natus XLTEK EEG32 Troubleshooting guide

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
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XLTEK EEG32U
User and Service Manual

User and Service Manual XLTEK EEG32U Amplifier
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Contact Information
Natus Medical Incorporated
DBA Excel-Tech Ltd. (XLTEK)
2568 Bristol Circle Oakville,
Ontario L6H 5S1 Canada
Tel: [phone]
Fax: [phone]
Toll Free (US & Canada): 800-303-0306
Technical Support Email:
[e-mail]
natus.com
UK Responsible Person
Natus Nicolet UK Ltd
Baynards Green Trading Estate
Prospect House
Oxfordshire
Bicester
OX27 7SG
England, United Kingdom
EU Representative / Importer
Natus Manufacturing Limited
IDA Business Park
Gort, Co. Galway, Ireland
VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE
PRODUTOS MÉDICOS LTDA.
Rua Batataes, 391, Conjuntos 11, 12 e 13, Jardim
Paulista
01423
-010, São Paulo, SP, Brazil
CNPJ: 04.718.143/0001
-94
Registro ANVISA nº:
80102512057
Arazy Group Switzerland GmbH
Bruderholzallee 53
4059 Basel
Switzerland
[e-mail]
Rx Only

XLTEK EEG32U Amplifier User and Service Manual
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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 ....................................................................................................................................................5
Clinical Benefit ...........................................................................................................................................................5
Essential Performance ...............................................................................................................................................5
Clinical Performance..................................................................................................................................................5
General and Network Security Measures..................................................................................................................6
General Security Policies .......................................................................................................................................6
Networked Environments......................................................................................................................................6
Secure Access to Windows Systems ......................................................................................................................6
Data Confidentiality...............................................................................................................................................6
Data Protection......................................................................................................................................................6
User Manual and eIFU ...............................................................................................................................................6
Specifications: EEG32U Amplifier ..................................................................................................................................7
EEG32U Amplifier Safety and Standards Conformity ....................................................................................................9
Standards of Compliance and Normative References ...............................................................................................9
Declaration of Compliance for IEC 60601-1-2 .........................................................................................................11
Declaration of Compliance for FCC..........................................................................................................................15
Warnings and Cautions................................................................................................................................................16
Contraindications.....................................................................................................................................................16
General Warnings ....................................................................................................................................................16
Electrical Warnings and Cautions ............................................................................................................................17
Patient Environment Warnings and Cautions..........................................................................................................18
Transportation Warnings.........................................................................................................................................19
Conducted Immunity Warnings...............................................................................................................................19
Procedures and Warnings............................................................................................................................................20
Electrostatic Discharge (ESD) Handling....................................................................................................................20
Conducted Immunity Procedures and Warnings.....................................................................................................21
Description of Symbols ................................................................................................................................................22
Product Images ............................................................................................................................................................30
EEG32U Amplifier ....................................................................................................................................................30
Unpacking ....................................................................................................................................................................31
Setting Up ....................................................................................................................................................................31
Placement of the Operator and Patient ..............................................................................................................31
Beginning a study.................................................................................................................................................31
Powering Down the System.................................................................................................................................31
Connecting to a Computer.......................................................................................................................................32
Testing the EEG32U Amplifier .................................................................................................................................32

User and Service Manual XLTEK EEG32U Amplifier
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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 ..................................................................................................36
Maintenance, Cleaning, & Disposal .............................................................................................................................37
Recommendations...................................................................................................................................................37
Disposal at End of Operating Life Instructions ........................................................................................................38
Troubleshooting ..........................................................................................................................................................39
Theory of Operation: ...................................................................................................................................................40
Introduction.............................................................................................................................................................40
System Overview .....................................................................................................................................................40
Features of the EEG32U Amplifier System ..........................................................................................................40
Components of the Communications Link ..........................................................................................................40
Power Sources to the Amplifier...........................................................................................................................40
Circuit Board Assemblies inside the Amplifier.........................................................................................................40
A. Analog Board ...............................................................................................................................................40
B. Digital Board ................................................................................................................................................40
Getting Help.................................................................................................................................................................41
Accessories & Replacement Parts ...............................................................................................................................42

XLTEK EEG32U Amplifier User and Service Manual
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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

User and Service Manual XLTEK EEG32U Amplifier
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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.
Residual Risks
There are no known residual risks or side effects for procedures performed with the EEG32U amplifier. Please note the
Warnings and Cautions before applying power to and using the system. Utilize best practices in your clinical environment.
Medical Conditions
Patients of all ages requiring EEG can be in all countries and can have all ages. EEG32U amplifier in conjunction with
NeuroWorks is used for patients suffering from the following clinical cases:
•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
Clinical Benefit
The EEG32U amplifier aids in measuring the electrical brain activity and in diagnosing brain disorders, such as epilepsy and
other seizure disorders.
Recording EEG with the EEG32U amplifier does not directly affect outcome; the collected EEG activity will allow the physician to
decide on treatment. Treatment directed by data recorded with the EEG32U amplifier may result in better outcomes than
treatment informed solely by data from clinical assessment.
Essential Performance
Essential performances of the EEG32U amplifier are identified in the standard IEC 60601-2-26:2012. Essential performance
relates to the quality of the signal recorded from the amplifier. Specific essential performances are:
1. accuracy of signal reproduction
2. dynamic range and differential offset voltage
3. input noise level
4. frequency response
5. common mode rejection
The definition of these essential performances can be found in the standard.
Clinical Performance
1. High quality signals resulting from specifications such as
•Noise level-Low
•High frequency range
•High common mode rejection
2. Ability to record artifact-free signals
3. Number of channels; ability to record studies using a full 1-20 EEG scheme

XLTEK EEG32U Amplifier User and Service Manual
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General and Network Security Measures
Use best practice security measures in your clinical environment including the following:
General Security Policies
•Prevent physical access to the system from unauthorized persons.
•Make frequent backup of the system. Store the backup on a safely stored device.
•Protect the system with updated antivirus.
•Use the Microsoft Windows firewall at all times.
•Store all flash drives provided with your system in a safe location.
Networked Environments
•Connect the system on secured networks only. Using the system on a wide-open network, including wi-fi,
Bluetooth, etc. based networks is not recommended.
•Keep the network software updated with latest patches.
•Use encrypted data communication over “less safe” network segments (ipsec, VPN).
•Enforce that all resources within the network (shares, printers, other equipment) can be accessed by
authenticated users only.
•All resources within the network can only be accessed by authenticated users.
•Avoid acquisition systems having contact with patient to act as network servers for different functionality.
Secure Access to Windows Systems
•Users should require an account with suitable privileges to use the system (note no special elevated rights are
required to use the EMG application).
•Policies should ensure passwords are complex, non-repeated and regularly changed.
•Enable auditing of system use including windows logins in the operating system.
Data Confidentiality
•The user should lock the system manually if they leave it unattended.
•Short inactivity timeouts are always active and lock the system when the timeout expires.
•The EMG application supports the use of windows screen saver, manual lock screen and automatic switch to the
home page after a timeout on review stations to prevent showing confidential information on unattended
systems.
Data Protection
•Do not install any 3rd party software which is not intended for use with the application. An unknown software
can possess a potential security risk.
•Encrypt system drives which contain local databases and temporarily store data files/reports.
•Disable unnecessary windows services designed for not work-related features.
User Manual and eIFU
This manual describes the theory, features, set up, operation, and maintenance of the EEG32U Amplifier. It also provides
information on specifications, troubleshooting, and getting help.
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 & Service Manual and choose the version for your local language. The files can be printed, saved, or searched
using Adobe Reader. A copy of Adobe Reader can be downloaded directly from Adobe Systems (www.adobe.com). A free paper
copy of the Instructions for Use in available languages can be obtained by contacting Natus Technical Support, or by contacting
a Natus representative.

User and Service Manual XLTEK EEG32U Amplifier
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Specifications: EEG32U Amplifier
Specification Value(s)
Analog Specifications Channels
Referential Channels 32
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) 1.66 µV @ 0.1Hz~70 Hz bandwidth
Input Noise (RMS) 0.65 μV @ 0.1Hz~70 Hz bandwidth
EEG Channel Hardware Gain 125
Maximum Differential AC Input Before Clipping (Referential) ± 20 mV
Maximum Operational DC Input Voltage Electrode Offset ± 1000 mV
Input Bias Current ≤ 20 pA
Channel Crosstalk ≥70 dB
Photic Stim Interface
Photic Stim Output 1 (TTL level, active high)
Photic Stim Input 1 (TTL level, active high)
User Interface
Push Buttons 1 (Impedance Check)
Event Switch Connection 1 on board
LED Indication 68 on board.
Digital Specifications
Sampling Frequency 256, 512 and 1024 Hz
Sampling Resolution - EEG Channels 16 bits
Sampling Quantization - EEG Channels 600 nV
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-peak
Host Interface
USB 2.0 USB 2.0 Full Speed (12Mbit/sec).
Amplifier Mechanical

XLTEK EEG32U Amplifier User and Service Manual
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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
Transport and Storage Humidity Range 10-95%, non-condensing
Transport and Storage Atmospheric Pressure Range 500 hPa to 1060 hPa

User and Service Manual XLTEK EEG32U Amplifier
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EEG32U Amplifier Safety and Standards Conformity
Standards of Compliance and Normative References
32 Channel Electroencephalograph (EEG) Amplifier; model EEG32U; rated 5Vdc,0.2A
1. Type of protection against electric shock: Class II
2. Degree of protection against electric shock: Type BF
3. Degree of protection against ingress of water: IPX0
4. 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
mixture with air or with oxygen or nitrous oxide.
5. Mode of operation: Continuous
6. Environmental Conditions : Normal : 10-40° C, 30-75% rH, 700-1060 hPa
The EEG32U amplifier and its accessories have been designed to comply with the following national and
international standards.
Table 1 – Safety Standard of Compliance and Normative References
CAN /CSA-C22.2 No. 60601-1: 08(R2013) +
C2:2011
ANSI/AAMI ES60601-1:2005/(R)2012 +
C1:2009/(R)2012 and A2:2010/(R)2012
IEC 60601-1:2005+A1:2012
EN 60601-1:2006/A1:2013
Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1-6:2010/AMD1:2013 Medical electrical equipment – Part 1-6: General requirements for
basic safety and essential performance – Collateral standard: Usability
IEC 62366-1:2015
IEC 62366-1:2015/AMD1:2020
Medical devices – Application of usability engineering to medical
devices
Medical devices - Part 1: Application of usability engineering to medical
devices Consolidated version
IEC 60601-2-26:2012
EN 60601-2-26:2003
Medical Electrical Equipment - Part 2-26: Particular Requirements for
the basic safety and essential performance of electroencephalographs
Medical electrical equipment – Part 2-26: Particular requirements for
the safety of electroencephalographs

XLTEK EEG32U Amplifier User and Service Manual
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Table 2 – EMC Standard of Compliance and Normative References
IEC 60601-1-2, Edition 4.0
EN 60601-1-2:2015
Medical electrical equipment – Part 1-2: General requirements for
basic safety and essential performance– collateral standard:
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
IEC 61000-4-3 ed 3.0 with A1:2007+A2:2010 Electromagnetic Compatibility (EMC) Part 4-3: Testing and
Measurement Techniques - Radiated, Radiofrequency, Electromagnetic
Field Immunity Test
IEC 61000-4-4:2012, ed 3.0 Electromagnetic Compatibility (EMC) Part 4-4: Testing and
Measurement Techniques - Electrical Fast Transient/Burst Immunity
Test
IEC 61000-4-5:2014, ed 3.0 Electromagnetic Compatibility (EMC) Part 4-5: Testing and
Measurement Techniques - Surge Immunity Test
IEC 61000-4-6 ed 2.0 with A1:2004 + A2:2006 Electromagnetic Compatibility (EMC) Part 4-6: Testing and
Measurement Techniques - Immunity to Conducted Disturbances,
Induced by Radio-frequency Fields
IEC 61000-4-8:2009, ed 2.0 Electromagnetic Compatibility (EMC) Part 4-8: Testing and
Measurement Techniques - Power Frequency Magnetic Field Immunity
Test
IEC 61000-4-11:2004, ed 2.0 Electromagnetic Compatibility (EMC) Part 4-11: Testing and
Measurement Techniques - Voltage Dips, Short Interruptions and
Voltage Variations Immunity Tests
IEC 61000-3-2:2014, ed 4.0 Electromagnetic Compatibility (EMC) Part 3-2: Limits - Limits for
Harmonic Current Emissions
IEC 61000-3-3:2013, ed 3.0 Electromagnetic Compatibility (EMC) Part 3-3: Limits - Limitation of
Voltage Changes, Voltage Fluctuations and Flicker in Public Low-voltage
Supply Systems
CISPR 11 ed 5.0 with A1:2010 Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment -
Electromagnetic Disturbance Characteristics - Limits and Methods of
Measurement
JIS T 1203:1998 Electroencephalographs

User and Service Manual XLTEK EEG32U Amplifier
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EN ISO 10993-1:2020
ISO 10993-1:2018
Biological evaluation of medical devices - Part 1: Evaluation and testing
within a risk management process
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. The customer or the user of
the EEG32U amplifier should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF emissions
CISPR 11
Group 1 The EEG32U amplifier uses RF energy only for its internal
function. Therefore, its RF emissions are very low and not
likely to cause any interference in nearby electronic
equipment
RF emissions
CISPR 11
Class A The EEG32U amplifier is suitable for use in all
establishments other than domestic and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Harmonic emissions IEC
61000-3-2
Class A
Voltage fluctuations/ flicker
emissions
IEC 61000-3-3
Complies

XLTEK EEG32U Amplifier User and Service Manual
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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
Test Level
Compliance
Level
Electromagnetic Environment - Guidance
Electrostatic Discharge
(ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
Complies Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the
relative humidity should be at least 30%.
Electrostatic fast
transient/burst
IEC 61000-4-4
±2 kV, 100Khz for
power supply lines
±1 kV, 100Khz for
input/output lines
Complies Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common
mode
Complies Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
<100% drop, 0/5
periods, 0°, 45°,
90°, 135°, 180°, 225°,
270°, 315°
100% dip, 1 period
30% dip, 25/30
periods
40% dip for 5 cycles
Complies Mains power quality should be that of a typical
commercial or hospital environment. If the user of
the EEG32U amplifier requires continued
operation during power mains interruption, it is
recommended that the EEG32U amplifier be
powered from an uninterruptible power supply or
a battery.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
30 A/m Complies Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE: UT is the AC supply voltage prior to application of the test level.

User and Service Manual XLTEK EEG32U Amplifier
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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
Test Level
Compliance
Level
Electromagnetic Environment - Guidance
Conducted RF IEC
61000-4-6
Radiated RF IEC 61000-
4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.7 GHz
3 V
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any part of
the EEG32U amplifier, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
d=1.2 ×√P 150kHz to 80MHz
d=1.2 ×√P 80MHz to 800MHz
d=2.3 ×√P 800MHz to 2.5GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site1should be
less than the compliance level in each frequency2.
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
1Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the
EEG32U is used exceeds the applicable RF compliance level above, the EEG32U should be observed to verify normal operation. If abnormal
operation is observed, additional measures may be necessary, such as re-orienting or relocating the EEG32U.
2Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Table 4 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
Test
frequency
(MHz)
Band a)
(MHz)
Service a)
Modulation b)
Maximum
Power
(W)
Distance
(m)
IMMUNITY
TEST LEVEL
(V/m)
385 380 –390 TETRA 400
Pulse
modulation b)
18 Hz
1,8 0,3 27
450 430 – 470 GMRS 460,
FRS 460
FM c)
± 5 kHz deviation
1 kHz sine
2 0,3 28
710
704 – 787 LTE Band 13, 17
Pulse
modulation b)
217 Hz
0,2 0,3 9745
780
810
800 – 960
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850, LTE
Band 5
Pulse
modulation b)
18 Hz
2 0,3 28870
930
1,720
1,700 –
1,990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT; LTE Band
1, 3, 4, 25;
UMTS
Pulse
modulation b)
217 Hz
2 0,3 281,845
1,970
2,450 2,400 –
2,570
Bluetooth,
WLAN, 802.11
b/g/n, RFID
2450, LTE Band
7
Pulse
modulation b) 217 Hz 2 0,3 28
5,240
5,100 –
5,800
WLAN 802.11
a/n
Pulse
modulation b)
217 Hz
0,2 0,3 9
5,500
5,785
NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME
EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent
actual modulation, it would be worst case.

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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. This equipment generates, uses, and can radiate radio frequency energy and, if not
installed and used in accordance with the instruction manual, may cause harmful interference to radio communications.
Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required
to correct the interference at his own expense.
Changes or modifications not expressly approved by the manufacturer could void the user's authority to
operate the equipment.

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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.
Contraindications
There are no known contraindications under normal clinical use.
General Warnings
NOTE: It is recommended that all data be stored using redundant storage capabilities. Using redundant storage can help to
minimize data loss in the event of a failure of the primary drive.
Proper use of this device depends on careful reading of all instructions and labels that come with or on the
system.
The EEG32U amplifier is classified as an IPX0 – ordinary degree of protection against ingress of water according
to IEC 529. The EEG32U amplifier is not waterproof.
Inaccurate measurements may be caused by incorrect application or use.
Only qualified personnel should operate this equipment.
Only use the EEG32U amplifier in conjunction with approved devices and accessories.
Use of cables other than those specified or sold by the manufacturer on the equipment, may result in increased
emissions or decreased immunity of the equipment and may cause the system to be non-compliant with the
requirements of IEC 60601-1-2:2014
The computer and the peripherals used with the EEG32U amplifier and the NeuroWorks EEG system must either
be approved by XLTEK and supplied as part of an IEC 601 approved system or it must be approved to IEC 950 or
similar and kept outside of the patient environment (that is, the area within 1.5 meters of the patient laterally
and within 2.5 meters of the floor in the area occupied by the patient).

User and Service Manual XLTEK EEG32U Amplifier
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To ensure the validity of signals, do not operate the device near any sources of electromagnetic interference.
Turn off the system power before cleaning. Prevent detergent solution or cold sterilization agents from seeping
into the electronics of the system. Be careful around all connectors and edges. Do not use abrasive agents.
The accessories of this device may include several kinds of disposable, sterile needle electrodes. These needles
may be labeled as STERILE. The EEG32U amplifier is not sterile and cannot be made sterile.
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.
This device does not contain any hazardous components; therefore, no special precautions are required for their
disposal.
No modification of this equipment is allowed.
Electrical Warnings and Cautions
XLTEK systems are intended for connection to a properly grounded electrical outlet only.
The EEG32U is an electrically isolated, electrically floating device. The computer that is part of the system
should be attached to a properly grounded electrical outlet.
Conductive parts of electrodes and their connectors are not to contact other conductive parts and earth.
Do NOT connect electrode inputs to earth ground. The EEG32U amplifier contains warning symbols reminding
you that the connections are intended for isolated patient connections only. Connecting an earth ground
might result in electrocution.
Do NOT turn on the system power until all cables have been connected, verified and visually inspected for any
damage. Failure to inspect the cables may result in electrocution. Verification of electrical safety should be
performed routinely.

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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. For grounding reliability, only connect the device to a hospital grade or hospital-only receptacle. Inspect
the power cord often for fraying or other damage. Do NOT operate the system with a damaged power cord or
plug.
If there is an isolation transformer with the system, do NOT place the isolation transformer on the floor. Only
plug XLTEK recommended components into the isolation transformer.
Do NOT connect non-medical equipment which has been supplied as part of the system directly to the wall
outlet when the system is supplied, via Multiple Portable Socket Outlet (MPSO), with a separating
transformer.
Do NOT connect electrical equipment which has not been supplied as a part of the system to the MPSO.
To avoid the possible hazards caused by the summation of leakage currents when all the parts of the system
are interconnected, no equipment other than devices connected to the EEG32U amplifier system may be
powered by the isolation transformer.
The EEG32U amplifier system is NOT designed to work with defibrillators. The system could be damaged
when used with this device.
Patient Environment Warnings and Cautions
NOTE: The patient environment is defined as the area within 1.5 meters of the patient laterally and within 2.5 meters of the
floor in the area occupied by the patient.
Connect all patient electrodes to fully electrically isolated physiological devices only. Connecting patient
electrodes to any other device or external outlet may result in personal injury.
The EEG32U amplifier accepts only touch-proof style electrode inputs. Do NOT attempt to use any other style
of patient electrode input.
To prevent cabling entanglement/strangulation, ensure no loose cables are accessible to the patient.
Patient connections are NOT intended for direct cardiac contact.

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Do NOT touch any earth-grounded components of the EEG32U amplifier and the patient simultaneously.
Do not use the EEG32U amplifier with HF surgical equipment.
Do not allow loose electrodes to contact metal parts.
The patient event switch attached to or on the EEG32U amplifier or other XLTEK device is not intended for
critical patient-safety-related incidents.
Do NOT use the XLDetect montage with custom channel labels.
As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement
or strangulation.
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. Natus is not responsible for any injury or damage that may result from improper
cable storage during transport.
TIPPING HAZARD: During transport, the user should guide the cart using both hands, ensuring the wheelbase is
aligned so that a single caster leads in the direction of motion. Failure to lead the cart with one wheel could
result in a tipping hazard when ascending or descending steps or thresholds.
Conducted Immunity Warnings
In environments where parasitic electrical noise interferes with the electrical biologic signal, there is no risk of
misinterpretation of EEG waveforms or ancillary data. Any abnormal pattern or out of range value is confirmed
by trained medical professionals performing the test. In addition to ancillary data, the accompanying EEG
(Electroencephalograph) amplifier’s signals will also be contaminated past the point where any clinical signal
interpretation is possible. Trained electroencephalographers and technologists are well equipped to identify
and disregard signals that are obscured by environmental noise.