natus Xltek EMU40EX Troubleshooting guide

Xltek®EMU40EX™
with Natus Base p/n 013926
User and Service Manual

User and Service Manual Xltek®EMU40EX™
1
Publisher’s Notice
017301 Rev 03
XLTEK EMU40EX with Natus Base 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: O[email protected]
Website: www.natus.com
EUROPEAN AUTHORIZED REPRESENTATIVE
Natus Manufacturing Limited
IDA Business Park, Gort,
Co. Galway, Ireland
Copyright © 2018 by Natus Medical Incorporated.
Issued in December 2018.
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.

Xltek®EMU40EX™ User and Service Manual
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Table of Contents
INTRODUCTION...........................................................................................................................................5
PRODUCT INTENDED USE..........................................................................................................................6
THE XLTEK 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.............................................................................................6
SYSTEM COMPONENTS.......................................................................................................................6
ESSENTIAL PEFORMANCE .........................................................................................................................6
ESSENTIAL PEFORMANCE DEGRADATION.............................................................................................6
USING THE MANUAL..................................................................................................................................7
MANUAL CONVENTIONS......................................................................................................................7
EMU40EX SAFETY AND STANDARDS CONFORMITY ............................................................................8
STANDARDS OF COMPLIANCE AND NORMATIVE REFERENCES.....................................................................8
DECLARATION OF COMPLIANCE FOR IEC 60601-1-2................................................................................10
DECLARATION OF COMPLIANCE FOR FCC ...............................................................................................13
CONTRAINDICATIONS, WARNINGS, AND CAUTIONS .........................................................................14
CONTRAINDICATIONS ..............................................................................................................................14
WARNINGS AND CAUTIONS......................................................................................................................15
GENERAL WARNINGS........................................................................................................................15
ELECTRICAL WARNINGS AND CAUTIONS..................................................................................................16
PATIENT ENVIRONMENT WARNINGS AND CAUTIONS .................................................................................18
PULSE OXIMETER WARNINGS..................................................................................................................19
PULSE OXIMETER SENSOR WARNINGS ....................................................................................................20
WIRELESS OPTION WARNINGS AND CAUTIONS ........................................................................................21
ELECTROMAGNETIC INTERFERENCE (EMI) WARNINGS .............................................................................22
CONDUCTED IMMUNITY WARNING............................................................................................................22
TRANSPORTATION WARNINGS.................................................................................................................22
PROCEDURES AND WARNINGS.............................................................................................................23
ELECTROSTATIC DISACHARGE (ESD) HANDLING.....................................................................................23
CONDUCTED IMMUNITY PROCEDURES AND WARNINGS .............................................................................23
DESCRIPTION OF SYMBOLS...................................................................................................................25

User and Service Manual Xltek®EMU40EX™
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SPECIFICATIONS: EMU40EX AMPLIFIER ..............................................................................................27
PRODUCT IMAGES ...................................................................................................................................30
EMU40EX SYSTEM................................................................................................................................30
BASE UNIT .............................................................................................................................................31
EMU40EX BREAKOUT BOX....................................................................................................................32
UNPACKING ..............................................................................................................................................33
SETTING UP...............................................................................................................................................34
CONNECTING TO THE COMPUTER.............................................................................................................34
USB-STYLE CONNECTION ................................................................................................................34
ETHERNET-STYLE CONNECTION........................................................................................................34
CONNECTION SETUP FOR THE BASE UNIT................................................................................................35
SETTING THE IP ADDRESS ................................................................................................................36
TOUCHSCREEN ICONS ......................................................................................................................39
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 EMU40EX BREAKOUT BOX TO A LANYARD OR BELT ......................................................41
POTENTIAL EQUALIZATION CONDUCTOR............................................................................................42
EMU40EX AMPLIFIER SYSTEM DESCRIPTION .....................................................................................43
FEATURE DESCRIPTION OF EMU40EX WITH WIRELESS OPTION DISABLED...............................................44
FEATURE DESCRIPTION OF EMU40EX WITH WIRELESS OPTION...............................................................47
SETTING THE WIRELESS POWER LIMIT.....................................................................................................50
TESTING THE EMU40EX AMPLIFIER........................................................................................................50
CALIBRATION AND VERIFICATION.......................................................................................................50
CHANNEL TEST ................................................................................................................................51
IMPEDANCE CHECK ..........................................................................................................................52
PULSE OXIMETER ....................................................................................................................................53
MASIMO PATENTS ............................................................................................................................53

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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
MEASUREMENTS.....................................................................................................................................56
CAUSES OF INACCURATE MEASUREMENTS ........................................................................................56
CAUSES OF LOSS OF PULSE SIGNAL..................................................................................................56
TRANSPORT SYSTEM SPECIFICATIONS AND MAINTENANCE..........................................................57
XLTEK TROLLEY SPECIFICATIONS..........................................................................................................57
NATUS ERGOJUST CART SPECIFICATIONS...............................................................................................58
MAINTENANCE........................................................................................................................................59
WARNINGS AND CAUTIONS......................................................................................................................59
ELECTRICAL INPUT AND ISOLATION TRANSFORMER DETAILS ......................................................60
MAINTENANCE, CLEANING, & DISPOSAL.............................................................................................61
RECOMMENDATIONS ...............................................................................................................................61
DISPOSAL...............................................................................................................................................62
TROUBLESHOOTING................................................................................................................................63
GETTING HELP..........................................................................................................................................64
ACCESSORIES & REPLACEMENT PARTS LIST....................................................................................65
INDEX .........................................................................................................................................................66

User and Service Manual Xltek®EMU40EX™
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Introduction
The Xltek®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, 4 DC input channels for
supplemental signal transducers and 2 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, 4 DC channels, and 2 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
WARNING: We strongly recommend that you read the Contraindications, Warnings and
Cautions section of this manual before operating this amplifier.

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Product Intended Use
The XLTEK EMU40EX EEG Headbox is an electroencephalograph that works in conjunction with XLTEK
NeuroWorks software.
The XLTEK 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 XLTEK 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.
System Components
The EMU40EX amplifier system is provided with optional system components. Computers are intended
to run the NeuroWorks software exclusively. Cameras are intended to acquire synchronized video of the
patient during long-term monitoring. Isolation transformers are intended to provide power for all system
components while ensuring the safety of operators and patients. Carts are intended to support and
facilitate the use of the EMU40EX amplifier while keeping the system mobile. Patient Event Switches are
handheld pushbutton switches used by the patient (or nearby attendant) to signal a significant clinical
event (e.g. an aura or the beginning of a seizure).
Essential Peformance
Essential performances of the EMU40EX amplifer 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 defitions 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 Peformance 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 behaviour.
If any of the above are observed or if unusual system behaviour is observed contact Natus Technical
support.

User and Service Manual Xltek®EMU40EX™
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Using the Manual
This manual provides basic information and instructions that will enable you set up and operate the
EMU40EX amplifier. When going through the procedures, we recommend that you read the whole section
first, before starting the sequence. Please follow the instructions carefully.
In addition to reading this manual, we encourage you to explore the online Help to enable you to take
advantage of everything that XLTEK has designed the EMU40EX amplifier to do. More detailed
instructions relating to the operation and customization of the system are provided in the online Help.
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.

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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 anaesthetic mixture with air or
with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable
anaesthetic 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 + C1:2006 and
C2:2007, Third Edition
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, Edition 3.0
Medical electrical equipment –Part 1-6: General
requirements for basic safety and essential performance –
Collateral standard: Usability
IEC 62366:2007, Edition 1.0
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

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

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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

User and Service Manual Xltek®EMU40EX™
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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
±6 kV contact
±8 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 for power
supply lines
±1 kV 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
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 250ec
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
3 A/m
Complies
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE: UT is the AC supply voltage prior to application of the test level.

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Table 3 - Electromagnetic Immunity–for EQUIPMENT and SYSTEMS that are not LIFE-
SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
The 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 2.5
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 site1
should 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 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.
2
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Table 4 - Recommended Separation Distances
Recommended separation distances between portable and mobile RF communications equipment and
the EMU40EX.
The EMU40EX is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the EMU40EX can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the EMU40EX as recommended below, according to the maximum output power of the communications
equipment.
Rated Maximum Output
Power of Transmitter
(W)
Separation Distance according to Frequency of Transmitter (m)
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for 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.
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, and Cautions
Contraindications
The Xltek EMU40EX with the Natus Base 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 Xltek EMU40EX with the Natus Base is NOT designed to work with defibrillators. The
system could be damaged when used with this device.

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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.
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 XLTEK 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.
Perform the recommended maintenance. Refer to the Maintenance, Cleaning, & Disposal
section for details.
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.

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The EMU40EX cannot be cleaned of bio-contaminate. Attempts to remove bio-contaminate will
damage the unit.
Device accessories may include several kinds of disposable, sterile needle electrodes. These
needles are labeled as STERILE, and the method of sterilization is documented on the
packaging. These electrodes should not be used if the sterile packaging has been tampered
with.
The sale, distribution, or use of this device is restricted to, by, or on order of a physician.
Printers and/or peripherals used with XLTEK 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 XLTEK.
Do not dispose of this medical product as unsorted municipal waste. At the end of an
EMU40EX’s life, please contact XLTEK at 1-800-303-0306 in order to arrange return shipping
for your EMU40EX amplifier.
WARNING: No modification of this equipment is allowed.
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.
Electrical Warnings and Cautions
XLTEK 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.
Ensure that the EMU40EX Amplifier System is solely connected to a three-wire, grounded,
hospital-grade receptacle.
Conductive parts of electrodes and their connectors are not to contact other conductive parts
and earth.

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Do not place MULTIPLE PORTABLE SOCKET-OUTLETS (MPSOs) on the floor.
Do not connect additional MPSOs or extension cords to the EMU40EX Amplifier System.
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.
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.
ELECTRICAL SHOCK HAZARD: Do NOT service the system. Refer servicing to qualified
personnel only. Do NOT use repaired components without proper testing.
For the use of an ELECTROENCEPHALOGRAPH without protective means to prevent
burning of the PATIENT, information on the location of the ELECTRODES is provided.
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 EMU40EX amplifier system is classified as a class I device according to IEC 60601-1.

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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.
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 devices only. Connecting patient
electrodes to any other device or external outlet may result in personal injury.
The Patient Breakout Box accepts only touch-proof style electrode inputs. Do NOT attempt to
use any other style of patient electrode input.
The Patient Event Switch attached to the Base Unit or Breakout Box is NOT intended for
critical patient-safety-related incidents.
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.
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.
The EMU40EX Amplifier system does 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.
User is not to position Medical Electrical equipment in such a way as to make it difficult to
operate the disconnection device.

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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.
Route patient cabling carefully to reduce the possibility of patient entanglement or
strangulation.
Do not use EMU40EX in the vicinity of MRI or CT systems.
Do not allow loose electrodes to contact metal parts.
Pulse Oximeter Warnings
The Masimo SET®Pulse Oximeter is to be operated by qualified personnel only. This manual,
accessory directions for use, all precautionary information, and specifications should be read
before use.
Explosion hazard. Do not use the MS board pulse oximeter in the presence of flammable
anesthetics or other flammable substance in combination with air, oxygen-enriched
environments, or nitrous oxide.
The EMU40EX Amplifier system does NOT include SpO2 or Pulse Rate alarms.
A pulse oximeter should NOT be used as an apnea monitor.
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.
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.