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
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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.

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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.

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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

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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

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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

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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

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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

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3 Warranty, Maintenance and After-Sales Service
This section offers you important information about:
▪warranty conditions
▪maintenance
▪cleaning and disinfection recommendations
▪handling disposables
▪recycling and disposal of the device
3.1 Warranty
The MAICO device is guaranteed for at least one year. Ask your authorized local
distributor for more information.
This warranty is extended to the original purchaser of the device by MAICO through
the distributor from whom it was purchased and covers defects in material and
workmanship for a period of at least one year from date of delivery of the device to the
original purchaser.
The device shall only be repaired and serviced by your distributor or by an authorized
service center. Opening the device case will void the warranty.
In the event of repair during the guarantee period, please enclose evidence of
purchase with the device.
3.2 Maintenance
In order to ensure that the device works properly, it has to be checked and calibrated
at least every twelve months.
The service and calibration must be performed by your dealer or to a service center
authorized by MAICO.
When returning the device for repairs or calibration it is essential to send the acoustic
transducers with the device. Please include a detailed description of faults. In order to
prevent damage in transit, please use the original packing when returning the device.
3.3 Cleaning and Disinfection Recommendations
It is recommended that parts (device like headphones, ear cushions) which come in
direct contact with the patient be subjected to standard cleaning and disinfecting
procedure between patients.
Recommendations for cleaning and disinfection of MAICO device presented in this
document are not intended to replace or contradict policies in effect or procedures
required for infection control at the facility.

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If there is not a high infection potential, MAICO recommends:
•For cleaning use a lightly dampened cloth with soap water solution.
•Disinfect the plastic housing of the MA 1 and its accessories by wiping the
surfaces with disinfectant wipes or a comparable product. Follow the
instructions on the specific disinfection product.
oWipe before and after each patient
oAfter contamination
oAfter infectious patients
To avoid damage of the device and its accessories, please mind
the following:
•Do not autoclave or sterilize.
•Do not use the device in the presence of fluid that can come into
contact with any of the electronic components or wiring.
Should the user suspect fluids have contacted the system
components or accessories, the unit should not be used until
deemed safe by a MAICO certified service technician.
Do not usehard orpointedobjects on the device or its accessories.
Use 70 % isopropyl alcohol only on hard cover surfaces.
3.4 Disposables
Use only the Sanibel Supply disposable supplies that are supplied with your device.
Ear cushion covers are intended for single-use only. These
should be discarded after use. They cannot be cleaned.
In case of re-use of the single-use disposables, you enhance
the risk of cross-contamination!
3.5 Components/Replacement Parts
Some reusable components are subject to wear with use over time. MAICO recommends
that you keep these replacement parts available (as appropriate for your MA 1 device
configuration). Ask your authorized local distributor when accessories needto be replaced.
3.6 Recycling and Disposal
Within theEuropean Union it is illegal to dispose of electric and
electronicwasteasunsortedmunicipalwaste.Accordingtothis,
allMAICOproductssoldafterAugust13,2005,aremarkedwith
a crossed-out wheeled bin. Within the limits of Article (9) of
DIRECTIVE 2002/96/EC on waste electrical and electronic
equipment (WEEE), MAICO has changed their sales policy. To
avoid additional distribution costs we assign the responsibility
for the proper collection and treatment according to legal
regulations to our customers.
Non-European countries
Outside the European Union, local regulations should be
followed when disposing of the product after its useful life.
CAUTION
CAUTION
WARNING

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4 Unpacking and Installation
This section provides information on:
▪unpacking the system
▪becoming familiar with the hardware
▪how to store the device
4.1 Unpacking the System
Check Box and Contents for Damage
•It is recommended that you unpack your MA 1 carefully making sure that all
components are removed from the packing materials.
•Verify that all components are included as shown on the packing slip included
with your shipment.
•If any component is missing, contact your distributor immediately to report the
shortage.
•If any component appears to be damaged in shipment, contact your distributor
immediately to report it. Do not attempt to use any component or device that
appears to be damaged.
Reporting Imperfections
Notify the carrier immediately if any mechanical damage is noted. This will insure that
a proper claim is made. Save all packaging material so the claim adjuster can inspect
it as well.
Report Immediately any Faults
Any missing part or malfunction should be reported immediately to the supplier of the
device together with the invoice, serial number, and a detailed report of the problem.
Keep Packaging for Future Shipment
Save all the original packing material and the shipping container so the device can be
properly packed if it needs to be returned for service or calibration (see section 3.2).

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The MA 1 comes with different components (see the following tables). The availability
of configurations with the following components is country and version specific.
Contact your local distributor for more information.
Table 2 Available Components
Components
MA 1 Base Unit
MA 1 Stand
DD45 Audiometric Headset*
DD65 v2 Audiometric Headset*
2x AA Batteries
Carrying Case
Operation Manual**
Quick Guide**
Audiogram Pad
*Applied parts according to IEC 60601-1
**As download from the download center - see accompanying leaflet.
Table 3 Replacement Parts and Disposables
Replacement Parts and Disposables
Ear Cushion Cover
Audiogram Pad
4.2 Hardware Orientation –Connection for Headphones
The MA 1 has a single socket for both right and left earphones. While the device is
off, insert the headphone into the socket ensuring it is completely seated prior to turning
the device on.
Figure 1
Socket for headphone

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4.3 Battery Compartment
Figure 2
To install batteries:
1. Pull the tab on the battery compartment and remove
panel.
2. Insert 2 AA batteries oriented as shown.
3. Reposition the panel and snap the tab back into place.
4.4 Battery Life
NOTE: MAICO recommends using AA Alkaline Batteries
Batteries will last approximately 30,000 tone presentations. The MA 1 has an auto
shut-off to conserve battery life. The device will power off after 90 s of inactivity.
When batteries get too low to produce the proper signal (remaining battery power of
2.1 V or lower), the device will shut off and will not turn back on until batteries are
replaced.
4.5 Storage
When the MA 1 is not in use, store in a location where it will be safe from damage to
sensitive components such as the acoustic transducers and cables. Store according
to the recommended temperature conditions described in section 6.1.
Leaking batteries can cause damage to the device.
Remove batteries from the device if you will not be using
it for a longer period of time.
CAUTION

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5 Operating the Device
This section offers you information about:
▪how to get started with the MA 1
▪preparing the patient for testing
▪performing a hearing screening
5.1 Getting Started with the MA 1
5.1.1 Use of Equipment After Transport and Storage
Make sure the device is functioning correctly before use. If the device has been stored in a
colder environment (even for shorter time) allow the device to become acclimatized. This
can take a long time depending on the conditions (like environmental humidity). You can
reducethecondensationbystoringthedeviceinitsoriginalpackaging.Ifthedeviceisstored
underwarmer conditions than the use conditionsno special precaution are required before
use. Always ensure proper operation of the device by following routine check procedures
for audiometric equipment.
5.1.2 Switching the Device On and Off
Switch on the device by pressing the black right/left button to turn on the MA 1.
An automatic power shutoff occurs after 90 s of inactivity to conserve battery life.
5.2 Front Panel Controls
Figure 3
Table 4 Explanation of Front Panel
No.
Function
1
Power button and R/L Ear Selector
2
LED Ear Indicator, R = right, L = Left
3
LED Level Indicator
4
dB Level selector buttons
5
Frequency selector buttons/stimulus presentation buttons
2
c
1
2
3
4
5
2
4

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5.3 Preparing for Testing
5.3.1 Preparing the Patient
The patient should sit with back to device and examiner so they do not see any
pressing of the buttons.
Prior to hearing threshold level measurements, the following instructions should be
given: "You will now hear a variety of tones with various loudness levels, raise your
hand as soon as you hear the tone in either ear“.
5.3.2 Placement of Headphones
Figure 4
Eliminate any obstructions which will interfere with the
placement of the ear cushions on the ear (i.e. hair,
eyeglasses).
Ensure that the headphones (Figure 4) are positioned
correctly: red phone on the right ear, blue phone on the left
ear. Adjust the headband of the headphones so that the
earphones are positioned at the correct height (i.e. the
sound output grid exactly facing the ear canal).
5.3.3 Test Environment
Excessive sounds or noises in the chosen test environment can produce a masking effect
and therefore affect test results. The selected site should be away from conversations,
hallway traffic, outside auto traffic, and other noise producing environments.
5.4 Performing Tone Tests with MA 1 (Air Conduction Testing)
5.4.1 Screening
A hearing screening utilizes a Pass or Refer result and is used to determine if further
testing is required as a hearing problem may exist. Patients are typically screened at
a level of 20 dB HL at 500 Hz, 1000 Hz, 2000 Hz, and 4000Hz in each ear. If a patient
hears all the tones in each ear, the result would be considered a Pass. Failure to hear
even one of the tones in either ear would result in a Refer.
NOTE: This is an example of one screening protocol. Each state may have their own
screening protocol. Contact your state health department for guidelines in your area.
5.5 Conducting a Hearing Screening
5.5.1 Familiarize the patient with the test procedure
1. Press the black right/left button to turn on the MA 1.
2. Use this same button to select the right ear (red LED).
3. Press the up or down arrow keys to select 50 dB HL.
4. Press the 1000 Hz button 1-2 seconds to present the tone to the patient. The tone
will be presented as long as the corresponding frequency key is held down. (This
level is loud enough that a normal hearing patient should hear the tone clearly in a
quiet setting.)
5. The patient should raise their hand when the tone is played. Play the tone a second
time to make sure they understand the task. If not, re-instruct and try again. If no
response is obtained, change to the left ear to confirm unresponsiveness.

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5.5.2 Perform the Hearing Screening
Once the patient understands the task, continue to the screening process.
1. Change the hearing level to 20 dB HL and press the 1000 Hz button 1-2 seconds
to present the tone to the patient.
2. Record whether the patient responded by raising their hand. Present again to
confirm response at 20 dB HL.
3. Continue the same procedure for the other frequencies. Record all results on the
audiogram card provided.
4. Patients are typically screened at a level of 20 dB HL at 500 Hz, 1000 Hz, 2000 Hz,
and 4000Hz in each ear. If a patient hears all the tones in each ear, the result would
be considered a Pass. Failure to hear even one of the tones in either ear would
result in a Refer.
Note: When presenting tones, be sure to vary the timing of the tone presentation.
This is to prevent the patient from routinely raising his/her hand instead of responding
to the actual tone presentation.
•Best practice is to confirm each frequencies response before moving to the
next frequency. Limit testing to no more than 4 presentations to reduce false
positive responses.
•When no response is given at one or more frequencies, reinstruct the patient,
reposition headphones and, when possible, change examiners. Continue
rescreen within the same screening period.
5.5.3 Results
PASS: The screening is considered a pass result if the child responds to all screening
frequencies in both ears.
REFER: The child does NOT pass the screening and should be referred for further
testing if:
•child misses any of the frequencies in either ear, even if it is just one, OR
•cannot complete the screening process.

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6 Technical Data
This section offers you important information about
▪the MA 1 hardware specifications
▪connections
▪the pin assignment
▪calibration values and maximum levels
▪electromagnetic compatibility (EMC)
▪electrical safety, EMC and associated Standards
6.1 MA 1 Hardware
The MA 1 is an active, diagnostic medical product
according to the class IIa of the Medical Device
Regulation (EU) 2017/745.
General Information About Specifications
The performance and specifications of the device canonly be guaranteed if it is subject
to technical maintenance at least once every 12 months.
MAICO Diagnostics puts diagrams and service manuals at the disposal of authorized
service companies.
STANDARDS
Safety Standards
IEC 60601-1:2005 + Cor. :2006 + Cor. :2007 + A1:2012
Internally powered, Type B Applied Parts
EMC Standard
IEC 60601-1-2:2014
The MA 1 is not classified according to the standard EN 60645-1 and is not in conformity
with this standard.
DEVICE SPECIFICATIONS
Mode of Operation
Continuous
Batteries
Battery Type
2 x AA
Battery power required for operation: > 2.1 V
Battery operation
Automatic battery on/off switching
Battery Life
Standby: 6 months, depending on the battery self-discharge,
Tone presentations: 30,000
Environmental
conditions
Operation:
+15 °C to +35 °C /
+ 59 °F to +95 °F
Relativehumidity 30 % to 90 % (non-condensing)
Air pressure 98 kPa to 104 kPa
Maximumaltitude:2000m/6561ftabovesealevel
Storage:
0 °C to + 50 °C / 32 °F to +122 °F
Humidity 10 to 95 % (non-condensing)
Transport:
-20 °C to + 50 °C / -4 °F to +122 °F
Humidity 10 % to 95 % (non-condensing)

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Calibration
Calibration information and instructions are located in the
MA 1 Service Manual.
Transducers
Air Conduction
DD45:
RadioEar Standard Values
DD65 v2:
RadioEar Standard Values
Transducers –
Headband tension
DD45:
Headband Static Force: 4.5 N ± 0.5 N
DD65 v2:
Headband Static Force: 10.0 N ± 0.7 N
Inputs
Tone
Accuracy
Level ± 4 dB
Precision
5 dB level steps
Outputs
Left, Right
Stimuli
Presentation
Manual, continuous
Intensity
AC: 15 dB HLto 50 dBHL
Frequency range
500 Hz to 4000 Hz
Weight
952,5 g/2.1 lbs with accessories and carry case.
Dimensions
6.35 x 15.24 x 2.22 cm / 2.5 x 6 x 7/8 inches
Warm Up Time
None
Distortion:
<3 %