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Product Certifications and Classifications

This product has received the following certifications and falls within the following
classifications:

•

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 60601-1, IEC
60601-1-4 and IEC 60601-1-2 and CE Marked.

•

FDA Class II Equipment

•

EC Certificate: EC #4132458

•

Type B Applied Part

•

Electromagnetic Compatibility: This equipment complies with the Medical

Equipment ICC 60601-2 EMC Standard.

NOTE:

Circuit diagrams for this product are provided in the Schematics section at the back

of this manual.

Authorized European Community Representative:

Emergo Europe
Prinsessegracht 20
2514 AP, The Hague
The Netherlands

Содержание ATOMLAB 500

Страница 1: ...ATOMLAB 500 DOSE CALIBRATOR OPERATION AND SERVICE MANUAL 086 330 086 332 FN 17 355 9 17...

Страница 2: ...Atomlab 500 Dose Calibrator This manual covers operation procedures for the following products 086 330 Atomlab 500 Dose Calibrator...

Страница 3: ...Indications for Use 16 Description 17 The Detector 17 Detector Well Liner 17 Source Holder 17 Current Measurement 17 Rear Panel 17 Response 18 The Display Unit 18 Measurement Method 18 Display Units 1...

Страница 4: ...Response Time 68 Determining Dial Value Adjustments 68 Zero Background 69 Select Isotope 71 Dose Calculation 71 6 Dose Calibrator Quality Assurance 75 QA Dose Calibrator 75 Constancy Test 75 Constancy...

Страница 5: ...B Atomlab Display Diagnostics 165 Appendix C Atomlab 500 Dose Calibrator Specifications 168 Appendix D Decay Calculations 172 Appendix E Calibration Values 180 Appendix F Atomlab Dose Calibrator Calib...

Страница 6: ...ad these instructions prior to use Caution General Warning General Mandatory Action Dangerous Voltage On Power Off Power Earth ground Alternating Current Fuse USB Connector Cable Waste in Electrical E...

Страница 7: ...iner The Atomlab Dose Calibrator is designed for use with specific printers Contact Biodex for compatible printers Never store sources in the dose calibrator except during a linearity test as the sour...

Страница 8: ...tector to further reduce background radiation The lead should be disposed of in accordance with local and national regulations when disposing of the unit AVERTISSEMENT l unit contient l avance pour pr...

Страница 9: ...ivit d une source radioactive d un isotope connu Cette mesure peut tre pour les buts de d termination ou du fait de v rifier une dose radiopharmaceutical pour le fait de refl ter nucl aire ou la m dec...

Страница 10: ...No 601 1 M90 IEC 60601 1 IEC 60601 1 4 and IEC 60601 1 2 and CE Marked FDA Class II Equipment EC Certificate EC 4132458 Type B Applied Part Electromagnetic Compatibility This equipment complies with...

Страница 11: ...ceeding section of this manual This product should be used only as specified in the operation manual This medical electrical equipment requires special precautions regarding EMC and must be installed...

Страница 12: ...s considered the method of disconnecting the product from main power Do not place the product in a position where the plug is not easily accessible ATTENTION Le bouchon est consid r e comme la m thode...

Страница 13: ...ETECTOR 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 the A...

Страница 14: ...vice performed by other than a BIODEX MEDICAL SYSTEMS INC authorized repair representative Misuse and abuse include but are not limited to subjecting limits and allowing the equipment to become contam...

Страница 15: ...time 5 The return call may be from a person other than the first to whom the problem was reported 6 After analyzing the problem we will decide if the unit can be repaired on site or replacement parts...

Страница 16: ...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 Additionally...

Страница 17: ...or example when measuring syringe doses when the volume is unimportant The detector has electronics and the calibration built into it the calibrator is built into the detector Therefore any Atomlab 50...

Страница 18: ...tector is measured in one of three ways depending upon the order of magnitude of the current At low currents the current from the detector is collected upon a capacitor in the feedback loop of the ele...

Страница 19: ...ab Dial Values Equal activities of two different isotopes will generate different amounts of current in the ion detector due to differences in the energy and particle emitted by the isotopes Dial valu...

Страница 20: ...on area and room for writing Suggested dimensions of the table top are 30 in deep 48 in wide 36 in high Physical Location and Environment Frequently dose calibrators are located in areas called hot la...

Страница 21: ...and Stowage Conditions Temperature 0 to 40 C Humidity 0 to 90 rh non condensing For optimum performance the Atomlab 500 should be operated in a normal laboratory environment where the temperature and...

Страница 22: ...Cable Connections Figure 2 1 The Atomlab 500 cable connections on back of unit Figure 2 2 The Atomlab 500 Display connected to a detector label printer and printer...

Страница 23: ...te end of the cable to the appropriate port on the display 7 Insert the round end of the power supply or power pack into the power port on the display unit 8 Insert the female end of the power cord in...

Страница 24: ...ctor Communication with the detector High voltage readings to be in range All detector firmware checksums Validity of calibration factor values Background factor for an excessively negative or large v...

Страница 25: ...g carton Label the carton and store it in a safe out of the way location If the dose calibrator is returned for updates calibration or repair use the original shipping carton boxes and shipping materi...

Страница 26: ...d Utilities Chapter 3 The following basic prompts appear throughout the program and unless otherwise noted always perform the following functions Basic Key Functions Home Returns the system to the Hom...

Страница 27: ...ed screen or report Print Labels Prints various labels based on the function currently selected Exits from the system NOTE When a Wipe Test Counter 086 331 is added to the Atomlab 500 the system autom...

Страница 28: ...lude System Configuration System Maintenance Dose Calibrator Configuration System Configuration Figure 4 2 The System Configuration Menu The System Configuration options allow the user to enter or cus...

Страница 29: ...uch Cancel to return to the System Configuration screen without changing the passcode Units The user has the ability to select between displaying the units of measure in Curies or Becquerels by touchi...

Страница 30: ...is displayed 3 To enter a new facility name and address key in the new facility name and address using the displayed keyboard Use the key to advance to the next line 4 When all of the desired informat...

Страница 31: ...w displayed 2 Touch System Configuration The System Configuration screen is now displayed 3 Touch Staff Members The Staff Members List is now displayed Figure 4 5 Staff Members List Screen To Add A St...

Страница 32: ...re on the line containing the staff member name to be edited 2 Touch the Edit icon 3 The Edit Staff Member screen is displayed 4 Touch the field in which the change is to be made e g Last Name field 5...

Страница 33: ...t person from the Staff Members List touch the Delete icon The system displays the following message 3 Touch Accept to delete the staff member and return to the System Configuration screen or Cancel t...

Страница 34: ...to convert the report to a PDF format Advanced Touch the Advanced icon to configure the information to be printed using screens similar to those within Windows Figure 4 11 Advanced Print Setup Screen...

Страница 35: ...re 4 12 3 Touch the Region Format field to highlight it and use the scroll bar at the right to navigate through the list until the desired region format is located Select the region format by touching...

Страница 36: ...ion of Date Formats Changes for Region and Time Zones 6 To change the time touch the desired field and use the or keys to scroll to the desired hour minute and or second Touching the last field will t...

Страница 37: ...iguration settings are permanently saved when exiting the Dose Calibrator Configuration screen To access the Dose Calibrator Configuration screen 1 Select Utilities from the Home screen The Utilities...

Страница 38: ...splayed 5 Touch Select Current Isotope The Select Current Isotope screen is displayed 6 Use the or keys to scroll through the list until the desired isotope is displayed 7 Touch the desired isotope to...

Страница 39: ...isotope to the buttons on the isotope list that is displayed on the Measure screen 1 From the Isotope List screen touch Setup Button Isotopes The Setup Button Isotopes screen is displayed 2 Use the or...

Страница 40: ...ions have been made are you sure you want to lose the changes prompt is displayed Figure 4 26 Button Isotopes Modification Prompt Press No to keep the changes followed by Accept on the Setup Button Is...

Страница 41: ...the new isotopes area of the Isotope List The individual aspects for the new isotope are input using the provided fields NOTE The user must enter information in every field Isotope Symbol Isotope Nam...

Страница 42: ...ter the isotope name Figure 4 30 Keypad with Isotope Name Entered If the isotope name entered matches a name currently on the list the following message is displayed Figure 4 31 Duplicate Isotope Name...

Страница 43: ...ancel is touched the following prompt is displayed Figure 4 32 Add Isotope Modifications Prompt Touch No to save the information entered or Yes to return to the Isotope List screen without saving the...

Страница 44: ...prompt is displayed Figure 4 35 Remove Isotope Prompt Touch Accept to remove the selected isotope or Cancel to retain the selected isotope and return to the Remove Isotope from List screen The system...

Страница 45: ...the original dial value for all isotopes and the new dial value for any that have been changed New dial values are preceded by an when viewed on the Dose Calibrator Measurement screen after touching S...

Страница 46: ...ge the value or touch Clear to empty the field and enter a new value using the keypad 11 Touch Accept to record the new dial value and return to the Change Dial Values screen with the new dial value d...

Страница 47: ...to return to the Isotope List screen with the new entry selected Cancel to return to the Isotope List screen without making a new selection NOTE After restoring factory dial values scroll the Isotope...

Страница 48: ...for which the default variance is to be changed Use the or keys to increase or decrease the value Variance is expressed as for Constancy Geometry Accuracy and Linearity Decay The Lineator test is expr...

Страница 49: ...n is used to enter data to add to sealed sources Up to fifty sealed sources including multiple sources for the same isotope with different source ID s can be entered The user can mark a selected seale...

Страница 50: ...Source The Select Isotope screen is displayed Figure 4 46 Select Isotope Screen 3 Use the or keys to locate the desired isotope When located touch anywhere on the line to highlight the desired isotope...

Страница 51: ...y has been entered the user can increase or decrease the amount by touching the or keys 5 The Sealed Source screen is redisplayed containing the calibration activity If necessary touch the appropriate...

Страница 52: ...and using the or keys to scroll to locate the desired date Touch Accept 7 The Sealed Source screen is redisplayed containing the Calibration Date Figure 4 51 Sealed Source Screen with Sealed Source Ca...

Страница 53: ...otopes selected The user is able to add and or delete isotopes from this screen To add an isotope to the list Touch Add Isotope The Select Isotope screen is displayed see Figure 4 46 Use the or keys t...

Страница 54: ...aled Source Screen and verify that the new source is listed Note When an isotope s has been entered in the Expanded Constancy List the system marks the number entered in the Source ID field with an as...

Страница 55: ...ight the sealed source to delete 2 Touch Delete The system will note that the sealed source selected will be deleted and prompt Are you sure Figure 4 58 Delete Sealed Source Prompt 3 Touch Accept to d...

Страница 56: ...ed Sources 1 At the Sealed Sources List screen touch Print The entire Technologist List will print to the currently selected printer 2 Touch Back to return to the Sealed Source List Figure 4 59 A Seal...

Страница 57: ...e Set Background Time screen is displayed The center of the screen displays the current Background Time in seconds 30 60 or 100 5 To change the existing background time click in the appropriate radio...

Страница 58: ...owing records Measure Activity Record Dose Calculation Future Dose Record Sample labels are presented throughout this manual with the specific function instructions The number of labels can be set fro...

Страница 59: ...Threshold value determines the system s response time Above the threshold response time is quick Below the threshold response time is significantly slower To Change The Source Threshold 1 From the Ut...

Страница 60: ...The Source Detection Threshold screen is displayed with the threshold value assigned to the selected isotope as illustrated in Figure 4 64 5 Touch the Reset Defaults button to revert to the factory de...

Страница 61: ...turn to the Utilities menu 3 Touch Measure to display the Dose Calibrator Measure screen Systems Maintenance Figure 4 67 Systems Maintenance Screen This option is used to address various system mainte...

Страница 62: ...tests Tests prior to or after a specified date Within a specific date range NOTE Be sure to install the thumb drive in one of the USB ports located on the back of the display panel before attempting t...

Страница 63: ...file proprietary to Biodex Data must be exported in this format if it will be input at a later date A csv file cannot be input 6 Touch the Export USB button 7 The total number of tests selected is dis...

Страница 64: ...ete Multiple Tests Select the category test type and time frame to delete 3 Touch Delete The total number of tests that will be deleted is displayed 4 Touch Delete again to delete the tests System Bac...

Страница 65: ...B ports on the back panel of the display 2 At the System Backup Restore screen touch Restore from USB A message will display noting that this procedure will overwrite all of the Atomlab 500 s files 3...

Страница 66: ...determining problems encountered with the system If needed this function will be explained by a Biodex Service Representative Detector Status A screen similar to the following example is displayed wh...

Страница 67: ...left isotope displayed The Dose Calibrator Measure screen activity reading defaults to the last selected isotope or to Tc 99m if no isotope has been previously selected The system selects the most rec...

Страница 68: ...lay will drop down to a near zero value NOTE Both the Detector Well Liner and Sample Holder should be periodically checked for contamination as described in Appendix J under Records and Maintenance Di...

Страница 69: ...for this isotope and container configuration NOTE Write down the determined dial value before exiting this screen as the dial value will not be saved 5 The Reset button sets the dial value back to th...

Страница 70: ...in or near the detector 2 Touch the Zero Background icon The Zero Background screen is displayed showing the current isotope activity see Figure 5 4 3 Touch the Zero Background prompt The message in...

Страница 71: ...selection 4 Touch Accept to select the desired isotope and return to the Measure screen with the new isotope selected or touch Cancel to return to the Measure screen without making a new selection Do...

Страница 72: ...ount displayed Note To use the or to change the amount displayed the field must contain a value i e it cannot be blank 5 Click on the radio button to the right of Activity Required to switch between C...

Страница 73: ...elds Month Day Year and use either the keypad at the right of the screen or the or keys to change the date c Time Touch any of the fields Hour Minute Second and use either the keypad at the right of t...

Страница 74: ...h the system automatically calculates the Dose Concentration the user can change the displayed amount 10 Touch Accept to return to the Dose Calculation screen The Volume To Draw for the dose ordered a...

Страница 75: ...ny of the eight QA procedures can be accessed Constancy Test Constancy Test History Geometry Test Geometry Test History Accuracy Test Accuracy Test History Linearity Test Linearity Test History Consta...

Страница 76: ...ange sources touch Select Sealed Source The Sealed Source List screen is displayed Locate the desired source by using the and arrows to scroll through the list Touch anywhere on the line containing th...

Страница 77: ...tandard is shown Figure 6 5 Record Readings from Constancy Test Screen 6 If Back is touched a message that recorded data will be lost is displayed Touch Yes to return to the Daily Constancy Test scree...

Страница 78: ...st 9 Touch Accept to save the test results Figure 6 7 Constancy Screen illustrating Test Results Saved Touch Measure to go to the Measure screen Figure 6 8 Dose Calibrator Measure Screen Touch New Tes...

Страница 79: ...tory View Options screen is displayed Figure 6 10 Expanded Constancy Test History View Options Screen 2 Select the sealed source from the drop down menu 3 Select the date range from the drop down menu...

Страница 80: ...6 11 Delete Stored Test Data Screen To View Details Figure 6 12 Constancy Test View Details Screen The Constancy Test History screen displays the constancy tests performed on the dose calibrator The d...

Страница 81: ...Print to print the constancy plot displayed The printout has the plot and the data 4 If desired touch Select Sealed Source if a different sealed source is desired 5 Touch Back to return to the Daily...

Страница 82: ...Summary Report Figure 6 15 Constancy Test Summary Report Detailed History Report Figure 6 16 Constancy Detailed History Report...

Страница 83: ...used for injections The following test assumes injections are done with 3 ml plastic syringes and the radiopharmaceutical kits are made in 30 ml glass vials If they are not used change the procedure t...

Страница 84: ...ml Material is glass or plastic 5 Touch to highlight volume 1 and use the and arrows to adjust the value Touch volume 2 and the system automatically increases by the appropriate volume Use the and arr...

Страница 85: ...in red When the measured activity settles touch Record Reading to record the measured activity reading The system advances to the second volume 10 Remove the sample and adjust the volume for the secon...

Страница 86: ...is on the list the system will default to that person on the Save Geometry Test Data screen Touch Accept to select the staff member and return to the Save Geometry Test Data screen If necessary touch...

Страница 87: ...he dose calibrator The display shows the isotopes used for a Geometry Test Any Geometry Test outside the acceptable variance is shown in red Touch Back to return to the QA Dose Calibrator screen Touch...

Страница 88: ...tivity and container description for the selected isotope Figure 6 27 Geometry Test View Details Screen 3 Touch Back to return to the Geometry Test History screen 4 Touch Delete to delete the stored t...

Страница 89: ...Figure 6 28 A Geometry Test Reports Screen...

Страница 90: ...9 Geometry Test Summary Report 3 Touch Detail History Figure 6 30 Geometry Test Detail History Report From either report the user has the ability to Export the data in PDF format Print the data to the...

Страница 91: ...keV Figure 6 31 The Accuracy Test Screen To Perform An Accuracy Test 1 From the QA Dose Calibrator screen touch Accuracy Test The Accuracy Test screen is displayed see Figure 6 31 2 Touch Select Seale...

Страница 92: ...he system calculates the average reading compares it to the calculated standard and determines the average variance Figure 6 33 Accuracy Test Screen NOTE If any of the readings are out of the acceptab...

Страница 93: ...9 Touch Measure to go to the Measure screen 10 Touch New Test to perform a New Accuracy Test 11 Touch Back to return to the Accuracy Test screen without saving 12 Touch Back a second time to return to...

Страница 94: ...locate the test date desired Figure 6 36 The Accuracy Test History Screen The Accuracy Data screen displays the Accuracy Tests performed on the dose calibrator The data is stored for the detector con...

Страница 95: ...s displayed listing the reading activity calculated standard and variance for the selected isotope Figure 6 38 Geometry Test View Details Screen 7 Touch Back to return to the Accuracy Test History scr...

Страница 96: ...Figure 6 39 Accuracy Test Reports Screen 2 Touch Summary History Figure 6 40 Accuracy Test Summary Report...

Страница 97: ...Touch Detail History Figure 6 41 Accuracy Test Detail History Report From either report the user has the ability to Export the data in PDF format Print the data to the system assigned or local printe...

Страница 98: ...in these methods are all acceptable for determining the normalized value 1 Decay correct the test sample from the first reading and compare each reading to the decay corrected reading 2 For Tc 99m se...

Страница 99: ...linearity readings each time that Record Reading is touched The user can select the calculation method using a normalized reading or an averaging method for the calculation This choice is made as part...

Страница 100: ...be changed by touching the and keys to enter the activity at which the test should end This number can be between 10 and 50 Ci 5 Touch Accept to return to the Manual Decay Test screen with the new var...

Страница 101: ...stabilized touch Record Reading The reading is recorded and the next line for the manual decay test is displayed The system will continue to display a live reading until Record Reading is selected Fig...

Страница 102: ...d reading and the system returns to the manual decay test screen NOTE The user can select the normalized reading while the decay test is underway If a normalized reading has not been selected before s...

Страница 103: ...low activity values The switchover to manual mode defaults to 100 Ci The switch from auto to manual can be set from 50 Ci to 500 Ci To Perform A Semi Automated Decay Test 1 From the Linearity Testing...

Страница 104: ...etween readings before the system calculates the results 5 Select the desired variance calculation method by touching the appropriate radio button 6 Select the desired reading interval units by touchi...

Страница 105: ...is reached the system will display a message that it is changing to manual readings From that point any readings require the user to touch Record Reading to take the reading NOTE Once the system switc...

Страница 106: ...ose Calibrator Measure Screen 15 Touch End Test to end the test Figure 6 57 The Semi Automated Decay Test Ended Screen 16 Touch Save to save the data The Save Results screen is displayed 17 If the app...

Страница 107: ...method using a normalized reading or an averaging method for the calculation These choices are made as part of setting the test parameters prior to starting the linearity test There is a Setup Options...

Страница 108: ...ing the reading interval in either half lives or hours use the and to increase or decrease the time in the Set Reading Interval field 7 Touch to highlight the Set Time Until Normalized Reading button...

Страница 109: ...use Test NOTE If the time for the reading has passed the system will take a reading and record the time once the test is resumed It does not skip a reading that was not taken at the correct time 13 To...

Страница 110: ...ance to the Dose Calibrator Measure screen 19 Touch Back to return to the Semi Automated Decay Test screen 20 Touch Back a second time to return to the Linearity Testing screen Linearity Automated Dec...

Страница 111: ...l store the initial factors and print them in the initial factor column of the results table The initial Lineator Test needs to be performed only once unless the Lineator is replaced or damaged in whi...

Страница 112: ...oggle between maximum activities of less than 55 mCi and greater than 55 mCi NOTE The system defaults to less than 55 mCi If the test starts with an activity greater than 55 mCi the user must select t...

Страница 113: ...light the staff member If a staff member has previously been selected the system will default to that person Touch Accept to save the data in memory and return to the Lineator Initial Test data screen...

Страница 114: ...imum activities of less than 55 mCi and greater than 55 mCi NOTE The system defaults to less than 55 mCi If the test starts with an activity greater than 55 mCi the user must select this range Figure...

Страница 115: ...test at any time Figure 6 70 Lineator Test End Test Touched 8 Touch Save to save the test just performed 9 If the appropriate staff member is not displayed touch Staff Touch any line on the display to...

Страница 116: ...alibration Factor Figure 6 72 The Calicheck Initial Test Screen The first time the Calicheck is used with Atomlab 500 calibrator factors for the Calicheck function must be set and the Atomlab 500 must...

Страница 117: ...as stabilized touch Record Reading The reading for the Black Tube is recorded and the line for the Black Red Tube is now displayed as a live reading Figure 6 73 Calicheck Initial Test Screen for Black...

Страница 118: ...11 Touch New Test to perform the test again 12 Touch Measure to advance to the Dose Calibrator Measure screen 13 Touch Back to return to the Lineator Testing screen Calicheck Test Figure 6 76 The Cali...

Страница 119: ...al into the Calicheck Black Tube Place the Black Tube into the detector The activity for the Black Tube is now displayed as a live reading 4 Once the reading has stabilized touch Record Reading The re...

Страница 120: ...Since there are several acceptable methods for performing linearity testing the Linearity History allows the user to select the category of test for which the history is to be displayed The following...

Страница 121: ...n The Decay Test View Options screen is displayed Figure 6 81 Decay Test History View Options Screen 2 Select an entry from the Date Range field and touch Cancel to return to the Decay Test History sc...

Страница 122: ...ific line on the Decay Test History screen to highlight the information 2 Touch View Details The Decay Test View Details screen is displayed Figure 6 84 Decay Test View Details Screen 3 Use the and to...

Страница 123: ...be displayed Figure 6 85 Linearity Decay Plots Screen 2 Use the and to toggle between dates 3 Touch Print to print the linearity plot displayed 4 Touch Back to return to the decay Test data screen 5...

Страница 124: ...view the tests desired The Decay Test Reports screen is displayed Figure 6 87 Decay Test Reports Screen The user has the option to view either a Summary or a Detailed History report Summary Report Fig...

Страница 125: ...assigned or local printer Lineator Test History Figure 6 90 The Lineator Test data Screen The Lineator Test data screen displays the Linearity Tests performed on the dose calibrator The display lists...

Страница 126: ...ntry from the Date Range field 3 Touch Cancel to return to the Decay Test History screen without making any changes 4 Touch Accept to change the view options and return to the Linearity Test History s...

Страница 127: ...ght the information 2 Touch View Details The Linearity Test View Details screen is displayed Figure 6 94 Linearity Test View Details Screen 3 Touch Print in the upper right of the screen to print the...

Страница 128: ...Figure 6 95 Decay Test Reports Screen The user has the option to view either a Summary or a Detailed History report Summary Report Figure 6 96 Linearity Test Summary Report...

Страница 129: ...Detailed Report Figure 6 97 Linearity Test Detail History Report From either report the user has the ability to Export the data in PDF format Print the data to the system assigned or local printer...

Страница 130: ...calibrator The display lists individual tests with the most recent test as the default Use the and to scroll to view the test results desired Touch Back to return to the QA Dose Calibrator screen To...

Страница 131: ...y screen Figure 6 100 Calicheck Test History Screen Updated View Options 5 Touch Back to return to the Lineator History screen To Delete Data 1 Touch Delete The Delete Stored Test Data confirmation sc...

Страница 132: ...Screen 3 Touch Print in the upper right of the screen to print the displayed test details 4 Touch Delete to delete the test details 5 Touch Back to return to the Calicheck Test History screen To View...

Страница 133: ...Calicheck Test Summary Report Detailed Report Figure 6 105 Calicheck Test Detail History Report From either report the user has the ability to Export the data in PDF format Print the data to the syste...

Страница 134: ...Calculation Half Life Verification Half Life Verification History Moly Assay Moly Breakthrough The Moly Assay test measures the amount of Mo 99 in a syringe or vial of Tc 99m To execute this test an...

Страница 135: ...ee Figure 7 3 3 The Moly Assay Background screen allows the user to change the background counting time The screen displays the current background time To change the background counting time select Ch...

Страница 136: ...Make sure there is no source in the detector Place the empty Moly Shield into the detector and touch Zero Background 6 Select Zero Background to begin a background count time lasting 30 60 or 100 sec...

Страница 137: ...ly Assay screen to count the vial or syringe of Tc 99m without the Moly Shield Figure 7 8 Moly Assay Screen with Record Reading Complete Message NOTE To recount the Moly touch Record Reading again 11...

Страница 138: ...Back to return to the Nuclear Pharmacy screen Figure 7 1 Half Life Verification Intended Use The Half Life Verification APP is intended to check a radioactive isotope to determine the actual Half Lif...

Страница 139: ...for the isotope selected and the calculated Half Life from the two or three activity readings NOTE It is up to the user to decide if this variance is acceptable or if there are too many contaminants i...

Страница 140: ...er 2 or 3 for the number of readings If the number is already highlighted no further action is required 8 Use the or arrows to set the time between readings If the default number is the desired time f...

Страница 141: ...nd the system returns to the Half Life Verification screen 12 Place the isotope sample into the dose calibrator chamber 13 Touch Start Recording to take the first reading The program will automaticall...

Страница 142: ...Life Verification APP will end and use the elapsed time for the calculation If the counting time is not long enough it could affect the results It is recommended to have the count complete the preset...

Страница 143: ...rformed the same way as the two reading test The difference is that three readings will be taken at the selected time interval When the test is complete the system calculates the Half Life between the...

Страница 144: ...uch any line on the display to highlight the staff member If a staff member has previously been selected the system will default to that person Touch Accept to select the staff member save the data an...

Страница 145: ...Figure 7 25 Dose Calibrator Measure Screen 23 Touch Back to return to the Nuclear Pharmacy screen 24 Touch Home to return to the Main Atomlab Menu...

Страница 146: ...al tests with the most recent test as the default Use the and to scroll to view the test results desired Touch Back to return to the Nuclear Pharmacy screen To View Options 1 Touch View Options The Ha...

Страница 147: ...Stored Test Data confirmation screen is displayed Figure 7 28 Delete Stored Test Data Screen 2 Touch Accept to delete the current test 3 Touch Cancel to return to the Half Life Verification History s...

Страница 148: ...asurement Calculate Half Life Example for F 18 Starting measurement 4122 Ending measurement 3860 Counting time 10 min Calculate Half Life 105 54796 min 60 Calculate Half Life 1 759 hr Variance Formula...

Страница 149: ...reen the user has the ability to Export the data in PDF format Print the data to the system assigned or local printer Figure 7 30 Half Life Verification Report 2 Touch Back to return to the Half Life...

Страница 150: ...button at the bottom of the Future Dose Calculation screen clears all data on this screen The Future Dose function automatically displays the isotope selected Future Dose Calculated Method 1 At the N...

Страница 151: ...The Dose Administration Date defaults to the current date It can be changed by touching any of the fields e g day month and year and using the or keys at the right of the screen to change the date 6 T...

Страница 152: ...Minute Second and use either the keypad at the right of the screen or the or keys to change the time d Activity Touch Activity and enter the activity required amount using the keypad at the right of...

Страница 153: ...se Concentration the user can change the displayed amount and the system will readjust the Activity Required and the Volume to Draw on the Future Dose Calculation screen to reflect that change as illu...

Страница 154: ...ses enter the administration time and dose ordered for another dose and the system calculates the requirements for that dose 12 Touch Clear to remove the Dose Concentration and Dose Ordered data from...

Страница 155: ...uch Print Labels icon in the upper right of the Future Dose Calculation screen to generate a label if a label printer is connected Figure 7 39 Future dose labels showing Dose Ordered volume to draw an...

Страница 156: ...s greater up to 40 curies of Tc 99m 1 5 up to 100 curies of Tc 99m Electrometer Accuracy 1 or 0 2 Ci whichever is greater Overall Accuracy 3 or 0 3 Ci whichever is greater overall accuracy is affected...

Страница 157: ...ied with the exception of accessories transducers and cables sold by the manufacturer of this equipment as replacement parts for internal and external components may result in increased emissions or d...

Страница 158: ...11 Class B The Atomlab 500 is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network supplying buildings used for domest...

Страница 159: ...in UT for 1 2 cycle 40 UT 60 of dip in UT for 5 cycle 70 UT 30 of dip in UT for 25 cycle 5 UT 95 of dip in UT for 5 sec Mains power quality should be that of a typical commercial or hospital environme...

Страница 160: ...ed transmitters such as base stations for radio telephones and land mobile radios amateur radio AM or FM broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electr...

Страница 161: ...1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applic...

Страница 162: ...10 Parts and Assembly Instructions TBD...

Страница 163: ...ot power up call the Biodex Customer Service Department Fluctuations in Activity Measurements When the system is displaying activity for the more common isotopes the electrometer continuously averages...

Страница 164: ...the reading on the activity display is inaccurate ensure that the calibration value for the isotope selection key is correct Detector Service CAUTION Only qualified service personnel should remove th...

Страница 165: ...r detector status error reporting screen is displayed with an audio tone to alert the user An error code is displayed with its brief description If WARNING is displayed next to the code it indicates t...

Страница 166: ...ning 5 Detector Gas Low Correctable If grams of argon drop by more than 5 of the factory measured value the error code is set There is no correction performed when the error code is active Fail 6 Dete...

Страница 167: ...kground PASS No Reported Problems no errors in effect ready for measuring activity WARNING n description 1 error code WARNING n n n Two or more error codes may be present FAIL n description FAIL n n n...

Страница 168: ...f 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 liste...

Страница 169: ...able C 3 Noise Fluctuation Table Display Fluctuations Activity Range 1 digit after 1 2 seconds 199 90 microcuries 4 after 3 seconds 2 after 10 seconds 19 99 microcuries 4 after 30 100 seconds 0 01 to...

Страница 170: ...ormal laboratory environment where the temperature and humidity are maintained for normal human comfort and the ambient radiation level is low and constant Physical Data Table C 5 Atomlab 500 Size and...

Страница 171: ...are six in total two for power two for chassis ground two for serial data Connectors RJ 12 Auxiliary Port RS 232 Connector USB Ports 3 Ethernet Port Calibration Constancy Isotopes Co 57 and Cs 137 are...

Страница 172: ...an be compared to the decayed calculated activity 2 Using the Decay Factor Chart below look up the half live of T1 2 for the radioisotope Note the time units 3 T1 2 Half life of the isotope t Elapsed...

Страница 173: ...units 3 T1 2 Half life of the isotope t Elapsed time A Current activity A0 Activity at the time of calibration 4 Calculate 2 5 Calculate the elapsed time t in the same units as the T1 2 that will elap...

Страница 174: ...e T1 2 that will elapse between the time the activity measurement was made and the time at which the decayed activity of the radioisotope must be known 4 Calculate in terms of N R where N is an intege...

Страница 175: ...Table D 1 ex Function Calculations N 0 1 1 0 5 2 0 25 3 0 125 4 0 0625 5 0 03125 6 0 01563 7 0 007813 8 0 003906 9 0 001953 10 0 000977...

Страница 176: ...0 85263 0 85204 0 85145 0 85086 0 85027 0 84968 0 84910 0 84851 0 84792 0 84733 24 0 84675 0 84616 0 84557 0 84499 0 84440 0 84382 0 84323 0 84265 0 84206 0 84148 25 0 84090 0 84031 0 83973 0 83915 0...

Страница 177: ...7 0 60207 0 60165 0 60123 0 60082 0 60040 0 59999 0 59957 74 0 59874 0 59832 0 59791 0 59791 0 59750 0 59708 0 59667 0 59625 0 59584 0 59543 75 0 59460 0 59419 0 59378 0 59378 0 59337 0 59296 0 59255...

Страница 178: ...T1 2 0 693 T1 2 Where T1 2 half life specific to the radioisotope Therefore using a calculator with the ex function decay calculations can be performed as illustrated in the beginning of this appendix...

Страница 179: ...mplify the calculations the above relation can be written as 2 The following expression is used to generate the values in Table D 1 The following expression is used to generate the Decay Factor Chart...

Страница 180: ...1d C 10 NIST At 211 Astatine 61 6 A E 7 21h C 10 NIST Au 198 Gold 24 1 B 406 2 69d C 10 NIST Au 199 Gold 46 7 B 87 3 139d C 10 NIST Ba 133 Barium 7 4 E 10 54y M 3 NIST Bi 212 Tl 208 Bismuth Thallium...

Страница 181: ...C 10 NIST F 18 Flourine 10 1 E B 242 1 83h M 3 NIST Fe 52 Iron 11 9 E B 189 8 275h C 10 NIST Fe 52 Mn 52 Iron Manganese 3 3 E B E B 189 1133 8 275h 21 1m C 10 NIST Fe 59 Iron 10 5 B 118 44 5d C 10 NI...

Страница 182: ...4 7 B 9 8 34 97d C 10 NIST O 15 Oxygen 10 0 E B 735 2 037m C 10 NIST Os 191 Osmium 27 2 B 37 5 15 4d C 10 NIST P 32 Phosphorous 509 0 B Pure 695 14 28d M 20 vial Vial P 32 Phosphorous 712 0 B Pure 695...

Страница 183: ...Sr 87m Strontium 30 9 IT 2 795h C 10 NIST Sr 89 Strontium 686 0 B 583 50 55d B 20 NIST Pure Sr 89 NIST Grade Brems Ta 178 Tantalum 16 6 E 9 31m C 10 NIST Pure Tc 99m Technelium 37 1 IT 6 007h M 3 NIST...

Страница 184: ...ser with the following procedure During the following steps set the DV to the Atomlab published value Container with No Source Material 1 Assay a quantity of isotope source material in a plastic syrin...

Страница 185: ...of a measurement made using the listed dial value M Measured directly S Special Case 3 As stated Dial Settings for Y 90 The typical Atomlab 500 Dose Calibrator dial setting for Y 90 activity in a 10 c...

Страница 186: ...ensate the change in constancy and vice versa Thus the CCPE will have the opposite sign as the DVE therefore adding them together should cancel to within 2 For example a new dial value for Y 90 is fou...

Страница 187: ...nse numbers were used to determine the photon response function of the ionization detectors The shielding configuration is identical to that of the Atomlab Dose Calibrator design The National Institut...

Страница 188: ...the display console These remote commands must be used with great care and consideration of how the unit is being used The ISO command for example when used to change an isotope is fine on a detector...

Страница 189: ...rts with a tilde character and the fields are separated by a space The activity reading always has three decimal digits in the report followed by the units For example Tc 99m 37 1 1404 767 Ci DSTAT Di...

Страница 190: ...0 OFF QADATA Displays a summary of QA data usage REQDATA Requests stored QA data matching the given criteria REQRECCNT Requests a count of QA records matching the given criteria RESET Resets Restarts...

Страница 191: ...nged and the displayed screen is not affected Note Reference the Isotope Index Table for programming MODEL Displays the abbreviated model name as follows Atomlab 500 500 Atomlab 500Plus 500W Wipe Test...

Страница 192: ...A 05 01 05 31 Retrieve all of the Restricted Unrestricted wipe results for the month of May 2 REQDATA BCK 05 22 Retrieve all of the wipe background results from May 22nd 3 REQDATA ALL Retrieve all rec...

Страница 193: ...ate range It can be used to determine how many records will be returned with the given filters for a REQDATA command to follow Filtering parameters are as follows 1 QA Type All CON Daily and Expanded...

Страница 194: ...command will turn on an on screen display of detector status on the Measure function 1 Set On 0 Turn Off If no parameter is given a detailed state of the current connected detectors is displayed VER D...

Страница 195: ...64 69 Ta 178 21 Zn 65 70 W 178 22 Cu 67 71 W Ta 178 23 Ga 67 72 Re 186 24 Ge Ga 68 73 Re 188 25 Se 73 74 W Re 188 26 Br 75 75 Os 191 27 Se 75 76 Ir 192 28 As 76 77 Pt 195m 29 Br 76 78 Ir 196 30 Br 77...

Страница 196: ...re tabulated in sources such as references 1 and 2 the detector response and dial value can be calculated using equations 1 2 and 3 The calculated dial values for many common isotopes are listed in th...

Страница 197: ...sed detector sensitivity in the 88 200 keV photon energy range The increase in sensitivity is already included in the sensitivity curve illustrated in Figure G 1 and can be seen in the peak at 88 keV...

Страница 198: ...he dial value can be calculated by the following formula 5 0 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...

Страница 199: ...b 500 Dose Calibrator Replacement Parts Part Number Part Description C13116 Power Supply C11789 Cord Set 086 241 Well Insert 086 242 Well Vial Syringe Dipper 086 330 E705 Chamber Cable C8187 Bumpons S...

Страница 200: ...ercent Accuracy At installation time and at least annually thereafter 5 percent After repair of the dose calibrator repeat the above tests as if it were a new installation Notes 1 A plastic well liner...

Страница 201: ...7 source when the activity is less than 200 Ci Dial Value Settings and Source Containers e g Glass Vial Glass Syringe The Atomlab Dial Value DV settings enable the software to convert ion chamber curr...

Страница 202: ...as Container Activity 1 2 Transfer part or all of the source material from the container into a plastic syringe with a nominal wall thickness of 1mm 3 Assay the plastic syringe with the isotope source...

Страница 203: ...ges the calculated activities and divides the average by the time corrected reading to determine a correction factor If the correction factor is between certain values the calibrator is linear Decay M...

Страница 204: ...ues the dose calibrator passes The two linearity tests should have overlapping activity values in the acceptable range 1 Hint Recalculate the first test M0 without including failing values from low M...

Страница 205: ...1 Sample Dose Calibrator Linearity Data Collection Form Atomlab Dose Calibrator Linearity Test Model Serial Number Date Time Activity Measured M Hours elapsed t M0 t cfm Avg M0 t Accept if 0 95 Avg M...

Страница 206: ...entration 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 th...

Страница 207: ...3 Calculate the results using one of the following methods Select a normalized volume and decay correct the activity readings for the other volumes to the same time Divide the calculated activity for...

Страница 208: ...v Volume cf Normalized Activity v Syringe Type Volume Decay correct if test not completed in 10 min Avg Time Volume Activity v Atomlab Dose Calibrator Geometry Test Model Serial Number Volume cf Avg...

Страница 209: ...e source 5 For both sources decay correct the reference source activity value and record it as true activity 6 Calculate the average for the three measurements and compare the average to the calculate...

Страница 210: ...he liner and dipper as follows 1 Remove the plastic dipper and liner from the well chamber 2 Touch Zero Background to zero the calibrator 3 Replace the liner in the well chamber If the display reading...

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Содержание ATOMLAB 500

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biodex ATOMLAB 500, Руководство по эксплуатации и обслуживанию, Страница: 10 / 212

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Содержание ATOMLAB 500

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