Maico MB 11 BERAphone User manual

Operation Manual
MB 11
BERAphone®/ Classic

Operation Manual MB 11 BERAphone
®
/Classic
8100496 Rev. 6
1
23/10/2019
Contents
1Introduction 3
General.......................................................................................................... 3
Intended Use Statement................................................................................ 3
Contraindications of Use ............................................................................... 4
Essential Performance .................................................................................. 4
Features and Benefits ................................................................................... 4
Description .................................................................................................... 5
2Warnings 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
3Warranty, Maintenance and After-Sales Service 13
Warranty.......................................................................................................13
Maintenance.................................................................................................13
Cleaning and Disinfection Recommendations..............................................14
Troubleshooting............................................................................................19
Recycling and Disposal................................................................................21
4Unpacking 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
5Operating 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
6Technical Data 73
MB 11 Hardware...........................................................................................73
Pin assignment.............................................................................................77
Calibration values.........................................................................................78
Electromagnetic Compatibility (EMC)...........................................................80
Electrical Safety, EMC and Associated Standards.......................................82

Operation Manual MB 11 BERAphone
®
/Classic
8100496 Rev. 6
2
23/10/2019
Title: Operation Manual MB 11 BERAphone®/ Classic
Date of issue/last revision: 23/10/2019
MAICO Diagnostics GmbH
Sickingenstr. 70-71
10553 Berlin
Germany
Tel.: + 49 30 / 70 71 46-50
Fax: + 49 30 / 70 7146-99
E-mail: [e-mail]
Internet: www.maico.biz
Copyright © 2019 MAICO Diagnostics
All rights reserved. No part of this publication may be reproduced or transmitted in any
form or by any means without the prior written permission of MAICO Diagnostics. The
information in this publication is proprietary to MAICO Diagnostics.
Compliance
MAICO Diagnostics is an ISO 13485 certified corporation.
Caution for USA: Federal Law restricts this device to sale by or on the order of a
licensed medical professional.
Trademark Notice
CE-CHIRP® is a trademark by MAICO Diagnostics GmbH registered in the USA,
the European Union, Switzerland and Norway.
Nuprep®is a U.S. registered trademark of Weaver and Company.
Windows® is a registered trademark of Microsoft in the USA and other countries.
NVIDIA® is a registered trademark of NVIDIA Corporationin the USA andother countries.
BERAphone®is a registered trademark of MAICO Diagnostics registered in the
European Union and Japan.
EarCupTM is an unregistered trademark of Sanibel Supply for use in the USA.
HiTrackTM is an unregistered trademark of NCHAM for use in the USA.

Operation Manual MB 11 BERAphone
®
/Classic
8100496 Rev. 6
3
23/10/2019
1 Introduction
This section offers you important information about:
▪the intended use of the device
▪indications and contraindications of use
▪essential performance
▪features and benefits
▪a description of the device
General
Thank you for purchasing a quality product from the MAICO product family.
TheMB 11isdesignedandmanufacturedtomeetallqualityandsafetyrequirements.When
designing the MB 11, MAICO placed particular importance on making it a user-friendly
device. The intent was to make its operation easy-to-learn, thus making the device simple
and easy to operate.
This operation manual is for MB 11 BERAphone®and Classic versions. If sections or
parts of sections of this operation manual apply only to certain versions of the device,
they are marked with the version names.
This operation manual is meant to make it as easy as possible for the operator to
become familiar with the operation and functions of the MB 11 when performing
automated ABR tests. If you have questions or suggestions for further improvements,
please do not hesitate to contact MAICO.
Intended Use Statement
The MAICO MB 11 BERAphone®and MB 11 Classic are intended for use in the
audiologic evaluation and documentation of ear and nerve disorders using auditory
evoked potentials from the auditory nerve and the brainstem.
The devices are intended to be used for Newborn Hearing Screening (NHS) using
automated auditory brainstem response tests. The aim is to detect those babies with
possible auditory or hearing-related deficits and to refer them on for further testing to
confirm or rule out a disorder.
Target population
The MB 11 Classic is intended tobe usedfor hearing screening of newborns andinfantsup
to 6 months.
The MB 11 BERAphone®includes components that are optimized in size and shape
for newborns up to approximately 3 months of age. Older infants with larger ears may
be difficult to test with the BERAphone®. The key to an acceptable fit is to achieve
contact of the ear cushion all around its edge with no gaps between the skin and the
cushion. Any gaps can lead to a reduction in the stimulus intensity, increasing test time
and the chance of a Refer outcome.