natus Xltek Trex HD Troubleshooting guide

Trex™HD Monitoring Amplifier
User & Service Manual

Publisher’s Notice
019694 Rev 03
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] or Fax: [phone]
Toll Free (US & Canada): 800-303-0306
Technical Support Email: [e-mail]
Website: www.natus.com
Copyright © 2016 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.

User & Service Manual Trex™ HD Monitoring Amplifier
3
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.............................................................7
2.1.1. Standards of Compliance and Normative References........................................................7
2.1.2. Declaration of Compliance for IEC 60601-1-2....................................................................9
2.1.3. Electromagnetic Immunity (EMI) Information –FCC........................................................13
3. Warnings and Cautions...............................................................................................14
3.1. General Warnings.....................................................................................................................14
3.2. Electrical Warnings and Cautions ..........................................................................................16
3.3. Electrostatic Discharge (ESD) Precautions:..........................................................................17
3.4. Wireless Option Warnings and Cautions...............................................................................17
3.5. Patient Environment Warnings and Cautions .......................................................................17
3.6. Pulse Oximeter Warnings........................................................................................................18
3.7. Pulse Oximeter Sensor Warnings...........................................................................................20
3.8. Transportation Warnings.........................................................................................................21
3.9. Conducted Immunity Warnings ..............................................................................................21
4. Procedures and Warnings ..........................................................................................22
4.1. Electrostatic Discharge (ESD) Handling Procedures and Warnings ..................................22
4.2. Conducted Immunity Procedures and Warnings..................................................................23
5. Description of Symbols...............................................................................................24
6. Specifications..............................................................................................................26
7. Product Images ...........................................................................................................28
7.1. Front View .................................................................................................................................28
7.2. Rear View...................................................................................................................................29
8. Unpacking....................................................................................................................30
8.1. Trex HD Monitoring Package Items........................................................................................30
8.2. Optional Accessories...............................................................................................................31
9. Setting Up ....................................................................................................................32
9.1. Getting Started..........................................................................................................................32
9.1.1. Placement of the Operator and Patient ............................................................................32
9.1.2. Beginning a study..............................................................................................................32
9.1.3. Monitoring an ongoing ambulatory study..........................................................................33
9.1.4. Backfill and reviewing an ongoing ambulatory study........................................................33
9.1.5. Powering Down the System..............................................................................................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............................................................37
9.4. Testing the Trex HD Amplifier.................................................................................................37
9.4.1. Calibration and Verification...............................................................................................37
9.4.2. Channel Test.....................................................................................................................38
9.4.3. Impedance Check .............................................................................................................39
10. Nonin Xpod Pulse Oximeter .......................................................................................40

Trex™ HD Monitoring Amplifier User & Service Manual
4
10.1. No Implied License.................................................................................................................40
10.2. Indications for Use .................................................................................................................40
10.3. Accessories.............................................................................................................................40
10.3.1. Cables.............................................................................................................................40
10.3.2. Available Oximetry Sensors............................................................................................41
10.4. Measurements ........................................................................................................................42
10.5. Displayed Ranges...................................................................................................................42
11. Guaranteeing Sufficient Battery Power .....................................................................43
11.1. Battery Power with AA Batteries (only)................................................................................43
11.2. Battery Power with AA Batteries and Power Pack..............................................................44
12. External Power Pack...................................................................................................45
12.1. Power Pack Symbols .............................................................................................................45
12.2. External Power Pack Specifications.....................................................................................45
12.3. External Power Pack Warnings and Cautions.....................................................................46
12.4. Using the External Power Pack Kit.......................................................................................47
12.5. External Power Pack and Charging Details.........................................................................48
12.5.1. External Power Pack LED Indicators..............................................................................48
12.6. Charging the External Power Pack.......................................................................................49
12.7. Disconnecting the External Power Pack..............................................................................49
12.8. Storing the External Power Pack ..........................................................................................49
12.9. Troubleshooting the External Power Pack ..........................................................................49
13. How to Disable Channels and Set Frequency...........................................................51
14. Maintenance, Cleaning, & Disposal............................................................................52
14.1. Recommendations .................................................................................................................52
14.2. Disposal...................................................................................................................................53
14.3. Expected Service Life ............................................................................................................53
15. Troubleshooting..........................................................................................................54
16. Getting Help.................................................................................................................55
17. EEG and Sleep Accessories.......................................................................................56
18. Index.............................................................................................................................57

User & Service Manual Trex™ HD Monitoring Amplifier
5
1. Introduction
The Natus Trex HD 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®v8.1.x software to assist with diagnosis.
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 Natus patient-worn transducers
Internal memory for up to 96hr of EEG recording
Battery powered by two AA alkaline batteries and an optional power 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
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.
WARNINGS:
The NeuroWorks 8.1.1 software for Trex HD monitoring is strictly for use with the Trex HD
monitoring amplifier. It does not support any other Natus amplifiers.
This Trex HD monitoring amplifier can only be used with the NeuroWorks 8.1.1 software for
Trex HD monitoring. This software comes installed on a qualified tablet computer. Do not load
the software on to any other computer model.
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 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).
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.

Trex™ HD Monitoring Amplifier User & Service Manual
6
1.1. Intended Use
The Trex HD 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 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 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.
1.3. 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.

User & Service Manual Trex™ HD Monitoring Amplifier
7
2. Safety and Standards Conformity
2.1. Safety and Standards Conformity for Natus Trex HD
2.1.1. Standards of Compliance and Normative References
Electroencephalograph system, model Trex HD; 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 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 and its accessories have been designed to comply with the following national and
international standards.
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

Trex™ HD Monitoring Amplifier User & Service Manual
8
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
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

User & Service Manual Trex™ HD Monitoring Amplifier
9
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
2.1.2. Declaration of Compliance for IEC 60601-1-2
Table 1 - Electromagnetic Emissions
1
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
1
The 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 amplifier via USB connection.
This testing was not performed on the Trex HD amplifier in isolation because it is a battery-powered
device.

Trex™ HD Monitoring Amplifier User & Service Manual
10
Table 2 - Electromagnetic Immunity
2
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
±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 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
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.
2
The electrostatic fast transient, surge, and voltage dips testing was only performed on the mains-
powered camcorder and mains-powered PC when providing power to the Trex HD amplifier via USB
connection. This testing was not performed on the Trex HD amplifier in isolation because it is a battery-
powered device.