natus neuro Embla Dx Series, User And Service Manual

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Natus® Brain Monitor &
Embla Dx Series™
User and Service Manual
2
Table of Contents
Introduction.................................................................................................................................................... 5
Intended Use ............................................................................................................................................. 5
System Components ................................................................................................................................. 6
Essential Performance .............................................................................................................................. 6
Essential Performance Degradation ...................................................................................................... 6
Operating Principle of the Amplifier ........................................................................................................... 6
Using the Manual ....................................................................................................................................... 7
Manual Conventions .............................................................................................................................. 7
Safety & Standards Conformity ..................................................................................................................... 8
Standards of Compliance and Normative References .............................................................................. 8
Safety Standard of Compliance and Normative References ................................................................. 8
EMC Standard of Compliance and Normative References ................................................................... 8
Declaration of Compliance for IEC 60601-1-2........................................................................................... 9
Table 1 - Electromagnetic Emissions .................................................................................................... 9
Table 2 - Electromagnetic Immunity .................................................................................................... 10
Table 3 - Electromagnetic Immunity
– for EQUIPMENT and SYSTEMS that are not LIFE-
SUPPORTING ..................................................................................................................................... 11
Table 4 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications
equipment ............................................................................................................................................ 12
Declaration of Compliance for FCC ......................................................................................................... 13
Contraindications, Warnings, & Cautions ................................................................................................... 14
Contraindications ..................................................................................................................................... 14
Warnings and Cautions ........................................................................................................................... 14
General Warnings ................................................................................................................................ 14
Electrostatic Discharge (ESD) Precautions: ........................................................................................ 15
Electrical Warnings and Cautions ........................................................................................................ 16
Patient Environment Warnings and Cautions ...................................................................................... 17
Transportation Warnings ..................................................................................................................... 18
Pulse Oximeter Sensor Warnings ........................................................................................................ 18
Conducted Immunity Warnings ............................................................................................................ 19
Procedures and Warnings........................................................................................................................... 20
Electrostatic Discharge (ESD) Handling .................................................................................................. 20
Conducted Immunity Procedures and Warnings ..................................................................................... 21
Description of Symbols ............................................................................................................................... 22
Specifications: Brain Monitor & Embla Dx Series Amplifiers ...................................................................... 24
Product Images ........................................................................................................................................... 26