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ATOMLAB 100Plus DOSE CALIBRATOR OPERATION AND SERVICE MANUAL VERSION 2.0 086-265 086-269 FN: 07-153 7/07 B IODEX Biodex Medical Systems, Inc. 20 Ramsay Road, Shirley, New York, 11967-4704, Tel: 800-224-6339 (In NY and Int’l, call 631-924-9000), Fax: 631-924-9241, Email: [email protected], www.biodex.com
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ATOMLAB 100Plus

DOSE CALIBRATOR

O P E R ATION AND SERVICE MANUA L

VERSION 2.0

0 8 6 - 2 6 5

0 8 6 - 2 6 9

FN: 07-153 7/07

BIODEXBiodex Medical Systems, Inc.

20 Ramsay Road, Shirley, New York, 11967-4704, Tel: 800-224-6339 (In NY and Int’l, call 631-924-9000), Fax: 631-924-9241, Email: [email protected], www.biodex.com

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This manual covers installation and operation of the following products:#086-265 Dose Calibrator, Atomlab 100Plus, 115 VAC#086-269 Dose Calibrator, Atomlab 100Plus, 250 VAC

ATOMLAB 100Plus DOSE CALIBRATOR

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Atomlab Dose CalibratorWarranty

1. InstrumentationA . This equipment and its accessories are warranted by BIODEX MEDICAL SYSTEMS, INC., against defects in materials and workmanship for a period of two years from the date of shipment from BIODEX MEDICAL SYSTEMS, INC. During the warranty period, BIODEX MEDICAL SYSTEMS, INC. will in its sole discretion, repair, recalibrate or replace the equip-ment found to have such defect, at no charge to the customer.

E X C E P T AS STATED ABOVE, THERE ARE NO WARRANTIES, EXPRESSE D OR IMPLIED, INCLUDING WITHOUT L I M I TATION WARRANTIES OR MERCHANTA B I L I T Y OR FITNESS FOR USE. BIODEX DOES NOT ASSUME LIABILITY FOR INCIDENTAL, CONSEQUENTIALOR INDIRECT DAMAGES INCLUDING LOSS OF USE, SALES, PROFITS OR BUSINESS INTERRUPTION.

B. This warranty does not apply if the product, as determined by BIODEX MEDICALSYSTEMS, INC., is defective due to abuse, misuse, modification or service performed by other than a BIODEX MEDICAL SYSTEMS, INC. authorized repair and calibration facility.Misuse and abuse include, but are not limited to, subjecting limits and allowing the equipment to become contaminated by radioactive materials.

C. In order to obtain warranty repair service, the equipment must be returned freight pre-paid to one of our facilities. The Return Authorization number (R.A. #) should be included, along with a statement of the problem. Equipment will be returned transportation prepaid.

2. CalibrationA. Instruments are warranted to be within their specified accuracy at the time of shipment. If a question arises and BIODEX MEDICAL SYSTEMS, INC. determines that the initial cali-bration is in error, the instrument will be recalibrated at no charge.

B. Mechanical products are warranted to meet written specifications and tolerances at the time of shipment.

C. The return policy is as stated in paragraph 1.C.

3. Warranty is non transferable.

4. Non-Warranty ServiceA. Repairs and/or replacements not covered by this warranty may be performed by BIODEX MEDICAL SYSTEMS, INC. at a factory authorized service location. Estimates of repair charges may be requested, however, a charge for estimate preparation may apply if the repair is later not authorized by the customer.

B. The cost of transportation into and out of the service location will be the responsibility of of the customer.

BIODEXBiodex Medical Systems, Inc.

20 Ramsay Road, Shirley, New York, 11967-4704, Tel: 800-224-6339 (In NY and Int’l, call 631-924-9000), Fax: 631-924-9241, Email: [email protected], www.biodex.com

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Service ProcedureIf you think you have a service problem, take the following action.

1. Check to see that the problem occurs more than once.

2. Check the instruction manual and operations procedure.

3. Check the instruction manual Trouble-shooting Guide.

If you still think you have a service problem, call BIODEX MEDICAL SYSTEMS, INC., Service Department at (800) 224-6339.

Keep yourself and the phone next to the equipment.1. Service will ask you for a brief description of the problem. We will ask specific questions

about the malfunction that occurred. This diagnostic process may take a few minutes, so call us when you have time to spare.

2. After taking the information, we will advise on the action we will take.

3. Sometimes service personnel must consult with engineering and it may take time to get back to you. Be sure to let the service representative know your schedule so that we can call at a convenient time.

4. The return call may be from a person other than whom you first reported the problem to.

5. After analyzing the problem, we will decide if the unit must be returned to us for repair,or replacement parts will be sent.

6. If unit must be returned, it will be given a return authorization (R.A. #) number by us. Pack the system in the carton that it was originally shipped in, or pack it safely and securely to avoid shipping damage. It is the customer's responsibility for any damage that occurs during shipping.

7. Non-warranty/non-service contract charges for repair are as follows:a. Materials

+b. Time

Service Currently $125.00 per Hour+

c. Shipping Charges

BIODEXBiodex Medical Systems, Inc.

20 Ramsay Road, Shirley, New York, 11967-4704, Tel: 800-224-6339 (In NY and Int’l, call 631-924-9000), Fax: 631-924-9241, Email: [email protected], www.biodex.com

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TABLE OF CONTENTSPage

Chapter One: Introduction to the Atomlab 100 Plus Dose Calibrator.........1-1Introduction to the Atomlab 100 Plus Dose Calibrator and this manual.

Chapter Two: Installing Your Dose Calibrator ...............................................2-1Describes what you need to properly use your Atomlab Dose Calibrator,powering up, installation and cleaning instructions.

Chapter Three: Getting Started .......................................................................3-1This chapter allows you to gain a quick familiarization of the operation of your Dose Calibrator.

Chapter Four: Description ...............................................................................4-1Describes features and functions of your Dose Calibrator, including the Detector and Display units.

Chapter Five: Operation...................................................................................5-1Describes the full operation of your Atomlab 100 Plus system.

Glossary .........................................................................................................GL-1

AppendicesAppendix A .......................................................................................................A-1

Atomlab Dose Calibrator Troubleshooting ProceduresAppendix B .......................................................................................................B-1

Atomlab 100 Plus Dose Calibrator SpecificationsAuthorized European Community Representative

Appendix C .......................................................................................................C-1Decay Calculations

Appendix D .......................................................................................................D-1Pre-Set Calibration Values

Appendix E........................................................................................................E-1Calibration Values for Other Isotope Selections

Appendix F ........................................................................................................F-1Atomlab Dose Calibrator Calibration and Traceability

Appendix G.......................................................................................................G-1Atomlab Computer Interconnection

Appendix H .......................................................................................................H-1Determining the Firmware Level of Your Dose Calibrator

Appendix I ..........................................................................................................I-1Electromagnetic Compatibility

Appendix J ........................................................................................................J-1Quality Assurance Testing of Atomlab Calibrators (Manufacturing Instructions)

Appendix K .......................................................................................................K-1SpecificationsQuick Reference ChartTrouble Shooting ChartSchematics

ATOMLAB Dose Calibrator Operation Manual Table of Contents

Biodex Medical Systems 5 Release 2.0

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CHAPTER ONE:INTRODUCTION TO THE ATOMLAB 100 PLUS

DOSE CALIBRATOR

IMPORTANT NOTE FOR ATOMLAB DOSECALIBRATOR USERS

The Atomlab Dose Calibrator you have purchased is a highquality, dependable and reliable instrument. Before using it,please review the following points.

Before using this devise, be certain to read the entire opera -tion manual. Failure to read the manual may result in usererror or inaccurate data

The Atomlab Dose Calibrator should be used only as speci -fied in the operation manual

The Atomlab Dose Calibrator is designed for use in apatient environment.

OVERVIEW

Biodex Medical Systems’ Atomlab 100 Plus dose calibratoris designed to perform accurate radioisotope measure-ments simply and quickly. Due to our unique electronicsand software, the performance you obtain when using thisunit will surpass the latest stringent regulatory performances t a n d a r d s .

In addition to performing standard radioisotope measure-ments, the Atomlab 100 Plus offers the ability to printSyringe Labels, Patient Chart Labels, and a System TestReport. This system can also store and print constancy forCo-57, Ba-133 and Cs-137. For each of these three iso-topes, the Atomlab 100 Plus will store up to two monthsconstancy data. A carbon copy of each of these printouts isavailable directly behind the self-adhesive labels.

ATOMLAB Dose Calibrator Operation Manual Chapter 1

Biodex Medical Systems 1-1 Release 2.0

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By familiarizing yourself with the procedures presented inthis manual, you will be able to carry out dose measure-ments while keeping your Atomlab 100 Plus functioningoptimally and reliably for years to come.

CONVENTIONS OF THIS MANUAL

The following conventions are used to provide graphic andother aids to facilitate following instructions given in this manual:

The Increment/Decrement keys are represented by ⇑ and ⇓.

Keys in Boldface Type (i.e., P R I N T) must be pressed for aresponse.

When there is an option in a step, it will be represented byupper case brackets { }.

ATOMLAB Dose Calibrator Operation Manual Chapter 1

Biodex Medical Systems 1-2 Release 2.0

Key Labels

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CHAPTER TWO:INSTALLING YOUR ATOMLAB 100 PLUS

DOSE CALIBRATOR

OVERVIEW

We strongly suggest that you read this chapter before movingon to the operation chapter. This will help ensure that yourAtomlab Dose Calibrator is up and running properly, and thatyou have adequate access to the unit to perform all the func-tions that will be discussed. It will also help you become familiarwith the various components of your dose calibrator.

OPERATING REQUIREMENTS

Prior to installing your equipment, plan a layout for yourAtomlab unit that will ensure it is convenient for measuringradionuclides and will not cause undue radiation exposurebecause of extra handling of high activity sources. T h e r eshould be ample room to place a vial shield on the work sur-face (preferably behind an L block shield), open the shield andremove the vial using tongs, quickly place the vial into theSample Holder and then place both into the Chamber Well.

Be sure to consider access to the Printer for changing the p a p e r, etc.

Remember that to make radioisotope measurements youwill have to place the clear plastic Chamber Well Liner intothe Chamber Well and lower the plastic Sample Holder intothe liner. Make sure there will be no obstructions, such aswall cabinets, above the Detector Unit. Such obstacles maymake it difficult to insert and remove the Sample Holder.

Choose a table or other counter which is free of vibration,does not wobble, and will easily support 300 lbs.

The surface area of the table top should provide ample areato accommodate the Detector Unit, Display Unit, the Printer,the L-Block shield, the shielded radionuclide preparationarea, and room for writing. See Figure 2-1 for a typical dosepreparation layout.

ATOMLAB Dose Calibrator Operation Manual Chapter 2

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Work Surface

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Suggested dimensions of the table top are:

• 30 in. deep• 48 in. wide• 36 in. high

Figure 2-1: A typical dose preparation layout.

F r e q u e n t l y, dose calibrators are located in areas called hotlabs in which there is a wet sink with plumbing. Do not locateyour dose calibrator on a table or other counter which canbecome wet or is subject to splashing or spraying.

Avoid areas which have drafts caused by heating or air con-ditioners, or are in direct sunlight. Electronics work bestwhen constant temperature is maintained.

The temperature range is from 0 to 40° C, and the relativehumidity range from 0 to 95%.

Choose a location for your dose calibrator which is not fre-quently used by other personnel — one where the table onwhich it lies will not be bumped.

In general, make sure your work area is clean, dry, and dustfree.

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Physical Locationand Environment

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Avoid locating your dose calibrator near a radioactive materialsstorage area. The 1/4-inch lead shield around the detectorshields it from changes in radiation levels from diagnostic ener-gy radionuclides (i.e., Tc-99m); however, the high energy radia-tion from sources such as Cs-137 and Co-60 will easily pene-trate the shield and change the background radiation level. T h elower the ambient radioactivity, the less background activity forwhich the Atomlab Dose Calibrator must compensate, and, thegreater the accuracy and reliability of the readings.

POWER REQUIREMENTS

Choose a line power source with a socket which mates secure-ly with the power plug provided.

Verify that the power line is properly grounded.

Do not choose an outlet that has a wall switch control.

100 to 120 VAC 1/2 A, or 200 to 240 VAC 1/4 A, selectablewith Fuse Holder (see Appendix A).

50/60 Hz.

POSITIONING

After you have chosen a suitable location for your AtomlabDose Calibrator and familiarized yourself with its compo-nents, position the various units. Make sure the Detectorand Display Units have been positioned to where they willnot have to be moved prior to connecting the cables.

CABLE CONNECTIONS

Refer to Figure 2-2 for an illustration of the Detector Unit'scable connector and rear panel. The Detector Cable is gray,ten feet long, and has white identical male connectors onboth ends. The connectors are of a self-locking type.

ATOMLAB Dose Calibrator Operation Manual Chapter 2

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Line Voltage

Line Frequency

Detector UnitConnection

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1) Rotate the Detector Unit so that you can see the rectangular opening in one side of the base.

2) Take one end of the Detector Cable, orient its connector so that it matches the openings on the connector of the Detector Unit (refer to Figure 2-2), and then insert the connector firmly until you feel it click. Do not force the c o n n e c t o r, it is self-locking! Gently pull on the connector to make sure it is firmly secured.

To remove the connector, squeeze both sides and pull.

3) Rotate the Detector Unit to its normal position so that the connector is facing away from the work area.

Figure 2-2: The Rear Panel of the Detector Unit, end of theDetector Cable, and the Operational Light.

NOTE: For the next procedure ensure your dose calibratoris turned OFF.

1 ) Rotate the Display Unit so that you are looking at the rear panel. Locate the connector labeled CHAMBER.

2 ) Take the connector on the free end of the Detector Cable,orient it so that it matches the openings on the connector of the Display Unit, and then insert the connector firmly

ATOMLAB Dose Calibrator Operation Manual Chapter 2

Biodex Medical Systems 2-4 Release 2.0

Display UnitConnection

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until you feel it click. Do not force the connector, it is self-locking! Gently pull on the connector to make sure it is firmly secured.

Figure 2-3: The rear panel of the Display Unit with ChamberC o n n e c t o r, the end of the Detector Cable, and the Displayend of the Power Cord.

1 ) Rotate the Display Unit so that you are looking at the rear panel. Directly to the right of the connector labeled CHAMBER, locate the Fuse Holder. This is labeled USEO N LY WITH 250V FUSES, with 100-120 read upright, and 200-240 read upside down.

2 ) The orientation of the Fuse Holder determines the power your dose calibrator requires. When the label 100-120 and its corresponding arrow points to the arrow directly below the Fuse Holder, you can plug your unitinto an 100 VAC power source.

If, conversely, the label 200-240 and its correspondingarrow points to the arrow directly below the Fuse Holder,you must plug your unit into a 240 VAC power source.

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Biodex Medical Systems 2-5 Release 2.0

Power CordConnection

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NOTE: Your Atomlab 100 Plus has already been configuredfor your use. If, however, you turn the Fuse Holder upsidedown to change the voltage required, the fuses within theFuse Holder must have the proper rating. See Appendix Afor details.

3) Locate the Power Switch to the right of the Fuse Holder and the socket for the Power Cable to the left.

4) Ensure the Power Switch is in the OFF position (0).

5) Plug the Power Cord into the socket.

6) Rotate the Display Unit back to its normal position.

7) Take the remaining end of the Power Cord and plug it into an outlet which meets the requirements previously outlined.

The following procedure tells you how to connect the Printerto the Display Unit. Refer again to Figure 2-3 for a view ofthe Display Unit's rear panel, to Figure 2-4 for the front viewof the Printer, and to Figure 2-5 for the rear view of thePrinter.

1) Place the Printer on top of the Display Unit, as shown in Figure 2-1.

2) Make sure the Power Switch for the Printer is OFF (see Figure 2-4).

3) Rotate both the Display Unit and Printer so that you are looking at their rear panels.

4) Locate the DC Power Connector on the rear panel of the Printer (see Figure 2-5). Plug in the Printer Power Cord. This cable is black with a three-prong male end and three socket female end.

NOTE: The ends of the Printer Power Cable are not inter -changeable.

ATOMLAB Dose Calibrator Operation Manual Chapter 2

Biodex Medical Systems 2-6 Release 2.0

Printer CableConnection

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Orient the Printer Power Cord so that it matches the open-ings on the connector of the Display Unit, and then insertthe connector firmly until you feel a click. Do not force theconnector, it is self-locking! Gently pull on the connector tomake sure it is firmly seated.

5) Locate the connector labeled PRINTER PWR on the rear panel of the Display Unit (see Figure 2-3). Plug in the remaining end of the Printer Power Cable.

6) Locate the Interface Connector (Modular Jack) on the rear panel of the Printer (see Figure 2-5). Plug in the Printer cable.

7) Locate the connector labeled PRINTER on the rear panel of the Display Unit (immediately to the right of the PRINTER PWR connector). Plug in the remaining end of the Printer cable.

Figure 2-4: Front view of the Printer

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Figure 2-5: Rear view of the Printer

NOTE: If you have purchased the RS-232 computer inter -face option for your Atomlab Dose Calibrator, you will nowwant to connect the interface cable into the connectorlabeled PC PORT. Connect the other end of the cable to theserial port of your computer. See Appendix G for furtherinformation.

POWERING UP

Reach behind the Display Unit and power up your A t o m l a bby flipping the Power Switch from the 0 (OFF) position to the– (ON) position. The Atomlab 100 Plus Self-Test will com-mence automatically.

If an error is detected, it will be noted on the ElectronicThumbwheel Display. You can then refer to Appendix A or theTroubleshooting Guide supplied with this manual to resolvethe problem. With the printer connected and turned ON, theAtomlab 100 Plus will print a Self-Test Form and print theerror number if any error is encountered. See Figure 4-2.

N O T E: After turning your Atomlab ON and completing theS e l f - Test or chamber selections, do not press any keys for atleast an hour. This allows the sensitive electronics to stabilize.

ATOMLAB Dose Calibrator Operation Manual Chapter 2

Biodex Medical Systems 2-8 Release 2.0

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PACKING MATERIAL

Now that you have set up your Atomlab Dose Calibrator, andeverything is intact and functioning properly, take a fewmoments to repack the packing material. This material wasespecially designed for safe shipment of the Atomlab DoseCalibrator and should be considered part of the instrument.Place the shipping material in the appropriate boxes and putthe boxes back into the shipping carton. Label the carton andstore it in a safe, out-of-the-way location. If you ever need toreturn your dose calibrator for updates, calibration, or repair,use the original shipping carton, boxes, and shipping material.

BASIC PRINTER INSTRUCTIONS

The following instructions will help you prepare your Printerfor operation. It is assumed that you have made the powerand data connections to your dose calibrator, as describedearlier in this chapter.

CAUTION: Ensure the Printer power is OFF prior to per -forming any of the installation procedures provided in thissection. Failure to do so may result in injury to yourselfand/or damage to the equipment.

MISE EN GARDE: Assurez-vous que l'alimentationelectrique est coupee avant d'executer les proceduresd'installation fournies dans cette section. A defaut decette precaution vous pourriez subir des blessures oucauser des dommages a l'equipement.

PRINTER TYPE

The Atomlab 100 Plus utilizes a model #DP8340 standardfeed printer. This 40-column, serial, dot matrix printer ispowered by the Atomlab unit.

DIP SWITCHES

Locate the DIP Switches (refer back to Figure 2-5). Theyshould all be set to the UP position (ON) except for switch2, which should be set to the DOWN position (OFF).

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Biodex Medical Systems 2-9 Release 2.0

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HANDLING NOTES

1 ) Place the Printer on a flat and stable surface (we suggest the top of the Display Unit).

2 ) Do not drop paper clips, pins or other foreign objects into the Printer.

3 ) Wipe off any dirt with a soft cloth soaked in alcohol or benzene. Do not use Lacquer thinner, Trichlorethelene orKetone solvents as they may damage the plastic c o m p o n e n t s .

4 ) Use a soft brush, etc., for cleaning the Printer mechanism and PCB.

5 ) Keep your hands out of the Printer while the power is ON.

6 ) Do not attempt to print when there is no ink ribbon or paper in the Printer. The Print Head life could be severely reduced.

7 ) If the paper is fastened tightly to the roll, the paper may not detach from the roll when the end is reached. If this happens, the No Paper detection function and Paper Feed will not operate.

8 ) Always keep the Printer Cover attached when printing toprevent paper jams, noise, and other problems.

UNPACKING

Make sure you have all the Printer accessories illustrated inFigure 2-6.

NOTE: The ribbon has already been installed.

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Install the Paper Holders in the outermost holes in the rear of thePrinter (see Figure 2-7). Insert the holders, positioned as shown,and push down slightly so that they lock into place. (The guideson the holders fit into the indentations beneath the outermostholes in the rear of the Printer.) Do not force the holders!

To install the Re-Roll Prevention Guard, insert one leg of theguard into one of the holes within the indentation of thePrinter Cover, as shown, and then insert the other leg, tak-ing care not to bend the Guard.

Figure 2-6: Printer accessories

Figure 2-7: Installation of Paper Holders and Re-RollPrevention Guard

ATOMLAB Dose Calibrator Operation Manual Chapter 2

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Installing thePaper Holdersand Re-RollPrevention Guard

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INSTALLING THE INK RIBBON

N O T E: The ribbon has already been factory installed. Thisprocedure is provided for future reference.

1 ) Turn the power OFF, lift the Printer Cover up, and remove it (see Figure 2-8). There is an indentation to the right and at the rear of the Printer Cover.

N O T E: Be careful not to touch the print head immediatelyafter printing as it may be very hot.

2 ) Unwind the ribbon so that the Ribbon Spools are separated, as shown in Figure 2-9.

N O T E: For the next two steps, hold the ribbon taut as you install it. Refer to Figure 2-10.

3 ) With the Spool Driving Pins facing down, slide the ribbon between the Print Head and the Platen.

Wrap one side around the black Ribbon Guide on the endof the Platen and drop one Spool on the Spool Shaft.

As you move the Spool downward, move the Detecting Lever aside to allow the Spool to drop into place.

Make sure the Spool Driving Pins engage with the Spool Drive Holes. As the spool drops into place there will be ac l i c k .

4 ) While continuing to hold the ribbon taut, install theremaining ribbon spool by following the same procedureas in step 3).

5 ) Turn the spool that rotates freely to take up the ribbon s l a c k .

Hold the spool and lift gently, rotating it until the ribbon sags.Push the ribbon Detecting Lever out, lift the spool until itcomes off the shaft. Remove the second spool by followingthe same procedure.

ATOMLAB Dose Calibrator Operation Manual Chapter 2

Biodex Medical Systems 2-12 Release 2.0

Removing the InkRibbon

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Figure 2-8: Printer Cover Removal

Figure 2-9: Printer Ribbon Spools

Figure 2-10: Installation of Printer Ribbon Spools

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PAPER INSERTION

1 ) Turn the power OFF.

N O T E: For the next three steps, refer to Figure 2-11 .

2 ) Tear the end of the label at the perforations to create astraight edge. Hold the roll so the paper comes from thebottom and towards the printer.

3 ) Attach the roll of label paper to the Paper Holders. To do this, put the rod through the center of the paper roll and slip one side onto the Hub while pulling the other Hub out to allow the roll and rod to slip into place.

4 ) Insert the label paper evenly into the Paper Insertion Slot until it hits the pin feed hubs.

5 ) Turn the printer Power Switch ON and press the FEED Button. Refer to Figure 2-12. The paper will automatically feed into the Printer. You may have to take hold of the paper and push it into the paper insertion slots slightly while pressing the feed button until the feed mechanism grabs hold of the paper perforations.

6 ) Stop the paper feed when the perforations line up withthe tearing mechanism on the top of the printer. If thepaper has advanced too far, continue advancing (feed-ing) the paper until the next perforation is reached, or,press down on the paper release lever and pull thelabels either forward or backward until the perforationsline up exactly. Release the paper release lever to lockthe labels in place.

PA P E R R E M O VA L

Cut the paper close to the slot and use the FEED b u t t o nuntil the paper has passed completely through the Printer.

N O T E: Do not try to remove the paper by hand as it couldbecome misaligned and get jammed inside the Printer.

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POWERING UP YOUR PRINTER

When you are confident you have made the proper cableconnections and installed the required accessories correctly,turn the Power Switch ON. If everything is right, the greenPOWER and ON LINE LEDs will come ON, and the redALARM LED will not come ON.

Figure 2-11: Printer Paper Roll Insertion

Figure 2-12: Printer Paper Insertion

As required, cleanse all exterior surfaces using a rag damp-ened slightly with a mild detergent solution.

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CHAPTER THREE:GETTING STARTED WITH YOUR

ATOMLAB 100 PLUS DOSE CALIBRATOR

OVERVIEW

This chapter provides a quick introduction to your A t o m l a b100 Plus Dose Calibrator. It will familiarize you with the basicoperation of making an Activity Measurement so that theinstructions provided in the rest of the manual will make moresense. This chapter will be especially valuable to those of youwho are already familiar with dose calibrator operation. Adetailed description of the Display and Detector Units is pro-vided in Chapter 4, and of operation procedures in Chapter 5.Also consult the Appendices for further information.

METHODOLOGY

An understanding of the following key functions, and aknowledge of the Atomlab Display Unit, will facilitate youruse of the Atomlab Dose Calibrator.

Whenever you initiate a mode, such as Setup, the AtomlabDose Calibrator will guide you by causing the LED's to flashon the keys you need to press.

When the manual specifies that an LED comes ON, italways means steadily, even if it was previously flashing. Insome instances, pressing a key will cause a flashing LED toturn OFF or come ON steadily.

Refer to the Front Panel Display in Figure 3-1. On theAtomlab 100 Plus the four-digit display associated with theElectronic Thumbwheel is referred to as the ElectronicThumbwheel Display. This display is used to set the date,time and dial values for the O T H E R key.

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Front PanelDisplay

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Figure 3-1: Atomlab 100 Plus Front Panel Display

GETTING STARTED

If you have not done so already, reach behind the DisplayUnit and flip up the power switch from the left position (0) tothe right (-) to power up your system. The TEST key LEDwill illuminate and the Atomlab will automatically initiate aSelf-Test program which will be completed without interrup-tion unless an error is detected.

Any error detected during the Self-Test will show as anError Message in the Activity Display. Refer to Appendix Afor a description of Error Messages and the proper courseof action.

NOTE: The top right four-digit LED Activity Display alwaysindicates activity in the Detector's Chamber Well, no matterwhich keys are pressed. (There are momentary exceptions:when you press the TEST key, for example.)

To the right of the Activity Display are the units of measure,e.g., microcuries (µCi). At this time, the display will indicatesome numeric value and the µCi symbol. Also lit is an LEDassociated with one of the Isotope Selection keys. When anisotope is selected, the Atomlab Dose Calibrator is automati-cally calibrated to display the activity of that isotope. Pressthe Tc-99m (or any other Isotope Selection key) and observe

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the LED on the key come on (the Tc-99m key may alreadybe selected). If there is no activity in the Detector, the dis-played value should be about 1.00 µCi or less. This valuemay get lower after "warm-up".

NOTE: The Mo-99 key has a special function for the MolyBreakthrough test, which is described in Chapters 4 and 5.

NOTE: The activity reading when you first power up yourdose calibrator may be any value, even negative, as youhave not yet corrected for the background radiation in yourwork area. After you use the B K G N D key as described below,and after the dose calibrator has warmed-up, the activitylevel should be close to zero (<0.1µCi).

Before activity measurements are normally made, a dosecalibrator requires a background adjustment to assure thereare no errors in the displayed value. The Atomlab DoseCalibrator automatically stores and subtracts theBackground Value before displaying the activity reading.

With nothing in the Detector but the Chamber Well Linerand empty Sample Holder, press the B K G N D key. The LEDon the key will come ON while background measurementsare made. The LED will go OFF automatically when com-pleted and the displayed value should be less than 0.1 µCi.The activity value will remain in memory until the B K G N D keyis pressed again or the system is turned OFF.

NOTE: The normal functions of the dose calibrator are dis -abled as the background is compensated for. This proce -dure will take anywhere from several seconds to 100 sec -onds, depending upon the level of activity of previous meas -urements. You may abort the background measurement atany point by simply pressing the B K G N D key a second time.

After the above background correction has been completed,remove your Cs-137 calibration Check Source from itsshield, place it in the Sample Holder and lower it into theChamber Well. Press the Cs-137 Isotope Selection key onthe front panel and observe that the LED on the key comeson. The Activity Display will now indicate the activity of yourCs-137 Check Source. Compare it to the decayed calibrated

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activity (see Appendix C for Decayed Activity Chart, Chapter5 for an explanation). For a properly calibrated sourceabove 200 µCi, the displayed value should be within a fewpercent of the decayed calibrated value. If you do not havea Cs-137 source, use a calibrated vial Co-57 source andrepeat the above by pressing the Co-57 key.

These calibration check sources provide a vital qualityassurance test which should be done daily to assure properperformance of the calibrator.

NOTE: The Atomlab 100 Plus provides automaticConstancy Checks for the Co-57, Cs-137 and Ba-133 keys.

AVERAGING PERIOD

The Atomlab 100 Plus automatically selects the properaveraging period or time constant for the proper display oflow activity sources. When you first lower the source intothe well, the activity value quickly jumps to the final value.For a few seconds the value may fluctuate, but then thevalue settles down to a small variation in the right digit. TheAtomlab Dose Calibrator will average the activity data whilethe source is in the Chamber Well, which over several sec-onds will result in a stable reading. As soon as the source isremoved from the Chamber Well, the Activity Display willdrop down to the near zero value.

RANGE SELECTION

The Atomlab Dose Calibrator automatically selects the prop-er range to display the activity results (either mCi or µCi ifyou have selected Ci, or GBq or MBq if you have selectedBq). The selection is made on the basis of providing maxi-mum resolution for the number displayed. Therefore, all youhave to do is place the source in the Chamber Well andread the activity value from the Activity Display.

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ISOTOPE SELECTION

Isotope selection can be done at any time before or afterplacing the source into the Chamber Well. As soon as youpress an Isotope Selection key, the displayed activity valueis corrected in accordance with the correspondingCalibration Value stored in memory.

DISPLAY UNITS

Proper units for radioactivity can be either the traditionalCurie (Ci) or the international unit Becquerel (Bq), whichev-er may be required in your facility. Your Atomlab DoseCalibrator has the ability to display in either system by userselection through the S E T U P key.

Isotope dial values may be displayed in microcuries or mil-libequerels. Whichever isotope key is illuminated will be thevalue displayed in the Electronic Thumbwheel. To g g l ebetween microcuries and millibequerels by pressing theO T H E R k e y.

(To access the isotope dial values, press the S E T U P key.The month/day setting will appear. Continue pressing theS E T U P key three more times to advance past theMonth/Date, Hour/Minute and Century/Year settings. Theunit should now display the dial value for the isotopes listedon the key pad.)

USING THE PRINTER

As an introduction to using the Atomlab 100 Plus and itsdedicated Printer, perform the following steps.

With a vial or syringe of radionuclide in the Chamber Well,for this example Tc-99m, press the Tc-99m key. When theActivity Display is stable, press the P R I N T key (bottom row,center of Display Unit).

The Atomlab 100 Plus printout will look similar to Figure 3-2.

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Figure 3-2: A sample Radionuclide Activity Report from theAtomlab 100 Plus dedicated printer.

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CHAPTER FOUR:ATOMLAB 100 PLUS DOSE CALIBRATOR DESCRIPTION

OVERVIEW

By this point, you should have already setup, installed andpowered up your Atomlab 100 Plus as described inChapters 1, 2 and 3. Now, before getting into the actualoperation procedures, we suggest you take a few minutesand review this chapter. It provides a complete descriptionof the Display and Detector units comprising your dose cali-brator. For an illustration of parts and components, referback to "Packing Slip", Figure P-1.

GENERAL DESCRIPTION

The Atomlab Dose Calibrators are used to measure theradioactivity of a known radioisotope. Their primary applica-tion is the measurement of the dose administered to apatient in nuclear imaging. The design for both units incor-porates unique electronics and software which surpassstringent regulatory performance standards and provide fastand accurate results.

The Detector Unit uses an ionization chamber for radiationdetection and an electrometer for ion current measurement.The chamber bias is generated with an electronic high volt-age supply, eliminating the need for expensive batterychanges.

The Display Unit communicates with the Detector Unit andprinter through serial ports.

An RS-232 computer interface comes standard with theAtomlab 100 Plus system. This interface will allow the userto send data and commands between the dose calibratorand a remote PC.

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THE DETECTOR

The Atomlab Detector Unit is a well type ionization chambercapable of measuring activity as low as 0.01 µCi and ashigh as 9999. mCi of Tc-99m. The chamber is surroundedon all sides and on the bottom with 1/4-inch lead to bothshield you from the source you are measuring and shieldthe dose calibrator from any ambient radiation.

THE CHAMBER

The well type chamber was carefully selected to provide anearly "4 pi" measuring geometry which means that theradiation detector nearly surrounds the radionuclide. Thisallows the Atomlab Dose Calibrator to measure the activityof a sample no matter what its volume or shape, as long asit fits into the Chamber Well. This is necessary, for example,when measuring syringe doses when the volume is unim-portant.

CHAMBER WELL LINER

Placed within the well is a plastic liner to protect the cham-ber from contamination in the event of the source leakingduring measurement. The liner is required for correct opera-tion of the unit.

CURRENT MEASUREMENT

The ionization current is measured by a microprocessor-controlled high impedance electrometer located within thebase of the Detector Unit.

REAR PANEL

On the rear panel of the Detector Unit are the connectorsfor power and data communication with the Display Unit.The Detector Unit can be located up to three meters awayfrom the Display Unit.

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RESPONSE

The response of this type of ionization chamber has been care-fully studied using radionuclides calibrated at the NationalInstitute of Standards & Te c h n o l o g y. The result is a well-definedenergy response curve which is used to determine the calibra-tion values for many different isotopes with high accuracy. Eachchamber has been calibrated with a National Institute ofStandards & Technology traceable source. The correspondingCalibration Value has been stored in the memory of the DetectorUnit. After calibration, the chamber's accuracy is tested with sev-eral sources of differing gamma energies whose activity valuesare traceable to the National Institute of Standards & Te c h n o l o g y.

THE DISPLAY UNIT

The Atomlab 100 Plus Dose Calibrator Display Unit consists of con-trol keys and displays that allow you to make activity measurements.Abuilt-in microprocessor executes commands input via the frontpanel keys and computes activity values from Detector data. T h i sunit can also print dose/syringe shield labels and store and printtwo months worth of Constancy for Co-57, Cs-137 and Ba-133.

The Display Unit, with a molded plastic case housing the elec-tronics, has been specifically designed to perform A c t i v i t yMeasurements in a laboratory setting. To allow easy fingertipcontrol of the keys, the front panel slopes gradually. The A c t i v i t yDisplay slopes as well, providing an optimum viewing angle. Onthe rear panel of the unit are the power and communication con-nectors, and the power switch, which remain out of the way asthey are infrequently needed.

ZERO CALIBRAT I O N

The innovative design of the Atomlab's Dose Calibrator's elec-trometer ensures that this zero adjustment is performed w h i l emeasurement of the activity values is being carried out, and istherefore continually updated.

The current from the chamber is collected on a capacitor in thefeedback loop of the electrometer whose capacitance valueis stable and measured to a high degree.

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Voltage measurements are made periodically. The time peri-od between measurements is accurately calibrated. Thesecond of two successive values is subtracted from the firstby the microprocessor, which yields the net voltage changeon the capacitor. Because the time interval between meas-urements is so small, any offset arising from fluctuations inthe electronics is the same for both measurements, and isautomatically compensated for during the subtraction.

DISPLAY UNITS

When you set your dose calibrator to display Activity Valuesin Ci (Curies), the conventional system of units, either µCior mCi will be indicated next to the numeric display. Theprefix micro or µ (10-6), or milli or m (10-3) is automaticallyselected by the system's microprocessor.

For example, if the numeric value displayed is 12.03, andµCi is indicated, the activity will be 12.03x10-6 Ci or0.00001203 Curies; if 63.9 is displayed and mCi indicated,the activity is 63.9x10-3 Ci or 0.0639 Curies.

In the same manner, when you set the dose calibrator tothe international system of units, Becquerels, either MBq orGBq will be indicated, where the prefix M represents Mega(106) and G represents Giga (109).

The absolute measurement range of the Atomlab DoseCalibrator is from 0.01 µCi to 9.999 Ci of Tc-99m (and theequivalent in Becquerels).

For example, 12.03 µCi = .445 MBq and 63.9 mCi = 2.36GBq. If the numeric display reads 0.445 and MBq is indicat-ed, the activity value is 445,000 Becquerels; if 2.36 is dis-played and GBq indicated, the activity is 2,360,000,000Becquerels.

THE DISPLAY UNIT-FRONT PANEL

To familiarize yourself with the location of the displays andvarious keys on the front panel, refer to Figure 4-1.

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The four-digit LEDs which make up the Activity Displayalways display measured activity, except during the Self-Test.

To the right of the Activity Display are the four display unit indi-cators: µCi, mCi, MBq, and GBq. If you select Ci as the dis-play units, the LED behind either µCi or mCi will come ON,depending on the range automatically selected by the A t o m l a bDose Calibrator; if you select Bq, MBq or GBq will be indicat-e d .

NOTE: If the Detector Well is empty, the display unitsshould be in the lower range, either µCi or MBq.

Figure 4-1: The Atomlab 100 Plus Front Panel

These keys allow you to select which radioisotope you willbe measuring. When, for example, you press the keymarked Tc-99m, the dose calibrator will be calibrated toaccurately measure the activity of Tc-99m. The LED on thekey you press will come ON so that you will always know forwhich radioisotope the system is currently calibrated.

The standard radioisotope (Isotope Selection) keys for theAtomlab 100 Plus include: Co-57, Cs-137, I-131, In-111,Ga-67, Xe-133, I-123, Tl-201, Ba-133, Sr-89, Mo-99 andTc-99m.

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StandardIsotopes

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The Self-Test is initiated by turning the Atomlab ON, or bypressing the T E S T k e y. The LED on the T E S T key comesON. Items tested include: electrometer sensitivity, chamberbias supply, software checksum, and the display. All LEDindicators are lit to let you know their condition. During theS e l f - Test, the Activity Display does not indicate activity.

The display test sequence is as follows.

1) All segments of the numeric LEDs or digits on the Ac-tivity Display, the decimal points, and all four Activity Display unit LED indicators, will come ON for four seconds. The display will look like:

8.8.8.8. µCi mCiMBq GBq

After 4 seconds, this display will turn OFF and the next test given in 2) will occur.

2) All Electronic Thumbwheel Display digits and decimal points will come ON. The display will read as follows:

8.8.8.8.

3) Next, the LED indicator on every key, will come ON.

When the Self-Test is completed and no faults have beendetected, the LED on the T E S T key turns OF and a Self-Te s tForm will be printed (see Figure 4-2). At this point, the systemis ready to use.

If there should be a problem detected, the LED on the T E S Tkey will flash and the Electronic Thumbwheel Display (#1) willshow a number corresponding to the fault. See Appendix A o rthe Atomlab Dose Calibrator Troubleshooting Guide for ErrorMessages and correction procedures. If you should decide tocontinue in spite of the fault, press the T E S T key to return tonormal operating mode. A S e l f - Test Form showing an ErrorMessage will print out. The LED on the T E S T key will continueto flash. In the event of an error message, we recommend youperform a Constancy and Linearity Test before continuing.

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Display TestSequence

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Figure 4-2: Atomlab 100 Plus Self-Test Form.

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When you press the B K G N D key to store the backgroundactivity, this value remains in memory until you press thekey again. Pressing the B K G N D key a second time will abortthe process.

NOTE: Even though the Atomlab 100 Plus Dose Calibratorcompensates for background interference, the accuracy ofActivity Measurements depends on the intensity of thebackground radiation. For this reason, store the new gener -ator, storage generator and check sources away from thedose calibrator.

SETUP MODE (SETUP KEY)

Pressing the S E T U P key accesses the Setup mode. A fulldescription of the functions you can perform is provided inChapter 5.

ELECTRONIC THUMBWHEEL

The Electronic Thumbwheel consists of a 4-digit LEDDisplay (Electronic Thumbwheel Display), ⇑ ⇓ keys, and thekey labeled E N T E R.

The Electronic Thumbwheel Display shows:

• The month and day• The time of day in hours and minutes• The century/year• Calibration Value when the O T H E R key has been selected

o r, when in the Setup mode, any selected, preset isotope key calibration value.

• Error numbers, if the self-test has a localized fault• Countdown for Moly Breakthrough Te s t

CONTROL FUNCTION KEYS

There are seven keys which perform specific functions: thekeys labeled S E T U P, T E S T, B K G N D, L A B E L, THIS MONTH,

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LAST MONTH and E N T E R. The E N T E R key is associatedwith the Electronic Thumbwheel Display. These keys allowyou to perform such functions as selecting the ActivityDisplay Units, setting the clock, calibrating the IsotopeSelection keys, performing constancy tests, storing the con-stancy standard data for the 3 isotopes, testing the instru-ment, and compensating for exterior conditions which affectthe accuracy of the Atomlab 100 Plus unit.

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CHAPTER FIVE:OPERATION OF YOUR ATOMLAB 100 PLUS

DOSE CALIBRATOR

NOTE: Most of the following functions and procedures arebriefly described on the Quick Reference Chart providedwith this manual.

Before proceeding, ensure that your Atomlab 100 Plus sys-tem has been installed according to tile conditions and proce-dures outlined in Chapters 2 and 3. A d d i t i o n a l l y, you shouldbe familiar With the descriptions provided in Chapter 4.

GENERAL OPERATING TIPSTo ensure accurate and reliable results when using theAtomlab 100 Plus, keep the following guidelines in mind atall times:

1) Perform the Self-Test, Daily Constancy, Quarterly Linearity and Annual Accuracy tests as required. Note that changes in operating parameters will affect the accuracy of readings if these tests are disregarded.

2) Do not introduce other high energy radioactive sources near the location of the Atomlab 100 Plus. Try to maintain a stable environment.

3) Leave your Dose Calibrator ON at all times, or makesure you turn prior to using it.

CAUTION: Keep the Chamber Well Liner in the Detector alltimes. Failure to do so will affect the accuracy of test resultsobtained and leave open the possibility of contaminating theC h a m b e r We l l.

MISE EN GARDE: Gardez le manchon protecteur à l'in -terieur de le chambre du calibrateur en tous temps. Adéfault de cette précaution, la précision des résultats de vostests peut être affectée et, laisse place à la possibilité decontaminer le puits de la chambre.

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DAILY CHECKS

Perform the following procedures on any day whenradioisotope activity measurements are to be taken.

The Self-Test is automatically initiated when the Atomlab100 Plus Dose Calibrator is turned ON. To run the Self-Testat any other time, simply press the TEST key. If any faultsare detected, see Appendix A or refer to the AtomlabTroubleshooting Guide.

Ensure the Chamber Well Liner and Sample Holder havebeen placed in the Detector. Press BKGND.

NOTE: Both the Chamber Well Liner and Sample Holdershould be should be checked periodically for contamination,as described later in the chapter (the more your dose calibra -tor for is in use, the greater the frequency of checks required).

1) Remove the Cs-137 check source from its shield and place it into the Sample Holder. Lower the holder,with source, into the Chamber Well.

2) Press the Cs-137 key (for the moment, ignore the blinking ENTER LED). The Activity Display will now show the activity of your Cs-137 check source.

3) Compare the displayed activity with the decayed calibrated activity (for an example of how to calculate a decayed activity see “Isotope Selection key Calibration’:later in this chapter). For a properly calibrated source above 100 µCi, the displayed value should be within a few percent of the decayed calibrated value.

4) You may also use the special function of the Cs-137 key to perform automatic Constancy Checks and datastorage, as described later in this chapter.

N O T E : If you do not have a Cs-137 source, use a calibratedBa-133 or Co-57 source and press the corresponding key(again, the special function of the Ba-133 and Co-57 keysenable you to carry out Constancy Checks automatically). Yo ucan perform constancy on all three radionuclides, if desired.

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SETTING TIME AND DATE

Time and Date values are programmed at the first level of theSetup mode. Once established, these values are used for allAtomlab 100 Plus functions for which Time and Date arerecorded including: test report printouts, activity record printoutswith the time the isotope was counted, and system constancyfunctions. The clock is also needed to properly decay thestored radionuclide standards that are used for constancy.

At the first level of the Setup mode, the month and day aredisplayed. To set month and day, use the following procedure:

1 ) Press SETUP to view the month/date. The month settingshould begin to flash.

2) Use the ⇑⇓ keys to Change the flashing month that is indicated on the electronic thumbwheel. When the proper number is displayed, press the ENTER key.This will cause the day setting to flash.

NOTE: An indicator light illuminates under the time or date digits, i.e., M/D H/M, C/Y to be changed.

3) Use the ⇑⇓ keys to change the day displayed to the correct date. Press the ENTER key to save the corrected month.

4) Press the SETUP key to display hour and minute.

5) Use the arrow keys to change the flashing hour digits displayed on the electronic thumbwheel.

6) With the correct hour displayed, press the ENTER key. This will lock in the new hour setting and cause the minute digits to start flashing. Use the ⇑⇓ keys to scroll to the desired minute digit. Press ENTER to save the new minute setting.

7 ) Press SETUP again to advance to century and year. The century setting will be flashing. Use the ⇑⇓ keys to display the correct century and then press the ENTER key to save. The year digits will now begin to flash.

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8) Use the ⇑⇓ keys to correct the year and then press the ENTER key to save.

9) Press the setup key twice, or until the setup LED turns OFF. The unit exits the Time/Date loop and is now ready for normal operation.

PRINTER OPERATION

The printer is a standard feed serial printer. lt will only func-tion with the Atomlab 100 Plus Dose Calibrator. To operatethe printer:

1) Ensure that the printer Power LED is illuminated.

2) To print radionuclide activity reports, press the LABELbutton while in normal mode. The system will print outthe activity in the chamber for the isotope button that is currently illuminated, along with two syringe or vial shield labels for the isotope. The main label can be taken and put on the patient’s chart, while the other syringe labels can be placed accordingly. There is also a carbon copy of the record that is printed behindthe label that can be saved in the department records.

3) To print constancy reports for this month or last month, press the CONSTA N C Y isotope and then press either the PRINT button for this month or last month to print the desired report. As the month changes on the clock and a new count is taken, the oldest month will print and then be wiped out of memory. The unit stores both this month and last month for the three constancy iso-topes on the front panel. The user must enter in the activity of their source into memory in order to use the C O N S TA N C Y b u t t o n s .

NOTE: After printing a label you can print another labelby pressing PRINT. Following a printout, you must pressan isotope button to clear the printer memory. Printing anisotope button allows the unit to print information from a different dose.

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STANDARD ACTIVITY MEASUREMENT

The following procedure allows you to make a typicalActivity Measurement with your Atomlab 100 Plus.

1 ) Place the radioisotope to be measured into the Sample Holder and carefully lower it into the Chamber We l l .

2) Press the Isotope Selection key corresponding to the isotope to be measured.

3) The Activity Display should now show the activity of the selected isotope.

NOTE: For Constancy Check Sources Co-57; Ba-133 and Cs-137; the ENTER LED will begin to flash after step 31 above. See Constancy Checks described later in this chapter: Press another isotope key to continue in normal operating mode.

MOLY BREAKTHROUGH TEST

A Moly Breakthrough test is an evaluation of the amount ofMo-99 contamination in a vial or syringe of Tc-99m. Tc99m,a decay product of Mo-99, is obtained from a generator byleaching it from the column of Mo-99 after it is formed.

The test method has been derived from the fact when Mo-99decays, high energy gamma photons (~75O keV) are producedwhich can “breakthrough” a lead wall with a thickness suff i c i e n tto totally absorb the lower energy Tc-99m gamma. T h e r e f o r e ,when a Tc-99m source is placed in the properly shielded leadcontainer and inserted into the Chamber Well of the A t o m l a blOO Plus, any measured radiation will be due to Mo-99 gamma transmission.

NOTE: The Mo-99 key has been calibrated to measure theactivity of Mo-99 in a source contained within the optionalMoly Shields. You must use a breakthrough shield. Failureto do so may result in inaccurate results. The ActivityDisplay will show a direct readout of the activity whichmeans that corrections for wall absorption have been included in the Calibration Value.

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There is a moly shield for vial model 086-423 and forsyringe 086-435.

Perform the following steps to carry out the MolyBreakthrough test.

1) Insert empty Moly Shield and press the Mo-99 key.The Electronic Thumbwheel Display will begin a 30-second countdown.

2) Once the countdown is finished, verify that the Activity Display reads 0.05 µCi or less. Wait about 30 seconds more for the Atomlab 100 Plus to stabilize. If the value is too high, press the BKGND key. You may continue when the BKGND LED indicator goes OFF.

3) Place the Tc-99m source in the Moly Shield and lowerit into the Chamber Well.

4) Again press the Mo-99 k e y. The Electronic T h u m b w h e e lDisplay will begin another 30-second countdown.

5) After the count reaches 0, the Activity Display should bes table enough for an accurate Mo-99 activity reading.

NOTE: Although the Mo-99 countdown is intended to suggest an adequate time frame, tile Atomlab 100 Plus will continue to acquire Mo-99 data as long as the Mo-99 key is selected. As a general rule, the onger you wait, the more stable the reading.

ISOTOPE SELECTION KEY CALIBRATION

If you have an isotope whose activity has already been accu-rately calibrated, such as a source obtained from the NationalInstitute of Standards & Te c h n o l o g y, you may use this sourceto set a Calibration Value for any of the Isotope Selection keys.

The procedure for Isotope Selection key Calibration is as follows.

1) Obtain the calibrated activity, write it on a piece of paper and set it next to the activity display.

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Procedure

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For example, the National Institute of Standards & Te c h n o l o g ysource you obtained is 1-125 with the following properties:Activity measured: 12/13188,12:00 ESTActivity per unit mass: 1195 MBq/g +0.005 (+0.5%)Mass:4.95863 g

The half-life is 59.6 days +O.2

Let A = current activityA0 = activity at time of calibration - ln(2)(t/T1/2)

A = A0ewhere t = time lapse since calibration and T1/2 = half life

A0 = (1195 MBq/g)(4.95863 g)= 5.926 MBq= 160.2 µCi

t = 60.25 days - ln(2)(60.25/59.6)A = 160.2 e= 79.5 µCi (2.94 MBq)

2) Insert the source with Sample Holder into the Chamber Well.

3) Press any standard Isotope Selection key, then press the SETUP key four times. The Atomlab 100 Plus is inthe four-level Setup mode. The current calibrated value for the key will show on Electronic Thumbwheel Display (#1).

NOTE: For the next step there is no need to pay attention to the Calibration Value you have set.

4) Use the Electronic Thumbwheel (#1) ⇑ ⇓ keys to change the setting on the display so that the Activity display showsthe current activity of the sample which was calculated in step 1 y. The ENTER LED starts flashing.

5 ) Press the ENTER key. The selected Isotope key is now programmed with the Calibration Value on the Electronic Thumbwheel 1 Display. The ENTER LED turns OFF

6) Press the SETUP key The SETUP LED turns OFF toindicate the Atomlab 100 Plus is out of Setup mode.

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SETTING OTHER ISOTOPE VALUES

The following procedure allows you to measure the activityof a radioisotope not included on the twelve standard presetkeys. The Calibration Value you set for the OTHER key isprogrammed into memory, eliminating the need to reset thekey later (unless you need to measure a different non-standard isotope).

NOTE: In order to change the default Calibration Value forthe OTHER key you must select this key prior to initiatingthe Setup mode.

NOTE: When you press the User Defined other IsotopeSelection key the Calibration Value will always appear onthe Electronic Thumbwheel Display. The only time theCalibration Value for the other Isotope Selection keys willappear on the Electronic Thumbwheel is when the Atomlab100 Plus is in the Setup mode.

1 ) Press the SETUP key four times. The SETUP LED comes ON. The OTHER key LED begins to flash indicating you may select the other display units if desired.

2 ) Press the key you wish to change the calibration value f o r. The Radionuclide LED comes ON. If you want to change the default for the other key, select the OTHERkey before entering the setup mode.

3 ) Select the Calibration Value from Appendix E corresponding to the radioisotope you intend to m e a s u r e .

4) Use the ⇑⇓ keys to set the Calibration Value on the Electronic Thumbwheel Display. The ENTER LED starts flashing.

5 ) Press the ENTER key. The Selected Isotope key is nowprogrammed and will retain the Calibration Value you set it to, even if you turn OFF your Atomlab 100 Plus.

6) Press the SETUP key. The Atomlab 100 PIus is now out of Setup mode.

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Should you need to return the standard Isotope Selectionkeys (labeled Co-57; Cs-137;... , Tc-99m), to their originalpreset Calibration Values, follow the above steps, but withthe following changes:

For step 2), press the standard Isotope Selection key in question.

For step 3), look up the preset Calibration Dial Value in Appendix D.

From time to time you may wish to check the CalibrationValues of the standard Isotope Selection keys. WithAppendix D before you, press SETUP four times and thenpress the standard Isotope Selection keys, comparing thesettings on the Electronic Thumbwheel Display with valuesin the appendix. Pressing SETUP again takes you out ofSetup mode. (These values also print on the Test Reportand can be used for comparison.)

To set a calibration value for the OTHER key, follow thesteps below.

1) Press OTHER.

2) Press SETUP four times. The SETUP LED will come ON.

3) Use the ⇑⇓ keys to set the Calibration Value on Electronic Thumbwheel (#1). The ENTER key begins to flash. The OTHER key flashes also, indicating that you can press the OTHER key to change Display Units at this point. Press ENTER to enter the value.

4) Press SETUP to Exit back to normal operating mode. Tile Calibration Value will be stored.

CONSTANCY CHECK

Constancy Checks should be performed on a daily basis toensure that the activity levels displayed by your dose calibratorare stable over a long period of time. Cs-137; Ba-133C andCo-57; because of their long half-lives, are the suggestedCheck Sources for the Atomlab Dose Calibrator.

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To Enter the Constancy Check Source data:

1) Place either a Co-57; Ba-133, or Cs-137 Check Source into the Sample Holder and lower the Holder into the Chamber Well.

2) Press either the Co-57, Ba-133, or Cs-137 Isotope Selection key. The ENTER LED begins to flash. Press the ENTER key and the selected isotope appears on Electronic Thumbwheel Display (#1). The ENTER LED should now be flashing. Press <SETUP>.

3) Calculate tile Co-57; Ba-133, or Cs-137 Decayed Activity and enter this value (in mCi or GBq) on Electronic Thumbwheel Display. Note that data entry has a .001 mCi precision when adjusting ⇑⇓ from the default 5.000 value. If you drive the value all the way down, the precision will switch to .0001 mCi, which is preferred for constancy check source entry.

4) Press the ENTER key to store the reference value just entered in step #3.

5) Press the Tc-99m key. The Atomlab 100 Plus returns to normal operating mode.

For all subsequent Constancy Checks, the Atomlab 100 Pluswill automatically perform decay calculations, using the Ti m eand Date stored in memory so that the calculations will alwaysbe current. Once you have performed the above procedureyou need not perform any additional decay calculations.

NOTE: The same procedure can be used to store the othertwo constancy isotopes’ activities

NOTE: An error 7 will be displayed if the constancy sourcefalls below 50 µCi of activity

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DAILY CONSTANCY CHECKS

In a Daily Check, the Atomlab 100 PIus measures the actualactivity of the Check Source placed in the Chamber Well,comparing this to the calculated decayed activity stored inmemory. Should it find a discrepancy of more than 5%, itwill beep, the TEST LED will flash and ElectronicThumbwheel will flash an Er. 7 message. To escape theError loop, see “In Case Of Er. 7” below.

Following step 5) above:

1) Using the Sample Holder, place the Check Source into the Chamber Well.

2) Select the appropriate Isotope Selection key (Co-S7; Cs-137 or Ba-133).

3) Press the flashing ENTER key to enter Check mode. The selected isotope will be displayed in ETD #1.

4) Press the flashing ENTER key to enter the isotope and bring up the operator I.D. number.

NOTE: Department personnel can be assigned any number between 1 and 25. A cross-reference chart should be created showing LD. number and operator:

5) Press the ENTER key a third time to measure the actual activity of the Source in the Chamber Well.

6) The Atomlab will now compare the current activity withthe calculated decayed activity stored in memory (this has automatically been updated in accordance with the current Time and Date).

7) Exit the Constancy Check and return to normal operatingmode by pressing another ISOTOPE key or PRINT. The latter option results in a form similar to that shown in Figure 5-1.

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Figure 5-1: A sample Daily Constancy Record. If theAtomlab 100 Plus detects a discrepancy greater than 5%, itwill print an error 7 Message:

CAUTION SYMBOLS◆ Indicates decayed activity is less than 0.050 mCi and

which may fall below your license requirement■ The measured activity error exceeds 5% but is less than

10%. Consult with your RSO or designated person from your license

■ The measured activity error exceeds 10% which is beyond your license requirements. Consult your RSO forrecomended action.

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MISEN EN GARDE: ◆Le degré d'activité théorique indiqué est moins de 0.050 mC ice qui peut êlre sous les normes requises de votre pemis. ■La mesure d'erreur d'activité excréde 5% mais est moins de

10%. Consultez votre officier de radi protection (physicien) ou la personne désignée sur votre permis.

■La mesure d'erreur d'activité excéde 10% ce qui dépasseles normes de votre permis. Consultez votre officier de radioprotection (physicien) pour ses recommentations.

NOTE: Only one Constancy Check measurement will besaved in memory each day. If you perform more than onecheck on a given day only the last one will be saved.

If the Atomlab 100 Plus detects more than a 5% discrepancyin its Daily Check it will beep, the T E S T LED will flash andElectronic Thumbwheel (#1) will display an Er. 7 messageafter you have pressed the ENTER key for the second time.To escape the error loop, press the T E S T k e y, followed by theT E S T k e y. This performs the test loop and generates a printedForm with the Evaluation Message noted in the caption forFigure 5-3. Press an isotope key to return to normal operation.

NOTE: Error 7 will display if the measurement errorexceeds 5% of the standard or the decayed standard is lessthan 50 µCi. Values outside the normal range are printed inbold on the report.

The Atomlab Dose Calibrator begins storing Daily Checksthe day you first enter the Check Source A c t i v i t y. T h eAtomlab 100 Plus stores two months worth of ConstancyCheck data for all three constancy isotopes. Two constancyreport keys are labeled “This Month” and “Last Month’:Pressing “This Month” will print a report from the first of thismonth up to and including today’s date. “Last Month” printsall of the previous months data. This report remains availablefor a full month. This allows ample opportunity for the user toprint their report. As the month rolls over to the next month,the “Last Month” data is replaced by the “This Month” data.

See end of chapter for sample pages that the reports couldbe place on and kept in the files.

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In Case of Er. 7

Monthly Report

Reports

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CONTAMINATION CHECKS

To ensure that your Sample Holder is not contaminated,perform the following steps.

1) Remove the Sample Holder from the Detector.

2) Ensure that the Activity Display reads less than O.05 µCi or (MBq). If not, use the BKGND key to correct for t h e change in background radiation.

3) Place the Sample Holder into the Chamber Well.

4) Press the Mo-99 key. If, after the 30-second countdown on the Electronic Thumbwheel Display, the activity is >2µCi, set the Sample Holder aside. Repeatthe test (steps 1 through 3) the next day or after a weekend. If, after the repeat test, the activity is still >2µCi or greater, you need to order a replacement Sample Holder because of contamination.

5) If the activity is <2µCi, place the Sample Holder back in the Chamber Well and, if the activity value now reads greater than 0.05 µCi, again press the BKGND k e y.

Repeat the above procedure, removing and replacing theWell Liner.

SAMPLE REPORTS

The remainder of this chapter offers a look at samples ofthe following Atomlab 100 Plus reports:

1) Radionuclide Activity Label2) Blank Test Report Page3) Test Report Page with Test Label put into place4) Blank Daily Constancy Report5) Daily Constancy Page with a month end report in place

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Detector LinerCheck

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Figure 5-2: A sample Radionuclide Activity Label.

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Figure 5-3: A sample Blank Test Report Page.

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Figure 5-4: A sample Test Report Page with Test Label put into place.

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Figure 5-5: A sample Blank Daily Constancy Report.

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Figure 5-6: A sample Daily Constancy Page with a month end report in place.

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GLOSSARY

OVERVIEW

This glossary provides definitions for the most commonterms relevant to the Atomlab 100 Plus Dose Calibrator.

The test of a dose calibrator to see how close the displayedactivity values are to the true values.

The time the Atomlab takes to display a stable activity reading.

The function of the Atomlab, initiated by pressing the B K G N Dkey, which stores a value for the ambient activity. This valueis automatically subtracted from all subsequent activitymeasurements to compensate for the background activitylevel.

The international unit of activity, corresponding to one dps(disintegration per second, or one nucleus decaying persecond). The Atomlab displays activity values in units ofMBq (million Bq) or GBq (billion Bq).

The use of calibrated activity sources traceable to theNational Institute of Standards & Technology to calibrateeach Atomlab unit and verify the accuracy of the activity val-ues it displays.

The value set on the Electronic Thumbwheel (#1) Display toadjust the Atomlab to correctly respond to a particularradioisotope. See Response, Ionization Chamber.

A sleeve shield package to perform linearity tests on dosecalibrators.

Performing daily checks using a radioisotope with a longhalf-life to ensure that the activity values a dose calibratordisplays is stable over a long period of time.

A chart projecting how the activity of a source will decayover a period of time at specified time intervals.

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Accuracy Tests

Averaging Period

BackgroundCorrection

Becquerel (Bq)

Calibration

Calibration Value

Calicheck

Constancy Check

Decay Chart

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An Atomlab component housing the ionization chamberdetector and the electrometer.

Displayed value changes without the removal or insertion ofa source in the Chamber Well.

The Atomlab component incorporating the electronics, con-trol keys and displays which perform and show activitymeasurements.

The verification of the activity of a radiopharmaceutical tobe administered to a patient, corresponding to the radiationto be delivered to the body.

Measures the current in the ionization chamber, which isproportional to the activity of a source within the chamber.

The section of the Atomlab Front Panel consisting of a 4-digit display, Increment/Decrement keys (⇑ and ⇓) and anassociated key, which allows the operator to enter any num-ber possible on the display into the Atomlab program.

The test of a dose calibrator to determine the variation inthe displayed activity values due to the geometric configura-tion of the source's container (vial, syringe, etc.) and itslocation within the ionization chamber detector.

A device which responds to the activity of a source by form-ing ion pairs which can be collected as a measure of theradioactivity.

A calibrated solution containing a compound labeled with aradionuclide such as Tc-99m (radiopharmaceuticals). Fromsuch kits doses are prepared to administer to patients tofacilitate nuclear imaging.

A partially transparent radiation shield behind which dosescan be prepared.

The test of a dose calibrator to determine the variation inthe displayed activity values from the true ones over themeasurement range of the instrument.

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Detector Unit

DisplayFluctuations

Display Unit

Dose Calibration

Electrometer

ElectronicThumbwheel

Geometry Tests

Ionization Chamber

Kit

L-Block Shield

Linearity Tests

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A sleeve shield package to perform linearity tests on dosecalibrators.

Used in the Moly Breakthrough Test to shield the radiationof the Tc-99m in an eluent so that the activity of the Mo-99can be measured.

Used to determine the percentage of parent Mo-99 remainingin the eluent containing the daughter Tc-99m radionuclide.

The parent radionuclide which decays into the daughter Tc-99m, used to generate radiopharmaceuticals.

National Institute of Standards & Technology, whose activi-ties include maintaining radioactive material standards.

Nuclear Regulatory Commission, which is the agency of theFederal Government which regulates radioactive materials.

The Atomlab unit automatically selects which range ofDisplay units (µCi or mCi, or MBq or GBq) to be used forthe Activity Display to show activity values with the most sig-nificant number of digits.

The variation of the ion current collected by an ionization cham-ber because of individual decay processes associated with dif-ferent radioisotopes. Calibration Values are required to adjustthe output of the electrometer for each radioisotope to compen-sate for this variation in response, thereby ensuring accuracyover the entire range of commonly used radioisotopes.

A method of performing linearity tests on a dose calibratorby encircling a single source with leaded sleeves of varyingthickness, thereby reducing the activity the dose calibratormeasures by a known amount. Comparison of the expectedand actual activity values constitutes the test of linearity.

A method of performing linearity tests on a dose calibrator bymeasuring the initial activity of a source, accurately calculating itsdecayed activity at prescribed time intervals, and making activitymeasurements at those time intervals. Comparison of the calcu-lated and actual activity values constitutes the test of linearity.

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Lineator

Moly BreakthroughShield

Moly Break-through Test

Molybdenum-99(Mo-99)

NIST

NRC

Range Selection

Response,Ionization Chamber

Sleeve Shield

Source Decay

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Refers to using sources for calibrating a dose calibratorwhose activities can be traced to the National Institute ofStandards & Technology.

Compensating for electronic drifts in the input and output ofthe electrometer of a dose calibrator so that they do notaffect the accuracy of the displayed activity. The Atomlab'selectrometer does this automatically by constantly subtract-ing the first of two successive activity measurements fromthe second, so that any offset is compensated for.

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Traceability

Zero Calibration

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APPENDIX A:ATOMLAB DOSE CALIBRATOR

TROUBLESHOOTING PROCEDURES

OVERVIEW

Should it appear that your Atomlab Dose Calibrator is notfunctioning properly, the procedures explained in this appen-dix, and on the Quick Reference Chart provided with thismanual, should allow you to determine whether a problemdoes indeed exist and what steps can be taken to correctthe difficulty.

Should you encounter any of the problems discussed in thefollowing sections, immediately perform the accompanyingsteps to ascertain whether your dose calibrator requiresservicing. If you conclude that it does, contact the BiodexCustomer Service Department at (631) 924-8355 for furtherinstructions.

This appendix assumes that you have performed all thebasic installation procedures presented in Chapter 2.

PROBLEM DESCRIPTIONS

The following problems are described in this appendix.

• System will not Power Up• Fluctuations in Activity Measurement• Unexpected Readings• Detector Unit Circuit Breaker Function• Printer Problems• Determining the current Software Version • Display Unit Fuse Inspection and Replacement• Setting Up the Atomlab to accept 100 VAC or 240 VAC• Important Notes about System Errors

SYSTEM WILL NOT POWER UP

If your Atomlab Dose Calibrator fails to power up, perform

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the following steps, proceeding to the next step only if thecurrent one fails to remedy the problem:

1) Turn the Power Switch OFF for several seconds, then switch it back on.

2) Turn the power OFF again and remove the Power Cord from the electrical outlet. Remove the other end of the Power Cord from the receptacle on the rear of the Display Unit.

3) Re-insert the Power Cord into the receptacle and then plug the Power Cord back into the outlet. Turn the power back ON.

4) Turn the power OFF, remove the Power Cord from the outlet and verify that the voltage of the outlet is correct. If not, repair the outlet or find another outlet that provides the required voltage. Re-insert the Power Cord and turn the power back ON.

5 ) Turn the power OFF, remove the Power Cord from the outlet and remove the Fuse Holder, as described later in this appendix (see Figure A-1). Verify that both fuses are intact. If one or both are not, replace. Re-insert the Fuse Holder into the rear panel of the Display Unit. Re-insert the Power Cord into the outlet and turn the power back ON.

If your system still will not power up, call the BiodexCustomer Service Department.

FLUCTUATIONS IN ACTIVITY MEASUREMENT

When the system is displaying activity for the more commonisotopes, the electrometer continually averages the data itreceives from the detector. This ensures, for most readings,a stable Activity Display.

After you insert an isotope into the Detector and select theproperly calibrated key, the display may vary at low activityvalues as the system acquires the new data. After a short

ATOMLAB Dose Calibrator Operation Manual Appendix A

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Procedure

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time the Activity Display will stabilize, with expected fluctua-tions described below. If the display continues to fluctuate,and you have verified it is not because of a high CalibrationValue, consult Biodex Customer Service Department.

For some isotopes which require a high Calibration Value,you may observe fluctuations of ±0.5 µCi or more. Keep inmind that the Calibration Value for an Isotope is related togain of the electrometer, or by what factor the electrometerhas to amplify the signal from the detector. The Calibrationfor Tc-99m is 33.6, and a reading of 10 µCi for Tc-99m isequivalent to 10-12 Amps measured by the electrometer.High Calibration Values impact gains so that the electrome-ter amplifies inherent noise to a greater degree. Thus,greater fluctuations are observed in the Activity Display.

For instance, the Calibration Value for Co-60 is 5.0. Thefluctuation due to noise probably would not be noticeable(±0.01 µCi). The fluctuation due to noise for Tc-99m (33.6)is approximately ±0.05 µCi. For an isotope requiring aCalibration Value of 500 (for P-32 it is 632) the fluctuationwill be ±0.5 µCi or more.

The Atomlab Dose Calibrator begins averaging display datathe moment you press the Mo-99 key (Calibration Value=180). This means that at first the fluctuations will seem rel-atively high before gradually decreasing. This is why theAtomlab Dose Calibrator provides the 30-second count-down. In addition, the relatively high Calibration Valuemeans the fluctuation due to inherent noise will be slightlyhigher than for the other common isotopes. Again, thesefluctuations are to be expected and do not require anyaction on your part.

UNEXPECTED READINGS

If for some reason you suspect that the reading on theActivity Display is inaccurate, ensure that the CalibrationValue for the proper Isotope Selection key is correct.

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Display Fluctua-tions For HighCalibration Values

Mo-99 Fluctuations

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PRINTER PROBLEMS

Should you experience problems with your Printer, consultthe manufacturer's manual or Chapters 2 and 5 of this man-ual. Also perform the following steps:

1 ) With the Display Unit power OFF, disconnect and re-connect the Printer cables (communication and power).

2 ) Ensure that the Printer has been properly configured for use: the Paper Holders, Paper Roll, and Ribbon have all been inserted properly, the DIP switches are set p r o p e r l y, the Power Switch is ON, etc.

DETERMINING THE CURRENT SOFTWARE VERSION

To determine the current software version for Atomlab 100Plus systems:

1) Press S E T U P four times. The isotope dial values will be displayed in the electronic thumbwheel display.

2 ) Press the T E S T button and the display software version will be listed in the electronic thumbwheel display. Press the T E S T button again, and the chamber software versionwill be listed.

3 ) Press the T E S T button again. The electronic thumbwheel will now indicate that the high voltage is ON. Press T E S Tagain to return to the standard isotope calibration dial r e a d i n g .

4 ) Press S E T U P to return to standard operating mode.

NOTE: The form printed out after power up, and afterpressing the T E S T key, also shows the software versions ofthe Display and Chamber Units.

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DISPLAY UNIT FUSE INSPECTION AND REPLACEMENT

The following section provides the procedure to remove theFuse Holder. Refer to Figure 2-3, which shows the rearpanel of the Atomlab Display Unit, and Figure A-1, whichillustrates the actual Fuse Holder replacement procedure.

CAUTION: Due to the possibility of electrical shock, dangerof injury to yourself and damage to the equipment doesexist. Be sure to switch the power OFF, and unplug the unit,before proceeding.

MISE EN GARDE: Due à la possibilité de choc électrique, ilexiste un danger de vous blesser ou de causer des dom -mages à l’équipement. Assurez-vous de bien fermer l’ap -pareil et de le débrancher avant de procéder.

1) Rotate the Display Unit so that you are looking at the rear panel. Directly to the right of the connector labeled CHAMBER (between the power plug and ON/OFF switch), locate the Fuse Holder. This is labeled in the center with USE ONLY WITH 250V FUSES, on the bottom with100V-120V read upright and on the top with 200V-240V read upside down.

2) The orientation of the Fuse Holder determines the Orientation power the Atomlab unit requires. If the label 100V-120V can be read upright (the label 200V-240V is upside down), and the corresponding arrow directly below the label points to the arrow on the rear panel directly below the Fuse Holder, then you must plug your dose calibrator into an 100 VAC power source.

If, conversely, the label 200-240 can be read upright (the label 100V-120V is upside down), and the corresponding arrow directly below the label points to the arrow on the rear panel directly below the Fuse Holder, then you must plug your dose calibrator into a 200 VAC power source.

3 ) There is a small indentation to the left of the Fuse H o l d e r. Insert the end of a flat-edged screwdriver into the indentation and gently pry the Fuse Holder out slightly. Now, use your fingers to pull the Fuse Holder out of the panel.

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Procedure

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Once the Fuse Holder is removed, inspect the filament atthe center of the two fuses. If it is burned or broken in anyway the fuse must be replaced. If the filament does notappear to be broken or burned, test the fuse for continuitywith an ohm meter.

Figure A-1: Removing the Fuse Holder

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Biodex Medical Systems A-6 Release 2.0

Fuse Inspection

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The following fuses must be used:

100-120 VAC Two SLO-BLO 5x20 mm 1/2 Amp

200-240 VAC Two SLO-BLO 5x20 mm 1/4 Amp

CAUTION: The danger of damage to the equipment exists.Be sure you properly orient the Fuse Holder prior to replac -ing it.

M I S E E N G A R D E : Danger de dommage à l’équipement.Assurez-vous de bien orienter le support de fusibles avantde le remplacer.

To replace the Fuse Holder, position it into the indentationfrom which it was removed and gently push it back intoplace. It is critical to first determine the particular powerrequirement (100 VAC or 240 VAC) and ensure the FuseHolder is properly oriented before turning the system backON. See step 2) above.

SETTING UP FOR 100 VAC OR 240 VAC

Figure 2-3 shows the proper orientation of the Fuse Holderto set up your Dose Calibrator for 100 VAC operation. TheFuse Holder contains two 1/2 Amp, 250 VAC fuses.

If you should wish to set up your system to accept 240 VAC,remove the Fuse Holder, as described above, replace theexisting fuses with 1/4 Amp, 250 VAC fuses, and thenreplace the Fuse Holder with the proper orientation.

IMPORTANT NOTES ABOUT SYSTEM ERRORS

Following the Self-Test, if a fault has been detected theT E S T LED will remain on and the Electronic ThumbwheelDisplay (#1) will show the first error message in the Form"Er.1, Er.2", etc. Each time you press the T E S T key the nextError Message, if further faults have been detected, will bedisplayed. The T E S T LED will flash continuously to informyou that more errors have been detected.

ATOMLAB Dose Calibrator Operation Manual Appendix A

Biodex Medical Systems A-7 Release 2.0

FuseReplacement

Fuse HolderReplacement

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NOTE: In some instances an electronics glitch will cause anerror to be displayed, even though there is no problem withyour dose calibrator. For this reason, be sure to run theSelf-Test a second time if an initial review of the problemindicates no fault exists.

NOTE: For certain error faults you can press the T E S T keyand continue to use your dose calibrator. The LED on theT E S T key will continue to flash, reminding you that action tocorrect the problem must eventually be taken. Some ofthese faults can be easily corrected over the phone by theBiodex Customer Service Department. Other faults, however,require that you return the dose calibrator to Biodex MedicalSystems for servicing.

Caution: Only qualified service personnel should removethe chamber cover. There is an electrical shock hazard.Components under the cover operate at aproximately 350volts. The chamber bias supply capacitors require at leasttwo weeks, with the power disconnected, to discharge toless than 50 volts

ATTENTION: On ne doit confier qu'à un personnel d'entre -tien qualifié le soin de déposer le couvercle de la chambred'ionisation. II y risque de danger électronique. Les com -posants sous le couvercle font ionnent sous une tensiond'environ 350 V. La chambre d'ionisation est dotée de con -densateurs qui nécessitent au moins deux semaines d'ali -mentation débranchée pour se décharger à moins de 50 V.

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APPENDIX B:ATOMLAB 100 PLUS DOSE CALIBRATOR

SPECIFICATIONS

OVERVIEW

This appendix provides the physical and operatingspecifications of your Atomlab Dose Calibrator.

MEASUREMENT RANGE

For Tc-99m, 0.01 µCi to 9999 mCi, auto-ranging.

DISPLAY RANGES

Units are user selectable:

Ci Bq Ci Equivalent

00.01-19.99 µC i .001-1.999 MBq 54.0 µC i20.0-199.9 µC i 2.00-19.99 MBq 540. µC i200.-1999. µC i 20.0-199.9 MBq 5.40 mCi2.00-19.99 mCi .200-1.999 GBq 54.0 mCi20.0-199.9 mCi 2.00-19.99 GBq 540. mCi200.0-9999. mCi 20.0-399.9 GBq 10.8 Ci

RESPONSE TIME

Auto selection:one second above 2 mCi;3 seconds between 200 µCi and 2 mCi;3-30 seconds below 200 µCi.

ACCURACY

Overall accuracy of activity determination for specific frontpanel isotopes using the factory set Calibration Values iswithin 3% or 0.3 µCi, whichever is greater.

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NOTE: Intercomparison of calibrated sources and theAtomlab 100 Plus requires combining the uncertainties ofboth the Atomlab 100 Plus and the calibrated source todetermine expected agreement.

Within 1% or 0.2 µCi, whichever is greater.

Within 1% or 0.2 µCi, whichever is greater.

Within 1% or 0.2 µCi, whichever is greater.

Short term (24 hours): within 0.3% above one mCi, exclusive of background.

Long term (one year): within 1%.

NOISE

Display Fluctuations Activity Range

< 1 Digit > 199.9 µCi< ±2 > 19.99 µCi< ±4 0.01 to 19.99 µCi

ENERGY RANGE

25 keV to 3 MeV

ISOTOPE SELECTION

Ten pre-set Keys: C o - 5 7, C s - 1 3 7, I - 1 3 1, I n - 1 1 1, G a -6 7, X e - 1 3 3, I - 1 2 3, T l - 2 0 1, M o - 9 9, and T c - 9 9 m.

Two user programmable keys: 1 and 2.

O T H E R key for setting on-the-spot calibration values for non-standard isotopes.

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Detector Linearity

ElectrometerLinearity

ElectrometerAccuracy

Stability

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The Mo-99 key is calibrated for Mo-99 assay in a shieldedvial of Tc-99m. The Atomlab 100 Plus provides a 30-secondcountdown.

DETECTOR TYPE

Well-type pressurized ionization chamber, with Argon filledgas. Replaceable plastic liner included. Dimensions are:

Well opening: 2.5 in. (6.4 cm)Well depth: 10.25 in. (26 cm)

1/4 in. (6.4 mm) lead surrounding ionization chamber, withtop well opening.

300 volt electronic power supply.

ENVIRONMENTAL OPERATING CONDITIONS

Temperature: 0 to 40°CHumidity: 0 to 95% rh, non-condensing

For optimum performance, the Atomlab 100 Plus should beoperated in a normal laboratory environment where the tem-perature and humidity are maintained for normal humancomfort and the ambient radiation level is low and constant.

PHYSICAL DATA

Display Unit Detector Unit

Size: 3.75 x 12 x 14.3" 7.5 x 7.5 x 16.25"(9.5 x 30.5 x 36.3 cm) (19 x 19 x 41.3 cm)

Weight: 6 lbs. (2.72 kgs.) 35 lbs. (15.9 kgs.)

POWER

100 to 120 VAC 1/2 A, or 200 to 240VAC 1/4 A, selectable with fuse card.

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Detector Shield

Chamber Bias

Line Voltage

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50/60 Hz

Detachable line cord. Built-in EMI filter and transient sup-pression.

DETECTOR CABLE

10 ft. (3.1 m)

Six total: two for power, one for chassis ground, three forserial data.

AMP Mate-n-Lock, white with hooded strain relief.

FRONT PANEL

Four digit, seven segment red LED, 0.57 in. (14.5 mm)high, four floating decimal point indicators between digits.

Four discrete inscriptions back lit with large red LEDs: m C i,µC i, M B q or G B q (right adjacent to digits).

Momentary contact, rubber with conductive pad.

Adjacent red LED to indicate selection.

I - 1 3 1, I n - 1 1 1, G a - 6 7, X e - 1 3 3, I - 1 2 3 , T l - 2 0 1 , M o - 9 9,and T c - 9 9 m .

Each key has a pre-assigned Calibration Value for activitymeasurements in a standard syringe or vial form.

Keys can be reset for new Calibration Values.

The M o - 9 9 key is calibrated for Mo-99 assay in a shieldedvial of Tc-99m. The Atomlab 100 Plus provides a 30-secondcountdown.

C o - 5 7 and C s - 1 3 7: used for accuracy and constancychecks.

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Line Frequency

Length

Conductors

Connectors

Activity Display

Activity Units

All Keys

Isotope SelectionKeys

CalibratorConstancy Isotope Keys

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O T H E R, 1, and 2: allows activity display of other isotopes. InSetup mode the O T H E R key selects units.

Four digit, seven segment red LED, 0.27 in. (6.9 mm) high,with colon between second and third digits, and three float-ing LED decimal point indicators between digits. Range isfrom 000.1 to 999.

Two round Increment/Decrement keys below Display. Whenan Increment/Decrement key is depressed momentarily, theDisplay changes accordingly by one digit. If the key is helddown, the Display changes slowly at first (1 digit per 1/4second), then more quickly after two-and-one-half seconds(ten digits per 1/4 second), after which the display willchange full range in about seven seconds.

Displays Calibration Value when O T H E R, 1, or 2 has beenselected;

Error Number when E r . is lit;

Calibration Value of pre-selected isotope when in Setupmode (000.1 - 999.).

The key immediately to the right of the ElectronicThumbwheel Display acts as an E N T E R key.

The S E T U P key allows Tme/Display setting, the selection ofactivity display units and the calibration of all of the IsotopeSelection keys.

The T E S T key enables the Dose Calibrator's Self-Test pro-gram, which includes a test of the electrometer sensitivity,chamber bias supply, software checksum, and the display.

The B K G N D key enables the background radiation measure-ment for storage and automatic correction.

The Print key allows the printing of the Radionuclide ActivityRecord.

ATOMLAB Dose Calibrator Operation Manual Appendix B

Biodex Medical Systems B-5 Release 2.0

Other IsotopeKeys

ElectronicThumbwheelDisplay

Increment/Decrement Keys

ElectronicThumbwheel

Associated Keys

Control FunctionKeys

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• Test: internal diagnostics

• Constancy: Stores daily constancy measurement and compares to decayed value (Co-57, Ba-133 & Cs-137

CLOCK

Displays time and calendar in Setup mode.

PRINT

Radionuclide Activity Record, this month, last month andQC Test results.

Impact dot matrix; rolled paper/labels.

• Dimensions: 3.9" x 7.9" x 7.9"(9.9cm x 20cm x 20cm)

• Weight: 4 lbs. (8.9 kgs.)

Authorized European Community Representative: Prothia, Paris, France

ATOMLAB Dose Calibrator Operation Manual Appendix B

Biodex Medical Systems B-6 Release 2.0

Calibrator QA

Printer

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APPENDIX C: DECAY CALCULATIONS

OVERVIEWThis appendix provides methods of performing radioisotopedecay calculations.

The first section provides two methods of performing DecayCalculations, the second section provides the Decay FactorChart, and the third section provides an explanation of howthe procedures used in the first section, and the DecayFactor Chart in the second section, are generated.

DECAY CALCULATION METHODS –CALCULATOR METHODIf you are using a calculator with the Yx function, performthe following:

1) Measure the current activity A0 of the radioisotope.

2) Look up the half life T1/2 of the radioisotope in Appendix D. Note the time units.

3) T1/2 = Half life of the isotopet = Elapsed TimeA = Current ActivityA0 = Activity at the time of calibration

4) Calculate A = A0 x 2(-t/T1/2)

5) Calculate the elapsed time (t) in the same units as the(T1/2) that will elapse between when the calibrated activitymeasurement was made and when you wish to know whatthe decayed activity of your radioisotope will be.

The following is a calculation of the decayed activity of Tc-99m, with an initial activity of 43 mCi, after 53 minutes:

1) A0 = 43 mCi.

2) For Tc-99m, T1/2 = 6.007 h.

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Sample Calculation

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3) Elapsed t = 53 min x 1 hr = 0.8833 hrs60 min

4) A0 x 2(-t/T1/2)A = 43 mCi x 2(-0.8833/6.007)A = 43 mCi x 2(-0.147045)A = 43 mCi x 0.903A = 38.83 mCi

DECAY FACTOR METHODThe following method is used to perform radioisotope decaycalculations using a calculator without the ex function:

1) Measure the current activity Ai of the radioisotope.

2 ) Look up the half life T1 / 2 of the radioisotope in Appendix D. Note the time units.

3) Calculate the time t, in the same units as T1/2, that will elapse between when the activity measurement was made and when you wish to know what the decayed activity of your radioisotope will be.

4) Calculate t / T1/2 in terms of N + R, where N is an integer (0, 1, 2, etc.) and R is less than 1.

5) Look up Xn (N) in Table 1.

6) Look up Xr (R) in the Decay Factor Chart.

7) Calculate Af = Ai x Xn (N) x Xr (R).

The following is a calculation of the decayed activity of Tc-99m, with an initial activity of 43 mCi, after 32.5 hours:

1) Ai = 43 mCi.

2) For Tc-99m, T1/2 = 6.007 h.

3) t = 32.5 h.

4) t / T1/2 = 32.5 h / 6.007 = 5.410. N = 5, R = 0.410.

ATOMLAB Dose Calibrator Operation Manual Appendix C

Biodex Medical Systems C-2 Release 2.0

Sample Calculation

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5) From Table 1, Xn (5) = 0.03125.

6) From the Decay Factor Chart, the .41 row and the .001column, Xr (.410) = .75262.

7) Af = Ai x Xn (N) x Xr (R) = 43 mCi x (0.03125) x(.75262)

= 1.01 mCi.

N Xn (N) = 2 -N

0 11 0.52 0.253 0.1254 0.06255 0.031256 0.015637 0.0078138 0.0039069 0.001953

10 0.000977

Table 1

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Biodex Medical Systems C-3 Release 2.0

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DECAY FACTOR CHARTXr (R), where R = t / T1/2 (0.000 to 0.499)

R .000 .001 .002 .003 .004 .005 .006 .007 .008 .009.00 1.00000 .99931 .99861 .99792 .99723 .99654 .99585 .99516 .99447 .99378.01 .99309 .99240 .99172 .99103 .99034 .98966 .98897 .98829 .98760 .98692.02 .98623 .98555 .98487 .98418 .98350 .98282 .98214 .98146 .98078 .98010.03 .97942 .97874 .97806 .97739 .97671 .97603 .97536 .97468 .97400 .97333.04 .97265 .97198 .97131 .97063 .96996 .96929 .96862 .96795 .96728 .96661.05 .96594 .96527 .96460 .96393 .96326 .96259 .96193 .96126 .96059 .95993.06 .95926 .95860 .95794 .95727 .95661 .95595 .95528 .95462 .95396 .95330.07 .95264 .95198 .95132 .95066 .95000 .94934 .94868 .94803 .94737 .94671.08 .94606 .94540 .94475 .94409 .94344 .94278 .94213 .94148 .94083 .94017.09 .93952 .93887 .93822 .93757 .93692 .93627 .93562 .93498 .93433 .93368.10 .93303 .93239 .93174 .93109 .93045 .92980 .92916 .92852 .92787 .92723.11 .92659 .92595 .92530 .92477 .92402 .92338 .92274 .92210 .92146 .92083.12 .92019 .91955 .91891 .91828 .91764 .91700 .91637 .91573 .91510 .91447.13 .91383 .91320 .91257 .91193 .91130 .91067 .91004 .90941 .90878 .90815.14 .90752 .90689 .90626 .90563 .90501 .90438 .90375 .90313 .90250 .90188.15 .90125 .90063 .90000 .89938 .89876 .89813 .89751 .89689 .89627 .89565.16 .89503 .89440 .89379 .89317 .89255 .89193 .89131 .89069 .89008 .88946.17 .88884 .88823 .88761 .88700 .88638 .88577 .88515 .88454 .88393 .88332.18 .88270 .88209 .88148 .88087 .88026 .87965 .87904 .87843 .87782 .87721.19 .87661 .87600 .87539 .87478 .87418 .87357 .87297 .87236 .87176 .87115.20 .87055 .86995 .86934 .86874 .86814 .86754 .86694 .86634 .86574 .86514.21 .86454 .86394 .86334 .86274 .86214 .86155 .86095 .86035 .85976 .85916.22 .85857 .85797 .85738 .85678 .85619 .85559 .85500 .85441 .85382 .85323.23 .85263 .85204 .85145 .85086 .85027 .84968 .84910 .84851 .84792 .84733.24 .84675 .84616 .84557 .84499 .84440 .84382 .84323 .84265 .84206 .84148.25 .84090 .84031 .83973 .83915 .83857 .83799 .83741 .83683 .83625 .83567.26 .83509 .83451 .83393 .83335 .83278 .83220 .83162 .83105 .83047 .82989.27 .82932 .82874 .82817 .82760 .82702 .82645 .82588 .82531 .82473 .82416.28 .82359 .82302 .82245 .82188 .82131 .82074 .82017 .81960 .81904 .81847.29 .81790 .81734 .81677 .81620 .81564 .81507 .81451 .81394 .81338 .81282.30 .81225 .81169 .81113 .81057 .81000 .80944 .80888 .80832 .80776 .80720.31 .80664 .80608 .80552 .80497 .80441 .80385 .80329 .80274 .80218 .80163.32 .80107 .80051 .79996 .79941 .79885 .79830 .79775 .79719 .79664 .79609.33 .79554 .79499 .79443 .79388 .79333 .79278 .79223 .79169 .79114 .79059.34 .79004 .78949 .78895 .78840 .78785 .78731 .78676 .78622 .78567 .78513.35 .78458 .78404 .78350 .78295 .78241 .78187 .78133 .78079 .78025 .77970.36 .77916 .77862 .77809 .77755 .77701 .77647 .77593 .77539 .77486 .77432.37 .77378 .77325 .77271 .77218 .77164 .77111 .77057 .77004 .76950 .76897.38 .76844 .76791 .76737 .76684 .76631 .76578 .76525 .76472 .76419 .76366.39 .76313 .76260 .76207 .76154 .76102 .76049 .75996 .75944 .75891 .75838.40 .75786 .75733 .75681 .75628 .75576 .75524 .75471 .75419 .75367 .75315.41 .75262 .75210 .75158 .75106 .75054 .75002 .74950 .74898 .74846 .74794.42 .74742 .74691 .74639 .74587 .74536 .74484 .74432 .74381 .74329 .74278.43 .74226 .74175 .74123 .74072 .74021 .73969 .73918 .73867 .73816 .73765.44 .73713 .73662 .73611 .73560 .73509 .73458 .73408 .73357 .73306 .73255.45 .73204 .73154 .73103 .73052 .73002 .72951 .72900 .72850 .72799 .72749.46 .72699 .72648 .72598 .72548 .72497 .72447 .72397 .72347 .72297 .72247.47 .72196 .72146 .72096 .72047 .71997 .71947 .71897 .71847 .71797 .71747.48 .71698 .71648 .71598 .71549 .71499 .71450 .71400 .71351 .71301 .71252.49 .71203 .71153 .71104 .71055 .71005 .70956 .70907 .70858 .70809 .70760

ATOMLAB Dose Calibrator Operation Manual Appendix C

Biodex Medical Systems C-4 Release 2.0

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DECAY FACTOR CHARTXr (R), where R = t / T1/2 (0.500 to 1.0)

R .000 .001 .002 .003 .004 .005 .006 .007 .008 .009.50 .70711 .70662 .70613 .70564 .70515 .70466 .70417 .70368 .70320 .70271.51 .70222 .70174 .70125 .70076 .70028 .69979 .69931 .69882 .69834 .69786.52 .69737 .69689 .69641 .69592 .69544 .69496 .69448 .69400 .69352 .69304.53 .69255 .69208 .69160 .69112 .69064 .69016 .68968 .68920 .68873 .68825.54 .68777 .68729 .68682 .68634 .68587 .68539 .68492 .68444 .68397 .68349.55 .68302 .68255 .68207 .68160 .68113 .68066 .68019 .67971 .67924 .67877.56 .67830 .67783 .67736 .67689 .67642 .67596 .67549 .67502 .67455 .67408.57 .67362 .67315 .67268 .67222 .67175 .67129 .67082 .67036 .66989 .66943.58 .66896 .66850 .66804 .66757 .66711 .66665 .66619 .66573 .66526 .66480.59 .66434 .66388 .66342 .66296 .66250 .66204 .66159 .66113 .66067 .66021.60 .65975 .65930 .65884 .65838 .65793 .65747 .65702 .65656 .65611 .65565.61 .65520 .65474 .65429 .65384 .65338 .65293 .65248 .65203 .65157 .65112.62 .65067 .65022 .64977 .64932 .64887 .64842 .64797 .64752 .64707 .64662.63 .64618 .64573 .64528 .64483 .64439 .64394 .64349 .64305 .64260 .64216.64 .64171 .64127 .64082 .64038 .63994 .63949 .63905 .63861 .63816 .63772.65 .63728 .63684 .63640 .63596 .63552 .63508 .63464 .63420 .63376 .63332.66 .63288 .63244 .63200 .63156 .63113 .63069 .63025 .62982 .62938 .62894.67 .62851 .62807 .62764 .62720 .62677 .62633 .62590 .62546 .62503 .62460.68 .62417 .62373 .62330 .62287 .62244 .62201 .62157 .62114 .62071 .62028.69 .61985 .61942 .61900 .61857 .61814 .61771 .61728 .61685 .61643 .61600.70 .61557 .61515 .61472 .61429 .61387 .61344 .61302 .61259 .61217 .61174.71 .61132 .61090 .61047 .61005 .60963 .60921 .60878 .60836 .60794 .60752.72 .60710 .60668 .60626 .60584 .60542 .60500 .60458 .60416 .60374 .60332.73 .60290 .60249 .60207 .60165 .60123 .60082 .60040 .59999 .59957 .59915.74 .59874 .59832 .59791 .59750 .59708 .59667 .59625 .59584 .59543 .59502.75 .59460 .59419 .59378 .59337 .59296 .59255 .59214 .59173 .59132 .59091.76 .59050 .59009 .58968 .58927 .58886 .58845 .58805 .58764 .58723 .58682.77 .58642 .58601 .58561 .58520 .58479 .58439 .58398 .58358 .58317 .58277.78 .58237 .58196 .58156 .58116 .58075 .58035 .57995 .57955 .57915 .57875.79 .57834 .57794 .57754 .57714 .57674 .57634 .57594 .57554 .57515 .57475.80 .57435 .57395 .57355 .57316 .57276 .57236 .57197 .57157 .57117 .57078.81 .57038 .56999 .56959 .56920 .56880 .56841 .56801 .56762 .56723 .56683.82 .56644 .56605 .56566 .56527 .56487 .56448 .56409 .56370 .56331 .56292.83 .56253 .56214 .56175 .56136 .56097 .56058 .56019 .55981 .55942 .55903.84 .55864 .55826 .55787 .55748 .55710 .55671 .55632 .55594 .55555 .55517.85 .55478 .55440 .55402 .55363 .55325 .55287 .55248 .55210 .55172 .55133.86 .55095 .55057 .55019 .54981 .54943 .54905 .54867 .54829 .54791 .54753.87 .54715 .54677 .54639 .54601 .54563 .54525 .54488 .54450 .54412 .54374.88 .54337 .54299 .54261 .54224 .54186 .54149 .54111 .54074 .53036 .53999.89 .53961 .53924 .53887 .53849 .53812 .53775 .53737 .53700 .53663 .53626.90 .53589 .53552 .53514 .53477 .53440 .53403 .53366 .53329 .53292 .53255.91 .53218 .53182 .53145 .53108 .53071 .53034 .52998 .52961 .52924 .52888.92 .52851 .52814 .52778 .52741 .52705 .52668 .52632 .52595 .52559 .52522.93 .52486 .52449 .52413 .52377 .52340 .52304 .52268 .52232 .52196 .52159.94 .52123 .52087 .52051 .52015 .51979 .51943 .51907 .51871 .51835 .51799.95 .51763 .51727 .51692 .51656 .51620 .51584 .51548 .51513 .51477 .51441.96 .51406 .51370 .51334 .51299 .51263 .51228 .51192 .51157 .51121 .51086.97 .51051 .51015 .50980 .50945 .50909 .50874 .50839 .50803 .50768 .50733.98 .50698 .50663 .50628 .50593 .50558 .50523 .50488 .50453 .50418 .50383.99 .50348 .50313 .50278 .50243 .50208 .50174 .50139 .50104 .50069 .500351.0 .50000

ATOMLAB Dose Calibrator Operation Manual Appendix C

Biodex Medical Systems C-5 Release 2.0

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EXPLANATION OF DECAY CALCULATION METHODSThe radioactivity of an isotope can be calculated as itdecays using the following expression:

Af = Ai e-λt

where

Af = final activity at the end of the decay time;

Ai = initial activity measured at some starting time;

t = net decay time in units inverse to λ; and

λ = (lamda) decay constant specific to the radioisotope.

λ = ln (2) / T1/2 = 0.693 / T1/2

where

T1/2 = half life specific to the radioisotope.

So, using a calculator with the ex function, decay calcula-tions can easily be performed, as shown in the first sectionof this appendix.

If you do not have a calculator with the ex function, theabove expression can be rewritten as follows:

Af = X Ai

where

X = Xn (N) x Xr (R)

N = integer number of half lives in time t; and

R = decimal remainder after dividing t by T1/2. To verify this,remember three important relations regarding exponentials:

e(A + B) = eA x eB ;

eln(A) = A ; and

ATOMLAB Dose Calibrator Operation Manual Appendix C

Biodex Medical Systems C-6 Release 2.0

CalculatorMethod

Decay FactorMethod

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eAB = (eA)B .

Now t / T1/2 = N + R

where N is an integer, and R is the remainder less than 1.

For t = 32.5 hours and T1/2 = 6.007 hours,

t / T1/2 = 32.5 / 6.007 = 5.410

so that N = 5 and R = 0.410.

Now, to simplify calculations, we can write the above rela-tion as:

Af = Ai e-λt = Ai e-ln (2)t / T1/2

Af = Ai e-ln (2)(N + R) = Ai e-ln (2)N x e-ln (2)R

= Ai x Xn (N) x Xr (R)

Xn (N) = e-ln (2)N = (eln (2))-N = 2-N

This expression is used to generate the values in Table 1.

Xr (R) = e-ln (2)R

This expression is used to generate the Decay Factor Chartfor values of R from 0.001 to 0.999.

For the above example

Xn (5) = 0.03125

Xr (0.410) = 0.75262Af = X Ai = [Xn (N) x Xr (R)] Ai = [0.03125 x 0.75262] 43 mCi

Af = 1.01 mCi

ATOMLAB Dose Calibrator Operation Manual Appendix C

Biodex Medical Systems C-7 Release 2.0

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APPENDIX DATOMLAB DOSE CALIBRATOR

PRE-SET CALIBRATION VALUES

OVERVIEW

This appendix provides the preset Calibration Values for thestandard Isotope Selection keys on your Atomlab DoseCalibrator, as well as the half-lives for the radioisotopes.

These preset calibration values are dependent on the firm-ware level of your Chamber Unit. Atomlab users with firm-ware level six or greatershould refer to Chart A, below. Ifyour firmware level is five or less, refer to Chart B on the following page.

To determine the firmware level of your dose calibrator, referto Appendix H.

Chart A(For Chamber Units with level six firmware only.)

Isotope Selection T1/2 Pre-SetKey Calibration Value

Tc-99m 6.007 h 33.6Mo-99 65.92 h 180Tl-201 72.91 h 18.8I-123 13.221 h 12.9

Xe-133 5.243 d 19.0Ga-67 3.261 d 30.2In-111 2.805 d 12.7I-131 8.021 d 22.2

Cs-137 30.0 y 17.4Co-57 271.7 d 29.3

NOTE: Refer to Appendix E for full level 6 dial value chart.

ATOMLAB Dose Calibrator Operation Manual Appendix D

Biodex Medical Systems D-1 Release 2.0

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Chart B(For Chamber Units with firmware level five or less.)

Isotope Selection T1/2 Pre-SetKey Calibration Value

Tc-99m 6.007 h 31.5Mo-99 65.92 h 179Tl-201 72.91 h 18.0I-123 13.221 h 14.4

Xe-133 5.243 d 19.6Ga-67 3.261 d 28.0In-111 2.805 d 13.5I-131 8.021 d 22.6

Cs-137 30.0 y 17.3Co-57 271.7 d 27.0

ATOMLAB Dose Calibrator Operation Manual Appendix D

Biodex Medical Systems D-2 Release 2.0

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APPENDIX E:CALIBRATION VALUES

FOR VERSION SIX FIRMWARE OTHER ISOTOPE SELECTIONS

OVERVIEW

This appendix provides Calibration Values which you mayuse to program the non-standard Isotope Selection keys ofyour Atomlab Dose Calibrator.

These values are dependent on the firmware level of yourChamber Unit. Atomlab users with firmware level six orabove should refer to Chart A on page D-1. If your firmwarelevel is five or less, refer to Chart B on page D-2.

To determine the firmware level of your dose calibrator, referto Appendix H.

NOTE: For Y-90, be sure to see the section "Dial Settingsfor Y-90", at the end of this chapter.

ATOMLAB Dose Calibrator Operation Manual Appendix E

Biodex Medical Systems E-1 Release 2.0

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ATOMLAB Dose Calibrator Operation Manual Appendix E

Biodex Medical Systems E-2 Release 2.0

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ATOMLAB Dose Calibrator Operation Manual Appendix E

Biodex Medical Systems E-3 Release 2.0

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ATOMLAB Dose Calibrator Operation Manual Appendix E

Biodex Medical Systems E-4 Release 2.0

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ATOMLAB Dose Calibrator Operation Manual Appendix E

Biodex Medical Systems E-5 Release 2.0

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ATOMLAB Dose Calibrator Operation Manual Appendix E

Biodex Medical Systems E-6 Release 2.0

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ATOMLAB Dose Calibrator Operation Manual Appendix E

Biodex Medical Systems E-7 Release 2.0

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ATOMLAB Dose Calibrator Operation Manual Appendix E

Biodex Medical Systems E-8 Release 2.0

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DIAL SETTINGS FOR Y-90 The typical Atomlab Dose Calibrator dial setting for Y-90activity in a 10 cc plastic syringe is 375. This value can beused as a starting point for initial measurements. However,it is recommended that the dial setting used for clinicalmeasurements be determined from the first dose of Zevalinreceived from the radiopharmacy, as outlined below. Followon doses should then be compared to the radiopharmacydoses for constancy.

A sampling of Atomlab Dose Calibrators has been testedwith a NIST traceable Y-90 activity in a 10 cc plastic syringegeometry with volumes ranging from three to nine cc. A Dialsetting range for Y-90 was determined to be 363 to 394 foran accurate activity measurement. The average volumedependence for this sampling of Atomlab Dose Calibratorswas determined to be 0.13%/cc, using three, four, five, six,seven, eight and nine cc in the 10 cc plastic syringe.Therefore, the volume dependence is negligible and thesame dial setting can be used for all volumes as distributedby IDEC for Y-90 Zevalin.

The Y-90 recipient, using an Atomlab Dose Calibrator,should determine the correct dial value from the first Y-90dose that they receive from a commercial radiopharmacy.This is determined by selecting the OTHER key and adjust-ing the dial setting until the displayed activity agrees withthe decay corrected Y-90 syringe activity as stated by thecommercial radiopharmacy. If the adjusted dial setting fallswithin the range of 363 to 394, then use that dial setting.

If it falls outside the range, then verify that:a) there is a well liner in placeb) a hook style dipper is usedc) the annual accuracy and daily constancy tests

results are acceptable

ATOMLAB Dose Calibrator Operation Manual Appendix E

Biodex Medical Systems E-9 Release 2.0

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If these criteria are met, then determine the percent differ-ence of the new dial value with respect to the nearest rangelimit value (363 or 394), i.e., Dial Value Error (DVE). Addthis percent to the Change in Constancy Percent Error(CCPE). If the sum of the errors is in the range of -2% to+2%, then the new dial value should be used. If not, contactBiodex Technical Support. The user may also want to con-tact the radiopharmacy to determine if a calibration errormay have occurred.

NOTE: The CCPE is the percent change from calibratorinstallation of the constancy measurement, where CCPE ="Today's" Constancy Percent Error – "Installation's"Constancy Percent Error. The Constancy Percent Error isthe measurement error with respect to the decay correctedsource activity. A change down in the Atomlab Calibratorconstancy will cause a change up in the dial value requiredto compensate the change in constancy, and visa-a versa.Thus, the CCPE will have the opposite sign as the DVE, soadding them should cancel to within 2%.

For example, a new dial value for Y-90 is found to be 400.This falls outside the range and is +1.5% higher than 394.The constancy measurement shows a -2.5% change sincethe Dose Calibrator was installed. Their sum is (+1.5%) + (-2.5%) = -1.0%, which within -2% and +2%. The dial valueof 400 should be used.

NOTE: For all Dose Calibrator Models, the well liner mustbe installed before making measurements. The well linerprovides attenuation for the Y-90 betas that would otherwiseenter the chamber and cause high readings.

ATOMLAB Dose Calibrator Operation Manual Appendix E

Biodex Medical Systems E-10 Release 2.0

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APPENDIX FATOMLAB DOSE CALIBRATOR CALIBRATION

AND TRACEABILITY

OVERVIEW

This appendix describes the calibration procedures per-formed on your Atomlab Dose Calibrator and their traceabili-ty to the National Institute of Standards & Technology.

CALIBRATION & TRACEABILITY

The calibration of the Atomlab Dose Calibrators is directlytraceable to the National Institute of Standards &Technology, formerly the National Bureau of Standards(NBS). This is achieved through the establishment of a setof working laboratory standards, the maintenance of theseworking standards, and the use of these working standardsto calibrate each Atomlab Dose Calibrator.

The working standards consist of two ionization chambersidentical to the chambers used in each Atomlab DoseCalibrator for radiation measurement, and several long-livedradiation sources.

The two standard ionization chambers have been calibratedusing radionuclides that were calibrated by the NationalInstitute of Standards & Technology, generating responsenumbers. These response numbers were then used todetermine the photon response function of the ionizationchambers. The shielding configuration is identical to that ofthe Atomlab Dose Calibrator design.

The National Institute of Standards & Technology sourcesare in glass ampule form and, because of the potential forbreakage, are not suitable for routine calibration. Instead theworking standards are in epoxy resin form in a plastic vial Epackage. These standards have been calibrated against theNational Institute of Standards & Technology sources in thetwo standard ionization chambers. Together, the chambers

ATOMLAB Dose Calibrator Operation Manual Appendix F

Biodex Medical Systems F-1 Release 2.0

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and the sources provide a high degree of accuracy andredundancy. Periodically, the source activity is measured inthe two standard chambers and the results are compared tothe expected decayed activity.

The Atomlab Dose Calibrator must first pass all electronictesting and operate for three days prior to calibration.Calibration then takes place with the Co-60 working stan-dard. The calibration value is stored in a special memorychip on the chamber circuit board. Calibration is then veri-fied by measuring the activity of all the working standards,including Co-60, Cs-137, Ba-133, and Co-57.

Finally a Tc-99m source in a 10 ml vial of saline is calibrat-ed in the two standard ionization chambers. After calibra-tion, the response to the Tc-99m standard is measured andverified to be within 2%.

ATOMLAB Dose Calibrator Operation Manual Appendix F

Biodex Medical Systems F-2 Release 2.0

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APPENDIX G: ATOMLAB 100 PLUS COMPUTER INTERCONNECTION

With the standard serial interface board installed, there will bea 9-pin male connector in the location labeled PC PORT on therear panel of the Display Unit. The Atomlab Dose Calibrator willcontinually transmit data to the port, whether a remote PC isconnected or not. Data transmitted is Activity Value, IsotopeSelected, and the Calibration Value for that isotope.

NOTE: The software to perform this remote communicationwill have to be individually tailored for the particular PC youintend to use. Although Biodex Medical Systems does notcarry the software, we can provide the names of companiesthat do.

PC PORT COMMUNICATIONS

The PC port is bidirectional and your dose calibrator recog-nizes the following commands:

Command

Hex Ascii Key Meaning Response

0x03 ETX ^C Send one record One record is sent0x11 DC1 ^Q Start automatic

transmission 0x06 ACK ^F0x13 DC3 ^S Stop automatic

transmission 0x06 ACK ^F0x31 1 1 Send one record One record is sent0x32 2 2 Start automatic

transmission 0x06 ACK ^F0x33 3 3 Stop automatic

transmission 0x06 ACK ^F

The second group of commands is included to aid develop-ers of third party software. The characters "1,2,3" will not beintercepted or interrupted by off-the-shelf serial port soft-ware packages, whereas the control characters very likelywill be.

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Do not attempt to communicate with the calibrator during itspower-up sequence. The response is undefined. All PC portcommands may be ignored after this attempt.

During normal operation, the above six characters are rec-ognized, all others are ignored.

The PC port operates at 4800 baud, no parity, 8 data bitsand 1 stop bit.

The start of a record character is a tilde (0x7E ~ ~) (HexAscii Key). The end of a record character is a line feed(0x0A LF ^J). A record is made up of four fields. The fieldseparator is one or more spaces (0x20 SPSpacebar).

The first field starts with the first character after the title andcontinues until a space is encountered. It may be from twotill six characters in length. There are thirteen isotopenames. Typical sample records are shown below (version 5firmware):

~Tc-99m 33.6 2.54 µCi~Mo-99 180. 25.6 mCi~Tl-201 18.8 14.0 MBq~I-123 12.9 19.5 GBq~Xe-133 19.0 1.57 µCi~Ga-67 30.2 2.24 µCi~In-111 12.7 -1.08 µCi~I-131 22.2 1.80 µCi~Sr-89 — —~O T H E R 17.~Cs-137 17.4 1.37 µCi~Ba-133 7.2~Co-57 29.3 2.15 µCi

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Records

Dose CalibratorRecords

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The second field is the dial value that is being used to cal-culate activity. The third field is the numerical value of activi-ty. This number may be positive or negative. The fourth andlast field is the units of activity. They will be either µCi, mCi,MBq or GBq. The final character is the end of record char-acter as described above.

NOTE FOR PCPLUS AND PROCOMM USERS

Load your communications software after your calibrator isup and running. Press Alt-W to bring up the translationtable. Change 10 to be translated to 13. Press F3 to acti-vate the translation table. (You may want to save this tablefor future use.) Press Esc to exit this option. Press Alt-F3 toadd a line-feed after each carriage return. Records willappear on your screen, one per line at the rate of approxi-mately one record per second. If this is not the case, press"3" to command the calibrator to use automatic transmis-sion. If you would like to use "records on request only",press "2". Then press "1" each time you would like the cali-brator to send you a record.

ADDITIONAL CONTROLS

As of Version 5.0 of the Atomlab 100 Plus software, the PCport for the calibrator will include additional commands thatwill allow full control of the calibrator through the PC port. Aseries of one byte codes are equated to each button on thekeyboard. All of the same key strokes that are valid from thekeyboard will be available to the user through the PC port.The commands are the letters A-Z plus "[" and "\" for the 28possible keys. This is Ascii codes 0x41 through 0x5C.

The Atomlab 100 Plus calibrator can be controlled throughthe PC port. A series of one byte codes are equated to eachbutton on the keyboard. All of the same key strokes that arevalid from the keyboard will be available to the user throughthe PC port. The commands are as follows:

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CODE BUTTONA Tc-99mB Mo-99C Ti-201D I-123E Xe-133F Ga-67G In-111H I-131I Sr-89J O T H E RK Cs-137L Ba-133M Co-57N S E T U PO T E S TP B K G N DQ LabelR This MonthS Last MonthT E N T E RU N/AV N/AW Up Arrow ETW#1X Up Arrow ETW#1Y N/AZ N/A[ N/A

N/A = Not Applicable

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APPENDIX HDETERMINING THE FIRMWARE LEVEL OF YOUR

DOSE CALIBRATOR

Use the following procedure to determine the firmware levelof your Atomlab 100 Plus Display and Chamber Units.

1 ) Press S E T U P four times.

2 ) Press T E S T. The Display Unit firmware level will appear on the Electronic Thumbwheel Display.

3 ) Press T E S T again to display the Chamber Unit firmware l e v e l .

4 ) Press T E S T once more to display high voltage.

5 ) Press T E S T once more to return to the isotope dial value s e t t i n g .

6 ) Press S E T U P to return to the normal operating mode of the system.

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APPENDIX I: ELECTROMAGNETIC COMPATIBILITY

NO T E: This MEDICAL E L E C T R I C A L EQUIPMENT needsspecial precautions regarding EMC and needs to be installedand put into service according to the EMC information pro -vided in the A C C O M PANYING DOCUMENTS.See chart on next page

NO T E: Portable and mobile RF communications equipmentcan affect MEDICAL E L E C T R I C A L E Q U I P M E N T.

NO T E: Contact Biodex Medical Systems for additionalEMC information.

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APPENDIX J: QUALITY ASSURANCE TESTING OF ATOMLAB CALIBRATORS

(MANUFACTURER'S* INSTRUCTIONS)

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DATE ON REPORT OF CALIBRATION FOR ATOMLAB DOSE CALIBRATOR

SIGNIFICANCE AND EXPIRATIONThe Report of Calibration that accompanies the Atomlab Dose Calibrator is intend-ed to represent evidence that the product was calibrated by the manufacturerbefore it was shipped. This report does not serve as an exemption to the accuracytest that is required at installation of the product in the facility where it will be used.

The date on the Report of Calibration does not expire since the report is notuseful, in the typical sense, as a record of calibration in a periodic maintenanceschedule.

For example, when a survey meter is purchased, it normally comes with a calibra-tion certificate, dated within the past 6 or 12 months. This meter is then placed ona re-calibration schedule, as determined by local regulations. The re-calibrationdate may be scheduled from the original calibration date, or simply placed on thei n s t i t u t i o n ’s normal schedule interval for such meters.Re-calibration requires themeter be shipped to a laboratory that is licensed to perform such a task. There isno need to check the accuracy of the survey meter upon installation at the facility;the facility generally has no means to check the accuracy of a survey meter.

The situation and requirement is different for Dose Calibrators. Although modernmanufacturing capabilities have improved the robust nature of dose calibratorsystems, these products tend to be more fragile than survey meters. Therefore,the NRC determined at an early date that the dose calibrator accuracy must betested on site, prior to its introduction into clinical use. This was prudent since, a)the dose calibrator was being used to measure radionuclides prior to administra-tion to a patient and, b) the availability of sealed long lived isotopes made thisaccuracy test very reasonable at a clinical facility.

The NRC now requires the facility using a dose calibrator to implement theManufacturer’s Instructions for Quality Assurance Testing of Dose Calibrators.Such Instructions accompany all Atomlab Dose Calibrators, and requires theAccuracy test "at installation and at least annually thereafter. After repair of thedose calibrator, repeat the above tests as a new installation."

Therefore, the date on the Report of Calibration cannot be used as a substitute forthe installation accuracy test. The only significance of the date is when the dosecalibrator was calibrated at the manufacturer. It never receives another calibrationunless it is returned to the manufacturer. The accuracy test at the facility is not acalibration; it is simply an accuracy test stating that the dose calibrator measures aspecific radionuclide within a stated error. The date on the Report of Calibrationdoes not expire until the dose calibrator is returned to the manufacturer.

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APPENDIX K:

SPECIFICATIONS

Isotope Selection Keys: 12 pre-programmed — Tc-99m, Sr-89, Tl-201, Mo-99, I-123, Xe-133, Ga-67, In-111, I-131, Cs-137, Co-57 and Ba-133; one additional for user defined isotopeActivity Range: 0.01 µCi to 9999 mCi (.001 mBq to 399.9 GBq) of Tc - 9 9 mEnergy Range: 25 keV to 3 MeV photonsResponse Time: One second for doses greater than 2 mCi; three seconds fordoses between 200 µCi and 2 mCi; 3-30 seconds for doses below 200 µCi Detector Linearity: ±1% or 0.2 µCi, whichever is greaterElectrometer Linearity: ±1% or 0.2 µCi, whichever is greaterElectrometer Accuracy: ±1% or 0.2 µCi, whichever is greaterOverall Accuracy: ±3% or 0.3 µCi, whichever is greater; overall accuracy isaffected by such factors as the accuracy of the specific source calibration, geo-metric variations due to sample volume or configuration, detector linearity, elec-trometer accuracy and readout accuracy Repeatability: ±0.3% above 1 mCi short term (24 hr); 1% long term (one yr)Digital Calibration Dial: Four-digit LED dial display with increment/decrementkeys to change the value; range is from 0.1 to 999Detector: Well-type pressurized ionization chamber, with Argon fill gas; wellopening 2.75" (7 cm), well depth 10.5" (26.7 cm)Detector Shielding: .25" (6.3 mm) lead on all sides except top well opening; sup-plementary shielding availableChamber Bias: 340 volt electronic power supplyEnvironmental Operating Conditions:

Temperature: 0-40° C Humidity: 0-90% rh, non-condensing

Power Requirements: 100 to 120 VAC @ 1/2A; 200 to 240 VAC @ 1/4ALine Frequency: 50/60 Hz; detachable line cord; built-in EMI filter and transientsuppressionDetector and Interface Cables: 10' (304.8 cm) long, six conductor cables (twocarry power, one is chassis ground, three carry serial data for digital I/O); endsterminated with AMP Mate-n-Lock connectors, white with hooded strain reliefDisplay Unit:

Dimensions: 12" w x 14.3" depth x 3.75" h (30.5 x 36.3 x 9.5 cm)Weight: 6 lb (2.7 kg)

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Detector Unit:Dimensions: 7.5" w x 7.5" depth x 16.25" h (19 x 19 x 41.3 cm)Well I.D.: 2.75" dia x 10.5" h (7 x 26.7 cm)Well I.D. with Liner: 2.5" dia x 10.25" h (6.35 x 26 cm)Lead Shielding: .25" lead (.63 cm)Weight: 35 lb (16 kg)

Approvals: E T L to UL 3101-1 and cETL to CAN/CSA C22.2 No. 1010.1-M92

086-265 Dose Calibrator, Atomlab™ 100Plus,115 VACIncludes: RS-232 port, vial/syringe dipper,well insert and printer

086-269 Dose Calibrator, Atomlab™ 100Plus, 230 VACIncludes: RS-232 port, vial/syringe dipper,well insert and printer

Related:086-301 Shielding Rings, Interlocking, 2" lead

For additional protection from high energy activity086-423 Moly Shield, Vial, .3" lead086-435 Moly Shield, Syringe, .3" lead086-509 Lineator

Replacement:086-242 Vial/Syringe Dipper086-241 Well Insert086-268 Labels, “peel & stick”, 200/roll086-278 Ribbon, Printer, 4/pkg

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BIODEXBiodex Medical Systems, Inc.

20 Ramsay Road, Shirley, New York, 11967-4704, Tel: 800-224-6339 (In NY and Int’l, call 631-924-9000), Fax: 631-924-9241, Email: [email protected], www.biodex.com

Certified Quality Management System


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