Introduction; Device Description; Intended Use; Indications For Use - natus XLTEK EEG32 User And Service Manual

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XLTEK EEG32U Amplifier

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 amplifier. This rugged device was designed with extensive clinical input to meet the
workflow and application needs of the basic EEG Lab.
EEG32U amplifier features include:
USB connectivity to XLTEK Desktop or Laptop
32 referential channels
Patient-event switch interface
Photic-stimulator interface for EEG applications
We strongly recommend that you read the Warnings and Cautions section of this manual before operating this
amplifier.

Device Description

The EEG32U amplifier is feature rich, providing all the resources needed for clinical EEG studies in the hospital EEG lab or in a
private practice. The EEG32U amplifier is the complete EEG instrument. Pre-amplifiers, amplifiers, signal conditioners, analog-
to-digital conversion and an impedance check are all packed solidly into this small, lightweight, tough and dependable package.
Amplifier is designed with rugged, fully enclosed touchproof connections to consistently provide the maximum level of
reliability.
Key Features:
Sample rate: up to 1024 Hz
Bandwidth is 0.1 Hz to 400 Hz
USB powered amplifier
Lightweight
10-20 head stamp with impedance LEDs
Quality signals mean quality analysis
Two dedicated ground and reference channels provide premium signal quality. Featuring 32 AC referential channels, the
EEG32U amplifier can simultaneously sample and store data at rates up to 1024 Hz with 16 bit analog conversion.

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. It can be used with patients of all ages but is not designed for fetal use.

Indications for Use

The EEG32U amplifier is intended to be used as an electroencephalograph to acquire, display, store and archive
electrophysiological signals. Intended medical indication for systems with EEG32U Amplifier devices:
Diagnosis of head trauma
Diagnosis of Brain Death
Monitoring brain functions in the ICU
Epilepsy
Head trauma
Patients suffering from "Stroke" (Vascular accident in the brain)
ICU patients requiring surveillance of brain disorders or brain maturity (pediatric)
ICU patients with suspicion of brain death
Diagnose Tumors
Monitor brain function during surgical procedures
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User and Service Manual

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