natus Trex HD, User & Service Manual, Page: 3 / 60

User & Service Manual Trex™ HD Monitoring Amplifier
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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