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
2
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™
3
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
4
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™
5
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.

Natus®Brain Monitor & Embla Dx Series™User and Service Manual
6
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™
7
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.

Natus®Brain Monitor & Embla Dx Series™User and Service Manual
8
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™
9
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