Capintec CAPRAC-t User manual

CAPRAC®-t
Well Counter
Manual Stock No. 9250-0140 March 22, 2021
Rev. M 2021/03/22
OWNER’S MANUAL
Mirion Technologies (Capintec), Inc.
7 Vreeland Road
Florham Park, NJ 07932, USA
Phone (800) ASK-4CRC
Fax [phone]
Atlantico Systems Ltd.
34 Oldfield, Kingston, Galway, Republic of Ireland
Copyright©2020 Capintec, Inc.
®CRC is a registered trademark of Capintec, Inc.
ALL RIGHTS RESERVED

CAPINTEC, INC. CAPRAC®-t
March 2020 TABLE OF CONTENTS TOC-1
TABLE OF CONTENTS
PREFACE
SAFETY ............................................................................................................................. 1-1
GENERAL ...................................................................................................................... 1-1
SYMBOL DEFINITIONS ................................................................................................. 1-1
WARNING AND CAUTION LABELS............................................................................... 1-2
CAUTIONS AND NOTES................................................................................................ 1-3
GENERAL SAFETY TIPS ............................................................................................... 1-4
FUNCTIONAL & TECHNICAL DESCRIPTION .................................................................. 2-1
INTENDED USE ............................................................................................................. 2-1
OPERATOR PROFILE ................................................................................................... 2-2
OPERATOR TRAINING.................................................................................................. 2-2
FUNCTIONAL DESCRIPTION........................................................................................ 2-2
POWER UP .................................................................................................................... 2-3
FUNCTIONS................................................................................................................... 2-4
Wipe Test.................................................................................................................... 2-5
TECHNICAL DESCRIPTION .......................................................................................... 2-5
On / Off Switch ............................................................................................................ 2-5
Warm Up Period.......................................................................................................... 2-6
Environment Requirements ......................................................................................... 2-6
Power Requirements................................................................................................... 2-6
Dimensions ................................................................................................................. 2-8
Performance................................................................................................................ 2-8
Regulatory Listings...................................................................................................... 2-9
GENERAL OPERATING INSTRUCTIONS ........................................................................ 3-1
GENERAL ...................................................................................................................... 3-1
MAIN SCREEN............................................................................................................... 3-1
MEASUREMENT Button 1 ......................................................................................... 3-2
AUTO CALIBRATE Button 2 ...................................................................................... 3-2
QUALITY ASSURANCE Button 3 .............................................................................. 3-2
REPORTS Button 4 ................................................................................................... 3-3
UTILITY Button 6 ....................................................................................................... 3-3
Date/Time Button 7 .................................................................................................... 3-3
SETUP Button 8......................................................................................................... 3-3
ENTERING DATA........................................................................................................... 3-4
Numeric Keypad Screen.............................................................................................. 3-4
Alphanumeric Keypad Screen ..................................................................................... 3-5
List Screen .................................................................................................................. 3-6
Date/Time Screen ....................................................................................................... 3-6
SYSTEM SETUP................................................................................................................ 4-1

CAPINTEC, INC. CAPRAC®-t
TOC-2 TABLE OF CONTENTS March 2020
GENERAL .......................................................................................................................4-1
RECEIVING CONDITION EXAMINATION ......................................................................4-1
UNPACKING AND INSTALLATION ................................................................................4-2
ASSEMBLY .....................................................................................................................4-2
Readout/Stand Base....................................................................................................4-2
System Assembly ........................................................................................................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 ................................................................................4-7
ACCEPTANCE TESTING................................................................................................4-7
Diagnostics Test ..........................................................................................................4-7
Well Counter Test ........................................................................................................4-7
SECURITY STATUS .......................................................................................................4-8
Security Status and Staff Setup ...................................................................................4-8
ADDING A USER ..........................................................................................................4-16
EDITING USER DATA ..................................................................................................4-20
Inactivating a User .....................................................................................................4-22
Reactivating a User....................................................................................................4-22
CHANGING USERS......................................................................................................4-23
Utility Screen..............................................................................................................4-23
Setup Staff Screen.....................................................................................................4-25
Guest Login ...............................................................................................................4-26
SYSTEM INITIALIZATION..................................................................................................5-1
SET DATE AND TIME.....................................................................................................5-1
CHOOSING Ci or Bq .......................................................................................................5-5
CHOOSING DATE FORMAT ..........................................................................................5-6
PRINTING .......................................................................................................................5-8
Printer Power Requirements ........................................................................................5-8
Printer Selection...........................................................................................................5-9
Okidata Menu Set-Up ................................................................................................5-10
Epson LX-300+II Menu Set-Up ..................................................................................5-12
USB PC DRIVER ..........................................................................................................5-18
SCREEN ADJUSTMENTS ............................................................................................5-19
Sleep Timeout............................................................................................................5-19
Sleep Brightness........................................................................................................5-20
Brightness..................................................................................................................5-20
Screen Calibration .....................................................................................................5-21
SPEAKER VOLUME .....................................................................................................5-22
WELL COUNTER INITIALIZATION....................................................................................6-1
GENERAL .......................................................................................................................6-1
WELL COUNTER SETUP ...............................................................................................6-2
TEST SOURCE DATA ....................................................................................................6-6
Serial Number (S/N) Field ............................................................................................6-7
Calibrated On Field ......................................................................................................6-8

CAPINTEC, INC. CAPRAC®-t
March 2020 TABLE OF CONTENTS TOC-3
Calibrated Activity Field ............................................................................................... 6-8
EFFICIENCIES DATA................................................................................................... 6-10
Wipe Full Spectrum Efficiency ................................................................................... 6-11
Nuclide Efficiency ...................................................................................................... 6-13
USER NUCLIDES......................................................................................................... 6-24
Adding a User Nuclide............................................................................................... 6-24
Editing a User Nuclide............................................................................................... 6-29
Deleting a User Nuclide............................................................................................. 6-30
WIPE TESTS SETUP ................................................................................................... 6-31
Trigger Levels ........................................................................................................... 6-35
Background Settings ................................................................................................. 6-36
Work Area Settings ................................................................................................... 6-38
Unrestricted Area Settings......................................................................................... 6-40
Sealed Sources Settings ........................................................................................... 6-41
Package Settings ...................................................................................................... 6-42
Setup Location .......................................................................................................... 6-42
SETUP PASSWORD .................................................................................................... 6-52
Change the Password ............................................................................................... 6-52
Set Password to the last 3 digits of the unit S/N ........................................................ 6-53
DIAGNOSTICS .................................................................................................................. 7-1
GENERAL ...................................................................................................................... 7-1
DIAGNOSTICS ............................................................................................................... 7-1
ACCEPTANCE & QUALITY ASSURANCE TESTS........................................................... 8-1
GENERAL ...................................................................................................................... 8-1
ACCEPTANCE TESTS................................................................................................... 8-1
QUALITY ASSURANCE TESTS ..................................................................................... 8-1
System Test ................................................................................................................ 8-1
Contamination Test ..................................................................................................... 8-2
TESTS ............................................................................................................................... 9-1
GENERAL ...................................................................................................................... 9-1
COUNT TIME ................................................................................................................. 9-1
AUTO CALIBRATE ......................................................................................................... 9-2
BACKGROUND .............................................................................................................. 9-7
QUALITY ASSURANCE TESTS ..................................................................................... 9-7
System Test ................................................................................................................ 9-8
MDA (Minimum Detectable Activity) Test................................................................... 9-14
Chi Square Test ........................................................................................................ 9-22
WIPE MEASUREMENT PROCEDURES ......................................................................... 10-1
GENERAL .................................................................................................................... 10-1
MEASURE BACKGROUND.......................................................................................... 10-3
Count Time................................................................................................................ 10-4
Measurement ............................................................................................................ 10-5
Results ...................................................................................................................... 10-5
MEASURE WIPES........................................................................................................ 10-7

CAPINTEC, INC. CAPRAC®-t
TOC-4 TABLE OF CONTENTS March 2020
Selecting Wipe Locations...........................................................................................10-8
Measuring Wipes .......................................................................................................10-9
Results.....................................................................................................................10-11
GENERAL MEASUREMENTS ....................................................................................10-13
Count Time ..............................................................................................................10-14
Set Nuclide/ROI .......................................................................................................10-14
Measuring General Sample .....................................................................................10-17
Results.....................................................................................................................10-18
REPORTS ........................................................................................................................11-1
GENERAL .....................................................................................................................11-1
AUTO CALIBRATION REPORT ....................................................................................11-3
Set Date.....................................................................................................................11-4
Search .......................................................................................................................11-5
Summary Report........................................................................................................11-6
Detailed Report..........................................................................................................11-6
SYSTEM TEST REPORT..............................................................................................11-8
Set Date.....................................................................................................................11-8
Search .......................................................................................................................11-8
Summary Report........................................................................................................11-9
Detailed Report........................................................................................................11-10
MDA REPORT ............................................................................................................11-15
Set Date...................................................................................................................11-15
Search .....................................................................................................................11-16
Summary Report......................................................................................................11-17
Detailed Report........................................................................................................11-17
CHI SQUARE REPORT ..............................................................................................11-19
Set Date...................................................................................................................11-20
Search .....................................................................................................................11-21
Summary Report......................................................................................................11-22
Detailed Report........................................................................................................11-22
WIPE REPORT ...........................................................................................................11-25
Set Date...................................................................................................................11-25
Wipe Type Selection ................................................................................................11-26
Search .....................................................................................................................11-27
Summary Report......................................................................................................11-28
Detailed Report........................................................................................................11-28
CALCULATION UTILITIES ..............................................................................................12-1
GENERAL .....................................................................................................................12-1
CONVERSION BETWEEN Ci AND Bq..........................................................................12-2
DECAY CALCULATOR .................................................................................................12-4
Select Nuclide............................................................................................................12-4
Date and Activity........................................................................................................12-4
Results.......................................................................................................................12-8
CLEANING AND MAINTENANCE ...................................................................................13-1
GENERAL .....................................................................................................................13-1

CAPINTEC, INC. CAPRAC®-t
March 2020 TABLE OF CONTENTS TOC-5
CLEANING INSTRUCTIONS........................................................................................ 13-2
Cleaning Instructions................................................................................................. 13-2
Disinfecting Instructions............................................................................................. 13-3
PREVENTATIVE MAINTENANCE................................................................................ 13-3
DISPOSAL.................................................................................................................... 13-4
SERVICING .................................................................................................................. 13-5
FUSE SERVICING........................................................................................................ 13-5
Readout Fuses.......................................................................................................... 13-5
Printer Fuse............................................................................................................... 13-6
BATTERY REPLACEMENT.......................................................................................... 13-6
TROUBLESHOOTING................................................................................................ 13-13
RELATED PRODUCTS .............................................................................................. 13-14
SHIPPING .................................................................................................................. 13-15
APPENDIX – NUCLIDE LIST
INDEX
WARRANTY
DECLARATION OF CONFORMITY

CAPINTEC, INC. CAPRAC®-t
April 2021 PREFACE p-1
PREFACE
GENERAL ........................................................................................................ 1
SYSTEM DESCRIPTION.................................................................................. 1
EQUIPMENT SAFETY .................................................................................... 2
ELECTROMAGNETIC INTERFERENCE POTENTIAL .................................... 2
IMPORTANT SAFETY INFORMATION............................................................ 2
GENERAL
Thank you for purchasing the Capintec, Inc. CAPRAC®-t Well Counter. 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:
Mirion Technologies (Capintec), Inc.
7 Vreeland Road
Florham Park, NJ 07932 USA
Phone (800) ASK-4CRC
Fax [phone]
CAPRAC®-t 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 CAPRAC®-t Well Counter has the following capabilities:
•perform wipe tests
•has MCA capabilities
•Performs automated quality assurance tests

CAPINTEC, INC. CAPRAC®-t
p-2 PREFACE March 2021
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 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. 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 Mirion Technologies (Capintec) Inc, which
is the only Authorized Service Center.
IMPORTANT SAFETY INFORMATION
The CAPRAC®-t Well Counter 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.
•Follow the unpacking and assembly instructions described in CHAPTER 4, and read
this manual carefully before using this equipment. Be sure to save all provided
documents for future reference.
•Understand all warning and caution labels as explained in CHAPTER 1: SAFETY
before operating this equipment.

CAPINTEC, INC. CAPRAC®-t
March 2021 SAFETY 1-1
CHAPTER 1
SAFETY
GENERAL .......................................................................................................1-1
SYMBOL DEFINITIONS..................................................................................1-1
WARNING AND CAUTION LABELS ..............................................................1-3
CAUTIONS AND NOTES ................................................................................1-4
GENERAL SAFETY TIPS ...............................................................................1-7
GENERAL
These warnings and instructions for use form an integral part of the CAPRAC®-t Well
Counter 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
Dangerous Voltage Present
Operator should consult accompanying documents
Follow instructions for use
General Warning
AC Voltage (Laptop computer, Power over Ethernet (PoE) Power Module)
“ON” (power) (Laptop computer)
“OFF” (power) (Laptop computer)
Date of manufacture

CAPINTEC, INC. CAPRAC®-t
1-2 SAFETY March 2021
CE Mark
Waste in Electrical and Electronic Equipment (WEEE) – This symbol
indicates that the waste of electrical and electronic equipment must not be
disposed as unsorted municipal waste and must be collected separately.
Environmentally Friendly Use Period (EFUP) – 20 years from the date of
manufacture – Toxic or hazardous substances or elements contained in
the unit will not leak or mutate under normal operating conditions resulting
in any environmental pollution, bodily injury or damage to assets.
Protective Earth Ground
Fuse
DC Voltage
Manufacturer
Serial number
Indicates the manufacturer's catalogue number to identify the
medical device
2017/745/EU symbol for hazardous substance. Contains lead.