Maico MA 1 User manual

Operation Manual
MA 1

Operation Manual MA 1
8100216 Rev. 5
1
21/02/2023
Table of Contents
1 Introduction............................................................................................................ 2
1.1 Intended Use...................................................................................................... 2
1.2 Indications for Use Statement............................................................................ 2
1.3 Contraindications of Use.................................................................................... 2
1.4 Features and Benefits........................................................................................ 2
1.5 Description......................................................................................................... 2
2 For Your Safety...................................................................................................... 3
2.1 How to Read this Operation Manual .................................................................. 3
2.2 Customer Responsibility .................................................................................... 4
2.3 Manufacturer’s Liability ...................................................................................... 4
2.4 Regulatory Symbols........................................................................................... 5
2.5 General Precautions .......................................................................................... 6
2.6 Electrical and Electrostatic Safety...................................................................... 6
2.7 Device Control.................................................................................................... 7
2.8 Electromagnetic Compatibility (EMC)................................................................. 7
3 Warranty, Maintenance and After-Sales Service ................................................ 8
3.1 Warranty ............................................................................................................ 8
3.2 Maintenance....................................................................................................... 8
3.3 Cleaning and Disinfection Recommendations.................................................... 8
3.4 Disposables ....................................................................................................... 9
3.5 Components/Replacement Parts ....................................................................... 9
3.6 Recycling and Disposal...................................................................................... 9
4 Unpacking and Installation................................................................................. 10
4.1 Unpacking the System..................................................................................... 10
4.2 Hardware Orientation –Connection for Headphones....................................... 11
4.3 Battery Compartment....................................................................................... 12
4.4 Battery Life....................................................................................................... 12
4.5 Storage ............................................................................................................ 12
5 Operating the Device........................................................................................... 13
5.1 Getting Started with the MA 1 .......................................................................... 13
5.2 Front Panel Controls........................................................................................ 13
5.3 Preparing for Testing........................................................................................ 14
5.4 Performing Tone Tests with MA 1 (Air Conduction Testing) ............................ 14
5.5 Conducting a Hearing Screening ..................................................................... 14
6 Technical Data ..................................................................................................... 16
6.1 MA 1 Hardware................................................................................................ 16
6.2 Connections..................................................................................................... 18
6.3 Pin Assignment................................................................................................ 18
6.4 Calibration Values and Maximum Levels ......................................................... 19
6.5 Electromagnetic Compatibility (EMC)............................................................... 20
6.6 Electrical Safety, EMC and Associated Standards........................................... 22
6.7 Checklist for Subjective Device Check............................................................. 23

Operation Manual MA 1
8100216 Rev. 5
1
09/03/2023
Title: Operation Manual MA 1
Date of issue/last revision: 09/03/2023
All available operation manuals can be found in the
download center on the MAICO homepage:
MAICO Diagnostics GmbH
Sickingenstr. 70-71
10553 Berlin
Germany
Tel.: [phone]
Fax: [phone]
E-mail: [email protected]
Internet: www.maico.biz
Germany:
https://www.maico-
diagnostics.com/german/support/resources/
International:
https://www.maico-
diagnostics.com/support/resources/
Copyright © 2023 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 GmbH 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.

Operation Manual MA 1
8100216 Rev. 5
2
09/03/2023
1 Introduction
This section offers you important information about:
▪the intended use of the device
▪indications and contraindications of use
▪features and benefits
▪a description of the device
1.1 Intended Use
The MA 1 is a device designed to perform a hearing screening. The instrument is
intended for all patient populations over 3 years old and able to respond to test signals
in a rational way
1.2 Indications for Use Statement
The MA 1 is a portable or hand-held device intended to be used for the identification of
hearing loss and the factors that contribute to the occurrence of hearing loss. It is used
as part of a total test battery to determine hearing acuity by audiologists, ENTs, hearing
healthcare professionals, or other trained technicians in a hospital, clinic, or healthcare
facility.
1.3 Contraindications of Use
The patient is too young, sick or uncooperative to perform the tasks.
1.4 Features and Benefits
The MA 1 gives you the benefit of
•Compact handheld portable device
•Multiple transducer options
•Air Conduction
•Battery operation
1.5 Description
The MA 1 screening device is designed for screening of hearing loss. Output and
specificity of this type of device are based on the test characteristics defined by the
user, and may vary depending on environmental and operating conditions. Screening
for hearing loss using this kind of device depends on the interaction with the patient.
As with any type of hearing screening, a “pass” result should not overrule any additional
concerns regarding hearing ability. A full audiologic evaluation should be administered
if concerns about hearing sensitivity persist.

Operation Manual MA 1
8100216 Rev. 5
3
09/03/2023
2 For Your Safety
This section offers you important information about:
▪how to read the operation manual
▪the customer responsibility
▪the explanation of all regulatory symbols used
▪important cautions and warnings that have to be considered during
the whole time handling and operating your device
2.1 How to Read this Operation Manual
This Operation Manual contains information pertinent to the use of the MAICO device
system including safety information as well as maintenance and cleaning
recommendations.
READ THIS ENTIRE OPERATION MANUAL BEFORE
ATTEMPTING TO USE THIS SYSTEM!
Use this device only as described in this operation manual.
In this operation manual, the following two labels identify potentially dangerous or
destructive conditions and procedures:
The WARNING label identifies conditions or practices that
may present danger to the patient and/or user.
The CAUTION label identifies conditions or practices that
could result in damage to the equipment
NOTE: Notes help you identify areas of possible confusion and avoid potential problems
during system operation.
WARNING
CAUTION

Operation Manual MA 1
8100216 Rev. 5
4
09/03/2023
2.2 Customer Responsibility
All safety precautions given in this operation manual must be observed at all times.
Failure to observe these precautions could result in damage to the equipment and
injury to the operator or subject.
The employer should instruct each employee in the recognition and avoidance of
unsafe conditions and the regulations applicable to his or her work environment to
control or eliminate any hazards or other exposure to illness or injury.
It is understood that safety rules within individual organizations vary. If a conflict exists
between the material contained in this manual and the rules of the organization using
this device, the more stringent rules should take precedence.
This product and its components will perform reliably only
when operated and maintained in accordance with the
instructions contained in this manual, accompanying labels,
and/or inserts. A defective product shouldnot be used. Make
sure all connections to external accessories are snug and
secured properly. Parts which may be broken or missing or
are visibly worn, distorted, or contaminated should be
replaced immediately with clean, genuine replacement parts
manufactured by or available from MAICO.
NOTE: Customer responsibility includes proper maintenance and cleaning of the
device (see sections 3.2 and 3.3). Breach of the customer responsibility can lead to
limitations of Manufacturer’s Liability and Warranty (see sections 2.3 and 3.1).
NOTE: In the unlikely case of a serious incident, inform MAICO as well as the
competent authority in the country where the user is established.
2.3 Manufacturer’s Liability
Usage of the device in a way deviant from the intended use will lead to a limitation or
termination of the manufacturer’s liability in case of damage. Improper use includes
disregarding the operation manual, the operation of the device by underqualified
personnel as well as making unauthorized alterations on the device.
WARNING

Operation Manual MA 1
8100216 Rev. 5
5
09/03/2023
2.4 Regulatory Symbols
The following Table 1 gives an explanation of the symbols used on the device itself,
on the packaging and the accompanying documents including the Operation Manual.
Table 1 Regulatory Symbols
REGULATORY SYMBOLS
SYMBOL
DESCRIPTION
Serial number
Date of manufacture
Manufacturer
Caution, consult accompanying documents
Warning, consult accompanying documents
Returntoauthorizedrepresentative,specialdisposalrequired
Reference number
Medical Device
Global Trade Item Number
Patient applied part type B according to IEC 60601-1
Refer to instruction manual (mandatory)
Keep away from rain
Transport and storage temperature range
Transport and storage humidity limitations
Transport and storage atmospheric pressure limitations
Do not reuse
Conforms to Medical Device Regulation (EU) 2017/745
Non-ionizing electromagnetic radiation
Logo

Operation Manual MA 1
8100216 Rev. 5
6
09/03/2023
2.5 General Precautions
Before starting a measurement make sure, that the device
works properly.
Use and store the device indoors only. For operation,
storage and transport conditions see table in section 6.1.
For operation in certain places, a recalibration may be
necessary.
No modification of this equipment is allowed.
Equipment is not user repairable. Repairs must be
performed by a qualified service representative only. No
modifications of the equipment are allowed by anyone
other than a qualified MAICO representative. Modification
of the equipment could be hazardous. No part of the
equipment can be serviced or maintained while in use with
the patient.
Do not drop or otherwise cause undue impact to this
device. If the device is dropped or otherwise damaged,
return it to the manufacturer for repair and/or calibration.
Do not use the device if any damage is suspected.
Calibration of the device: The device and the transducers
complement each other and share the same serial number
(i.e. MA7663252). Therefore, the device shall not be used
with any other transducer prior to recalibration.
Recalibration also needs to be conducted, when a
defected headphone is replaced.
Uncalibrated devices may lead tofaulty measurement results
and could even damage the hearing of theexaminee.
2.6 Electrical and Electrostatic Safety
This icon indicates that patient applied parts of the device
conform to IEC 60601-1 Type B requirements.
Donottouchthecontactsofthedeviceandthepatientatthesame
time.
The consequence of not following this warning could be a
too high leakage current to the patient.
The device is not intended for operation in areas with an
explosion hazard. Do NOT use the device in a highly
oxygen-enriched environment, such as a hyperbaric
chamber, oxygen tent, etc.
Prevent cable breakage: cables must not be bent or
buckled.
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING

Operation Manual MA 1
8100216 Rev. 5
7
09/03/2023
2.7 Device Control
The user of the device should perform a subjective device check once a week
according ISO 8253-1. See section 6.7 for a checklist.
For annual calibration see section 2.5 and 3.2.
2.8 Electromagnetic Compatibility (EMC)
This device is suitable in hospital environments except for
near active HF surgical equipment and RF shielded rooms
of systems for magnetic resonance imaging, where the
intensity of electromagnetic disturbance is high.
The device fulfills the relevant EMC requirements. Avoid
unnecessary exposure to electromagnetic fields, e.g. from
mobile phones etc.
Use of this device adjacent to or stacked with other
equipment should be avoided because it could result in
improper operation. If such use is necessary, this device
and the other equipment should be observed to verify that
they are operating normally.
Use of accessories, transducers and cables other than
those specified or provided by the manufacturer of this
equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
Portable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part
of the device, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment
could result in improper operation.
WARNING
WARNING
WARNING