Capintec CRC-25R User manual

CRC®-25R
Manual Stock No. 9250-0122 Rev. H – March 2015
OWNER’S MANUAL
Capintec, Inc.
Sales and Marketing
and Customer Support
6 Arrow Road
Ramsey, NJ 07446
Phone (800) ASK-4CRC
Fax [phone]
Capintec, Inc.
Only Authorized Service Center
620 Alpha Drive
Pittsburgh, PA 15238
Phone [phone]
Fax [phone]
Copyright©2006 Capintec, Inc.
®CRC is a registered trademark of Capintec, Inc.
ALL RIGHTS RESERVED
An Eczacɩbaşɩ-Monrol company

CAPINTEC, INC. CRC®-25R
TABLE OF CONTENTS
PREFACE
SAFETY.............................................................................................................................1-1
SYMBOL DEFINITIONS ................................................................................................. 1-1
WARNING AND CAUTION LABELS...............................................................................1-2
CAUTIONS AND NOTES................................................................................................1-3
GENERAL SAFETY TIPS...............................................................................................1-6
FUNCTIONAL & TECHNICAL DESCRIPTION..................................................................2-1
INTENDED USE.............................................................................................................2-1
OPERATOR PROFILE....................................................................................................2-1
OPERATOR TRAINING..................................................................................................2-1
FUNCTIONAL DESCRIPTION........................................................................................ 2-2
OVERALL PROGRAM FLOW......................................................................................... 2-3
Utility Programs...........................................................................................................2-3
Test Programs.............................................................................................................2-3
TECHNICAL DESCRIPTION .......................................................................................... 2-4
On / Off Switch............................................................................................................2-4
Warm Up Period..........................................................................................................2-4
Environment Requirements.........................................................................................2-4
Operational.............................................................................................................2-4
Storage...................................................................................................................2-4
Power Requirements...................................................................................................2-5
Line Voltage............................................................................................................2-5
Line Filter................................................................................................................2-5
Ground Current.......................................................................................................2-5
Power Connector and Cable...................................................................................2-5
Dimensions .................................................................................................................2-6
Console ..................................................................................................................2-6
Chamber.................................................................................................................2-6
Cables ....................................................................................................................2-6
Performance................................................................................................................2-6
Regulatory Listings......................................................................................................2-7
EMC .......................................................................................................................2-7
Electrical.................................................................................................................2-7
ETL Listed ..............................................................................................................2-7
GENERAL OPERATING INSTRUCTIONS ........................................................................3-1
GENERAL.......................................................................................................................3-1
KEYBOARD....................................................................................................................3-1
Layout.........................................................................................................................3-1
Key Usage...................................................................................................................3-2
NUCLIDE Keys.......................................................................................................3-2
USER Keys.............................................................................................................3-2
March 15 TABLE OF CONTENTS TOC - 1

CAPINTEC, INC. CRC®-25R
SOURCES Key .......................................................................................................3-2
NUCL Key ...............................................................................................................3-2
CAL# Key................................................................................................................3-2
TIME Key ................................................................................................................3-2
TEST Key................................................................................................................3-2
BKG Key .................................................................................................................3-2
HOME Key ..............................................................................................................3-3
MENU Key ..............................................................................................................3-3
Ci / Bq Key ..............................................................................................................3-3
CE Key....................................................................................................................3-3
ENTER (PRINT) Key...............................................................................................3-3
NUMBER / LETTER (Alphanumeric) Keys ..............................................................3-3
ARROW Keys (and )........................................................................................3-3
ENTERING DATA ...........................................................................................................3-4
Numeric Data...............................................................................................................3-4
Alphanumeric Data ......................................................................................................3-4
MAKING MENU SELECTIONS .......................................................................................3-4
RESPONDING TO QUESTIONS (YES) or (NO)..............................................................3-4
SYSTEM SETUP ................................................................................................................4-1
GENERAL.......................................................................................................................4-1
RECEIVING CONDITION EXAMINATION.......................................................................4-1
UNPACKING AND INSTALLATION.................................................................................4-1
ASSEMBLY.....................................................................................................................4-2
Liners, Dippers, Optional Dipper and Holders ..............................................................4-4
ENVIRONMENT REQUIREMENTS.................................................................................4-5
POWER REQUIREMENTS .............................................................................................4-5
Readout.......................................................................................................................4-5
Printers (optional).........................................................................................................4-5
TURN ON PROCEDURES..............................................................................................4-6
GENERAL OPERATIONAL SETUP ................................................................................4-6
ACCEPTANCE TESTING................................................................................................4-8
Chamber Tests ............................................................................................................4-8
Diagnostics Test......................................................................................................4-8
Daily Test ................................................................................................................4-8
Accuracy Test..........................................................................................................4-8
OPERATIONAL SUMMARY............................................................................................4-8
SYSTEM INITIALIZATION..................................................................................................5-1
GENERAL.......................................................................................................................5-1
SETTING DATE AND TIME ............................................................................................5-1
CHOOSING Ci or Bq.......................................................................................................5-3
PRINTING.......................................................................................................................5-4
Printer Power Requirements........................................................................................5-4
Printer Selection...........................................................................................................5-5
RS-232....................................................................................................................5-6
USB.......................................................................................................................5-16
NONE....................................................................................................................5-17
SCREEN SETUP...........................................................................................................5-17
TOC - 2 TABLE OF CONTENTS March 15

CAPINTEC, INC. CRC®-25R
Screen Saver ............................................................................................................5-18
Screen Contrast ........................................................................................................5-19
CHAMBER INITIALIZATION .............................................................................................6-1
GENERAL.......................................................................................................................6-1
USER KEY ASSIGNMENT ............................................................................................. 6-1
Selecting User Key......................................................................................................6-2
Current Assignment Display........................................................................................6-2
Nuclide Name Assignment..........................................................................................6-3
Assignment Confirmation ............................................................................................6-3
TEST SOURCES............................................................................................................ 6-3
Source Verification......................................................................................................6-5
Entering Serial Number...............................................................................................6-6
Entering Calibration Date ............................................................................................6-6
Entering Calibration Activity.........................................................................................6-7
Indicating Daily Usage................................................................................................. 6-8
Confirming Calibration Data ........................................................................................6-8
CONSTANCY TEST SOURCE....................................................................................... 6-8
No Daily Source Chosen.............................................................................................6-8
One Daily Source Chosen...........................................................................................6-9
More than One Daily Source Chosen..........................................................................6-9
MOLY ASSAY SETUP.................................................................................................. 6-10
Selecting Moly Assay Method.................................................................................... 6-11
Moly Assay Limit .......................................................................................................6-13
ADDING A NUCLIDE.................................................................................................... 6-14
Entering Nuclide Name..............................................................................................6-14
Entering Half-Life.......................................................................................................6-15
Entering Calibration Numbers....................................................................................6-16
Determining Calibration Numbers......................................................................... 6-16
DELETING A NUCLIDE................................................................................................ 6-17
CALIBRATION NUMBERS ........................................................................................... 6-18
Entering New Calibration Numbers............................................................................6-19
Changing Calibration Numbers..................................................................................6-21
Restoring Original Calibration Numbers ....................................................................6-22
LINEARITY TEST DEFINITION.................................................................................... 6-23
Setting Up Standard Linearity Test............................................................................ 6-24
Setting Up Lineator Test............................................................................................6-25
Setting Up Calicheck Test .........................................................................................6-27
REMOTE NUCLIDE ASSIGNMENT (LEGACY SYSTEMS ONLY) ............................... 6-28
Remove Nuclides......................................................................................................6-29
Adding Nuclides ........................................................................................................6-30
USB PORT SETTINGS................................................................................................. 6-30
ACCEPTANCE & QUALITY ASSURANCE TESTS........................................................... 7-1
GENERAL.......................................................................................................................7-1
ACCEPTANCE TESTS...................................................................................................7-1
Diagnostic Test ...........................................................................................................7-1
Daily Test....................................................................................................................7-1
Accuracy Test .............................................................................................................7-2
March 15 TABLE OF CONTENTS TOC - 3

CAPINTEC, INC. CRC®-25R
Linearity Test ...............................................................................................................7-2
DAILY QUALITY ASSURANCE TESTS ..........................................................................7-2
Daily Tests...................................................................................................................7-2
Accuracy Test..............................................................................................................7-2
Contamination Test......................................................................................................7-3
QUARTERLY TESTS......................................................................................................7-4
Diagnostic Test............................................................................................................7-4
YEARLY TESTS..............................................................................................................7-4
Linearity Test ...............................................................................................................7-4
BACKGROUND AND TESTS.............................................................................................8-1
GENERAL.......................................................................................................................8-1
BACKGROUND...............................................................................................................8-1
DAILY TEST....................................................................................................................8-3
Auto Zero.....................................................................................................................8-3
Background..................................................................................................................8-4
Chamber Voltage.........................................................................................................8-6
Data Check..................................................................................................................8-7
Accuracy and Constancy Test in Daily Test.................................................................8-7
CHAMBER VOLTS..........................................................................................................8-9
ACCURACY TEST ........................................................................................................8-10
DIAGNOSTICS...................................................................................................................9-1
GENERAL.......................................................................................................................9-1
MEASUREMENT PROCEDURES....................................................................................10-1
GENERAL.....................................................................................................................10-1
MEASUREMENT PROCEDURES.................................................................................10-2
General Activity Measurement Procedure..................................................................10-2
Optimizing Low Activity Measurements......................................................................10-2
Specifying Nuclide .....................................................................................................10-2
Pre-Set Nuclide key:..............................................................................................10-2
User Key: ..............................................................................................................10-3
NUCL Key: ............................................................................................................10-3
Entering Calibration Number......................................................................................10-4
SOURCES Key..........................................................................................................10-5
Selecting Resolution..................................................................................................10-5
ACTIVITY AT A DIFFERENT TIME...............................................................................10-6
USER ID........................................................................................................................10-8
PRINTING A RECORD OF THE MEASUREMENT .......................................................10-9
OKIDATA Printer........................................................................................................10-9
Ticket Chosen: ......................................................................................................10-9
Single Line Chosen: ..............................................................................................10-9
Epson LX-300+II Printer.............................................................................................10-9
Ticket Chosen: ......................................................................................................10-9
Single Line Chosen: ..............................................................................................10-9
Roll Printer.................................................................................................................10-9
Slip Printer...............................................................................................................10-10
TOC - 4 TABLE OF CONTENTS March 15

CAPINTEC, INC. CRC®-25R
MOLY ASSAY............................................................................................................. 10-10
Mo99 Background................................................................................................... 10-11
Mo99 Assay ............................................................................................................ 10-13
Tc99m Assay ..........................................................................................................10-14
Moly Assay Results................................................................................................. 10-14
ENHANCED TESTS......................................................................................................... 11-1
GENERAL..................................................................................................................... 11-1
ENHANCED TESTS MENU.......................................................................................... 11-1
GEOMETRY TEST....................................................................................................... 11-2
Measuring with Syringe.............................................................................................11-2
Measuring with Vial...................................................................................................11-4
Measurement Results ...............................................................................................11-5
PERFORMING LINEARITY TEST ................................................................................ 11-6
Standard Test............................................................................................................11-7
First Measurement................................................................................................11-7
Second Through Last Measurements ................................................................... 11-8
Lineator Test...........................................................................................................11-10
Calicheck Test.........................................................................................................11-12
QUALITY CONTROL (QC) ......................................................................................... 11-14
Single Strip Test...................................................................................................... 11-15
Two Strips Test .......................................................................................................11-16
HMPAO Test...........................................................................................................11-19
MAG3 Test.............................................................................................................. 11-22
INVENTORY ....................................................................................................................12-1
GENERAL..................................................................................................................... 12-1
INVENTORY MENU ..................................................................................................... 12-1
ADDING TO THE INVENTORY.................................................................................... 12-2
Input Activity..............................................................................................................12-4
Measuring Activity.....................................................................................................12-6
Mo/Tc Ratio...............................................................................................................12-6
MAKING A KIT.............................................................................................................. 12-7
WITHDRAWING FROM INVENTORY ........................................................................ 12-10
PRINTING THE INVENTORY..................................................................................... 12-12
DELETING FROM INVENTORY................................................................................. 12-13
Deleting Individual Items from the Inventory............................................................ 12-13
Deleting All Items in the Inventory ........................................................................... 12-14
DOSE TABLE..................................................................................................................13-1
CALCULATION UTILITIES.............................................................................................. 14-1
GENERAL..................................................................................................................... 14-1
CONVERSION BETWEEN Ci and Bq (Ci ↔Bq).......................................................... 14-2
DECAY CALCULATION................................................................................................ 14-3
March 15 TABLE OF CONTENTS TOC - 5

CAPINTEC, INC. CRC®-25R
CLEANING AND MAINTENANCE ...................................................................................15-1
GENERAL.....................................................................................................................15-1
CLEANING and DISINFECTING...................................................................................15-1
Cleaning Instructions .................................................................................................15-1
Readout Unit and Chamber...................................................................................15-1
Liner/Dipper...........................................................................................................15-2
Printer....................................................................................................................15-2
Remote Display.....................................................................................................15-2
Disinfecting Instructions.............................................................................................15-2
Liner/Dipper...........................................................................................................15-2
PREVENTATIVE MAINTENANCE ................................................................................15-3
SERVICING...................................................................................................................15-3
DISPOSAL ....................................................................................................................15-4
FUSE SERVICING........................................................................................................15-5
Readout Fuses ..........................................................................................................15-5
Printer Fuse...............................................................................................................15-5
BATTERY REPLACEMENT ..........................................................................................15-6
TROUBLESHOOTING.................................................................................................15-12
Nothing appears on the display................................................................................15-12
Nothing happens when any key is pressed..............................................................15-12
Buzzer buzzes continuously.....................................................................................15-12
High background indication......................................................................................15-12
Zero activity is indicated with a source in the well. ...................................................15-13
Readings appear overly noisy for low activities........................................................15-13
Indication of significant negative activity...................................................................15-13
The time is reset to 00:00.........................................................................................15-13
Printer prints junk or prints with incorrect spacing. ...................................................15-13
Print head hangs up when printing tickets................................................................15-13
Printer will not respond.............................................................................................15-13
ACCESSORIES AND REPLACEMENT PARTS..........................................................15-14
SHIPPING...................................................................................................................15-15
APPENDIX I – Principle of the Calibrator
APPENDIX II – Calibration Numbers
APPENDIX III – Multiplication Factors for Non-Equilibrium Radioisotopes
APPENDIX IV – Operational Summary
INDEX
WARRANTY
DECLARATION OF CONFORMITY
TOC - 6 TABLE OF CONTENTS March 15

CAPINTEC, INC. CRC®-25R
PREFACE
Thank you for purchasing the Capintec, Inc. CRC®-25R Radioisotope Dose Calibrator. Every
effort has been made to insure that the information in this document is complete, accurate,
and up-to-date. Capintec, Inc. 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, Inc.
Please address any comments pertaining to this manual to:
CAPINTEC, Inc.
620 Alpha Drive
Pittsburgh, PA 15238
Phone [phone]
Fax [phone]
CRC®-25R and CII are registered trademarks of Capintec, Inc.
Note: Federal Law restricts this device to sale by or on the order of a physician,
pharmacist or other licensed professional.
SYSTEM DESCRIPTION
The CRC®-25R Radioisotope Dose Calibrator consists of the following:
•Display Unit (Readout)
•Chamber
•Power Cord
•Printer (optional)
The Enhanced functions provide the following enhancements:
•Inventory Functions
•Geometry Test
•Linearity Tests
oStandard Test
oLineator
oCalicheck
•QC Tests
oSingle Strip
oTwo Strips
oTc99m HMPAO
oTc99m MAG3
February 15 PREFACE p - 1

CAPINTEC, INC. CRC®-25R
YEAR 2000 COMPLIANCE
The CRC®-25R measurement system contains 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 or particulates
(IP00).
•Suitable for CONTINUOUS OPERATION.
•NOT suitable for use in an OXYGEN or a FLAMMABLE ENVIRONMENT.
ELECTROMAGNETIC INTERFERENCE POTENTIAL
This equipment complies fully with interference immunity requirements of the standard IEC
61326 “Electrical equipment for measurement control and laboratory use – EMC
requirements”.
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. If
this equipment does cause harmful interference, the user is encouraged to try to correct the
interference by one of the following measures:
•Increase the separation between the equipment and the affected device.
•Plug the unit into an outlet on a circuit different from that which the affected device is
connected.
If this fails to correct the problem, please contact Capintec’s only Authorized Service Center.
p - 2 PREFACE February 15