natus Xltek EMU40EX, User And Service Manual, Page: 3 / 63

User and Service Manual EMU40EX™
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Table of Contents
Device Description ......................................................................................................................................................... 5
Intended Use .......................................................................................................................................................... 5
Indications for Use .................................................................................................................................................. 6
Intended Users and Patient Target Group ............................................................................................................. 6
Clinical Benefits ...................................................................................................................................................... 6
Contraindications and Side Effects ......................................................................................................................... 6
Essential Performance ............................................................................................................................................ 7
Essential Performance Degradation ................................................................................................................ 7
Instructions to access the eIFU ............................................................................................................................... 7
EMU40EX Safety and Standards Conformity ................................................................................................................. 8
Standards of Compliance and Normative References ............................................................................................ 8
Declaration of Compliance for IEC 60601-1-2 ........................................................................................................ 9
Declaration of Compliance for FCC ....................................................................................................................... 12
Warnings, and Cautions ............................................................................................................................................... 13
General Warnings ................................................................................................................................................. 13
Electrical Warnings and Cautions ......................................................................................................................... 14
Patient Environment Warnings and Cautions ...................................................................................................... 16
Pulse Oximeter Warnings and Cautions ............................................................................................................... 17
Wireless Option Warnings .................................................................................................................................... 18
Electromagnetic Interference (EMI) Warnings ..................................................................................................... 19
Transportation Warnings...................................................................................................................................... 19
Cleaning Warnings ................................................................................................................................................ 19
Procedures and Warnings............................................................................................................................................ 21
Electrostatic Discharge (ESD) Handling ................................................................................................................ 21
Conducted Immunity Procedures and Warnings.................................................................................................. 21
Glossary of Symbols ..................................................................................................................................................... 22
System Symbols .................................................................................................................................................... 28
Specifications: EMU40EX Amplifier ............................................................................................................................. 29
Product Images ............................................................................................................................................................ 32
EMU40EX System ................................................................................................................................................. 32
Base Unit .............................................................................................................................................................. 33
EMU40EX Breakout Box ....................................................................................................................................... 34
Unpacking .................................................................................................................................................................... 35
Additional EEG System Components .................................................................................................................... 35
Setting Up .................................................................................................................................................................... 36
Connecting to the computer ................................................................................................................................ 36
USB-Style Connection .................................................................................................................................... 36
Ethernet-Style Connection ............................................................................................................................ 36
Connection Setup for the Base Unit ..................................................................................................................... 36
Setting the IP Address ................................................................................................................................... 38
Touchscreen Icons ......................................................................................................................................... 41
Amplifier Usage and Features ..................................................................................................................................... 42
Getting Started ..................................................................................................................................................... 42