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Capintec CRC-25R User Manual

Capintec CRC-25R
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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 (201) 825-1336
Capintec, Inc.
Only Authorized Service Center
620 Alpha Drive
Pittsburgh, PA 15238
Phone (800) 227-6832
Fax (412) 963-0610
Copyright
©
2006 Capintec, Inc.
®
CRC is a registered trademark of Capintec, Inc.
ALL RIGHTS RESERVED
An Eczacɩbaşɩ-Monrol company

Table of Contents

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Capintec CRC-25R Specifications

General IconGeneral
TypeDose Calibrator
ManufacturerCapintec
ModelCRC-25R
DisplayLCD
Chamber Well Diameter2.5" (6.35 cm)
Accuracy± 5%
Response Time1 second
CalibrationAutomatic or manual
Nuclide LibraryOver 100 nuclides
ConnectivityRS232, USB
Power100-240 VAC, 50/60 Hz

Summary

PREFACE

SYSTEM DESCRIPTION

Details the components of the CRC®-25R Radioisotope Dose Calibrator and its enhanced functions.

PREFACE

MEDICAL EQUIPMENT SAFETY CLASSIFICATION

Classifies the CRC®-25R based on power source, patient contact, and environment suitability.

ELECTROMAGNETIC INTERFERENCE POTENTIAL

Addresses compliance with EMC requirements and potential interference issues.

PREFACE

IMPORTANT SAFETY INFORMATION

Highlights essential precautions for safe operation and handling of the equipment.

CHAPTER 1 SAFETY

SYMBOL DEFINITIONS

Defines various safety symbols used throughout the manual for hazard identification.

WARNING AND CAUTION LABELS

Explains the meaning of warning and caution labels affixed to the equipment for user awareness.

CAUTIONS AND NOTES

Provides critical cautionary statements regarding operation, storage, and sample handling to prevent damage or injury.

GENERAL SAFETY TIPS

Offers general guidelines for safe operation, cleaning, and maintenance practices.

CHAPTER 2 FUNCTIONAL & TECHNICAL DESCRIPTION

INTENDED USE

Describes the intended users and applications for the CRC®-25R Radioisotope Dose Calibrator.

OPERATOR PROFILE

Outlines the recommended education, knowledge, and experience for device operators.

OPERATOR TRAINING

States that the Owner's Manual contains all necessary information for operating the CRC®-25R.

FUNCTIONAL DESCRIPTION

Explains the primary functions, features, and capabilities of the CRC®-25R Dose Calibrator.

OVERALL PROGRAM FLOW

Illustrates the navigation and access to various programs and menus within the CRC®-25R system.

TECHNICAL DESCRIPTION

Details the instrument's specifications including on/off switch, warm-up, environment, power requirements, dimensions, performance, and regulatory compliance.

CHAPTER 3 GENERAL OPERATING INSTRUCTIONS

KEYBOARD

Details the layout and usage of the CRC®-25R keyboard, including specific key functions.

ENTERING DATA

Explains how to input numeric and alphanumeric data using the keyboard and special keys.

MAKING MENU SELECTIONS

Guides on how to navigate and make selections within the instrument's menus.

RESPONDING TO QUESTIONS (YES) or (NO)

Details the procedure for answering Yes/No prompts within the system interface.

CHAPTER 4 SYSTEM SETUP

RECEIVING CONDITION EXAMINATION

Provides instructions for inspecting the instrument upon receipt for any shipping damage.

UNPACKING AND INSTALLATION

Guides on safely unpacking the instrument and its components after delivery.

ASSEMBLY

Details the steps for connecting the readout unit, chamber, cables, and optional printer.

ENVIRONMENT REQUIREMENTS

Specifies the recommended environmental conditions for optimal instrument performance.

POWER REQUIREMENTS

Lists the power specifications for the readout unit and optional printers.

TURN ON PROCEDURES

Provides a step-by-step guide for powering on the CRC®-25R instrument.

GENERAL OPERATIONAL SETUP

Outlines essential initial setup tasks before first-time use, including date/time, units, and test sources.

ACCEPTANCE TESTING

Lists the critical tests that must be performed before the unit can be used operationally.

CHAPTER 5 SYSTEM INITIALIZATION

SETTING DATE AND TIME

Explains how to view and change the instrument's date and time settings.

CHOOSING CI OR BQ

Describes how to select the measurement units (Curies or Becquerels) for the displayed results.

PRINTING

Covers printer compatibility, power requirements, selection, and configuration for system output.

SCREEN SETUP

Allows adjustment of screen contrast and screen saver (backlight) timeout settings.

CHAPTER 6 CHAMBER INITIALIZATION

USER KEY ASSIGNMENT

Guides on assigning nuclides to user-programmable keys (U1-U5) for quick selection.

TEST SOURCES

Describes the purpose and input procedure for Test Sources used in Accuracy and Constancy Tests.

MOLY ASSAY SETUP

Explains how to set up Moly Assay procedures using CapMac or Canister.

ADDING A NUCLIDE

Provides instructions for adding new nuclide data (name, half-life, calibration number) to the system.

ENTERING CALIBRATION NUMBERS

Explains how to input or change calibration numbers for nuclides.

DETERMINING CALIBRATION NUMBERS

Outlines the procedure for determining calibration numbers for new nuclides.

DELETING A NUCLIDE

Guides on how to delete user-added nuclides from the system's memory.

CALIBRATION NUMBERS

Explains how to change calibration numbers for existing nuclides and restore original values.

LINEARITY TEST DEFINITION

Explains the prerequisite of defining a Linearity Test method before execution.

SETTING UP STANDARD LINEARITY TEST

Guides on setting up the Standard Linearity Test by specifying measurements and timing.

SETTING UP LINEATOR TEST

Explains the calibration procedure and measurement prompts for the Lineator Test.

SETTING UP CALICHECK TEST

Details the setup for the Calicheck Test, including measurement prompts and verification.

REMOTE NUCLIDE ASSIGNMENT (LEGACY SYSTEMS ONLY)

Explains nuclide assignment for legacy Remote Display systems.

USB PORT SETTINGS

Discusses adjusting USB port settings for Nuclear Management software connectivity.

CHAPTER 7 ACCEPTANCE & QUALITY ASSURANCE TESTS

ACCEPTANCE TESTS

Lists the critical tests to be performed before the initial use of the CRC®-25R.

DIAGNOSTIC TEST

Explains the Diagnostic Test function for checking instrument memories and programs.

DAILY TEST

Describes the daily routine tests including Auto Zero, Background, and Constancy.

ACCURACY TEST

Explains performing accuracy tests for nuclides not used in daily tests.

LINEARITY TEST

Recommends checking linearity over the entire anticipated activity range.

CONTAMINATION TEST

Details the procedure for testing the dipper and liner for contamination.

QUARTERLY TESTS

Specifies the Diagnostic Test as part of the quarterly tests.

YEARLY TESTS

Recommends checking linearity over the entire anticipated activity range annually.

CHAPTER 8 BACKGROUND AND TESTS

BACKGROUND

Explains how to perform background measurements using the BKG key and view results.

DAILY TEST

Details the components of the Daily Test and how to initiate it, including Auto Zero.

AUTO ZERO

Describes the Auto Zero function as the first part of the Daily Test and its results.

CHAMBER VOLTAGE

Explains the Chamber Voltage test and its results, including factory comparisons.

DATA CHECK

Describes the Data Check function for verifying built-in nuclide data integrity.

ACCURACY AND CONSTANCY TEST IN DAILY TEST

Explains how Accuracy and Constancy tests are performed as part of the Daily Test sequence.

CHAMBER VOLTS

Guides on performing the Chamber Voltage measurement and viewing results.

ACCURACY TEST

Explains how to perform an Accuracy Test using available Test Sources and verify results.

CHAPTER 9 DIAGNOSTICS

DIAGNOSTICS

Explains the diagnostics function for checking system integrity and generating a configuration report.

CHAPTER 10 MEASUREMENT PROCEDURES

MEASUREMENT SCREEN

Describes the layout and components of the main Measurement Screen interface.

MEASUREMENT PROCEDURES

Details general activity measurement, printing, and determining activity at a different time.

OPTIMIZING LOW ACTIVITY MEASUREMENTS

Provides conditions and tips for making meaningful measurements at low activity levels.

SPECIFYING NUCLIDE

Explains methods for specifying a nuclide for measurement via PRE-SET, USER Keys, or NUCL.

ENTERING CALIBRATION NUMBER

Guides on entering a Calibration Number instead of selecting a nuclide from memory.

SOURCES KEY

Explains the function of the SOURCES key for cycling through selected Test Sources.

SELECTING RESOLUTION

Describes how to adjust the displayed activity resolution using arrow keys.

ACTIVITY AT A DIFFERENT TIME

Explains how to determine the activity of a sample at a future date and time.

USER ID

Explains the User ID feature for including operator identification on printed records.

PRINTING A RECORD OF THE MEASUREMENT

Guides on printing measurement records for various printer types.

MOLY ASSAY

Explains how to perform a Moly Assay procedure using CapMac or Canister.

MO99 ASSAY

Guides on measuring the eluate in the CapMac or Canister for the Mo99 Assay.

TC99M ASSAY

Explains the procedure for performing the Tc99m Assay.

MOLY ASSAY RESULTS

Details Moly Assay results, including activity checks, Mo/Tc ratio, and elution concentration.

CHAPTER 11 ENHANCED TESTS

GEOMETRY TEST

Explains the Geometry Test purpose and how to select sample type (Syringe/Vial) and input volume.

PERFORMING LINEARITY TEST

Explains the prerequisite of defining a Linearity Test method before execution.

STANDARD TEST

Details the Standard Test measuring Tc99m activity over time for linearity assessment.

LINEATOR TEST

Explains the Lineator Test measuring each tube for linearity and verifying results.

CALICHECK TEST

Details the Calicheck Test setup, measurements, and result verification.

QUALITY CONTROL (QC)

Introduces Quality Control tests, including Single Strip, Two Strips, HMPAO, and MAG3.

SINGLE STRIP TEST

Details the Single Strip Test procedure, measuring top and bottom of the strip.

TWO STRIPS TEST

Explains the Two Strips Test consisting of 4 measurements for strips A and B.

HMPAO TEST

Details the HMPAO Test consisting of 6 measurements for strips A, B, and C.

MAG3 TEST

Describes the MAG3 Test, comprising 3 measurements: Fraction #1, Fraction #2, and Cartridge.

CHAPTER 12 INVENTORY

INVENTORY MENU

Shows how to access the Inventory Menu with options for Add, Make Kit, Withdraw, Print, Delete.

ADDING TO THE INVENTORY

Guides on adding items to the Inventory, including choosing nuclide, study, ID, lot number, volume, and activity.

MAKING A KIT

Guides on creating a kit from plain Tc99m in Inventory and selecting a study.

WITHDRAWING FROM INVENTORY

Guides on withdrawing activity from an Inventory item for patient use, including entering required data.

PRINTING THE INVENTORY

Describes how to print the current contents of the Inventory, showing activity, volume, and ratio.

DELETING FROM INVENTORY

Guides on deleting one or more items from the Inventory, including individual items or all items.

CHAPTER 13 DOSE TABLE

DOSE ENTRY

Guides on inputting the desired dose and selecting activity units for the Dose Table calculation.

CHAPTER 14 CALCULATION UTILITIES

CONVERSION BETWEEN CI AND BQ (CI ↔ BQ)

Details the process of converting activity values between Curies and Becquerels.

DECAY CALCULATION

Explains how to calculate the activity of a source at a different time using decay data.

CHAPTER 15 CLEANING AND MAINTENANCE

CLEANING AND DISINFECTING

Details safety precautions and instructions for cleaning and disinfecting the equipment.

PREVENTATIVE MAINTENANCE

Recommends periodic Quality Assurance Tests and immediate checks for stress or damage.

SERVICING

Covers warranty, user-serviceable parts, and recommendations for professional servicing.

DISPOSAL

Lists items for disposal consideration and advises on following regulations.

FUSE SERVICING

Provides detailed instructions for replacing readout unit fuses safely.

BATTERY REPLACEMENT

Guides on replacing the internal Lithium Coin Battery and reconfiguring the calibrator.

TROUBLESHOOTING

Provides solutions for common problems like display issues, key response, buzzing, and printer errors.

ACCESSORIES AND REPLACEMENT PARTS

Lists available accessories and replacement parts with part numbers for ordering.

SHIPPING

Provides labeling requirements and environmental conditions for returning the CRC®-25R for service.

APPENDIX I PRINCIPLE OF THE CALIBRATOR

DEFINITION OF ACTIVITY

Defines activity and its units (Curie and Becquerel) for radioactive nuclides.

MEASUREMENT OF ACTIVITY

Explains how activity is measured by detecting alpha, beta, and gamma radiation.

PHOTONS

Classifies photons (gamma rays, X-rays, Bremsstrahlung) by their production method.

INTERACTIONS OF PHOTONS WITH MATTER

Explains the three mechanisms of photon interaction with matter: Photoelectric, Compton, and Pair Production.

IONIZATION CHAMBER MEASURING PROCESS

Describes how an ionization chamber measures radiation fields by detecting charge produced.

EFFECTS OF THE INTEGRAL SHIELD

Discusses the impact of shielding on radiation exposure and chamber sensitivity.

EFFECTS OF THE CONTAINER

Explains how container material and wall thickness affect measurement accuracy.

EFFECTS OF IMPURITIES

Discusses the impact of radioisotope impurities on instrument readings.

APPENDIX II CALIBRATION NUMBERS

DETERMINING CALIBRATION SETTING NUMBERS

Describes the method for determining calibration setting numbers for radioisotopes.

RESPONSE AND SENSITIVITY

Explains expressing detector response relative to a standard and defining detector sensitivity.

CALIBRATION SETTING NUMBERS

Explains the relationship between detector response and gain setting for direct reading of activity.

ABBREVIATIONS USED IN TABLE I

Lists abbreviations and their meanings used in Table I for clarity.

UNCERTAINTY DUE TO SYRINGE CORRECTION

Explains syringe corrections for activity measurements based on container material.

UNCERTAINTY DUE TO PUBLISHED DATA

Discusses the source of uncertainty in calibration numbers from published data.

HALF-LIFE

Explains the format for reporting half-life values and their uncertainties.

REFERENCES

Lists sources used for radionuclide decay schemes and nuclear parameters.

TABLE I

Presents calibration setting numbers, syringe corrections, and half-lives for various radioisotopes.

APPENDIX III MULTIPLICATION FACTORS FOR NON-EQUILIBRIUM RADIOISOTOPES

MULTIPLICATION FACTORS FOR CA47 ACTIVITY MEASUREMENTS

Provides multiplication factors for Ca47 activity measurements based on time 't' days.

MULTIPLICATION FACTORS FOR NI56 ACTIVITY MEASUREMENTS

Provides multiplication factors for Ni56 activity measurements based on time 't' days.

MULTIPLICATION FACTORS FOR ZN62 ACTIVITY MEASUREMENTS

Provides multiplication factors for Zn62 activity measurements based on time 't' minutes.

MULTIPLICATION FACTORS FOR Y87 ACTIVITY MEASUREMENTS

Provides multiplication factors for Y87 activity measurements based on time 't' hours.

MULTIPLICATION FACTORS FOR ZR95 ACTIVITY MEASUREMENTS

Provides multiplication factors for Zr95 activity measurements based on time 't' days.

MULTIPLICATION FACTORS FOR TE121M ACTIVITY MEASUREMENTS

Provides multiplication factors for Te121m activity measurements based on time 't' days.

MULTIPLICATION FACTORS FOR SB125 ACTIVITY MEASUREMENTS

Provides multiplication factors for Sb125 activity measurements based on time 't' days.

MULTIPLICATION FACTORS FOR TE129M ACTIVITY MEASUREMENTS

Provides multiplication factors for Te129m activity measurements based on time 't' hours.

MULTIPLICATION FACTORS FOR TE132 ACTIVITY MEASUREMENTS

Provides multiplication factors for Te132 activity measurements based on time 't' hours.

MULTIPLICATION FACTORS FOR XE133M ACTIVITY MEASUREMENTS

Provides multiplication factors for Xe133m activity measurements based on time 't' days.

MULTIPLICATION FACTORS FOR XE135M ACTIVITY MEASUREMENTS

Provides multiplication factors for Xe135m activity measurements based on time 't' minutes.

MULTIPLICATION FACTORS FOR W188 ACTIVITY MEASUREMENTS

Provides multiplication factors for W188 activity measurements based on time 't' hours or days.

MULTIPLICATION FACTORS FOR PB212 ACTIVITY MEASUREMENTS

Provides multiplication factors for Pb212 activity measurements based on time 't' hours.

APPENDIX IV OPERATIONAL SUMMARY

GETTING STARTED

Introduces the start-up aid for performing immediate nuclide measurements.

QUALITY CONTROL & DAILY TESTS

Summarizes the importance of performing Daily Tests before any activity measurements.

BACKGROUND ADJUSTMENT

Explains how background adjustment is performed automatically or manually.

MEASURING NUCLIDE ACTIVITY

Summarizes how to measure nuclide activity by selecting the nuclide.

SELECTING A NUCLIDE FOR MEASUREMENT

Outlines methods to indicate the nuclide: PRE-SET KEYS, USER KEYS, NUCL KEY, CALIBRATION NUMBERS.

FUTURE ACTIVITY

Highlights the feature to automatically determine future activity of a sample.

ENTER TEST DATA

Refers to Chapter 6 for entering Test Source Data via the Main Setup Menu.

NEW PRODUCT WARRANTY

CONDITIONS AND LIMITATIONS

Outlines the terms, limitations, and exclusions of the CAPINTEC product warranty.