Home

UTAS service manual

Contents

1. SOFTWARE LICENCE 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 stand alone computer system Version 1 4 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 t
2. Interface printed circuit board A custom ordered toroidal transformer Version 1 4 Page 12 of 41 2 4 UBA 4204 Patient Amplifier and Interface UBA 4204 is the patient amplifier board The electrodes used on the patient plug in the head end of the amplifier The amplifier converts data from analog to digital signal and transfer the data to its interface via a fiber optic cable TOSlink Then the data is converted in the UBA 4204 to go to the computer via USB 1 1 connection LKG TECHNOLOGIES UBA 4200 Series Unesal DC Biomedical Amplifier Press to turn the amplifier OFF oF Press to test the amplifier p Test The green light will come on when the Test button is pressed if 9 the amplifier is functioning properly am Press to turn the amplifier ON a 224 Power battery status indicator S Battery Charging indicator TOSlink Battery Charger Connecter Connector 2 4 1 UBA 4204 controls Powering On Off Press the On button for at least 2 second to turn the Amplifier on The Power Light Battery Status Indicator will illuminate and the test indicator light illuminate for 2 seconds Within approximately one second it may change color to indicate the remaining battery capacity If the amplifier is not in use for more than 30 minutes it will automatically turn off To conserve battery power press the Off button before this 30 minute time Self Test To verify that the system is wor
3. In addition to the UTAS software on hard disk the software program EMWin as well as SVEP and or MFERG MFVEP if applicable is supplied on one CD ROM This is a backup copy in the event that the program on your hard disk becomes corrupted As a precaution it is recommended that an additional backup copy of the disk be made using the rewriteable CD ROM drive on the system computer Keep the copy near the UTAS system and store the original in a safe place preferably in another location Version 1 4 Page 26 of 41 5 0 Checking UBA 4204 Amplifier Response Using the balck plastic Verif Eye box that was shipped with the system it is possible to check the performance of the UBA 4204 9 9 9 9 9 9 Plug the box s red wire in channel 1 and the black wire in channel 1 Turn switch on the box up for ON Place the box in the ganzfeld gently to avoid scratching the paint Turn UBA 4204 ON Start EMWIN gt Perform Test gt ERG gt Standard ERG Go to step 2 OdB scotopic flash In Sunburst Parameters TURN THE IR LED OFF Skip this step for BigShot as it doesn t have IR LEDs Click on Baseline and Record Stop Baseline and then Record Once the test is finished remember to TURN THE IR LED back ON Turn switch OFF The ganzfeld will deliver a OdB flash that will trigger the photo sensor of the pulse box and will display a 150 uV pulse of 20ms width see picture below The IR LEDs are automatically turned on
4. Tel 31 70 345 8570 Fax 31 70 346 7299 Version 1 4 Page 9 of 41 2 0 Functional Description In this section the function of each equipment group is explained and a block diagram is discussed which shows equipment interrelationships The UTAS system can either come with a Sunburst ganzfeld fits humans most primate faces and small animals or the BigShot ganzfeld which is designed for larger animals and humans The BigShot ganzfeld can be upgraded with a UV stimulator 2 1 UTAS System Quick Specs SUNBURST GANZFELD STIMULATOR Size and Weight 13 5 W x 10 5 Dx 8 H 5 0 Ibs Flash Intensity Maximum Luminance of 25000 cd m 30dB for Xenon Flash Typical Maximum Luminance of 160 cd s m 18dB for white LED flash 18 dB for green LED flash 16 dB for red LED flash and 11 dB for blue LED flash Dynamic Range of 105dB 30dB to 75dB in 1dB steps Flash Intensity Tolerance 0 2dB Background Intensity up to 5000 cd m in white or any color in 1 dB step Background Intensity 10 Tolerance LED wavelength Red 627 nm Green 530nm Blue 470 nm and Amber 590 nm BIGSHOT GANZFELD STIMULATOR Size and Weight 15 5 W x 12 5 Dx 19 5 H 17 0 Ibs 14 Diameter Full Field Globe Flash Intensity Maximum Luminance of 800 cd m 25dB for Xenon Flash Typical Maximum Luminance of 25 cd m 12 dB for white LED flash 10 dB for green LED flash 8 dB for red LED flash and 4 dB for blue LED flash Dynamic Range of 100
5. on the back of the computer and the male end goes to the interface rear panel A USB cable connects into the back of the interface unit The other end connects to any available USB port on the computer UBA 4204 to UBA 4204 Interface Unit Connect using a fiber optic cable TOSlink The two ends are interchangeable UBA 4204 Interface Unit to Computer Connects via USB 1 1 cable to the back of the computer WARNING The USB cable should be in the USB port that was labeled for it before shipping If the USB cable is plugged in another USB port the computer won t recognize the device System Interface Unit Ganzfeld Sunburst or BigShot An 8 Foot fiberglass sleeved cable connects the ganzfeld s interface to ganzfeld The 16 pin plastic connector on the cable goes to the back panel of the system interface unit Computer to CMGS 1 MGS 2 Control Unit optional If the optional CMGS 1 or MGS 2 was purchased with the system a splitting serial cable will be provided The female end goes to the 9 pin RS232 connector on the back of the computer one of the two male ends goes to the interface rear panel and the other goes to the CMGS 1 or MGS 2 CMGS 1 MGS 2 Control Unit to Color White Mini Ganzfeld optional The Control box end of the mini Ganzfeld cable has a 25 pin connector which connects to the rear panel of the box and the other end is permanently attached to the hand held mini Ganzfeld head Power Connections The equipment requiring
6. or excessive baseline noise contact the LKC Service Department Electrode Noise Electrical contact between the subject and recording electrodes is never perfect The quantity of the contact is termed the electrode impedance the lower this quantity is the better Some electrical noise will be generated by the electrode impedance The higher the electrode impedance the more noise is generated Also the susceptibility of the patient amplifiers to electrical noise generated by the external environment increases with increasing electrode impedance The greater the electrode impedance is the greater the noise in the recording Electrode impedance as measured by the system should in general be less than 25 KQ for low noise recordings However if the baseline noise level is not excessive it is acceptable for the electrode impedance to be higher Artifacts Generated by the External Environment 60 Hertz Noise The principal external interfering signal is electrical noise generated by power lines or by electrical equipment connected to power lines The typical electrical outlet provides a ready source of 110 Volts electricity more than a million times greater than the amplitude of the ERG Examples of equipment that generate electrical interference are fluorescent lights motors including motorized chairs and power transformers These items produce powerful electromagnetic fields that can induce or couple 60 Hertz interference into the rec
7. 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 Version 1 4 Page 6 of 41 m 1 7 Warning The Ganzfeld is capable of producing intense light which patient exposure may ZN 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 3E 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 m Caution Read instructions before using Contains UV stimulator og Power Off lt gt 9 v Self Test Po
8. Control e Display Signals travel from the patient to the amplifier unit where the signals are converted from Analog to Digital and passed on to UBA 4204 interface In UBA 4204 the data is then converted to be sent to the computer via USB 1 1 connection to the computer The computer collects signals for digital amplification and filtering averaging computing display and analysis The user utilizes the mouse and keyboard of the computer and the computer controls the pattern monitor stimulator Ganzfeld or Mini Ganzfeld and amplifier unit There are three displays in the system the computer operator display the pattern monitor stimulator display and the printer The operator display is controlled by the added video card the pattern monitor is controlled by the video board that is already on the computer motherboard The printer is connected via USB connection Version 1 4 Page 18 of 41 a woven Sa CHARGER Pa SUPPLY cat AER l E vn fm rdc CH MGFIOO mD fivc Cia v UTAS OVERALL CESKIOP VERRON Version 1 4 Page 19 of 41 ae Coin ra SAJ CHARGER PAR SUPPLY p I Fani Onin Com LUBA INTERFACE xo um Comi ra UTAS OVERALL LAPTOP VERRON Version 1 4 Page 20 of 41 Ref ID Description i Manufacturer Manufacturer Part Num wil AC Input Power Cord 2 4 VOLEX INC 17031 8 S2
9. W2 W8 Power Cord 1 5 INTERPOWER 86557040 W9 W10 W15 USB Cable 2 GENERIC USB 1037 2 0 6 BK W11 W13 Serial Cable 1 8 TE LKC 91 172 W12 Ganzfeld Cable 2 4 LKC LKC 91 183 W14 Fiber Optic Cable 2 LIFA TEC USA POF TOCP255K List of cables used in UTAS desktop Ref ID Description Length m Manufacturer Manufacturer Part Num wil AC Input Power Cord 2 4 VOLEX INC 17031 8 S2 W2 W7 Power Cord 1 5 INTERPOWER 86557040 W8 W9 W14 USB Cable 2 GENERIC USB 1037 2 0 6 BK W10 W12 Serial Cable 1 8 xm LKC 91 172 wil Ganzfeld Cable 2 4 LKC LKC 91 183 W13 Fiber Optic Cable 2 LIFA TEC USA POF TOCP255K UTAS Cable List Notebook Warning The use of cables other than those specified in these lists may result in increased EMISSIONS or decreased IMMUNITY of the UTAS Version 1 4 Page 21 of 41 3 0 Setting Up the System 31 Inventory The UTAS testing system consists of a system interface unit an amplifier unit a pattern stimulator a Ganzfeld and or a mini Ganzfeld stimulator with a control unit and a computer with its associated peripherals The equipment should be arranged on workstations or tables Make sure that the patient location is as far as possible from power mains or electromagnetic devices to minimize 60 or 50 Hz electromagnetic interference Additionally the patient should not be seated where he or she can be touching the Interface Unit or other electrical apparatus during testing Therefore the Pattern Stimulator and Ganzfe
10. built in using RGB stimuli to 2000 points 10 seconds per cycle BigShot has 3 red EOG fixation LEDs in 15 horizontally with brightness adjustable over 20 dB range in 1 dB steps BigShot has an optional UV stimulator that can be used for flash and background to stimulate mouse S Cones contact LKC if interested in upgrading to UV 2 6 Pattern Monitor The pattern stimulator is controlled by the AGP video card installed in the computer and consists of either a color VGA or DVI LCD or CRT monitor for Pattern VEP Pattern ERG or a high brightness monochrome monitor if selected as an option with Multi Focal ERG Multi Focal VEP Commands sent by the computer to the video card produce changes in the display on the pattern stimulator screen The stimuli have three pattern formats checkerboards square wave gratings and sinusoidal gratings Grating pattern stimuli can be presented vertically or horizontally Pattern alternation rate can be set at 0 25 0 5 1 2 3 8 5 7 5 15 25 or 32 5 Hz All three pattern formats provide red green blue white and black colors except for the high brightness monochrome monitor for Multi Focal ERG testing which is black and white only In addition hemifield 14 V2 patterns can be displayed and the pattern contrast can be adjusted from 1 to 100 Patterns can be presented in either alternating pattern or pattern blank Version 1 4 Page 17 of 41 2 7 CMGS 1 Color Mini Ganzfeld Stimulator optional Th
11. connections to A C power of the MGIT are the following Computer Computer Monitor or AC DC Adaptor if LCD Monitor is used and DC powered Printer or AC DC Adaptor for Printer Pattern Stimulator Monitor System Interface Unit Battery Charger for Patient Amplifier UBA 4204 CMGS 1 MGS 2 Control Unit optional accessory Version 1 4 Page 24 of 41 IMPORTANT An isolation transformer MGIT 100 is included to provide additional isolation from the power line ground system The transformer will limit leakage current to inconsequential levels should there be a failure in the grounding system NOTE The Transformer is required to limit the leakage current to established safe levels if there is a failure in the grounding system No part of the system except the Isolation Transformer Unit should be plugged into an A C primary wall outlet Other subsystems should be connected to the power receptacles on the MGIT 100 The MGIT 100 should be plugged directly into a designated wall outlet and not through an intermediate power strip WARNING The installation of any software on the UTAS Windows based computer that is not provided directly by LKC can cause the system to stop functioning crash unexpectedly or disrupt the timing of the stimulus presentation and data collection The LKC UTAS Visual Electrophysiology System is a precision standalone medical device The computer provided with the system has been specifically manufactured a
12. fL The photometer must also be capable of integrating its response to measure candela seconds per square meter cd s m or foot Lambert seconds fL s Conversion 34264 l1ft L m A CS 100 Minolta Chroma Meter to check calibration of the Red Green and Blue LED flashes and background 0 5000 cd m and the Amber background 6 3 1 Checking Calibration of Dim White LED In order to check calibration for the dim white flashes the DR 2550 should be used in integrating mode The dim white LEDs have such low luminance that they have to be integrated over a large amount of time Place the photometer on integrating mode probe pointed at the back of the ganzfeld Set background light to 50dB Turn off the lights and cover ganzfeld with its cover Measure background light 99 9 6 3 2 Checking Calibration of Xenon Flash To check the dim white flash calibration the DR 2550 must be in integrating mode Place the photometer on integrating mode probe pointed at the back of the ganzfeld Turn off the lights and cover the ganzfeld with its cover Fire the Xenon flash at 10dB and measure in fL s 6 3 3 Checking Calibration of Color LEDs To check calibration for the color LEDs the CS 100 Chroma Meter is needed Colors green red and blue LEDs are used for background light and flash Assume that if the calibration of intensity and color coordinate is correct for background it will be also be correct for flashes
13. ganzfeld cover on Also be sure that the fixation is turned off during calibration The photometric measurement of most relevance to clinical electrophysiology is luminance Luminance is a measure of light per unit area emitted from an extended source or reflecting surface This measure is independent of distance Intuitively one can think of luminance as roughly equivalent to brightness and as an object is approached its brightness does not change appreciably The Syst me Internationale SI unit of luminance is the candela per square meter cd n The relationship between this measure and older measures of luminance is shown in Table 1 below For brief flashes of light such as those used for the flash ERG and VEP the luminance of the stimulus must be weighted by flash duration since temporal integration of the neuronal visual pathways is longer than the duration of the flash Thus the appropriate unit of time integrated luminance for brief flashes of light is cd s m Version 1 4 Page 28 of 41 Multiply number of Candela Footlambert Millilambert Candelain Candelaft Apostilb Stilb To obtain by number of Candela m 2 1 3 426 3 183 1550 10 76 0 3183 10000 footlambert 0 2919 1 0 929 452 3 142 0 0929 2919 millilambert 0 3142 1 076 1 487 3 382 0 1 3142 Candeda in 2 0 000645 0 00221 0 00205 1 0 00694 0 000205 6 45 Candela t7 0 0929 0 3183 0 2957 144 1 0 02957 929 apostilb 3 142 10 76 10 4870 33 82 1 31420 stilb 0 00
14. is broken Wrong color display or reverse video display Potential Reasons 1 Thereisaloose video cable 2 Bad video card 3 Bad monitor 4 Wrong display setting 9 3 Keyboard No keyboard acknowledgment or keyboard error Potential Reasons 1 Keyboard is not connected to the computer 2 The keyboard is malfunctioning 3 A key was held down or stuck at the time of boot up 4 Dirty contacts inside keyboard 9 4 Mouse Mouse error message at the time of boot up Potential Reasons 1 Mouse is not connected to the connector on the computer Version 1 4 Page 34 of 41 Service Manual 2 The mouse is bad Mouse screen cursor not moving without boot up error message as described above Potential Reasons 1 No mouse software driver has been installed 2 Two different and conflicting versions of the software mouse drivers installed 9 5 Printer Printer Does Not Print or Prints Garbage Potential Reasons 1 Printer is not powered on 2 Printer out of paper 3 Disconnected printer cable at either computer or printer end 4 Wrong printer type selected in software 5 Printer driver not install 6 Ink of Cartridge low or dried out 9 6 Ganzfeld No flash LED background Light stimulators functioning No Ganzfeld function Potential Reasons 1 Loose or disconnected RS 232 cable from computer to interface unit 2 Bad serial port in computer 3 Loose connector to the interface serial port control board 4 J Bad interface serial p
15. 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 p
16. system interface unit and controlled by the system s computer The UTAS system can come with either a Sunburst Ganzfeld or a BigShot ganzfeld 2 5 1 Sunburst Sunburst has a compact size 13 5 W x 10 5 Dx 8 H 34 3 cm x 26 7 cm x 20 3 K cm 5 0 Ibs 3 7 kg It has an ergonomic mounting arm which provides easy adjustment to any patient and a quick disconnect feature and built in handles for easy positioning over prone patient The inside of the ganzfeld is washable with a damp cloth and mild detergent Sunburst has a built in camera to monitor fixation of the patient Sunburst uses Red 627 nm Green 530 nm Blue 470 nm Amber 590 nm and white LEDs for dim flashes and Xenon flash It has a total dynamic flash luminance range of 105 dB 30 dB to 75 dB in 1 dB steps All flash durations are less than 5ms The xenon flash luminance range is 2 5 2500 cd s m 0 dB to 30 dB LED flash luminance is of 2 5 10 to 160 cd s m 50 dB to 18 dB in any arbitrary color LED flash luminance is of 75 dB to 50 dB in white The background light can be controlled from 0 005 to 5000 cd n in 0 01 dB increments in any color and as low as 10 cd m in white The flicker stimuli goes up to 20 dB 1 Hz repetition rate for intensities gt 20 dB Sunburst also has the capability to produce long duration flash On Off response stimuli programmable to 6 5 seconds in 5 ms increments with adjustable intensity and chromaticity An arbitrar
17. 01 0 00034 0 00032 0 155 0 00108 0 000032 1 1 nit 1 candelam Table 1 Luminance Conversion Factors Another measure of importance to clinical electrophysiology is retinal illuminance an estimate of the effective stimulus at the retina The standard measure of retinal illuminance is calculated by multiplying stimulus luminance by pupillary area The unit of retinal illuminance is the Troland td The Troland is defined as the retinal illuminance obtained when a stimulus of 1 cd m is viewed through a pupillary area of 1 square mm diameter of 1 128 mm Scotopic Trolands td can also be measured using V A to calculate stimulus luminance Flash intensities are often referred to in decibels dB The term dB is a relative one as shown in the equation dB 10log od I 0 Where I 0 is the intensity at OdB and I x is the intensity at x dB The intensity at OdB for Sunburst is 2 5 cd s m 6 2 Checking Calibration Using Zenith Software for SunBurst Only Zenith software will allow the user to run a calibration check It measures values of all of Sunburst light sources 10 times and alerts the user if the value varied from the initial factory calibration If there is more than 1dB difference in calibration values please contact LKC Technologies Note this is not available with the BigShot Ganzfeld To perform this check follow the instructions displayed by the Zenith prompt Version 1 4 Page 29 of 41 Zent
18. Only 29 6 3 Checking Calibration On Your Own 2 esses 31 Version 1 4 Page v of 41 6 3 1 Checking Calibration of Dim White LED aiii te horror toU res 31 6 3 2 Checking Calibration of Xenon Flash lt 4 oed eee steer iene PE pera nae 31 6 3 3 Checking Calibration OF Color EBDS 2 5 52 cr p ete Phe not Hr pee sua E EEE 31 6 4 Replacing Background or Flash Lamps LEDS eee 31 7 0 External Triggers Input and Output sss 32 7 1 Triggering External Equipment Trigger Out eeseeee 32 7 2 Receiving Triggers from External Equipment Trigger In 32 8 0 Cleaning The System Between Patients esses 33 8 1 Cleaning Reusable Burian Allen Contact Lens Electrodes 33 8 2 Cleaning the Forehead Rest ccccssccssssccsssscesscecssncesssnecssnensnenensnenevsnesensnesessseeeess 33 9 0 Troubleshooting Guide seeessoessocssecesscsesocesocsssocesoeessocesocesocessocesocsssosesocesocessocesocsssosesocesoesssose 34 8 1 Computer Boot up oe EI ERR ee OR S EO T REN 34 8 2 Computer MOTION cde oct EY ND o e o beu uat lS esed EE ae fede cipe 34 8 3 SC DOJPU oo reet esc osa t ames a lala Seca Delon te geb AA co acus oid uv dL EA 34 Bed SINIOUSE S eut t tei ipaum ui caius avis tale e posa cse a prs pnm PE Prev i
19. Set the background light of ganzfeld to the coordinate you wish to measure intensity and X y coordinate for color Turn lights off Place the Chroma Meter inside of ganzfeld make sure the image is in focus and set it on cd m Read off measurement and compare to the intensity and color coordinate you chose 6 4 Replacing Background or Flash Lamps LEDs LEDs and Xenon tubes can only be changed in factory at LKC Technologies Inc Please contact the LKC support line to get information on how to send your system Version 1 4 Page 31 of 41 Service Manual 7 0 External Triggers Input and Output The rear of the LKC Interface Unit contains two BNC connectors labeled Trigger In and Trigger Out These connectors allow the user to connect external stimulators to the UTAS system This section will provide the information necessary to connect external stimulators to the UTAS system Trigger In and Trigger Out are default to negative going TTL unless specified otherwise at time of purchase Contact LKC for information on how to change trigger polarity 7 1 Triggering External Equipment Trigger Out The BNC connector marked Trigger Out on the back of the Interface can be used to trigger an external piece of equipment The trigger signal is a negative going TTL compatible output of approximately 1 ms duration Note that the trigger should be providing the voltage through a 1k resistor to the UTAS Interface A signal appears at the Tri
20. UTAS Visual Electrodiagnostic System with EM for Windows Service Manual Version 1 4 November 1 2011 CE 0086 LKC Technologies Inc 2 Professional Drive Suite 222 Gaithersburg MD 20879 301 840 1992 800 638 7055 301 330 2237 fax Supporta 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
21. as the system up is powered They are used in conjunction with the mini webcam to visualize the patient while recording in the dark However the IR LEDs saturate the photo sensor of the check box and need to be turned off during this testing time 1 uv R Version 1 4 Standard Electro Retinogram moy P Len S dme aar rrr A T eap PA ROS IRE d 209 AAP Ite t Scotopic O dB Flash 50 100 150 200 milliseconds Page 27 of 41 6 0 Checking Ganzfeld Calibration for Sunburst and BigShot 6 1 Overview The UTAS with Sunburst comes with a calibration checking application Original calibration values are stored in the memory of the system The calibration check software allows the user to check new calibration measurement and compare it to the original factory calibration data Note that there is no way for the user to calibrate any of the light sources the unit needs to be returned to the factory if recalibration is needed Also note that this application is NOT available for BigShot Sunburst and BigShot have three different light sources that are used for background and or flash purposes Those are the dim white LEDs the red green blue LEDS the amber LEDs and the Xenon Flash Light Source Used for Used for Flash Background Light Dim White LEDs Yes Yes Red Green Blue LEDs Yes Yes Amber LEDs Yes No Xenon Flash No Yes IMPORTANT Calibration checks should be performed in a dark room with the
22. cal ground 3 3 Equipment Interconnections The equipment is interconnected as shown in Figure 1 for a desktop version of the UTAS system and Figure 2 for a laptop version system Make certain that the power is off before making any connections All of the equipment in the UTAS system must be connected correctly for the system to function properly Computer to Operator s Monitor The desktop version system comes with connections for two monitors They will be labeled User s Monitor and Pattern Monitor Plug the operator s monitor into the connection labeled User s Monitor Computer to Pattern Stimulator Plug the pattern monitor into the connection labeled Pattern Monitor Computer to Printer Plug the printer into any USB connector on computer rear panel using a standard USB cable Computer to Keyboard A cable connects the keyboard to the computer The keyboard end is permanently attached the computer end is a plug that connects to a receptacle or to one of the USB connectors on the back of the computer Version 1 4 Page 23 of 41 Computer to Mouse A flexible cable connects the mouse to the computer The mouse end is permanently attached the computer end is a plug that connects to a receptacle or to one of the USB connectors on the back of the computer Computer to UTAS System Interface Unit A serial port extension cable connects the computer to the UTAS system interface unit The female end goes to the 9 pin RS232 connector
23. control box 9 9 Interference Excessive interference appearing on recordings Potential Reasons 1 SeeSection 3 1 for setup precautions 2 Besure that good electrode contact has been achieved a Care should be taken to thoroughly clean the site of the electrode placement with skin cleaner b All electrode cups should be filled with an adequate amount of electrode gel or cream e In ERG recording adding an extra drop of artificial tears to the contact lens electrode while it is in the patient s eye may reduce the electrode impedance d Check that recording connections are as recommended in the Operations manual In addition electrode leads should be as short as possible and kept away from any electrical equipment power lines or MRI machines It often helps to twist the positive and negative electrode leads to cancel signals caused by magnetic induction About one twist per inch should be adequate With these precautions electrical noise due to radio frequency equipment will ordinarily be within acceptable limits After all steps to minimize noise have been taken and interference is still present in the recording signal the Notch filter can be used The Notch filter is a very narrow bandwidth filter centered at 60 50 Hertz which will reduce power line noise There will however be some loss of waveform information since part of the waveform spectrum is affected To check if the Notch filter is working properly unplug the calibrati
24. dB 25dB to 75dB in 1dB steps Flash Intensity Tolerance 0 2dB Background Intensity up to 1000 cd m in white or any color in 1 dB step up to 500 cd m for optional UV Background Intensity 10 Tolerance LED wavelength Red 627 nm Green 530nm Blue 470 nm and Amber 590 nm Optional UV LED Wavelength 365 nm typical maximum flash intensity of 0 dB PATTERN STIMULATOR Checkerboard Sizes 1 x 1 to 128 x 128 in powers of 2 Alternation Rate 0 25 Hz to 32 5 Hz Screen Luminance 140 cd m 5 AMPLIFIER UNIT Input Type Analog Differential Version 1 4 Page 10 of 41 Input Channels Input Impedance Connector Type Background Noise CMRR Frequency Range Input Gain DC Input Range Stability Accuracy Calibration Data Resolution Sampling Rate Data Connection Safety Power Source 4 user selectable 210 MQ 1 5 mm Male DIN Safety electrode connections 0 7 uV p p 100 Hz Sampling Rate Open Input lt 1 8 uV p p 1000 Hz Sampling Rate Open Input gt 100 dB at 50 60 Hz DC to gt 1 0 MHz without aliasing High frequency cutoff depends on sampling rate 1 2 4 8 16 32 64 user selectable 2 V Gain 1 250 nV C drift 0 296 absolute Nonlinearity 0 001096 Automatic gain and offset calibration on demand 0 25 uV bit Gain 1 to 3 7 nV bit Gain 64 5 Hz to 3750 Hz Bidirectional fiber optic cable TOSlink to UBA 4204 interface lt 1 nA Leakage Current gt 10 kV Isolation
25. e optional CMGS 1 Color Mini Ganzfeld Stimulator consists of two units the control box and hand held mini Ganzfeld The CMGS 1 is controlled by the system computer via a serial port connection Various color LEDs are used to produce red green blue or white stimuli The intensity of white flash flicker can be set to the following levels 10 dB 5 dB 0 5 10 15 20 or 25 dB while color R G B stimuli can reach a maximum intensity of 2 dB The background intensity can be set to any of three levels for the white red green and blue colors The CMGS 1 also provides On Off Response stimuli with W R G B color A dim red LED is mounted at the back of the mini Ganzfeld for fixation 2 8 MGS 2 White Only Mini Ganzfeld optional The optional MGS 2 Mini Ganzfeld consists of two units the control box and hand held mini Ganzfeld The MGS 2 is controlled by the system computer via a serial port connection A number of bright white LEDs are used to produce the stimulus The intensity of the stimulus can be set to 5dB 0 5 10 15 20 or 25 dB level The brightness of the background light is fixed to 30cd m for flash and flicker stimuli A dim red LED is mounted at the back of the mini Ganzfeld for fixation 2 9 Overall Equipment Interrelations Figures 1 and 2 below are the block diagrams of the system in the two versions showing how the various elements of an UTAS system are interconnected The functional paths are e Signal e
26. ed 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 IEC 60601 Compliance Electromagnetic environment test test level level 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 Conducted 3 Vrms 3 Vrms RF IEC 150 kHz to 80 d 1 2VP 61000 4 6 MHz Radiated RF 3 V m 3 V m d 1 2VP 80MHzto 800 MHz IEC 61000 80 MHz to 2 5 a9 GHz d 2 34P 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 e 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 4 Page 5 of 41 a Field strengths from fixed tra
27. eds repair please contact LKC Note ERG Jets and DTL electrodes are disposable This cleaning method does NOT apply to them 8 2 Cleaning the Forehead Rest The patient s forehead will come into contact with the ganzfeld forehead rest during testing The forehead rest should be cleaned and disinfected between uses to prevent the spread of skin infections The simplest method of cleaning and disinfecting the forehead rest is to wipe it down with a 7096 isopropyl alcohol solution Using a disinfecting wipe is a good way to do this It may also be cleaned using a glutaraldehyde solution such as those mentioned in Section 8 1 Version 1 4 Page 33 of 41 Service Manual 9 0 Troubleshooting Guide This section lists the most frequently encountered problems along with typical solutions 9 1 Computer Boot up The computer does not boot up properly Potential Reasons 1 There is a bad power supply 2 The computer battery discharged 4 Windows operating system file s damaged 5 The hard disk power cable is loose WARNING Tighten or hook up cables with system power OFF Cables hooked up backwards will permanently damage the hard disk 6 If none of the above seems to be the problem then the hard disk controller may be defective 9 Computer Monitor No display on the computer monitor Potential Reasons 1 Power is off 2 The video cable is loose 3 The power cable to monitor is loose 4 The video board is bad 5 The monitor
28. f there is concern about light adapting the subject from repeated flashes setting the time between sweeps to 15 seconds will minimize the problem Although averaging is the preferred solution in most cases muscle artifacts may also be filtered to a degree by the amplifier filters Since muscle generated noise is generally at the high end of the spectrum it can be reduced in the ERG by setting the low pass high cut filter to 100 Hz rather than the usual ERG default of 500 Hz The 70 Hz filter may also be tried but significant distortion of the ERG recording will result and proper latency measurements will not be possible In the standard EOG protocol the filter values are preset and cannot be changed Another option for dealing with muscle noise is to smooth the waveform The Smoothing Waveform function results in a filtering effect that will not alter the waveform latency Eye Movement Artifacts If a steady baseline cannot be obtained the baseline may be stabilized to a degree by averaging With averaging the effects of positive and negative going eye movements are partially canceled Averaging 10 sweeps will generally allow a satisfactory recording to be obtained If you are concerned about light adapting the subject from repeated flashes setting the time between sweeps to 15 seconds will minimize the problem When employing signal averaging with automated artifact rejection the artifact reject level should be set to eliminate those wave
29. forms that are obviously not representative of the true response The artifact reject criterion should be selected to be about 2096 greater than the largest true signal expected If too many waveforms are rejected increase the criterion Although averaging is the preferred solution in most cases eye movements can also be removed by analog filtering Since eye movement noise affects the low frequency end of the waveform spectrum it can be reduced by setting the high pass low cut filter to 1 Hz rather than the default of DC for the ERG The 5 Hz filter may also be tried for difficult cases but significant distortion of the recording will result Version 1 4 Page 40 of 41 Appendix 1 EEG Artifacts The primary mechanism for reducing EEG artifacts in the VER is signal averaging Theoretically EEG noise and other noise that is uncorrelated with the stimulus will be reduced by the square root of the number of sweeps averaged For example if 50 sweeps were averaged the noise would be reduced by a factor of approximately 7 This is usually adequate to obtain satisfactory VER recordings The use of low pass high cut filtering can also be helpful The VER default filter setting is at 100 Hz The averaged waveforms will be smoother if the 30 Hz filter is used Note that the use of the 30 Hz filter will add 5 to 10 ms to the latency estimate Artifacts Generated by the Equipment Other than taking the precautions previously discussed there
30. ge to operate the unit for approximately 1 2 hour The battery charge indicator is the LED next to the Battery Check symbol on the front of the UBA 4204 it indicates the remaining amount of battery charge d 4 Battery Check Symbol Remaining Battery LEDs Illuminated Charge Green gt 30 Green Red 10 30 Red lt 10 Do not charge the battery while the UBA 4204 Amplifier Unit is connected to a patient Version 1 4 Page 14 of 41 To charge the battery insert the Battery Charger Power Supply connector into the Amplifier Unit directly below the DC Power symbol and plug the power cord into a wall outlet or isolation transformer The Battery Charger Power Supply can be used with inputs from 100 240V 50 60 Hz DC Power Symbol 2 4 4 Changing The Battery The battery is designed to withstand approximately 5 000 discharge cycles As this number is approached the operating time per recharge will decline If a battery replacement is needed the amplifier unit should be returned to LKC Technologies where trained personnel will install a replacement battery Battery replacement is not covered under warranty Please contact LKC Technologies Customer Support before returning the amplifier for this service Use only a genuine replacement battery from LKC Technologies Use of other batteries may be hazardous Version 1 4 Page 15 of 41 2 5 Ganzfeld The Full Field Ganzfeld Stimulator is connected to the
31. gger Out BNC whenever Sunburst or BigShot produces a flash In case of an ON OFF response the trigger will go low at the start of the stimulus and will go high again once the stimulus is over 7 2 Receiving Triggers from External Equipment Trigger In If you have a stimulator that can provide a trigger signal to the UTAS Interface you may record data using your own stimulator The BNC connector marked Trigger Out on the back of the interface can be used to receive triggers from an external piece of equipment Please contact LKC Technologies Inc before connecting any external equipment to the Trigger In or Out connector of the Interface Unit Warning If the stimulators are not connected properly to the Interface Unit damage may result to either the Interface Unit or to your stimulator If you have any doubts please contact LKC before proceeding Version 1 4 Page 32 of 41 Service Manual 8 0 Cleaning The System Between Patients 8 1 Cleaning Reusable Burian Allen Contact Lens Electrodes Clean electrodes with a 50 50 mixture of liquid Tide detergent or any mild detergent and distilled water note that letting tears dry on the lens after testing makes them very difficult to remove The water used to soak them in should not be acidic i e hard water as it will cause the electrolysis between the solder tin zinc which will turn the silver black If left soaking over a weekend the solder will fall apart and have to be recondi
32. he patient Please note that not all system configurations include every hardware component described in this manual Version 1 4 Page iv of 41 EN PRODUC DION Dore nS iv 10 Introduchon scsi tak eae ee ia utate ae a es 1 1 1 OVEEVIEW occas sates phia ata o t D tuts edes T LOT Lis 1 1 2 Safety oM E EU REM EME 1 1 3 SG eee 1 1 4 Essential Performance cfc cass oet terii Fn d p erret rass PE EM Eget do sirve bala alba a aci eade 1 DS PrecgutiOHs h ss E Ee ep SABA Ud e MR LE 1 1 6 Special Precautions Concerning EMC esee 3 T7 WAMI PA NUES EEUU 7 1 8 SV EMMI ONS us iet etr at UE E iM E 7 19 Approvals bred dee tian b Maux editi E E teat itis as 8 1 10 European Representallve eee eit b ERR DO Red e bene ED ME R wenn Sa tet abut 9 2 0 Functional DesertpHton uote o e i oe VEM ex edes ei es ove tuta abs 10 2 1 UTAS System Quick Spe cccssscccsssscsssssccssscesssneeessnesenecessnesecsnesecsnasevssseeessneeesaes 10 22 Computer and Associated Devices ssssssssssssssseeseeeeeeeeee enne 12 2 3 MArirQuBblgsClcc e Nc 12 2 4 UBA 4204 Patient Amplifier and Interface eee 13 2 4 1 IBAA 2 OF control ias eo tpe Ea Ioui Sutedcnsaswnanta vars debe gave cata bate doe I2 2H cata eaa iT ie 13 2 4 2 UBA 4204 Inp ltsc iaces tea cO M rette celal ranted t tb ed bin eR M utis 14 2 4 3 Batte
33. ih Keep your SunBurst in top shape EJ Zentih Keep your SunBurst in top shape Ed x TECHNOLOGIES TECHNOLOGIES Please turn on the SunBurst cover it and turn the lights off in the room before you begin To begin press Test Ganzfeld Step 1 Sunburst ON with cover Lights OFF Step 2 Click on Test Ganzfeld E Zentih Kee Ed Zentih Kee Ea p your SunBurst in top shape p your SunBurst in top shape g gt TECHNOLOGIES TECHNOLOGIES If any of the values above are greater than 1 0 or if you have 4 question about the results of this test Please contact LKC Technologies Inc at Component DB XXXXXXXXXXXXXXXXXXXXXXXXXXKXXXXXXXXXXXXXXXXXXXX 0 65 Bright Red izl 1 49 2 Professional Drive Suite 222 2 72 Gaithersburg MD 20879 USA 2 26 0 97 Tel 800 638 7055 0 Tel 301 840 1992 9 57 Fax 301 330 2237 If any of the values above are greater than 1 0 xl Test Ganzfeld Step 3 Review Calibration Values Email support lke com x Test Ganzfeld Version 1 4 Page 30 of 41 6 3 Checking Calibration On Your Own In order to check calibration without the software the equipment needed will be A Model 2550 Digital Radiometer Photometer for calibrating the dim white and Xenon flashes Other photometers are acceptable for calibration if they measure light intensity in either candelas per square meter cd m or in foot Lambert
34. is not surprising that significant distortion of the ERG and EOG can be produced by subjects who Tense their jaw muscles Tense their eyelid muscles Blink Muscle artifacts of the type that interfere with the ERG and EOG produce high frequency random noise that rides on the baseline The amplitude of this interference may be as high as 50 uV which can obscure the recording Jaw muscle noise can be particularly devastating to EOG recordings Eye Movement Artifacts Eye movements can produce serious errors in the ERG They also produce EOG errors when they do not represent controlled movements in response to the alternating stimulus There are two types of eye movement artifacts that affect the ERG One type is unrelated to the stimulus and represents the subject s inability to fixate The second type is due to a reflex contraction of the orbicularis muscle in response to the strobe flash This latter artifact is called the photomyoclonic reflex PMR and can sometimes interfere with the interpretation of the B wave 1 For a further discussion of the photomyoclonic reflex see Johnson MA and Massof RW The photomyoclonic reflex an artefact in the clinical electroretinogram Brit J Ophthalmol 66 368 372 1981 Version 1 4 Page 37 of 41 Appendix 1 Eye movement artifacts resulting from improper fixation produce baseline shifts The baseline may be shifted entirely off the screen or may be seen to slant up or down acro
35. king properly press the Test button If the associated green light turns on the Amplifier Unit microprocessor is working properly If the green light does not illuminate press the OFF button then turn the unit back on by pressing the ON button This will reset the system Note The Self Test button does not work if the unit is turned off The Power Battery Status indicator must be illuminated for the Self Test to work Version 1 4 Page 13 of 41 2 4 0 UBA 4204 Inputs UBA 4204 has 1 5 mm male DIN safety connectors which accommodate connections to most electrodes The channel connections are indicated on the back label of the Amplifier Unit It has 4 differential inputs and a ground 4 321 0000 COgecee Foe ee O N Model UBA 4204 PATENT PENDING Serial Number LKC Technologies Inc 2 Professional Drive Suite 222 Gaithersburg MD 20879 USA Phone 301 840 1992 Fax 301 330 2237 Info LKC com www LKC com 0086 A UBA 4204 Inputs back label 2 4 3 Battery Charging The UBA 4204 Amplifier Unit is powered by an internal rechargeable Lithium ion battery A fully charged battery will allow continuous date collection for up to 12 hours The required time to recharge a fully depleted battery is 8 hours with 80 of the charge restored within the first 4 hours If the battery is fully depleted unit will not turn on recharging the battery for 10 minutes should provide enough char
36. ld Stimulator should be placed on the instrument table that does not contain the Interface Unit The best arrangement for the UTAS system is where interface unit and Computer Unit are placed on one workstation and the Stimulators on one instrument table as follows A Operator s Station on workstation Computer Operator Monitor Keyboard Mouse Printer UTAS Interface Unit UBA 4204 Interface Unit B Patient s Station Video Pattern Stimulator Ganzfeld or Mini Ganzfeld Stimulator with control unit Note that the amplifier unit is not listed on either station It will be worn by the patient during testing 3 2 Precautions 3 2 1 Power Main Interference The principal external interfering signal is electrical noise generated by power lines or by electrical equipment connected to power lines The typical electrical outlet provides a ready source of 110 220 Volts which is about a million times greater than the amplitude of the ERG Examples of equipment that generate electrical interference are fluorescent lights motors including motorized chairs and power transformers Power transformers radiate primarily third harmonic e g 180 Hz These items produce powerful electromagnetic fields that can induce or couple power line interference into the recordings The closer the patient and the equipment are to these sources the more interference will be introduced into the recording equipment LKC s revolutionary Universal Biomedical Amplifier
37. le artifacts and eye movement artifacts that are due to improper fixation can be minimized by encouraging the subject to relax and to fixate on the Ganzfeld central fixation light Press the baseline key and observe the baseline as the subject becomes calm When the baseline remains essentially horizontal and the random noise level appears normal testing may commence The photomyoclonic reflex PMR is ubiquitous occurring to some degree in most ERGs If it occurs early in the ERG the PMR can obscure the entire waveform If the PMR occurs somewhat later on the rising portion of the b wave it can prevent ERG amplitude estimation Sometimes the PMR can mimic an ERG or can add apparent amplitude to ERG responses Subtle PMRs can be recognized in ERG waveforms in several ways 1 Changes in ERG waveform slope that are not consistent with the expected slope 2 ERGs of unusual amplitude or shape and 3 ERGs that do not replicate Sometimes the eye movement is preceded by stimulation of the orbicularis muscle and the resultant spiking can be observed in the waveform If the PMR is present it can frequently be habituated by presenting repetitive predictable flashes of light to the subject Stimulating approximately once per second will properly habituate the subject s response without causing too much light adaptation Artifacts Generated by the Environment As mentioned above the first step in minimizing this interference is to be sure that g
38. may not be much that can be done to reduce the effects of high frequency noise artifacts It may in fact be difficult to recognize this form of interference since the interference is translated to lie within the bandwidth of the recording As a rule if the interference is periodic and not 60 Hertz then high frequency noise should be suspected Depending on the frequency of the interference and where it originates it may be possible to reduce it by with either the high pass or low pass filters Version 1 4 Page 41 of 41
39. nd configured for a specific purpose It is absolutely essential that the timing of the stimulus presentation and data collection not be impeded by any non LKC provided software products The warranty on the UTAS system does not cover problems caused by installation of non approved software on the computer The UTAS system is a medical device that uses a Windows based computer Installation of additional software on the UTAS computer may result in improper operation of the UTAS system It is the customer s responsibility to assure that any additional software installed on the UTAS computer does not affect the performance of their UTAS system LKC is not liable or responsible for improper operation of the UTAS system caused by customer installed software Therefore LKC strongly recommends that the system be used as a standalone medical device LKC also strongly recommends that 1 the user does not change any user privileges or software settings 2 No non LKC approved software products be installed on the system Version 1 4 Page 25 of 41 4 0 Before You Use the System The UTAS system comes with a PC that contains a hard disk drive All of the UTAS software has been installed on the hard disk and all recordings will be stored on the hard drive as well Unfortunately hard disk drives sometimes fail and when they do there may be no way to recover the lost information For this reason all important information should be backed up on disks
40. nic equipment RF emissions CISPR 11 Group 1 The UTAS is suitable for use in all Class A establishments other than domestic and those directly connected to the public low voltage RF emissions CISPR 11 power supply network that supplies buildings Harmonic emissions used for domestic purposes IEC 61000 3 2 Eden PSE Voltage fluctuations flicker emissions Complies IEC 61000 3 3 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 Compliance level environment guidance IEC 60601 Immunity test test level Floors should be wood concrete or ceramic tile If Electrostatic 6 kV contact 6 kV contact floors are covered with discharge ESD synthetic material the IEC 61000 4 2 8 kV air 8 kV air relative humidity should be at least 30 96 Version 1 4 Page 3 of 41 Electrical fast transient burst 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that of a typical commercial or ho
41. nsmitters 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 maxim m Separation distance a to frequency of transmitter output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz w d 1 24P d 1 2VP d 2234 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38
42. on box change the amplifier setting to 30 Hz for low cut and 70 Hz for high cut and get a baseline Then place the Notch filter ON and try to get a baseline again Measure how much the peak to peak amplitude of the interference has been reduced If the ratio is about ten then the Notch filter is working properly Version 1 4 Page 36 of 41 Appendix 1 Appendix 1 Artifacts in Electrophysiological Testing The first part of this appendix describes the most significant artifacts encountered in Visual Electrodiagnostic Testing The second part describes various methods of limiting or minimizing artifacts and the third part explains how certain features of the equipment may be used to yield the best possible recordings artifacts notwithstanding Artifacts in electrophysiological testing are any electrical signal generated either by the subject the recording equipment or by the environment that do not represent the subject s response to the stimulus Artifacts can distort or obscure the evoked response to a degree that renders the recording of little or no use for diagnosis Artifacts Generated by the Subject Muscle Artifacts Tense muscles can generate very significant electrical activity For example the heart muscle generates up to 4 millivolts at electrodes placed on the chest In comparison the ERG signal is only about 150 to 400 uV in amplitude which is about a factor of 10 less than the electrical impulses generated by the heart It
43. ood electrode contact has been achieved e Care should be taken to thoroughly clean the site of the electrode placement with skin cleaner e All electrode cups should be filled with an adequate amount of electrode gel or cream If an ECG electrode is used for the reference electrode make sure that its gel is still wet Version 1 4 Page 39 of 41 Appendix 1 Good reference connections must be made e In ERG recordings adding an extra drop of artificial tears to the contact lens electrode while it is in the patient s eye may reduce the electrode impedance e Any unused recording channels should be shorted by placing a jumper cable between the and inputs In addition electrode leads should be as short as possible and kept away from any electrical equipment or power lines The subject should not be near strong electromagnetic fields or close to a power line It often helps to twist the positive and negative electrode leads to cancel signals due to magnetic induction About one twist per inch should be adequate With these precautions electrical noise due to primary power source equipment and radio frequency equipment will ordinarily be within acceptable limits How to Deal with Artifacts Using System Features Muscle Artifacts If after applying the suggestions made above the muscle artifacts are still excessive they may be reduced by averaging For the ERG averaging 10 sweeps should reduce the noise level to an acceptable level I
44. ordings The closer the patient and the equipment are to these sources the more interference will be induced into the recording equipment LKC s balanced patient amplifiers will cancel most of this Version 1 4 Page 38 of 41 Appendix 1 interference However 60 Hertz interference will probably be seen in the recordings if any one of these conditions exists If the patient leads or amplifiers are close to the power lines or to electrical equipment e the electrode impedance is high Therefore care should be taken to locate the testing equipment and subject away from any major source of electrical interference and to make sure that electrode impedances are as low as possible High Frequency Electrical Noise Besides the power lines or equipment such as motors and transformers electrical noise can be produced by equipment generating noise at radio frequencies Although one might expect such signals to be filtered out by the amplifier filters it is possible for this type of noise to generate low frequency artifacts by nonlinearities in the recording equipment and by mixing with other signals Care should be exercised to keep the recording equipment and subject away from strong sources of radio frequency signals Principal Artifacts and How to Limit or Minimize Them Understanding the sources of artifacts permits appropriate action to be taken to minimize the magnitude of this interference at the source Artifacts Generated by the Subject Musc
45. ort control board 5 Ganzfeld cable not connected or not tight enough 6 Bad power supply in interface unit 9 7 Data Waveforms are perfectly flat for all channels even with patient cable leads left open Potential Reasons 1 Amplifier unit is off Press ON button and verify that the power LED is lit 2 Interface unit is off make sure it is plugged in the computer 3 USB cable is unplugged from computer or interface 4 TOSlink cable is unplugged from either amplifier or interface 5 TOSlink cable is broken 6 Bad USB port 7 USB plugged in wrong USB port 8 USB port needs to be reset remove the USB connector from the UBA 4204 interface and plug it back in 9 USB port has been changed from its manufacturing position please plug interface where the label UBA is on ganzfeld 9 8 X Mini ganzfeld Mini ganzfeld does not function no flash no fixation and no background light Potential Reasons 1 Mini ganzfeld not selected in system setup Version 1 4 Page 35 of 41 Service Manual 2 Standard with Kurbisfeld or Flicker with Kurbisfeld protocol not selected 3 Bad serial port in computer 4 Loose or disconnected RS 232 cable from computer to interface unit 5 Loose connector to the serial port control board inside the control box 6 Loose connector to the control board inside the control box 7 Bad mini ganzfeld control board in the control box 8 Bad serial port control board in the control box 9 Bad power supply in
46. 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 e Accuracy of intensity and timing of various visual stimuli e 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 4 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
47. recaution 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 4 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 HF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electro
48. reveal The price of our instruments makes provision for such service but it does not l Provide for transportation charges to our factory for service 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 4 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 LKC Technologies Inc Customer Service Support 800 638 7055 US amp Canada 301 840 1992 Worldwide 301 330 2237 FAX Support LKC com www LKC com
49. ry Range sds EP 14 2 4 4 Changin Th Battery eisereen oni comantap ei E A E EES 15 2 5 G nzIeli nenei nee een oltm E ode Sa Sa A a 16 2 5 1 SUnDUrSt kaemen E ERG UAR RAIN EEES rE A EE A O 16 2 5 2 lubjindeer E 17 26 Pattern MOnHMOL ini iie o OUR E EE E e tQ Pe bert os ed ee 17 2 7 CMGS 1 Color Mini Ganzfeld Stimulator optional eesseeess 18 2 8 MGS 2 White Only Mini Ganzfeld optional sseseeeenenee 18 2 9 Overall Equipment Interrelations ssssssessseeeeeeeeeeneee nee 18 3 0 Setting Up the Syste nnn eo ete Seed Vatic ure aerated 22 3 1 MTN TRO ysis aaa E E e MD is Mec ETE ctu ter ca Wace Lio equ 22 3 2 PRECAUTIONS MEC 22 3 2 1 Power Main Interf renc niityn n e Ro Re aa ERA wise ee 22 2 212 High Frequency Electrical Nossa oe or pede a a 23 3 2 3 She LTA Dacor e eos tec greed ia a des ena wap e s riore Peas item enya Uaioe 23 3 3 Equipment Interconmections cccccccssscccsssecesssccesscccsseceeesecessseeeessneesssnenssanensnenes 23 4 0 Before You Use the System sss nennen enne nnns 26 5 0 Checking UBA 4204 Amplifier Response esses enne 27 6 0 Checking Ganzfeld Calibration for Sunburst and BigShot ssusss 28 6 1 Oy r Vie f MEM p PENES 28 6 2 Checking Calibration Using Zenith Software for SunBurst
50. sang suns 34 8 6 PEIBIGE ae eisdoru i Per potum are esti rtetasastuuy bs Desesdei ete E aolet ee ORES 35 5 71 Ganzfeld i e aee bo ADU GR dee de RES RUE ZA AA More UT EA RUN REOR OR Ev e cd S RO 35 ce D E E H 35 8 9 Mint ganzfelq e oe reb or eb pt d eo me dps e bita IE 35 8 10 Interference ooi IRI ites ares ada 36 Appendix 1 Artifacts in Electrophysiological Testing eee e eee e eee eee eee eee eee en eee eaeeea 37 Version 1 4 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
51. spital environment IEC 61000 4 4 1 kV for input output 1 kV for input output lines lines 1 h Mains power quality should Surge 1 kV line s to line s 1 kV line s to line s be that of a typical IEC 61000 4 5 45 kV line s to earth 42 kV line s to earth COmMercial or hospital environment lt 5 UT lt 5 UT Mains power quality should MOM op teat be that of a typical ies b ete ee Nee E oe ery commercial or hospital SE ae aot a environment If the user of Voltage dips the UTAS requires continued 40 UT 40 UT d snor 60 dip in UT 60 dip in UT operation during power interruptions and tor evcles forb aucles mains interruptions it is voltage y y recommended that the UTAS variations be powered from an 70 96 UT 70 96 UT on power supply isa By iis uninterruptible power supply input lines 30 dip in UT 30 dip in UT or a battery IEC 61000 4 11 for 25 cycles for 25 cycles lt 5 UT lt 5 UT gt 95 dip in UT gt 95 dip in UT for 5 sec for 5 sec Power frequency magnetic Power fred sne fields should be at levels 50 60 Hz y characteristic of a typical magnetic field 3 A m 3 A m location in a typical IEC 61000 4 8 commercial or hospital environment NOTE Ur is the a c mains voltage prior to application of the test level Version 1 4 Page 4 of 41 Guidance and manufacturer s declaration electromagnetic immunity The UTAS is intend
52. ss the screen Thus the recording may be off the screen or severely distorted because of the eye movement Ideally the baseline should appear as a horizontal line with minimal noise riding on it If the baseline is drifting wildly instruct the patient to carefully fixate on the red light in the sphere EEG Artifacts For VER recordings the principal artifact is the EEG signal Ideally the baseline response is primarily EEG noise The amplitude of the EEG signal is about 50 uV while the amplitude of the VER is about 10 V In a single sweep recording EEG noise completely obscures the VER Artifacts Generated by the Recording Equipment Baseline or Amplifier Noise All electrical circuits generate electrical noise due to molecular activity and other non ideal aspects of signal amplification Equipment baseline noise level can be observed by short circuiting the patient input terminals This noise level is usually a few microvolts and is random in nature Its amplitude depends upon the characteristics of the amplifier and on the recording bandwidth filter settings The amplitude of this baseline noise is small and therefore does not ordinarily interfere with the evoked potential recordings If the baseline noise is greater than a few microvolts with shorted inputs the equipment may be malfunctioning However absence of typical baseline noise is generally indicative of a dead or saturated amplifier If there is a complete absence of baseline noise
53. tioned The electrode may then be rinsed off with tap water Rinsing will not cause electrolysis unlike soaking for extended periods of time in hard water After cleaning the Burian Allen electrode it can be disinfected with 1 10 bleach mixture for 5 minutes no longer Using the same soapy water mixture the silver on the electrode can be scrubbed lightly with a toothbrush only the silver be sure not to scrub the wire spring This should be followed by a thorough rinse Note that the electrode should not be exposed to the bleach for more than 5 minutes longer can cause the silver to turn brown and the concentration of the bleach should be 0 5 not 5 straight Clorox is 5 25 Also note that some deterioration of the electrode will occur over time even when this method is used properly The Burian Allen electrode can also be disinfected with activated dialdehyde Glutaraldehyde sold under the trade names Cidex CabcoCide and Sporcide All of these will have usage instructions on the containers which should be followed Note that LKC has soaked the electrode in activated dialdehyde for over 4 days and noticed no visible effects A third method of disinfecting is to use Ethylene Oxide at 125 degrees Fahrenheit The heat will not harm the electrode To check the electrode for damage inspect the ring the speculum inner edge the speculum outer edge the speculum surface and the lens edge for chips If the electrode is damaged and ne
54. wer On qd 4 Battery Check mm DC Power K IEC 60601 1 Class I Type BF Version 1 4 Page 7 of 41 XK IEC 60601 1 Class I Type B Fuse Rating T2 5A 250V is for 210 230 VAC power line countries a 250V T5 0A 250V is for 100 120 VAC power line countries T5 0A 250V N CE 0086 L Volts AC Council Directive Compliance Earth ground connection point functional earth terminal QD 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 4 Page 8 of 41 1 10 European Representative Emergo Europe Symbol Molenstraat 15 2513 BH The Hague REP The Netherlands EMERGO EUROPE
55. when operated according to instructions Rechargeable Li Ion Battery Battery Charger 100 240 V 50 60 Hz 12 V 1 0 A included Operating Time Up to 12 hours of continuous use before recharging Recharge Time 4 hours to 80 capacity 8 hours to 100 Environmental 0 C to 55 C 32 F to 131 F Size 534 x 3 x 1 14 6 cm x 8 3 cm x 2 5 cm Weight 8 oz 225 g including battery SYSTEM INTERFACE UNIT Computer Interface Power Source USB 1 1 RS 232 100 240 VAC 100W Size 10 x 10 x 4 Weight 6 5 Ib UBA 4204 INTERFACE Computer Interface USB 1 1 Power Source USB Powered Size 6 x 3 x 244 15 cm x 7 6 cm x 5 7 cm Weight 80z 225g POWER REQUIREMENTS Input Voltage 100 115 230 VAC 10 Input Frequency 47 to 63Hz Power Consumption 520 watts maximum OPERATING ENVIRONMENT Operating Temperature 5 to 35 C Humidity 15 to 80 RH non condensing Version 1 4 Page 11 of 41 Storage Temperature 10 to 70 C 2 2 Computer and Associated Devices The computer is either a desktop or notebook PC with a minimum of 1 8 GHz CPU speed 448 MB of Random Access Memory RAM at least 80GB hard disk drive and a rewritable CD drive The computer provides the control of all test and analysis operations An additional video card is added to the computer by LKC This video board sends video signal to the operator s LCD monitor 2 3 System Interface The system interface contains 24V Medical Grade Power Supply
56. will cancel most of this interference However if the patient leads or amplifier are close to the power lines or to Version 1 4 Page 22 of 41 electrical equipment power mains interference may be seen in the recordings Therefore care should be taken to position the testing equipment and subject away from any major source of electrical interference 3 2 20 High Frequency Electrical Noise Beyond the power lines or equipment such as motors and transformers electrical noise can be produced by equipment generating noise at radio frequencies Although one might expect such signals to be filtered out by the amplifier filters it is possible for this type of noise to generate low frequency artifacts by nonlinearities in the recording equipment and by mixing with other signals Therefore care should be exercised to keep the recording equipment and subject away from strong sources of radio frequency interference Noisy signals can also be coming from near by MRI systems this will create noise and or unrecordable data 3 2 3 Shielding If a location which is free of interfering apparatus cannot be found it is possible to create simple shielding which will usually control the interference The shielding material can be copper or aluminum screening material which should be placed below the patient and covered with an anti static mat or placed around an interfering apparatus The screen and mat if used should be securely connected to electri
57. y waveform capability is also built in using RGB stimuli to 2000 points 10 seconds per cycle Sunburst also has 9 red EOG fixation LEDs in 15 horizontally with brightness adjustable over 20 dB range in 1 dB steps Version 1 4 Page 16 of 41 2 5 2 BigShot BigShot is large enough to fit larger animals such as dogs pigs cats It has a size of 19 5 50 cm H x 15 5 40 cm W x 12 5 32 cm D and weighs 17 Ib 7 7 kg The ez inside of the ganzfeld is not washable Used compressed air can to blow dust particles out Do not use water BigShot uses Red 627 nm Green 530 nm Blue 470 nm Amber 590 nm and white LEDs for dim flashes and Xenon flash It has a total dynamic flash luminance range of 100 dB 25 dB to 75 dB in 1 dB steps All flash durations are less than Sms The xenon flash luminance range is 2 5 800 cd s m 0 dB to 25 dB LED flash luminance is of 2 5 10 to 25 cd s m 50 dB to 10 dB in any arbitrary color LED flash luminance is of 75 dB to 50 dB in white The background light can be controlled from 0 005 to 1000 cd m in 0 01 dB increments in any color and as low as 10 5 cd m in white The flicker stimuli goes up to 10 dB 1 Hz repetition rate for intensities gt 10 dB BigShot also has the capability to produce long duration flash On Off response stimuli programmable to 6 5 seconds in 5 ms increments with adjustable intensity and chromaticity An arbitrary waveform capability is also

Download Pdf Manuals

Related Search

Related Contents

Bosch UHO-HBGS-10  Lab1 - Xilinx  Tcl3D: Doing 3D with Tcl  Maintenance Manual  HPRcv™ - Datamed  Adjunto 1 - Universidad de Zaragoza  catalogo dei prodotti - Audio  Epson TM-S2000MJ (002): 110DPM, 2Pocket, USB HUB, MSR  

Copyright © All rights reserved. Failed to retrieve file