Xltek
®
EMU40EX™ User and Service Manual
2
Table of Contents
INTRODUCTION ........................................................................................................................................... 5
PRODUCT INTENDED USE .......................................................................................................................... 6
THE XLTEK EMU40EX EEG HEADBOX REQUIRES COMPETENT USER INPUT, AND ITS OUTPUT MUST BE
REVIEWED AND INTERPRETED BY TRAINED MEDICAL PROFESSIONALS WHO WILL EXERCISE PROFESSIONAL
JUDGEMENT IN USING THIS INFORMATION. ............................................................................................ 6
SYSTEM COMPONENTS ....................................................................................................................... 6
ESSENTIAL PEFORMANCE ......................................................................................................................... 6
ESSENTIAL PEFORMANCE DEGRADATION ............................................................................................. 6
USING THE MANUAL .................................................................................................................................. 7
MANUAL CONVENTIONS ...................................................................................................................... 7
EMU40EX SAFETY AND STANDARDS CONFORMITY ............................................................................ 8
STANDARDS OF COMPLIANCE AND NORMATIVE REFERENCES ..................................................................... 8
DECLARATION OF COMPLIANCE FOR IEC 60601-1-2 ................................................................................ 10
DECLARATION OF COMPLIANCE FOR FCC ............................................................................................... 13
CONTRAINDICATIONS, WARNINGS, AND CAUTIONS ......................................................................... 14
CONTRAINDICATIONS .............................................................................................................................. 14
WARNINGS AND CAUTIONS ...................................................................................................................... 15
GENERAL WARNINGS........................................................................................................................ 15
ELECTRICAL WARNINGS AND CAUTIONS .................................................................................................. 16
PATIENT ENVIRONMENT WARNINGS AND CAUTIONS ................................................................................. 18
PULSE OXIMETER WARNINGS .................................................................................................................. 19
PULSE OXIMETER SENSOR WARNINGS .................................................................................................... 20
WIRELESS OPTION WARNINGS AND CAUTIONS ........................................................................................ 21
ELECTROMAGNETIC INTERFERENCE (EMI) WARNINGS ............................................................................. 22
CONDUCTED IMMUNITY WARNING ............................................................................................................ 22
TRANSPORTATION WARNINGS ................................................................................................................. 22
PROCEDURES AND WARNINGS ............................................................................................................. 23
ELECTROSTATIC DISACHARGE (ESD) HANDLING ..................................................................................... 23
CONDUCTED IMMUNITY PROCEDURES AND WARNINGS ............................................................................. 23
DESCRIPTION OF SYMBOLS ................................................................................................................... 25
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