Maico ERO SCAN User manual

Operation Manual
ERO•SCAN®
Screening and Diagnostic Version

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Table of Contents
1Introduction..................................................................................................4
1.1 Intended Use Statement.....................................................................4
1.2 Indications for Use Statement............................................................4
1.3 Contraindications of Use Statement...................................................4
1.4 Features.............................................................................................5
1.5 Description......................................................................................... 6
2For Your Safety ............................................................................................ 7
2.1 Reading this Operation Manual..........................................................7
2.2 Customer Responsibility.....................................................................8
2.3 Manufacturer’s Liability.......................................................................8
2.4 Regulatory Symbols...........................................................................9
2.5 General Precautions ........................................................................10
2.6 Electrical and Electrostatic Safety....................................................10
2.7 Electromagnetic Compatibility (EMC)............................................... 12
2.8 Battery Safety...................................................................................13
3Warranty, Maintenance and After-Sales Service.......................................14
3.1 Warranty...........................................................................................14
3.2 Maintenance..................................................................................... 14
3.3 Cleaning and Disinfection Recommendations..................................15
3.4 Disposables –Eartips.......................................................................16
3.5 Disposables –Probe Tubes.............................................................17
3.6 Troubleshooting ...............................................................................18
3.7 Recycling/Disposal........................................................................... 22
4Unpacking and Hardware Orientation........................................................23
4.1 Unpacking the System .....................................................................23
4.2 ERO•SCAN®Hardware and Components........................................ 25
4.3 Handling the Micro-Probe................................................................. 26
4.4 Battery Charging ..............................................................................26
4.5 Establishing a PC-Connection.......................................................... 27
4.6 Using the MPT-IIThermal Printer...................................................... 28
4.7 Storage............................................................................................. 30
5Operating the Device ...................................................................................31
5.1 Getting Started with the ERO•SCAN®.............................................. 31
5.2 Indicator Lights................................................................................. 32
5.3 Control Panel ................................................................................... 33
5.4 Turning On the Device .....................................................................33
5.5 Turning Off the Device .....................................................................34

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5.6 Main Menu ....................................................................................... 34
5.7 Testing Procedure............................................................................ 34
5.8 Interpreting Test Results..................................................................40
5.9 Managing Test Results.....................................................................44
5.10 Settings......................................................................................... 47
6Technical Data..............................................................................................59
6.1 ERO•SCAN®Hardware....................................................................59
6.2 Pin Assignment................................................................................64
6.3 Electromagnetic Compatibility.......................................................... 65
6.4 Electrical Safety, EMC and Associated Standards...........................68
6.5 Configurations and Test Protocols................................................... 69
6.6 Flowcharts........................................................................................70

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Title: Operation Manual ERO•SCAN®Screening and Diagnostic Version
Date of issue/last revision: 13/08/2020
MAICO Diagnostics GmbH
Sickingenstr. 70-71
10553 Berlin
Germany
Tel.: + 49.30.70 71 46-50
Fax: + 49.30.70 71 46-99
E-mail: [email protected]
Internet: www.maico.biz
Copyright © 2020 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. The information
in this publication is proprietary to MAICO.
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
ERO•SCAN®is a U.S. registered trademark of Etymotic Research, Inc.
HearSIMTM is an unregistered trademark of OtoAccess A/S for use in the USA.
OtoAccess is a trademark of OtoAccess A/S registered in the USA and Europe.
Sanibel Supply®is a trademark of Interacoustics A/S registered in the USA and
Europe.

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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 Statement
The ERO•SCAN®Hearing Test System is indicated for testing of cochlear function in
infants, children, and adults by measuring otoacoustic emissions (OAEs). This
instrument is suitable for use in all settings, including hospitals, schools, physician's
offices, and audiologist practices. Factory defined protocols allow for simple screening
measurements and user customizable protocols allow for diagnostic evaluations. The
ERO•SCAN®is intended to be used by hearing healthcare professionals (i.e. ENT
doctors, audiologists) and/or technicians, neonatal nurses and school nurses who have
been trained by a hearing healthcare professional.
1.2 Indications for Use Statement
The OAEs are generated by a series of clicks that are directed into the ear canal.
Otoacoustic emissions are low level audio-frequency sounds that are produced by the
cochlea as part of the normal-hearing process. Available evidence suggests that
otoacoustic emissions are generated by the cochlea’s outer hair cells and that the
presence of OAEs is an indication that the outer hair cells are viable. Clinical evidence
indicates that these emissions normally occur with normal hearing, or at most, mild
hearing loss (usually 30-40 dB HL). The majority of hearing-impaired individuals will
be identified by a simple OAE test.
1.3 Contraindications of Use Statement
Testing should not be performed on patients with one of the following symptoms
without a medical doctor’s approval:
•Recent stapedectomy or other middle ear surgery
•Discharging ear
•Acute external auditory canal trauma
•Discomfort (e.g. severe otitis externa)
•Occlusion of the external auditory canal
Visual inspection for obvious structural abnormalities of the external ear structure and
positioning as well as the external ear canal should be performed before testing.

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1.4 Features
1.4.1 General Information About the ERO•SCAN®
The ERO•SCAN®features:
•Screening and diagnostic measurements with TEOAE and/ or DPOAE
•Fast automatic OAE screening with Pass/Refer results and graphical displays
•2 predefined protocols for screening version, 5 DP and 3 TE protocols for
diagnostic devices
•High noise immunity for operation in normal clinical environment
•Lightweight, small ear probe
•Sharp, colored OLED display
•Wireless printing
•Various software solutions available
1.4.2 Licenses
The ERO•SCAN®is available in versions (each with or without printer):
•ERO•SCAN®Screener DPOAE
•ERO•SCAN®Screener TEOAE
•ERO•SCAN®ScreenerDPOAE+TEOAE(2DPand2TEprotocolswithfixparameters)
•ERO•SCAN®Diagnostic DPOAE
•ERO•SCAN®Diagnostic TEOAE
•ERO•SCAN®Diagnostic DPOAE + TEOAE (5 DP and 3 TE protocols (4 DPOAE
and 2 TEOAE are customizable)
1.4.3 Printing Options
Printing test results from the ERO•SCAN®is accomplished in a variety of ways:
•Print directly from ERO•SCAN®using the optional wireless label printer that is
available from MAICO.
•Transfer test data into a PC Software and print results using your standard
printer attached to the PC.
1.4.4 PC-Software
The ERO•SCAN®can be connected to the following PC software:
•MAICO Sessions Standalone
•MAICO Sessions with OtoAccess®Database
•MAICO Sessions with Noah Database
•MAICO Sessions with your existing Practice Management Software via GDT or
XML interface
•HearSIMTM Software with OtoAccess®Database (ERO•SCAN® Screener only)

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1.5 Description
1.5.1 General
The purpose of the ERO•SCAN®test system is to provide a rapid measurement and
documentation of Distortion Product Otoacoustic Emissions (DPOAEs) or Transient
Evoked Otoacoustic Emissions (TEOAEs) at several frequencies.
The ERO•SCAN®is available as a Screening or Diagnostic version.
1.5.2 TEOAE
Transient Evoked Otoacoustic Emissions (TEOAE) technology uses a click stimulus to
screen patients’ ears for cochlear hearing loss. The emissions are clearly related to
the stimulus and therefore can be measured via a sensitive microphone placed in the
patient’s ear canal. The responses can be divided into frequency bands for
assessment.
1.5.3 DPOAE
Distortion product otoacoustic emissions (DPOAE) technology uses pairs of pure tones
presented in sequence to screen patients for cochlear hearing loss. The emissions are
clearly related to the stimulus and therefore can be measured via a sensitive
microphone placed in the patient’s ear canal.
1.5.4 Sensitivity and Specificity
Sensitivity 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. The presence of otoacoustic emissions suggests normal outer hair cell
function, which in turn correlates to normal hearing. However, a passing result using
this device is not an indication that the full auditory system is normal. Thus, a PASS
result should not be allowed to override other indications that hearing is not normal. A
full audiologic evaluation should be administered if concerns about hearing sensitivity
persist. A REFER test result should not be assumed to be an indicator of a lack of
auditory function, however, it should be followed with full audiologic diagnostic testing.

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2 For Your Safety
This Section offers you important information about:
▪how to read the operation manual
▪where to spend special attention
▪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 Reading this Operation Manual
This operation manual contains information pertinent to the use of the ERO•SCAN®
system including safety information as well as maintenance and cleaning
recommendations.
It is highly recommended that users read the operation manual in its entirety prior to
use of the ERO•SCAN®device on a patient.
READ THIS ENTIRE OPERATION MANUAL BEFORE ATTEMPTING
TO USE THIS SYSTEM!
Use this device only as described in this operation manual.
All images and screenshots are only examples and may differ in
appearance from the actual device settings.
In this 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
The information sign displays alternative documents or sections
in this operation manual that provide more detailed information.
NOTE: Notes help you identifyareas 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.
Section 3.2
Maintenance
Section 3.3
Cleaning and Disinfection Recommendations
Breach of the customer responsibility can lead to limitations of Manufacturer’s
Liability and Warranty.
Section 2.3
Manufacturer’s Liability
Section 3.1
Warranty
NOTE: In the unlikely case of a serious incident, inform MAICO as well as the
competent authority of the Member State in which the user and/or the patient 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
Information sign (reference for more detailed information)
Return to authorized representative, special disposal required
Reference number
Medical Device
Global Trade Item Number
Patient applied part type B according to IEC 60601-1
Refer to operation manual (mandatory)
Keep away from rain
Transport and storage temperature range
Transport and storage humidity limitations
Transport and storage atmospheric pressure limitations
Voltage transformer
Do not reuse
Conforms to European Medical Device Directive 93/42/EEC
FCC marking with ID
Non-ionizing electromagnetic radiation
Label Marking of Radio Equipment based on Certified Type
Direct Current (DC)
ETL listed mark
Underwriters Laboratories, Inc. Label
Logo
REF

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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.
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.
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 parts of the equipment can be serviced or maintained
while in use with the patient.
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.
Thelistofaccessories,transducersandcablescanbefoundin:
Section 6.3
Electromagnetic Compatibility
Do not immerse the device in any fluids. Should the user
suspect fluids have contacted the system components or
accessories, the device should not be used until deemed
safe by a MAICO certified service technician.
2.6 Electrical and Electrostatic Safety
This device complies with part 15 of the FCC Rules. Operation is subject to the
condition that this device does not cause harmful interference
This icon indicates that patient applied parts of the device
conform to IEC 60601-1 Type B requirements.
The system is internally powered.
In Case of Emergency
In case of emergency, disconnect the device from the
computer.
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING

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In Case of Emergency
In case ofemergency,disconnectthedevicefrompowersupply.
Position the device in such a way that it can be easily
disconnected from the USB cable at any time.
Do not use the device if the mains cable and/or the plug is
damaged.
To transferdatatoaPC,establishing aPC-connectionviaUSB
is required.
To learn how to safely establish a connection with a power
supplied PC or laptop (medical device/non-medical device) or
to a battery-driven laptop see:
Section 4.5
Establishing a PC-Connection
This equipment is intended to be connected to other equipment
thus forming a Medical Electrical System. External equipment
intended for connection to signal input, signal output or other
connectors shall comply with the relevant product standard e.g.
IEC 60950-1 for IT equipment and the IEC 60601-series for
medical electrical equipment. In addition, all suchcombinations
–Medical Electrical Systems –shall comply with the safety
requirements stated the general standard IEC 60601-1, edition
3, clause 16. Any equipment not complying with the leakage
current requirements in IEC 60601-1 shall be kept outside the
patient environment i.e. at least 1.5 m from the patient support
or shall be supplied via a separation transformer to reduce the
leakagecurrents.Anypersonwhoconnectsexternalequipment
to signal input, signal output or other connectors has formed a
Medical Electrical System and is therefore responsible for the
system to comply with the requirements. If in doubt, contact
qualified medical technician or your local representative. If the
device is connected to a PC (IT equipment forming a system)
ensure not to touch the patient while operating the PC. Do not
touch the patient and the printer at the same time.
If the device is connected to a PC (IT equipment forming a
system) assembly and modifications shall be evaluated by
qualified medical technician according to safety regulations
in IEC 60601.
The consequence of not following this warning could be a
too high leakage current to the patient.
Do not touch the contacts on the bottom of the device and
the patient at the same time. When connected to computer
equipment do not simultaneously touch the computer
equipmentandthepatientatthesame time.Theconsequence
could be a too high leakage current to the patient.
WARNING
WARNING
WARNING

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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. If the device is not used switch it
off and disconnect it from the power supply.
Never short-circuit the terminals.
To avoid the risk of electric shock, this equipment must only
be connected to the medical power supply originally
delivered by MAICO. Using another power supply can also
lead to electrical damage on the device.
Prevent cable breakage: cables must not be bend or buckled.
Before performing any service to the insert earphones, such
as disconnecting the transducer boxes from the cable, you
must uncouple the ERO•SCAN®transducers and electrodes
from the patient.
Do not open the case of the ERO•SCAN®device. Refer
servicing to qualified personnel.
2.7 Electromagnetic Compatibility (EMC)
The device fulfills the relevant EMC requirements. Avoid
unnecessaryexposuretoelectromagneticfields,e.g.frommobile
phones etc. If the device is used adjacent to other equipment it
must be observed that no mutual disturbance appears.
Also refer to EMC consideration in:
Section 6.3
Electromagnetic Compatibility
The ERO•SCAN®has been verified by an independent
laboratory to conform to international standards for EMC
(electromagnetic emissions and immunity). The user is advised
to avoid installation and use of this device in proximity with other
devices or equipment that may emit or be susceptible to
electromagnetic interference, including mobile phones. If the
device is used adjacent to other devices or equipment, the user
is instructed toverifythatnodisturbance isfound inthe operation
of this or other equipment in proximity. It may be necessary to
take mitigation measures, such as reorienting or relocating
the ERO•SCAN®or shielding the location.
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING

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2.8 Battery Safety and Capacity
2.8.1 Battery Safety
Explosion hazard
The internal battery must be only replaced by an authorized
service representative. Damage to the electronics resulting
from an attempt to change the battery by someone other
than an authorized representative will not qualify for repair
under the product warranty.
2.8.2 Battery Capacity
The capacity of the battery will degrade over time with repeated charging/discharging
cycles. The need to replace the battery due to diminishing capacity depends on usage
patterns.
To extend battery capacity, do not allow the battery to fully discharge. To learn how to
charge the device correctly see:
Section 4.4
Battery Charging
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
▪accessory and replacement parts
▪recycling and disposal of the device
3.1 Warranty
The MAICO ERO•SCAN®is guaranteed for at least one year.
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 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 voids 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 once 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.

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3.3 Cleaning and Disinfection Recommendations
3.3.1 General
It is recommended that parts (device and accessories like probe tips) 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.
If there is not a high infection potential, MAICO recommends:
•Before cleaning always switch off anddisconnect the device from power supply.
•Remove disposable eartips or probes prior to disinfection.
•For cleaning use a lightly dampened cloth with soap water solution.
•Disinfect the plastic housing of the ERO•SCAN®and its accessories by wiping
the surfaces with wet disinfection wipes. Follow the instructions on the specific
disinfection product.
•Wipe before and after each patient
•After contamination
•After infectious patients
To avoid damage of the device and its accessories, please
mind the following:
•Do not autoclave or sterilize the device or probes.
•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 device should not be used
until deemed safe by a MAICO certified service technician.
Do not use hard or pointed objects on the device or its
accessories.
For more detailed cleaning recommendations see the following Sections and follow the
instructions on the items that are relevant for your system.
NOTE: Long-term exposure to any disinfecting agents has the potential to alter the
material properties of the plastic housing and labeling of the device
Always follow the safety and disposal guidelines given by the manufacturer of cleaning
and disinfectant chemicals.
CAUTION

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3.3.2 Cleaning and Disinfecting the Screen
Use a lens cleaning or microfiber cloth to clean the screen.
Disinfect the screen of the device by wiping the surfaces with wet disinfection wipes.
3.4 Disposables –Eartips
3.4.1 Safe Use of Eartips
Figure 1
Operating the ERO•SCAN®requires the use of eartips (Figure 1)
and probe tubes.
Eartips and probe tubes are intended for single-use only. They
must be discarded after use. They cannot be cleaned.
If you use the same eartips for different patients you enhance
the risk of bacterial cross-contamination which can cause
serious infections!
Replace the eartips with unused ones at the end of each
patient's examination and discard the used ones.
IMPORTANT NOTE: All disposable supplies included with the ERO•SCAN®are
produced by Sanibel Supply®. The system has only been tested using disposables
supplied by Sanibel Supply®. Use of other supplies could alter the behavior and results
obtained with the device and is not recommended. Sanibel disposables are latex,
DsEHP and BPA free and have been tested for bio-compatibility. Data sheets are
available upon request.
1
WARNING

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3.4.2 Applying Eartips
The ERO•SCAN®comes with a box of disposable eartips that fit a variety of ear canal
sizes. The probe tubemust have an eartip attached before inserting itinto an ear canal.
NOTE: See Section 5.7.2 on how to properly insert a probe into the patient’s ear canal.
Figure 2
Choose an eartip that is appropriate for the patient's ear
volume.
Push the eartip onto the probe tube until it is flush against
the base of the probe tube (Figure 2). Twisting the eartip
slightly while pushing it onto the probe is recommended.
Be sure the eartip is fully seated on the probe.
Figure 3
There shall be no gaps between the eartip and the collar
of the probe head (Figure 3).
3.4.3 Removing Eartips
Figure 4
In order to remove the eartip, grasp the eartip at the base
using the eartip removal tool and pull it smoothly straight
off the probe tube (Figure 4). If you do not have a Removal
tool, grasp the eartip at the base with your fingers and twist
it while pulling off the probe tube. Grasping the base of the
eartip will prevent the probe tube from being inadvertently
pulled out of the probe head along with the eartip.
3.5 Disposables –Probe Tubes
3.5.1 Safe Use of Probe Tubes
If you use the same probe tube for different patients you enhance
the risk of bacterial cross-contamination which can cause serious
infections!
Replace the probe tube with an unused one at the end of each
patient's examination, and discard the used one.
If the probe tube is re-used after it was removed from the probe it
can damage the probe head since it will not sit as tight as before.
CAUTION
WARNING

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3.5.2 Probe Tube Removal
Use the Probe Tube Removal Tool for replacement of probe tubes.
Figure 5
Figure 6
1. Place the front hole of the Probe Tube Tool over
the end of the probe, as shown. The probe should
be seated against the face of the tool and snap in
place.
2. Squeeze the tool closed and hold it.
3. Twist the tool a couple of times while holding the
tool closed and pulling away from the probe(Figure
5).
4. The probe tube will pull out from the probe. Discard
the probe tube (Figure 6).
3.5.3 Applying a New Probe Tube
Figure 7
Figure 8
1. Place a new tube into the hole on the top of the tool.
2. Align the probe with the probe tube (Figure 7).
3. Push the probe onto the probe tube until the probe
contacts the face of the probe tube tool and a
snapping sound is heard (Figure 8).
4. Slide the tool off leaving the tube in place in the
probe.
3.6 Troubleshooting
If problems occur while working with your ERO-SCAN®, you can usually easily solve
them yourself. Follow the instructions in Table 2 for general problems or Table 3 if
display messages are shown.
Contact MAICO for service if a problem persists.