. of current which is produced by a Co 60 source is defined as a dial value of 5 0 all other isotopes are defined relative to the Co 60 value Co 60 was chosen as the defining isotope due to its high energy photon emission and long half life The high energy reduces the effect of container geometry syringe vial etc and the long half life ensures that a single calibrated source can be used for many calibrations The Dial Value for certain isotopes have been directly measured using NIST calibrated sources provided from the NIST Standard Reference Materials program These isotopes include Ga 67 Y 90 Tc 99m Mo 99 In 111 1 125 I 131 Xe 133 and TI 201 In addition the Cs 137 Dial Value has also been measured directly using a NIST calibrated source Using the measured chamber response for the isotopes listed above in conjunction with a Monte Carlo model of the ion chamber chamber response curves have been generated Using information on photon electron and positron emission from Table of Radioactive Isotopes by Browne and Firestone verified with the Nuclear Data Center s Nudat 2 2 Database calculated dial values have been generated for those isotopes for which direct measurement of the Dial Value was not possible Biodex Medical Systems 5 5 ATOMLAB Dose Calibrator Operation Manual Chapter 6 CHAPTER 6 GLOSSARY This glossary provides definitions for the most common terms relevant to the Atomlab Dose Calibrators Accuracy Tests
24. of these commands that actively change settings and operation of the display can cause corruption of an activity someone may be in progress of at the display console These remote commands must be used with great care and consideration of how the unit is being used COMMAND DESCRIPTIONS There are commands to report status and some control the unit Following is a list with descriptions in alphabetic order AC Hex 0x03 Sends the most current activity reading out the serial port A Carriage Return 0x0D is not required Please refer to the DS command for details of the activity report format 1 Hex 0x31 same as C above A Carriage Return OxOD is not required Displays all available commands with a brief description BEEP Issues a beep tone on the display for milliseconds If not specified it defaults to 100 Longest beep sounded can be for 10 seconds Biodex Medical Systems G 1 ATOMLAB Dose Calibrator Operation Manual Appendix G BCKGND DS 1 0 DSTAT ECHO 1 0 FIRM 1 2 HELP This command will do a Zero Background on the connected chamber If the command cannot be performed the following error will be returned ERROR Measure Screen Not Active the Measure screen must be on view for this command to work If the command succeeds it may be done instantly taking effect on the very next activity reading or may take up to 100 readings If the Zero Background does not happen instantly each
25. reading from that detector will be preceded by Calculating background followed by CR LF When this command is received the Zero Background screen will be displayed However if any screen other than the Measure screen is on view a Zero Background cannot be performed and the displayed screen will not be affected Turns Data Streaming Mode On 1 Off 0 If no parameter is given the current Data Streaming Mode is displayed When On every time a reading is reported from a chamber the isotope s symbol dial values and activity reading is reported continuously until turned off If there is more than 1 chamber connected the detector number is appended on the end of each report The report starts with a tilda character with the fields separated by a space The activity reading always has 3 decimal digits in the report followed by the units Here is an example of a report Tc 99m 37 1 1404 767 uCi Displays Detector Status The data returned is in this order separated by a space Detector Id High Voltage Pressure Temperature and Argon gas in grams Here is an example of the returned data 10 353 9 245 0 23 4 6 9 Display or turn local character echo ON 1 or OFF 0 Local character echo is ON by default If using data streaming this should be turned OFF to avoid mangling the streaming reports Displays which one of the 2 main firmware programs is active and scheduled It can also select the other main firmware program to
26. regulatory performance standards and provide fast and accurate results The Detector Unit uses an ionization chamber for radiation detection and an electrometer for ion current measurement The chamber bias is generated with an electronic high voltage supply eliminating the need for expensive battery changes The Display Unit communicates with the Detector Unit through a detector cable with RJ 12 connectors on both ends A RS 232 nine pin serial port computer interface is available on the rear of the display This interface will allow the user to send data and commands between the dose calibrator and a remote PC The Atomlab 400 does not supply the software for the PC If the host computer has no serial port a USB serial converter cable is available THE DETECTOR The Atomlab Detector Unit is a well type ionization chamber capable of measuring activity as low as 0 01 pCi and as high as 40 curies of Tc 99m The chamber is surrounded on all sides and on the bottom with 25 inch lead to both shield you from the source you are measuring and shield the dose calibrator from any ambient radiation THE CHAMBER The well type chamber was carefully selected to provide a nearly 4 pi measuring geometry which means that the radiation detector nearly surrounds the radionuclide This allows the Atomlab Dose Calibrator to measure the activity of a sample no matter what its volume or shape as long as it fits into the Chamber Well This is necessary for
27. the proportionality of the measurement result to the activity mea sured as determined over the intended range of use for the dose calibrator This test is done using a vial or syringe of Tc 99m whose activity is at least as large as the maximum activity normally assayed in a prepared radio pharmaceutical kit in a unit dosage syringe or in a radio pharma ceutical therapy whichever is largest There are several acceptable methods for preparing linearity testing The difference in these methods is which reading is used for decay correction of the activities The following methods are all acceptable for determining the normalized value a Decay correct the test sample from the first reading and compare each read ing to the decay corrected reading For Tc 99 select 30 hours as the nor malized reading and decay correct this reading to calculate the expected activities at the times you took your readings Compare the readings to the calculated activities You can change from 30 hours to another time point and perform your normalized calcula tion from that time point The Atomlab 500 automated linearity test uses 30 hours as the default method The following decay method described in detail decay corrects each reading then averages these calculated activi ties and then divides the average by the time corrected reading to deter mine a correction factor If the correction factor is between certain values the calibrat
28. the rear panel of the Detector Unit are the connectors for power and data communication with the Display Unit The Detector Unit can be located up to 20 feet 6 09 meters away from the Display Unit The standard cable measures eight feet 2 43 meters in length RESPONSE The response of this type of ionization chamber has been carefully studied using radionuclides calibrated at the National Institute of Standards amp Technology The result is a well defined energy response curve which is used to determine the calibration values for many different isotopes with high accuracy Each chamber has been calibrated with a National Institute of Standards amp Technology traceable source The corresponding Calibration Value has been stored in the memory of the Detector Unit After calibration the chamber s accuracy is tested with several sources of differing gamma energies whose activity values are traceable to the National Institute of Standards amp Technology Biodex Medical Systems 5 2 ATOMLAB Dose Calibrator Operation Manual Chapter 5 THE DISPLAY UNIT The Atomlab 400 Dose Calibrator Display Unit consists of function keys and an LCD display that allows you to make activity measurements A built in microprocessor executes commands input via the front panel keys and computes activity values from Detector data The Display Unit with a molded plastic case housing the electronics has been specifically designed to perform Activity Measurements
29. was made and when you wish to know what the decayed activity of your radioisotope will be Sample Calculation The following is a calculation of the decayed activity of Tc 99m with an initial activity of 43 mCi after 53 minutes 6 Ag 43 mCi 7 For Tc 99m T 6 007 h 8 Elapsed t 53 min x 1 hr 0 8833 hr 60 min Biodex Medical Systems D 1 ATOMLAB Dose Calibrator Operation Manual Appendix D 9 A Ag x 2 T112 A 43 mCi x 2 0 8833 6 007 A 43 mCi x 2 0 147045 A 43 mCi x 0 903 A 38 83 mCi ALTERNATE DECAY CALCULATION METHOD If you are using a calculator with the Y function perform the following 1 Measure the current activity of the radioisotope Ao which can be compared to the decayed calculated activity 2 Look up half life Ty o of the radioisotope in Appendix E Note the time units 3 T Half life of the isotope t Elapsed Time A Current Activity A Activity at the time of calibration n elapsed time half life 4 Calculate A A 2 5 Calculate the elapsed time t in the same units as the T4 2 that will elapse between when the calculated activity measurement was made and when you wish to know what the decayed activity of your radioisotope will be Sample Calculation 6 A 43 mCi 7 For Tc 99m Tu 6 007 h 8 Elapsed t 53 min x 1 hr 0 8833 hr 60 min 9 Replace equation with following A A 2 43 mCi 2 0 8833 6 007 A 43 mCi 2 0 1470451 A
30. 0 INSTALLATION We strongly suggest that you read this chapter before moving on to the operation chapter This will help ensure that your Atomlab Dose Calibrator is up and running properly and that you have adequate access to the unit to perform all the functions that will be discussed OPERATING REQUIREMENTS Prior to installing your equipment plan a layout for your Atomlab unit that will ensure it is convenient for measuring radionuclides and will not cause undue radiation exposure because of extra handling of high activity sources There should be ample room to place a vial shield on the work surface preferably behind an L Block shield open the shield and remove the vial using tongs quickly place the vial into the vial syringe dipper and then place both into the Chamber Well Remember that to make radioisotope measurements you will have to place the clear plastic Chamber Well Liner into the Chamber Well and lower the plastic vial syringe dipper into the liner Make sure there will be no obstructions such as wall cabinets above the Detector Unit Such obstacles may make it difficult to insert and remove the vial syringe dipper NOTE You must use a well liner at all times Work Surface Choose a table or other counter which is free of vibration does not wobble and will easily support 300 pounds The surface area of the table top should provide ample area to accommodate the Detector Unit Display Unit the L Block Shield the shield
31. 1 52015 51979 51943 51907 51871 51835 51799 D I 51763 51727 51692 51656 51620 51584 51548 51513 51477 51441 96 51406 51370 51334 51299 51263 51228 51192 51157 51121 51086 97 51051 51015 50980 50945 50909 50874 50839 50803 50768 50733 98 50698 50663 50628 50593 50558 50523 50488 50453 50418 50383 99 50348 50313 50278 50243 50208 50174 50139 50104 50069 50035 1 0 50000 Biodex Medical Systems D 6 ATOMLAB Dose Calibrator Operation Manual Appendix D EXPLANATION OF DECAY CALCULATION METHODS Calculator Method The radioactivity of an isotope can be calculated as it decays using the following expression A Aj elt where A final activity at the end of the decay time A initial activity measured at some starting time t net decay time in units inverse to A and A lamda decay constant specific to the radioisotope A In 2 Tyo 0 693 Ty 0 where T4 2 half life specific to the radioisotope So using a calculator with the ex function decay calculations can easily be performed as shown in the first section of this appendix Decay Factor Method If you do not have a calculator with the e function the above expression can be rewritten as follows Ay X A where X Xn N x X R N integer number of half lives in time t and R decimal remainder after dividing t by T4 2 To verify this remember three important relations regarding exponentials
32. 1 77647 77593 77539 77486 77432 37 77378 77325 77271 77218 77164 77111 77057 77004 76950 76897 38 76844 76791 76737 76684 76631 76578 76525 76472 76419 76366 39 76313 76260 76207 76154 76102 76049 75996 75944 75891 75838 40 75786 75733 75681 75628 75576 75524 75471 75419 75367 75315 41 75262 75210 75158 75106 75054 75002 74950 74898 74846 74794 42 74742 74691 74639 74587 74536 74484 74432 74381 74329 74278 43 74226 74175 74123 74072 74021 73969 73918 73867 73816 73765 44 73713 73662 73611 73560 73509 73458 73408 73357 73306 73255 45 73204 73154 73103 73052 73002 72951 72900 72850 72799 72749 46 72699 72648 72598 72548 72497 72447 72397 72347 72297 72247 47 72196 72146 72096 72047 71997 71947 71897 71847 71797 71747 48 71698 71648 71598 71549 71499 71450 71400 71351 71301 71252 49 71203 71153 71104 71055 71005 70956 70907 70858 70809 70760 Biodex Medical Systems D 5 ATOMLAB Dose Calibrator Operation Manual Appendix D DECAY FACTOR CHART X R where R t T yyo 0 500 to 1 0 R 000 001 002 003 004 005 006 007 008 009 50 70711 70662 70613 70564 70515 70466 70417 70368 70320 70271 51 70222 70174 70125 70076 70028 69979 69931 69882 69834 69786 52 69737 69689 69641 69592 69544 69496 69448 69400 69352 69304 53 69255 69208 69160 69112 69064 69016 68968 68920 6
33. 1 Ir 192 Ir 196 Iridium Gd 153 Gadolinium s7 ec 241 6 da 1 10 e Includes Bremsstralung 10 contributions 3 10 3 3 3 10 10 10 Q 52 seconds includes Bremsstahlung contributions p skeklei ekkerehkl Iridium Beta 1 4 hours 10 Potassium EC Beta 7 636 minutes 10 K 43 Potassium 314 22 3 hours La 140 Lanthanum 525 1 678 days Lu 177 Lutetium Beta 133 6 71 days Mo 99 Molybdenum 175 0 Beta 390 2 748 days S 3 In 1 4 inch lead wall Bes breakthru shield N 13 Nitrogen 10 1 EC Beta 491 9 965 minutes c Scheme EC Electron Capture IT Isomeric Transition NOTES 1 Isotope A B implies that B is in equilibrium with A 2 Half Life s seconds m minutes d days y years 3 Scheme EC Electron Capture B Beta decay IT Isomeric transition A Alpha Decay 4 Cal Value Atomlab Dose Calibrator dial setting to calibrate for corresponding isotope 5 Notes H r Half life ratio of daughter over parent implies daughter is ignored Bremsstrahlung includes implies low energy photons from electron interaction in saline Isotope should be measured in plastic syringe or vial or thin wall glass ampule Isotope should be measured in CONFIDENCE VALUES lastic syringe or vial r thin wall Calculated with corrected Monte Ca
34. 4 59832 59791 59750 59708 59667 59625 59584 59543 59502 75 59460 59419 59378 59337 59296 59255 59214 59173 59132 59091 76 59050 59009 58968 58927 58886 58845 58805 58764 58723 58682 TT 58642 58601 58561 58520 58479 58439 58398 58358 58317 58277 78 58237 58196 58156 58116 58075 58035 57995 57955 57915 57875 79 57834 57794 57754 57714 57674 57634 57594 57554 57515 57475 DO 57435 57395 57355 57316 57276 57236 57197 57157 57117 57078 EN 57038 56999 56959 56920 56880 56841 56801 56762 56723 56683 ER 56644 56605 56566 56527 56487 56448 56409 56370 56331 56292 83 56253 56214 56175 56136 56097 56058 56019 55981 55942 55903 84 55864 55826 55787 55748 55710 55671 55632 55594 55555 55517 85 55478 55440 55402 55363 55325 55287 55248 55210 55172 55133 86 55095 55057 55019 54981 54943 54905 54867 54829 54791 54753 87 54715 54677 54639 54601 54563 54525 54488 54450 54412 54374 88 54337 54299 54261 54224 54186 54149 54111 54074 53036 53999 89 53961 53924 53887 53849 53812 53775 53737 53700 53663 53626 90 53589 53552 53514 53477 53440 53403 53366 53329 53292 53255 91 53218 53182 53145 53108 53071 53034 52998 52961 52924 52888 92 52851 52814 52778 52741 52705 52668 52632 52595 52559 52522 93 52486 52449 52413 52377 52340 52304 52268 52232 52196 52159 94 52123 52087 5205
35. 43 mCi 1 1072992 A 38 83 mCi Biodex Medical Systems D 2 ATOMLAB Dose Calibrator Operation Manual Appendix D DECAY FACTOR METHOD The following method is used to perform radioisotope decay calculations using a calculator without the ex function 1 Measure the current activity Aj of the radioisotope 2 Look up half life T of the radioisotope in Appendix E Note the time units 3 Calculate the time t in the same units as Ty 2 that will elapse between when the activity measurement was made and when you wish to know what the decayed activity of your radioisotope will be 4 Calculate t T in terms of N R where N is an integer 0 1 2 etc and R is less than 1 5 Look up X N in Table 1 on page D 4 6 Look up X R in the Decay Factor Chart 7 Calculate A Aj x Xp N x X R Sample Calculation The following is a calculation of the decayed activity of Tc 99m with an initial activity of 43 mCi after 32 5 hours 1 A 43 mCi 2 For Tc 99m T472 6 007 h 3 t 32 5 h 4 t 14 32 5 h 6 007 5 410 N 5 R 0 410 5 From Table 1 X 5 0 03125 6 From the Decay Factor Chart the 41 row and the 000 column X 410 75262 Biodex Medical Systems D 3 ATOMLAB Dose Calibrator Operation Manual Appendix D 7 A Aj X Xp N x X R 43 mCi x 0 03125 x 75262 1 01 mCi Z Xn N 2 N 4 0 5 0 25 0 125 0 0625 0 03125 0 01563 0 007813 0 003906 0 001
36. 8873 68825 54 68777 68729 68682 68634 68587 68539 68492 68444 68397 68349 55 68302 68255 68207 68160 68113 68066 68019 67971 67924 67877 56 67830 67783 67736 67689 67642 67596 67549 67502 67455 67408 57 67362 67315 67268 67222 67175 67129 67082 67036 66989 66943 58 66896 66850 66804 66757 66711 66665 66619 66573 66526 66480 59 66434 66388 66342 66296 66250 66204 66159 66113 66067 66021 60 65975 65930 65884 65838 65793 65747 65702 65656 65611 65565 DI 65520 65474 65429 65384 65338 65293 65248 65203 65157 65112 62 65067 65022 64977 64932 64887 64842 64797 64752 64707 64662 63 64618 64573 64528 64483 64439 64394 64349 64305 64260 64216 64 64171 64127 64082 64038 63994 63949 63905 63861 63816 63772 D 63728 63684 63640 63596 63552 63508 63464 63420 63376 63332 66 63288 63244 63200 63156 63113 63069 63025 62982 62938 62894 67 62851 62807 62764 62720 62677 62633 62590 62546 62503 62460 68 62417 62373 62330 62287 62244 62201 62157 62114 62071 62028 69 61985 61942 61900 61857 61814 61771 61728 61685 61643 61600 70 61557 61515 61472 61429 61387 61344 61302 61259 61217 61174 71 61132 61090 61047 61005 60963 60921 60878 60836 60794 60752 72 60710 60668 60626 60584 60542 60500 60458 60416 60374 60332 Ke 60290 60249 60207 60165 60123 60082 60040 59999 59957 59915 74 5987
37. 9 Gold 46 7 Beta SI 3 139 days 10 Ba 133 7 Barium 7 4 EC i 10 54 years ti 3 Bi 213 Bismuth 53 5 Beta 12 3 45 6 minutes 10 Br 75 Bromine 8 3 EC Beta 499 1 62 hours H r 00056 did not include Se Bromine 4 4 EC Beta 642 16 2 hours Bromine 20 6 EC Beta 1 12 2 376 days Carbon 10 1 EC B 385 20 39 minutes Cd 109 Cadmium 32 0 EC 2 1 267 years Ce Pr 144 Ce Praseodymium 57 4 Beta Beta L 82 amp 1209 285 days 17 minutes Co 55 Cobalt 5 6 EC B 430 17 53 hours Fe ignored AA PEA p ii contribution is insignificant Co 57 Cobalt J TES 271 77 days Co 58 Cobalt 11 5 EC NS 70 9 days Co 60 Cobalt 5 0 Beta 96 5 271 years Cal values defined relative Kass al to Co 60 Cr 51 Chromium 295 0 Ec 27 7 days Pc 10 Cs 134 Cesium k seta 8 157 2 06 years LC 10 Cs 137 Cesium 17 1 Beta 188 30 0 years 3 Cu 61 Copper 12 3 EC B 306 3 408 hours C 10 Cu 62_ __ Copper 9 7 EC B 9 74 minutes C 10 Cu 64 Copper 55 0 Beta Beta 12 701 hours y Cu 67 _Copper a 43 6 Beta Dy 165 Dysprostum 92 8 Beta 2 334 hours Includes Bremsstralung a o contributions Eu 152 Europium _ __6 2 EC Beta 496 13 33 years C F 18 Flourine 9 6 EC Beta 242 1 83 hours H Fe 52 Iron 11 9 EC Beta I 189 8 275 hours Le NOTES Scheme EC Electron Capture IT Isomeric Transition Isotope A B implies that B is in e
38. 9317 89255 89193 89131 89069 89008 88946 17 88884 88823 88761 88700 88638 88577 88515 88454 88393 88332 18 88270 88209 88148 88087 88026 87965 87904 87843 87782 87721 19 87661 87600 87539 87478 87418 87357 87297 87236 87176 87115 20 87055 86995 86934 86874 86814 86754 86694 86634 86574 86514 21 86454 86394 86334 86274 86214 86155 86095 86035 85976 85916 22 85857 85797 85738 85678 85619 85559 85500 85441 85382 85323 23 85263 85204 85145 85086 85027 84968 84910 84851 84792 84733 24 84675 84616 84557 84499 84440 84382 84323 84265 84206 84148 25 84090 84031 83973 83915 83857 83799 83741 83683 83625 83567 26 83509 83451 83393 83335 83278 83220 83162 83105 83047 82989 27 82932 82874 82817 82760 82702 82645 82588 82531 82473 82416 28 82359 82302 82245 82188 82131 82074 82017 81960 81904 81847 29 81790 81734 81677 81620 81564 81507 81451 81394 81338 81282 20 81225 81169 81113 81057 81000 80944 80888 80832 80776 80720 31 80664 80608 80552 80497 80441 80385 80329 80274 80218 80163 32 80107 80051 79996 79941 79885 79830 79775 79719 79664 79609 33 79554 79499 79443 79388 79333 79278 79223 79169 79114 79059 34 79004 78949 78895 78840 78785 78731 78676 78622 78567 78513 35 78458 78404 78350 78295 78241 78187 78133 78079 78025 77970 36 77916 77862 77809 77755 7770
39. 953 0 000977 O O1 BR D OH o Table 1 Biodex Medical Systems D 4 ATOMLAB Dose Calibrator Operation Manual Appendix D DECAY FACTOR CHART X R where R t T4 0 000 to 0 499 R 000 001 002 003 004 005 006 007 008 009 00 1 00000 99931 99861 99792 99723 99654 99585 99516 99447 99378 01 99309 99240 99172 99103 99034 98966 98897 98829 98760 98692 02 98623 98555 98487 98418 98350 98282 98214 98146 98078 98010 03 97942 97874 97806 97739 97671 97603 97536 97468 97400 97333 04 97265 97198 97131 97063 96996 96929 96862 96795 96728 96661 05 96594 96527 96460 96393 96326 96259 96193 96126 96059 95993 06 95926 95860 95794 95727 95661 95595 95528 95462 95396 95330 07 95264 95198 95132 95066 95000 94934 94868 94803 94737 94671 08 94606 94540 94475 94409 94344 94278 94213 94148 94083 94017 09 93952 93887 93822 93757 93692 93627 93562 93498 93433 93368 10 93303 93239 93174 93109 93045 92980 92916 92852 92787 92723 11 92659 92595 92530 92477 92402 92338 92274 92210 92146 92083 12 92019 91955 91891 91828 91764 91700 91637 91573 91510 91447 13 91383 91320 91257 91193 91130 91067 91004 90941 90878 90815 14 90752 90689 90626 90563 90501 90438 90375 90313 90250 90188 15 90125 90063 90000 89938 89876 89813 89751 89689 89627 89565 16 89503 89440 89379 8
40. ATOMLAB 400 DOSE CALIBRATOR OPERATION AND SERVICE MANUAL 086 335 BIODEX 20 Ramsey Road Shirley New York 11967 4704 Tel 800 Be ae ae en 324 SN Tex 631 924 9241 Email info biodex com www biodex com FN 07 263 Rev C 10 13 ATOMLAB 400 DOSE CALIBRATOR This manual covers installation and operation of the following product 086 335 Atomlab 400 Dose Calibrator A CAUTION Federal Law restricts this device to sale by or on the order of a physician pharmacist or other licensed professional ZN ATTENTION La loi f d rale limite ce dispositif la vente par ou sur l ordre d un m decin du pharmacien ou de tout autre professionnel autoris 1 ATOMLAB DOSE CALIBRATOR WARRANTY Instrumentation A This equipment and its accessories are warranted by BIODEX MEDICAL SYSTEMS INC against defects in materials and workmanship for a period of two years from the date of shipment from BIODEX MEDICAL SYSTEMS INC During the warranty period BIODEX MEDICAL SYSTEMS INC will in its sole discretion repair recalibrate or replace the equipment found to have such defect at no charge to the customer EXCEPT AS STATED ABOVE THERE ARE NO WARRANTIES EXPRESSED OR IMPLIED INCLUDING WITHOUT LIMITATION WARRANTIES OR MERCHANTABILITY OR FITNESS FOR USE BIODEX DOES NOT ASSUME LIABILITY FOR INCIDENTAL CONSEQUENTIAL OR INDIRECT DAMAGES INCLUDING LOSS OF USE SALES PROFITS OR BUSINESS INTERRUPTION B This warranty does not app
41. B is in equilibrium with A 2 Half Life s seconds m minutes d days y years 3 Scheme EC Electron Capture B Beta decay IT Isomeric transition A Alpha Decay 4 Cal Value Atomlab Dose Calibrator dial setting to calibrate for corresponding isotope 5 Notes H r Half life ratio of daughter over parent implies daughter is ignor Bremsstrahlung includes implies low energy photons from electron in Isotope should be measured in plastic syringe or vial or thin wall glass ampule ed teraction in saline Isotope should be measured in plastic syringe or vial or thin wall glass ampule unless otherwise stated above CONFIDENCE VALUES Calculated with corrected Monte Carlo Beta MC response strongly dependent upon measurement geometry using the listed dial value Measured directly Special Case As stated determined using actual measurement with clinical geometry confidence value of a measurement made best if Cal Value used is Biodex Medical Systems E 4 ATOMLAB Dose Calibrator Operation Manual Appendix E Page 5 of 5 SUPPLEMENTAL ALPHABETICAL LISTING OF ISOTOPES rev 4 20 09 ATOMLAB 400 and ATOMLAB 500 DOSE CALIBRATORS Nuclide Average Beta Half Life Scheme Energy KeV Uncertainty E 10 Zr Y m 89 A AA EC Beta IT 7 1 3 268 days 16 1 seconds Dial Value Settings and Source Containers Glass Vial Glass Syringe etc The Atomlab Dial Value DV settings
42. Biodex Medical Systems D 7 ATOMLAB Dose Calibrator Operation Manual Appendix D eln A A and eAB eA B Now t Ty2 N R where N is an integer and R is the remainder less than 1 For t 32 5 hours and Ty 6 007 hours t T4 2 32 5 6 007 5 410 so that N 5 and R 0 410 Now to simplify calculations we can write the above relation as As Aje M A e 2 t Tu A A ein 2 N R A e In 2 N y ehn 2 R A X Xn N x X R Xn N e In 2 N _ eln 2 N 2 N This expression is used to generate the values in Table 1 X R ein 2 R This expression is used to generate the Decay Factor Chart for values of R from 0 001 to 0 999 For the above example Xn 5 0 038125 X 0 410 0 75262 A X A Da N x X R A 0 03125 x 0 75262 43 mCi A 1 01 mCi Biodex Medical Systems D 8 ATOMLAB Dose Calibrator Operation Manual Appendix E APPENDIX E PRE SET CALIBRATION VALUES Page 1 of 5 SUPPLEMENTAL ALPHABETICAL LISTING OF ISOTOPES rey 4 20 09 ATOMLAB 400 and ATOMLAB 500 DOSE CALIBRATORS Nuclide Dial Decay Average Beta T Half Life Expected Value Scheme Energy KeV Uncertainty As 76 Arsenic 24 4 Beta 1068 1 1 days Hi 10 Au 198 Gold 24 1 Beta 406 2 69 days 5 H 10 Au 19
43. E PRE SET CALIBRATION VALUES 000 ooocconicccnncconnnnnnana nono nnrnnananancc cnn E 1 Supplemental Alphabetical Listing of Isotopes sssssssnnneesennennnneeneeeneeeene E 1 Dial Settings For EE E 6 F ATOMLAB DOSE CALIBRATOR CALIBRATION AND TRACEABILITY F 1 Calibration and Traceability AEN F 1 G ATOMLAB 400 SERIAL COMMUNICATIONS INTERFACE seen G 1 Connection Ota E G 1 Command Descriptions E G 1 Usage EE G 1 Command Descriptions EE G 1 Atomlab 400 Isotope Index G 4 H ELECTROMAGNETIC COMPATIBILITY ccccccesseeeeeseeeeeeeesneneeeeeeeeeeeeees H 1 I DETERMINING DIAL VALUES sisscsctscsssnstciccccsccessisseaseersissesasnsancuaccceeccesceeseaes 1 1 J QUALITY ASSURANCE TESTING OF ATOMLAB CALIBRATORS J 1 K ATOMLAB 400 REPLACEMENT PARTG cccccccceseeeeeeeseeeeeeeseeeeeeees K 1 E SCHEMATICS 2000000 rana L 1 Biodex Medical Systems V ATOMLAB Dose Calibrator Operation Manual Chapter 1 CHAPTER 1 ATOMLAB 400 INTRODUCTION Atomlab Dose Calibrators use an argon gas filled pressurized chamber to measure the activity of a radionuclide source of a known isotope Their primary application is the measurement of the dose administered to a patient in nuclear imaging or nuclear medicine The Atomlab dose calibrator is comprised of a display unit and a connected ionization chamber detector unit It provides fast accurate radionuclide activity measurements with performance that easily surpasse
44. MJ9q uogeinq ZH 09 05 SNUW VE WV 08 ZUMA SULLA ZH 08 01 ZHY OST IWA daa ZHAS 89U 29 sod AMZ AMT A00S Speo mdu Y Md SAB M IUIS 08 WV ZUAL TENNA 9 ZUOH W A ZHIN 00S7 01 ZHINO8 yunwu pajerpey s01 103 sdd 3au sod ay AMP ANZ asreYyosiq 9118I501909 4 TID seg g tay uo sidn1193u pue sdiq 93e J0A JUN HOUSE Sper Jomog An poyonpuod spray 19M0q sing jusisuel ISLA LIAA I1 00019 DAI 8 p 00019 OAI WE gouruoyiod Jo uoyepeisop ou Be goueuLlojiod Jo uorepei 9p ou O a9uBuLIoj1ad zo uorepel 9p ou Ppoydwos aoueuLioj1ad jo uonepeI3op ou LSd A9S 12X01 WIE Hoys SESCH 25000 e ODEO Jo uonEmp Co wo METE ee OOO 7 EE 9 v 00019 OUI b v 00019 JAI p 00019 JAI T p 00019 DAI Biodex Medical Systems ur OT QD un woneamsqo HAN ECOS VOLS HI VSD ze ve O0 NOM 2 00019 oa msg me poemes Fe SYOLVUESEITVS 3800 EVINOLV 404 ALMISILLVANOS DILANDSVNOYLOATSA H 2 ATOMLAB Dose Calibrator Operation Manual Appendix APPENDIX DETERMINING DIAL VALUES Because the dose calibrator is not inherently capable of detecting which radioisotope has been inserted in the re entrant chamber the user must select which isotope is currently being measured Each radioisotope selection has a corresponding calibration value also referred to as a dial value for historical reasons The dial value for a given isotope is a unitless
45. OMLAB Dose Calibrator Operation Manual Chapter 3 ISOTOPE SELECTION KEY CALIBRATION If you have an isotope whose activity has already been accurately calibrated such as a source obtained from the National Institute of Standards amp Technology you may use it to set a Calibration Value for any of the Standard Isotope Selection keys The procedure is as follows 1 Obtain the calibrated activity and its date For example the National Institute of Standards amp Technology source you obtained is I 125 with the following properties Activity measured 12 13 88 12 00 EST Activity per unit mass 1 195 MBq g 0 005 0 5 Mass 4 95863 g The half life is 59 6 days 0 2 Let A current activity A activity at time of calibration A A e In 2 UT 4 2 where t time lapse since calibration and T1 2 half life A 1 195 MBa g 4 95863 g 5 926 MBq 160 2 pCi t 60 25 days A 160 2 e 2 6025 506 79 5 pCi 2 94 MBq 2 Calculate the current activity Compare this value to the source reading in the chamber If you want to change the dial setting note that this will also change the activity displayed See the next step On the Home Menu press lt Utilities gt Select lt Dial Values gt from the Utilities screen Select the isotope for which you would like to adjust the dial value by using the lt Toggle List gt keys to scroll up and down to the desired isotope then press the desired isotope button Make a no
46. PE SELECTION Ten Routine isotope selections Tc 99m TI 201 Co 57 Cs 137 I 131 In 111 Ga 67 Xe 133 1 123 and Mo 99 The unit displays readings in uCi mCi Ci MGq or GBq Dial values can be reset for new calibration values The Mo 99 key is calibrated for Mo 99 assay in a shielded vial of Tc 99m The Atomlab 400 provides a 30 second countdown Alphabetical List Seven settable selections Two user programmable selections New Isotope 1 and 2 Biodex Medical Systems C 2 ATOMLAB Dose Calibrator Operation Manual Appendix C CALIBRATION VALUE DISPLAY Up and down arrow control with dial values from 0 0 to 999 9 DETECTOR TYPE Well type pressurized ionization chamber with Argon filled gas Replaceable plastic liner included Dimensions are Well opening 2 75 in 7 cm Well depth 10 50 in 26 7 cm Well opening with liner 2 5 in 6 4 cm Well depth with liner 10 25 in 26 cm Detector Shield 25 in 6 mm lead surrounding ionization chamber with top well opening Chamber Bias 355 5 volts ENVIRONMENTAL OPERATING CONDITIONS Temperature 0 to 40 C Humidity 0 to 95 rh non condensing For optimum performance the Atomlab 400 should be operated in a normal laboratory environment where the temperature and humidity are maintained for normal human comfort and the ambient radiation level is low and constant PHYSICAL DATA Display Unit Detector Unit Size 6 75 w x 5 H x 6 d 6 dia x 15 5 h 17 15 x 12 7 x
47. Screen Key gt opposite the desired choice to either enable or disable the audio beep Once the desired key has been pressed the system returns to the Utilities Menu If you did not make a change and the ON or OFF is not changed press lt Back gt to return to the Utilities Menu Biodex Medical Systems 4 4 ATOMLAB Dose Calibrator Operation Manual Chapter 4 SYSTEM TEST See Figure 4 5 ATOMLAB 400 poss catisrator System Test CPU PASS Toggle List RAM PASS Firmware PASS BIODEX Program PASS Run 2 Chamber 1d 6 SH 5300101 86 Measuring Background Continue Select Isotope Zero Background Figure 4 5 The System Test screen following power up If System Test is accessed while power is already ON the Measuring Background line is not displayed The System Test runs an internal program to check function of the CPU RAM Firmware Program and Chamber 1 Press the lt Screen Key gt opposite the System Test prompt to access the System Test Results screen The system will perform an internal test and report with pass or fail prompts for each parameter tested The system test always shows a current chamber status 2 Press the lt Screen Key gt opposite the Continue prompt to return to the Utilities Menu NOTE If any parameter should fail the system test the system will display an error message For example if the chamber is not connected the system will note Error Code 7
48. a M M 2 7 where Tin 6 007 h Record the values See linearity form Figure 1 Calculate activity correction factors cf by divid ing the average of all decay corrected measurements Mp by each Mg i e _ Average of all Mg chy Mun Accept if 0 95 lt cfiy lt 1 05 Consider correcting the displayed activity mea surement M of radio pharmaceuticals if a linearity error is greater than 5 and less than 10 i e 0 90 lt chu lt 0 95 or 1 05 lt cfy lt 1 10 Corrected M M y where subscript M is closest in value to M in most recent linearity form For low activity values if cfyy lt 0 95 see the following note about Mo 99 contamination NOTE If there is any Mo 99 contaminant in the Tc 99m sample then long decay times gt 48h will compromise the decay linearity test This will be apparent with decreasing cu values for the lowest displayed activity measurements M In order to test for this prepare another linearity test sample with an activity of about 1 mCi Repeat the lin earity test If the due values are within an acceptable range and if the 1st linearity test by decay produced acceptable Ou values at higher M values then the dose calibrator passes The two linearity tests should have overlapping activity values in the acceptable range Hint Recalculate first test M without including failing values from low M Mo 99 contamination 5 Ifcfyy lt 0 90 or gt 1 10 contact Biodex t
49. a Tc 99m source which would produce the same current as the isotope source when placed in the well chamber NOTE Unless you are reading activities less than 20 uCi it is recommended to leave the threshold level for Tc 99m at 20 pCi The minimum threshold is 1 to 2 uCi for TC 99m at this threshold setting the display activity readings have a higher fluctuation Biodex Medical Systems C 1 ATOMLAB Dose Calibrator Operation Manual Appendix C ACCURACY Overall accuracy of activity determination for isotopes Co 57 Co 60 Ga 67 Tc 99m In 111 1 131 Ba 133 Cs 137 and Tl 201 using the factory set calibration values are within 3 or 0 3 microcuries whichever is greater NOTE Intercomparison of calibrated sources and the Atomlab 400 requires combining the uncertainties of both the Atomlab 400 and the calibrated source to determine expected agreement DETECTOR LINEARITY Within 1 or 0 2 OC whichever is greater ELECTROMETER LINEARITY Within 1 or 0 2 Ci whichever is greater ELECTROMETER ACCURACY Within 1 or 0 2 pCi whichever is greater STABILITY Short term 24 hours within 0 3 above one mCi exclusive of background Long term one year within 1 NOISE FLUCTUATIONS Display Fluctuations Activity Range lt 1 digit after 1 2 seconds gt 199 9 microcuries lt 4 after 3 seconds 2 after 10 seconds gt 19 99 microcuries lt 4 after 50 100 seconds 0 01 to 19 9 microcuries ENERGY RANGE 25 keV to 3 MeV ISOTO
50. after several seconds 3 Remove the power cord from the outlet and verify that the voltage of the outlet is correct If not repair the outlet or find another outlet that provides the required voltage Re insert the power cord and turn the power back ON The power pack converts wall power from 100V to 240 V to the correct voltage for the dose calibrator If your system still will not power up call the Biodex Customer Service Department Biodex Medical Systems A 1 ATOMLAB Dose Calibrator Operation Manual Appendix A FLUCTUATIONS IN ACTIVITY MEASUREMENT When the system is displaying activity for the more common isotopes the electrometer continually averages the data it receives from the detector This ensures for most readings a stable Activity Display After you insert an isotope into the Detector and select the properly calibrated key the display may vary at low activity values as the system acquires the new data After a short time the Activity Display will stabilize with expected fluctuations described below If the display continues to fluctuate and you have verified it is not because of a high Calibration Value consult Biodex Customer Service Department Display Fluctuations For High Calibration Values For some isotopes which require a high Calibration Value you may observe fluctuations of 0 5 Ci or more Keep in mind that the Calibration Value for an Isotope is related to gain of the electrometer or by what factor the el
51. al practice it is strongly recommended that such configuration be standardized and used every single time Biodex Medical Systems 1 3 ATOMLAB Dose Calibrator Operation Manual Appendix Determining Your Own Dial Values Dial Values can be determined by the user for isotopes for which no published dial value exists In order to do this you will need a sample for which the activity value is known The activity value may be provided by the isotope producer or pharmacy or it may be measured by a method independent of the dose calibrator The accuracy of the dial value will depend upon the accuracy of the known activity value of the sample used because of this it is best if an estimate of the accuracy of the isotope calibration is available To determine the dial value for the isotope select the Co 60 isotope key and measure the isotope sample in the same container and geometry which will be used to measure the isotope in clinical practice The dial value can then be calculated by the following formula activity New Dial value 5 0 x ___ measurement where the activity is the known activity of the source and the measurement is the displayed activity when measured on the Co 60 isotope key Remember to decay correct the source s activity for time elapsed since source activity calibration Once the new dial value has been calculated a new isotope name should be created on the display for the isotope with the dia
52. alue for the proper Isotope Selection key is correct Chamber Service CAUTION Only qualified service personnel should remove the chamber cover There is an electrical shock hazard Components under cover operate at 350 volts The chamber bias supply capacitors require at least two weeks with power disconnected to discharge to less than 50 volts ATTENTION On ne doit confier qu un personnel d entretien qualifi le soin de d poser le couvercle de la chambre d ionisation Il y risque de danger lectronique Les composants sous le couvercle fonctionnent sous une tension d environ 350 V La chambre d ionisation est dot e de condensateurs qui n cessitent au moins deux semaines d alimentation d branch e pour se d charger moins de 50 V Biodex Medical Systems A 3 ATOMLAB Dose Calibrator Operation Manual TROUBLE SHOOTING GUIDE Problem No Power No Display No Chamber Found Low Readings Probable Cause No AC line input Check for attached AC line cord Check connection of 15VDC Power pack on back of display Check output of power pack Should be 15VDC at 1 6 Amp max See power problems above Brightness too low Reseat ribbon cable between display board and LCD display Comm failure between display and chamber System locked up Bad cable Incorrect dial value used Incorrect unit of measurement Low chamber gas pressure Biodex Medical Systems A 4 Appendix A Solution Check outlet for AC Re
53. an accurately measure This error code should be only temporary for the time a very high reading is being measured If this occurs without an explainable cause the chamber may be faulty and should be serviced Biodex Medical Systems B 6 ATOMLAB Dose Calibrator Operation Manual Appendix C APPENDIX C ATOMLAB 400 DOSE CALIBRATOR SPECIFICATIONS OVERVIEW This appendix provides the physical and operating specifications of your Atomlab 400 Dose Calibrator MEASUREMENT RANGE For Tc 99m 0 01 pCi to 40 curies auto ranging DISPLAY RANGES Units are user selectable Ci Bq 00 00 1999 pci 00 00 19 99 MBq 2 00 19 99 mCi 20 0 199 MBq 20 0 199 9 mCi 200 1999 MBq 200 9999 mCi 2 00 399 9 GBq 10 00 40 00 Ci 10 0 1500 0 GBq RESPONSE TIME Auto Selection Display updates once per second 1 2 seconds gt 200 microcuries Tc 3 seconds gt 20 microcuries Tc 50 100 seconds lt 20 microcuries Tc NOTE Response time for activity of less than 20 microcuries can be decreased by reducing the measurement threshold Reducing the measurement threshold decreases response time at the cost of higher fluctuation NOTE All activities listed in specifications are for Tc 99m for the specifications concerning other isotopes please convert to Tc 99m equivalent The Tc 99m equivalent of an isotope can be found by multiplying the source activity by the Tc 99m dial value then dividing by the isotope dial value The Tc 99m equivalent is the activity of
54. ason the dose calibrator is operated without the integral shield installed the sensitivity curve will be incorrect in this energy range resulting in incorrect measurements for isotopes which emit photons in this range It is recommended that the dose calibrator always be operated with the lead shield in place Radioisotope container The style and type of container a radioisotope is in can effect the measurement Users should have a standard procedure container and solution volume for measuring radioisotopes Plastic syringes are often used as a standard container as they are usually the means of delivery to the patient in a clinical environment The dial values generated using the photon sensitivity curve above should be appropriate for most plastic and thin glass syringes Glass vials may require a correction factor for some isotopes The wall thickness of the container is especially important when measuring isotopes which emit low energy photon and or high energy beta radiation 1 125 I 123 and Xe 133 are especially susceptible to errors caused by low energy photon absorption In cases where a container has a wall thickness or material significantly different from the NIST standards used above it is recommended that a correction factor or corrected dial value be used to correct for the difference in absorption between the NIST configuration and the configuration used in clinical practice Whichever container and configuration is used in clinic
55. b Assurezvous que la table supportera un minimum de 300 livres Nous sugg rons que vous placiez le carton sur son c t afin que vous puissiez faire glisser L UNITE DE DETECTION du carton sa base Dans la chambre du calibrateur vous devriez trouver un manchon protecteur Un chantillon en plastique est emball avec l unit de pr sentation NOTE Do not discard the packing materials cartons or shipping boxes You will need them should it become necessary to return any of the Atomlab components in the future Biodex Medical Systems Il ATOMLAB Dose Calibrator Operation Manual Table of Contents TABLE OF CONTENTS Page 1 INTRODUCTION eeciccsicsicatisinsciaieiaicittacuatncicicnstncneatetneadedietatsansancesseteteteecntacs 1 1 Important Notes For Atomlab Dose Calibrator Users ccccccccccccncnnnanns 1 2 A TO 1 2 dications TOUS a iia 1 2 2 ATOMLAB 400 INSTALLATION occccooicicianicnnmenonmocinncionen saca dndnnndanainadanadonsinnaia 2 1 Operating Requirements sis 2 1 Cable Connection S adi nea 2 4 PONS as a aida 2 5 A A A eu aul tal Sud le 2 6 SB OPERATION E 3 1 KEY FUNCIONS EE 3 1 A nent en Rein 3 2 SE e Une RE tee 3 3 SEUNG an SOS E 3 4 Defining an Isotope PR PR Re 3 5 26r Background e E hee 3 6 CS 137 Constancy Lekt cional arica 3 7 Isotope Response Period REENEN 3 8 Moly Breakthrough Testa see eege 3 8 Isotope Selection Key Calibration 3 9 Checki
56. ber monitored and measured The results are reported as a coded value with an associated description Space on the display is tight to accommodate up to 7 detectors so if there s only 1 error in effect we display the associated description If there are multiple errors we display only the codes Here is the list of error codes their class and their description for Dose Calibrators Error Code Class Code 2 FAIL Code 3 FAIL Code 4 FAIL Code 5 WARNING Code 6 FAIL Code 7 FAIL Code 8 FAIL Code 9 FAIL Code 10 WARNING Biodex Medical Systems 500 Description Firmware Checksum Electrometer Needs Recalibration EEPROM Data Corrupt Chamber Gas Low Correctable Chamber Gas Too Low to Use Communications Error Chamber Bias Voltage Anomaly Electrometer Monitor Voltage Anomaly OverRange Chamber Reading Too High B 4 Appendix B 400 Description Firmware Checksum Electrometer Recalibration EEPROM Data Corrupt Chamber Gas Low Chamber Gas Too Low Communications Error Chamber Voltage Electrometer Voltage OverRange Reading ATOMLAB Dose Calibrator Operation Manual Appendix B Following is the display status displays for the Dose Calibrators Warming Up chamber is in a power warm up state Initializing Background Count Down initial background reading calc is in effect PASS no reported problems no errors in effect ready for measuring activity WARNING n lt descriptio
57. by the commercial radiopharmacy If the adjusted dial setting falls within the range of 333 to 368 then use that dial setting If it falls outside the range verify that e there is a well liner in place a hook style dipper is used the annual accuracy and daily constancy test results are acceptable If these criteria are met then determine the percent difference of the new dial value with respect to the nearest range limit value 833 or 368 i e Dial Value Error DVE Add this percent to the Change in Constancy Percent Error CCPE If the sum of the errors is in the range of 2 to 2 then the new dial value should be used If not contact Biodex Technical Support The user may also want to contact the radiopharmacy to determine if a calibration error may have occurred Biodex Medical Systems E 6 ATOMLAB Dose Calibrator Operation Manual Appendix E NOTE The CCPE is the percent change from calibrator installation of the constancy measurement where CCPE Today s Constancy Percent Error Installation s Constancy Percent Error The Constancy Percent Error is the measurement error with respect to the decay corrected source activity A change down in the Atomlab Calibrator constancy will cause a change up in the dial value required to compensate the change in constancy and visa a versa Thus the CCPE will have the opposite sign as the DVE so adding them should cancel to within 2 For example a new dial value for Y 90 is
58. cation to set up your Atomlab for operation be sure to read Chapter Two on installation This chapter notes operating and environmental requirements and offers several tips on choosing a location for your dose calibrator The DISPLAY UNIT Carton The Display Unit Carton also contains the Atomlab Operation Manual Report of Calibration the Vial Syringe Dipper in a foam holder and a small box containing the power cord power pack and chamber to display cable The DETECTOR UNIT Carton This carton contains the detector and well liner inserted into the chamber CAUTION The carton labeled DETECTOR UNIT is very heavy 38 pounds Severe damage to the unit may result if this carton is dropped Remove the detector from the carton and carefully place it on the table or other counter where you will set up and use your Atomlab unit Make certain the table top will support a minimum of 300 pounds We suggest that you place the carton on its side so that you can slide the Detector Unit out of the carton onto its base Inserted into the Chamber Well should be a Chamber Well Liner Biodex Medical Systems l ATOMLAB Dose Calibrator Operation Manual Packing Slip ATTENTION Le carton tiquet UNITE DE DETECTION est tr s lourd 38 livres Cet appareil peut subir de s rieux dommages sii est chapp Retirez le d tecteur de son carton et utiliserez le avec prudence sur la table ou le computoir ou vous installerez et utiliserez l unit Atomla
59. connect line cord Reset power pack jack Contact Biodex Adjust Brightness pot R 15 on display board MOD 400 Contact Biodex Reseat display chamber interface cable Cycle AC power Replace interface cable Confirm and reinstall correct dial value Confirm Bequerel or Curie as unit of measurement Contact Biodex ATOMLAB Dose Calibrator Operation Manual Appendix B APPENDIX B ATOMLAB DISPLAY DIAGNOSTICS FOR 400 500 SERIES OVERVIEW The nine button black amp white Atomlab 400 and color touch screen Atomlab 500 for the new generation of AtomLab products have built in boot up self diagnostics along with real time monitoring of the detector statuses The detectors themselves have real time self tests the results of which are reported back to the display approximately once per second Dose Calibrator chambers and Well Counters are the two types of detectors supported The results of the display module s self test are displayed during the display s power up as well as on demand shown on the System Test screen under Utilities in the upper section of the display results In addition during normal operation detector status changes are handled by the display reported on screen with a popup screen and audio tone alert and actions taken based on the severity of the reported status The System Test screen displayed results are divided into two sections Upper half is the display modules details static result from boot
60. d Bremsstrahlung includes implies low energy photons from electron interaction in saline Isotope should be measured in plastic syringe or vial or thin wall glass ampule Isotope should be measured in plastic syringe or vial or thin wall glass ampule unless otherwise stated above CONFIDENCE VALUES C Calculated with corrected Monte Carlo Beta MC response strongly dependent upon measurement geometry best if Cal Value used is determined using actual measurement with clinical geometry confidence value of a measurement made using the listed dial value M Measured directly Biodex Medical Systems E 5 ATOMLAB Dose Calibrator Operation Manual Appendix E DIAL SETTINGS FOR Y 90 The typical Atomlab 400 Dose Calibrator dial setting for Y 90 activity in a 10 cc plastic syringe is 350 This value can be used as a starting point for initial measurements However it is recommended that the dial setting used for clinical measurements be determined from the first dose of Zevalin received from the radiopharmacy as outlined below Following doses should then be compared to the radiopharmacy doses for constancy The Y 90 recipient using an Atomlab dose Calibrator should determine the correct dial value from the first Y 90 dose that they receive from a commercial radiopharmacy This is determined by selecting the Y 90 button and adjusting the dial setting until the displayed activity agrees with the decay corrected Y 90 syringe activity as stated
61. d the greater the accuracy and reliability of the readings Biodex Medical Systems 2 2 ATOMLAB Dose Calibrator Operation Manual Chapter 2 Power Requirements Choose a line power source with a socket which mates securely with the power plug provided Verify that the power line is properly grounded Do not choose an outlet that has a wall switch control This system uses APS Advanced Power Solution Power Supply for Medical use model APS22ES 150160 Line Voltage 100 to 240 VAC auto selectable by the power supply Line Frequency 50 60 Hz Positioning After you have chosen a suitable location for your Atomlab Dose Calibrator and familiarized yourself with its components position the various units Make sure the Detector and Display Units have been positioned to where they will not have to be moved prior to connecting the cables Biodex Medical Systems 2 3 ATOMLAB Dose Calibrator Operation Manual Chapter 2 CABLE CONNECTIONS See Figures 2 1 and 2 2 Chamber RJ 12 Computer RS Figure 2 1 Atomlab 400 Figure 2 2 Atomlab 400 display cable connections connected to a chamber Rotate the detector unit to access the connector on the base of the detector Insert one end of the RJ12 detector cable into the mating detector port Rotate the detector unit to its normal position so that the detector jack is facing away from the work area Rotate the display unit to access the connection ports located on the under
62. e of the radioactivity Kit A calibrated solution containing a compound labeled with a radionuclide such as Tc 99m radiopharmaceuticals From such kits doses are prepared to administer to patients to facilitate nuclear imaging Biodex Medical Systems 6 2 ATOMLAB Dose Calibrator Operation Manual Chapter 6 L Block Shield A partially transparent radiation shield behind which doses can be prepared Linearity Tests The test of a dose calibrator to determine the variation in the displayed activity values from the true ones over the measurement range of the instrument Lineator A sleeve shield package to perform linearity tests on dose calibrators Moly Breakthrough Shield Used in the Moly Breakthrough Test to shield the radiation of the Tc 99m in an eluent so that the activity of the Mo 99 can be measured Moly Break through Test Used to determine the percentage of parent Mo 99 remaining in the eluent containing the daughter Tc 99m radionuclide Molybdenum 99 Mo 99 The parent radionuclide which decays into the daughter Tc 99m used to generate radiopharmaceuticals NIST National Institute of Standards amp Technology whose activities include maintaining radioactive material standards NORMALIZED READING This is the measurement that pre calibration and post calibration factors are applied to for determining the calculated activity NRC Nuclear Regulatory Commission which is the agency of the Federal Government which reg
63. e saline into the same syringe total volume 1 0 ml and assay again Record the volume and measured activity on the form 6 Repeat step 5 twice more until you have assayed 1 5 ml and 2 0 ml vol umes and recorded them 7 Assay the vial used to draw saline into the syringe If the measured activity is greater than 1 of the 0 5 ml syringe assay Tc99m was lost during filling Repeat the procedure 8 Divide the average activity by the activ ity indicated for each volume The quotient is a volume correction factor 9 If any correction factors are greater than 1 05 or less than 0 95 it will be necessary to make a correction table that will allow you to convert from indicated activity to true activity If this is necessary be sure to label the table syringe geometry dependence and note the date of the test as well as the model number and serial number of the dose calibrator Vial Test 10 ml example 1 Totest the geometry dependence for a 10 ml glass vial draw 1 0 ml of Tc 99m solution between 1 and 10 mCi ml into a syringe and inject it into the vial Assay the vial Record the volume and activity indicated Appendix J 2 Remove the vial from the calibrator and using a clean syringe inject 2 0 or 3 0 ml of non radioactive saline and assay again Record the volume and activity indicated on the form Figure 2 Repeat the process until you have assayed a 8 0 ml volume The entire process must be comp
64. echnical support and provide full details including all linearity decay data Attenuation Tube Method or Sleeve Test Method If you decide to use a set of sleeves of various thicknesses or combination of sleeves to test for linearity it will be nec essary to first use the Decay Method to show the calibrator is linear Then immedi ately repeat the test Follow the directions furnished with your lead sleeves i e Linea tor instructions If failure occurs at the low activities check for Mo 99 contamination by repeating the test with 1 mCi See NOTE under Decay Method step 4 NOTE You can perform the Sleeve Test proce dure first and immediately perform a traditional Linearity test This allows the user to perform both tests with one dose NOTE Other isotopes can be used to perform linearity such as F 18 The sleeves can only be used with Tc 99 1 See Quality Control Testing of Dose Calibra tors R Y L Chu and W imon Journal of Nu clear Medicine Technology 24 2 June 1996 pp 124 128 15 February 2010 Biodex Medical Systems ATOMLAB Dose Calibrator Operation Manual Appendix J AtomLab Dose Calibrator Linearity Test Model Date Time HUDD Activity Measured M Hours elapsed t HUDD HUDD Avg Accept if 0 95 lt Avg M lt 1 05 Serial Number Mot Chy Avg Mos Figure 1 Sample dose calibrator linearity test data collection form
65. ectrometer has to amplify the signal from the detector The Calibration for Tc 99m is 37 1 and a reading of 10 pCi for Tc 99m is equivalent to 160 to 180 femtoamps of current measured by the electrometer High Calibration Values impact gains so that the electrometer amplifies inherent noise to a greater degree Thus greater fluctuations are observed in the Activity Display For instance the Calibration Value for Co 60 is 5 0 The fluctuation due to noise probably would not be noticeable 0 01 Ci The fluctuation due to noise for Tc 99m 37 1 is approximately 0 05 pCi For an isotope requiring a Calibration Value of 500 for P 32 it is 530 the fluctuation will be 0 5 Ci or more Mo 99 Fluctuations The Atomlab Dose Calibrator begins averaging display data the moment you press the Mo 99 key Calibration Value 175 This means that at first the fluctuations will seem relatively high before gradually decreasing This is why the Atomlab Dose Calibrator provides the 30 second countdown In addition the relatively high Calibration Value means the fluctuation due to inherent noise will be slightly higher than for the other common isotopes Again these fluctuations are to be expected and do not require any action on your part Biodex Medical Systems A 2 ATOMLAB Dose Calibrator Operation Manual Appendix A UNEXPECTED READINGS If for some reason you suspect that the reading on the Activity Display is inaccurate ensure that the Calibration V
66. ed radionuclide preparation area and room for writing Suggested dimensions of the table top are 30 in deep e 48 in wide e 36 in high Biodex Medical Systems 2 1 ATOMLAB Dose Calibrator Operation Manual Chapter 2 Physical Location and Environment Frequently dose calibrators are located in areas called hot labs in which there is a wet sink with plumbing Do not locate your dose calibrator on a table or other counter which can become wet or is subject to splashing or spraying Avoid areas which have drafts caused by heating or air conditioners or are in direct sunlight Electronics work best when constant temperature is maintained The temperature range is from 0 to 40 C and the relative humidity range from 0 to 90 Choose a location for your dose calibrator which is not frequently used by other personnel one where the table on which it lies will not be bumped In general make sure your work area is clean dry and dust free Avoid locating your dose calibrator near a radioactive materials storage area The 25 inch lead shield around the detector shields it from changes in radiation levels from diagnostic energy radionuclides i e Tc 99m however the high energy radiation from sources such as Cs 137 F 18 and Co 60 will easily penetrate the shield and change the background radiation level The lower the ambient radioactivity the less background activity for which the Atomlab Dose Calibrator must compensate an
67. eld place it in the vial syringe dipper and lower it into the Chamber Well Press the Cs 137 key The Activity Display will now show the activity of your Cs 137 reference source Compare the displayed activity with the decayed calculated activity for an example of how to calculate a decayed activity see Appendix D Decay Calculation For a properly calibrated source above 100 pCi the displayed value should be within a few percent of the decayed calibrated value NOTE If you do not have a Cs 137 source use a Calibrated Co 57 source and press the Co 57 key to perform the above steps NOTE Both the Chamber Well Liner and vial syringe dipper should be periodically checked for contamination as described later in this chapter the more your dose calibrator is in use the greater the frequency of contamination checks required Many users use two reference sources to perform constancy checks These calibration reference sources provide a vital quality assurance test which should be done daily to assure proper performance of the calibrator Biodex Medical Systems 3 8 ATOMLAB Dose Calibrator Operation Manual Chapter 3 ISOTOPE RESPONSE PERIOD The Atomlab 400 normally settles within three seconds as long as the threshold level is exceeded When you first lower the source into the well the activity value quickly jumps to the final value For a few seconds the value may fluctuate but then the value settles down to a small variation As soo
68. enable the software to convert ion chamber current into a displayed activity value for the isotope corresponding to the DV selected The displayed activity value is directly proportional to the DV The isotope s source container is either a vial or syringe the composition of the vial or syringe MAY influence the accuracy of the activity measurement The DV supplied in the Atomlab User Guide Instruction Manual or pre programmed into the isotope dial value are calibrated for use with the source material in an un shielded plastic syringe nominal 1mm wall while hanging in the supplied source dipper syringe support For isotopes contained in sealed long lived QA sources Cs 137 etc the DV supplied are calibrated for use with type Vial E epoxy sources or equivalent Yttrium 90 is listed in both a plastic syringe and a vial Accurate measurement of unsealed sources in any other configuration must be with a new Container Dial Value CDV determined by the USER with the following procedure During following steps set DV to the Atomlab published value Container with NO source material 1 Assay a quantity of isotope source material in a plastic syringe nominal wall thickness of 1mm record as Plastic Syringe Activity 1 2 Transfer part or all of the source material from the plastic syringe into the empty Container 3 Assay the Container with the isotope source material record as Container Activity 4 Assay the partial or
69. g laboratory standards the maintenance of these working standards and the use of these working standards to calibrate each Atomlab Dose Calibrator The working standards consist of two ionization chambers identical to the chambers used in each Atomlab Dose Calibrator for radiation measurement and several long lived radiation sources The two standard ionization chambers have been calibrated using radionuclides that were calibrated by the National Institute of Standards amp Technology generating response numbers These response numbers were then used to determine the photon response function of the ionization chambers The shielding configuration is identical to that of the Atomlab Dose Calibrator design The National Institute of Standards amp Technology sources are in glass ampule form and because of the potential for breakage are not suitable for routine calibration Instead the working standards are in epoxy resin form in a plastic vial E package These standards have been calibrated against the National Institute of Standards amp Technology sources in the two standard ionization chambers Together the chambers and the sources provide a high degree of accuracy and redundancy Periodically the source activity is measured in the two standard chambers and the results are compared to the expected decayed activity The Atomlab Dose Calibrator must first pass all electronic testing and operate for three days prior to calibration Calibra
70. he lt Toggle List gt keys to scroll through the Routine List and press the lt Screen Key gt to the right of the Select From List prompt The Full Alphabetical List is now displayed 3 Use the lt Toggle List gt keys to scroll up and down through the Full Alphabetical List 4 Press the lt Screen Key gt to the right of the desired isotope The system returns to the Measure screen with the selected isotope displayed 5 Using this option the selected isotope is not maintained by the Routine List and will have to be selected again from the Full Alphabetical List if you change isotopes at any point ATOMLAB 400 pose catisrator Full List BLANK pa As 76 Au 198 ve o 0 E rox Back Select Isotope Zero Background Figure 3 4 The Alphabetical List provides an alphabetical listing of all isotopes for which the Atomlab 400 is designed to measure SETTING AN ISOTOPE See Figure 3 5 To specifiy an isotope to match one of the Set lt Screen keys gt 1 Press lt Select Isotope gt The Routine List is displayed 2 Use the lt Toggle List gt keys to scroll to any of the seven Set Button prompts See Figure 3 5A 3 Press the lt Screen Key gt to the right of the Set prompt to access the Full List See Figure 3 4 Biodex Medical Systems 3 4 ATOMLAB Dose Calibrator Operation Manual Chapter 3 4 Use the lt Toggle List gt keys to scroll up and down through the Full List and press the lt Screen Key gt
71. he Full Isotope List NOTE To Clear the Set Button select lt Blank gt 7 Press the lt Screen Key gt next to the OK prompt to set the selected set button for the desired isotope and return to the Reset Isotope Button selection screen or press lt Cancel gt to exit without changing the set button value 8 Press lt Back gt to return to the Utilities Menu Biodex Medical Systems 4 3 ATOMLAB Dose Calibrator Operation Manual Chapter 4 BACKLIGHT TIME See Figure 4 4 ATOMLAB 400 pose catisraror Toggle List BIODEX Back Select Isotope Zero Background Figure 4 4 The Backlight Time screen The backlight feature illuminates display values and is adjustable in one hour increments 1 Press the lt Screen Key gt opposite the Backlight Time prompt to access the Backlight Time screen 2 Use the lt Toggle List gt keys to increase or decrease the length of time the backlight is ON 3 Press the lt Screen Key gt opposite the OK prompt to set the new backlight time value and return to the Utilities Menu or press the lt Screen Key gt opposite Cancel to exit without changing backlight value NOTE The minimum time is one hour Adjustments are made in one hour increments up to approximately 10 hours NOTE If the backlight goes off press any button to turn it back ON BEEP ON OFF Use this setting to enable or disable the audio beep that confirms your selections Use the lt
72. hen the activity is below 100 OCT It is recommended to replace a Co 57 source when the activity is less than 1 mCi Recommended Action Large difference skewed low Probable source calibration activity error Examine sources with Large difference skewed high error gt 5 lt 10 Both skewed low e e el EE Probable dose calibrator error If average error lt 5 continue use If average error gt 5 contact manufacturer Continue use under advisement Both high within tolerance Contact manufacturer Continue to use under advisement Both low within tolerance Both high straddling 10 H Both high outside tolerance E fi Both low straddling 10 SES Both low outside tolerance gt A dot represents a source accuracy error Dot location represents a ny value between the error bars For example in the 3rd row the left dot indicates a source error of any value between 5 an aa manufacturer to return for repair 0 and the right dot any value between 0 and 5 Figure 3 Recommended action for Accuracy test error conditions Biodex Medical Systems 15 February 2010 Records and Maintenance ATOMLAB Dose Calibrator Operation Manual Appendix J Records Article 10 CFR 35 2060 requires that a NRC licensee maintain instrument qualification records for 3 years The records must include the model and serial number ofthe instrument the date of the qualification the
73. ing menu or take appropriate action to correct any errors noted on the display such as connecting the chamber if the Chamber Not Found prompt appears The Atomlab 400 Home Menu allows the user to proceed with measuring or advance to the Utilities Menu NOTE After turning your Atomlab ON and completing the Self Test for the very first time do not press any keys for at least an hour This allows the sensitive electronics to stabilize The backlight will turn OFF when no button has been pressed on the calibrator for an hour You can still see the display with the backlight off When you press a button the backlight comes on If you turn the Dose Calibrator OFF when you turn it back on you should wait several minutes for the electronics to stabilize before using it If it is turned OFF for a prolonged period of time or moved to another location you should wait longer for it to stabilize before use Biodex Medical Systems 2 5 ATOMLAB Dose Calibrator Operation Manual Chapter 2 PACKING MATERIAL Now that you have set up your Atomlab Dose Calibrator and everything is intact and functioning properly take a few moments to repack the packing material This material was especially designed for safe shipment of the Atomlab Dose Calibrator and should be considered part of the instrument Place the shipping material in the appropriate boxes and put the boxes back into the shipping carton Label the carton and store it in a safe out of the way
74. iodex Medical Systems 6 1 ATOMLAB Dose Calibrator Operation Manual Chapter 6 Decay Chart A chart projecting how the activity of a source will decay over a period of time at specified time intervals Detector Unit An Atomlab component housing the ionization chamber detector and the electrometer Dial Values The section of the Atomlab Display using Increment Decrement keys A or W and an associated isotope key which allows the operator to enter any dial value possible on the display into the Atomlab program for an isotope Display Fluctuations Displayed value changes without the removal or insertion of a source in the Chamber Well Display Unit The Atomlab component incorporating the electronics control keys and displays which perform and show activity measurements Dose Calibration The verification of the activity of a radiopharmaceutical to be administered to a patient corresponding to the radiation to be delivered to the body Electrometer Measures the current in the ionization chamber which is proportional to the activity of a source within the chamber Geometry Tests The test of a dose calibrator to determine the variation in the displayed activity values due to the geometric configuration of the source s container vial syringe etc and its location within the ionization chamber detector lonization Chamber A device which responds to the activity of a source by forming ion pairs which can be collected as a measur
75. is required contact Biodex Medical Systems for instructions 15 February 2010 ATOMLAB Dose Calibrator Operation Manual Appendix J DATE ON REPORT OF CALIBRATION FOR ATOMLAB DOSE CALIBRATOR SIGNIFICANCE AND EXPIRATION The Report of Calibration that accompanies the Atomlab Dose Calibrator is intended to represent evidence that the product was calibrated by the manufacturer before it was shipped This report does not serve as an exemption to the accuracy test that is required at installation of the product in the facility where it will be used The date on the Report of Calibration does not expire since the report is not useful in the typical sense as a record of calibration in a periodic maintenance schedule For example when a survey meter is purchased it normally comes with a calibration certificate dated within the past 6 or 12 months This meter is then placed on a re calibration schedule as determined by local regulations The re calibration date may be scheduled from the original calibration date or simply placed on the institution s normal schedule interval for such meters Re calibration requires the meter be shipped to a laboratory that is licensed to perform such a task There is no need to check the accuracy of the survey meter upon installation at the facility the facility generally has no means to check the accuracy of a survey meter The situation and requirement is different for Dose Calibrators Although moder
76. king Gas or Chamber Gas Low warnings there is a 24 hour reminder warning implemented If either of these warnings is in effect for a connected chamber every 24 hours the Detector or Chamber Status screen will display with this warning code and description All the 24 hour reminders are scheduled to appear 8AM and only if 4 hours elapsed since the warning was first detected and displayed System Test Screen The System Test screen is divided into two sections where the upper half of the screen shows diagnostics of the display module unit itself from the boot up self diagnostics and the lower half shows diagnostics relating to the detectors dynamically updated while the detectors are connected and communicating Display Module Diagnostics Display upper half There are three fields displayed in this section CPU Functions result of testing the main processor s basic functionality PASS FAIL RAM Tests results of performing 4 different tests on the integrity of the main memory chip 8 MB of storage stuck bit test for O and 1 alternating bit cross over test and an addressing test Firmware Check displays the results of checking the CRC s of 3 different program loaded in flash memory the Boot program Main 1 program and Main 2 program Program Load displays the results of checking the Boot configuration in flash memory CRC ed and if it was required to changed the default program selected to load
77. l value as calculated above Then the source should be measured again and compared with its known time decayed activity in order to verify that the calculation is correct It may be necessary to adjust the dial value very slightly in order to match the known activity if necessary do so at this time Once the dial value has been determined by means of comparison to a source of known activity it should not be changed unless access to a source with an activity known to higher accuracy allows determination of a more accurate dial value Dial values should never be adjusted daily to make a source match daily isotope measurements The dial value should only be determined with a calibrated isotope source of known accuracy Biodex supplies dial values for many isotopes Many of these dial values are calculated using a Monte Carlo simulation corrected by actual measurements If a source is available which has calibrated accuracy better than the uncertainty listed in the table in Appendix E then this source can be used to modify the dial value for an existing isotope Biodex Medical Systems LA ATOMLAB Dose Calibrator Operation Manual Appendix Biodex is interested in users measurements which have better accuracy than the uncertainty listed in the dial value table If you have a more accurate dial value for an isotope listed in the table please contact us and supply documentation including the measurements isotope calibration and independe
78. leted within ten 10 minutes or if not decay correct the activity 3 Divide the average activity by the activ ity indicated for each volume The quotient is a volume correction factor 4 Ifany correction factors are greater than 1 05 or less than 0 95 it will be necessary to make a correction table that will allow you to convert from indicated activity to true activity If this is necessary be sure to label the table vial geometry dependence and note the date of the test and the model number and serial number of the calibrator NOTE Perform the vial test with the vial size you commonly use NOTE Other isotopes can be used for perform ing Geometry testing AtomLab Dose Calibrator Geometry Test Model Serial Number Decay correct if test not completed in 10 min Activity Volume cf Avg Activity Volume Volume E H Vial Date Volume Volume Type Time Decay correct if test not completed in 10 min Activity Volume cf Avg Activity III III III III III Avg Figure 2 Sample AtomLab dose calibrator geometry test form 15 February 2010 al Biodex Medical Systems J ATOMLAB Dose Calibrator Operation Manual Appendix J Accuracy Accuracy means a determination of the dose calibrator s absolute error resulting from a measurement of a suitable NIST traceable radionuclide activity Traceable sources are available fro
79. ly if the product as determined by BIODEX MEDICAL SYSTEMS INC is defective due to abuse misuse modification or service performed by other than a BIODEX MEDICAL SYSTEMS INC authorized repair and calibration facility Misuse and abuse include but are not limited to subjecting limits and allowing the equipment to become contaminated by radioactive materials C In order to obtain warranty repair service the equipment must be returned freight pre paid to one of our facilities The Return Materials Authorization number D MA should be included along with a statement of the problem Equipment will be returned transportation prepaid Calibration A Instruments are warranted to be within their specified accuracy at the time of shipment If a question arises and BIODEX MEDICAL SYSTEMS INC determines that the initial calibration is in error the instrument will be recalibrated at no charge B Mechanical products are warranted to meet written specifications and tolerances at the time of shipment C The return policy is as stated in paragraph 1 C Warranty is non transferable Non Warranty Service A Repairs and or replacements not covered by this warranty may be performed by BIODEX MEDICAL SYSTEMS INC at a factory authorized service location Estimates of repair charges may be requested however a charge for estimate preparation may apply if the repair is later not authorized by the customer B The cost of transportation into a
80. m NIST and from many radioisotope suppliers At least two sources with different principal photon energies such as Co 57 Co 60 Cs 137 or Ba 133 should be used One should have a principal photon energy between 100 keV and 500 keV 1 Press the Zero Background Bkgnd button which zeroes the dose calibrator Assay a calibrated reference source of appropriate activity at the appropriate setting i e use the Co 57 setting to assay Co 57 Record the displayed Error Condition 10 Percent Error Between 0 and 5 Between 0 and 5 Less than 5 activity measurement M the date and the reference source identification nuclide activity date of calibration serial number model number and manufacturer Take 3 readings for the reference source Remove and reinsert the refer ence source between readings Repeat the procedure for the other cal ibrated reference source For both sources decay correct the reference source activity value and record as true activity Calculate the average for the 3 mea surements and compare the average to the calculated activity 5 10 Calculate activity measurement error from AM True Error True 100 8 Evaluate the calculated errors according to the approximate location of the dots in Figure 3 and take the rec ommended action corresponding to your error condition NOTE It is recommended that the Cs 137 and Ba 133 sources be replaced w
81. ms 4 8 ATOMLAB Dose Calibrator Operation Manual Chapter 4 FACTORY DEFAULTS See Figure 4 9 ATOMLAB 400 pose catisraror Factory Defaults _ Do You Want to DN eset All Settings o Factory Defaults Toggle List OK canco 49 BIODEX Select Isotope Zero Background Figure 4 9 The user must confirm the process of resetting the Atomlab 400 to its factory defaults The Factory Defaults feature is used to reset all settings to their factory default values 1 Press the lt Screen Key gt opposite the Factory Defaults prompt to access the Factory Defaults screen 2 Press the lt Screen Key gt opposite the OK prompt to reset all settings to factory defaults or press lt Cancel gt to return to the Utilities Menu without making changes 3 If you elected to reset to the factory defaults press lt OK gt to confirm the change The system will reset all values to their factory defaults and return to the Utilities Menu Biodex Medical Systems 4 9 ATOMLAB Dose Calibrator Operation Manual Chapter 4 ATOMLAB 400 pose catisrator Source Threshold Tc 99m ES uCi OK Use Arrows toAdust Cancel FA BIODEX Select Isotope Zero Background Figure 4 10 SOURCE THRESHOLD The Source Threshold value determines the system s response time Activities above the threshold response time is quick Below the threshold response time is significantly slower 1 To change the Source Threshold press the lt Screen Key g
82. n manufacturing capabilities have improved the robust nature of dose calibrator systems these products tend to be more fragile than survey meters Therefore the NRC determined at an early date that the dose calibrator accuracy must be tested on site prior to its introduction into clinical use This was prudent since a the dose calibrator was being used to measure radionuclides prior to administration to a patient and b the availability of sealed long lived isotopes made this accuracy test very reasonable at a clinical facility The NRC now requires the facility using a dose calibrator to implement the Manufacturer s Instructions for Quality Assurance Testing of Dose Calibrators Such Instructions accompany all Atomlab Dose Calibrators and requires the Accuracy test at installation and at least annually thereafter After repair of the dose calibrator repeat the above tests as a new installation Therefore the date on the Report of Calibration cannot be used as a substitute for the installation accuracy test The only significance of the date is when the dose calibrator was calibrated at the manufacturer It never receives another calibration unless it is returned to the manufacturer The accuracy test at the facility is nota Calibration it is simply an accuracy test stating that the dose calibrator measures a specific radionuclide within a stated error The date on the Report of Calibration does not expire until the dose calibrator is retu
83. n as the source is removed from the Chamber Well the Activity Display will drop down to the near zero value MOLY BREAKTHROUGH TEST A Moly Breakthrough Test is an evaluation of the amount of Mo 99 contamination in a vial or syringe of Tc 99m Tc 99m a decay product of Mo 99 is obtained from a generator by leaching it from the column of Mo 99 after it is formed The test method has been derived from the fact when Mo 99 decays high energy gamma photons 750 keV are produced which can breakthrough a lead wall with a thickness sufficient to totally absorb the lower energy Tc 99m gamma 140 keV Therefore when a Tc 99m source is placed in a properly shielded lead container and inserted into the Chamber Well of the Atomlab 400 any measured radiation will be due to Mo 99 gamma transmission NOTE The Mo 99 key has been calibrated to measure the activity of Mo 99 in a sample contained within the optional Moly Breakthru Shield You must use this breakthrough shield Failure to do so may result in inaccurate results The Activity Display will show a direct readout of the activity which means that corrections for wall absorption have been included in the Calibration Value NOTE Although the Mo 99 countdown is intended to suggest an adequate time frame the Atomlab 400 will continue to acquire Mo 99 data as long as the Mo 99 key is selected As a general rule the longer you wait the more stable the reading Biodex Medical Systems 3 9 AT
84. n gt 1 error code WARNING n n n 2 or more error codes may be present FAIL n lt description gt FAIL n n n 2 or more error codes may be present Warnings are errors flagged by the self tests but not considered permanent or serious enough to not use the reported activity measurements Failures FAIL are considered serious enough to not use the chamber for any activity measurements The chamber will automatically be taken offline by the system no longer selectable CHAMBER ERROR CODE DESCRIPTIONS Code 2 Firmware Checksum FAIL The chamber s firmware has a checksum pre calculated and stored and it s verified during chamber power up This error indicates the checksum calculated failed to match the checksum stored Continuing to operate the chamber would be at risk The chamber should be serviced Code 3 Electrometer Needs Recalibration FAIL On startup this error code is set if any of the following numbers don t exist or fail a sanity check Activity calibration factor ump ubp factors for linearity corrections for higher gains monitor channel scaling factor any of the four linearity correction constants The chamber should be serviced Biodex Medical Systems B 5 ATOMLAB Dose Calibrator Operation Manual Appendix B Code 4 EEPROM Data Corrupt FAIL The chamber s stored data has a checksum pre calculated and stored and it s verified during chamber power up This error indicates the checksum
85. nd out of the service location will be the responsibility of the customer 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 Service Procedure If you think you have a service problem take the following action 1 2 3 Check to see that the problem occurs more than once Check the instruction manual and operations procedure Check the instruction manual Trouble shooting Guide If you still think you have a service problem call BBODEX MEDICAL SYSTEMS INC Service Department at 800 224 6339 Keep yourself and the phone next to the equipment 1 Service will ask you for a brief description of the problem We will ask specific questions about the malfunction that occurred This diagnostic process may take a few minutes so call us when you have time to spare After taking the information we will advise on the action we will take Sometimes service personnel must consult with engineering and it may take time to get back to you Be sure to let the service representative know your schedule so that we can call at a convenient time The return call may be from a person other than whom you first reported the problem to After analyzing the problem we will decide if the unit must be returned to us for repair or replacement parts will be sent If unit must be returned it will be given a
86. ndix J Dial Value Settings and Source Containers Glass Vial Glass Syringe etc The Atomlab Dial Value DV settings enable the software to convert ion cham ber current into a displayed activity value for the isotope corresponding to the DV selected The displayed activity value is directly proportional to the DV The isotope s source container is either a vial or syringe the composition of the vial or syringe MAY influence the accuracy of the activity measurement The DV supplied in the Atomlab User Guide Instruction Manual or pre programmed into the iso tope buttons are calibrated for use with the source material in an un shielded plastic syringe nominal Imm wall while hanging in the supplied source dipper syringe support For isotopes contained in sealed long lived QA sources Cs 137 etc the DV supplied are calibrated for use with type Vial E epoxy sources or equivalent Accurate measurement of unsealed sources in any other configuration must be with a new Container Dial Value CDV determined by the USER with the following procedure NOTE This is important to determine the appropriate Dial Value for Beta and low energy gammas when the container syringe or vial changes Biodex Medical Systems During following steps set DV to the Atomlab published value Container with no source material 1 Assay a quantity of isotope source material in a plastic syringe nominal
87. ner other than a Constancy plastic syringe 10 from decay cor rected calibration activity Linearity at installation and at least quarterly thereafter 5 percent Geometry at installation 5 percent Accuracy at installation and at least annually thereafter 5 percent After repair of the dose calibrator repeat the above tests as a new installation NOTE A plastic well liner and source dipper must be used in all measurements NOTE If possible leave the dose calibrator powered on 24 hours a day 7 days a week If not allow 1 hour warm up after power on before performing these procedures NOTE We have an acceptance variance per centage listed for each test These are the default settings You can use 10 for accept ability and 5 for investigation Call Biodex Service Dept ifreadings are outside the accept able range The default acceptable range is based on 10CFR35 60 of January 1 2003 and 1EC 61145 You must consider what your state or government regulations require NOTE Assay means to place the source con tainer into the dose calibrator so that the dipper is resting in the well liner NOTE The AtomLab 500 control module has built in Constancy Linearity Geometry and Accuracy software functions which provide ease of use to the user in performing the func tions below Constancy means reproducibility in mea suring the same source over a period of time with decay correction Assa
88. ng The Standard KeyS AA 3 10 Contamination Checks EE 3 11 4 ATOMLAB 400 UTILITIES cniccsiccsiecsieseceneesnsenncstececnwensececcusccessestxesennedsxesivewesse 4 1 The Utilities Menu SE 4 1 STEWS e a RA E E maser E EE ee 4 2 Reset User Defined Buttons ss 4 3 ABACKION MM EE 4 4 Beep ON OR EE 4 4 System TeSt Ache ide 4 5 Change EE 4 6 e BI WT 4 7 Factory DETAUNS ss Hansen db ada 4 9 SOURCE Threshold a aid EE 4 10 5 ATOMLAB 400 DOSE CALIBRATOR DESCRIPTION cccccccceceeeeeees 5 1 the Detectan aia 5 1 SCT ee natal Aca 5 1 Chamber Well Linera canoas d motorola rs 5 1 Current Measurement usas dadas 5 1 gt REA e EE 5 1 SFE SPOS Sas Eer 5 2 The Display Oil EE 5 2 Measurement Methods oleada 5 2 Biodex Medical Systems 111 ATOMLAB Dose Calibrator Operation Manual Table of Contents ei BIC VR E 5 3 Routine Ee ele 5 4 Atomlap Dial VAISS wiiskecccssecsnchstenranad dui leida 5 5 B GLOSSARY E 6 1 APPENDIX A ATOMLAB DOSE CALIBRATOR TROUBLE SHOOTING PROCEDURES A 1 System Will Not Power Up EE A 1 Fluctuation in Activity Measurement A 2 Unexpected Readings isivcsesisestcscsied DR SOERENSEN ENEE ES A 3 Trouble Shooting Guide ennea A 4 B ATOMLAB DISPLAY DIAGNOSTICS FOR 400 500 SERIES 0000 B 1 OVNI Wi id io B 1 Detector Diagnostics Display erebrusttesb eesrchateug daban eee eel B 4 Chamber Error Code Descriptions
89. nt measurement method measurement geometry and source container and calculation so that we may share this information with other users References 1 National Nuclear Data Center Nudat 2 2 Database Upton NY Brookhaven National Laboratory 2007 2 Browne Edgardo and Richard B Firestone Table of Radioactive Isotopes New York John Wiley and Sons Inc 1986 3 David C Rayburn Determination of the Response Characteristics of the Atomlab Re entrant lonization Chamber Melbourne FL Florida Institute of Technology 2007 Biodex Medical Systems l 5 ATOMLAB Dose Calibrator Operation Manual APPENDIX J Appendix J QUALITY ASSURANCE TESTING OF ATOMLAB DOSE CALIBRATORS MANUFACTURER S INSTRUCTIONS Introduction The following procedures are the manufacturer s instructions for qualifying AtomLab 100 100 200 300 400 and 500 dose calibrators in accordance with NRC regulation 10 CFR 35 60 of 1 January 2003 or applicable agreement State Regulation Use of these instructions outside the USA may require modification in order to satisfy local regulations Qualification is the determination oferrors associated with the following tests at the indicated frequency Acceptable errors for each test are indicated in parentheses Constancy Starting at installation and at least once each day before measuring patient dosages 5 percent Dial Value Setting at first receipt of iso tope activity in contai
90. number which is a means of expressing the chamber s sensitivity to the radiation produced by that isotope Dial values are defined relative to Co 60 an isotope chosen for its high energy gamma radiation and long term stability The chamber response R for a given isotope is defined as the amount of chamber current produced by a given amount of isotope activity chamber current Risotope isotope activity yl The dial value for Co 60 is defined to be 5 0 The dial value for any other isotope is defined as 5 0 times the response of the chamber to Co 60 divided by the response of the chamber to the isotope Rco 60 Dial valu isotope 5 0 X BH 2 R isotope The response of the chamber can be calculated as the sum of the chamber sensitivity to photons of energy e times the intensity of the photon radiation of energy e from the radioisotope solapa gt Se le 3 Where the sensitivity of the detector chamber to photons of energy e in nA mCi is 4 S chamber current nA e 8 7 x 10 photons of energy e A sensitivity curve can be made by plotting the sensitivity of a detector with respect to photon energy Given the photon sensitivity curve and the intensity of photon emission from radioisotopes which are tabulated in sources such as reference 1 and 2 the chamber response and dial value can be calculated using equations 1 2 and 3 The calculated dial values for many common isotopes are listed in the appendix
91. ny list displayed Use the lt A gt key to scroll up the list and the lt W gt to scroll down the list Biodex Medical Systems 3 1 ATOMLAB Dose Calibrator Operation Manual Chapter 3 MEASURING AN ISOTOPE See Figure 3 2 ATOMLAB 400 pose catisrator Toggle List CD BIODEX Back Select Isotope Zero Background Figure 3 2 The Measure screen Selecting lt Measure gt from the Home Menu allows counting of the currently selected isotope The screen defaults to the last selected isotope or to Tc 99m if no prior isotopes have been selected All readings are live and displayed while the chamber is reading The system selects the most recently used units of measure mCi or Becquerels or defaults to uCi if units have not been previously selected To Measure An Isotope 1 Press lt Select Isotope gt if the isotope desired is not displayed 2 Press the appropriate isotope key or use the lt Toggle List gt keys to scroll up and down through the isotope list 3 Place the isotope in the chamber The activity level is immediately displayed 4 Press lt Back gt to return to the Home Menu lt Select Isotope gt to select a different isotope to measure or lt Zero Background gt to zero the background measurement NOTE If you select Mo 99 the system will prompt you to wait at least 30 seconds for the activity reading For all other isotopes the activity reading should settle almost immediately Biodex Medical Systems
92. or is linear Decay Method 1 2 Zero the Background by pressing the Zero Background Bkgnd button Assay the Tc 99m syringe or vial in the dose calibrator to obtain the activity This first assay should be done in the morning at a convenient time for example 8 A M Repeat steps 1 and 2 several times per day until the displayed activity is 10 microcuries or below the lowest activ ity assayed in accordance with applicable State NRC regulation or the condition of your license One should collect 2 to 4 readings per day Addi tional readings are acceptable depending on the isotope used If the display indicates less than 50 HCI 1 85 MBq wait 30 seconds before recording the reading To get a faster reading on the Atomlab 100 100 Plus 200 and 300 press the Mo 99 button and then the Tc 99m button or adjust the transition threshold on the AtomLab 400 or 500 controllers Record the date time to the nearest minute and activity for each reading NOTE Some state regulations allow linearity tests to end at activities greater than 10 CL You may discontinue the linearity test at the activity which your state regulations or license permit NOTE Use of a spreadsheet such as Microsoft Excel in steps 4 and 5 will simplify calculations 4 Convert the time and date information you recorded to hours t elapsed since the first assay Decay correct each dis played activity measurement M using the equation t Ti
93. previous screen To Zero Background 1 Press lt Zero Background gt The Zero Background screen is displayed The message Zeroing in XXX seconds is displayed with the time counting down to zero from the point the isotope was actually removed 2 If desired you can adjust the background reading resolution using the lt Toggle List gt keys 3 At the end of the countdown 0 0 the previous screen is displayed 4 Pressing lt Zero Background gt starts the process again if for example the user accidentally leaves an item in or near the chamber and the unit has completed the background count Biodex Medical Systems 3 7 ATOMLAB Dose Calibrator Operation Manual Chapter 3 NOTE Even though the Atomlab Dose Calibrators compensate for background interference the accuracy of Activity Measurements depends on the intensity of the background radiation For this reason store the new generator old generators and check sources away from the dose calibrator NOTE If you start a background count with a source in or near the chamber you can abort or stop the background count by removing the source pressing lt Back gt putting a source into the chamber to get an activity reading then removing the source and pressing lt Zero Backgrouna gt to restart the zero background procedure at 100 sec CS 137 CONSTANCY CHECK TEST After the zero background correction has been completed remove your Cs 137 calibration reference source from its shi
94. ptied fast enough Instead the switch which controls when the capacitor is emptied is closed and the electrometer is nulled The value of the Digital to Analog Converter DAC which which is used to null the electrometer is used to determine the chamber current at high currents During calibration multiple measurements are made at current values at which two modes of current measurement can be used effectively These calibration measurements are used to set the calibration parameters of the medium and high current modes so as to meet the linearity required of the electrometer Biodex Medical Systems 5 3 ATOMLAB Dose Calibrator Operation Manual Chapter 5 DISPLAY UNITS When you set your dose calibrator to display Activity Values in Ci Curies the conventional system of units either OC mCi or Ci will be indicated next to the numeric display The prefix micro or y 10 or milli or m or Curies is automatically selected by the system s microprocessor For example if the numeric value displayed is 12 03 and pCi is indicated the activity will be 12 03x10 Ci or 0 00001203 Curies if 63 9 is displayed and mCi indicated the activity is 63 9x10 Ci or 0 0639 Curies In the same manner when you set the dose calibrator to the international system of units Becquerels either MBq or GBq will be indicated where the prefix M represents Mega 10 and G represents Giga 10 The absolute measurement range of the Atomlab Dose Calib
95. quilibrium with A Half Life s Cal Value Notes seconds m minutes d days y years Atomlab Dose Calibrator dial setting to calibrate for corresponding isotope 1 2 3 Scheme EC Electron Capture B Beta decay IT Isomeric transition A Alpha Decay 4 5 H r Half life ratio of daughter over parent implies daughter is ignored Bremsstrahlung includes implies low energy photons from electron interaction in saline Isotope should be measured in plastic syringe or vial or thin wall glass ampule CONFIDENCE VALUES c Calculated with corrected Monte Carlo B Beta MC response strongly dependent upon measurement geometry best if Cal Value used is determined using actual measurement with clinical geometry confidence value of a measurement made using the listed dial value Measured directly Special Case As stated Biodex Medical Systems E 1 ATOMLAB Dose Calibrator Operation Manual Appendix E Page 2 of 5 SUPPLEMENTAL ALPHABETICAL LISTING OF ISOTOPES rev 4 20 09 ATOMLAB 400 and ATOMLAB 500 DOSE CALIBRATORS Value Scheme Energy KeV Uncertaint EC Beta 21 1 minutes Fe 59 10 5 Beta po me Says c miom Ga 67 Gallium 32 5 EC LL 3ds S 3 Ge Ga 68 Germanium Gallium 10 1 EC EC Beta 1 14 hours Hg 197 EC Ho 166 lodine Mercu 32 1 Holmium 77 0 Beta 16 5 Indium Indium Iridium In 113 m 31
96. rator is from 0 01 pCi to 40 00 Ci of Tc 99m and the equivalent in Becquerels For example 12 03 Ci 445 MBq and 63 9 mCi 2 36 GBq If the numeric display reads 0 445 and MBq is indicated the activity value is 445 000 Becquerels if 2 36 is displayed and GBq indicated the activity is 2 360 000 000 Becquerels ROUTINE ISOTOPES The Routine radioisotope Isotope Selection keys for the Atomlab 400 include Tc 99m TI 201 Co 57 Cs 137 1 131 In 111 Ga 67 Xe 133 1 123 and Mo 99 The Co 57 and Cs 137 keys are primarily used for accuracy and Constancy Tests while the Mo 99 key is used for the Moly Breakthrough Test Compare the displayed activity with the decayed calibrated activity for an example of how to calculate a decayed activity see Appendix D Decay Calculations For a properly calibrated source above 100 pCi the displayed value should be within a few percent of the decayed calibrated value NOTE If you do not have a Cs 137 source use a Calibrated Co 57 source and press the Co 57 key to perform the above check Biodex Medical Systems 5 4 ATOMLAB Dose Calibrator Operation Manual Chapter 5 ATOMLAB DIAL VALUES Equal activities of two different isotopes will generate different amounts of current in the ion chamber due to differences in the energy and particle emitted by the isotopes Dial Values are a means of calibrating the source activity measured for an isotope due to these differences in chamber current The amount
97. reen saver time in seconds It s in effect only until the next reboot then the configured screen saver takes effect If no parameter is given it displays the current screen saver time in effect This is for more advanced chamber status viewing This command will turn on an on screen display of chamber status on the Count screen 1 Set On O Turn Off If no parameter is given a detailed state of the current connected chamber is displayed Displays the Atomlab display unit s firmware versions Two lines are displayed The first line shows the version and date of the current running main firmware program The second line displays what firmware is loaded as Main 1 Main 2 and the boot firmware Here is an example 0 84 07 06 2007 Running 0 84 0 82 1 03 MAIN 1 MAIN 2 BOOT Biodex Medical Systems G 3 ATOMLAB Dose Calibrator Operation Manual Index Joo oh ca ATOMLAB 400 ISOTOPE INDEX Symbol C 11 N 13 O 15 F 18 Na 22 P 32 K 38 K 43 Sc 46 Cr 51 Fe 52 Fe Mn 52 Co 55 Co 57 Co 58 Fe 59 Co 60 Cu 61 Cu 62 Cu 64 Zn 65 Cu 67 Ga 67 Ge Ga 68 Se 73 Br 75 Se 75 As 76 Br 76 Br 77 Rb Kr 81 Rb 82 Sr 85 Y 86 Sr 87m Y 88 Sr 89m Sr 89 Zr Y 89m Y 90s Nb 95 Mo 99 Tc 99m Cd 109 In 111 In 113m Biodex Medical Systems Index 47 48 49 50 51 G 4 Symbol 1 122 1 123 1 124 Sb 124 1 125 Xe 127 1 131 Ba 133 Xe 133 Cs 134 Cs 137 La 140 Ce Pr 144 Pm 149 Eu 152 Gd 153 Sm 153 Sm 156
98. results of the qualification and the name of the individual who performed the qualification Dipper and Well Liner Inspect the instrument on a quarterly basis to ascertain that the well liner is in place and is not damaged Check for contamina tion of the liner and dipper as follows 1 Remove the plastic dipper and liner from the well chamber Biodex Medical Systems 2 Press the Zero Background Bkgnd button to zero the calibrator 3 Put the liner back in If the display reading increases the liner may be contaminated 4 Ifthe liner is OK put the dipper back in and check for contamination 5 If any part is contaminated you must decontaminate or replace the item and then recheck for contamination Dial Value Checks Monthly Each isotope button is programmed with a specific dial value DV The user can adjust the DV for a particular need Each isotope button should be checked periodically to verify it is set to the correct dial value for that isotope The method of displaying the dial values varies by model consult the operation manual for your dose calibrator to see how to display the dial values NOTE The Dial Value check is to verify that no one has accidentally changed the Dial Value from the factory settings or the appropriately determined facility settings Repair or Replacement Consider repair or replacement ifthe dose calibrator falls outside the suggested tolerances If repair or replacement
99. rlo Beta MC response strongly dependent upon measurement geometry best if Cal Value used is determined using actual measurement with clinical geometry confidence value of a measurement made using the listed dial value Measured directly Special Case lass ampule unless otherwise stated above Biodex Medical Systems E 2 ATOMLAB Dose Calibrator Operation Manual Appendix E Page 3 of 5 SUPPLEMENTAL ALPHABETICAL LISTING OF ISOTOPES rev 4 20 09 ATOMLAB 400 and ATOMLAB 500 DOSE CALIBRATORS Value Scheme Energy KeV Uncertaint 10 EE EE ara loas ouge tenfeciBem mso 2037 miowes Le orsi Omim EE ss issan fef si EE Pb 203 Lead E 2 169 days c 5 Promethium aa 366 2 212 days includes Bremsstrahlung 40 Platinum 22 6 IT Ir O 4 02 days 10 Pt 197 Platinum 103 0 Beta 20 Rb 82 Rubidium 8 7 EC Beta 1273 minutes Rb Kr 81 Rubidium Krypton 14 5 EC Beta IT 4 6 hours 13 seconds Re 186 Rhenium 110 3 EC Beta 3 777 days includes Bremsstrahlung contributions 16 98 hours includes Bremsstrahlung contributions Rhenium 82 5 Beta G 10 EE 83 83 days Se 73 Selenium 7 2 EC Beta 7 15 hours C 10 H r 0037 did not include As Se 75 Selenium 176 EC y 119 8 da C 10 Sm 153 Samarium 19 0 Beta 225 1 946 days in plastic s
100. rned to the manufacturer 15 February 2010 Biodex Medical Systems J 8 ATOMLAB Dose Calibrator Operation Manual Appendix K APPENDIX K ATOMLAB 400 REPLACEMENT PARTS ATOMLAB 400 REPLACEMENT PARTS C11782 Adapter AC to DC Ext 15VDC 086 330 E601 DC Function Pad 086 335 E745 LCD Display Board Assy 086 335 E800 Display Board Atomlab 400 086 241 Well Insert 086 242 Well Vial Syringe Dipper C13116 Power Supply 086 330 E705 Chamber Cable C8187 Bumpons Self Adhesive Grey O OT TP 4 PLS D amor E DETAIL A Figure K 1 Atomlab 400 replacement parts Biodex Medical Systems K 1 ATOMLAB Dose Calibrator Operation Manual Appendix L APPENDIX L SCHEMATICS Biodex Medical Systems L 1 TAN co D ANAB SE Intertek Certified Quality Management System BIODEX Biodex Medical Systems Inc 20 Ramsey Road Shirley New York 11967 4704 Tel 800 224 6339 Int 631 924 9000 Fax 631 924 9241 Email info biodex com www biodex com
101. s the most stringent regulatory requirements With its small footprint the Atomlab 400 fits easily into even tight work areas The display screen features large easy to read prompts and activity readings Selections are made via screen labeled buttons and data can be exported to a computer program via an RS 232 cable Figure 1 1 Compact and lightweight the Atomlab 400 also features large easy to read display values Biodex Medical Systems 1 1 ATOMLAB Dose Calibrator Operation Manual Chapter 1 This system features 10 factory pre set routine isotope buttons an alphabetical isotope list seven set buttons that can be designated from the full alphabetical isotope list of 87 isotopes including Y 90 and Sr 89 plus two new custom user defined isotope set buttons Activity is displayed in either Curie or Becquerel units Background zero adjustment is performed at the touch of a key while activity range selection is automatic Activity measurements are performed by a microprocessor controlled electrometer located at the base of the detector assembly of the ionization chamber The chamber is shielded with 25 64 cm of lead It can be located up to eight feet away from the display unit The display unit can be wall mounted or set on the table top Chamber bias is generated within the chamber unit by an electronic high voltage supply eliminating the need for expensive battery charges The Atomlab 400 is covered by an industry exclu
102. side of the display Insert the free end of the detector cable into the mating display port If you would like to connect a computer to the Atomlab 400 attach an RS 232 cable with a DB9 connector to the serial port and then attach the opposite end of the cable to the appropriate port on the computer Insert the free end of the power supply cord into the power port on the display unit Insert the small end of the power cord into the black rectangular power supply box The display should turn ON once the power cord is plugged into the wall and the system test will run automatically to check for proper function of the CPU RAM Firmware Program and Chamber It will then automatically perform a background measurement as part of the power up process ol NE N D NOTE As long as the Atomlab 400 is plugged in and power turned ON the system will be functioning Depending on the Backlight Time setting the display screen will eventually turn OFF Press any key on the display to reactivate the display screen You can still set the display with the backlight off Biodex Medical Systems 2 4 ATOMLAB Dose Calibrator Operation Manual Chapter 2 POWER UP See Figure 2 3 ATOMLAB 400 pose catisraror 77 y Toggle List net Zero Background Measure Utilities Figure 2 3 The Atomlab 400 Home Menu Once the system check is completed press the lt Screen Key gt next to the Continue prompt to advance to the open
103. sive two year warranty INTENDED USE The Atomlab Dose Calibrator is intended to measure the activity of a radioactive source of a known isotope This measurement may be for purposes of determining or verifying a radiopharmaceutical dose for nuclear imaging or nuclear medicine This measurement may also be for the purpose of determining the radioactivity of a sample for dose calibrator constancy and accuracy testing or to measure other non medical radioactive samples INDICATIONS FOR USE The Atomlab Dose Calibrators are used in Nuclear Medicine Departments clinics and nuclear pharmacies to measure radioactive doses for administration to patients The instrument is used to verify the radioactivity of a radionuclide before administration to the patient IMPORTANT NOTES FOR ATOMLAB DOSE CALIBRATOR USERS The Atomlab Dose Calibrator you have purchased is a high quality dependable and reliable instrument Before using it please review the following points Before using this device be certain to read the entire operation manual Failure to read the manual may result in user error or inaccurate data The Atomlab Dose Calibrator should be used only as specified in the operation manual The Atomlab Dose Calibrator is designed for use in a patient environment Quality Assurance Testing of Atomlab Dose Calibrators is provided in Appendix J Biodex Medical Systems 1 2 ATOMLAB Dose Calibrator Operation Manual Chapter 2 CHAPTER 2 ATOMLAB 40
104. ss B requirements ETL Listed Electrical Equipment Laboratory Use Part 1 General Requirements for Safety conforms to UL 60601 1 CAN CSA C22 2 No 601 1 M90 IEC 601 1 IEC 60601 1 1 4 and IEC 60601 1 2 EN Intertek CE Authorized European Community Representative ec free Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Biodex Medical Systems C 4 ATOMLAB Dose Calibrator Operation Manual Appendix D APPENDIX D DECAY CALCULATIONS OVERVIEW This appendix provides methods of performing radioisotope decay calculations The first section provides two methods of performing Decay Calculations the second section provides the Decay Factor Chart and the third section provides an explanation of how the procedures used in the first section and the Decay Factor Chart in the second section are generated DECAY CALCULATION METHODS CALCULATOR METHOD If you are using a calculator with the Y function perform the following 1 Measure the current activity of the radioisotope Ap which can be compared to the decayed calculated activity 2 Look up the half life T of the radioisotope in Appendix E Note the time units 3 T4 2 Half life of the isotope t Elapsed Time A Current Activity Ao Activity at the time of calibration 4 Calculate A A x 26UT172 5 Calculate the elapsed time t in the same units as the T 2 that will elapse between when the calibrated activity measurement
105. t opposite the Source Threshold prompt 2 Use the lt Toggle List gt arrows to increase or decrease the source threshold value or press lt Cancel gt to return to the Utilities Menu without making changes 3 If you have changed the source threshold value press lt OK gt to confirm and return to the Utilities Menu 4 To select a different isotope to use to set the system threshold level press lt Select Isotope gt and then select the isotope desired Use the lt Toggle List gt to increase or decrease the source threshold NOTE Changing any isotope s threshold changes the isotope threshold levels for all isotopes NOTE The default threshold for Tc 99m is 20 uci If a different isotope is selected the activity level will be different for the threshold level NOTE Unless you are reading activities less than 20 Ci it is recommended to leave the threshold level for Tc 99m at 20 Ci The minimum threshold is 1 to 2 uCi for TC 99m at this threshold setting the display activity readings have a higher fluctuation Biodex Medical Systems 4 10 ATOMLAB Dose Calibrator Operation Manual Chapter 5 CHAPTER 5 ATOMLAB 400 DOSE CALIBRATOR DESCRIPTION The Atomlab Dose Calibrators are used to measure the radioactivity of a known radioisotope Their primary application is the measurement of the dose administered to a patient in nuclear imaging The design for the Atomlab 400 incorporates unique electronics and software which meet stringent
106. te of the original dial value Use the lt Toggle List gt keys to raise or lower the dial value Press lt OK gt Press lt OK gt again to confirm the dial value change 0 Press lt Back gt twice to return to the opening screen oR w oO NO Biodex Medical Systems 3 10 ATOMLAB Dose Calibrator Operation Manual Chapter 3 11 Press lt Measure gt and take a reading If the reading matches the calculated activity use that dial setting If the reading does not match repeat steps 3 through 10 until you get a matching activity reading NOTE This will be the dial setting used until you change it Make a note of the revised setting An will be placed next to the isotope for which you adjusted the dial setting CHECKING THE STANDARD KEYS From time to time you may wish to check the Calibration Dial Values of the Routine and Alphabetical Isotope Selection Keys To check the dial values at Home Screen press lt Utilities gt and then lt Toggle List gt to Dial Values Press lt Dial Values gt Any isotope that has been changed will appear with an in front of it If you press that isotope you will see the current dial setting Compare this to the Pre Set Calibration Values in Appendix E CONTAMINATION CHECKS Vial Syringe Dipper Check To ensure that your vial syringe dipper is not contaminated perform the following steps 1 Remove the vial syringe dipper from the Detector 2 Ensure that the Activity Display reads less than
107. tion then takes place with the Co 60 working standard The calibration value is stored in a special memory chip on the chamber circuit board Calibration is then verified by measuring the activity of all the working standards including Co 60 Cs 137 Ba 133 and Co 57 Biodex Medical Systems F 1 ATOMLAB Dose Calibrator Operation Manual Appendix F Finally a Tc 99m source in a 10 ml vial of saline is calibrated in the two standard ionization chambers After calibration the response to the Tc 99m standard is measured and verified to be within 2 Biodex Medical Systems F 2 ATOMLAB Dose Calibrator Operation Manual Appendix G APPENDIX G ATOMLAB 400 SERIAL COMMUNICATIONS INTERFACE The Atomlab 400 has the ability to be controlled and monitored with limitations via the DB 9 RS 232 serial port CONNECTION DETAILS Cable RS 232 Male Female wired straight through for connection to a standard PC COM Port Port Settings 19 2 KBAUD no parity 1 stop COMMAND FORMAT All commands are in ASCII format terminated by a Carriage Return 0x0D and no longer than 7 letters If a parameter is given the command must be separated from the parameter by at least 1 space and or comma If the command or parameter has a format error or a numeric parameter is out of range an error message is sent out the serial port terminated by a CR LF All data transmitted as a result of a command is also in ASCII and terminated by a CR LF USAGE NOTES Some
108. tivities can be traced to the National Institute of Standards amp Technology Biodex Medical Systems 6 4 ATOMLAB Dose Calibrator Operation Manual Appendix A APPENDIX A ATOMLAB DOSE CALIBRATOR TROUBLE SHOOTING PROCEDURES Should it appear that your Atomlab Dose Calibrator is not functioning properly the procedures explained in this appendix should allow you to determine whether a problem does indeed exist and what steps can be taken to correct the difficulty Should you encounter any of the problems discussed in the following sections immediately perform the accompanying steps to ascertain whether your dose calibrator requires servicing If you conclude that it does contact the Biodex Customer Service Department at 1 800 224 6339 for further instructions The following problems are described in this appendix e System will not Power Up e Fluctuations in Activity Measurement e Unexpected Readings Important Notes about System Errors SYSTEM WILL NOT POWER UP If your Atomlab Dose Calibrator fails to power up perform the following steps proceeding to the next step only if the current one fails to remedy the problem Procedure 1 Remove the power cord from the electrical outlet Remove the other end of the Power Cord from the receptacle on the power pack 2 Re insert the power cord into the receptacle and then plug the Power Cord back into the power pack The dose calibrator should restart and the display will boot up
109. to the Utilities Menu Use the lt Toggle List gt Keys to scroll up or down the Utilities menu and then press the appropriate lt Screen Key gt to choose desired function Selections on the Utilities Menu include Status Reset ISO Button Backlight Time Beep ON OFF System Test Change Units Dial Values Factory Defaults Source Threshold Biodex Medical Systems 4 1 ATOMLAB Dose Calibrator Operation Manual Chapter 4 STATUS See Figure 4 2 ATOMLAB 400 pose catirator Status Argon g Pressure kPa _ Temperature C High Voltage Firmware v1 00 06 26 09 Chamber v1 00 02 1 00 02 Toggle List BIODEX Select Isotope Zero Background Figure 4 2 The Status screen The Status screen is used to check the status of various system parameters It displays values for Argon g Pressure kPa Temperature C and High Voltage The Status screen also displays the current Firmware version and Chamber version Biodex Medical Systems 4 2 ATOMLAB Dose Calibrator Operation Manual Chapter 4 RESET USER DEFINED BUTTONS See Figure 4 3 ATOMLAB 400 pose causraror Reset Isotope Bi 3 Select Button to Reset Set 1 125 Set F 18 Set Ge Ga 68 Figure 4 3 The Reset Isotope Button screen The Reset ISO Button is used to set the initial isotope value for user defined isotopes or to reset the isotope value for any isotope that has been defined by the user A Setting Initial Set Button Values
110. to this manual Biodex Medical Systems Li ATOMLAB Dose Calibrator Operation Manual Appendix The sensitivity curve of the Atomlab chamber with respect to photon energy has been determined by means of measuring NIST calibrated isotopes at a multitude of photon energies The isotopes Ga 67 Tc 99m Mo 99 In 111 1 125 1 131 Xe 133 and TI 201 were provided from the NIST Standard Reference Materials program In addition NIST traceable sources of the isotopes F 18 Co 57 Co 60 Ba 133 and Cs 137 were measured All of the NIST SRM isotopes with the exception of Xe 133 were contained liquid solutions of 5 ml volume in sealed borosilicate glass ampules of wall thickness 0 6 mm The Xe 133 samples were sealed mixed with non radioactive xenon gas in borosilicate glass ampules of wall thickness 1 3 mm The F 18 source was measured in a 10 ml B D plastic syringe The Co 57 Co 60 Ba 133 and Cs 137 sources were contained within epoxy sealed Type E vials In addition to the isotopes measured a Monte Carlo simulation of the Atomlab chamber has been created The Monte Carlo simulation allows better determination of the shape of the sensitivity curve in the regions between measured data points The photon sensitivity curve generated by the Monte Carlo simulation was found to be consistent with the sensitivity curve generated by the isotope measurements The Atomlab chamber sensitivity curve is plotted below with a logarithmic scale for photon energy
111. tor Operation Manual Appendix E Page 4 of 5 SUPPLEMENTAL ALPHABETICAL LISTING OF ISOTOPES rev 4 20 09 ATOMLAB 400 and ATOMLAB 500 DOSE CALIBRATORS Nuelide Dial Average Beta Half Life Expected Value Scheme Energy KeV Uncertain Sr 89 Strontium 686 0 Beta 50 55 days 20 Pure Sr 89 NIST Pure Sr 89 NIST Grade Grade Brems Brems Sr 89 m Strontium 583 50 55 days 20 Metastron Brems with Sr 85 impurity Ta 178 Tantalum 16 6 EC 9 31 minutes 10 Pure Te 99m Technetium 37 1 IT ae 6 007 hours 3 Ti 201 Thalium 20 9 EC W 178 Tungsten 68 7 EC San ie A 10 Pure W 178 Tungsten 13 4 EC EC 21 5 days 10 Ta 178 Tantalum 9 31 minutes Equilibrium Ta 178 in equilibrium with W 178 use for W i Contamination activity W ReEq 188 Tungsten 82 1 Beta 99 765 69 4 days C 10 includes Bremsstrahlung contributions from Re Xe 127 Xenon 11 0 36 4 da 10 Xe 133 Xenon 19 5 Beta 100 5 245 days 3 Y 86 Yttrium 3 4 Beta 2 88 14 74 hours E 10 B contribution is 12 Y 88 Y ttrium 4 9 EC 106 6 days C 10 Y 90 Yttrium 350 0 Beta 2 671 days S 5 Bremsstrahlung only 10cc plastic syringe from 2002 vol study Yttrium 2 671 days S 3 Bremsstrahlung only NIST vial measurement Ytterbium 32 days 10 2 244 1 days 10 B contribution is 3 Scheme EC Electron Capture IT Isomeric Transition NOTES 1 Isotope A B implies that
112. ulates radioactive materials Range Selection The Atomlab unit automatically selects which range of Display units uCi mCi Ci MBq or GBq to be used for the Activity Display to show activity values with the most significant number of digits Response lonization Chamber The variation of the ion current collected by an ionization chamber because of individual decay processes associated with different radioisotopes Calibration Values are required to adjust the output of the electrometer for each radioisotope to compensate for this variation in response thereby ensuring accuracy over the entire range of commonly used radioisotopes Biodex Medical Systems 6 3 ATOMLAB Dose Calibrator Operation Manual Chapter 6 Sleeve Shield A method of performing linearity tests on a dose calibrator by encircling a single source with leaded sleeves of varying thickness thereby reducing the activity the dose calibrator measures by a known amount Comparison of the expected and actual activity values constitutes the test of linearity Source Decay A method of performing linearity tests on a dose calibrator by measuring the initial activity of a source accurately calculating its decayed activity at prescribed time intervals and making activity measurements at those time intervals Comparison of the calculated and actual activity values constitutes the test of linearity Traceability Refers to using sources for calibrating a dose calibrator whose ac
113. up e Lower half lists diagnostic and status results for each identified detector up to 7 on an Atomlab 500 Dynamically updated in real time about once second Real Time Operating Detector Status Changes During the course of normal operation detectors report their status constantly to the display unit including any detectable error conditions The status reports are available as long as the power to the display remains on the detectors stay connected and the system is not in a severe fault state communication error So this means even if the detectors are not being used or the display is blanked from the screen saver the detectors are still communicating and being monitored For each error status newly reported a Detector or Chamber Status error reporting screen will appear with a 3 beep audio tone to alert the user An error code will be displayed with it s brief description If WARNING is displayed next to the code it indicates the chamber is still usable If FAIL is displayed next to the code the chamber will automatically be dropped from being selectable by the user For an Atomlab 500 with multiple chambers the next available detector will automatically be selected If there are no available detectors the activity readings displayed will be dashed out and activity screen will indicate no available chamber or chamber error Biodex Medical Systems B 1 ATOMLAB Dose Calibrator Operation Manual Appendix B For Chamber Lea
114. wall thickness of 1mm record as Plas tic Syringe Activity 2 Transfer part or all of the source mate rial from the plastic syringe into the empty Container 3 Assay the Container with the isotope source material record as Container Activity 4 Assay the partial or empty plastic syringe for residual activity record as Plastic Syringe Activity 5 Calculate the Container Dial Value for use with isotope assayed in that type of container PSA PSA CDV Dy L _2 Container Activity where PSA Plastic Syringe Activity Container with source material 1 Assay Container with the isotope source material record as Container Activity 2 Transfer part or all of the source mate rial from the Container into a plastic syringe nominal wall thickness of 1mm 3 Assay the plastic syringe with the iso tope source material record as Plastic Syringe Activity 4 Assay the partial or empty Container for residual activity record as Con tainer Activity 5 Calculate the Container Dial Value for use with isotope assayed PSA CDV DR en CA CA where PSA Plastic Syringe Activity and CA Container Activity Typically for glass wall source Containers CDV will be higher than DV when the iso tope has a significant portion of low energy photons in its emission spectrum 15 February 2010 ATOMLAB Dose Calibrator Operation Manual Appendix J Linearity Linearity means
115. y a relatively long lived source such as Cs 137 each day before using the calibrator Cs 137 100 uCi minimum activity is strongly recommended because the 30 year half life will assure use of the same source throughout the life of the calibra tor and it is readily available Consider using the following procedure or equivalent 4 Press the Zero Background Bkgnd button When the display zeroes the unit has automatically adjusted for Background 2 Assay each reference source using the appropriate dose calibrator setting i e use the Cs 137 setting to assay Cs 137 3 Record the activity reading of the con stancy source in a permanent log 4 Compare the measurement observed to the calculated activity of the source and if the measurement exceeds 5 of Manufactured by Sun Nuclear Corporation Melbourne FL distributed by Biodex Medical Systems Biodex Medical Systems predicted investigate potential sources of error patients in the area exposed sources use of the wrong iso tope or setting etc 5 Ifthe constancy result is determined to be greater than 10 of predicted sus pend the use of the instrument and repair or replace the dose calibrator NOTE It is recommended that the Cs 137 and Ba 133 sources be replaced when the activity is below 100 Ci It is recommended to replace a Co 57 source when the activity is less than 1 mCi 15 February 2010 ATOMLAB Dose Calibrator Operation Manual Appe
116. yringe hep imn Samarium 8 1 Beta 9 4 hours 10 H r 0258 ignored Eu daughter Strontium 20 elec 64 84 da Cc 10 8 E Sea GE Scheme EC Electron Capture IT Isomeric Transition Sr 87 m NOTES 1 Isotope A B implies that B is in equilibrium with A 2 Half Life s seconds m minutes d days y years 3 Scheme EC Electron Capture B Beta decay IT Isomeric transition A Alpha Decay 4 5 Cal Value Atomlab Dose Calibrator dial setting to calibrate for corresponding isotope Notes H r Half life ratio of daughter over parent implies daughter is ignored Bremsstrahlung includes implies low energy photons from electron interaction in saline Isotope should be measured in plastic syringe or vial or thin wall glass ampule Isotope should be measured in plastic syringe or vial or thin wall glass ampule unless otherwise stated above CONFIDENCE VALUES Calculated with corrected Monte Carlo Beta MC response strongly dependent upon measurement geometry best if Cal Value used is determined using actual measurement with clinical geometry confidence value of a measurement made using the listed dial value Measured directly Special Case As stated Biodex Medical Systems E 3 ATOMLAB Dose Calibra

ATOMLAB 400 DOSE CALIBRATOR

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