natus neuro Embla Dx Series Troubleshooting guide

User and Service Manual Natus® Brain Monitor & Embla Dx Series™
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Publisher’s Notice
022571 Rev 02
Natus Brain Monitor & Embla Dx Series Amplifier User and Service Manual
Natus Medical Incorporated
DBA Excel-Tech Ltd. (XLTEK)
2568 Bristol Circle
Oakville, Ontario, L6H 5S1 Canada
Tel: [phone] or Fax: [phone]
Toll Free (US & Canada): 800-303-0306
Technical Support Email: [email protected]
Website: www.natus.com
EUROPEAN AUTHORIZED REPRESENTATIVE
Natus Manufacturing Limited
IDA Business Park, Gort,
Co.Galway, Ireland
Tel: [phone]
Fax: [phone]
Copyright © 2018 by Natus Medical Incorporated.
All rights reserved. This manual contains proprietary information, which is protected by copyright and may
not be copied in whole or in part except with the prior written permission of Natus Medical Incorporated.
The copyright and the foregoing restrictions on the copyright use extend to all media in which this
information is preserved.
This copy of the User Manual shall be used only in accordance with the conditions of sale of Natus
Medical Incorporated or its distributors. Natus Medical Incorporated makes no representations or
warranties of any kind whatsoever with respect to this document. Natus Medical Incorporated disclaims all
liabilities for loss or damage arising out of the possession, sale, or use of this document.

Natus® Brain Monitor & Embla Dx Series™ User and Service Manual
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Table of Contents
Introduction....................................................................................................................................................5
Intended Use .............................................................................................................................................5
System Components.................................................................................................................................6
Essential Performance ..............................................................................................................................6
Essential Performance Degradation......................................................................................................6
Operating Principle of the Amplifier...........................................................................................................6
Using the Manual.......................................................................................................................................7
Manual Conventions..............................................................................................................................7
Safety & Standards Conformity.....................................................................................................................8
Standards of Compliance and Normative References..............................................................................8
Safety Standard of Compliance and Normative References.................................................................8
EMC Standard of Compliance and Normative References...................................................................8
Declaration of Compliance for IEC 60601-1-2...........................................................................................9
Table 1 - Electromagnetic Emissions ....................................................................................................9
Table 2 - Electromagnetic Immunity ....................................................................................................10
Table 3 - Electromagnetic Immunity –for EQUIPMENT and SYSTEMS that are not LIFE-
SUPPORTING .....................................................................................................................................11
Table 4 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications
equipment ............................................................................................................................................12
Declaration of Compliance for FCC.........................................................................................................13
Contraindications, Warnings, & Cautions ...................................................................................................14
Contraindications.....................................................................................................................................14
Warnings and Cautions...........................................................................................................................14
General Warnings................................................................................................................................14
Electrostatic Discharge (ESD) Precautions:........................................................................................15
Electrical Warnings and Cautions........................................................................................................16
Patient Environment Warnings and Cautions......................................................................................17
Transportation Warnings .....................................................................................................................18
Pulse Oximeter Sensor Warnings........................................................................................................18
Conducted Immunity Warnings............................................................................................................19
Procedures and Warnings...........................................................................................................................20
Electrostatic Discharge (ESD) Handling..................................................................................................20
Conducted Immunity Procedures and Warnings.....................................................................................21
Description of Symbols ...............................................................................................................................22
Specifications: Brain Monitor & Embla Dx Series Amplifiers ......................................................................24
Product Images...........................................................................................................................................26

User and Service Manual Natus® Brain Monitor & Embla Dx Series™
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Brain Monitor ...........................................................................................................................................26
Embla NDx...............................................................................................................................................26
Embla SDx...............................................................................................................................................26
Natus Base Unit.......................................................................................................................................27
Breakout Boxes .......................................................................................................................................28
Brain Monitor........................................................................................................................................28
Embla NDx...........................................................................................................................................29
Embla SDx...........................................................................................................................................30
Setup...........................................................................................................................................................31
Connections.............................................................................................................................................31
Setting the IP Address.............................................................................................................................32
Touchscreen Icons...............................................................................................................................34
Amplifier Usage and Features.....................................................................................................................35
Getting Started ........................................................................................................................................35
Placement of the Operator and Patient ...............................................................................................35
Beginning a study ................................................................................................................................35
Powering Down the System.................................................................................................................36
Adding the Breakout Box to a Pouch ......................................................................................................36
Potential Equalization Conductor ............................................................................................................37
Connection Mode ....................................................................................................................................37
Connecting the Natus Base Unit and Brain Monitor & Embla Dx Series Breakout Boxes......................38
Removing the Connections .....................................................................................................................38
Connecting to the Body Position Pod......................................................................................................39
Connecting to the Luer Lock Pressure Sensor .......................................................................................39
Transport System Specifications and Maintenance....................................................................................40
XLTEK Trolley Specifications..................................................................................................................40
Neurowand Cart (No PC) Specifications.................................................................................................41
Breakout Box Holster with Roll Cart........................................................................................................42
Natus ErgoJust Cart Specifications.........................................................................................................42
Maintenance............................................................................................................................................42
Warnings and Cautions...........................................................................................................................43
Electrical Input and Isolation Transformer Details...................................................................................43
Pulse Oximeter............................................................................................................................................44
Pulse Oximeter Specifications.................................................................................................................44
Pulse Oximeter Instruction for use ..........................................................................................................44
Pulse Oximeter Accessories....................................................................................................................44
Available Nonin Oximetry Sensors ......................................................................................................44

Natus® Brain Monitor & Embla Dx Series™ User and Service Manual
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Pulse Oximeter Precautions and Warnings.............................................................................................45
Maintenance, Cleaning, & Disposal............................................................................................................46
Brain Monitor & Embla Dx Series Amplifiers Pouch................................................................................46
Recommendations...................................................................................................................................46
Disposal...................................................................................................................................................47
Troubleshooting ..........................................................................................................................................48
Troubleshooting Checklist.......................................................................................................................48
Problems with Signal Quality...................................................................................................................49
Accessories & Replacement Parts List.......................................................................................................50
Getting Help ................................................................................................................................................52
Step 1: Document the Incident................................................................................................................52
Step 2: Search NeuroWorks Online Documentation...............................................................................52
Step 3: Restart the Computer..................................................................................................................52
Step 4: Shut Down the Computer............................................................................................................52
Step 5: Contact Technical Support..........................................................................................................52
Appendix A..................................................................................................................................................53
Digital Trigger Input Port Wiring Diagram................................................................................................53
Appendix B..................................................................................................................................................54
Headcap Connector Wiring .....................................................................................................................54
Appendix C..................................................................................................................................................55
Frequency Response Curves..................................................................................................................55
Sample Rate: 256Hz............................................................................................................................55
Sample Rate: 512Hz............................................................................................................................55
Sample Rate: 1024Hz..........................................................................................................................56
Sample Rate: 2048Hz..........................................................................................................................56
Sample Rate: 4096Hz..........................................................................................................................57
Index............................................................................................................................................................58

User and Service Manual Natus® Brain Monitor & Embla Dx Series™
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Introduction
The Natus® Brain Monitor & Embla Dx Series amplifiers are designed for the acquisition of EEG and
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 4 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
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 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.

Natus® Brain Monitor & Embla Dx Series™ User and Service Manual
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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 performances 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
Pinbox disconnected events. (Quantum)
Interruptions in signal transmission resulting from external electromagnetic events. (Ex:
Electrocautery, Operation of wireless equipment in close proximity to the amplifier, etc.)
Any form or random or intermittent system behavior.
If any of the above are observed or if unusual system behavior is observed contact Natus Technical
support.
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 and Service Manual Natus® Brain Monitor & Embla Dx Series™
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Using the Manual
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.
When reviewing the procedures, we recommend you read the entire section first, before beginning a
sequence. Please follow the instructions carefully.
Manual Conventions
Various symbols and typographical conventions are used throughout the manual. The following table
illustrates them and describes their meanings and functions.
Symbol /
Convention
Description / Function
This symbol denotes a warning or important information that should not be missed. Read
all warnings and cautions carefully before starting the system for the first time.
A note that contains important supplemental information.
Bold
Names of control keys, function keys, options, and labels are shown in bold. Bold text is
also used to emphasize important names or ideas.
Italic
Italic text is used for captions.

Natus® Brain Monitor & Embla Dx Series™ User and Service Manual
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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 expose
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

User and Service Manual Natus® Brain Monitor & Embla Dx Series™
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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

Natus® Brain Monitor & Embla Dx Series™ User and Service Manual
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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 require 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.

User and Service Manual Natus® Brain Monitor & Embla Dx Series™
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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 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.
1
Field 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.
2
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Natus® Brain Monitor & Embla Dx Series™ User and Service Manual
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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.

User and Service Manual Natus® Brain Monitor & Embla Dx Series™
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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.
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
The Brain Monitor & Embla Dx Series Amplifiers shall NOT be used in the following conditions:
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.
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 in the vicinity of 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.
Warnings and Cautions
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.

User and Service Manual Natus® Brain Monitor & Embla Dx Series™
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Perform the recommended maintenance. Refer to the Maintenance & 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.
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) Precautions:
Electrostatic Discharge (ESD) Precaution: 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.

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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.
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.

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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.
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.
Do not use the Brain Monitor & Embla Dx Series Amplifier system in the vicinity of MRI or CT
systems.
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.

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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.
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.
Do not use the Brain Monitor & Embla Dx Series Amplifier system in the vicinity of MRI or CT
systems.
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 wheel base 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.

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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.