natus XLTEK EEG32U User And Service Manual
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natus XLTEK EEG32U User And Service Manual

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XLTEK EEG32U
User and Service Manual

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Summary of Contents for natus XLTEK EEG32U

  • Page 1 XLTEK EEG32U User and Service Manual...
  • Page 2 This copy of the User Manual shall be used only in accordance with the conditions of sale of Natus Medical Incorporated or its distributors. Natus Medical Incorporated makes no representations or warranties of any kind whatsoever with respect to this document.

  • Page 3: Table Of Contents

    XLTEK EEG32U Amplifier User and Service Manual Table of Contents Introduction ........................4 Product Intended Use ........................4 Essential Performance .......................4 Using the Manual ........................4 Manual Conventions ............................5 Specifications: EEG32U Amplifier .................. 6 EEG32U Safety and Standards Conformity ..............8 Standards of Compliance and Normative References ............8...
  • Page 4 User and Service Manual XLTEK EEG32U Amplifier Channel Test ..............................27 Impedance Check ............................. 28 Transport System Specifications and Maintenance ........... 30 XLTEK Trolley Specifications ....................30 Maintenance ..........................31 Warnings and Cautions ......................31 Electrical Input and Isolation Transformer Details ............... 31 Maintenance, Cleaning, &...

  • Page 5: Introduction

    User and Service Manual Introduction The XLTEK EEG32U amplifier offers advanced signal acquisition capabilities for accurate data acquisition with 1kHz sampling rates and 16 bit analog-to-digital data conversion. The highest signal-to- noise ratios and fast recovery from saturation for stable baselines are available with the EEG32U. This rugged device was designed with extensive clinical input to meet the workflow and application needs of the basic EEG Lab.

  • Page 6: Manual Conventions

    User and Service Manual XLTEK EEG32U Amplifier Manual Conventions Various symbols and typographical conventions are used throughout the manual. The following table illustrates them and describes their meanings and functions. Symbol/ Description/Function Convention This symbol denotes a warning or important information that should not be missed.

  • Page 7: Specifications: Eeg32U Amplifier

    XLTEK EEG32U Amplifier User and Service Manual Specifications: EEG32U Amplifier Specification Value(s) Analog Specifications Channels Referential Channels ≥ 100 MOhms Differential Input Impedance ≥ 50 MOhms Common Mode Input Impedance Common Mode Rejection Ratio - 110 dB @ 60 Hz Channel Bandwidth 0.1 Hz to 400 Hz...
  • Page 8 User and Service Manual XLTEK EEG32U Amplifier Specification Value(s) Modes of Operation Power Consumption <1 W @ 5 V Impedance Check < 2.5, < 5, < 10, < 25 KOhms Channel Test Signal Programmable Sine: 16-32 Hz, 158-10110 μV peak-to-peak Square: 0.25-0.5 Hz, 50-6400 μV peak-to-...

  • Page 9: Eeg32U Safety And Standards Conformity

    XLTEK EEG32U Amplifier User and Service Manual EEG32U Safety and Standards Conformity Standards of Compliance and Normative References 32 Channel Electroencephalograph (EEG) Headbox; model EEG32U; rated 5Vdc,0.2A Type of protection against electric shock: Class II Degree of protection against electric shock: Type BF...
  • Page 10 User and Service Manual XLTEK EEG32U Amplifier IEC 61000-4-2:2008, ed 2.0 Electromagnetic Compatibility (EMC) Part 4-2: Testing and Measurement Techniques - Electrostatic Discharge Immunity Test IEC 61000-4-3 ed 3.0 with Electromagnetic Compatibility (EMC) Part 4-3: Testing A1:2007+A2:2010 and Measurement Techniques - Radiated, Radio- frequency, Electromagnetic Field Immunity Test IEC 61000-4-4:2012, ed 3.0...

  • Page 11: Declaration Of Compliance For Iec 60601-1-2

    XLTEK EEG32U Amplifier User and Service Manual Declaration of Compliance for IEC 60601-1-2 Table 1 - Electromagnetic Emissions Guidance and manufacturer’s declaration – electromagnetic emissions The EEG32U is intended for use in the electromagnetic environment specified below. The customer or the user of the EEG32U should assure that it is used in such an environment.
  • Page 12 User and Service Manual XLTEK EEG32U Amplifier Table 2 - Electromagnetic Immunity Guidance and manufacturer’s declaration – electromagnetic immunity The EEG32U is intended for use in the electromagnetic environment specified below. The customer or the user of the EEG32U should assure that it is used in such an environment.
  • Page 13 XLTEK EEG32U Amplifier User and Service Manual Table 3 - Electromagnetic Immunity– for EQUIPMENT and SYSTEMS that are not LIFE- SUPPORTING Guidance and manufacturer’s declaration – electromagnetic immunity The EEG32U is intended for use in the electromagnetic environment specified below. The customer or the user...
  • Page 14 User and Service Manual XLTEK EEG32U Amplifier Table 4 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Band Service Maximum Distance IMMUNITY Modulation frequency Power TEST LEVEL (MHz) (MHz) (V/m) Pulse 380 –390 TETRA 400...

  • Page 15: Declaration Of Compliance For Fcc

    XLTEK EEG32U Amplifier User and Service Manual Declaration of Compliance for FCC Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment.

  • Page 16: Warnings And Cautions

    User and Service Manual XLTEK EEG32U Amplifier Warnings and Cautions General Warnings NOTE: It is recommended that all data be stored using redundant storage capabilities. This can help to minimize data loss in the event of a failure of the primary drive.

  • Page 17: Electrical Warnings And Cautions

    WARNING: Third-party software installed on the acquisition computer may interfere with the operation of the Natus software. Please consult Natus Technical Support before installing third-party software on the computer. This device does not contain any hazardous components; therefore, no special precautions are required for their disposal.

  • Page 18: Patient Environment Warnings And Cautions

    User and Service Manual XLTEK EEG32U Amplifier ELECTRICAL SHOCK HAZARD: Do NOT service the system. Refer servicing to qualified personnel only. Do NOT use repaired components without proper testing. The computer attached to the EEG32U should use a three-wire power cord with a hospital grade plug.

  • Page 19: Transportation Warnings

    Make sure that any platform, table, cart, or other surface used during the operation, transport, or temporary or permanent storage of the system and its components is adequate, sturdy, and safe. Natus is not responsible for any injury or damage that may result from inadequate, poorly constructed, or unapproved transports, carts, or operating surfaces.

  • Page 20: Procedures And Warnings

    User and Service Manual XLTEK EEG32U Amplifier Procedures and Warnings Electrostatic Discharge (ESD) Handling Before performing any setup or placement procedures, read the precautions outlined in this section. WARNING: Be sure to take the appropriate Electrostatic Discharge (ESD) precautions. Disconnect the cables before moving, cabling, or performing any set up procedures.
  • Page 21 XLTEK EEG32U Amplifier User and Service Manual Follow these techniques to help identify the sources, and to increase the immunity towards parasitical noise: • Verify the power supply and all portable multiple socket-outlets are off the floor and in a dry location.

  • Page 22: Description Of Symbols

    User and Service Manual XLTEK EEG32U Amplifier Description of Symbols Symbol Description ATTENTION: Consult Accompanying Documents Consult Accompanying Documents Protective Earth (Ground) Type BF Equipment Dangerous Voltage Alternating Current Direct Current 5VDC 0.2A Power On Power Off EU only: Do Not Dispose as Unsorted Municipal Waste...
  • Page 23 XLTEK EEG32U Amplifier User and Service Manual Symbol Description ESD Sensitive Static Sensitive Manufacturer Information Reference Number. This is the part number for the device. The ETL mark is a safety symbol that shows the product was independently tested and certified to applicable U.S. and Canadian product safety standards.

  • Page 24: Product Images

    User and Service Manual XLTEK EEG32U Amplifier Product Images EEG32U Headbox EEG32U Headbox Standard 10-20 Channel Inputs Impedance LEDs Patient Ground Additional Referential Inputs Impedance Threshold LEDs Impedance Button Photic Stim Connection USB Connection Patient Event Connection...

  • Page 25: Unpacking

    XLTEK EEG32U Amplifier User and Service Manual Unpacking When you unpack your EEG32U, make sure the following items are included: • EEG32U headbox • USB 2.0 cable • Patient event switch Optional Accessories: • EEG accessory kit NOTE: The EEG32U amplifier should be used only with cables, transducers,...

  • Page 26: Setting Up

    Beginning a study Once the equipment has been installed by your Natus qualified representative and a patient has been connected to the EEG32U system, a new EEG study can be started. For details on beginning a new EEG study, consult the NeuroWorks manual directly.

  • Page 27: Connecting To A Computer

    XLTEK EEG32U Amplifier User and Service Manual Connecting to a Computer Hardware Connections for an EEG32U Amplifier To connect the EEG32U to the XLTEK computer: 1. Use the supplied USB 2.0 cable (026620 – 3m USB 2.0 A/B Cable - Black (9.8ft)) to connect the EEG32U headbox to the 4 port USB hub (026274 –...

  • Page 28: Calibration And Verification

    User and Service Manual XLTEK EEG32U Amplifier Calibration and Verification There is no need to calibrate the NeuroWorks Software or the EEG32U headbox. All calibration is done at the factory before the system is shipped. To verify that the EEG32U headbox system is correctly calibrated, perform the following procedure: 1.

  • Page 29: Impedance Check

    XLTEK EEG32U Amplifier User and Service Manual Channel Test Signal Toolbar Available Channel Test Signal Settings Shape Sine or Square Amplitude Sine wave amplitude can be 79, 158, 316, 632, 1264, 2527.5, 5055 and 10110 µV peak to peak. Square wave amplitude can be 50, 100, 200, 400, 800, 1600, 3200, and 6400 µV peak to peak.
  • Page 30 User and Service Manual XLTEK EEG32U Amplifier Save the impedance check as part Click End and Start Recording of the study Interpreting an Impedance Check An impedance check displays bar graphs that show the impedance of each electrode connection. A green bar indicates the reading is below the threshold.

  • Page 31: Transport System Specifications And Maintenance

    Refer to the corresponding Instructions for Use for all system components prior to use. This should include, but is not limited to: cameras, computers, stimulators, and software. NOTE: Transportation System setup and installation should be performed by Natus qualified personnel only.

  • Page 32: Maintenance

    Make sure that any platform, table, cart, or other surface used during the operation, transport, or temporary or permanent storage of the system and its components is adequate, sturdy, and safe. Natus is not responsible for any injury or damage that may result from inadequate, poorly constructed, or unapproved transports, carts, or operating surfaces.

  • Page 33: Maintenance, Cleaning, & Disposal

    Regular preventive maintenance does not involve access to the interior of the EEG32U headbox and components. For service problems that require corrective maintenance and/or internal component service, call the Natus Technical Support at 1-800-303-0306 or OTS@natus.com, or contact your local XLTEK representative.

  • Page 34: Disposal

    At the end of the expected service life, when disposing of the EEG32U amplifier and its components, it is recommended that federal, state, and local laws be followed for proper disposal of printed circuit boards, plastics, and metal parts. For disposal of non-Natus accessories, please follow the instructions provided with these items.

  • Page 35: Troubleshooting

    XLTEK EEG32U Amplifier User and Service Manual Troubleshooting If the acquired waveforms are flat, do not appear, or do not appear correctly (or as expected), try shutting down the computer for at least 10 seconds. Then set up the test again from the beginning. Shutting down and starting over resets the headbox and sometimes solves the problem.

  • Page 36: Theory Of Operation

    User and Service Manual XLTEK EEG32U Amplifier Theory of Operation: Introduction This section describes the theory of operation of the 32 channel EEG headbox. The initial discussion is primarily signal flow oriented. Detailed board level theory is provided later in this section.

  • Page 37: Digital Board

    XLTEK EEG32U Amplifier User and Service Manual B. Digital Board • Analog to Digital converters digitize the amplified EEG signals. Signals are periodically sampled and converted to a binary number. • The micro controller transmits the digitized signals to the computer over USB 2.0 connection.

  • Page 38: Getting Help

    XLTEK EEG32U Amplifier Getting Help Natus is committed to providing you with support so you can operate the EEG32U headbox with ease and confidence. If you need help, follow these steps to find a solution: Step 1: Document the Incident Carefully document the incident.

  • Page 39: Eeg Accessories & Replacement Parts

    EEG32U & Brain Monitor Breakout Box Wall and Roll Stand Mounting Kit EEG accessories which can be used with the EEG32U amplifier are available for you to browse in the Natus Neurology Accessories Catalog online at www.natus.com or call Natus Sales and Support 1-800- 303-0306.

  • Page 40: Index

    User and Service Manual XLTEK EEG32U Amplifier Index Electrical Warnings and Cautions ..........17 Electrical Input ..............31 Beginning a Study ............. 25 Electrostatic Discharge Handling Procedures ............ 19 Precautions ..............16 EMC Standards ..............8 Cautions ................15 Cart ................31 Handling Procedures ............
  • Page 41 XLTEK EEG32U Amplifier User and Service Manual Signal Control ............27 Impedance Check ............28 Patient Environment Interpreting ............. 29 Warnings and Cautions..........17 Running ..............28 Patient Placement............. 25 Verification..............27 Precautions Testing the EEG32U Amplifier .......... 26 Electrostatic Discharge ..........16 Transport System ESD ................
  • Page 42 A Total Service Solution Standing behind every XLTEK product is Natus Medical Incorporated, an internationally respected innovator of medical products and services. Our Neurology systems are backed up by an in-house support team staffed with technical and clinical experts, 24/7 support, remote support via WebEx or VPN, the largest clinical and technical field support network in Neuro/Sleep and customized service contracts that include preventative maintenance visits and computer upgrades.

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