natus Embla Dx Series Troubleshooting guide

Part Number: 022571 Rev 04 2023/01/27
System Model Numbers: PK1274, PK1270, PK1245
© 2018 - 2023 Natus Medical Incorporated or one of its subsidiaries. All rights reserved.
Natus is a registered trademark of Natus Medical Incorporated. All product names appearing on this document are trademarks or registered
trademarks owned, licensed to, promoted or distributed by Natus Medical Incorporated, its subsidiaries or affiliates. All other trademarks are
the property of their respective owners.
Natus®Brain Monitor &
Embla Dx Series™
User and Service Manual

User and Service Manual Natus®Brain Monitor & Embla Dx Series™
1
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
Arazy Group Switzerland GmbH
Bruderholzallee 53
4059 Basel
Switzerland
[e-mail]
EU Representative / Importer
Natus Manufacturing Limited
IDA Business Park
Gort, Co. Galway, Ireland
Tel: [phone]
Fax: [phone]
UK Responsible Person
Natus Nicolet UK Ltd
Baynards Green Trading Estate
Prospect House
Oxfordshire
Bicester
OX27 7SG
England, United Kingdom
Rx Only

Natus®Brain Monitor & Embla Dx Series™User and Service Manual
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Table of Contents
Introduction ...................................................................................................................................................................................... 5
Device Description........................................................................................................................................................................ 5
Intended Use, Intended User and Patient Groups ....................................................................................................................... 5
Clinical Benefit.............................................................................................................................................................................. 5
Medical Conditions....................................................................................................................................................................... 6
Residual Risks and Side Effects ..................................................................................................................................................... 6
System Components..................................................................................................................................................................... 6
Essential Performance.................................................................................................................................................................. 6
Essential Performance Degradation......................................................................................................................................... 6
General and Network Security Measures..................................................................................................................................... 7
General Security Policies.......................................................................................................................................................... 7
Networked Environments ........................................................................................................................................................ 7
Secure Access to Windows Systems......................................................................................................................................... 7
Data Confidentiality ................................................................................................................................................................. 7
Data Protection ........................................................................................................................................................................ 7
Operating Principle of the Amplifier............................................................................................................................................. 8
User Manual and eIFU .................................................................................................................................................................. 8
Safety & Standards Conformity ........................................................................................................................................................ 9
Standards of Compliance and Normative References .................................................................................................................. 9
Safety Standard of Compliance and Normative References .................................................................................................... 9
EMC Standard of Compliance and Normative References ....................................................................................................... 9
Declaration of Compliance for IEC 60601-1-2 ............................................................................................................................ 10
Table 1 - Electromagnetic Emissions...................................................................................................................................... 10
Table 2 - Electromagnetic Immunity ...................................................................................................................................... 11
Table 3 - Electromagnetic Immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING................................. 12
Table 4 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment ........................ 13
Declaration of Compliance for FCC............................................................................................................................................. 13
Contraindications, Warnings, & Cautions ....................................................................................................................................... 14
Contraindications ....................................................................................................................................................................... 14
Warnings and Cautions............................................................................................................................................................... 14
General Warnings .................................................................................................................................................................. 14
Electrostatic Discharge (ESD) Warnings: ................................................................................................................................ 15
Electrical Warnings and Cautions........................................................................................................................................... 16
Patient Environment Warnings and Cautions ........................................................................................................................ 16
Transportation Warnings ....................................................................................................................................................... 18

User and Service Manual Natus®Brain Monitor & Embla Dx Series™
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Pulse Oximeter Sensor Warnings........................................................................................................................................... 18
Conducted Immunity Warnings ............................................................................................................................................. 18
Procedures and Warnings............................................................................................................................................................... 18
Electrostatic Discharge (ESD) Handling ...................................................................................................................................... 18
Conducted Immunity Procedures and Warnings........................................................................................................................ 19
Description of Symbols ................................................................................................................................................................... 20
Specifications: Brain Monitor & Embla Dx Series Amplifiers .......................................................................................................... 28
Product Images ............................................................................................................................................................................... 30
Brain Monitor ............................................................................................................................................................................. 30
Embla NDx .................................................................................................................................................................................. 30
Embla SDx................................................................................................................................................................................... 30
Natus Base Unit .......................................................................................................................................................................... 31
Breakout Boxes........................................................................................................................................................................... 32
Brain Monitor......................................................................................................................................................................... 32
Embla NDx.............................................................................................................................................................................. 33
Embla SDx .............................................................................................................................................................................. 34
Brain Monitor SpO2 Sensor Cable Clip................................................................................................................................... 35
Setup............................................................................................................................................................................................... 36
Connections................................................................................................................................................................................ 36
Setting the IP Address ................................................................................................................................................................ 37
Touchscreen Icons ................................................................................................................................................................. 38
Amplifier Usage and Features......................................................................................................................................................... 40
Getting Started ........................................................................................................................................................................... 40
Placement of the Operator and Patient................................................................................................................................. 40
Beginning a study ................................................................................................................................................................... 40
Powering Down the System ................................................................................................................................................... 40
Adding the Breakout Box to a Pouch ..................................................................................................................................... 41
Potential Equalization Conductor............................................................................................................................................... 41
Connection Mode ....................................................................................................................................................................... 42
Connecting the Natus Base Unit and Brain Monitor & Embla Dx Series Breakout Boxes.......................................................... 43
Removing the Connections......................................................................................................................................................... 43
Connecting to the Body Position Pod ......................................................................................................................................... 44
Connecting to the Luer Lock Pressure Sensor ............................................................................................................................ 44
Transport System Specifications and Maintenance........................................................................................................................ 45
XLTEK Trolley Specifications ....................................................................................................................................................... 45
Breakout Box Holster with Roll Cart ........................................................................................................................................... 46
Natus ErgoJust Cart Specifications ............................................................................................................................................. 46
Maintenance .............................................................................................................................................................................. 46
Transportation System Specifications and Maintenance Warnings and Cautions .................................................................... 47

Natus®Brain Monitor & Embla Dx Series™User and Service Manual
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Electrical Input and Isolation Transformer Details ..................................................................................................................... 47
Pulse Oximeter................................................................................................................................................................................ 48
Pulse Oximeter Specifications .................................................................................................................................................... 48
Pulse Oximeter Instruction for Use ............................................................................................................................................ 48
Pulse Oximeter Accessories........................................................................................................................................................ 48
Available Nonin Oximetry Sensors ......................................................................................................................................... 49
Pulse Oximeter Precautions and Warnings ................................................................................................................................ 49
Maintenance, Cleaning, & Disposal ................................................................................................................................................ 50
Brain Monitor & Embla Dx Series Amplifiers Pouch ................................................................................................................... 50
Warnings .................................................................................................................................................................................... 50
Disposal ...................................................................................................................................................................................... 51
Troubleshooting.............................................................................................................................................................................. 52
Troubleshooting Checklist .......................................................................................................................................................... 52
Problems with Signal Quality...................................................................................................................................................... 52
Accessories & Replacement Parts List ............................................................................................................................................ 53
Getting Help.................................................................................................................................................................................... 55
Step 1: Document the Incident................................................................................................................................................... 55
Step 2: Search NeuroWorks Online Documentation .................................................................................................................. 55
Step 3: Restart the Computer..................................................................................................................................................... 55
Step 4: Shut Down the Computer............................................................................................................................................... 55
Step 5: Contact Technical Support ............................................................................................................................................. 55
Appendix A...................................................................................................................................................................................... 56
Digital Trigger Input Port Wiring Diagram .................................................................................................................................. 56
Appendix B...................................................................................................................................................................................... 57
Headcap Connector Wiring ........................................................................................................................................................ 57
Appendix C...................................................................................................................................................................................... 58
Frequency Response Curves....................................................................................................................................................... 58
Sample Rate: 256Hz ............................................................................................................................................................... 58
Sample Rate: 512Hz ............................................................................................................................................................... 58
Sample Rate: 1024Hz ............................................................................................................................................................. 59
Sample Rate: 2048Hz ............................................................................................................................................................. 59
Sample Rate: 4096Hz ............................................................................................................................................................. 60

User and Service Manual Natus®Brain Monitor & Embla Dx Series™
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Introduction
Device Description
The Natus®Brain Monitor & Embla Dx Series amplifiers are designed for the acquisition of EEG and Polysomnographic (PSG)
data. The amplifiers design consists of a Natus Base unit and an amplifier breakout box. The Natus Base is common for all
variations of the amplifier and the breakout box varies depending on the amplifier model. There are three variations of the
Natus Brain Monitor & Embla Dx Series amplifier as follows:
•Natus Brain Monitor
•Natus Embla NDx
•Natus Embla SDx
The amplifiers feature referential and differential AC inputs, dedicated sensor inputs for respiratory signals, a removable
stainless steel luer lock pressure input, an integrated Nonin®pulse oximeter, event button connection, and up to 16 DC inputs.
This rugged device was designed with extensive clinical input to meet the workflow and application needs of the EEG, LTM, or
PSG Lab.
A “+” logo on the front of the Natus Base unit indicates that the base unit is a 2nd generation Natus base. The 2nd generation
Natus base is compatible with the 3 amplifiers described in this manual, as well as the EMU40EX and the Quantum Breakouts
which bear the same “+” logo. The Natus Base offers TCP/IP and USB connectivity for quick and easy installation.
Amplifier features include:
•Up to 64 AC inputs (40 referential, and 24 referential/differential configurable)
•Up to 16 DC channels (12 on Natus Base unit + 4 on Brain Monitor & Embla NDx Breakouts)
•Integrated Pulse Oximeter including SpO2, Pulse Rate and Plethysmogram signals
•Ability to initiate an impedance test, change the threshold, and view the results in the patient room
•Digital Trigger Input
•A small and lightweight breakout box
•TCP/IP and USB connectivity
•Patient-event switch interface on both the breakout box and base units
•Photic stimulator interface for EEG applications (excluding Embla SDx).
•Holster for cart mounting
•Pouch for extended EEG studies
WARNING: We strongly recommend that you read the Contraindications, Warnings and Cautions sections of this
manual before operating this amplifier.
Intended Use, Intended User and Patient Groups
The Natus Brain Monitor 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™/ SleepWorks™software to acquire scalp and intracranial
electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.
The Natus Brain Monitor & Embla Dx Series Amplifier is intended to be used by trained medical professionals and is designed
for use in clinical environments such as hospital rooms, epilepsy monitoring units, intensive care units, and operating rooms. It
can be used with patients of all ages but is not designed for fetal use.
Clinical Benefit
The Natus Brain Monitor and Natus Embla Dx series devices record EEG used in diagnosing brain disorders and are capable of
collecting other physiological data that can be used for diagnosing sleep disorders.
Recording EEG and PSG data with the Natus Brain Monitor & Embla Dx series does not directly affect outcome; the collected
EEG and PSG data will allow the physician to decide on treatment. Treatment directed by data recorded with the Natus Brain
Monitor & Embla Dx series may result in better outcomes than treatment informed solely by data from clinical assessment.

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Medical Conditions
•Sleep related breathing disorders
•Epilepsy
•Any another seizure disorders
•Brain tumors
•Sleep disorders (including Narcolepsy, Parasomnias, sleep-related movement disorders etc.)
•Brain damage from head injury
•Brain encephalopathy
•Herpes Encephalitis (Inflammation of the brain)
•Stroke
•Dementia
•Attention disorders
•Monitor brain function during surgical procedures
•ICU patients requiring surveillance of brain disorders or brain maturity (pediatric)
•ICU patients with suspicion of brain death
Residual Risks and Side Effects
There are no known residual risks or side effects for procedures performed with the Natus Brain Monitor. Please note the
Warnings and Cautions before applying power to and using the system.
Utilize best practice security measures in your clinical environment.
System Components
The Amplifier system is provided with several optional system components. Computers are intended to run the NeuroWorks /
SleepWorks software exclusively. Cameras are intended to acquire synchronized video of the patient during EEG or Sleep
studies. Isolation transformers are intended to provide power for all system components while ensuring the safety of the
operators and the patients. Carts are intended to support and facilitate the use of the Brain Monitor & Embla Dx Series
Amplifiers while keeping the system mobile.
Essential Performance
Essential performance of the Natus Brain Monitor is 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, and (5) common
mode rejection. The definitions of these essential performances can be found in the standard.
The standard ISO 80601-2-61 also applies as the amplifier is considered pulse oximeter equipment without an alarm system.
The additional essential performance required of the amplifier as laid out in this standard includes SpO2 and pulse rate
accuracy, to be verified by an electronic patient simulator; and indication of abnormal operation, including notification of signal
inadequacy and probe faults. Evidence of SpO2 accuracy by controlled desaturation study to be covered by the manufacturer of
the pulse oximeter probe or sensor used.
Essential Performance Degradation
Professional healthcare trained personnel will observe essential performance degradation which includes but are not limited to:
•Loss of EEG signal/data
•Amplifier saturation indication on the computer monitor,
•Intermittent bursts of noise on random EEG leads.
•Loss of communications from the computer to the Natus base
•Pin box disconnected events. (Quantum)
•Interruptions in signal transmission resulting from external electromagnetic events. (Ex: Electrocautery, Operation of
wireless equipment near the amplifier, etc.)
•Any form of random or intermittent system behavior.
If any of the above are observed or if unusual system behavior is observed contact Natus Technical support.

User and Service Manual Natus®Brain Monitor & Embla Dx Series™
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General and Network Security Measures
Utilize 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 backups 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 the 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.

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Operating Principle of the Amplifier
The Natus Brain Monitor & Embla Dx Series amplifiers are comprised of a base unit and a breakout box. The variation of the
amplifier and feature subset is defined by the model of breakout that is connected to the base unit. It is part of a system that is
made up of a personal computer, a photic stimulator, an isolation transformer, video and audio equipment, networking
equipment, and mechanical supports.
Electrophysiological signals, from electrodes, sensors, and other accessories such as pulse oximeters can be acquired by the
amplifier. These signals are digitized and transmitted to the personal computer running the Natus NeuroWorks / SleepWorks
software. The signals are displayed on the personal computer and can be recorded to the computer's local storage or to remote
networked storage for later review.
User Manual and eIFU
This manual describes the theory, features, set up, operation, and maintenance of the Natus Brain Monitor & Embla Dx Series
Amplifiers. It also provides information on specifications, troubleshooting, and getting help.
Copies of the User Guide may also be accessed at natus.com in the Support section. Scroll to the PSG Product IFUs, select Brain
Monitor Embla NDxSDx 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 Natus®Brain Monitor & Embla Dx Series™
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Safety & Standards Conformity
Standards of Compliance and Normative References
Multichannel Sleep/EEG Headbox System, Models: Brain Monitor, Embla NDx, Embla SDx Amplifiers, detachable cord
connected, portable 100-230Vac, 50/60Hz, 80VA.
1. Type of protection against electric shock: Class I
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: 10-30°C, 30-75% rH, 700-1060hPa
The Brain Monitor & Embla Dx Series Amplifiers and accessories have been designed to comply with the following national and
international standards.
Safety Standard of Compliance and Normative References
•IEC 60601-1:2012 - General Safety Third Edition
•CAN / CSA-C22.2 No. 60601-1: 08(R2013) +C2:2011
•IEC 60601-1-6:2010 – Usability Third Edition
•IEC 62366:2007, Edition 1.0
•IEC 60601-2-26:2012 – Electroencephalographs Third Edition
•IEC60601-2-61:2011 - Pulse Oximeters
•EN ISO 80601-2-61:2011, Edition 1
EMC Standard of Compliance and Normative References
•IEC 60601-1-2:2014 – EMC Fourth Edition
•IEC 61000-3-2:2014, Fourth Edition
•IEC 61000-3-2 Harmonic emissions – Class A
•IEC 61000-3-3:2013, Third Edition Voltage Fluctuations/ Flicker emissions
•CISPR11, Edition 5.0 A1:2010 RF emissions – Group 1, Class A
•IEC 61000-4-2:2008, Second Edition
•IEC 61000-4-2 Electrostatic Discharge (ESD) ±8 kV contact (to the patient lead and exposed metal), ±15 kV air
•IEC 61000-4-3 Third Edition with A1:2007+A2:2010
•IEC 61000-4-3, 3 Vrms, 80 MHz to 2.7 GHz
•IEC 61000-4-4:2012, Third Edition, fast transient/burst ±2 kV power supply ±1 kV
•IEC 61000-4-5:2014, Third Edition
•IEC 61000-4-5 ±1 kV Surge differential mode ±2 kV common mode
•IEC 61000-4-6 Second Edition with A1:2004 + A2:2006
•IEC 61000-4-6, 150 kHz to 80 MHz
•IEC 61000-4-8:2009, Second Edition
•IEC 61000-4-8, Power frequency (50/60 Hz) magnetic field, 30 A/m

Natus®Brain Monitor & Embla Dx Series™User and Service Manual
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Declaration of Compliance for IEC 60601-1-2
Table 1 - Electromagnetic Emissions
Guidance and manufacturer’s declaration – electromagnetic emissions
The amplifier is intended for use in the electromagnetic environment specified below. The customer or the user of the
amplifier should ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF emissions
CISPR 11
Group 1 The Brain Monitor & Embla Dx Series Amplifiers use RF energy
only for its internal function. Therefore, their RF emissions are
very low and not likely to cause any interference in nearby
electronic equipment
RF emissions
CISPR 11
Class A The Brain Monitor & Embla Dx Series Amplifiers are 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

User and Service Manual Natus®Brain Monitor & Embla Dx Series™
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Table 2 - Electromagnetic Immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
The Brain Monitor & Embla Dx Series Amplifiers are intended for use in the electromagnetic environment specified below.
The customer or the user of the Brain Monitor & Embla Dx Series Amplifiers should assure that they are 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 Brain Monitor & Embla Dx Series Amplifiers
requires continued operation during power mains
interruption, it is recommended that the Brain
Monitor & Embla Dx Series Amplifiers 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.

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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 Brain Monitor & Embla Dx Series Amplifiers are intended for use in the electromagnetic environment specified below.
The customer or the user of the Brain Monitor & Embla Dx Series Amplifiers should assure that they are 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 Brain Monitor & Embla
Dx Series Amplifiers, 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 site 1should be less than the compliance
level in each frequency 2.
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 Brain
Monitor & Embla Dx Series Amplifiers are used exceeds the applicable RF compliance level above, the Brain Monitor & Embla Dx Series
Amplifiers should be observed to verify normal operation. If abnormal operation is observed, additional measures may be necessary, such as
re-orienting or relocating the Brain Monitor & Embla Dx Series Amplifiers.
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
9
745
780
810
800 – 960
GSM 800/900, TETRA
800, iDEN 820, CDMA
850, LTE Band 5
Pulse
modulation b)
18 Hz
2
0,3
28
870
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
28
1,845
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.
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.
WARNING: Changes or modifications not expressly approved by the manufacturer could void the user's
authority to operate the equipment.

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Contraindications, Warnings, & Cautions
Contraindications
There are no known Contraindications to using this device.
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.
NOTE: Any serious incident that has occurred in relation to the Natus Brain Monitor Embla NDxSDx system be reported to the
manufacturer and the competent authority of the Member State in which the user and/or patient is established.
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.
This equipment/system is intended for use by Healthcare professionals ONLY. Please read this section before
installing any of the hardware. Refer to this section when you operate, transport, store, or re-install the system.
Only use the Brain Monitor & Embla Dx Series Amplifiers 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 60601-1-2:2007
Never use equipment that has parts missing or equipment that might contain loose parts inside of it (that is, inside
an enclosed portion of the equipment). If you suspect a piece of equipment has missing or loose parts, contact
Natus. Routinely inspect system cables and components for regular wear and tear.
Perform the recommended maintenance. Refer to the Maintenance and Cleaning section for further details.
Do not immerse the amplifier or any of its components in water or other fluid.
Proper use of this device depends on the careful reading of all instructions and labels that come with or on the
system. Inaccurate measurements may be caused by incorrect application or use.
When replacing the fuse for the Brain Monitor & Embla Dx Series Amplifiers, it must be replaced by a fuse with the
same type and rating as the original fuse. Replacement fuses should be purchased from Natus directly.
The Brain Monitor & Embla Dx Series Amplifiers are compatible with NeuroWorks / SleepWorks v9.0 and newer.
The amplifier base unit is classified as an IPX0 – ordinary degree of protection against ingress of water according to
IEC 60529.
The amplifier Breakout is classified as body worn and has an IPX1 rating while inside the pouch (-61) and meets
IEC 60601-2-26 spillage requirement without the pouch.

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The system is classified as a class I device according to IEC 60601-1.
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.
WARNING: No modification of this equipment is allowed.
Electrostatic Discharge (ESD) Warnings:
Be sure to take the appropriate Electrostatic Discharge (ESD) precautions. Disconnect the cables
before moving, cabling, or performing any set up procedures. Connectors marked with the ESD
protection symbol should not be touched. For detailed handling procedures, refer to the Electrostatic
Discharge (ESD) Handling Procedures and Warnings section.
Turn off all system power and disconnect the power cord from the system and the wall before attempting to clean
the unit. The Brain Monitor & Embla Dx Series Amplifiers can be wiped clean with a soft, damp cloth using non-
conductive distilled water, electrically non-conductive inert surfactants or a Natus approved cold sterilizing agent. It
is important to dry off the unit quickly. Avoid letting liquid seep into any of the internal electronics of the system. Do
not use any abrasive cleaner on the system.
Device accessories may include several kinds of disposable, sterile needle electrodes. These needles are labeled as
STERILE, and the method of sterilization is documented on the packaging. These electrodes should not be used if the
sterile packaging has been tampered with.
The Brain Monitor & Embla Dx Series Amplifiers need special precautions regarding Electromagnetic Compatibility
(EMC) and must be installed and operated according to EMC guidelines. Refer to the EMC Standard of Compliance
and Normative References table in the Safety & Standards Conformity section.
Using the Brain Monitor & Embla Dx Series Amplifiers with cables and accessories not approved by Natus may
negatively affect EMC performance, including electromagnetic immunity. Refer to the Electromagnetic Immunity
table in the Safety & Standards Conformity section.
External equipment may interfere with the performance of the Brain Monitor & Embla Dx Series Amplifiers, even if
other equipment complies with CISPR Emission requirements. Refer to the EMC Standard of Compliance and
Normative References table in the Safety & Standards Conformity section.
The Brain Monitor & Embla Dx Series Amplifiers should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the amplifier should be observed to verify normal operation in the
configuration in which it will be used. Refer to the Recommended Separation Distances table in the Safety &
Standards Conformity section for minimum recommended separation distances.
Do not connect items which are not specified as part of the Brain Monitor & Embla Dx Series Amplifier system to the
system.

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Electrical Warnings and Cautions
Natus systems are intended for connection to a properly grounded electrical outlet only.
Conductive parts of electrodes and their connectors are not to contact other conductive parts and earth.
Do not place MULTIPLE PORTABLE SOCKET-OUTLETS (MPSOs) on the floor.
Do not connect additional MPSOs or extension cords to the Brain Monitor & Embla Dx Series Amplifier systems.
ELECTRICAL SHOCK HAZARD: 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.
ELECTRICAL SHOCK HAZARD: Do NOT service the system. Refer servicing to qualified personnel only. Do NOT use
repaired components without proper testing.
Do not use the MPSO with the Brain Monitor & Embla Dx Series Amplifiers system for supplying power to any
equipment that is not part of the system.
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 Brain Monitor & Embla Dx Series Amplifier
systems may be powered by the isolation transformer.
The current rating of the isolation transformer must be sufficient to operate all of the devices powered by it. Refer
to the current ratings of the isolation transformer and current rating for each individual device connected.
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 MPSO, with a separating transformer.
Do NOT connect electrical equipment which has not been supplied as a part of the system to the MPSO.
Ensure that the Brain Monitor & Embla Dx Series Amplifiers system is solely connected to a three-wire, grounded,
hospital-grade receptacle.
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.
Do NOT operate the system in the presence of flammable anesthetics.
Check areas of use to avoid using the system in the presence of flammable gases.
To ensure the validity of signals, do not operate the device near any sources of electromagnetic interference.
Natus systems are not AP or APG rated. DO NOT USE a Natus system in the presence of a flammable anesthetic
mixture with air, oxygen, or nitrous oxide.

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The Brain Monitor & Embla Dx Series Amplifiers are NOT designed to work with defibrillators. The Brain Monitor &
Embla Dx systems could be damaged when used with this device.
When using the Brain Monitor & Embla Dx Series Amplifiers together with electrosurgical units (cautery devices) it is
recommended to connect to the acquisition PC using the TCP/IP interface.
Operation of this equipment with input signals in excess of a range of +/-10mV may cause incorrect results.
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.
If a computer is located in the patient environment and is connected to a network, a network isolator MUST be
used.
The patient event button attached to the Brain Monitor & Embla Dx Series Amplifiers system is NOT intended for
critical patient-safety-related incidents.
Patient connections are NOT intended for direct cardiac contact.
As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or
strangulation.
Do NOT touch any system accessible metal parts and the patient simultaneously.
Do NOT touch any earth-grounded components of the Brain Monitor & Embla Dx Series Amplifier system and the
patient simultaneously.
Do NOT allow loose electrodes to contact metal parts.
Connection of a patient to high-frequency surgical equipment and to electroencephalography equipment
simultaneously may result in burns at the site of bio-potential input electrodes and possible damage to the
biological amplifiers. Please consult the user documentation of the surgical equipment for instruction as to its
proper use.
Do not use the Brain Monitor & Embla Dx Series Amplifier system in the vicinity of MRI systems.
As with all medical equipment, there is a risk of injury if the harness/belt and pouch are used without ensuring they
are secured to the patient properly. Refer to the Adding the breakout box to a pouch section for details.
REPETITIVE STRESS INJURY HAZARD: Sustained use of this product without ergonomic consideration may result in
repetitive stress injury.
User is not to position ME equipment in such a way as to make it difficult to operate the disconnection device.
The Brain Monitor & Embla Dx Series Amplifier systems do NOT include SpO2 or Pulse Rate alarms.
If a video camera is present in the patient environment, it should be connected via Ethernet directly to the
computer, and not to a network.

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Neither the pouch nor the breakout box should be covered by blankets or any other material; nor should they be
placed back-to-back. Failure to follow these instructions could raise the temperature of the Breakout above normal
operational levels.
The breakout box should only be used in conjunction with the Modular Pouch.
If a computer is located in the patient environment, it must be 60601-1 approved or 60950-1 approved and powered
by a 60601-1 approved isolation transformer.
Check areas of use to avoid using the system in the presence of vicinity gases.
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.
Pulse Oximeter Sensor Warnings
Refer to the pulse oximeter sensor user manual for associated precautions, warnings, and instructions for use.
Wireless Option Warnings and Cautions
Mobile RF communications can affect the operation of this medical equipment.
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 (e.g., SpO2), 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.
Procedures and Warnings
Electrostatic Discharge (ESD) Handling
Before performing any setup or placement procedures, read the precautions outlined in this section.

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Be sure to take the appropriate Electrostatic Discharge (ESD) precautions. Disconnect the cables before moving,
cabling, or performing any set up procedures.
Some semiconductor (solid state) devices can be easily damaged by static electricity. Such components are
commonly called Electrostatically Sensitive Devices (ESD). Do not touch the accessible conductive parts for the
Connectors marked with the ESD symbol.
Follow these techniques to help reduce the incidence of component damage caused by static electricity:
•Immediately before handling any product components assemblies, drain the electrostatic charge from your body by
touching a known earth ground.
•Minimize body motions when handling unpackaged replacement ESDs. Motions such as brushing clothes together or
lifting your foot from a carpeted floor can generate enough static electricity to damage the product components.
•Avoid carpets in cool, dry areas. If provided, leave the product components in their anti-static packaging until ready to
be installed.
•Take care when connecting or disconnecting cables. When disconnecting a cable, always pull on the cable connector
or strain-relief loop, not on the cable itself.
A damaged cable can cause a short in the electrical circuit. Prevent damage to the connectors by aligning connector
pins before you connect the cable.
Misaligned connector pins can cause damage to system components at power-on.
Changes or modifications not expressly approved by the manufacturer could void the user's authority to operate the
equipment.
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 is usually propagated through the connecting
cables. The functionality of some Semiconductor devices and high sensitivity amplifiers (EEG, EMG ECG) may be affected by
induced parasitic signals.
This effect could be described as noise and/or channel saturation on the EEG waveforms, which are coupled together with off
the scale values for auxiliary sensors.
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.
•If parasitic noise is present on the EEG waveforms, try to identify possible culprits by disconnecting nearby equipment
from the common power source.
•Lay out the interconnection cables as far as possible from the cables being used by nearby equipment.
•Verify the Power cord integrity. Do not use portable multiple socket outlets that are not properly grounded.
•Do not use power outlets without a protective ground
•When isolation transformers are used, ensure that the Medical System is properly grounded.