natus XLTEK EEG32 User And Service Manual
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natus XLTEK EEG32 User And Service Manual

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XLTEK EEG32U
User and Service Manual
Part Number: 105491-EN Rev Q
09/JAN/2022
System Model Numbers: PK1088, 10399
© 2016 - 2023 Natus Medical Incorporated or one of its subsidiaries. All rights reserved.
This manual contains proprietary information, which is protected by copyright laws and may not be copied in whole or in part
except with the prior written permission of Natus Medical Incorporated. The copyright and the foregoing restrictions on the
copyright use extend to all media in which this information is preserved.
This copy of the User Manual shall be used only in accordance with the conditions of sale of Natus Medical Incorporated or its
distributors, including without limitation the Natus Software License Agreement. Natus Medical Incorporated makes no
representations or warranties of any kind whatsoever with respect to this document. Natus Medical Incorporated disclaims all
liabilities for loss or damage arising out of the possession, sale, or use of this document.

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  • Page 1 This copy of the User Manual shall be used only in accordance with the conditions of sale of Natus Medical Incorporated or its distributors, including without limitation the Natus Software License Agreement. Natus Medical Incorporated makes no representations or warranties of any kind whatsoever with respect to this document.

  • Page 2: Contact Information

    User and Service Manual XLTEK EEG32U Amplifier Contact Information UK Responsible Person Natus Medical Incorporated Natus Nicolet UK Ltd DBA Excel-Tech Ltd. (XLTEK) Baynards Green Trading Estate 2568 Bristol Circle Oakville, Prospect House Ontario L6H 5S1 Canada Oxfordshire Tel: 905-829-5300...

  • Page 3: Table Of Contents

    XLTEK EEG32U Amplifier User and Service Manual Table of Contents Contact Information ..............................1 Introduction ................................... 4 Device Description ..............................4 Intended Use ................................4 Indications for Use ..............................4 Intended User ................................5 Patient Target Group ..............................5 Residual Risks ................................5 Medical Conditions ..............................
  • Page 4 User and Service Manual XLTEK EEG32U Amplifier Calibration and Verification ..........................32 Channel Test ................................ 33 Impedance Check ..............................34 Transport System Specifications and Maintenance ....................35 XLTEK Trolley Specifications ............................ 35 Maintenance ................................36 Useful Life ................................36 Warnings and Cautions ............................36 Electrical Input and Isolation Transformer Details ....................

  • Page 5: Introduction

    Intended Use The EEG32U Amplifier is intended to be used as an electroencephalograph to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks™ software to acquire scalp electroencephalographic (EEG) signals. The EEG32U Amplifier is intended to be used by trained medical professionals and is designed for use in clinical environments such as hospital rooms and epilepsy monitoring units.

  • Page 6: Intended User

    User and Service Manual XLTEK EEG32U Amplifier Intended User The EEG32U amplifier is intended to be used by trained medical professionals such as neurologists, EEG technicians, intensivists and researchers and is designed for use in clinical environments such as hospital rooms and epilepsy monitoring units. Patient Target Group EEG32U amplifier can be used with patients of all ages but is not designed for fetal use.

  • Page 7: General And Network Security Measures

    A PDF copy of this user manual (eIFU) is available on the USB flash drive, Information for Use, provided with your system. Copies of the User Guide may also be accessed at natus.com in the Support section. Scroll to the EEG Product IFUs, select EEG32U User &...

  • Page 8: Specifications: Eeg32U Amplifier

    User and Service Manual XLTEK EEG32U Amplifier Specifications: EEG32U Amplifier Specification Value(s) Analog Specifications Channels Referential Channels Differential Input Impedance ≥ 100 MOhms Common Mode Input Impedance ≥ 50 MOhms Common Mode Rejection Ratio -≥ 110 dB @ 60 Hz Channel Bandwidth 0.1 Hz to 400 Hz Input Noise (peak to peak)
  • Page 9 XLTEK EEG32U Amplifier User and Service Manual Specification Value(s) Interface Cable USB 2.0 cable, maximum 3m Approximate Size 160 mm (l) x 97mm (w) x 29mm (d) Environmental Conditions for Use Operating Environmental Limits Temperature: 10° to 40°C Relative Humidity: 30%-75% Atmospheric Pressure: 700 hPa to 1060 hPa Transport and Storage Temperature Range - 25°C to 60°C...

  • Page 10: Eeg32U Amplifier Safety And Standards Conformity

    User and Service Manual XLTEK EEG32U Amplifier EEG32U Amplifier Safety and Standards Conformity Standards of Compliance and Normative References 32 Channel Electroencephalograph (EEG) Amplifier; model EEG32U; rated 5Vdc,0.2A Type of protection against electric shock: Class II Degree of protection against electric shock: Type BF Degree of protection against ingress of water: IPX0 Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable anesthetic...
  • Page 11 XLTEK EEG32U Amplifier User and Service Manual Table 2 – EMC Standard of Compliance and Normative References IEC 60601-1-2, Edition 4.0 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance– collateral standard: EN 60601-1-2:2015 electromagnetic compatibility – requirements and tests IEC 61000-4-2:2008, ed 2.0 Electromagnetic Compatibility (EMC) Part 4-2: Testing and Measurement Techniques - Electrostatic Discharge Immunity Test...

  • Page 12: Declaration Of Compliance For Iec 60601-1-2

    User and Service Manual XLTEK EEG32U Amplifier EN ISO 10993-1:2020 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process ISO 10993-1:2018 Declaration of Compliance for IEC 60601-1-2 Table 1 - Electromagnetic Emissions Guidance and manufacturer’s declaration – electromagnetic emissions The EEG32U amplifier is intended for use in the electromagnetic environment specified below.
  • Page 13 XLTEK EEG32U Amplifier User and Service Manual Table 2 - Electromagnetic Immunity Guidance and manufacturer’s declaration – electromagnetic immunity The EEG32U amplifier is intended for use in the electromagnetic environment specified below. The customer or the user of the EEG32U amplifier should assure that it is used in such an environment. Immunity Test IEC 60601 Compliance...
  • Page 14 User and Service Manual XLTEK EEG32U Amplifier Table 3 - Electromagnetic Immunity– for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration – electromagnetic immunity The EEG32U amplifier is intended for use in the electromagnetic environment specified below. The customer or the user of the EEG32U amplifier should assure that it is used in such an environment Immunity test IEC 60601...
  • Page 15 XLTEK EEG32U Amplifier User and Service Manual 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 modulation 18 Hz GMRS 460,...

  • Page 16: Declaration Of Compliance For Fcc

    User and Service Manual XLTEK EEG32U Amplifier 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 17: Warnings And Cautions

    XLTEK EEG32U Amplifier User and Service Manual Warnings and Cautions Two labels identify potentially dangerous or destructive conditions and procedures: Warning A WARNING indicates that there is a risk of death or serious injury to the user or patient. Caution A CAUTION indicates that there is a risk of injury to the user or patient or risk of damage to the device. Any serious incident that has occurred in relation to the XLTEK EEG32U amplifier system be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

  • Page 18: Electrical Warnings And Cautions

    The sale, distribution, or use of this device is restricted to, by, or on order of a physician. 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.

  • Page 19: Patient Environment Warnings And Cautions

    XLTEK EEG32U Amplifier User and Service Manual 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 amplifier should use a three-wire power cord with a hospital grade plug.

  • Page 20: 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 21: Procedures And Warnings

    XLTEK EEG32U Amplifier User and Service Manual Procedures and Warnings Electrostatic Discharge (ESD) Handling Before performing any setup or placement procedures, read the precautions outlined in this section. Be sure to take the appropriate Electrostatic Discharge (ESD) precautions. Disconnect the cables before moving, cabling, or performing any set up procedures.

  • Page 22: Conducted Immunity Procedures And Warnings

    User and Service Manual XLTEK EEG32U Amplifier Conducted Immunity Procedures and Warnings Conducted immunity is defined as the ability of an electronic product to tolerate the influence of electrical energy from other electronic products or electromagnetic phenomena. The electrical energy from other electronic devices located in nearby equipment are usually propagated through the connecting cables.

  • Page 23: Description Of Symbols

    XLTEK EEG32U Amplifier User and Service Manual Description of Symbols Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard ISO 15223-1 Medical devices An indication This product is a Symbol 5.7.7 — Symbols to be of Medical medical device.
  • Page 24 User and Service Manual XLTEK EEG32U Amplifier Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard IEC 60601-1, Reference Part 1: General Type BF To identify a type no. Table D.2, Symbol requirements for applied part BF applied part 20 (IEC 60417-5333) basic safety and...
  • Page 25 XLTEK EEG32U Amplifier User and Service Manual Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard ISO 15223-1 Medical devices Legal Indicates the Symbol 5.1.1 — Symbols to be Manufacturer medical device used with manufacturer. information to be supplied by manufacturer —...
  • Page 26 User and Service Manual XLTEK EEG32U Amplifier Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard ISO 15223-1 Medical devices Temperature Indicates the Symbol 5.3.7 — Symbols to be limit temperature limits used with to which the information to medical device can be supplied by...
  • Page 27 XLTEK EEG32U Amplifier User and Service Manual Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard ISO 15223-1 Medical devices Caution Indicates the need Symbol 5.4.4 — Symbols to be for the user to used with consult the information to instructions for use...
  • Page 28 User and Service Manual XLTEK EEG32U Amplifier Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard Graphical Protective earth; Identifies any ISO 7000 / symbols for use protective terminal which is IEC 60417 on equipment ground intended for Symbol 5019...
  • Page 29 XLTEK EEG32U Amplifier User and Service Manual Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard Graphical Universal Serial To identify a port or ISO 7000 symbols for use Bus (USB), plug as meeting the Symbol 3650 on equipment port/plug...
  • Page 30 User and Service Manual XLTEK EEG32U Amplifier Symbol Title Standard Title as per Symbol Standard Reference Explanation of Symbol Referenced Standard Medical Alternating Indicates on the IEC 60601-1, electrical current rating plate that the Table D.1 #1 equipment — equipment is suitable Part 1: General for alternating requirements for...

  • Page 31: Product Images

    XLTEK EEG32U Amplifier User and Service Manual Product Images EEG32U Amplifier EEG32U Amplifier 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 32: Unpacking

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

  • Page 33: 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 amplifier to the XLTEK computer: Use the supplied USB 2.0 cable (026620 – 3m USB 2.0 A/B Cable - Black (9.8ft)) to connect the EEG32U amplifier to the 4 port USB hub (026274 –...

  • Page 34: Channel Test

    User and Service Manual XLTEK EEG32U Amplifier Start XLTEK Database (XLDB). To start a new study, click New. Choose Edit > Settings > Acquisition. In the Acquisition tab, set the Reference Electrode to Common. Design a bipolar montage using pairs of the channels to be verified. For example, to verify C3, C4, O1 and O2, use a montage with C3-C4 and O1-O2.

  • Page 35: Impedance Check

    XLTEK EEG32U Amplifier User and Service Manual Impedance Check An Impedance Check is performed to ensure that the electrode contact with the patient is satisfactory. You can perform an impedance check at any time during a study. The impedance check will exhibit high accuracy only if at least six patient leads plus Common electrode are connected.

  • Page 36: 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. XLTEK Trolley Specifications...

  • Page 37: Maintenance

    XLTEK EEG32U Amplifier User and Service Manual Maintenance Regularly inspect the trolley to ensure that casters, bolts, equipment mounting, stand shelf fasteners are always secured tight. Regularly inspect all wires and cables for cuts and damages. Regularly inspect all electrical plugs to ensure they are securely inserted into their mating receptacles. Useful Life The EEG32U amplifier has an expected use life of at least 7 (seven) years.

  • Page 38: Maintenance, Cleaning, & Disposal

    EEG32U amplifier 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 39: Disposal At End Of Operating Life Instructions

    WEEE is reused or recycled safely. In line with that commitment Natus may pass along the obligation for take back and recycling to the end user unless other arrangements have been made. Please contact us for details on the collection and recovery systems available to you in your region at natus.com...

  • Page 40: Troubleshooting

    User and Service Manual XLTEK EEG32U Amplifier 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 amplifier and can be a solution.

  • Page 41: Theory Of Operation

    XLTEK EEG32U Amplifier User and Service Manual Theory of Operation: Introduction This section describes the theory of operation of the 32 channel EEG amplifier. The initial discussion is primarily signal flow oriented. Detailed board level theory is provided later in this section. System Overview Features of the EEG32U Amplifier System The EEG32U amplifier performs these basic functions of a digital EEG front end:...

  • Page 42: Getting Help

    XLTEK EEG32U Amplifier Getting Help Natus is committed to providing you with support so you can operate the EEG32U amplifier 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 43: Accessories & Replacement Parts

    EEG32U & Brain Monitor Breakout Box Roll Stand 10351 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...
  • Page 44 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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