CRC@-I5R
`
`RADIOISOTOPE DOSE
`CALIBRATOR
`
`OWNER'S MANUAL
`
`Capintec, Inc.
`Sales and Marketing
`and Customer Support
`6 Arrow Road
`Ramsey, NJ 07446
`Phone (800) ASK-4CRC
`Fax (201) 82s-1336
`
`Capintec, Inc.
`Service Center
`540 Alpha Drive
`Pittsburgh, PA 15238
`Phone (800)227-6832
`Fax (412) 963-0610
`
`Copyrighto 1990, Capintec, Inc.
`
`CRC@ is a registered trademark of Capintec, Inc.
`U.S. Patents - 3,748,476 and3,840,745
`ALL RIGHTS RESERVED
`
`Manual Stock No. 9250-0038
`Rev. W-November2004
`
`Bracco Ex. 2014
`Jubilant v. Bracco
`IPR2018-01449
`
`1
`
`
`
`RADIOISOTOPE DOSE
`CALIBRATOR
`
`OWNER'S MANUAL
`
`Capintec, Inc.
`Sales and Marketing
`and Customer Support
`6 Arrow Road
`Ramsey, NJ 07446
`Phone (800) ASK-4CRC
`Fax (201) 82s-1336
`
`Capintec, Inc.
`Service Center
`540 Alpha Drive
`Pittsburgh, PA 15238
`Phone (800)227-6832
`Fax (412) 963-0610
`
`Copyrighto 1990, Capintec, Inc.
`
`CRC@ is a registered trademark of Capintec, Inc.
`U.S. Patents - 3,748,476 and3,840,745
`ALL RIGHTS RESERVED
`
`Manual Stock No. 9250-0038
`Rev. W-November2004
`
`Bracco Ex. 2014
`Jubilant v. Bracco
`IPR2018-01449
`
`1
`
`
`
`2
`
`
`
`CAPINTEC, INC
`
`cRC@-15R
`
`TABLE OF CONTENTS
`
`PREFACE
`
`SAFETY
`SYMBOL DEFINITIONS .............
`WARNING AND CAUTION LABELS.....
`CAUTTONS AND NOTES ......................
`GENERAL SAFETY TIPS..........
`
`FUNGTIONAL & TECHNICAL DESCRIPTION
`FUNCTIONAL DESCRI PTION
`Program Organization ................
`Overall Program F|ow...........
`Utility Programs ...........
`TECHNICAL DESCRIPTION.........
`On / Off Switch
`Warm Up Period..
`Environment Requirements...........
`Operationa|.................
`Storage
`Power Requirements...............
`Line Vo|tage................
`Line Filter..
`Ground Current......
`Power Connector and Cable
`Dimensions
`Performance ...............
`Regulatory Listings......
`EMC..........
`Electrical
`ETL Listed
`
`GENERAL OPERATING INSTRUCTIONS
`GENERAL.
`KEYBOARD
`Layout
`Key Usage
`NUCLIDE Keys: Co57, Ga67, Tc99m, F18, 1n111,
`USER Keys: U1, U2, U3, U4.............
`NUCL Key............
`CAL # Key...........
`TIME Key..
`TEST Key............
`BKG Key...
`HOME Key............
`
`1-1
`1-1
`1-2
`1-3
`1-5
`
`.2-1
`.2-1
`.2-2
`.2-2
`.2-2
`.2-3
`.2-3
`.2-3
`.2-3
`.2-3
`.2-3
`.2-4
`.2-4
`.2-4
`.2-4
`.2-4
`.2-4
`.2-5
`.2-5
`.2-5
`.2-5
`.2-5
`
`l': I]ir i:lrr:iilo'
`
`................3-1
`.............3-1
`................3-1
`.............3-1
`
`f,i
`................3-2
`................3-2
`................3-2
`................3-2
`................3-2
`................3-2
`
`November 04
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`TABLE OF CONTENTS
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`TOC-1
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`3
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`CAPINTEC, INC
`
`CRC@-15R
`
`UTIL Key
`Mo ASSAY K"v ..........:..:........:.:..:
`NUMBER/LETTER Keys...............
`CE Key
`ENTER Key............
`ARROW Keys (lt and Sl)
`Ci/ Bq Key............
`Entering Data...........
`Numeric Data ..........
`Alphanumeric Data......
`Making Menu Se|ections....................
`Responding to Questions (Yes or No)
`
`SYSTEM SETUP
`GENERAL
`RECEIVING CONDITION EXAMINATION
`UNPACKING AND INSTALLATION ..........
`ASSEMBLY
`ENVIRONMENT REQUIREMENTS
`POWER REQUIREMENTS
`Readout
`Printers
`Remote Display Unit............
`TURN ON PROCEDURES
`GENERAL OPERATIONAL SETUP
`ACCEPTANCE TESTING ...............
`Diagnostics Test ..........
`Daily Test..
`Accuracy Test ...........
`OPERATIONAL SUMMARY...........
`
`SYSTEM INITIALIZATION
`GENERAL
`ENTERING DATE AND TIME.........
`CHOOSING Cior Bq
`INPUTTING TEST SOURCE DATA
`Source Verification
`Entering Serial Number
`Entering Calibration Date.............
`Entering Calibration Activity.........
`lndicating Daily Usage
`Confirming Calibration Data.........
`CONSTANCY TEST SOURCE .......
`USER KEY ASSIGNMENT..............
`Selecting User Key
`Current Assignment Display ........
`Nuclide Name Assignment ..........
`Assignment Confirmation.............
`ADDING A NUCLIDE
`
`3-2
`3-2
`3-2
`3-3
`3-3
`3-3
`3-3
`3-3
`3-3
`3-3
`3-4
`3-4
`
`4-1
`4-1
`4-1
`4-1
`4-2
`4-4
`4-4
`4-4
`4-4
`4-5
`4-5
`4-5
`4-6
`4-6
`4-7
`4-7
`4-7
`
`,.5-1
`.5-1
`,.5-1
`.5-3
`.5-4
`,.5-5
`,.5-6
`,.5-6
`..5-7
`..5-7
`.5-8
`.5-8
`.5-9
`5-1 0
`5-1 0
`5-11
`5-11
`5-11
`
`TOC-2
`
`TABLE OF CONTENTS
`
`November 04
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`4
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`CAPINTEC, INC
`
`CRC@-15R
`
`Entering Nuclide Name
`Entering Half-Life
`Entering Calibration Number......
`Determining Calibration Numbers
`DELETING A NUCLIDE
`CHANGING CALIBRATION NUMBERS .......
`Entering User Defined Calibration Number
`Restoring Original Calibration Number ......
`SELECTING MOLY ASSAY METHOD,.........
`VIEWING AND CHANGING MO/TC LIMIT...
`PRINTING.
`Printer Power Requirements ......................
`Printer Selection...
`Okidata Menu Setup
`
`ACCEPTANCE & QUALITY ASSURANCE TESTS
`GENERAL.
`ACCEPTANCE TESTS.
`Diagnostic Test ..........
`Daily Test
`Accuracy Test ..........
`QUALITY ASSURANCE TESTS
`Daily Tests
`Contamination Test
`QUARTERLY TESTS
`Daily and Diagnostic Tests.........
`Accuracy Test ..........
`Linearity Test ..........
`Decay Method
`Sleeve Method......
`Proportional Method
`
`TESTS......
`GENERAL.
`DAILY TEST
`Auto Zero
`Background
`System Test ...........
`Data Check
`Accuracy Test and Constancy Test .................
`Accuracy and Constancy Test in Daily Test
`Accuracy Test from Menu.........
`DIAGNOSTIC TEST
`Diagnostics Printout
`
`MEASUREMENT PROCEDURES.................
`GENERAL.
`MEASUREMENT PROCEDURES .............
`
`.5-12
`.5-12
`.5-13
`.5-13
`.5-14
`.5-14
`.5-14
`.5-15
`.5-1 6
`.5-17
`.5-18
`.5-18
`.5-18
`.5-19
`
`6-2
`6-4
`6-4
`6-4
`6-4
`6-5
`6-5
`6-7
`6-7
`6-7
`6-7
`
`.7-1
`.7-1
`7-1
`7-1
`7-3
`7-4
`7-5
`7-5
`7-5
`7-7
`7-7
`7-9
`
`8-1
`B-1
`8-1
`
`November 04
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`TABLE OF CONTENTS
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`TOC-3
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`5
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`CAPINTEC, INC
`
`cRC@-15R
`
`General Activity Measurement Procedure ...........
`Specifying Nuclide
`Pre-Set Nuclide Key: ...........
`User Key:
`NUCL Key: ..........
`Entering Calibration Number
`Selecting Range
`ACTIVITY AT A DIFFERENT TIME..........
`PRINTING A RECORD OF THE MEASUREMENT
`OKIDATA Printer
`Ticket Chosen:
`Single Line Chosen: ...............
`Roll Printer
`Slip Printer
`MOLY ASSAY
`Mo99 Background.......
`Mo99 Assay..............
`Tc99m Assay
`Moly Assay Results
`
`CALCULATION UTILITIES .....
`GENERAL
`CONVERSION BETWEEN Ciand Bq (Ci<+ Bq)
`DECAY CALCULATION ............
`Calculations for Nuclides in Memory
`Calculations for Nuclides not in Memory ... ..
`
`CLEANING AND MAINTENANCE.
`GENERAL
`CLEANING INSTRUCTIONS .........
`PREVENTATIVE MAI NTE NANCE
`SERVICING
`DISPOSAL
`FUSE SERVICING
`Readout Fuses
`Printer Fuse ..........
`TROUBLESHOOTING
`Nothing appears on the display.
`Nothing happens when any key is pressed. ........
`Buzzer buzzes continuously ..............
`High background indication. ...........
`Zero activity is indicated with a source in the well
`Readings appear overly noisy for low activities. ..
`lndication of significant negative activity.
`Printer prints junk or prints with incorrect spacing
`Print head hangs up when printing tickets.
`Printer will not respond.
`ACCESSORIES AND REPLACEMENT PARTS.....
`SHIPPING
`
`B-1
`8-1
`B-2
`8-2
`8-2
`8-2
`8-3
`B-3
`B-4
`8-4
`B-4
`B-4
`B-5
`B-5
`B-5
`8-5
`8-7
`8-8
`B-9
`
`9-1
`9-1
`9-1
`9-2
`9-2
`9-4
`
`10-1
`10-1
`10-1
`10-2
`10-2
`10-2
`10-3
`10-3
`10-3
`10-4
`10-4
`10-4
`10-4
`10-4
`10-4
`10-4
`10-4
`10-4
`10-5
`10-5
`10-5
`10-6
`
`TOC-4
`
`TABLE OF CONTENTS
`
`November 04
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`6
`
`
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`CAPINTEC, INC
`
`cRc@-15R
`
`APPENDIX I - Principle of the Calibrator
`
`APPENDIX ll - Table of Galibration Setting Numbers
`
`APPENDIX lll - Multiplication Factors for Non-Equilibrium Radioisotopes
`
`APPENDIX lV - Operational Summary
`
`INDEX
`
`WARRANTY
`
`DECLARATION OF CONFORMITY
`
`November 04
`
`TABLE OF CONTENTS
`
`TOC-5
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`7
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`
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`8
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`CAPINTEC, INC
`
`CRC@-15R
`
`PREFACE
`
`Thank you for purchasing the Capintec, lnc. CRC@-15R Radioisotope Dose Calibrator. Every
`effort has been made to insure that the information in this document is complete, accurate,
`and up{o-date. Capintec, lnc. assumes no responsibility for the results of errors beyond its
`control. Mention of products manufactured by other companies does not necessarily
`constitute endorsement by Capintec, lnc.
`
`Please address any comments perlaining to this manual to:
`
`CAPINTEC, lnc.
`540 Alpha Drive
`Pittsburgh, PA 15238
`Phone (412) 963-1988
`Fax (412) 963-0610
`
`CRC@-15R and Cll are registered trademarks of Capintec, lnc
`
`SYSTEM DESCRIPTION
`The basic CRC@-15R Radioisotope Dose Calibrator consists of the following
`. Display Unit
`. Chamber
`. Power Cord
`. Printer (optional)
`
`YEAR 2OOO COMPLIANCE
`The CRC@-15R measurement systems contain information technology that accurately
`processes date and time data between the years 1999 and 2000. These products, when
`used in combination with products purchased from other manufacturers whose products
`properly exchange date and time information, will accurately process the date and time. All
`future products are committed to meeting the same Year 2000 compliance.
`
`MEDICAL EQUIPMENT SAFETY CLASSIFICATION
`. CLASS I EQUIPMENT energized from an external power source.
`. TYPE B EQUIPMENT with no applied parts to the patient.
`. Ordinary EQUIPMENT without protection against the ingress of water.
`. Suitable for CONTINUOUS OPERATION.
`. NOT suitable for use in an OXYGEN or a FLAMMABLE ENVIRONMENT
`
`November 04
`
`PREFACE
`
`9
`
`
`
`CAPINTEC, INC
`
`cRc@-15R
`
`ELECTROMAGNETIC INTERFERENCE POTENTIAL
`This equipment complies fully with interference immunity requirements of the standard EN
`60601-1-2 "Medical electrical equipment: Part 1: General safety requirements; 2.
`Supplementary standard : Electromagnetic compatibility".
`
`This equipment generates radio frequency energy and, if not installed and used in
`accordance with the instructions, may cause harmful interference to nearby devices.
`However, there is no guarantee that interference will not occur in a particular installation. lf
`this equipment does cause harmful interference, the user is encouraged to try to correct the
`interference by one of the following measures:
`. lncrease the separation between the equipment and the affected device.
`. Plug the unit into an outlet on a circuit different from that to which the affected device
`is connected.
`
`lf this fails to correct the problem, please contact Capintec.
`
`IMPORTANT SAFETY INFORMATION
`The CRC@-15R measurement system has been carefully designed to give you years of safe
`and reliable performance. As with all electrical equipment, however, there are basic
`precautions you must observe to avoid injuring yourself, the patient or damaging the
`equipment.
`. Followthe unpacking and assembly instructions document, and readthis manual
`carefully before using this equipment. Be sure to save all provided documents for
`future reference.
`. Understand a// warning and caution labels as explained in the "SAFETY" chapter
`before operating this equipment.
`
`PREFACE
`
`November 04
`
`10
`
`
`
`CAPINTEC, INC
`
`cRC@-15R
`
`CHAPTER 1
`
`SAFETY
`
`These warnings and instructions for use form an integral part of the CRC@-15R and must
`therefore be kept available for consultation at all times. Precise compliance with the
`instructions is an essential condition for normal use, correct application and thus safety of the
`user.
`
`SYMBOL DEFINITIONS
`
`Protective Earth Ground
`
`I Functional Earth Ground
`
`Attention: consult owner's manual for further information
`
`Fuse
`
`AC Voltage
`
`"ON" (power)
`
`"OFF'(power)
`
`November 04
`
`SAFETY
`
`1-1
`
`11
`
`
`
`CAPINTEC, INC
`
`CRC@-15R
`
`WARNING AND CAUTION LABELS
`Located on the backof the Readout Unit is a label, (see Fig. 1-1), providing the system
`power requirements and the replacement fuse values for power line voltages.
`
`Please refer to CHAPTER 10: CLEANING AND MAINTENANCE for instructions on how to
`change the fuses of the CRC@-15R.
`
`A fire hazard may exist if the wrong size of fuse is installed.
`
`F 1.64H 25OV
`100- 240V ^., 50/60H2, 120mA
`Figure 1-1
`
`Located on the bottom of the chamber is 2 labels
`
`The first label, (see Figure 1-2), contains statements denoting not to remove the cover
`because there are no adjustments that the user can perform in the chamber.
`
`CAUTION: oo Nor REMovE covER.
`NO USER-SERVICEABLE PARTS INSIDE.
`REFER SERVICING TO AUTHORIZED
`SERVICE PERSONNEL. pN 7r2o-1zos
`
`Figure 1-2
`
`The second label (Figure 1-3) pertains to the electricalsafety of the chamber. lt is necessary
`because of the high voltage present (approximately 180 volts)on the PC board installed in
`the chamber. A screwdriver is necessary to remove the cover.
`
`+ cAUroN $
`
`HIGH VOLTAGE
`
`Figure 1-3
`
`1-2
`
`SAFETY
`
`November 04
`
`12
`
`
`
`CAPINTEC, INC
`
`CRC@-15R
`
`CAUTIONS AND NOTES
`
`onty quatified/trained personnel should "ffiervice
`Highvoltageispresentinside,o""nu,o,ffia0Votts).Duetothepresenceofthishigh
`voltage, opening the covers with the sysfem plugged in may be hazardous. Refer all
`seruicing to qualified personnel.
`
`this unit.
`
`Nointernatadjustmentsinside,n",n"*offiperformedbytheuserwithinthe
`conditions of the warranty, except for changing the fuse. Due to the presence of high
`voltages, opening the cover with the sysfem plugged in may be hazardous. Refer all
`servicing to qualified personnel.
`
`Neverusethecalibratorwithoutthewett,#u,o*e.Linersareinexpensiveandeasyto
`replace. A contaminated chamber is a very costly mistake. lf unit becomes contaminated
`remove liner and clean unit as sfafed in CHAPTER 10: CLEANIA/G AND MAINTENANCE
`before operating.
`
`CAUTION
`Care must be exercised when moving the instrument or when maintenance is performed.
`The shielded cylinder is heavy (13.6 kg or 30 lb.). ln order to provide the required sensitivity,
`the wall of the ionization chamber is extremely thin and the chamber is filled with pressurized
`gas. lt is therefore, essential to avoid mechanical shock or vibration of any kind.
`
`CAUTION
`When working with a heavy sample (especially a CapMac or Moly Assay Canistef always
`lower it gently into the chamber well. Dropping any heavy object into the well can cause
`permanent, expensive damage.
`
`CAUTION
`The use of multiplication and division factors in Calibration Numbers ig only to maintain a
`degree of consistency with other Capintec dose calibrators. The CRCG-I5R ls a direct
`reading instrument. lf multiplication or division is required, the arithmetic will be done by the
`sysfem. The actual activity is displayed. DO NOT apply these factors to the displayed activity
`yourself.
`
`CAUTION
`It is desirable to leave the unit powered at all times in order to prevent moisture absorption
`and to maintain the stability of the instrument (especially if the instrument is subjected to high
`humidity or low temperature).
`
`November 04
`
`SAFETY
`
`1-3
`
`13
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`CAPINTEC, INC
`
`CRC@-15R
`
`CAUTION
`The sensitivity of the chamber is somewhat dependent upon the veftical position of the
`sample within the well. All calibrations were done with a Standard Sample placed in the
`supplied sample holder (dipper). lt should be noted that in this configuration, the sample is
`not quite at the bottom of the well. lf, for any reason, you make a measurement without using
`the dipper, be sure that the sample is in the correct vertical position. Both the CapMac and
`the Standard Moly Assay Canister maintain the same position as the dipper.
`
`CAUTION
`This equipment generates radio frequency energy and, if not installed and used in
`accordance with the instructions, may cause harmful Electromagnetic lnterference (EMl) to
`nearby devices. However, there is no guarantee that interference will not occur in a pafticular
`installation.
`
`CAUTION
`lf any printer other than one of the three models supplied by Capintecis used, the safety of
`the unit may be compromised or Electromagnetic lnbrterence (EMl) may be introduced into
`other devices located in the same general area as the CRC@-I5R or the CRC@-I5R may
`become susceptible to EMl.
`
`Theunitcontainstead.Approp,iut""",tioY"noudbetakeniftheinterioroftheunitis
`exposed. The unit should be disposed of in accordance with local and national regulations.
`
`The unit contains a Lithium Battery. rni, ffi#dirposed of in accordance with tocat and
`national regulations.
`
`Theusershoutdalwaysverifytheuaiaityffi^"usurementorfesfresultinorderto
`m i n i m ize m ea su re me nt e rro rs.
`
`NOTE
`It is recommended that periodic (every five years) re-calibration of the unit be performed by
`Capintec to guarantee that the instrument's high reliability is maintained.
`
`1-4
`
`SAFETY
`
`November 04
`
`14
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`CAPINTEC, INC
`
`CRC@-15R
`
`GENERAL SAFETY TIPS
`. Unplug the equipment before cleaning it. Use only a damp cloth; do not use liquids or
`aerosol cleaners.
`. To protect the equipment from overheating, do not use the equipment directly in front
`of a radiator or heat register.
`. Do not use the equipment near water, or spill liquids of any kind into the equipment.
`. Be sure that your power source matches the rating listed on the CRC@-15R calibrator.
`. The CRC@-15R power cord has a grounded, 3-prong plug as a safety feature, and it
`will only fit into a grounded outlet. Do not use an adapter to defeat the grounding.
`. To avoid damaging the power cord, do not place anything on it or place it where it will
`be stepped on. lf the cord becomes damaged, replace it immediately.
`. Aside from the routine maintenance described in this manual, do not try to service
`this equipment yourself. Do not make any adjustments other than those outlined in
`this manual, as you may in-validate the calibration or cause damage requiring
`extensive repair work. Refer servicing to qualified service personnel.
`
`November 04
`
`SAFETY
`
`1-5
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`15
`
`
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`16
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`16
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`CAPINTEC, INC
`
`CRC@-15R
`
`CHAPTER 2
`
`FUNCTIONAL & TECHNIGAL
`DESCRIPTION
`
`FUNCTIONAL DESCRIPTION
`The CRC@-15R provides a precise, accurate, fast and very convenient method of measuring
`the activity of a radioisotope sample for Nuclear Medicine and Brachytherapy.
`
`The activity of the sample will be displayed with a proper unit when a sample of unknown
`strength (activity) of a known radioisotope is placed in the ionization chamber and the correct
`calibration number is selected.
`
`The sample must be placed in the same geometry as the reference source used to
`determine the calibration number by using the appropriate source holder.
`
`Nofe; For a detailed description of the basic principles of the calibrator, see fo APPENDIX I
`PRINCIPLE OF THE CALIBRATOR.
`
`Activity measurements are performed by the state of the art electronic circuits in conjunction
`with an ionization chamber possessing extremely high sensitivity and stability.
`
`The effects of the sample container, sample volume, and activity concentration are
`minimized by optimizing the counting geometries.
`
`Nine preset nuclide keys are provided for the most often used radioisotopes.
`
`Four user assignable nuclide keys are provided for commonly used radioisotopes that do not
`have a preset nuclide key.
`
`Assays may be made reliably in the Chamber, from as low as 1 microcurie^(0.1
`megaUequerel)for most radioisotopes to as high as 8 curies [200 giga (10e) Becquerel]of
`Tc99m.
`
`The 6cm diameter and 25cm deep ionization chamber well allows convenient measurements
`of virtually any radioisotope geometry in clinical use including whole generators, syringes and
`seed trains.
`
`The external shield of the ionization chamber protects users from exposure to intensive
`radiation and reduces the effect from background radiation on low-level measurements
`
`November 04
`
`FUCTIONAL & TECHNICAL DESCRIPTION
`
`2-1
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`17
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`CAPINTEC, INC
`
`cRc@-15R
`
`Program Organization
`Overall Program Flow
`When the power is turned on, the Sign-On Screen appears. When the ENTER key is
`pressed, the Measurement Screen is displayed and the CRC@-15R begins measuring
`the activity in the Chamber.
`
`Utility Programs
`Utility Programs can be accessed by pressing UTIL key from the Measurement
`Screen. Figure 2-1 illustrates utilities available from the Utility Menu.
`
`Chamber
`Measurement
`Screen
`
`UTIL
`Key
`
`Ci-Bq
`Conversion
`
`Decay
`Calculation
`
`convert from Ci to Bq or Bq to Ci
`
`calculate activity at another date/time
`
`Diagnostics
`
`confirm all the programs, memories and setups
`
`Time
`
`reset date and time
`
`Setup
`
`Ci/Bq
`
`Ci only, Bq only, User selectable
`
`Printing
`
`select printer
`
`Other
`
`User Keys
`
`assign nuclides to User keys
`for Chamber measurement
`
`Enter
`Password
`(last 3
`digits of
`Serial
`Number)
`
`Test Sources
`
`enter Test Source data
`
`Mo Assay
`
`choose CAPMAC or Canister
`enter Mo/Tc limit
`
`Nuclide Data
`
`Add Nuclide
`
`add nuclide data
`
`Delete
`Nuclide
`
`delete nuclide data
`added by user
`
`Calibration
`Numbers
`
`enter new Cal #
`restore original Cal #
`
`Figure 2-1 Program Flow
`
`2-2
`
`FUCTIONAL & TECHNICAL DESCRIPTION
`
`November 04
`
`18
`
`
`
`CAPINTEC, INC
`
`cRC@-15R
`
`TECHNICAL DESCRIPTION
`On / Off Switch
`The on/off switch (l = on; O = off) is located on the back of the instrument
`
`Warm Up Period
`Approximately 30 minutes should be allowed for the instrument to stabilize. While the
`instrument is warming up, it is strongly recommended that you become familiar with the
`cRc@-15R.
`
`Environment Req uirements
`Operational
`The instrument should be located where the level of the background radiation is as
`low and as constant as possible.
`
`The instrument should be located where the temperature is stable within a range of
`+50'F to +85"F (+10'C to +30"C) and the maximum relative humidity is 90% non-
`condensing to warrant maximum reliability and accuracy.
`
`The instrument should be located where the barometric pressure is within a range of
`27 - 31 inches of mercury (91 - 105 kilopascals).
`Storage
`The instrument should be stored where the temperature is stable and the range is
`from +39'F to +110'F (+4"C to +43'C) and the maximum relative humidity is 90%
`non-condensing to warrant maximum reliability.
`
`The instrument should be stored where the barometric pressure is within a range of
`15 - 33 inches of mercury (51 - 112 kilopascals).
`
`CAUTION
`lf these environmental requirements are not followed,
`the instrument ma display erroneous
`
`November 04
`
`FUCTIONAL & TECHNICAL DESCRIPTION
`
`2-3
`
`19
`
`
`
`CAPINTEC, INC
`
`Power Requirements
`
`cRC@-15R
`
`CAUTION
`lf the input voltage to the following ifems rs not within the stated limits, the unit may not
`function correctly or may be damaged.
`
`Line Voltage
`Readout
`100-240VAC, 120mA, 50/60H2
`
`Printers
`Okidata Microline 320
`120VAC,60H2,0.9A or
`2301240V AC, 50/60H2, 0.5A
`
`Epson TM-29511 Slip Printer (optional)
`Input: 100-240VAC, 50/60H2 , 1 .2Ai Output: +24VDC, 0.8A
`
`Epson TM-U200D Roll Printer (optional)
`lnput:120VAC, 60H2, 0.454; Output:33VDC, 1.2A or
`ln put: 220V AC, 50/60H2, 1 .2A; Output: +24YDC, 0.BA
`
`Remote Display Unit
`Input:90-264VAC , 47-63H2,0.404; Output: +5.0 VDC, 2.4A
`
`Line Filter
`Line filter is provided internally.
`Use of a filtered line is recommended if excessive line noise is anticipated
`
`Ground Current
`less than 0.SmA
`
`Power Gonnector and Cable
`A grounded 3-prong plug cord for the instrument which is approved for use at the
`user's site must be used.
`lnterconnection of devices must be made using the cables supplied with the
`instrument.
`
`Dimensions
`Console:
`
`Height
`width
`Depth
`Weight
`
`12.1cm
`25.4cm
`26.7cm
`1.8kg
`
`(4.75in)
`(10.0in)
`(10.5in)
`(3.erb)
`
`2-4
`
`FUCTIONAL & TECHNICAL DESCRIPTION
`
`November 04
`
`20
`
`
`
`cRc@-15R
`
`(16.5in)
`(6.76in)
`(30rb)
`(2.4in)
`(10.0in)
`(8ft)
`
`(6ft)
`(6ft)
`
`Height
`41.9cm
`Diameter 172cm
`Weight
`13.6k9
`Well Dia.
`6.1cm
`Well Depth 25.4cm
`Cable Lengthl 2.4m
`
`m m
`B B
`
`Power
`Printer2
`
`CAPINTEC, INC
`
`Well Chamber:
`
`Cables:
`
`Performance
`Measurement Range:
`Maximum Activity (Tc99m in CAPMAC)
`Maximum Activity (Tc99m)
`Resolution
`Electrometer Accu racy3
`System Precision
`System Linearity
`Response Time (Low activity sample)
`Response Time (All other samples)
`
`300 GBq
`(8 ci)
`240 GBq
`(6.5 ci)
`.001 MBq (.01 uci)
`better lhan *2oh
`better than + 0.1% of FSD
`within t2%
`within 4 or 16 sec.
`within t1%
`
`Regulatory Listings
`The CRC@-15R has been independently tested and is manufactured in compliance with the
`following Standards:
`
`EMC
`
`a
`
`European Union Norm EN 60601-1-2: Medical Electrical Equipment - Part 1
`General Requirements for Safety - Section 1.2 Collateral Standard:
`Electromagnetic Compatibility - Requirements and Tests
`
`Electrical
`. European Union Norm EN 60601-1: Medical Electrical Equipment - Part 1
`General Requirements for SafetY
`. European Union Norm EN 60601-1-1: Medical Electrical Equipment - Part 1
`General Requirements for Safety - Section 1.1 Collateral Standard: Safety
`Requirements for Medical Electrical Systems
`
`ETL Listed
`
`' Longer cables are available. Consult factory.
`'Optional
`3 Overall accuracy is determined by the calibration for the specific nuclide and the sample configuration and the accuracies of
`the standard sources used for calibration of the electrometer.
`
`November 04
`
`FUCTIONAL & TECHNICAL DESCRIPTION
`
`2-5
`
`21
`
`
`
`22
`
`22
`
`
`
`CAPINTEC, INC
`
`CRC@-15R
`
`CHAPTER 3
`
`GEN ERAL OPERATING INSTRUCTIONS
`
`GENERAL
`This section describes general operating procedures: the keyboard, how to enter data and
`make menu selections.
`
`TIME
`
`TEST
`
`BKG
`
`HOME
`
`ABC
`
`DEF
`
`UTIL
`
`... Bq
`ci ':
`
`OE
`
`3
`
`6
`
`I
`
`MNO
`
`WXY
`
`2
`
`5
`
`8
`
`JKL
`
`TUV
`
`\*
`
`1
`
`4
`
`a
`
`0
`
`GHI
`
`PRS
`
`QZ
`
`SPC
`
`ENTER
`
`KEYBOARD
`Layout
`
`CRC@-15R keyboard is shown below
`
`Ga
`67
`
`I
`
`123
`
`Xe
`133
`
`TI
`201
`
`Tc
`99m
`
`131
`
`NUOL
`MULTI
`
`OAL#
`
`Co
`57
`
`ln
`111
`
`U3
`
`MO
`ASSAY
`
`F1
`
`8
`
`U1
`
`U2
`
`U4
`
`Figure 3-1 Keyboard
`
`November 04
`
`GENERAL OPERATING INSTRUCTIONS
`
`3-1
`
`23
`
`
`
`CAPINTEC, INC
`
`CRC@-15R
`
`Key Usage
`General usage of keys is briefly described. Specific key usage will be given in the
`appropriate sections.
`
`NUCLIDE Keys: Co57, Ga67, Tc99m, F18, lnl'11, l'123, I 131, Xe133, T1201
`Pressing one of these keys selects that nuclide.
`
`USER Keys: U1,U2, U3, U4
`Any nuclide in memory may be assigned to each User Key. When a key is assigned,
`it acts just like a Nuclide Key.
`
`NUCL Key
`Pressing this key allows the user to select any nuclide in memory (including nuclides
`added by the user). The nuclide is chosen using the number/letter keys.
`
`GAL # Key
`Pressing this key allows the user to input a calibration number to be used for the
`current measurement.
`
`TIME Key
`After pressing this key, a time and date is input. The activity at the input time of the
`source being measured is displayed under the current activity along with the input
`time and date.
`
`TEST Key
`Pressing this key brings up the Test Menu
`
`BKG Key
`Pressing this key steps the user through the Background Measurement
`
`HOME Key
`Pressing this key will return the user to the Measurement Screen
`
`lf this key is pressed before ending the task being performed, the task will be
`terminated without being finished (e.9. entered data will not be stored and previous
`values are maintained).
`
`UTIL Key
`Pressing this key brings up the Utility Menu
`
`MO ASSAY Key
`Pressing this key steps the user through a Molyassay Procedure
`
`NUMBER/LETTER Keys
`The keys with Numbers and Letters on them are used to enter data. The decimal
`point is the UP ARROW (tS) key.
`
`5-Z
`
`GENERAL OPERATING INSTRUCTIONS
`
`November 04
`
`24
`
`
`
`CAPINTEC, INC
`
`CRC@-15R
`
`CE Key
`This is the Clear Entry key and is used to erase the last character when entering
`data.
`
`ENTER Key
`This is used to accept entered data and print a record of the measurement.
`
`ARROW Keys (R and J)
`When alpha numeric input is being entered, the Arrow keys are used to scroll through
`the possible values on each number/letter key.
`
`During a Chamber measurement, the arrows are used to change the precision of the
`displayed measurement for low activity.
`
`When a multi-field entry is being made (e.9. date, time, activity, half-life)the arrows
`are used to move to the next field or to change the value of the unit.
`
`Ci / Bq Key
`Pressing this key toggles the measurement between Curies and Becquerels
`It is only active if USER SELECTABLE has been chosen for Ci/Bq.
`
`Entering Data
`Numeric Data
`Numeric data is entered via the NUMBER/LETTER keys on the right hand side of the
`keyboard.
`
`The decimal point is on the same key as the UP ARROW (lS).
`
`lf the entry must be an integer, the decimal point will not be allowed.
`
`Press CE to erase the last digit entered.
`
`Press ENTER when a correct entry has been made.
`
`Alphanumeric Data
`Alphanumeric data (numbers and letters) are also entered via the NUMBER/LETTER
`keys.
`
`When a NUMBER/LETTER key is pressed, the number appears. Use the ARROW
`keys to change the number into one of the letters on the same key. When the UP
`ARROW (lS) is pressed, the letters appear in the clockwise direction. When the
`DOWN ARROW (J) is pressed, the letters appear in the counter clockwise direction
`
`November 04
`
`GENERAL OPERATING INSTRUCTIONS
`
`3-3
`
`25
`
`
`
`CAPINTEC, INC
`
`CRC@.15R
`
`Making Menu Selections
`All menus appear with a number in front of each selection
`
`To make a selection, press the NUMBER/LETTER key corresponding to the desired
`selection.
`
`Responding to Questions (Yes or No)
`There are several occasions where the user is asked a question which is to be answered
`Yes or No.
`
`Press Y (9, \A/)(Y) for Yes. Press N (6, MNO) for No
`
`3-4
`
`GENERAL OPERATING INSTRUCTIONS
`
`November 04
`
`26
`
`
`
`CAPINTEC, INC
`
`CRC@-15R
`
`CHAPTER 4
`
`SYSTEM SETUP
`
`GENERAL
`lnitial installation and checkout procedures are described in this section
`
`RECEIVING CONDITION EXAMINATION
`Be sure to verify that the shipping carton is received in good condition, i.e., no damage
`should be visible and the box should be dry and clean.
`
`Should the instrument be received in a damaged condition, save the shipping container and
`the packing material and request an immediate inspection by the carrier.
`
`Capintec, lnc. is not responsible for the damage, which occurs during shipment but will make
`every effort to help obtain restitution from the carrier.
`
`UNPACKING AND INSTALLATION
`The instrument is packed and shipped as a complete unit. Allthe accessories are contained
`in the carton. (lf an optional printerorremote display is included, theywill be in separate
`cartons)
`
`The instrument is shipped in a plastic bag in order to provide a dry and clean environment
`during shipment.
`
`CAUTION
`Be sure the instrument has reached room temperature prior to opening the bag
`(Leave the box in the room 4 hours before opening it.)
`
`1. Remove all outer packing material and tapes. The shipping and packing material
`should be saved for future use.
`2. The following equipment should be found upon unpacking
`. Readout Unit
`. Chamber and Liner/Dipper
`. Power Cord
`. Remote Display and cable (if ordered)
`. Printer (if ordered)
`o OKIDATA MICROLINE 320, or
`o EPSON SLIP PRINTER, or
`o EPSON ROLL PRINTER
`
`November 04
`
`SYSTEM SETUP
`
`4-1
`
`27
`
`
`
`CAPINTEC, INC
`
`CRC@-15R
`
`The Printer should have the following accessories
`. Power Supply
`. Printer Ribbon
`. Communications Cable
`. Roll Paper (lf Roll printer ordered)
`. Tickets (lf Ticket printer ordered)
`
`A/ofe; lf Test Sources are ordered, they will be shipped separately,
`3. Be sure to remove all tape and protective material from the instrument prior to
`connecting to the power line.
`
`NELI
`
`)
`
`)
`
`I
`
`I I
`
`I I
`
`i
`
`I j
`
`l\
`
`P R II'ITER
`
`CFIA[iBIR..
`
`DiPPtR-
`
`'t
`
`'LIhIE CORD
`
`e
`
`I
`
`Figure 4-1
`
`ASSEMBLY
`
`R EMOTT
`D IS P LAl'
`
`CRC_ 1 5R READOUT
`
`1. Verify that all power switches (Readout, Printer, Remote Display) are in the "OFF" or
`"0" position. (Nofe; lf using the Slip-Ticket printer, please unplug from AC Power)
`2. Connect the Chamber Cable to the connector at the rear of the CRC@-15R Readout
`labeled "CHAMBER".
`
`3. Attach the Power Cable to the receptacle on the Power Module located on the back
`of the Readout Unit.
`
`4-2
`
`SYSTEM SETUP
`
`November 04
`
`28
`
`
`
`CAPINTEC, INC
`
`cRc@-15R
`
`SLIP_TICKET PRINTER
`
`ROLL PRINTER
`
`OKIDATA PRINTER
`
`Figure 4-2 Printers
`
`4. Attach the printer cable (one end has a 9 pin "D" connector, the other end has a 25
`pin "D" connector) to the connector at the rear of the CRC@-15R Readout marked
`'PRINTER". Attach the other end to the printer.
`
`Note: Do not attach the printer cable to the "RS-232" connector.
`5. For each printer type, verify that the correct paper is installed. (Note; the Slip-Ticket
`printer paper is manually inserted at the time of printing.)
`
`.re;A e ft- ffi
`
`E. l?u[i
`
`f0g9m
`
`10:52
`
`m CAPINTEC
`
`REMOTE DISPLAY
`
`Figure 4-3 Remote Display
`
`6. Connect the Remote Display Cable (both ends have a 9 pin "D" connector) to the
`connector at the rear of the CRC@-15R labeled "RS-232'. Attach the other end to the
`Remote Display labeled'DATA'.
`
`November 04
`
`SYSTEM SETUP
`
`4-3
`
`29
`
`
`
`CAPINTEC, INC
`
`CRC@-15R
`
`Note: Do not attach the Remote Display cable to the "PRINTER" connector.
`7. Attach the Remote Display Power supply to the Remote Display power input jack
`labeled as "DC lN".
`
`ENVIRONMENT REQUIREMENTS
`The instrument should be located where the levelof the background radiation is as low and
`as constant as possible.
`
`The instrument should be located where the temperature is stable within a range of 50'F to
`85"F (10'C to 30'C)and the maximum relative humidity is g0% non-condensing to warrant
`maximum reliability and accuracy.
`
`The instrument should be located where the barometric pressure is within a range of 27 - 31
`inches of mercury (91 - 105 kilopascals).
`
`CAUTION
`lf these environmental requirements are not followed,
`the instrument
`erroneous
`
`POWER REQUIREMENTS
`
`CAUTION
`lf the input voltage to the following ffems is not within the stated limits,
`the unit
`not function correctly or ma be
`
`Readout
`
`1 00-240V AC, 1 20mA, 50/60H2
`
`Printers
`Okidata Microline 320
`120VAC,60H2,0.9A or
`2301240V AC, 50/60H2, 0.5A
`
`Epson TM-29511 Slip Printer (optional)
`Input: 100-240VAC, 50/60H2 , 1.2A; Output: +24VDC, 0.8A
`
`Epson TM-U200D Roll Printer (optional)
`lnput:120VAC, 60H2, 0.454; Output:33VDC, 1.2A or
`Input. 220V AC, 50/60H2, 1 .2A; Output: +24YDC, 0.8A
`
`4-4
`
`SYSTEM SETUP
`
`November 04
`
`30
`
`
`
`CAPINTEC, INC
`
`CRC@-15R
`
`Remote Display Unit
`Input:90-264VAC , 47-63H2,0.40A; Output: +5.0 VDC, 2.4A
`
`TURN ON PROGEDURES
`1. Be sure the interconnecting cable from the detector assembly is properly plugged into
`the back of the main unit.
`2. Confirm the power requirements of the instrument.
`3.
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