LKC Utas Service manual
0086
UTAS
Visual Electrodiagnostic
System with
EM for Windows
Service Manual
Version 1.3
April 20, 2009
Version 1.1 Page 49 of 47
LKC Technologies, Inc.
2 Professional Drive
Suite 222
Gaithersburg, MD 20879
301.840.1992
800.638.7055
301.330.2237 (fax)
Support@LKC.com
www.LKC.com
Copyright © 2007, LKC Technologies. All Rights Reserved
WARRANTY
LKC Technologies, Inc. unconditionally warrants this instrument to be free from defects in materials
and workmanship, provided there is no evidence of abuse or attempted repairs without authorization
from LKC Technologies, Inc. This Warranty is binding for one year from date of installation and is
limited to: servicing and/or replacing any instrument, or part thereof, returned to the factory for that
purpose with transportation charges prepaid and which are found to be defective. This Warranty is
made expressly in lieu of all other liabilities and obligations on the part of LKC Technologies, Inc.
DAMAGE UPON ARRIVAL. Each instrument leaves our plant, after rigorous tests, in perfect
operating condition. The instrument may receive rough handling and damage in transit. The shipment
is insured against such damage. The Buyer must immediately report, in writing, any concealed or
apparent damage to the last carrier. Report any damage also to us, and issue an order for replacement or
repair.
DEFECTS OCCURRING WITHIN WARRANTY PERIOD. Parts of units may develop defects
which no amount of initial testing will reveal. The price of our instruments makes provision for such
service, but it does not:
1. Provide for transportation charges to our factory for service,
2. Provide for services not performed or authorized by us,
3. Provide for the cost of repairing instruments that have obviously been abused or subjected to
unusual environments for which they have not been designed.
We will be happy at any time to discuss by phone, letter, FAX, or e-mail suspected defects or
aspects of instrument operation that may be unclear. We advise you to inform us by phone, letter, FAX,
or e-mail of the nature of the defect before returning an instrument for repair. Many times a simple
suggestion will solve the problem without returning an instrument to the factory. If we are unable to
suggest something that solves the problem, we will advise you as to what parts of the equipment should
be returned to the factory for service.
Version 1.3 Page ii of 41
DEFECTS OCCURRING AFTER WARRANTY PERIOD. Charges for repairs after the warranty
period will be based upon actual hours spent on the repair at the then prevailing rate, plus cost of parts
required and transportation charges; or you may elect to purchase an extended warranty.
We will be happy to discuss by phone, letter, FAX, or e-mail any problem you may be experiencing.
The UTAS software is a copyrighted product of LKC Technologies, Inc. and is included with the UTAS
system under the following license agreement:
The software may be used in conjunction with the UTAS system only. The purchaser of the
UTAS system may make copies of the software for convenience of use, provided the LKC
copyright notice is preserved with each copy. This license specifically prohibits the use of this
software in a system that does not include an LKC Technologies, Inc. UTAS Interface Unit.
Additional copies of the software may be purchased to produce reports of UTAS data using a
LKC Technologies, Inc.
Customer Service/Support
800.638.7055 (US & Canada)
301.840.1992 (Worldwide)
301.330.2237 (FAX)
Support@LKC.com
www.LKC.com
SOFTWARE LICENCE
stand-alone computer system.
Version 1.3 Page iii of 41
INTRODUCTION
LKC’s UTAS visual electrodiagnostic test system is designed for
electroretinogram (ERG), visually evoked response (VER), and electro-oculogram (EOG
testing. It can also be upgraded with additional software allowing for multifocal ERG,
multifocal VEP and Sweep VEP testing. Those last three are covered in different
manuals. The UTAS is a fully automated system providing the featured needed for both
clinical and research applications. The UTAS meets all the specifications and
requirements of the International Society for the Clinical Electrophysiology of Vision
(ISCEV).
This Hardware Manual covers setting up and calibrating the equipment. This
equipment is offered for sale only to qualified Health Professionals. The improper use of
this equipment may be injurious to the patient.
Please note that not all system configurations include every hardware
component described in this manual.
Version 1.3 Page iv of 41
INTRODUCTION.................................................................................................................................... iv
1.0 Introduction............................................................................................................................... 1
1.1 Overview ................................................................................................................................ 1
1.2 Safety...................................................................................................................................... 1
1.3 Use .......................................................................................................................................... 1
1.4 Essential Performance .......................................................................................................... 1
1.5 Precautions ............................................................................................................................ 1
1.6 Special Precautions Concerning EMC................................................................................ 3
1.7 Warning ................................................................................................................................. 7
1.8 Symbols .................................................................................................................................. 7
1.9 Approvals............................................................................................................................... 8
1.10 European Representative ..................................................................................................... 9
2.0 Functional Description ........................................................................................................... 10
2.1 UTAS System Quick Specs................................................................................................. 10
2.2 Computer and Associated Devices .................................................................................... 12
2.3 System Interface.................................................................................................................. 12
2.4 UBA-4204 Patient Amplifier and Interface ...................................................................... 13
2.4.1 UBA-4204 controls....................................................................................................... 13
2.4.2 UBA-4204 Inputs.......................................................................................................... 14
2.4.3 Battery Charging........................................................................................................... 14
2.4.4 Changing The Battery ................................................................................................... 15
2.5 Ganzfeld ............................................................................................................................... 16
2.5.1 Sunburst........................................................................................................................... 16
2.5.2 BigShot ............................................................................................................................. 17
2.6 Pattern Monitor .................................................................................................................. 17
2.7 CMGS-1 Color Mini-Ganzfeld Stimulator (optional) ..................................................... 18
2.8 MGS-2 White-Only Mini-Ganzfeld (optional) ................................................................. 18
2.9 Overall Equipment Interrelations ..................................................................................... 18
3.0 Setting Up the System............................................................................................................. 22
3.1 Inventory.............................................................................................................................. 22
3.2 Precautions .......................................................................................................................... 22
3.2.1 Power Main Interference............................................................................................... 22
3.2.2 High Frequency Electrical Noise .................................................................................. 23
3.2.3 Shielding ....................................................................................................................... 23
3.3 Equipment Interconnections.............................................................................................. 23
4.0 Before You Use the System .................................................................................................... 26
5.0 Checking UBA-4204 (Amplifier) Response .......................................................................... 27
6.0 Checking Ganzfeld Calibration (for Sunburst and BigShot) ............................................. 28
6.1 Overview .............................................................................................................................. 28
6.2 Checking Calibration Using Zenith Software ( for SunBurst Only).............................. 29
6.3 Checking Calibration On Your Own ................................................................................ 31
Version 1.3 Page v of 41
6.3.1 Checking Calibration of Dim White LED .................................................................... 31
6.3.2 Checking Calibration of Xenon Flash........................................................................... 31
6.3.3 Checking Calibration of Color LEDs ........................................................................... 31
6.4 Replacing Background or Flash Lamps/LEDs ................................................................ 31
7.0 External Triggers (Input and Output) .................................................................................. 32
7.1 Triggering External Equipment – Trigger Out ............................................................... 32
7.2 Receiving Triggers from External Equipment – Trigger In ........................................... 32
8.0 Cleaning The System Between Patients ................................................................................ 33
8.1 Cleaning Reusable Burian-Allen Contact Lens Electrodes ............................................ 33
8.2 Cleaning the Forehead Rest ............................................................................................... 33
9.0 Troubleshooting Guide............................................................................................................... 34
8.1 Computer Boot-up .................................................................................................................. 34
8.2 Computer Monitor.................................................................................................................. 34
8.3 Keyboard ................................................................................................................................. 34
8.4 Mouse ....................................................................................................................................... 34
8.6 Printer ...................................................................................................................................... 35
8.7 Ganzfeld ................................................................................................................................... 35
8.8 Data .......................................................................................................................................... 35
8.9 Mini-ganzfeld........................................................................................................................... 35
8.10 Interference ............................................................................................................................. 36
Appendix 1: Artifacts in Electrophysiological Testing........................................................................ 37
Version 1.3 Page vi of 41
1.0 Introduction
1.1 Overview
The Hardware Manual will explain how your system is connected together, the specifications for
the system, how to use the hardware features, and how to assist LKC in servicing your system
should trouble arise. Subsequent sections, the Software Manual and the Testing manual will
explain how to use the software and the details of performing a test.
1.2 Safety
The equipment has been tested in accordance with IEC EN60601-1-2:2001 and meets all
requirements for type B Patient Connections.
1.3 Use
The LKC UTAS Visual Electrodiagnostic Testing System is an ophthalmic evoked potential
system. Its function is to elicit electrical responses from the retina and visual pathways for
diagnostic purposes.
The UTAS is designed for the electroretinogram (ERG), electro-oculogram (EOG), visual
evoked potential (VEP), sweep VEP and multi-focal ERG tests. These tests are useful in the
diagnosis of a wide range of visual disorders.
The system also has the capability to run multi-focal electroretinogram (mfERG) and multi-focal
visual evoked potentials (mfVEP) and sweep visually evoked potential (SVEP) tests. A UV
stimulus add-on is also possible on BigShot ganzfeld. These tests can be purchased as options
(contact LKC for availability), and are discussed in detail in separate user’s manuals.
This equipment is offered for sale only to qualified Health Professionals. The improper use of
this equipment may be injurious to the patient.
1.4 Essential Performance
♦
Correct operation of system components, including visual stimuli, i.e. flash, flicker, fixation,
background light and pattern stimulus; data acquisition; data analysis and test result display.
♦
Accuracy of intensity and timing of various visual stimuli.
♦
Accuracy of patient amplifier gain, and data acquisition timing.
♦
Accuracy of data analysis and result display.
1.5 Precautions
♦
All servicing of this equipment is to be performed by LKC Technologies, Inc. or by a service
center approved by LKC Technologies, Inc.
♦
Only equipment supplied by LKC Technologies, Inc. shall be plugged into the 115V~ outlets
at the back of the MGIT-100.
Version 1.3 Page 1 of 41
♦
The UTAS needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided in the User’s Manual.
♦
Portable and mobile RF communications equipment can affect the UTAS performances.
♦
Input overload can occur with defibrillator or electrocautery if used in the operating room.
♦
Any device connected to this system must be explicitly approved by LKC Technologies, Inc.
and must meet the relevant requirements of IEC60601-1.
♦
The use of any accessories or replacement of components other than those supplied by or
approved by LKC Technologies, Inc. may compromise patient safety.
♦
Eye infections may result from use of non-sterilized contact-lens electrodes.
♦
The forehead rest should be cleaned and disinfected after each patient.
♦
This device is not protected against the ingress of water and should not be used in the
presence of liquids which may enter the device.
♦
This device is not suitable for use in the presence of a flammable anesthetic mixture of air, or
with oxygen or nitrous oxide.
♦
Replacement AC fuses shall only be - T2.5A 250V (Slow-Blow) for 210-230 volt power-line
countries, and T5.0A 250V (Slow-Blow) for 100 – 120 volt power-line countries.
♦
This is an EU/MDD class I device requiring a three pronged grounded outlet.
♦
The UTAS system is an FDA Class II medical device that incorporates an IBM-compatible
personal computer. To ensure patient safety, the personal computer and all of its peripherals
are powered from an isolation transformer, through the power receptacles on the back of the
MGIT-100. All devices connected to the computer must be powered from these isolated
power receptacles. Failure to observe this precaution may endanger patient safety and will
void your warranty. LKC Technologies, Inc. will not service a system whose computer is
connected to external devices, nor will it give permission for others to service such a system.
♦
Examples of improper connections include connecting the UTAS computer (whether
supplied by LKC or by another party) to a laser printer, or to any other device that is plugged
into a wall outlet or that is connected to another device that is plugged into a wall outlet (such
as a printer sharing unit connected to another computer). If you have specific questions on
this matter, please contact LKC Technologies, Inc. for advice.
♦
Ensure the amplifier unit battery is fully charged prior to use.
♦
A fully charged battery will provide 12+ hours of useable recording time.
Version 1.3 Page 2 of 41
♦
Do not record while amplifier is recharging! This will compromise the quality of recordings
and subject isolation.
1.6 Special Precautions Concerning EMC
Guidance and manufacturer’s declaration – electromagnetic emissions
The UTAS is intended for use in the electromagnetic environment specified below. The customer
or the user of the UTAS should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
The UTAS uses RF energy only for its internal
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Group 1
Class A
Class A
function. Therefore, its RF emissions are very
low and are not likely to cause any interference
in nearby electronic equipment.
The UTAS 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.
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Warning: The UTAS system should not be used adjacent to or stacked with other equipment
and if adjacent or stacked use is necessary, the UTAS should be observed to verify normal
operation in the configuration in which it will be used.
Guidance and manufacturer’s declaration – electromagnetic immunity
The UTAS is intended for use in the electromagnetic environment specified below. The customer
or the user of the UTAS should assure that it is used in such an environment.
Electromagnetic
environment –
guidance
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be at
least 30 %.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
IEC 60601
test level
±6 kV contact
±8 kV air
Compliance level
±6 kV contact
±8 kV air
Version 1.3 Page 3 of 41
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips,
short
interruptions and
voltage
variations
on power supply
input lines
IEC 61000-4-11
±2 kV for power
supply lines
±1 kV for input/output
lines
±1 kV line(s) to line(s)
±2 kV line(s) to earth
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
±2 kV for power
supply lines
±1 kV for input/output
lines
±1 kV line(s) to line(s)
±2 kV line(s) to earth
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
Mains power quality should
be that of a typical
commercial or hospital
environment.
Mains power quality should
be that of a typical
commercial or hospital
environment.
Mains power quality should
be that of a typical
commercial or hospital
environment. If the user of
the UTAS requires continued
operation during power
mains interruptions, it is
recommended that the UTAS
be powered from an
uninterruptible power supply
or a battery.
Power frequency magnetic
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
3 A/m 3 A/m
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Version 1.3 Page 4 of 41
Guidance and manufacturer’s declaration – electromagnetic immunity
The UTAS is intended for use in the electromagnetic environment specified below. The customer
or the user of the UTAS should assure that it is used in such an environment.
Immunity
test
Conducted
RF IEC
61000-4-6
Radiated RF
IEC 610004-3
IEC 60601
test level
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2,5
GHz
Compliance
level
3 Vrms
3 V/m
Electromagnetic environment –
guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the UTAS, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
Pd 2.1=
Pd 2.1=
80 MHz to 800 MHz
Pd 3.2=
800 MHz to 2,5 GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in each
frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
Version 1.3 Page 5 of 41
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the UTAS is used exceeds the applicable RF compliance
level above, the UTAS should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting
or relocating the UTAS.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between
portable and mobile RF communications equipment and the UTAS
The UTAS is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the UTAS can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the UTAS as recommended below, according
to the maximum output power of the communications equipment.
Rated maximum
output power
of transmitter
W
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
Pd 2.1=
80 MHz to 800 MHz
Pd 2.1=
800 MHz to 2,5 GHz
Pd 3.2=
Version 1.3 Page 6 of 41
UV
UV
1.7 Warning
The Ganzfeld is capable of producing intense light, which patient exposure may
exceed ICNIRP guidelines. Users should consider the effects of producing stimuli at
these intensities.
If your BigShot ganzfeld contains the UV stimulator option, it may potentially emit
hazardous levels of ultraviolet radiation at 365 nm. This condition will only occur
if you use the UV stimulator as a background light – brief flashes of UV light from
this instrument are not hazardous. If you will be using the BigShot to produce UV
background lights, we recommend that you wear UV-blocking eye protection while
looking into the ganzfeld.
1.8 Symbols
Caution! Read instructions before using.
Contains UV stimulator
Power Off
Self-Test
Power On
Battery Check
DC Power
IEC 60601-1 Class I Type BF
Version 1.3 Page 7 of 41
IEC 60601-1 Class I Type B
Fuse Rating: “T2.5A 250V” is for 210-230 VAC power-line countries
T2.5A 250V
“T5.0A 250V” is for 100-120 VAC power-line countries
Or
T5.0A 250V
Volts AC
Council Directive Compliance
0086
Earth ground connection point, functional earth terminal
Chassis ground, protective earth terminal
1.9 Approvals
This product has been tested for EMI and complies with the requirements of EN 60601-1-
1-2:2001 (Group 1 Class A device under CISPR 11). Use of this equipment in the vicinity of
other equipment with excessive EMI may interfere with the proper operation of this product.
This product conforms to IEC601-1:1988 with Amendments A1:1991 and A2:1995, and
to EN60601-1:1990.
This product has been tested in accordance with AAMI Safe Current Limits Standard and
meets all requirements for direct patient connection. The product is an AC line powered device
designed to meet the applicable requirements of UL 60601-1 Standard for Safety (Medical and
Dental Equipment). This device should only be used according to the manufacturer’s instructions
and by qualified health professionals.
This product has been approved for both CE and CB certificates
Version 1.3 Page 8 of 41
1.10 European Representative
Emergo Europe Symbol
Molenstraat 15
2513 BH The Hague
The Netherlands
Tel: +31 70-345-8570
Fax: +31 70-346-7299
Version 1.3 Page 9 of 41
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