Capintec CAPTUS 4000e Manuale utente

CAPTUS®4000e

Manual Stock No. 9250-0151 August 12, 2020

Rev. K 2020/12/08

THYROID UPTAKE SYSTEM

OWNER’S MANUAL

Mirion Technologies (Capintec), Inc.

7 Vreeland Road

Florham Park, NJ 07932 USA

Phone (800) ASK-4CRC

Fax (201) 825-1336

The authorized representative located within the Community is:

Atlantico Systems Ltd.

34 Oldfield, Kingston, Galway, Republic of Ireland

CAPTUS®is a registered trademark of Capintec, Inc.

CAPINTEC, INC. CAPTUS® 4000e

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CAPINTEC, INC. CAPTUS® 4000e

August 20 PREFACE p-1

PREFACE

GENERAL ........................................................................................................ 1

SYSTEM DESCRIPTION.................................................................................. 1

MEDICAL EQUIPMENT SAFETY CLASSIFICATION...................................... 2

ELECTROMAGNETIC INTERFERENCE POTENTIAL .................................... 2

INSTALLATION ............................................................................................... 3

IMPORTANT SAFETY INFORMATION............................................................ 3

TRADEMARKS ................................................................................................ 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.

7 Vreeland Road

Florham Park, NJ 07932

Phone (800) ASK-4CRC

Fax (201) 825-1336

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® 4000e 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:

• Floor Stand or Optional 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.

CAPINTEC, INC. CAPTUS® 4000e

p-2 PREFACE August 20

• All-in-One Touchscreen Computer System

• CAP-MCA

• Printer

• Cables for connecting detector, printer, etc.

• 15 foot power cord with hospital grade plug

• Software and Documentation

• Windows 8.1 or later,

• CAPTUS® 4000e Manual and Installation Disks or CDs

• 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

• 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 “Medical electrical equipment: Part 1: General safety requirements; 2.

Supplementary standard: Electromagnetic compatibility”.

This equipment generates radio frequency energy and, if not installed and used in

accordance with the instructions, may cause harmful interference to nearby devices.

However, there is no guarantee that interference will not occur in a particular installation. If

this equipment does cause harmful interference, the user is encouraged to try to correct the

interference by one of the following measures:

• Increase the separation between the equipment and the affected device.

• Plug the unit into an outlet on a circuit different from that which the affected device is

connected.

If this fails to correct the problem, please contact Capintec’s only Authorized Service Center.

CAPINTEC, INC. CAPTUS® 4000e

August 20 PREFACE p-3

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.

IMPORTANT SAFETY INFORMATION

The CAPTUS® 4000e measurement system has been carefully designed to give you years of

safe and reliable performance. As with all electrical equipment, however, there are basic

precautions you must observe to avoid injuring yourself, the patient or damaging the

equipment.

• 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.

TRADEMARKS

CAPTUS® 4000e and CII are registered trademarks of Capintec, Inc.

Microsoft® and MS Windows® are U.S. registered trademarks of the Microsoft Corporation.

Hewlett Packard® Officejet is a registered trademark of the Hewlett Packard Company.

CAPINTEC, INC. CAPTUS® 4000e

August 20 TABLE OF CONTENTS TOC-1

TABLE OF CONTENTS

PREFACE

SAFETY ............................................................................................................................. 1-1

GENERAL....................................................................................................................... 1-1

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

WARNING AND CAUTION LABELS ............................................................................... 1-2

CAUTIONS AND NOTES ................................................................................................ 1-3

ELECTROMAGNETIC COMPATABILTIY TEST DATA................................................... 1-7

GENERAL SAFETY TIPS ............................................................................................. 1-11

FUNCTIONAL & TECHNICAL DESCRIPTION .................................................................. 2-1

INTENDED USE ............................................................................................................. 2-1

INCIDENT REPORTING ................................................................................................. 2-1

CONTRAINDICATION .................................................................................................... 2-2

OPERATOR PROFILE.................................................................................................... 2-2

OPERATOR TRAINING .................................................................................................. 2-2

FUNCTIONAL DESCRIPTION ........................................................................................ 2-2

Thyroid Uptake ............................................................................................................ 2-2

Wipe Test .................................................................................................................... 2-3

Bioassay ..................................................................................................................... 2-3

TECHNICAL DESCRIPTION .......................................................................................... 2-3

Detector ...................................................................................................................... 2-4

Multi-Channel Analyzer ............................................................................................... 2-4

TECHNICAL SPECIFICATIONS ..................................................................................... 2-6

System Hardware ........................................................................................................ 2-6

Detectors, Data Acquisition, and Computer ............................................................ 2-6

Floor Stand ............................................................................................................. 2-6

Isolation Transformer .............................................................................................. 2-6

Printer ..................................................................................................................... 2-6

Computer System (Minimum System Requirements) .............................................. 2-7

CAP-MCA ............................................................................................................... 2-7

TUS Probe Detector ................................................................................................ 2-8

Well Detector – Optional ......................................................................................... 2-8

Environment Requirements ......................................................................................... 2-8

Operational ............................................................................................................. 2-8

Storage ................................................................................................................... 2-9

Warm Up Period .......................................................................................................... 2-9

System Power Requirements ...................................................................................... 2-9

Input Power ............................................................................................................ 2-9

Isolation Transformer Output .................................................................................. 2-9

Printer ................................................................................................................... 2-10

Regulatory Listings .................................................................................................... 2-10

EMC ..................................................................................................................... 2-10

Safety ................................................................................................................... 2-10

CAPINTEC, INC. CAPTUS® 4000e

TOC-2 TABLE OF CONTENTS August 20

Life Time (End of Life) ................................................................................................ 2-10

GENERAL OPERATING INSTRUCTIONS.........................................................................3-1

INTRODUCTION ............................................................................................................. 3-1

WINDOWS OPERATING CONVENTIONS ...................................................................... 3-1

Common Controls and Techniques .............................................................................. 3-1

Windows Controls ........................................................................................................ 3-2

Pointing Device Cursor ............................................................................................ 3-2

Command Button .................................................................................................... 3-3

Frame ...................................................................................................................... 3-3

Text Entry Box ......................................................................................................... 3-4

Scroll Bars .................................................................................... 3-5

Spin Control .................................................................................................. 3-6

List Controls ............................................................................................................ 3-6

Menu Bars ............................................................................................................... 3-6

Buttons .................................................................................................................... 3-6

Keyboard Control .................................................................................................... 3-7

CAPTUS SCREENS ........................................................................................................ 3-7

Typical Test Screen ..................................................................................................... 3-9

Typical Input Screen .................................................................................................. 3-10

Measurement Screen ................................................................................................. 3-11

Add Comments Screen .............................................................................................. 3-12

SHORTCUT KEYS ........................................................................................................ 3-13

All Screens ................................................................................................................. 3-13

Input Screens ............................................................................................................. 3-13

GENERAL SETUP .............................................................................................................4-1

INSTALLATION ............................................................................................................... 4-1

ENVIRONMENT REQUIREMENTS ................................................................................. 4-3

Operational .................................................................................................................. 4-3

Storage ........................................................................................................................ 4-3

POWER REQUIREMENTS ............................................................................................. 4-4

Input Power .................................................................................................................. 4-4

Isolation Transformer Output........................................................................................ 4-4

TURN ON PROCEDURE ................................................................................................ 4-4

LOG ON .......................................................................................................................... 4-5

Sign In ......................................................................................................................... 4-6

Sign Off ........................................................................................................................ 4-6

Admin Log On .............................................................................................................. 4-6

User Log On ................................................................................................................ 4-7

Add User ......................................................................................................................... 4-8

Add User – Staff Member ............................................................................................. 4-8

Add User – Not a Staff Member ................................................................................... 4-9

Change Password ......................................................................................................... 4-10

LOG ON REPORT ......................................................................................................... 4-11

Displaying Selected User ........................................................................................... 4-12

Delete User ................................................................................................................ 4-12

CAPINTEC, INC. CAPTUS® 4000e

August 20 TABLE OF CONTENTS TOC-3

Invalidate User .......................................................................................................... 4-13

Revalidate User ......................................................................................................... 4-13

Displaying Data by Date ............................................................................................ 4-13

Printing Report .......................................................................................................... 4-13

Exiting ....................................................................................................................... 4-14

FIRST TIME STARTUP ................................................................................................ 4-14

System Parameters ................................................................................................... 4-15

Quality Assurance Tests ............................................................................................ 4-16

Reference Pages .................................................................................................. 4-17

Measurement Setups ................................................................................................ 4-17

Reference Pages .................................................................................................. 4-18

NORMAL STARTUP ..................................................................................................... 4-18

QUALITY ASSURANCE .................................................................................................... 5-1

INTRODUCTION ............................................................................................................ 5-1

Recommended Routine for CAPTUS® 4000e System ................................................. 5-1

SETTING UP QA PARAMETERS ................................................................................... 5-2

AUTO CALIBRATION ..................................................................................................... 5-5

About Auto Calibration............................................................................................... 5-10

CONSTANCY TEST ..................................................................................................... 5-11

CHI-SQUARE TEST ..................................................................................................... 5-15

MDA TEST .................................................................................................................... 5-19

VIEWING SYSTEM PARAMETERS ............................................................................. 5-23

VIEWING AND PRINTING HISTORY ........................................................................... 5-24

ISOTOPES......................................................................................................................... 6-1

INTRODUCTION ............................................................................................................ 6-1

VIEWING AND PRINTING ISOTOPE LIBRARY ............................................................. 6-2

ADDING A NEW ISOTOPE TO THE LIBRARY .............................................................. 6-3

EDITING ISOTOPE INFORMATION ............................................................................... 6-4

DELETING AN ISOTOPE ............................................................................................... 6-5

MEASURING EFFICIENCY ............................................................................................ 6-5

ENTERING EFFICIENCY ............................................................................................... 6-9

THYROID UPTAKE ........................................................................................................... 7-1

INTRODUCTION ............................................................................................................ 7-1

QUICK STEP GUIDE FOR THYROID UPTAKE PROCEDURE ...................................... 7-3

MEASUREMENT PROTOCOLS ..................................................................................... 7-3

Counting Methods ....................................................................................................... 7-3

Dose Administration .................................................................................................... 7-4

Adding Protocols ......................................................................................................... 7-5

Editing Protocols ......................................................................................................... 7-7

Deleting Protocols ....................................................................................................... 7-9

Printing Protocol Report ............................................................................................ 7-10

PATIENT INFORMATION ............................................................................................. 7-10

Adding Patients ......................................................................................................... 7-10

Viewing Patient Information ....................................................................................... 7-13

Editing Patient Information ........................................................................................ 7-13

CAPINTEC, INC. CAPTUS® 4000e

TOC-4 TABLE OF CONTENTS August 20

Deleting Patient Records ........................................................................................... 7-15

VIEWING AND CHANGING THE SETUP ...................................................................... 7-16

MAKING MEASUREMENTS ......................................................................................... 7-18

Counting Selected Patient .......................................................................................... 7-20

Administering Dose .................................................................................................... 7-24

RESULTS ...................................................................................................................... 7-24

Patients Reports ........................................................................................................ 7-25

Sources of Error ......................................................................................................... 7-28

WIPE TESTS ......................................................................................................................8-1

INTRODUCTION ............................................................................................................. 8-1

QUICK STEP GUIDE FOR WIPE TEST .......................................................................... 8-3

SETTING UP DEFAULTS ............................................................................................... 8-3

SELECTING ISOTOPES FOR WIPE TEST ..................................................................... 8-4

ADDING WIPE LOCATIONS TO PRESET GROUPS ...................................................... 8-6

ADDING WIPE LOCATIONS TO USER DEFINED GROUPS .......................................... 8-7

EDITING WIPE LOCATION INFORMATION ................................................................... 8-8

DELETING WIPE TEST LOCATION ............................................................................. 8-10

MAKING MEASUREMENTS ......................................................................................... 8-12

Results ....................................................................................................................... 8-17

VIEWING AND PRINTING RESULTS ........................................................................... 8-18

Search ....................................................................................................................... 8-19

Viewing Wipe Test Data Selectively ...................................................................... 8-21

Selecting Results ................................................................................................... 8-22

Exporting Wipe Test Results ................................................................................. 8-22

Printing Wipe Test Results .................................................................................... 8-23

Exiting Search ....................................................................................................... 8-23

Summary Reports ...................................................................................................... 8-24

Printing Wipe Test Summary Report ..................................................................... 8-29

Exiting Summary Reports ...................................................................................... 8-30

ISOTOPE EFFICIENCY ................................................................................................ 8-30

ABSORBED DOSE ALERT................................................................................................9-1

INTRODUCTION ............................................................................................................. 9-1

Basis for Conversion Calculations ................................................................................ 9-2

MAIN SCREEN ............................................................................................................... 9-2

INCIDENT SETUP ........................................................................................................... 9-4

Setup Incident Parameters ........................................................................................... 9-4

Incident / Site ID ...................................................................................................... 9-4

Date of Intake .......................................................................................................... 9-4

Select Isotope .......................................................................................................... 9-5

Screening Level ....................................................................................................... 9-5

Counting Parameters Frame ................................................................................... 9-5

Repetitions Frame ................................................................................................... 9-5

New Incident ................................................................................................................ 9-6

Select Incident ............................................................................................................. 9-6

Delete Incident ............................................................................................................. 9-8

Edit Incident ................................................................................................................. 9-9

ADDING PATIENTS ...................................................................................................... 9-11

CAPINTEC, INC. CAPTUS® 4000e

August 20 TABLE OF CONTENTS TOC-5

EDITING PATIENTS ..................................................................................................... 9-14

DELETING PATIENTS.................................................................................................. 9-15

MAKING MEASUREMENTS ......................................................................................... 9-16

Data Acquisition ........................................................................................................ 9-20

CREATING AN ARCHIVE ............................................................................................. 9-21

OPENING AN ARCHIVE ............................................................................................... 9-22

PATIENT REPORTS .................................................................................................... 9-23

Displaying and Printing .............................................................................................. 9-23

Exporting ................................................................................................................... 9-26

BIOASSAY ...................................................................................................................... 10-1

INTRODUCTION .......................................................................................................... 10-1

BIOASSAY SETUP ....................................................................................................... 10-2

I 131/I 125 and I 123/1 125 Cross Contamination ...................................................... 10-9

ADDING STAFF MEMBERS ......................................................................................... 10-9

EDITING STAFF MEMBER INFORMATION ............................................................... 10-10

DELETING STAFF MEMBER ..................................................................................... 10-11

MAKING MEASUREMENTS ....................................................................................... 10-12

VIEWING AND PRINTING REPORTS ........................................................................ 10-15

TIME ACTIVITY ANALYSIS............................................................................................. 11-1

INTRODUCTION .......................................................................................................... 11-1

SETTING UP PARAMETERS ....................................................................................... 11-2

MAKING MEASUREMENTS ......................................................................................... 11-5

Saving the Results .................................................................................................... 11-8

VIEWING PREVIOUSLY SAVED RESULTS ................................................................ 11-9

MCA................................................................................................................................. 12-1

INTRODUCTION .......................................................................................................... 12-1

ACQUISITION AND COUNT DATA .............................................................................. 12-2

Channel Data Display ................................................................................................ 12-2

CHANGING DETECTORS ............................................................................................ 12-3

SPECTRUM SCALE & ZOOMING ................................................................................ 12-3

Vertical Zoom ............................................................................................................ 12-3

Horizontal Zoom ........................................................................................................ 12-4

Pre-Defined Channel Ranges ............................................................................... 12-4

User Selectable Range ......................................................................................... 12-5

COUNTING SETUP ...................................................................................................... 12-7

SPECTRUM ID (NAME) ................................................................................................ 12-7

REGIONS OF INTEREST (ROI) ................................................................................... 12-8

SAVE AND RESTORE COUNT DATA OR MCA SETTINGS ...................................... 12-10

Save Spectrum ........................................................................................................ 12-10

Recall Spectrum ...................................................................................................... 12-11

Export to Excel ........................................................................................................ 12-12

Export Raw Spectrum ............................................................................................. 12-13

Save MCA Settings ................................................................................................. 12-13

Recall MCA Settings ............................................................................................... 12-13

Save Counting Setup .............................................................................................. 12-13

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