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Published by capintec, 2015-10-08 15:42:05

CAPTUS 700t Thyroid Uptake System Manual- Revision F

CAPTUS 700t Manual - 9250-0142 Rev G

CAPTUS® 700t

Manual Stock No. 9250-0142 October 29, 2015
Rev. G 2015/10/29

THYROID UPTAKE SYSTEM

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© 2011 Capintec, Inc.

CAPTUS is a registered trademark of Capintec, Inc.
U.S. Patent - 4,649,276

ALL RIGHTS RESERVED

An Eczacɩbaşɩ-Monrol company



CAPINTEC, INC. CAPTUS® 700t

TABLE OF CONTENTS

PREFACE

SAFETY ............................................................................................................................. 1-1
GENERAL ...................................................................................................................... 1-1
SYMBOL DEFINITIONS ................................................................................................. 1-1
LABELING ...................................................................................................................... 1-2
CAUTIONS AND NOTES................................................................................................ 1-6
GENERAL SAFETY TIPS ............................................................................................... 1-8
LIFETIME ....................................................................................................................... 1-8

FUNCTIONAL & TECHNICAL DESCRIPTION .................................................................. 2-1
INTENDED USE ............................................................................................................. 2-1
OPERATOR PROFILE ................................................................................................... 2-2
OPERATOR TRAINING.................................................................................................. 2-2
FUNCTIONAL DESCRIPTION........................................................................................ 2-2
Thyroid Uptake............................................................................................................ 2-3
Wipe Test .................................................................................................................... 2-3
Lab Tests .................................................................................................................... 2-3
Urine Test ............................................................................................................... 2-3
Blood Tests............................................................................................................. 2-4
Bioassay ..................................................................................................................... 2-4
FUNCTIONS................................................................................................................... 2-5
Overall Program Flow.................................................................................................. 2-6
TECHNICAL DESCRIPTION .......................................................................................... 2-8
Detector ...................................................................................................................... 2-8
Multichannel Analyzer ................................................................................................. 2-8
TECHNICAL SPECIFICATIONS ..................................................................................... 2-9
System Hardware........................................................................................................ 2-9
Floor Stand ............................................................................................................. 2-9
Table Top Stand (optional)...................................................................................... 2-9
Isolation Transformer .............................................................................................. 2-9
Readout Unit......................................................................................................... 2-10
Printer ................................................................................................................... 2-10
TUS Probe Detector.............................................................................................. 2-11
Well Detector – Optional ....................................................................................... 2-11
On / Off Switch .......................................................................................................... 2-11
Environment Requirements ....................................................................................... 2-11
Operational ........................................................................................................... 2-11
Storage ................................................................................................................. 2-12
Warm Up Period........................................................................................................ 2-12
System Power Requirements .................................................................................... 2-12
Input Power .......................................................................................................... 2-12
Readout ................................................................................................................ 2-12
Printers ................................................................................................................. 2-12
Line Filter.............................................................................................................. 2-13

October 15 TABLE OF CONTENTS TOC-1

CAPINTEC, INC. CAPTUS® 700t

Ground Current .....................................................................................................2-13
Power Connector and Cable..................................................................................2-13
Regulatory Listings ....................................................................................................2-13
EMC ......................................................................................................................2-13
Safety ....................................................................................................................2-13

GENERAL OPERATING INSTRUCTIONS.........................................................................3-1
GENERAL .......................................................................................................................3-1
MAIN SCREEN ...............................................................................................................3-2
MEASUREMENT Button 1..........................................................................................3-3
AUTO CALIBRATE Button 2.......................................................................................3-3
QUALITY ASSURANCE Button 3 ...............................................................................3-3
REPORTS Button 4 ....................................................................................................3-3
BIO ASSAY Button 5 ..................................................................................................3-3
THYROID UPTAKE Button 6 ......................................................................................3-4
LAB TESTS Button 7 ..................................................................................................3-4
UTILITY Button 8 ........................................................................................................3-4
Date/Time Button 9.....................................................................................................3-4
SETUP Button 10 .......................................................................................................3-4
DETECTOR Button 11................................................................................................3-4
Detector Indicator 12 ..................................................................................................3-4
ENTERING DATA ...........................................................................................................3-5
Numeric Data...............................................................................................................3-5
Alphanumeric Data ......................................................................................................3-6
List Screen...................................................................................................................3-7
Date/Time Screen ........................................................................................................3-8

SYSTEM SETUP ................................................................................................................4-1
RECEIVING CONDITION EXAMINATION ......................................................................4-1
INSTALLATION ...............................................................................................................4-2
ENVIRONMENT REQUIREMENTS ................................................................................4-5
Operational ..................................................................................................................4-5
Storage ........................................................................................................................4-5
POWER REQUIREMENTS .............................................................................................4-5
Input Power .............................................................................................................4-5
TURN ON PROCEDURES ..............................................................................................4-5
GENERAL OPERATIONAL SETUP ................................................................................4-7
ACCEPTANCE TESTING................................................................................................4-7
Diagnostics Test ..........................................................................................................4-7
Detector System Test...................................................................................................4-7
SECURITY STATUS .......................................................................................................4-8
Security Status and Staff Setup ...................................................................................4-9
Login in as root......................................................................................................4-10
ADDING A USER ..........................................................................................................4-16
UserName Field ....................................................................................................4-17
Password Field......................................................................................................4-18
Password (again) Field..........................................................................................4-19
First Name Field ....................................................................................................4-19

TOC-2 TABLE OF CONTENTS October 15

CAPINTEC, INC. CAPTUS® 700t

Last Name Field.................................................................................................... 4-19
Role Field ............................................................................................................. 4-19
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 ...................................................................................................... 5-4
CHOOSING DATE FORMAT.......................................................................................... 5-5
PRINTING ...................................................................................................................... 5-7
Printer Power Requirements........................................................................................ 5-7
Included Printer (Recommended) ........................................................................... 5-7
Optional Printers ..................................................................................................... 5-7
Printer Selection .......................................................................................................... 5-8
Okidata Menu Set-Up.................................................................................................. 5-9
Epson LX-300+II Menu Set-Up.................................................................................. 5-11
USB PC DRIVER.......................................................................................................... 5-17
SCREEN ADJUSTMENTS............................................................................................ 5-18
Sleep Timeout ........................................................................................................... 5-18
Sleep Brightness ....................................................................................................... 5-19
Brightness ................................................................................................................. 5-19
Screen Calibration..................................................................................................... 5-20
SPEAKER VOLUME..................................................................................................... 5-21

DETECTOR INITIALIZATION ............................................................................................ 6-1
GENERAL ...................................................................................................................... 6-1
CHANGING DETECTOR ................................................................................................ 6-5
TEST SOURCE DATA.................................................................................................... 6-6
Serial Number (S/N) Field ........................................................................................... 6-7
Calibrated On Field ..................................................................................................... 6-8
Calibrated Activity Field ............................................................................................... 6-9
EFFICIENCY DATA ...................................................................................................... 6-10
Wipe Full Spectrum Efficiency ................................................................................... 6-11
Nuclide Efficiency ...................................................................................................... 6-13
Setting Photopeaks............................................................................................... 6-15
Input Efficiency ..................................................................................................... 6-15
Measure Efficiency................................................................................................ 6-16
USER NUCLIDES......................................................................................................... 6-24
Adding a User Nuclide............................................................................................... 6-24
Nuclide Field ......................................................................................................... 6-25
Element Field........................................................................................................ 6-26
Halflife Field.......................................................................................................... 6-26
Energy1(keV) Field ............................................................................................... 6-26
Energy2(keV) Field ............................................................................................... 6-27

October 15 TABLE OF CONTENTS TOC-3

CAPINTEC, INC. CAPTUS® 700t

Energy3(keV) Field................................................................................................6-27
Well/Probe Efficiency(%) Fields.............................................................................6-27
Editing a User Nuclide................................................................................................6-29
Deleting a User Nuclide .............................................................................................6-30

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
Changing Detector .......................................................................................................9-4
Auto Calibration with a Probe or Well...........................................................................9-5
Auto Calibration with a Drilled Probe............................................................................9-7
Linearity Correction with Eu152 .................................................................................9-10
BACKGROUND.............................................................................................................9-11
Count Time ................................................................................................................9-13
Measurement .............................................................................................................9-14
Results.......................................................................................................................9-15
QUALITY ASSURANCE TESTS....................................................................................9-16
System Test...............................................................................................................9-18
Count Time............................................................................................................9-19
Measurement ........................................................................................................9-20
Results ..................................................................................................................9-22
MDA (Minimum Detectable Activity) Test ...................................................................9-24
Measured Background ..........................................................................................9-26
Select Nuclide .......................................................................................................9-29
Precision Factor ....................................................................................................9-29
Correction Factor...................................................................................................9-30
Results ..................................................................................................................9-30
Chi Square Test .........................................................................................................9-32
Duration.................................................................................................................9-34
Number of Samples...............................................................................................9-34
Measurement ........................................................................................................9-35
Results ..................................................................................................................9-38
Interpreting the Chi Square Results.......................................................................9-40

WIPE TESTS ....................................................................................................................10-1
GENERAL .....................................................................................................................10-1

TOC-4 TABLE OF CONTENTS October 15

CAPINTEC, INC. CAPTUS® 700t

WIPE TESTS SETUP ................................................................................................... 10-3
Trigger Levels ........................................................................................................... 10-7
Background Settings ................................................................................................. 10-8
Background Trigger Level ..................................................................................... 10-8
Background Counting Time................................................................................... 10-9
Work Area Settings ................................................................................................. 10-10
Work Area Trigger Level ..................................................................................... 10-10
Work Area Counting Time................................................................................... 10-11
Work Area Nuclides ............................................................................................ 10-11
Unrestricted Areas Settings..................................................................................... 10-12
Sealed Sources Settings ......................................................................................... 10-13
Package Settings .................................................................................................... 10-14
Setup Location ........................................................................................................ 10-14
Adding a Location ............................................................................................... 10-15
Editing a Location ............................................................................................... 10-20
Deleting a Location ............................................................................................. 10-21

MEASURE BACKGROUND........................................................................................ 10-23
Count Time.............................................................................................................. 10-24
Measurement .......................................................................................................... 10-25
Results .................................................................................................................... 10-25

MEASURE WIPES...................................................................................................... 10-26
Selecting Wipe Locations ........................................................................................ 10-27
Measuring Wipes..................................................................................................... 10-28
Count Time ......................................................................................................... 10-28
Measure.............................................................................................................. 10-29
Results .................................................................................................................... 10-30

GENERAL MEASUREMENTS.................................................................................... 10-32
Count Time.............................................................................................................. 10-33
Set Nuclide/ROI....................................................................................................... 10-34
Nuclide................................................................................................................ 10-35
ROI ..................................................................................................................... 10-36
Measuring General Sample..................................................................................... 10-37
Results .................................................................................................................... 10-38

LAB TESTS ..................................................................................................................... 11-1
GENERAL .................................................................................................................... 11-2
SCHILLING TEST......................................................................................................... 11-3
Measured Background .............................................................................................. 11-5
Urine Volume ............................................................................................................ 11-7
Urine Aliquot Volume................................................................................................. 11-7
Standard Dilution Factor............................................................................................ 11-8
Measured Standard................................................................................................... 11-8
Measured Urine Aliquot ............................................................................................. 11-9
Results .................................................................................................................... 11-11
Recalculate......................................................................................................... 11-12
Print Results ....................................................................................................... 11-12
View Measurement Spectrums ........................................................................... 11-12
Saving Data ........................................................................................................ 11-13
Exit Results......................................................................................................... 11-14

October 15 TABLE OF CONTENTS TOC-5

CAPINTEC, INC. CAPTUS® 700t

PLASMA VOLUME (I 125)...........................................................................................11-14
Measured Background .............................................................................................11-15
Standard Dilution Factor ..........................................................................................11-18
Sample Volume........................................................................................................11-18
Hematocrit ...............................................................................................................11-19
Patient Weight .........................................................................................................11-19
Measured Standard .................................................................................................11-19
Measured Whole Blood Sample...............................................................................11-20
Measured Plasma Sample .......................................................................................11-21
Results.....................................................................................................................11-23
Recalculate .........................................................................................................11-25
Print Results........................................................................................................11-25
View Measurement Spectrums ............................................................................11-26
Saving Data.........................................................................................................11-27
Exit Results .........................................................................................................11-28

RBC VOLUME (Cr51)..................................................................................................11-28
Measured Background .............................................................................................11-29
Dose Hematocrit ......................................................................................................11-31
Patient Hematocrit ...................................................................................................11-31
Patient Weight .........................................................................................................11-32
Measured Whole Blood Standard ............................................................................11-32
Measured Plasma Standard.....................................................................................11-33
Measured Whole Blood Sample...............................................................................11-34
Measured Plasma Sample .......................................................................................11-35
Results.....................................................................................................................11-37
Recalculate .........................................................................................................11-38
Print Results........................................................................................................11-38
View Measurement Spectrums ............................................................................11-38
Saving Data.........................................................................................................11-39
Exit Results .........................................................................................................11-40

RBC SURVIVAL TEST ................................................................................................11-40
Normal Values .........................................................................................................11-40
Minimum Days.....................................................................................................11-43
Maximum Days....................................................................................................11-43
Clearing Days......................................................................................................11-44
Patient Information...................................................................................................11-44
Adding a Patient ..................................................................................................11-44
Patient Information ..............................................................................................11-45
Dosage Information .............................................................................................11-48
Count Time..........................................................................................................11-51
Viewing/Editing Patient Information..........................................................................11-52
Deleting a Patient.....................................................................................................11-54
Making Measurements.............................................................................................11-55
Hematocrit ...........................................................................................................11-57
Background .........................................................................................................11-58
Measurement ......................................................................................................11-58
Comment.............................................................................................................11-59
Finish Measurement ............................................................................................11-59
View Normal Values ............................................................................................11-60
Patient Report..........................................................................................................11-60

TOC-6 TABLE OF CONTENTS October 15

CAPINTEC, INC. CAPTUS® 700t

Viewing Measurements ........................................................................................... 11-61
Completing a Patient ............................................................................................... 11-62

THYROID UPTAKE ......................................................................................................... 12-1
INTRODUCTION .......................................................................................................... 12-1
QUICK STEP GUIDE FOR THYROID UPTAKE PROCEDURE .................................... 12-4
MEASUREMENT PROTOCOLS................................................................................... 12-5
Adding a Protocol ...................................................................................................... 12-9
Location Name...................................................................................................... 12-9
Counting Methods............................................................................................... 12-10
Dose Measurement............................................................................................. 12-11
Nuclide................................................................................................................ 12-12
Dose Form.......................................................................................................... 12-12
Pre-Dose ............................................................................................................ 12-12
Residual.............................................................................................................. 12-13
Counting Time .................................................................................................... 12-13
Probe Distance ................................................................................................... 12-13
ROI Selection...................................................................................................... 12-14
Restore Original ROI........................................................................................... 12-14
Save Protocol ..................................................................................................... 12-14
Editing Protocols ..................................................................................................... 12-15
Deleting Protocols ................................................................................................... 12-16
Printing Protocols .................................................................................................... 12-17
NORMAL VALUES ..................................................................................................... 12-17
PATIENT INFORMATION........................................................................................... 12-20
Adding Patients ....................................................................................................... 12-20
Select Protocol.................................................................................................... 12-20
Count Time ......................................................................................................... 12-22
Probe Distance ................................................................................................... 12-23
View Protocol...................................................................................................... 12-24
Patient Information.............................................................................................. 12-26
Dosage Information............................................................................................. 12-29
Viewing/Editing Patient Information ......................................................................... 12-33
Deleting a Patient .................................................................................................... 12-35
MAKING MEASUREMENTS....................................................................................... 12-36
Decay Correct Administered Dose .......................................................................... 12-36
Pre-Dose Measurement...................................................................................... 12-36
Administered Dose Measurement ....................................................................... 12-40
Enter Administration Date/Time .......................................................................... 12-44
Residual Measurement ....................................................................................... 12-46
Measure Patient.................................................................................................. 12-48
Measure Same Reference Dose Before Each Uptake............................................. 12-51
Pre-Dose Measurement...................................................................................... 12-51
Enter Administration Date/Time .......................................................................... 12-52
Residual Measurement ....................................................................................... 12-52
Measure Patient.................................................................................................. 12-52
View Protocol .......................................................................................................... 12-55
RESULTS ................................................................................................................... 12-55
Patients Reports...................................................................................................... 12-55

October 15 TABLE OF CONTENTS TOC-7

CAPINTEC, INC. CAPTUS® 700t

Viewing Measurements............................................................................................12-56
COMPLETING A PATIENT .........................................................................................12-59

BIOASSAY .......................................................................................................................13-1
INTRODUCTION ...........................................................................................................13-1
BIOASSAY SETUP .......................................................................................................13-3
Count Time ................................................................................................................13-6
Probe Distance ..........................................................................................................13-7
Nuclide to Use in BioAssay ........................................................................................13-7
Trigger Levels ............................................................................................................13-7
Setup BioAssay ROI ..................................................................................................13-8
Load Original Values .............................................................................................13-9
Efficiency ...................................................................................................................13-9
Measure Efficiency ................................................................................................13-9
Enter Efficiency ...................................................................................................13-16
Saving BioAssay Setup............................................................................................13-18
BIOASSAY MEASUREMENTS ...................................................................................13-19
Staff .........................................................................................................................13-19
Probe Distance ........................................................................................................13-23
Background..............................................................................................................13-24
Neck Measurement..................................................................................................13-24
Results.....................................................................................................................13-24
Comment.............................................................................................................13-25
Save Report ........................................................................................................13-25
Save and Print Report .........................................................................................13-26

REPORTS ........................................................................................................................14-1
GENERAL .....................................................................................................................14-1
AUTO CALIBRATION REPORT ....................................................................................14-3
Set Date.....................................................................................................................14-4
Detector Selection......................................................................................................14-5
Search .......................................................................................................................14-6
Summary Report........................................................................................................14-7
Detailed Report ..........................................................................................................14-7
SYSTEM TEST REPORT..............................................................................................14-8
Set Date.....................................................................................................................14-8
Detector Selection......................................................................................................14-9
Search .....................................................................................................................14-10
Summary Report......................................................................................................14-11
Detailed Report ........................................................................................................14-11
Print Detailed Result............................................................................................14-12
Inactivate a System Test .....................................................................................14-12
View System Test Spectrum................................................................................14-14
View Background Spectrum ................................................................................14-15
Exit Detailed Result .............................................................................................14-16
MDA REPORT ............................................................................................................14-16
Set Date...................................................................................................................14-16
Detector Selection....................................................................................................14-16
Search .....................................................................................................................14-17

TOC-8 TABLE OF CONTENTS October 15

CAPINTEC, INC. CAPTUS® 700t

Summary Report ..................................................................................................... 14-18
Detailed Report ....................................................................................................... 14-18

Print Detailed Result ........................................................................................... 14-19
Inactivate an MDA Test....................................................................................... 14-19
View MDA Test Spectrum ................................................................................... 14-20
Exit Detailed Result............................................................................................. 14-20
CHI SQUARE REPORT.............................................................................................. 14-21
Set Date .................................................................................................................. 14-21
Detector Selection ................................................................................................... 14-21
Search..................................................................................................................... 14-22
Summary Report ..................................................................................................... 14-23
Detailed Report ....................................................................................................... 14-23
Print Detailed Result ........................................................................................... 14-24
Inactivate a Chi Square Test............................................................................... 14-24
View Chi Square Test Spectrum ......................................................................... 14-25
Exit Detailed Result............................................................................................. 14-25
WIPE REPORT........................................................................................................... 14-26
Set Date .................................................................................................................. 14-26
Wipe Type Selection ............................................................................................... 14-27
Search..................................................................................................................... 14-28
Summary Report ..................................................................................................... 14-29
Detailed Report ....................................................................................................... 14-30
Print Detailed Result ........................................................................................... 14-31
Inactivate a Wipe Test ........................................................................................ 14-31
View Wipe Test Spectrum................................................................................... 14-32
View Background Spectrum................................................................................ 14-32
Exit Detailed Result............................................................................................. 14-33
SCHILLING REPORT ................................................................................................. 14-33
Set Date .................................................................................................................. 14-33
Search..................................................................................................................... 14-34
Summary Report ..................................................................................................... 14-35
Detailed Report ....................................................................................................... 14-35
Print Detailed Result ........................................................................................... 14-36
Inactivate a Schilling Test ................................................................................... 14-36
View Schilling Test Spectrums............................................................................ 14-37
Exit Detailed Result............................................................................................. 14-37
PLASMA REPORT ..................................................................................................... 14-38
Set Date .................................................................................................................. 14-38
Search..................................................................................................................... 14-39
Summary Report ..................................................................................................... 14-39
Detailed Report ....................................................................................................... 14-39
Print Detailed Result ........................................................................................... 14-40
Inactivate a Plasma Test..................................................................................... 14-40
View Plasma Test Spectrums ............................................................................. 14-41
Exit Detailed Result............................................................................................. 14-41
RBC REPORT ............................................................................................................ 14-42
Set Date .................................................................................................................. 14-42
Search..................................................................................................................... 14-42
Summary Report ..................................................................................................... 14-43
Detailed Report ....................................................................................................... 14-44

October 15 TABLE OF CONTENTS TOC-9

CAPINTEC, INC. CAPTUS® 700t

Print Detailed Result............................................................................................14-44
Inactivate a RBC Test..........................................................................................14-44
View RBC Test Spectrums ..................................................................................14-45
Exit Detailed Result .............................................................................................14-46
RBC SURVIVAL REPORT ..........................................................................................14-46
Search .....................................................................................................................14-46
Report ......................................................................................................................14-49
Print Result..........................................................................................................14-49
Reactivate a Patient ............................................................................................14-49
View Normal Values ............................................................................................14-50
Viewing Measurements .......................................................................................14-50
Exit Results .........................................................................................................14-52
THYROID UPTAKE REPORT .....................................................................................14-52
Search .....................................................................................................................14-53
Detailed Report ........................................................................................................14-55
Print Detailed Result............................................................................................14-56
Reactivate a Patient ............................................................................................14-56
View Protocol ......................................................................................................14-57
Viewing Measurements .......................................................................................14-58
Exit Detailed Result .............................................................................................14-60
BIOASSAY REPORT ..................................................................................................14-61
Set Date...................................................................................................................14-61
Staff .........................................................................................................................14-62
Search .....................................................................................................................14-64
Summary Report......................................................................................................14-65
Detailed Report ........................................................................................................14-66
Print Detailed Result............................................................................................14-67
Inactivate a BioAssay Test ..................................................................................14-67
View BioAssay Test Spectrums...........................................................................14-68
Exit Detailed Result .............................................................................................14-68

CALCULATION UTILITIES ..............................................................................................15-1
GENERAL .....................................................................................................................15-1
CONVERSION BETWEEN Ci AND Bq..........................................................................15-2
DECAY CALCULATOR .................................................................................................15-4
Select Nuclide............................................................................................................15-4
Date and Activity ........................................................................................................15-4
Beginning Date and Time ......................................................................................15-5
Beginning Activity ..................................................................................................15-6
Ending Date and Time...........................................................................................15-7
Results.......................................................................................................................15-8

CLEANING AND MAINTENANCE ...................................................................................16-1
GENERAL .....................................................................................................................16-1
CLEANING and DISINFECTING ...................................................................................16-2
Cleaning Instructions .................................................................................................16-2
Disinfecting Instructions .............................................................................................16-2
Liner ......................................................................................................................16-3
Printer....................................................................................................................16-3

TOC-10 TABLE OF CONTENTS October 15

CAPINTEC, INC. CAPTUS® 700t

PREVENTATIVE MAINTENANCE................................................................................ 16-3
DISPOSAL.................................................................................................................... 16-4

Floor Stand................................................................................................................ 16-4
Table Top Stand........................................................................................................ 16-5
SERVICING .................................................................................................................. 16-5
Collimator Block Inspection ....................................................................................... 16-6
Spring-Arm Inspection............................................................................................... 16-6
FUSE SERVICING........................................................................................................ 16-8
Power Line Fuses...................................................................................................... 16-8
Readout Fuses.......................................................................................................... 16-9
Printer Fuse............................................................................................................... 16-9
BATTERY REPLACEMENT........................................................................................ 16-10
TROUBLESHOOTING................................................................................................ 16-17
REPLACEMENT PARTS ............................................................................................ 16-18
SHIPPING .................................................................................................................. 16-19

APPENDIX – NUCLIDE LIST

INDEX

WARRANTY

DECLARATIONS OF CONFORMITY

October 15 TABLE OF CONTENTS TOC-11

CAPINTEC, INC. CAPTUS® 700t

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CAPINTEC, INC. CAPTUS® 700t

PREFACE

GENERAL ........................................................................................................ 1
SYSTEM DESCRIPTION.................................................................................. 1
MEDICAL EQUIPMENT SAFETY CLASSIFICATION...................................... 2
ELECTROMAGNETIC INTERFERENCE POTENTIAL .................................... 2
INSTALLATION ............................................................................................... 2
IMPORTANT SAFETY INFORMATION............................................................ 3

GENERAL
Thank you for purchasing the Capintec line of Thyroid Uptake Measurement Systems. Every
effort has been made to ensure that the information in this document is complete, accurate,
and up-to-date. Mention of products manufactured by other companies does not necessarily
constitute endorsement by Capintec, Inc. Capintec assumes no responsibility for the results
of errors beyond its control.

Please address any comments pertaining to this manual to:

CAPINTEC, Inc.
620 Alpha Drive
Pittsburgh, PA 15238
Phone (412) 963-1988
Fax (412) 963-0610

CAPTUS® 700t 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
Your new CAPTUS® 700t is available in several configurations. Please take a moment to
review your system to determine exactly the configuration you have received. The basic
Thyroid Uptake System consists of the following:

• Optional Floor Stand or Table Top Stand
• TUS Collimator
• Isolation Transformer
• NaI (sodium iodide) Detector with Detector Socket Base

Note: Two versions of detectors are available: Flat Face or Drilled.

• Readout Unit
• Printer

October 15 PREFACE p-1

CAPINTEC, INC. CAPTUS® 700t

• Cables for connecting detector, printer, etc.
• 15 foot power cord with hospital grade plug
• CAPTUS® 700t Manual
• Optional Well Counter with drilled Well Detector

MEDICAL EQUIPMENT SAFETY CLASSIFICATION

• CLASS I EQUIPMENT energized from an external power source

• TYPE B EQUIPMENT with applied part (Positioning Rod)

• Ordinary EQUIPMENT without protection against the ingress of water or particulates
(IP00)

• Suitable for CONTINUOUS OPERATION

• NOT suitable for use in the presence of a an FLAMMABLE ANAESTHETIC
MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE

ELECTROMAGNETIC INTERFERENCE POTENTIAL
This equipment complies fully with interference immunity requirements of the standard IEC
60601-1-2 (2007): Medical Electrical Equipment – Part 1-2: General Requirements for Basic
Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility –
Requirements and Tests.

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.

INSTALLATION

Your system has been shipped from the factory pre-configured and fully tested. Installation
consists of placing the components and securing them in place. Detailed installation and
assembly instructions are provided in the included Unpacking and Assembly Instructions
for your system.

p-2 PREFACE October 15

CAPINTEC, INC. CAPTUS® 700t

IMPORTANT SAFETY INFORMATION
The CAPTUS® 700 measurement system has been carefully designed to provide years of
safe and reliable performance. As with all electrical equipment, however, there are basic
precautions that must be observed to avoid injuring yourself, the patient or damaging the
equipment.

• Follow the unpacking and assembly instructions document 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 the CHAPTER 1:
SAFETY before operating this equipment.

October 15 PREFACE p-3

CAPINTEC, INC. CAPTUS® 700t

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CAPINTEC, INC. CAPTUS® 700t

CHAPTER 1

SAFETY

GENERAL .......................................................................................................1-1
SYMBOL DEFINITIONS..................................................................................1-1

LABELING ......................................................................................................1-2
CAUTIONS AND NOTES ................................................................................1-6

GENERAL SAFETY TIPS ...............................................................................1-8
LIFETIME ........................................................................................................1-8

GENERAL

These warnings and instructions for use form an integral part of the CAPTUS® 700t 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
Protective Earth Ground
Caution
Operator should consult accompanying documents
Fuse
AC Voltage
“ON” (power)
“OFF” (power)

October 15 SAFETY 1-1

CAPINTEC, INC. CAPTUS® 700t

Type B Equipment

Date of Manufacture

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.

LABELING

Located in the center section on both sides of the Spring-Arm is a warning label (Figure 1-1)
concerning the hazard of removing the Collimator when the Spring-Arm is in the wrong
position. If the weight of the Collimator is removed from the Spring-Arm, the arm may
forcefully spring upward causing serious injury to the operator. The Spring-Arm must be fully
extended in the upright position to prevent this from happening.

Figure 1-1

Located in the front section on both sides of the Spring-Arm is a warning label (Figure 1-2)
concerning the hazard of improperly installing the Collimator onto the Spring-Arm. If the
Collimator Support Pin is not fully inserted and latched into the Receptacle Block of the
Spring-Arm, the Collimator may detach from the Spring-Arm and fall onto the patient. In
addition, the arm can forcefully swing upward and cause serious injury to the operator. The
Collimator is safely installed on the Spring-Arm when the red warning ring is not visible
between the Collimator and the Receptacle Block. Refer to the UNPACKING AND
ASSEMBLY INSTRUCTIONS for illustrations.

1-2 SAFETY October 15

CAPINTEC, INC. CAPTUS® 700t

Figure 1-2

Located on the top of the Isolation Transformer is a label (Figure 1-3) providing the System
power requirements, the input voltage, the Serial Number of the System, the Date of
Manufacture of the System and the replacement fuse values for both power line voltages.
The label also denotes the authorized European representative is Atlantico Systems, Ltd.

t

An Eczacibasi-Monrol company

0413

Figure 1-3

CAUTION: Please reference CHAPTER 16: CLEANING AND MAINTENANCE,
SECTION: FUSE SERVICING/Power Line Fuses for instructions on
how to change the fuses of the Isolation Transformer.

CAUTION: A fire hazard may exist if the wrong size of fuse is installed.

Located on the back of the CAPTUS® 700t Readout is a label (Figure 1-4) providing the
Readout power requirements, the input voltage, the Serial Number of the Readout, the Date
of Manufacture of the Readout and the replacement fuse values for the power line voltages.
The label also denotes the authorized European representative is Atlantico Systems, Ltd.

October 15 SAFETY 1-3

CAPINTEC, INC. CAPTUS® 700t

An Eczacibasi-Monrol company 0413

Figure 1-4

CAUTION: Please reference CHAPTER 16: CLEANING AND MAINTENANCE,
SECTION: FUSE SERVICING/Readout Fuses for instructions on
how to change the fuses of the CAPTUS® 700t Readout Unit.

CAUTION: A fire hazard may exist if the wrong size of fuse is installed.

Located on the left side of the Isolation Transformer is a label (Figure 1-5) with two caution
statements pertaining to the main power cord of the Isolation Transformer:

• READ INSTRUCTIONS CAREFULLY BEFORE CONNECTING TO OUTLET – This
statement directs the user to the owner's manual before connecting the power.

• “HOSPITAL ONLY” or “HOSPITAL GRADE” – This statement alerts the user to
select an electrical power receptacle that is designated as such, to ensure reliable
grounding to the CAPTUS® system. Note: This statement only pertains to facilities
located in the United States.

1-4 SAFETY October 15

CAPINTEC, INC. CAPTUS® 700t

Figure 1-5
Located by each line cord on the Isolation Transformer is a label (Figure 1-6) indicating
which device to connect the particular cord to.

Figure 1-6
Located on the Connector Guard on the back panel of the CAPTUS® 700t Readout Unit is a
label (Figure 1-7) with the caution statement pertaining to safety of the operator. This
statement is necessary because of the presence of high voltage on the connectors and on
the inside of the Instrument. A screwdriver is necessary to remove the cover.

Figure 1-7

October 15 SAFETY 1-5

CAPINTEC, INC. CAPTUS® 700t

CAUTIONS AND NOTES

CAUTION: Changing the date or time while a timed test is in progress (for example,
a 24 hour Thyroid Uptake Test) might affect the results or introduce
unexpected error. Care should be taken to evaluate any potential impact
for ongoing tests before changing the date or time.

CAUTION: Only qualified/trained personnel should operate or service this unit.

CAUTION: If the equipment is used in a manner not specified in this manual, the
protection provided by the equipment may be impaired.

CAUTION: Do not store high activity radioactive samples in the CAPTUS® 700t Well
Counter. It was not designed to function as a long term storage vessel.
Prolonged storage of high activity radioactive samples in the Well
Counter may cause premature failure of the unit.

CAUTION: High voltage is present inside the Detectors (up to 1100 Volts). Due to
the presence of this high voltage, opening the covers with the system

plugged in may be hazardous. Refer all servicing to qualified personnel.

CAUTION: No internal adjustments inside the Readout, Detector(s) or printer may
be performed by the user within the conditions of the warranty, except for
changing the Readout and Isolation Transformer fuses. Due to the
presence of high voltages, opening the covers with the system plugged
in may be hazardous. Refer all servicing to qualified personnel.

CAUTION: Never use the Well Detector without the well liner in place. Liners are
inexpensive and easy to replace. A contaminated Detector is a very
costly mistake. If the unit becomes contaminated, remove liner and clean
unit as stated in CHAPTER 16: CLEANING AND MAINTENANCE before
operating.

CAUTION: Care must be exercised when moving the system or when maintenance
is performed. If the system is inclined at more than a 15-degree angle, it

may tip over.

CAUTION: Verify that the Collimator is correctly installed as stated in the
UNPACKING AND ASSEMBLY INSTRUCTIONS. Failure to follow these
instructions could result in injury or product malfunction.

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).

1-6 SAFETY October 15

CAPINTEC, INC. CAPTUS® 700t

CAUTION: This equipment generates radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful
Electromagnetic Interference (EMI) to nearby devices. However, there is
no guarantee that interference will not occur in a particular installation.

CAUTION: If any Detectors or printer other than one of the models supplied by
Capintec is used, the safety of the unit may be compromised or
Electromagnetic Interference (EMI) may be introduced into other devices
located in the same general area as the CAPTUS® 700t or the CAPTUS®
700t may become susceptible to EMI.

CAUTION: If any components are used other than those supplied by Capintec, the
power and signal connections must be the same as those for the original
manufacturer’s configuration or the safety of the unit may be
compromised.

CAUTION: The equipment should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, the
equipment should be observed to verify normal operation in the
configuration in which it will be used.

CAUTION: Do not disconnect or connect Detectors from the Readout Unit, while the
system is on. Shut down the Readout Unit first.

CAUTION: The unit contains lead. Appropriate caution should be taken if the interior
of the unit is exposed. The unit should be disposed of in accordance with

local and national regulations.

CAUTION: The unit contains a Lithium Battery. This should be disposed of in
accordance with local and national regulations.

CAUTION: The user should always verify the validity of any measurement or test
result in order to minimize measurement errors.

CAUTION: To remove main power from the system, the Isolation Transformer power
cable must be unplugged from the medical grade wall socket.

Note: It is recommended that periodic (every five years) re-calibration of the unit be
performed only by Capintec’s Authorized Service Center (reference CHAPTER 16:
CLEANING AND MAINTENANCE) to guarantee that the instrument's high reliability is
maintained).

October 15 SAFETY 1-7

CAPINTEC, INC. CAPTUS® 700t

GENERAL SAFETY TIPS
• Unplug the equipment before cleaning it. Use only a damp cloth; do not use solvents
or aerosol cleaners.

• To protect the equipment from overheating, make sure none of the openings (vents)
on the Readout Unit or the printer are blocked.

• Do not use the equipment directly in front of a radiator, heat register or air
conditioning duct.

• 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 Isolation
Transformer.

• The CAPTUS® 700t 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.

• The CAPTUS® 700t Readout Unit is connected to the Isolation Transformer to comply
with electrical safety for Medical Electrical Equipment.

• To avoid damaging the cable, do not place anything on it or place it where it will be
stepped on. If 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.

• Do not subject the Detectors to rough handling or rapid temperature changes, as the
NaI Scintillation Crystal can be damaged.

• Do not subject the system to hard impact shock. (i.e. running into walls or going down
steps.

LIFETIME
The unit can be used over a period of 15 years with proper maintenance.

1-8 SAFETY October 15

CAPINTEC, INC. CAPTUS® 700t

CHAPTER 2

FUNCTIONAL & TECHNICAL
DESCRIPTION

INTENDED USE ..............................................................................................2-1
OPERATOR PROFILE ....................................................................................2-2
OPERATOR TRAINING ..................................................................................2-2
FUNCTIONAL DESCRIPTION ........................................................................2-2

Thyroid Uptake ...........................................................................................2-3
Wipe Test ....................................................................................................2-3
Lab Tests ....................................................................................................2-3
Bioassay .....................................................................................................2-4
FUNCTIONS....................................................................................................2-5
Overall Program Flow ................................................................................2-6
TECHNICAL DESCRIPTION...........................................................................2-8
Detector ......................................................................................................2-8
Multichannel Analyzer................................................................................2-8
TECHNICAL SPECIFICATIONS .....................................................................2-9
System Hardware .......................................................................................2-9
On / Off Switch...........................................................................................2-11
Environment Requirements......................................................................2-11
Warm Up Period ........................................................................................2-12
System Power Requirements ...................................................................2-12
Regulatory Listings...................................................................................2-13

INTENDED USE
The primary intended use of the device is to make Thyroid Uptake measurements by
measuring in vivo the activity level given off by a radiopharmaceutical through the interaction
of the emitted atomic particles of the radiopharmaceutical with the Sodium-Iodide (NaI)
detector.

The device can also preform Thyroid Bioassay using the same measurement process as the
Thyroid Uptake.

An optional secondary intended use of the device is to perform the following Lab tests:

• Schillings Test,

• Plasma Volume Test with I125,

• RBC Volume Test with Cr51 and

• RBC Survival Test with Cr51.

This is done by measuring the activity level given off by a radiopharmaceutical in the sample,
through the interaction with the Sodium-Iodide (NaI) detector.

October 15 FUNCTIONAL & TECHNICAL DESCRIPTION 2-1

CAPINTEC, INC. CAPTUS® 700t

OPERATOR PROFILE
The operator profile for the Nuclear Medicine Technologists, Physicians and Health
physicists is as follows:

• Education:
o Minimum: at least an Associate Degree
o No maximum

• Knowledge:
o Minimum: Understands the basic concepts of nuclear medicine.
o No maximum

• Language Understanding:
o English
o Other languages are available for instructions for use

• Experience:
o Minimum: Has minimum training or is under surveillance by a trained user.
o No maximum

OPERATOR TRAINING
This Owner’s Manual contains all of the information required to operate the CAPTUS® 700t.

FUNCTIONAL DESCRIPTION
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 Well Counter or Probe and the
correct efficiency is input or measured.

With its NaI drilled-well crystal detector, the Well Counter offers greater sensitivity and faster
results than other wipe test monitors that use Geiger-Mueller (GM) tubes.

The microprocessor-controlled CAPTUS® 700t has an automatic internal energy calibration
feature, which permits self-calibration of the keV per channel ratio.

For isotopes that have a measured efficiency, the CAPTUS® 700t will convert readings in
cpm [counts per minute] to dpm [disintegrations per minute]. Most federal and state
regulations require survey monitoring results in dpm.

Note: The CAPTUS® 700t Well Counter is not designed to provide conclusive identification
of radionuclides in samples. The CAPTUS® 700t Well Counter is designed to provide
the first step for users who need to identify contaminants by narrowing down the
possibilities of which isotopes are contained in wipe test samples.

2-2 FUNCTIONAL & TECHNICAL DESCRIPTION October 15

CAPINTEC, INC. CAPTUS® 700t

The CAPTUS® 700t also provides a “Full Spectrum Efficiency” result for a wipe sample by
grouping all 512 channels together as one open-energy window. This indicates whether a
sample exceeds trigger levels, but does not help identify the contaminant.

Thyroid Uptake

Thyroid Uptake is a measurement of the ratio of the amount of radioactive material
concentrated in the thyroid gland to the amount of radioactive material administered to the
patient. Thyroid Uptake measurements are generally used to determine conditions of
hyperthyroidism. High uptake results are found in Graves disease, toxic nodular goiter, and
stimulator secreting tumors or can be TSH-induced. Low uptake results are found with
thyroid hormone secretion in ectopic tumors, hormonal release in thyroid injury, after intake
of thyroid hormone, or in Jod-Basedow disease. During the treatment of thyroid cancer by I-
131 ablation, uptake measurements are used to monitor thyroid activity.

The CAPTUS® 700t system will store patient demographic and dosage information, count
data for both the administered dosage and the patient, decay correct all count data, calculate
Thyroid Uptake results, and store all of this information in the Thyroid Uptake database.
Regions of Interest have been defined for three isotopes: I-131, I-123, and Tc-99m. If normal
values have been entered, results exceeding these values will be flagged. All of the patient
information may be printed. The Thyroid Uptake software has been designed to
accommodate a variety of different counting protocols, using either capsules or liquid
dosages.

Wipe Test

The Wipe Test measures radioactive contamination for nuclear medicine departments and
laboratories, as mandated by state and federal radiation safety requirements.

Lab Tests

Urine Test
Schilling Test
The Schilling Test utilizes Cobalt 57 labeled Vitamin B-12 and is used to determine B-
12 deficiencies from either malabsorption, lack of intrinsic factor (pernicious anemia),
or intraintestinal destruction. The test entails collection of urine for 24 or 48 hours
after the oral administration of radioactive labeled vitamin B-12. The ratio of excreted
to administered Co57 is calculated. If the initial results indicate a reduced amount of
excreted vitamin, the test is repeated with a second sample of labeled B-12 and
intrinsic factor. For Schilling Test I, abnormal results are generally less than 8%-10%.
Normal range is generally 11% to 26%. For Schilling Test II, no change indicates
malabsorption, while an improved percentage indicates pernicious anemia.

October 15 FUNCTIONAL & TECHNICAL DESCRIPTION 2-3

CAPINTEC, INC. CAPTUS® 700t

Blood Tests
Plasma Volume Test

Blood Volume determinations involving radioactive tagging are most frequently used
in specific disease conditions when the hematocrit may not accurately estimate true
blood volume. Such conditions include extensive trauma or burn patients, certain
types of anemia, and polycythemia. Most frequently used radioactive tracers are
protein labeled I-125 for plasma measurements and Cr51 tagged RBCs for red cell
mass determinations.

RBC Volume Test
This test is used to determine red blood cell volume or mass and is most frequently
used in specific disease conditions when the hematocrit may not accurately estimate
true blood volume. In this test, Cr51 tagged RBCs are used as radioactive tracers for
red cell mass determination.

RBC Survival Test

RBC survival determination involving radioactive tagging is most frequently used in
diagnosis of hemolytic anemia. The CAPTUS® 700t software and default counting
parameters follow the testing protocol outlined in the Mallinckrodt RBC Survival Kit
that utilizes Sodium Chromate Cr51 injections. The software standardizes the 24-hour
sample to 100% survival, and automatically decay corrects each subsequent sample.
This permits the user to measure each sample as soon as it is collected. For this
reason, all sample volumes must be the same. Each sample must also have a
hematocrit (HCT) entered. The subsequent samples are corrected for any differences
in hematocrit.

Bioassay

All staff members who work with Iodine-131, Iodine-125, or Iodine-123 need to have regular
Bioassay measurements taken to monitor exposure levels. Most state and federal radiation
safety regulations mandate that these thyroid measurements be taken periodically.

The CAPTUS® 700t uses one bioassay protocol, which is user-defined. Before performing
bioassay measurements on the staff, the staff member names and ID numbers should be
added to the database and parameters for the bioassay protocol should be set up.

2-4 FUNCTIONAL & TECHNICAL DESCRIPTION October 15

CAPINTEC, INC. CAPTUS® 700t

FUNCTIONS
When the instrument is first powered up, Figure 2-1 Startup Screen will appear.

Figure 2-1 Startup Screen

Note: The screen will display the revision level of the installed software.

Note: If the Security Status is set to Traditional, the CONTINUE button will be replaced with
a Login button. The Login Screen will include input boxes which will enable the user
to enter a User ID and a Password or to login as a guest. After logging in, the
CONTINUE button will appear. Reference CHAPTER 4: SYSTEM SETUP, SECTION:
SECURITY STATUS for more information.

When the CONTINUE button is touched, Figure 2-2 Main Screen will appear and the system
is ready to perform measurements.

October 15 FUNCTIONAL & TECHNICAL DESCRIPTION 2-5

CAPINTEC, INC. CAPTUS® 700t

Figure 2-2 Main Screen

Overall Program Flow
The functions for the CAPTUS® 700t are displayed on Figure 2-2 Main Screen. These
consist of Measurements (Background, Wipes and General), Auto Calibration, Quality
Assurance (System Test, MDA Test, and Chi Square Test), Reports and Utilities (Ci-Bq
Converter, Decay Calculator and Diagnostics).

If a Well Counter or Drilled Probe is included with the system, the Lab Tests (Schilling,
Plasma, RBC, RBC Survival) button will be displayed.

If a Probe or Drilled Probe Detector is included with the system, the Bio Assay and Thyroid
Uptake buttons will be displayed.

The currently selected detector (Well, Probe or Drilled Probe) will be displayed in the lower
left hand corner.

Figure 2-3 illustrates the overall program flow of the CAPTUS® 700t.

2-6 FUNCTIONAL & TECHNICAL DESCRIPTION October 15

CAPINTEC, INC. CAPTUS® 700t

Main
Screen

Measurement

Auto Calibrate *Schilling Measure
*Lab Tests Background

*Measure Wipes

Quality Assurance System Test *Plasma General
MDA Test *RBC Measurement
Setup
Chi Square Test *RBC Survival *Setup

Setup Screen Setup Password
Activity Unit (Ci/Bq) Password
Date Format *Setup Location
Printer Test Source
USB PC Driver *Edit Background
Display Sleep Timeout Efficiencies Trigger
Display Sleep Brightness
Display Brightness *Wipe Tests *Edit Default Work
Volume *RBC Survival Area Settings
Normal Values
Advanced Password User Nuclides *Edit Default
Detector Unrestricted Area
**Bio Assay
Screen Calib Settings

Staff *Edit Default
Sealed Settings
Set Time Auto Calibration
(requires Report *Edit Default
password) Package Settings
**Bio Assay System Test
Report **Thyroid Uptake
**Thyroid Uptake
MDA Report **Thyroid Uptake
Reports Normal Values
Chi Square Report
NOTE:
**Bio Assay * The items marked with a single asterisk will only be
Report displayed if the system is configured for use with a Well
Counter or a Drilled Probe.
*Wipe Report
** The items marked with double asterisks will only be
*Schilling Report displayed if the system is configured for use with a Probe
or a Drilled Probe.
*Plasma Report

*RBC Report

*RBC Survival
Report

**Thyroid Uptake
Report

Utility Ci-Bq Converter
Decay Calculator

Diagnostics

Figure 2-3

October 15 FUNCTIONAL & TECHNICAL DESCRIPTION 2-7

CAPINTEC, INC. CAPTUS® 700t

TECHNICAL DESCRIPTION
Detector

The CAPTUS® 700t system is equipped with one or two NaI (Tl) (Thallium-activated Sodium
Iodide) crystal and photomultiplier tube detector assemblies, a 512 channel MCA
(Multichannel Analyzer), along with associated electronics and electronic controls which
provide power and amplification of the pulses generated by the detectors, as well as software
modules which record, analyze, manipulate, and store the measured data.

Since NaI crystals are hygroscopic, the detector assemblies are hermetically sealed with an
aluminum coating. If the seal is broken, then water will be absorbed by the crystal, causing
deterioration of its measurement capabilities, and eventually it will require replacement. For
this reason, always handle the detector with care. Avoid scratching the surface with metal
objects such as pens.

When a gamma or x-ray from a radioactive source reaches the NaI crystal, it collides with the
electrons in the crystal matrix and transfers energy, primarily through Compton interaction.
The excited electron releases this energy as visible light in direct proportion to its absorbed
energy. For this reason, NaI detectors are classified as scintillation detectors. The higher the
energy of the incident ray, the more Compton collisions and consequently the more visible
light emissions will be measured before all of the energy is absorbed. These sequential
emissions of light for each incident ray generated from the sequential Compton collisions
appear to the measuring system as a single light pulse. The intensity of the pulse is directly
proportional to the energy of the incident gamma or x-ray. The light is eventually directed
toward the photomultiplier tube, either by the direction in which it was emitted or by reflection
from the interior of the aluminum housing. The photomultiplier tube, which is optically
connected to the sodium iodide crystal, converts the visible light pulses into electrical energy
and amplifies the signal through a series of dynodes. The resultant electrical signal is directly
proportional to the intensity of the incident light pulse. Therefore, the pulse height generated
by the system is directly proportional to the energy of the incident gamma or x-ray detected
by the system.

Multichannel Analyzer

A multichannel analyzer records the number and height of the electrical pulses generated by
the system, divides the pulses into groups based upon pulse height, and provides a visible
picture or spectrum of the pulses as well as count information. The CAPTUS® 700t divides
the pulses into 512 groups or channels. Since pulse height is directly related to the energy of
the incident photon, the spectrum displays the pulse heights as a graph of pulses or counts
on the vertical scale and energy on the horizontal scale. By matching the displayed spectrum
to the decay scheme of an isotope, positive identification of the radioactive source can be
achieved.

Electronics associated with the process include the high voltage power supply, amplifiers,
and gain adjustments. The high voltage power supply provides voltage to the photomultiplier
tube for the light to electrical impulse conversion and amplification process. The amplifiers
linearly amplify the electrical signal produced by the photomultiplier tube before the signal is

2-8 FUNCTIONAL & TECHNICAL DESCRIPTION October 15

CAPINTEC, INC. CAPTUS® 700t

passed to the MCA. The pulse height remains proportional to the energy of the incident ray.
The gain controls the amount of amplification that is performed by the card.

The spectral display also has adjustments which control the pulse height that include zero
adjust and lower level discriminators (threshold). The zero adjust controls the channel used
for 0 pulse height or 0 energy. The threshold sets the limit for the lowest pulse height to be
analyzed.

TECHNICAL SPECIFICATIONS
System Hardware

Floor Stand
Rugged Floor Stand with heavy duty locking casters and an articulating arm for the
positioning of the Detector/Collimator. Individual shelves are provided for the
CAPTUS® 700t Readout Unit and the printer. Mounting for the Isolation Transformer
and the optional Well Detector is provided at the base of the Floor Stand.

Dimensions
Height........................ 175.3 cm........ (69”)
Width......................... 71.1 cm.......... (28”)
Depth ........................ 78.7 cm.......... (31”)
Weight....................... 181.8 kg......... (400 lb.)
(with optional well)..... 213.6 kg......... (470 lb.)

Table Top Stand (optional)
An excellent alternative to the Floor Stand when space is at a premium, the Table
Top Stand allows for positioning of the Detector/Collimator and is very stable when
placed on a sturdy table or bench, yet the unit may be easily moved to another
location when desired.

Dimensions:
Height........................ 37.1 cm.......... (14.6”)
Width......................... 25.4 cm.......... (10”)
Depth ........................ 25.4 cm.......... (10”)
Weight....................... 3.7 kg............. (8.1 lb.)

Isolation Transformer
An Isolation Transformer is provided with the CAPTUS® 700t system to ensure that
the leakage current meets IEC 60601-1 Medical Equipment Safety Standard. A
detachable 4.6m (15 ft) power cord, with a hospital grade plug, is provided to connect
the Isolation Transformer to the power source. Dual power line fuses are provided at
the power entry module for quick replacement.

October 15 FUNCTIONAL & TECHNICAL DESCRIPTION 2-9

CAPINTEC, INC. CAPTUS® 700t

Dimensions

Height ....................... 13.3 cm ......... (5.25”)
Width ........................ 17.5 cm ......... (6.88”)
Depth ........................ 10.9 cm ......... (4.31”)

Readout Unit

MCA

512 Channels
Maximum Count Rate 100,000 cps
ROI's – Automatic or Manual
QA automatic – gain adjust, energy calibration, resolution, chi-squared, constancy
Automatic efficiency calculation and storage
Differential Nonlinearity <2% over the top 98% of channels
Integral Nonlinearity <1% over the top 98% of channels
Preset Live Time
Automatic Peak Finding

Detector Inputs

Software control of Detector selection
SHV connectors for TUS Probe and Well Detectors

CAPTUS® 700t Software

Stores and prints all test data results
Reference library for isotopes
User definable normal ranges on printout
Thyroid Uptake
Bioassay
Wipe Test
Schilling Test
Plasma Volume
RBC Volume
RBC Survival

Dimensions
Height ....................... 42.0cm .......... (9.5in)
Width ........................ 23.0cm .......... (9.0in)
Depth ........................ 27.0cm .......... (10.5in)
Weight ...................... 3.4kg ............. (7.5lb)

Printer
HP Officejet 6000 series Inkjet – inkjet color printer, prints results of studies including
graphic displays.

2-10 FUNCTIONAL & TECHNICAL DESCRIPTION October 15

CAPINTEC, INC. CAPTUS® 700t

TUS Probe Detector
NaI(TI) flat face crystal / PM Tube:... 5.1 x 5.1 cm ...(2” x 2”)
Monoline construction
Resolution (Full Width-Half Max) – ≤9.5% or better for Cs137

Lead Shielded Collimator
Complies with ANSI Standard N44.3-1973

10 ft. (maximum) coaxial signal/high voltage cable

Well Detector – Optional
With attached 10 ft. (maximum) coaxial signal/high voltage cable. (Allows for the
placement of the Well away from the Stand.)
NaI(TI) well type crystal / PM Tube: . 5.1 x 5.1 cm ...(2” x 2”)
Well diameter: ...................... 1.6 cm ............(0.625”)
Well depth: ........................... 4 cm ...............(1.5”)
Monoline construction
Resolution (Full Width-Half Max) – ≤10.0% or better for Cs137

Lead shielding – lined with brass (0.16 cm (1/16”) thick) to minimize backscatter
Thickness: ............................ 2.5 cm ............(1”)
Height:.................................. 32.5 cm ..........(12.8”)
Diameter: ............................. 11.4 cm ..........(4.5”)
Weight:................................. 27.9 kg ...........(61.4 lb.)

On / Off Switch
The on/off switch (I = on;  = off) is located on the back of the Readout Unit.

Environment Requirements
Indoor use only. Pollution Degree 2, Altitude, and Installation Cat. II.

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).

October 15 FUNCTIONAL & TECHNICAL DESCRIPTION 2-11

CAPINTEC, INC. CAPTUS® 700t

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: If these environmental requirements are not followed, the instrument may
display erroneous readings

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
CAPTUS® 700t.

System Power Requirements

CAUTION: If the input voltage to the following items is not within the stated
limits, the unit may not function correctly or may be damaged

Input Power
Line Voltage: .............115 or 230 Vac depending on model ordered
Line Frequency:.........60 or 50 Hz
Current: .....................0.7 Ampere @ 115V
0.4 Ampere @ 230V
Fuse: For 115V use T 3.15AH, 250V, (Time Delay)
For 230V use T 2.5AH, 250V, (Time Delay)

Readout
100-240Vac, 50/60Hz, 230mA

Printers
Included Printer (Recommended)
HP Officejet 6000 Series (or equivalent) Printer (optional)
100-240Vac, 50/60Hz, 1.5A

Optional Printers
Okidata Microline 320 (optional)

120Vac, 60Hz, 0.9A or
230/240Vac, 50/60Hz, 0.5A

Epson LX-300+II printer (optional)
99-132Vac, 50/60Hz, 0.6A (maximum 1.4A depending on the character type)
198-264Vac, 50/60Hz, 0.3A (maximum 1.4A depending on the character type)

2-12 FUNCTIONAL & TECHNICAL DESCRIPTION October 15

CAPINTEC, INC. CAPTUS® 700t

Epson TM-295II Slip Printer (optional)
Input: 100-240Vac, 50/60Hz, 1.2A; Output: +24Vdc, 0.8A

Epson TM-U220D Roll Printer (optional)
Input: 100-240Vac, 50/60Hz, 1.0A max; Output: 24Vdc, 1.5A

Line Filter
Line filter is provided internally.
Use of a filtered line is recommended if excessive line noise is anticipated.

Ground Current
Less than .5mA

Power Connector and Cable
A grounded 3-prong plug cord for the instrument that is approved for use at the user's
site must be used.

Interconnection of devices must be made using the cables supplied with the
instrument.

Regulatory Listings

The CAPTUS® 700t has been independently tested and is manufactured in compliance with
the following Standards:

EMC

• 60601-1-2 (2007): Medical Electrical Equipment – Part 1-2: General
Requirements for Basic Safety and Essential Performance – Collateral
Standard: Electromagnetic Compatibility – Requirements and Tests

Safety AAMI ES60601-1 Issued: 2005: Medical electrical equipment Part 1: General
• requirements for basic safety and essential performance

• CAN.CSA-C22.2 No. 60601-1:08: Medical electrical equipment – Part 1:
General requirements for basic safety and essential performance

IEC 60601-1 Issued: 2005 Ed:3: Medical electrical equipment Part 1: General
• requirements for basic safety and essential performance

IEC 60601-1-6 2010 3rd Edition: Medical electrical equipment – Part 1-6:
General requirements for basic safety and essential performance – Collateral
Standard: Usability

Risk

• ANSI/AAMI/ISO 14971:2007/(R)2010: Medical Devices – Application of risk
management to medical devices

• BS EN ISO 14971:2012: Medical Devices – Application of risk management to
medical devices

October 15 FUNCTIONAL & TECHNICAL DESCRIPTION 2-13

CAPINTEC, INC. CAPTUS® 700t

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CAPINTEC, INC. CAPTUS® 700t

CHAPTER 3

GENERAL OPERATING INSTRUCTIONS

GENERAL .......................................................................................................3-1
MAIN SCREEN................................................................................................3-2

MEASUREMENT Button 1.........................................................................3-3
AUTO CALIBRATE Button 2 .....................................................................3-3
QUALITY ASSURANCE Button 3 .............................................................3-3
REPORTS Button 4 ...................................................................................3-3
BIO ASSAY Button 5 .................................................................................3-3
THYROID UPTAKE Button 6 .....................................................................3-4
LAB TESTS Button 7.................................................................................3-4
UTILITY Button 8 .......................................................................................3-4
Date/Time Button 9 ...................................................................................3-4
SETUP Button 10.......................................................................................3-4
DETECTOR Button 11 ...............................................................................3-4
Detector Indicator 12 ................................................................................3-4
ENTERING DATA ...........................................................................................3-5
Numeric Data ..............................................................................................3-5
Alphanumeric Data.....................................................................................3-6
List Screen..................................................................................................3-7
Date/Time Screen .......................................................................................3-8

GENERAL
This section describes general operating procedures, the touch screen, and how to access
all other tests and screens

October 15 GENERAL OPERATING INSTRUCTIONS 3-1

CAPINTEC, INC. CAPTUS® 700t

MAIN SCREEN
The CAPTUS® 700t Main screen is shown below.

9
15

26

37

48
10

12

11 Figure 3-1 Main Screen

The BIO ASSAY and THYROID UPTAKE buttons will only be displayed if a Probe or Drilled
Probe Detector is included with the system. The LAB TESTS button will only be displayed if
the Well Detector or Drilled Probe is included with the system.
The currently selected detector (Probe, Well or Drilled Probe) will be displayed in the lower
left hand corner.
The DETECTOR button will only be displayed if the system is configured for both Probe and
Well Detectors.
General usage of the touchable buttons is briefly described. Specific button usage will be
given in the appropriate sections.

3-2 GENERAL OPERATING INSTRUCTIONS October 15

CAPINTEC, INC. CAPTUS® 700t

MEASUREMENT Button 1

This button provides access to the Probe and Well Counter measurements. Touching this
button provides access to the following: MEASURE BACKGROUND, MEASURE WIPES,
and GENERAL MEASUREMENT.

Measure Background and General Measurement can be performed for the Probe and Well.
Measure Wipes can only be performed using the Well or Drilled Probe.

AUTO CALIBRATE Button 2
This button provides access to the CAPTUS® 700t’s automatic calibration measurement
procedure.

Auto Calibrate is performed for both the Probe and Well Detectors.

QUALITY ASSURANCE Button 3
This button provides access to the CAPTUS® 700t’s Quality Assurance Tests module.
Touching this button provides access to the following: SYSTEM TEST, MDA TEST, CHI
SQUARE TEST, and SETUP for the Test Source.

These functions are performed for both the Probe and Well Detectors.

REPORTS Button 4

This button provides access to the CAPTUS® 700t’s reports. Touching this button provides
access to the following reports: AUTO CALIBRATION REPORT, SYSTEM TEST REPORT,
MDA REPORT, CHI SQUARE REPORT, BIO ASSAY REPORT, WIPE REPORT,
SCHILLING REPORT, PLASMA REPORT, RBC REPORT, RBC SURVIVAL REPORT and
THYROID UPTAKE REPORT.

The WIPE REPORT, SCHILLING REPORT, PLASMA REPORT, RBC REPORT and RBC
SURVIVAL REPORT buttons will only appear if the Well Detector or Drilled Probe is included
with the system.

The BIO ASSAY REPORT and THYROID UPTAKE REPORT buttons will only appear if the
Probe or Drilled Probe is included with the system.

BIO ASSAY Button 5

This button provides access to the CAPTUS® 700t’s Bio Assay module. If there is no Probe
or Drilled Probe in the system, this button will not be displayed.

October 15 GENERAL OPERATING INSTRUCTIONS 3-3

CAPINTEC, INC. CAPTUS® 700t

THYROID UPTAKE Button 6

This button provides access to the CAPTUS® 700t’s Thyroid Uptake module. If there is no
Probe or Drilled Probe in the system, this button will not be displayed.

LAB TESTS Button 7
This button provides access to the CAPTUS® 700t’s Lab Tests module. Touching this button
provides access to the following: SCHILLING, PLASMA, RBC, and RBC SURVIVAL.

These tests are performed using the Well or Drilled Probe. If the system only has a Probe,
this button will not be displayed.

UTILITY Button 8

This button provides access to the CAPTUS® 700t’s utility functions. Touching this button
provides access to the following: CURIE/BECQUEREL CONVERTER, DECAY
CALCULATOR and DIAGNOSTICS.

Date/Time Button 9

Touching the date/time will display a screen allowing the setting of the current date/time. A
password is required to change the date and/or time.

SETUP Button 10

The lower right part of the screen contains the SETUP button. This button allows for setting
up the system for activity units, date format, type of printer, display adjustments, Staff
Member setup and advanced Probe and Well Counter settings.

DETECTOR Button 11
Note: If the system is a Probe only or Well only, this button will not be displayed.

Touching the DETECTOR button allows the selection of which Detector’s to use for the
measurement procedure.

Detector Indicator 12

The currently selected detector (Probe, Well or Drilled Probe) is displayed in the lower left
hand corner.

3-4 GENERAL OPERATING INSTRUCTIONS October 15

CAPINTEC, INC. CAPTUS® 700t

ENTERING DATA
Numeric Data

When a numeric only data entry is required, Figure 3-2 Numeric Keypad Screen will appear
as shown below. This keypad is touchable for entering the data.

Figure 3-2 Numeric Keypad Screen

If units of measure are also required, such as Ci, mCi, µCi, GBq, MBq, kBq for activity or Yr,
Hr, Day, Min, Sec for half-life, they will appear on the keypad between the number pad and
the data entry box.

October 15 GENERAL OPERATING INSTRUCTIONS 3-5

CAPINTEC, INC. CAPTUS® 700t

Alphanumeric Data

When an alphanumeric data entry is required, Figure 3-3 Alphanumeric Keypad Screen will
appear as shown below. This keypad is also touchable for entering the data.

Figure 3-3 Alphanumeric Keypad Screen

Touching the SHIFT key on the alphanumeric keypad will cycle between 4 modes:

• Lock/Upper Case – If “Lock” is displayed above the SHIFT key and upper case
letters are displayed on the keys, the keypad is locked in upper case letters. All
selected letters will be in upper case.

• 1Chr/Lower Case – If “1Chr” is displayed above the SHIFT key and lower case
letters are displayed on the keys, the first letter selected will be in lower case and the
keypad will change to Lock/Upper case mode.

• Lock/Lower Case – If “Lock” is displayed above the SHIFT key and lower case letters
are displayed on the keys, the keypad is locked in lower case letters. All selected
letters will be in lower case.

• 1Chr/Upper Case – If “1Chr” is displayed above the SHIFT key and upper case
letters are displayed on the keys, the first letter selected will be in upper case and the
keypad will change to Lock/Lower case mode.

3-6 GENERAL OPERATING INSTRUCTIONS October 15

CAPINTEC, INC. CAPTUS® 700t

List Screen

When an item is to be selected from a group, a list appears showing the available selections.
Figure 3-4 List Screen is an example of a List Screen.

Figure 3-4 List Screen

If there are more items on the list than can fit on one page, a DOWN ARROW (▼) button will
appear on the first page. Touching the DOWN ARROW (▼) button will display the next page.
If there is a previous page of the list, an UP ARROW (▲) button will appear. Touching the
UP ARROW (▲) button will display the previous page. The number of pages (or screens) will
be shown in the upper right corner of the screen indicating the length of the list.

Quickly touching any line will highlight that line, selecting the information on that line.

Note: When touching the screen on a list, you should withdraw your finger quickly. If you
hold your finger down too long, the touched line will be blanked until your finger is
removed. Moving your finger down the list will make it appear that the line has
vanished. To restore the data to the screen, simply touch the line quickly again.

October 15 GENERAL OPERATING INSTRUCTIONS 3-7

CAPINTEC, INC. CAPTUS® 700t

Date/Time Screen

When a Date and/or Time entry is required, Figure 3-5 Date/Time Screen will appear as
shown below.

Figure 3-5 Date/Time Screen

The screen displays the currently set date and time. The date and time are divided into the
following fields:

• mm.......... Month (1-12)
• d.............. first digit of the Day (0-3)
• d.............. second digit of the Day (0-9)
• yyyy ........ Year (1970-2030)
• h.............. first digit of the Hour (0-2)
• h.............. second digit of the Hour (0-9)
• m............. first digit of the Minute (0-5)
• m............. second digit of the Minute (0-9)

Above and below each of the fields are + and – buttons, respectively. To adjust the displayed
value for a specific field, touch the + button to increase the displayed value or the – button to
decrease the displayed value.

For the year, +10 and -10 buttons are provided to quickly change the tens column of the
years.

3-8 GENERAL OPERATING INSTRUCTIONS October 15

CAPINTEC, INC. CAPTUS® 700t

CHAPTER 4

SYSTEM SETUP

RECEIVING CONDITION EXAMINATION ......................................................4-1
INSTALLATION ..............................................................................................4-2
ENVIRONMENT REQUIREMENTS .................................................................4-5

Operational .................................................................................................4-5
Storage........................................................................................................4-5
POWER REQUIREMENTS..............................................................................4-5
TURN ON PROCEDURES ..............................................................................4-5
GENERAL OPERATIONAL SETUP................................................................4-7
ACCEPTANCE TESTING................................................................................4-7
Diagnostics Test.........................................................................................4-7
Detector System Test.................................................................................4-7
SECURITY STATUS .......................................................................................4-8
Security Status and Staff Setup ................................................................4-9
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

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(es) should be dry and clean.

Should the instrument be received in a damaged condition, save the shipping container(s)
and the packing material and request an immediate inspection by the carrier.

Capintec, Inc. is not responsible for damage which occurs during shipment but will make
every effort to help obtain restitution from the carrier.

October 15 SYSTEM SETUP 4-1

CAPINTEC, INC. CAPTUS® 700t

INSTALLATION
CAUTION: Be sure the instrument has reached room temperature prior to opening
the box. (Leave the box in the room 24 hours before opening it.)

Initial installation and checkout procedures are described in this section. Your system has
been shipped from the factory pre-configured and fully tested. Refer to the included
"UNPACKING AND ASSEMBLY INSTRUCTIONS" document for more details.

If your system includes a Floor Stand, installation consists of placing the components on the
Stand and securing them in place as shown in Figure 4-1.

Collimator with
Probe Detector

CAPTUS® 700t
Readout

Isolation Printer
Transformer
Well Counter
(Optional)

Floor
Stand

Figure 4-1 Complete Assembly with Floor Stand

4-2 SYSTEM SETUP October 15


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