natus Xltek EMU40EX Troubleshooting guide

EMU40EX
™
User and Service Manual

EMU40EX™User and Service Manual
2
Publisher’s Notice
023528 Rev 03
EMU40EX User and Service Manual
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:
[email protected]
natus.com
Arazy Group Switzerland GmbH
Bruderholzallee 53
4059 Basel
Switzerland
[email protected]
EU Representative / Importer
Natus Manufacturing Limited
IDA Business Park
Gort, Co. Galway, Ireland
Tel: [phone]
Fax: [phone]
Natus Nicolet UK Ltd
Baynards Green Trading Estate
Prospect House
Oxfordshire
Bicester
OX27 7SG
England, United Kingdom
Copyright © 2018 - 2023 by Natus Medical Incorporated.
Issued February 17, 2023
Associated product part numbers: PK1072-NTB-9, 021743-9
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.

User and Service Manual EMU40EX™
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Table of Contents
Device Description.........................................................................................................................................................5
Intended Use ..........................................................................................................................................................5
Indications for Use..................................................................................................................................................6
Intended Users and Patient Target Group .............................................................................................................6
Clinical Benefits ...................................................................................................................................................... 6
Contraindications and Side Effects.........................................................................................................................6
Essential Performance............................................................................................................................................7
Essential Performance Degradation................................................................................................................7
Instructions to access the eIFU...............................................................................................................................7
EMU40EX Safety and Standards Conformity .................................................................................................................8
Standards of Compliance and Normative References............................................................................................8
Declaration of Compliance for IEC 60601-1-2 ........................................................................................................9
Declaration of Compliance for FCC.......................................................................................................................12
Warnings, and Cautions...............................................................................................................................................13
General Warnings.................................................................................................................................................13
Electrical Warnings and Cautions .........................................................................................................................14
Patient Environment Warnings and Cautions ......................................................................................................16
Pulse Oximeter Warnings and Cautions ...............................................................................................................17
Wireless Option Warnings....................................................................................................................................18
Electromagnetic Interference (EMI) Warnings.....................................................................................................19
Transportation Warnings......................................................................................................................................19
Cleaning Warnings................................................................................................................................................19
Procedures and Warnings............................................................................................................................................21
Electrostatic Discharge (ESD) Handling ................................................................................................................21
Conducted Immunity Procedures and Warnings..................................................................................................21
Glossary of Symbols.....................................................................................................................................................22
System Symbols....................................................................................................................................................28
Specifications: EMU40EX Amplifier .............................................................................................................................29
Product Images............................................................................................................................................................32
EMU40EX System .................................................................................................................................................32
Base Unit ..............................................................................................................................................................33
EMU40EX Breakout Box .......................................................................................................................................34
Unpacking ....................................................................................................................................................................35
Additional EEG System Components....................................................................................................................35
Setting Up ....................................................................................................................................................................36
Connecting to the computer ................................................................................................................................36
USB-Style Connection....................................................................................................................................36
Ethernet-Style Connection ............................................................................................................................36
Connection Setup for the Base Unit .....................................................................................................................36
Setting the IP Address ...................................................................................................................................38
Touchscreen Icons.........................................................................................................................................41
Amplifier Usage and Features .....................................................................................................................................42
Getting Started .....................................................................................................................................................42

EMU40EX™User and Service Manual
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Placement of the Operator and Patient ........................................................................................................42
Beginning a study ..........................................................................................................................................42
Powering Down the System ..........................................................................................................................42
Adding the EMU40EX Breakout Box to a Lanyard.........................................................................................42
Potential Equalization Conductor..................................................................................................................43
EMU40EX Amplifier System Description .....................................................................................................................44
EMU40EX Breakout Box to Base Unit Data Link ...................................................................................................44
Feature Description of EMU40EX with Wireless Option Disabled .......................................................................45
Feature Description of EMU40EX with Wireless Option ......................................................................................48
Testing the EMU40EX Amplifier ...........................................................................................................................50
Calibration and Verification...........................................................................................................................50
Channel Test..................................................................................................................................................51
Impedance Check ..........................................................................................................................................52
Pulse Oximeter ............................................................................................................................................................53
Masimo Patents.............................................................................................................................................53
No Implied License ........................................................................................................................................53
Indications for Use................................................................................................................................................53
Instruction for Use................................................................................................................................................53
How the Pulse Oximeter Works ...........................................................................................................................53
Pulse Oximeter Accessories..................................................................................................................................55
Available Oximeter Sensors...........................................................................................................................55
Oximeter Specifications........................................................................................................................................56
Measurements .....................................................................................................................................................56
Causes of Inaccurate Measurements ............................................................................................................56
Causes of Loss of Pulse Signal .......................................................................................................................57
Transport System Specifications and Maintenance ....................................................................................................58
Trolley* Specifications..........................................................................................................................................58
Natus ErgoJust Cart Specifications .......................................................................................................................58
Transportation Maintenance................................................................................................................................59
Maintenance, Cleaning, & Disposal.............................................................................................................................59
Recommendations: ..............................................................................................................................................59
Disposal ................................................................................................................................................................59
Troubleshooting ..........................................................................................................................................................60
Getting Help.................................................................................................................................................................61
Accessories & Replacement Parts List .........................................................................................................................62
Replacement Parts List .........................................................................................................................................62
Optional Accessories List ......................................................................................................................................62

User and Service Manual EMU40EX™
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Device Description
The EMU40EX™amplifier is a powerful and flexible EEG recording system. This rugged device was designed with extensive
clinical input to meet the workflow and application needs for diagnostic EEG and Long Term Monitoring (LTM).
EMU40EX records a total of 46 channels: 40 referential EEG channels, four DC input channels for supplemental signal
transducers and two SpO2 and Pulse Rate channels from its internal pulse oximeter.
The EMU40EX data stream acquired by the EMU40EX amplifier system is reviewed, analyzed, and archived using a Natus
NeuroWorks®workstation. Standard TCP/IP or USB connectivity is supported for quick and easy installation. The Natus base
unit offers TCP/IP and USB connectivity for quick and easy installation. This rugged device was designed with extensive clinical
input to meet the workflow and application needs of the EEG, LTM, or PSG Lab.
EMU40EX features include:
•40 referential channels, four DC channels, and two pulse oximeter channels (Sp02 and Pulse Rate)
•Ability to initiate an impedance test, change the threshold and view the results in the patient room
•Ambulatory Mode maintains data acquisition upon disconnection of the patient data cable
•Automatic fall-over to internal storage of full-resolution data for up to two hours
•Live display of EEG waveforms remains available over a secure Bluetooth connection during Ambulatory Mode
•Data acquired on the Breakout Box while in Ambulatory Mode is transparently and seamlessly transferred to the Base
Unit after resuming wired-mode operation
•Standard TCP/IP and USB connectivity to Natus NeuroWorks®workstations
•DC inputs on Base Unit to interface a wide variety of auxiliary signal transducers
•Two Patient Event Button Switch interfaces: one on the Breakout Box for patient use, and another on the Base Unit
for family or staff
•Photic stimulator interface for diagnostic EEG
•Small, lightweight patient-connected Breakout Box – 3.9 x 6.2 x 0.9 in (10.0 x 15.8 x 2.3 cm) and 0.73 lb (333 g)
•Rugged and durable design for reliable operation in clinical and research environments
NOTE: Carefully read the User Manual/Instructions for Use (including all contraindications, warnings, cautions, notes, and labels
that are on or come with the system) before operating the device for safe use of the system.
Intended Use
The EMU40EX EEG Headbox is an electroencephalograph that works in conjunction with NeuroWorks software.
The EMU40EX EEG Headbox is used to acquire, digitize, store, and transmit physiological signals (such as EEG, pulse and
oximetry signals) for EEG studies in research and clinical environments.
The EMU40EX EEG Headbox requires competent user input, and its output must be reviewed and interpreted by trained
medical professionals who will exercise professional judgement in using this information.

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Indications for Use
The EMU40EX Amplifier aids in measuring the electrical brain activity and in diagnosing various conditions such as:
•Brain tumors
•Epilepsy
•Other seizure disorders
•Stroke
•Brain encephalopathy
•Herpes Encephalitis (Inflammation of the brain)
•Dementia
•Psychiatric conditions
Intended Users and Patient Target Group
The EMU40EX device is used by trained medical professionals including EEG Technologists and EEG Technicians, for performing
EEG studies on patients of all ages from neonatal to adult, but not fetal use.
Clinical Benefits
The EMU40EX Amplifier aids in measuring the electrical brain activity and in diagnosing brain disorders, such as epilepsy and
other seizure disorders. Recording EEG with the EMU40EX amplifier does not directly affect outcome; the collected EEG activity
will allow the physician to decide on treatment. Treatment directed by data recorded with the EMU40EX may result in better
outcomes than treatment informed solely by data from clinical assessment.
Contraindications and Side Effects
There are no known contraindications and side effects for using the EMU40EX.

User and Service Manual EMU40EX™
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Essential Performance
Essential performances of the EMU40EX amplifier are identified in the standard IEC 60601-2-26:2012. Essential performance
relates to the quality of the signal recorded from the amplifier. Specific essential performances are (1) accuracy of signal
reproduction, (2) dynamic range and differential offset voltage, (3) input noise level, (4) frequency response, 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
•Interruptions in signal transmission resulting from external electromagnetic events. (Ex: Operation of wireless
equipment near 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.
Any serious incident that has occurred in relation to the device should be reported to
Natus Medical Incorporated and the competent authority of the Member State in which the user and/or patient is established.
Instructions to access the eIFU
A copy of the Instructions for Use in PDF format is in: https://neuro.natus.com/neuro-support
Search for “EMU40EX User and Service manual” and choose the version for your local language for the Instructions For Use.
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). To request a paper copy in English or available translations, contact Natus Customer
Support.

EMU40EX™User and Service Manual
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EMU40EX Safety and Standards Conformity
Standards of Compliance and Normative References
Multichannel Sleep/EEG Amplifier System, Model EMU40EX, detachable cord connected, portable 115/230Vac, 50/60Hz, 30W.
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 : 10-40°C, 30-75% rH, 700-1060hPa
The EMU40EX and its accessories have been designed to comply with the following national and international standards.
Table 1 – Safety Standard of Compliance and Normative References
CAN /CSA-C22.2 No. 60601-1: 08(R2013) +
C2:2011
ANSI/AAMI ES60601-1:2005/(R)2012 +
C1:2009/(R)2012 and A2:2010/(R)2012
IEC 60601-1:2005 (Third Edition) + CORR. 1:2006
+ CORR. 2:2007 + A1:2012
CENELEC EN 60601-1:2006 + A1:2013
Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1-6:2010/AMD1:2013 Medical electrical equipment – Part 1-6: General requirements for
basic safety and essential performance – Collateral standard: Usability
IEC 62366-1 2020 Medical devices – Application of usability engineering to medical
devices
IEC 60601-2-26:2012, Edition 3
CENELEC EN 60601-2-26L2003, Edition 2
Medical electrical equipment – Part 2-26: Particular requirements for
the safety of electroencephalographs
EN ISO 80601-2-61:2011, Edition 1 Medical electrical equipment – Part 2-61: Particular requirements for
basic safety and essential performance of pulse oximeter equipment
Table 2 – EMC Standard of Compliance and Normative References
IEC 60601-1-2, Edition 4.0,
February 1, 2014
Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – collateral standard: electromagnetic
compatibility – requirements and tests
IEC 61000-4-2:2008, ed 2.0 Electromagnetic Compatibility (EMC) Part 4-2: Testing and Measurement
Techniques - Electrostatic Discharge Immunity Test
IEC 61000-4-3 ed 3.0 with A1:2007+A2:2010 Electromagnetic Compatibility (EMC) Part 4-3: Testing and Measurement
Techniques - Radiated, Radiofrequency, Electromagnetic Field Immunity
Test
IEC 61000-4-4:2012, ed 3.0 Electromagnetic Compatibility (EMC) Part 4-4: Testing and Measurement
Techniques - Electrical Fast Transient/Burst Immunity Test

User and Service Manual EMU40EX™
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IEC 61000-4-5:2014, ed 3.0 Electromagnetic Compatibility (EMC) Part 4-5: Testing and Measurement
Techniques - Surge Immunity Test
IEC 61000-4-6 ed 2.0 with A1:2004 + A2:2006 Electromagnetic Compatibility (EMC) Part 4-6: Testing and Measurement
Techniques - Immunity to Conducted Disturbances, Induced by Radio-
frequency Fields
IEC 61000-4-8:2009, ed 2.0 Electromagnetic Compatibility (EMC) Part 4-8: Testing and Measurement
Techniques - Power Frequency Magnetic Field Immunity Test
IEC 61000-4-11:2004, ed 2.0 Electromagnetic Compatibility (EMC) Part 4-11: Testing and
Measurement Techniques - Voltage Dips, Short Interruptions and
Voltage Variations Immunity Tests
IEC 61000-3-2:2014, ed 4.0 Electromagnetic Compatibility (EMC) Part 3-2: Limits - Limits for
Harmonic Current Emissions
IEC 61000-3-3:2013, ed 3.0 Electromagnetic Compatibility (EMC) Part 3-3: Limits - Limitation of
Voltage Changes, Voltage Fluctuations and Flicker in Public Low-voltage
Supply Systems
CISPR 11 ed 5.0 with A1:2010 Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment -
Electromagnetic Disturbance Characteristics - Limits and Methods of
Measurement
Declaration of Compliance for IEC 60601-1-2
Table 1 - Electromagnetic Emissions
Guidance and manufacturer’s declaration – electromagnetic emissions
The EMU40EX is intended for use in the electromagnetic environment specified below. The customer or the user of the
EMU40EX should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF emissions
CISPR 11
Group 1 The EMU40EX uses RF energy only for its internal function.
Therefore, its RF emissions are very low and not likely to
cause any interference in nearby electronic equipment
RF emissions
CISPR 11
Class A The EMU40EX is suitable for use in all establishments other
than domestic and those directly connected to the public
low-voltage power supply network that supplies buildings
used for domestic purposes.
Harmonic emissions IEC
61000-3-2
Class A
Voltage fluctuations/ flicker
emissions
IEC 61000-3-3
Complies

EMU40EX™User and Service Manual
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Table 2 - Electromagnetic Immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
The EMU40EX is intended for use in the electromagnetic environment specified below. The customer or the user of the
EMU40EX should assure that it is used in such an environment.
Immunity Test IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment - Guidance
Electrostatic Discharge
(ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
Complies Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the
relative humidity should be at least 30%.
Electrostatic fast
transient/burst
IEC 61000-4-4
±2 kV, 100Khz for
power supply lines
±1 kV, 100Khz for
input/output lines
Complies Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common
mode
Complies Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
<100% drop, 0/5
periods, 0°, 45°,
90°, 135°, 180°, 225°,
270°, 315°
100% dip, 1 period
30% dip, 25/30
periods
40% dip for 5 cycles
Complies Mains power quality should be that of a typical
commercial or hospital environment. If the user of
the EMU40EX requires continued operation during
power mains interruption, it is recommended that
the EMU40EX 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 EMU40EX™
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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 EMU40EX is intended for use in the electromagnetic environment specified below. The customer or the user of the
EMU40EX should assure that it is used in such an environment
Immunity test IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment - Guidance
Conducted RF IEC
61000-4-6
Radiated RF IEC 61000-
4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.7 GHz
3 V
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any part of
the EMU40EX, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
d=1.2 ×√P 150kHz to 80MHz
d=1.2 ×√P 80MHz to 800MHz
d=2.3 ×√P 800MHz to 2.5GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site1should be
less than the compliance level in each frequency2.
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
1Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the
EMU40EX is used exceeds the applicable RF compliance level above, the EMU40EX should be observed to verify normal operation. If abnormal
operation is observed, additional measures may be necessary, such as re-orienting or relocating the EMU40EX.
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 28870
930
1,720
1,700 –
1,990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT; LTE Band
1, 3, 4, 25;
UMTS
Pulse
modulation b)
217 Hz
2 0,3 281,845
1,970
2,450 2,400 –
2,570
Bluetooth,
WLAN, 802.11
b/g/n, RFID
2450, LTE Band
7
Pulse
modulation b) 217 Hz 2 0,3 28
5,240
5,100 –
5,800
WLAN 802.11
a/n
Pulse
modulation b)
217 Hz
0,2 0,3 9
5,500
5,785
NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the Medical
Electrical EQUIPMENT or Medical Electrical 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.
Changes or modifications not expressly approved by the manufacturer could void the user's authority to operate the
equipment.

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Warnings and Cautions
We strongly recommend that you read the Contraindications, Warnings and Cautions section of this manual
before operating this amplifier.
General Warnings
NOTE: 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.
Warning A WARNING indicates that there is a risk of death or serious injury to the user or patient.
Caution
A CAUTION indicates that there is a risk of injury to the user or patient or risk of damage to the
device.
Any serious incident that has occurred in relation to the Natus EMU40EX system must be reported to the manufacturer and the
competent authority of the Member State in which the user and/or patient is established.
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.
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.
The equipment/system is intended for use by trained users. Please read the manual before installing any of the
hardware, and refer to the appropriate section when you operate, store or re-install the system.
Only use the EMU40EX system 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.
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 EMU40EX system is classified as a class I device according to IEC 60601-1.
The computer used with an EMU40EX system must either be approved by Natus and supplied as part of an IEC
60601 approved system, or it must be approved to IEC 60950 or similar and kept outside of the patient
environment (that is, the area within 1.5 meters of the patient laterally and within 2.5 meters of the floor in the
area occupied by the patient).
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.
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.
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.

EMU40EX™User and Service Manual
14
The sale, distribution, or use of this device is restricted to, by, or on order of a physician.
Printers and/or peripherals used with Natus devices should be marked and approved for use in their appropriate
medical environment in accordance with the regulations of the country in which they are used.
Do not attempt to connect any third-party devices to the Patient Breakout Box except those approved by Natus.
WARNING: No modification of this equipment is allowed.
WARNING: Misaligned connector pins can cause damage to system components at power-on.
WARNING: 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.
Changes or modifications not expressly approved by the manufacturer could void the user's authority to operate
the equipment.
Perform the recommended maintenance. Refer to the Maintenance, Cleaning, & Disposal section for details.
The Natus EMU40EX with the Natus Base is NOT designed to work with defibrillators. The system could be
damaged when used with this device.
EMU40EX Amplifiers are compatible with NeuroWorks / SleepWorks v9.0 and newer.
Operation of this equipment with input signals in excess of a range of +/-10mV may cause incorrect results.
REPETITIVE STRESS INJURY HAZARD: Sustained use of this product without ergonomic consideration may result in
repetitive stress injury.
Do NOT position Medical Electrical equipment in such a way as to make it difficult to operate the disconnection
device.
Do not dispose of this medical product as unsorted municipal waste. At the end of an EMU40EX's life, please
contact Natus at 1-800-303-0306 in order to arrange return shipping for your EMU40EX amplifier.
Electrical Warnings and Cautions
Natus systems are intended for connection to a properly grounded electrical outlet only. Ensure that the
EMU40EX Amplifier System is solely connected to a three-wire, grounded, hospital-grade receptacle.
The use of accessories, transducers and/or cables other than those specified, with the exception of those sold by
the manufacturer as replacement parts for internal components, may result in increased emissions or decreased
immunity of the equipment or system and may cause the system to be non-compliant with the requirements of
IEC 60601-1-2:2007.

User and Service Manual EMU40EX™
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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 EMU40EX Amplifier System.
WARNING: 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 EMU40EX Amplifier System for supplying power to any equipment that is not part
of the system.
Do NOT connect electrical equipment which has not been supplied as a part of the system to the MPSO.
ELECTRICAL SHOCK HAZARD: Do NOT connect electrode inputs to earth ground. The Patient Breakout Box contains
warning symbols reminding you that the connections are intended for isolated patient connections only.
Connecting to an earth ground might result in electrocution.
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.
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 EMU40EX Amplifier system 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
When replacing the fuse for the EMU40EX, 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 Patient Breakout Box accepts only touch-proof style electrode inputs. Do NOT attempt to use any other style
of patient electrode input.
For the use of an ELECTROENCEPHALOGRAPH without protective means to prevent burning of the PATIENT,
information on the location of the ELECTRODES is provided.

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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.
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.
Connect all patient electrodes to fully electrically isolated 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.
Do NOT touch any EMU40EX system accessible metal parts and the patient simultaneously.
Do NOT touch any earth-grounded components of the EMU40EX system and the patient simultaneously.
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.
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.
Do NOT position Medical Electrical equipment in such a way as to make it difficult to operate the disconnection
device.
No parts of the Medical Electrical equipment shall be serviced or maintained while in use with a patient.
Patient connections are NOT intended for direct cardiac contact.
Do not use EMU40EX in the vicinity of MRI or CT systems.
Do not allow loose electrodes to contact metal parts.
The pouch and belt or lanyard system must be worn over top of the patient’s clothes or hospital garment.
WARNING
Be sure to take the appropriate Electrostatic Discharge (ESD) precautions. Disconnect the cables before moving,
cabling, or performing any set up procedures.

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17
The Patient Event Switch attached to the Base Unit or Breakout Box is NOT intended for critical patient-safety-
related incidents.
The EMU40EX Amplifier system does NOT include SpO2 or Pulse Rate alarms.
Route patient cabling carefully to reduce the possibility of patient entanglement or strangulation.
As with all medical equipment, there is a risk of injury if the lanyard/belt and pouch(es) are used without ensuring
they are secured to the patient properly. Refer to the Adding the EMU40EX breakout box to a lanyard or belt
section for details.
Pulse Oximeter Warnings and Cautions
NOTE: Tissue damage can occur due to incorrect placement of sensor.
A pulse oximeter should NOT be used as an apnea monitor.
Significant levels of dysfunctional hemoglobins (HbCO or MetHb) may cause inaccurate measurements.
Intravascular dyes such as indocyanine green or methylene blue may cause inaccurate measurements.
Excessive illumination may cause inaccurate measurements or loss of pulse signal.
Excessive patient movement may cause inaccurate measurements.
Venous pulsations may cause inaccurate measurements.
Carboxyhemoglobin may erroneously increase readings. The level of increase is approximately equal to the
amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change usual arterial
pigmentation may cause erroneous readings.
Loss of pulse signal may occur when the patient has hypotension, severe vasoconstriction, severe anemia or
hypothermia, leading to misdiagnosis.
Loss of pulse signal can occur when there is arterial occlusion proximal to the sensor.
Loss of pulse signal can occur when the patient is in cardiac arrest or is in shock.
Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line may
cause inaccurate measurements.
Loss of pulse signal can occur when the sensor is too tight.

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A pulse oximeter should be considered an early warning device. As a trend towards patient deoxygenation is
indicated, blood samples should be analyzed by a laboratory CO-oximeter to completely understand the
patient’s condition.
The EMU40EX Amplifier system does NOT include SpO2 or Pulse Rate alarms.
Wireless Option Warnings
NOTE: The EMU40EX contains FCC ID: SQGBT700 which complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that may cause undesired operation.
Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to
operate the equipment.
NOTE: The EMU40EX contains a Class 1 Bluetooth module which has passed the Bluetooth Qualification/Certification process as
specified within the Bluetooth Specifications.
NOTE: There are no devices known to cause disturbance to the performance of the wireless radios in this device. However,
precautions should be made to keep the EEG device a safe distance from any other wireless products. Refer to Table 4 in the
Declaration of Compliance for IEC 60601-1-2 section. Should interference with the wireless radios in this device occur, relocate
the devices causing the issue, or contact Natus Technical Support at 1-800-303-0306 or [email protected].
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided in this manual and any other Accompanying Documents.
The wireless feature of this amplifier/headbox presents a passive visualization of the EEG signal. This feature is
not a substitute for other means of patient monitoring and supervision.
Like other wireless devices, this feature is limited in operating range. The range will also be reduced
substantially if there is any physical interference between the Base Unit and the Breakout Box. In either of
these situations, the wireless data will not be received by the acquisition computer.
The EMU40EX contains a Class 1 Bluetooth module which has passed the Bluetooth Qualification/Certification
process as specified within the Bluetooth Specifications.
There are no devices known to cause disturbance to the performance of the wireless radios in this device.
However, precautions should be made to keep the EEG device a safe distance from any other wireless
products. Refer to Table 4 in the Declaration of Compliance for IEC 60601-1-2 section.
Should interference with the wireless radios in this device occur, relocate the devices causing the issue, or
contact Natus Technical Support at 1-800-303-0306 or [e-mail].

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Electromagnetic Interference (EMI) Warnings
Only use the EMU40EX system 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.
Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment.
To ensure the validity of signals, do not operate the device near any sources of electromagnetic interference.
The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent
or stacked use is necessary, the equipment or system should be observed to verify normal operation in the
configuration in which it will be used
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
Do not tilt the trolley/cart more than 10° incline as this will compromise the stability of the trolley/cart.
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.
WARNING: Only use Natus approved equipment on the trolley/cart. Non-approved equipment may compromise
the function and safety of the system.
Do not leave the amplifier attached to the computer when transporting the unit.
Cleaning Warnings
Do not immerse patient cables in water, solvents, or cleaning solutions (the patient cable connectors are not
waterproof). Do not sterilize patient cables by irradiation, steam or ethylene oxide.
Do NOT soak or immerse the amplifier in any liquid.
Be careful not to allow any fluid to seep into the internal electronic components of the system.

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Turn off all system power and disconnect the power cord from the system and the wall before attempting to clean
the unit. Cleaning must be done very carefully. Do not allow any liquid to seep into any of the connectors or into
the internal electronics of the system.
Refer to the Maintenance, Cleaning, & Disposal section for details.
Do NOT touch, press or rub the LCD with abrasive cleaning compounds, instruments, brushes, rough-surface
materials, or bring them into contact with anything that could scratch the panel.
Use cleaning solution sparingly. Excessive solution can flow into the amplifier and cause damage to internal
components.
Disconnect all cables from the EMU40EX before cleaning. Use a lint-free cloth. Do not use cleaners on any system
component.
Do NOT use petroleum-based or acetone solutions, or other harsh solvents, to clean the amplifier. These
substances attack the device's materials and device failure can result.
Do NOT autoclave, pressure sterilize, or gas sterilize this amplifier. It is not possible to clean bio-contaminate from
the amplifier.
A cleaning solution of 70% isopropyl alcohol is recommended.