CAPTUS ® 4000e Thyroid Uptake System Manual- Revision J

CAPTUS® 4000e

Manual Stock No. 9250-0151 June, 28 2017
Rev. F 2017/06/28

THYROID UPTAKE SYSTEM
OWNER’S MANUAL

Capintec, Inc.
7 Vreeland Road
Florham Park, NJ 07932
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

Copyright© 2015 Capintec, Inc.

CAPTUS® is a registered trademark of Capintec, Inc.

ALL RIGHTS RESERVED



CAPINTEC, INC. CAPTUS® 4000e

TABLE OF CONTENTS

PREFACE

SAFETY ............................................................................................................................. 1-1
GENERAL....................................................................................................................... 1-1
SYMBOL DEFINITIONS ................................................................................................. 1-1
WARNING AND CAUTION LABELS............................................................................... 1-2
CAUTIONS AND NOTES................................................................................................ 1-3
GENERAL SAFETY TIPS ............................................................................................... 1-6

FUNCTIONAL & TECHNICAL DESCRIPTION .................................................................. 2-1
INTENDED USE ............................................................................................................. 2-1
OPERATOR PROFILE.................................................................................................... 2-2
OPERATOR TRAINING.................................................................................................. 2-2
FUNCTIONAL DESCRIPTION........................................................................................ 2-2
Thyroid Uptake............................................................................................................ 2-2
Wipe Test .................................................................................................................... 2-3
Lab Tests .................................................................................................................... 2-3
Urine Tests ............................................................................................................. 2-3
Blood Tests............................................................................................................. 2-3
Bioassay ..................................................................................................................... 2-4
TECHNICAL DESCRIPTION .......................................................................................... 2-4
Detector ...................................................................................................................... 2-4
Multi-Channel Analyzer ............................................................................................... 2-5
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

November 16 TABLE OF CONTENTS TOC-1

CAPINTEC, INC. CAPTUS® 4000e

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
Invalidate User ...........................................................................................................4-13
Revalidate User .........................................................................................................4-13
Displaying Data by Date.............................................................................................4-13

TOC-2 TABLE OF CONTENTS November 16

CAPINTEC, INC. CAPTUS® 4000e

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
Deleting Patient Records........................................................................................... 7-15
VIEWING AND CHANGING THE SETUP ..................................................................... 7-16
MAKING MEASUREMENTS......................................................................................... 7-18

November 16 TABLE OF CONTENTS TOC-3





















































































CAPINTEC, INC. CAPTUS® 4000e

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.

POWER REQUIREMENTS
CAUTION: If the input voltage 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: .....................2.6 Ampere @ 115V
1.1 Ampere @ 230V
Fuse: For 115V use T 3.15AH, 250V, (Time Delay)
For 230V use T 2.5AH, 250V, (Time Delay)

Isolation Transformer Output
Computer and Monitor combined
Output Voltage:......... 115Vac
Current Output: ......... 2.9A
Frequency:................ 50/60Hz

Printer
Output Voltage:......... 115Vac
Current Output: ......... 0.7A
Frequency:................ 50/60Hz

CAP-MCA
Output Voltage:......... +5Vdc
Current Output: ......... 3.0A

TURN ON PROCEDURE
Verify all system components are mounted securely and all cables are connected. Connect
the Isolation Transformer main power cable to a medical grade wall socket.

All software necessary for proper operation of your CAPTUS® 4000e Thyroid Uptake System
has been pre-installed and tested at the factory to ensure trouble-free setup.

4-4 GENERAL SETUP November 16

CAPINTEC, INC. CAPTUS® 4000e

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

There are three power switches associated with the system:
• the computer has a power switch, and
• the CAP-MCA has a power switch,
• the printer has a power switch.

Turn on all three switches.

Your system will power up, go through the computer boot-up sequence, and display the
Windows® start up screen.

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. Verify that the under
the Date and Time Properties in Windows that the Automatically adjust
clock for daylight saving changes checkbox is not checked.

LOG ON
Note: Before performing any measurements, allow the system to warm up at least 30

minutes.

To run the CAPTUS® 4000e software, double-click on the CAPTUS® 4000e icon. When the
program is launched, Figure 4-3 Log On Sign In Window will appear:

November 16 Figure 4-3 Log On Sign In Window 4-5

GENERAL SETUP

CAPINTEC, INC. CAPTUS® 4000e

Sign In
Users must set up by the Administrator prior to logging on to the CAPTUS® 4000e. User
Names and Passwords are case sensitive.

Input the User Name and then the Password. Asterisks (*) will appear when the Password is
entered.

The OK button will be enabled when entries have been made in both User Name and
Password.

When the User Name and Password are correct, selecting the OK button will exit the Sign
On screen and Figure 4-13 Main Screen will appear.

Note: If the Startup Tips option is enabled, Figure 4-10 Startup Tips Window
will appear instead of Figure 4-13 Main Screen.

Sign Off
After signing in to the CAPTUS® 4000e, a user may sign off by selecting the Sign Off button
(Refer to Figure 4-13 Main Screen). Selecting this button will end the session for the
currently logged on user and display Figure 4-3 Log On Sign In Window so that another user
can sign on.

Admin Log On
The Administrator is the user who has control of user management. The Administrator can
view and print Log On / Log Off Reports and can add, delete or invalidate users.

For the Administrator to log on:
• In the User Name text box, input Admin and press the Tab key.
• In the Password text box, input the password (AlphaDrive is default) and press the
Tab key.

Note: User Names and Passwords are case sensitive.

Note: It is recommended that the Admin password be changed at first log in.

4-6 GENERAL SETUP November 16