Contents
1 Introduction 3
General .......................................................................................................... 3
Intended Use Statement ................................................................................ 3
Contraindications of Use ............................................................................... 4
Essential Performance .................................................................................. 4
Features and Benefits ................................................................................... 4
Description .................................................................................................... 5
2 Warnings and Cautions 7
Reading this Operation Manual ..................................................................... 7
Customer Responsibility ................................................................................ 8
Precautions for Patient Confidentiality ........................................................... 8
Manufacturer’s Liability .................................................................................. 8
Regulatory Symbols ...................................................................................... 9
General Precautions .....................................................................................10
Electrical and Electrostatic Safety ................................................................10
Electromagnetic Compatibility (EMC) ...........................................................12
3 Warranty, Maintenance and After-Sales Service 13
Warranty .......................................................................................................13
Maintenance .................................................................................................13
Cleaning and Disinfection Recommendations ..............................................14
Troubleshooting ............................................................................................19
Recycling and Disposal ................................................................................21
4 Unpacking and Hardware Orientation 22
Unpacking the System ..................................................................................22
Use of Equipment after Transport and Storage ............................................23
MB 11 Hardware and System Assembly ......................................................24
MB 11 Software Installation ..........................................................................25
Storage .........................................................................................................37
5 Operating the PC Software 38
Getting Started with MB 11 Software ............................................................38
Preparing for Testing ....................................................................................41
Starting the MB 11 Software .........................................................................48
Automatic Testing in the ABR Screening Mode ............................................49
Performing the Screening Test .....................................................................49
Managing Test Results .................................................................................56
Settings ........................................................................................................65
About Menu ..................................................................................................72
6 Technical Data 73
MB 11 Hardware...........................................................................................73
Pin assignment .............................................................................................77
Calibration values .........................................................................................78
Electromagnetic Compatibility (EMC) ...........................................................80
Electrical Safety, EMC and Associated Standards .......................................82
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