ULTRASOUND TRANSDUCER
LEAKAGE TESTER
ULT-2000 SERIES
USER MANUAL
i
BC BIOMEDICAL
ULT-2000 SERIES
TABLE OF CONTENTS
WARNINGS, CAUTIONS, NOTICES .............................................................................. ii
DESCRIPTION .............................................................................................................. 1
BACKGROUND ............................................................................................................. 4
TEST PROCESS ........................................................................................................... 8
LAYOUT ........................................................................................................................ 9
KEYS ............................................................................................................................ 10
SCREENS ................................................................................................................... 11
SETUP ......................................................................................................................... 18
PC SOFTWARE ........................................................................................................... 21
COMMUNICATION PROTOCOL ................................................................................. 27
MANUAL REVISIONS .................................................................................................. 30
LIMITED WARRANTY ................................................................................................. 30
SPECIFICATIONS ....................................................................................................... 31
NOTES ......................................................................................................................... 33
ii
WARNING - USERS
The ULT-2000 is for use by
skilled technical personnel only.
WARNING - USE
The ULT-2000 is intended for testing only and
should never be used in diagnostics, treatment
or any other capacity where it would come in
contact with a patient.
WARNING - CONNECTIONS
All connections to patients must be removed
before connecting the DUT to the ULT-2000. A
serious hazard may occur if the patient is
connected when testing with the ULT-2000.
Do not connect any leads from the patient
directly to the ULT-2000 or DUT.
WARNING – POWER ADAPTER
Remove power before
cleaning the surface of the ULT-2000.
WARNING - LIQUIDS
Do not submerge or spill liquids on the ULT-2000.
Do not operate the ULT-2000 if internal
components may have been exposed to fluid.
WARNING - MODIFICATIONS
The ULT-2000 is intended for use within the
published specifications. Any application
beyond these specifications or any unauthorized
user modifications may result in hazards or
improper operation.
iii
WARNING - VOLTAGE
High Voltages are generated by the ULT-2000
when running tests. Do not touch any surface
that is in contact with or connected to the ULT-
2000, including the ultrasound transducer,
adapter, conductivity probe, basin or liquid
medium contained in the basin, as it might be at
an electrical potential of 90 to 275 VAC.
CAUTION - SERVICE
The ULT-2000 is intended to be serviced only by
authorized service personnel. Troubleshooting
and service procedures should only be
performed by qualified technical personnel.
CAUTION - ENVIRONMENT
Exposure to environmental conditions outside
the specifications can adversely affect the
performance of the ULT-2000. Allow ULT-2000 to
acclimate to specified conditions for at least 30
minutes before attempting to operate it.
CAUTION - CLEANING
Do not immerse. The ULT-2000 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 should be inspected before each
use for obvious signs of abuse or wear. The
ULT-2000 should not be used and should be
serviced if any parts are in question.
iv
NOTICE – CE
The ULT-2000 Analyzers bear the mark
Based on the following testing standards:
ELECTROMAGNETIC COMPATIBILITY DIRECTIVE
EMC – Directive 89/336/EEC and 2004/108/EC as amended by
92/31/EEC, 93/68/EEC and Directive 91/263/EEC [ TTE/SES ]
EN 61326-1:1997 + A1:1998 + A2:2001 + A3:2003
“Electrical equipment for measurement, control and
laboratory use – EMC requirements”
This equipment has been type tested and compliance was demonstrated
to the above standard to the extent applicable.
EMISSIONS
Radiated and Line Conducted Emissions
EN 61000-3-2 Harmonic Current Emissions
EN 61000-3-3 Voltage Fluctuation and Flicker
IMMUNITY– CLASS C
EN 61000-4-2 Electrostatic Discharge
EN 61000-4-3 Radiated Electric Field Immunity
EN 61000-4-4 Electrical Fast Transients / Bursts
EN 61000-4-5 Surge Voltage
EN 61000-4-6 Conducted Disturbance
EN 61000-4-11 Voltage Dips and Short Interrupts
LOW VOLTAGE DIRECTIVE
EC – Directive 73/23/EC
EN 61010-1:2001
“Safety requirements for electrical equipment for measurement, control, and
laboratory use – General requirements”
This equipment has been type tested and compliance was demonstrated
to the above standard to the extent applicable.
v
NOTICE – SYMBOLS
Symbol
Description
Caution
(Consult Manual for Further Information)
Electrical Caution
(Consult Manual for Further Information)
Center Negative
(Refers to Battery Eliminator Connector)
Per European Council Directive 2002/95/EC, do not
dispose of this product as unsorted municipal
waste.
NOTICE – ABBREVIATIONS
ANSI
American National Standards Institute
C
Celsius
°
degree(s)
DC
Direct Current
DUT
Device Under Test
Euro
European
FS
Full Scale
Hz
Hertz
kg
kilogram(s)
µA
microampere(s)
mA
milliampere(s)
mm
millimeter(s)
NEDA
National Electronic Distributors Association
Ω
ohm(s)
PC
Personal Computer
Lbs
pounds
sec
second(s)
TEE
Transesophageal Echocardiography
ULT
Ultrasound (Transducer) Leakage Tester
USA
United States of America
V
Volt(s)
VAC
Volts Alternating Current
VDC
Volts Direct Current
vi
NOTICE – DISCLAIMER
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.
NOTICE – CONTACT INFORMATION
BC BIOMEDICAL
BC GROUP INTERNATIONAL, INC.
3081 ELM POINT INDUSTRIAL DRIVE
ST. CHARLES, MO 63301
USA
1-800-242-8428
1-314-638-3800
www.bcgroupintl.com
sales@bcgroupintl.com
NOTICE – DISCLAIMER
BC GROUP INTERNATIONAL, INC. WILL NOT BE RESPONSIBLE
FOR ANY INJURIES SUSTAINED DUE TO UNAUTHORIZED
EQUIPMENT MODIFICATIONS OR APPLICATION OF EQUIPMENT
OUTSIDE OF THE PUBLISHED INTENDED USE AND
SPECIFICATIONS.
ULT-2000 Series User Manual Copyright © 2012
www.bcgroupintl.com Made in the USA
10/12 Rev 13
1
BC BIOMEDICAL
ULT-2000 SERIES
ULTRASOUND TRANSDUCER LEAKAGE TESTER
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 the same
features of the ULT-2010, plus a Meter mode and Data Logging.
The following are highlights of some of the main features:
ULT-2010 (BASIC FEATURES):
GRAPHICAL LCD DISPLAY WITH CURSOR SELECTION OF OPTIONS
AND SETUP OF PARAMETERS
USER-SELECTABLE SOURCE (CHALLENGE) VOLTAGE
(90 TO 275 VAC) & FREQUENCY (50 OR 60 Hz)
USER-SELECTABLE TEST LIMITS BY ULTRASOUND TRANSDUCER
MANUFACTURER AND MODEL
AUTO RANGING WITH 10, 250, OR 500 A FS RANGES
AUTOMATIC INTERNAL SELF TEST
SINGLE BUTTON PRESS FOR FULL SYSTEM TEST
SIMPLE PASS / FAIL 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 INTERFACE
PC SOFTWARE (LIMIT CONFIGURATION TOOL)
SERIAL PRINTER OUTPUT WITH PROGRAMMABLE USER HEADER
REAL TIME CLOCK ALLOWING TEST RECORDS TO HAVE A TIMESTAMP
COMPATIBLE WITH DALE® TECHNOLOGY DALE800® AND FLUKE®
BIOMEDICAL ULT-800® ULTRASOUND TRANSDUCER ADAPTERS AND
DUAL CONDUCTIVITY PROBES
ULT-2020 (METER, DATALOG)
HAS ALL THE BASIC MODEL FEATURES PLUS:
METER MODE FOR EXTENDED MEASUREMENT PERIODS
PROGRAMMABLE METER SOURCE (CHALLENGE) VOLTAGE AND
FREQUENCY
2
PROGRAMMABLE METER TIMER
TRANSDUCER
MANUFACTURER
MODEL
ADAPTER
PART NUMBER
Acuson / Siemens
8v5, 15l8w, V5M, V7M, 3V2c
ULT-PA-10
Acuson / Siemens
ALL 260-pin Transducers
ULT-PA-12
Acuson / Siemens
ALL 156-pin Transducers
ULT-PA-13
Aloka
UST-934N/945BP, ASU-32-3-M,
ASU-32-WSJ, UST-556/5512,
UST-5514DTU
ULT-PA-22
DATALOG WITH STORAGE OF 99 TEST RECORDS
STANDARD ACCESSORIES:
BC20-21103 BATTERY ELIMINATOR (USA Version)
(OR)
BC20-21106 BATTERY ELIMINATOR (Euro Version)
BC20-41357 PC SOFTWARE (LIMIT CONFIGURATION TOOL)
OPTIONAL ACCESSORIES:
BC20-30106 CASE, SMALL SOFT SIDED CARRYING(Instrument only)
BC20-30107 CASE, MEDIUM SOFT SIDED CARRYING(Instrument and printer)
BC20-40614 BATTERY ELIMINATOR, 220V (US Version)
BC20-41337 RS-232 COMMUNICATIONS CABLE (7 Pin Mini-Din to DB-9F)
BC20-41339 USB COMMUNICATION CABLE ADAPTER (USB to DB-9M)
(For use with BC20-41337)
BC20-42200 CIDEX® COMPATIBLE TEST BASIN
BC20-42300 EXTERNAL PRINTER
BC20-42310 PACKAGE OF 5 ROLLS OF PAPER FOR BC20 – 42300
BC20-42322 CABLE, CONDUCTIVITY TEST FIXTURE
(For use with ULT-TF-T2)
BC20-42324 CABLE, BATH TEST FIXTURE (For use with ULT-TF-T2)
BC20-42330 Print Kit (Includes 1: BC20-42300, BC20-42310, BC20-42321,
BC20-30107)
BC20-42331 ULT Kit (Includes 1: BC20-30106, BC20-41337, BC20-41339
ULT-TF-T2 ULT Test Box (Simulates conductivity and leakage current)
CONDUCTIVITY PROBES: (not included, order separately)
ULT-PC-10 DUAL CONDUCTIVITY PROBE (Short)
ULT-PC-15 DUAL CONDUCTIVITY PROBE (Medium)
ULT-PC-20 DUAL CONDUCTIVITY PROBE (Short & Long)
ULTRASOUND TRANSDUCER ADAPTERS: (not included, order separately)
3
ATL / Philips
ATL C9-5 curved array; ATL l7-4
linear array; ATL UM9HDI; ATL HDJ
3000, 3500, 5000; ATL MPT74
ULT-PA-14
ATL / Philips
L7-4 Linear Array
ULT-PA-24
GE
Logiq; Vivid 3, 5, 7, 6T, 9T; P9603AU
ULT-PA-16
GE
Logiqbook, and VIVID I
ULT-PA-25
GE
46-280678P1
ULT-PA-27
Hitachi
Hi Vision 900, 5500, 6500, 8500,
EUB-2000, EUB-525, EUB-405 Plus
ULT-PA-21
Philips
iE33, iU22, S7-2, S7-3t, S3-1, C8-4v,
C9-5
ULT-PA-17
Philips / HP
Philips / HP 4500; Sonos 5500 / 7500
ULT-PA-18
Philips
Cx50 Series
ULT-PA-19
Sonosite
ALL
ULT-PA-11
Toshiba
Aplio XG, Xaria, Nemio XG, Fanio
ULT-PA-20
Zonare
E9-4
ULT-PA-29
All Manufacturers
Universal Pen Style
(For small surface area testing)
ULT-PA-23
For compatibility with specific manufacturer and model ultrasound transducers, please visit our
website at www.bcgroupintl.com . There may be additional adapters available that are not listed
above.
4
BACKGROUND
The following is the minimal equipment needed to test the electrical safety of ultrasound
transducers:
1) ULT-2000 Series Ultrasound Transducer Electrical Leakage Tester
2) Dual Conductivity Probe (See list on page 8)
3) Ultrasound Transducer Adapter (See list on page 9)
4) Test Basin (BC20-42200)
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 (Transesophageal 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 and
transducer cable as well as the existing capacitive leakage currents. Due to the proximity
of the TEE transducer to the human heart during a normal procedure, abnormally elevated
electrical leakage currents can be hazardous to the patient. Excessive electrical leakage
could induce microshock, resulting in cardiac fibrillation. It is therefore vital to routinely test
TEE (and other types of) ultrasound transducers prior to their use.
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
5
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 upper and lower
limit thresholds for electrical leakage currents.
Typical electrical safety (leakage) testing of the diagnostic ultrasound transducer should
occur as part of the routine cleaning and disinfecting activity that is performed between
patient ultrasound procedures. The ultrasound transducer (see Item 5 in Figure 1) is
immersed in a basin (see Item 4 in Figure 1) containing conductive liquid (see Item 7 in
Figure 1) suitable for performing electrical safety tests. This liquid can be the routine
cleaning and disinfecting agent used, as long as it is suitably conductive to electrical
current flow. Cidex is an example of a widely used disinfecting agent used for cleaning
ultrasound transducers, and is suitably conductive for performing electrical safety tests on
transducers.
The ultrasound transducer is immersed in this conductive liquid 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 conductive probe is also immersed in the basin of conductive liquid,
creating the second electrical pole. The setup is now complete for the testing of the
connected transducer.
6
During testing, the transducer is subjected to a user selectable source voltage. This
5 – Transducer (DUT)
4 – Test Basin
2 – Conductivity Probe
1 – ULT-2000
3 – Transducer Adapter
6 – Transducer
Electrical Connector
7-Conductive Liquid Medium
voltage is typically set to the normal operating voltage of the transducer’s ultrasound
machine. In North America, the source voltage is typically set to 120 VAC @ 60 Hz. For
countries where the normal operating voltage is 230 VAC, the source voltage can be set to
this level, at either 50 or 60 Hz, as appropriate.
Figure 1
Typical Test Setup for ULT-2000
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