natus Xltek Trex HD Troubleshooting guide

Xltek®Trex HD
User & Service Manual

User & Service Manual Xltek® Trex HD Amplifier
1
Publisher’s Notice
104497 Rev N
XLTEK Trex HD User & Service Manual
Natus Medical Incorporated
DBA Excel-Tech Ltd. (XLTEK)
2568 Bristol Circle
Oakville, Ontario, L6H 5S1 Canada
Tel: [phone] or Fax: [phone]
Toll Free (US & Canada): 800-303-0306
Technical Support Email: [email protected]m
Website: www.natus.com
EUROPEAN AUTHORIZED REPRESENTATIVE
Natus Manufacturing Limited
IDA Business Park
Gort, Co.Galway
Ireland
Copyright © 2018 by Natus Medical Incorporated.
Issued on October 16, 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.

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Table of Contents
1. INTRODUCTION..............................................................................................................................5
1.1. INTENDED USE................................................................................................................................5
1.2. ESSENTIAL PERFORMANCE .............................................................................................................6
1.3. USING THE MANUAL........................................................................................................................6
1.4. MANUAL CONVENTIONS ..................................................................................................................6
2. SAFETY AND STANDARDS CONFORMITY.................................................................................8
2.1. SAFETY AND STANDARDS CONFORMITY FOR XLTEK TREX HD........................................................8
2.1.1. STANDARDS OF COMPLIANCE AND NORMATIVE REFERENCES..................................................8
2.1.2. DECLARATION OF COMPLIANCE FOR IEC 60601-1-2.............................................................10
2.1.3. ELECTROMAGNETIC IMMUNITY (EMI) INFORMATION –FCC....................................................14
3. WARNINGS AND CAUTIONS ......................................................................................................15
3.1. GENERAL WARNINGS....................................................................................................................15
3.2. ELECTRICAL WARNINGS AND CAUTIONS........................................................................................17
3.3. WIRELESS OPTION WARNINGS AND CAUTIONS ..............................................................................18
3.4. PATIENT ENVIRONMENT WARNINGS AND CAUTIONS .......................................................................18
3.5.PULSE OXIMETER WARNINGS........................................................................................................19
3.6. PULSE OXIMETER SENSOR WARNINGS ..........................................................................................21
3.7. TRANSPORTATION WARNINGS.......................................................................................................22
3.8. CONDUCTED IMMUNITY WARNINGS................................................................................................22
4. PROCEDURES AND WARNINGS................................................................................................23
4.1. ELECTROSTATIC DISCHARGE (ESD) HANDLING PROCEDURES AND WARNINGS...............................23
4.2. CONDUCTED IMMUNITY PROCEDURES AND WARNINGS...................................................................24
5. DESCRIPTION OF SYMBOLS......................................................................................................25
6. XLTEK TREX HD SPECIFICATIONS ...........................................................................................27
7. PRODUCT IMAGES ......................................................................................................................29
7.1. TREX HD (FRONT VIEW) ...............................................................................................................29
7.2. TREX HD (REAR VIEW).................................................................................................................30
8. UNPACKING .................................................................................................................................31

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8.1. TREX HD PACKAGE ITEMS............................................................................................................31
8.2. OPTIONAL ACCESSORIES..............................................................................................................32
9. SETTING UP..................................................................................................................................33
9.1. GETTING STARTED .......................................................................................................................33
9.1.1. PLACEMENT OF THE OPERATOR AND PATIENT.......................................................................33
9.1.2. BEGINNING A STUDY ............................................................................................................33
9.1.3. POWERING DOWN THE SYSTEM ...........................................................................................34
9.1.4. TREX HD AMPLIFIER LED COLOR FUNCTIONALITY:................................................................34
9.2. ADDING THE TREX HD UNIT TO A BELT OR A LANYARD....................................................................34
9.2.1. BELT SETUP........................................................................................................................34
9.2.2. LANYARD SETUP .................................................................................................................35
9.3. SETTING UP TREX HD AMPLIFIER FOR A NON-VIDEO STUDY ...........................................................35
9.4. SETTING UP TREX HD AMPLIFIER FOR AN AMBULATORY VIDEO STUDY...........................................36
9.4.1. SETTING UP CAMCORDER AND TREX HD VIDEO INTERFACE (TVI)..........................................37
9.5. TESTING THE TREX HD AMPLIFIER ................................................................................................40
9.5.1. CALIBRATION AND VERIFICATION..........................................................................................41
9.5.2. CHANNEL TEST ...................................................................................................................41
9.5.3. IMPEDANCE CHECK .............................................................................................................42
10. TRANSPORT SYSTEM SPECIFICATIONS AND MAINTENANCE.............................................43
10.1. XLTEK TROLLEY SPECIFICATIONS..............................................................................................43
10.2. ERGOJUST CART SPECIFICATIONS..............................................................................................44
10.3. MAINTENANCE............................................................................................................................44
10.4. WARNINGS AND CAUTIONS..........................................................................................................44
10.5. ELECTRICAL INPUT AND ISOLATION TRANSFORMER DETAILS........................................................44
11. NONIN XPOD PULSE OXIMETER ...............................................................................................45
11.1. NO IMPLIED LICENSE ..................................................................................................................45
11.2. INDICATIONS FOR USE.................................................................................................................45
11.3. PULSE OXIMETER SPECIFICATIONS..............................................................................................45
11.4. PULSE OXIMETER INSTRUCTION FOR USE.....................................................................................45
11.5. ACCESSORIES ............................................................................................................................46
11.5.1. CABLES ............................................................................................................................46
11.5.2. AVAILABLE OXIMETRY SENSORS ........................................................................................46
11.6. MEASUREMENTS.........................................................................................................................47

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11.7. DISPLAYED RANGES...................................................................................................................48
12. GUARANTEEING SUFFICIENT BATTERY POWER...................................................................49
12.1. BATTERY POWER WITH AA BATTERIES (ONLY)............................................................................49
12.2. BATTERY POWER WITH AA BATTERIES AND POWER PACK...........................................................50
13. EXTERNAL POWER PACK..........................................................................................................51
13.1. POWER PACK SYMBOLS .............................................................................................................51
13.2. EXTERNAL POWER PACK SPECIFICATIONS ..................................................................................51
13.3. EXTERNAL POWER PACK WARNINGS AND CAUTIONS...................................................................52
13.4. USING THE EXTERNAL POWER PACK KIT.....................................................................................53
13.5. EXTERNAL POWER PACK AND CHARGING DETAILS ......................................................................54
13.5.1. EXTERNAL POWER PACK LED INDICATORS ........................................................................54
13.6. CHARGING THE EXTERNAL POWER PACK ....................................................................................55
13.7. DISCONNECTING THE EXTERNAL POWER PACK............................................................................55
13.8. STORING THE EXTERNAL POWER PACK.......................................................................................55
13.9. TROUBLESHOOTING THE EXTERNAL POWER PACK.......................................................................56
14. HOW TO DISABLE CHANNELS AND SET FREQUENCY..........................................................57
15. MAINTENANCE, CLEANING, & DISPOSAL................................................................................58
15.1. RECOMMENDATIONS ...................................................................................................................58
15.2. DISPOSAL...................................................................................................................................59
15.3. EXPECTED SERVICE LIFE ............................................................................................................59
16. TROUBLESHOOTING...................................................................................................................60
17. GETTING HELP.............................................................................................................................61
18. EEG AND SLEEP ACCESSORIES...............................................................................................62
19. INDEX ............................................................................................................................................64

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1. Introduction
The Xltek®Trex HD amplifier, with its leading-edge mechanical design, provides you with maximum
reliability and performance for clinical electroencephalographic (EEG) and polysomnographic (PSG)
recordings. It is designed to be used with Natus SleepWorks™or NeuroWorks®software to assist with
diagnosis.
The Trex HD is equipped with a Bluetooth module which communicates wirelessly with a Trex HD Video
Interface that communicates with a video camcorder.
The Trex HD offers these features:
Connects to Natus computer
24 referential AC inputs
4 differential AC inputs
4 non-isolated DC inputs for connection to patient-worn transducers
Internal memory for up to 96hr of EEG recording
Battery powered by two AA alkaline batteries
Optional power pack providing up to 72 hours of continuous recording when used with two AA
alkaline batteries
Bluetooth module for wireless synchronization with HD video
Isolated serial port
Patient-event switch interface
WARNING: We strongly recommend that you read the Warnings and Cautions section of
this manual before operating this amplifier.
1.1. Intended Use
The Trex HD is intended to be used as an electroencephalograph: to acquire, digitize, store and archive
electroencephalographic signals.
The Trex HD is intended to be used by either trained medical professionals or someone instructed by a
trained medical professional. It is designed for use in clinical environments such as hospital rooms,
epilepsy monitoring units, intensive care units, and operating rooms. It can be used with patients of all
ages, but is not designed for fetal use.
The sale, distribution, or use of this device is restricted to, by, or on order of a physician.
The Trex HD is supplied with a standard label displaying markings for EEG studies. For convenience,
when performing Sleep studies, the user may apply the “Trex HD Sleep” label with markings designed for
Sleep studies (provided). See “Section 8 - Unpacking” for pictures of the labels.
NOTE: The functionality of the Trex HD is not affected by the label and all instructions,
warnings and cautions described in this manual still apply.
WARNING: The Trex HD should NOT be used as an apnea monitor.

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1.2. Essential Performance
Essential performances of the Trex HD 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
(5) common mode rejection.
The definition 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.
1.3. Using the Manual
This manual provides basic information and instructions that will enable you to set up and operate the
Trex HD amplifier. When going through the procedures, we recommend that you read the whole section
first, before starting the sequence. In order to achieve the optimal use, Trex HD must be installed and
operated according to the instructions provided in this user manual. Please follow all instructions
carefully.
NOTE: In addition to reading this manual, we encourage you to explore the online Help of the
software to enable you to take advantage of everything that Natus has designed the Trex HD
amplifier to do. More detailed instructions relating to the operation and customization of the
system are provided in the online Help.
1.4. 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.
This symbol indicates a note that contains important supplemental information.

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Symbol/
Convention
Description/Function
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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2. Safety and Standards Conformity
2.1. Safety and Standards Conformity for XLTEK Trex HD
2.1.1. Standards of Compliance and Normative References
Electroencephalograph system, model Trex HD; rated two AA 1.5 V batteries, 0.065 A, 0.170 W.
1. Type of protection against electric shock: Internally Powered Equipment
2. Degree of protection against electric shock: Type BF
3. Degree of protection against ingress of water: IPX0
4. Mode of operation: Continuous
5. Environmental Conditions: Normal: 5-40°C, 15-93% rH, 700-1060hPa
Trex HD Video Interface.
1. Type of protection against electric shock: Class II
2. Degree of protection against electric shock: No applied parts
3. Degree of protection against ingress of water: IPX0
4. Mode of operation: Continuous
5. Environmental Conditions: Normal: 5-40°C, 15-93% rH, 700-1060hPa
The Trex HD 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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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
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, 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

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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
2.1.2. Declaration of Compliance for IEC 60601-1-2
Table 1 - Electromagnetic Emissions
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The Trex HD is intended for use in the electromagnetic environment specified below. The customer or the
Trex HD should assure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment –Guidance
RF emissions
CISPR 11
Group 1
The Trex HD uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
The Trex HD is suitable for use in all establishments,
including domestic establishments and those directly
connected to 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

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Table 2 - Electromagnetic Immunity
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Trex HD is intended for use in the electromagnetic environment specified below. The customer or the
user of the Trex HD 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 Trex
HD requires continued operation
during power mains interruption, it is
recommended that the Trex HD to be
powered from a suitable
uninterruptible power supply or a
battery.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
30 A/m
Complies
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
NOTE: UT is the AC supply voltage prior to application of the test level.

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Table 3 - Electromagnetic Immunity –for EQUIPMENT and SYSTEMS that are not LIFE-
SUPPORTING
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Trex HD is intended for use in the electromagnetic environment specified below. The customer or the
user of the Trex HD should assure that it is used in such an environment.
Immunity test
Test Level
IEC60601-1-2
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 Vrms
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the Trex HD,
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 dis the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic Site survey1,
should be less than the compliance level in each
frequency range2.
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.
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
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 Trex HD is used exceeds the applicable RF
compliance level above, the Trex HD should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the Trex HD.
2
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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450
430 –470
GMRS 460,
FRS 460
FM c)
± 5 kHz deviation
1 kHz sine
2
0,3
28
710
704 –787
LTE Band 13, 17
Pulse
modulation b)
217 Hz
0,2
0,3
9
745
780
810
800 –960
GSM 800/900,
TETRA 800, iDEN
820, CDMA
850,LTE Band 5
Pulse
modulation b)
18 Hz
2
0,3
28
870
930
1,720
1,700 –1,990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT; LTE Band
1, 3, 4, 25;
UMTS
Pulse
modulation b)
217 Hz
2
0,3
28
1,845
1,970
2,450
2,400 –2,570
Bluetooth,
WLAN, 802.11
b/g/n, RFID
2450, LTE Band
7
Pulse
modulation b) 217 Hz
2
0,3
28
5,240
5,100 –5,800
WLAN 802.11
a/n
Pulse
modulation b)
217 Hz
0,2
0,3
9
5,500
5,785
NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME
EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual
modulation, it would be worst case.

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2.1.3. Electromagnetic Immunity (EMI) Information –FCC
NOTE: This equipment has been tested and found to comply with the limits for Class B digital
devices, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. 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. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one of more of the following measures:
Reorient or relocate the receiving antenna
Increase the separation between the equipment and receiver
Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
Consult the dealer or an experienced radio/TV technician for help.
WARNING: Changes or modifications not expressly approved by Natus may void the user’s
authority to operate the equipment.

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3. Warnings and Cautions
3.1. 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 amplifier is classified as an IP0 –ordinary degree of protection against ingress of water
according to IEC 529. The amplifier is classified as a class II device according to IEC601-1.
The computer used with a Trex HD amplifier must either be approved by Natus and
supplied as part of an IEC 601 approved system, or it must be approved to IEC 950 or
similar and kept outside of the patient environment, (that is, at least 1.5 meters from the
patient laterally and not within a height of 2.5 meters from the floor in the area occupied by
the patient).
Only use the Trex HD 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
To ensure the validity of signals, do not operate the device near any sources of
electromagnetic interference.
Electrostatic Discharge (ESD) Precaution: Be sure to take the appropriate
Electrostatic Discharge (ESD) precautions. Disconnect the cables before
moving, cabling, or performing any set up procedures. Connectors marked
with the ESD protection symbol should not be touched. For detailed handling procedures,
see Section 3.6.
Turn off all system power and disconnect the power cord from the system and the wall
before attempting to clean the unit. The Trex HD unit can be wiped clean with a soft, damp
cloth using non-conductive distilled water, electrically non-conductive inert surfactants or an
Natus-approved cold sterilizing agent. It is important to dry off the unit quickly. Avoid letting
liquid seep into any of the internal electronics of the system. Do not use any abrasive
cleaner on the system.
When the Trex HD amplifier is in the IPX2-certified pouch, it is offered protection from
dripping water from above the device for up to 10 minutes in duration.
Natus systems are not AP or APG rated. DO NOT USE an Natus system in the presence
of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.

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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 two AA batteries used to operate the Trex HD should be removed if the Trex HD is not
likely to be used for some time.
Dispose of used, non-rechargeable batteries in accordance with local regulations.
The Trex HD needs special precautions regarding Electromagnetic Compatibility (EMC) and
must be installed and operated according to EMC guidelines (see Section 2.1.2).
Using the Trex HD with cables and accessories not approved by Natus may negatively
affect EMC performance, including electromagnetic immunity (see Section 2.1.3).
External equipment may interfere with the performance of the Trex HD, even if that other
equipment complies with CISPR Emission requirements (see Section 2.1.3).
The Trex HD should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, the amplifier should be observed to verify normal operation in the
configuration in which it will be used. See Section 2.1.2 for minimum recommended
separation distances.
Do not connect items which are not specified as part of the Trex HD system to the system.
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.
WARNING: Third-party software installed on the acquisition computer may interfere with the
operation of the Natus software. Please consult Technical Support before installing third-
party software on the computer.
WARNING: No modification of this equipment is allowed.
The Trex HD is IPX2 marked when inside the carrying case.
Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the Trex HD System, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.

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3.2. Electrical Warnings and Cautions
XLTEK systems are intended for connection to a properly grounded electrical outlet only.
Conductive parts of electrodes and their connectors are not to contact other conductive parts
including earth.
Do not place MULTIPLE PORTABLE SOCKET-OUTLETS (MPSOs) on the floor.
Do not connect additional MPSOs or extension cords to the Trex HD system.
Do not use the MPSO with the Trex HD system for supplying power to any equipment that is
not part of the system.
To avoid the possible hazards caused by the summation of leakage currents when all the
parts of the system are interconnected, no equipment other than devices connected to the
Trex HD may be powered by the isolation transformer.
The current rating of the isolation transformer must be sufficient to operate all of the devices
powered by it. Refer to the current ratings of the isolation transformer and current rating for
each individual device connected.
Do NOT connect non-medical equipment which has been supplied as part of the system
directly to the wall outlet when the system is supplied, via MPSO, with a separating
transformer.
Do NOT connect electrical equipment which has not been supplied as a part of the system to
the MPSO.
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.

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3.3. Wireless Option Warnings and Cautions
The wireless feature of the Trex HD presents a synchronization of the EEG signal with the
video recording. 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 Digital Camcorder unit
and the Trex HD. In either of these situations, the wireless data will not be received by the
acquisition computer.
The Trex HD contains FCC ID: QOQBT121which 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.
Mobile RF communications equipment may affect the Trex HD and interfere with wireless
operation. See Section 2.1.3 for guidelines.
3.4. 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.
The Trex HD amplifier is NOT intended for use with High Frequency Surgical Equipment.
Connect all patient electrodes to fully electrically isolated physiological devices only.
Connecting patient electrodes to any other device or external outlet may result in personal
injury.
The amplifier accepts only touchproof style electrode inputs. Do NOT attempt to use any
other style of patient electrode input.
The patient event switch attached to the Trex HD is NOT intended for critical patient-safety-
related incidents.
Patient connections are NOT intended for direct cardiac contact.
As with all medical equipment, carefully route patient cabling to reduce the possibility of
patient entanglement or strangulation.

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Connecting other medical equipment, such as an electrical stimulator, simultaneously to the
same patient may constitute a safety hazard.
Do NOT touch any Trex HD system accessible metal parts and the patient simultaneously.
If a computer is located in the patient environment, it must be 60601-1 approved or 60950-1
approved and powered by a 60601-1 approved isolation transformer.
Do not use the Trex HD system in the vicinity of MRI or CT systems.
Do not allow loose electrodes to contact metal parts.
As with all medical equipment, carefully route patient cabling to reduce the possibility of patient
entanglement or strangulation.
User is not to position ME equipment in such a way as to make it difficult to operate the
disconnection device.
Potential allergic reactions could occur. Consult clinician on any allergies before use.
Do not use the Trex HD system when outside its carrying case as the device is not IPX
certified when used outside of the case.
No parts of the ME equipment shall be serviced or maintained while in use with a patient.
3.5. Pulse Oximeter Warnings
The Nonin XPOD pulse oximeter is to be operated by qualified personnel only. This manual,
the instructions for use for any pulse oximeter sensor or cable extender, the accessory
directions for use, all precautionary information, and specifications should be read prior to
use.
EXPLOSION HAZARD: Do not use the pulse oximeter in the presence of flammable
anesthetics or other flammable substance in combination with air, oxygen-enriched
environments, or nitrous oxide.
A pulse oximeter should NOT be used as an apnea monitor.