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natus XLTEK EEG32 User Manual

natus XLTEK EEG32
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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
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XLTEK EEG32U
User and Service Manual

Table of Contents

Questions and Answers:

natus XLTEK EEG32 Specifications

General IconGeneral
Input Impedance>100 MΩ
TypeEEG System
Channels32
Sampling RateUp to 2000 Hz per channel
Amplifier TypeDifferential
A/D Resolution24-bit
InterfaceUSB
CompatibilityWindows-based software
Safety StandardsIEC 60601-1

Summary

EEG32U Amplifier Introduction and Overview

EEG32U Amplifier Features

Lists key features like USB connectivity, 32 channels, patient-event switch, and photic-stimulator interface.

Device Description and Key Features

Details the amplifier's design, key features like sample rate, bandwidth, and connectivity.

Intended Use and Indications

Explains the amplifier's purpose and the medical conditions it's used to diagnose or monitor.

EEG32U User, Safety, and Performance

Intended User and Target Group

Defines who can use the amplifier and the patient age groups it serves.

Residual Risks and Medical Conditions

Outlines residual risks and the medical conditions for which the amplifier is used.

Clinical Benefit and Performance

Details the clinical benefits, essential, and clinical performance aspects of the EEG32U amplifier.

EEG32U Security Measures and Documentation

General and Network Security

Covers security policies, networked environments, secure access, data confidentiality, and protection.

User Manual and eIFU Information

Describes the content of the user manual and the availability of the eIFU.

EEG32U Amplifier Specifications

EEG32U Safety and Standards Conformity

Standards of Compliance and Normative References

Lists the national and international standards the EEG32U amplifier complies with.

IEC 60601-1-2 Compliance Declaration

Details compliance with electromagnetic compatibility standards.

IEC 60601-1-2 Compliance Declaration

FCC Declaration of Compliance

EEG32U Warnings and Cautions

Contraindications

States there are no known contraindications under normal clinical use.

General Warnings

Provides general warnings related to system use, water resistance, and qualified personnel.

EEG32U Electrical Warnings and Cautions

Electrical Safety Precautions

Details warnings about grounding, isolation, conductive parts, and connecting/powering the system.

EEG32U Patient Environment Warnings

Patient Environment Safety

Outlines precautions for the patient environment, including electrode connections and cable management.

EEG32U Transport and Immunity Warnings

Transportation Warnings

Provides warnings and precautions related to the system's transport and handling.

Conducted Immunity Warnings

Discusses potential interference from parasitic electrical noise and its interpretation.

EEG32U Procedures and Warnings

Electrostatic Discharge (ESD) Handling

Details precautions for handling components sensitive to static electricity.

EEG32U Conducted Immunity Procedures

Reducing Parasitical Noise

Provides steps to identify and reduce parasitical noise by checking power sources and cable layout.

EEG32U Symbol Descriptions

EEG32U Amplifier Product Images

EEG32U Amplifier Diagram and Labels

Shows a visual representation of the EEG32U amplifier with labeled components and a key.

EEG32U Unpacking and Setup

Unpacking the EEG32U Amplifier

Lists the EEG32U amplifier, USB cable, patient event switch, and optional accessories.

EEG32U System Setup and Operation

Setting Up the EEG32U Amplifier

Provides notes on setup, system compatibility, and operator/patient placement.

Beginning a Study

Guides on starting a new EEG study after installation and patient connection.

Powering Down the System

Details the safe procedure for shutting down the EEG32U system.

EEG32U Computer Connection

Hardware Connections for EEG32U Amplifier

Provides step-by-step instructions for connecting the amplifier to a computer via USB.

Testing the EEG32U Amplifier

Introduces the procedures for verifying the amplifier's performance after setup.

EEG32U Calibration and Channel Testing

Calibration and Verification Procedure

Details the procedure to verify the EEG32U amplifier system's calibration with a signal generator.

Channel Test Functionality

Explains how to run a channel test to verify signal processing integrity and view waveforms.

EEG32U Impedance Check Procedures

Running and Interpreting Impedance Checks

Covers activating, running, and interpreting impedance checks for electrode contact.

EEG32U Transport System Specifications

XLTEK Trolley Specifications and Maintenance

Details the specifications and maintenance for the XLTEK trolley system.

EEG32U Maintenance and System Details

General Maintenance and Useful Life

Covers routine maintenance checks and the expected useful life of the EEG32U amplifier.

Warnings and Electrical Details

Highlights warnings about approved equipment and provides details on electrical input and isolation transformers.

EEG32U Maintenance, Cleaning, and Disposal

Cleaning and Maintenance Recommendations

Provides instructions for cleaning the amplifier and general recommendations for its care.

EEG32U Disposal Instructions

End of Operating Life Disposal

Explains the procedures and regulations for disposing of the EEG32U amplifier at the end of its service life.

EEG32U Troubleshooting Guide

Troubleshooting Checklist and Solutions

Provides a checklist of common issues and steps to resolve them, including filter and gain settings.

EEG32U Theory of Operation

System Overview and Components

Explains the system overview, features, communication link, and power sources for the EEG32U amplifier.

Circuit Board Assemblies

Details the Analog and Digital circuit board assemblies within the EEG32U amplifier.

EEG32U Getting Help and Support

Contacting Technical Support

Provides steps for troubleshooting and contacting technical support for assistance with the EEG32U amplifier.

EEG32U Accessories and Replacement Parts

Compatible Accessories List

Lists compatible accessories and replacement parts for the EEG32U amplifier.

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