atomlab 450 wipe test system user’s manualfemale end of the power connector cord plugs in beneath...

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ATOMLAB 450 WIPE TEST SYSTEM USER’S MANUAL (#187-450) Biodex Medical Systems, Inc. • Brookhaven R & D Plaza • 20 Ramsay Road • Box 702 • Shirley • New York • 11967-0702 • 516-924-9000 • Fax 516-924-9241 FN: 94-118 12/96

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Page 1: ATOMLAB 450 WIPE TEST SYSTEM USER’S MANUALfemale end of the power connector cord plugs in beneath the Hewlett Packard printer and plugs into the side of the printer underneath it

ATOMLAB 450WIPE TEST SYSTEMUSER’S MANUAL(#187-450)

Biodex Medical Systems, Inc. • Brookhaven R & D Plaza • 20 Ramsay Road • Box 702 • Shirley • New York • 11967-0702 • 516-924-9000 • Fax 516-924-9241

FN: 94-118 12/96

Page 2: ATOMLAB 450 WIPE TEST SYSTEM USER’S MANUALfemale end of the power connector cord plugs in beneath the Hewlett Packard printer and plugs into the side of the printer underneath it

IMPORTANT NOTES• Before you use this device, be certain to read the entire manual. Failure to read this

manual may result in user error or inaccurate data.

• This unit uses the Mallinckrodt In-Vitro Kit procedures. In order to use the automaticcalculation functions of the Atomlab system, you must follow exactly the KITdilution and counting procedures. If your facility follows a different procedureand/or uses different dilutions, you must then use the manual mode of the Atomlabsystem. If you try to use the automatic In-Vitro mode using different dilutions, yourresults will not be correct.

• For Wipe Test Mode, the activity shown is NET activity. This means that thebackground count is subtracted from the count before the activity is calculated. Forall other modes, counts shown are the actual counts detected and are not netted forbackground.

• All activities, count values on the sample reports in this manual are for illustrationpurposes only. They do not represent actual study values.

WARRANTYThe ATOMLAB Wipe Test System carries the industry’s best warranty.

Biodex Medical Systems backs this product with a truly comprehensive full one-yearwarranty. It covers both parts and labor, and includes all unit elements. Biodex’s one-year warranty is a sure sign od product quality and dependability.

With this one-year warranty, quality assurance, guaranteed delivery from stock, andresponsive customers service, Biodex Medical Systems gives the nuclear medicine fieldthe right answer…ATOMLAB Wipe Test Systems.

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1. Introduction ............................................................................................................ 1-1

2. Setup Instructions.................................................................................................. 2-1• Components and Parts.......................................................................................... 2-1• Setup Procedure .................................................................................................. 2-1• Power-Up and Self-Test ........................................................................................ 2-3• Computer Preliminaries ...................................................................................... 2-3

3. Administration ...................................................................................................... 3-1• Daily Calibration.................................................................................................. 3-1• Chi-Square .......................................................................................................... 3-3• High Voltage Adjustment.................................................................................... 3-6• Isotope Editing .................................................................................................... 3-6• Isotope Efficiencies ............................................................................................ 3-12• Site Information ................................................................................................ 3-12• Spectrum Analysis.............................................................................................. 3-16• How is ROI Determined? .................................................................................. 3-19

4. Wipe Test ..................................................................................................................4-1• The Wipe Area Setup Page .................................................................................. 4-1• The Wipe Counting Page .................................................................................... 4-1• The Spectrum Analysis Page ................................................................................ 4-3

5. Schilling Measurement ...................................................................................... 5-1• The Schilling Patient Page .................................................................................. 5-1• The Mallinckrodt-Squibb Counting Page ............................................................ 5-1• The Dicopac Counting Page ................................................................................ 5-7

6. In-Vitro .................................................................................................................... 6-1• The In-Vitro Patient Page .................................................................................... 6-1• The IHSA Iodine 125 Test Page .......................................................................... 6-1• The Cr-51 Blood Volume Test Page...................................................................... 6-5• The Red Cell Survival Count for Cr-51 ................................................................ 6-8

7. Manual Operation................................................................................................ 7-1• The Manual Mode Setup Page .............................................................................. 7-1• The Manual Mode Counting Page ........................................................................ 7-3• The Spectrum Analysis Page ................................................................................ 7-3

Appendix A: Geometric and Detector Efficiency .......................................................... A-1Appendix B: Archiving ................................................................................................ B-1Appendix C: Troubleshooting ...................................................................................... C-1Appendix D: Specifications .......................................................................................... D-1Appendix E: Schematics................................................................................................ E-1

TABLE OF CONTENTS

TABLE OF CONTENTS

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1. INTRODUCTION

— 1-1 — INTRODUCTION

The Atomlab 450 Wipe Test System is designed to provide fast, accurate results for Wipe Testing,Schilling Testing using the Mallinckrodt, Squibb or Medi+Physics Dicopac® Schilling kits, and In-Vitrotesting using the Mallinckrodt kits. The system can also be used as a manual mulit-channel analyzer.

The heart of the Atomlab 450 is a microprocessor-controlled 1024 channel Multi-Channel Analyzer,coupled to a 2" x 2" NaI(Tl) well detector and Macintosh interface. The system offers simple, straight-forward operation using 23 pre-programmed isotopes, 50 user-defined radionuclides, and menu-drivenprompts to guide the user step by step through each procedure. The pre-programmed radionuclidesinclude, I-123, I-125, I-131, Co-57, Cr-51, Tc-99m and Cs-137. The user-defined radionuclides also allowfor isotope identification while the printer provides hard copy printouts for patient and departmentrecord keeping.

The Atomlab 450 has a memory of 100 patients, allowing storage of multiple studies on each patient.Additional features include an automatic self-diagnostic program, automatic calibration mode, andautomatic Chi-Square Test. These features help make this the most simple and accurate well systemavailable today.

NOTE: The Well Detector is used for all operations using this device. The Probe Detector, although listed on somescreens as an option, is not available for use with this Wipe Test System.

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SETUP INSTRUCTIONS — 2-1 —

Components and PartsBefore beginning to set up and position your new Atomlab 450 Wipe Test System, check to ensure thatyou have received each of the components and parts ordered. The following list shows all componentscurrently available for the Atomlab 450 system.

• Model #187-450-A100 MCA Unit with Cable (includes mouse)• Model #187-950-E330 HP DeskWriter Printer with cables• Model #187-246 Well Counter• Model #187-950-E350 Qudra 605 MAC CPU• Model #187-950-E240 MAC Keyboard• Model #187-950-E305 Color Monitor• Model #C5010 4' Signal Coax Cable• Model #C5000 4' High Voltage Coax Cable• Model #187-950-E295 Printer Cable

Setup Procedure(See Figure 2-1.)

1. Remove the Macintosh computer and monitor from their packing and place the CPU on the secure, flatsurface where it will be used.

2. Place the monitor on top of the CPU. Connect the monitor signal cable to the back of the CPU at theport directly below the monitor symbol. Secure the connection by tightening the two screw-in cableholders.

3. Make sure both the monitor and CPU are turned OFF. For the CPU, the ON/OFF switch should betoggled towards the 1 and away from the 0 position.

4. Unpack the MCA box and place it next to the CPU.

5. Connect the 9-pin din communications cable connector to the back of the MCA box. Connect theopposite end of this cable to the back of the CPU port directly below the phone symbol.

6. Connect a power cord to the power cord port on the MCA box.

7. Connect a power cord to the CPU.

8. Connect a power cord to the monitor and plug all three cords into an electrical power socket. Confirmthat the CPU, monitor and MCA box are all OFF.

9. Unpack the keyboard and mouse. Connect the mouse cable to the mouse port on the right side of thekeyboard.

10. Connect the partially coiled keyboard cable (with DIN connectors on both ends) by the DIN connectorcloset to the coiled cord on the left side of the keyboard. Connect the opposite end of this cable to theback of the CPU at the port below the keyboard symbol.

11. Unpack the printer and printer power pack and place these on the table next to the CPU. The angledfemale end of the power connector cord plugs in beneath the Hewlett Packard printer and plugs intothe side of the printer underneath it. The male end of the power pack should be plugged into anelectrical outlet.

12. Take the long, straight, printer power cord with DIN connectors on both ends and plug one end intothe underside of the HP printer. Connect the opposite end to the back of the CPU port below the printersymbol.

13. Remove the well counter, and the two cables from their shipping carton. Place the well counter on thecounter next to the computer and MCA.

14. Connect the two well counter cables to the well counter fittings. The larger connector (MHV) should beconnected to the high voltage fittings on the well. The smaller connector (BNC) connects to the wellsignal fittings.

15. Connect the opposit end of each well counter cable to the back of the MCA box. The larger fitting(MHV) connects to the high voltage well fitting on the back of the MCA. The smaller fitting (BNC)connects to the signal port on the MCA.

16. Make sure there is paper in the printer paper tray. Add a stack of paper if needed. The Atomlab 450System is now fully assembled and ready for operation.

Turn the MCA, printer and monitor ON before turning ON the power to the CPU. The system willautomatically power-up once the CPU is turned ON.

2. SETUP INSTRUCTIONS

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1. INTRODUCTION

— 2-2 — SETUP INSTRUCTIONS

Figure 2-1. The Atomlab 450 Wipe Test System.

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Power-Up and Self-Test

At this point, your Atomlab 450 Wipe Test System should be operational. It is recommended that thesystem be turned ON at least one hour before use or, if possible, left on at all times. This will provideoptimum performance and will not effect the longevity of any part or component except the monitor,which should be turned OFF if the Atomlab 450 will not be used for a prolonged period of time.

To Power-up and run the Self-Test:

Turn on all components, including the printer. The system immediately begins a Power ON and Self-Testto ensure all aspects are functioning properly. The Self-Test includes:

• MCA firmware and hardware checks• DAC value verification• Display of software/firmware revisions• Communication link between the MCA and computer

At this point, if the system has yet to be calibrated on this date, a message will be displayed stating that acalibration should be performed. Click <OK>.

The system now prompts the user to click the mouse on <Done> to continue. Select <Done> and thesystem automatically advances to the Main Menu screen (see Figure 2-2). The system is now ready for use.

Computer PreliminariesWindows FormatThe Atomlab 450 is a Macintosh computer based system. All menus and screens function in standardMacintosh windows fashion. Each screen prompts the user, either through screen prompts or icons, as toall available options. As you begin to explore the Atomlab 450 menus, you’ll quickly learn that someoptions are available from every screen, others are offered only on selected screens and some are specificonly to the operation being performed.

Using the MouseWhile numeric “data” is entered into the system by simply typing on the keyboard, options, menus andpages are selected via the mouse. The mouse is simple to use, it responds instantly to all movement bypositioning the screen pointer appropriately. To select any option on the screen, simply use the mouse tolocate the cursor over the desired icon and click the left mouse button. A small clock icon appears overthe selected option icon, indicating that the system is advancing to the selected option. After a second ortwo, the new menu, screen or page appears.

To see how the mouse works, select the <Administration> icon at the bottom right of the Main Menu. TheDaily Calibration page should appear. Now, select the <Main Menu> icon at the bottom right-handcorner of the Daily Calibration page, the system will return to a version of the Main Menu page.

Select the <Administration> icon once again to return to the Daily Calibration page. Notice on left side ofthis page the two triangular icons, one for well and one for probe. Throughout the system, suchtriangular icons function as toggles, i.e., selecting <well> turns OFF the <probe> icon and vice versa.

NOTE: The probe is not available to count with the Atomlab 450 system.

System-Wide IconsNotice the <Page Index> icon at the top right of the Daily Calibration page. This icon is availablethroughout the system. Selecting the <Page Index> icon at any time allows the user to view a listing ofpages associated with the current operation or mode. Position the cursor over this icon while holdingdown the mouse button. A scroll bar displays the page listings, in this case, Calibration, Chi-Square Test,

1. INTRODUCTION

SETUP INSTRUCTIONS — 2-3 —

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CONTENTS

— 2-4 — SETUP INSTRUCTIONS

Figure 2-2. The Main Menu.

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High Voltage Adjustment, Isotope Editing, Isotope Efficiencies, and Site Information. You can now slidethe cursor up or down the bar, highlighting any page you wish to view. When you release the mousebutton, the system advances to the last page highlighted on the scroll bar.

Below the <Page Index> icon is the <Page Turn> icon. This icon looks like a folded page corner. Clickingthe mouse on this icon advances you forward, one page at a time, through the currently selectedoperation.

The <Page Index>, <Page Turn>, <Main Menu> and <Exit> icons are available from every page andmenu throughout the program. Additional icons, such as the <Preferences> icon which allows the user toset such functions as automatic or manual count time, are offered where appropriate.

NOTE: Any prompt or icon that is highlighted with a bold border can be activated by pressing the return key, oryou can move the cursor over the prompt and click the mouse. At some points in the program, the next most logicaland useful selection will appear in bold, although this does not hold for every page.

Setting Date and TimeTo ensure that the correct date and time appear on printed reports it is necessary to set the system clock andcalendar as follows.

1. From any Atomlab 450 screen, press and hold down the <Apple> key located directly to the left ofthe <Space Bar>, followed by the <Back Tic> key located to the left of the <#1> key on the keyboard.The border will disappear and the Macintosh Apple icon will appear at the top left side of the screen.

2. Use the mouse to position the cursor over the Apple icon and hold down the mouse button to revealthe “About the A450” window. Continue to hold down the mouse button while guiding the cursor tothe “Control Panels” prompt. With the Control Panels prompt highlighted, release the mouse buttonto access the Control Panels window.

3. With the Control Panels window displayed, double-click the cursor on the Date and Time icon. Thecurrent computer date and time will now be displayed.

4. To change the Time setting, use the mouse to position the cursor on hour, minutes, seconds, A.M. orP.M., and click the mouse once. The selected Time segment will now be highlighted.

5. With the desired Time segment highlighted, use the mouse to click on either the <Up> or <Down>arrows in the Date and Time window to increase or decrease the time setting appropriately. The sameprocedure is usedto change hours, minutes and seconds. To change the date, follow the sameprocedure, highlighting the segment of the date to be changed, i.e., day, month or year.

6. If you wish to change the Date or Time format, i.e., select between a 12 and 24-hour clock, etc., clickthe mouse on the “Formats” prompt and refer to the Macintosh User’s Guide for more detailedinstruction.

7. Once the Date and Time are set, click the mouse on the Date and Time close icon in the upper leftcorner of the Date and Time window. Now click the mouse on the close icon for the Control Panelswindow to return to the Atomlab 450 screen from which you began.

8. To remove the Apple icon and restore the background border to the Atomlab 450 screen, click themouse on the approximate center of the screen. Now press and hold down the <Apple> key,followed by the <Back Tic> key.

1. INTRODUCTION

SETUP INSTRUCTIONS — 2-5 —

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Before using the Atomlab 450 for counting purposes, it is important that you take a few minutes andprepare the system for operation. The following functions are set from the Administration loop andcontrol the system throughout the different program modes.

• Daily Calibration• Chi-Square Test• High Voltage Adjustment• Isotope Editing• Isotope Efficiencies• Spectrum Analysis (also available for each operation)• Setup Information

Daily Calibration(See Figure 3-1.)

NOTE: The system must be ON for at least one hour before performing a calibration. This will allow time for theunit to warm-up and stabilize.

A daily system calibration must be performed each day the Atomlab 450 is to be used. The system keepsan internal listing of its last calibration date and will not allow measurement procedures to commenceuntil this requirement has been met. Standard calibration may be performed from any operating mode.

For the daily calibration, the user selects the Well detector from the Daily Calibration page then clicks the<Calibrate> icon. The system prompts the user to position the Cs-137 source and click <Calibrate>. Areport, with calibration data and a graph of the spectrum, can then be generated by selecting <Analysis>followed by <Report>. Full width at half maximum (FWHM) is determined by interpolation between thetwo immediate points above and below the 50% value of the spectrum peak on both sides of the peak.The difference between the two interpolated channel values is then divided by the channel of the peakitself and multiplied by 100% to arrive at FWHM. The peak is simply the maximum value in thespectrum.

If desired, you may perform additional calibrations on the same day from within the Administrationmode.

Both the daily calibration and Chi-Square Test are performed using a 10 µCi Cs-137 button source. Oncecalibration is underway, the system’s unique differential spectrometer automatically measures the peakheight and subtracts the baseline which makes zero adjustment obsolete. It does this for 100,000 pulsesand then plots the spectrum in internal memory. The peak channel is located and equated to 662 keV,which is the Cs-137 gamma energy. This gives the spectrometer the keV/channel which is used tocalibrate all the other isotope gains. Each clinical isotope has an ROI defined with lower and upperenergy limits. These energy limits are then converted to channels in the MCA when a particular isotope iscounted. Corrections are made for NaI non-linearity. There is no need to view the spectrum of calibrationor any isotope, though this is available on the monitor display and in hard copy by selecting <Analysis>followed by <Report>.

The multi-channel analyzer in the Atomlab 450 has several fixed precision gains and a regulated highvoltage supply. The pulse shapes are digitized and then processed by a high speed digital signalprocessor. This processing results in a possible 1024 pulse heights which has zero offset. A spectrumresults when a histogram of these pulse heights (channels) is plotted. Calibration of the spectrometer isdefined as knowing the energy equivalence of each channel. This is accomplished by determining the Cs-137 spectrum and then calculating the ratio of the 662 keV/peak channel. After calibration, the reportshould always print a peak value very close to 662 keV (some precision round-off may occur), and thechange in calibration will be reflected in the keV/channel slope value. The fine gain can be thought of as afloating point numerical gain. The HV adjust will ultimately determine the maximum energy one canmeasure on the gain selected. It can be calculated by multiplying the keV/channel times 1024.

3. ADMINISTRATION

— 3-1 — ADMINISTRATION

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CONTENTS

ADMINISTRATION — 3-2 —

Figure 3-1. The Daily Calibration Page.

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To perform a Daily Calibration:1. From the Main Menu select <Administration>. The Daily Calibration screen is displayed on the

monitor.

2. At the Daily Calibration screen select <Well>.

3. Select <Calibrate>.

4. Position the Cs-137 source as instructed by the screen prompt.

5. Select <Calibrate> from the window prompt. The system begins the calibration. Elapsed time, timeremaining and the visible spectrum analysis all show data while counting.

6. If the calibration is successfully completed, the system will prompt the user to select <OK> to save. Ifthe calibration is not acceptable, the prompt will note whether the count rate was too low or too high.You can then make appropriate adjustments and redo the calibration procedure.

Chi-Square(See Figures 3-2 and 3-3.)

As is the case with Daily Calibration, Chi-Square is performed using a 10 µCi Cs-137 button source. TheChi-Square Test is independent of the counting time, counting rate, and number of counts performed. Forthis reason, Chi-Square is a very valuable test for a detector system which is recording truly randomevents. For example, if systematic failure occurs at low counting rates but passes at high rates, there is anindication of a non-random event occurring which is comparable to the low counting rates. Since time isprecise to within 10 microseconds with a crystal controlled clock, 10 second count times should have verylittle error due to the timer itself.

The number of counts performed is 10, which determines the number of degrees of freedom (9) for theanalysis. The lower limit is 4.168, the upper limit is 14.68. These correspond to a 90% probability for passingthe lower limit, and 10% probability for passing the upper limit, respectively. In all, one would expect a 20%failure rate frequency for the Chi-Square test. It is not reasonable to always pass or always fail Chi-Squarewithout raising concerns that there may be a systematic problem in the detector or counter.

To perform Chi-Square:1. From the Main Menu select <Administration>. The Daily Calibration screen is displayed on the

monitor.

2. Select Chi-Square Test from the <Page Index> or use the <Page Turn> icon to call up the Chi-Squarepage.

3. Preform <Chi-Square>.

4. Position the Cs-137 source as instructed by the screen prompt.

5. Select <Chi-Square> from the window prompt. The system begins the Chi-Square test. Elapsed time,samples remaining to be counted, and the visible spectrum analysis all show data while counting.

6. If the Chi-Square calibration is successfully completed, the system will prompt the user to select<OK> to save. If the Chi-Square result is not acceptable, the prompt will note whether it was too highor too low. You can then make appropriate adjustments and redo the procedure.

7. You can now print a Chi-Square report. After clicking on <Report>, the screen displays theannotation screen, allowing the user to enter typed comments and the name of the technologistperforming the test to the report.

1. INTRODUCTION

— 3-3 — ADMINISTRATION

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CONTENTS

ADMINISTRATION — 3-4 —

Figure 3-2. The Chi-Square Page.

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1. INTRODUCTION

— 3-5 — ADMINISTRATION

Figure 3-3. The Chi-Square Report.

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High Voltage Adjustment(See Figure 3-4.)

High Voltage Adjustment should be performed the very first time the system is used, if the system is tobe used in a new environment or in the instance where a substantial change has been made, i.e., whenusing a new tube.

NOTE: The system must be ON and warmed-up prior to setting the high voltage.

To perform a High Voltage Adjustment:1. From the Main Menu select <Administration>. The Daily Calibration screen is displayed on the monitor.

2. Select High Voltage Adjustment from the <Page Index> or use the <Page Turn> icon to call up theHigh Voltage Adjustment page.

3. Select <Adjust>.

4. Position the Cs-137 source as instructed by the screen prompt. You can now cancel or start the H.V.adjustment.

5. Select <Adjust> from the window prompt. The system begins the adjustment, elapsed time and thevisible spectrum analysis show data while counting.

6. If the High Voltage Adjustment is successfully completed, the system will prompt the user to select<OK> to save. If the High Voltage Adjustment is not acceptable, the prompt will note whether thecount was too high or too low. You can then make appropriate adjustments and redo the procedure.

7. If you cancel the H.V. while counting, the system will prompt you to <Cancel> or reposition thesource and press <Adjust> to continue.

Administration Report (See Figure 3-5.)Following Daily Calibration, the user can print an Administration Report showing the High Voltage DACValue, Calibration Factor, FWHM, most recent Chi-Square results, a list of technologists, the personperforming the calibration, and comments. This report can be printed from the Calibration, High Voltage,and Site Information screens using the following procedure.

1. Following Daily Calibration, click on <Report>. The system will display the Annotation Page.

2. Click on the Comments Box and enter any comments desired via the keyboard and/or choose thetechnologist that performed the calibration.

3. Click on the <OK> button to print the report or choose <Cancel> if you do not want a report to beprinted.

Isotope Editing(See Figures 3-6 and 3-7.)

This option allows the user to select and view a preset isotope, add a new isotope to the isotope list, oredit an existing user entered isotope. The Atomlab 450 isotope list comes with 23 preset isotopes. Forthese factory isotopes, Lower Level Discriminator (LLD), Upper Level Discriminator (ULD), regulatoryalarm levels and Gain are factory preset and cannot be changed. For all user entered isotopes, LLD, ULDand Gain can be edited. While this option is active, the currently selected isotope is always highlighted inthe isotope name at the top left of the page.

To Access Isotope Editing: 1. From the Main Menu select <Administration>. The Daily Calibration screen is displayed on the monitor.

CONTENTS

ADMINISTRATION — 3-6 —

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1. INTRODUCTION

— 3-7 — ADMINISTRATION

Figure 3-4. The High Voltage Adjustment Page.

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CONTENTS

ADMINISTRATION — 3-8 —

Figure 3-5. An Administration Report.

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1. INTRODUCTION

— 3-9 — ADMINISTRATION

Figure 3-6. The Isotope Selection screen.

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CONTENTS

ADMINISTRATION — 3-10 —

Figure 3-7. The Isotope Editing Page.

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1. INTRODUCTION

— 3-11 — ADMINISTRATION

2. Select Isotope Editing from the <Page Index> or use the <Page Turn> icon to call up the IsotopeEditing page.

To Select an Isotope:1. Click on the <Select> prompt or use either <Previous> or <Next> to scroll through the isotope list.

2. Use the mouse to position the cursor over any desired isotope and click the left mouse button tohighlight. You can now click on <Select> to choose the highlighted isotope. Once selected, the isotopename, LLD, ULD, regulatory levels, half life and gain setting will show in the isotope information box.

To Add a New Isotope:1. At the Isotope Editing page, click on the <Select> prompt at the bottom left side of the page. The

Isotope Select page is now displayed.

2. Click on <New> and enter the new isotope name via the keyboard. The other information on thescreen is for the previous isotope. You can now use the mouse to advance the cursor through theLLD, ULD, regulatory limit, half life and Gain setting prompts, entering the appropriate values forthe new isotope. When setting the gain, the user is offered a scroll bar with appropriate gain settings.Simply highlight the desired setting to input the gain.

NOTE: If you have displayed an isotope similar to the new one being entered, you need only make changeswhere values are different. You do not need to re-enter all the information on the screen.

3. To save the new isotope to the isotope list, select <Save> and follow the screen prompts. To discardthe new isotope without saving, select <Discard> and proceed as instructed.

NOTE: You must either save or discard to exit the New Isotope loop. Choosing <Cancel> during the save ordiscard process returns the user to the isotope input stage of this operation.

To Delete an Isotope:1. At the Isotope Editing page, use the mouse to position the cursor over the isotope you wish to delete.

Press the left mouse button to select the isotope to delete.

2. The <Delete> button is now active. Select <Delete> at the bottom left side of the page to continue.

3. The system will now ask you to confirm the deletion or cancel without deleting. If you choose todelete, the isotope will be removed from the isotope list. If you choose to cancel without deleting, thesystem will return to the Isotope Selection screen.

NOTE: Only user-entered isotopes can be deleted from the isotope list. The 23 preset isotopes on the list can notbe removed.

To Edit an Isotope:1. At the Isotope Editing page, select the isotope you wish to edit via the <Select>, <Next> or

<Previous> prompts. Move the cursor to the isotope name line. You can now use the keyboard to editany user-entered isotope. Pressing <Tab> on the keyboard advances the cursor to the next line. The23 preset isotopes cannot be edited.

2. To save any isotope editing changes, select <Save> and follow the screen prompts. To discard theediting changes, without saving, select <Discard> then proceed as instructed or choose <Cancel>during the save process to return to the isotope input stage of this operation.

NOTE: You must either save or discard to exit this portion of the Edit Isotope loop.

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Isotope Report (See Figure 3-8.)

A report showing isotope editing and efficiencies information can be printed from either the IsotopeEditing or Isotope Efficiencies Page. Using the <Notes> button, it’s possible to add the technologist nameand comments to the report as previously described.

1. With either isotope screen displayed, click on <Report>.

2. Choose to print all isotopes or only non-factory isotopes. After clicking on the desired option, thereport is printed. To cancel the report without printing, press <Cancel>.

Isotope Efficiencies(See Figure 3-9.)

This page is used for setting the geometric efficiency and detector efficiency for the well for every isotope thatthe system will be counting. It can also be used to provide the decayed activity of a calibrated source. You canenter the efficiency on this page from other calculations or use the Assay portion of Isotope efficiency fordetermining your isotope efficiency with the medical spectrometer system. You must also turn on each specificisotope that you wish to use for wipe testing work. If an isotope is not highlighted for Wipe in the isotopeefficiency screen, it is not an available choice for Wipe Testing. You want to limit the number of isotopes thatyou have turned on to only the isotopes that you actually will be testing or counting for. For each isotope thatis turned on, the system will do a background count in those gains that correspond with that isotope. Thismeans every isotope that is turned on with a different gain lengthens the time it takes to do background.

Setting Geometric Efficiency (See Figure 3-10.)The geometric efficiency for the system is independent of the isotope being used. The geometric efficiencyrefers to the placement of the isotope in relation to the detector.

1. To set well geometric efficiency, click the mouse on the <Well> button. The unit now brings up ageometric efficiency window. Enter in centimeters, the outside diameter of the well and the distancethe activity will be from the well, and the system will automatically calculate the geometric efficiency.

2. If you click on the well button and enter the inside diameter of your well cavity and the source depthin the well in centimeters, the unit once you press the <OK> button, automatically calculates thegeometric efficiency and updates the geometric efficiency screen.

3. You can manually calculate and enter the geometric efficiencies for the well instead of having thesystem calculate them for you. (See the Geometric Efficiency screen and Appendix A for additionalGeometric Efficiency information.)

Detector EfficiencyThe detector efficiency for the well must be entered for each individual isotope. The efficiency is differentbecause the detector sizes are different and each isotope has a different energy and characteristic when itinterfaces with a sodium iodide detector. You can enter the efficiency if it is known by double-clicking on theefficiency box. To calculate the efficiency for an isotope, enter the Assay date and time for that isotope and thenclick on the activity button and enter the unit of measure and the activity for that isotope. Once that is set, clickon the <OK> button and proceed to the <Calculate Efficiency> button. Once you press the calculate efficiencybutton, it tells you to “Prepare for background count,” and press <OK> to start. When it is finished counting for100 seconds, you can accept, discard, or re-start the count. If you accept the count, the screen displays “Preparefor Isotope count” and press <OK>. When you press <OK>, the unit starts counting the isotope that you haveplaced in the probe. It counts for 100 seconds to get enough counts to have a good statistical evaluation. You canstop the count and accept, discard, or re-start along the way, or wait for it to time out, and accept the count.Once you have accepted the count, the detector efficiency that you just counted is updated to the new efficiency.You can display the spectrum analysis for the isotope that you counted and print that if desired.

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ADMINISTRATION — 3-12 —

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Figure 3-8. An Isotope Report.

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ADMINISTRATION — 3-14 —

Figure 3-9. The Isotope Efficiency Page.

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— 3-15 — ADMINISTRATION

Figure 3-10. The Geometric Efficiency Window.

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Site Information (See Figure 3-11.)

The Site Information page is used to record the hospital’s name, address, and phone number, and forlisting the technologists in the department. The hospital name and address prints out on all reports. Atechnologist can be chosen from the list for patient studies or wipe testing. Note that an AdministrationReport may also be printed from this screen as previously described.

To Enter the Hospital Name and Address:1. Double-click on line 1 for the Report Letter Head. Enter the hospital name or facility name here using

the keyboard.

2. After entering the facility name, use the <Tab> key or move the pointer to line 2 and double-click. Proceedto line 3 for continued address. Line 4 can be used for address or for the hospital’s phone number.

3. You must now save the information.

To Add a Technologist to the Technologist List:1. Move the pointer to technologist #1 and enter the name of the technologist using the keyboard.

2. The <Tab> key can be used for moving to other technologists and entering their names as well.

3. When you are finished entering the different technologists names, you can go to the mode select orback to the page index and continue on with other functions.

Spectrum Analysis(See Figure 3-12.)

Spectrum Analysis is available in any operational mode throughout the program. The option allows the userto change the ROI on the display, add additional ROI’s, or print the spectrum with counting information.

The print icon is located at the bottom right of the screen. Located directly below the spectrum display isa set of icons which function as follows:

<OFF>: Used to turn OFF the <SET> and <CLEAR> options.

<SET>: This icon is used to set the left and right channel markers for a selected ROI andoverrides the ROI set automatically by simply selecting an isotope. Use the mouse toposition the pointer at the desired channel and press the left mouse button. The cursorchannel moves to the selected channel. This is the starting place for your region ofinterest. Select the set by clicking the cursor on the <Set> icon. You can now use themouse to position the pointer on the ending channel of the ROI. If you now press theright mouse button, the ROI is set between the start channel and current pointer position.

<CLEAR>: Select this icon to remove any selected channel(s) from the ROI. Place the cursor on the startingchannel and click the left mouse button. Now move the cursor over the <Clear> icon and click.The Clear option is now active. Move the cursor to the ending channel and click the mousebutton to clear all data between the marked channels. You can also clear data at this point byusing the <Left Arrow> or <Right Arrow> icons to remove data one channel at a time.

<CLEAR ENTIRE SPECTRUM>: Select this icon to clear ALL channels in the entire spectrum.

<SET ENTIRE SPECTRUM>: Select this icon to highlight the entire spectrum.

<MOVE 1 CHANNEL LEFT>: Each time you click the left mouse button with the cursor on this icon, thechannel marker moves one channel to the left.

<MOVE 1 CHANNEL RIGHT>: Each time you click the left mouse button with the cursor on this icon,the channel marker moves one channel to the right.

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Figure 3-11. The Site Information Page.

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ADMINISTRATION — 3-18 —

Figure 3-12. A sample Spectrum Analysis Report.

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How is ROI Determined?The preset ROI energy window values do not change as the user switches between modes (i.e., Uptake,Schilling, MCA, etc.). The ROI is defined in units of energy (keV) and then converted to channel numberswith the keV/channel slope value that is measured during calibration. The channel number for the ROIvalues can and will change from probe to well if the calibration keV/channel is different between probeand well.

ExampleTc-99m has a peak energy of 140 keV according to the radionuclide decay scheme. The Atomlab 450 usesa default of +/- 15% energy window around the peak energy. These values calculate to be 119 keV to 162keV and are displayed on the Isotope Editing page. When the well is selected, the ROI channels arecalculated based upon the Cs-137 calibration results for that particular detector. If the calculation of thewell results in a .3775 keV/channel on gain 8, the TC-99m default gain, the channel ROI will be 119keV/.3775 keV channel = channel 315 and 162/.3775 = channel 429. For the well detector, we might have acalibration of .3325 keV/channel. In this case, the ROI channels will calculate channel 358 to 487. Eventhough the ROI channels are different, the energy windows are the same. This will become apparentwhen the spectrum for each detector is printed.

NOTE: It is not necessary to fix a symmetrical percent around the peak. In fact, some isotopes are multi-peaked,which can cause an asymmetric spectrum. Keep in mind that if a calibration is performed you must save the resultin order to have it used in ROI calculations.

If you select an isotope from the Administration Isotope Editing page, the screen will display the isotopename, LLD, ULD, and gain setting (see chart).

Gain Max keV Half Scale1 3000 15002 1500 7504 750 3758 375 18712 250 12548 64 32

A. Lower Level Discriminator (LLD) = 0.85 times the Min keV of interest.B. Upper Level Discriminator (ULD) = 1.15 times the Max keV of interest.

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NOTE: For Wipe Test Mode, the activity shown is NET activity. This means that the background count issubtracted from the count before the activity is calculated. For all other modes, counts shown are the actual countsdetected and are not netted for background.

The Wipe Test is used to determine the DPM of swipes taken in the designated areas of a departmentusing the well counter. A total of 10 swipes may be identified and counted for each area. When wipecounting is completed, a report of the Wipe Test results can be printed out with each test identified by thearea number and result.

There are three Wipe Test Pages from which to choose: Wipe Area Setup, Wipe Count and SpectrumAnalysis.

The Wipe Area Setup Page(See Figure 4-1.)

At this page, the user enters or selects the Wipe Area, Wipe Locations, Available Isotopes, Area Type andTrigger Level as follows. To access the Wipe Area Setup page, select <Wipe Test> from the Main Menu.The Wipe Area Count page is automatically displayed. Turn the page to access the Wipe Area SetupPage.

Wipe AreaThis refers to an area such as a specific camera room, i.e. Camera Room 1. In this area there can exist up toten locations for individual wipes. Locations are entered by name using the keyboard and starting withlocation number 1. Press the <Tab> key to advance to the next location. On the right side of the screen is alist of available isotopes. To add an isotope to what will be counted for a particular area, highlight thedesired isotope with the pointer and click the mouse. Now, click on the <ADD TO AREA> prompt andthe isotope will be moved into the isotopes that are used. If desired, you can now go back and selectanother isotope in the available isotope list. To remove an isotope from the list, highlight the isotope todelete and click on <DELETE FROM AREA>.

NOTE: Only isotopes turned ON for wipe testing in the Isotope Efficiency page, located in the Administrationmode, are available in the wipe isotope list.

Area TypeUse the mouse to toggle between Restricted, Unrestricted or Sealed Source.

Trigger LevelSet the percentage of FDA regulated isotope contamination at which to fail the wipe by holding down themouse button to scroll to the appropriate percentage.

Wipe Area Summary Report (See Figure 4-2.)To generate a printout of the areas and locations for each area, press <Report>. The printed report willshow each area’s name, each location in the area, the isotopes to be counted in each area, and the triggerlevel for that area for each isotope to be counted.

The Wipe Counting Page(See Figure 4-3.)

At this page, the user performs the desired type of count.

1. If desired highlight <Estimated LLD> to take a quick background count and display the lower limitof detection for each active isotope. (If a background count has not been taken on this day, the systemwill force the user to take a background count.)

4. WIPE TEST

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Figure 4-1. The Wipe Area Setup Page.

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NOTE: A minimum of 60 seconds should be used for background counting of each isotope gain.

2. You can click on <COUNT BACKGROUND> to count or re-do the background count at any time.You do not have to wait for the count to become expired.

NOTE: Background is for all areas.

3. Choose the proper area for your wipe. To actually count a wipe, you must highlight one of the wipelocations in your area list. To do this, move the cursor onto the desired location and click the mousebutton. This highlights that location. The <Count Wipe> button is now active.

4. Click on <Count Wipe>. The unit now displays a screen with directions and displays the count time.You can adjust count time for the wipe, if desired, and then click on <COUNT> to count or<CANCEL> to return to the previous menu. If you press COUNT, a screen showing “Counting inProgress, please wait” and a bar graph showing that the unit is counting is displayed. The systemcounts on each gain for an isotope that has been selected for this area. If there are multiple isotopesper area, per gain, it only counts once for each gain.

5. When the unit has finished counting this wipe, it displays the isotopes and shows the level of thecount. There is a dot shown when a location has not been counted, a short line if it’s been countedand if it is acceptable, a check mark when the activity is greater than the lower limit of detection andan exclamation point if the activity is greater than the trigger level. On the right side of the screen isdisplayed activity, background, lower limit of detection and the trigger level. In order to highlightand learn exactly what your readings are, you must move the cursor to one of the isotopes in your listand click the mouse button. When you do this, activity, background, LLD and trigger level aredisplayed in the selected unit of measure for that isotope in this wipe location. The display can bechanged for units of activity by just moving the mouse and clicking on the desired unit of activity inthe activities box, either DPM, Bequerels or Microcuries.

6. If you wish to change from one activity to another, simply move the cursor and click on the desiredunit. The data on the screen will be recalculated in the selected format. If you move the cursor toanother isotope, and click on that isotope, the activity numbers change to correspond to the count forthat isotope.

7. Once you have highlighted a wipe location and an isotope, you can press <COUNT ISOTOPE> tocount for a longer period of time a specific isotope for which you have either a contaminant orpossible contaminant. If you press <COUNT ISOTOPE>, a window is displayed with informationand a previously set count time. You can adjust the count time displayed by double-clicking themouse cursor on the time box. Re-enter the time, press the <COUNT> button, and the system willcount for that period of time.

8. When the system is done counting, it will update the displayed wipe for the proper count. Youwould use this after doing a quick count of the wipe, and having the unit display that there is aproblem with the count level.

Estimate LLDThis button can be used to give a quick count and estimate of the Lower Limit of Detection using theactual counting parameters. By lengthening count times the system will have a better LLD.

The Spectrum Analysis AnalysisIf you want to do a detailed spectrum analysis, you must count an isotope using the COUNT ISOTOPEbutton for a specific wipe before you go to spectrum analysis. If you attempt to do a spectrum analysisbefore you’ve counted an isotope, a window will display advising you of this and you press “OK” tocontinue. The rest of spectrum analysis functions the same way as described previously in this manual.

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— 4-4 — WIPE TEST

Figure 4-2. A Wipe Area Summary Report.

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Also on the wipe counting page, the next and previous arrows can be used to move to other areas thatyou have entered in the system. This will allow you to avoid having to go back to the wipe area Setuppage.

Setup Button (See Figure 4-4.) The Setup button sets the preferences for wipe testing. This can be accessed from either of the screens inthe wipe testing mode. The wipe preferences allow you to:

• Set the detector for the well.

• Set the geometric efficiency for the well by entering a value or clicking on <Geometric Efficiency>and using the calculated values.

• Set the default count times for background, wipe and isotope.• Set report activity units for sealed sources and restricted or unrestricted areas.

Once you have set this information, click on <Okay> to continue or <CANCEL> to go back to the menuwithout making any changes.

Wipe Test Report (See Figure 4-5).After completing your wipe testing a printed report can be generated by choosing <Report>. Commentsmay be added to the report by choosing <Notes> as previously described.

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1. INTRODUCTION

— 4-6 — WIPE TEST

Figure 4-3. The Wipe Area Counting Page.

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WIPE TEST — 4-7 —

Figure 4-4. The Wipe Preference Screen.

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1. INTRODUCTION

— 4-8 — WIPE TEST

Figure 4-5. A Wipe Test Report.

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This mode allows the technologist to use a Squibb, Mallinckrodt or Medi+Physics Schilling kit. A step-by-step procedure for the kit selected guides the user through the test. Upon conclusion of the test, aspecially designed report is printed with the test results plus other useful patient information.

To access the Schilling Measurement mode, at the Main Menu click on the Schilling icon.

There are three pages in the Schilling Mode, the Patient page, the Mallinckrodt-Squibb page, and theDicopac page. The Patient page is used for all operations in this mode. The other two pages are selectedbased on the Schilling kit used.

The Schilling Patient Page(See Figure 5-1.)

From this page the operator can enter new patients or select and edit existing patients. The conventions inthis mode are the same as the previously described modes.

Enter all the patient information on this page, starting with the last name, first name, middle initial andthen an identification number. Remember that the identification number should be unique to this patient.The patient’s address, phone number, a code number (if desired), sex, weight, date of birth, physician andreferring physician can also be entered. Patients entered in other modes are also listed here.

Schillings Preferences SetupBefore advancing onto the Mallinckrodt-Squibb or Dicopac Counting pages for the first time, be sure to setyour preferences by clicking on the Preferences <Setup> icon at the bottom of the screen to access and fill outthe Schilling Preferences window. This window will allow the user to set the default test type, count times,volume and correction factor. Generally, each facility deals with only one type of Schillings Kit. This kit typeshould be selected during Preferences Setup. Selecting <OK> will return the user to the Patient page.

Once the patient data is entered or a patient is chosen from the list of patients, click on the page turn toadvance to either the Mallinckrodt-Squibb or Dicopac Counting page.

The Mallinckrodt-Squibb Counting Page(See Figure 5-2.)

This page is used for all Squibb, Mallinckrodt and Simple Mallinckrodt Schillings Test kits. The values areautomatically set to the default preferences selected for Schilling Setup preferences. As describedpreviously, the <Patient Name> key is used to aid in selecting the correct patient.

NOTE: If there is already count data displayed, you must create a new test by clicking on <Select> then <New>.You can then proceed to the Parameters button and enter Total Volume before counting.

The Parameters Window (See Figure 5-3.)On the Mallinckrodt-Squibb page, the <Parameters> key, positioned slightly above center on the left sideof the page, allows the user to view or change the parameters that will be used for the current SchillingsTest only. Use the <Parameters> key to access the Schillings Paramaters window where you can view orchange kits, select Detector or Well, change count time, enter total volume, change sample volume orchange the correction factor for the current study only. The correction factor is determined by the kitprocedure you use and is defined in the pharmaceutical test procedures.

NOTE: You must enter the Total Volume in the Parameters window before proceeding with the test. If you trycounting before you have entered the total volume, a message will appear to “Enter Total Urine Volume.”

Once all information in the Parameters window is corrrect, click on <OK> to return to the Mallinckrodt-Squibb page.

5. SCHILLING MEASUREMENT

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Figure 5-1. The Schilling Patient Page.

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Figure 5-2. The Mallinckrodt-Squibb Page.

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— 5-4 — SCHILLING MEASUREMENT

Figure 5-3. The Mallinckrodt-Squibb Parameters Window.

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SCHILLING MEASUREMENT — 5-5 —

Schillings Background CountAt this point <Background> should be highlighted on the Mallinckrodt-Squibb page. To perform theBackground count:

1. Clear all sources from the area of the probe.

2. If you have not entered a Total Urine Volume, enter it now in the Parameters section.

3. Click on <Acquire>, prepare for the background count. When ready to count, click <OK> or press<Enter> on the keyboard. The system proceeds to count using the specified count time.

4. If the background count displayed is satisfactory, click on <Accept>. If the background countobtained is not acceptable, click on <Discard> to discard the count or press <Restart> to count againusing the same parameters.

Squibb or Mallinckrodt Schillings Test ProcedureFollowing acceptance of the Background count, the system automatically highlights <Co-57 Standard>.The system is now ready to commence the Schillings count. The procedure for both Squibb andMallinckrodt Schillings test are identical.

1. Click on <Acquire>. Position a Cobalt 57 Standard and click on <OK>. The system will begin counting.

2. If the Co-57 count displayed is satisfactory, click on <Accept>. If the background count obtained isnot acceptable, click on <Discard> to discard the count or click on <Restart> to count again.

3. Upon acceptance of the Co-57 count, the system highlights <Urine Sample>. Click on <Acquire> tocount the urine sample.

4. Position the urine sample and click on <OK>. The system begins counting. If the urine sample countdisplayed is satisfactory, click on <Accept>. If the count obtained is not acceptable, click on<Discard> to discard the count or click on <Restart> to count again.

5. Having accepted the urine sample count, the user is returned to the counting page and the systemdisplays the Schilling value for this test. You can now print a report if you desire by clicking on the<Report> icon.

6. At this point, you may choose to save this study by clicking on the <Save> icon at the bottom of thescreen and following the standard save procedure. A message will appear on the display warningthat if the study is saved, you will not be able to change any functions for this study in the future.Click on <OK> to save the study.

7. To exit the Schilling Test mode, click on the <Mode> icon at the bottom of the screen to return to theMain Menu. To perform another Schilling test on a new patient, click on <Name> near the top of thescreen to access the patient list and continue as explained above.

Performing a Simple Mallinckrodt TestBy choosing Simple Mallinckrodt from the Schillings Parameters Setup or Schillings Preference window,a procedure similar to, but slightly different from the standard Mallinckrodt count is used. In the SimpleMallinckrodt procedure, total volume must still be entered through the Parameters window, but the userwill not be allowed to change the sample volume or correction factor used by the system. These valuesare defined in the instructions for the simple Mallinckrodt test. Counting proceeds in the same manner asfor the Squibb and Mallinckrodt Test Kits, i.e., count the background, followed by the Cobalt 57 Standardand, lastly, the urine sample. When all three counts have been completed and accepted, the systemdisplays the calculated Schilling Measurement.

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— 5-6 — SCHILLING MEASUREMENT

Figure 5-4. The Schillings Report using the Squibb Kit.

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NOTE: Before saving the study, any one of the counts can be redone by highlighting the item to be counted and thenclicking on <Acquire>. Once saved, the study cannot be redone.

Printing a Schillings Report (See Figure 5-4.) To generate a printout of Schillings Test results:

1. Ensure the proper patient and study are displayed.

2. If comments are desired on the report, click on the <Notes> key and use the keyboard to enter theappropriate comments, technologist, activity, administration time, etc.

3. Click on <Report> to print.

The Dicopac Counting Page(See Figures 5-5 and 5-6.)

This page is used for Schilling counts using the Medi-Physics Dicopac kit. It automatically sets to thedefault preferences selected during Schilling Setup on the Patient Page.

Dicopac Preferences are identical to those used in the Mallinckrodt and Squibb test kits, as is theParameters window. As in other Schilling tests, the total volume must be entered through the Parameterswindow before counting can begin.

Performing a Dicopac TestAt this point <Background> should be highlighted on the Dicopac page. To perform a Dicopac Test,complete the following procedure.

1. Clear all sources from the area of the probe.

2. Enter the Total Urine Volume in the Parameters section.

3. Click on <Acquire>, prepare for the background count. When ready to count, click <OK> or press<Enter> on the keyboard. The system proceeds to count, first for Cobalt 57, then for Cobalt 58. Bothcount numbers are then displayed on the screen.

4. If the background counts displayed are satisfactory, click on <Accept>. If the background countsobtained are not acceptable, click on <Discard> to discard the count or press <Restart> to count againusing the same parameters.

5. Following acceptance of the Background counts, the system automatically highlights <Co-58Standard>. Click on <Acquire>, position the Cobalt 58 standard and click on <OK>. The countingspectrum is displayed as the system counts. If the count displayed is satisfactory, click on <Accept>.If the count obtained is not acceptable, click on <Restart> to count again using the same parameters.

6. Once the Cobalt 58 Standard count is accepted, the count number is divided up according to theROI’s for Cobalt 58 at the Cobalt 58 Standard Setting, and for Cobalt 58 at the Cobalt 57 StandardSettings. The system now highlights the Cobalt 57 Standard. Click on <Acquire>, position the Cobalt57 Standard and click <OK>. The system counts Cobalt 57 at the Cobalt 57 window setting.

7. Once again, choose to <Accept>, <Reject> or <Restart> the Cobalt 57 count. Once the Co-57 count isaccepted, the system returns to the Dicopac counting page. <Sample> is now highlighted.

8. Click on <Acquire>, position the urine sample and click on <OK>. The counting spectrum isdisplayed as the system counts the sample. If the count displayed is satisfactory, click on <Accept>. Ifthe count obtained is not acceptable, click on <Restart> to count again using the same parameters.

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9. Upon acceptence, the urine sample counts are divided according to the Cobalt 57 and Cobalt 58settings. The system will now do the calculations and display at the bottom of the screen thepercentage of Cobalt 57 excreted, the percentage of Cobalt 58 excreted and the excretion ratio. Youcan now click on the <Printer> icon to print out a report.

10. To save the study, click the mouse on the <Save> icon at the bottom of the page. Once the study issaved you cannot alter the numbers that you have saved.

11. If desired, click on <Name> at the top left of the screen to bring up another patient and continue onwith another Schillings Test, or click the <Mode> icon on the bottom right of the screen to return tothe Main Menu.

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Figure 5-5. The Dicopac Counting Page.

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Figure 5-6. The Dicopac Report.

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This mode is used for in-vitro testing of patients using the Mallinckrodt Kits and procedures. In the In-Vitro mode, the user can perform Iodine 125 Blood Volume Measurements, Chromium 51 Blood VolumeMeasurements, and Chromium Red Cell Survival testing. All the above tests function with theMallinckrodt Medical Diagnostic Test Kits.

The available pages in the In-vitro testing are patient entry, the IHSA Iodine 125 Test page, theChromium 51 Blood Volume page and the Chromium 51 Red Cell Survival page.

NOTE: If you use different dilutions than the Mallinckrodt Kits, you can not use the automatic In-Vitro mode. Youmust use the manual mode in this case or your results will not be correct.

The In-Vitro Patient Page(See Figure 6-1.)

The standard Patient Page serves as the starting point for the In-Vitro mode. After filling out allappropriate patient data, select the <Preferences Setup> icon to set the system defaults for this mode.

In order to perform actual testing, you need to have a patient selected and entered in the in-vitro patientpage. To do this, either select a patient from the patient list as in any other mode, or enter a new patient tocreate a new study. You do not have to enter a new patient each time this mode is entered. If desired,simply choose a patient that has previously been entered for another type of diagnostic test.

In-Vitro Preferences SetupThe In-Vitro Preferences window allows the user to select the well, set count time, and set the number ofsamples to be taken in a chromium 51 red cell survival test. To change any default setting, double-clickthe mouse on the item to change, then enter the new value using the keyboard number keys.

Once a patient has been selected and all data, including preferences, has been set on the Patient Page,click on the page turn index and select the appropriate page for the test to be performed. An explanationof the the three test pages follows.

The IHSA Iodine 125 Testing Page(See Figures 6-2 and 6-3.)

When you enter the Iodine 125 Test page, confirm that the patient name and I.D.# are correct for thepatient to be tested. If there are any changes needed, click on <Patient Name> to call up the patient listand choose the proper patient.

With the proper patient selected, click on <Parameters> to call up the IHSA 125 Parameters window andconfirm the detector and count time settings. To change the detector, click on the appropriate choice. Tochange count times, double-click on the box for time and enter the new counting time via the keyboard.When the parameters are set to your satisfaction, click on <OK> to return to the ISHA Iodine 125 page.

Performing the IHSA Iodine 125 Test1. After choosing the patient and setting all parameters, on the IHSA Iodine 125 Test page click on <Acquire>.

2. Prepare for the Iodine 125 standard count and press <OK>. The system will start counting. Thespectrum screen will appear allowing the user to stop and discard the count if desired, or repositionand restart the count. When counting is complete press <Accept> to accept the data displayed.

3. After accepting the standard count, the <Whole Blood> is highlighted on the screen. Click <Acquire>,prepare for the whole blood count and click on <OK> to begin counting. You can stop the wholeblood count and discard it at any time during the count or restart if you need to reposition thesample. When the count time has stopped, press <Accept> to accept the count.

6. IN-VITRO

IN-VITRO — 6-1 —

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1. INTRODUCTION

— 6-2 — IN-VITRO

Figure 6-1. The In-Vitro Patient Page.

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CONTENTS

IN-VITRO — 6-3 —

Figure 6-2. The IHSA I-125 Test Page.

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1. INTRODUCTION

— 6-4 — IN-VITRO

Figure 6-3. An IHSA I-125 Test Report.

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4. After accepting the whole blood count, <Plasma> is highlighted. Click on <Acquire>, prepare for theplasma count and press <OK> to begin the count. Again, you can stop and discard the count at anytime, or reposition and restart the count. When the count is done and acceptable, select <Accept>.

5. After accepting the plasma count, <Background> is highlighted. Click on <Acquire>, clear allsources, and prepare for the background count. Click on <OK> to begin counting. The system willnow count background and display the spectrum while it is counting. Stop and discard the count orrestart the count at any time if you desire. When the background count is complete, click on<Accept>. The system will display the calculated plasma volume, red cell volume, whole bloodvolume and radioactive hematocrit. The calculations are done using the formulas listed in theMallinckrodt Test Kit insert.

NOTE: If any of the counts are incorrect, thus causing the calculated plasma volume to be greater than thewhole blood volume, a message will appear on the screen. Click on <OK> to advance beyond this message. Ifthere is a problem that the user sees with any count, highlight the item that needs to be recounted by clicking onit and then either clear that count using the <Clear> followed by <Acquire> to recount, or just click on<Acquire> then recount the parameter.

6. Use the <Notes> button to add the Technologist name, comments and administration time to thestudy.

7. To print a hard-copy report, click on <Report>. It takes a few seconds for the report information to besent off to the spooler. Once the report data is spooled, you can proceed on with any other function.

8. To save the study, click the <Save> icon at the bottom of the page and proceed in the standardmanner. If you choose to save, a message will appear warning that since the results have beencalculated this record cannot be altered once it is saved. Click on <OK> if you still want to save thestudy to the hard drive. You can now proceed and take a new study by clicking on <Select> followedby <New>, turn the page and do a different test with the system in In-Vitro mode, or click the<Mode> icon to return to the Main Menu. If you turn the page and select the Chromium 51 BloodVolume page, you can now do tests with Cr-51.

The Cr-51 Blood Volume Test Page(See Figures 6-4 and 6-5.)

When you enter the Cr-51 Blood Volume Test Page, confirm that the patient name and I.D.# are correctfor the patient to be tested. If there are any changes needed, click on <Patient Name> to call up thepatient list and choose the proper patient.

With the proper patient selected, click on <Parameters> to call up the Cr-51 Blood Volume Parameterswindow and confirm the detector, count time, % Patient Hematocrit and % RBC Suspension Hematocritlevels. To change the detector, click on the appropriate choice. To change count times or hematocritsettings, double-click on the appropriate label and use the keyboard to make your entry.

When the parameters are set to your satisfaction, click on <OK> to return to the Cr-51 Blood Volumepage.

NOTE: You must enter a patient hematocrit and a red blood cell (RBC) suspension hematocrit in order to do the test.

Performing the Cr-51 Blood Volume Test1. On the Cr-51 Blood Volume page, ensure that <Whole Blood Std> is highlighted on the screen. Click

<Acquire>, prepare for the whole blood count and press <OK> to begin counting. You can stop thewhole blood count and discard it at any time during the count or restart if you need to reposition thesample. When the count time has stopped, click on <Accept> to accept the count.

CONTENTS

IN-VITRO — 6-5 —

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1. INTRODUCTION

— 6-6 — IN-VITRO

Figure 6-4. The Cr-51 Blood Volume Test Page.

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CONTENTS

IN-VITRO — 6-7 —

Figure 6-5. A Cr-51 Volume Test Report.

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2. After accepting the whole blood count, <Plasma Std> is highlighted. Click <Acquire>, prepare for theplasma count and press <OK> to begin the count. Again, you can stop and discard the count at anytime, or reposition and restart the count. When the count is done and acceptable, click on <Accept>.

3. After accepting the plasma count, <Whole Blood Sample> is highlighted. Press <Acquire>, preparefor the count and press <OK> to begin counting. Stop and discard the count at any time, or repositionand restart the count if desired. When the count is done and acceptable, click on <Accept>.

4. <Plasma Sample> should now be highlighted. Press <Acquire>, prepare for the count and press<OK> to begin counting. Stop and discard the count at any time, or reposition and restart the count ifdesired. When the count is done and acceptable, click on <Accept>.

5. Following acceptance of the plasma count, <Background> is highlighted. Click on <Acquire>, clearall sources from the area and prepare for the background count. Press <OK> to begin counting. Oncethe background count is accepted, the system calculates red cell volume, whole blood volume andplasma volume and displays these values on the screen.

NOTE: If the counts are not in a logical relationship (such as the background count being greater than astandard count), a message to this effect will display on the screen and prompt you to recount any one of thecounts you have previously taken.

6. Use the <Notes> button to add the Technologist name, comments and the administration time to thestudy.

7. To print a hard-copy report, click on <Report>. It takes a few seconds for the report information to besent off to the spooler. Once the report data is spooled, you can proceed on with any other function.You can also print out immediately after saving any study.

8. To save the study, click the <Save> icon at the bottom of the page and proceed in the standardmanner. If you choose to save, a message will appear warning that since the results have beencalculated this record cannot be altered once it is saved. Click on <OK> if you still want to save thestudy to the hard drive. You can now proceed and take a new study by clicking <Select> followed by<New>. Turn the page and do a different test with the system in In-Vitro mode, or click the <Mode>icon to return to the Main Menu.

The Red Cell Survival Count for Chromium 51Upon entering the Red Cell Survival Counting page, there is a patient displayed in the upper left-handcorner. If you do not wish to count this patient, then click on <Patient Name> to call up the patient list.You can now choose a patient from the existing menu list. If you need to enter a new patient, return to thePatient page and use the <Select> icon at the bottom of the screen. After entering the patient, return to theCr-51 Red Cell Survival page.

With the proper patient selected on the Cr-51 Red Cell Survival page, click on <Parameters>. The Cr-51Red Cell Parameters Window is displayed. Confirm the detector type, count time in seconds, and numberof samples. To change the detector, click on the appropriate choice. To change count times or number ofsamples, double-click on the appropriate label and use the keyboard to make your entry.

When the parameters are set to your satisfaction, click on <OK> to return to the Red Cell SurvivalCounting page.

Performing the Red Cell Survival Count (See Figures 6-6 and 6-7.)1. At this point, <Background> should be highlighted on the Red Cell Survival page. Click on

<Acquire>, clear all sources, prepare for the background count and press <OK> to begin counting.

1. INTRODUCTION

— 6-8 — IN-VITRO

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You can stop the background count and discard it at any time during the count or restart if you needto reposition the sample. When the count time has stopped, click on <Accept> to accept the count.

2. After accepting the background count, <24 Hour Sample> is highlighted. Press <Acquire> andprepare to count the sample. There should now be two boxes displayed on the screen: one is thesample hematocrit in which you must enter a hematocrit value. In order to enter a hematocrit value,double-click on the box and then enter the number via the keyboard. In the other box, the SampleDay is noted as being “one” at all times for the 24 hour test. You cannot change the sample daysetting. Once satisfied with all settings, press <OK>. (You could also cancel at this time if desired.)The unit now starts counting and displays the counting spectrum while it counts. If desired, you maystop and discard the count at any time, or reposition and restart the count. When the count iscomplete and acceptable, click on <Accept>.

3. The screen now highlights <Sample #2>. Press <Acquire> and prepare to count sample #2. (First besure to change the sample hematocrit if it has changed and be sure to enter the Sample Day. The dayis important because this is used for plotting out results. Double-click on the sample day and thenenter the day.) Press <OK> to begin counting. The system now starts counting and the spectrumscreen is displayed. You can stop it, discard, restart or accept the count. If you accept the count, thescreen advances to sample #3.

4. With sample #3 highlighted, press <Acquire> and the count parameters are displayed for the thirdsample. Adjust the hematocrit if it has changed and double-click on the sample day box and enter theday that this was drawn. When the parameters are correct, press the <OK> key and the system willstart counting. When it counts the display shows the counting spectrum. You can stop it, discard,restart or accept when done. If you accept the count, then the unit advances to count #4.

5. The exact same procedure is used to complete all the remaining samples. If there are 20 samples, theuser would continue on as each sample is highlighted. This system exactly follows the MallinckrodtTest Kit insert.

6. Once all samples have been counted, click on <Results> for a display of graphical results for the Cr-51Red Cell Survival Test. If the results are acceptable, you can save the study, then print a report of thechromium 51 red cell survival test. Use the <Notes> button to add the technologist name, commentsand administration time to the study before pressing <Report>. You can now perform other in-vitrotests if desired by creating and selecting a new patient, turning the page and going back to one of theother tests, or clicking on the <Mode> icon to return to the Main Menu.

CONTENTS

IN-VITRO — 6-9 —

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1. INTRODUCTION

— 6-10 — IN-VITRO

Figure 6-6. The Cr-51 Red Cell Survival Test Page.

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CONTENTS

IN-VITRO — 6-11 —

Figure 6-7. A Cr-51 Survival Test Report.

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The MCA Manual mode is used as a rate counter that functions in either a preset time, preset count orcontinuous counting mode. You can press Spectrum for any count that you take in this mode and createreports from the data obtained. The standard ROI is determined by the isotope that you are counting andthe spectrum analysis page will allow you to create multiple ROI’s or change the ROI displayed. From themanual mode Setup page you can set a title and select the isotope to be counted.

The Manual Mode Setup Page(See Figure 7-1.)

Manual Operation:This is the first page that appears after the user selects <Manual Mode> from the Main Menu. It is herethat paramters for the count to be taken are entered. Prior to setting the count parameters, however, youshould set the defaults on the Manual Mode Setup page to match your normal counting preferences withthe following procedure.

To Set Manual Mode Defaults:1. Click on the <Setup> prompt at the bottom right side of the Manual Mode Setup page.

2. Select Preset Time, Preset Counts or Continuous Counts as the default settings.

3. Set the default time, counts, isotope and detector.

You may now proceed to count by Preset Time, Preset Counts or Continuous Counting.

To Count by Preset Time1. Use the mouse to select the Title field for the count to be taken and type in the name of this specific

count. If the isotope is unknown, type in a Custom Isotope title.

2. If desired, choose a different isotope for the Isotope Name field by selecting a new isotope from theisotope list at the bottom left of the page. You may also edit the Gain, LLD and ULD settings. Use themouse and scroll function to dial in the appropriate gain for the isotope selected. For an unknownisotope, be sure to set a wide window.

3. Click the mouse on <Preset Time>. You can now accept the current preset time or enter a new presettime value.

4. Select the well detector then select the Manual Mode Counting page from the <Page Index> tocontinue.

To Count by Preset Counts1. Use the mouse to select the Title field for the count to be taken and type in the name of this specific

count. If the isotope is unknown, type in a Custom Isotope title.

2. If desired, choose a different isotope for the Isotope Name field by selecting a new isotope from theisotope list at the bottom left of the page. You may also edit the Gain, LLD and ULD settings. Use themouse and scroll function to dial in the appropriate gain for the isotope selected. For an unknownisotope, be sure to set a wide window.

3. Click the mouse on <Preset Counts>. You can now accept the current preset counts entry or enter anew preset count value.

4. Select the well detector then select the Manual Mode Counting page from the <Page Index> tocontinue.

7. MANUAL OPERATION

— 7-1 — MANUAL OPERATION

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CONTENTS

MANUAL OPERATION — 7-2 —

Figure 7-1. The Manual Mode Setup Page.

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To Count by Continuous Counting1. Use the mouse to select the Title field for the count to be taken and type in the name of this specific

count. If the isotope is unknown, type in a Custom Isotope title.

2. If desired, choose a different isotope for the Isotope Name field by selecting a new isotope from theisotope list at the bottom left of the page. You may also edit the Gain, LLD and ULD settings. Use themouse and scroll function to dial in the appropriate gain for the isotope selected. For an unknownisotope, be sure to set a wide window.

3. Click the mouse on <Continuous Counting>.

4. Select the well detector then select the Manual Mode Counting page from the <Page Index> tocontinue.

Manual Mode Counting Page(See Figure 7-2.)

It is from this page that manual counts are performed. Count data, including Elapsed Time, ROI Counts,and ROI Rate are displayed immediately under the Spectrum Window while a list of reports is offered inthe Report Box at the right of the screen. Counts are performed based on Preset Time, Preset Counts orContinuous Counting as selected on the Manual Mode Setup page.

To Begin a Manual Mode Count1. Select <Start Counting> at the bottom left of the page. The count begins, based on the Preset Time,

Preset Counts or Continuous Counting parameters selected on the Manual Mode Setup page. ElapsedTime, ROI Counts and ROI Rate are displayed directly beneath the Spectrum Window.

2. When the count is finished, select <Add Count To Report> to add the count to the Report List. Todiscard the count, or stop the count at any time and remove all count data, select <Clear Count>.

3. For review and comparison, the Report Box at the right of the screen offers the user the opportunityto view data on any listed count. You may remove any count from the list by highlighting the countand selecting <Delete From List>. To clear all counts from the list, select <Clear List>.

To Print the Manual Mode Report1. Click on the <Report> button. (There must be at least one item in the list to print.)

2. After clicking on <Report>, a screen is displayed on which the user can enter the technologist andcomments. Press <OK> after entering this information and the report will begin printing.

The Spectrum Analysis Page(See Figure 7-3.)

Spectrum Analysis functions as explained previously in Chapter 3, Administration.

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— 7-3 — MANUAL OPERATION

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CONTENTS

MANUAL OPERATION — 7-4 —

Figure 7-2. The Manual Mode Counting Page.

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1. INTRODUCTION

— 7-5 — MANUAL OPERATION

Figure 7-3. The Manual Mode Spectrum Analysis Page.

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ISOTOPE EFFICIENCY CALCULATION

A. Geometric Efficiency (G.E.)The value for Geometric Efficiency (G.E.) is calculated from the following equations for a well and probe:

WELL:

I.D. = Inner diameter of the well openingX = Depth into the well, measured from the top surface

Example: The Biodex Nal well dimensions have an I.D. = 0.75 inches and a well depth of 1.432 inches.When the wipe (or calibration source) is placed in the well, the isotope emitting radiation will not be atthe very bottom. If we take the isotope position to be 1 inch from the top, then G.E. = 96.82%. (For X = 1.25 inches deep, G.E. = 97.89%For X = 0.75 inches deep, G.E. = 94.72%, which are +1.07% and -2.1% respectively, from 1 inch.)

PROBE:

O.D. = Outer diameter of the probeX = Distance from the probe

Example: The Biodex Nal probe O.D. = 1.75 inches. When the wipe (or calibration source) is placed 1/2inch from the probe, then G.E. = 25.2%. (For X = 0.25, G.E. = 36.3%For X= 0.75, G.E. = 17.4%, which are +11.1% and -7.6% respectively, from 1/2 inch.)

From these two examples, you can see that the well is at least 4 to 5 times more efficient for wipe testcounting than the probe and is less dependent upon wipe positioning errors.

B. Detector Efficiency (D.E.)D.E. can be calculated theoretically from system parameters or can be empirically determined bymeasuring the count rate from a known activity of each isotope. The empirical method results in acomposite value (G.E. * D.E.) which can be reduced to D.E. by dividing by the calculated value for G.E.Only the empirical method will be discussed below. The theoretical (analytic) method is discussed (ItemE) following an example calculation.

C. Efficiency Values for Wipe TestingAll isotopes for which wipes are to be counted shall either be prepared from a known liquidconcentration or if possible, a standard source can be purchased in a wand form from variousmanufacturers. Generally, the isotopes Cs-137, Co-57, Co-60, Ba-133, and Am-241 are available in wand form with a stated activity anduncertainty. The activity should be kept in the range of 0.01 to 0.1 µCi, and should not exceed 0.2 µCi.This will generally keep the overall counting rate below 10,000 cps and will eliminate any spectrumdistortion or non-linearity from playing a role in the efficiency calculation.

APPENDIX A

APPENDIX A — A-1 —

G.E. WELL =1/2 1+ 1 * 100%

1+ ID2

2X

12

G.E. PROBE =1/2 1- 1 * 100%

1+ OD2

2X

12

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A suggested procedure for source preparation is outlined on the next page. The liquid source will bedeposited on an absorbent material in the bottom of a plastic vial which fits inside the well. It isrecommended that no more than 10 ul of liquid be dispensed in order to reduce spilling radioactive material.

NOTE: If a probe is being tested for efficiency, a method for holding the source or vial in proximity of the probe,approximately one (1) cm, must be arranged and then the following procedure followed with modification as needed.If a greater distance is used then you must increase activity according to the inverse square law.

Source Preparation:1. Prepare an activity of 0.1 to 0.01 mCi of the isotope in 10.0 ml of saline. This will result in a

concentration of approximately 0.01 to 0.001 mCi/ml. The volume should be either controlled as closeas possible to 10.0 ml or precisely measured.

2. Assay the activity in the vial in a dose calibrator which has a resolution of 0.01 µCi. Compensate forbackground before making the measurement. Record the time of measurement.

3. Calculate concentration by dividing the measured activity by the source volume and record with thetime of measurement.

4. Prepare the vial with absorbent material (such as a portion of a wipe pad or the end of a Q-tip) at thebottom of the vial.

5. Draw off 10 ul of source material and carefully place the end of the syringe tip at the bottom of thevial. Deposit all of the source material onto the absorbent material.

6. Withdraw the syringe and immediately rinse it in saline at least ten (10) times. This will reduce thechance of contamination of the next source which will be a different isotope.

7. Record the activity in the test vial as AXx-123 at the time T is recorded in step 2. (The Xx-123subscript is meant to designate the isotope symbol which should be recorded, i.e., Am-241.)

NOTE: A tuberculin syringe is not suitable in this procedure. Hamilton microliter syringe, model 701-N, has acapacity of 10 ul with 0.2 ul resolution and will provide the necessary precision. Hamilton Co., P.O. Box10030, Reno, Nevada, 89520. Phone: 800-648-5950.

After the source preparation, the efficiency can be measured by counting the source in the AdministrationMode “Isotope Efficiency” page of the Atomlab 950.

D. Efficiency Measurement1. Make sure the Atomlab 950 has a current Cs-137 calibration.

2. Then go to the “Isotope Efficiency” page. Use the arrow keys <previous> or <next> to display theisotope you wish to set the efficiency for.

3. Set the Geometric Efficiency using the buttons near the top right of the display. (See AdministrationMode in manual for directions.)

4. At the top left of the screen is an isotope activity calculator. Enter the source calibration time andactivity. If you press <Show Current Activity> button, the unit displays the calculated decayedactivity of the standard you created.

5. Now near the bottom of the display screen, click the mouse on the <well>.

1. INTRODUCTION

— A-2 — APPENDIX A

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6. Perform an automatic 100 second background count with an empty well by clicking on the <CalculateEfficiency> button to the right of the displayed detector efficiency values.

7. When the background count is completed, if you wish to manually calculate detector efficiency,record the counts in the ROI as (B). The display will direct you to place the standard into the well andpress <Adjust>. The system will now perform an automatic 100 second count on your preparedstandard. The system displays the spectrum as it counts.

NOTE: The A950 system will automatically record and calculate for you.

8. If you wish to manually calculate the efficiency, record the counts in the ROI as (S). (Proceed withstep 10 for Manual Calculation.)

9. Click the mouse on Accept and the system will automatically calculate and display the isotopedetector efficiency.

NOTE: Total efficiency is a combination of the geometric and detector efficiencies.

10. Calculate the composite efficiencies D.E. * G.E. using one of the following equations:

S and B are defined in steps 7 and 8 under Efficiency Measurement.

A is the activity determined in step 7 under Source Preparation for isotope Xx-123 with units ofmicrocuries.

Exponent of “2”:This is a decay correction. For short lived isotopes such as Tc-99m, it is important. For long livedisotopes such as I-125, it may not be important unless the source is saved for future efficiencychecks.

T1/2 is the half life of isotope Xx-123, in units of H, days, etc.

T and t are respectively the time of source measurement in the dose calibrator and the same ofcounting the source in the well detector. Both should have the same units as T1/2. For example:If T = 08:31 h and t = 15:49 h, then T - t = -7.300 h. If T1/2 = 3.261 days for Ga-67, then T - t should be converted to days = -0.3041 days. In this case,the decay result would be 0.937.

CONTENTS

APPENDIX A — A-3 —

(S - B) counts

D.E. * G.E. =100 sec

* 100%

AµCi * 37000dps/µCi * 2(T-t)T1/2

(S - B) counts

D.E. * G.E. =100 sec

* 100%current activity displayed

OR

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11. Calculate D.E. from the composite (D.E. * G.E.) found in step 10 above and from the calculated valueof G.E. found earlier in the discussion on GEOMETRIC EFFICIENCY. The following equation definesthe calculation.

Note that the two terms (D.E. * G.E.) and G.E. are both calculated as percents in the earlierexpressions and the above result preserves D.E. as a percentage.

Example Calculation:Determine the detector efficiency of Am-241 in a well detector with an opening of 0.625 inches and thesource located in the well at 1 inch below the surface.

Geometric Efficiency for a Well: I.D. = 0.625 inchesX - 1.00 inch

G.E. = 97.7% (see earlier example)

Detector Efficiency for Am-241: A = 0.095 µCi @ T = 8/15/84T1/2 = 432.2 t = 5/1/93 (date counted in well)

Am-241 was programmed for gain of 12 and an ROI of 50 to 69 keV.100 second counts resulted in the following:

S = 99,403B = 83

Now calculate the individual parts of the equation for (D.E. * G.E.)

Count rate = (S-B)/100 s = 993 cps

Disintegration rate = A µCi * 37000 dps/µCi = 3515 dpm

Decay Correction = 2 (T-t)T1/2 = 2 (84.71 y - 93.42 y)/432.2 y = 0.986

D.E. * G.E. = 0.286 * 100% = 28.6%

D.E. = {(D.E. * G.E.)/G.E.} * 100% = (28.6/97.7) * 100 = 29.3%

We should now check our result for common sense. The photon emission from Am-241 are 59.5 keV at35.9% intensity and 26.3 keV at 2.4% intensity. The interaction probability for a 60 keV photon is veryhigh in the Nal well detector (Nal thickness on sides and bottom is about 0.625 inches), the bulk of thisinteraction will be photoelectric which puts most of the counts recorded in the photo peak. The ROI is setto integrate the photo peak of 59.5 keV. Therefore, we would expect a detector efficiency to be a little lessthan photon intensity at 59.5 keV which it is.

Example of a Well Compared to a Probe for Counting EfficiencyIf we assume the following parameters:

Isotope: Cs-137

D.E. Probe: 9.86%

— A-4 — APPENDIX A

D.E. = (G.E. * D.E.) * 100%G.E.

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D.E. Well: 13.47%

G.E. Well: 96.816% for a source placed 2.54 cm deep in the wellG.E. Probe: 0.278% for a source placed 21 cm in front of the probe

Probe: D.E. * G.E. = 9.86% * 0.278% = .02741%

Well: D.E. * G.E. = 13.47% * 96.816% = 13.04%

A.) If the detector counts 54 cpm that is equivalent to the following dpm for the parameters listedabove.

Probe: 54 cpm/.02741% = 197,008 dpm

Well: 54 cpm/13.04% = 414 dpm

E. Analytically Determined (Theoretical) Detector EfficienciesThe following table of 25 isotopes contains analytically determined efficiency values for use with thisinstrument. Stated with the efficiency value is lower and upper region of interest for which the efficiencyis valid. In the wipe test program, these ROI’s are fixed and cannot be adjusted. Therefore, theseefficiency values may be used in the wipe test program of this instrument instead of empiricallydetermining the efficiency for each isotope.

NOTE: It is recommended that you empirically determine the detector efficiency of your system, the analyticallydetermined values are approximations.

The detector efficiency “D.E.” is a composite number which allows conversion from detector counts todisintegrations for a given isotope. Three factors affect it:

1. The photon intensity in the isotope decay scheme defines the number of photons which are emittedper 100 disintegrations of the isotope. This number can be less than or greater than 100% as exhibitedby Cr-51 (~10%) and Co-60 (~200%). The photon energy and percent abundance in the decay schemecan be found in “Table of Radioactive Isotopes” by Edgardo Browne and Richard B. Firestone, pubJohn Wiley & Sons, 1986, ISBN 0-471-84909-X.

2. The photon interaction in the detector will produce counts which integrate to a fraction of the totalnumber of photons passing through the detector. This will always be less than 100% and will dependupon the window thickness which the photon detector must pass through, detector crystal geometryand the photon energy. This photon interaction has been calculated using “Nal (TL)SCINTILLATION DETECTORS”, published by Bicron, manufacturer of the probe and well detectors.This publication contains two sets of curves which were used in the calculation of detector efficiency:Figure 14 “Absorption Efficiency of Nal (TL)” for various thicknesses of Nal, and Figure 17 “X-Rayand Gamma Transmission Through Bicron Detector Windows” for various window thicknesses.

3. The ROI setting in the MCA determines the fraction of the MCA counts which are accumulated.Normally the ROI is adjusted around the photo peak, however, there can be several photon energieswhich are not included in this ROI because they may have a low emission intensity or their energiesmay cover a range too broad to be practical for background subtraction. The photo peak contributionto the photon calculation in the Nal crystal was calculated using “GAMMA-RAY ABSORPTIONCOEFFICIENTS FOR ELEMENTS 1 THROUGH 100 DERIVED FROM THE THEORETICALVALUES OF THE NATIONAL BUREAU OF STANDARDS”, published by Los Alamos ScientificLaboratory of the University of California, Los Alamos, New Mexico, Pub # LA-2237.

CONTENTS — 1-1 —

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The Detector Efficiency (D.E.) has been calculated for both probe and well detectors. There is a differencebecause the photon path length through the Nal detector is different in the two detector configurations.There are some isotopes that the well efficiency has not been analytically determined due to gamma raysumming in the well. You must use the empirical method for these isotopes. You may have to create acustom version of the isotope with a different ROI to properly count the isotope in the well.

Analytically Determined Detector Efficiencies

Please refer to this table below for Analytically Determined Detector Efficiency (%) settings on thefollowing Atomlab products: Thyroid Uptake Models 930 and 950, Wipe Test Counter Model 450.

Probe WellIsotope Left-ROI Right-ROI Efficiency Efficiency

Na-24 1162 3167 3.7 ——

K-42 1296 1754 0.4 0.9

Cr-51 272 368 4.5 6.7

Co-57 103 158 92.8 93.8

Co-58 434 933 12.8 ——

Co-60 997 1533 6.9 ——

Fe-59 934 1486 3.8 7.7

Ga-67 79 345 66.7 ——

Se-75 102 461 126.8 ——

Sr-85 437 591 18.2 32.6

Tc-99m 119 162 82.3 84.3

Pd-103 17 27 62.3 62.3

In-111 145 281 138.7 163.4

I-123 134 183 75.4 79.5

I-125 23 41 133.5 133.5

I-131 309 420 30.1 47.4

Ba-133 256 410 40.0 ——

Cs-137 561 761 9.7 18.2

Yb-169 41 228 306.0 ——

Ir-192 250 703 81.9 ——

Hg-197 56 90 89.1 89.1

Hg-203 237 322 44.8 62.8

Ti-201 57 96 93.2 ——

Au-198 349 474 28.0 46.4

Am-241 50 69 35.7 35.7

NOTE: It is recommended that users use the Empirical testing procedures for setting detector efficiency.

— 1-1 — INTRODUCTION

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APPENDIX B — B-1 —

ARCHIVING

While computer systems today are very reliable, problems can still occur. Defects in manufacturing,physical catastrophes and plain bad luck can lead to a situation where the patient and clinical data storedon the hard drive of your computer can become unusable. For this reason it is a good idea to makeperiodic backups of the database that is maintained by the Atomlab 450.

The frequency of your backups is largely determined by the pattern with which you use the system.Choose a frequency that balances the risk of losing work that you have done with the time and effort ittakes to perform the backup.

Entering Archive ModeThe Atomlab 450 provides backup services through a separate mode of the product. Unlike the othermodes, the Archiving mode is not reached by pressing a mode button on the main menu or the modeswitching screen. Rather, the archive mode is reached through the Atomlab Macintosh File menu which isgenerally hidden behind the Atomlab 450 background.

To gain access to the Archive mode you must first gain access to the Atomlab 450 menu bar. To do this,press and hold down simultaneously the Apple button (located on the keyboard to the left of the spacekey) and the <Back Tic> button (located immediately to the left of the <1> key on the Keyboard). Onceyou do this, the program background will disappear and you will be able to make a selection from theFile menu. Move the mouse over “File”, press and hold the mouse button and move to the Archiveselection, then let go of the mouse button.

The Database Management Page (See Figure B-1.)There is only one page in the Archive mode. This page is used both to backup the entire database and todelete patients from the database.

At the top of the Management page you are presented with a subset of the information that is stored foreach patient (the Patient Name, ID, code and whether the patient is an employee or not). The patientrecords may be viewed on this page in the same way that they can be viewed in the other modes of theprogram (with the next, previous, and select buttons). You cannot, however, make changes to thedisplayed information.

To the right of the patient information are two buttons that you can use to operate on the displayedpatient.

The first button, <Show Tests>, will cause a dialog box to be displayed which shows the number of eachstyle of test that the Atomlab 450 has stored that are associated with the displayed patient. Thisinformation is also displayed on the patient report that can be printed for each patient.

The second button, <Delete Patient and Tests>, allows you to delete the patient and all of the tests andnotes associated with the patient from the database. When you press this button, you will be asked toconfirm that you wish to delete the patient and associated tests. If you press <OK> the operation will beperformed. You can press <Cancel> to return to the Database Management session.

Generally speaking, it is a good idea to make a backup of the database before you delete a set of patients.This way if any patients are deleted by mistake, it is possible to recover them by restoring the backup.

Database BackupThe Database Backup portion of the Database Management page provides a mechanism whereby theentire database can be backed up for safekeeping. There are 4 buttons that are used to provide theseservices.

APPENDIX B

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— B-2 — APPENDIX B

CONTENTS

Figure B-1. The Database Management Page.

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APPENDIX B — B-3 —

Duplicate DatabasePressing this button will cause a copy to be made of the current database. This copy is stored on the harddrive. Making such a backup is less secure than backing the database up to floppy diskettes since a harddrive failure will make the duplicate as inaccessible as the database itself.

This form of backup can be useful, however, if you simply want to check point the database beforemaking a series of deletions — if something goes wrong and you wish to “start over” you can restore theduplicate. The duplicate is also useful if you wish to “temporarily” restore a backup from floppies. Youcan make a duplicate of the current database, restore the floppy backup, perform whatever options youwish on these older records and then restore the duplicate to return to the status quo.

Note that only one duplicate is stored at a time. Thus, only the most recent duplicate is available forrestoration. When you store a duplicate, it replaces any duplicate you may have stored.

Restore Duplicate DatabasePressing this button restores the current duplicate and makes it the current database. Note that restoringthe duplicate overwrites the current database. Be sure that this is what you want before restoring theduplicate database.

Backup to FloppyThis button is used to make a copy of the current database on a floppy disk. There are several steps thatare set into motion when you press this button.

Since it is possible that your database will have grown to the point that it will not fit on a single floppydiskette, the database is first split into floppy disk sized portions. Once this is done, you will be told howmany floppies will be required. At this point, you can either proceed or cancel the backup.

If you proceed with the backup, you will be asked to insert a floppy in the diskette drive. The floppy youinsert should be a High Density 3 1/4" floppy diskette. It does not have to be formatted for the Macintoshbefore you use it in the backup process.

When you insert the floppy, the system will prepare the disk for use as a backup floppy. Any informationstored on the floppy will be removed to make room for the backup files. You will be prompted to allowthe backup to continue. If you cancel the operation at any time, the backup process will be terminated. Ifthe disk is not originally formatted for the Macintosh, you will be given an opportunity to provide aname for the disk. It does not matter what name you enter at this point since the Atomlab 450 will namethe disk automatically after the database has been moved.

You will be prompted to insert floppies until the entire database is backed up. You should carefully labeleach floppy as it is ejected with the date, time and floppy number. Be sure to keep the set of disks for abackup together. You should also be sure to note the total number of floppies in the set on each floppy:

Atomlab 450 Database Backup10/20/93Floppy #2 of 4

Note, the process of preparing a backup floppy, copying the files and resetting the systems can take sometime. This is because extensive operation of the disk drives (as is necessary in a backup process) is arelatively slow operation as compared to the normal operation of the computer.

1. INTRODUCTION

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Restore From FloppyThis button reverses the process that has just been described. When you press it, you are asked to insertthe first floppy of the backup set. As with the backup process, you are repeatedly asked for floppies untilthe entire backed up database has been obtained. Note that the system expects the floppies to be insertedin order and automatically checks to make sure that you have done so.

When all of the floppies have been read, the system rejoins the files and makes them the current database(overwriting what had been the current database — it is a good idea to make a duplicate of the currentdatabase before doing a restore from floppy… just in case).

1.

— B-4 — APPENDIX B

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TROUBLESHOOTING GUIDE

Problem: Screen displays: ”Please bring HP monitor to the front.“

Solution:

1. Add paper to the printer.

2. Click the mouse on the <OK> button displayed on the screen. The screen will return to the operation displayed prior to the ”HP print monitor“ message but the printer‘s <Error> button will continue to flash.

3. Instruct the printer to continue printing by pressing and holding down the <Apple> button (located immediately to the left of the <Space Bar> on the keyboard) and the <Back Tic> button (located immediately to the left of the <1> key on the keyboard). Pressing these two buttons simultaneously will bring a menu bar to the top of the screen. The Monitor and HP symbols at the top right of the screen will be flashing back and fourth.

4. Move the trackball pointer up to the flashing Monitor/HP symbols and press and hold down the trackball button. This will cause several options to be displayed on the screen.

5. Keeping the trackball button depressed, slide the pointer down to the HP print monitor prompt and release the button. This following message now appears:

”The printer is out of paper. Load more paper and press the <Select> key. Click <Cancel> to terminate printing.“

6. Press the <Select> key on the printer to begin printing or click <Cancel> on the display if you do not wish to print.

7. If you press <Cancel> in step #6, the screen will display a chart of the HP print monitor screen. Click the upper left hand corner of the screen to return to the Atomlab program you were running originally.

8. Perform any Atomlab function, or click the pointer on the Atomlab header, then press the <Apple> key and <Back Tic> key simultaneously to return the normal border to the screen..

Problem: Overload in MCA bins will not clear.

Solution: 1. Turn MCA OFF.

2. Wait 10 seconds.

3. Turn MCA back ON.

The Atomlab System retains the calibration data for the MCA. The system will now displayan ”acquisition error“ message. Press <OK> to verify the communication path between thecomputer and MCA. You can now continue counting.

Problem: Blank monitor on power-up.

Solution: 1. Turn the monitor OFF.

2. Wait 10 seconds.

3. Turn the monitor back ON.

If the monitor does not come ON at this point:

1. Turn the computer OFF while leaving the monitor ON.

2. Wait 10 seconds.

3. Turn the computer back ON.

APPENDIX C

APPENDIX C — C-1 —

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Problem: Wipe Test shows no activity or zero activity for the activity number and background.

Solution:

1. Go to Administration mode Isotope Efficiencies page, Detector Efficiency section, and confirm that efficiency values are listed for the isotopes being counted.

2. If there are no values listed for the isotopes to be used, you must enter the values or count standards of the isotopes to have proper efficiency values listed.

Note: If an isotope is turned ON but there is no efficiency value, it will read as zero when the wipe test isperformed.

1.

— C-2 — APPENDIX C

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SPECIFICATIONS

System HardwareMacintosh Quadra 605: 4 megabyte RAM with 80 megabyte hard drive. 12" Apple® Basic Color Monitor,Apple® standard keyboard and Macintosh mouse.Printer: Hewlett-Packard DeskWriterMulti-Channel Analyzer: Channels: 1024Inputs: WellSpectral Resolution: FWHM 10%Count Rate: (Maximum) 100,000 cpsCount Rate Stability: 99%Gross Count Rate Linearity: Within 5% up to 100,000 cpsPulse Height Linearity: Within 2% (independent of detector)Connectors: Signal - BNC, High Voltage - MHVPower Supply: Regulared from 775-1125 VDC at 2 mAmpsDetector High Voltage Adjustment: Automatic H.V. adjustment for well; uses Cs-137 as the calibrationsource.Power Requirement: 110-240 VAC 50/60 HzWell Counter (Model #187-246):Detector: 2" x 2" Nal (Tl) Integral Line Scintillation Detector with .75" diameter x 1-7/16" deep well.Shielding: 1" Lead

System Software includesProgram Modes: Wipe Test, Schilling, Manual, Administration/QA, In-Vitro, and Start-Up Self Test.Radionuclides: Factory Set: Au-198, Ba-133, Co-57, Co-58, Co-60, Cr-51, Cs-137, Fe-59, Ga-67, Hg-197, I-123, I-125, I-131,In-111, Ir-192, K-42, Na-24, Pd-103, Se-75, Sr-85, Tc-99m, Tll-201, Yb-169.User Set: Unlimited user defined isotopes, setting ROI, half life, name, efficiency and gain.Administration Functions: Automatic daily calibration, automatic Chi-Square, automatic high voltageadjustment, isotope editing, isotope efficiency and site information.

APPENDIX D

APPENDIX D — D-1 —

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SCHEMATICS

APPENDIX E

— E-1 — APPENDIX E