natus Trex HD Troubleshooting guide

Trex™HD Monitoring Amplifier
User & Service Manual

Publisher’s Notice
019694 Rev 04 09/2021
Trex HD Monitoring Amplifier User & Service Manual
Natus Medical Incorporated
DBA Excel-Tech Ltd. (XLTEK)
2568 Bristol Circle
Oakville, Ontario, L6H 5S1 Canada
Tel: [phone]
Website: natus.com
EU Representative / Importer
Natus Manufacturing Limited
IDA Business Park
Gort, Co. Galway, Ireland
Copyright © 2021 by Natus Neurology Incorporated.
All rights reserved. This manual contains proprietary information, which is protected by copyright and may not be copied in
whole or in part except with the prior written permission of Natus Neurology 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 Neurology
Incorporated or its distributors. Natus Neurology Incorporated makes no representations or warranties of any kind
whatsoever with respect to this document. Natus Neurology Incorporated disclaims all liabilities for loss or damage arising
out of the possession, sale, or use of this document.
All product names appearing in this document are trademarks or registered trademarks owned, licensed to, promoted or
distributed by Natus Medical Incorporated, its subsidiaries or affiliates. Xpod®is a registered trademark of Nonin Medical.
Duracell®and COPPERTOP®are registered trademarks of the Duracell company. Panasonic® is a registered trademark of
Panasonic Corporation.

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Table of Contents
1. Introduction .................................................................................................................. 5
1.1. Intended Use ............................................................................................................................... 6
1.2. Using the Manual........................................................................................................................ 6
1.3. Manual Conventions .................................................................................................................. 6
2. Safety and Standards Conformity ............................................................................... 7
2.1. Safety and Standards Conformity for Natus Trex HD Monitoring ......................................... 7
2.1.1. Standards of Compliance and Normative References........................................................ 7
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. Electrostatic Discharge (ESD) Precautions:.......................................................................... 18
3.4. Wireless Option Warnings and Cautions............................................................................... 18
3.5. Patient Environment Warnings and Cautions ....................................................................... 18
3.6. Pulse Oximeter Warnings ........................................................................................................ 20
3.7. Pulse Oximeter Sensor Warnings........................................................................................... 21
3.8. Transportation Warnings......................................................................................................... 22
3.9. Conducted Immunity Warnings .............................................................................................. 23
4. Procedures and Warnings ..........................................................................................24
4.1. Electrostatic Discharge (ESD) Handling Procedures and Warnings .................................. 24
4.2. Conducted Immunity Procedures and Warnings .................................................................. 25
5. Description of Symbols...............................................................................................26
6. Specifications ..............................................................................................................30
7. Product Images ...........................................................................................................32
7.1. Front View ................................................................................................................................. 32
7.2. Rear View................................................................................................................................... 33
8. Unpacking....................................................................................................................34
8.1. Trex HD Monitoring Package Items ........................................................................................ 34
8.2. Accessories and Replacement Parts ..................................................................................... 35
9. Setting Up ....................................................................................................................36
9.1. Getting Started.......................................................................................................................... 36
9.1.1. Placement of the Operator and Patient ............................................................................ 36
9.1.2. Performing a standard study............................................................................................. 36
9.1.3. Performing an ambulatory monitoring study in NeuroWorks. ........................................... 37
9.1.4. Powering Down the System.............................................................................................. 39
9.2. Adding the Trex HD Monitoring unit to a belt or a lanyard .................................................. 40
9.2.1. Belt Setup.......................................................................................................................... 40
9.2.2. Lanyard Setup................................................................................................................... 41
9.3. Setting up Trex HD Monitoring Amplifier for a non-Video Study ........................................ 42
9.4. Testing the Trex HD Monitoring Amplifier ............................................................................. 43
9.4.1. Calibration and Verification ............................................................................................... 43
9.4.2. Channel Test..................................................................................................................... 43
9.4.3. Impedance Check ............................................................................................................. 44
10. Nonin Xpod Pulse Oximeter .......................................................................................45
10.1. No Implied License................................................................................................................. 45
10.2. Indications for Use ................................................................................................................. 45

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10.3. Accessories............................................................................................................................. 45
10.3.1. Cables ............................................................................................................................. 45
10.3.2. Available Oximetry Sensors............................................................................................ 46
10.4. Measurements ........................................................................................................................ 47
10.5. Displayed Ranges................................................................................................................... 47
11. Guaranteeing Sufficient Battery Power .....................................................................48
11.1. Battery Power with AA Batteries (only)................................................................................ 48
11.2. Battery Power with AA Batteries and External Battery Pack............................................. 49
12. Natus External Battery Pack.......................................................................................50
12.1. External Battery Pack Warnings and Cautions ................................................................... 50
12.2. Using the External Battery Pack with the Trex HD Monitoring System............................ 51
13. How to Disable Channels and Set Frequency ...........................................................52
14. Maintenance, Cleaning, & Disposal............................................................................53
14.1. Recommendations ................................................................................................................. 53
14.2. Disposal................................................................................................................................... 54
14.3. Expected Service Life ............................................................................................................ 54
15. Troubleshooting ..........................................................................................................55
16. Getting Help .................................................................................................................56
17. EEG and Sleep Accessories .......................................................................................56
18. Index.............................................................................................................................57

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1. Introduction
The Natus Trex HD Monitoring amplifier for ambulatory monitoring 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®v9.3.x software to assist with
diagnosis.
Trex HD Monitoring offers these features:
•Connects to Natus computer
•24 referential AC inputs
•4 differential AC inputs
•4 non-isolated DC inputs for connection to Natus patient-worn transducers
•Internal memory for up to 96hr of EEG recording
•Battery powered by two AA alkaline batteries and an optional battery pack providing up to 72
hours of continuous recording
•Bluetooth module for live monitoring during ambulatory recording
•Ability to backfill and review an ongoing ambulatory study
•Isolated serial port
•Patient-event button
•Carrying case
Please read and follow all instructions that are provided with the system.
WARNING: We strongly recommend you read and follow the Safety and Warnings and
Cautions section of this manual before operating this amplifier.
WARNING:
This Trex HD Monitoring amplifier can only be used with the NeuroWorks/SleepWorks 8.1.1,
and 9.3 and later.
The Trex HD Monitoring 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 Trex HD Monitoring 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).
NOTE: The functionality of the Trex HD Monitoring is not affected by the label and all
instructions, warnings and cautions described in this manual still apply.
WARNING: The Trex HD Monitoring should NOT be used as an apnea monitor.

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1.1. Intended Use
The Trex HD Monitoring is an Electroencephalograph intended to be used to acquire, display, store and
archive electroencephalographic signals, intended for electroencephalographic (EEG) or level 1-2
polysomnographic (PSG) recordings. The Trex HD Monitoring amplifier is designed to be used with Natus
NeuroWorks or Natus SleepWorks software.
1.2. Using the Manual
This manual provides basic information and instructions that will enable you to set up and operate the
Trex HD Monitoring 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 Monitoring
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 Monitoring amplifier to do. More detailed instructions relating to the operation and
customization of the system are provided in the online Help.
1.3. 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.
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 Natus Trex HD Monitoring
2.1.1. Standards of Compliance and Normative References
Electroencephalograph system, model Trex HD Monitoring; rated two AA 1.5V batteries, 0.065A,
0.170W.
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
The essential performance of the Trex HD Monitoring amplifier system is defined in the particular
standards IEC 60601-2-26 and ISO 80601-2-61. It is EEG equipment that incorporates a pulse oximeter
without an alarm.
The Trex HD Monitoring and its accessories have been designed to comply with the following national
and international standards.

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Table 1 - Safety Standard of Compliance and Normative
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
CAN/CSA C22.2 No 601.1-M90
UL 60601-1:2003
IEC 60601-1:1988 + A1:1991 + A2:1995
Medical Electrical Equipment Part 1: General
Requirements for Safety
IEC 60601-2-26:2012, Edition 3
CENELEC EN 60601-2-26 L2003, Edition 2
CAN/CSA C22.2 No. 60601-2-26-04
IEC 60601-2-26: 2002
Medical Electrical Equipment - Part 2-26: Particular
Requirements for the Safety of Electroencephalographs
CAN/CSA C22.2 No. 60601-1-4-02
IEC 60601-1-4: 1996 + A1: 1999
Medical Electrical Equipment - Part 1-4: General
Requirements for Safety - Collateral Standard:
Programmable Electrical Medical Systems
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
IEC 60601-1-6:2010, Edition 3.0
CAN/CSA C22.2 No. 60601-1-6-05
IEC 60601-1-6: 2004
Medical Electrical Equipment - Part 1-6: General
requirements for safety - Collateral Standard: Usability
IEC 62366:2007, Edition 1.0 Medical devices – Application of usability engineering to
medical devices
IEC 60601-1-11:2010, Edition 1.0 Medical electrical equipment – Part 1-11: General
requirements for basic safety and essential performance
– Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems
used in the home healthcare environment
CAN/CSA C22.2 No. 60601-1-1-02
IEC 60601-1-1: 2000
Medical Electrical Equipment - Part 1-1: General
Requirements for Safety - Collateral Standard: Safety
Requirements for Medical Electrical Systems

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Table 2 - EMC Standard of Compliance and Normative References
IEC 60601-1-2:2007, Edition 3.0
IEC 60601-1-2:2001 +A1:2004 / EN 60601-
1-2:2001 +A1:2006
Medical Electrical Equipment Part 1-2:General
Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility - Requirements and
Tests
IEC 61000-4-2:2008 / EN 61000-4-2:2009 Electromagnetic Compatibility (EMC) Part 4-2: Testing
and Measurement Techniques - Electrostatic Discharge
Immunity Test
IEC 61000-4-3:2006 +A1:2007 +A2:2010 /
EN 61000-4-3:2006 +A1:2008 +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
IEC 61000-4-4:2004 +A1:2010 / EN 61000-
4-4:2004 +A1:2010
Electromagnetic Compatibility (EMC) Part 4-4: Testing
and Measurement Techniques - Electrical Fast
Transient/Burst Immunity Test
IEC 61000-4-5:2014, ed 3.0
IEC 61000-4-5:2005 / EN 61000-4-5:2006
Electromagnetic Compatibility (EMC) Part 4-5: Testing
and Measurement Techniques - Surge Immunity Test
IEC 61000-4-6:2008 / EN 61000-4-6:2009 Electromagnetic Compatibility (EMC) Part 4-6: Testing
and Measurement Techniques - Immunity to Conducted
Disturbances, Induced by Radio-frequency Fields
IEC 61000-4-8:2009 / EN 61000-4-8:2010 Electromagnetic Compatibility (EMC) Part 4-8: Testing
and Measurement Techniques - Power Frequency
Magnetic Field Immunity Test
IEC 61000-4-11:2004 / EN 61000-4-
11:2004
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
IEC 61000-3-2:2005 +A1:2008 +A2:2009 /
EN 61000-3-2:2006 +A1:2009 +A2:2009
Electromagnetic Compatibility (EMC) Part 3-2: Limits -
Limits for Harmonic Current Emissions
IEC 61000-3-3:2013, ed 3.0
IEC 61000-3-3:2008 / EN 61000-3-3:2008
Electromagnetic Compatibility (EMC) Part 3-3: Limits -
Limitation of Voltage Changes, Voltage Fluctuations and
Flicker in Public Low-voltage Supply Systems
CISPR 11:2009 +A1:2010 / EN 55011:2009
+A1:2010
Industrial, Scientific and Medical (ISM) Radio-
Frequency Equipment - Electromagnetic Disturbance
Characteristics - Limits and Methods of Measurement

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2.1.2. Declaration of Compliance for IEC 60601-1-2
Table 1 - Electromagnetic Emissions1
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The Trex HDTrex HD Monitoring is intended for use in the electromagnetic environment specified
below. The customer or the Trex HD Monitoring 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 Monitoring 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 Monitoring 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
1The conducted, harmonic, and flicker emissions testing was only performed on the mains-powered
camcorder and mains-powered PC when providing power to the Trex HD Monitoring amplifier via USB
connection. This testing was not performed on the Trex HD Monitoring amplifier in isolation because it is
a battery-powered device.

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Table 2 - Electromagnetic Immunity2
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Trex HD Monitoring is intended for use in the electromagnetic environment specified below. The
customer or the user of the Trex HD Monitoring 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
±6 kV contact
±8 kV air
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
±2 kV for power
supply lines
N/A – lines <3m
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV Line to Line
±2 kV Line to
Earth
±1 kV Line to Line
±2 kV Line to
Earth
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 5 sec
<5% UT
(>95% dip of UT)
for 0.5 cycle
40% UT
(>60% dip of UT)
for 5 cycles
70% UT
(>30% dip of UT)
for 25 cycles
<5% UT
(>95% dip of UT)
for 5 sec
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the Trex
HD Monitoring requires continued
operation during power mains
interruption, it is recommended that
the Trex HD Monitoring to be
powered from a suitable
uninterruptible power supply or a
battery.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
3 A/m 3 A/m 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.
2The conducted, harmonic, and flicker emissions testing was only performed on the mains-powered
camcorder and mains-powered PC when providing power to the Trex HD Monitoring amplifier via USB
connection. This testing was not performed on the Trex HD Monitoring amplifier in isolation because it is
a battery-powered device.

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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 Monitoring is intended for use in the electromagnetic environment specified below. The
customer or the user of the Trex HD Monitoring 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 2.5
GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the Trex HD
Monitoring, 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 survey3,
should be less than the compliance level in each
frequency range4.
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.
3Field 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 Monitoring is used exceeds the applicable RF compliance level above, the Trex HD
Monitoring 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 Monitoring.
4Over 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 Trex HD Monitoring
The Trex HD Monitoring is intended for use in the electromagnetic in which radiated RF disturbances
are controlled. The customer or user of the Trex HD Monitoring can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the Trex HD Monitoring as recommended below, according to the
maximum output power of the communications equipment.
Rated maximum
output power of
transmitter (W)
Separation distance according to the frequency of transmitter (m)
from 150kHz to
80MHz
d= 1.2 x √P
from 80MHz to
800MHz
d= 1.2 x √P
from 800MHz to
2.5GHz
d= 2.3 x √P
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 the 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

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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 or 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 IPX0 – 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 Monitoring 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 Monitoring 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.
Nonin 8000J pulse oximeter sensors used with the Trex HD Monitoring amplifier are in
compliance with the requirements of 6.1 and 6.2 when used with the Natus Nonin LP Trex
Cable (p/n 010382).
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 Monitoring unit can be wiped clean with a
soft, damp cloth using non-conductive distilled water, electrically non-conductive inert
surfactants or a Natus -approved cold sterilizing agent. It is important to dry off the unit
quickly. Avoid letting liquid seep into any of the internal electronics of the system. Do not
use any abrasive cleaner on the system.
When the Trex HD Monitoring amplifier is in the Trex HD Monitoring IPX2-certified pouch
(p/n 021995), it is offered protection from dripping water from above the device for up to
10 minutes in duration.

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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.
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 Monitoring should be removed when
the Trex HD Monitoring is not in use.
Dispose of used, non-rechargeable batteries in accordance with local regulations, and
manufacturer’s instructions.
The Trex HD Monitoring 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 Monitoring 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 Monitoring, even
if that other equipment complies with CISPR Emission requirements (see Section 2.1.3).
The Trex HD Monitoring 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 Monitoring 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.

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Do not install the Trex HD Monitoring system or use an electrical outlet within 10 feet of a
swimming pool.
Do not use with an electrical outlet in the bathroom.
3.2. Electrical Warnings and Cautions
Natus systems are intended for connection to a properly grounded electrical outlet only.
Conductive parts of electrodes and their connectors are not to contact other conductive
parts including earth.
Do not place MULTIPLE PORTABLE SOCKET-OUTLETS (MPSOs) on the floor.
Do not connect additional MPSO’s or extension cords to the Trex HD Monitoring system.
Do not use the MPSO with the Trex HD Monitoring 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 Monitoring 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.

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18
ELECTRICAL SHOCK HAZARD: Do NOT service the system. Refer servicing to qualified
personnel only. Do NOT use repaired components without proper testing.
3.3. Electrostatic Discharge (ESD) Precautions:
Electrostatic Discharge (ESD) Precaution: Be sure to take the appropriate
Electrostatic Discharge (ESD) precautions. Disconnect the cables before
moving, cabling, or performing any set up procedures. Connectors marked with
the ESD protection symbol should not be touched. For detailed handling
procedures, refer to the Electrostatic Discharge Handling Procedure section.
3.4. Wireless Option Warnings and Cautions
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 acquisition computer
and the Trex HD Monitoring. In either of these situations, the wireless data will not be
received by the acquisition computer.
The Trex HD Monitoring contains FCC ID: R47F2M03GL 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.
The Trex HD Monitoring contains F2M03GLA which has passed the Bluetooth
Qualification/Certification process as specified within the Bluetooth Specifications and as
required within the PRD 2.0.
QDID: B012541.
Mobile RF communications equipment may affect the Trex HD Monitoring and interfere
with wireless operation. See Section 2.1.3 for guidelines.
3.5. 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 Monitoring amplifier is NOT intended for use with High Frequency Surgical
Equipment.

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19
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 touch proof style electrode inputs. Do NOT attempt to use any
other style of patient electrode input.
The patient event button attached to the Trex HD Monitoring 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.
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 Monitoring system accessible metal parts and the patient
simultaneously.
Do not use the Trex HD Monitoring 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 with the use of system accessories and application
products. Consult clinician on any allergies before use.
Do not use the Trex HD Monitoring system when outside the Trex HD Monitoring pouch as
the device is not IPX certified when used outside of the pouch.

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20
3.6. 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.
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.
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 can occur when the patient has hypotension, severe vasoconstriction,
severe anemia or hypothermia.
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.