Capintec CAPTUS 4000e User manual

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 [phone]
The authorized representative located within the Community is:
Atlantico Systems Ltd.
34 Oldfield, Kingston, Galway, Republic of Ireland
Copyright©2020 Capintec, Inc.
CAPTUS®is a registered trademark of Capintec, Inc.
ALL RIGHTS RESERVED

CAPINTEC, INC. CAPTUS® 4000e
This page intentionally left blank.

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 [phone]
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

CAPINTEC, INC. CAPTUS® 4000e
TOC-6 TABLE OF CONTENTS August 20
Recall Counting Setup ............................................................................................. 12-14
Restore Current Settings .......................................................................................... 12-14
PRINTING MCA DATA ................................................................................................ 12-14
CUSTOMIZING MCA SETTINGS ................................................................................ 12-14
High Voltage ............................................................................................................ 12-15
Gain ......................................................................................................................... 12-15
Zero Offset ............................................................................................................... 12-16
Threshold ................................................................................................................. 12-16
MANUAL CALIBRATION ............................................................................................. 12-17
ARCHIVE..........................................................................................................................13-1
INTRODUCTION ........................................................................................................... 13-1
DOING SYSTEM BACKUP (CREATING AN ARCHIVE) ............................................... 13-3
OPENING AN ARCHIVE ............................................................................................... 13-4
VIEWING AND PRINTING RECORDS FROM ARCHIVE .............................................. 13-5
Selecting Tests for Viewing ........................................................................................ 13-5
Viewing or Printing a Record ...................................................................................... 13-6
Printing All Records in Selected Tests ....................................................................... 13-8
CUSTOM PROTOCOLS ...................................................................................................14-1
INTRODUCTION ........................................................................................................... 14-1
STARTING CUSTOM PROTOCOLS ............................................................................. 14-2
PROTOCOLS ................................................................................................................ 14-3
Adding Protocols ........................................................................................................ 14-3
Viewing Protocols ...................................................................................................... 14-7
Deleting Protocols ...................................................................................................... 14-7
Deleting Selected Protocols ................................................................................... 14-7
Deleting All Protocols ............................................................................................ 14-7
Selecting the Excel Workbook for the Protocol ........................................................... 14-7
PATIENT DATA ............................................................................................................. 14-8
Adding Patients .......................................................................................................... 14-8
Editing Patient Information ....................................................................................... 14-10
Deleting Patient Information ..................................................................................... 14-10
Deleting Selected Patients ................................................................................... 14-10
Deleting All Patients ............................................................................................ 14-11
MAKING MEASUREMENTS ....................................................................................... 14-12
Data Acquisition ....................................................................................................... 14-13
After Counting .......................................................................................................... 14-15
Report ...................................................................................................................... 14-15
CUSTOM PROTOCOLS EXCEL WORKBOOK ........................................................... 14-16
Creating a Workbook for a Protocol (Setup Mode) ................................................... 14-16
Setting Up the Workbook ......................................................................................... 14-18
Protocol Selection ............................................................................................... 14-19
Patient Selection ................................................................................................. 14-20
Entering Formulas ............................................................................................... 14-22
Creating a Report ................................................................................................ 14-23
Viewing Patients from Workbook (User Mode) ......................................................... 14-24

CAPINTEC, INC. CAPTUS® 4000e
August 20 TABLE OF CONTENTS TOC-7
CLEANING AND MAINTENANCE................................................................................... 15-1
INTRODUCTION .......................................................................................................... 15-1
CLEANING and DISINFECTING ................................................................................... 15-2
Cleaning Instructions ................................................................................................. 15-2
Disinfecting Instructions ............................................................................................. 15-4
Liner ..................................................................................................................... 15-4
Printer ................................................................................................................... 15-4
PREVENTIVE MAINTENANCE .................................................................................... 15-4
DISPOSAL .................................................................................................................... 15-5
SERVICING .................................................................................................................. 15-6
Collimator Block Inspection ....................................................................................... 15-6
Spring-Arm Inspection ............................................................................................... 15-7
Computer Battery Replacement ................................................................................ 15-9
FUSE SERVICING ........................................................................................................ 15-9
Power Line Fuses ...................................................................................................... 15-9
Computer and Printer Fuses ................................................................................... 15-11
ACCESSORIES AND REPLACEMENT PARTS ......................................................... 15-12
SHIPPING................................................................................................................... 15-13
Cap-DICOM ..................................................................................................................... 16-1
INTRODUCTION .......................................................................................................... 16-1
CONFIGURING Cap-DICOM ........................................................................................ 16-1
License Information ................................................................................................... 16-1
Settings ..................................................................................................................... 16-4
AE Title ................................................................................................................. 16-5
Text Color ............................................................................................................. 16-5
Display Patient ...................................................................................................... 16-5
Study Date ............................................................................................................ 16-6
Institution Information ............................................................................................ 16-6
Worklist Provider ....................................................................................................... 16-6
Adding Worklist Provider ....................................................................................... 16-6
Editing Worklist Provider ....................................................................................... 16-9
Deleting Worklist Provider ................................................................................... 16-10
Storage Provider ..................................................................................................... 16-11
Adding Storage Provider ..................................................................................... 16-11
Editing Storage Provider ..................................................................................... 16-13
Deleting Storage Provider ................................................................................... 16-14
IMPORTING PATIENTS ............................................................................................. 16-15
Query Worklist ......................................................................................................... 16-15
Start Date/End Date ............................................................................................ 16-17
Modality .............................................................................................................. 16-17
Scheduled Station AE Title ................................................................................. 16-17
Schedule Performing Physicians Name .............................................................. 16-17
Accession Number, Patient Id and Patient Name ................................................ 16-18
Import Patient .......................................................................................................... 16-18
VIEWING THE DICOM REPORT ................................................................................ 16-19
EXPORTING A STUDY .............................................................................................. 16-21
VERIFYING STUDY ................................................................................................... 16-22

CAPINTEC, INC. CAPTUS® 4000e
TOC-8 TABLE OF CONTENTS August 20
INDEX
WARRANTY
DECLARATION OF CONFORMITY

CAPINTEC, INC. CAPTUS® 4000e
August 20 SAFETY 1-1
CHAPTER 1
SAFETY
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
GENERAL
These warnings and instructions form an integral part of the CAPTUS® 4000e system and
must be kept available for consultation at all times. Precise compliance with the warnings
and instructions is an essential condition for correct usage and safety of patients and users.
SYMBOL DEFINITIONS
Dangerous Voltage Present
Protective Earth Ground
Caution
Operator should consult accompanying documents
Fuse
AC Voltage
DC Voltage
“ON” (power)
“OFF” (power)
Date of Manufacture

CAPINTEC, INC. CAPTUS® 4000e
1-2 SAFETY August 20
CE Mark
2017/745/EU symbol for Medical Device
2017/745/EU symbol for hazardous substance. The
Captus 4000e contains lead as shielding.
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.
Manufacturer
Serial number
Authorized representative in the European Community
Consult Instructions for Use
WARNING AND CAUTION LABELS
Located on the Isolation Transformer is a label (Figure 1-1) providing the system power
requirements, the voltage of the system, the replacement fuse values for both power line
voltages and the fuse replacement warning.
Figure 1-1

CAPINTEC, INC. CAPTUS® 4000e
August 20 SAFETY 1-3
CAUTION: Please reference CHAPTER 15: CLEANING AND MAINTENANCE
for instructions on how to change the fuses of the Isolation
Transformer.
CAUTION:
For continued protection, replace only with same type and rating of
fuse(s). A fire hazard may exist if the wrong rating of fuse is installed.
Located by each line cord on the Isolation Transformer is a label (Figure 1-2) indicating
which device each cord is to be connected to and the power availability for that device.
Figure 1-2
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. Verify that in the Date
and Time Properties in Windows Control Panel that the “Automatically
adjust clock for daylight saving changes” checkbox is not checked.
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: High voltage is present inside the Detectors (up to 1000 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: The assembled CAPTUS® 4000e system is very heavy (up to a
maximum of 740lb [336kg] fully loaded) Use caution when moving.
Reference CHAPTER 4: GENERAL SETUP, Section: Moving the
System for moving instructions.

CAPINTEC, INC. CAPTUS® 4000e
1-4 SAFETY August 20
CAUTION: There are no internal adjustments inside the detector, computer or
printer that should be performed by the user within the conditions of the
warranty, except for changing the Isolation Transformer fuse. Due to the
presence of high voltages, opening the cover of the computer 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 unit becomes contaminated remove liner and clean unit
as stated in CHAPTER 15: 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: This equipment generates radio frequency energy and is susceptible to
radio frequency energy (such as from other equipment and portable and
mobile RF communications equipment). The equipment needs to be
installed and used accordingly with these instructions; otherwise the
equipment may not function properly or may cause harmful
Electromagnetic Interference (EMI) to nearby devices. There is,
however, no guarantee that interference will not occur in a particular
installation/location.
CAUTION: If any Computer, Printer or cables other than the model supplied by
Capintec is used, the safety of the unit may be compromised or other
devices located in the same general area as the CAPTUS® 4000e may
become susceptible to EMI.
CAUTION: If any detectors other than those supplied by Capintec are used, the
safety of the unit may be compromised or other devices located in the
same general area as the CAPTUS® 4000e 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: Do not disconnect or connect detectors from the computer, while the
system is on. Shut down the computer first.

CAPINTEC, INC. CAPTUS® 4000e
August 20 SAFETY 1-5
CAUTION: Only the included USB devices should be connected to the USB ports on
the Computer. If any USB devices other than the models supplied by
Capintec are used, the safety of the unit may be compromised or other
devices located in the same general area as the CAPTUS® 4000e may
become susceptible to EMI. The maximum Input/Output voltages are
5Vdc.
CAUTION: Do not attach a monitor to the VGA port on the rear of the Computer. If a
Monitor is attached to this port, the safety of the unit may be
compromised or other devices located in the same general area as the
CAPTUS
®
4000e may become susceptible to EMI.
CAUTION: Do not connect the CAPTUS® 4000e to a network. If the system is
attached to a network, the safety of the unit may be compromised or
other devices located in the same general area as the CAPTUS® 4000e
may become susceptible to EMI.
CAUTION: The unit contains lead. 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.
WARNING: The CAPTUS® 4000e must be connected a supply mains with protective
earth.
WARNING: The use of accessories, transducers and/or cables other than those
specified, with the exception of those sold by the manufacturer as
replacement parts for internal components, may result in increased
emissions or decreased immunity of the equipment or system.
CAUTION: This equipment generates radio frequency energy and is susceptible to
radio frequency energy (such as from other equipment and portable and
mobile RF communications equipment). The equipment needs to be
installed and used accordingly with these instructions; otherwise the
equipment may not function properly or may cause harmful
Electromagnetic Interference (EMI) to nearby devices. There is,
however, no guarantee that interference will not occur in a particular
installation/location

CAPINTEC, INC. CAPTUS® 4000e
1-6 SAFETY August 20
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.
WARNING: Medical Electrical Equipment needs special precautions regarding EMC
and needs to be installed and put into service according to the EMC
information provided in the Accompanying Documents.
WARNING: Portable and Mobile RF Communications Equipment can affect Medical
Electrical Equipment.
CAUTION: The USB cable lengths should not exceed 9.8 ft (3.0 m). Cable length
longer than this may affect the electromagnetic compliance.
CAUTION: The detector base cable lengths should not exceed 9.8 ft (3.0 m). Cable
length longer than this may affect the electromagnetic compliance.
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 15:
CLEANING AND MAINTENANCE) to guarantee that the instrument's high reliability is
maintained).

CAPINTEC, INC. CAPTUS® 4000e
August 20 SAFETY 1-7
ELECTROMAGNETIC COMPATABILTIY TEST DATA
Table 1 - Guidance and Manufacturer's Declaration -
Emissions All ME Equipment and ME
Systems
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF Emissions
CISPR 11
Group 1
The CAPTUS® 4000e uses RF energy only for
its internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in
nearby electronic equipment.
RF Emissions
CISPR 11
Class A
The CAPTUS® 4000e is suitable for use in all
establishments, other than domestic, and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes.
Harmonics
IEC 61000-
3-2
Class A
Flicker
IEC 61000-3-3
Complies
Table 2 - Guidance and Manufacturer's Declaration -
Immunity All ME Equipment and ME Systems
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnet
ic
Environment -
Guidance