electrical leakage tests.
Do not touch any surface that is in contact with
the Tester, including the ultrasound transducer
and the adapter.
Do not touch the liquid in the test basin, as it is
at an electrical potential that is equal to the
“challenge” voltage being used to perform the
electrical safety test.
CAUTION - SERVICE
The ULT-2000 Testers are intended to be
serviced only by authorized service personnel.
Troubleshooting and service procedures
should only be performed by
qualified technical personnel.
CAUTION - ENVIRONMENT
The ULT-2000 Testers are intended to function
between 15 and 30 °C.
Exposure to temperatures outside this range can
adversely affect the performance of the Tester.
CAUTION - CLEANING
Do not immerse. The Tester should be cleaned
by wiping gently with a damp, lint-free cloth.
A mild detergent can be used if desired.
CAUTION - INSPECTION
The ULT-2000 Testers should be
inspected before each use for wear and
the Tester should be serviced
if any parts are in question.
3
NOTICE – SYMBOLS
Symbol Description
Caution
(Consult Manual for Further Information)
Electrical Caution
(Consult Manual for Further Information)
Center Negative
Direct Current
NOTICE – ABBREVIATIONS
Amps Ampheres
c centi- (10
C Celsius
CF Crest Factor
° degree
DFA Digital Fast Acquisition
DUT Device Under Test
hrs hours
Hz hertz
k kilo- (10
kg kilograms
kHz kilohertz
lbs pounds
L1, L2, L3 Location 1, 2, 3
M Mega- (10
MHz Megahertz
µ micro- (10
µA microampere
m milli- (10
mA milliampere
mHz millihertz
mm millimeter
ms millisecond
mV millivolts
Ω ohm
PC Personal Computer
Pk peak
RF Radio Frequency
RMS Root Mean Square
US United States
V volt
3
)
-3
-2
)
6
)
-6
)
)
4
USER ASSUMES FULL RESPONISIBILITY FOR UNAUTHORIZED
EQUIPMENT MODIFICATIONS OR APPLICATION OF EQUIPMENT
OUTSIDE OF THE PUBLISHED INTENDED USE AND
SPECIFICATIONS. SUCH MODIFICATIONS OR APPLICATIONS
MAY RESULT IN EQUIPMENT DAMAGE OR PERSONAL INJURY.
BC GROUP INTERNATIONAL, INC. RESERVES THE RIGHT TO
MAKE CHANGES TO ITS PRODUCTS OR SPECIFICATIONS AT
ANY TIME, WITHOUT NOTICE, IN ORDER TO IMPROVE THE
DESIGN OR PERFORMANCE AND TO SUPPLY THE BEST
POSSIBLE PRODUCT. THE INFORMATION IN THIS MANUAL HAS
BEEN CAREFULLY CHECKED AND IS BELIEVED TO BE
ACCURATE. HOWEVER, NO RESPONSIBILITY
IS ASSUMED FOR INACCURACIES.
The Model ULT-2000 Series is a family of Microprocessor based, Ultrasound Transducer
Leakage Testers. The ULT-2010 measures both the conductivity of the cleaning medium
and the leakage current of the ultrasound transducer. The ULT-2020 offers a Meter mode
and a Datalog.
The following are highlights of some of the main features:
ULT-2010 (BASIC FEATURES):
• LARGE GRAPHICS DISPLAY WITH CURSOR SELECTION
OF OPTIONS AND SETUP OF PARAMETERS
• USER-SELECTABLE CHALLENGE (TEST) VOLTAGE
(90 TO 275 VAC)
• USER SELECTABLE CHALLENGE (TEST) FREQUENCY
(50 OR 60 HZ)
• USER-SELECTABLE TEST LIMITS BY ULTRASOUND TRANSDUCER
MANUFACTURER AND MODEL
• 1% FS MEASUREMENT ACCURACY
• AUTO RANGING WITH 10, 250, OR 500 µA FS
• AUTOMATIC INTERNAL SELF TEST
• SINGLE BUTTON PRESS FOR FULL SYSTEM TEST
• SIMPLE GO-NOGO MODE – FOR NON-TECHNICAL USERS
• ANALYTICAL MODE – FOR TECHNICAL USERS
• DIGITAL CALIBRATION – NO POTS TO TURN
• USER-SELECTABLE DISPLAY OPTIONS
• BATTERY LIFE DISPLAY (0 to 100%)
• PROGRAMMABLE BACKLIGHT TIMER
• CONTRAST IS SOFTWARE ADJUSTABLE
• FLASH UPGRADEABLE FIRMWARE
• RS232 & PC SOFTWARE
• SERIAL PRINTER OUTPUT WITH PROGRAMMABLE USER HEADER
• REAL TIME CLOCK
• COMPATIBLE WITH DALE
BIOMEDICAL ULT-800® ULTRASOUND TRANSDUCER ADAPTERS AND
DUAL CONDUCTIVITY PROBES
®
TECHNOLOGY DALE800® AND FLUKE®
6
ULT-2020 (METER, DATALOG)
HAS ALL THE BASIC MODEL FEATURES PLUS:
• METER MODE FOR EXTENDED MEASUREMENT PERIODS
• PROGRAMMABLE METER CHALLENGE VOLTAGE AND FREQUENCY
(For use with Philips/HP 4500 and Sonos 5500/7500 transducers)
For compatibility with specific manufacturer and model ultrasound transducers, please contact
BC Group International and request the most recent copy of the ULT-2000 Ultrasound
Transducer and Adapter Compatibility chart. There may be additional adapters available that
are not on the above list. The above list is accurate as of the date of this User Manual revision.
8
OVERVIEW
This section looks at the physical layout of the ULT-2000 Series and gives descriptions of
the elements that are present.
Locking Device Under
Test (DUT) connector
– to conductive bath
via Dual Conductivity
Probe
6 Light Touch Keys for
Selecting Parameters and
Settings:
POWER for Turning Unit On
and Off
FULL TEST / UP for Testing
both Conductivity and
Leakage and for Scrolling
Through Selected Options
SELECT/PRINT for
Selecting Next Available
Parameter and Printing
MODE for Changing
Operating mode and
Entering/Exiting Setup Mode
BATH ONLY / DOWN for
Testing Conductivity and for
Scrolling Through Selected
Options
RESET for Canceling Test or
for Returning to Main Screen
after Test
Locking DUT
connector – to
ultrasound
transducer via
transducer adapter
Backlit LCD
Graphical
Display
RS232:
7 PIN Mini-Din
(Optional)
Power
2.1 mm Jack
(Optional Battery
Eliminator)
9V Battery
Compartment
(Back)
9
KEYS
Six tactile-touch keys with audio feedback are provided for system operation:
– This key turns the unit off and on. The unit will initiate with the Main Screen .
– When not in SETUP mode, this key will initiate the Full System Test, which
includes both a bath conductivity test and a transducer electrical leakage test.
When in the SETUP mode, this key will scroll up through the available settings.
– When not in SETUP mode, this key will initiate a conductivity test of the
conductive liquid medium in the bath. When in the SETUP mode, this key will
scroll down through the available settings.
– When not in the SETUP mode, this key will print the latest test results to the
serial port. When in the SETUP mode, this key will select the next available
parameter.
– When not in SETUP mode, this key is used to Reset the system to the main
screen.
10
– This key toggles the unit into and out of the system modes. Depressing this key
will toggle from the Main screen to the Meter Screen (ULT-2020 Only) and then
to the Datalog Screen (ULT-2020 only).
Depressing and holding this key will allow entry to the SETUP mode where the
configuration can be viewed and adjusted. When in the SETUP mode, this key
will exit the SETUP mode and return to the previously viewed screen. This will
also save the system settings to the internal EEPROM memory so they will be
retained even with the power turned off or battery removed
11
SCREENS
MAIN SCREEN
– The main screen indicates to the user that the ULT-2000 Series unit is
initialized and ready for testing. This screen is loaded after power-up initialization and can
be shown by pressing the key after a test is complete.
FULL TEST SCREEN – This screen is accessed by pressing the button. The
FULL TEST consists of a Self Test, Bath Conductivity Test and a Probe Leakage Test. The
Self Test ensures that the ULT-2000 is working properly before checking the Device Under
Test (DUT). The Bath Conductivity Test ensures that the test fluid has proper conductivity.
The Probe Leakage Test measures the leakage current of the DUT.
Test Procedure:
SOURCE TEST to verify voltage
used during test.
CIRCUIT TEST to verify
measurement circuitry.
BATH CONDUCTIVITY TEST to
validate cleaning solution.
PROBE LEAKAGE TEST to
measure the leakage current of
the DUT.
Progress Indicator
Test Measurements
(Optional, see SETUP
Section for more details.)
DUT Information
Manufacturer: Model
(Optional, see SETUP
Section for more
details.)
12
BATH ONLY SCREEN
– This mode is used when preparing the bath solution. This screen
is accessed by pressing the button. The BATH TEST consists of a Self-Test and a
Bath Conductivity Test. The Self Test ensures that the ULT-2000 Series unit is working
properly before checking the DUT. The Bath Conductivity test ensures that the test fluid
has the proper level of electrical conductivity needed for a good electrical leakage test.
Test Procedure:
SOURCE TEST to verify voltage
used during test.
CIRCUIT TEST to verify
measurement circuitry
BATH CONDUCTIVITY TEST to
validate cleaning solution.
DUT Information
Manufacturer: Model
(Optional, see SETUP
Section for more
details.)
Progress Indicator
Test Measurements
(Optional, see SETUP
Section for more details.)
TEST MESSAGES – If a test passes, the progress bar indicator will change to indicate that
the DUT passed the limits selected in the SETUP menu.
If a test fails, the screen will change to indicate what portion of the test failed.
13
METER SCREEN (ULT-2020 ONLY)
– The meter screen allows for extended leakage
current measurements. This helps in troubleshooting ultrasound probes. This screen is
accessed by pressing the key. The test voltage, frequency, and output control
are selected by pressing the key.
Source Voltage
Selectable from 90
to 275 VAC
Source Frequency
Selectable 50/60 Hz
Output Control
Off
ON
30 Seconds
60 Seconds
90 Seconds
2 Minutes
5 Minutes
10 Minutes
15 Minutes
30 Minutes
14
DATALOG SCREEN (ULT-2020 ONLY)
(
µ
– The Datalog screen shows the test results
for up to 99 test records. The datalog includes a Time/Date Stamp, the Test Type,
Pass/Fail, Test Measurements, and Test Limits. This screen is accessed by pressing
the key. In this screen, the arrows are used to scroll through the test
records.
The key is used to print the displayed record to the serial printer.
Test Timestamp
Date and Time test
was run.
Probe Type
Probe Manufacturer and
Model. Blank if Fixed or
User Test Limits.
Test Measurements
Measurements taken
during test.
Record Number
1-99)
Test Results
Pass/Fail
Test Limits
Pass/Faill Test
Limits1-500
A
15
LOW BATTERY
– When the battery life reaches 10 percent, the LOW BATTERY
message box will be displayed.
BATTERY ELIMINATOR – A 2.1 mm jack is provided for the optional 9 VDC Battery
Eliminator (BC20-21100, BC20-21101) that may be used for continuous run applications. It
bypasses the internal battery when plugged in.
NOTE: The unit is shipped with the battery installed. To ensure that the battery is fresh
when received, there is a red plug in the Power Input jack. This plug must be removed
before use.
16
SETUP
The SETUP Mode allows the user to adjust the configuration of the meter. The Setup
screen can be entered by depressing and holding using the key until the Access
code screen appears (5 sec). The arrows are then used to enter the access code.
When the access code is displayed, the key is then depressed again to gain
access to the SETUP mode. The parameters can be changed by using the key
to scroll down through the list and highlight the line and the arrows to toggle the
available options.
The Setup screen can be exited using the key.
The following is a typical screen for the System Configuration and a table of the available
setting options with a brief description of each Parameter.
17
System Setup Configuration
Parameter Description Range
Test Mode
Test Limits
DUT Manuf
DUT Model
Test Voltage
Frequency
Cond Limit
Lkg Upper Limit
Lkg Lower Limit
Setup Clock
Clear Datalog
Battery Life
Contrast Adjust
Backlight (Sec)
Determines whether the test measurements (actual test
readings) are shown in the test screen, or if the unit will
simply give a PASS or FAIL result. The Default setting
is Numerical.
Determines the settings for the test limits. Fixed limits
are set by the factory and cannot be adjusted. User
limits are programmed by the User through a special
access code. Manufacturer Default limits are suggested
test settings by probe manufacturer and model. Custom
limits are a set of settings by probe manufacturer and
model programmed by the user with a PC configuration
program.
Selects the DUT manufacturer.
NOTE: Only available when Test Limits is set to
Manufacturer Default or Custom.
Selects the DUT Model.
NOTE: Only available when Test Limits is set to
Manufacturer Default or Custom.
Displays the source “challenge” voltage to be used
during the Test. The Fixed setting is 120 volts, as
normally used in North America.
Displays the Frequency of the source “challenge”
voltage. The Fixed setting is 60 Hz, as set for use in
North America.
Displays the test limit for Bath Conductivity Test.
The measured leakage must be higher than this value to
pass and confirm that the Bath Solution is a valid media
for the Leakage Test. This setting is for display only and
cannot be modified.
Displays the upper test limit for Transducer Leakage
Current Test. The measured Leakage Current must be
lower than this value to pass. The Fixed setting is 100
µA
Displays the lower test limit for Transducer Leakage
Current Test. The measured Leakage Current must be
higher than this value to pass. The Fixed setting is 40
µA
Pressing the Up arrow while this parameter is selected
displays the Clock Configuration screen where the Date
and Time are configured.
Pressing the Up arrow while this parameter is selected
will erase the test records stored in the Datalog (ULT2020 Only)
Displays current life of the battery.
At 10%, a warning screen will appear.
Sets the contrast of the display screen.
The Default setting is 15.
Off – Always off
1-30 sec – The elapsed time after which the backlight
will automatically turn off.
ON – Always ON.
The Default setting is 30 seconds.
18
PASS/FAIL or
Numerical
Fixed, User, Manuf
Deflt, or
Custom
User Defined
User Defined
90-275 VAC
(Read Only)
50 or 60 Hz
(Read Only)
500 µA
(Read Only)
1-500 µA
(Read Only)
1-500 µA
(Read Only)
Press UP
Press UP
0-100%
(Read Only)
0-20
Off, 1-30 sec, ON
System Setup Configuration
Parameter Description Range
Determines the period of inactivity before the meter is
turned OFF. A timer is started when the meter is turned
ON and is reset each time a key is pressed. When the
timer reaches the value set in this parameter, the power
is automatically turned OFF.
Auto Off Timer (Min)
Access Code
Software
The Default setting Is 15 minutes.
(NOTE: Setting this parameter to 0 disables the Auto Off
timer.)
(NOTE: Running from line power disables the Auto Off
Timer.)
Sets the required code entry to gain access to the Setup
Menu. If this parameter is set to Zero, the Access Code
feature is disabled and the user will gain direct access to
the Setup Menu.
Displays current software program.
0-30 Minutes
0-9999
(Read Only)
19
The following is a typical screen for the User Test Configuration and a table of the available
setting options with a brief description of each Parameter.
User Test Configuration
Parameter Description Range
Test Voltage
Frequency
Lkg Upper Limit
Lkg Lower Limit
Access Code
Determines the source “challenge” voltage to be used
during the Test when the Test Limits setting is set to
User.
Determines the Frequency of the source “challenge”
voltage when the Test Limits setting is set to User.
Determines the upper test limit for Transducer Leakage
Current Test when the Test Limits setting is set to User.
The measured Leakage Current must be lower than this
value to pass.
Determines the lower test limit for Transducer Leakage
Current Test when the Test Limits setting is set to User.
The measured Leakage Current must be higher than this
value to pass.
Sets the required code entry to gain access to the User
Test Configuration Menu. If this parameter is set to
Zero, the Access Code feature is disabled and the user
will gain direct access to this Menu.
90-275 VAC
50 or 60 Hz
1-500 µA
1-500 µA
0-9999
20
OPERATION
The ULT-2000 is designed to test the electrical safety of all types of diagnostic ultrasound
transducers, independent of the ultrasound machines on which they are typically used.
Although the ULT-2000 can be used on virtually any type of ultrasound transducer, it is
especially recommended in the testing of TEE (Transesaphogeal Echocardiography)
transducers prior to each use, as recommended by many TEE ultrasound manufacturers.
The ULT-2000 tests the integrity of the outer insulation barrier of the transducer as well as
the capacitive leakage currents that exist. Due to the proximity of the TEE transducer to
the human heart during normal operation in a patient procedure, abnormally elevated
electrical leakage currents can be hazardous to the patient, and could induce microshock,
resulting in cardiac fibrillation. It is therefore vital to routinely test TEE (and other types of)
GENERAL OPERATING OVERVIEW
ultrasound transducers prior to their use on a patient.
All ultrasound transducers have inherent electrical leakage characteristics, and the
manufacturers of these transducers have carefully tested and documented these
characteristic leakages. These transducers each have characteristic minimum and
maximum leakage currents and associated PASS/FAIL limits as prescribed by the
manufacturer. These are different than the acceptable electrical leakage current limits for
the actual ultrasound machines. The ULT-2000 is the only battery-operated handheld
tester on the market today that tests according to these established protocols, which have
been adopted by diagnostic ultrasound manufacturers. It tests both the high and low limit
thresholds for electrical leakage currents.
21
Typical electrical safety (leakage) testing of the diagnostic ultrasound transducer should
occur as part of the routine cleaning and disinfecting activity that is undertaken between
patient ultrasound scanning procedures. The ultrasound transducer (see Item 5 in Figure
1) is immersed in a basin (see Item 4 in Figure 1) that contains a suitable electrically
conductive liquid (see Item 7 in Figure 1). This liquid can be the liquid cleaning and
disinfecting agent if it is suitably conductive to electrical current flow. Cidex
is a typically
used disinfecting agent for cleaning ultrasound transducers and is suitably electrically
conductive for performing electrical safety tests on transducers.
The ultrasound transducer is immersed in this conductive medium and the electrical
connector of the transducer (see Item 6 in Figure 1) is attached to a suitable adapter (see
Item 3 in Figure 1) for that particular manufacturer and model transducer. This creates one
electrical “pole” for the test. The transducer adapter is then attached to the ULT-2000 as
shown in Figure 1. A special conductive probe (see Item 2 in Figure 1) is then attached to
the ULT-2000. This probe is immersed in the basin of conductive liquid. The setup is now
complete for the testing of the transducer.
During testing, the transducer is subjected to a user selectable “challenge” voltage. This
voltage is typically set to the normal operating voltage level of the ultrasound machine that
the transducer is normally used with. In North America, this “challenge voltage” is typically
set to 120 VAC @ 60 Hz. For countries where the normal operating voltage is 230 VAC,
the challenge voltage can be set to this level, at either 50 or 60 Hz, as appropriate.
22
The first part of an actual ultrasound transducer electrical safety testing procedure is to test
the conductivity of the liquid medium in the test basin. The ULT-2000 accomplishes this
test quite easily, and reports either a simple PASS/FAIL or the actual numerical conductivity
of the medium (according the user-selectable setup of the unit). If the conductivity of the
liquid medium is insufficient to perform a valid electrical leakage current test, the ULT-2000
will report this and will not allow the leakage current test to be performed. If the
conductivity test is satisfactory, the ULT-2000 will proceed to the electrical leakage test.
Again, the results of the test will be reported as either a simple PASS/FAIL, or the actual
leakage current values will be displayed.
The operating “mode” may be easily set by the user. Items such as high and low limits,
conductivity PASS/FAIL limit, challenge voltage, challenge voltage frequency, etc. can also
be set by the user. See the details in the preceding section on familiarizing yourself with
the ULT-2000 functions and controls.
23
r
2 – Conductivity Probe
1 – ULT-2000
7-Conductive Liquid Medium
Figure 1
Typical Test Setup for ULT-2000
4 – Test Basin
5 – Transducer (DUT)
6 – Transducer
Electrical Connecto
3 – Transducer Adapter
24
SELF TEST
The ULT-2000 performs an internal self test in two steps prior to doing either a Bath or
Transducer Test.
Voltage Source Test - The first step is to read the actual high voltage (challenge voltage)
that will be used during the testing to ensure that it is within range. If it is not, an alarm is
activated and the test is halted.
Circuit Test - The second step checks the Leakage Measuring Circuitry. A relay switches
in a dummy internal load. The challenge voltage is then applied to this load. The unit must
correctly read the known leakage current. If it is not read correctly, an alarm is activated
and the test is halted.
ITEMS REQUIRED FOR TESTING THE
ULTRASOUND TRANSDUCERS
The following is the minimal equipment needed to test the electrical safety of the
3) Ultrasound Transducer Adapter (See list on page 4)
4) Test Basin
5) Conductive liquid medium (Cidex
sufficiently electrically conductive to support electrical leakage testing)
is an excellent medium for use, as it is
25
MANUAL REVISIONS
A
A
Revision #
Program # Revisions Made
Rev 01 DT7331CA Origination
Rev 02 DT7331CA Miscellaneous Edits
Rev 03 DT7331CA Adapters Updated
Rev 04 DT7331CB ULT-2010 and ULT-2020 Added
LIMITED WARRANTY
WARRANTY: BC GROUP INTERNATIONAL, INC. WARRANTS ITS NEW PRODUCTS TO BE FREE
FROM DEFECTS IN MATERIALS AND WORKMANSHIP UNDER THE SERVICE FOR WHICH THEY
RE INTENDED. THIS WARRANTY IS EFFECTIVE FOR TWELVE MONTHS FROM THE DATE OF
SHIPMENT.
EXCLUSIONS: THIS WARRANTY IS IN LIEU OF ANY OTHER WARRANTY EXPRESSED OR
IMPLIED, INCLUDING, BUT NOT LIMITED TO ANY IMPLIED WARRANTY OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE.
BC GROUP INTERNATIONAL, INC. IS NOT LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL
DAMAGES.
NO PERSON OTHER THAN AN OFFICER IS AUTHORIZED TO GIVE ANY OTHER WARRANTY OR
SSUME ANY LIABILITY.
REMEDIES: THE PURCHASER'S SOLE AND EXCLUSIVE REMEDY SHALL BE: (1) THE REPAIR OR
REPLACEMENT OF DEFECTIVE PARTS OR PRODUCTS, WITHOUT CHARGE. (2) AT THE OPTION
OF BC GROUP INTERNATIONAL, INC., THE REFUND OF THE PURCHASE PRICE.