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Related Manuals for LKC TECHNOLOGIES UTAS
Summary of Contents for LKC TECHNOLOGIES UTAS
- Page 1 UTAS System Hardware User’s Manual Issue Date: 2023-02-13 Rx only 2797 Part No. 96-020-EN...
- Page 2 UTAS Hardware EN - http://www.lkc.com/IFUsPrintable instructions for use (IFU) in multiple languages are stored on the UTAS computer as PDF files in the IFU folder on the computer desktop screen, or go to www.lkc.com/IFUs DE - Druckbare Nutzungsanweisungen (IFU) in mehreren Sprachen werden auf dem UTAS- Computer als PDF-Dateien im IFU Ordner auf Ihrem Desktop gespeichert.
- Page 3 UTAS Hardware European regulatory data Basic UDI-DI (for EUDAMED database searches) – 0857901006UTAS79 Instructions for use (IFUs) in other languages may be found at www.lkc.com/IFUs To request a printed copy of this manual please send an email to support@lkc.com include the following information:...
- Page 4 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.
- Page 5 We will be happy to discuss by phone, letter, FAX, or e-mail any problem you may be experiencing. LKC PRODUCT LIFETIME POLICY The lifetime of a UTAS system is 7 years from the original shipment date of the UTAS system. LKC will service any UTAS system that is within its lifetime. DISPOSAL Follow all local and national regulations regarding proper disposal.
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Page 6: Table Of Contents
1.10 Swiss Representative ....................19 1.11 Reporting of serious incidents ................20 1.12 Functional Description/ Technical Specifications ............20 2.1 UTAS System Specifications ..................20 2.1.1 Sunburst Ganzfeld Stimulator ................. 20 2.1.2 Bigshot Ganzfeld Stimulator ................21 2.1.3 Pattern Stimulator ..................21 2.1.4... - Page 7 UTAS Hardware 2.4.1 SunBurst ......................25 2.4.2 BigShot ......................26 Pattern Monitor ..................... 26 Overall Equipment Interrelations ................27 Setting Up the System ....................29 Inventory ........................ 29 3.1.1 Operator's Station on workstation ..............29 1.12.1 Instrument/Patient's Station ................29 Precautions ......................
- Page 8 UTAS Hardware Page 8 of 46...
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Page 9: Introduction
Operator training is provided by LKC upon installation of the UTAS, training is typically 2 or 3 days depending on the system configuration upon user request. This training, along with this User’s Manual, should be adequate. -
Page 10: Product Performance
Contact your distributor or LKC if changes in performance are noted. 1.4 Essential Performance The UTAS is neither life supporting nor life sustaining nor is it a primary diagnostic device; its function is to aid a physician in making a diagnosis in combination with other data and in light of the physician’s knowledge and experience, as such the UTAS has no Essential Performance... - Page 11 • WARNING: Do not modify this equipment without authorization of the manufacturer. • Connect the UTAS Interface directly to a wall outlet. Do not connect the UTAS Interface to a wall outlet through an extension cord or a multiple socket-outlet •...
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Page 12: Electromagnetic Compatibility (Emc)
UTAS Hardware 1.6 Electromagnetic compatibility (EMC) The UTAS device should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used. - Page 13 Guidance and Manufacturer’s Declaration – Immunity The UTAS device is intended for use in the electromagnetic environment specified below. The customer or user of the UTAS device should ensure that it is used in such an environment. Immunity Test IEC 60601 Compliance Level Electromagnetic Environment –...
- Page 14 Guidance and Manufacturer’s Declaration – Immunity The UTAS device is intended for use in the electromagnetic environment specified below. The customer or user of the UTAS device should ensure that it is used in such an environment. Immunity Test IEC 60601 Compliance Electromagnetic Environment –...
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Page 15: Warnings And Symbols
UTAS Hardware Separation (m) Separation (m) Separation (m) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz √P √P √P Max Output Power (Watts) 0.01 0.117 0.117 0.233 0.369 0.369 0.738 1.17 1.17 2.33 3.69... -
Page 16: Approvals
UTAS Hardware Volts AC Council Directive Compliance 2797 Earth ground connection point, functional earth terminal Chassis ground, protective earth terminal Read the directions before use to ensure safety Keep dry WEEE directive. In applicable countries, the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. -
Page 17: Environmental
Environment Friendly Use Period (EFUP) of 25 years. 1.9.3 WEEE Compliance At the end of the product’s lifetime the UTAS must be disposed of in accordance with all local and national regulations. Please contact your local authorized representative of the manufacturer for information concerning the decommissioning of your equipment. - Page 18 UTAS Hardware Interior paperboard boxes (non-corrugated cardboard) Plastic foam packing materials Plastic bags Bubble Wrap Page 18 of 46...
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Page 19: California Proposition 65
UTAS Hardware 1.9.5 California Proposition 65 Warning: This product can expose you to chemicals including lead, which are known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov/ Substance Tables: The table below lists substances which may be contained within this product. -
Page 20: Reporting Of Serious Incidents
In this section, the function of each equipment group is explained and a block diagram showing equipment interrelationships is discussed. The UTAS system can come with either a SunBurst Ganzfeld (designed for humans and larger animals) or the BigShot Ganzfeld (fits most small animals and primate faces). -
Page 21: Bigshot Ganzfeld Stimulator
UTAS Hardware 2.1.2 Bigshot Ganzfeld Stimulator Size 39 cm x 32 cm x 50cm (15.5” x 12.5” x 19.7”) 35.6 cm (14”) Diameter Full Field Globe Weight 9.5 kg (21 lbs.) Flash Intensity Maximum Luminance of ~800 cd·s/m (+25 dB) for Xenon Flash Typical Maximum Luminance of ~25 cd·s/m... -
Page 22: Utas Interface Unit
Computer Interface USB (Type-A male connector) Power Source USB powered Timing Accuracy <±2.0 ms 2.1.5 Utas Interface Unit Computer Interface RS-232 Size 26 cm x 26 cm x 10 cm (10” x 10” x 4”) Weight 7.3 kg (16 lb) 2.1.6 UTAS System... -
Page 23: System Interface
UTAS Hardware The UTAS has very specific configuration requirements. Only a computer purchased from LKC specifically for your UTAS should be used. Use of other computers may compromise performance and/or test results. The computer provides the control of all test and analysis operations. -
Page 24: Uba Inputs
UTAS Hardware 2.3.3 UBA Inputs UBA has 1.5 mm male DIN safety connectors. The channel connections are indicated on the front label of the Amplifier adjacent to the connection points. The UBA has 6 differential inputs, the Positive inputs have RED connectors, the Negative inputs have BLACK connectors and the Ground input has a GREEN connector. -
Page 25: Ganzfeld
UTAS Hardware Ganzfeld The Full-Field Ganzfeld Stimulator connected system interface unit and controlled by the system’s computer. The UTAS system can come with either a SunBurst Ganzfeld or a BigShot Ganzfeld. 2.4.1 SunBurst SunBurst has a compact size. It has... -
Page 26: Bigshot
Pattern Monitor The pattern stimulator monitor supplied with your UTAS was selected by LKC to meet the rigorous requirements of Multi-Focal ERG/Multi-Focal VEP. Commands sent by the computer to the pattern stimulator produce changes in the display on the pattern stimulator screen. -
Page 27: Overall Equipment Interrelations
Figure 1 below show the block diagrams of the system in the two versions (desktop and laptop), showing how the various elements of an UTAS system are interconnected. The UTAS has three patient stimulus options: the SunBurst Ganzfeld, the BigShot Ganzfeld, and the patient monitor. - Page 28 UTAS Hardware Figure 1 Ref. ID Description Length (m) LKC No. AC Input Power Cord 65-010 Page 28 of 46...
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Page 29: Setting Up The System
3 Setting Up the System Inventory The UTAS testing system consists of a system interface unit, an amplifier unit, a pattern stimulator, a Ganzfeld, and a computer with its associated peripherals. The equipment should be arranged on workstations or tables. -
Page 30: Precautions
Equipment Interconnections The equipment is interconnected as shown in Figure 1. Make certain that the power is off before making any connections. All of the equipment in your UTAS must be connected for the system to function properly. The system comes with connections for two monitors. The two monitors have different video... - Page 31 Computer to Mouse. Connect the mouse to the computer using its integral USB cable. Computer to UTAS Interface Unit. Connect the serial port on the Interface unit to the computer using the supplied adapter cable. This cable has a 9-Pin Serial connector on one end and a USB connector on the other end.
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Page 32: System Maintenance & Calibration
4 System Maintenance & Calibration Computer Backup The UTAS system comes with a PC that contains a hard disk drive. The UTAS software has been installed on the hard drive, and the recordings will be stored on the hard drive as well. -
Page 33: Calibration
• Clean patient contact area per instructions in Section 7 between each patient. • There are no user serviceable parts in the UTAS. If service is required contact LKC. • Cleaning must not be performed while testing is in process. - Page 34 UTAS Hardware • Go to a 0 dB scotopic flash step. Set the Ganzfeld Parameters to turn the IR LED off (if your ganzfeld is a BigShot it might not have IR LEDs) • Click on Baseline and Record – Stop Baseline and then Record •...
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Page 35: Checking Ganzfeld Calibration
5.2 Checking Ganzfeld Calibration 5.2.1 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 measurements and compare them to the original factory calibration data. -
Page 36: Checking Calibration Using Zenith Software (For Sunburst Only)
UTAS Hardware Calibration check should be performed in a dark room with the Ganzfeld cover on. Also make sure that the fixation LED is turned off during calibration. The photometric measurement of most relevance to clinical electrophysiology is the luminance. Luminance is a measure of light per unit area emitted from an extended source or reflecting surface. - Page 37 UTAS Hardware Step 1: SunBurst ON with cover, Lights OFF Step 2: Click on Test Ganzfeld Page 37 of 46...
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Page 38: Checking Calibration On Your Own
UTAS Hardware Step 3: Review Calibration Values 5.2.3 Checking Calibration on Your Own In order to check calibration, you need to have a light meter calibrated for photopic luminance for background lights and photopic luminance energy for flashes. 6 External Triggers (Input and Output) The rear of the LKC Interface Unit contains a BNC connector labeled Trigger Out and a phone jack labeled and Trigger In. -
Page 39: Triggering External Equipment - Trigger Out
(the UTAS Trigger-In Cable) Additionally, if you have a stimulator that can provide a trigger signal to the UTAS Interface, data may be recorded using that stimulator. The phone jack connector marked Trigger In on the back of the interface can be used to receive triggers from an external piece of equipment. -
Page 40: Cleaning The Exterior
Cleaning of the patient-contacting parts of the device (Sunburst forehead rest, multifocal chin/forehead rest) is recommended between patient uses. The UTAS exterior is chemically compatible to wipes containing 70% isopropyl alcohol and with wipes containing alkyl dimethyl benzyl ammonium chloride. The use of other wipes may damage the device. -
Page 41: Appendix 1: Lkc Accessory Electrode And Supplies List
Appendix 2 Appendix 1: LKC Accessory Electrode and Supplies List Electrodes & Jumper Cables LKC Part No. Jumper Cable 91-171 DTL Electrode Extension Cable 95-028 1 to 2 Electrode Splitter (1M-2F) 95-001 1 to 3 Electrode Splitter (1M-3F) 95-083 1 to 4 Electrode Splitter (1M-4F) 95-084 DTL Plus Electrodes 95-003... -
Page 42: Appendix 2: Artifacts In Electrophysiological Testing
Appendix 2 Appendix 2: 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. - Page 43 Appendix 2 EEG Artifacts. For VER recordings, the principal artifact is the EEG signal. The baseline response is primarily EEG "noise", whose amplitude is about 50 µV (compared to the VER amplitude of about 10 V). In a single sweep recording, EEG noise completely obscures the VER. Artifacts Generated by the Recording Equipment Baseline or Amplifier Noise.
- Page 44 Appendix 2 High Frequency Electrical Noise. Besides the power lines or equipment such as motors and transformers, electrical noise can also 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 the equipment to generate low frequency artifacts by nonlinearities in the recording equipment and by mixing with other signals.
- Page 45 Appendix 2 • Electrode leads should be as short as possible and kept away from any electrical equipment, power lines, or electromagnetic fields (it helps to twist the positive and negative electrode leads in order to cancel their magnetic induction; about one twist per inch is adequate).
- Page 46 Appendix 2 Whereas the VER default filter setting is at 100 Hz, the 30 Hz filter will produce a smoother waveform. Note: 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 listed precautions, there may not be much that can be done to reduce the effects of high frequency noise artifacts.
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